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CLONING: A RISK TO WOMEN?

HEARING

BEFORE THE

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY AND 

SPACE

OF THE

COMMITTEE ON COMMERCE, 

SCIENCE, AND TRANSPORTATION 

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

MARCH 27, 2003

Printed for the use of the Committee on Commerce, Science, and Transportation

(

(II)

SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

JOHN MCCAIN, Arizona, Chairman 

TED STEVENS, Alaska 

CONRAD BURNS, Montana 

TRENT LOTT, Mississippi 

KAY BAILEY HUTCHISON, Texas 

OLYMPIA J. SNOWE, Maine 

SAM BROWNBACK, Kansas 

GORDON SMITH, Oregon 

PETER G. FITZGERALD, Illinois 

JOHN ENSIGN, Nevada 

GEORGE ALLEN, Virginia 

JOHN E. SUNUNU, New Hampshire 

ERNEST F. HOLLINGS, South Carolina 

DANIEL K. INOUYE, Hawaii 

JOHN D. ROCKEFELLER IV, West Virginia 

JOHN F. KERRY, Massachusetts 

JOHN B. BREAUX, Louisiana 

BYRON L. DORGAN, North Dakota 

RON WYDEN, Oregon 

BARBARA BOXER, California 

BILL NELSON, Florida 

MARIA CANTWELL, Washington 

FRANK LAUTENBERG, New Jersey 

JEANNE BUMPUS, Republican Staff Director and General Counsel 

ROBERT W. CHAMBERLIN, Republican Chief Counsel 

KEVIN D. KAYES, Democratic Staff Director and Chief Counsel 

GREGG ELIAS, Democratic General Counsel 

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE 

SAM BROWNBACK, Kansas, Chairman 

TED STEVENS, Alaska 

CONRAD BURNS, Montana 

TRENT LOTT, Mississippi 

KAY BAILEY HUTCHISON, Texas 

JOHN ENSIGN, Nevada 

GEORGE ALLEN, Virginia 

JOHN E. SUNUNU, New Hampshire 

JOHN B. BREAUX, Louisiana 

JOHN D. ROCKEFELLER IV, West Virginia 

JOHN F. KERRY, Massachusetts 

BYRON L. DORGAN, North Dakota 

RON WYDEN, Oregon 

BILL NELSON, Florida 

FRANK LAUTENBERG, New Jersey 

(III)

C O N T E N T S 

Page 

Hearing held on March 27, 2003 ............................................................................ 1

Statement of Senator Brownback ........................................................................... 1

WITNESSES

Bruchalski, Dr. John T., Obstetrician and Gynecologist, Fairfax, Virginia ........ 3

Prepared statement .......................................................................................... 7

Bustillo, Dr. Maria, Director, Assisted Reproductive Technologies, South Florida Institute for Reproductive Medicine ............................................................. 9

Prepared statement .......................................................................................... 12

Charo, R. Alta, J.D., Associate Dean, Professor of Law and Bioethics, University of Wisconsin Law and Medical Schools ....................................................... 25

Prepared statement .......................................................................................... 27

Doerflinger, Richard M., Deputy Director, Secretariat for Pro-Life Activities, 

U.S. Conference of Catholic Bishops .................................................................. 36

Prepared statement .......................................................................................... 40

Kimbrell, Andrew, Executive Director, International Center for Technology 

Assessment ........................................................................................................... 29

Prepared statement .......................................................................................... 33

Landrieu, Hon. Mary L., U.S. Senator from Louisiana ........................................ 18

Millican, Lynne, R.N., B.S.N., Paralegal, Boston, Massachusetts ....................... 48

Prepared statement .......................................................................................... 50

APPENDIX

Wyden, Hon. Ron, U.S. Senator from Oregon, prepared statement .................... 99

Response to written questions submitted by Hon. Frank Lautenberg to Richard M. Doerflinger ................................................................................................ 99

Prepared statements on the risks of Lupron usage: 

Kimberly Bradford ............................................................................................ 100

Melody Hampton .............................................................................................. 106

Susan Hayward ................................................................................................ 106

Lisa A. Plante ................................................................................................... 110

Melanie Waldman ............................................................................................. 110

J. Wolf ............................................................................................................... 111

(1)

CLONING: A RISK TO WOMEN? 

THURSDAY, MARCH 27, 2003

U.S. SENATE, SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE, COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION, Washington, DC. 

The Subcommittee met, pursuant to notice, at 9:35 a.m. in room 

SR–253, Russell Senate Office Building, Hon. Sam Brownback, 

Chairman of the Subcommittee, presiding. 

OPENING STATEMENT OF HON. SAM BROWNBACK,

U.S. SENATOR FROM KANSAS 

Senator BROWNBACK. Good morning. The hearing will come to 

order. Today, we will conduct our second hearing in this Subcommittee on the issue of human cloning. We particularly want to 

try and better understand whether or not human cloning for socalled ‘‘therapeutic purposes’’ poses a risk to women’s health. That 

will be the question we will examine today. 

Many of the proponents of human cloning claim that a cure to 

many of the diseases that plague humanity lies just around the 

corner. In this hearing, we will examine some of these claims and 

also what would have to happen in order for these claims to be realized. 

First, we should start with a few definitions. The bipartisan 

Human Cloning Prohibition Act of 2003, S. 245, sponsored by myself and Senator Landrieu, defines ‘‘human cloning’’ as human 

asexual reproduction that is accomplished by introducing nuclear 

material from one or more human somatic cells into a fertilized or 

unfertilized oocyte, or human egg, whose nuclear material has been 

removed or inactivated so as to produce a living organism at any 

stage of development that is genetically virtually identical to an existing or previously existing human organism. 

The definition is very important. The fusion of the somatic cell 

and the oocyte creates a human embryo that is genetically identical 

to the somatic cell donor. This genetic match is what proponents 

of human cloning claim will solve the immune-response rejection 

problem and will provide treatment to millions of people. 

This hearing will examine what would be necessary in order to 

realize the promise held out to those suffering by those who are advocating human cloning as a means to cure the diseases that 

plague humanity. And clearly, we all want to see a cure for these 

horrible diseases. 

However, it is clear that in order to be effective, ‘‘therapeutic’’ 

cloning must rely on the collection of a vast number of human eggs. 

2

In order to conduct so-called ‘‘therapeutic cloning’’ on the scale that 

would yield just a portion of the benefit that the advocates promise, 

one would need to harvest a vast number of human eggs from 

women of childbearing age. Dr. David Stevens estimates that—and 

this is a quote from him—‘‘To get enough eggs to seek clone cures 

for these four diseases’’—just four diseases—‘‘ALS, Parkinson’s, 

Alzheimer’s, and diabetes, every woman in the U.S. aged 18 to 44—

that is approximately 55 million—would have to endure two cycles 

of ovarian hormone hyperstimulation and then undergo surgery.’’

The ‘‘egg dearth’’ is a mathematical certainty. It is one reason 

why some researchers say that therapeutic cloning will not be generally available as a medical treatment. 

Recently, biotech researchers, John Odorico, Dan Kaufman, and 

James Thompson, admitted the following in the research journal, 

Stem Cells, and stated this, ‘‘The poor availability of human oocytes, or eggs, the low efficiency of the nuclear cell procedure, and 

the long population doubling time of human ES cells make it difficult to envision this—therapeutic cloning—becoming a routine 

clinical procedure, even if ethical considerations were not a significant point of contention.’’ 

Perhaps this is what led Dr. Thomas Okarma, Chief Executive 

of Geron Corporation, to state that it would take, quote, ‘‘thousands 

of human eggs on an assembly line’’ to produce a custom therapy 

for a single person. He then goes on, ‘‘This process is a nonstarter, 

commercially.’’

Concerns such as these, as well as others, have led a group of 

progressive activists, many of whom support abortion rights, to 

state in their letter of support for a ban on all human cloning that, 

‘‘Although we may differ in our views regarding reproductive 

issues, we agree that a human embryo should not be cloned for the 

specific intention of using it as a resource for medical experimentation or for producing a baby. Moreover, we believe that the market for eggs, women’s eggs, that would be created by this research 

will provide unethical incentives for women to undergo healththreatening hormone treatment and surgery. We are also concerned about the increasing bio-industrialization of life by the scientific community and life science companies, and shocked and dismayed that clonal human embryos have been patented and declared to be human, ‘inventions.’ ’’

As I am sure many of our witnesses are already aware, and as 

many in this audience already know, the typical in vitro fertilization procedure involves the collection of eggs from women who seek 

to become pregnant in this manner. The market for these eggs is 

already developing. In fact, it is now known that Advanced Cell 

Technology of Massachusetts, the pioneers in human cloning, paid 

women up to $4,000 per egg donation. Such a market for women’s 

eggs will clearly be a threat to the health of many women. That 

women undergo the health risks associated with egg donation for 

the purpose of having children is one thing; but that they would 

be induced by some to undergo this health risk for money is another matter. 

I am hopeful that we can use this hearing to better understand 

the threats posed to women and whether or not this is a route we 

should even consider. But more importantly, I am growing increasVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
3

ingly concerned that some of the proponents of human cloning are 

holding out the hope for a cure as a tool to build support for a morally dubious enterprise. 

In the past, we have heard that fetal tissue research held the 

cure to the whole host of dread diseases that plague humanity. To 

date, we have met only with failure upon failure from fetal tissue 

research. Almost five years ago, we heard that human embryonic 

stem cell research held the cure. In fact, at one hearing Senator 

Specter asked Dr. James Thompson, ‘‘Illustrative for Parkinson’s 

now, for Parkinson’s, how long for a cure?’’ And Dr. Thompson’s response, ‘‘Parkinson’s? I am going to say five to ten years more. It 

will be one of the first ones.’’ This December marks five years since 

he made that statement, and, to date, there is no cure for Parkinson’s from human embryonic stem cells in sight. 

I want to fight for a cure to Parkinson’s disease. I want to see 

cures. I want to see us going routes and ways that we can get 

there. I want to get to the bottom of this, but we cannot continue 

to play with people’s hopes. 

Finally, I would like to note, with some satisfaction, that we are 

making some clear progress on the issue of human cloning. The 

Governor of Arkansas signed a bill very similar to S. 245, the bipartisan Human Cloning Prohibition Act of 2003, into law earlier 

this week. The State Senate of North Dakota voted, 46 to zero, yesterday to approve similar legislation, the State House in North Dakota having already voted, 90 to one, to approve the same legislation. There is a movement taking place across the board in a number of states. 

We want to examine this, in particular, regarding women’s 

health. And with that, I want to call up the first panel to testify 

here today. And if you would come forward. I think Senator 

Landrieu may be coming up later on. But the first panel of Dr. 

John Bruchalski, from Fairfax, Virginia, Dr. Maria del Carmen 

Bustillo, from Miami, Florida, and I think Lynne Millican called in 

earlier, sick, so I do not know if she has been able to arrive yet 

or not, apparently not. So we’ll proceed with the two of you as the 

first panel. 

I very much appreciate your attendance and your presentations. 

I will be happy to take your full written statement into the record 

and allow you to summarize, if you would like to; or if you would 

like to present that full statement, that would be fine, as well. 

Dr. Bruchalski, I am sure I butchered your name. Would you 

give me the correct pronunciation? 

Dr. BRUCHALSKI. Bruchalski. 

Senator BROWNBACK. Bruchalski. I was making too much of it. 

I apologize for that. 

Dr. Bruchalski, the floor is yours. Thank you very much for joining us here today. 

STATEMENT OF DR. JOHN T. BRUCHALSKI, OBSTETRICIAN 

AND GYNECOLOGIST, FAIRFAX, VIRGINIA 

Dr. BRUCHALSKI. Thank you, Senator, and good morning. 

The tragic human backdrop to this Senate hearing is the very 

real and painful reality that one in six women of reproductive age 

4

will seek professional help during their lifetimes because of infertility. 

I come before you today because of my personal experience as an 

obstetrical and gynecologic resident from 1987 to 1991 at the Norfolk Medical Program, the home of the Jones Institute for Reproductive Medicine. It is the American infertility center that not only 

successfully produced America’s first in vitro child, but was also 

the center that coined the term ‘‘pre-embryo’’ while I was there. 

And because of what I have learned in the last dozen years as 

a practicing obstetrician and gynecologist, I want to focus my remarks to the very real issues of egg donation in the cloning process, otherwise termed ‘‘human somatic cell nuclear transfer,’’ and 

their detrimental impact on women. 

To appreciate this deleterious effect and the massive scope of this 

risk to women, I would just like to briefly review the cloning process. An egg is surgically, usually transvaginally, taken from the 

hormonally treated woman’s ovary. The nucleus is removed from 

that egg, and a somatic nucleus from the individual to be cloned 

is transferred into an empty egg and fused with electric current. 

Then development occurs through the morula stage when the preembryo is screened for gene expression and imprinting defects. 

This is done until the blastocyst stage, when it is implanted into 

the woman’s uterus. 

However, this process is quite fragile, that despite having cloned 

five animal species, we hypothesize the need for hundreds, if not 

thousands, of eggs to be obtained for each clone to be used to treat 

the mentioned diseases of Parkinson’s, Alzheimer’s, and diabetes, 

to name a few. 

Where and how and from whom are these eggs to be obtained? 

We need look no further than our present IVF data. If IVF donors 

average 10 to 15 eggs retrieved per hyper-stimulated cycle and 

each patient with Parkinson’s disease needs 50 to a hundred eggs 

to clone to obtain stem cells, for the 1 million people with Parkinson’s disease, 50 million eggs would be required to be retrieved 

from possibly 5 million egg donors. For the 17 million people with 

diabetes, 850 million eggs would be required, and, subsequently, 85 

million egg donors needed. 

To obtain these eggs, we must turn to drugs and/or to donors. 

But remember, the success of cloning in the IVF process used rests 

literally on the bodies of the women experimented on. IVF was successful in humans before it was successful in animals. ICSI, 

intracytoplasmic sperm injection, an assisted reproductive technology used in up to 40 percent of all cycles now was successful in 

humans before it was successful in animals. There appears to be 

a fuzzy boundary between research and treatment when it comes 

to those women undergoing these processes. 

Our reproductive industry is not enveloped by a coherent, whole, 

regulatory framework. The drugs are regulated by the FDA without 

long-term data, and the process of mixing sperm and egg together 

in any way in combination is not regulated at all. The natural progression of research is to do experiments in cell cultures in animal 

models to look at safety issues first and whether these experiments 

are effective. Then, after you have this data, you move on to humans, specifically women in the case of this reproductive techVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
5

nology. This has not happened with the reproductive technologies 

up until now, and this is my concern. 

Institution review boards that are found in hospitals are only required for research in federally backed institutions or for FDA-regulated products. And ART has been largely privately funded. 

The Genetics and Public Policy Center at Johns Hopkins Hospital University is beginning to look into this travesty. Women 

have borne the positive and negative effects of being experimented 

on through the years of IVF, and now it appears the same with 

cloning. 

Kathy Hudson, who is the director of the above-mentioned institute at Hopkins said, ‘‘Scientifically, there are some unanswered 

questions about the long-term consequences those drugs might 

have on women. There are questions about whether they lead to 

the production of unhealthy eggs and whether they pose a cancer 

risk to the mother. That is an area that we, at the center, hope to 

examine.’’

Drugs such as Fertinex, Gonal-F, Pergonal, Cetrotide, and 

Lupron are all to be under review. Significant headaches, abdominal swelling, abdominal pain are some of the more common side 

effects. And since we have now had a plateau in the success of IVF 

procedures, we are now beginning to look into other user-friendly 

protocols that have fewer side effects. 

In 2002, alone, at least 12 studies in articles in peer-review journals suggest a potential link between these reproductive technologies and birth defects, like heart defects and genetic diseases, 

childhood cancers, decreased cognition, and others. We truly do not 

know whether it is due to the nature of the problems of infertility 

or due to the drugs and the procedures of assisted reproduction. 

The fertility drug-cancer link refers to ovarian stimulation in 

ovarian cancer. The initial Whittemore study, a meta-analysis of 12 

case-controlled studies on ovulation induction seemed to show a 27-

fold increased odds ratio for developing ovarian cancer, even 

though some of the analysis was determined to be flawed. Later, 

the Rossing study reported a similar association between the drugs 

of ovulation and ovarian cancer. 

This alleged increased risk of ovarian cancer in patients using 

ovulation-inducing agents is very disturbing, and a consensus 

among our American Fertility Society recommends that women 

who are considering the use of fertility drugs should be told that 

there is a possibility of increased risk and should be given alternatives. But at this point, there is no data overall to support discontinuing or changing these ovulation-induction procedures. Two 

small numbers, detection bias and recall bias, were all used to statistically support their conclusions. 

These drugs also have spurred the profound rise in multiple 

births—twins, triplets, and above. In the year 2000, 35 percent of 

ART births were multiples, and their higher risks for birth defects 

and low birth weight and added healthcare costs are a significant 

psychological burden for women, not to mention the process of selection reduction where the infertile woman is faced with the decision to terminate one of her fetuses to improve outcome. 

Now, the other approach to obtain eggs is to seek a donor, a 

woman who is willing to donate her eggs for the cloning process. 

6

Again, we can look to in vitro experience for what to expect in the 

cloning scenario. Last month, experts in the United Kingdom publicly questioned whether such selfless acts are justified given the 

health risks they may face in later life. These women are paid between 1,500 to 3,500 American dollars, or 4,000 to 5,000 British 

pounds, oftentimes going to the highest bidder over the Internet. 

A prominent physician at a London IVF clinic, citing the unknown long-term effects and the possible cancer risks, says that 

they cannot duck this issue any longer for their donor egg patients. 

However, the British Human Fertilization and Embryology Authority says it has no plans to review the system for egg donation. 

On this side of the Atlantic, it is illegal to buy or sell human 

body parts, except eggs. In 1999, we transferred more than 8,000 

embryos produced from fresh or frozen donated eggs into the uteri 

of women, according to the American Society for Reproductive Medicine. Ads placed in campus newspapers dangling tens of thousands 

of dollars before women with the right pedigree of looks, talent, 

and SAT scores is the method for attracting these precise donors. 

For a month, the woman turns over her body to the process of 

superovulation with the above-mentioned agents and the harvesting procedure of transvaginal aspiration. One out of a hundred 

will develop the hyperstimulation syndrome, which includes ascites, pulmonary overload, and sometimes hospitalization. One Stanford woman recently even had a stroke while being treated for egg 

donation. 

The psychological component of this process is being questioned. 

‘‘Are we leading them to make a decision that later in life they may 

regret? The money will be spent, and, in the end, she will have 

given up her genetic child forever. We have to really care about 

these women.’’

So, in conclusion, I agree that the problem of infertility is quite 

enormous and that we have made great strides since the late 1970s 

and early 1980s. However, my profession has recently seen the 

data on the benefits of menopausal hormonal therapy crumble in 

less than a year while listening to all the angst and betrayal spoken of by my older patients who have taken these hormonal therapies. 

After considerable pressure, my alma mater, despite private 

funding, decided to stop creating human embryos specifically for 

stem cell research this past January. That is the Jones Institute. 

They were the first institute in the world to make human embryos 

for research and then to destroy them after harvesting the stem 

cells. We perfected ART in humans before we did it in animals, 

using women as research subjects and treatment end points. There 

was no animal data before IVF and ICSI were done in humans. 

In 1993, the award-winning prized paper at the conjoined meeting of the American and Canadian Fertility Societies came out of 

George Washington University and Dr. Hall. Seventeen abnormal 

human embryos were taken and multiplied to obtain 48 embryos. 

Two embryo clones developed to the 32-cell stage before the procedure was stopped. This was done in 1993 and presented at that 

conference and received the top prize. 

I come before this Committee, and I urge this Subcommittee to 

see cloning as another risk to women. 

7

Thank you very much. 

[The prepared statement of Dr. Bruchalski follows:]

PREPARED STATEMENT OF DR. JOHN T. BRUCHALSKI, OBSTETRICIAN AND

GYNECOLOGIST, FAIRFAX, VIRGINIA

Introduction 

Good morning. The tragic human backdrop to this Senate hearing is the very real 

and painful reality that one in six women of reproductive age will seek professional 

help during their lifetimes because of infertility. 1 I come before you today because 

of my personal experiences as an obstetrical and gynecologic resident from 1987 to 

1991 at the Norfolk medical program that houses the Jones Institute for Reproductive Medicine, the preeminent, American infertility Center that not only successfully 

produced America’s first in vitro child, but also the Center that coined the term 

‘‘pre-embryo’’ while I was there; and because of what I have learned in the last 

dozen years as a practicing obstetrician and gynecologist I want to focus my remarks to the very real issues of egg donation in the cloning process, (human somatic 

cell nuclear transfer), and their detrimental impact on women. 

Cloning’s Abuse of Women: Issues With Egg Donation 

To appreciate the deleterious effects and the massive scope of this risk to women, 

let’s briefly review the cloning process. An egg is surgically, usually transvaginally, 

taken from the hormonally treated woman’s ovary. The nucleus is removed from the 

egg, and a somatic nucleus from the individual to be cloned is transferred into the 

empty egg and fused with electric current. Then development occurs through the 

morula stage when the pre-embryo is screened for gene expression and imprinting 

defects, until the blastocyst stage (64 to 200 cell stage) when it is implanted into 

the woman’s uterus. 2

However, this process is so fragile that despite having already cloned five animal 

species, we hypothesize the need for hundreds, if not thousands of eggs to be obtained for each clone to be used to treat the mentioned diseases of ALS, Parkinson’s, 

Alzheimer’s and diabetes. Where and how and from whom are these eggs to be obtained? We need look no further than our present IVF data. If IVF donors average 

10 to 15 eggs retrieved per hyper-stimulated cycle presently, and each patient with 

Parkinson’s Disease need 50 to 100 eggs to clone, to obtain stem cells; for the one 

million Parkinson patients, 50 million eggs would be required to be retrieved, from 

possibly 5 million egg donors. For the 17 million with diabetes, 850 million eggs 

would be required, and subsequently, 85 million egg donors needed. 3

To obtain these eggs we must turn to drugs and/or to donors, but remember, the 

success of cloning and the IVF processes used rests literally on the bodies of the 

women experimented on. IVF was successful in humans before it was successful in 

animals. ICSI, an assisted reproductive technology, used in up to 40 percent of all 

cycles, was successful in humans before it was successful in animals. There is a 

fuzzy boundary between research and treatment when it comes to those women undergoing these processes. 4 Our reproductive industry is not enveloped by a coherent, whole regulatory framework. The drugs are regulated by the Food and Drug 

Administration without long term data, and the process of mixing sperm and egg 

together in any way and combination is not regulated at all. The natural progression of research is to do experiments in cell culture or animal models, to look at 

safety issues first, and whether these experiments are effective. Then after you have 

a lot of animal data, you move into humans, specifically women in the case of reproduction. This hasn’t happened with ART and this is my concern. Institutional Review Boards are only required for research if federally backed institutions, or for 

FDA regulated products, and ART has been largely privately funded. The Genetics 

and Public Policy Center at Johns Hopkins University is beginning to look into this 

travesty. Women have born the positive and negative effects of being experimented 

on through the years of IVF and now it appears the same with cloning. 

Drugs 

Kathy Hudson, the director of the above mentioned new institute at Hopkins said, 

‘‘Scientifically, there are some unanswered questions about the long term consequences those drugs might have on women. There are questions about whether 

they lead to the production of unhealthy eggs, and whether they pose a cancer risk 

to the mother. That’s an area that we at the Center hope to examine’’. 5 Fertinex, 

purified FSH from urine; Gonal F, FSH engineered from recombinant DNA; 

Pergonal, a mixture of FSH and LH collected from postmenopausal women; 

Cetrotide, a GnRH antagonist; and Lupron, the initial GnRH agonist mainstay are 

8

all to be under review. Significant headaches, abdominal bloating changing clothes 

size, and abdominal pain are some of the more common side effects. 6

In 2002 alone, at least 12 studies and articles in peer-reviewed journals suggest 

a potential link between ART and birth defects like heart defects and genetic diseases; childhood cancer; decreased cognition and more. We do not know whether it 

is due to the nature of the problems of infertility or due to the drugs and the procedures of assisted reproduction. 7, 8

The fertility drug/cancer link refers to ovarian stimulation and ovarian cancer. 

The initial Whittemore study, a metaanalysis of 12 case controlled studies on ovulation induction seemed to show a 27 fold increased odds ratio for developing ovarian 

cancer even though some of the analysis was determined to be flawed. 9 Later, the 

Rossing study reported a similar association between the drugs of ovulation and 

ovarian cancer. 10 This alleged increased risk of ovarian cancer in patients using 

ovulation inducing drugs is very disturbing, and a consensus among our American 

Fertility Society recommends that women who are considering the use of fertility 

drugs should be told that there is a possibility of increased risk and should be given 

alternatives, but there is no data to support discontinuing or changing ovulation induction, follicular stimulation, or in-vitro fertilization. 11 Too small numbers, detection bias, and recall bias were used to support their conclusion. 

These drugs also have spurred the profound rise in multiple births; twins, triplets, 

and above. In 2000, 35 percent of all ART births were multiples, and their higher 

risk for birth defects and low birth weight and added health care costs are a significant psychological burden for women, not to mention the process of selective reduction where the infertile woman is faced with the decision to terminate one of her 

fetuses to improve outcome. 12

Egg Donors 

The other approach to obtain eggs is to seek a donor, a woman who is willing to 

donate her eggs for the cloning process. Again, we can look to the in-vitro experience 

for what to expect in the cloning cases. 

Last month, experts in the United Kingdom publicly questioned whether such 

selfless acts are justified given the health risks they may face in later life. These 

women are paid from $1,500 to $3,500 in America to 4,000 to 5,000 pounds in the 

UK, oftentimes going to the highest bidder over the internet. 13 A prominent physician at a London IVF clinic citing the unknown long term effects, and the possible 

cancer risks says they can not duck this issue any longer for their donor egg patients. However, the British Human Fertilization and Embryology Authority says it 

has no plans to review the system for egg donation. 13

On this side of the Atlantic it is illegal to buy or sell human body parts, except 

for eggs. In 1999, we transferred more than 8,000 embryos produced from fresh or 

frozen donated eggs into the wombs of women according to the American Society 

for Reproductive Medicine. 14 Ads placed in campus newspapers, dangling tens of 

thousands of dollars before women with the right pedigree of looks, talent and SAT 

scores is the method for attracting the precise donor. 15 For a month, the woman 

turns over her body to the process of superovulation with the above mentioned 

drugs and the harvesting procedure of transvaginal aspiration. One out of hundred 

will develop the ‘‘hyperstimulation’’ condition that includes: fluid shifts, ascites, pulmonary overload and sometimes hospitalization. One Stanford woman even had a 

stroke while being treated for egg donation. The American Society for Reproductive 

Medicine developed guidelines that place a $5,000 limit on donor compensation, and 

calling for independent medical and psychological evaluations of the donors. The 

guidelines seem to be on target but not all centers adhere to them. 15

The psychological component of this process is being questioned, ‘‘Are we leading 

them to make a decision that later in life they may regret? The money will be spent 

and, in the end, she has given up her genetic child forever. We have to really care 

about these women.’’ 16

Conclusion 

We have to really care about these women. My profession has seen the data on 

the benefits of menopausal hormonal therapy crumble in less than a year, while listening to all the angst and betrayal spoken by my elder patients. 

After considerable pressure, my alma mater, despite private funding, decided to 

stop creating human embryos specifically for stem cell research this past January. 

They were the first institute in the world to make human embryos for research and 

then to destroy them after harvesting the stem cells. 17

We perfected ART in humans before we did it in animals, using women as research subjects and treatment endpoints. There was no animal data before IVF and 

9

ICSI were done in humans. With this as background and fact, I urge this Subcommittee to see cloning as another risk to women. 

BIBLIOGRAPHY

1 Abma, JC et.al. Centers for Disease Control and Prevention, National Center for 

Health Statistics. Fertility, family planning and women’s health: new data from the 

1995 National Survey of Family Growth, Report No. 19; Series 23, 1997. 2Geron Inc. Advanced Cell Technology. 

3David Stevens, MD, private communication, 7 May 2002. 

4www.popsci.com/popsci/medicine/article/0,12543,419326–2,00.html

5www.popsci.com/popsci/medicine/article/0,12543,419326,00.html

6Physicians’ Desk Reference 2003, Thompson, 3119–3136. 

7www.popsci.com/popsci/medicine/article/0,12543,411770–2,00.html

8www.popsci.com/popsci/medicine/article/0,12543,411770–3,00.html

9 Am. J. Epidemiol. 136:1175–1220, 1992. 

10 N. Engl. J. Med. 331:771–6, 1994. 11Ob.Gyn. News October 15, 1993, 12, 13. 12 Blickenstein I, Keith LG, eds. Iatrogenic Multiple Pregnancy: Clinical Implications. London: Parthenon Publishing; 2000. 13 //society.guardian.co.uk/publichealth/story/0,11098,892559,00.html 14 //seattletimes.nwsource.com/cgi-bin/

PrintStory.pl?documentlid=134568946&zsection lid=268448406&slug=egg04m&date=20021104

15www.usnews.com/usnews/issue/030113/health/13donor.b.htm 16Martha Frase-Blunt, Ova-Compensating? Women Who Donate Eggs To Infertile 

Couples Earn a Reward—But Pay A Price, Washington Post, Tuesday, December 4, 

2001; page HE01. 17 Carol Morello, Center Shifts Stem Cell Approach, Washington Post, Friday, January 18, 2002, page A14.

Senator BROWNBACK. Thank you, Dr. Bruchalski. I appreciate 

that. 

Dr. Bustillo, thank you very much for joining us here today. We 

look forward to your testimony. 

STATEMENT OF DR. MARIA BUSTILLO, DIRECTOR, ASSISTED 

REPRODUCTIVE TECHNOLOGIES, SOUTH FLORIDA

INSTITUTE FOR REPRODUCTIVE MEDICINE 

Dr. BUSTILLO. Thank you very much. Good morning, Mr. Chairman. 

I am Dr. Maria Bustillo. I am the director of Assisted Reproductive Technologies, or ART, at the South Florida Institute for Reproductive Medicine in Miami, Florida. However, today I am representing the Coalition for the Advancement of Medical Research. 

It is a group of more than 75 patient advocacy, scientific, and research organizations dedicated to stem cell research. 

Since 1981, I have been involved in ART working to assist 

women and their families to bring children into this world. I have 

worked in human reproduction since the earliest days of in vitro 

fertilization and its related technologies. The field, which, like embryonic stem cell research and somatic cell nuclear transfer today, 

was filled with controversy. 

Over the last 20 years, the science and clinical practice of ART 

has improved dramatically. To date, more than 150,000 children 

have been born in the United States thanks to these treatments. 

Over the past two decades, I have advocated for the adequate inclusion of women in clinical trials. Early on in this debate, some 

individuals were concerned about the exploitation of women, but 

the Institute of Medicine of the National Academy of Sciences, in 

its landmark 1994 report, concluded that both justice and science 

10

* The information referred to has been retained in Committee files. 

were best served by the adequate inclusion of women in well designed scientific research. 

Similarly, today, as we view this new area of science, regenerative medicine, individuals again have expressed concerns about the 

exploitation of women. I believe that this relatively new area of 

science, properly regulated, potentially holds more hope for treatments and cures for diseases for which women and men suffer than 

it poses risks to their health. In this belief about therapeutic 

cloning I am in agreement with 40 Nobel Prize winners and the 

former First Lady, Nancy Reagan. 

Today’s discussion relates to research to improve the health of 

millions of patients, many of whom are women, while preventing 

the specter of human reproductive cloning in an area which I believe is unethical and unsafe. Categorically, I am against the 

cloning of a new human being, and I believe that most Americans, 

including scientists and physicians, would agree. 

Opponents of therapeutic cloning protest that women will become 

egg-producing factories endangering themselves and deepening the 

divide between socioeconomic classes, because poor women will be 

more willing to sell their eggs. Donating eggs is far more complicated than contributing sperm, but women are smart enough to 

make informed choices about their bodies, including what they 

want to do with their eggs. 

It is important that we deal with facts, not speculation and not 

rhetoric. We have a great deal of experience with egg donation. It 

is a vital therapeutic option which has been used to help more than 

15,000 American families to have children. 

I was a member of the American team that performed the first 

egg donation in 1983, and I have personally treated many egg donors over the last 20 years. I can assure you that I would not do 

that if it were not safe. All potential egg donors first undergo extensive medical and psychological screening. Ordinarily, a woman 

matures and releases only one egg in a menstrual cycle. In our 

techniques, including egg donation, medications are given to 

achieve the development of multiple eggs. Over that time period, 

the woman is monitored. And after the development is deemed appropriate, the eggs are retrieved transvaginally using ultrasound 

guidance. 

The American Society for Reproductive Medicine and the Society 

for Assisted Reproductive Technology have guidelines which they 

have promulgated extensively that are both clinical and ethical 

guidelines for gamete donation. And all its member clinics, 370 

member clinics of SART, are required to adhere to these guidelines. 

I would like to ask that these reports and statement be entered 

into the record. 

Senator BROWNBACK. Without objection, they will be in the 

record. * 

Dr. BUSTILLO. Many of the standards the profession has had in 

place for a number of years will now be enforced by the FDA as 

they make final the regulations of reproductive tissues within the 

next year. 

11

In sum, there is a long history of egg donations for reproductive 

uses. Protections and safeguards for both the donor and the recipient are in place and, I think, could be easily modified to accommodate egg donation for research or clinical applications of embryonic 

stem cells. 

As a scientist and long-time women’s health advocate, I also find 

a complete ban on research troubling. About 25 years ago, because 

of similar religious and ethical considerations, there was a call for 

a ban on research involving recombinant DNA. Today, hundreds of 

thousands of people are healthier or alive because of the use of recombinant DNA to produce insulin, interferons, and other therapeutic recombinant molecules. 

This leads me to discuss why I believe women, as well as men, 

have tremendous potential to benefit from therapeutic cloning. Regenerative medicine, including using cloning techniques to create 

new cells more like a patient’s own cells holds the promise to treat 

and cure numerous debilitating and deadly diseases like cancer, 

autoimmune diseases like lupus, multiple sclerosis, and early-onset 

diabetes, cardiovascular disease, and neurological diseases like Alzheimer’s and Parkinson’s. Annually, these diseases strike more 

than a hundred million individuals, a large proportion of whom are 

women. This field of research holds the potential to restore normal, 

healthy functions to cells and replace those that no longer function. 

Therapeutic cloning using somatic cell nuclear transfer holds 

great promise to develop new and innovative treatments for numerous diseases. For instance, let us discuss breast cancer. Using somatic cell nuclear transfer, scientists could take a cell from a patient with breast cancer and reprogram the cell to its earliest stage 

of development. Then they can compare the diseased cell’s development to the healthy cell’s development. In so doing, scientists could 

learn about the trigger mechanisms that lead to that disease. 

These fundamental insights offer tremendous potential for the development of interventions to treat or prevent disease. This is an 

example of why extracting stem cells from in vitro fertilized embryos is inadequate in tackling certain research. 

Women are affected not only by the diseases that attack them, 

but also by the diseases contracted by other family members, as 

they, women, are routinely their families’ predominant caretakers. 

Women’s, wives’, mothers’, daughters’ lives quickly become subsumed by the illnesses within their families. 

I realize that embryonic stem cell research is in its infancy and 

an enormous amount of research must be performed before it can 

be translated into medical treatments, but we must carefully weigh 

the implications of any roadblocks that might halt this research. As 

with any technology, procedures become more efficient in time, so 

fewer eggs will be required. Researchers in therapeutic cloning also 

are hopeful that in the future they will know how to generate stem 

cells without needing eggs. 

Senate bill 303, the Hatch-Feinstein bill, strictly punishes unlawful conduct by providing criminal and civil penalties for violating 

the law while at the same time allowing physician and patient access to potential life-saving therapies without the fear of reprisal. 

I thank you for your time. 

[The prepared statement of Dr. Bustillo follows:]

12

PREPARED STATEMENT OF DR. MARIA BUSTILLO, DIRECTOR, ASSISTED REPRODUCTIVE

TECHNOLOGIES, SOUTH FLORIDA INSTITUTE FOR REPRODUCTIVE MEDICINE

Good morning, Mr. Chairman and Members of the Subcommittee. I am Dr. Maria 

Bustillo, Director of the ART at the South Florida Institute for Reproductive Medicine in Miami, Florida. I also am a founding member and former board member and 

vice president of the Society for Women’s Health Research; past President of the Society for Assisted Reproductive Technology and former board member of the American Society of Reproductive Medicine. Today I am representing the Coalition for the 

Advancement of Medical Research, a group of more than 75 patient advocacy, scientific and research organizations dedicated to stem cell research. 

Since 1981, 1 have been involved in assisted reproductive technology, working to 

assist women and their families to bring children into this world. I have worked 

since the earliest days of In-Vitro Fertilization and related Assisted Reproductive 

Technologies, a field which like embryonic stem cell research and somatic cell nuclear transfer today, was filled with controversy. Over the last twenty years, the 

science and clinical practice of ART has improved dramatically. To date, more than 

150,000 children have been born in the United States thanks to these treatments. 

Throughout my career I also have worked to advance research on women’s health 

and supported work to alleviate their suffering and improve the quality and longevity of their lives. With the Society, over the past decade, I have advocated for 

the adequate inclusion of women in clinical trials and the subsequent analysis of 

resultant data so that scientific conclusions take into account any differences between women and men. Early on, in this debate, some individuals were concerned 

about the exploitation of women. But, the Institute of Medicine (of the National 

Academy of Sciences) in its landmark 1994 report concluded that both justice and 

science were best served by the adequate inclusion of women in well-designed scientific research. 

Similarly, today as we view this new area of science, regenerative medicine, individuals again have expressed concerns about the exploitation of women. Once again, 

I am in agreement with the National Academy of Sciences. Two of its recently published reports support the exploration of the potential of regenerative medicine and 

therapeutic cloning. I believe that this relatively new area of science, properly regulated, potentially holds more hope for treatments and cures for diseases from which 

women and men suffer than it poses risks to their health. 

Today’s discussion relates to research to improve the health of millions of patients, many of whom are women, while preventing the specter of human reproductive cloning—an area which I believe is unethical and unsafe. Categorically, I am 

against the cloning of a new human being, and I believe that most Americans, including scientists and physicians, would agree. Just this month, in a poll commissioned by the Coalition for the Advancement of Medical Research, more than two 

thirds of Americans support therapeutic cloning research to produce stem cells for 

treating life-threatening diseases and conditions and want the government to allow 

it to proceed. I agree with them and the National Academy of Sciences, 40 Nobel 

Prize winners, and former First Lady Nancy Reagan in my support for therapeutic 

cloning. 

Initially, I would like to counter opposition to therapeutic cloning as it relates to 

women. First, opponents of cloning protest that women will become egg-producing 

factories, endangering themselves and deepening the divide between socioeconomic 

classes because poor women will be more willing to sell their eggs. 

It is true that donating eggs is far more complicated than contributing sperm. But 

women are smart enough to make informed choices about their bodies, including 

what they want to do with their eggs. Women who believe that they can help an 

ailing family member or even help women like themselves who have a history of, 

say, Alzheimer’s disease, should be allowed to make these choices. 

It is important that we deal with facts, not speculation and not rhetoric. We have 

a great deal of experience with egg donation. It is a vital therapeutic option which 

has been used to help more than 15,000 American families have children. Twenty 

years ago, I was on the team that performed the first egg donation and I have personally treated many egg donors over the past 20 years. I can assure you I would 

not do that if it were not safe. 

All potential egg donors first undergo extensive medical and psychological screening. Women who are deemed as suitable donors enter a pool of potential donors who 

are then matched with recipient couples. The donor undergoes what is known as 

controlled superovulation. Ordinarily a woman matures and releases only one egg 

in each menstrual cycle. In ART techniques, including egg donating, the physician 

administers a combination of hormonal medications for about two to three weeks to 

trigger the development of many eggs. Over that time period, the patient is monVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00016 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
13

itored using ultra sound technology and diagnostic blood tests. Finally the eggs are 

retrieved using transvaginal aspiration, using an ultrasound guided needle and intravenous sedation. 

As with any medical procedure, there are some potential risks to the patient/

donor. There is a slight risk (less than 1 percent) of ovarian hyper stimulation, 

though even this risk is thought to be lower in donors than in normal ART patients. 

There have also been some studies reporting a link between some of the medicines 

used in ART procedures and ovarian cancer, which caused some initial concern. 

However further research has led us to conclude that there may well be an underlying medical problem which may be associated with both infertility and ovarian 

cancer. That is, it is not the medicines which lead to a higher cancer rate. 

The American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology have promulgated extensive clinical and ethical guidelines on 

gamete donation, and all 370 member clinics of SART are required to adhere to 

these standards. I would like to ask that these reports and statement be entered 

into the record. 

These standards include the extensive screening I described early, a limitation on 

the number of times any one woman can donate, and a cap on compensation to the 

donor. The ASRM ethics committee has determined that sperm and egg donors can 

be compensated for the time and trouble associated with the donation, but that compensation should not vary according to the traits of the donor. 

Many of the standards the profession has had in place for a number of years will 

now be enforced by the FDA as they make final their regulations of reproductive 

tissues next year. 

In sum, there is a long history of egg donation for reproductive uses. Protections 

and safeguards for both donor and recipient are in place and could easily be modified to accommodate egg donation for research or clinical applications of embryonic 

stem cells. 

As a scientist and longtime women’s health advocate, I also find a complete ban 

on research troubling. I am aware that the word ‘‘moratorium’’ is used in Senator 

Brownback’s legislation, but I view a ‘‘moratorium’’ the same as a ban because after 

a hiatus in an area of scientific research, trained scientists are no longer available, 

the field diminishes, and the United States would have to play catch-up with other 

nation’s research achievements. About 25 years ago, because of similar religious and 

ethical considerations, there was a call for a ban on research involving recombinant 

DNA. Today hundreds of thousands of people are healthier or alive because of the 

use of recombinant DNA to produce insulin, interferons, and other therapeutic recombinant molecules. 

This leads me to discuss why I believe women, as well as men, have tremendous 

potential to benefit from therapeutic cloning. Regenerative medicine, including using 

cloning techniques to create new cells more like a patient’s own cells, holds the 

promise to treat and cure numerous debilitating and deadly diseases, like cancer, 

autoimmune diseases like lupus erythematosus (lupus), multiple sclerosis, and early 

onset diabetes, cardiovascular disease and neurological diseases like Alzheimer’s 

and Parkinson’s disease. Annually, these diseases strike more than 100 million individuals, a large proportion of whom are women. This field of research holds the potential to restore normal healthy functions to cells and replace those that no longer 

function. 

Therapeutic cloning, using Somatic Cell Nuclear Transplantation (SCNT) holds 

great promise to develop new and innovative treatments for numerous diseases. For 

instance, let us discuss breast cancer. Using SCNT, scientists can take the cell of 

a patient with breast cancer and reprogram the cell to its earliest stage of development. Then, they can compare the diseased cell’s development to the healthy cell’s 

development. In so doing, scientists can learn about the trigger mechanisms that 

lead to disease. These fundamental insights offer tremendous potential for the development of interventions to treat or prevent disease. This is an example of why 

extracting stem cells from In-Vitro Fertilization (IVF) embryos is inadequate for 

tackling certain research. 

Cardiovascular disease, including heart attacks and congestive heart failure, is 

the nation’s number one killer of both women and men. Annually, approximately 

one-half million more women than men die of this dreaded disease. Restoring the 

function of damaged heart cells is a daunting challenge. The National Institutes of 

Health reports that recent research provides early evidence that adult and embryonic stem cells may be able to replace damaged heart muscle cells and establish new 

blood vessels to supply them. Scientists believe that embryonic stem cells in contrast 

to adult stem cells hold greater potential because they have the ability to be come 

any type of cell in the human body and hold virtually unlimited ability to replicate. 

14

Many autoimmune diseases like lupus, multiple sclerosis, rheumatoid arthritis, 

and Sjogren’s disease, strike women disproportionately. Lupus and Sjogren’s are 

nine times more frequent in women; rheumatoid arthritis is four times more frequent in women; and multiple sclerosis strikes women twice as frequently as men. 

(Other autoimmune diseases like early onset diabetes are more evenly distributed 

among the population.) For all autoimmune diseases, complex biological questions 

remain unanswered about why the body’s immune system fails to protect the body 

against disease and allows it to turn against itself. Research on stem cells is providing new ways to remove errant immune cells and restore normal immune cells 

to the body. However, obstacles to some type of adult stem cells are the limited 

number that can be harvested and the difficulties in propagating them in the laboratories. 

Women also are affected not only by the diseases that attack them but also by 

the diseases contracted by other members of their family, as they routinely are their 

family’s predominant caretakers. Wives’, mothers’, and daughters’ lives quickly become subsumed by the illnesses within their families. 

I realize that embryonic stem cell research is in its infancy, and an enormous 

amount of research must he performed before it can be translated into medical 

treatments. But we must carefully weigh the implications of any roadblocks that 

might halt this scientific research. 

S. 245, the Human Cloning Prohibition Act, legislation introduced by Senator 

Brownback, to my knowledge, for the first time in U.S. history, dead ends a promising new avenue of research, perhaps sending it underground, or at the least, sending it overseas along with our most promising scientists. It outlaws research that 

scientists believe could play a critical role in curing and alleviating the suffering of 

millions of patients, including women. This bill also makes criminals of anyone who 

would bring into this country the potential products of this research. 

The Coalition for the Advancement for Medical Research believes that S. 303, the 

Human Cloning Ban and Stem Cell Research Protection Act, the legislation introduced by Senators Hatch, Feinstein, Specter, Kennedy, Harkin, and Miller strikes 

the appropriate balance between preventing unsafe and unethical research on 

human reproductive cloning and permitting scientific research endorsed by the National Academy of Sciences, 40 Nobel laureates, former First Lady Nancy Reagan, 

and former Presidents Gerald Ford and Jimmy Carter. 

S. 303 applies the Common Rule, the law governing federal ethical standards, to 

SCNT research so that institutional review boards already in place at universities 

and hospitals would ensure that women participating in research are fully informed 

about the procedures and risks involved in donating eggs. As in all areas of research, stringent safeguards must be in place to protect people against coersion. 

Otherwise informed consent is not truly informed consent. As I already discussed, 

egg donation in all circumstances must be conducted with rigorous informed-consent 

procedures. (As with any technology, procedures become more efficient in time, so 

fewer eggs will be required. Researchers in therapeutic cloning also are hopeful that 

in the future they will know how to generate stem cells without needing eggs.) S. 

303 also strictly penalizes unlawful conduct by providing for criminal and civil penalties for violating the law while allowing physician and patient access to potentially 

life-saving therapies without fear of reprisal. 

Thank you.

Senator BROWNBACK. Thank you. Thank you for your testimony. 

Dr. Bustillo? Am I——

Dr. BUSTILLO. Bustillo, uh-huh. 

Senator BROWNBACK. Bustillo. There a number of diabetes cases 

in the country, how many people suffer from diabetes in the U.S.? 

Dr. BUSTILLO. Well, there are two different kinds of diabetes, but 

the majority of patients with diabetes have adult-onset diabetes. 

But juvenile-onset diabetes affects millions of young people, as 

well. 

Senator BROWNBACK. Just walk me through the numbers of what 

it would take if human cloning were allowed for treatment just in 

diabetes, of how many——

Dr. BUSTILLO. I think what we——

Senator BROWNBACK.—eggs it would take to provide this as a 

broad-scale treatment across the country. 

15

Dr. BUSTILLO. I think what we need to remember is that those 

numbers seem huge, but the issue is that I think we need to do 

some very basic research that would allow us to generate, for instance, stem cell lines that would divide themselves and that would 

need, as the technology gets more efficient, fewer and fewer eggs 

to treat the patients. But we are at the stage where we really are 

just beginning to learn about this. 

So, yes, it will take hundreds and thousands of eggs to do this. 

Senator BROWNBACK. Where will we come up with those eggs? 

Dr. BUSTILLO. Well, I think there are a number of ways to come 

up with those eggs. The one is what the folks at Norfolk did, which 

is actually to recruit women, under review, institutional review 

board, screened, paid to do this as they would otherwise do it, as 

most women who do egg donation do get paid in the United States 

and are often anonymous to the recipient couple, and would provide these eggs for the purpose of research either because they 

have a family member that might in the future benefit from this 

research or because they are interested in helping humanity. 

Senator BROWNBACK. Should we be paying women for eggs? 

Dr. BUSTILLO. I think the position of the Fertility Society or the 

Society of Reproductive Medicine is that we should pay women for 

their time and trouble. This is a procedure not as easy as just giving a sperm sample. And as my colleague here stated, it does take 

several weeks, several medications, so we are really paying them 

for time off, babysitting, the things that they need. So we have determined what a reasonable cost is to them. 

Senator BROWNBACK. So you would put a cap on how much we 

could pay women for eggs? 

Dr. BUSTILLO. Yes. 

Senator BROWNBACK. Have you come up with a——

Dr. BUSTILLO. I think——

Senator BROWNBACK.—position of what that——

Dr. BUSTILLO.—as he mentioned it——

Senator BROWNBACK.—price——

Dr. BUSTILLO.—in the United States, it is somewhere between 

1,500, and in states like New Jersey and New York it is a lot higher. So it varies, depending on the part of the country that you are 

with. But I think, no, not more than 5,000, 6,000 would be a very 

reasonable amount. 

Senator BROWNBACK. To put a national upper price tag on women’s eggs? 

Dr. BUSTILLO. I think it would be dangerous to do that, because—again, hopefully, as we get more efficient with new medications, new protocols, it may involve less trouble, less time, et 

cetera, so to put a national cap which may actually be higher than 

you might need in the future would not be wise. 

Senator BROWNBACK. But you agree that now some women are 

being recruited and paid very high prices based upon their mental 

capacity, their physical nature, is that correct? 

Dr. BUSTILLO. Well, they are being recruited. I do not know how 

widespread that is. And again, the American Society for Reproductive Medicine, the Fertility Society, is definitely opposed to that 

and encourages its members not to proceed in that fashion. 

16

Senator BROWNBACK. But you would encourage women to be recruited for egg donation for human cloning. 

Dr. BUSTILLO. For therapeutic cloning, yes. 

Senator BROWNBACK. And you would——

Dr. BUSTILLO. For the generation of stem cells, yes, sir. 

Senator BROWNBACK. Okay, so you would. And you do agree that 

that—if we were to go with this on a broad-scale effort to try to 

cure a number of these diseases, we are talking of, you said, hundreds of thousands of eggs. 

Dr. BUSTILLO. Yes, sir. 

Senator BROWNBACK. And that is going to involve at least hundreds of thousands of women, is that correct, or millions? 

Dr. BUSTILLO. Well, also another source of eggs would be infertility patients. We cannot forget them. And especially as infertility 

patients, if we get the younger infertility patient—if we should provide insurance coverage, for instance, for in vitro and make it amenable to the younger patient, they generally would produce more 

eggs than they require to generate their own, to solve their own 

fertility problem. 

Senator BROWNBACK. But how many women are you envisioning? 

Let us say we just said therapeutic cloning is fabulous, we are 

going to go full scale with therapeutic cloning, start recruiting 

women. We have got a hundred million people, in your testimony, 

that suffer from these debilitating diseases. Are we not talking 

about millions of women donating——

Dr. BUSTILLO. No, because——

Senator BROWNBACK.—their eggs? 

Dr. BUSTILLO.—again, I think as the research gets better, hopefully we will not even need eggs at some point once—I mean, we 

will still need some eggs for some of the cell-development studies 

that I mentioned, with breast cancer and other diseases, but as we 

get more efficient and we learn how to replicate and keep stem cell 

lines going, et cetera, I think we are going to need fewer and fewer 

fresh donated eggs. 

Senator BROWNBACK. Well, let us say we really get good at this 

and you only need five eggs per patient. I mean, that is a fabulous 

number relative to—I think Dolly was 300 tries, something like 

that, to get——

Dr. BUSTILLO. Two hundred and almost forty experiments, yes. 

Senator BROWNBACK. So let us say we get it to a five to one ratio, 

that you only need five eggs for the try, which would be a—that 

would be a great technological move forward. 

Dr. BUSTILLO. Uh-huh. 

Senator BROWNBACK. Are you not truly still talking about millions of women who are going to have to sell their eggs for this 

process——

Dr. BUSTILLO. Again——

Senator BROWNBACK.—to really be engaged? 

Dr. BUSTILLO. Again, it would be—you know, there are probably 

close to 50,000 women undergoing in vitro for therapeutic reasons 

for their own infertility, so that would also add to the pool of the 

donation. 

Senator BROWNBACK. Okay. All right, 50,000, and we get five—

let us say—how many eggs do we get per those——

17

Dr. BUSTILLO. It is——

Senator BROWNBACK.—50,000? 

Dr. BUSTILLO.—age related, and you can—in donors, in general, 

we get 15 to 20, 25 eggs. In——

Senator BROWNBACK. Say we get 20. 

Dr. BUSTILLO.—patients, we get fewer. 

Senator BROWNBACK. What if we—can we get 20 eggs from those 

50,000 women? Twenty eggs——

Dr. BUSTILLO. We could——

Senator BROWNBACK.—each? 

Dr. BUSTILLO.—we could get 15 eggs from each, right. But I 

think what we have to do to make it much more efficient is not 

each time get the egg, but obtain stem cells from the initial few 

women who would donate eggs for research purposes, obtain these 

stem cells, do the research, do the work, keep them going, and then 

this would be much more effective than having to do the therapeutic cloning each time you want to treat a patient. 

Senator BROWNBACK. Okay, so you are saying you just do not 

think we are going to be needing therapeutic cloning in the future. 

You think we need it now, but we are not going to need it in the 

future. Is that——

Dr. BUSTILLO. That’s very——

Senator BROWNBACK.—correct? 

Dr. BUSTILLO.—possible. 

Senator BROWNBACK. But, now, you base that on——

Dr. BUSTILLO. Just——

Senator BROWNBACK.—nothing but hope at this point——

Dr. BUSTILLO. No, I think——

Senator BROWNBACK.—in time. 

Dr. BUSTILLO.—I base that on some of the things we are learning 

about what to do, how to treat these cells to make them go in certain tissues, like, you know, pancreatic tissue, et cetera; and if we 

can learn the mechanisms of how these cells go from undifferentiated cells to these specific cells, then I think we will be able to 

reproduce those and need them less and less. 

Senator BROWNBACK. Okay, then why do we not do that in animals first and than take that to humans? Why do we not perfect 

what you are saying first in animals before we go to——

Dr. BUSTILLO. Well——

Senator BROWNBACK.—humans? 

Dr. BUSTILLO.—always, animals are wonderful, but they are not 

necessarily humans. 

Senator BROWNBACK. But do we not normally, in this country, 

start with animal——

Dr. BUSTILLO. And we——

Senator BROWNBACK.—models and——

Dr. BUSTILLO.—do, and we have, and there are some wonderful 

animal models and some recent data on the model for Parkinson’s 

disease in the mouse. And work has been done in that area which 

shows very promising results in the mouse now being mobile after 

transferring of cells generated from stem cells from mouse embryos. 

Senator BROWNBACK. No, I understand, but why would you not 

perfect your technique that you are hoping we get to so we do not 

18

* The information referred to was not available at the time this hearing went to press. 

need the millions of women’s eggs? Why do we not perfect that first 

in animals and then take it to humans? 

Dr. BUSTILLO. No, I think we have been doing that. However, the 

animal is never a perfect model for the human. 

Senator BROWNBACK. Well, have we developed what you have 

said in animals yet and perfected it and the technique so we do not 

have to do the cloning, which you are saying we——

Dr. BUSTILLO. I think——

Senator BROWNBACK.—should need to in the future? 

Dr. BUSTILLO. I think we are in the process of doing that, yes, 

sir. 

Senator BROWNBACK. But it has not been done yet. 

Dr. BUSTILLO. Not perfected for every cell type. 

Senator BROWNBACK. It is not even close, is it? 

Dr. BUSTILLO. I do not think so. 

Senator BROWNBACK. So you are basing this, that we are going 

to do this in humans, off of what you hope will take place but what 

we have not produced in animal models even yet, is that correct? 

Dr. BUSTILLO. I think so. You have to remember that the isolation of stem cells in animals has only been around for about 10, 

15 years, so the work is just beginning. Things in science often 

take a long time. So we are at a very early stage of this kind of 

research. 

Senator BROWNBACK. Do we normally, then, in early stages of research, do that on humans? 

Dr. BUSTILLO. In this country, we have done that—for instance, 

as my colleague mentioned, in vitro fertilization—because often 

there is absolutely no financing for this kind of work, particularly 

from the Federal Government. So, oftentimes, this research is advocated and driven by the patients affected by the disease, such 

as——

Senator BROWNBACK. But is it not normally true we develop our 

animal models first; and then, when we perfect it, we take it to humans? 

Dr. BUSTILLO. Again, that was not done in in vitro fertilization. 

Senator BROWNBACK. I understand, but do we not normally——

Dr. BUSTILLO. Yes, and I——

Senator BROWNBACK. We are talking about therapeutic cloning 

here, correct? 

Dr. BUSTILLO. Right. 

Senator BROWNBACK. Okay. 

Senator Landrieu has arrived and is limited on her time. Would 

you mind if we have her testify now, and you can stay seated there, 

and we will receive her testimony? 

Senator Landrieu, thank you very much for joining us. I appreciate you being here, a cosponsor of the bill, and I am happy to receive your testimony. 

STATEMENT OF HON. MARY L. LANDRIEU,

U.S. SENATOR FROM LOUISIANA 

Senator LANDRIEU. Thank you, Mr. Chairman. I am going to submit a more detailed statement for the record. * I would like to 

19

thank our witnesses for being a part of this very important hearing. I also wanted to thank you, Mr. Chairman, and to show my 

support for your efforts to try to help the public better understand 

that the alternative to a ban on human cloning is actually the licensing of a brand-new industry. I think this hearing is very important in trying to communicate to the public what that industry 

would look like. 

What the witnesses have just described, I think, would be very 

upsetting to many, many people in this country. The level of experimentation that would have to go on, the numbers of women 

that would be needed for these types of experiments, and the lack 

of fine-tuning of the procedures is concerning. I think that your 

point about the normal course of scientific work in this country is 

to perfect some of these techniques on animals before we move to 

the human population is a good one. 

I applaud your efforts this morning to help focus on the shortcomings of this Feinstein-Kennedy proposal, and force us to consider how licensing a brand-new industry, crosses the ethical line, 

as well as the line of common sense. 

I also want to note for the record that as the weeks and months 

go on with many legislatures in session around the country, two 

legislatures have recently passed a ban in North Dakota and Arkansas. Many people in my State of Louisiana, are very concerned 

about this issue, not because they are against research, or because 

they oppose science or finding cures for the terrible diseases that 

our children and our grandchildren suffer from, but because we 

have grave concerns about opening up an industry where the marketplace dictates or moves women to donate hundreds and thousands of the—what is to prevent the situation arising where the 

smarter you are, ‘‘prettier’’ you are, the ‘‘more attractive’’ you are, 

you get paid more for your egg than someone else, who is ‘‘less attractive’’ or ‘‘less smart,’’ to have an industry that virtually is, in 

many ways, unregulated. Even if it were regulated with our best 

attempts here, I am not sure that we could eliminate some of the 

more gruesome aspects of what is being discussed here today. 

I thank the scientists here for their work and their efforts. I appreciate we have different views. But again, it is important to be 

clear what Congress is debating. The issue is whether to license a 

new industry that would use women as manufacturers and eggs as 

commodities. Do we want to be setting prices on eggs and injecting 

hormones into women to produce eggs for the benefit of experimentation? I think this is too far for where the American people want 

to go at this time. 

Thank you, Mr. Chairman. 

Senator BROWNBACK. Thank you for submitting the statement for 

the record, and thank you for coming by, Senator Landrieu. 

Dr. Bruchalski, what would happen if you took just a hundred 

thousand women and collected their eggs for therapeutic cloning? 

What is the likely impact on that hundred-thousand women? Do we 

have any notion of studies of how many would be impacted negatively, physically, by just that many going through? Not a million, 

but just a hundred thousand. 

Dr. BRUCHALSKI. At a hundred thousand people undergoing this 

process——

20

Senator BROWNBACK. Pull that microphone a little closer. 

Dr. BRUCHALSKI. For a hundred thousand women undergoing 

this process, there would be the effects of hyperstimulation on all 

these women, including abdominal bloating, tenderness so significant that we are now trying to perform or have newer protocols to 

decrease these side effects that are so pervasive. We believe that 

it is close to 1 percent of these women would undergo the 

hyperstimulation syndrome, so whatever 1 percent of a hundred 

thousand—it is in this small subset where you have a fluid overload situation, where the abdomen is filled with fluid, and it is 

called ascites. You can develop pulmonary edema, and you have to 

hospitalize this group of patients to prevent further decompensation. And so that occurs in 1 percent of the present—almost 1 percent of the present-day cycles. So you are looking at a sizeable 

number of women who would undergo serious side effects in order 

to obtain the outcomes desired. And at a hundred thousand, that 

is, relatively, a very, very, very conservative estimate for any of the 

diseases mentioned. 

Senator BROWNBACK. Well, what if we extend that to a million 

women? I would gather we are going to get a broader cross-section 

of women to donate—or sell eggs, rather—at that point in time, a 

broader cross-section of health potential difficulties if you are going 

at a million women. What potential health side-effects could we 

have with that large of a pool? 

Dr. BRUCHALSKI. Well, you would still be looking at the numbers 

that I suggested, but it would be, you know, multiplied by a factor 

of ten. You would have still that 1 percent of a million having to 

be hospitalized, and the vast majority of those other women having 

to often take time off through that month’s therapy to deal with 

not only the procedures itself, but many of the side effects, which 

I just mentioned, which include headache, abdominal tenderness, 

abdominal pain, pelvic pain. 

Senator BROWNBACK. Do we have any idea of the price we would 

have to pay to get women to do this, where it is not for a child for 

themselves, which I would think—you know, a number of women, 

if this is for a child, their child, they are willing to go through a 

lot of things to do that, and I am so grateful, but if this is to sell 

eggs, do we have any notion of price that you are going to have to 

bid to to be able to get a million women to donate eggs and go 

through this process? 

Dr. BRUCHALSKI. No, we do not know exactly the amount. The 

guidelines that are given are—how can I say? They are encouraged. 

They are not really required; they are encouraged for the various 

centers to follow. And I appreciate my colleague’s hopeful optimism 

in regard to this, how possibly we can try to decrease that number 

over time so we do not have this impact. 

But I still keep coming back to the reality that in in-vitro fertilization cycles today, we still are able to get 10 to 15 eggs per 

cycle. We have not improved on our efficiency in 20-plus years of 

in vitro fertilization work in this country. We have made incredible 

strides. We have helped many centers, instead of placing six, seven, 

eight, nine, ten embryos back into uteri, we are now recommending 

only three to four, in many cases, because of the horrors and the 

difficulties with multiple births. We have made many strides. 

21

But I do not know the exact top-dollar amount that would have 

to be placed, because right now, as you mentioned, that number is 

quite high, in some cases. 

Senator BROWNBACK. Dr. Bustillo, do we have any idea of how 

many women now sell their eggs, not for their own childbearing for 

themselves, but for somebody else? Do we have any notion of what 

that market is now? 

Dr. BUSTILLO. Well, we have——

Senator BROWNBACK. The total number? 

Dr. BUSTILLO. Right. We have data, the American Society of Reproductive Medicine, actually under the—the CDC collects that 

data from these member clinics of the American Society for Reproductive Medicine, and the last—we collect the data after birth, so 

we have numbers, and I believe the 2000 data, which he mentioned 

was the last data, and I believe it was around 8-, 9,000 cycles of 

egg donation. Now, those women do not necessarily all sell their 

eggs, because some women who donate their eggs are actually relatives—i.e., sisters, friends—of the women who need the eggs. 

Senator BROWNBACK. Okay. 

Dr. BUSTILLO. So we do not have a hard number on how many 

are actually paid. But I would suspect that the majority of egg donation is done with paying the donors. And again, just for the——

Senator BROWNBACK. Somewhere 8- to 9,000? 

Dr. BUSTILLO. No, sir. 

Senator BROWNBACK. 8- to 9,000 that——

Dr. BUSTILLO. Yes. 

Senator BROWNBACK.—did not——

Dr. BUSTILLO. That——

Senator BROWNBACK.—this is not for their own child. 

Dr. BUSTILLO. Right, that is correct. 

Senator BROWNBACK. Okay. So let us say we have got to increase 

that number up to a hundred thousand, which I think is dreadfully 

low. I mean, for what we have of current technology, you are really 

looking at the millions to make this broadly available for people. 

But let us say it is just a hundred thousand women that we want 

to pay to give eggs so that we could go on some scale of therapeutic 

cloning across the United States, just a hundred thousand women. 

So these are not going to be for a baby for themselves; this is going 

to be for research purposes, this is going to be for trying to develop 

health cures. How much of a market bid-up are we going to have 

to do to get a hundred thousand women to donate eggs? 

Dr. BUSTILLO. Again, you are assuming that those eggs will only 

come from women who are volunteering for the research, because 

I still think that some women who are going through in vitro fertilization for their own benefit, again, as we—and I disagree with 

my colleague; we have made great strides in the success rate of 

IVF. 

Senator BROWNBACK. How much would we have to pay to get a 

hundred thousand women to donate eggs? 

Dr. BUSTILLO. How much do we have to pay them? Again, it depends on what they have to go through, and——

Senator BROWNBACK. Well, you know what they have to go 

through. 

22

Dr. BUSTILLO. Well, I know what they have to go through today. 

I know what they had to go through 20 years ago, which is much 

more than they have to go——

Senator BROWNBACK. Well, how much——

Dr. BUSTILLO.—through today. 

Senator BROWNBACK.—what they’ll have to go through next year. 

Dr. BUSTILLO. Next year? They——

Senator BROWNBACK. Are we just going to open it up——

Dr. BUSTILLO. Yes. 

Senator BROWNBACK. So the technology is basically——

Dr. BUSTILLO. I would say——

Senator BROWNBACK.—what you have today. 

Dr. BUSTILLO.—you’d have to pay about $3,000. 

Senator BROWNBACK. You think we can get a hundred thousand 

women for $3,000 each to donate eggs, go through the process that 

we’re involved in. 

Dr. BUSTILLO. I mean, it’s not going to be easy. They need to be 

motivated, you know, for the betterment of humanity, for the relative with diabetes. 

Senator BROWNBACK. Well——

Dr. BUSTILLO. It’s going to be——

Senator BROWNBACK.—if you were asked to do this, could do this, 

or had a daughter that wanted to do this, would you do this for 

$3,000? 

Dr. BUSTILLO. Yes, sir. 

Senator BROWNBACK. And you would recommend your daughter 

to do it for——

Dr. BUSTILLO. I would——

Senator BROWNBACK.—3,000. 

Dr. BUSTILLO.—if she was comfortable with it. She would have 

to be screened medically, psychologically, all the implications of 

that, yes. 

Senator BROWNBACK. What all is the screening that’s going to 

need to take place? 

Dr. BUSTILLO. Well, we have been doing this for a number of 

years, but you would have to screen them for—and the screening 

may be different, because the screening we do now is because 

they’re going to hopefully produce babies, so we screen them genetically, a number of tests, routine tests, that we do for cystic fibrosis, et cetera. We screen them to make sure they have no other 

medical illnesses. We screen them for their family history. They 

meet with psychologists. They have a number of visits to make 

sure they understand the implication of their eggs going either to 

someone else or to research, so they have to be very comfortable 

with it. 

Senator BROWNBACK. So——

Dr. BUSTILLO. I would say, in my practice, we screen ten women 

to have one accepted, just—and this is for——

Senator BROWNBACK. So we’re talking about a million women 

needing to come forward to get a hundred thousand to——

Dr. BUSTILLO. It’s very possible. 

Senator BROWNBACK. Wow. 

Dr. BUSTILLO. But, again, you are assuming that you’re going to 

need this sort of generation of fresh eggs on a continuing basis. 

23

Senator BROWNBACK. Well, if we start this right now, we obviously are going to need that. 

Dr. BUSTILLO. No, because you’re talking about treating everyone 

at once. All research, you know, doesn’t start by application to a 

hundred million people that are affected by these diseases. We’re 

talking about beginning slowly and hopefully perfecting it so we 

need fewer eggs, you know, because we’re going to create stem cell 

lines, et cetera. 

Senator BROWNBACK. We are going to perfect it amongst people 

as we go along. 

Dr. BUSTILLO. Because, again, animal models are being worked 

on, but I think they are not perfect. And eventually you will have 

to jump from animals to people. 

Senator BROWNBACK. It would be nice if we knew it worked in 

animals first before we tried it in people, do you not think? 

Dr. BUSTILLO. I think it would, and I think we have some very 

encouraging new data coming out that it does for certain diseases, 

like Parkinson’s. 

Senator BROWNBACK. With therapeutic cloning, we are—talking 

about therapeutic cloning at this point. Do you think we are——

Dr. BUSTILLO. We are talking——

Senator BROWNBACK.—perfected enough on the——

Dr. BUSTILLO. We are talking——

Senator BROWNBACK.—cloning process to take that from animals 

to humans and move this on forward? 

Dr. BUSTILLO. I am talking about the generation of stem cells 

that then can be directed to make tissues that would treat diseases 

like Parkinson’s, diabetes, et cetera. 

Senator BROWNBACK. Now, have you studied the cloning research 

in animals and whether or not we have any health problems in 

those animals. If we have——

Dr. BUSTILLO. Not——

Senator BROWNBACK.—perfected the cloning process in animals. 

Dr. BUSTILLO. You are now talking, sir, about reproductive 

cloning, and I am adamantly opposed to that. 

Senator BROWNBACK. But would you agree that there are health 

problems in reproductive clones? 

Dr. BUSTILLO. In reproductive cloning, yes, sir. 

Senator BROWNBACK. Where would they carry those health problems from? Do they get them from the very first genetic pool that 

they are in or not? 

Dr. BUSTILLO. We do not know what the problems are—I mean, 

how the problems start. And as you said, there were over 200 experiments to generate Dolly. But——

Senator BROWNBACK. Dolly——

Dr. BUSTILLO.—we are confusing the issue a little bit that——

Senator BROWNBACK. Well——

Dr. BUSTILLO.—we are talking now about——

Senator BROWNBACK.—but let me ask you——

Dr. BUSTILLO.—reproductive cloning. 

Senator BROWNBACK. Then correct me as I go through this. Dolly 

was just put to sleep. 

Dr. BUSTILLO. Yes. 

24

Senator BROWNBACK. Aged prematurely, I believe. Did she have 

lung and liver problems? 

Dr. BUSTILLO. Yes. 

Senator BROWNBACK. Okay. 

Dr. BUSTILLO. Lung problems, I believe. 

Senator BROWNBACK. Do we think any of these, or do we know, 

if these were genetic problems that she had? 

Dr. BUSTILLO. We do not know for sure. 

Senator BROWNBACK. Is it a good chance they were——

Dr. BUSTILLO. But again, sir——

Senator BROWNBACK.—genetic problems? 

Dr. BUSTILLO.—we are talking about reproductive cloning. I am 

not in——

Senator BROWNBACK. I understand. 

Dr. BUSTILLO.—favor of——

Senator BROWNBACK. I understand. 

Dr. BUSTILLO.—reproductive cloning. 

Senator BROWNBACK. I understand we are talking about reproductive cloning. But when does gene imprinting occur? 

Dr. BUSTILLO. It depends on the gene, but I think usually very 

early. 

Senator BROWNBACK. Are you not given the very first gene pool 

as what you start with? And does it change——

Dr. BUSTILLO. That is——

Senator BROWNBACK.—at a very——

Dr. BUSTILLO.—correct. But again, when we are talking about 

stem cells, we are talking about a cell that is undifferentiated——

Senator BROWNBACK. I understand, but——

Dr. BUSTILLO.—not imprinted——

Senator BROWNBACK. Well, then maybe I just need to be much 

more clear with you on my question. If Dolly has genetic problems—she is given a genetic pool from the very outset that does not 

change, so if she has genetic problems, she has them as a therapeutic clone or as a reproductive clone if she has a genetic defect 

in this system. Is that correct? 

Dr. BUSTILLO. No, sir, because it is a——

Senator BROWNBACK. Okay, but——

Dr. BUSTILLO.—different——

Senator BROWNBACK.—when does the gene change? 

Dr. BUSTILLO. It is one cell versus an organism, so it is a very 

different situation. 

Senator BROWNBACK. Is the gene pool any different? 

Dr. BUSTILLO. Well, yes, it is different in that it does not—in 

some cases, it does not have, you know, the immunologic signals, 

et cetera, so it depends on the cell. Yes, it is very different. 

Senator BROWNBACK. So the gene pool that Dolly had as a onecell embryo is different from what she has as an adult. 

Dr. BUSTILLO. No, but the gene pool of Dolly as an organism and 

the interaction between the genes and the different cells between 

the different organ systems is a whole different situation from taking a few cells from a five day old embryo and generating stem 

cells that are undifferentiated. 

Senator BROWNBACK. Is it possible that Dolly had genetic defects 

as a one-cell embryo? 

25

Dr. BUSTILLO. Yes, it is very possible. 

Senator BROWNBACK. Isn’t it even likely? 

Dr. BUSTILLO. It is likely, because, again, Dolly, again, was generated from an adult somatic cell, and we are not talking about 

doing that with therapeutic cloning utilizing stem cell generation 

from normally in vitro fertilized embryos. It is a different experiment. 

Senator BROWNBACK. Are you comfortable with the level of 

knowledge we have of therapeutic cloning amongst animals 

today——

Dr. BUSTILLO. I think——

Senator BROWNBACK.—that this is a technology to be transferred 

to humans? 

Dr. BUSTILLO. I think, in certain areas, I think it is very promising and probably ready for some early human experiments, like 

Parkinson’s disease. 

Senator BROWNBACK. And you are comfortable with what we 

know in the animal to transfer it into the human model today? 

Dr. BUSTILLO. I am not an expert on Parkinson’s disease or in 

this area, but I think it is, again, promising, and I think what we 

need is more research utilizing human tissues. I know we are not 

ready to institute medical therapy utilizing therapeutic cloning 

today. 

Senator BROWNBACK. Okay. 

Thank you, panelists, very much for your interest and your information, and we appreciate very much your coming here and testifying today. 

I would call up our next panel, Ms. Alta Charo, Associate Dean 

for Research and Faculty Development, University of Wisconsin 

Law School, Mr. Andrew Kimbrell, International Center for Technology Assessment, and Mr. Richard Doerflinger, Associate Director for Policy Development, U.S. Conference of Catholic Bishops. 

I was just informed that a witness in that first panel, Lynne 

Millican, is in at Union Station, so we may add her to you as a 

panel when she comes on forward. 

Ms. Charo, thank you very much for joining us today, and the 

floor is yours. 

STATEMENT OF R. ALTA CHARO, J.D., ASSOCIATE DEAN,

PROFESSOR OF LAW AND BIOETHICS, UNIVERSITY OF

WISCONSIN LAW AND MEDICAL SCHOOLS 

Ms. CHARO. Thank you very much, Senator Brownback, and 

thank you for the opportunity to discuss with you a shared goal of 

preventing irresponsible efforts to use cloning to produce children. 

As you know, Congress has repeatedly tried to bolster the FDA’s 

already successful efforts to prohibit reproductive cloning, but each 

effort has become bogged down in a related, but distinctly separate, 

debate concerning the use of cloning for nonreproductive research 

or therapeutic purposes, and I urge you today to separate those two 

debates. 

S. 303 bans reproductive cloning with stiff penalties for those scientists and doctors who might dare to make such an attempt by 

transferring a cloned embryo into a woman’s body, and it builds on 

26

the extensive existing regulation of cloning research by adding even 

further regulatory safeguards. 

Now, if and when cloning research is done in humans for therapeutic ends—that is, to produce embryos whose stem cells will be 

transplanted back into the donor to repair damaged organs—it is 

clearly and indisputably covered by the FDA regulations on cellbased therapy and transplantation, regulations that already apply 

to privately funded activity and that, by virtue of the congressional 

delegation of power to FDA, answers some of the very questions 

raised earlier today about the appropriate transition from animal 

to human research and the scaling of human research under close 

monitoring. 

FDA’s regulations cover myriad aspects of the work, from the 

labs where it is done to the collection of the eggs, the nuclear 

transfer procedure, the derivation of stem cells, and, finally, the 

transplant back to the donor. The regulations also require that 

every aspect of the work be carried out under the strict oversight 

of an institutional review board. Those IRBs ensure that reimbursement to egg donors is reasonable and poses no risk of donors 

being tempted to abandon their own good judgment. The IRBs also 

review the scientific basis for determining the risks and benefits 

that will be described to these women and the actual documents 

that will embody the information for their use when they give their 

informed consent. IRBs also monitor the research while it goes on, 

with periodic updates to guard against unexpected side effects. 

This is the same comprehensive scheme of protections used generally for human subjects research in the United States. 

Now, S. 303 would build on this very extensive set of current regulations that governs all publicly or privately transplant-related 

work by extending the common rule to even privately funded work 

that does not involve transplantation as an end point. Under S. 

303, even basic research that involves only developing stem cell 

lines for work in the laboratory would still require informed consent from egg donors and oversight by IRBs so that no aspect of 

cloning work, whether for therapeutic or purely research purposes, 

could proceed unmonitored. 

Now, given the extensive existing and proposed regulation, I believe that prohibiting all cloning research is unduly burdensome 

and, in addition, subject to constitutional challenge. For 30 years, 

courts and scholars have discussed the scope of the First Amendment and its protection of scientific research as part of the freedom 

of thought, inquiry, and dissemination of knowledge that is at the 

core of that aspect of the Bill of Rights. Thought and the testing 

of thoughts through science facilitates the dissemination of ideas 

just as much as monetary contributions to political campaigns facilitates the expression of political ideas. And indeed, in many 

cases, research is, in and of itself, a form of political expression. 

In other places and other times, governments have sought to ban 

the dissection of the human body because it would interfere with 

deeply felt notions of the body as a reflection of the divine order; 

or sought to ban investigation of the orbits of the planets, as it 

would interfere with essential views about the place of humankind 

in the universe. So, too, does investigation of the origins of life, of 

the secrets of conception and development, threaten our deepest 

27

views concerning the sources of life. But the First Amendment exists precisely to protect the development and dissemination of 

knowledge and truth and opinion so that it may be tested and retested over time in the marketplace of ideas. 

Certainly, of course, protected activities are still subject to reasonable regulation; but where prohibitions are designed merely to 

guard against the development of knowledge for fear it might 

someday be used in controversial ways, it runs afoul of the very 

basis of the First Amendment protection of inquiry. 

And where prohibitions are designed to guard against violating 

the rights of embryos, they run athwart of the legal reality that 

federal law does not grant embryos the same rights as live born 

children. Indeed, the Supreme Court has repeatedly reiterated its 

view that even while science and theology and philosophy continue 

to debate the biological and moral status of the embryo, the Constitution does not grant them the rights of persons under the law. 

Any federal law that goes beyond reasonable regulation and instead entirely bans nonreproductive research and therapeutic 

cloning applications, therefore, is vulnerable to challenges in interference in the First Amendment rights of patients, doctors, and scientists, a challenge that might well result in an injunction on the 

enforcement of the entire federal law during the many years that 

judicial review runs its course. 

I, therefore, urge the Congress to focus on legislation that prevents the unsafe practice of reproductive cloning. I also urge it to 

adopt the additional regulatory protections for nonreproductive research uses of cloning, as proposed in S. 303, so the public is reassured that every measure has been taken to guide the research in 

a responsible way. 

A debate on embryo research, generally, or on nonreproductive 

cloning research, in particular, can always proceed separately, to be 

debated on its own merits and ultimately to be tested on its own 

terms before the constitutional authorities of the Nation. 

Thank you very much, Senator Brownback. 

[The prepared statement of Ms. Charo follows:]

PREPARED STATEMENT OF R. ALTA CHARO, J.D., ASSOCIATE DEAN, PROFESSOR OF

LAW AND BIOETHICS, UNIVERSITY OF WISCONSIN LAW AND MEDICAL SCHOOLS

Mr. Chairman and Members of the Committee, 

My name is Alta Charo, and I am a professor of law and bioethics at the University of Wisconsin. Thank you for this opportunity to discuss with you a shared goal, 

the goal of preventing irresponsible experimentation that involves the use of somatic 

cell nuclear transfer (that is, cloning) to produce a live-born child. 

Because cloning is not, and may well never be, a safe method for conceiving children, there is virtually perfect consensus that such attempts ought to be discouraged. The Federal Food and Drug Administration has already taken a first and definitive step toward this goal, by announcing that it views attempts to use somatic 

cell nuclear transfer to create a child to fall within the scope of its regulatory authority, and by further announcing that this technique may not legally be used in 

the United States for this purpose. 

While scholars may argue about the precise statutory language behind this action, 

it is a fact that FDA has already enforced its authority, by investigating alleged attempts to use cloning to produce a live-born child, and by issuing warning letters 

to those suspected of being most likely to try this unsafe experiment. The small 

number of eccentric scientists who claim an interest in pursuing this effort have reacted by moving their activities to other countries, and by acknowledging in the 

press that they understand that cloning to produce a live-born child is illegal in the 

United States, thus confirming the effectiveness of FDA’s enforcement efforts. 

28

The Congress has repeatedly demonstrated its interest in bolstering FDA’s already successful efforts, whether by re-affirming and particularizing its jurisdiction 

over this activity or by banning the practice directly by legislative action. In each 

effort, however, Congress has become bogged down in a related but distinctly separate debate concerning the use of cloning for research or therapeutic purposes. 

I urge you today to separate these two debates, both to protect the valuable scientific and medical advances that may emerge from non-reproductive cloning research, and to pave the way to effective action to discourage attempts to use this 

technique to produce children. 

S. 303, introduced and co-sponsored in the Senate by Members such as Senators 

Hatch, Feinstein, Kennedy, and Specter would prohibit all efforts to use cloning to 

produce children. Stiff penalties are applied to those who would dare to make such 

an attempt. The simple act of transferring a cloned embryo into a woman’s womb 

becomes definitive proof of the attempt and triggers criminal penalties for those doctors or scientists who make the attempt. 

Critics of this approach express concern that such legislation would be difficult 

to enforce, and urge Congress to ban basic research lest it lead to the prohibited 

act of transferring a cloned embryo into a womb for development. But criminal law 

is almost always grounded in a theory of deterrence. We do not prohibit the manufacture of guns in order to guard against the possibility of their future misuse in 

homicide. Rather, we criminalize misuse of guns and prosecute the offenders accordingly. 

Critics of this approach also worry that this leaves other, non-reproductive forms 

of research unregulated, and fear it may lead to exploitation of egg donors or the 

diversion of this research toward eugenic ends. But these critics overlook both the 

extensive existing regulation of cloning research and the additional regulatory safeguards that have been proposed in new legislation before the Senate. 

If and when cloning research is done for therapeutic ends, that is, when it is done 

to produce embryos whose stem cells will be transplanted back into the donor in 

an effort to repair or regrow damaged tissues of the brain, the heart and other organs, it is clearly and indisputably covered by the FDA regulations on cell-based 

therapy and transplantation. These regulations cover all such research, even when 

it is done with private funding. 

FDA’s regulations cover myriad aspects of the research, from the laboratories 

where it may be done, to the collection of eggs, to the nuclear transfer procedure, 

to the derivation of stem cells, to the final transplant back to the donor. And FDA 

regulation also requires that every aspect of the work be carried out under the strict 

oversight of an Institutional Review Board (IRB), whose job is to guarantee that 

eggs are donated only after voluntary and fully informed consent. 

IRBs ensure that reimbursement to egg donors for their time and inconvenience 

is reasonable and poses no risk of donors being tempted to abandon their own good 

judgement. And IRBs review the scientific basis for the information given to egg donors about the risks associated with egg donation, as well as the actual documents 

they will be given to ensure that their consent is genuinely informed. IRBs also 

monitor research, with periodic updates to guard against unexpected side-effects in 

donors or unexpected problems in the laboratory management of the cloned materials and stem cells. This is the same, comprehensive scheme of protections used 

generally for human subjects research, and our experience in the United States 

demonstrates that research with human subjects, is not only extremely safe, it is 

far safer than the ordinary practice of medicine. 

This system of protections is supplemented with an extra layer of safeguards 

whenever genetic engineering is introduced into research. If and when cloning research comes to involve genetic manipulation of any sort involving the embryo or 

its stem cells, it will also be screened by the Federal Recombinant DNA Advisory 

Committee, which has long functioned as the gatekeeper to gene therapy. This Committee’s charge is broad, and it is empowered to examine every aspect of research 

to ensure its safety for all participants. 

S. 303 would extend this comprehensive system of protections to all cloning research, by extending the Common Rule for human research protections even to privately funded research that does not involve transplanting the resulting stem cells 

back into the donor. Unique to cloning research is the possibility of cloning tissue 

from women who suffer from breast cancer or autoimmune diseases, so that specialized stem cell lines that exhibit these diseases can be grown in the laboratory for 

further research and testing. No other source of stem cells, neither those from surplus IVF embryos at infertility clinics nor those from bone marrow or other sources 

of adult stem cells can be used for this crucial research. Here, S. 303 would require 

informed consent from egg donors and oversight by IRBs, so that no aspect of 

29

cloning work, whether for therapeutic or purely research purposes, would proceed 

unmonitored. 

Given the extensive regulation that already exists, and the proposals for extending that regulation even further, outright prohibitions or moratoria on cloning research are unduly burdensome and subject to constitutional challenge. 

For thirty years, federal courts and nationally recognized scholars have discussed 

the scope of the First Amendment and its protection of scientific research as part 

of the freedom of thought, inquiry, and dissemination of knowledge that is at the 

core of that aspect of the Bill of Rights. Research is an integral part of the scientific 

method, a form of inquiry that fits uniquely within the purposes, histories, and 

structures of the First Amendment. Thought and the testing of thoughts through 

science facilitates the dissemination of ideas just as much as monetary contributions 

to political candidates facilitates the expression of political ideas. 

Indeed, in many cases, research is in and of itself a form of challenging political 

ideas. In other places and other times, governments have sought to ban the dissection of human bodies, because it would interfere with deeply felt notions of the body 

as a reflection of the divine order, or have sought to ban investigation of the orbits 

of the planets, as it would interfere with essential views about the place of humankind in the universe. So, too, does investigation of the origins of life, of the secrets 

of conception and development, threaten our deepest views concerning the sources 

of life. But the First Amendment exists precisely to protect the development and dissemination of knowledge and truth and opinion, so that they may be tested and retested over time in the marketplace of ideas. 

Certainly, even protected activities are subject to reasonable regulation to avoid 

interfering with the rights of others. But where prohibitions are designed merely to 

guard against the development of knowledge, for fear it might someday lead to new 

and controversial ways to manipulate cells and genes, they run afoul of the very 

basis of the First Amendment protection of inquiry, association, and dissemination. 

And where prohibitions are designed to guard against violating the rights of embryos, they run athwart of the legal reality that federal law does not grant embryos 

the same rights as live-born children. Indeed, the Supreme Court has repeatedly reiterated its view that even while science, theology and philosophy continue to debate 

the biological and moral status of the embryo, the Constitution does not grant them 

the rights of other persons under the law. 

Any federal law that goes beyond reasonable regulation of cloning research and 

enacts a temporary or permanent ban on this form of scientific inquiry is thus vulnerable to challenge in court as an interference with the First Amendment rights 

of patients and researchers. Such challenges might well result in an injunction to 

forbid enforcement of the federal law until judicial review has been completed, a 

process that can take years. During such a hiatus, the federal law is inoperative, 

thus thwarting Congressional efforts to use legislation to prevent reproductive uses 

of cloning. 

If the Congress wishes to take action with regard to reproductive cloning, I urge 

it to focus on legislation that prevents that unsafe practice. 

I also urge it to adopt the additional regulatory protections proposed in S. 303 for 

research and therapeutic applications of cloning, so that the public can be reassured 

that every measure has been taken to guide this research along a responsible path. 

A separate debate, on embryo research generally or non-reproductive cloning research in particular, can always proceed separately, to be debated on its own merits, 

and ultimately to be tested on its own terms before the constitutional authorities 

of the nation.

Senator BROWNBACK. Thank you very much. 

Mr. KIMBRELL.

STATEMENT OF ANDREW KIMBRELL, EXECUTIVE DIRECTOR,

INTERNATIONAL CENTER FOR TECHNOLOGY ASSESSMENT 

Mr. KIMBRELL. Thank you very much, Mr. Chairman, for the opportunity to speak today, and I also thank you for having a hearing 

on this very important subject that I think too often has been ignored in the multiyear debate now that we have had in Congress 

on cloning, the very crucial issue of the women’s health implications of both research and reproductive cloning. 

I am an attorney and the executive director of the International 

Center for Technology Assessment. But also, for ten years I served 

30

as the chairman of the National Coalition Against Surrogacy, 

where I, firsthand, litigated on behalf of dozens of women across 

the country who were victimized by commercialized childbearing. 

And so I saw firsthand what these fertility drugs can do and what 

this process can do, both physically and psychologically, to women 

around the country. 

Now, I have submitted a more detailed statement for the record, 

Mr. Chairman. I would like to just summarize and perhaps focus 

on a couple of the points that have been made and see if I can be 

of some help on this. 

Senator BROWNBACK. Your statement will be in the record. 

Mr. KIMBRELL. Thank you. 

Perhaps, first, in that there seems to be, sort of, a cost-benefit 

analysis going on here, I wonder how many Senators would answer 

a certain pop quiz correctly, Mr. Chairman, and that would be, 

‘‘How many stem cells have been garnered from cloned human embryos as we sit here today?’’ And this is by peer-reviewed studies, 

which show how many. And the answer, Mr. Chairman, is zero. 

Zero. With all the testimony I have heard in five years, and I’ve 

testified myself, about all these cures—I have heard scientists come 

here for five years—the number of stem cells that have been garnered from cloned human embryos is zero. 

And I think this is essential for a couple of reasons as we look 

toward this, because I think that we are seeing recent science that 

suggests that—exactly as you were suggesting, Mr. Chairman, in 

that Dolly was the 277th try and the horrible birth defects that 

were testified in the Senate about—that research is showing that 

something happens during the cloning process. 

Dr. Yenich has a recent study, peer reviewed, that says there is 

silencing of certain genes once a cell, an embryo, is cloned. And I 

think we may be looking, in the future, at a scenario where it is 

understood that cloning harms embryos in a way that will never 

allow them—never allow them—to be a consistent source of stem 

cells. 

So at the outset, I would suggest that we separate these two debates. I am here representing a coalition of environmentalists and 

feminists and over a hundred others who have signed on for a ban 

on reproductive cloning and a moratorium on research cloning. 

Many of them support expanded stem cell research. But to confuse 

the stem cell debate with the cloning debate, when right now we 

have zero stem cells coming from embryo cloning, to me is disingenuous at best, and it has been done time and time again. 

There are a couple of other points that I think are very, very important to make here, and one has to do with the enforcement. The 

Hatch bill, S. 303, seeks to both halt reproductive cloning and encourage research cloning. And if you look at that bill and the definitions of that bill, there is a definition of a ‘‘cloned embryo’’ as an 

unfertilized blastocyst. 

And let us consider this term for a moment, an ‘‘unfertilized blastocyst.’’ This appears to me to be intentionally misleading. 

‘‘Unfertilized’’ seems to me that it would be unviable, or could 

never become a child. We know that is not true. If that 

‘‘unfertilized blastocyst’’ were transplanted into a woman’s womb, 

it, indeed, would grow into a child—perhaps not a healthy child, as 

31

we have learned from the Dolly experience, but it would become a 

child. And second of all, there seems to be the idea that because 

it is a blastocyst, it is not an embryo, and that is not correct. Of 

course it is an embryo. 

As a matter of fact, and this is absolutely critical—and before the 

Senate, the Department of Justice testified last year that once a 

cloned embryo has been created, it is indistinguishable, biologically, 

from a normal fertilized embryo. All right? Once the cloned embryo 

is created, it is indistinguishable from a fertilized embryo. 

Now, think about the enforcement issues this raises once, as in 

the Hatch bill, thousands, perhaps millions, of these cloned embryos are created, once they are out there, once they are in an IVF 

clinic, once they are transported, shipped, frozen, which this bill allows, 303. They will be indistinguishable from other embryos, biologically. That is an enforcement nightmare. Imagine trying to enforce firearms or drugs if once they were created, they became literally invisible and were allowed to be shipped, transported, frozen. 

So the question is, in S. 303, where they try and enforce their 

ban on reproductive cloning by basically saying that the illegal act 

is the transferring of this embryo into a woman, how are we going 

to know which kind of embryos are being transferred into a 

woman? At that late stage, how do you even know whether it is a 

cloned embryo or a conventional fertilized embryo? There is no way 

to know. 

Additionally, the idea of having a police force that is going into 

doctors’ offices around the country to try and find out whether the 

transfer to a woman was from a cloned or a fertilized embryo is not 

only a huge invasion of privacy, but is obviously, from an enforcement standpoint, ridiculous. But even if you had that police force, 

they would not be able to tell, right? Because they would not be 

able to distinguish that embryo from a normal embryo. 

So this term ‘‘unfertilized blastocyst’’ hides the fact that these 

embryos, indeed, are identical, and that the only way—the only 

way—you can have responsible legislation in this area is at the 

supply level. In that once they are created, they are indistinguishable from other embryos, clearly the only way to stop this is at the 

supply level; in other words, to either ban the process of creating 

cloned embryos or to have it so restricted and so monitored that we 

have custody of each and every embryo created. Otherwise, no 

one—you, me, no one in this room, no scientist—can tell us which 

embryos are out there and what is being done with them. As such, 

the enforcement scheme, as laid out in 303, is legally incoherent, 

scientifically incoherent, and will do nothing to halt reproductive 

cloning. 

Now, adding insult to injury, 303 then has a provision that 

seems to admit that there are some enforcement problems here and 

says one year after the bill has been passed, they want a report on 

exactly what enforcement is happening or not happening. 

Mr. Chairman, I would suggest that the time to do studies on enforcement is not after a harmful practice has been allowed to be 

disseminated and perhaps creating its harm in this invisible way 

throughout the country, but before we allow a harmful practice to 

ever be sanctioned by law. The idea of having a bill that says, 

32

‘‘Let’s look at enforcement a year after we allow this process,’’ 

again, is legally incoherent, and I cannot understand it. 

Now, Ms. Charo mentioned that the—correctly, I think—that 303 

relies on these institutional review boards for a case by case study 

and approval of research cloning. Let me read you a 1998 report 

by the HHS office, the Inspector General’s report to the HHS, on 

the efficacy of institutional review boards in monitoring and reviewing these kinds of human subject experiments. In this report, 

the Inspector General found, ‘‘that the IRBs reviewed too much, too 

quickly, with too little expertise, that they conducted minimal continuing review of approval research, that they faced conflicts of interest that threatened their independence, provided far too little 

training for investigators and board members.’’ A 2000 report looking at how these reforms were possibly carried out, they basically 

said, ‘‘minor changes, but these problems still exist, are endemic to 

these IRBs and have not been cured.’’

Well, I find it very troubling, Mr. Chairman, that the core, the 

backbone, of regulations, S. 303, is these IRBs that HHS, for the 

last five years, has been saying are not working. 

A couple of final points. One of the first opportunities I had in 

Washington many, many years ago, was working with then-Representative Al Gore to help create and then pass the Organ Transplant Act. This, as you know, is the act that prohibits the sale of 

organs in the United States. And as such, we faced a very difficult 

question about what kind of reasonable compensation people 

should be given for organ donation. One of the considerations we 

had at that time was whether ‘‘time and inconvenience,’’ those 

terms, should be used for something that you could recompense 

people who had donated their organs. We rejected it at that time, 

because we viewed it as I think it is, a loophole for virtually any 

kind of payments you want to give. 

Now, a couple of years ago, a spokesman for the infertility industry admitted that time and inconvenience was simply, ‘‘semantics.’’ 

It means ‘‘payment.’’

So the fact that we are talking about—in S. 303, the fact that 

they are saying you cannot have valuable consideration to these 

egg donors, but you can pay them for their time and inconvenience, 

according to the infertility industry, itself, is semantics. ‘‘Payment’’ 

and ‘‘time and inconvenience’’ are the same thing. 

And let me read you from the marvelous legal scholar, George 

Annas on this, on the term ‘‘inconvenience’’ as used in this valuable 

consideration for paying for women’s eggs. This is George Annas 

now, ‘‘Of course, you’re not really buying a woman’s inconvenience. 

It’s a bogus argument that you’re not actually selling these eggs. 

Clearly, donors are selling their reproductive capacity. And if you 

can sell your egg, then shouldn’t you sell your child, too?’’

Again, in contrast to this, I urge the Committee to look at the 

Organ Transplant Act, where we do not allow this huge loophole 

that has been allowed in this bill. 

A couple of final points, if I could. One is this idea that we are 

restricting science and that that is a possible offense to the First 

Amendment. One of my privileges as an attorney has been to do 

numerous litigations under the Animal Welfare Act. In order to 

protect animals from cruel experiments, experiments that offend 

33

both their dignity and their physical and psychological wellbeing, 

we have numerous restrictions on experiments that can be conducted in virtually every area of medicine. Numerous. None of 

those has ever been subjected, to my knowledge, to any kind of constitutional attack, and I think anybody who thought that they 

could do that would not be taken seriously, legally. If, to protect 

animals, we can have significant restrictions on research, I do not 

know why we cannot do the same thing for women’s health. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Kimbrell follows:]

PREPARED STATEMENT OF ANDREW KIMBRELL, EXECUTIVE DIRECTOR, INTERNATIONAL CENTER FOR TECHNOLOGY ASSESSMENT

Mr. Chairman and Members of the Committee: 

My name is Andrew Kimbrell. I am the Executive Director of the international 

Center for Technology Assessment, an attorney and author of The Human Body 

Shop: the engineering and marketing of life (Harper Collins 1991, 3rd Edition 1998). 

I am here today as part of a broad coalition of progressive environmental, consumer 

and women’s health groups who agree that responsible policy on the matter of 

human cloning requires a ban on reproductive cloning and a moratorium on human 

cloning for research. The potential impacts to women of human reproductive cloning, 

but especially, human research cloning have received insufficient attention in the 

cloning debate, and I’m grateful to the Committee both for recognizing the importance of this issue and providing me the opportunity to testify today. I’d like to 

begin by summarizing the physical and psychological risks to women posed by 

human reproductive and research cloning. I will then provide a brief analysis of S. 

303, introduced by Senators Hatch and Feinstein and explain why, as currently 

written, this bill would neither effectively ban human reproductive cloning nor provide adequate protection to women. 

The Impacts of Human Cloning to Women 

Human cloning is a process in which a nucleus from a human somatic cell is fused 

with an enucleated human egg cell to produce a cloned embryo. The technical term 

for this process is ‘‘somatic cell nuclear transfer.’’ There are two potential uses of 

cloned embryos produced by nuclear transfer, each of which pose significant risks 

to women. In the case of human reproductive cloning, cloned embryos would be 

transferred into a woman’s uterus, and, if brought to term, would result in a child 

that would be a genetic duplicate of the nuclear donor. In the case of human cloning 

for research purposes, these cloned embryos would be used to develop stem cell lines 

for regenerative tissue research. The following describes the risks to women posed 

by each of these two types of human cloning. 

Human Reproductive Cloning 

Human reproductive cloning is widely condemned and has been outlawed by more 

than 30 countries. Many scientists agree that reproductive cloning is an inherently 

unsafe procedure that could only he made ‘‘safe’’ by carrying out extensive, unethical 

experimentation on women. The physical risks associated with this procedure cannot be overstated. Almost all cloning experiments in mammals have resulted in miscarriages, stillbirths, and deformities. Many efforts to clone mammals have resulted 

in abnormally large fetuses, often up to twice the average size. In humans, ‘‘large 

offspring syndrome’’ of this magnitude could be fatal to a surrogate mother as well 

as to the fetus. Finally, experiments in mammals have been highly inconsistent and 

unpredictable. As such, endless experimentation with mice, sheep, cats, even monkeys may never provide us the level of confidence required to attempt this procedure 

in humans. 

As many scientists, health professionals, ethicists and others have noted, these insurmountable risks, alone, warrant a permanent ban on human reproductive 

cloning. In addition, reproductive cloning poses significant psychological and social 

risks to women. Surrogate mothers who would have to undergo the stillbirths and 

miscarriages and witness the deformities involved in attempting to create a successful clone would suffer an enormous emotional and psychological toll. In addition, if 

reproductive cloning were allowed, an increase in demand for surrogate mothers 

would exacerbate an already coercive market in the buying and selling of women’s 

wombs. That demand would likely be met by low-income women, pressured into selling their bodies as ‘‘mother machines’’ to those who can afford the price. 

34

Human Embryo Cloning for Research 

The impacts to women (and social consequences, generally) posed by human research cloning have been less widely discussed, but are nonetheless compelling. 

They include the following:

• Research cloning is a highly inefficient process, which would require an unlimited supply of human eggs. It has been estimated that research cloning might 

be able to provide up to 1.7 million therapies per year. Assuming a highly optimistic success rate of 1 stem cell culture per 5 cloned embryos, and one cloned 

embryo per 10 eggs, these therapies would require 85 million eggs, or 8.5 million egg donors.

• Egg donation is a burdensome, risky, and painful procedure. Egg donation is not 

a simple process; it lasts several weeks, and includes repeated injections of fertility hormones and super-ovulatory drugs and finally, surgery. Risks associated 

with egg extraction include a potential link to ovarian cysts and cancers, severe 

pelvic pain, abdominal bleeding, and ovarian hyperstimulation syndrome, a potentially life-threatening condition.

• An explosion in demand for human eggs would exacerbate the coercive nature 

of the lucrative egg donation industry. Currently, compensation to women for 

egg ‘‘donation’’ is uncapped, and ranges from an average payment of $5,000–

$6,000 to as high as $80,000. The increase in egg demand created by research 

cloning is likely to increase the price of eggs and coercive potential of the egg 

market.

• The burden of egg supply will likely fall on underprivileged women. There are 

no federal standards concerning limitations on the number of times a woman 

can donate eggs. Low-income women may feel obliged to choose repeated egg donation as a source of income.

• Research cloning will result in a loss of choice for women. Researchers can clone 

embryos from any number of body cells. A woman’s cells could be removed for 

the creation of any number of cloned embryos without her knowledge or choice.

• The perfection of techniques to create cloned human embryos through research 

cloning would make it far more likely that reproductive cloning will occur. The 

major barrier to successful reproductive cloning lies not in implantation, but in 

the development of the ability to clone embryos free of reprogramming errors. 

Allowing the creation of cloned embryos would encourage the perfection of this 

technical barrier, after which uterine implantation would be a trivial step. As 

such, research cloning is the gateway for eventual reproductive cloning and its 

profound impacts on women’s health described above.

• Perfection of research cloning techniques will also open the door to creating ‘‘designer babies.’’ Inheritable genetic modification, or germline engineering, is a 

process that involves changing genes that are passed on to future children. This 

technique has been used to create ‘‘transgenic’’ animals for commercial and research purposes, and some scientists and others are advocating its acceptance 

and use in humans. Perfection of research cloning techniques is necessary for 

‘‘designer babies’’ to become commercially practicable. Allowing genetic ‘‘enhancements’’ in humans would unleash a powerful new eugenics, and could lead 

to unacceptable forms of genetic discrimination and inequality, not unlike those 

that many advocates for women’s health and rights have worked so hard to 

overcome.

A Misguided Legislative Approach: S. 303 

On February 5, 2003, Senators Hatch (R–UT), Feinstein (D–CA), Specter (R–PA), 

Kennedy (D–MA), Harkin (D–IA), and Miller (D–GA) announced the introduction of 

S. 303, a new bill to address the issue of human cloning. At a hearing held by the 

Senate Committee on the Judiciary on March 19, Senator Hatch stated that the 

purpose of the bill is twofold: (1) To stop any attempts to facilitate the birth of a 

cloned baby; and (2) to allow a promising form of stem cell research to go forward 

under ‘‘strict ethical guidelines.’’ A closer examination of S. 303 reveals that neither 

of these goals will be accomplished by this bill. In particular, the bill, as currently 

written, will not effectively prevent human reproductive cloning, nor will it adequately protect women. CTA is preparing a thorough, in-depth analysis of this deeply flawed and misguided legislation, which it will provide the Committee in the near 

future. However, today I would like to focus on just a few of the more egregious 

failings of S. 303. 

35

S. 303 Fails To Effectively Prevent Human Reproductive Cloning: 

Among the changes from last year’s incarnation of this bill is its use of the term 

‘‘unfertilized blastocyst’’ to describe a cloned human embryo. The use of this term 

appears to be intentionally misleading. It suggests that, once created, clonal embryos (i.e., ‘‘unfertilized blastocysts’’) could he distinguished from ‘‘fertilized’’ embryos, namely those created from the union of an egg and a sperm. Additionally it 

seems to suggest that the ‘‘unfertilized blastocyst’’ is in some way not viable, that 

if it were transferred to a woman’s womb it would not result in a child. It is true 

that a cloned embryo is not fertilized in the traditional sense, by way of the union 

of an egg and sperm. However a cloned embryo is potentially as viable as a conventional embryo and if implanted in a womb could result in a cloned child. Moreover, 

and very importantly, once created a cloned embryo (‘‘unfertilized blastocyst’’) cannot be distinguished from a ‘‘fertilized’’ embryo. To repeat once an embryo is cloned 

it is biologically identical to a fertilized embryo and cannot be distinguished from 

a fertilized embryo nor identified as a cloned embryo. 

This important fact, purposely obscured by S. 303, underscores the enormous challenge in enforcing any restriction on the sale or use of cloned embryos after they 

have been created. The bill allows for the production of an endless supply of cloned 

human embryos without acknowledging that once they are produced they are biologically identical to conventional embryos and will be virtually impossible to find. 

This simple fact demonstrates that any attempt to regulate the use of cloned embryos after they have been created is legislating the impossible. Imagine trying to 

regulate the use of drugs or firearms if they became invisible once they were created 

and you get the scope of the difficulty in enforcing the ban on reproductive cloning 

attempted by S. 303. 

Clearly the only coherent approach to halting reproductive cloning is at the supply 

level, that is to either ban or significantly restrict the creation of cloned embryos. 

S. 303 does the reverse. it encourages the creation of cloned embryos but does not 

in any way provide direct oversight of the number of facilities creating human 

cloned embryos, limit the number of clonal embryos created, or create a strict chain 

of custody requirement for each individual cloned human embryo produced for research purposes. As such, there is no way to ensure that cloned embryos purportedly produced for research purposes are not subsequently transferred to a woman’s 

uterus. This potential that these embryos will be used for reproductive cloning is 

exponentially increased because the bill explicitly allows for: (1) Freezing; (2) transport; and (3) export of cloned human embryos. Without either a ban on the production of cloned embryos or a highly restricted production of cloned embryos that is 

subject to a rigorously enforced system of monitoring that tracks the chain of custody 

of each and every cloned human embryo produced, there can be no way to ensure 

that attempts to clone human beings are not being undertaken. S. 303 provides for 

neither of these alternatives and therefore will completely fail in its stated purpose 

of halting human reproductive cloning and will also fail in preventing the serious 

impacts on women’s health which reproductive cloning will bring. 

Rather than addressing this enforcement issue directly, S. 303 calls for a series 

of reports on enforcement mechanisms found in state or international laws to be 

completed one year after the bill has been passed. This is incomprehensible. Allowing human cloning to proceed for a year, or potentially several years, while various 

enforcement schemes are reviewed and studied in order to arrive at adequate enforcement is legally incoherent. The whole point of regulatory legislation is to develop an effective enforcement regime before allowing a certain potentially harmful 

activity to proceed, not after it has been disseminated and creates the harm the legislation was intended to avoid. 

S. 303 Fails to Provide Adequate Protection to Women Egg Donors: 

The bill assigns the primary load of protecting women in research cloning to existing human subject protection regulations. Yet it is probable that these regulations 

would not even apply to egg donors or somatic cell donors. This is because these 

donors would not be ‘‘research subjects’’ as contemplated under the regulations; instead, they are ‘‘donors’’ of biological material, not a class currently covered under 

the regulations. Even if these regulations did apply, companies involved in cloning 

embryos could avoid these requirements by obtaining human eggs and cells from 

outside sources and not directly from the donors. In addition, standards of Investigational Review Board (IRB) review are not the most efficient or practical way to 

provide consistent protection to these participants. Decisions about the appropriate 

process for extracting and using human eggs and somatic cells in research should 

not be made on an individual, case-by-case basis, or left to the whim of a given IRB. 

Instead, federal standards should be developed that are specific to women’s health 

concerns. 

36

I would add that the bill’s reliance on IRBs as the primary means to monitor and 

control human cloning activity also ignores serious issues that have been raised 

about these Boards. A number of recent major failures in human research protection 

have led me, and many in the scientific community, to believe that most of the important issues raised in the 1998 HHS Office of Inspector General Report ‘‘Institutional Review Boards: A Time for Reform’’ have yet to be effectively addressed. 

In this 1998 report the Inspector General found that IRBs:

• reviewed too much, too quickly, with too little expertise; 

• conducted minimal continuing review of approved research; 

• faced conflicts that threatened their independence; and 

• provided too little training for investigators and board members.

They also found that neither IRBs nor HHS devoted much attention to evaluating 

IRB effectiveness. 

In a follow up investigation in 2000, the OIG found that while several promising 

steps had been taken by NIH and FDA, few of the recommended reforms had been 

enacted. Of particular continuing concern to the IG were the areas of:

• flexibility and accountability; 

• oversight and human protections; 

• board and investigator education; 

• conflicts of interest; 

• workload; and 

• federal oversight.

Virtually the same list as in 1998. Given these findings, if we are serious about 

ensuring that reproductive cloning cannot occur, and that women’s health be protected IRBs are not any kind of answer for at least the foreseeable future. 

Let me conclude with S. 303’s handling of the exploitation of women in the egg 

donation process. There can be no doubt that the endorsement of research cloning 

in S. 303 would stimulate a major expansion in the market for women’s eggs. At 

the same time, the bill does not adequately address the coercive aspects of the egg 

donation industry, which would be exacerbated by a massive increase in the demand 

for women’s eggs. While the bill prohibits the purchase or sale of human eggs for 

use in embryo cloning research ‘‘for valuable consideration’’, it does so with a large 

loophole. While ‘‘valuable consideration’’ is prohibited the bill does allow for payment to egg donors for the ‘‘time or inconvenience’’ associated with the donation. 

This vague provision has been used for years by institutions around the country to 

allow them to pay tens of thousands of dollars to egg donors. Ultimately, there is 

little real difference between paying for eggs or for the ‘‘time and inconvenience’’ of 

their removal. ‘‘It’s almost a matter of semantics,’’ admits Joyce Zeitz, former public 

relations coordinator for the American Fertility Society. Legal scholar George Annas 

sees the term ‘‘inconvenience’’ as nothing more than a ruse: ‘‘Of course, you’re not 

really buying a woman’s inconvenience. It’s a bogus argument that your not actually 

selling these eggs. Clearly, donors are selling their reproductive capacity. And if you 

can sell your egg, then why shouldn’t you sell your child too?’’ In contrast to S. 303 

language, I would point out that the U.S. Organ Transplant Act prohibiting sale of 

organs does not have the ‘‘time and inconvenience’’ loophole. I would further note 

that S. 303 contains no caps on the number of times a woman can donate/sell eggs. 

As such, economically disenfranchised women are likely to become repeat donors. 

In sum, if passed S. 303, will encourage unlimited production of unidentifiable 

cloned embryos. This will not halt but rather facilitate human reproductive cloning 

and thus will completely fail to adequately protect women’s health from the dangers 

of all forms of human cloning. The bill is deeply flawed both in concept and in its 

specifics. It is simply irresponsible legislation. 

Thank you.

Senator BROWNBACK. Thank you, Mr. Kimbrell. 

Mr. Doerflinger? 

STATEMENT OF RICHARD M. DOERFLINGER, DEPUTY

DIRECTOR, SECRETARIAT FOR PRO–LIFE ACTIVITIES, U.S.

CONFERENCE OF CATHOLIC BISHOPS 

Mr. DOERFLINGER. Thank you, Mr. Chairman. 

Human cloning is an unethical and dehumanizing procedure; 

and, ironically, the most startling evidence of its dehumanizing asVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00040 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
37

pects can be found in some proposals ostensibly aimed at preventing human cloning. A case in point, in my view, is the HatchFeinstein Human Cloning Ban and Stem Cell Research Protection 

Act, S. 303. The bill is gravely deficient in at least eight ways. I 

say ‘‘at least,’’ because I had one day to write the testimony. I will 

find 20 more tomorrow. 

Very briefly, first, the bill is offered under false pretenses. In 

fact, it does not ban human cloning at all, for any purpose. ‘‘Human 

cloning’’ is defined by the National Academy of Sciences as the production of an organism that has the same nuclear genome as another organism. And contrary to the fertility doctor who testified 

earlier, there is a virtually unanimous consensus among Congress, 

the NIH, the National Bioethics Advisory Commission, and many 

others that the embryo, even at the earliest stage, is an organism 

of the human species. That is not a moral or political statement; 

it is simply basic science. In fact, there is a great deal of law on 

stem cell research right now that is based on the legal opinion that 

a stem cell is not an organism, but an embryo is. When you 

produce that embryo, you have done human cloning. S. 303 does 

nothing whatever to place any limits on cloning, for any purpose 

or no purpose. 

Two, what it does ban is embryo transfer, which is a distinct procedure also defined by the National Academy of Sciences. And that 

creates a great many problems, some of which Mr. Kimbrell has 

just gone over. The bill’s penalties are directed not at irresponsible 

cloning researchers, but at anyone engaged in trying to implant 

such an embryo in a woman’s womb—presumably, by the language 

of the bill, including the woman herself. In fact, everyone else could 

simply evade penalties under the law by training the woman to 

transfer the embryos to her own womb. If the woman is exempt 

from penalties, then the law simply evaporates. It is simply a regulation on who can do human cloning, rather than on whether you 

can do it at all, even reproductive cloning. 

S. 303 recognizes the enforcement problem here that, as Mr. 

Kimbrell said, you simply cannot tell, even if you were standing 

right over the shoulder of the fertility physician, whether any given 

embryo about to be transferred to a woman is from cloning or fertilization. You cannot even do it with all the prenatal diagnostic 

tests that we have now—because we do not have a test, for example, for the disorderly gene imprinting and gene expression that are 

found in cloned embryos. And so the Act tries to resolve this by forbidding researchers to conduct human cloning research in the same 

place where IVF is done in assisted reproduction. 

That only confirms what the Justice Department has said in its 

House testimony some time ago. You cannot enforce this bill without placing new and unprecedented restrictions on assisted reproduction techniques that are widely accepted. Whether you are banning the location of an IVF clinic, or banning the location of a 

cloning research facility, is simply going to depend on which one 

got there first. You cannot operate the second one in the same 

place as the first one. This would be the first federal law in history 

that bans the location of IVF clinics in certain places. 

Third, the bill allows research that will facilitate what its sponsors claim to oppose—that is, cloning to produce children. My 

38

longer statement has quotes from people who favor research 

cloning, confirming that, of course, if you allow cloning for research 

it will facilitate and bring closer the day when this procedure is refined and people can conduct it for reproductive purposes. In fact, 

some of the organizations supporting S. 303 have exactly that view 

themselves—that when research cloning is allowed to make the 

procedure, ‘‘safer,’’ they might then support reproductive cloning as 

well. 

Fourth, the bill allows—and this is a very odd clause—it allows 

exporting of cloned embryos to other countries, but only if they do 

not—I have to read this, because the double negatives are a little 

odd—it forbids exporting of cloned embryos, called unfertilized 

blastocysts, to a foreign country only if such country does not prohibit human cloning. So the only circumstance in which you can export cloned embryos to another country is where they will be used 

for illegal activity. We are pretending to ban even reproductive 

cloning, and then facilitating it in violation of other countries’ laws 

elsewhere. I do not think that will increase our standing abroad. 

Fifth, the bill has a number of careless and incoherent passages 

that end up potentially restricting activities that are not human 

cloning at all. One I would like to mention briefly is this 

‘‘unfertilized blastocyst’’ term which is defined in such a way that 

it fails even to make the distinction between an embryo and a stem 

cell. ‘‘Any intact cellular structure,’’ made by nuclear transfer is 

covered. And so the very sort of things that some people have 

talked about to bypass the moral problem of cloning, ways of adapting the procedure so that, from the outset, it only makes stem cells 

instead of an organism, an embryo, that then has to be killed for 

its stem cells, would be as restricted by this bill as actually making 

an embryo is. This is not a defect in the Brownback bill. 

Sixth, regarding protection of women, this bill is really a 

Potemkin Village. It is very carefully crafted so that it takes the 

whole body of current law and regulation on human subjects research, finds the areas that would actually have some relevance to 

cloning research, and then makes sure they are not applied. The 

only regulations it does apply are rather vague and general provisions that, in fact, do not have much of anything to do with cloning, 

for reproduction or research. It does not apply, for example, the 

protections for unborn children in pregnant women. It does not 

apply the current federal law that has been in place for six years 

on embryo research. It only applies these vague informed consent 

standards, and these provisions on compensation for time or inconvenience. I have a hard time with the idea of the ‘‘inconvenience’’ 

of getting ovarian cancer. 

Here is something that the National Bioethics Advisory Commission said about the IRB system. Professor Charo was a member of 

the commission at the time. ‘‘In our view, IRBs should appreciate 

that, for some components of a study, participants might incur 

risks with no personal potential benefit. For these elements’’—and 

that is what happens with egg donation for cloning research—‘‘For 

these elements, there should be some limitation on the amount of 

social and physical risk that can be imposed, regardless of the participant’s willingness to participate or the monetary or other enticement being offered.’’ That is the advice that this bill ignores. It 

39

thinks that if you throw in some compensation and have people 

sign a form, then this inherently ethically questionable practice of 

having women undergo the risks of these egg donation practices for 

no possible benefit to themselves is perfectly all right. 

The bill’s reference to FDA oversight is even more unpersuasive, 

because it requires you to treat the cloned embryo as a biological 

product, as a commodity to be regulated, presumably in order to 

prevent harm to others. So it has nothing to do with the ostensible 

purpose of the bill in terms of its stance against reproductive 

cloning, which was to protect the safety of the child who is going 

to be receiving birth defects and miscarrying from being cloned. 

You cannot call the child a dangerous biological product, and say 

it is the person to be protected from risk at the same time. 

There are many other defects here, but I want to end with just 

this one, because it is not widely known here. This bill is already 

obsolete. The biotechnology movement has moved on. There are 

eight states now where state biotechnology alliances are supporting 

bills that have language like the following. ‘‘It is the public policy 

of this state to promote research involving the derivation and use 

of human embryonic stem cells, human embryonic germ cells’’—

those can only be obtained from fetuses eight weeks old—‘‘and 

human adult stem cells from any source, including somatic cell nuclear transplantation.’’ Now, that language is no accident. It has 

been simultaneously introduced in eight states in the last couple of 

months. 

The researchers have looked at the field, and they have found 

what anyone can find by looking at the medical literature. There 

are only two studies in all the vast sea of medical literature that 

showed any therapeutic benefit from cloning in animals; and one 

of them required taking the clone to the fetal stage, and the other 

required taking it to the newborn stage. 

They are already moving on past this bill, the 14-day limit on 

maintaining embryos—morally reprehensible though that is because, for the first time in history, the Federal Government would 

actually define a class of humanity it is a crime not to destroy at 

a certain stage. That limit is going to be infinitely flexible, because 

tomorrow the researchers will come back and say, ‘‘We need 20 

days, we need 30, we need a hundred.’’ They are already saying it 

in the laboratory of the states, and we should beware of something 

that is far too much of a free fall even to be called a ‘‘slippery 

slope.’’ We are already there. They are already taking these animal 

studies, and saying that the human model for therapeutic cloning 

may have to exploit human beings into much later stages than the 

embryonic. 

Embryonic stem cells have been found to have many serious 

problems in terms of integrating with tissues, in terms of tumor 

formation and overproliferation. And the logical way, unfortunately, for the researchers to get more usable cells is to grow those 

cells to a later stage in the original organism, and then destroy 

that organism. 

Mr. Chairman, we should ban human cloning, but we should do 

it by banning human cloning. Legislation which allows the practice, 

and then seeks to destroy the humans thus produced so that we 

can pretend we have banned cloning, is worse than doing nothing. 

40

1 Reflections from the Pontifical Academy for Life, ‘‘Human Cloning Is Immoral’’ (July 9, 

1997), in The Pope Speaks, vol. 43, no. 1 (January/February 1998), p. 29. Also see: Congregation 

for the Doctrine of the Faith, Donum Vitae (Instruction on Respect for Human Life in its Origin 

and on the Dignity of Procreation) (March 10, 1987), I.6 and II.B. 2Leon R. Kass, ‘‘The Wisdom on Repugnance,’’ in The New Republic, June 2, 1997, p. 23.

I urge Congress to oppose S. 303 and to approve the BrownbackLandrieu bill, S. 245. Thank you. 

[The prepared statement of Mr. Doerflinger follows:]

PREPARED STATEMENT OF RICHARD M. DOERFLINGER, DEPUTY DIRECTOR, 

SECRETARIAT FOR PRO-LIFE ACTIVITIES, U.S. CONFERENCE OF CATHOLIC BISHOPS

I am Richard M. Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities at the U.S. Conference of Catholic Bishops. I also serve as Adjunct Fellow 

in Bioethics and Public Policy at the National Catholic Bioethics Center. It is on 

behalf of the bishops’ conference that I wish to speak to you today about the moral 

challenge presented by radically different congressional proposals on human cloning. 

The sanctity and dignity of human life is a cornerstone of Catholic moral reflection and social teaching. We believe a society can be judged by the respect it shows 

for human life, especially in its most vulnerable stages and conditions. 

Human cloning is sometimes presented as a means for creating life, not destroying it. Yet it shows disrespect toward human life in the very act of generating it. 

Cloning completely divorces human reproduction from the context of a loving union 

between man and woman, producing children with no ‘‘parents’’ in the ordinary 

sense. Here human life does not arise from an act of love, but is manufactured to 

predetermined specifications. A developing human being is treated as an object, not 

as an individual with his or her own identity and rights. As one group of scientific 

and other experts advising the Holy See has written:

In the cloning process the basic relationships of the human person are perverted: filiation, consanguinity, kinship, parenthood. A woman can be the twin 

sister of her mother, lack a biological father and be the daughter of her grandmother. In vitro fertilization has already led to the confusion of parentage, but 

cloning will mean the radical rupture of these bonds. 1

Such moral concern transcends denominational bounds and has been eloquently 

expressed by some of our country’s most respected philosophers and ethicists. Writes 

Professor Leon Kass of the University of Chicago, now chairman of the President’s 

Council on Bioethics:

Human cloning would... represent a giant step toward turning begetting 

into making, procreation into manufacture (literally, something ‘‘handmade’’)... [W]e here would be taking a major step into making man himself 

simply another one of the man-made things. 2

From the dehumanizing nature of this technique flow many disturbing consequences. Because cloned humans are produced by a means more suited to more 

primitive forms of life—a means which involves no loving relationship, no personal 

investment or responsibility for a new life, but only laboratory technique—they 

would be uniquely at risk of being treated as ‘‘second-class’’ human beings. 

The very scenarios often cited as justifications for human cloning are actually 

symptoms of the moral problem it creates. It has been said that cloning could be 

used to create ‘‘copies’’ of illustrious people, to replace a deceased loved one, or even 

to provide a source of spare tissues or organs for the person whose genetic material 

was used for the procedure. In each proposal we see a utilitarian view of human 

life, in which a human being is treated as a means to someone else’s ends instead 

of as a person with his or her own inherent dignity. This same attitude lies at the 

root of human slavery. 

Let me be perfectly clear. In reality a cloned human being would not be, in any 

sense, an ‘‘object’’ or a substandard human being. Whatever the circumstances of his 

or her origin, he or she deserves to be treated as a human person with an individual 

identity. But the depersonalized technique of manufacture known as cloning disregards this dignity and sets the stage for further exploitation. Cloning is not wrong 

because cloned human beings lack human dignity—it is wrong because they have

human dignity, and deserve to come into the world in ways that respect this dignity. 

Each child has a right to be conceived and born as the fruit of a loving union between husband and wife, to be loved and accepted as a new and distinct individual. 

41

3 National Academy of Sciences, Scientific and Medical Aspects of Human Reproductive 

Cloning (National Academy Press 2002), p. E–4. 4See the Dickey amendment enacted as part of the annual Labor/HHS appropriations bills 

since 1996: ‘‘ ‘human embryo or embryos’ includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, 

parthenogenesis, cloning, or any other means from one or more human gametes or human 

diploid cells.’’ The current version of this amendment is Sec. 510 of Pub. L. 108–7, the Omnibus 

Appropriations Act of 2003 (enacted Feb. 20, 2003). 5 NBAC defined ‘‘embryo’’ as ‘‘the developing organism from the time of fertilization until significant differentiation has occurred . . .’’ NBAC, Cloning Human Beings (Rockville, MD: June 

1997), Vol. I, p. A–2. This term encompasses the cloned embryo: ‘‘The Commission began its discussions fully recognizing that any effort in humans to transfer a somatic cell nucleus into an 

enucleated egg involves the creation of an embryo, with the apparent potential to be implanted 

in utero and developed to term.’’ Id., p. 3. Similarly, the NIH defines ‘‘embryo’’ as follows: ‘‘In 

humans, the developing organism from the time of fertilization until the end of the eighth week 

of gestation.’’ NIH, Stem Cells: Scientific Progress and Future Research Directions (U.S. Department of Health and Human Services: June 2001), p. F–3. 6The President’s Council on Bioethics, Human Cloning and Human Dignity (Washington, DC: 

July 2002), pp. 54–55. 7NAS, note 3 supra, p. A–2. 

Ironically, the most startling evidence of the dehumanizing aspects of cloning is 

found in some proposals ostensibly aimed at preventing human cloning. Some Members of Congress favor legislation that would not ban human cloning at all—but 

would simply ban any effort to allow cloned human beings to survive. In these proposals, researchers are allowed to use cloning for the unlimited mass production of 

human embryos for experimentation—after which they are required to destroy 

them. Enactment of such a proposal would mark the first time in history that the 

U.S. government defined a class of human beings that it is a crime not to destroy. 

Specifically I have been asked to comment on the two pending federal bills now 

offered as a response to human cloning: the Hatch/Feinstein ‘‘Human Cloning Ban 

and Stem Cell Research Protection Act’’ (S. 303), and the Brownback/Landrieu 

‘‘Human Cloning Prohibition Act’’ (S. 245). 

Let me begin with the bill that is, in my view, offered under false pretenses—

the bill that, despite its title, is not a ban on human cloning at all. 

S. 303 (Hatch/Feinstein) 

This bill is gravely deficient in at least eight ways. 

1. It does not, in fact, ban human cloning at all. The National Academy of 

Sciences (NAS) has defined ‘‘cloning’’ as the production of ‘‘an organism that has the 

same nuclear genome as another organism.’’ 3 As Congress has formally acknowledged since 1996, the early embryo produced by fertilization or cloning is an organism of the human species.4 The National Institutes of Health (NIH), and President 

Clinton’s National Bioethics Advisory Commission (NBAC), have acknowledged the 

same fact.5 To produce that embryo—using, for example, the somatic cell nuclear 

transfer procedure used to make Dolly the sheep—is to conduct human cloning, 

whatever else one may plan to do with that embryo afterwards. This is scientific 

fact, not ethics or politics. It was, in fact, a unanimous point of agreement in the 

recent report on cloning by the President’s Council on Bioethics, whose Members 

otherwise disagreed sharply on moral and policy issues.6 S. 303 does nothing whatever to ban the use of the cloning procedure to create human embryos, for any purpose (or even to restrict someone’s ability to create them for no discernible purpose 

at all). 

2. What it does ban is ‘‘embryo transfer,’’ a distinct procedure already in 

use by fertility clinics across the world for many years; and this creates serious legal and enforcement problems. The NAS defines ‘‘embryo transfer’’ as 

‘‘the introduction of a preimplantation embryo into the uterus for growth and development.’’ 7 S. 303 bans this procedure, if it involves an embryo produced earlier by 

cloning (page 2 lines 10–13). This has certain consequences: 

(A) The bill’s penalties are directed not against irresponsible researchers engaged 

in human cloning, but against those engaged in implanting or attempting to implant 

the cloned embryo in a womb—presumably including the woman herself. (If the penalty did not apply to the woman, of course, this would create an enormous loophole—the law could be completely evaded by having the woman herself conduct the 

embryo transfer, a realistic possibility if she has any training as a fertility doctor 

or technician.)

(B) Such a law is inherently almost impossible to enforce, because at this stage 

of embryonic development there is no reliable way for law enforcement to distinVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00045 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
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8See Written Statement of Daniel J. Bryant, Assistant Attorney General, before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the House Committee on 

Government Reform, May 15, 2002 (www.house.gov/weldon/issues/doj.htm). 9For example, see: Testimony of Dr. Mark E. Westhusin before the House Energy and Commerce Subcommittee on Oversight and Investigations, March 28, 2001; R. Jaenisch and I. 

Wilmut, ‘‘Don’t Clone Humans!’’, 291 Science (30 March 2001), p. 2552. 10This provision illustrates the truth of the Justice Department’s testimony: One cannot enforce this ban without imposing new and unprecedented restrictions on fertility procedures already widely practiced in this country. For the provision is double-edged: Its text says that one 

may not conduct cloning research in a laboratory where eggs are subjected to assisted reproduction procedures (page 10 lines 21–24); but its heading calls for ‘‘separation of in vitro fertilization laboratories’’ from locations where cloning research is conducted (page 10 lines 19–21). If 

a laboratory started conducting cloning research first, in vitro fertilization is banned there. This 

would be the first federal law to restrict where one may establish a private fertility clinic. 11Lanza et al., ‘‘The ethical validity of using nuclear transfer in human transplantation,’’ 284 

(24) Journal of the American Medical Association (Dec. 27, 2000), pp. 3175–9 at p. 3178. 12 Ethics Committee of the American Society for Reproductive Medicine, ‘‘Human somatic cell 

nuclear transfer (cloning),’’ 74 (5) Fertility and Sterility (Nov. 2000), pp. 873–6 at p. 873. 13 ‘‘There is not yet clear consensus that reproductive SCNT in cases of infertility serves a 

compelling need... Nor is there clear consensus on a compelling need to bar the technique.’’ 

Id., p. 875. ASRM can support S. 303, consistent with its own policy, because the bill’s authorization for research cloning will help make its ban on ‘‘reproductive cloning’’ a temporary one. 

guish cloned embryos from fertilized embryos.8 Even to initiate such scrutiny would 

require delaying embryo transfer until the results of all relevant tests were obtained, at which time the embryo in question (whether cloned or fertilized) would 

most likely be dead. In this context it is important to note that while cloned animal 

embryos seem much more likely to suffer from serious problems of disorderly gene 

expression than embryos created by union of sperm and egg, these problems are not 

detectable by any prenatal diagnostic test in current use.9

(C) The bill recognizes this problem, and tries to resolve it by forbidding researchers to conduct human cloning research at the same laboratory where ‘‘assisted reproduction’’ occurs (page 10 lines 19–24). But of course this begs the question, which 

is: How do you tell which of the two is being done at any given time? And how 

would you create a closed system to prevent cloned embryos from being brought 

from one laboratory to the one next door? 10

3. This bill allows cloning research that will facilitate what its sponsors 

claim to oppose—that is, cloning to produce born children. Again, this is 

widely acknowledged by experts who support cloning for research in general and S. 

303 in particular. For example, researchers and ethicists who support cloning for 

research purposes (which they call CRNT for ‘‘cell replacement through nuclear 

transfer’’) admit that ‘‘the techniques developed in CRNT research can prepare the 

way scientifically and technically for efforts at reproductive cloning.’’ 11 Similarly, 

the ethics committee of the American Society for Reproductive Medicine (ASRM), 

which supports S. 303, has stated regarding human cloning for research purposes: 

If undertaken, the development of SCNT [somatic cell nuclear transfer] for such 

therapeutic purposes, in which embryos are not transferred for pregnancy, is 

likely to produce knowledge that could be used to achieve reproductive SCNT.12

To be sure, this does not create an intractable conflict for ASRM itself in terms 

of supporting S. 303, because ASRM does not support a permanent ban on (even) 

‘‘reproductive’’ cloning.13 The conflict is between the public statements of the bill’s 

supporters in Congress, and the real-world impact of the legislation they support. 

4. The bill allows exporting of cloned embryos to facilitate violations of 

other countries’ laws. Incredibly, the bill forbids exporting of cloned embryos 

(‘‘unfertilized blastocysts’’) to a foreign country only ‘‘if such country does not prohibit human cloning’’ (page 3 lines 19–21). Under S. 303, cloned embryos can be exported to foreign countries that do prohibit ‘‘human cloning’’ as defined by the bill, 

where they will be used in illegal efforts to initiate pregnancies with cloned embryos. Thus the bill would facilitate abroad what it purports to make illegal here. 

5. Through careless and incoherent drafting, the bill potentially restricts 

activities that are not human cloning. To mention only a few: 

(A) ‘‘human somatic cell’’—defined to include ‘‘any human cell other than a 

haploid germ cell’’ (page 2 lines 14–16), so that it includes even the one-celled embryo. It will be a crime to implant in a uterus any embryo produced by transferring 

the nucleus from one single-celled embryo into another embryo or an unfertilized 

egg. By most definitions this is not cloning; it is a nuclear transfer technique used 

in some fertility clinics in an effort to circumvent mitochondrial disease (by replacing the defective mitochondrial DNA found in the protoplasm of the woman’s own 

egg), to allow women with this disease to have healthy children. S. 303 bans this 

43

14 In embryology the ‘‘blastocyst’’ is the embryo from four to around seven days old. 15Statement of Senator Orrin Hatch before the Senate Commerce Subcommittee on Science, 

Technology and Space, January 29, 2003. 16One threshold question would be: What activities involving nuclear transplantation will 

count as ‘‘research’’? The question is now easily answered operationally in the case of federally 

funded research, because each research proposal must be submitted to the Federal Government 

in the form of a grant request. Potential grantees have an interest in arguing that what they 

wish to do is research. Is any current federal definition of ‘‘research’’ clear and specific enough 

to be applied to those conducting privately funded activities, even when the researchers will 

have an interest in denying that they are conducting ‘‘research’’ (so they can exempt themselves 

from this Title of the bill)? Does this bill really intend to say that if a project is not research—

if cloning is used to produce human embryos simply for sport, or in order to ‘‘farm’’ them for 

strictly commercial purposes, such activity is exempt from these restrictions? 

nuclear transfer procedure itself (page 9 line 23 to page 10 line 2), and also bans 

transferring any of these repaired embryos to a woman’s womb (page 3 lines 13–

14, in light of the definitions on page 2). 

(B) ‘‘unfertilized blastocyst’’ (page 3 lines 3–9)—This is apparently intended as a 

demeaning reference to cloned embryos, but the word ‘‘blastocyst’’ is inaccurately 

used here to refer to the one-celled embryo initially produced by cloning, and even 

to the 14-day-old cloned embryo (whose further survival is made illegal by S. 303).14

More broadly, ‘‘unfertilized blastocyst’’ is defined as any ‘‘intact cellular structure’’ 

produced by somatic cell nuclear transfer, so the bill bans transferring this product 

to a woman’s womb whether it is an embryo or not. For example, if researchers develop a way to modify the egg or the somatic cell in advance, so that the initial 

product of this technique is not a living organism but a culture of stem cells (as 

some researchers say they may be able to do), this would be covered by the ban. 

Placing, say, endothelial stem cells produced by this hypothetical technique into a 

woman’s womb to help heal her endometrial tissue would not be forbidden by any 

moral principle of which I am aware—but under a literal reading of this bill, it 

could provoke a ten-year prison sentence. 

(C) ‘‘the functional equivalent of a uterus’’ (page 2 line 13)—This odd phrase is 

not defined, leaving room for much confusion. For example, S. 303’s prime sponsor 

has repeatedly said there is no such thing as the functional equivalent of a uterus, 

because the function of a uterus is to turn the new embryo into a ‘‘human life’’ and 

no artificial environment can fulfill this task:

After many conversations with scientists, ethicists, patient advocates, and religious leaders and many hours of thought, reflection, and prayer, I reached the 

conclusion that human life does not begin in the petri dish. I believe that 

human life requires and begins in a mother’s nurturing womb.15

If, on the other hand, the phrase ‘‘functional equivalent’’ is to have any application, one can only guess how effective an artificial environment must be to qualify 

as a ‘‘functional equivalent’’ of a uterus. Certainly a Petri dish itself does not qualify, for then even cloning for research (which requires developing the cloned embryo 

to the blastocyst stage in that dish) would be banned. Perhaps a ‘‘functional equivalent’’ is an environment that could sustain the cloned embryo to live birth, because 

any womb that fails to do so would not fulfill the usual ‘‘function’’ of a womb. In 

that case, one may transfer the embryo to any artificial environment that would fall 

short of this function to any extent—in other words, at present one may transfer 

the embryo to any and all artificial environments. This will be important in the likely event (discussed below) that the bill’s ‘‘14-day rule’’ for maintaining a cloned embryo is later changed. 

6. The bill erects a Potemkin village, a mere facade, of protection against 

research risks for human subjects involved in cloning research. Title II of 

the bill (page 8 ff.) claims to expand current regulations on federally funded research involving human subjects (Subpart A of 45 CFR Part 46), so they will now 

apply to all ‘‘research involving nuclear transplantation’’ (even if privately funded). 

This one-sentence expansion of federal regulations into the private sphere raises a 

number of serious legal and jurisdictional issues that cannot be explored in depth 

here.16

However, assuming that the goal here is to place real ethical limits on human 

cloning for biomedical research, that goal is not met at all. Three distinct classes 

of humans may be involved in cloning research—the embryos created by cloning, the 

women solicited for their eggs, and the patients who donate body cells in the hope 

of receiving a genetically compatible stem cell treatment—and this Title lets them 

all down: 

(A) There is no ethical limit on what one may do to cloned embryos outside the womb, because there are no such limits in federal human subjects regulaVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00047 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
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17See the Dickey amendment, note 4 supra. 18 HHS General Counsel Harriet S. Rabb, Memorandum to NIH Director Harold Varmus on 

‘‘Federal Funding for Research Involving Human Pluripotent Stem Cells,’’ Jan. 15, 1999. 19The NIH notes: ‘‘The potential disadvantages of the use of human ES cells for transplant 

therapy include the propensity of undifferentiated ES cells to induce the formation of tumors 

(teratomas).’’ NIH, note 5 supra, p. 17. In short, ‘‘undifferentiated embryonic stem cells are not 

considered as suitable for transplantation due to the risk of unregulated growth.’’ Id., p. 97. Also 

see S. Wakitani et al., ‘‘Embryonic stem cells injected into the mouse knee joint form teratomas 

and subsequently destroy the joint,’’ 42 Rheumatology (2003), pp. 162–5. And recent studies indicate that even stem cells from cloned embryos, supposedly a genetic match, may be rejected by 

recipients’ bodies. See Y.L. Tsai et al., ‘‘Plasticity, Niches, and the Use of Stem Cells,’’ 2 Developmental Cell (June 2002), pp. 707–712 at p. 710. 

tions. To be sure, there are limits—in fact, there is an absolute ban—on federally 

funded research that harms or destroys human embryos, specifically including 

cloned embryos.17 However, that is statutory language, not part of the Code of Federal Regulations, so it will not apply. This is, of course, by design—if S. 303 did

extend Congress’s policy on federally funded human embryo research to the private 

sector, the research favored by supporters of S. 303 would be illegal. This raises a 

very odd contradiction: Congress will enshrine as permanent law whatever regulatory language happens to have been written by the staff of the Executive branch 

up to the moment when this bill is enacted (page 9 lines 15–22)—but Congress will 

ignore its own statutory language that has been duly enacted and signed into law 

by Democratic and Republican presidents every year for the past six years, although 

it is the only federal policy that directly relates to the issue at hand. The only relevant provision that S. 303 itself provides on this point is in direct contradiction 

to current federal policy on embryo research—that is, the provision requiring all 

cloned embryos to be destroyed at the age of 14 days (page 10 lines 3–7). In federally funded projects, of course, Congress forbids researchers to destroy or harm 

cloned human embryos. 

(B) Title II places no ethical limits on what may be done to human subjects who may be the recipients of stem cells from cloned embryos. The bill’s 

expansion of federal human subjects regulations into the private sector applies only 

to ‘‘research involving nuclear transplantation’’ (that is, the act of creating cloned 

embryos). Since 1999, the law on federally funded research involving human embryos has been construed not to apply to activities using stem cells derived from 

those embryos.18 The sponsors of S. 303 certainly agree with this legal opinion, 

which allows the Federal Government to fund embryonic stem cell research even 

when it cannot fund the research in which the embryos are created or destroyed. 

S. 303 actually reinforces this distinction, by explicitly defining the ‘‘unfertilized 

blastocyst’’ produced by nuclear transplantation to exclude any stem cells derived 

from this blastocyst (page 3 lines 6–9). So the considerable risks involved in placing 

embryonic stem cells from cloned embryos into patients—an activity that in animals 

can produce tissue rejection, overproliferation, and tumor formation—are completely 

unaddressed by this bill.19

(C) Title II places only the vaguest and most inadequate limits on what 

can be done to women selected as ‘‘donors’’ of eggs. Again, current federal regulations contain no specific guidance on the standards for donating eggs to make 

embryos, for the obvious reason that it has been a de facto federal policy for 23 

years not to fund human in vitro fertilization research. The regulations contain 

some vague and general guidelines regarding risks, informed consent, and approval 

by institutional review boards (IRBs). But egg donation for the purpose of creating 

embryos for research is one of those practices that the entire IRB system is supposedly designed to discourage—that is, the practice of involving human subjects in 

research that imposes significant risks upon them but can be of no benefit to them 

as individuals. S. 303 wrongly seems to assume that a signature on a consent form 

(page 10 lines 9–13) and compensation for ‘‘time or inconvenience’’ (page 9 lines 12–

14) will justify researchers in subjecting women to serious risks, including a potentially increased risk of ovarian cancer, in the name of progress. This approach ignores what Professor Alta Charo and the other members of the National Bioethics 

Advisory Commission warned in 2001, when they issued a report on the inadequacy

of current safeguards against such exploitation of human subjects:

No matter what potential benefit is offered to individual participants 

or society at large, the possibility of benefit from one element of a 

study should not be used to justify otherwise unacceptable elements . . . In our view, IRBs should appreciate that for some components of 

a study, participants might incur risks with no personal potential 

benefit... For these elements, there should be some limitation on the 

45

20 NBAC, Ethical and Policy Issues in Research Involving Human Participants (Bethesda, 

Maryland: August 2001), p. iii (emphasis added). 21 Id. p. iii, vii (emphasis added). For an extreme recent case of ‘‘conflict of interest,’’ see the 

findings of Maryland’s highest court in Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. 

2001). The court found that the IRB at Johns Hopkins University had ‘‘abdicated’’ its responsibility to protect children from research risks, and had shown itself ‘‘willing to aid researchers 

in getting around federal regulations designed to protect children used as subjects in nontherapeutic research’’ (that is, research that would not benefit those particular children). No one who 

has read this decision will want to entrust all ethically controversial research decisions solely 

to IRBs. 22 Id., p. xvi (emphasis added). 23 Hearing before the House Energy and Commerce Subcommittee on Oversight and Investigations, March 28, 2001. The opening remarks by Committee Chairman Rep. Billy Tauzin were 

characteristic of Members’ reactions: ‘‘The FDA argues these old federal laws regulating new 

drugs cover a human cell or a human fetus. I frankly do not find it obvious that a human fetus 

is a drug.’’

amount of social and physical risk that can be imposed, regardless of 

the participants’ willingness to participate or the monetary (or other) 

enticement being offered.20

This NBAC report also called attention to serious deficiencies in the IRB system 

itself as it currently exists, including the conflicts of interest that often allow IRBs 

to represent the interests of their own research institution rather than those of vulnerable human subjects:

In recent years, increasing strains on the system have undermined the practice of independent review. IRBs are overburdened by the volume of research coming before them, a strain that is compounded by concerns about 

training of IRB members and possible conflicts of interest. In addition, the 

constantly changing nature of research challenges existing notions about what 

constitutes risks and potential benefits... Today, investigators and IRBs are 

rightly confused over issues as basic as which areas of inquiry should be reviewed and who constitutes a human participant.21

The Commission even noted with concern that ‘‘there are no clear criteria for 

IRBs to use in judging whether the risks of research are reasonable in terms of 

what might be gained by the individual or society.’’ 22

It is difficult to reconcile this pointed and well-deserved critique of the current 

system with the enthusiastic endorsement given to it by Professor Charo in her testimony before this Subcommittee today. How can this new, complex and ethically 

controversial field of human cloning research—research that may endanger women 

and desperately sick patients as well as embryonic humans—be adequately addressed by a system so often found incapable even of meeting its current obligations 

to protect human subjects in traditional medical research? 

(D) Title II’s reference to FDA oversight is confusing, unpersuasive and 

incoherent. At an earlier hearing before the House of Representatives, Members 

of Congress of both parties found the claim of FDA jurisdiction over human cloning 

to be unpersuasive.23 At the very least, any such claim must address a very basic 

threshold question. In order to claim that FDA regulations can be applied to research involving ‘‘nuclear transplantation’’ (page 9 lines 19–20), what kind of entity 

does the cloned embryo have to be? These regulations do not cover medical techniques or procedures as such, but relate to ‘‘products’’ such as ‘‘foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human 

use, biological products for human use, and electronic products’’ (21 CFR 

§ 56.101(a)). Assuming that the cloned embryo is not a food additive or a drug, he 

or she must be a ‘‘biological product’’—a commodity to be tested for its dangers to 

others. Not only is this a false, demeaning and dehumanizing label for a fellow 

member of the human species, but it directly contradicts the sponsors’ alleged rationale for banning ‘‘reproductive’’ cloning—that is, the risks to the child, including 

the massive risk of miscarriage and birth defects. One and the same entity cannot 

be the innocent victim of the experiment, and at the same time be the dangerous 

‘‘biological product’’ from whom others must be protected by the Food and Drug Administration. 

(E) The bill’s policy on research involving the cloned child in the womb 

raises especially disturbing moral and legal issues. While current federal regulations on protection of human subjects do not cover the embryo outside the womb, 

they do protect the embryo and fetus implanted in the womb as well as the pregnant woman (45 CFR §§ 46.201 to 46.207). However, S. 303 refuses to expand to the 

private sector these specific protections for the cloned unborn child or the woman 

46

24Transferring such an embryo to the womb is of course illegal under S. 303, and those who 

perform this activity would be prosecuted and imprisoned. If the woman is not herself punished, 

she will still be potentially available as a subject for observational research on human clonal 

pregnancies (research conducted by researchers other than the original felons). If she, too, is 

imprisoned, however, she might be protected by the federal regulations providing additional protections for prisoners subjected to research (Subpart C, 45 CFR §§ 46.301 to 306)—if not for the 

fact that S. 303 excludes Subpart C as well. 25See Testimony by Dr. Paul Berg (‘‘We take considerable pride in being a pluralistic society’’), 

Dr. Harold Varmus (‘‘(W)ho has such moral standing that they [sic] would impose on our multiethnic, pluralistic society an ethical standard that only a minority would endorse?’’); and Dr. 

Thomas Murray (‘‘Respecting the diversity of beliefs about families, about women, men, children—and embryos—honors our most noble traditions’’) before the Senate Judiciary Committee, 

March 19, 2003. 26 ‘‘We can debate all day whether an embryo is or isn’t a person. But it is unquestionably 

human life, complete with its own unique set of human genes that inform and drive its own 

development. The idea of the manufacture of such a magnificent thing as a human life purely 

for the purpose of conducting research is grotesque, at best.’’ Editorial, ‘‘Embryo Research Is Inhuman,’’ Chicago Sun-Times, October 10, 1994, p. 25. 27See ‘‘Statement of Dr. Krauthammer,’’ in The President’s Council on Bioethics, note 6 supra, 

pp. 277–285. 28 Id., p. 285.

who may bear him or her—for these are found in Subpart B of Part 46, and Title 

II expands the reach only of Subpart A (see page 9 line 18).24 Researchers who were 

not themselves involved in the illegal act of transferring the cloned embryo to a 

uterus would surely be interested in observing any special risks or other developments arising from the first human clonal pregnancy. Apparently S. 303 refuses to 

expand protections for pregnant women and their cloned unborn children in order 

to avoid a direct contradiction: The existing federal regulations forbid federally funded researchers to impose significant risks of harm and death on the unborn human 

subject (see 45 CFR § 46.204), but sponsors of S. 303 want to ban ‘‘maintaining’’ the 

cloned unborn child for more than 14 days in any environment except a deep freezer 

(page 10 lines 3–7). It seems this latter requirement can only be obeyed by forcing 

an abortion about one week after implantation (which usually occurs about six days 

after the embryo is formed). This raises a moral and perhaps even constitutional 

nightmare, and directly contradicts federal policies that have sought to protect 

fetuses and pregnant women from harmful research since 1975. 

7. Most generally, this bill’s policy on the human embryo ratifies one 

gravely demeaning view that lies at an extreme end of the spectrum in our 

divided and pluralistic society: The embryo as commodity, as nothing more 

than disposable property to be manufactured and discarded to suit the desires of others. It is important to note this, because supporters of cloning for research have wrongly applied this ‘‘pluralistic society’’ argument against the 

Brownback bill.25 The fact is that a complete ban on cloning, already approved by 

a number of states as well as foreign countries, can be supported and is supported 

by Americans with a wide array of views on the moral status of the embryo—those 

who, like myself, hold that each and every member of the human species deserves 

to be protected as a human person; those who, like some ethicists, columnists and 

others, hold that the embryo (if not a ‘‘full’’ person) is at least a developing human 

life that deserves respect and should not be created solely to be destroyed; 26 and 

those who are agnostic on the status of the embryo but recognize that a complete 

ban on cloning is the only effective and enforceable way to prevent cloning for 

babymaking as well as further assaults on human dignity.27 By contrast, the enactment of S. 303 would assume, and seek to promote, a national consensus that the 

cloned embryo has no moral status whatever, or has the status of a being whose 

survival is an active threat to the public good. No other view is consistent with a 

policy that this embryo may be created at will, but that government can mandate

its destruction at a certain stage. 

Under S. 303 it would be a federal offense to let such an embryo survive, or to 

show this fellow human being any degree of respect. Dr. Charles Krauthammer has 

observed:

Creating a human embryo just so it can be used and then destroyed undermines 

the very foundation of the moral prudence that informs the entire enterprise 

of genetic research: the idea that, while a human embryo may not be a person, 

it is not nothing. Because if it is nothing, then everything is permitted. And if 

everything is permitted, then there are no fences, no safeguards, no bottom.28

I am confident that Congress will not enact such a gravely immoral policy and 

that President Bush would refuse to sign it. 

47

29 R. Lanza et al., ‘‘Generation of histocompatible tissues using nuclear transplantation,’’ 20 

Nature Biotechnology (July 2002), pp. 689–96. The authors wrote: ‘‘Because the cloned cells were 

derived from early-stage fetuses, this approach is not an example of therapeutic cloning and 

would not be undertaken in humans.’’ Id, p. 689. Now lead researcher Robert Lanza has reversed his stand, insisting that this study is indeed a model for ‘‘therapeutic cloning.’’ See Do 

No Harm: The Coalition for Research Ethics, ‘‘Reality Check: Proof of ‘Therapeutic’ Cloning?’’, 

March 10, 2003 (www.stemcellresearch.org/pr/pr20030310.htm). 30W. Rideout et al., ‘‘Correction of a Genetic Defect by Nuclear Transplantation and Combined 

Cell and Gene Therapy,’’ 109 Cell (April 15, 2002), pp. 17–27. For a critique of this study see 

Americans to Ban Cloning, ‘‘Why the ‘Successful’ Mouse ‘Therapeutic’ Cloning Really Didn’t 

Work,’’ April 2002 (http://cloninginformation.org/info/unsuccessfullmouseltherapy.htm). 31See note 19 supra. 32Such language was enacted into law in California in September 2002. Virtually identical 

language has been proposed in: Illinois (HB 3589, introduced February 2003), Maryland (HB 

482, introduced February 2003), New Jersey (S. 1909, introduced September 2002), New York 

(A. 1819, introduced January 2003), Pennsylvania (HB 422, introduced February 2003), Texas 

(SB 1034, introduced March 2003), Vermont (H. 326, introduced in 2003), and Washington (SB 

5466, approved by Committee March 2003).

8. Finally, this bill as written cannot achieve its stated objective of advancing therapies, and the biotechnology lobby has already moved on to 

broader policies for exploiting cloned humans at the fetal and newborn 

stages. The sponsors of this bill have apparently failed to notice that only two animal studies have claimed to show any ‘‘therapeutic’’ benefits from cloning for research. One study, seeking to provide kidney tissue for cows, found it necessary to 

develop the cloned cow embryos to the fetal stage so they could be aborted for their 

partly formed kidney tissue.29 The other, seeking to remedy an immune deficiency 

in mice, found it necessary to produce a newborn mouse whose adult stem cells 

could be transplanted into the original mouse.30 These and other studies have found 

embryonic stem cells to be enormously difficult to culture, to control, and to develop 

into usable cells that will integrate with the host animals’ cells; they have found 

these cells to have a disturbing tendency to form lethal tumors in recipients’ bodies; 

and they have found that even embryonic cells from cloning can be rejected by the 

recipients’ bodies, perhaps because of inherent differences between embryonic and 

adult cells.31 Reading the handwriting on the wall, state biotechnology alliances 

have conducted simultaneous campaigns in several states to pass legislation authorizing 

research involving the derivation and use of human embryonic stem cells, 

human embryonic germ cells, and human adult stem cells from any 

source, including somatic cell nuclear transplantation.32

Embryonic germ cells, of course, are harvested at the fetal stage (at around 8 

weeks’ gestation), while adult stem cells are harvested from infants and children. 

In this new generation of cloning legislation, the old distinction between ‘‘therapeutic’’ cloning and ‘‘reproductive’’ cloning has been obliterated: Researchers will 

conduct ‘‘reproductive’’ cloning (developing cloned embryos to at least the fetal stage) 

to achieve ‘‘therapeutic’’ cloning (producing usable stem cells for supposed therapies). 

At present S. 303 punishes efforts to maintain the cloned embryo past the 14th 

day. But this is an arbitrary limit, and Congress will be hard pressed to find a principled reason not to extend this to 20 days, or 30, or 100, if (as now seems more 

than likely) researchers report that such an extension is necessary to fulfill the 

‘‘promise’’ of ‘‘therapeutic cloning.’’ In the laboratory of the states, this broader agenda has already been launched. 

S. 245 (Brownback/Landrieu) 

By contrast, S. 245 has none of the serious problems outlined above. Very briefly, 

this bill:

1. Does ban human cloning, as that is accurately and scientifically defined.

2. Imposes its penalties on irresponsible researchers, not on vulnerable women, 

and avoids the moral, legal and constitutional problems raised by efforts to 

‘‘ban’’ pregnancy and birth.

3. Effectively attacks the threat of ‘‘reproductive cloning’’ at its root, by preventing the production of cloned human embryos.

4. Bans shipping, receiving or importing of cloned human embryos for any purpose, preventing any collusion by the U.S. Government with those who wish to 

violate other countries’ laws against cloning.

5. Is carefully crafted to avoid interference with any activity other than human 

cloning.

48

6. Directly protects all humans who would be harmed by the practice of human 

cloning (embryos, patients, and women who might be exploited for their eggs), 

by banning the practice for any purpose.

7. Respects the diversity of American views on the human embryo, by enacting 

only those provisions necessary to ban human cloning and leaving other research (including embryonic stem cell research that does not involve cloning) to 

be addressed by other proposals.

8. Prevents future ‘‘slippery slopes’’ that would require us to demean and exploit 

ever wider classes of our fellow humans as sources of body parts.

This is a case in which how we achieve an important goal is at least as important 

as whether we achieve it. We should ban human cloning—by banning the use of the 

cloning procedure to create new developing humans in the first place, as in the 

Brownback/Landrieu cloning ban (S. 245). Legislation which allows the practice, and 

then seeks to dehumanize and destroy the humans thus produced so we can pretend 

we have banned cloning, is worse than doing nothing. I urge Congress to oppose S. 

303, and to approve the genuine ban on human cloning offered by S. 245.

Senator BROWNBACK. Thank you very much, Mr. Doerflinger. 

We have now been joined by Ms. Lynne Millican. She is a patient/advocate, had difficulty getting in this morning, and, I think, 

was not feeling quite the best, and we are very appreciative of your 

willingness to come and testify this morning in spite of how you 

have been feeling. Thank you for joining us, and the floor is yours. 

STATEMENT OF LYNNE MILLICAN, R.N., B.S.N., PARALEGAL, 

BOSTON, MASSACHUSETTS 

Ms. MILLICAN. Well, I am honored to be here, and I did have 

great difficulty in getting here. 

I actually should not have to be here. I underwent fertility treatment to have a baby. However, I think I am more like egg donors 

than anybody else, because the extent of my disease was such that 

I needed a hysterectomy. I never expected to have children. I just 

wanted to make sure that I would not be 40 years old and look 

back and think, ‘‘What if I had tried?’’

So that is the context that I underwent this treatment, and I was 

given the drugs Lupron and Pergonal. Before I took these drugs, 

I had endometriosis, misdiagnosed which resulted in infertility, a 

knee injury, colds, flus, and usual childhood illnesses. Since 

Lupron, it has been a nightmare. Everybody wants to promote research, but who is looking out for the harm that is being caused 

by this? I am just one—there are thousands of Lupron victims, and 

they are one of the reasons why I am here today, because when I 

was vomiting at 5 o’clock this morning, all I could think of is if I 

do not come here and tell you people about all of these sick women 

out there, I would never be able to live with myself. 

I am a registered nurse, but I cannot help these people. I have 

had difficulty getting help myself. In 1995, after six years of going 

through this, I testified at the Massachusetts Health Care Committee, because when I realized, in 1990, that there were no regulations, no laws, no protections, no nothing, no consumer advocacy, 

no governmental assistance, no state assistance, no consumer agency assistance, I wound up getting involved in drafting a piece of 

legislation, a first-in-the-Nation bill in Massachusetts that would 

require fertility clinics to have a license to operate. I provided written and oral testimony every year. 

In 1995, at that time, I sat down at my computer and I typed 

in single space on continuous computer paper every doctor’s office 

49

visit, surgery test, lab, procedure that I had, and this is just to 

1995. This paper is seven and a half feet tall. And I am just one 

victim. 

If you go on the National Lupron Victims Network, yesterday 

morning there were over 2 million hits, and the counter just started January 1st, 2000. Lupron is not FDA approved for fertility 

treatment. It is a pregnancy category-X drug, according to the 

FDA. It is a hazardous drug according to NIH and OSHA. It is a 

reproductive and developmental teratogen. It has been referred to 

as a toxicant. I was told it was safe and effective and used successfully throughout the world. I run into women who never heard this 

risk information. This is unacceptable. 

The Boston Globe, in August of 1996, quoted the Nation’s largest 

volume fertility clinic, a physician, as stating, ‘‘Women do not need 

to know that Lupron is not FDA-approved for fertility treatment.’’ 

I disagree. 

I have had adenoma, breast cysts, cardiac arrhythmias, dizziness, edema, fatigue, gastritis, gastroesophageal reflux disease, 

hyperlipidemia, immune system abnormalities, joint pain, knee 

pain, lymphadenopathy, myalgia, neuralgia, osteopenia, now I have 

severe osteoporosis. My dentist said my jaw is dissolving. I have 

lost one tooth, and the rest of them are loosened. 

I am not alone. Initially, I did think I was alone. I would ask all 

the doctors, ‘‘I just took Lupron. Is this related to Lupron?’’ They’d 

say: ‘‘No, nothing to do with it. Just coincidence. It is just your 

time.’’ Well, it is not my time. 

Candice Hedin, of Marlboro, Mass., seven years ago took Lupron 

for fertility treatment, with Clomid. She suffered multiple unexplained serious illnesses. She has been hospitalized for unexplained 

chest pain, inability to breathe, about 15 times. She has hives inside her mouth and throat, open sores. She cannot eat or drink 

anything. She gets hospitalized. 

Wendy Camacho, Cherry Hill, New Jersey, took Lupron for IVF 

years ago. As she puts it, ‘‘my IVF baby is now nine and my health 

is a mess. It has been downhill since. I have seen neurologists, 

rheumatologists, orthopedists. None of them have any answers for 

me. I have severe fatigue, fibromyalgia, trouble sleeping, nightmares, gross motor skills are disintegrating fast.’’ I could go on and 

on, and these are just a few people——

Senator BROWNBACK. Would you——

Ms. MILLICAN.—that I put in. 

Senator BROWNBACK.—would you submit those for the record? 

Ms. MILLICAN. I have. 

Senator BROWNBACK. Okay, I just want to make sure that we 

have those in the record, those of other people, other statements 

from individuals. 

Ms. MILLICAN. I included them within my own statement. 

Senator BROWNBACK. Good. 

Ms. MILLICAN. There is much more that I could have put in my 

statement. Time did not permit. 

I do not feel that any victim should ever have to do what I have 

had to do. I brought this just simply as a display. 

I had to file my own lawsuit without a lawyer. I am not a lawyer. 

There is nobody to help these people. Although I do have to say 

50

now—you know, I started this in 1989—now there are lawsuits 

that are being filed. 

TAP has been sued for product liability. They are being settled. 

I do know that cases are being consolidated, and I do foresee a 

class action looming large. TAP has been declared a criminal enterprise based upon its scheme with physicians and billing fraud and 

kickbacks and—they just paid the largest fine in history at the 

time, $875 million. They allegedly have been maintaining a registry of babies exposed, inadvertently exposed, to Lupron, and they 

have a registry of over a hundred babies. That data is as of 1992. 

Somebody needs to find out how these babies are. TAP Pharmaceuticals maintains that there are no birth defects attributable to 

the drug. 

I know women myself with adverse pregnancy: birth outcomes 

after Lupron, and there are women on the Internet who report 

similar problems. There are problems with all of these drugs. I am 

especially concerned about Lupron, because I do believe that it is 

an especially toxic drug. But I have concerns about other drugs, as 

well. There has been no long-term epidemiologically sound research 

looking into the long-term health effects of any of these drugs. 

And where are you going to get these eggs from? You are going 

to get them from women who think they are doing a good thing, 

maybe who need some money. I have seen egg donor ads in Boston, 

‘‘We’re on the T.’’ Poor women who do not have cars, who need 

money, who are going to be going for this, and they need to know 

about the risks. And where are they going to hear it from? Only 

from somebody like me or other victims. And I do not get an opportunity to do this, because I am sick a lot of the time. But where 

are these women going to hear about this? The fertility industry is 

not telling them. I call them a bunch of ‘‘reproductive endo-criminologists.’’

There is a lot more that I have to say, but——

[The prepared statement of Ms. Millican follows:]

PREPARED STATEMENT OF LYNNE MILLICAN, R.N., B.S.N., PARALEGAL, BOSTON, 

MASSACHUSETTS

Mr. Chairman, and Members of the Committee: 

I am honored for the invitation to speak to you today on this very important issue. 

And although I am a registered nurse, I am here before you because of personal 

experiences as a patient undergoing superovulation during in vitro fertilization 

(IVF) attempts at several Boston fertility clinics over a decade ago—and because of 

what I’ve learned in the interim. My focus will be upon the adverse effects to the 

eggs, embryos, fetuses and women from one particular and commonly used drug, 

Lupron (leuprolide acetate), which is not FDA approved for fertility treatment; as 

well as addressing the risks from other fertility drugs and the assisted reproductive 

technology (ART) procedures in general. 

For ease of reading and reference, this paper will be arranged under the following 

13 headings:

1. Preliminary Comments 

2. Dead Women Don’t Talk—p.4

3. On The Count Of Eggs And Money—p. 5

4. A Brief Overview of the ‘‘Hazardous’’, ‘‘Commonly Prescribed’’ Agent 

Lupron—p.12

5. Impact of Lupron Upon Women’s Brains, Bodies, and Bones—p.14

6. Known Effects Of Lupron On Eggs, Embryos, and Babies—p.16

7. Examples of Iatrogenic Illnesses Induced By Exposure—p.19

8. Rita Abend, D.D.S.—Her Story & The Inception Of The NLVN—p.29

9. The State of the ART, And The ART of Stating—p.32

51

10. The Check is in the Fe/male—p.33

11. Considering Cloning? Consider the Myths of Hype, and The Realities of Scientific Misconduct—p.36

12. The Marginalization Of Victims And Lack Of Medico-legal Advocacy—p.39

13. A Request To Congress Asking For An Investigation Into Lupron and ART—

p.44

1. Preliminary Comments 

The drugs and fertility agents and the processes used in superovulation regimes 

for fertility treatments are exactly the same as that used to obtain women’s eggs 

for cloning research (although numerous variations of the protocols exist within the 

core group of ‘fertility drugs’). Cloning cannot take place without women’s eggs, and 

therefore the information I have to offer concerning the risks of fertility treatment 

have direct application to the process of therapeutic cloning. It has been estimated 

that some 8 million eggs per year may be necessary to sustain therapeutic cloning 

research—how many women would that entail? My research into the medical literature revealed the maximum top three reports of numbers of eggs retrieved at one 

time as being: 91 eggs from one woman at one time (Source, 1995), 71 eggs from 

one woman at one time (Lewit, 1995), and 56 eggs from one woman at one time 

(Lim, 1995). Since this research will require millions of eggs, this demand translates 

into the need to obtain as many eggs as possible from each woman per attempt. To 

quote from the consent form for egg donation for purposes of stem cell research at 

Advanced Cell Technology: ‘‘The idea is that the greater number of fully mature 

eggs, the greater the chance of successfully utilizing them in this research.’’ (ACT) 

A dozen years ago, an article examined ‘‘[t]he risks associated with ovulation induction’’, identifying that ‘‘epidemiologic studies are needed to determine the true 

risks associated with exposure’’ to the older, ‘traditional’ fertility drugs (St. Clair 

Stephenson, 1991). More than a decade later, the question is still being asked: ‘Are 

we ignoring potential dangers of in vitro fertilization and related treatments?’ (Winston, 2002). Costly complications from ART were, in part: a high incidence of first 

and second trimester bleeding, spontaneous abortion, toxemia, fetal growth restriction, anemia, anesthetic complications, ovarian hyperstimulation syndrome, culture 

medium infections (hepatitis and AIDS), visceral and vascular injuries, pathogenic 

infections, and breast and ovarian cancer. (Schenker, 1994). I believe it was 

Mirabella’s August 1993 issue which carried ‘A Doctor’s Story’, about a physician 

who took Clomid and was diagnosed with breast cancer. Large scale, epidemiological 

sound studies remain lacking on these earlier drugs, and yet in the interim years, 

the newer fertility ‘agents’ have been added and have themselves become ‘traditional’, standard, chemicals used in ovulation induction—but again, this standard 

has developed without any epidemiologically sound, long-term, safety data. It is 

noteworthy that while Lupron has become ‘standard’ within superovulation regimes, 

it is administered at various doses for various times, varying even within the various patients, and has varying effects. 

There have been a number of past, as well as a flurry of recent, published reports 

of birth defects in babies born from superovulation, IVF and other variants of ART, 

and it is widely acknowledged that critical long-term studies of the risks of ART are 

lacking (i.e., among others: Kola, 1988; Fischel, 1989; Saunders, 1989; Tanbo, 1995; 

Silver, 1999; Aboulghar, 2001; Mitchell, 2002; BBC, 2002; Sutcliffe, 2002; Skloot, 

2003). Titles often tell the story: ‘‘Ocular Manifestations in Children Born After In 

Vitro Fertilization’ (Anteby, 2001), ‘Congenital malformations in infants born after 

IVF: a population-based study’ (Ericson, 2001), ‘Hormone and Fertility Drug Use 

and the Risk of Neuroblastoma: A Report from the Children’s Cancer Group and the 

Pediatric Oncology Group’ (Olshan, 1999), ‘Congenital malformations in infants born 

after IVF: a population-based study’ (Ericson, 2001), ‘Brain worry over IVF children’ 

(Health, 2002), ‘Low and very low birth weight in infants conceived with use of assisted reproductive technology’ (Schieve, 2002), ‘The Risk of Major Birth Defects 

after Intracytoplasmic Sperm Injection and in Vitro Fertilization’ (Hansen, 2002), ‘In 

Vitro Fertilization May Be Linked To Bladder Defects’ (Trock, 2003), ‘Some Studies 

Sees Ills for In Vitro Children’ (Mestel, 2003), ‘Incidence of retinoblastoma in children born after in-vitro fertilisation’ (Moll, 2003). March 2002 brought headline 

news that the highly promoted and touted low incidence of birth defects from IVF 

(always stated as ‘‘similar to the general population, about 2–3 percent’’) was now 

being reported as 9 percent—much higher than the general population. And now 

March 2003 brings news that IVF babies are at increased risk for urologic birth defects (Wood, 2003). 

The American Society for Reproductive Medicine, in its Annual Meeting in 2002, 

released the following statement on October 14, 2002: ‘‘Studies Show Children of 

ART Develop Normally’’ (ASRM, 2002—note link of ‘kidsareallright’). Figures don’t 

52

lie, but liars figure. (In 1990, the Federal Trade Commission brought complaints 

against 4 fertility providers for false claims in fertility treatment success rates 

[FTC, 1990]). To quote the New York Times: ‘‘Since the 1970’s, fertility clinics have 

created almost a million children through experimental technologies. They’ve used 

untested and unregulated procedures... Where is Washington in all of this?’’ 

(Skloot, 2003). 

Online transcripts from the FDA’s Reproductive Health Drugs Advisory Committee Public Meeting, held October 18, 1999, identified ‘‘the need for pregnancy 

registries of babies born resulting from such [ART] treatment. These drugs include 

GnRH agonists and antagonists, human menopausal gonadotropins, purified 

urofillitropin, recombinant follicle stimulating, chorionic gonadotropin, and progesterone’’. The United Kingdom recently announced plans to study 68,000 people 

born as a result of ART (Kaiser, 2002). Will the percentage of birth defects from 

ART continue to climb in the U.K., and the U.S., with further study? Do human 

embryos really need to be grown in human ovarian cancer cell lines (see BenChetrit, 1996)? ‘‘Abnormal embryos’’ have been implanted into women (Munne, 

1995)—what kind of consent did that experiment entail? One treatment, using intravenous immunoglobulin (IVIG), has raised questions about the ‘‘ability to screen 

for any diseases that could crop up 20 or 30 years down the road. Some doctors have 

even gone so far as to denounce [the] practice not as medicine, but witchcraft.’’ 

(Arnot, 2000). 

Children have been born from co-culture with animal sera that could potentially 

contain prions, viruses, and/or unknown infectious agents—and my questions from 

the mid 1990’s about risks from such co-cultures to embryos, children, and women 

went unanswered. In 2002, the FDA sent a ‘Dear Colleague’ letter, announcing that 

the transfer of such co-cultured embryos ‘‘constitute[d] a clinical investigation involving xenotransplantation’’ (Letter, 2002), but no enforcement action would be 

based on already existing embryos; and FDA and U.S. Public Health Service guidance documents recommend, among others, ‘‘follow patients for their lifetimes and 

counsel them to be alert to any unusual symptoms... [and] they and their intimate contacts should defer from donation of blood and other tissues.’’ (CBER, 2002). 

Vero cells, from African green monkey kidney cells, have been used frequently in 

human embryo co-culture (i.e., see Veiga, 1999). In an online 1994 report of ART 

practices, it was stated that ‘‘[a]lthough the firm of Merieux refuses to accept any 

responsibility for the use of these [Vero] cells for the culture of human embryos, 

they are already widely used for this purpose by many specialists in medically assisted procreation . . .’’ (Report, 1994). Who is minding this store? 

The nation’s highest volume clinic was one of 10 participating clinics in a 1988 

national study that attempted to look at the long-term health consequences of ART 

and drugs on the women and offspring—however the study made no mention of 

GnRHa’s—the results were touted as ‘reassuring’, yet results were inconclusive (although ‘‘warrant[ing] epidemiologic study’’), and with too few study subjects 

(NICHHD, 1992). Of note, this writer, who developed multiple health problems, was 

a fertility patient at this clinic during this study—but was never asked to participate in this study. More significantly, another patient who was asked and did participate in this study (and shared her study documents with me) was subsequently 

dropped from the study following her hospitalization for severe ovarian 

hyperstimulation syndrome during her fertility treatment—in which she went into 

kidney failure and nearly died. 

Many follow-up studies I’ve read of ART children do not identify the specific drugs 

received. My own experiences highlight the lack of informed consent that women experience when they ‘‘agree’’ to take fertility drugs. The best illustration of this is 

found in the Boston Globe’s quote of the Director from Boston IVF, the ‘nation’s largest volume fertility clinic’ (one of the two clinics I attended) who proclaimed ‘‘women 

do not need to know about the lack of FDA approval [of Lupron for fertility treatment] . . .’’ (Kong, 1996) Years later, this clinic would receive ‘‘$180,000 over two 

years to cover the cost of providing the embryos’’ ‘‘to Harvard University scientists 

for stem cell research. . . . Harvard researchers plan to offer the new stem cells 

to any interested scientist at no cost, with no commercial restrictions. . . .’’ 

(Mishra, 2001) 

The profit within the fertility industry that exists today, as well as the hyped potential profit of therapeutic cloning tomorrow, along with lack of informed consent, 

the risks, and inherent exploitation all point to this issue having very serious ramifications upon many lives. 

A recent Popular Science article unintentionally highlights the issue of consent: 

in the March 2003 series, the McNamara’s were featured as they had undergone experimental fertility treatment using cow uterus to grow their embryos. This Popular 

Science piece examined the risks of ART, and the McNamara’s conclusion at the end 

53

of this article was ‘‘Yeah, there is [a possibility of long-term effects] . . . But . . . 

we would still have done it.’’ (Skloot, 2003). However, Popular Science held a Popular Science Infertility Chat on America Online, and, in fact, the McNamara’s stated 

in the chat—after they had read the article—that ‘‘I think it’s important to point 

out that the information in the article wasn’t available when we made our decisions. . . . Honestly, if it was presented in a way that it would cause trauma to 

our offspring, we probably wouldn’t have done it.’’ (Chat, 2003) 

2. Dead Women Don’t Talk 

Not until long after my fertility treatment did I learn that, before my treatment, 

there were questions raised and warning given regarding the fertility industry’s use 

of lack of informed consent, deceptive advertising and manipulated statistics. The 

first survey in the world of IVF clinics was done by two journalist/authors, Gena 

Corea and Susan Ince, and this survey revealed that while half of responding clinics 

had claimed high success rates, they had, in fact, produced not one baby (Corea, 

1987). In 1992 I had begun legal action against my fertility treatment providers, 

and in 1997, Gena Corea (see also Corea, 1985) provided a statement to me intended 

for inclusion into the Offer of Proof for my medical malpractice tribunal (Millican

v. Harvard Community Health Plan, Boston IVF, Natalie Schultz M.D., Brian 

Walsh M.D., Mahmood Niaraki M.D., Selwyn Oskowitz M.D., Michael Alper M.D.) 

The following 5 paragraphs are from that statement: 

‘‘ . . . A lack of informed consent to IVF has been a constant and continuing 

problem with IVF from its earliest days when Lesley Brown, pregnant with the first 

IVF baby, Louise, was under the misapprehension that hundreds of such babies had 

already been born. She had no idea that she was in such an experimental program. . . .’’

‘‘ . . . The exact number of women who have died in in vitro fertilization programs is not known. However I have information on the deaths of ten women: in 

Germany, Brazil, Israel, Spain, and Martinique (in all these countries, I have taperecorded interviews with the physicians and/or relatives of the dead women), and 

in Australia, New Zealand and Canada. Women entering IVF programs do not know 

of these deaths. Even physicians practicing IVF do not know of most of the deaths 

or their causes. With the exception of the Israelis, the IVF teams involved are not 

writing reports on the deaths for their professional publications nor are they delivering papers on the deaths at international meetings . . . No professional or governmental organization is recording the deaths in a data bank.’’

‘‘Some Brazilians know of the first death—of a woman named Zenaide Maria 

Bernardo, whose daughter and physician I interviewed in, respectively, Araraquara 

and Sao Paulo, Brazil. They know of her death because it occurred during a course 

on IVF for physicians and the course was a huge media event, covered by Globo, 

a national television station and the fourth largest in the world. The death could 

hardly be covered up when the television cameras were rolling. But aside from these 

Brazilian citizens, few in the public know of any IVF deaths.’’

‘‘To date, IVF deaths are known to have occurred due to hyperstimulation of the 

ovaries through the administration of hormones; anesthesia for laparoscopy; infection following laparoscopy; bleeding following laparoscopy; bleeding following 

ultrasonically-guided puncture of egg follicles; and ectopic pregnancy.’’

‘‘Physicians and the public relations firms hired by the IVF industry often give 

women the impression that IVF is a low-risk procedure. How do they know it is lowrisk? I have interviewed physicians around the world on IVF deaths and without 

exception, I have known of, and had documentation on, more IVF deaths than any 

of them claimed to. Why is that? If scientists doing IVF do not know of the deaths 

their programs are causing, why don’t they? What are the mechanisms by which 

this information has been obscured? Through their journals and conferences, physicians share information on every slight change in drug protocol for inducing artificial ovulation. Shouldn’t information on deaths, injuries, psychotic breaks, lengthy 

recoveries also be shared? It’s not. . . .’’

3. On The Count of Eggs and Money 

Early articles describe Lupron’s application in ovulation induction regimes as ‘‘in 

special situations’’ (Blankstein, 1988), yet Lupron ‘‘began to be widely used for IVF 

in 1989’’ (Martin, 1994). By 1990 fertility industry figures, GnRHa’s were utilized 

in 97 percent of reported assisted reproductive technology cycles (MRI, 1992), with 

Lupron identified as the ‘‘prevalent choice’’ and most frequently prescribed GnRHa 

in this country (Keenan, 1991; Martin, 1994). The fertility industry had already 

achieved the recognition of being more than a billion dollar industry by 1990 (Talan, 

1990), and sounding like a trumpet, a 1991 publication proclaimed ‘‘Chronic indications for GnRH agonist therapy among IVF/GIFT patients are likely to increase sigVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00057 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
54

nificantly in the immediate future.’’ (Gordon, 1991). Early on, Lupron’s use had been 

described as increasing the use/purchase of Pergonal (manufactured by Serono) by 

50 percent (Keenan, 1991), and it was known that ‘‘[t]he direct financial cost of cycles incorporating adjunctive leuprolide therapy was 40 percent greater than the 

cost of cycles in which no leuprolide therapy was used.’’ (Dodson, 1991). At this 

time, the failure rates for IVF were around 80–85 percent: ‘‘rarely has a technology 

that has had such dismal success rates been so quickly accepted.’’ (Raymond, 1993). 

When I complained to my Harvard HMO about their use of this experimental 

drug, their response was an illustration in how definitions can easily be changed; 

they state that institutional review board (IRB) review was unnecessary because 

Lupron was not being used in ‘‘research’’, but rather Lupron was being used in a 

‘‘therapeutic’’ manner. The Office for Protection from Research Risks has received 

reports from major research institutions of ‘‘startling ignorance’’ of IRB policies regarding informed consent in reproductive research (Ellis, 1995). 

Because of my nightmare experiences as a fertility consumer, I became involved 

in drafting a first in the nation bill which would have required fertility clinics to 

have a license to operate, and which would have mandated informed consent of ART 

risks (Millican (2), 1992; Lasalandra, 1995). My collaborator in drafting this bill, 

Linda DeBenedictis, had also attended Boston IVF and had also been mandated to 

switch to Lupron—and her story was told over a 3 part series on Boston TV news. 

Doctors from Boston IVF told the DeBenedictis’ that 3 eggs had fertilized and 3 embryos were ready for implantation the next morning. Upon arrival at the clinic the 

next morning, there were not 3 embryos for implantation—there were no embryos 

for implantation. The clinic maintained there had been an ‘‘error in communication’’, 

and that no embryos had fertilized (WHDH, 1989). 

From 1992–1999, I provided verbal and written testimony to the MA. Health Care 

Committee in support of this bill (MA. H. 3308), and these documents are a testament to my experiences, my learning curve, and the mounting evidence against 

Lupron. My 1992 written testimony states: ‘‘... nearly every IVF clinic has mandated that women take Lupron—or they will not be allowed to cycle . . . Women 

are told that Lupron results in better quality and better quantity of eggs.’’ In 1995, 

my testimony states I was told that I ‘‘must use Lupron’’ if I wanted to undergo 

IVF. Women reported successful IVF births without Lupron, yet were made to use 

Lupron nonetheless, and reported subsequent failure in these switched cycles. Other 

women using Lupron complain of failure to suppress and canceled IVF cycles, premature leutinization, and poor quality eggs with Lupron (see Chetkowski, 1989; 

Schoolcraft, 1991). The internet posts of women identify the badgering, and coercion, 

and manipulation, and threats used to convince women into taking Lupron for a variety of indications—many refer to their doctor as trying to ‘‘shove it down [their] 

throat’’. 

Later I would learn that the first survey in the world of IVF clinics was conducted 

in 1986 (Raymond, 1993), revealing deceptive success rate claims and manipulated 

figures (Corea, 1987). As a result, the 101st Congress held hearings in the Subcommittee on Regulation, Business Opportunities, and Energy, House of Representatives, in which data from 191 fertility clinics was published. This clinic specific information shows a significant number of these reporting fertility clinics had recently 

‘‘switched’’ and/or ‘‘began to use’’ Lupron in their superovulation regimes—without 

any IRB review (Hearing, 1989). One reporting clinic provided testimony identifying 

Lupron as ‘‘a costly, experimental medicine . . .’’ (Kemmann, 1989). 

One of the fertility clinics that I attended in 1990, Brigham & Womens, had as 

its protocol in its IVF brochure that ‘‘Lupron is only used in certain diagnosis’’, but 

in 1991 this clinic changed its brochure to read ‘‘Lupron is widely prescribed’’. I 

would later learn that the director of this IVF clinic, Dr. Andrew Friedman, had 

been a lead Lupron investigator, had received numerous grants and funds from 

Lupron’s manufacturer, Takeda Abbott Pharmaceuticals (TAP), and had published 

extensively on Lupron. Dr. Friedman was ultimately found guilty of falsifying and 

fabricating approximately 80 percent of the data in four Lupron studies, two of 

which had been published and were subsequently retracted. Friedman had ‘‘altered 

and fabricated information in patient medical records, falsified research notes by 

changing dates and changing and adding text’’, and fabricated notes and fabricated 

patients for clinical visits that had not taken place. (Federal Register, 1996; see also 

Lasalandra, 1998; Millican, 1998; Kong, 1999). 

My 1995 written testimony in support of MA. H 3308 identified ‘‘manipulated figures’’ in a fifth Friedman Lupron study (Millican, 1995). To the best of my knowledge, while confidential Harvard documents state further investigation into other 

Friedman Lupron data should be explored, no investigation has been conducted beyond the four, identified, fraudulent Friedman Lupron studies. Two years after the 

Federal Register publication of Friedman’s fraud, the MA. Board of Registration 

55

‘acted’ by temporarily suspending his medical license, however the published and 

cited bogus data is irretrievable. And in fact, one fraudulent and retracted Friedman 

Lupron study was cited as a credible reference and data source in an article published on Medscape (Women’s Health) in August 2001 (Data, 2001). In a similar 

faux pas, FDA Consumer magazine recently had to provide a correction to an article 

in which it erroneously stated GnRHa’s would ‘‘shrink fibroids’’—a statement told 

repeatedly to women despite the fact Lupron has only been approved for ‘‘the anemia associated with fibroids, when iron therapy alone has been ineffective’’. The indication of Lupron’s use to ‘‘shrink fibroids’’ received the FDA’s rejection in the past, 

and no FDA approval has ever been granted for this indication. (FDA, 2002) 

NBC Dateline did a story January 2, 2000 about severe side effects experienced 

by women taking Lupron for endometriosis (adverse events such as joint pain, 

numbness, memory loss, irregular heart beat, suicidal depression, whole body swelling, grand-mal seizures). Quoting from the Dateline story transcript: ‘‘[Dateline] 

asked TAP about the complaints of these women, given TAP’s marketing of Lupron 

as ‘‘perhaps making miracles possible.’’ While the company declined an on-camera 

interview, [Dateline] met with several top executives, who told [Dateline] the preponderance of evidence suggests that Lupron works, otherwise women wouldn’t continue to use it.’’ Dateline’s story concluded with ‘‘[Lupron] is also widely and routinely used for women going through fertility treatments.’’ (Dateline, 2000). 

In 2001, the U.S. Attorney’s office in Boston would land the largest fine in his- tory—$875 million—from TAP for its lucrative, unethical, illegal, conspiratorial 

scheme involving urologists and kickbacks, gifts, trips, TV’s, computers, VCR’s, as 

well as gifts of free samples of Lupron which were then billed to Medicare. Confidential documents of Lupron’s ‘‘return to practice’’ scheme were revealed during 

Chairman Bliley’s hearings (Oversight Hearings). This prosecution resulted in TAP 

officially earning the title of ‘‘a criminal enterprise’’, and a decade earlier TAP had 

profitably tarnished itself with receipt of Notices of Adverse Findings from the FDA 

due to its incessant and ‘‘deliberate campaign to promote this product [Lupron] for 

a wide range of unapproved uses.’’ (FDA, FDC; 1990). ‘‘In addition to offering inducements to hospitals and doctors, TAP was encouraging its salespeople to approach patients in support groups.’’ (Pitchmen, 2002). And I aware of one gynecologist who TAP approached and indicated he could clear $98,000 to his income by 

prescribing Lupron. 

Government documents of the TAP prosecution reveal that TAP also attempted 

to make deals involving the costs of gynecological uses of Lupron. And, incredulously, these government documents state that ‘‘Lupron depot 3.75 mg is indicated 

for treatment of... infertility’’. This statement contradicts the FDA’s lack of approval of Lupron for the indication of infertility, but the presence of this erroneous 

and promotional language within these government documents well illustrates the 

extent of pervasive influence of the industrial mantra that ‘Lupron is standard in 

fertility treatment’ (U.S.A., 1998). The rationale for so many unreasonable heated 

decrees of ‘‘you must take Lupron if you want IVF (to get good quantity and quality 

eggs)’’, ‘‘you must take Lupron for your endometriosis (if you ever want to get pregnant)’’, ‘‘you must take Lupron for your fibroids (or you’ll bleed to death or have to 

have a hysterectomy)’’ was now as clear as a solid gold bell struck with a silver 

spoon. 

Fertility clinics have been generating in the multi-million dollar annual surplus 

range, and years ago claimed a 37.5 percent profit margin and physician salaries 

up to one million (Gabriel, 1996). For quite some time, reproductive endocriminology 

has enjoyed the label of a multi-billion dollar industry. In such an area of ‘obscene 

profiteering’, every attempt at regulation has met with stiff opposition. The MA. bill 

(H. #3308) has habitually died and been refiled each session, although it has not 

been refiled this year to date. And I understand a recent provision by Senator Frist 

to study the adverse health effects of ART on women and babies was also defeated 

(Skloot, 2003). Patient protections are nowhere to be found, while patent and industry protections abound—and market/ing forces rather than science dictate the 

‘standard of care’. 

When discussions of the lack of regulation within the fertility industry arise, the 

industry refers to the Federal bill, the ‘Fertility Clinic Success Rate and Certification Act of 1992’, as the answer. Yet this Act, Public Law 102–493 (signed into 

law by President George H.W. Bush on October 24, 1992), does not contain any language whatsoever to address or mandate informed consent to the risks of the drugs 

and procedures. And, in H.R. 4772 (which directs the Secretary of the Department 

of Health and Human Services to develop a model embryo laboratory certification 

program for the states), there are ‘‘Limitations’’ (in ‘Section 3:i’) which declare: ‘‘(1) 

In developing the certification program, the Secretary may not establish any regulation, standard, or requirement which has the effect of exercising supervision or conVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00059 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
56

trol over the practice of medicine in assisted reproductive technology programs; 

[and] (2) In adopting the certification program, a state may not establish any regulation, standard, or requirement which has the effect of exercising supervision or 

control over the practice of medicine in assisted reproductive technology programs. 

This language, which was crafted at the behest of the industry (Lawrence, 1993), 

appears from my vantage point to illustrate the Lupron loophole well—‘you can tell 

us what to do, as long as you don’t tell us what we can’t do . . . including patentable, profitable, ventures involving injecting hazardous drugs without informed consent.’ What we have here is unconscionable stealthcare: an entire ‘profession’ and 

industry utilizing hazardous and untested drugs and procedures upon vulnerable 

women attempting to conceive, without informed consent, under the guise of 

‘‘science’’ and ‘‘under the law’’. For a preyed upon victim to have to try to sort this 

out without advocacy, and to have to learn how and then search applicable law to 

try to make sense of this outrageousness, is patently absurd. Judge Learned Hand 

precisely captured the essence of this matter: ‘‘... there are precautions so imperative that even their universal disregard will not excuse their omission’’ (T.J. Hooper, 1932). 

Of critical note is the increasing number of states that have passed legislation 

that mandates insurance coverage for fertility treatment—in essence, promoting further use of experimental agents such as Lupron (and in the case of MA., it would 

appear that the state has become complicitous in the advancement of human experimentation in light of failure to pass informed consent legislation). These states have 

been, and/or are being, lobbied heavily by RESOLVE, Inc., an organization that alleges to ‘‘educate, support, and advocate’’ for the infertile, yet was taking thousands 

of dollars from TAP Pharmaceuticals as early as 1989 (before any female indication 

had ever been FDA approved for Lupron). RESOLVE, Inc. admits to receiving hundreds of thousands of dollars from numerous fertility drug manufacturers in its 

itemizations in Annual Report disclosures, however RESOLVE claims in published 

Boston reports that RESOLVE ‘‘does not receive any funding from drug companies’’ 

(Seiffert, 2000). 

RESOLVE has a history of opposing regulation of the fertility industry, including 

MA. H #3308 (Millican (1), 1992), and of ‘‘mov[ing] quickly to downplay’’ information 

pertaining to risks from fertility drugs and treatment (Dezell, 1994). And, in similar 

fashion, the Endometriosis Association (EA), which testified at the FDA on behalf 

of, and claims an active role in the approval of, Synarel, the first GnRHa FDA approved for use in women with endometriosis—with the EA providing testimony to 

the FDA on behalf of Lupron as well... yet the EA has also received thousands 

upon thousands upon thousands of dollars from GnRHa manufacturers, including 

TAP (see www.lupronvictims.com, ‘Endometriosis’, for partial list of specific years, 

companies, and dollar donation amounts). Another younger endometriosis association, founded in 1997, the Endometriosis Research Center (ERC), like the EA, publicizes clinical drug trials for endometriosis. The ‘‘ERC March 2000’’ was ‘‘presented 

by the ERC and Amgen Praecis’’ (manufacturer of a GnRH antagonist) (ERC, 2001); 

and an ERC Board Member and Director of Operations is also the ‘‘co-ordinator of 

the AstraZeneca [manufacturer of Zoladex] Pharmaceutical Corporation website, the 

Endometriosis Zone’’ (Operations, 2003). While the disease of endometriosis and the 

havoc it wreaks needs as much attention as possible, the eternal presence of conflicts is quite troubling. 

For years the FDA has been making annual seizures at ports of unlabeled and 

illegal fertility medications, including Lupron. I have also seen a publicly posted 

note on a fertility message board advertizing an ultrasound machine, and media reports have been made in the past of ‘black market’ Lupron and sales. Just what 

type of underground market exists out there? Just how many people are lining their 

plush pockets while their victims simply line and pile up? 

‘Follow the money’ is an apt adage for this unregulated billion-dollar industry and 

all its associates groups. The value of eggs and embryos for research was clearly 

identified in the transcripts of the National Institutes of Health’s 1994 Human Embryo Research Panel Hearings, wherein the profit from human embryo research in 

the form of vaccines, hormones, proteins, stem cells, gene therapy, cell lines, 

organogenesis, ectogenesis, parthenogenesis, chimeras, patents, etc. was amply highlighted. There were a few voices of caution: i.e., Dr. Van Blerkom stated ‘‘The [medical] literature is the quality of the science in the field, and without offending anybody who might have a vested interest, I think the quality of science in this field 

has been awful, in this country at least, from the very beginning, awful because 

there are reports that get into journals based on handfuls of patients.’’ And C.A. 

Tauer stated ‘‘I think the fact that the research enterprise has gone on out there 

without peer review and without the appropriate safeguards is something very bad 

that has happened.’’ (NIH, 1994) 

57

One patent relating to assessing eggs and pre-implantation embryos noted that 

‘‘[s]ignificant improvements in ovulation induction, oocyte retrieval, and in vitro culture techniques have resulted in an abundance of embryos per patient or experimental animal.’’ (Assignee, 1996). One gross eggsample of commercialism at its 

highest level of crass was the website auction of the eggs of ‘‘beautiful young models 

for as much as $150,000 a pop’’ (Oldenburg, 1999). Hundreds of ‘‘egg donor wanted’’ 

ads litter the nation’s newspapers and college campuses, with financial enticement 

as high as $50,000 for Ivy league eggs (Padawer, 2002) and $100,000 for the preference of ‘proven college-level athletic ability’ (Enge, 2000)—and the industry proclaims the ‘‘shortage of egg donors’’—yet it would seem that the published medical 

literature tells a different story. 

In curiosity, I added the number of human oocytes and embryos identified in a 

mere, random, 20 pages in just one of the numerous relevant medical journal publications available, and arrived at a total of 7,845 human oocytes [eggs] and 266 

human embryos used in research in these few pages. These 20 pages contained 

roughly 80 abstracts, published in just one supplement of this one journal, from just one month, in just one year (Journal, 1995). This genetic ‘research material’ is described in the published medical literature as ‘‘coming from the IVF program’’, ‘‘surplus’’, ‘‘left-over’’, ‘‘discarded’’, ‘‘extra’’, ‘‘spare’’, ‘‘clinic’’, ‘‘donated’’, ‘‘research’’, ‘‘abnormal’’, ‘‘fertilized’’, ‘‘unfertilized’’, ‘‘nontransferable’’, ‘‘suboptimal’’, ‘‘nonviable’’, and 

‘‘aspirated’’. In Britain’s The Times, an article entitled ‘Scientists pillaging foreign 

embryos’ qualified that ‘‘the stem cells are derived from an anonymous embryo in 

the United States, left over from an IVF procedure.’’ (Hawkes, 2000). And, again for 

curiousity, I tallied the incidence of ‘egg donor wanted’ ads published in the Boston 

Globe for the month of February 2001; and found ‘egg donor wanted’ ads published 

on February 4th, 6th, 7th, 8th, 11th, 14th, 18th, 20th (twice), 21st, 22nd, 25th, and 

27th. 

The Washington Post reported in 1998 on ‘Experimenting with eggs’: ‘‘ . . . No 

one was paying attention... The research required many eggs to practice on, said 

[][one] clinic’s director, so doctors there turned to women who were donating eggs 

to infertile women and used some of the leftover eggs for their research. ‘We call 

it sharing with the lab’ he said.’’ (Weiss, 1998). And there are few embryologists who 

admit to ‘‘hav[ing] played around with embryos after hours.’’ (Rogers, 2001). 

The same researcher who recruited egg donors for Advanced Cell Technology’s 

human embryo cloning endeavors has a mobile embryology lab—‘‘a conventionallooking recreation vehicle with a connected trailer. Inside is nearly all the gear 

needed for in-vitro fertilization.’’ (MSNBC, 2002). Currently this mobile embryology 

lab is utilized to serve HIV+ clients who wish IVF, but it is noted that such a traveling lab ‘‘could potentially provide location-flexible ART for under served populations’’ (Foundation, 2002). In the matter presently before Congress, there is discussion that if therapeutic cloning were allowed, it should be removed from the fertility clinic setting. Are traveling embryology vans, pulling trailers and driving 

throughout the streets of the country, the answer? With the value of human eggs 

as research material increasing, imagine the obscene profit that an unscrupulous 

scientist could envision with a mobile IVF unit traveling the country, trafficking in 

underground egg sales. 

The profoundly significant and despicable thefts (‘‘conversion’’, ‘‘sharing’’) of women’s ova and embryos by Drs. Ricardo Asch, Sergio Stone and Jose Balmaceda at 

the University of California at Irvine (Regents; Press; 1995) should be a serious reminder to the utter (and anesthetized) ease with which such menacing maneuvers 

can be executed. (And Dr. Asch had co-authored studies of Lupron, ‘‘which was kindly provided by Abbott’’ [Guerrero, 1993]). The contemptible violations of stealing 

women’s eggs and embryos should highlight the profitability of schemes to procure 

women’s eggs and embryos for use in research and/or covert ‘re-sale’. Dr. Asch reportedly ‘left his office daily with briefcase stuffed with thousands of dollars’. And 

attention should be directed to the drug protocol(s) used—medications administered 

‘‘deliberately’’ ‘‘so there would be a surplus of eggs’’ (Challender, 1995). Who is exerting any oversight over the field of reproductivity? Who would exert oversight over 

therapeutic cloning—this same industry? 

The conflicts within this arena are excessive and have had a tremendously negative impact upon care. For one example, I pursued initial rheumatology work up for 

bone pain post-Lupron at the renowned hospital which had first prescribed Lupron 

to me, and during the course of my visits I was met with the standard ‘‘(pain) has 

no connection to Lupron’’. Years later I would read that the head of this department 

had been a long-term highly paid consultant and scientific advisor for Lupron’s 

manufacturer (with compensations rising each of the many years displayed)—and 

I’ve seen this doctor’s signature on the contract where the pledge is taken to ‘defend 

the company’s products at all times in all ways’. In retrospect, I’m able to say ‘no 

58

wonder no one there wanted to even hear about any connection between Lupron and 

problems’—but how many other patients know of conflicts of interest in their circumstance(s)... and who will tell them? 

4. A Brief Overview of the ‘‘Hazardous’’, ‘‘Commonly Prescribed’’ Agent 

Lupron 

Lupron, referred to as a GnRHa (gonadotropin releasing hormone analog/agonist 

[and also previously referred to as LHRH]), will be the focus of my comments as 

it is one of the most commonly used agents, but it should be recognized that numerous other GnRHa’s as well as the newer GnRH antagonists are being used in superovulation of women—and the risks from all of these agents should be taken into 

consideration. Thousands of women have become seriously ill after taking Lupron 

(and there have also been complaints about other GnRHa’s, such as Buserelin, 

Synarel and Zoladex); and the alleged safety and mechanism of action of these drugs 

needs attention. A National Lupron Victims Network (NLVN) was founded in 1993, 

and when I learned of their existence in 1994, they were the only entity who was 

interested in the results of my searches into the medical literature; and this information, along with many other sources of information, continues to serve as the 

‘clearinghouse’ of information on the risks of Lupron at their website, 

www.lupronvictims.com. The NLVN began a visit counter on January 1, 2000: as 

of 3/25/03 there were 2,119,422 hits made to this site. While the NLVN provides 

detailed information on Lupron, other internet sites contain public message boards 

about problems after Lupron, i.e., Delphi message boards such as ‘Julie’s After 

Lupron Page’ (Julie’s Page), and AOL message boards, among many others. 

The initial patent filed for Lupron involved ovulation induction (Patent 

#4,005,063), and Lupron has been used in drug company funded studies to induce 

ovulation (i.e., Segal, 1992). Lupron has become the ‘‘standard of care’’ for some 15 

years, for a variety of reasons, including to maximize number of eggs produced. A 

multitude of many, including numerous Internet pharmacy websites, hawk Lupron 

as a ‘‘fertility medication’’... yet the FDA has never approved Lupron for infertility, or fertility treatment, or IVF treatment, or any variant of IVF or ART. According to the Physician’s Desk Reference, the FDA classifies Lupron as a Pregnancy 

Category X drug, meaning any woman who is or who may become pregnant should 

not use. Lupron is a known teratogen (Shephard, 1992), and Lupron is a known developmental and reproductive toxicant (Scorecard). NIH and OSHA place Lupron 

(leuprolide) on its list of hazardous drugs (NIH, OSHA). Yet, inexplicably, medical 

literature reports Lupron to be the most commonly prescribed and ‘‘prevalent 

choice’’ of GnRHa used in fertility treatment (Keenan, 1991; Martin, 1994). 

Medical literature regularly refers to Lupron as an antineoplastic and chemotherapy, with some references characterizing Lupron as an antineoplastic hormone. 

Yet, according to deHaen modified American Hospital Formulary System, Lupron is 

not listed in the antineoplastic/hormone category (Classification No. 10:00.10, as are 

the drugs Tamoxifen, Megestrol, Flutamide)—but rather Lupron is listed in the 

antineoplastic/OTHER category (Classification No. 10:00.12, listed along with 

Interferon) (deHaen, 1995). No one seems to know what the ‘‘other’’ in Lupron is! 

But it is known that Lupron was originally approved out of the FDA’s Office of Biologics Research and Review. (NDA [New Drug Application] 19–010). 

Clinical studies conducted by the manufacturer to evaluate Lupron’s efficacy (and 

‘not’ safety) in fertility treatment and in IVF occurred between 1988 through 1992, 

according to Abbott Annual Reports (see also FDC, 1988). The ‘‘IVF clinical trials’’ 

and ‘‘fertility treatment clinical trials’’ using Lupron ‘‘were discontinued’’, according 

to the manufacturer (Abbott correspondence, 1995), and I’ve been unable to learn 

whether these Lupron IVF and Lupron fertility trials were discontinued because of 

efficacy reasons, safety reasons, both reasons, or other reasons. 

Lupron has never gained FDA approval for any type of fertility treatment, however, Lupron did gain FDA approval for use in women for pain management of endometriosis in 1990—yet the clinical studies for these approvals are a joke—conducted 

on a handful of women, by paid investigators, and with an endpoint of establishing 

Lupron’s efficacy in pain management of endometriosis while the women in these 

studies were simultaneously allowed to take narcotics, including Dilaudid and parenteral narcotics. These women were also expected to ‘recall and record their adverse events at the end of the study month’, yet were not informed that Lupron was 

known to affect memory (NDA 19–010; see also Newton, 1996). Problems with this 

trial alone could fill this document—never mind attempting to address the numerous and gross problems evident within other Lupron NDA’s. 

Lupron is alleged to cause menopausal symptoms such as hot flashes and headaches, and Lupron’s categorization as a ‘‘hormone’’ is an allusion that is frequently 

conveyed to women. Women are often told by the physician, and TAP continues to 

59

state, that side effects to Lupron disappear after the ‘drug’ is stopped. Yet FDA documents for the endometriosis NDA identify that the majority of hot flashes occurred 

after stop of study (NDA 20–011). One clinical trial evaluating memory loss and cognitive effects of Lupron in young women undergoing IVF showed that ‘‘[72 percent] 

showed difficulty with memory while on leuprolide’’ and there was ‘‘no correlation 

between estradiol levels and tests results on any test’’ (Varney, 1993); and another 

study showed 11 percent continued with memory complaints 6 months after stop of 

study (Newton, 1996). In the March 1984 FDA’s toxicological reviews of Lupron, it 

is stated that ‘‘[rat] testes showed various degrees of testicular degeneration which 

were detectable within 2 days. The severity of the lesions were greater in the testes 

of rats sacrificed 7 days after cessation of treatment indicating that the effects continued after drug withdrawal. . . .’’ (Jordan, 1984). 

Women are told that Lupron will ‘‘shut down their system’’, allowing ‘‘control’’ 

over their system, and that the side effects are related to menopausal symptoms. 

But in fact, it was known prior to my ‘treatment’ with Lupron (but not disclosed 

to me) that Lupron causes a ‘‘hypophysectomy’’ (Holmes, 1988)—which, by definition, is ‘‘destruction or removal of the pituitary’’; and it was known (but not disclosed to me) that ‘‘sustained treatment with GnRH agonists most likely abolishes 

pituitary function’’ (Bischof, 1988). I would also later learn that in the original rat 

studies submitted to the FDA for Lupron’s initial approval of palliative prostate cancer, all rats at all doses developed pituitary adenomas (tumors)—and it was stated 

that ‘‘there is no obvious reason to suggest that the same process could not occur 

in humans’’ (NDA 19–010). 

Years following these Lupron animal studies, it would be reported ‘‘[w]e cannot 

exclude that [GnRHa] may cause not only adenomas in rat pituitary glands as reported previously, but also a (nodular) hyperplasia of the pituitary gland in man.’’ 

(Radner, 1991) While the industry maintains that the hot flashes from Lupron are 

due to lack of estrogen, women complain of hot flashes while on Lupron but not 

achieving ‘suppression’ (termed ‘‘Lupron escape’’), and women complain of hot 

flashes while on Lupron plus estrogen, and women complain of hot flashes after 

stopping Lupron that do not go away. Years later, I’d read that it is the ‘‘interference with the pulsatile pattern of GnRH that causes flushes’’ (van Leusden, 

1994)—thus, the alteration, impairment, destruction, of the pituitary (as never explained to me or others). To quote one investigator: ‘‘GnRH analogs are not like any 

other medication currently available for treatment of disease. As we continue to 

learn more about these analogs’ mechanisms of action, it is increasingly apparent 

that they do not just affect the gonadal [sex] hormones, but are powerful modulators 

of autonomic neural function.’’ (Mathias, 1995) 

5. Impact Of Lupron Upon Women’s Brains, Bodies, and Bones 

By way of understanding the significance of this information, the hypothalamus 

and pituitary are considered the master glands of the body, and both are directly 

connected to each other by neurons and blood supply; and are responsible and required for proper functioning of the autonomic nervous system (involving hunger, 

thirst, temperature, heart rate, blood pressure), and the production of numerous 

hormones necessary for life. GnRH, gonadotropin releasing hormone, which is made 

by only around 1000 neurons in the hypothalamus (Wierman, 1995), is sent to the 

pituitary and causes the secretion of (among others) the hormones necessary for normal ovulation (leutenizing hormone [LH] and follicle stimulating hormone [FSH]). 

Lupron is a synthetic copy of the GnRH found in pig and sheep, except that Lupron 

has an added, unnatural amino acid substitution inserted into the structure of the 

molecule, causing it to become an ‘analog’ of GnRH and far more potent than the 

original molecular structure. Which brings me to several pertinent comments made 

by the FDA that sum up some of the problems and concerns with the use of such 

a new molecular entity: 

One year prior to Lupron’s initial FDA approval for palliative treatment of prostate cancer, members of the FDA’s Center for Drugs and Biologics wrote an article 

entitled ‘Trends in Drug Development with Special Reference to the Testing of 

LHRH [GnRH] Analogues’—stating ‘‘[c]onceivably, LHRH analogues may be 

antigenic... [and] may even cause immune-related disorders. . . . The long-term 

safety of LHRH analogues have not yet been fully investigated, especially when we 

are dealing with structures drifting farther and farther from the original molecule.’’ 

(Gueriguian, 1984). 

Lupron’s structure indeed differs from the original structure in that it contains 

an UN-natural amino acid, making the ‘drift’ of Lupron, in my opinion, far from the 

original ‘natural’ (pig/sheep) structure. Bear in mind that other GnRHa’s have modifications of the original GnRH molecule with their own unnatural substitutions at 

different and differing places along the structure of the original GnRH molecule—

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and the newest ‘models’, the GnRH antagonists, are even further modified. It would 

seem that there was recognition by these FDA members that ‘tinkering’ with this 

molecule raised long-term safety issues for human health. 

Five years following the publication of ‘Trends in Drug Development with Special 

Reference to the Testing of LHRH Analogues’, prior to any FDA approval of any 

GnRH analog use in women, the FDA Medical Review Officer of GnRH drugs for 

gynecology closed her comments at a public hearing with her ‘‘experience in observing the course of GnRH analog research over the past year.’’ These were Dr. 

Ragavan’s comments in 1989: ‘‘Most of the studies that have been presented for 

[GnRH] analog research are presently being conducted in young women for benign 

indications.... The number of studies trying to use these drugs has by no means 

slowed down recently. Industrial sponsors have been quick to fund these studies on 

the drugs seeing a potential market.... [The Committee] may wish to consider 

the ethical issues of continued intellectual searches for the use of analogs and the 

possible risks associated with such studies in this study population. We have always 

used with extreme caution in our abilities to render men hypogonadal albeit for different reasons. And have reserved this treatment for life threatening conditions in 

the male, such as prostate cancer. Should we use the same caution in women, especially when we treat benign chronic non-life threatening conditions such as endometriosis? In fact, I propose for you an even more caution in this population who 

must live with the consequences of treatment for a very long time.’’ (Ragavan, 1989) 

In 1994, the FDA issued recommendations (authored by FDA Medical Officer Reviewers of either Lupron’s prostate or endometriosis NDA’s) that ‘‘only pertain to 

GnRH analogs and should not be considered as guidance for the testing of any drug 

classes’’; and with acknowledgment of ‘‘unpublished work’’ from TAP Pharmaceuticals, these Reviewers recommended: ‘‘At necropsy, special attention should be 

given to the anterior pituitary, adrenal, pancreas, testes, and ovaries, since an increased incidence of neoplasia in these organs has been associated with GnRH 

agonist treatment. . . . Following restoration of fertility after cessation of treatment, the possibility exists that some germ cells may have been permanently affected by drug treatment. It is therefore important to investigate the effects of fetal 

morphology (teratogenicity) and on postnatal development of the offspring.’’ (Raheja, 

1994). 

An FDA Medical Officer, in reviewing a proposed study for Lupron in high risk 

breast cancer patients stated the ‘‘[d]evelopment of this drug as a general contraceptive should meet with substantial reservations . . . it is an adventure into the unknown’’, and a Committee Chairman recommended ‘‘find out what its [Lupron plus 

oral contraceptives] long-term effects were, and then consider it for a larger population.’’ (FDC, 1994) 

Medical literature reports that the use of GnRHa’s in IVF has caused neurological 

symptoms—migraines, numbness and tingling, paresthesia and weaknesses and 

sensory ataxia—‘‘Transient cerebral ischemia is one possibility that may explain the 

symptoms . . . a direct effect of potent GnRHa on the central nervous system resulting in neurological effects independent of the hypothalamic-pituitary-gonadal 

axis is possible . . . [and] it is quite possible that mild cases with minor symptoms 

have escaped notice; thus, the occurrence of this type of complication may be far 

more common that we realize.’’ (Ashkenazi, 1990). Of note within the latter article’s 

Medline abstract on PubMed is the mesh heading: ‘‘Nervous System Diseases/chemically induced’’. 

Another study using Lupron and Synarel, for endometriosis alone or with infertility, was titled ‘‘Memory complaints associated with the use of gonadotropin-releasing hormone agonists: a preliminary study’’ (Newton, 1996). ‘‘Profound luteinizing 

hormone suppression after stopping the gonadotropin-releasing hormone-agonist 

leuprolide acetate’’ is another study’s title (Sungurtekin, 1995). 

In 1995, the first bone biopsy was done on the bones of young women receiving 

GnRHa therapy for endometriosis, and results showed that after 6 months of GnRH 

use in young women, there was ‘‘severe disruption of the cancellous microstructure’’ 

of the bone, and the ‘‘results suggest that bone loss induced by GnRH analogs may 

be associated with adverse effects on cancellous microstructure which are unlikely 

to be reversed following cessation of therapy.’’ (Compston, 1995; See reprint of bone 

biopsy results before and after GnRHa at www.lupronvictims.com—‘Effects on 

bone’). 

Ovarian enlargement and development of ovarian cysts frequently occurs during 

superovulation, with ovarian cyst formation ‘‘occur[ring] in up to 35 percent of 

women receiving leuprolide acetate’’ (Serafini, 1988; Gocze, 1993). And during clinical trials of Lupron’s use in endometriosis, it is noted that no difference in ovarian 

enlargement/decrease was noted compared to control patients (NDA 20–011), yet in 

a separate study (co-authored by a Lupron endometriosis clinical trial investigator) 

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it was noted that ‘‘significant changes were noted’’ and ‘‘the identifiability of the 

ovaries [by MRI] was significantly poorer . . . The effects of [Lupron] therapy on 

the normal uterus and the ovaries were statistically significant’’, predicting an ‘‘experienced radiologist should expect to be able to identify the ovaries on only 70 percent of the images.’’ (Zawin, 1990) 

In the Journal of American Medical Association, a letter reported ‘‘[p]ossible ocular adverse effects associated with leuprolide injections’’, and noted ‘‘11 reported 

cases of pseudotumor cerebri’’ (Fraunfelder, 1995) Thousands of women (and men 

as well) have contacted the NLVN, filled out surveys detailing their medical complaints after Lupron, and continue to report adverse events post-Lupron to the FDA, 

to TAP, to doctors, to lawyers, to legislators, to federal, state, and consumer agencies, and to the media). The FDA and TAP continue to receive these reports, and 

women continue to receive Lupron, without receiving informed consent. 

6. Known Effects Of Lupron On Eggs, Embryos, and Babies 

Ovarian cyst formation ‘‘occurs in up to 35 percent of women receiving leuprolide’’ 

(Serafini, 1988). Even though Lupron is allegedly prescribed to prevent ovarian 

hyperstimulation syndrome, the use of Lupron (including the sole use of Lupron 

alone, with no other fertility drugs) has caused the life threatening condition of ‘severe ovarian hyperstimulation syndrome’ (Yeh, 1989; Barbieri, 1991; Hampton, 

1991; Droesch, 1994; Weissman, 1998). ‘‘[U]nacceptable level[s] and variability of 

stimulation prior to suppression’’ was encountered early with Lupron’s use in ovulation induction regimes (Meldrum, 1988), and aberrant estradiol flares and an inability of Lupron to establish ‘‘any ovarian response’’ were noted elsewhere (i.e., 

Chetkowski, 1989; Penzias, 1992, 1994). Lupron is commonly used during the superovulation regime prior to egg aspiration/donation, and one study using Lupron in 

an egg donor program concluded that ‘‘continuous postaspiration GnRHa [Lupron] 

may be beneficial for oocyte donors whose ovaries are hyperstimulated’’. In this latter egg donor study utilizing Lupron, 1 of 6 patients required hospitalization. (Ng, 

1995). ‘‘Fertility clinics will not be informing their patients that in Collingswood 

N.J. there flourishes a National Lupron Victims Network.’’ (Millican (3), 1995) 

Published medical reports have noted the occurrence of abnormal human pregnancy outcomes associated with the use of Lupron—43.5 percent in one 1996 study 

(Karande, 1996). Another report, using the ‘long Lupron protocol’, showed a 38 percent abortion rate (Shanis, 1995), and a study of ‘low responders’ using Lupron 

showed a 66.6 percent spontaneous first trimester abortion rate (Droesch, 1989). In 

‘healthy women undergoing ovarian stimulation’ using Lupron in another study, another 66.6 percent abortion rate was noted (Minaretzis, 1995). Another study’s title 

states ‘‘Exposure to [Lupron] in Early Pregnancy is Associated With High Pregnancy 

Wastage That Could be Related to the Length of Exposure’’ (Sasy, 1997). 

What are the known effects of Lupron upon eggs? In a 1994 study of chickens 

using Lupron, 1 out of 25 of the hens died, and at the end of the 30-day experiment, 

all egg shells had thinned (Burke, 1994). A study using two GnRHa’s (including 

Lupron) involving rabbit ovaries, concluded ‘‘GnRHa act directly in the rabbit 

ovary . . . increasing oocyte [egg] degeneration’’ (Yoshimura, 1991). In studies involving Lupron in human fertility cycles, it was reported that ‘‘some retrieved oocytes exhibit incomplete nuclear and cytoplasmic maturation after the use of this 

agonist [Lupron]’’ (Racowsky, 1997) as well as ‘‘maturational asynchrony between 

oocyte cumulus-coronal morphology and nuclear maturity’’ (Hammitt, 1993). In ‘Designs on Life’, by Robert Lee Hotz, it was revealed that ‘‘[s]cientists . . . noticed 

that Lupron embryos were different. They grew faster, developed more rapidly. They 

were more fragile when frozen and less likely to survive thawing. Nobody knew why 

or what it meant for the long-term health of the woman or any resulting child.’’ 

(Hotz, 1991) 

According to the 1998 text, ‘Drugs in Pregnancy and Lactation’, TAP communicated in 1992 that it was ‘‘maintaining a registry of inadvertent human exposure 

during pregnancy to leuprolide and currently has over 100 such cases. No cases of 

congenital defects attributable to the drug have been reported . . .’’ (Briggs, 1994). 

And ‘‘[f]etal growth retardation was observed with increased frequency among the 

offspring of rats or rabbits treated during pregnancy with subcutaneous doses of 

leuprolide similar to those used in humans.’’ (Friedman JM, 1994). In a study using 

Lupron and other GnRHa’s on rabbit eggs, ‘‘[t]he rates of normal fertilization and 

early embryonic development were significantly reduced in the oocytes matured by 

GnRHa’’, and it was noted that ‘‘one cannot exclude the possibility that GnRHa in 

pharmacological dosages may be cytotoxic against oocytes.’’ (Yoshimura, 1992) 

In a patent for embryo culture composition, it is noted that ‘‘culture of primate 

embryos in the presence of a GnRH agonist . . . unexpectedly dramatically reduces 

the rate of embryo attachment and cell differentiation.’’ (Hearn, 2000). Using 

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Lupron in fertility cycles, ‘‘some retrieved oocytes exhibit incomplete nuclear and 

cytoplasmic maturation after the use of this agonist’’ (Racowsky, 1997). Growth retardation has been noted in young monkeys given Lupron (Golub, 1997). 

But TAP has maintained a registry from over a decade ago of more than 100 

Lupron exposed babies in which no ‘‘attributable’’ defect has allegedly been found 

Perhaps someone needs to investigate the veracity of this data. There have been accounts by women, including on the internet, reporting birth defects in babies conceived on or after stopping Lupron—including Lupron use for fertility as well as use 

for endometriosis. It is not uncommon to see an internet infertility message board 

note stating ‘‘I have one Lupron 2-week kit for sale. I just lost my third baby and 

can’t go through this any more’’. Public posts have described babies conceived spontaneously within several months of stopping Lupron, and born with birth defects 

such as Total Anomalous Pulmonary Venous Return, a heart defect. I personally 

know women who conceived babies from IVF using Lupron whose children have 

anatomic anomalies and developmental delays, and I know women who conceived 

babies after using Lupron for endometriosis who’ve experienced loss of child, developmental delays, esophageal stricture, attention deficit, and serious seizure disorders. I personally know 3 women, with 5 children (conceived on Lupron either 

through IVF or unintentionally during Lupron for endometriosis) who have serious 

seizure disorders, and I have heard of other similar cases. Internet message boards 

about parenting problems with ART children show notes of ART children undergoing a variety of tests (i.e., CAT scans) and surgeries (i.e., open heart) and being 

prescribed a variety of drugs for a variety of ailments including poor muscle tone, 

jerkiness, choking, esophageal stricture, spinal cord abnormalities, GERD 

(gastroesophageal reflux disease). 

The first published long-term study of babies born after accidental exposure to 

GnRHa’s revealed that 4 out of 6 babies have severe neurodevelopmental abnormalities, and the conclusion of this study was that ‘‘[t]his observation . . . justifies the 

need for long-term follow-up of more children previously exposed to GnRHa’’ (Lahat, 

1999). When Lupron is used in superovulation regimes, upwards of 1 mg/day will 

be injected for several weeks to one month or more, and to within days of egg retrieval. Women are given both the daily Lupron and depot Lupron (monthly formulation) for superovulation regimes (i.e., Ruhlmann, 1993)—yet Lupron depot brochures for endometriosis and fibroids state barrier contraception should be used during depot Lupron and that pregnancy should not be attempted until 2 months after 

therapy (meaning 3 months from the last injection). Again—TAP Lupron depot brochures advise barrier contraception during Lupron and recommend pregnancy not 

be attempted until 3 months after last injection, yet TAP has funded studies using 

Lupron depot and Lupron daily in infertility and IVF. Regardless of daily or depot 

Lupron use, women are told that Lupron will be out of their system before any fertilized egg is implanted—yet published medical literature by, among others, a TAP 

Medical Director, identified that detectable levels of Lupron remained after 11 

weeks following the last injection. (Miller, 1990) 

Women are prescribed anywhere from 10–45 days of Lupron during one superovulation regime (see, i.e., Nader, 1988), often being put on prolonged Lupron—a 

‘‘delay’’. (Damario, 1997). And women are frequently prescribed birth control pills 

before Lupron to prevent Lupron-induced ovarian cysts that are known to develop. 

One woman from the ‘Surrogates’ Corner’, having already given birth twice to twins 

in the past as a surrogate, describes how she’s working with a new couple: ‘‘ . . . 

I have been on Lupron since May 26 . . . I can’t take much more Lupron!’’—the 

date of her note was July 28th (Surrogate, 2000). A woman could receive a range 

of 5–22.5 mgs in one ‘fertility’ cycle with Lupron if using Lupron 0.5 mg per day, 

or she could receive a range of 10–45 mgs in one ‘fertility’ cycle if using Lupron 1 

mg per day. Some women are prescribed more, some less, in a superovulation regime. Women receiving Lupron for endometriosis receive 3.75 mg per month in one 

injection—for a total of 22.5 mgs in 6 months of treatment (a limit recommended 

by the FDA due to occurrence of bone loss). The woman who undergoes one ‘‘controlled ovarian hyperstimulation’’ regimen may be very well be exposed to more 

Lupron than a woman undergoing six months of treatment for endometriosis. 

While the endometriosis patient may undergo more than 6 months of Lupron 

‘treatment’, women who undergo fertility treatment are well known to be ‘frequent 

fliers’ (given the failure rate and need for repeated IVF trials to attempt ‘success’). 

One published study reported a woman undergoing superovulation 18 times (Check, 

1988). Women who take Lupron for fibroids use 3.75 mgs per month for 3 months—

although variations in dose and duration are often reported. Consider that men in 

the final stages of prostate cancer are currently prescribed Lupron 7.5 mg per 

month (depot), and not the daily Lupron, yet the daily Lupron was the initial form 

of Lupron first approved by the FDA (for palliative treatment of prostate cancer). 

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Currently, daily Lupron is rarely used in prostate cancer, but it is this daily Lupron 

that is most frequently prescribed in superovulation regimes, despite discontinued 

clinical trials and despite never having gained FDA approval for fertility or IVF. 

7. Examples of Iatrogenic Illnesses Induced By Exposure 

In 1999, the FDA reported on their review of MedWatch Reports for adverse 

events from Lupron. The FDA reviewed more than 6000 reports, concluding ‘‘there 

were high prevalence rates for serious side effects’’. The FDA’s action was to reexamine the product label, ‘‘to ensure that these events are adequately addressed.’’ 

(Lazar, 1999). It is my understanding that the FDA was to undertake another review. In the meantime, what, if anything, has been done ‘‘to ensure that these 

events are [] addressed’’? After FOX 25’s 2 part series on the adverse effects of 

Lupron, FOX informed Senator Kennedy of their series and quoted the Senator as 

stating he found their ‘‘report on possible side effects of Lupron was troubling. Physicians have an obligation to inform patients of the risks of drugs they prescribe, 

and promotion of potentially risky ‘off-label’ uses of products by manufacturers is 

illegal and unethical.’’ (Kennedy, 1999) 

The medical literature offers numerous examples of iatrogenic illnesses following 

exposure to GnRHa’s. For example, in a 1990 study utilizing GnRHa in IVF treatment, one of a group of women who had developed severe ovarian hyperstimulation 

syndrome and liver function abnormalities, had a liver biopsy performed (at the end 

of surgical removal of conceptus due to intrauterine death 2 months into the pregnancy). This liver biopsy showed ‘‘a striking abnormality consisting of 

macrovesicular fatty infiltration around and linking the portal tracts. This appearance could not be classified into any well-recognized clinical entity.’’ (Forman, 1990). 

These, and other, clinical reports are disturbing, especially as they pile on top of 

one another. Case report or study titles often tell the story: ‘Adverse effects of 

leuprolide acetate depot treatment’ (Friedman, 1993), ‘Neuropsychologic Dysfunction 

in Women Following Leuprolide Acetate Induction of Hypoestrogenism’ (Varney, 

1993), ‘Angina and myocardial infarction with use of leuprolide acetate’ (McCoy, 

1994), ‘Memory complaints associated with the use of gonadotropin-releasing hormone agonists: a preliminary study’ (Newton, 1996), ‘Leuprolide Causes Pure Red 

Cell Aplasia’ (Maeda, 1998), ‘Transient thyrotoxicosis and hypothyroidism following 

administration of the GnRH agonist leuprolide acetate’ (Kasayama, 2000), ‘A case 

of atypical absence seizures induced by leuprolide acetate’ (Akaboshi, 2000). Case 

reports of Lupron-treated fibroids having ‘‘striking vascular changes and histologic 

features of vasculitis and atherosclerosis’’ note that ‘‘[t]he florid and rapid development of vascular inflammation, fibrinoid deposits, and thrombosis after leuprolide 

acetate therapy [‘‘rarely seen in non-leuprolide treated {fibroids}’’] suggest an immune-mediated process. . . . these observations are significant and worrisome if 

such changes affect other organs.’’ (Mesia, 1997). Lupron has been listed among 

those medications that may cause lupus. (Greenberg, 1999). 

Problems associated with Lupron are also identified in the titles of male uses of 

Lupron as well, i.e. ‘Leuprolide therapy for prostate cancer. An association with 

scintigraphic ‘‘flare’’ on bone scan’ (Johns, 1990), ‘Sudden death due to disease flare 

with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the 

prostate’ (Thompson, 1990), ‘Possible Ocular Adverse Effects Associated With 

Leuprolide Injections’ (Fraunfelder, 1995), ‘Pituitary apoplexy after leuprolide administration for carcinoma of the prostate’ (Morsi, 1996; multiple other similar case 

reports have been published), ‘Localized Amyloidosis of the Seminal Vesicle: Possible 

Association With Hormonally Treated Prostatic Adenocarcinoma’ (Unger, 1997), ‘Incidence of bone fracture in patients receiving luteinizing hormone-releasing hormone 

agonists for prostate cancer’ (Hatano, 2000), ‘Altered cognitive function in men 

treated for prostate cancer with luteinizing hormone-releasing analogues and 

cyproterone acetate: a randomized controlled trial’ (Green, 2002). 

In the animal testing data submitted for Lupron’s initial approval, the FDA Review and Evaluation of Pharmacology and Toxicology Data states, among others: 

‘‘ . . . There are other, inconsistent, effects of Leuprolide in the various toxicology 

studies but potentially the most serious effect of Leuprolide, in my view, is its effect 

on spinal column bone marrow. This increased fat deposition and subsequent 

hypocellularity was explained as a physiological response to the drug. . . .’’ (Jordan, 

1984). Years later, other animal testing would reveal ‘‘[a]lterations in thymic and 

bone marrow lymphocyte subpopulations in GnRH agonist [Lupron] treated 

prepubertal female mice’’ (Rao, 1993). 

Many, many relevant studies and case reports are left unmentioned here. Many 

effects of Lupron, such as upon the bone, heart, immune, and other systems, have 

barely, if at all, been touched upon. But it is the people with real names, real faces, 

and real pain that is most upsetting. Many women, and sometimes family of these 

64

women, have contacted me over the years with varied complaints following 

Lupron—always looking for help. It is extremely difficult for me to hear these horror 

‘stories’. 

As a former full-time career R.N. who has been able to effectively advocate for 

any patient, and did so for many patients in the past, after Lupron I suddenly found 

myself in a land somewhere beyond the upper level of nowhere—and all rules had 

changed. It was an awful moment when I realized that I was not alone and there 

were many other Lupron victims—comforted by company, but horrified at the scope 

involved. All other victims were echoing my words that ‘‘after lupron’’ thus and such 

started. And all other victims have interesting doctor ‘stories’ to tell. My experiences 

were simply inexplicable at times, and I quickly learned (but fiercely resisted) the 

fact that Lupron was not open for substantive discussion. I would self-triage my own 

various symptoms and prioritize before arriving at the doctor’s office, otherwise s/

he would be overwhelmed. One physician replied after I reported dizziness, pedal 

edema (swelling in feet), and gastric pain, that ‘‘those are bullshit symptoms’’. That 

atrocious answer and behavior is never a correct response to any patient, and after 

I changed doctors a small gastric bleed was diagnosed. These few personal details 

barely convey the level of destruction this drug and the subsequent unmerry-goround has had upon my life and the lives of countless others. Here is a glimpse into 

the experiences of some other women who want you to know that they’re hurt and 

they want attention paid to this public health issue. 

Candace Hedin, of Marlboro MA., was told seven years ago, at age 25, that she’d 

need Lupron prior to undergoing fertility treatment with Clomid. Candace was put 

on Lupron for six monthly shots, and has suffered with multiple, unexplained, serious illnesses since. She’s been hospitalized for unexplained chest pain and inability 

to breath about 15 times, and each time it just ‘‘goes away after 3 or 4 days’’ until 

the next time ‘‘it’’ returns. Candace also has extensive and extreme hives, including 

inside her mouth and throat, which become open sores and she cannot eat or drink 

anything—resulting in hospitalizations for dehydration. She also reports continued 

vaginal bleeding despite having undergone a total hysterectomy and a battery of 

tests (including full body CAT scan) to establish the reason(s) for this bleeding, and 

all tests have been inconclusive. In addition, her mammogram is normal, her 

prolactin level is normal, but she lactates daily. ‘‘Nobody’s even looking at any of 

this—I can’t get any diagnoses! All they tell me is my immune system stinks—I’m 

allergic to my own body is the diagnosis. My toenails are coming out and now my 

fingernails are coming out too!’’ Candace’s husband says ‘‘How can you take a girl, 

at 25, who’d never had any medical problems, and suddenly become so sick and debilitated—we’ve gone to 5000 medical doctors and they say ‘think of something that 

might have caused all these things to suddenly come about’ and I tell them ‘Ya!—

she took lupron and she’s been sick ever since’—but they say Lupron doesn’t have 

anything to do with it. I think I’m watching my wife die in front of my eyes and 

no one wants to do a thing about it.’’ (personal communications) 

Wendy Camacho of Cherry Hill NJ took Lupron for IVF years ago, and as she 

puts it ‘‘my IVF baby is now 9 and my health is a mess . . . it has been downhill 

since.’’ Wendy writes ‘‘I have seen neurologists, rheumatologists and orthopedists, 

and none of them have any answers for me. I have been experiencing severe fatigue 

(diagnosed as fibromyalgia), trouble sleeping, nightmares, gross motor skills are disintegrating fast. I am unable to work as a waitress anymore because my arms can’t 

balance anything, and my legs give out from under me at will. I also have severe 

osteoarthritis. During a routine eye exam, at which I was diagnosed with cataracts 

(rare at age 38), I was asked by the doctor if I ever took fertility drugs. When I 

said yes, I was told I was one of many, but she said she didn’t know enough about 

it to go into detail. . . . I now have the corneas of a 6 year old boy. . . . I was diagnosed with MS, benign remittent, Thank God. I awoke one morning with a very 

weakened left side. EMG showed I have only 35 percent strength on that side. I 

have spent ages going to doctors. . . . I would tell everyone—RUN in the opposite 

direction from Lupron.’’ (personal correspondence) 

Linda DeBenedictis, a teacher from MA., mandated to use Lupron without rationale, has testified at the MA. Health Care Committee regarding the health problems 

she’s experienced. At the 1995 hearings for MA. H #3308, at the close of her testimony, Linda stood up, faced the crowd, and removed her wig. She is totally bald, 

and has lost every single hair on her entire body (FOX News, 1999). [Unlike other 

chemotherapy/antineoplastics, hair growth had not returned years after Lupron.] 

Gilda Radner posthumously is associated with ovarian cancer awareness, however 

little focus has been placed upon her fertility treatment. In her book ‘Its Always 

Something’, Gilda questioned red meat and hair dyes, among other potential causes 

for her ovarian cancer—but never questioned her use of fertility drugs. 

65

And Barbara Mays, and her offspring, are two others whom I believe deserve consideration as victims of fertility treatment: Barbara Mays was infertile for 10 years, 

underwent fertility treatment, and ultimately gave birth to a baby born with a heart 

defect. The Mays baby was intentionally switched in the hospital nursery, and the 

Mays went home with a healthy baby (named Kimberly ‘Mays’) who had been born 

to the Twiggs. The baby that the Twiggs took home, the biological child of the Mays, 

died at age 9 from congenital heart problems. Several years ago, a national news 

broadcast aired an interview with the dying LPN who admitted she was instructed 

to switch the babies and remained silent for fear of losing her job, but no rationale 

was offered for the switch. Based upon historical fact and my observations of the 

machinations of this industry, the field of reproductive endocriminology can be characterized as utilizing a multitude of slick maneuvers to deny, disinform, mislead, 

discount, dismiss, diminish, and suppress risks. The U.S. investigation of TAP’s billing practices revealed that a computer program given by TAP to many doctors in 

the country (some 10,000 urologists received gifts from TAP), which computated the 

amount of money per Lupron prescription the doctor could earn, also harbored a ‘secret key’—and in the event the secret computer program was in danger of discovery, 

a secret key was struck and !presto! all incriminating information disappeared. 

Given the history of the fertility industry, it appears plausible that !presto! any incriminating association between the use of fertility treatment and congenital birth 

defects could disappear if you ‘remove’ the association by ‘simply’ switching babies. 

In a 1996 Boston Globe story, available industry figures (for 1993) showed that 

more than 50,000 assisted reproduction procedures were performed, and about 8,500 

came home with babies—noting that ‘‘thousands of others bring home only disappointment and a lingering anxiety about the aftereffects of treatment.’’ Susan 

McCarthy, attending Boston IVF, had 34 eggs ripen at once—which ‘‘led to kidney 

failure, and she developed a massive, life-threatening infection. She was hospitalized for days, connected to tubes delivering intravenous antibiotics and draining the 

fluid that was swelling her abdomen, making her look four months pregnant. ‘I felt 

terrible for the longest time . . . And it’s not just that. I don’t have anything to 

show for it. . . . ’ [Susan] recalls ‘‘ovarian hyperstimulation was mentioned by the 

clinic staff. But the risk was dismissed with the comment ‘it never happens’ ’’(Kong, 

1996). 

The story also described an egg donor, Debra Christensen of Divide, CO., who 

took Lupron, and suffered ovarian hyperstimulation, ripening 30 eggs, and experiencing a lot of pain. Following soon after Debra’s egg donation, she became pregnant 

and experienced problems with this, her 3rd child, that she hadn’t experienced before—‘‘The placenta grew into her uterine lining, huge uterine cysts developed and 

her son had to be delivered two months prematurely. Nine months later, when the 

cysts had swollen her uterus to about six times normal size, Christensen—at 32—

had to have her uterus and ovaries removed.’’ (Kong, 1996) 

According to Stanford Magazine, Calla Papademas, a 22-year old Stanford graduate ‘‘slipped in and out of a coma in the intensive care unit at Stanford Hospital’’ 

after responding to an egg donor ad ‘‘promising $25,000 or more’’ and agreeing to 

donate her eggs for a $15,000 fee. . . . A few days after Calla began the drug regimen [Lupron], a benign, undetected tumor on her pituitary gland—which Calla’s 

doctors believe was stimulated by the Lupron—grew at a furious rate and ultimately ruptured, causing a massive stroke. Calla suffered brain damage and lasting 

weakness on her left side. Her academic and career plans were derailed, and she 

and her family incurred $100,000 in uninsured medical bills. . . .’’ (Hamilton, 2001) 

In my own situation, within months of stopping Lupron I began to experience a 

variety of ailments, was unable to work for 3 years (and have yet to be able to return to full-time employment since Lupron), lost my job and home, and slowly came 

to the terrifying realization that I was in for the fight of my life at a time in which 

I had never felt sicker or had so many health problems. Six years later, in 1995, 

in preparation for written testimony in support of MA. H #3308, I audited my 

health records and compiled a chronological list. All doctors visits, surgeries, labs, 

tests, procedures, ultrasounds, etc. were typed, in single space, on continuous computer paper—and the end product was 71⁄2 feet tall. This sheet of paper represented: 

adenoma (tumor), breast cysts, cardiac arrhythmias, dizziness, edema (swelling), fatigue, gastritis, gastro-esophageal reflux disease (GERD), hyperlipidemia, immune 

system abnormalities, joint pain, knee pain (exacerbated), lymphadenopathy (swollen glands), myalgia (muscle pain), neuralgia (nerve pain), osteopenia, and spasms, 

to name a few. And, most importantly, knowing the many serious health problems 

of so many other very sick women post-Lupron, I consider myself to be one of the 

‘luckier’ and ‘healthier’ victims—causing me to fight even more. 

All my symptoms/diagnoses/diseases have been acknowledged as adverse events 

reported to the FDA following Lupron, yet none of my symptoms or diagnoses or 

66

diseases have ever been reported to the FDA as adverse events from Lupron. Since 

1995 this list has grown: arthritis, ascites (abnormal collection of fluid in abdomen), 

adrenal problems (abnormal cortisol and ACTH levels—workup ongoing), degenerative disk disease, ‘‘dissolving jaw’’ per dentist, enlarged liver (pre-Lupron operative 

reports indicate normal liver), fibromyalgia-like syndrome, lesions in nerves in 

arms, lesions on skin, scoliosis (presently ‘‘mild’’, and childhood screenings and preLupron X-Rays evidence normal spinal curvature), the osteopenia has now progressed to severe osteoporosis, telemetry monitoring of cardiac status (pulse noted 

at 38, blood pressure roughly 60/42) raised the specter of a pacemaker should I become symptomatic, and a few other problems I can’t recall at the moment. In the 

last seven months, I’ve been hospitalized twice, and officially rang in this spring at 

the endocrinologists office, reviewing recent abnormal cortisol and ACTH levels, and 

heard orders I’ve never heard in my life: ‘‘[I] need to avoid stress’’. 

For ‘fun’ during recent hospitalizations for gastritis, I’d ask the nurses to explain 

the following: at times (not always) when they’d check my resting pulse and the machine would register a heart rate of, say, 41—I’d ask ‘‘do you know how I can make 

my pulse go down?’’ I’d get out of bed and momentarily jog in place and the pulse 

oximeter would go down to 38. When they’d wonder what would make that happen, 

Lupron and autonomic nervous system dysfunction becomes the topic. Invariably, 

I’ve met nurses, phlebotomists, ultrasonographers, and fellow patients who’ve been 

prescribed Lupron without informed consent of the risks. And I’ve met a number 

of doctors who report seeing patients in their own practice with similar ‘‘bone, gastric, and cardiac problems after Lupron’’. 

Nurses are also not informed, despite OSHA recommendations, to use two pair 

of chemotherapy gloves and a chemotherapy gown (among other precautions) when 

handling and administering Lupron. And any healthcare worker who is planning on 

conceiving or fathering a child is advised to avoid handling the hazardous drug 

Lupron at least 3 months prior to conception attempts (AHFS, 1999). Three years 

ago, I conducted a survey of random U.S. healthcare institutions, inquiring what 

policy and procedure they had for the administration of Lupron by healthcare workers. 100 percent of the respondents stated they had no such policy or procedure (unpublished data). I’ve met, talked to, and read online plenty of women complaining 

about Lupron, and I’ve never once seen anyone say their doctor or nurse was 

gowned and double-gloved during their injection. TAP states in its product literature 

that there are no hazardous components to Lupron. Would you consent to an injection of a hazardous agent for a benign condition from a gowned and double-gloved 

health worker? 

Many women undergoing 3 months of treatment for fibroids or 6 months of treatment for endometriosis with Lupron have been complaining about post-Lupron problems for years, and again, sometimes these women can receive less Lupron than 

someone undergoing repeated IVF or egg donation. Some women use Lupron for 

endometriosis and IVF, as in my situation. And some women have also been maintained on Lupron for years on end. Dr. Mercola states Lupron for endometriosis 

‘‘could be the Kiss of Death . . . Lupron is a disaster drug that in no way shape 

or form treats the cause of the problem. I have seen it absolutely devastate many 

women’s lives. It is one of the few drugs that I actually cringe when patients tell 

me that they have taken it. It is my experience and belief that this drug causes permanent neurological damage. This drug needs to be avoided at all costs.’’ (Mercola, 

2002) 

Paula Andrade, an R.N. from Methuen MA., provided a statement of her experiences as supportive testimony for my 1997 Offer of Proof for my medical malpractice 

tribunal: ‘‘Four years ago I took a GnRH analogue [Lupron and Synarel] for problems with endometriosis. I took the medication for 53⁄4 months. The week before I 

was due to discontinue the medication I became ill. I experienced flu like symptoms 

with severe muscle pain, paresthesias, and bone crushing fatigue. Four weeks later 

I developed a host of neurological problems including vertigo, nausea, loss of balance, blurred vision, muscle twitching, and fasciculations with difficulty walking 

and constant muscle stiffness. Since then I have been seen by several neurologists 

and rheumatologists who remain baffled by my condition. I haven’t been able to receive any help within the medical community. Prior to taking the medication I was 

an active and healthy individual who had worked as an RN for many years. I took 

care of my home and family. Since the medication I have been unable to work and 

have difficulty performing daily activities. I have spoken with other women from 

around the United States who have taken this medication and are now suffering 

with similar problems and whose lives have been drastically altered. I swear under 

the pains and penalty of law that the above statements are true.’’ Today Paula says 

she hasn’t seen a doctor in years—‘‘For what—they can’t find out what’s wrong and 

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nothing they did changes the way I am, so what good is it to keep going?’’ (personal 

correspondence and communications) 

Lisa Plante, Fall River, MA., was a former congressional staffer who was prescribed Lupron for presumed endometriosis—and Lisa and I traveled to Washington 

together last year to speak to Senate staff on the issue of Lupron and its connection 

to cloning. Lisa experienced extreme and unbearable bone and joint pain from the 

time of her first of three injections, and this pain has gradually worsened. Eight 

years later Lisa says ‘‘I now have arthritic bones, very bad bone loss, constant bone 

pain and joint pain, and basically feel like I have aged 30 years since Lupron. I have 

not been able to live a normal life with my family because of this bone pain and 

want others to be fully informed of the dangers of Lupron. Women must not be put 

at risk like this and MUST NOT be used as guinea pigs!’’ Lisa recently went on 

a long promised overseas vacation with her family, fearing that her future might 

prevent her from ever going—and during this trip Lisa spent 50 percent of her time 

in the hotel bed, in pain. Lisa is not able to travel here today. (personal correspondence and communications) 

Paulette Wilson, Newport News, VA, took two monthly injections of Lupron for 

endometriosis, and after the second shot she ‘‘woke up with chest pain and needed 

to go to the emergency room.’’ She was told she had ‘reflux disease’, a gastrointestinal disorder. ‘‘I never had any problem like that before. . . . Tests showed 

that I had acid burns from my esophagus to my rectum.’’ Paulette now lives with 

severe pain, which sometimes affects her entire body. Paulette also has been diagnosed with fibromyalgia (Regush, 2002) and liver problems (personal correspondence). 

Jeanne Wolf, from Orange County, NY, had to have her gallbladder removed after 

Lupron, and was diagnosed with gastritis for years until stomach testing showed 

that she had gastroparesis—her stomach was paralyzed and was not emptying food. 

‘‘I am waiting for these bastards to pay for what they poisoned me with. Funny 

thing is I was given the poison because they said I had endometriosis, well I obtained my laparoscopy biopsy results and no endo was ever found! My body and 

mind will never be the same.’’ (personal correspondence) 

Melanie Waldman Lloyd, Corvallis, OR, took Synarel to treat her endometriosis 

prior to attempting pregnancy, and subsequently developed immune problems, suffered 8 miscarriages due to antibody formation, has developed thyroid problems, eye 

problems affecting eye muscles and seeing double, and now takes an IV treatment 

every 2 months (which runs at cost some $600 per dose). Melanie writes ‘‘My health 

is ruined from this drug. . . . No one should take this drug without knowing the 

risks.’’ (personal correspondance) 

Melody Hampton, Mt. Victory, OH, more than 7 years after Lupron, continues to 

experience tremendous headaches, rash, joint pain, nausea, heart palpitations, high 

white cell count, bone loss, high blood pressure, blood in urine, atrophy of muscles, 

leg swelling—all beginning shortly after her first Lupron injection. (personal 

correspondance; Regush, 2002) 

Kimberly Bradford of FL, also started complaining right after her first injection, 

and continues with complaints a decade later. Kimberly suffered a miscarriage following her use of Lupron, experienced intense migraines, and has neuropathy and 

Adie syndrome in her right eye. She started to trip over everything and began to 

notice a smell of ‘‘burning’’ which led to an MRI of her brain. An MRI ‘‘showed lesions on my brain. There was a question of ‘‘demyelinating lesions’’ or MS, and Kimberly has come to call this ‘‘my spot’’—‘‘it’s in the white matter, in the middle, near 

the pituitary gland, but not in an area they can biopsy without causing more injury.’’ When Kimberly’s doctor was filling out her Family Medical Leave Act paperwork, he stated that ‘‘this all started when [Kimberly] unknowingly got [her]self involved with the FDA’s phase IV clinical trial of Lupron.’’ Kimberly says: ‘‘I did not 

know until my own research that I was part of a clinical trial. I never signed a consent for this.’’ (Bradford, 2002). [Kimberly is not the only patient with a diagnosis 

of brain lesions following Lupron use]. 

Diane DeFeo, a teacher from Yonkers, NY, lost two teaching jobs as a result of 

being on Lupron. Diane writes ‘‘This was disabling. I was exhausted and still experiencing pain, had migraines, mood swings, bone and muscle aches and pains, not to 

mention that I gained 35 pounds. I have lapses of memory I call ‘‘lupron moments.’’ 

I was constantly dizzy. And I waited for the symptoms of Lupron poisoning to diminish. Seven years later I still experience effects from this drug. And TAP Pharmaceuticals, the company that manufacturers this poison, simply—this is evil at work. 

The physicians that continue to prescribe this drug knowing the possible repercussions are the most evil of all. I pray for the day when people will take us seriously 

and that women do not need to suffer permanent illness and damage. (personal 

correspondance). 

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Julie Johnson, Chicago, IL., relates how her doctor told her ‘‘its lupron or 

hysterectomy, so I agreed to the lupron. I had my first shot at the end of October 

1996, and I was fine—for about 20 hours. Then I developed a terrible pain at the 

injection site and I could not move, walk, or sit, but my doctor said it was not the 

Lupron and I probably hurt my back and it eventually eased with a dull ache remaining at that site.’’ She received a second shot and experienced achiness but attributed it to the flu and received her third shot, to awake the next day with hives. 

‘‘And then my knees started to ache, and every morning for the next week I woke 

up with pain in another part of my body. By New Years I hurt very badly—even 

wiggling my toes to slip on shoes was excruciating. The pain went on for months 

and months and I noticed that I was losing strength in my legs.’’ Julie continues 

to suffer from fibromyalgia, has lost her libido and has dealt with chronic depression 

since Lupron. She tells of her phone calls to TAP, in which ‘‘he refused to listen 

to me—I’ve often wondered, if they refuse to listen or take this type of information 

from the women who have taken lupron—how will they know what type of problems 

lupron causes?’’ (personal correspondance). Julie is the founder of ‘Julie’s After 

Lupron Page’, on Delphi.com, a public internet message board where Lupron victims 

share information and experiences. (Julie’s Page). 

Susan Hayward, Lake Havasu City, AZ, says ‘‘I would rather suffer with my initial diagnosis, endometriosis, than what this drug has done to the rest of my body 

and life’’. Susan relates how, in attempts to maintain her career amidst endometriosis, 2 doctors administered a total of either 19 or 20 Lupron injections over 

a five year period. ‘‘When I first started using the drug I had to purchase it like 

any other prescription. Later, both doctors had me skip going to the pharmacy and 

they obtained the drug for me. I believe I was sold prescription samples. The kickback schemes involved with TAP and physicians are well documented . . .’’. Since 

Lupron, Susan reports experiencing ‘‘vertebrae bone loss diagnosed as degenerative 

disk disease, arthritis, myalgia, bone pain, fatigue, swelling in hands and feet, severe allergies, nausea, weight increase, severe memory loss, vision changes, sleep 

changes, rapid heart beat, and abdominal pain. . . . After taking Lupron, I don’t 

go a day without pain and am under constant doctor care to control pain and autoimmune problems. I left my home and moved to Arizona where I didn’t know a soul 

so I could get relief from the arthritis problems. . . . The total lack of support from 

the medical profession is appalling, and all lawyers say ‘without a doctor saying 

your problems are related to Lupron you don’t have a case’. . . . I lost my career 

and am disabled, but more than that it has robbed me of any faith in our system 

of justice and what is right.’’ Susan points out that her disability has resulted in 

‘‘approximately $900,000 disability costs being paid by Social Security and the Federal Retirement Program, plus factor in the increased insurance premiums from 

hundreds of thousands in medical bills from hospitalizations, surgeries and tests.’’ 

(personal correspondence; see also Lazar, 1999). 

Judy Norsigian, Co-director of the Boston Women’s Health Book Collective, also 

provided a statement for my 1997 Offer of Proof in my medical malpractice tribunal: 

‘‘ . . . No fewer than 15–20 women have called our Women’s Health Information 

Center over the past 5–6 years about totally debilitating and frightening reactions 

to this drug . . .’’. 

In 1995 Donna Kuha, of MA., entered one of Dr. Andrew Friedman’s Lupron clinical trials for fibroids—‘‘The doctor told me it would be good for me. . . . He didn’t 

tell me of any possible danger. . . . I sure didn’t expect a stroke.’’ Donna Kuha, 

‘‘who lost the use of a hand and most of the use of one leg, is one of a disturbing 

number of patients who have been harmed by clinical trials.’’ (Lasalandra (2), 1998; 

personal communications, 1998). Publicly available court records in Kuha’s medical 

malpractice trial, containing medical records, indicate Donna suffered her first 

stroke while in the Lupron clinical trial, and she suffered another stroke subsequent 

to Lupron discontinuation, as well as developing a seizure disorder. In my professional opinion, the medical records within these court documents compel one to entertain ‘the magic clot theory’ and are deserving of a close and critical review. According to the public records, Donna’s expert medical witness concluded that a drug 

other than Lupron caused her stroke, and twenty-one pages into this plaintiff’s medical expert’s curriculum vitae it is learned that he’s been an Abbott consultant since 

‘‘1987 through present’’, and had served on Abbott Young Investigator Award Advisory Board in 4 previous years. (Kuha, 1997). Donna suffered her first stroke in 

March, 1995—just prior to Lupron’s FDA approval for ‘anemia associated with 

fibroids when iron therapy alone is ineffective’. (NDA 19–943) 

The Boston Herald did a 3-part series on Lupron, the second part entitled ‘Women 

seek answers on drug’s suspected side effects’. A dozen women were interviewed for 

this story, which began ‘‘Hundreds of women nationwide, with nowhere else to turn, 

are forging a campaign against a drug they believe has ruined their health and 

69

their lives.’’ Quoting one victim in the series: ‘‘My knees tremble a lot and get very 

weak, and I have to use a cane now to go up and down the stairs,’’ says Kimberly 

Savino, 17, of Easton, who was prescribed Lupron last year for a gynecological problem. Before taking the drug, Savino said she often rode horses and jogged. Today, 

three months after stopping Lupron, the teenager has trouble even walking and has 

been diagnosed with a degenerative arthritis, which usually develops over many 

years. Her mother is worried—and suspects Kimberly’s strange bone problems were 

triggered by Lupron. ‘‘It’s very hard to see her, all of a sudden, moving around like 

an old lady with a cane,’’ said Susan Savino. ‘‘Now we don’t know if she is going 

to end up in a wheelchair. This shouldn’t be happening to someone who is 17.’’ 

(Lazar, 1999) 

This shouldn’t happen to anyone at any age. And problems with Lupron appear 

throughout all ages and all indications. For example, a public internet post from another mother about her 15 year old daughter who at age 51⁄2 was treated with 

Lupron for 31⁄2 years. The mother reports her daughter had no problems on Lupron, 

but writes that ‘‘her period has never been real regular . . . she has been having 

severe pains in her leg joints. Started in the knees and have moved to the hips. 

. . . Now she is having similar pains in her elbows and shoulders. She was always 

a small girl until about the same time as the pain started, she gained almost 50 

pounds and can’t seem to get it off. Does anyone out there know if this could be 

some long term affects of Lupron???? We have had her to 2 different doctors and 

they can’t seem to figure out what is going on. . . .’’

Numerous men have reported a multitude of adverse events following their use 

of Lupron for palliative treatment of prostate cancer (Abend, personal communication, 1994). Zoladex (goserelin) is another GnRHa used in prostate cancer, as well 

as used in endometriosis and infertility. Lupron, Zoladex, and Synarel are all advertised as ‘‘fertility medications’’ (Fertilitext, 2003; Members, 2003), yet no GnRH analog has been approved for fertility treatment or IVF or any variant of infertility 

treatment. In an overseas IVF study using GnRHa’s Zoladex and Buserelin with 

clomiphene (CC) and hMG, ‘‘[i]f no selection against chromosomally abnormal oocytes takes place at the time of fertilization, more abnormal oocytes are harvested 

with GnRHa/hMG protocols than with CC/hMG.’’ (DeSutter, 1992). Studies in pregnant baboons using Zoladex resulted in numerous abortions and stillbirths and neonatal death (Kang, 1989). 

Debbie Arnason wants you to know about her husband’s experience with Zoladex 

treatment: ‘‘Arne Arnason of Naples FL was diagnosed with prostate cancer about 

18 months ago and was put on Zoladex 3-month depots with resulting side effects 

of debilitating hot flashes, extreme weakness, breathing difficulties, irritability, bone 

mineral density loss, hip, back and joint pain as well as muscle pain. He was unable 

to work. With each successive treatment, the symptoms became worse. We truly believe the 3rd and last shot was unnecessary—this treatment aged him 20 years in 

9 months, requiring 2 ER visits, one for arrhythmia and one for a retinal tear. Arne 

continues to have symptoms related to the calcium imbalances the Zoladex created—he was referred for surgery of the neck to remove his parathyroid gland. It’s 

just been one scary thing after another. No one warned us of any of this!! I had 

to do all my own research. We feel for people who don’t know the awful consequences of the use of this goserelin acetate drug, Zoladex by AstraZeneca (similar 

to Lupron)’’. (Arnason, personal communications and correspondence) [AstraZeneca 

‘‘is in negotiations with U.S. state and federal authorities over the potential settlement’’ involving ‘‘improper claims for its prostate cancer treatment Zoladex, in a 

ruse similar to that of TAP . . .’’ (Pharmafocus, 2003; Church, 2002)]. 

8. Rita Abend, D.D.S.—Her Story & The Inception Of The NLVN 

The following is testimony of Linda Abend, D.D.S., dated December 5, 1997, and 

submitted into the public record as expert witness testimony within my Offer of 

Proof in my medical malpractice tribunal (Millican v. Harvard Community Health 

Plan, Boston IVF, Natalie Schultz M.D., Brian Walsh M.D., Mahmood Niaraki M.D., 

Selwyn Oskowitz M.D., Michael Alper M.D.; No. 92–2140A). At that time, in 1997, 

there was no medical expert that I could locate who was willing to publicly address 

Lupron’s causality to adverse health problems. Linda Abend’s testimony is reprinted 

below in its entirety: 

‘‘Dear Tribunal Members: Many years ago I founded The National Lupron Victims 

Network to inform people about the risks involved in taking the drug Lupron. The 

network does not accept any money from either victims or external sources. All of 

our information is available for free on the internet. I hope that the information I 

have found in my years of research will help other people so that they are fully informed of the risks involved in taking Lupron.’’

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‘‘Women and men from all over the world have contacted the network. Nearly all 

of the people I have spoken to were not informed of the risks involved in taking 

Lupron. The majority of the people who continue to have medical problems after 

taking Lupron are finding that they are having an unusually hard time getting adequate medical care.’’

‘‘The individual case that I have the greatest knowledge of is that of my sister, 

Dr. Rita Abend. Before Rita took Lupron, difficulty in obtaining medical care was 

something neither Rita nor I could comprehend. Once she took Lupron everything 

changed. While on Lupron Rita experienced horrendous side-effects. Doctors had 

never informed Rita of any risks. Ultimately, we realized that she probably would 

never receive the medical care that she so desperately needed.’’

‘‘Since taking Lupron, Rita has been diagnosed with seizures, autonomic nervous 

system dysfunction and myeloma/plasmacytomas (a rare form of bone marrow cancer). All of these diagnoses were given and then rescinded at one time or another. 

Results on her blood laboratory reports and numerous pages of medical documents 

were whited-out, and vials of blood lost by a physician before they even left his office. Doctor after doctor has refused to treat her including one who plainly stated 

that it would not be in his best interest to do so. Rita went all over the country 

in search of medical care after taking Lupron. Rita, like many others who took 

Lupron, could not get honest medical care after taking Lupron. And without honest 

medical care and doctors to testify, due process in the courts is an impossibility.’’

‘‘In one instance, Rita had to obtain a court order in order to get her medical 

records from one doctor, Orin Devinsky. Devinsky had threatened to ‘‘destroy’’ the 

continuous audio-visual video tapes that he had made of her electroencephalograms 

(EEGs) during a 9 day hospital stay in a specialized epilepsy unit, approximately 

two weeks after stopping Lupron. (Rita spent three of these days in intensive care). 

Despite the fact that these tapes had over 600 computerized ‘‘events’’ (alerting the 

viewer to abnormal brain activity) Devinsky wanted to destroy them. During the 

hospital stay Devinsky learned that Rita’s IQ had dropped to 97 on an IQ test and 

her manual dexterity was in the bottom 8 percent of the nation. Instead of informing us of this drastic decline after taking Lupron, he informed us that the tests 

came back ‘‘normal’’. Although Devinsky’s admitting diagnosis was ‘‘convulsions’’ 

(based on an EEG), he claimed that this was all a mistake and in the end nothing 

was wrong with Rita. Even with the court order Devinsky did not turn over all of 

the medical records. He claims to have ‘‘lost’’ some tapes.’’

‘‘Instead of offering Rita anti-seizure medication, Devinsky tried to coax Rita into 

taking a derivative of pentamethylenetetrazole (PTZ), insisting that it was perfectly 

safe and that no one had ever been hurt by it. Rita refused the PTZ. After researching PTZ I discovered that PTZ is no longer given to humans since it is not safe. 

It has been found to cause seizures and effects the autonomic nervous system. It 

is used in the laboratory to make animals epileptic for experimentation purposes. 

When Rita finally found a doctor to monitor her seizure condition caused by Lupron, 

she was offered not one, but four anti-seizure medications.’’

‘‘In another instance, Rita was experiencing extreme pain in her hip. An x-ray revealed that she had lost 30–50 percent of her bone density at the head of her femur. 

Lupron is known to cause bone loss at the head of the femur. Rita was instructed 

to use a walker because her hip could fracture from the loss of bone. Rita was referred to a specialist. He refused to treat her. He refused to run a single test, not 

even a blood test. Rita was left in bed suffering with excruciating pain for one year, 

unable to get up without the use of a walker.’’

‘‘Today, my sister, a once actively employed, vital, energetic and intelligent 

woman who graduated from New York University Dental School, is now totally and 

permanently disabled. It is hard to say which is most difficult for Rita; relinquishing 

her dental license, relinquishing her drivers license, accepting the fact that comprehensive medical care (no testing, no answers) will always be denied because she 

took Lupron, or that justice will probably not prevail if one has been injured by 

Lupron.’’

‘‘Doctors who prescribe Lupron are denying people the accurate information they 

need in order to make an informed decision. Once people become ill on Lupron, 

these physicians are denying the temporal relationship between Lupron and the 

onset of symptoms. They even deny information in respected peer-reviewed medical 

journals. For example, two studies reported memory loss with Lupron occurring in 

72 percent and 75 percent of the studied populations. Both studies were published 

in the Journal of Assisted Reproduction and Genetics, and Fertility & Sterility, respectively. The percentages reported are quite high. In fact, if an individual does 

not experience memory loss with Lupron that individual is in the minority. Yet, doctors who prescribe Lupron are continuing to deny that Lupron causes memory loss. 

Doctors who prescribe Lupron are also denying that Lupron can cause other sideVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00074 Fmt 6633 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
71

effects that have already been ackowledged in the medical literature and printed in 

the package insert. They deny the correlation of side-effects while on Lupron. They 

deny the correlation when one stops taking Lupron and the side-effects persist.’’

‘‘I certainly do not want to leave you with the impression that I believe all physicians are bad. There are many good, caring physicians out there treating people 

with all kinds of medical problems. But when Lupron victims turn to physicians for 

help and answers they get a deaf ear and the run-around. Lupron victims are not 

victims of Lupron alone, but are also victims of a medical system that has failed 

them. And without medical care and doctors to testify, they are unable to obtain 

justice in the courts. If you have any questions, please feel free to contact me. Respectfully, Linda Abend, D.D.S., Founder, The National Lupron Victims Network.’’

Although Linda Abend closed this 1997 statement with an invitation for contact, 

attempts to contact the NLVN (by myself, other victims, lawyers, and media) have 

been in vain. Phone calls go unanswered and certified mail to their long-held address returned ‘‘unk’’. No new information has been posted at the NLVN website 

for years, and the private NLVN message group (where there had been postings by 

hundreds of members) has long been inaccessible. Thousands of women contacted 

the NLVN and had filled out the detailed questionnaire that the NLVN had mailed 

out, and was processing, in the 1990’s. Now, the question is not only what happened 

to all that information—but what has happened to Rita, Linda, and the NLVN? 

9. The State Of The ART, And The Art Of Stating 

In February 1995 I noticed a surrogate ad running in a college newspaper, offering $17,000 plus expenses to carry the gift of life for an infertile couple, and I called 

the ad. A Dr. Radecki answered the phone, and I heard all about the wonders of 

IVF and ‘‘there were no long-lasting risks’’ and ‘‘no one ever suffered serious harm 

from the drugs.’’ On March 21, 1995, I was surprised to see CBS Evening News 

interviewing this Dr. Radecki—and became even more surprised to learn that Dr. 

Radecki was not a fertility doctor—he was a psychiatrist who had lost his license 

for sexually abusing his patients. By the end of March 1995, Dr. Radecki had closed 

shop—the telephone number for the surrogate ads was disconnected, the ads were 

gone, and he was under siege for misrepresentation. 

A TAP advertisement in a fertility journal gives a glimpse into the sly canvas 

upon which the industry paints its picture: This TAP Lupron ad read: ‘‘Remote Control: Your patient with endometriosis doesn’t have to remember her daily therapy—

Lupron Depot 3.75 mg remembers it for her. . . . She only needs to remember six 

monthly visits.’’ (Ad, 1992). Nowhere does the consumer learn that memory loss has 

been known to be ‘‘a commonly observed’’ side effect to Lupron, or that patient noncompliance with daily Lupron could likely have been related to a memory disorder 

(listed as a known adverse event to Lupron), or that clinical trials conducted for 

Lupron depot approval utilized methodologically flawed study design that was conducive to subjects forgetting adverse events (surveyed every 30 days). 

In 1990, several Brigham & Womens physicians (including the lead author who 

would later admit to falsifying and fabricating approximately 80 percent of 4 Lupron 

studies) would write ‘‘not since the development of oral contraceptives has there 

been so much excitement and enthusiasm among basic scientists, clinical investigators, and practitioners of reproductive medicine.’’ (Friedman, 1990). A coauthor in 

the latter article, Robert Barbieri M.D., has also been a lead investigator for 

Lupron, authoring or co-authoring (including with Friedman) many Lupron or 

GnRHa studies and books, and has received TAP funds for numerous studies, and 

serves also as a Medical Advisor on TAP’s Lupron endometriosis website. 

In 1997, Dr. Barbieri, representing the industry, testified in opposition to the MA. 

bill which would have mandated state regulation and informed consent of the risks 

of ART. Following the hearing, when I asked Dr. Barbieri why memory loss, along 

with all of the other hundreds of reported side effects, was not included in their IVF 

Clinic’s consent form, he subsequently forwarded their consent form with an attached, handwritten note stating: ‘‘Here is a copy of our current Lupron consent 

form for IVF. I am going to ask Dr. Hornstein to add memory loss as a potential 

side effect. I don’t think we can add 300 side effects. Do you have 3 or 4 others that 

would be important to add?’’ That such a lead and allegedly prestigious Lupron investigator should query me as to what adverse events are important to include within their Lupron informed consent document (presumably approved by an IRB) is 

troubling, disgraceful, and the epitome of the ‘state of this art’. 

‘‘Inclusion of patients with a poor response to GnRHa therapy has not always occurred in outcome analysis in the published medical literature.’’ (Redwine, 1994). 

Conflicts of interest are extensive, troubling, and have far reaching consequences 

upon standards of care and the state of science. Two cases in point: Another lead 

Lupron investigator alleged in a study that reduced bone mass was associated with 

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endometriosis (Comite, 1989), yet another investigator with contrasting findings reported that ‘‘One explanation for the difference between the results of this study and 

those of Comite et al. is that they included women who previously had been treated 

with GnRH agonists and these agonists are associated with bone loss.’’ (Dochi, 

1994). (See www.lupronvictims.com, ‘Endometriosis’ for further elaboration on these 

studies). Claims of the disease endometriosis being associated with bone loss, while 

deliberately omitting patient’s prior use of GnRHa (which is known to causes bone 

loss), is a perilous concept of manipulating iatrogenic, adverse, drug effects into a 

disease-related non-tort phenomenon—and deserves attention. 

A 2002 Human Reproduction article, ‘High rates of autoimmune and endocrine 

disorders, fibromyalgia, chronic fatigue syndrome and atopic diseases among women 

with endometriosis: a survey analysis’, co-authored by the President of the Endometriosis Association, failed to mention GnRHa’s within the article (Sinaii, 2002). 

The survey upon which the article is based, which was sponsored by Zeneca (1998), 

does contain reference to GnRHa use in survey participants. Despite the presence 

of a National Lupron Victims Network, with many women complaining of autoimmune and endocrine disorders, fibromyalgia, chronic fatigue syndrome, etc. postLupron, this article makes no mention of these adverse advents. 

I do not think any of this is funny—but if there were ever a game involving 

Lupron and/or GnRHa titled something like ‘Patent—Conflict . . .Yea or Nay’, I’d 

participate. For example: Issue—Person involved with the testing of animals and 

Lupron and FDA approval submission . . . Yea Patent! Yea Conflict! Issue—Person heading major reproductive research unit and member of RESOLVE’s Advisory 

Board . . . Yea Patent! Yea Conflict! Issue—Member of major Institutional Review 

Board, who has performed numerous TAP-sponsored Lupron studies, and published 

numerous articles on Lupron . . . Yea Patent! Yea Conflict! Issue—Individuals 

promoting awareness of risks of Lupron and ART . . . Patently NayNay! 

10. The Check Is In The Fe/male 

‘‘GnRH and its analogs have led to exciting new avenues of therapy in virtually 

every subspecialty of internal medicine as well as in gynecology, pediatrics, and 

urology . . . virtually every subspecialty of medicine will be touched by the GnRH 

analogues . . .’’ (Conn, Crowley; 1994). 

The following is a fairly comprehensive, alphabetical, list of clinical uses, case reports, or studies involving Lupron’s use in unapproved and off-label indications. 

These uses were mostly found within published medical literature, although some 

were noted within patents, or advertisements for clinical trials, and one was a personal clinical observation. Citations have been omitted for brevity, but are available 

upon request. 

A:adjuncts for IVF; adjunct to fibroid surgery; anovulation; autism [management 

of sexual behaviors]; acute intermittent porphyria; Alzheimer; adenomyosis; severe 

adenomyosis; adhesions; amenorrhea [functional]; angiomyxoma of vulva; autoimmune disease; autonomic neuropathies; ‘add-back’ regimen [estrogen/progestin 

with lupron]; advanced breast cancer. 

B:before hysterectomy for leiomyomas; benign prostatic hyperplasia; benign prostatic hypertrophy; birth control; breast cancer; breast cancer prevention; bioavailability following nasal and inhalation delivery to healthy humans. 

C:catamenial insulin reaction; catamenial pneumothorax; chronic intestinal pseudo obstruction [in patient with heart-lung transplant]; cluster headaches; colorectal 

cancer, congenital adrenal hyperplasia with oligomenorrhea; contraception; 

cryptorchidism; controlled ovarian hyperstimulation in normal, abnormal and poor 

responders; combination therapy with flutamide and castration; colonic endometriosis; comparison of suppressive capacity of different GnRHa’s in women; comparison of hCG versus lupron for releasing oocytes. 

D:dysfunctional uterine bleeding prior to hysterectomy. 

E:egg donation; endometrial ablation; endometrial cancer, endometrial glandular 

hyperplasia; endometrial hyperplasia without atypia; endometrial cancer; 

endometrial stromal sarcoma; epithelial ovarian cancer; exhibitionism; effect of very 

high dose in prostate cancer; effects in animal and man; effect on embryos (‘‘accelerated development’’); endometrial preparation for transfer of frozen-thawed pre-embryos in patients with anovulatory or irregular cycles; effects on follicular fluid hormone composition at oocyte retrieval for IVF; effect on hair growth and hormone levels in hirsute women; effects on glucose metabolism in a diabetic patient; equivalency of hMG and FSH stimulation following suppression; effect on LH surge; effect 

on adrenocorticotropin and cortisol secretion in premenopausal women; effect on 

seminal vesicles; effects of lupron on luteal-phase hyperprolactinemia during ovarian stimulation. 

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F:fallopian tube obstruction; functional ovarian hyperandrogenism, functional abdominal pain from functional bowel disease; fibrocystic breast disease; first cycles 

of IVF/GIFT; follicular development and oocyte maturation. 

G:GIFT. 

H: Headache, Huntington’s Disease (for exhibitionism), hyperandrogenism, 

hysteroscopic surgery; hilus cell hyperplasia within ovarian cyst wall; 

hypermenorrhea in premenopausal women with acute leukemia; hypermenorrhea 

with severe thrombocytopenia; hypergonadotropic hypogonadism; hypergonadotropic 

amenorrhea; hypothalamic-pituitary axis disease; hypothalamic hamartomas and 

sexual precocity; hirsutism; moderate and severe hirsutism; hysteroscopic surgery; 

benign symptomatic hyperandrogenism in a postmenopausal woman; hidradenitis 

suppurativa. 

I: infertility; IUI; IVF; IVF–ET in insulin-dependent diabetics; irritable bowel syndrome; intravenous leiomyomatosis with cardiac extension; intranasal lupron for 

endometriosis; intranasal/sc lupron for fibroids. 

K:Kallmann syndrome. 

L: leuprolide flare regime for IVF/GIFT & embryo cryopreservation; lupron screening test for IVF; luteal phase lupron flare protocol; luteinized unruptured follicle 

syndrome; leiomyosarcoma; leiomyomatosis peritonealis disseminata. 

M:male contraception; ‘male’ factor infertility (female is treated—male is not); 

Meniere’s Disease; menstrual migraines; motility disorders. 

O:ovarian cysts; ovarian cysts after ovarian transposition; ovarian epithelial tumors; ovarian granulosa cell tumor; ovarian hyperthecosis; advanced epithelial ovarian carcinoma; ovulation induction; ovarian stimulation; ovarian stimulation with 

lupron and norethindrone in IVF/GIFT; ovarian hyperstimulation; oocyte release; 

ovarian hyperstimulation syndrome; severe ovarian hyperstimulation; oocyte donation, oocyte donation [post-menopausal]; operable breast cancer; ovarian carcinoma 

[refractory]; ovarian remnant syndrome [diagnostic]. 

P:pancreatic cancer; paraphilias; Parkinson’s Disease symptoms, pedophilia, pelvic 

pain not associated with endometriosis; pituitary metastatic mass; polycystic ovarian disease; PMS; protection against chemotherapy-induced testicular damage; 

postpartum depression; premenopausal breast cancer; post-menopausal breast cancer [advanced]; pre-implantation [embryonic] diagnosis; prevention of 

hypermenorrhea in premenopausal women undergoing bone marrow transplantation; prostate cancer (Stage C adenocarcinoma]; endometroid adenocarcinoma of 

prostate; pseudo intestinal blockage, psychosis in PMS, resistant paraphilia, pulmonary endometriosis; pulmonary tuberous sclerosis; pulmonary delivery of 

leuprolide in health male volunteers; pre-myomectomy; poor prognosis patients for 

IVF/poor responders; preservation of fertility in a woman with menorrhagia; pharmacokinetic studies in humans [iv and sc]; preoperative treatment of complicated 

myomata; pre-surgical treatment of fibroids. 

R:resectoscopic endometrial ablation; rectal endometriosis; routine pituitary suppression before ovarian stimulation. 

S:sexual offenders; sexual precocity; Sickle-cell anemia associated priapism; 

surrogacy, SUZI; steroid-cell tumor (advanced); systemic lupron erythematosis; submucous myomas; sexual behavior disorders; syndrome of familial virilization, insulin 

resistance, and acanthosis nigricans; stimulation test in Tourette’s syndrome; small 

cell carcinoma of prostate. 

T:transgender adjunct, testicular function effects; transdermal vs. subcutaneous 

leuprolide—a comparison; triggering follicular maturation. 

U:urinary retention in prostate cancer; ureteral obstruction caused by endometriosis; urinary retention due to benign prostatic hyperplasia. 

W:with or without medroxyprogesterone in treatment of fibroids. 

Z:ZIFT 

And the following list is simply an odd collection of TAP-funded Lupron studies 

that were jotted down along the way. This list should not be construed as any formal, complete, or even partial, audit of the numbers of published TAP funded 

Lupron studies. Even if the total tally of TAP funded Lurpron grants and investigators could be counted today, that figure would be obsolete with the next publication 

of TAP funded Lupron studies. But here’s a few examples, with duplicative years 

indicating separate studies. 

In Alabama, there was one of 13 investigative sites conducting TAP funded research; in Arizona, TAP funded a symposium; in California, numerous investigators 

for numerous indications; in Colorado, 5 physicians received TAP funds; in Connecticut, another one of the 13 investigative sites conducting TAP funded Lupron 

research; in Florida, another one of the 13 investigative sites conducting TAP funded Lupron research, and in Florida, a TAP sponsored educational program at Walt 

Disney for unapproved female uses (FDA memo by David Banks, 1990); in Illinois, 

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numerous investigators supported by grants from either Abbott or TAP or both, in 

1988, 1989, 1991, and another one of the 13 investigative sites conducting TAP 

funded Lupron research; in Kansas, another one of the 13 investigative sites conducting TAP funded Lupron research; in Massachusetts, another one of the 13 investigative sites conducting TAP funded Lupron research, and in Massachusetts in 

1987 numerous investigators conducted TAP funded Lupron research, and in Massachusetts in 1988 numerous investigators conducted TAP funded Lupron research, 

and in Massachusetts in 1989 numerous investigators conducted TAP funded 

Lupron research, and in Massachusetts in 1989 numerous investigators conducted 

TAP funded Lupron research, and in Massachusetts in 1990 numerous investigators 

conducted TAP funded Lupron research, and in Massachusetts in 1991 numerous 

investigators conducted TAP funded Lupron research, and in Massachusetts in 1995 

numerous investigators conducted TAP funded Lupron research, and in Massachusetts in 1997 Brigham & Women’s website identified two grants were funded by 

TAP; in Maryland, another one of the 13 investigative sites conducing TAP funded 

Lupron research; in North Carolina, numerous investigators (including an FDA Advisory Committee member) received funding from TAP, and had Lupron ‘‘generously 

provided’’ by TAP for a study involving ovulation induction; in New York, another 

one of the 13 investigative sites conducting TAP funded Lupron research; in Pennsylvania, another one of the 13 investigative sites conducting TAP funded Lupron 

research; in Tennessee, one physician was on TAP’s Speaker’s Bureau and is an ‘‘active contributor’’ to the EA (personal correspondence, 1998); in Texas, another one 

of the 13 investigative sites conducting TAP funded Lupron research; and in Texas 

an educational grant from TAP to numerous investigators; and in Washington, another one of the 13 investigative sites conducting TAP funded Lupron research. 

11. Considering Cloning? Consider The Myths of Hype & The Realities of 

Scientific Misconduct 

It is outrageous to hype cloning research, which will involve superovulation with 

drugs such as Lupron, as probable cures for diabetes, Parkinson disease, Alzheimer, 

etc.—when women who’ve received Lupron have now iatrogenically DEVELOPED 

these and other diseases. It is appalling that this debate has not centered on the 

adverse health effects of superovulation and Lupron upon the women, and especially 

the reports of adverse pregnancy and birth outcomes associated with treatment. 

Without proper long-term follow-up study of the reports of adverse health outcomes to the superovulated women and without proper long-term follow-up of the 

adverse pregnancy and adverse birth outcomes in the babies conceived and exposed 

to drugs such as Lupron, how can you propel recklessly forward to create a massive 

demand for more superovulation of women for research eggs? 

The message of research and biotech has resulted in the impression of hope, 

promise, cure, and benefit. My personal experience can be summed up by the words 

hype, myth, research fraud, conflicts of interest, and injury . . . and all without 

any medicolegal advocacy for the injured victim. It is a myth that public safety is 

being protected by the FDA, evidenced by the fact that some 20 million people have 

taken drugs that have been recalled—drugs that were initially deemed ‘safe and effective during study’, only to later learn that data identifying serious problems, including deaths, had been suppressed. 

Somewhere it is written that it was a ‘‘comforting but erroneous myth’’ that research involving drugs and devices still serves medicine. Time magazine’s 4/22/02 

cover, of a woman crouched within a laboratory cage, epitomized the story within, 

depicting yet another research debacle in which data identifying adverse side effects 

was kept secret—and only revealed by a whistleblower (Lemonick, 2002). Time also 

noted that there were more than 60 institutions that ‘‘failed to protect human subjects adequately.’’ Other recent articles have identified the dramatic disparity in research results and reporting, depending on who is paying for the research—with 

contracts allowing pharmaceutical companies control over disclosure of bad data. 

Furthermore, large sums of money in the form of grants, stock options, company 

ownership, patents, consulting agreements, scientific agreements, speaking engagements, symposiums, trips, gifts, etc. (which are disclosed in less than 1⁄2 of 1 percent 

[Stolberg, 2001]), have created an environment conducive to suppressing bad data 

and inducing outright fabrication of data. It would be nice to think that ethical behavior is the norm, but a review of recent news compels one to notice the increasingly rampant unethical machinations of research medicine. 

To date there have been a number of renowned reproductive physicians/surgeons 

who have been found to have fabricated and/or falsified data: Dr. Andrew J. Friedman, a lead investigator for Lupron, recipient of many TAP grants to study Lupron, 

and director of Brigham & Women’s IVF Program (where this writer was mandated 

to use Lupron), was found to have falsified and fabricated approximately 80 percent 

75

of the data in 2 published, and 2 unpublished Lupron journal articles (Federal Register, 1996). Is it any wonder that during the time Dr. Friedman was director of 

Brigham & Women’s IVF Program, the criteria for the administration of Lupron 

with IVF changed from ‘‘Lupron is only used in certain diagnoses’’ to ‘‘Lupron is 

widely prescribed’’? Where is the data to justify such widespread application of a 

hazardous, reproductive and developmental toxicant? 

There has also been the brothers Drs. Nezhat (one of whom serves as a Scientific 

Advisor for the EA, according to the EA website) who have been found to have fabricated research involving laparoscopic surgery for endometriosis, resulting in the 

retraction of two published journal articles (Nezhat; 1991, 1992). An attorney, as a 

result of litigation (on behalf of a client who believed she had signed an informed 

consent form to authorize surgery but had instead signed a waiver of right to receive informed consent), doggedly pursued to have this bogus published surgical procedure data examined—and only after 6 years was the data finally produced, examined, and retracted. In one study, more than half of the patients were used for premarket testing of a new, non-FDA approved, circular stapling device. ‘‘The Doctors 

Nezhats’ retracted bowel surgery articles are included in Ethicon’s coursebook for 

surgeons. . . . While the Doctors Nezhat reported no ‘‘short or long term ill effects’’ 

with this new technique, there were significant complications in these subjects, 

some severe. A portion of one woman’s bowel died during surgery, another’s anastomosis (where bowel is rejoined) massively hemorrhaged a few days post-op requiring 

repair, one patient’s bowels fell into the toilet post-operatively, several patients had 

bowel leaks in the staple line, several patients were incontinent of feces, some could 

no longer evacuate normally, etc. Yet, the operation was promoted for 185,000 

women by Johnson and Johnson based on the Doctors Nezhats’ research’’ (Attorney 

James J. Neal, 2003: www.mdjdfraud.com; see also Neal, 2002). 

The father of GIFT, gamete intrafallopian transfer, Dr. Cecil Jackobson, rounded 

off his accomplishments with 52 convictions of perjury and fraud. He had been substituting his own sperm for that of some 75 women’s husbands’ sperm resulting in 

these women (initially) unknowingly giving birth to children fathered by this ‘expert’. To quote USA Today, ‘‘ . . . His case taught a valuable lesson about the fertility industry: Self-regulation is not enough. . . . Many of his most offensive acts 

were legal—like donating his own sperm. The only way Jacobson was stopped was 

on federal wire, mail fraud and perjury charges. . . .’’ (USA Today, 1992). 

The ‘‘Dyno Gyno’’, Dr. Niels Lauersen (and a cohort) were convicted of billing fraud, ‘‘falsif[ying] bills to get $2.5 million in payments from insurers for a variety 

of fertility procedures’’ (Barrett, January 2001), and Dr. Lauersen was ‘‘jailed as 

flight risk’’ (Barrett, March 2001). Dyno Gyno loyalists attempted to assign this 

fraudulent billing as nothing but ‘an attempt to provide otherwise denied procedures’, causing ‘‘prosecutors [to] fume that the case is not about health-care policy, 

but a thief with a medical degree and a lab coat.’’ (Barrett, 2000). Of note is an 

aside mentioned in the latter article, which relates one loyal Lauersen patient’s position that women’s health issues don’t get enough insurance coverage. The aside 

is a description of this patient, ‘‘whose three children all needed special attention 

from the doctor due to different complications at birth.’’ (Ibid). No further elaboration is made on these ‘‘birth complications’’, and the implications of such ‘‘complications’’ appear to be unrecognized. 

And the story of Dr. Asch, et al. is well known: Dr. Asch, who was overdosing 

women in superovulation to steal their eggs and then sell them to researchers and 

other unsuspecting women, reportedly often left his office with a briefcase stuffed 

with thousands of dollars in cash—while he was also preaching and publishing on 

the psychological effect of egg donation on women (Lessor, 1993). 

A renowned group of fertility experts published a study, a report of ‘‘the first case 

of human germline genetic modification resulting in normal healthy children’’ 

(Barritt, 2001), however the expert group ‘‘failed to disclose that along with 15 

healthy babies it produced two fetuses with a rare genetic disorder. Experts are horrified because the fault can be passed to future generations’’ (Hill, 2001). The fertility clinic and fertility experts report published claims of healthy children from 

their procedure . . . yet the Washington Post reported ‘‘[i]nternal documents from 

Saint Barnabas explicitly acknowledge that the novel technique may be causing the 

problem . . .’’ (Weiss, 2001). The ‘Birth Defects Research for Children’ points out 

that ‘‘the two cases of Turner’s syndrome should have been mentioned in the report 

so that doctors and others would be aware of all the facts’’ (Birth Defects, 2001). 

The group would later report that the ‘‘children born after IVF with cytoplasmic 

transfer have been carefully evaluated and one 18-month-old child was recently diagnosed with a pervasive development disorder . . . a broad spectrum of disorders 

with mixed prognosis. . . . . Because the procedure is experimental, protocols have 

been supervised and re-evaluated in 1999 and 2001. . . . However, this research 

76

has been suspended since early July 2001, pending clarification of new requirements 

suggested by the Federal Food and Drug Administration.’’ (Institute, 2001). Six 

years prior, in an abstract published by one of this group, 4 abnormal embryos were 

implanted into women—and this act brought little, if any, attention from anyone or 

anywhere. (Munne, 1995). At St. Barnabas’ webpage on egg donation (in which 

Lupron is used), the question of ‘‘What are the risks of being an egg donor’’ is answered . . . ‘‘Donors may risk psychological distress if they are rejected from the 

program . . .’’ (St. Barnabas, 2001). 

Falsified and suppressed data (which can set, alter, and impact standards of care), 

along with conflicts of interest and abuses of human subjects in research endeavors 

are poisoning medicine systemically. Shouldn’t you begin to address the forces that 

result in profit via dictation of data and spin and to-hell-with ‘first do no harm’? 

And should you really open the reproductive research doors wider to the inevitable 

abuses in human embryo cloning research? The criminal penalties of jail and fines 

of at least $1 million that President Bush has proposed should be applied not just 

to the use or importation of cloning technology, but rather should be applied like 

a heavy wet blanket over every research discipline in medicine in attempts to quash 

this destructive slow burn. 

12. The Marginalization of Victims and Lack of Medico-Legal Advocacy 

The consumer who has been victimized by the fertility industry and/or Lupron has 

no recourse. Consumer protections are woefully lacking in the fertility research enterprises today—and there is no reason to assume that adequate ‘measures’ will 

take place or be enforced in the cloning arena. Start cleaning up the mess in today’s 

fertility clinic before you create nightmares at the human embryo farms. 

Who or what is in place now to assist the injured egg donor, or the harmed fertility patient—and whomever or whatever is offered as an answer to that question, 

please then answer what are they doing now about Lupron victims? My complaints 

to the FDA about Lupron and lack of informed consent promulgate the mantra that 

the FDA has no supervision over the practice of medicine, which falls to state 

Boards of Medicine. State Boards of Medicine state a doctor can prescribe any drug 

they want off-label, and drugs are under the purview of the FDA. The Department 

of Public Health has no jurisdiction over fertility clinics, so refers one to the Board 

of Registration in Medicine. The FTC round-robins the consumer to the FDA. And 

there you go, round and round . . . no informed consent, no advocacy, no accountability, no protection. The consumer is left stranded, while profits and abuses 

exponentiate, and her medical needs, costs, tests, and doctor/hospital visits accumulate. 

Fiscal prudence would seem to imply that insurance companies would audit their 

costs of members 5 years prior to and then 5 years post Lupron, for expenditure 

comparison. My medical bills, and the medical bills of others, both before and after 

Lupron, speak for themselves. After enjoying a full-time salary for many years, it 

would be 8 years post-Lupron before I had earned a total of my formerly annual 

years salary. Illnesses, medical costs, inability to work, no medical or legal advocacy—all are extreme hindrance to the effort, energy and time necessary to mobilize 

for survival. Eggs donors, et al. beware! My advice to those considering undergoing 

superovulation and Lupron is: first, establish independent wealth in the event you 

become disabled; second, you will not be able to recognize lack of informed consent 

or be able to rely on the information or advice given to you, therefore some type 

of healthcare degree, preferably M.D., is necessary; third, having advanced chemistry will be especially helpful, so bone up there also; fourth, you may need to become quite familiar with the legal system and you might be on your own—so prepare yourself beforehand to save yourself a lot of grief; fifth, make sure you have 

family and friends available who can help you as you may find you are in need; 

sixth, make sure you can type real fast as you may find yourself having to write 

thousands of letters; and seventh, buy a head-phone because you will need to talk 

to as many people as you can. 

It is ‘‘very bad’’, indeed, that reproductive experimentation has been conducted 

without informed consent, and with ‘treatment’ using hazardous agents propagandized as safe and as science—but is neither. ‘‘It no longer appears possible to 

consider the marketing of new drugs for stimulating the gonadicpituitary axis unless they have been tested within the framework of IVF’’ (Buvat-Laborie, 1988). The 

Health, Education, and Welfare Department, in 1979, advised that a global study 

be undertaken to establish the safety of IVF, and although no such undertaking was 

done, it was proclaimed at the 1994 Human Embryo Research Panel Hearings that 

former concerns about IVF’s safety had been abated. The March 2000 study indicating a 9 percent rate of major birth defects from IVF represents a substantial increase from former reports. Dolly, the cloned sheep, became lame and was 

77

euthenized. And there are thousands of Lupron victims who appear to have no voice, 

and are crying out for medical care and legal representation. 

The FDA has had a ‘‘fatal erosion of integrity’’ (Horton, 2001), and conflicts of interest on 18 FDA Advisory Committees were revealed several years ago. (Cauchon, 

2000; Mercola(2), 2000). The protections allegedly in place for federal research subjects were recently shown to have failed—and in private research enterprise the consumer is just plain out of luck. Conflicts of interest abound in clinical trials—‘‘Let’s 

be realistic’’ said [the] commissioner of the FDA, ‘‘Profits do drive this business’’ 

(Agnew, 2000). Where are the consumer protections? 

While there has been some litigation recently, in the early 1990’s there was little 

legal recourse available, and I am aware of 2 other women who attempted to bring 

their own lawsuit involving Lupron pro se because they couldn’t find an attorney. 

I searched high and low, east and west, north and south, individual and firm and 

agency alike. Never having been inside a law library and needing to know everything about a foreboding and alien process with requirements and deadlines I’d yet 

to learn creates a most precarious and unfortunate position. Having to learn how 

to draft a complaint, and having to figure out the problem in terms of legal issues, 

identify the law and find other case law, file motions to compel, file answers and 

promulgate interrogatories and requests for production of documents, undergo 7 motions for summary judgment and a medical malpractice tribunal—without any attorney or real guidance beyond cursory advice by attorneys over the phone. I was told 

by numerous attorneys ‘‘you most definitely have a case, but without laws and 

standards—its a legal vacuum’’ and then years later, ‘‘if you can find the expert, 

I’ll take the case’’. 

Not until my case approached the MA. Appellate level did I pursue obtaining a 

paralegal certificate, but clearly, without counsel, and without laws and regulations, 

I understood that I had limited abilities to do justice to the case or the issue. I tried 

over and over, again and again, to find an attorney, each attempt to no avail—and 

it was very unnerving to try to prepare an appeal to the MA. Supreme Judicial 

Court pro se. Incredibly, a final online internet plea for some legal guidance was 

seen by an appellate attorney with endometriosis, Barbara Sosin, from Chicago IL. 

Barbara’s reproductive endocrinologist ‘‘fired [her] because [she] refused to take 

Lupron’’. This doctor told her ‘‘I’ve been so patient with your irrational refusal to 

take this medication, and there’s nothing more that I have to offer you’’. Therefore, 

through just a few phone calls of my presenting the legal issues, cases, and facts, 

Attorney Sosin was able to help me assemble this information in the most appropriate format, and I was very grateful for that last minute support. But, nonetheless, from start to almost finish (some 8 years), traveling that road alone is unacceptable; and was not the way for such an important matter to have had to be handled. Filing a case pro se is something that no victim should ever have to do. 

Many product liability cases have been filed against TAP regarding adverse 

events to women following Lupron—and quietly settled. Through the grapevine, I 

became aware of 5 cases in the latter 1990’s, and obtained court records for 

Villarreal v. TAP (Sacramento County, CA., No 528453; 1993), and Gantner v. TAP

(Cook County, Il, No. 96L11379; 1997)—and have since become aware of a separate, 

additional settled case, and there are many potential-plaintiffs searching for counsel. I am aware that cases are being consolidated, and do foresee a class action suit 

looming on the horizon. But it has taken a very long time to get to that point, and 

an awful lot of wonderful, innocent, misled people have been hurt. My lawsuit was 

initially filed in 1992, and was terminated at the MA. Supreme Court level in 2000, 

the day Boston papers broke the Lupron urology kickback scam story—but I left 

nearly 1000 pages of medical, scientific, pharmaceutical, and governmental documents involving Lupron’s risks for the next victim/case. 

Since then, and after 11 years of seeing untold numbers of doctors and specialists, 

I finally received documentation that my ‘‘multiple medical problems [are] consistent with case reports following Lupron exposure . . . [and have] an extremely 

complex, multifaceted, constellation of medical problems.’’ I’d like to quote the final 

paragraph from my MA. Supreme Judicial Court appeal: ‘‘Moreover, Defendants 

claims of lupron’s ‘menopausal’ action does not correlate with known science. (Appendix p. 290 & 293). And studies for lupron’s use in IVF were ‘‘discontinued’’. (Appendix p. 358). Therefore, her IVF treatment with lupron was not grounded in reliable scientific methodology. The opinions of the Defendants, as well as the accepted 

‘standard of care’ regarding the use of lupron, cannot meet the threshold requirements of Daubert and is ‘‘junk science’’, creating a genuine issue of material fact 

for a jury. (Daubert v. Merrell Dow Pharmaceuticals . . .)’’ (Millican vs. Harvard 

Community Health Plan, Boston IVF, Natalie Schultz MD, Brian Walsh MD, 

Mahmood Niaraki MD, Selwyn Oskowitz MD, Michael Alper MD. Docket No. 98–

P–1472.) 

78

An online investigation of Lupron (www.redflagsweekly.com), as well as the 

NLVN, myself, other victims, and media such as FOX News and Dateline, have 

challenged TAP to produce data and to answer questions—but there has been no 

response from TAP. The FDA was to take another look at its damaging 1999 review, 

but no word has been heard. The NIH just conducts more Lupron studies, while 

shielding consumers from its webpages for its Hazardous Drug List and Material 

Data Safety Sheets (MSDS). The MSDS for Lupron, available to all hospitals and 

healthcare institutions, states that leuprolide acetate is ‘‘hazardous per OSHA criteria’’, and identifies that ‘‘women of childbearing potential must be excluded from 

working directly with product.’’ This is information necessary for consumers to make 

an informed decision about ‘treatment’ with a hazardous, toxic substance. Questions 

were posed to several NIH Lupron investigators inquiring whether their Lupron 

trials followed NIH and OSHA guidelines in use of protective gear for healthworkers 

administering Lupron, and these questions were responded to by several NIH investigators—however, the replies do not answer the question as to whether NIH 

Lupron clinical trials follow NIH guidelines (personal communications). More than 

thirty years after the debacle of DES, the CDC (in 2003) began a campaign to inform people about the potential health effects of DES (www.cdc.gov/DES). The 

CDC’s annual report of fertility clinic data has been questioned in the past, and 

issues regarding its reliability have again been raised, pointing out its ‘‘lack of reliable information’’, citing data that is up to 3 years old, and clinic success rates that 

are ‘‘too easy to fudge’’ (Report, 2002). 

In one aspect of my ‘fertility treatment nightmare’, the dates and details of an 

office visit were deliberately altered in the computer through collusion and deliberative machinations by several of the defendants in my case—and my HMO had steadfastly denied that I had ever received treatment or prescriptions on that date 

(Millican v. Harvard Community Health Plan, Boston IVF, Natalie Schultz M.D., 

Brian Walsh M.D., Mahmood Niaraki M.D., Selwyn Oskowitz M.D., Michael Alper 

M.D.; see also Donahue, 1996). Given the ease with which my computer record data 

was deleted and altered, along with numerous other experiences, as well as the 

known fraudulent Lupron data, and recent newsreports on fraudulent research elsewhere, ‘‘data’’ coming from self-interested parties should always be viewed as potentially unreliable, to say the least. 

A few more comments from Gena Corea’s supportive statement for my lawsuit are 

pertinent here: ‘‘After discussing the death of a woman in the IVF program in a Seville clinic with Dr. Francesca Martinez of the IVF program at Instituto Dexeus in 

Barcelona, Spain, I said to her: If it’s so difficult for you, who are practicing IVF, 

to find information on women who died of IVF, how can you say what the risks of 

IVF are? She replied that she and her colleagues knew what happened in their own 

center and they had many cases—2,000. So she is telling potential IVF candidates 

what the risks of IVF are based on her own clinic’s experience. This is a pitiful situation.’’ And Gena concludes by saying ‘‘I don’t know what will happen with Ms. 

Millican’s complaint. What often occurs in such situations is that women, with only 

their own limited financial resources, without even an attorney, doing the labor 

themselves when they come home tired from their jobs, seek justice. Few can do it. 

Few can break silence on the abuse to which they have been subjected. But it is 

vital to talk back, to insist one’s reality into the fictional never-never land of miracle 

babies and ecstatic, unharmed mothers. I applaud [those women] for speaking 

[t]he[i]r truth.’’

The answers do not lie in continued exposure to Lupron, which would definitely 

occur should the Senate pass any bill allowing therapeutic cloning research. Does 

Lupron sound like the kind of drug you want to give to young healthy women who 

are ‘offering’ to donate eggs? Does Lupron sound like the kind of drug you would 

want to take for any benign condition, without informed consent? It appears that 

the majority of women whose eggs are harvested used Lupron. How many women 

know Lupron has never been approved for fertility? How many women know the 

facts and the tragedies mentioned in these pages? If millions of women are needed 

to meet the demand for research ‘material’, what will these women be told? My advice to them is—instead of asking questions to the Industry . . . read the Congressional Record. 

13. A Request To Congress Asking For An Investigation Into Lupron and 

ART 

In closing, the data in this paper barely scratches the surface of problems associated with Lupron and ART, and Committee Members should know that there are 

unknowns and redflags beyond those described in this submission. Time limits did 

not prevent further detail or elaboration, and wish to add that any references or 

further information are available upon request. 

79

For all of the above stated reasons, I would respectfully urge the Committee to 

ban reproductive and therapeutic cloning. 

And I would like to also respectfully urge the Committee and Congress to undertake a formal investigation into Lupron and its victims, as well as investigating the 

long and short term safety of ART drugs and procedures on women and offspring. 

Respectfully submitted. 

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Senator BROWNBACK. Well, thank you for making it in and for 

coming here to give your personal testimony and also the statements of other people who have contacted you. 

You mentioned the National Lupron Victims Network on the 

Internet——

Ms. MILLICAN. Yes. 

Senator BROWNBACK.—and that a number of suits have been 

filed against Lupron. 

Ms. MILLICAN. Yes, they have. 

Senator BROWNBACK. And those are being settled? Have any of 

them been tried yet? Do you know? 

Ms. MILLICAN. To my knowledge, none have been tried, no. 

Senator BROWNBACK. Okay. 

Ms. MILLICAN. They are all settled. 

Senator BROWNBACK. Mr. Kimbrell, this hearing is primarily 

about the issue of egg donation and an egg market and its impact 

on women. And as I have heard you speak over the years on this 

topic, that has been an area that your group has been as focused 

on as anybody in the starting of a new bio-industrialization. Have 

you done any studies, do you know of any economists who have 

looked at any studies, as to what price would need to be paid to 

get a million qualified women to be able to donate eggs? Do you 

know of anybody who has looked at that and the numbers associated with it? 

Mr. KIMBRELL. You know, it is hard to say. And let me just—I 

have this in the record, but I will show it here. We talked about 

this earlier. I thought it might be good to have an example right 

in front of us. We got this last month from the Stanford Daily. This 

is an ad that was put in the newspaper, the Stanford Daily. It 

says, ‘‘Special egg donor needed’’—let’s see here—‘‘height approximately 5’9’’ or taller, Caucasian, SAT score around 1250 or high 

ACT, college student or graduate, under 30, athletic, no genetic 

medical issues, compensation $80,000.’’

[The information referred to follows:]

89


327kim01.eps
90

Senator BROWNBACK. Wow. 

Mr. KIMBRELL. ‘‘Extra compensation available for someone who 

might be especially gifted in athletics, science, mathematics, or 

music.’’

So it is pretty hard, Senator, to really see what, you know, the 

price will be or will not be, but I will tell you, for whoever is tempted by these ads, and we know they are always targeted, as was 

surrogate motherhood, always targeted to poor women. You know, 


327kim02.eps
91

wealthy women do not sell their reproductive heritage. They do not 

sell their bodies. They do not sell their eggs. These are poor 

women. These are basically turning the poor women of this country 

and around the world into ‘‘mother machines.’’

So what amount would actually be required, perhaps in an economy that is not that good, to encourage these women? I do not 

know. But I do wish that a part of the informed consent of these 

women will be to listen to Ms. Millican and what has happened to 

her. I think we should make that legislatively part of consent, because I think a great many women have come into this—and we 

interviewed numbers of them, both in the surrogate motherhood 

when we wrote our book and in reports on this and the egg donation, and they had no idea. They thought they were trying to do 

a good thing for somebody else, they desperately needed the money, 

and the screening that was talked about before is minimal, at best, 

and the real reason they are there, quite often, is because they are 

in desperate need of money, and so informed consent virtually 

never happens. And so I think that, again, a requirement that they 

hear the kind of health effects that they could suffer would be key. 

Senator BROWNBACK. When you were doing the Organ Donor 

Bill, I was taken by your statement about no payments for the donations allowed, and it strikes me that that has worked just fine—

I mean, that people continue to donate organs and they do not seek 

the compensation for it. 

Mr. KIMBRELL. That is right. And then, of course, any of us 

who—and I hope all of us do—give blood know that that works just 

fine, too. It is an extraordinarily important thing we can all do. 

Yes, when we first passed that bill, Senator, there was a lot of 

discussion about black market organs in this country and that it 

would not work, and it has worked very, very well, indeed. 

And I think that, again, the important point here when we’re 

looking at 303 is that second provision that says ‘‘time and inconvenience.’’ A number of States have that same provision, and they 

do not prevent ads like this. It is a loophole. ‘‘Inconvenience,’’ as 

George Annas, in the quote that I cited before, means virtually 

nothing. It means that you can pay anything you want for, ‘‘inconvenience.’’

I certainly second Mr. Doerflinger’s point that it is also hard to 

calculate, when you hear what Ms. Millican was saying and you 

know the cancer risks involved, exactly how far you take that term, 

‘‘inconvenience.’’

But, yes, I think it is very instructive to compare this with 

NOTA, the Organ Transplant Act, and note how this bill has been 

purposely changed to allow for this loophole. 

Senator BROWNBACK. Ms. Charo, you have served on the National Bioethics Board previously, is that correct? 

Ms. CHARO. That is correct. 

Senator BROWNBACK. I am sure this has to be troubling to you 

about bidding for women’s eggs. Was that issue handled by the National Bioethics Board when you were serving on it, and did it take 

a position against the compensation of women for the donation of 

eggs? 

92

Ms. CHARO. First, before I answer, if I may, I would like to also 

indicate I did have a longer statement and ask that it be put in 

the record, if I may. 

Senator BROWNBACK. Without objection. 

Ms. CHARO. And one other quick clarification. With respect, I 

think Mr. Doerflinger lacks the anatomy that every woman in the 

room has to know that it is really not possible to transfer embryos 

into yourself. 

[Laughter.] 

Ms. CHARO. But putting that aside—and I say that with respect 

and affection, because Richard and I have dealt with each other. 

With response to your question about egg donation, specifically, 

the National Bioethics Advisory Commission, which did do a report 

on stem cell policy—a report from which I recused myself due to 

the possible appearance of a conflict of interest, as I was at the 

University of Wisconsin—did not touch directly on the question of 

sale of human eggs. However, I would note that in many cases 

what we have been hearing today are descriptions of a market that 

takes place in the context of eggs being sought for reproductive 

purposes. That is, somebody—we do not know who—has the misguided belief that SAT scores are inheritable and, therefore, is offering a high price to somebody who they think could transmit that 

SAT score to an offspring. That is not the kind of incentive structure that would exist if you are looking for people to donate or provide eggs in other ways for a research context in which the eggs 

are not going to be used for reproductive purposes and there is no 

expectation of a long-term outcome, only be used for stem cells. 

Second, the American Society for Reproductive Medicine has set a $5,000 limit on what is expected to be a notion of ‘‘reasonable 

compensation,’’ a notion that is also reflected——

Senator BROWNBACK. Is that——

Ms. CHARO.—in the National——

Senator BROWNBACK. Excuse me. Is that a hard limit? And that 

does not carry the weight of law, does it? 

Ms. CHARO. It does not carry the weight of law. This is a professional society guideline——

Senator BROWNBACK. Just a recommendation. 

Ms. CHARO.—as I understand it. And I will happily stand corrected by those who know it more precisely. But these guidelines 

have——

Senator BROWNBACK. I am sorry. If I could, I want to be——

Ms. CHARO. Sure. 

Senator BROWNBACK.—clear on this. That is a recommendation of 

that group that the compensation not be above $5,000? 

Ms. CHARO. That is correct. That is——

Senator BROWNBACK. Okay. 

Ms. CHARO.—correct. And——

Senator BROWNBACK. Can I get to the very specific point? Because I really want to get—and then I will give you time——

Ms. CHARO. Sure. 

Senator BROWNBACK.—to answer the rest of this. But have you 

seen any studies, anybody calibrate, saying if we want to get simply a million women to donate eggs—say, we are three, five years 

down the road, this has come along great, we want to do this for 

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diabetes, for ALS or something, but we want to get a million 

women to donate eggs—what is the market? What are we going to 

have to pay to get—as I understand from the testimony earlier, you 

are going to probably have to go through 10 million women to find 

1 million who would be qualified if you have got this ten to one 

ratio. 

Ms. CHARO. Well, actually——

Senator BROWNBACK. And you are going to have to——

Ms. CHARO. Right. 

Senator BROWNBACK. I mean, there is going to have to be a pretty heavy recruitment, I think, if—the experience under anybody’s 

scenario is a pretty difficult one to go through this, for a woman 

to go through it. Have you seen any numbers on this? 

Ms. CHARO. There are no numbers, because the scenario is not 

realistic. I think the premise is the problem, Senator Brownback. 

I do not share the premise. And I think this is what Dr. Bustillo 

was trying to get at, as well. 

The way this research will proceed, first on the therapeutic arm 

and on the purely research laboratory study arm, is that it starts 

very small, with very small numbers of people under close control 

by the Food and Drug Administration, in which they are looking 

at the animal data, whether it’s ready for laboratory work with 

human materials, and you start with very small numbers of people. 

And as you continue to do the work and slowly scale up as you perfect your techniques, you are simultaneously developing methods 

by which you no longer need as many eggs for the next stage, per 

procedure, as you did in the first stages of research. 

So the scenario of using millions of women——

Senator BROWNBACK. Then you paint——

Ms. CHARO.—at an early stage for all diseases, I do not think is 

realistic vision. 

Senator BROWNBACK. Then you paint for me—we have got a hundred million people with these diseases we are going to cure with 

the cloning——

Ms. CHARO. No, I do not think a hundred million people are 

going to be the patient population for therapeutic cloning, either. 

Senator BROWNBACK. What is the——

Ms. CHARO. This would be one——

Senator BROWNBACK. What is the patient population going to be? 

Ms. CHARO. No, it is the patient population people with the diseases, but for each——

Senator BROWNBACK. Okay, well, what is it——

Ms. CHARO.—person, there are——

Senator BROWNBACK.—going to be? Please——

Ms. CHARO. There are many——

Senator BROWNBACK.—come up with the number, if you can, or 

a round figure for me, if you can. What is the patient population 

going to be? 

Ms. CHARO. We do not know that yet, because the research is 

just beginning. The point is, for every disease, whether it is heart 

disease or Parkinson’s, there are multiple therapies. It is not one 

therapy that is used for every person. Different things work in different people, and therapeutic cloning may work for some subset of 

that patient population. 

94

I do not think I have ever heard any responsible doctor or scientist suggest that this therapy will be used for every patient——

Senator BROWNBACK. Well, why——

Ms. CHARO.—with every one of these diseases, and that’s another 

reason why the numbers——

Senator BROWNBACK.—do they keep saying, then——

Ms. CHARO.—can become misleadingly large. 

Senator BROWNBACK.—we are going to—we have got all these 

cures for—and then they list a litany of diseases that are going to 

be cured by therapeutic cloning, the same list that was put forward 

in the fetal tissue debate that we are going to cure with that, the 

same list that was put forward in embryonic stem cell. I mean, at 

some point in time there has to be some coming up with, ’’Here is 

the product of what we have done.’’

Ms. CHARO. Oh, but I think it is unfair, with research aspects of 

human cloning, to ask for an actual approved, FDA-reviewed and 

-approved, therapy to emerge within five years. 

When Jamie Thompson said what he did about Parkinson’s at 

that hearing, what he was talking about was, ‘‘When would we be 

able to move into clinical trials for Parkinson’s disease?’’ And he 

predicted five to ten years out. It is now five years out, as you correctly note. 

Senator BROWNBACK. And there is no——

Ms. CHARO. And we are now at——

Senator BROWNBACK.—limitation on therapeutic cloning to date, 

is there? 

Ms. CHARO. We are now at the stage at which we have successfully seen human embryonic stem cells—and, remember, he was 

not talking about cloning them; he was talking about stem cells 

from extra IVF embryos—so we have now seen those stem cells 

successfully differentiated into neurological tissue. And the next 

step is to see whether or not that tissue can be developed to the 

appropriate stage for transplant into a patient. That requires lab 

work, animal work, and, eventually, human trials. We still have 

another five years on his prediction to see if we can get that next 

stage of the work done to the point where the FDA would permit 

that work to go on. 

The FDA, remember, keeps a very tight lid on all of this. It requires licensing of establishments that do this kind of research. It 

has an extremely tight tracking and monitoring system so it can 

track viral transmissions as well as everything else in its comprehensive tissue action plan, and it has comprehensive donor suitability requirements. That is, it has already issued Federal regulations—proposed, interim, and finalized—that cover every aspect of 

this but keep it moving slowly and responsibly. 

Senator BROWNBACK. I want to ask Mr. Doerflinger or Mr. 

Kimbrell about this issue. I think both of you were around Washington when the fetal tissue debate started going, and I believe 

fetal tissue was stated that it was going to cure a myriad of diseases at that time. And these are actually even cells that were further developed; they are less primitive than the embryonic, the 

therapeutic embryonic. 

These are a couple of quotes from New York Times of some extensive studies on fetal tissue impact in Parkinson’s patients, which 

95

were, ‘‘Disastrous side effects. Absolutely devastating. It was tragic. 

Catastrophic. It’s a real nightmare, and we can’t selectively turn it 

off,’’ because the cells were, as I understand, uncontrollable. Instead of making brain cells, they make various different tissues or 

tumors. 

Were people saying, at this same time, we were going to do with 

fetal tissue what is being proposed with therapeutic cloning? 

Mr. KIMBRELL. Yes, Senator. I was working with then-Senator 

Humphrey and Senator Kennedy to try and get adequate regulation at that time on fetal tissue research. 

To step back just a second, though, just so we can get some clarity on a prior issue, I would note that 18 months ago, Michael 

West, of Advanced Cell Technology, at a Senate hearing, predicted 

that within six months, his company would be ready to create stem 

cells from cloned human embryos that would save 3,000 lives a 

day. And he warned that for those—and, Senator, you may be one 

of these that was suggesting a six month moratorium on this—that 

that would cause the loss of perhaps as many as a half million 

lives. 

So I did want to just clear the record that these claims have been 

made, and, at that time, Senator Harkin said, ‘‘Thank you. Now at 

least we have some—I am quoting—real numbers.’’ So these claims 

have been made, and I just wanted to clear that piece of it up. 

And yes, indeed, I think one of the things we have to be very 

careful with here that I have seen in 15 years of working on these 

issues, and this includes fetal tissue research and somatic gene 

therapy research, is hype over healing. Quite often, what we have 

seen is, with a lot of hype, some early investment capital, and some 

sometimes overly ambitious researchers, the real victims have been 

those who are suffering from these diseases. 

And this happened with fetal tissue. The claims were extraordinary. We were talking about claims, at that time, or the researchers were, of a hundred million lives being saved by fetal tissue research. They pushed it through, despite the best efforts of 

many in this body. We were not able to get adequate regulation. 

We were not able to impose a moratorium. And you see what has 

happened. Approximately 15 to 20 percent of all patients that have 

been given these fetal tissue for Parkinson’s have uncontrolled motion 24 hours a day. They cannot feed. They cannot speak properly. 

And that has led to this front page New York Times story saying, 

‘‘My God, what have we done?’’ Many of these researchers are now 

saying we should never have done it. 

So, again, before we jump into these predictions such as the one 

that Dr. West made at a prior Senate hearing, we need to realize 

that the real victims, quite often, of this hype over healing turn out 

to be those who are suffering from those diseases, themselves, and 

I think that it is the responsibility of this body and every legislative body to look out after their interests and realize that those interests are not always being served by those who are pushing these 

technologies. 

Senator BROWNBACK. Good. I want to thank—Mr. Doerflinger, 

yes, do you have a statement? 

Mr. DOERFLINGER. I wanted to say something about that issue, 

too. The fetal tissue did have very mixed and often devastating efVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00099 Fmt 6633 Sfmt 6601 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
96

fects. I think what the federally funded research showed was that 

there seemed to be some benefits only in younger patients with 

Parkinson’s. None of the patients over 60 years old were really 

helped. And I think about 15 percent had these devastating side effects that made them worse. 

There was one study in the Journal of Neurology, May of 1996, 

that may be an even more disturbing sign of what we may face 

with embryonic cells. That was the story of a man who went to 

China for his fetal tissue transplant for Parkinson’s. He was dissatisfied with the slow pace of progress in this country. They seem to 

have implanted in him some cells that were somewhat earlier in 

gestational age than the usual eight weeks. What happened to him 

was that he seemed to get some benefit from it, but within a year 

he had mysteriously died. And on autopsy, what they found was 

that bone and skin and hair tissue had proliferated in the middle 

of his brain and filled up the ventricles of his brain and killed him, 

cut off his breathing reflex among other things. 

So having failed with fetal tissue, it does not seem logical to me 

to say, ‘‘What we need is earlier cells, embryonic stem cells,’’ that 

now, in animal trials, are proving to have a very disturbing tendency, when tried for Parkinson’s, when tried for spinal cord injury 

in rats, for example, when tried in knee repair in mice—one of the 

studies quoted in my testimony—have the very disturbing tendency 

to form tumors, and even, in one of the rat experiments, to simply 

kill 20 percent of the rats in the study. 

We are finding, at this point, almost an obsession with this as 

the Holy Grail for medical cures. And it is really tending to divert 

people away from things that are far less morally controversial 

that are far, far closer to actually helping human patients. 

There was almost no news in most news sources about the first 

clinical trial of a patient with Parkinson’s disease using his own 

adult neural stem cells. But that man, three years later, has 83 

percent reversal of his symptoms in a study by Dr. Michel 

Levesque, and they are trying for broader clinical trials and approval from the FDA for that. 

There are so many things moving forward that do not require 

having to worry about lethal tumor formation, having to worry 

about harvesting women’s eggs, having to worry about overproliferation and uncontrolled growth in patients’ bodies, that it is becoming increasingly clear this whole agenda of therapeutic 

cloning—in which as Mr. Kimbrell noted, they still have not managed to make a single cloned human embryo that survived long 

enough to get any embryonic stem cell—is becoming an enormous 

digression away from medical progress that we could otherwise 

have. 

Mr. KIMBRELL. Mr. Chairman, just one quick note on that. Since 

I am here representing Friends of the Earth and Greenpeace and 

other environmental groups, let me note that as of this morning’s 

E-mail, I saw a peer-reviewed study that associates Parkinson’s 

with early exposure to pesticides. I would suggest that it might be 

reducing our exposure to pesticides might be a far better place to 

start than trying to harvest fetal tissue. 

Senator BROWNBACK. Well, you are all very kind to come forward 

and to testify. Ms. Millican, in particular, I am appreciative of you 

97

fighting through your difficulties to be here today. We do all want 

to find cures, and we want to do it as best we possibly can for everybody who is involved. 

The record will stay open for the requisite number of days. I do 

appreciate all the witnesses for coming here. 

The hearing is adjourned. 

[Whereupon, at 11:30 a.m., the hearing was adjourned.] 

(99)

APPENDIX

PREPARED STATEMENT OF HON. RON WYDEN, U.S. SENATOR FROM OREGON

Chairman Brownback, in any new field of research, it is important to oversee 

closely the clinical practices of researchers to assure that abuses do not occur. We 

have done this in the past with in vitro fertilization, and I think we can do it in 

the future to produce vitally important therapeutic nuclear transfer treatments safely. 

In 1992, when in vitro fertilization was a relatively new technology, I authored 

the Fertility Clinic Success Rate and Certification Act. This remains the only federal 

legislation regulating these clinics. My legislation provided women and their families the information that they needed to make educated choices about embryo clinics 

by requiring the publication of clinic success rates. In addition, individuals can now 

also learn who accredits the clinic they are considering. All this information is available on the U.S. Centers for Disease and Control website and the information is updated annually. My legislation also called for the creation of a state model regulatory program for certification of embryo laboratories. This was accomplished in 

1999, when the U.S. Department of Health and Human Services published a state 

model regulatory program. Combining consumer information, the state model regulatory program and the guidelines that this medical field had developed for itself, 

I think IVF has been a clear success story for the treatment of women. 

We can continue this kind of successful oversight in therapeutic nuclear transfer 

research and its applications to the treatment of disease and injuries. As I stated 

clearly in this Subcommittee’s January 29th hearing, I support the strong ethics requirements—which would be enforced by the Department of Health and Human 

Services—contained in the bipartisan legislation ‘‘The Human Cloning Ban and 

Stem Cell Research Protection Act of 2003,’’ S. 303. These provisions require informed consent, prohibit the purchase or sale of an egg cell, and apply all of the 

existing federal ethical research standards to nuclear transfer treatments. Tough 

penalties give this law teeth, but do not stand in the way of the many medical advances that can be made through nuclear transfer. 

It is important to remember that this research will help women. Nuclear transfer 

technology is crucial to treating diseases which affect women disproportionately or 

exclusively. By increasing our understanding of how cells predisposed toward diseases like ovarian cancer develop, we can learn how to fight these diseases. Promising treatments for osteoporosis, arthritis, and autoimmune diseases could be supplied by replacing damaged tissues with cells grown through nuclear transfer. 

Women would directly benefit from such advances, and would be helped as well as 

the primary care givers for those who suffer from chronic diseases. 

I hope we can work together to protect women’s health at the same time that we 

allow for careful progress in nuclear transfer research. 

RESPONSE TO WRITTEN QUESTIONS SUBMITTED BY HON. FRANK LAUTENBERG TO

RICHARD M. DOERFLINGER

Question. If the egg could be manipulated so that it could not implant and therefore would not have the potential to become a child, would you still oppose any research or therapeutic cloning? 

Answer. First, a clarification: No mere egg can implant in a womb. If we are discussing the new embryo created by human cloning, which is no longer simply an 

egg, then in our view that embryo deserves respect as a new developing member 

of the human species—a human life with potential, not only a potential life. The 

cloned human deserves that respect because he or she is already a human life here 

and now, not only because of what he or she may become in the future.

An embryo with no ability to implant in the mother’s womb will not survive very 

long. Nor will a newborn infant who has no ability to ingest his or her mother’s milk 

or other nutrients. But we would not say of the infant that he or she is less than 

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human due to the lack of potential to become an adult, and we should not say of 

the embryo that he or she is less than human due to the lack of potential to survive 

long enough to be born. In either case, deliberately manipulating these humans in 

order to deprive them of these abilities needed for survival would be gravely immoral in itself. So my answer to the question is in the affirmative. 

There may, in fact, be ways to modify the nuclear transfer procedure so that it 

produces stem cells without ever producing a living human organism (that is, an 

embryo) in the first place. The Brownback/Landrieu cloning ban (S. 245), which we 

support, explicitly allows for this, and bans only the use of the somatic cell nuclear 

transfer procedure to create a human embryo. But an embryo that has been 

unethically manipulated to be short-lived is still a human embryo. 

PREPARED STATEMENT OF KIMBERLY BRADFORD, ORLANDO, FLORIDA

My name is Kimberly Bradford, I’m 34, the mother of one 7 year old son and have 

been very ill for the past 10 years due to the use of Lupron for Endometriosis. When 

we are younger, in our late teens, in high school and college we start thinking, 

dreaming about what our life is going to be like. We start setting goals. All of mine 

were cut short. Lupron robbed me of the good health I once had. It stole my ability 

to participate in most physical activities. It took my ability to think clearly and 

make rational decisions. At times it took my ability to move at all and left me paralyzed. 

I am very grateful for the one child I was able to have . . .I had some VERY good 

surgeons who made that possible. I had several operations that led to my ability 

to bear my one and only child. 

I lost my first child. I got pregnant four months after my last Lupron shot. I 

thought enough time had passed, I was wrong. The toxin was not gone, considering 

how sick I was I should have known but all I could see what the need to have a 

child. This is the same need that MANY women have when they undergo infertility 

treatment and agree to use Lupron, even though it is NOT approve for such use. 

How Lupron became used for this I can’t imagine. It’s toxin is so sickening. I know 

they use Lupron for superovulation, a procedure that Puts women’s lives in jeopardy. The use of Lupron to gain eggs for stem cell research is wrong! The same diseases that they are trying to cure, Lupron is causing! 

It is risking the health of the women who innocently volunteer for this, not to 

mention possible passing on a toxin contained in the egg itself. 

My Whole Story: 

My diagnosis of Endo came in October of 92, but my ordeal started when I was 

11. Like most of us I had the usual, painful period then painful ovulation. My period 

kept getting longer and longer despite being on birth control pills at age 16. I complained to my GYN for years about the pain, but it was not until I had a class II 

pap (Dyplasia) that she finally listened. She wanted to do a biopsy and laser my 

cervix so she agreed to do a Lap at the same time. I was 24 at the time of my lap. 

I worked in the same hospital as my doctor so she knew me by name. She was also 

my mothers doctor. Needless to say I trusted her. I think she agreed to do the lap 

to try and prove me wrong. I had been doing research on my pain and knew I had 

Endo. Well, I had it. It was covering my bladder. This explained why I always 

thought I had a bladder infection or UTI only to have the tests come back negative. 

It also explained why Sex hurt so much. She told my parents afterwards that she 

didn’t remove any, she told us it was inoperable and wanted to put me on a drug 

called Lupron. I had to watch a video prior to getting an injection. It was made by 

TAP holdings, the pharmaceutical CO that makes Lupron. In the video was this 

very perky women spewing the benefits of Lupron and how you can find relief for 

up to a WHOLE YEAR. A year sounded like a long time then. . . . Little did I 

know. The only info I could find on Lupron was mostly for men with Prostate cancer. It was listed in the PDR but that doesn’t really give you an idea on how ‘‘real’’ 

people react. I gave up my search and took the drug. I mean after all I trusted my 

doctor. I was told about the pseudo-menopause symptoms, hot flashes and such. She 

also told me to drink milk, but not to worry about it too much because of my age. 

I started complaining right after my first injection. The hot flashes were horrible. 

My poor mother felt so sorry for me she stopped taking her hormones so we could 

‘‘flash’’ together. It was winter so at least we could just go outside and melt snow. 

But this was fun compared to the rest. . . . I started bruising really bad, like just 

from wearing shoes. No one could even touch me without an imprint of their finger 

or hand showing up on my skin. I called the doctor, the one I trusted, and was told 

‘‘don’t go horseback riding’’ She said it as if it was part of my daily routine. 

101

I felt like I was in a ‘‘fog.’’ I couldn’t think. Decision’s like what color sweater to 

wear became a major ordeal. When I looked in the mirror I always expected to see 

someone else. I felt 80. Everything hurt, like someone drained my blood and replaced it with acid. 

The shots were given by one of the nurses in her office. When I received my 

records in the mail a few months ago the notes were filled with stuff like ‘‘Kim is 

very excited planning her wedding,’’ NO complaints, nothing medical! Nothing I said 

was documented. I did complain!! About headaches, insomnia, joint pain, pain at the 

injection site for days, I was told that none of these things could be caused by 

Lupron and not to worry about them. I was left believing that I just had an overactive imagination. My doctor did only one exam during those 6 months and it was 

really bad! I wanted to kick her in the face. I told her it hurt and she said ‘‘what 

about sex?’’ Was she kidding? I couldn’t stand the Q-tip never mind actually having 

sex. She said ‘‘everything looks great, you’re going to be just fine.’’ I was so naive. 

I wanted so badly to believe her. I tried to put it out of my mind, after all I had 

a wedding to plan. All my energy went to that and just trying to get thorough a 

week of work without missing too much time. I got married on June 5, 1993, one 

month after my last injection. 400 invited guests, family, friends, members of his 

family I had not met yet . . .they all witnessed my total emotional breakdown. It 

was REALLY awful! I can’t even bear to watch the video as all you see is my head 

bobbing as I cried, I should have bought stock in Kleenex. I must have gone through 

4 boxes during the service. I could not even say my vows because I was crying so 

hard. My husband thought I wanted out. I did but only to put an end to the embarrassment. We could not kiss because I had to blow my nose, as if no one would notice. Somehow we got through the night. Next came the honeymoon and a week of 

unbelievable pain. I kept quiet, I was supposed to be OK, this was just in my 

head. . . . When we got back we moved from Maryland to Virginia, about 3 hrs away. By 

August I couldn’t stand the pain anymore. I finally broke down and told my husband everything. I told him he could leave me if he wanted. I was not the same 

person he thought he had married and I was not sure if I would ever be the same. 

The pain was getting worse, not better as the doctor had promised. I called her, desperate for answers. Her reply ‘‘there is nothing more I can do for you, find another 

doctor.’’ I was devastated, but I needed help so I searched for a new doctor. I finally 

found one who specialized in high risk pregnancy and GYN disorders. 

She met with my husband and I for over an hour. She had lots of questions. The 

biggest being ‘‘why was the Endo not removed’’? Good Question!!! I was told it was 

inoperable. This was the beginning of an eye opening experience. I finally realized 

that my doctor of nine years had deceived me. Anyway, the new doctor wanted to 

do another lap. I had it in October 93. Almost exactly a year from the first one. Despite my old doctors promises of Lupron helping me, it actually made it worse!!! It 

had gone from just my bladder to my bladder, cul de sac, ovaries, and tubes. Basically there was a little bit everywhere and I would not have been able to have children without her intervention. She removed all she could and did a LUNA as well 

but could not get to as much of the nerve as she would have liked. We had no time 

to waste planning a pregnancy. My husband knew when we got married that our 

window of opportunity for children would be small. We got the green light and I 

was pregnant by January 94. Sadly, Our happiness did not last long. I miscarried 

in March. 

I shut myself off from the rest of the world for a while. That summer I 

drank . . . a lot . . . Looking back it wasn’t fully out of depression it was also to 

hide my other problems. It was easier to hide my dizziness and stumbling and visual problems if I had a few drinks than to admit there was something else wrong 

with me. Somehow we got through it and by September I was pregnant again. This 

time I told no one until I was past the point of my last miscarriage. I was so fearful 

of losing this one I would wake up thinking I was in labor, pushing and everything. 

The pain was pretty intense the first couple of months, but it did give me an excuse 

again for my klutziness. Then around 31⁄2 months an amazing thing happened, I felt 

great!!!! For about 5 months I was almost pain free, symptom free, headache free. 

WOW! My son was born on May 11, 1995. I nursed for about 3 months then tried 

to go back on birth control pills. But surprise, I could not remember to take them 

everyday. I talked to my doctor and finally decided that Depo Provera may be the 

best choice. It offered me a chance to ‘‘save’’ my uterus until I was ready to have 

another one. I wouldn’t get a period so the pain I had with them and ovulation 

would be gone. At the time it made sense. But with it I also lost my excuses for 

not facing the other problems my body was having. And just to prove it they started 

knocking me on my butt. I started to get sinus infections. I should say again, my 

VERY first sinus infection ever came after my second injection. I never had allergy 

102

problems before. After months of trying different antibiotics my doctor finally sent 

me to an allergy specialist. That’s when I found out I now had an IGA deficiency. 

Which had been checked by the doctor I saw for the infections I got while on 

Lupron? My IGA at that time was low, but still in normal range. Basically your 

body has five different Ig’s for different systems in your body. They are the ‘‘brains’’ 

behind your white blood cells and tell your white blood cells what to attack when 

you have an infection. I don’t have enough to fight infections in my respiratory system. I also learned that when I get a sinus infection I am more susceptible to other 

infections like strep throat and bacterial laryngitis. They put me on Prednisone and 

a long course of Biaxin. Still it took months to get well. I was miserable and thought 

for sure I was going to lose my mind!!! When the infections finally settled down I 

went back to work for the Orthopedic practice I was with before I had my son. He 

was almost two and I thought he needed to be with children his age, rather than 

a mother who was sick all the time. It didn’t take long for myself and others to realize something was wrong. I mean you can only walk into so many walls before someone asks if you’re alright. My right foot has a tendency to ‘‘disappear’’ on me at 

times. I hardly noticed my tripping over it anymore, but others noticed. I started 

getting these intense migraines with an Olfactory aura. Everything smelled like it 

was burning. My PCP thought I should have an MRI of my brain. I had it on a 

Thursday. That evening I got a call from my doctor. They wanted to do more. I 

needed to go back to the hospital in the morning for more MRIs. Then when we 

got home I got another call. They still wanted more, so back we went. Since it was 

a Friday and I was scarred to death at this point my PCP gave me her home number to call if I needed anything. She also wanted to see me Monday morning. She 

didn’t have the results but thought I should see a Neurologist. The one she had 

called in to read my MRI was not in my insurance plan, so she went through the 

book and found one that could see me right away. I can tell you this was the single 

most humiliating experience in my entire life!!!!! He came into the exam room 

abruptly, he did not even introduce himself. He picked up my chart and looked at 

me and said ‘‘So you’re feeling dizzy, what does that mean? Look at the wall, is the 

wall spinning or are you spinning’’ I was speechless!!! I was also very scared, I still 

didn’t have the results of my MRI, but I had brought the films with me and he proceeded to read them by holding them up to the light above his head, no light board. 

The whole time he is looking at them he’s saying ‘‘Well you get headaches because, 

unfortunately, you are a women.’’ I kid you not he really said this!!!! Then he looks 

at my eyes and asks if I had been checked for syphilis. I had enough and left. What 

a jerk!!!!!!! 

I took my MRI films back to the hospital and called my PCP to tell them what 

happened. That doctors name is no longer in their book!! They still had not received 

a report on my MRI. In the mean time I went to an ENT to rule out Menergies 

disease. The doctor was very nice and said I had classic vertigo but did not know 

why. He said maybe it was just a virus and would go away. At this point all I could 

do was hope and pray. I made an appointment to see him back in three weeks. He 

said he would run more tests if nothing had improved. About one week before my 

follow-up with him I got a call from my PCP. She said she really wanted me to see 

another Neurologist. I got nervous and told her I was willing to go out of my Insurance network if she could get me in. The best the Neuro’s office could do was 2 

months away. I took it and kept my appointment with the ENT. This is when I 

learned what everyone already knew. My MRI showed lesions on my brain. There 

was a question of ‘‘demylinating lesions’’ or M.S. I don’t remember the drive back 

to my office that day. Only my supervisor driving me home. And the look on my 

husbands face when he came home and found me curled up on the kitchen floor. 

We had tried to convince ourselves that no news was good news. I kept thinking 

‘‘this is not real, this is not happening to me, to us.’’ I kept calling the Neurologists 

office in hopes of a cancellation or something. I was very angry, how could everyone 

just expect me to put my brain on hold? 

When I finally saw him he showed me the area everyone was fussing about. I 

have come to call it ‘‘my spot.’’ It is an area about the size of a quarter on the left 

side of my brain. It’s in the white matter, in the middle, near the pituitary gland, 

but not in an area they can biopsy without causing more injury. He wanted to do 

a battery of tests, lab work, visual evoke potentials and a spinal tap. So far so good, 

then about four days after my spinal tap on a Saturday morning my husband tried 

to hand me the phone. It was my parents. I could hardly move the right side. I 

couldn’t grip the phone with my right hand. I couldn’t talk, just slur. My husband 

was scarred, I was worse. I tried to get up, the right side of my body felt like it 

weighed 300 lbs. We called the neurologist and he met us in the ER. He did some 

tests and seemed worried. He decided that I should stay in the hospital for a few 

days and take IV steroids, salumedrol. He also thought that I may still be leaking 

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spinal fluid and should have a blood patch, and more MRIs. While I was in the hospital he got the results of my Spinal tap, No M.S. But that did not help tell us what 

was going on. They took me to the O.R. and did the blood patch, YUCK!!!! And then 

off to MRI to do more MRIs and a MRA to check for stroke. Lesions still there but 

nothing else. After four days I still did not have the use of my right hand. Two days 

after I got home I started to swell. I though I was having a reaction to something, 

but did not know to what. As I swelled it felt like every cell in my body was exploding. I called the Neuro just to have him refer me back to my PCP. They wanted 

to see me first thing in the morning, but that meant still getting through the night. 

I should have gone to the ER but instead just sat up all night. I felt like I had been 

hit by a Mac truck. When I woke in the morning I looked like I had the chicken 

pox, but I could finally move my hand. My stomach hurt pretty bad but I thought 

it was just from the swelling as everything else hurt as well. When I got to my 

PCP’s office she did an exam, made an appointment for me with a dermatologist 

for the rash and to top it all off she explained that the stomach pain could possibly 

be from the steroids. I have stomach problems anyway and she was afraid it ripped 

a hole in my stomach. So back to the hospital for an Upper GI. That turned out 

OK, no holes. She gave me darvocet for pain. That to go along with the bag of Meds 

I already had from the Neurologist: Fiorocet, imitrex, erogot, Noratryptoline, 

Inderol, and midrin. I am a walking pharmacy. Now I add Zantac back to my list. 

My Neurologist thought it would be a good idea for me to get another opinion 

since he was still not sure what to pinpoint everything to. So I took my MRIs and 

records to The Medical College of Virginia (MCV), to the Neurology department. 

There I was examined by three students, one resident and one fully certified physician. After two hours of questions and following pen lights they finally looked at 

my MRIs. The doctor turned to everyone in the room and said ‘‘Do you see it?’’ I 

felt like a lab rat!! ‘‘WELL’’ he finally gets back to me ‘‘The good news is you don’t 

have M.S., the bad news is I think you have Lupus’’? When will this nightmare ever 

end??????? It took a while to let this ‘‘new’’ diagnosis set in. Then to organize it in 

my mind as to how they could go from one end of the spectrum to another. I started 

to do some research and it seems that Lupus and M.S. have a lot of the same symptoms. Even the treatment is the same. Change your diet, get more exercise, take 

steroids when you have a ‘‘flare.’’ Someone at work recommended a Rheumotologist 

and I made an appointment. He is known for having the longest living Scleroderma 

patient and very well respected in our community. Unfortunately it made his ego 

quite large. He, like ALL the other doctors spent a great deal of time with me during the initial evaluation. He ordered his own round of blood work and checked all 

my joints and muscles. He told me to bring my husband with me for the follow-up 

because he wanted him to understand EVERYTHING that was happening. A month 

later we found ourselves in the exam room with the doctor telling us that as far 

as the question of Lupus goes my SED RATE was OK so we should talk about something else for now... Fibromyalgia. I sat there for a half hour and only heard 

about 3 words he said. Rub here, Rub there, get more exercise, see me in a 

month... Now this time I am sure I was losing my mind!! I have to be, that is 

the only explanation for what has been happening to me the past few years. I went 

back for the follow up and with a list of questions. None of which were answered. 

He seemed uninterested in the Neurological things that were happening. I was worried about this happening in public or while I was alone with my son, what would 

happen to him??? Then it happened. I picked him up from pre-school and wanted 

to buy him a new pair of shoes. I was carrying him because it was a busy parking 

lot and he is very active. We had to walk up about 5 concrete steps to get into the 

shopping center. On the second step my right foot just ‘‘disappeared’’ and down we 

went. His back slammed into the concrete as did my right knee. He’s screaming, 

I’m dazed and hurt and people are running at us, out from the stores. This has to 

be a nightmare. I shut my eyes and tried to wish it all away. It didn’t work. We 

finally got up. His back was OK, just a little scrape and a lot of scared. I looked 

around and could not remember where I parked the car. Then I saw it but it kept 

getting farther and farther away. My heart raced and I felt cold sweat just pouring 

out of me. An anxiety attack on top of it all. The doctor heard none of this. He said 

‘‘perhaps you’re not getting enough sleep . . . he handed me a prescription for 

Flexeril and Ambien... ‘‘see me back in a month or two’’. I wanted to scream! 

I finally sought out a counselor and saw her for about 6 months, once a week. It 

felt so good to be told that I wasn’t crazy, I really needed to hear that. It also felt 

good to be treated like my problems were important. She never once said the old 

‘‘it could be worse, you could have X, Y or Z.’’ She was just as appalled at the way 

I had been treated and shuffled around from doctor to doctor, none of them taking 

into account the other’s findings. She helped me come to terms with things I already 

knew, but could not except. There is no going back, I can’t turn back the clock and 

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not take Lupron, it’s already done. There most likely is no cure for what is wrong 

with me, but there can be peace. It’s just finding a way to obtain it. She gave me 

the courage to do my own research and ways of reaching out to others who this has 

happened to. She helped me find my voice. Now I am able to share my story, this 

story, with others and possibly prevent this from happening to someone else. This 

is my path to peace. Through this search I have found that My illness is probably 

not M.S. or Lupus... but something else, something somewhere in-between. I 

have begun seeking out other doctors. Ones to help me deal with the pain I have 

daily. Most of my physical pain is on the right side. There are signs of Arthritis 

in my neck, right hand and elbow and right knee. I also still see the Neurologist 

to keep an eye on the lesions and help with headaches. I see a Neuro-opt, one of 

my Neuro’s partners to keep track of the Neuropathy and Adie syndrome in my 

right eye. My husband has been VERY supportive. He bought me this computer to 

help me research. He has gone to the library with me and tries to find contacts who 

may be able to help us. He kept me grounded when I found the information on the 

NLVN. He was with me when we brought all this to the attention of my PCP and 

was told by them that ‘‘the only way for the medical community to know these 

things is when a group of people search each other out and find that they have the 

same problems and the only common denominator is a certain drug . . . in this 

case LUPRON.’’ He filled out my FMLA stating that this all started when I unknowingly got myself involved with the FDA’s phase IV clinical trial of LUPRON. 

I did not know until my own research that I was part of a clinical trial. I never 

signed a consent for this. I am just a sure that the doctor who gave it to me NEVER 

filled out the MEDWATCH forms or reported any of my problems with this drug. 

I called TAP in the beginning just to see what they would say. I asked if they were 

going to do any long term studies on Lupron. They told me ‘‘Maybe in another 20–

25 years, look how long it took them to find out about DES.’’ I can’t wait that long. 

For now I will continue to spread this story to as many people as I can. I will continue to have a battery of tests done every couple of months. I will continue to try 

to find doctors who have some answers. I will continue to take various combinations 

of medications to try to keep my illness as stable as possible. I will try to continue 

to be the best mother and wife as I can be. I will continue my search for peace. . . 

To those of you who made it this far in this story and are facing problems from 

taking Lupron, please know that you are not alone in your fears or concerns about 

what this drug has done to you. There is a lot of information out there and a few 

very good sources of support. If there is anything I can do to help you, just ask! 

There is info available on Medscape and from the National Library of Medicine 

at pubmed. Dateline aired a show on Lupron on January 2, 2000. They interviewed 

9 women who all have permanent damage from taking Lupron. One of those women, 

started a website to offer support: Julie’s After Lupron Forum I believe 8 of the 9 

women post there as well as many, many others. There is also a petition: Lupron 

Petition. Kay Lazar, a reporter for the Boston Herald, wrote a 2 part article on our 

Lupron Damage in August 1999. If anyone would like the links or the articles, just 

ask. Until we find a lawyer who will take our case our own stories are the most 

powerful tool we have. 

If you have not taken Lupron yet and are trying to decide please do your research 

before you do anything that could alter your life forever. I know that Endometriosis 

is VERY painful. I still have it. I know that pain can cloud our judgment. The promises of a Painfree period of time. The HOPE it brings to be Painfree is a very persuasive reason for taking it. Please do not take what I have said lightly. I am not 

the only one. This is only one story, I am only one person. All I ask is that you 

search. Search your heart, your mind and weigh the price of your soul . . . . 

Good luck to all! 

Adendum 

It is now July of 1999 and some things have changed for me since I ended this 

story. But of course, there really is no end . . . My husband was offered a promotion that could not be turned down. We moved to Orlando, FL in February of 

this year. We are now settled in our new house and my son has started in Montessori school. Before we moved I asked for recommendations for a GYN and have 

found a really good one. I had stopped taking Depo Provera in January of 1998, in 

hopes of having another baby. It took 14 months for my period to return. And it 

came with vengeance!! My Endo pain has been increasing every month. I told my 

GYN at the first visit my problems from Lupron. He had me start taking Prenatal 

vitamins to boost my immune system. He also referred me to a Reproductive 

Endocrinologist. We have met with him once and his acknowledgment of my Lupron 

trouble has been the best I have received. He added more B–6 and evening primrose 

oil to my list of meds. The bad news is he has diagnosed me with secondary inferVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00108 Fmt 6601 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
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tility. He does not think I am ovulating at all and when he did an internal 

sonogram he did not like the looks of my ovaries. I will have an HSG next month 

and possibly start fertility drugs. His biggest concern with these meds is that they 

DO make Endo worse. They are all high in estrogen, which most of you know feeds 

the endo. He is also concerned about what other antibodies Lupron may have caused 

me to develop, so I will be tested for those soon. My pregnancy, if it happens, must 

also be followed by a Neurologist. I have an appointment with one soon. Basically 

I am starting from ground 0. Being a ‘‘new’’ patient, filling out endless forms, explaining my condition(s) and it’s cause, hoping they believe me or at least understand. Not to mention waiting MONTHS for that new patient slot to open up. 

It’s now the end of August. I’ve had the HSG, it wasn’t good and it hurt like Hell! 

He was able to force the Dye through. I emphasize ‘‘force.’’ Rob and I have talked 

and all this pressure to try and get pregnant has been wearing me down. It’s felt 

like something I have to do, like having to do the laundry or dishes. The reality 

is we don’t know if I am even healthy enough to have another child. My Endo pain 

is controlling me right now. I can feel it building up on my bladder. It hurts to pee 

and I feel like I have to go all the time. I went and had a check for a UTI, almost 

hoping that is all it was . . . no such luck. I am going to go with Lap #3 and see 

how I feel afterwards. 

November 10, 1999 

I am now almost 2 weeks post Laperoscopy. DR found more Endo and adhesions. 

Also said my uterus was VERY red and not the color of salmon it should be. He 

also said my right ovary spasms when he touched it. I know that sounds kinda 

gross... Well, I don’t know what any of this means just yet. My follow up with 

him is on the 15th. I am not recovering as quickly as I should. I can’t seem to shake 

the ‘‘flu’’ like symptoms and fatigue. I had a few complications after surgery. My 

blood pressure dropped and heart rate dropped very low. They had to keep waking 

me up. Plus I had trouble peeing. Don’t understand why it never occurred to them 

that I might have a UTI since I had a low grade fever and pain. The pain meds 

they were giving me came by the way of hip injection. Well, one struck a nerve and 

now my leg feels like I have a HUGE gaping wound in it. It hurts to shave. Supposedly this will slowly go away. I hope so!!! I am not feeling well today! I am nauseous and my stomach hurts, right around my uterus. 

I have received more published articles on Lupron. Two from the Boston globe 

from 1996. It details two women taking Lupron for infertility and it caused 

hyperstimulation of the ovaries. They both almost died. The others are from the 

HERS foundation from back in 1989–1990. The founder of this group had all the 

research info on Lupron prior to it’s approval. She has proof to show that they knew 

of the dangers of this drug before it got approved. She also gives her strong opinion 

that Lupron will turn out to be worse than Thalidomide or DES ever was. For my 

son’s sake (he is a post Lupron baby) I pray to GOD every night that he is spared! 

It is bad enough that he got me for a Mom. 

November 20, 1999

Had my Post op on Monday. It didn’t go so well. Since he was unsure about my 

uterus he took biopsies of it in different places. Turns out it is ALL Endo with the 

added probability that I now also have Adenomyosis. This is when Endometriosis 

is found embedded in the uterine muscle and the ligaments that attach it. He feels 

bad for second guessing and not removing what he could. I am still kinda numb and 

don’t really know how to react to all this. He also showed me a cyst he ruptured 

and the ‘‘redness’’ where all the nerves are hyperstimulated from the endo and told 

me I have some PCS (pelvic congestion syndrome). This he explained is from an injury to the uterus. Most likely from delivering my son. I will start continuous BC 

Pills for now, try to buy some time while I sort through all this. 

June 2000

Had another appointment with the GYN. I wanted to see the pictures again. 

UGH! All that endo still there. So far the Continuous Loestrin Fe has been helping. 

At least as far as no added ovulation or period pain. He brought up the ‘‘H’’ word. 

He wanted to tell me what his thoughts on it are. Wanted to tell me that he has 

turned women away because he did not feel a hyst was the right choice for them. 

He says he does NOT believe in just yanking out a women’s organs. Then he said 

whenever I was ready, so was he. . . 

November 2000 

Here I am one year post op and all was going relatively well until I got home 

from a long summer vacation. Apparently at some point during my long trip up the 

east coast I got bit by a deer tick and developed Lymes disease. I have spent 5 of 

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the last 8 weeks on antibiotics. I still have Lupron to thank for my poor immune 

system. It makes everything so much harder to fight. The lymes got into my joints 

and I have a stress fracture in my rt foot. That pain started 3 weeks ago. Then to 

top it all off the antibiotics weekend the pill enough to cause some severe pain. After 

being in bed for 2 days with a migraine my neurologist called in some vicodin. Rob 

picked it up for me and my plan was to take 2 and hop in the tub for a good long 

soak. Except that as soon as I actually go up the pain began. By the time I knelt 

to start the water I knew I was not going to get back up. The pain took my breathe 

away and I could not even yell to Rob for help. Zak found me on the bathroom floor 

whimpering. I HATE that he saw me like this. I hate even more that he had to 

come with us to the ER. Odd but in all my years with endo this was my first trip 

to the ER because of it. It took 2 shots of demerol to calm me down and be able 

to tell them what was wrong. When someone came in to check my uterus, I think 

I could have kicked him into the next room! The pain was incredible. They gave me 

another shot before sending me on my way. Nothing they can do for me there. I 

went to see the GYN the next day and the word Hysterectomy was tossed around 

again. He gave me more pain med and told me to return in 3 weeks. WELL I’m 

not going to make it to 3 weeks. Zak came into my room 2 nights ago looking for 

the dog and when I got up to help him the pain started again. This time the pain 

was alone. I made it to the bathroom in time to pass a few large clots and am still 

bleeding today. I have an appointment Friday morning. . . . If I can just make it 

through the holidays. . . . Jan 2001—Another Laperoscopy only reinforces Pelvic Congestion and 

Adenomyosis is worse. A hyst is unavoidable and Dr. doubts I will get much relief. 

November—Have Ovarian Vein Embolization. DO NOT Recommend!!!! AWFUL 

procedure! 7 hours, through Jugular, AWAKE no less. . . filling left ovarian veins 

with Coils, Balloons and glue. . . 

This procedure caused MAJOR pain and problems. Large Endometromas grew in 

left ovary. At scheduled Ultrasound in January they have ruptured. Talk about 

pain!!! Dr. does not know what to do. For the first time he is at a loss for a plan. 

My endo is beyond his capabilities. There is more to it but I’m running out of room. 

March 2002—Fly to California to see Dr. Andrew Cook. . . I honestly believe this 

man saved my life. I had a hysterectomy and Bowel resection. He FULLY understands all problems from Lupron and did a LOT of testing for problems he is aware 

of. Specifically Allergy related. . . I am allergic to ALL my hormones and 6 of 9 

foods tested for. 

This Doctor was amazing! WWW.PELVICPAIN.COM. . . now if I can get the rest 

of my pain under control. . .If my hands could stop hurting for just one day. . . Or 

my head . . . That would be really nice! I am actually not sure what I would do 

with no pain in my life. I have lived with it for so long now . . .I do NOT remember 

what it is like to live without pain. Maybe someday. . . 

PREPARED STATEMENT OF MELODY HAMPTON

My name is Melody Hampton. My testamony is part of the testimony Lynne 

Millican gave to the Senate Subcommittee. I would like to add a few things. I am 

now 44 years old and I feel 94. I am sick all the time and a lot of days I just hardly 

can move due to the stiffness and pain in my body. I ask you to please do what 

ever you can to stop Lupron from being put into anyones body. I do not know what 

can be done for us who have the drug in our bodies already, but please don’t let 

others be hurt like this. I will die knowing Lupron ruined my body and my life as 

I knew it. For me not to plead for others would be a sin. Thank you in advance 

for your efforts. 

PREPARED STATEMENT OF SUSAN HAYWARD, LAKE HAVASU CITY, ARIZONA

My name is Susan Hayward and I moved to Lake Havasu City, AZ two years ago 

from Massachusetts where I was born. In 1997 at the age of 42, I became disabled 

from the U.S. Postal Service. I have been receiving Social Security Disability Payments and Disability from the Office of Personnel Management under the FERS 

program. I worked my entire life up until the point where I became disabled, 28 

years straight, with the last 10 with the Federal Government. I had a great job with 

a private office making good wages. It was a career and I planned to work there 

until retirement in my 60s. 

The reason I am writing to you is because I want to offer my experience with the 

drug Lupron to bring awareness of the harmful side effects of this prescription drug. 

In my situation, I was administered 19–20 injections of Lupron as treatment for 

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endometriosis. The recommended dosage is 6. When you examine marketing techniques of the manufacturer, Abbott Laboratories and Takeda Pharmaceuticals, TAP, 

then you can understand why doctors continued to prescribe the drug. Samples were 

offered to physicians who were able to bill patients and insurance companies for 

hundreds of dollars. The total for my prescriptions is approximately $7,000 alone. 

Two doctors gave me my injections and they had something in common; both had 

me skip going to the pharmacy and they obtained the drug for me. When I first 

started using the drug I had to purchase it like any other prescription. Later, I believe I was sold prescription samples. The kickback schemes involved with TAP and 

physicians are well documented in the litigation resulting in the largest fine in U.S. 

History against a drug company. We are all paying the price for this so TAP and 

doctors could profit. 

Please think for a moment about the costs of lost productivity from my being dis- abled: approximately $900,000 disability costs being paid by Social Security and the 

Federal Retirement Program. Factor in the increased insurance premiums from 

hundreds of thousands in medical bills from hospitalizations, surgeries and tests. 

None of this considers the personal loss of my Thrift Savings Plan, the loss of contributions to the economy in commuting costs from using an automobile to buying 

lunches, or what this has done to me physically and emotionally. 

My motives are not monetary. I simply want to warn other individuals how dangerous Lupron is so they too don’t become ill or disabled. I feel that my life has already been ruined, but perhaps I can help another person from having their life destroyed. Against the advice of lawyers I went public with my story in the Boston 

Herald in 1999. By publishing my story I could compromise any future legal case, 

but it was too important for me to warn others. 

I have written to Hillary Clinton when she was in the White House, Senator Ted 

Kennedy, and my local State Representative in the past. My understanding of such 

abuses TAP makes is that individuals hide behind the guise of a corporation and 

are not accountable, all in the promotion of capitalism and profit. If one of those 

people at TAP thought they’d go to jail for selling poison to the public, they wouldn’t 

be marketing this drug. There is a history in this country of exposing the public 

to dangerous drugs, pharmaceutical giants making huge profits with full knowledge 

of the harm they are causing, and by the time litigation catches up with the profiteers they have bailed out and reorganized. The paltry settlements offered through 

class actions are eaten up by lawyers and never truly compensate the victims for 

the amount of damage. The pharmaceutical lobby in Washington, DC is quite powerful and has strong influence over political voting. Understandable when you consider how much money they’ve made from all the profits. Who is watching out for 

the citizens when you have this dragon to slay? The FDA has done little to help 

claiming there is no other drug available that will do what Lupron does. My firsthand experience is that I would rather suffer with my initial diagnosis, endometriosis, than what this drug has done to the rest of my body and life. What I 

believe is that TAP will not stop selling Lupron until it no longer is profitable. The 

only way to make it unprofitable is through a barrage of litigation or a huge class 

action suit. But TAP has even found a way around that. All the successful lawsuits 

against TAP brought on behalf of victims for the damage it causes are SEALED 

with secrecy agreements. This makes it that much more difficult for victims to 

argue a new case and delaying a class action. If we can’t find out what constitutes 

successful litigation then we get stalled, the statute of limitations runs out, lawyers 

don’t have the resources to start a class action, and all these victims linger in silence. Unlike other pharmaceutical lawsuits where there is a direct cause and effect, 

i.e., Fen-Fen and heart disease, Lupron causes a syndrome with a host of symptoms 

that are very easy to blame on something else and difficult to prove. The ailments 

often don’t show up in tests until much later if at all, so we get grouped into garbage diagnoses such as chronic fatigue, fibromyalgia, and degenerative disk disease. 

TAP continues to create more profits and victims with few obstacles. 

Please consider who the people are that are using Lupron and how TAP has consistently tried to find new ways to market it. Originally it was developed for men 

with late stage prostrate cancer. Any cry of foul play would be discounted by this 

group because ‘‘they are dying anyway.’’ Who knows how many of these men suffered more problems than they already had and nobody listened. Women desperate 

to have a baby were given Lupron for invitro fertilization. Many were so happy to 

finally have a child that they overlooked the health problems these children face. 

TAP decided they could use it for treatment of endometriosis. It doesn’t cure it and 

causes a rapid regrowth once it’s stopped. Like myself, most of these women are suffering with incredible pain and having to fight to receive the proper treatment, painkillers and surgical excision requiring a skilled surgeon. Fibroids temporarily shrink 

in some cases but still need to be removed. If they aren’t there is rapid regrowth. 

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Lupron only postpones the inevitable so why are they giving it to us? The FDA 

claims there is nothing else doctors can offer. TAP says we need it so they can profit. It doesn’t make sense if it doesn’t help, and it actually causes us harm. 

Precoscious puberty is being treated with Lupron with younger victims without the 

opportunity to gain an education before their memories are compromised. The memory problems can best be described as Swiss Cheese, neither long or short term, 

more like holes with total blanks. It is my understanding this is some form of seizure where thought processes are interrupted mid sentence and you draw a complete blank. Sex offenders are given probation if they take the drug as a form of 

chemical castration. The majority of the public hold sex offenders with disdain, so 

who is going to be looking out for their interests? Are there other markets for TAP 

to sell Lupron? I assume they are lobbying for cloning so they can sell more in IVF 

to harvest doner eggs. With each new group of users it lends credibility to the use 

of Lupron i.e., they’ve been using it for years to treat prostate cancer so it’s safe 

for treatement of endometriosis. In reality, it should not be prescribed for anyone 

who isn’t terminal, and then only as a last resort. That’s what it was developed for 

and that’s the only way it should be used. 

As a way to offer greater understanding of what Lupron can do to someone’s life, 

I’d like to offer background on my situation and illustrate the difficulties this drug 

has caused. 

Like many people in this country, I was born into a lower middle class family. 

There were difficulties in my parents’ marriage and I ended up being raised by my 

grandparents with 3 siblings with help from public assistance, or welfare. This humbled me a great deal and I learned a good work ethic early. We were raised with 

strong morals and religious background. 

My whole life I aspired to be a success and have a normal lifestyle. I knew education was important and had planned to attend college after high school, but the 

year I qualified for a free college education was in 1973 when Richard Nixon cut 

the welfare bill. A lot of hope went away when that happened but I started working 

and eventually went through college attaining my Bachelor’s in Business 10 years 

later and even took a post graduate course at Harvard. I worked full time during 

those years with the exception of one when I was writing my thesis, and worked 

part time instead. 

Upon completion of college I decided on a career in the U.S. Postal Service. I was 

very proud to work in the largest mail processing facility in my area. We were voted 

#1 in the country for customer satisfaction and I met the Postmaster General. There 

was a tremendous sense of pride for all the employees but with me, it was even 

more so because I tied a lot of my sense of self esteem and worth in with my job 

and accomplishments. 

A few years into my career I applied for a managerial promotion and wasn’t 

awarded it. The person who received the promotion had a high school diploma and 

military background as a prison guard in the Coast Guard. The next several years 

I endured extreme stress at the hands of this professionally jealous supervisor. I 

sought assistance from the American Postal Workers’ Union, higher level management including the Plant Manager, EEO, and the Employee Assistance Program. By 

the time I was allowed to report to a different supervisor, I had developed endometriosis. 

What followed was years of pain and surgeries. I needed my job in order to support myself and lived in fear that I would not be able to maintain the schedule from 

illness. I sought treatment in Boston at University Hospital, now a part of Boston 

Medical Center. I assumed I would receive the best care with the newest techniques. 

The doctor who treated me was well known for his research and after a few months 

and diagnosis, placed me on Lupron. Between October 1992 and October 1997 I received 19–20 injections of the drug from my doctor in Boston and my local gynecologist. Both doctors knew of each other and the number of shots I was receiving. 

Instead of finding a solution for the pain the doctors would put me right back on 

Lupron until the bone loss was too great. 

People ask me how I could allow the doctors to give me so much Lupron. It’s a 

multifaceted issue. From my background you can see that my sense of self worth 

directly correlated to my accomplishments at work. I struggled to get myself educated and gain a career. It took many years for me to attain the level I was at and 

I was in the career I chose to be. This was my lifelong plan and goals. How could 

I maintain that if I was always sick? I had to do everything I could in order to keep 

working for the financial and emotional benefits. Eventually it got to the point 

where I could no longer do it. Later on I was diagnosed with post traumatic stress 

disorder. 

The main symptoms that I attribute to my using Lupron are the vertibrae bone 

loss diagnosed as degenerative disk disease, arthritus, myalgia, bone pain, fatigue, 

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swelling in hands and feet, severe allergies, nausea, weight increase, severe memory 

loss, vision changes, sleep changes, rapid heart beat, and abdominal pain. During 

the first doses of Lupron I developed panic attacks which I never had. The first few 

years after using Lupron I had horrendous migraines. Before I took Lupron I had 

none of these conditions; I was a normal woman in her 30s with endometriosis. 

After taking Lupron, I don’t go a day without pain and am under constant doctor 

care to control pain and autoimmune problems. I left my home and moved to Arizona where I didn’t know a sole so I could get relief from the arthritus problems. 

It was worth the chance that maybe I could gain my health back and be able to 

work again. That is all I’ve ever wanted when you consider where I came from. 

I’d like to outline the frustration we Lupron patients suffer at the hands of the 

medical establishment. The symptoms and diagnostic tests don’t always show what 

we experience and often we have to be tactful in how we approach doctors. If you 

mention Lupron sometimes they brush us off because they know it’s a bad situation 

and fear being dragged in a lawsuit. What’s the alternative, not tell them? Others 

dismiss you like you are making the whole thing up in your head like a 

hypocondriac. In 6 years of dealing with my health problems post Lupron, I have 

yet to find an MD who believes my problems are caused by it. You don’t take a 

healthy woman in her 30s to a woman with a host of medical issues in her 40s by 

endometriosis alone. Stress didn’t cause my back to become herniated in 3 places. 

I didn’t move to Arizona for arthritus relief because I don’t have it, but that’s what 

my tests say. The total lack of support from the medical profession is appauling, 

and there are thousands of people who need this documented. We need to know 

which tests to have, the proper pain relief medications, what we can do to help ourselves. Right now all we are doing is muddling along trying to help each other and 

most of us have no medical background. I attempt reading studies and biology reports that I struggle to understand because I know there are answers. Isn’t that 

what we pay doctors to do? We don’t all become doctors because we get sick, but 

that’s what we are expected to do when it comes to Lupron. 

The other side of the equation is the legal establishment. I’ve contacted half a 

dozen lawyers and they all say the same thing; without a doctor saying your problems are directly related to the use of Lupron, you don’t have a case. This is a need 

for an expert witness. It costs thousands to hire one. Most of us don’t have the resources and law firms won’t proceed without the guarantee of a positive outcome 

in the case. Another issue is the recommendation of only 6 doses of Lupron during 

the course of a lifetime. I had two doctors who ignored that and when presented 

to a lawyer they said it’s a matter of opinion regardless of it being in the Physicians 

Desk Reference. That attitude has resulted in people like me with multiple injections over the course of years. Patients have no recourse and doctors don’t face any 

consequences. With all the sealed verdicts and secrecy agreements, it makes it very 

difficult to obtain legal representation within the window of opportunity the statute 

of limitations allows. Once a class action does finally open up the lawyers will be 

looking for a percentage of ALL claims, probably a third of any settlement. Class 

actions are historically lower awards than a regular court case because there are 

so many litigants and often they drive the company into bankruptcy. As one lawyer 

put it, you are likely to receive a dime on a dollar. Class actions have administators 

too and they also take a portion. The true victims in these cases rarely get compensated for what they endure, while the tag-a-longs get rewarded handsomely. My 

feelings are to forget the money, let’s stop poisoning new people, but that won’t happen without TAP feeling the financial pinch. 

I have mentioned what this whole experience with Lupron has done to me physically and the frustrations I continue to endure with the legal and medical professionals, but I want to stress what this has done to me personally. Yes, I lost my 

career and am disabled, but more than that it has robbed me of any faith in our 

system of justice and what is right. How disheartening do you think it is for me 

knowing they are poisoning innocent teens because their bodies are developing too 

quickly? I worry so much about other people and what will happen to them knowing 

what this has done to me. How can everyone turn a blind eye to what is going on 

here? Do the lobbyists hold that much influence that people toss their morals out 

the window? Isn’t that why people go into politics to begin with, to make a difference for the good of all? I know in my heart there are caring people in this world 

who just don’t understand this situation with Lupron. I want as many people to 

know about it as possible so they can warn people not to take it, and hopefully 

someone will become motivated enough to do something to help the ones like myself 

who are just too sick to do anything about it. 

Also on a personal level, I enjoy travel more than any other passtime. Now I can 

no longer carry a bag or wheel a suitcase because my back can’t sustain it. I was 

lucky enough to visit Europe before I stopped working and at the time, I kept thinkVerDate 0ct 09 2002 12:44 Apr 27, 2006 Jkt 096697 PO 00000 Frm 00113 Fmt 6601 Sfmt 6621 S:\WPSHR\GPO\DOCS\96697.TXT JACKF PsN: JACKF
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ing I better go now while I can. Thank goodness I had the insight to know to go 

when I did because I could never travel long distance again. This is the most enjoyable aspect of my life and now it’s gone caused by the bone damage Lupron gave 

me. The most frustrating aspect of this whole situation is the fact that people have 

known about this for a very long time. I uncovered data published in 1990 warning 

about Lupron and feel it is important to incorporate it into this letter. It is obvious 

to me that the FDA is not protecting the public. TAP continues to find new ways 

to market this dangerous prescription drug and the doctors don’t delve into it deeply 

enough to understand exactly what it does to our pituitary gland, hypothalmus, and 

adrenal systems that make us have problematic autoimmune responses. The economic costs will be catastrophic with millions of victims should this continue unbridled. It will make my loosing my Thrift Savings Plan look like a drop in the bucket. 

In closing I’d like to express my appreciation for you taking the time to listen and 

showing interest. We need caring individuals to take a stand against this multi-national corporation harming us so more people won’t suffer. I am sincerely grateful 

for anything you can do to help. 

PREPARED STATEMENT OF MELANIE WALDMAN

I am one of the women named in the testimony about Lupron. I am not looking 

for a lawsuit, reparations, etc., I just beg that someone does something to stop this 

drug from being used without more information to all parties. 

Before taking the spray version of Lupron (synarel) I was an architect and able 

to work full time. Since my health was destroyed by this drug I have not been able 

to work. I am fortunate that I am married and that my husband is able to support 

us on his salary. I am also fortunate that his health insurance coverage allows no 

more than 1,000 dollars out of pocket expenses because without that we would never 

be able to afford the IV treatments for the resulting joint pain that keep me functioning at all. I also know the drug is commonly used off label for people like me 

who suffer from endometriosis. (the ironic piece is that I’m used to it hoping to increase my chances to get pregnant and it destroyed my ability to carry a pregnancy, 

I am also lucky that we were able to afford to adopt a child) yet Doctors are not 

aware that so many of us have horrible permanent side effects. It seems like this 

issue falls throughout the regulatory cracks. The FDA has not approved it for this 

use, the manufacturer promotes it but is not responsible for its off label repercussions and the Doctors. have no way to find out the facts. 

In a time with more important issues like war and the economy, I am sure this 

issue doesn’t seem pressing, but I ask that you do your best to see that something 

is done to prevent more woman from being needlessly harmed. 

PREPARED STATEMENT OF LISA A. PLANTE, FORMER U.S. CONGRESSIONAL STAFF

PERSON

My problems with Lupron started when I was wrongly diagnosed with endometriosis (all I had was adhesions) I was suffering from years of pain with adhesions attached to many internal organs. After many surgeries due to cysts I still experienced much pain. 

I asked a young doctor (OBGYN) to please make me better so I could live normally, enjoy my family and 2 children. This particular doctor said I would have to 

try Lupron before he did anything invasive. I was never properly diagnosed with 

endo before my injections of Lupron but was absolutely desperate to get better and 

decided to trust this doctor’s advice. 

Immediately after having the first injection of Lupron I experienced terrible bone 

& joint pain, chest pain, depression, insomnia, foggy brain. . . etc., the doctor said 

it would be temporary and to stick with more monthly injections.. 

I questioned doctor prior to Lupron injections on a pamphlet an organization 

(NLVN) was leaving in libraries that a friend had given me. The doctor asked to 

keep the pamphlet and told me not to worry that it was probably a competing drug 

company. I spoke with people who warned me of Lupron but thought they were 

spewing lies for one reason or another. I decided to trust my doctor in thinking he 

would never give me something that would harm me. I desperately wanted to work 

with him in getting me better and took 3 more injections of Lupron. 

I was encouraged to take more injections of Lupron but abdominal pain was unbearable plus the side effects... this was a nightmarish time. . . 

The doctor and his partner decided to take out my only remaining ovary plus the 

adhesions. After adhesion removal, I felt better in the abdomen but continued to 

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have bad side effects from Lupron. After 8 years, I still have bone and joint pain, 

foggy brain, chest pain, bloating . . . My teeth have thinned out tremendously, 

hips hurt, arms & joints are weak and sore. I do excercise a little, which helps some 

but feel like a very old lady at age 46. 

I don’t think the doctor meant to cause me any harm and realize the constraints 

of many doctors these days but to give this drug out to just anybody is not a good 

idea. I especially don’t think it’s good to use in helping women’s fertility! My gosh, 

where is the common sense? 

dates took Lupron:

Lupron Depot 3.75 kit TAP—1/20/1995

Lupron Depot 3.75 kit TAP—2/27/1995

Lupron Depot 3.75 kit TAP—3/29/1995

Lupron Depot 3.75 kit TAP—4/28/1995

PREPARED STATEMENT OF J. WOLF

Dear Senator, 

I was given your name by someone who is aggressively trying to help those of us 

who were poisoned by Lupron, I appreciate you reading this, my experience with 

this drug. I went to my doctor complaining of cramps, I was told to have an exploratory laparoscopy, when this was completed, I went back to the doctor and was told 

I had endometriosis. I was a little mystified since that is related to infertility and 

other symptoms that I did not have but he was my doctor and I had no reason to 

doubt his findings. He prescribed Lupron injections and told me it was a safe drug 

and I would only experience mild menopause symptoms with the loss of my menstrual cycle but all would return to normal as soon as the injections were stopped 

so I began them Sept. 1996. I returned to his office for monthly injections until Nov. 

1996, when I began to complain of worsening pain, the injections were stopped and 

I became worse. I repeatedly went back to the doctor sometimes doubled over in 

pain (which was not there before Lupron). He did another laparoscopy with no findings and I was then sent to a gastroentologist for which he referred me also with 

no findings from the endoscopy and colonoscopy he performed, I kept going back in 

major pain (not present before Lupron) He then started to patronize me insinuating 

this was a women’s problem and maybe in my head and suggested I go get the 

nerve in my gut cut, in other words, let’s stop the pain without finding the cause, 

I began to doubt this doctor, I requested all my medical records from his office and 

to my shock found that the laparoscopy he performed before Lupron showed NO 

endometriosis and neither did the biopsy! By now it’s the end of 1997 and I’m suffering to no end. I realized I may have been used for this experimental drug on 

women and I believe it was because of my insurance that I was placed on this drug, 

had I not been able to afford it I don’t think I would be suffering right now. I took 

matters into my own hands and started all over again seeing a different set of doctors, I went through a series of tests all over again when a doctor suggested I get 

a nuclear stomach emptying test. This test showed an extremely delayed emptying 

(normal stomach is less then 60 minutes and mine was 500 minutes!!). I finally had 

a diagnosis to go with the pain, I saw several doctors that took several more tests 

and I was told I had gastroparisis (a paralyzed stomach). With research and many 

questions I learned that this does not go away and I’d have it for the rest of my 

life, I knew Lupron did this to me because I never had stomach problems before 

Lupron so I requested the test again a few months later, my theory was since 

Lupron did this to me perhaps as it leaves my system I will improve, I was right 

4 months later it was better, I repeated it a total of 4 times in two years each getting a little better as the Lupron was further from my system, I began to research 

Lupron and to my horror found it was used for prostate cancer and on sex offenders 

to castrate them, I was not told this by my doctor nor was I allowed to see the paper 

work accompanying this drug because it was giving to me at the doctors office. 

Given these facts I would have chose NOT to take this drug, I was deceived in the 

worse way possible first by a doctor who gave me a drug with no known medical 

diagnosis and then by the drug company for not disclosing the facts, side effects, 

uses, ect. . . , I am left with a stomach that will never be the same, my personality 

has changed, I have weight issues that I never had before, with a paralyzed stomach 

the food just sat there for days causing my gallbladder to become so infected I had 

to have it removed, I had doctors tell me I needed a hysterectomy and almost removed all my women parts for no reason, I had a doctor tell me to get the nerve 

in my stomach cut to ‘‘shut me up’’, my hair has fallen out, my menstrual cycle is 

now painful, I have fits of rage from my hormones being sent into overdrive and 

suffer from major depression, I was basically castrated myself because Lupron has 

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murdered my sex drive. I am not the same person and know I will never get back 

the person I was before this poison, I want help, I need help, This drug is a danger 

and it shouldn’t be given, The drug company needs to be held accountable for the 

pain it caused and will cause in the future. I only hope you can do something because as I understand a new generation of Lupron babies will be popping up soon 

as the gynecological field is pushing this drug to desperate infertile women without 

knowing the ramifications of it’s use! 

Thank You,

PS: Please be advised I have my test results and all records proving everything 

said in above statement.

Æ