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97–963 PDF 2005

BALANCING ACT: THE HEALTH ADVANTAGES OF

NATURALLY-OCCURRING HORMONES IN HORMONE REPLACEMENT THERAPY

HEARING

BEFORE THE

SUBCOMMITTEE ON HUMAN RIGHTS AND

WELLNESS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

JULY 22, 2004

Serial No. 108–249

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform
(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

BETTY MCCOLLUM, Minnesota

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNET, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS

DAN BURTON, Indiana, Chairman

CHRIS CANNON, Utah

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

DIANE E. WATSON, California

BERNARD SANDERS, Vermont

(Independent)

ELIJAH E. CUMMINGS, Maryland

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

MARK WALKER, Chief of Staff

MINDI WALKER, Professional Staff Member

DANIELLE PERRAUT, Clerk

RICHARD BUTCHER, Minority Professional Staff Member
(III)

C O N T E N T S

Page

Hearing held on July 22, 2004 ............................................................................... 1

Statement of:

Alving, Barbara, M.D., Acting Director, National Heart, Lung, and Blood

Institute, National Institutes of Health, U.S. Department of Health

and Human Services ..................................................................................... 10

Fugh-Berman, Adriane, M.D., associate professor, Department of Physiology and Biophysics, Georgetown University School of Medicine; David

Brownstein, M.D., Center for Holistic Medicine; Carol Petersen, managing pharmacist, Women’s International Pharmacy; Vicki Reynolds,

owner, Texas Reliant Air-Conditioning and Heating, Inc.; and Steven

F. Hotze, M.D., Hotze Health and Wellness Center .................................. 29

Letters, statements, etc., submitted for the record by:

Alving, Barbara, M.D., Acting Director, National Heart, Lung, and Blood

Institute, National Institutes of Health, U.S. Department of Health

and Human Services, prepared statement of ............................................. 14

Brownstein, David, M.D., Center for Holistic Medicine, prepared statement of ........................................................................................................... 41

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of .......................................................................... 5

Fugh-Berman, Adriane, M.D., associate professor, Department of Physiology and Biophysics, Georgetown University School of Medicine, prepared statement of ........................................................................................ 32

Hotze, Steven F., M.D., Hotze Health and Wellness Center, prepared

statement of ................................................................................................... 69

Petersen, Carol, managing pharmacist, Women’s International Pharmacy,

prepared statement of ................................................................................... 57

Reynolds, Vicki, owner, Texas Reliant Air-Conditioning and Heating, Inc.,

prepared statement of ................................................................................... 62

(1)

BALANCING ACT: THE HEALTH ADVANTAGES

OF NATURALLY-OCCURRING HORMONES IN

HORMONE REPLACEMENT THERAPY

THURSDAY, JULY 22, 2004

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 2:30 p.m., in room

2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the subcommittee) presiding.

Present: Representatives Burton and Watson.

Staff present: Mark Walker, chief of staff; Mindi Walker, Brian

Fauls, and Dan Getz, professional staff members; Nick Mutton,

press secretary; Danielle Perraut, clerk; Sarah Despres, minority

counsel; Richard Butcher, minority professional staff member; and

Cecelia Morton, minority office manager.

Mr. BURTON. First of all, I want to apologize for my tardiness.

We were supposed to start at 2:30, but we’ve had a very involved,

contentious hearing down in the committee room. And I’ve learned

something after 22 years, and that is that the last week of the session before we go out on the August break, you shouldn’t have a

hearing. Because it’s absolutely a madhouse around here. We’ve got

a lot of votes and a lot of things going on.

Good afternoon. A quorum being present, the Subcommittee on

Human Rights and Wellness will come to order.

I ask unanimous consent that all Members and witnesses’ written and opening statements be included in the record. Without objection, so ordered.

I ask unanimous consent that all articles, exhibits and extraneous or tabular materials referred to be included in the record,

and without objection, so ordered.

And in the event that other Members attend the hearing that are

not on the committee, I ask unanimous consent that they be permitted to serve as a member of the subcommittee for today’s hearing. And without objection, so ordered.

We’re convening today to examine the health benefits of using

natural hormones in hormone replacement therapy.

As you might know, millions of American women are prescribed

synthetic hormones by their doctors to assist with the decreasing

levels of estrogen and progesterone in their bodies experienced during menopause as well as other hormonal fluctuations that might

occur. It might be surprising to note that many men in the United
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States are administered testosterone for similar decreases in hormonal levels during the aging process, which progresses at a similar rate as menopause, called andropause.

While the declining concentrations of hormones in the body is entirely normal, hormone replacement therapy should not be undervalued as a highly effective medical treatment. It not only balances

the hormone level within a patient, but it also serves as a preventative measure to ward off potential health risks associated with imbalanced hormones such as osteoporosis and the No. 1 cause of

death in the United States, heart disease.

Because naturally occurring substances cannot be patented in

the United States, pharmaceutical companies must somehow manipulate hormones with additional chemicals in order to be able to

hold the manufacturing rights of these formulas.

Since pharmaceutical companies must mass produce these synthetic hormones according to the formulations covered by a patent,

they are only offered in certain doses as a ‘‘one size fits all’’ solution to hormonal imbalances. This results in many American

women and men being administered either too much or too little

of the hormones they need to properly address their wellness

needs, thus creating the potential for further health complications.

Even more concerning is the nature of the synthetic hormones.

Because natural hormones must be manipulated by chemicals in

order to be patented, the body does not recognize some of the components of the synthetic hormones, which causes some serious and

potentially life-threatening side effects.

In 1991, the National Institutes of Health [NIH], launched the

‘‘Women’s Health Initiative,’’ one of the largest studies on hormone

replacement therapy ever initiated in the United States. This clinical trial observed 16,608 postmenopausal women who received estrogen and progestin therapy or a placebo, as well as 10,739 women

who had a hysterectomy and were given estrogen alone or a placebo. This study was supposed to continue until 2005; however, it

was ceased in July 2002 because the NIH’s Data and Safety Monitoring Board found an increased risk of breast cancer, heart attacks, strokes and total blood clots.

This information is especially sobering to me, as it has devastated my family forever. Barbara, my wife, was taking synthetic

hormones when she contracted breast cancer that eventually, at

least in part, took her life. And I firmly believe that her overall

health and quality of life deteriorated because she was taking those

doctor-prescribed hormones. Of course, at the time, we didn’t know

that.

There is an alternative to the mass produced and chemically altered hormones, and these are called biologically identical or natural hormones. Essentially, there are entities known as

compounding pharmacies that are smaller scale operations to pharmaceutical companies that produce medicines more specialized to

accommodate a wide variety of patients, rather than the one size

fits all approach to manufacturing hormones.

These compounding pharmacies are located around the country

and have the capacity to concoct natural, plant-based hormone

medications for use in hormone replacement therapy. Because

these biologically identical hormones are the same chemical struc-
3

ture as the hormones created in the body, the body does not have

the same harmful reactions as it does when the synthetic hormones

are administered.

To better explain the health benefits of naturally occurring hormones, as well as the operation of compounding pharmacies, the

subcommittee will have the pleasure of hearing from Dr. Steven

Hotze, a physician and founder of the Hotze Health and Wellness

Center located in Houston, TX. Dr. Hotze’s practice specializes in

using biologically identical hormones to assist both men and

women correct hormonal imbalances. To gain a better perspective

into the benefits of natural hormones in hormone replacement therapy, Ms. Vicki Reynolds, a patient of Dr. Hotze’s, is here with us

today to share her personal experience.

In addition, the subcommittee will hear testimony from Ms.

Carol Petersen with the Women’s International Pharmacy, to discuss the operations of compounding pharmacies in the United

States.

Dr. David Brownstein is with us as well to discuss the further

benefits of using natural hormonal therapy to combat

hypothyroidism. Dr. Brownstein has written a number of books on

this subject and is considered one of the foremost experts in the

field of holistic medicine. The doctor also serves as the medical director at the Center for Holistic Medicine.

While many physicians believe that administering their patients

hormones, whether synthetic or natural, is a beneficial tool to assist with hormonal transitions, there are some doctors who contend

that scientific literature shows that these tactics are not necessarily the healthiest option for patients. In order to explain this

viewpoint, the subcommittee will hear testimony from Dr. Adriane

Fugh-Berman, an associate professor with the Department of Physiology and Biophysics at Georgetown University. Dr. Fugh-Berman

is internationally known as an expert in the scientific evaluation

of alternative medicine, as well as nationally recognized expert on

the topic of women’s health.

The U.S. Federal Government has produced many studies and

has approved various drugs to assist in hormone replacement therapy. The subcommittee has the distinct pleasure of hearing from

Dr. Barbara Alving, who is married to a Hoosier, is that what you

told me?

Dr. ALVING. No, I’m the Hoosier.

Mr. BURTON. You’re the Hoosier? Where are you from?

Dr. ALVING. Fort Wayne, IN.

Mr. BURTON. That’s right on the edge of my district, so God bless

you, my child. [Laughter.]

Dr. ALVING. My brother lives in Indianapolis.

Mr. BURTON. What part?

Dr. ALVING. The south part.

Mr. BURTON. Oh, well, he may not be able to vote for me, so I’ll

have to pass on him. [Laughter.]

She’s the Acting Director of the National Heart, Lung and Blood

Institute at the Department of HHS, and she will give an overview

of the Department’s activities in regard to this issue.
4

I look forward to hearing from all of you today. And once again,

since we started late, we’ll get started right away with you, Dr.

Alving. We appreciate your being here.

[The prepared statement of Hon. Dan Burton follows:]
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STATEMENT OF BARBARA ALVING, M.D., ACTING DIRECTOR,

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE, NATIONAL

INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Dr. ALVING. Thank you, Mr. Chairman. I’m pleased to appear before this committee in my capacity not only as the Acting Director

of the National Heart, Lung and Blood Institute, but also Director

of the NIH’s Women’s Health Initiative. I have been the Director

of this since 2002. This was after the first paper was released on

the role of Prempro in protection against heart disease. The Women’s Health Initiative, however, has been administered by my institute since 1997.

So I’m first here to tell you what we’ve learned from the WHI,

with regard to hormone therapy, using conjugated equine estrogen,

and second, to comment on alternative therapies that are now receiving attention. The WHI began in 1991 and the purpose was to

really investigate approaches that might be helpful to older women

in preventing common chronic diseases, particularly coronary heart

disease and also to determine if this would increase the risk for

breast cancer, alter the risk for colorectal cancers and have an effect on osteoporosis.

Estrogen replacement was just one such approach. For much of

the 20th century, popular thinking was that restoring the levels of

estrogen which ebb during middle age would enable women to remain forever young. And we’re still trying on that end. Although

estrogen was initially prescribed to alleviate troublesome menopausal symptoms, a number of observational or epidemiologic studies really suggested that women who took estrogen experienced a

lower incidence of chronic diseases, particularly heart disease, and

enjoyed better health overall than women who did not take prolonged hormone therapy. And data from many basic science investigations really provided explanations for how this might occur.

But we really didn’t have actual proof that this was the case. So

in 1991, a very bold woman, Dr. Bernadine Healy, said it’s time to

really initiate a very large scale study. So the Women’s Health Initiative hormone trial was designed to answer these questions. And

remember, this was before the era of statins and other therapies

that have been widely accepted in this current era.

So as you’ve said, the Women’s Health Initiative recruited about

27,000 healthy postmenopausal women of 50 to 79 years of age.

This age group was recruited because this is the age at which one

would begin to see cardiovascular events and other adverse effects.

And these women were divided into one of two groups, depending

on whether or not they had undergone a hysterectomy. Those who

still had a uterus were assigned to take a pill containing estrogen

and progestin. This was 0.625 milligrams of conjugated equine estrogen, plus 2.5 milligrams of medroxyprogesterone acetate, also

known as Prempro, or a placebo. And those who had undergone a

hysterectomy took Premarin, 0.625 milligrams of conjugated equine

estrogen or a placebo.

And you may say, well, why those drugs? Why those doses?

These drugs were the most widely used at this time in the United

States. So it was decided that not all doses and not all different
11

combinations could be studied. So this was the one that was accepted for study.

It’s worth noting that there was a lot of controversy at the beginning of this trial. Many interested parties said the trial should not

be done, it’s obvious that hormone therapy is beneficial, it’s a foregone conclusion. Some even said it was not ethical to do, because

it would take half of the participating women to take placebos and

thereby deny them the positive effect of hormones.

Nonetheless, the arguments in favor of a randomized placebo

controlled clinical trial prevailed, so now as we know, we’ve seen

results. The WHI trial of estrogen plus progestin was halted in

2002, as you have said, Mr. Chairman, after an average followup

of 5.2 years. Compared with women who took a placebo, women

taking the hormones of Prempro or estrogen plus progestin experienced an increased risk of breast cancer and more episodes of heart

attacks, strokes and blood clots. However, they also had lower rates

of colo-rectal cancer and fractures. But it was felt that overall, this

did not merit using this drug as protection against chronic disease.

And furthermore, an ancillary study, that is a study that really

hadn’t been included in the beginning but was sort of added on,

well, which actually was funded by the manufacturer, Wyeth funded this study initially in women 65 years and older who were in

this study were tested for cognitive effects of Prempro. Surprisingly

enough, it was found that in these older women, there was an increased risk of dementia and no really improvement of cognitive

impairment with the taking of Prempro. This too was a very big

surprise because there had been papers suggesting that Prempro

could actually be protective against cognitive impairment.

Subsequently, in the spring of 2004, the estrogen alone trial,

which the DSMB, or Data Safety Modern Board have said should

be continued was halted, because the NIH, on looking over all of

the data and in listening to the DSMB, felt that there was really

no effect on coronary heart disease, that is, there was no benefit

or risk but there was a continued increased risk for stroke. What

was also interesting with the estrogen alone study was that there

did not appear to be any increased risk for breast cancer during the

time of this study. There was, however, an increased risk of deep

venous thrombosis, and there was a reduced risk of hip and other

fractures.

And again, finding from the cognitive study in women taking estrogen alone revealed that really, estrogen did not reduce the incidence of dementia and really did not have any improvement, in fact

had an adverse effect on cognitive function.

So in light of the WHI findings and the findings from the dementia studies, the Food and Drug Administration provided the following update in April 2004. Estrogens and progestins should not be

used to prevent chronic diseases, such as memory loss, heart disease, heart attacks or stroke. Estrogens provide valuable therapy

for many women for menopausal hot flashes. But they do carry

risks. And therefore, menopausal women who are considering using

estrogen or estrogen with progestin should discuss with their physicians the benefits versus risks and for hot flashes and significant

symptoms of vulvar and vaginal atrophy, the products are approved and effective therapies.
12

There are also approved for women whose significant risk of

osteoporosis outweighs the potential adverse effects and if they

cannot other drugs that are approved for postmenopausal

osteoporosis. And then the FDA said, estrogens and progestins

should be used, when they’re used, at the lowest doses for the

shortest duration to reach treatment goals. Although we do not

know at what dose there may be a less risk of serious side effects

and that women indeed are encouraged to talk to their health care

provider regularly about their ongoing treatment.

There’s also in women who take hormone therapy a higher incidence of abnormal mammograms which require medical attention

and really need to be evaluated in greater detail when those abnormalities do occur. Therefore, each woman’s individual medical situation needs to be carefully discussed with her health care provider

to make the best decisions.

Now, for prescription hormone formulations other than those

studied in the WHI, the FDA advises, although other estrogens and

progestins were not studied, it’s important to tell postmenopausal

women who take hormone therapy about the potential risks which

are assumed to be the same for other products, and they have put

these labels on those products.

In the aftermath of the Women’s Health Initiative finding, increased attention has been focused on the use of complementary

and alternative medicine to manage symptoms associated with the

menopausal transition. This includes dietary supplements,

botanicals, which are probably the most commonly used. The National Center for Complementary and Alternative Medicine supports both basic and clinical research on the safety and efficacy of

botanicals such as soy, black cohosh and red clover in alleviating

hot flashes, osteoporosis and cognitive and affective problems.

Other studies are generating laboratory data that are vital to the

understanding of the mechanism of action and characterizing these

botanicals to identify the active ingredients in the botanicals so

that standardized supplements can be prepared. For example, two

ongoing basic studies are looking at the effect of black cohosh extract on human breast tissue and its role as a serotonin modulator

and other research is looking at the effect of soy on breast and

endometrial tissue, as well as on bone. In addition to individual research project grants, the National Center for Complementary and

Alternative Medicine supports several research centers on women’s

health.

The National Institute of Aging is supporting a 4-year randomized control trial to evaluate the efficacy and safety of

phytoestrogen based approaches, such as black cohosh and multibotanical preparations given with and without soy diet counseling

for treating vasomotor symptoms in premenopausal and in postmenopausal women. The toxicity of black cohosh and other herbals

and phytoestrogens is being evaluated by the National Institute of

Environmental Health Sciences as a part of an overall effect to establish the safety of herbal medicines.

The scientific literature on complementary and alternative medicines is equivocal, due to problems of very small trials, short duration of treatment, very large placebo effects and very imprecise

measures for measuring hot flashes. Investigations of the efficacy
13

of soy to treat cognitive changes has produced conflicting results.

Now, the NCCAM, National Center for Complementary and Alternative Medicine, has contracted with the Agency for Health Care

Research and Quality to conduct and review and to assess the literature to provide a clearer idea of what is known about soy.

Clearly, additional research will be needed to provide the safety

and efficacy of the information on the range of these alternative

modalities. And the NIH is working with other institutes all together in this area, as well as with the FDA and the women’s

health component of the Department of Health and Human Services. Also, there are studies on assessing hot flashes, what is the

biology behind the hot flashes and in March 2005, the NCCAM,

National Institute of Aging and other institutes will co-sponsor a

state of the science meeting on the management of menopausal related symptoms.

So women are eagerly awaiting the outcome of Federal efforts to

uncover new approaches to address the menopausal symptoms.

And in discussions with gynecologists, we know that women also

are seeking natural or biologically identical hormone therapies via

entities such as the Women’s Health International Pharmacy. In

addition, the FDA has been very proactive in the approval of additional hormone therapy since the ending of the Women’s Health

Initiative. For example, lower doses of Premarin are now available

as well as Prempro. And most recently, a drug known as

Menotestam has just been approved by the FDA. This is an estrogen patch.

So some of what the FDA has approved is biologically identical

and other components are not. I thought that all of this was very

well laid out on the Web site of the Women’s International Pharmacy.

So I thank you for the opportunity to address you, and I’d be

pleased to answer any questions.

[The prepared statement of Dr. Alving follows:]
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Mr. BURTON. Thank you very much.

I heard you mention there were studies on dementia.

Dr. ALVING. Yes.

Mr. BURTON. Who conducted those studies? Was that the FDA?

Dr. ALVING. No. The investigators in the Women’s Health Initiative conducted those studies.

Mr. BURTON. What company sponsored those studies?

Dr. ALVING. Actually, one of the principal investigators received

funding from Wyeth to do——

Mr. BURTON. OK, that’s all I wanted to know. A pharmaceutical

company. That’s all I wanted to know.

Dr. ALVING. However, they switched the funding after that.

Mr. BURTON. I know. Did you know, Doctor, that they’ve been

putting mercury in vaccines, which is another subject——

Dr. ALVING. Yes.

Mr. BURTON [continuing]. Since 1929. Do you know the FDA has

never tested it, ever? And yet our kids are getting up to 26 vaccinations before they start to school? And they’ve been containing mercury, and we’ve gone from 1 in 10,000 children that were autistic

to 1 in 166? An absolutely epidemic. And the FDA never really

tested it.

What I’d like to know about estrogen is, why did it take so long

to do these tests? They’ve been giving synthetic estrogen for how

many years?

Dr. ALVING. I think they were probably developed, maybe in the

last, about 40, 45 years old.

Mr. BURTON. Did the FDA test those?

Dr. ALVING. In terms of tests such as the Women’s Health Initiative?

Mr. BURTON. Yes.

Dr. ALVING. They did not. And I think really the only——

Mr. BURTON. You don’t need to go into detail. They didn’t do it?

Dr. ALVING. As far as I know, they did not.

Mr. BURTON. And they just conducted a test in 1991?

Dr. ALVING. They started it in 1991.

Mr. BURTON. And the tests showed that the people who had the

estrogen had higher rates of heart disease and what else was it?

Dr. ALVING. Well, if you look at Prempro or estrogen plus progestin, it was a higher rate of heart disease and breast cancer and

stroke, blood count.

Mr. BURTON. This they found after 40 years?

Dr. ALVING. Five years.

Mr. BURTON. But they’ve been using it for 35 or 40 years?

Dr. ALVING. Yes.

Mr. BURTON. What do we pay those people for over there? I’m not

being facetious. I mean, because they’re getting billions and billions

and billions of dollars and they are still putting mercury in almost

every vaccination for adults and we have a tremendous increase in

Alzheimer’s. My grandson got autism after getting nine shots in 1

day, seven of which contained mercury. We’ve got an epidemic in

that. And now we’re finding out that the synthetic estrogen caused

problems probably more than it helped.

Now, you said they’ve gone to lower doses of some of these estrogen products, right? Those are still the synthetics, aren’t they?
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Dr. ALVING. Yes, lower doses have been approved by the FDA.

Mr. BURTON. OK, they’ve been approved. Have they tested those

lower doses?

Dr. ALVING. No.

Mr. BURTON. Oh, my God. Do you mean to tell me they had a

test, then went 5 years, and it showed that people were getting

sicker by using the stuff, and so they went to lower doses? Why?

If it’s causing more problems than it’s solving, why not take it off

the market until they do all the testing? Until they test lower

doses, higher doses, middle doses? It makes no sense.

Do you know why they didn’t? I want to tell you why they didn’t.

I know why. Because the pharmaceutical companies would lose a

lot of money. Just like they would lose a lot of money if they took

mercury out of all the vaccines.

Do you know, and I want you to hear all this, because I want

you to take it back to FDA and HHS. The NIH, I think it was, just

completed a study saying that the mercury in children’s vaccines

and adult vaccines really didn’t cause any problems. One of the

principal studies that they cited was from Denmark. And the company in Denmark that did the study manufactures thimerosal,

which is 50 percent mercury, and they sell it into the United

States.

Would you say they have a conflict of interest? Hell, I would

think so.

Anyhow, the NIH and HHS and the other agencies over there are

too tied to the pharmaceutical industry and it’s going to come up

and bite them in the butt one of these days. It really is. Because

the American people are finding this out.

Now, why in the world they’re going with lower doses of a product that caused women’s problems like high blood pressure, heart

attacks, whatever else you mentioned there, I don’t have it all in

front of me right now, why in the world they would even continue

to do that instead of taking it off the market until it’s properly tested boggles my mind. And the only conclusion you can come to is

the pharmaceutical companies would take a hit. And they don’t

want to do that. They just don’t want to do that.

Can you give me another answer?

Dr. ALVING. Yes.

Mr. BURTON. What’s the other answer? I’d like to hear it.

Dr. ALVING. I think you make some very good points. I think

what women want hormone therapy for most, if you ask any

woman of a certain age in this room, is for hot flashes, for the

symptoms of menopause.

Mr. BURTON. Well, I date some women about your age, and I

want to tell you, they take them for other reasons, too. [Laughter.]

Dr. ALVING. And so, I think that what the, we are unable to really, we’d have to wait another 5, 10 years go get the answer on

these hormones. So what has been asked in the meantime is to

take the lowest dose for the shortest period of time, and the FDA

has put this type of branding and warning on every product,

whether it’s bioidentical or not.

Mr. BURTON. But these are still the synthetic hormones, are they

not?

Dr. ALVING. No, they put the branding also on the bioidenticals.
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Mr. BURTON. Oh. Well, you said that the FDA was evaluating the

safety of herbal medicines now, didn’t you?

Dr. ALVING. I said the NIH, because the FDA has not approved

any herbal medicines. It is not under FDA approval. They do not

regulate them.

Mr. BURTON. Does the FDA have to approve herbals?

Dr. ALVING. No, they don’t.

Mr. BURTON. But they do have to approve the synthetics?

Dr. ALVING. Well, anything that is made by a drug company, yes.

Mr. BURTON. So the synthetics that have been causing all these

health side effects, they have to approve but they never tested until

just recently. And the herbals, I noticed the way you phrased that,

you said that HHS is looking at the safety of the herbal medicines.

Why didn’t they look at the safety of the biologically altered

medicines that they’ve been prescribing for years, doctors have? I

wonder why they didn’t do that earlier?

Dr. ALVING. That would be in the province of the NIH to conduct

the clinical trials. And I think that this was then started in 1991,

and as I’ve told you even then it was considered to be a very brave

undertaking.

Mr. BURTON. In 1991?

Dr. ALVING. Yes.

Mr. BURTON. But the women who didn’t take the hormones, synthetic hormones, did better over all the ones that didn’t?

Dr. ALVING. That’s correct.

Mr. BURTON. Oh, man.

Dr. ALVING. Well, it all depends on what you’re talking about.

Mr. BURTON. Let’s just look at overall health.

Dr. ALVING. Overall, I would say yes, that’s why the trial was

stopped.

Mr. BURTON. Yes, they did a lot better if they didn’t take the

synthetics.

Dr. ALVING. Absolutely. And that’s why the trial was stopped.

Mr. BURTON. And synthetics have been used for 40 some years,

approximately.

Dr. ALVING. Yes.

Mr. BURTON. And they started testing them 10 years ago?

Dr. ALVING. Yes.

Mr. BURTON. And HHS and FDA let that happen. What are we

paying them for over there? I just don’t understand it.

I still can’t understand why they went to lower doses of a product

that was causing all of these health side effects. I just can’t understand it. Do they know? Does HHS and FDA and our health agencies, do they know that the smaller doses won’t produce the same

side effects?

Dr. ALVING. They do not know that.

Mr. BURTON. Then why do they do it?

Dr. ALVING. Because what they’ve also done, what they have

seen is that these side effects occur over a period of time. And

that’s why they have said, in the absence of knowing, we are going

to tell all women about these risks at whatever dose, even though

we don’t know if it’s safer or better, but we’re going to let them

know the risks and we’re going to say, use it the shortest period

of time at the lowest possible dose.
24

Mr. BURTON. You know, in a perfect world, every doctor in the

country, in the world, would know what the HHS and FDA are saying should be done. But they don’t. They don’t read all the circulars

and they don’t see all this stuff. When my wife was dying of cancer,

I talked to doctors about the things that were talked about in medical journals and they didn’t know anything about it. We changed

doctors, but it was too late, she died anyhow.

But it just boggles my mind that you would go on with lower

doses of a substance that’s caused all these problems when you

know that they cause severe side effects and you knew that women

that didn’t even take the stuff did better health-wise, so you go to

lower doses. Then the doctors back at my hometown and elsewhere

are supposed to understand all this when they’ve been out of medical school for 10, 15 years. I just don’t get it.

And I don’t understand why they haven’t done studies on the

herbals right now. Why hasn’t HHS conducted a study on biological

hormones, bioidentical hormones? If they did a study on the synthetics, why didn’t they do it on those?

Dr. ALVING. I think the reason that they chose, as I said, that

dose and that particular drug at that particular time in 1991 was

that is what the majority of American women who were taking hormone therapy were taking.

Mr. BURTON. Well, this is 2004.

Dr. ALVING. Yes, and times have changed.

Mr. BURTON. That was 13 years ago.

Dr. ALVING. I know. Times have changed.

Mr. BURTON. Why haven’t they started testing on these bioidentical hormones that aren’t from pigs and cows and all this other

stuff?

Dr. ALVING. I think if the funding were available——

Mr. BURTON. If the funding—do you know how much money we

give you guys over there? Do you have any idea? We give you billions and billions and billions and every year you want more. And

we’ve got women who are getting sicker than a dog and some probably dying from something that was never tested. And then what

you say after you find out that the stuff that you were putting in

their bodies was causing more problems than if they didn’t take it

at all, you say, oh, we’re going to go back and we’re going to just

cut the doses, instead of saying, why not just get off of it or go on

these bioidentical hormones, or at least study them? And you

haven’t even started to study on them, have you, the bioidentical

hormones?

Dr. ALVING. They have not started any long terms studies in

terms of women’s health as an issue.

Mr. BURTON. Have you started any short term studies?

Dr. ALVING. The bioidenticals that have received FDA approval

have undergone short term studies.

Mr. BURTON. What do they show?

Dr. ALVING. They are looking for efficacy against hot flashes and

any adverse effects that could be picked up on a short term study.

Mr. BURTON. I see. Are they showing any side effects at all like

the long term study that we showed with the synthetics?

Dr. ALVING. Not that I am aware of. And that would be for the

labeling of the FDA.
25

Mr. BURTON. If they did a short term study, why didn’t they decide to go on with a long term study? If the short term study was

beneficial, why not go with a long term study to find out their side

effects?

Dr. ALVING. I think one of the issues is that of cost and duration.

One would have to continue such a study for about 10 years——

Mr. BURTON. Well, if you did it with synthetics and you knew it

didn’t work and it cost a lot of money to do that study, why

wouldn’t you say, OK, we’re going to spend a like amount on the

bioidentical hormones? Why?

Dr. ALVING. May I say why?

Mr. BURTON. Yes, I’d like to know. I think I know why. It’s because the pharmaceutical companies won’t make any money off of

it.

Dr. ALVING. What I would say is that what it appears is that the

reason one would take hormones long term is to prevent chronic

diseases. Most women take hormone therapy for about 5 years or

less. And they take it for menopausal symptoms. Since this study

was started in 1991, newer drugs have come out. For example, we

have other drugs that will protect against osteoporosis.

Mr. BURTON. Are they synthetics?

Dr. ALVING. I’m talking about other drugs against osteoporosis,

the bisphosphonates, for example. We have other drugs for heart

disease, statins.

Mr. BURTON. Have those been tested, the ones that you’re talking

about that just came out?

Dr. ALVING. Well, yes. In terms of risks and benefits, and all of

them have——

Mr. BURTON. No, no, no. Have they had any long term tests with

placebos and all that?

Dr. ALVING. As long term as the FDA requires.

Mr. BURTON. And how long is that?

Dr. ALVING. I think, I am going to say at least 3 to 4 to up to

10 years. I would have to go back and look at that literature to get

the specific literature.

So what I’m trying to say is that there has been a changing of

the landscape in terms of the drug therapies. Some women don’t

even want to take hormone therapy at all——

Mr. BURTON. I wouldn’t either.

Dr. ALVING [continuing]. And don’t have hot flashes.

Mr. BURTON. You say they’ve got these for men. There ain’t no

way, Jose, I’m going to take that stuff. You guys over there are

using human beings as guinea pigs without testing them. You’re a

lovely lady, but this, it really isn’t right. It isn’t right to run a

study after 40 years or 30 years and then find out that the people

who are taking the medicine that the pharmaceutical companies

are producing are doing worse than the ones that aren’t taking it.

Then what you say instead of stopping it is, OK, we’re going to go

to lower doses.

That’s like saying, OK, one bullet won’t kill you, so we’ll cut it

in two and just use half a bullet.

Dr. ALVING. It will half kill you.

Mr. BURTON. Yes, it will half kill you. Let me ask you this. Is

the National Center for Complementary and Alternative Medicine
26

looking at bioidentical hormones as a possible recommendation for

FDA to suggest to women? Are they looking at that right now?

Dr. ALVING. They are not looking at that to my knowledge.

Mr. BURTON. Why? Why?

Dr. ALVING. Because they are centered on the other alternatives

that are undergoing study that I mentioned.

Mr. BURTON. And the other alternatives are?

Dr. ALVING. As I mentioned, black cohosh and the flavonoids,

phytoestrogens, other things such as that.

Mr. BURTON. Are those natural hormones?

Dr. ALVING. They’re natural agents, in that you can buy black

cohosh, it’s extracted. Now, you don’t know what else is in there,

because it’s not regulated by the FDA.

Mr. BURTON. Well, you know what, I really would want the one

that’s approved by the FDA because it would only kill me. [Laughter.]

And I don’t mean to be facetious, but since my grandson became

autistic, I started checking into the things that FDA is putting on

the market and the conflicts of interest that have taken place by

some of the advisory committees over there who have an interest

in pharmaceutical stocks that are making the decisions on this

stuff. There’s too much money and too much complicity between

the pharmaceutical companies and our health agencies.

And if you’ve got a study that shows that women are getting

more heart disease, for instance, from taking these synthetic hormones than a woman who doesn’t take any, that would lead you

to believe they’re better off not taking it. Wouldn’t that lead you

to believe you’re better off not taking it?

Dr. ALVING. But I would make another——

Mr. BURTON. You can answer in just a second. And if that conclusion is accurate, why would you say, OK, we’re going to cut the

dose in half and you just take half the poison? Why?

Dr. ALVING. In the Women’s Health Initiative, the women who

were enrolled in the studies were between 50 and 79 years. The

mean age was 63 years. In fact, it’s been very highly criticized for

that. When you do a study, as you can see, you get criticism from

all sides.

So one of the critics, a big criticism of this, you started this in

women whose mean age is 63 years old. That’s not who has hot

flashes. Well, this was not a hot flash study. Currently, the FDA

guidelines, and I don’t work for the FDA, I work for NIH, are that

these drugs are to be used for treatment of menopausal symptoms.

And about the average age of women having menopausal symptoms

is around 45 to 50. So you’re getting a different age range.

Mr. BURTON. I hear you. I’m going to yield to Ms. Watson, but

let me just say one more thing in conclusion. That is when my wife

got breast cancer, and she took those damned hormones for years,

those synthetics, we found, when we went to buy furniture, went

to buy groceries, an absolute plethora of women who were having

breast cancer problems. It is an epidemic. Women don’t talk about

it to people like me, but they’ll talk about it to another woman

who’s experiencing breast cancer.

And I want you to know, it’s an epidemic. It’s absolutely a sin.

It’s a sin. It’s an absolute sin for our Government to approve things
27

that we’re putting into human bodies, especially women, of age 30,

50, 100 that hasn’t been properly tested. And you say they don’t

have enough money over there. They have enough money. It’s just

where they set their priorities. And if they find out that the synthetic estrogen is causing women to have severe heart trouble and

other problems, and the women who don’t take it are doing much,

much better, then why in the world would they not take it off the

market?

And the reason is the same reason that they haven’t taken mercury out of vaccines. Mercury is one of the most toxic substances

on the face of the Earth. When we had a spill in my district, they

brought in people who looked like they were from outer space, in

uniforms, to clean up a spill of this much. And they evacuated the

neighborhood. And yet we’re putting it into our kids’ bodies, into

your body, if you got a flu shot or a tetanus shot or anything else

right now. And it’s one of the contributing factors, according to scientists around the world, of autism and other neurological diseases,

like Alzheimer’s.

Yet the FDA continues to let it be on the market. And at the

same time, they’re doing the same thing with estrogen, only in

lower doses. And it is absolutely criminal. And that’s being subsidized by me and you and the taxpayers, and nobody’s doing a

doggone thing about it. And it really bothers me.

And you’re a lovely lady, but we’ve got a problem.

Go ahead, Ms. Watson.

Ms. WATSON. I want to thank Mr. Chairman for his passion, his

interest, his concern. And we work together as a team. We both

have an aversion to using these toxic substances in medication

that’s ingested by humans, and so I’ve always looked for a biological, natural kind of alternative.

If you don’t get anything else out of these hearings, Madam Colonel, just know that there is a directive to ask NIH and WHI to

start research that will include the biological identical hormones.

We are finding from casual information coming in that they are far

more healthful and they have a far more beneficial way of treating.

Because they’re done on an individual basis.

Dr. ALVING. Yes.

Ms. WATSON. And not everything works for everyone.

Dr. ALVING. I understand that.

Ms. WATSON. So I wish that you would go back as an emissary

of this approach. The women of the world will thank you, particularly the women here. And I as a woman definitely am going to

push this with my partner here, who, and I don’t have to explain

to you how deeply he feels about this, I think you’ve been hearing

it for quite a few minutes. And we’re going to work as a team to

be sure that we take the toxic substances out of the environment.

My big thing right now is mercury. We’re trying to get mercury

out of dental amalgams and we’re being fought by the dental community. And they say, well, it’s sealed and so on. But you crack a

tooth, vapors come up.

So we have to change the thinking. We have to change the culture. And I hope that now that we’re in a new millennium, the

FDA can follow behind us a little bit in changing the culture. We
28

certainly are going to be working toward that. And thank you, Mr.

Chair. I’m going to zip to the floor.

Mr. BURTON. Well, Doctor, thank you very much. We didn’t mean

to abuse you. But the one thing I try to do when we have witnesses

from HHS and our health agencies, FDA, is to try to impress upon

them the strong feelings that we have in the Congress. And it’s not

just me. We’ve had a number of votes on the floor on reimportation

and other things where the pharmaceutical companies are concerned. And they’ve been surprising in that the representatives of

the people realize what’s going on.

I want to continue to give you guys billions of dollars. I really

do. I think we have the highest quality and standard of life and

health of any country on the face of the Earth, because we have

good health agencies. But they drop the ball too many times. And

they’re allowing the pharmaceutical industry to have too much influence.

I want the pharmaceutical industry to make a lot of money. But

I don’t want them to do it at the expense of people because we

haven’t tested these things properly. And I hope that you’ll look at

these complementary medical procedures, the hormones, the natural hormones we’re talking about, we’re going to have witnesses

testify at the next panel. And incidentally, if you’ve got a minute,

if you can stick around and listen to what they say, or have you

already heard what they have to say?

Dr. ALVING. I’d be happy to stick around.

Mr. BURTON. OK, well, thank you very much for being here.

Well, we have 10 minutes before we conclude our first vote. I

think I probably ought to run over and vote and come back. I really

apologize for the mess we’ve got today. What you’re saying and

doing is going to be recorded and passed onto my colleagues, and

it’s very important. So I hope you’ll bear with me and stick around

for a little bit. We’ll be right back as soon as the votes are taken.

[Recess.]

Mr. BURTON. First of all, I want to apologize once again. It’s been

a long day. But we want to get as much information from this

hearing as possible. So we’re going to be here as long as it takes.

We now have Adriane Fugh-Berman. Would you come to the

table, Dr. Fugh-Berman. And David Brownstein, Dr. Brownstein,

he’s the director of Holistic Medicine. Ms. Carol Petersen, pharmacist with the Women’s International Pharmacy.

Ms. Fugh-Berman is the assistant professor of physiology and

biophysics at Georgetown Medical Center.

Ms. Vicki Reynolds, hormone replacement therapy patient, Houston, TX. And Steven F. Hotze, Dr. Hotze, founder of the Hotze

Health and Wellness Center.

OK, we’re going to start with Dr. Fugh-Berman. Since we have

a pretty large panel, we’d like to get to questions as quickly as possible. So if you can keep your comments to 5 or 6 minutes, we’d

really appreciate it, if it’s possible. Thank you.
29

STATEMENTS OF ADRIANE FUGH-BERMAN, M.D., ASSOCIATE

PROFESSOR, DEPARTMENT OF PHYSIOLOGY AND BIOPHYSICS, GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE; DAVID BROWNSTEIN, M.D., CENTER FOR HOLISTIC

MEDICINE; CAROL PETERSEN, MANAGING PHARMACIST,

WOMEN’S INTERNATIONAL PHARMACY; VICKI REYNOLDS,

OWNER, TEXAS RELIANT AIR-CONDITIONING AND HEATING,

INC.; AND STEVEN F. HOTZE, M.D., HOTZE HEALTH AND

WELLNESS CENTER

Dr. FUGH-BERMAN. Thank you, Mr. Chairman.

I’m here today representing the National Women’s Health Network, which is a consumer advocacy group that takes no money

from drug companies, medical device companies or dietary supplement companies.

Sex hormones, including estrogen and testosterone, do decline

with age. But restoring hormone levels to youthful levels has not

restored youth in anyone. But it’s quite an old concept. It’s actually

more than 100 years old. Animal testicle extracts used to be injected into men, and in the 1920’s there was a briefly popular operation in which slices of animal testicles were actually inserted into

men’s scrota.

So the first promotion of hormones for rejuvenation was first directed toward men. But in the last few decades, most of the emphasis of hormones for sort of achieving youthfulness has really been

aimed at women. And hormones are very useful therapies for many

medical conditions, insulin, for example, for diabetes. Estrogens are

actually very, and different kinds of estrogens are very useful for

treating hot flashes. Hot flashes and vaginal dryness are actually

the only proven benefits of hormone therapy, estrogen therapy at

this point.

But unfortunately, hormones don’t prevent aging, and unfortunately, there is no such thing as a harmless hormone. All hormones, including the hormones that we make within our own bodies, have side effects. And claims that bioidentical, natural or naturally occurring hormones are safer than conventional hormones are

not backed by science. I’m just going to talk about estrogen today,

just for time reasons. The three estrogens that humans make are

estriol, estradiol and estrone. And these are the hormones that are

touted by compounding pharmacies and some alternative physicians as harmless alternatives to conventional therapy.

So people may recommend estriol alone, estriol and estradiol,

which is called Bi-Est sometimes, or all three, which are called TriEst. Sometimes they’re combined with other hormones. Synthesized

versions of these hormones, and they are synthesized, are identical

to human versions. But just because humans make a hormone

doesn’t mean that it’s good for us. High doses of insulin can kill

you. High doses of adrenaline can kill you. High doses of thyroid

can kill you, even if they’re natural. And cortisol, which is an adrenal hormone that is promoted on Dr. Hotze’s site, for example, increases the risk of osteoporosis, increases glucose levels and causes

immune suppression. It is, however, a mood elevator, so probably

people feel good as they’re developing osteoporosis and diabetes.

[Laughter.]
30

I’ve said that even the hormones that we make within our bodies

are not harmless. There are many studies that show that women

who have naturally higher levels of estrone, estradiol, and estriol,

actually of estradiol and estrone in their bodies, are at higher risk

of breast cancer than women who have naturally lower levels of

these hormones. A meta-analysis, for example, that was published

in the Journal of the National Cancer Institute in 2002 analyzed

nine studies on the subject and found that levels of estradiol,

estrone, testosterone, DHEA and other sex hormones were strongly

associated with breast cancer risk in postmenopausal women. So

postmenopausal women who had higher naturally occurring levels

of these natural hormones had higher breast cancer risk.

And more recent studies that have been done in 2003, 2004, have

also backed this up. Higher levels of testosterone are also associated with higher breast cancer risk in women.

Natural hormone proponents believe that estriol decreases breast

cancer risk. And in contrast to other estrogens, does not increase

uterine cancer risk. This belief is based on publications, every single one of them more than 30 years old and all of them written by

one guy, Henry Lemon. Lemon theorized that estriol could be a

useful treatment in preventing and treating breast cancer. There’s

only one commentary by a guy named Fallingstad that isn’t written

by Lemon, and it quotes an unpublished study by Lemon that says

that Lemon successfully treated some cases of breast cancer with

estriol.

Even Henry Lemon never claimed that. Henry Lemon never published a clinical study of estriol. There is some evidence, he did

have some evidence from cell cultures, high doses of estriol in

breast cancer cells in culture will decrease the growth of cells. But

this is true of every estrogen. Low doses stimulate growth, high

doses decrease growth. In fact, estrogen used to be used as a treatment, high doses of estrogen. So that’s true of any estrogen, it does

not evidence.

Henry Lemon never published a clinical study. He did, however,

publish a review on estriol in 1980 in which he describes giving estriol to 24 women. Six of them had their metastases grow. That’s

one quarter of the treated population. So this experiment can hardly be considered a success in breast cancer treatment. Two women

also developed endometrial hyperplasia, a precancerous condition

to endometrial cancer. We know that estrogen causes endometrial

or uterine cancer. And 2 out of 24 subjects in this study did develop

the precursor to uterine cancer.

In the review that the author wrote, he still seems to be enthusiastic about estriol. I have no idea why. But I think it’s really

frightening that there are still people today who think that his theory holds any water.

We actually have information on estriol. Estriol is a perfectly decent treatment for hot flashes. And it’s used in Europe, it’s a very

commonly used hormone therapy in Europe. It’s been used for decades in England and Sweden and other countries. It’s a conventional treatment, sold by conventional drug companies. And in conventional medicine in Europe, it was thought that you didn’t have

to use it with a progestin to protect the uterus because it’s such

as weak estrogen.
31

So there were many women who received estriol alone because

it was thought it was too weak to cause estrogen induced uterine

cancer. That turned out that to be wrong. We now know that estriol is associated with endometrial hyperplasia and endometrial

cancer. Women who have ever used estriol, this is a Swedish study,

had twice the risk of endometrial cancer as women who never used

estriol, and 5 years worth of use of oral estriol tripled the risk. The

use of vaginal estriol did not seem to be associated with an increased risk.

So this is less of a risk than with stronger estrogens, but it still

caused cancer in women. So nowadays, estriol is used with a progestin in the same way that other estrogens are.

In terms of cardiovascular risk——

Mr. BURTON. Excuse me, Doctor, if you could summarize. I want

to make sure we get to the questions. We have six people, five people on the panel.

Dr. FUGH-BERMAN. OK. Then I won’t cover the data on cardiovascular risk.

There is no reason to think that the estrogens promoted by

compounding pharmacies protect against heart disease or stroke

because estradiol has actually been tested in trials. There has been

a randomized placebo controlled trial of estradiol and natural bioidentical hormone in 664 women after a stroke, and it did not protect against stroke. There is also another trial, the Esprit trial, in

more than 1,000 women with a previous heart attack, estradiol did

not protect against heart attack or death.

So it’s not true that only conjugated estrogens have been tested

in randomized controlled trials. So has estradiol.

So compounding pharmacies are uniquely unregulated, at least

with commercially available pharmaceuticals of the quality of the

preparations is regulated, that’s not true of those in compounding

pharmacies.

And I’ll just conclude by saying that human studies, and they

have all the references, show that naturally high levels of estrone

and estradiol are associated with breast cancer risks. Estriol pills

increase uterine cancer risk and estradiol does not protect against

heart disease or stroke.

And I just wanted to add one thing, Mr. Chairman. I’m very

sorry about your wife, and I agree with you that pharmaceutical

estrogens were really over-promoted inappropriately for really dozens of years for things that they shouldn’t have been used for. And

that they do contribute to increased breast cancer. But the estrogens that are promoted by compounding pharmacies are also very

likely to increase the risk of breast cancer in other women. Thank

you.

[The prepared statement of Dr. Fugh-Berman follows:]
32
33
34
35
36
37
38

Mr. BURTON. Before we go to the next witness, who did you say

sponsors your foundation?

Dr. FUGH-BERMAN. I don’t have a foundation. I’m an associate

professor of physiology at Georgetown University School of Medicine.

Mr. BURTON. Does Georgetown get any grants from NIH?

Dr. FUGH-BERMAN. Does Georgetown get any grants from NIH?

I’m sure there are researchers there who do. I do not.

Mr. BURTON. Do you get any benefit from any of the pharmaceutical companies or any of that?

Dr. FUGH-BERMAN. No. And if you’re talking about my consumer

advocacy, the consumer advocacy group that I represent, the National Women’s Health Network, we also do not get any NIH funding.

Mr. BURTON. Where do you get your funding?

Dr. FUGH-BERMAN. Twenty-five dollar a year membership and

some foundation support.

Mr. BURTON. What foundations?

Dr. FUGH-BERMAN. Private foundations not associated with any

drug companies.

Mr. BURTON. Where do the foundations get their money?

Dr. FUGH-BERMAN. From their investment portfolios, I assume.

Mr. BURTON. Could you for the record give me a list of the people

that contribute to the foundation? I’d like to see where the money

comes from.

Dr. FUGH-BERMAN. I can give you a list of the foundation funders

of the organization.

Mr. BURTON. That would be helpful. Thank you.

Dr. Brownstein.

Dr. BROWNSTEIN. Chairman Burton, I’m honored to be speaking

to you, and I bring you greetings from the Wolverine State.

Mr. BURTON. Just north.

Dr. BROWNSTEIN. Many of us involved in holistic medicine have

gotten into it because of an ill family member or an illness themselves. And I got involved in it just as your interest seems to have

been peaked in it from ill family members because my father was

very ill with heart disease.

I had wanted to be a doctor since I was a little child. And I was

conventionally trained in medical school, began a conventional

practice, was not interested in anything alternative or holistic. I

used to tell my patients, don’t do the alternative therapies, because

I thought they were worthless, even though I didn’t know much

about that. And I would make derisive comments to them. I remember telling my mother-in-law, don’t take your vitamins, because I thought she was wasting her money, which she never fails

to remind me of today.

However, all through medical school and post-medical school and

residence, my father was very ill with heart disease. He had his

first heart attack at 40, his second heart attack a few years later.

He had bypass surgeries in the midst of a number of years. He had

a couple of angioplasties. He had continual angina for 25 years,

cholesterol that was uncontrolled in the 300’s or 400’s on cholesterol lowering medications. He was seeing the best doctors from the

University of Michigan and wasn’t getting any better.
39

And I finished my residency, I’m in a busy conventional practice.

And a patient sees me and gives me a book, Healing with Nutrition

by Dr. Jonathan Wright. I took that book home, wasn’t much interested in it, but I flipped to the section on cardiovascular disease,

since my father was dying before my eyes. He did not have long

to live at that point. And Dr. Wright talked about how he used natural hormones to treat heart disease.

When I started pulling the literature on natural hormones and

heart disease, there was a plethora of literature on testosterone

and heart diseases dating back to the early 1900’s, most of it out

of Europe. And I became very interested in that, and I checked my

father and his testosterone level and DHEA level and estrogen levels, and ended up putting my father on three or four natural hormones, natural testosterone, DHEA, natural progesterone and

pregnenolone.

Within a matter of a week of putting him on these four hormones, a 25 year history of angina resolved, never to return. His

cholesterol, which was stuck in the mid 300’s, went below 200, off

cholesterol lowering medication. He lost weight, he had a pale, sick

looking face that now turned pink. His friends and my mothers

friends were asking what’s going on with him, he’s looking so much

better. He was able to walk around without popping nitro pills all

day. Once this conventional physician saw the changes in my father with using natural hormones, I decided that’s what I wanted

to do in medicine.

Since that point about 12 years ago, I have been researching and

utilizing natural hormones. And though I agree with Dr. Fugh-Berman that there are a lot of problems with estrogens in the environment, I think most of us men and women are over-estrogenized.

The problem isn’t so much estrogen deficiency, it’s a hormonal imbalance, in part exacerbated by estrogen excess. And the use of

conventional hormones exacerbates that and causes problems, like

stroke, heart disease, heart attacks, just as was found in the Women’s Health Initiative.

What I’ve found is that an imbalanced hormonal system leads to

chronic illness, such as auto-immune disorders, lupus, MS,

Hashimoto’s, Grave’s Diseases, the list can go on and on. It leads

to cancer, breast cancer, uterine cancer, ovarian cancer, thyroid

cancer, headaches, heart disease, the list goes on and on.

And when somebody can get their hormonal system rebalanced

natural hormones, these conditions get markedly better. I see it

every day in my practice. Those of us that have used natural hormones see the results in our patients and these items need to be

studied and they need to be kept available for patients. As a physician, I want to be able to prescribe natural hormones when they

are indicated. We need the help of compounding pharmacists to utilize these items.

My experience has been that most people with chronic disorders

have severely deficient levels of hormones when I check them, including DHEA and pregnenolone and thyroid and testosterone,

with elevated estrogen levels present.

I’d like to just close by just explaining to you what a normal hormone is. And I’ve got it in my handout, I wanted to do a Power
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Point presentation, but I was told I wasn’t able to do it, although

I would have my own projector.

Mr. BURTON. If we had the other committee room. But we had

a big hearing there on scandal in Iraq. So we had to pass on that.

Dr. BROWNSTEIN. Well, you don’t even have to look at that handout. Let me just explain to you in my mind what a natural hormone is. The hormones work in our body in a lock and key model.

Just as you go out to your car door to start your car, your key fits

in your car door fine. If I put my key in your car door, it’s not going

to fit quite right.

A natural hormone has the same structure as our own hormones.

So it’s like the key that goes to find its lock. And there are hormone receptors in our bones, our hearts, our brain, our lungs. So

when this key or this hormone goes to find its receptor, it’s like a

perfect fit. It’s like a perfect puzzle fit.

When you use a synthetic hormone that’s been altered, this puzzle piece doesn’t fit quite right. It’s been altered. And that’s what

I had for the slides to show you, just the difference between the

two. But this difference in this puzzle piece not fitting quite right

is what leads to the adverse effects of synthetic hormones. And you

just, as a practicing physician, you just don’t see the adverse effects

with the natural hormones that you do with the synthetic hormones. It doesn’t make sense to me to use something that doesn’t

fit quite right in the body, when there is something available that

has a perfect fit.

[The prepared statement of Dr. Brownstein follows:]
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Mr. BURTON. I want to talk to you after the hearing.

Dr. BROWNSTEIN. And I have some books for you that I’d like to

give you.

Mr. BURTON. Well, don’t give me too much to read. I have in my

office 9 million books. And although I read fairly fast, I ain’t going

to get through them all. But I would like to talk to you about that.

Ms. Petersen.

Ms. PETERSEN. Thank you, Chairman Burton. It’s a pleasure to

be here.

I am one of the compounding pharmacists. I can speak for thousands and thousands of patients and thousands of practitioners

throughout the United States. We have a quiet revolution going on

here in health care. People are no longer accepting substandard

care, and they’re finding alternatives and alternative practitioners

such as Dr. Brownstein and Dr. Hotze. It makes a huge difference

in their lives.

I’ve been involved in this business since 1993, and professionally

and personally it’s been the most rewarding business of my whole

life. People often ask us, where do these hormones come from,

when we talk about natural or bioidentical hormones. Because they

are identical to human, conceivably you could think, well, maybe

we squeeze these out of humans, and certainly it could be done. In

France for the longest time their source of progesterone was human

placenta, and they extracted it from there.

But it’s made semi-synthetically. Many plants have a compound

in their body made from cholesterol that is very, it’s in their body

and it’s similar to cholesterol in the human body. This is the basis

for all the steroidal hormones, like estrogen, progesterone, testosterone, DHEA, cholesterol is. From this plant nucleus that is similar to cholesterol, they can make in the laboratory any of the hormones that you would wish to have. You can make them chemically

identical to human, you can alter them and get a patent. For example, birth controls are 100 percent synthetic, but also made from

this beginning plant material.

So the big difference is what it does in your body, just as Dr.

Brownstein had said. I’d like to say that the FDA has the ability

to authorize drugs in this country. And I believe that they should

have full power to do so when anybody wishes to introduce into the

general population something that is a brand new chemical. Lord

knows we have plenty of those. And I think they don’t regulate

them as well as they should in many cases.

We don’t reward manufacturers very well, there are some ways

around it, for instance the estrogen patches. The companies have

to obtain a patent on the patch, not the hormone. I think if our

medical industry took a positive stance and looked for ways to be

using these hormones in a positive way, and some of them are,

we’d end up much better.

The other really interesting thing about using bioidentical hormones is I think reflected in some papers that were written by a

professor at the University of Washington. He wrote several papers

on N–1 studies. He believes that our current gold standard of double blind placebo crossover studies are a farce. You and I are not

biochemically identical, you and I aren’t biochemically identical. If

you participate in a study, no matter how large, whatever you
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glean from there does not apply to me as an individual. It never

can. I am biochemically unique.

So with N–1 studies, a certain protocol is embarked on with a

patient for a particular issue and it’s done for a while, a washout

period maybe, another trial tried, until you find what works best.

And I submit that compounded bioidentical hormones made for the

individual and done in a clinical practice satisfies this N–1 study.

That’s probably the only real scientific, true scientific method for

each individual.

Bioidentical hormones are very easy to track. You can test, as

Dr. Brownstein has mentioned, you can test in saliva, urine, blood.

It doesn’t take a rocket scientist to figure out if something is lower

than normal. I’m not talking about higher than normal, lower than

normal. And you have symptoms of those hormones being lower

than normal. And you take those hormones and you put it back in

that patient, you can recheck clinically, you can recheck blood saliva and urine, it’s all available now. And you can make a big difference for that particular person’s life. And I have heard it over

and over and over again, thank you for giving me back my life,

thank you for giving me back my brain, thank you for giving me

back my wife. And money can’t buy what that kind of practice is.

[The prepared statement of Ms. Petersen follows:]
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Mr. BURTON. I have some questions for you when we get to how

you determine what the level should be in each individual.

Ms. Reynolds.

Ms. REYNOLDS. I’m also very honored to be here, and I want to

thank you for your time, because I know your time is important

now.

Mr. BURTON. That’s fine. No more votes for another hour or so.

Ms. REYNOLDS. After 40 years, 40 plus years of frustration, exasperation and desperation, I finally had what I considered at least

now a quality of life, because of prescribed all natural hormone replacement therapy. And my saga began at age 13, and I know that

I speak for many women in America and many of my friends who

have suffered the same symptoms and the same things that I have

suffered. As a teenager, it began with excessive pain, excessive

bleeding that would last sometimes a solid week, extreme pain and

nausea and missing school.

This continued throughout my teen years. This continued on up

into my 20’s. And after I married, I don’t know if some of the symptoms disappeared, or maybe you just get so busy that maybe you

put some of those symptoms behind you. But these continued, these

same symptoms continued. I went for my year examinations as I

thought I was supposed to. I would explain each time, and I would

go through these symptoms. And either I got a shake of the head

or I got, well, some women are just that way. I thought, well, OK,

so some women are just that way.

OK, so you go to another doctor and you explain your symptoms

and finally in your 30’s, you tell them, you know, I think I’m losing

some of my hair. I only have half my eyebrows. Do you think possibly maybe I have a problem? And they prescribe things for you

that then cause you to have other things that they then have to

prescribe something else on top of that to counteract what they

have already prescribed for you, which causes you to have other

problems, such as dizziness, nausea and breaking out in rashes.

So then you decide, well, you know, I believe I could live with

what I was presently having rather than go into a whole new

realm of concerns for which I’m sure there would not be an answer.

So I thought, OK, I think I look forward to menopause, because I

bet all this will be behind me.

Well, of course, that’s not the case. Once you hit menopause, you

have those symptoms you’ve carried over from teenage years and

your married life, and you’ve just about killed everyone in your

family. So then you get to move into menopause with a whole new

set of symptoms, of fatigue, of dizziness, of nausea, of high fevers

and you still are not given answers to your problems, except that,

well, you know you are getting older. Well, yes, I know that I’m

getting older. But when I was here when I was 30, it was because

some women are just that way. Now suddenly it’s because I’m just

getting older is why I’m having these symptoms.

So after being prescribed about six synthetic medications, which

each one gave me a new symptom with which I had to deal, and

of course, you don’t know what to do except go back to your doctor,

who then gives you another prescription drug in order to treat the

new problem you’ve just acquired.
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Well, when I went through a series of all of these where I had

other symptoms with which they were now going to give me other

prescription medications to treat those new symptoms, on the last

prescription drug I was given, which was the patch, which caused

a whole realm of new things that we could be all day into the next

vote on this one, so I’ll just tell you that I had several symptoms

to deal with at that point. And the last climactic symptom I had

was severe migraine headaches that lasted 3 days. And so when I

called the doctor, and I noticed that one of the side effects listed

other than the fact that I could die of a heart attack was also one

of the side effects, and that I could have dizzy spells. But in case

I had severe migraine headaches, do notify your physician.

I notified my physician. And my physician called me in a prescription for the severe migraine headache, without saying, oh, by

the way, why don’t you come in to see me. When I hung up the

phone and I realized he was just going to call me in a prescription

for something to cover that new symptom, I called him back and

I said, you don’t want to see me, you don’t want to know why I’m

having this headache? I believe there must be a reason. He said,

no, I don’t need to see you, I have called you in a prescription.

I said, and what is this prescription? And when he told me the

name of it, he said, it’s the newest thing on the market for treating

severe migraine headaches. I said, oh, wonderful, could you give me

the name of some patients for whom you’ve given this to that I

might talk to them about what now this might do to me? And he

said, no, because it’s so new I haven’t prescribed anyone this medication yet. I said, thank you so much. Since you don’t need to see

me, I don’t need to see you again either.

At that point, I found a magazine article that talked about Dr.

Hotze’s wellness center that treated with all natural medications.

I ended up there, and I ended up getting on all natural hormone

therapies, which I have yet to have a symptom that I have to take

something else for.

And I am well. I have energy, which we have more than just

night sweats when we go into menopause, ladies and gentlemen.

We have all kinds of things happen to us. And all of those things

are gone. I have energy. I feel good. I lost the 20 pounds that I

gained during all this 40 plus years of battling with this. And I am

at least alive. My family can tolerate me. I don’t feel the need to

strangle people at any moment, in some cases. And I have a quality

of life.

And I hope that this option is never taken from me.

[The prepared statement of Ms. Reynolds follows:]
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Mr. BURTON. Thank you for that story. It’s very, very interesting.

Do men get night sweats, too? [Laughter.]

Ms. REYNOLDS. They’re contagious. [Laughter.]

Mr. BURTON. Dr. Hotze.

Dr. HOTZE. There is a solution for women in mid-life who experience a host of health problems related to hormonal decline and hormonal imbalances. The solution is natural, biologically identical

hormones. They are safe, they are natural and they are effective.

As Vicki so articulately presented her history of problems that

she had, in our Health and Wellness Center in Houston, I have

seen thousands of women, we see 1,500 new guests every year, we

call our patients guests, they’re not patients, they’re guests. We

elevate treatment, we think doctors ought to treat their customers

as nicely as other businesses do. So we take care of our guests

when they come in.

And 35 percent fly in from across the country. They have sought

help in their local areas, New York, Los Angeles, and they can’t

find physicians that will help them overcome their problems. And

their problems can be as simple as breast tenderness, mood swings,

fluid retention, weight gain and headaches that may happen

premenstrually, irregular menstrual periods, breakthrough bleeding, depressed moods, premenstrual and irritable moods.

Eventually, as Vicki mentions, as they move through their menstrual life, their hormones begin to decline, particularly progesterone. And what do they get? They get loss of energy, they get weight

gain, they begin to lose their hair. Their eyebrows start to fall out,

their hands are cold, they shiver, they can’t think clearly, they’re

irritable, they’re depressed, they’re anxious, they get panic attacks,

they go to bed, they can’t sleep. They channel surf all night long.

We channel surf during the day, they gripe at us. But at night,

they channel surf all night long because they can’t get to sleep.

They wake up tired, they go to bed tired and they wake up tired.

And they often have to slug it out all week at work so they can

get home on Saturday so they can go to bed for 2 days so they can

make it through the next week.

They visit their physician and their physician runs a blood test

and says, everything is normal. And they go, I’m not normal. Well,

you’re not normal, but I think there might be a problem. You need

a little antidepressant. And they’ll put them on Prozac and Effexor

and Zoloft and a whole host of them and completely ruin their

lives. If they didn’t have libido before they start, though, they won’t

have any libido after that. If they used to say, well, I don’t think

about sex, now they say, I don’t even care that I don’t think about

it any more when they get on these drugs.

Then they get headaches, so they put them on the headache

medication and they put them on sleep medication and anti-inflammatory medication and before you know it, these women, their personalities have been completely changed, and then they may try

the birth control pills or the counterfeit hormones, which cause a

host of problems, as Dr. Alving so clearly told us. The Women’s

Health Initiative clearly told us what has been in the literature for

over 14 years. Since 1989 there have been five major studies that

showed that the counterfeit hormones are dangerous, they cause

tremendous side effects.
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And any physician that listens to a woman, the woman will tell

you, Doctor, these make me feel bad. And I say, if they make you

feel bad, don’t take them. That’s the best sign in the world is how

you’re feeling. If your energy level is gone, you gain weight, you

don’t think clearly, get off the stuff. My dad used to tell me, and

he wasn’t a doctor, beware of doctors, they will poison you to death

with their drugs. And do you know that the leading cause of death

in America is not cancer, it’s not heart diseases, if you look at the

facts, it’s iatoragenic illness, drug-induced illness from the drugs

that doctors give patients. It’s the leading cause of death. You’ll

find it’s the third leading cause, but if you do the statistics, it’s the

leading cause of death.

The drugs that the FDA approves kill Americans every day,

100,000 in the hospital every year. And these are drugs that are

given and prescribed by doctors and given in appropriate doses in

the hospital and it kills them. My suggestion is, well, why do people get sick to begin with? Well, they get sick because their hormones decline. Just like a diabetic young person may get diabetes

when their insulin declines. We would never withhold insulin, we

replenish insulin.

When your hormones, Congressman and Congresswoman and

staff members, begin to decline, you’re going to begin to feel the

symptoms of the aging process. Yes, it’s natural. Yes, it’s common.

But it’s not healthy. That’s when you’re going to get heart disease,

that’s when you’re going to get diabetes, that’s when you’re going

to get cancer, you’re going to get arthritis.

What can you do to prevent that? You’re not going to prevent

death, but you can sure improve the quality of life by simply replenishing, in your body, replenishing in your body the same hormones that your body used to make in adequate amounts when you

were younger. Keep them at a normal level.

And for gosh sakes, do not take the drugs that the drug companies are putting out. Because they will kill you, and the women’s

health study has said that, I’ve been saying that for 10 years. And

I was out on the extreme when I said that 10 or 15 years ago on

my radio programs and all over town. Well, Dr. Hotze’s a little out

on a limb, he’s saying these drugs are bad for you.

Well, guess what? Now that it turns out I was right, did they say

Dr. Hotze was right? No, they went, well, we don’t want to bioidentical, let’s just put them on some other drugs. So we’re going to go

on Premarin light. You’ve heard of Miller and Miller Lite. Dr.

Alving told us that now they have offered Prempro light. We’ll kill

you slower, not as fast as we would have. You’ll get cancer, it will

take you twice as long to get cancer. Then if that doesn’t work,

we’ll just put you on drugs and drug you up.

So ladies, if you start acting a little bit weird, and you don’t feel

good and your doctor, most likely it’s going to be a man, and the

way men look at women, he’s going to look at you and say, I just

think you’re a hypochondriac. But he’s not going to say that. He’ll

go, I think you might have a little problem with depression. Ninety

percent of the women between 35 and 55, 90 percent of the

antidepressants that are prescribed are prescribed to women. Why

do doctors give women all the antidepressants? Why don’t the men

get the antidepressants?
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As to studies, there is a plethora of studies, and I would be glad

to forward these to the doctor at the end of the table, who is an

academician at a medical school and frankly, with all due respect,

should be ashamed that she hasn’t read this plethora of literature.

I’ll be glad, I’m the president of the American Academy for Biologically Identical Hormone Therapy. Dr. Fugh-Berman, I will be

glad to forward you catalogs of all this information that you can

read and make up your own decision. I’ll be glad to send you that.

And I will send you that as soon as we get back to Houston. Then

you can comment on it after that.

In 1981, the Johns Hopkins Public School of Health did a study

published in the American Journal of Epidemiology, a 20 year

study. It showed that there was one chemical in a woman, when

she lost the chemical, she had a 555 percent increase of breast cancer and a 1,000 percent increase of death of all kinds from cancer.

And wouldn’t it be nice if you knew what that particular molecule

was? The Johns Hopkins School of Public Health determined when

it was missing, that women had a 555 percent increase of breast

cancer. Dr. Berman, do you know what that was, have you read the

article?

Dr. FUGH-BERMAN. Perhaps if you had included a reference in

your testimony, that would have been helpful.

Dr. HOTZE. I did.

Dr. FUGH-BERMAN. It’s also a epidemiological study, not a randomized control trial, and I am extremely familiar with hormones.

Mr. BURTON. I don’t want to lose control of the hearing. [Laughter.]

Dr. HOTZE. Anyway, the hormone was progesterone. So the dramatic increase in risk factor for women getting cancer is the decline in their progesterone levels and progesterone is a naturally

occurring hormone that women have and every cell in their body

requires it.

Finally, there is a solution for women’s health problems in midlife and thereafter. When should a woman start taking bioidentical

hormone replacement therapy? As soon as she starts having symptoms, which can happen, in the case of somebody like Vicki, at 13.

She may need just a little bit of progesterone.

But this is the solution, and this is safe and it’s effective. We

have treated thousands of women. I have done numerous clinical

studies and presented them at medical conferences. We are now

training doctors, OB-GYNs in Houston, TX. We are leading a

wellness revolution that will change the way mainstream medicine,

and the way men and women in America area treated in mid-life

through the use of biologically identical hormones.

And we thank you, Congressman Burton and you, Congresswoman Watson, for your interest in alternative, safe, effective alternatives for health problems. And this would save the country

billions of dollars. The last thing that people need when they’re

older is all these drugs they drug them up with. Why do you think

sitting in a nursing home they drool and they can’t talk to you and
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you go, Mama’s losing her mind? They’ve got her drugged up on

anti-anxiety, anti-depressants and sleep medications. Get her off

the drugs, get her out of there, she’s liable to be normal again. I’ve

seen this happen.

[The prepared statement of Dr. Hotze follows:]
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Mr. BURTON. Thank you, Doctor.

Dr. HOTZE. Thank you, sir.

Mr. BURTON. The one thing I wish you could help me with is, I’m

a little bit older now and I’ve never understood women. And if you

could find some way to give me some kind of a hormone replacement that would make me understand women. [Laughter.]

Dr. Brownstein, Dr. Fugh-Berman, I will have some questions for

you in a minute. But I have to tell you, after listening to your testimony, it sounds remarkably similar to testimony we’ve had from

people who represent the pharmaceutical companies who have been

before me over 4 years. And that’s why, and I don’t mean to impute

your integrity at all, but that’s why I asked you where your funding was coming from and what the foundation funding sources

were.

Dr. FUGH-BERMAN. Could I respond?

Mr. BURTON. Sure.

Dr. FUGH-BERMAN. I’m really flattered to be accused of that, or

even——

Mr. BURTON. You’re not accused.

Dr. FUGH-BERMAN. No, no, but I am really flattered, because actually I do a lot of work against pharmaceutical companies. And

the National Women’s Health Network does as well. Pharmaceutical companies shudder when we come into FDA advisory committee rooms. So yes, it’s a novel position to be in.

But I just also wanted to say that actually, I have practiced alternative medicine for many years. I was medical director of two

clinics in Washington, and I currently teach in the only masters degree granting program in alternative medicine in the United States

at Georgetown, which we just started last year. So I’m normally

seen as a sort of nuts and granola, herbs and dietary supplement

person. So this is a very interesting position for me to be in.

Mr. BURTON. OK. Dr. Brownstein and Dr. Hotze, what I’d like to

know is, where is your practice, Dr. Brownstein?

Dr. BROWNSTEIN. Outside of Detroit.

Mr. BURTON. You’re outside of Detroit. Do you have people come

in, like Dr. Hotze, that stay for a while and you do a battery of

tests on them and then you decide what hormone replacement therapy, natural hormone replacement therapy they should take?

Dr. BROWNSTEIN. We have people come in from all over the country and out of the country. We check levels before we institute any

hormonal therapy, pre and post. And we follow our patients closely.

Mr. BURTON. I was looking at your chart here. In the chart there

was a picture who looked like she was severely overweight. And

then it shows another picture right after that. Is that the same

lady?

Dr. BROWNSTEIN. That’s the same lady with 6 months of treatment with natural hormones.

Mr. BURTON. Six months? How much weight did she lose?

Dr. BROWNSTEIN. About 75 pounds.

Mr. BURTON. Was this without weight control?

Dr. BROWNSTEIN. She was a lady around 40 years old, had a

baby and fell apart during the pregnancy. And she had normal

blood tests for thyroid levels. When I put her on a small amount
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of thyroid hormone plus a few natural hormones that were imbalanced, her health recovered.

Mr. BURTON. And she lost weight?

Dr. BROWNSTEIN. She lost that weight.

Mr. BURTON. Without any dietary weight loss substances?

Dr. BROWNSTEIN. Took no dietary substances.

Dr. FUGH-BERMAN. Thyroid will make anyone lose weight.

Mr. BURTON. Yes. Thank you, Dr. Berman.

[Simultaneous conversations.]

Dr. HOTZE. That’s not correct.

[Simultaneous conversations.]

Dr. BROWNSTEIN. That’s not correct.

Mr. BURTON. In any event——

Dr. HOTZE. That’s the difference between a clinician and an academician.

Mr. BURTON. Well, I don’t want to get into a fight here. I’m glad

you’re sitting at opposite ends of the table. [Laughter.]

But what I’d like to——

Dr. HOTZE. Well, we’ll juice it up a little bit, because we heard

your hearings get pretty good.

Mr. BURTON. Well, I’ve never been known to back way from a

fight. [Laughter.]

But in any event, what I’d like to know is, you’ve spoken in generalities. She mentioned studies, clinical studies, that sort of thing.

Do you have any clinical studies or anything that we could—and

I don’t want you to give me this much——

Dr. HOTZE. Yes, sir, I do, and we will send you those. I have clinical studies from my office, and I will send you the clinical studies

also that I promised you.

Mr. BURTON. Has the FDA or HHS ever taken issue with you,

come into your office and——

Dr. HOTZE. No. And they can’t, because FDA has no authority

over the practice of medicine. That’s all governed by the State

Board of Medical Examiners.

Mr. BURTON. How about HHS or any of the health agencies?

Dr. HOTZE. They have no authority over——

Mr. BURTON. Have any of the State health agencies given you a

hard time?

Dr. HOTZE. No.

Mr. BURTON. The reason I ask is because, some people who practice alternative modalities of medicine have had problems with various Government agencies. And they literally put some of them out

of business.

Dr. HOTZE. True, they do. Unfortunately, they pick on the little

ones that aren’t strong. They will pick on people that will back

down. But they don’t pick on us.

Mr. BURTON. Got that. Ms. Petersen, how do you determine

through your pharmacy, how do you determine what substances

people need to take, hormone replacement, that will help make

them better?

Ms. PETERSEN. Actually, we don’t. The practitioners do.

Mr. BURTON. So you work with people like Dr. Brownstein and

Dr. Hotze?
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Ms. PETERSEN. That’s quite right. And as both doctors referred

to, there’s really a plethora of information out there. There’s very

much a lot of basic research in the fields of endocrinology, physiology and even medicine that identify what symptoms are related to

what hormone. We know that from those basic studies. And then

we also have quite a bit of literature on when you use a particular

hormone, how much it takes to get to normal blood levels. So there

are ranges of these hormones that are used.

And within that paradigm, knowing what clinical response you

expect to get, and what the usual dose ranges are and what blood

levels or saliva levels or urine levels you can anticipate improving,

with all those tools, the clinician is very straightforward, very scientific to determine what people need.

Mr. BURTON. So what you do, Dr. Brownstein, Dr. Hotze, is that

you take blood tests, saliva tests, urine tests, and you analyze

those and you decide from those tests whether or not there’s a deficiency of certain hormones?

Dr. HOTZE. First, everyone in this room, as you age, your hormones are going to decline. There are scientific studies on that.

And women know that.

So the first thing we do, I do, I’m a clinician, the first thing we

do is take a copious 26 page history. The history tells you everything. If you understand how the hormones work, when a woman

walks into your office, she’s 38, she had a baby, and now she’s experiencing breakthrough bleeding and she’s experiencing mood

swings, breast tenderness, you know she needs progesterone.

Mr. BURTON. Yes.

Dr. HOTZE. So we don’t draw a blood level on progesterone, we

will draw a blood level on thyroid and some of the other hormones.

But if a woman is menopausal, she’s not making any hormones,

you don’t have to check her blood for that, she’s already told you.

So you replenish it in the average normal range that is accepted

and that relives the symptoms.

Mr. BURTON. How do you determine that?

Dr. HOTZE. Well, you do a physical exam.

Mr. BURTON. Do you do diagnostic tests?

Dr. HOTZE. Yes, we do tests. But if any woman in menopause

walks in, I can look at her and know what her size and weight is,

and she tells me her symptoms, I’m going to know the dosage that

she needs to take. And that’s the starting dose. And then we work,

we see her back in followup and make adjustments.

Mr. BURTON. How about you, Dr. Brownstein? Do you do it the

same way?

Dr. BROWNSTEIN. I check, as I said before, pre and post levels in

everyone.

Mr. BURTON. How do you do that, through blood tests, saliva

tests, urine tests?

Dr. BROWNSTEIN. Blood and urine tests. And the idea of being a

physician is to put the whole picture together for the patient, to

look at their physical exam, look at their history, look at their

blood work and look at whatever other signs you can come up with

and then put the whole picture together, not rely on one aspect

only to treat people.
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And when you look at the whole picture, I think you can get a

better treatment regimen together for somebody.

Mr. BURTON. I see, and then you prescribe pretty much all holistic hormonal replacements?

Dr. BROWNSTEIN. If someone has strep throat, I’ll prescribe penicillin. There is a place for drug therapies.

Mr. BURTON. I know, but I’m talking about as far as the deficiencies in people.

Dr. BROWNSTEIN. I will only prescribe natural hormones.

Mr. BURTON. What about men? You’ve been talking a lot about

women.

Dr. HOTZE. I’ll speak specifically. Men also, as they age, lose,

their testosterone level declines. So a man at 40 will have one-half

the testosterone level he had in his 20’s, at 50 a third, at 60 a

quarter. Testosterone is essential. It affects your initiative, your assertiveness, sense of well-being, self-confidence, moods, goal orientation, your drive, direction, decisiveness, analytical ability——

Mr. BURTON. I feel sick already. [Laughter.]

Dr. HOTZE. Your analytical ability, and we know this because if

a man loses his testicles from cancer or injury, he has difficulty,

he can’t read a map, he can’t think in three dimensional terms.

Mr. BURTON. But you treat——

Dr. HOTZE. So when you give them testosterone, oh, my gosh, it’s

huge, and I take it myself, and I have for 7 years. It’s remarkable.

Dr. BROWNSTEIN. Mr. Chairman, you mentioned that heart disease, or somebody mentioned heart disease was the No. 1 killer in

the United States. I have yet to see a patient with severe heart disease have a normal testosterone level, man or woman. They all

have low levels. And when you look at the literature on testosterone and heart disease, there is tons of it. I have file cabinets at

work of testosterone and heart disease relationships.

Mr. BURTON. So for men, you will check their testosterone levels

and you’ll compensate?

Dr. HOTZE. Prescribe, yes.

Dr. BROWNSTEIN. Check all their hormone levels, but yes, testosterone is one of the things.

Mr. BURTON. Ms. Watson.

Ms. WATSON. I want to thank all the witnesses, and sorry to be

late coming in. We’re always conflicted.

Dr. Hotze, I believe in holistic medicine. What do you see are the

problems today, when I say today, I mean today, in the use of naturally occurring biological methods for addressing the hormone loss?

What is the problem? Is the problem with the FDA?

Dr. HOTZE. There is a potential coming problem with the FDA.

Pharmacies, just like medical doctors, are all governed and regulated by their various State boards of pharmacy. The FDA has recently tried to extend, and we believe illegally attempted to extend

its jurisdiction to govern pharmacies, particularly compounding

pharmacies. They have already issued a compliance policy guideline that would prohibit compounding pharmacies that make products for veterinarians where they prohibit them from buying it in

bulk. That’s what their compliance policy is, which has no force of

law, but people think it does, and they intimidate people.
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Now, what they want to do, and all compounding pharmacies buy

their products in bulk from a pharmaceutical manufacturer, whether their products are synthetic or whatever. Compounding pharmacies don’t just make bioidentical hormones, they make a plethora of drugs based upon a doctor or pharmacist patient relationship.

So the FDA wants now to restrict bulk use of ingredients in that

pharmacy. That shuts them down. They can’t do it any more.

That’s how you make a compounded product, you buy in bulk. They

will next move to humans and say, we’re going to restrict you doing

this in humans, you can’t buy the bulk product.

And then Vicki won’t be able to get hormones any more, because

the way they want to control the doctors that are practicing alternative medicines is shut down the compounding pharmacies. That’s

their goal.

So what we would like to ask you, we need your help, Congresswoman Watson and Chairman Burton. We need to ask you if you

would consider writing a letter to the FDA, asking them to focus

their efforts on tracking all these dangerous drugs from the pharmaceutical companies, which they say they don’t have enough

money to do, and leave the pharmacies under the jurisdiction of the

State boards of pharmacies, in other words, stop the intervention.

They are intimidating the little guys.

Now, I’m big enough, I can go out and hire a lawyer and spend

hundreds of thousands of dollars. I haven’t had to do this, but I’ve

joined in coalitions that have fought the FDA. I’m willing to do

that. But a little guy on the corner can’t do it. And they’re going

to shut all the little people down.

Ms. WATSON. Let me ask you, what is the FDA’s position on intervening? Do they feel that maybe the studies have not been——

Dr. HOTZE. They don’t intervene on biologically identical—they

haven’t intervened on biologically identical hormones. They haven’t

done that. But they want to shut down compounding pharmacies.

Ms. WATSON. Why is this?

Dr. HOTZE. Because, with all due respect to the FDA, they’re regulatory bureaucrats. Every regulatory agent wants to control

things. And when Kesler got into power, he wanted to control dietary supplements. He wanted—you couldn’t get a vitamin unless

you went to your doctor and your doctor wrote a prescription.

What are the odds of your doctor writing you a prescription for

vitamins? In most people, they’ll never do it, because when my dad

asked me, when he had heart disease in 1988, he said, son, I read

about vitamins, the doctor says I need to take vitamins. He said,

what do I take? I said, Dad, what the hell do I know? I’m a doctor.

I don’t know anything about vitamins. And he said, will you find

out? And I did. That’s how I got into alternative medicine. Very

similar story to Dr. Brownstein’s, my dad’s heart disease and

health problems got me into alternative medicine.

Ms. WATSON. Well, do they lean more toward the synthetics?

Dr. HOTZE. Yes, of course. Yes, they do.

Ms. WATSON. Is it to the benefit of the pharmaceutical companies?

Dr. HOTZE. Voila! If something doesn’t seem logical, like, you

mean, I can get something, I can replenish my body with water if
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I’m thirsty, but you want me to drink Coke when I’m thirsty, but

all I need, I’m dying in the desert and all I want is water, and

you’re going to do a double blind study, well, you’re trying to sell

me that Coke.

The same thing with the hormones. We have available, as we

age, the ability to replenish our hormones with the same identical

hormones your body used to make in adequate amounts. Oh. But

you can’t patent those.

Dr. FUGH-BERMAN. Could I clarify something about bioidentical

hormones? This is important.

Bioidentical hormones are available in commercial pharmaceutical preparations. Compounding pharmacies buy them from

drug companies. You can get 17 beta estradiol, the exact bioidentical estrogen that is in our bodies, in patches, in pills, in vaginal

tablets, inc reams. Is that not correct?

Ms. PETERSEN. That’s absolutely correct, it’s only partial.

Dr. HOTZE. It’s partial.

Dr. FUGH-BERMAN. What is different? What is different in the

preparations that you use than in the commercially available pharmaceutical versions of estrone, estradiol and testosterone?

Ms. PETERSEN. I can tell you that in a minute. Say prometreium

progesterone comes in 100, 200 milligrams. I have many, many

people who use 10 milligrams, 15 milligrams, 50 milligrams, 250

milligrams. You cannot do it with a commercial product and it’s not

appropriate for them.

Also the fillers and the binders in some things, our pharmacy

does a lot of work with environmentally sensitive people. We pay

attention to that. Commercial products are not appropriate. There’s

dyes and fillers that will cause severe reactions with them.

Dr. BROWNSTEIN. The other thing that Carol is pointing out is

that, all these therapies need to be individualized.

Ms. PETERSEN. Yes.

Dr. BROWNSTEIN. You require a different dose than the lady next

to you. And when you’re relying on pharmaceutical companies, they

only have a couple of doses fits all size.

Ms. WATSON. Let me just say this. I’m an example——

Mr. BURTON. Hold on a second.

Dr. FUGH-BERMAN. We tailor medications in conventional medicine. What my problem with this is not that these people are too

alternative, but that they’re too conventional. These are the same

sorts of claims that were made without data by the company that

made Premarin.

Mr. BURTON. Would you yield?

Ms. WATSON. I’ll yield to the Chair.

Mr. BURTON. Let me just say this. As we age, and I know you’re

very young, we take a lot of pills. Can you imagine me breaking

these pills apart and trying to see? You can’t do that. You’d go

crazy first of all, and you’d probably kill yourself.

I think what Drs. Brownstein and Hotze are trying to say is that

this is going to be, they’re going to try to find out what your deficiencies are and tailor it to the individual. And a one size fits all

commodity coming out of a pharmaceutical company won’t cut it.
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Dr. FUGH-BERMAN. Right. And it’s fine to tailor therapy. We do

that in conventional medicine, we do it in alternative medicine, and

I consider myself a practitioner of both.

Mr. BURTON. Well, my doctors don’t.

Dr. FUGH-BERMAN. But the idea that there are known normal

levels of all hormones is actually not true. That we don’t know

what the normal age levels are of, for example, estrogen. You cannot tell from blood levels of estrogen who’s having hot flashes and

who isn’t. So blood levels of 20 year olds are higher in estrogen

than blood levels of 70 year olds, but you can’t tell who’s having

hot flashes, you don’t know what a normal level of estrogen in a

70 year old is.

So this is an aura of science over something that is not scientific.

Also saliva is not an appropriate, salivary hormone tests are not

appropriate for several hormones, including progesterone, and

that’s been shown in scientific studies.

Ms. WATSON. Can I get my time back? [Laughter.]

Mr. BURTON. Ms. Petersen, do you want to respond real quick,

and then it’s back to my good buddy.

Ms. PETERSEN. I did. It’s like looking at one thing, and none of

the practitioners look at an estradiol level without looking at the

clinical picture. Some women normally have very high estrogen levels throughout their whole lifetime. And when they drop, they may

not drop very much, but they notice a huge difference. You have

to tie the two.

You can’t rely on a test, and I agree, saliva tests are not the best

tests. And there is some possibility of its use for some diagnostics,

but not across the board. I agree entirely. It’s just a tool. You can’t

just use one tool. You can’t take a saliva test, no matter how good

the test, or the blood test, and you can’t figure out how many milligrams of this or that will do it for you. It’s trial and error. You

have to work with the patient and the clinical response.

Dr. HOTZE. And that’s scientific. That’s the history of medicine.

Evaluate, make a diagnosis. Start on preparation of medications,

see how the guest or the patient does. Make adjustments. That’s

scientific. That’s the science of medicine.

Ms. WATSON. Dr. Fugh-Berman, I wasn’t here for all the testimony, so let me direct this to you. In describing the condition of

my own health, I have difficulty with patent medicines. I have side

effects, and I have to continue to change. I use holistic medicine

most often, because it has been customized to my own system. I

can’t take anything harsh and I usually have to break down prescriptions because they’re just too strong for my system.

Can you explain what problems you might have with seeking the

natural hormones that are customized and will help an individual?

I find that in patent medicine, there are so many additives, and I

remember my doctor said, read labels. So I read labels on everything. When I see the additives, I know I’m going to be in trouble.

And I’m trying to find the right kinds of foods that will go with my

system. I don’t know if that’s a hormonal thing or not. But as I age

I become more and more allergic to almost everything.

So can you describe for me why you think the natural kinds of

hormonal treatments are not as good as the others?
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Dr. FUGH-BERMAN. I wouldn’t actually say that. I would say that

the use of estriol, Bi-Est, Tri-Est or commercially available pharmaceutical preparations are effective for hot flashes and vaginal

dryness. Those are the only things that they have been proven to

be effective for.

It’s important to individualize any of these medications to a

woman, especially now that we know that estrogens don’t provide

other health benefits, and that they do provide risks. However,

there is no evidence that natural bioidentical hormones, whether

they are in pharmaceutical drugs or in compounded prescriptions,

are safer than synthetic estrogens.

Ms. WATSON. You said there is no evidence?

Dr. FUGH-BERMAN. There is evidence that they are——

Ms. WATSON. Hold on. How do we gather evidence?

Dr. FUGH-BERMAN. From observational studies or randomized

controlled trials. We have randomized controlled trials showing

that estradiol increases stroke risk. We have information from epidemiological studies that estriol increases endometrial cancer risk.

This is not an unknown. This is known, and it’s consistent with

what we know about other estrogens. In my testimony, while you

were away, I pointed out that even higher levels of naturally occurring estrogens in our own body are actually associated with higher

levels of breast cancer risk. So there’s no such thing as a harmless

hormone. Hormones have risks.

Sometimes it’s worth it taking those risks for somebody who has

very severe hot flashes, taking a risk of a slightly increased chance

of having breast cancer might be worth it. But there is no evidence

that these have other health benefits and it’s really bothersome to

me as a public health physician, as a physician concerned about

public health, that there are claims being made that these compounded prescriptions will increase quality of life or prevent any

disease. There is no evidence to support that, and there is evidence

to support that they are harmful.

Ms. WATSON. I heard you say twice there is no evidence. And it

would seem to me that if we did short term and long term studies

across the board, maybe it would yield some empirical evidence

that then we can base claims on both sides on.

I would think, and in my own case, as I said, I chose to go to

a holistic provider because the patent medicines were not helping

me. I was becoming allergic to them.

So would you not agree that we need to go into the studies and

try using these hormones beyond just the hot flashes and the dryness in the uterus? Would you not agree that we really need to do

some studies to see in what levels, in what dosages and so on they

could or could not work?

Dr. FUGH-BERMAN. You know, for many years, the medical profession thought that hormones were going to be helpful.

Ms. WATSON. No, no, no, no. Let me direct—my time is getting

short. Let me get you on point.

Dr. FUGH-BERMAN. There have been studies already done about

these natural hormones.

Ms. WATSON. But I thought you said there was no evidence, no

empirical evidence.
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Dr. FUGH-BERMAN. No. I said that there are randomized controlled trials showing that estradiol increases stroke risk.

Ms. WATSON. OK, time.

Dr. FUGH-BERMAN. They’re referenced in my written testimony.

Ms. WATSON. Dr. Fugh-Berman, what would you have against,

starting today, I think it’s July 22nd, going forward to do some indepth kinds of studies to see about the effects of using these natural hormones and customizing them to the individual? Would you

be, as an educator, as a clinician, as a doctor, would you be against

that kind of research?

Dr. FUGH-BERMAN. It depends on what the indications were for,

Congresswoman Watson.

Ms. WATSON. Will you write a hypothesis——

Dr. FUGH-BERMAN. There already have been studies of estriol for

hot flashes and bone. It helps them.

Ms. WATSON. Hold on. I was very clear in giving you a date. And

I——

Dr. FUGH-BERMAN. What’s the position you’re studying?

Ms. WATSON. Well, that’s your hypothesis, you know. And I have

a Ph.D in education, I don’t have one in medicine. But I do know

how you formulate a study. What I’m saying to you is, would you

have, would you object to studies going forward? Not what they’ve

already done, but going forward to then be able to present empirical evidence?

Now, let me tell you, I’ve been in this business of making policy

for many, many years. For 17 years, I headed up the health and

human services committee in the State Senate in California. We

decided many years ago that smoking was bad for your health. So

I came in with proposals, and I would have to convince my own colleagues that we ought to look and do research. They laughed, and

they said, oh, no, and they were looking at the tobacco industry

and protecting them and so on.

So I found that education was the thing. And it took us 14 years,

but we were the first State that prohibited smoking in California

air space, and now it’s pretty universal. So I know what it takes

to educate, when you make policy, that does no harm and does the

best good.

And so I would think that you’ve got tremendously compelling arguments on the other side, and I hear you kind of stuck in what

was. I’m wondering if you could be flexible to see what could be.

Dr. FUGH-BERMAN. I wouldn’t be against doing long term studies

with a reasonable hypothesis. However, it’s generally considered

unethical to study a drug with no proven benefit when we have evidence of harm.

Ms. WATSON. That is why you do a hypothesis. You make a proposal. And I also established bioethics committees in every hospital

in the State of California, because we were having problems with

the HMO movement and so on.

So I was, what I wanted to hear from, and anyone can response

to this, maybe Dr. Brownstein, would you feel that it was ethical

to start doing some short and long term studies to be able to determine with empirical evidence if this was an effective kind of treatment?
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Dr. BROWNSTEIN. Well, certainly we need to do studies and answer as many questions as we can. I would agree with Dr. Berman,

I think estrogens are a major problem in the environment. They’re

in pesticides, they’re fattening up the animals with estrogens,

they’re in plastics. The natural estrogens are the least of any natural hormone that I use. I don’t use them in most women, I don’t

use them in men. And I use a lot of the other natural hormones

to reverse or improve people’s health and help them get over their

chronic illness.

Dr. HOTZE. And Congresswoman Watson, I have already initiated

studies, and there are a lot of clinical studies. In fact, the PEPI

study, which was completed in 1995, which is the Postmenopausal

Estrogen Progestin Intervention study, and I think that was Government funded as well, first line of treatment for women on estrogen therapy, postmenopausal, the first line of treatment they said

they needed natural progesterone first. But very few doctors prescribe natural progesterone, they all prescribe the counterfeit—

provera, medroxyprogesterone and the other counterfeits, because

that’s what the drug companies sell.

The drug companies can’t patent anything biologically identical.

They can’t do it. You can patent the strength or the formula, but

you can’t patent the hormone. There’s no money in it for the drug

companies. That’s the way it is.

If there’s no money in it, they’re not going to promote it. And

that’s why we in private practice, like Dr. Brownstein and myself

and hundreds and thousands of other doctors across the country

and compounding pharmacists have embraced, we’ve seen what it’s

done to our patients, and I would say for Dr. Berman, I would be

glad to offer her a one person test, I invite you to come to our office

in Houston, be worked up, be evaluated, do a 2-month trial and see

how you feel.

Dr. FUGH-BERMAN. Thank you. That would save me $3,000.

Dr. HOTZE. Yes, it would, it would save you that. I’d be glad to.

Then you could do it from personal experience, see how you feel

and then talk about it. Because I’ve been on both sides of the aisle.

I was over on your side of the aisle at one time, too. But I decided

to challenge it, think out of the box, think unconventionally. And

believe it or not, the world would always be the same if people

never thought out of the box and thought conventionally. Thank

God you all didn’t.

Congresswoman Watson, if you hadn’t been willing to challenge

the tobacco industry and everybody said, you’re crazy as you can

be——

Ms. WATSON. Do you know what my last proposal to my colleagues was? I was commissioning the University of California to

research the connection between wrinkling and smoking. Well, the

guys almost laughed me off the floor.

Dr. HOTZE. And they’re doing it now probably.

Ms. WATSON. The bill passed. Three years later, they came back

and made the connection and the rest is history.

Dr. HOTZE. There you go. And of course, Congressman Burton

too, with the mercury problem.

Mr. BURTON. I thought you were going to talk about my wrinkles. [Laughter.]
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Go ahead, I’m just kidding.

Dr. HOTZE. But you thought out of the box and challenged the

conventional thinking on mercury, both of you have. And to your

credit. That’s wonderful. Thank God for you all being willing to do

that. And that’s what we need, people in the medical community

to challenge it. All you have to do is listen to women and the way

they’re treated and how they feel and they’re not being taken care

of.

There’s a revolution coming. The doctors in this room and across

the country, they don’t even know it’s coming. But there are going

to be women like Vicki Reynolds that go, Doctor, guess what, I’m

firing you, good-bye, click.

Mr. BURTON. In any event, what I’d like to do, because it’s getting late and some of you have to catch planes and so forth, I’d like

to have your recommendations on what we can do to make holistic

medicine and these complementary and alternative therapies more

available and also, any information you have on the safety of them

and the efficacy of them.

Dr. HOTZE. I will send you that.

Mr. BURTON. We would like to have that.

And you said something about a letter earlier.

Dr. HOTZE. A letter to the FDA. And if I could have your permission to visit with one of your staff members——

Mr. BURTON. Yes. I think Mindi and Brian, Brian is my right

arm in the office. Brian and Mindi will be happy to sit down with

you and talk with you about that.

Dr. HOTZE. Thank you very much.

Ms. PETERSEN. Chairman Burton, if I might say something.

Mr. BURTON. Sure.

Ms. PETERSEN. I would like to propose that we have a money

back guarantee.

Mr. BURTON. What?

Ms. PETERSEN. A money back guarantee.

Mr. BURTON. On what?

Ms. PETERSEN. On health care. If you go to your doctor and he

doesn’t get you healthy and that prescription you got doesn’t make

you better, money back.

Mr. BURTON. You know, I want to tell you, that’s a very interesting statement. We have 600 lobbyists in Washington that represent

the pharmaceutical industry, 600. There’s 535 Members of Congress and the Senate. They outnumber us. And any time we talk

about, Congresswoman Watson and myself, or anybody else talks

about anything, you would not believe the attacks and everything

else that takes place.

Just to give you a little aside, so you’ll know why I’m saying that

what you’re talking about is crazy, because it’s never going to happen, is that in Canada, a woman who buys tamoxifen can buy it

for $50, $60, and it’s a very big help for women that have had cancer. In the United States, it costs as much as $350 for a 30 day

supply. And yet the Food and Drug Administration and the pharmaceutical companies and everybody else have said, oh, my gosh,

we don’t want reimportation. And they come up with a million reasons why we can’t have it.
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That’s just one example. There are hundreds and hundreds and

hundreds of pharmaceutical products that cost four, five, six, seven

times as much here as they do elsewhere. And yet the pharmaceutical companies have been fighting like crazy to stop reimportation. They are a very, very powerful lobby. And doctors, I think a

lot of doctors probably would not be aware of a lot of things, so I’m

not sure they’re going to give you a money back guarantee on

things they’re not aware of, so I don’t think that’s going to happen.

In any event, I would like to have from you, including you, Dr.

Fugh-Berman, I’d like to have any recommendations that you have

that you think we could utilize to help the health of women. And

don’t forget the men. You haven’t talked much about the men

today, and you know, I’m getting up there, I’d kind of like to know

how I can be more virile and keep my hair and keep the color

down. So if you have any testosterone with you, throw a couple

packages up here for me before you leave. [Laughter.]

In any event, thank you all for being here. Did you have any

other questions, Ms. Watson?

Ms. WATSON. No, thank you, Mr. Chairman.

Mr. BURTON. But I would like to have anything you think we

should be doing in writing, so we can followup on it, because we

will do that.

Thank you very much. We stand adjourned.

[Whereupon, at 5:35 p.m., the subcommittee was adjourned, to

reconvene at the call of the Chair.]

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