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37–150 PDF 2007

S. HRG. 110–129

Bioidentical Hormones: Sound Science or Bad

Medicine

HEARING

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

WASHINGTON, DC

April 19, 2007

Serial No. 110–5

Printed for the use of the Special Committee on Aging

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

THOMAS R. CARPER, Delaware 

BILL NELSON, Florida 

HILLARY RODHAM CLINTON, New York 

KEN SALAZAR, Colorado 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

GORDON H. SMITH, Oregon 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

MEL MARTINEZ, Florida 

LARRY E. CRAIG, Idaho 

ELIZABETH DOLE, North Carolina 

NORM COLEMAN, Minnesota 

DAVID VITTER, Louisiana 

BOB CORKER, Tennessee 

ARLEN SPECTER, Pennsylvania 

JULIE COHEN, Staff Director 

CATHERINE FINLEY, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Gordon H. Smith ................................................. 1

Opening Statement of Senator Larry Craig .......................................................... 3

PANEL I 

Jacques Rossouw, chief of the Women’s Health Initiative Branch, National 

Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, 

MD ......................................................................................................................... 4

Steve Galson, director, Center for Drug Evaluation and Research, Food and 

Drug Administration, Rockville, MD .................................................................. 15

Eileen Harrington, deputy director, Bureau of Consumer Protection, Federal 

Trade Commission, Washington, DC .................................................................. 33

PANEL II 

JoAnn Manson, chief of Preventive Medicine, Brigham and Women’s Hospital, 

professor of Medicine, Harvard Medical School, Boston, MA ........................... 51

Leonard Wartofsky, president, The Endocrine Society, Chevy Chase, MD ........ 66

Loyd Allen, editor-in-chief, International Journal of Pharmaceutical 

Compounding, on behalf of The International Academy of Compounding 

Pharmacists, Sugarland, TX ............................................................................... 73

T.S. Wiley, writer/researcher, Creator of the Wiley Protocol, Santa Barbara, 

CA .......................................................................................................................... 85

APPENDIX 

Responses to Senator Smith Questions from JoAnn Manson .............................. 141

Responses to Senator Smith Questions from Leonard Wartofsky ....................... 142

Response to Senator McCaskill Question from Leonard Wartofsky .................... 143

Responses to Senator Smith Questions from Loyd Allen ..................................... 144

White Paper submitted by Loyd Allen ................................................................... 146

Additional Information submitted by National Institutes of Health .................. 156

Statement of the American Pharmacists Association ........................................... 230

Written Testimony of Jane L. Murray, board chair, Women in Balance ............ 239

Written Testimony of Steven F. Hotze, MD .......................................................... 240

Statement of David Adams, Venable LLP ............................................................. 242

(III) 

(1)

BIOIDENTICAL HORMONES: SOUND SCIENCE 

OR BAD MEDICINE? 

THURSDAY, APRIL 19, 2007 

U.S. SENATE, 

SPECIAL COMMITTEE ON AGING, 

Washington, DC. 

The Committee met, pursuant to notice, at 10:05 a.m., in room 

526, Dirksen Senate Office Building, Hon. Gordon H. Smith presiding. 

Present: Senators Smith and Craig. 

OPENING STATEMENT OF SENATOR GORDON H. SMITH, 

RANKING MEMBER 

Senator SMITH. Good morning, ladies and gentlemen. With the 

permission of the Chairman, Senator Kohl—he has asked us to proceed. 

We thank you for attending today’s hearing, ‘‘Bioidentical Hormones: Sound Science or Bad Medicine?’’ 

As the title suggests, we are here today to closely examine the 

controversy surrounding the production and use of bioidentical hormones as an alternative to conventional hormone therapy. 

The intent of this hearing is not to endorse one therapy over another. Rather, it is to ensure that the Federal Government is providing the information and oversight necessary so that consumers, 

women specifically, are able to make safe and well-informed decisions about their individual health-care needs. 

From my review, it seems that the Federal Government and 

medical practitioners are playing a guessing game with women’s 

health in the prescribing of hormone therapies. Today’s hearing reflects my belief that women deserve better. I hope to get some answers today regarding the state of the science and the Federal Government’s oversight role in this arena. 

Over a decade ago, the National Institutes of Health set out to 

shed some light on the effect of hormone therapy on preventing 

heart disease in women through the largest research initiative ever 

undertaken of this kind: the Women’s Health Initiative. 

When evidence indicated that the health risks of the therapies 

studied in the WHI exceeded the benefits, the study was prematurely ended, scaring thousands of women away from traditional 

hormone therapy. 

As an alternative, bioidentical hormones have become a popular 

and controversial option, not only for aging women, but for men 

and women of all ages seeking a route to the fountain of youth. 

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The sale of bioidentical hormone products are on the rise and 

have been promoted by such distinguished actresses as Suzanne 

Somers and major marketing campaigns in doctors’ offices, pharmacies and the Internet touting bioidenticals as natural and, thus, 

safer alternatives to traditional hormone therapies. 

There has been much debate in the scientific community, however, as to whether the science exists to support these claims. By 

the end of this hearing, I hope to have a clear understanding of 

whether additional federally funded studies are needed to address 

concerns regarding the safety and efficacy of these products. 

Today, we will also address the regulatory issues relating to the 

manufacturing of these products, especially those that are custommade or compounded in pharmacies. 

I am particularly troubled that compounded medications are not 

routinely tested and are not accompanied by warning labels and 

risk indicators that are required for traditionally manufactured 

medications. 

Further, there is a lack of information available to assist Congress in determining the proper roles of the Federal Government, 

the State Governments and the industry in regulating pharmacy 

compounding. That is why I have asked the Congressional 

Research Service to conduct a 50-State survey that will help me 

and my colleagues determine the best course of action going forward. 

Ultimately, the Federal Government must do a better job of empowering consumers to make informed decisions regarding hormone therapies and compounded medications. But the current regulatory framework is hazy and creating confusion between the Federal Trade Commission, the Food and Drug Administration, and 

State boards of pharmacy, regarding who has ultimate regulatory 

responsibility. 

I fear that lack of consistent and certain oversight has created 

an atmosphere ripe with opportunities for fraud and abuse. By the 

end of this hearing, I would like to have some confidence that the 

regulatory agencies are taking these issues seriously and have a 

concrete plan of action to address the committee’s concerns. 

On our first panel this morning, I am pleased that NIH will be 

testifying for the first time before Congress regarding the latest 

findings in the Women’s Health Initiative study. Also on the first 

panel will be the FDA and the FTC, who will speak about the 

agencies’ enforcement efforts. 

Our second panel promises a lively discussion regarding the 

science of bioidentical hormones and the regulatory issues relating 

to pharmacy compounding. I look forward to that dialog. 

With that, I will turn to my colleague, Senator Craig, from Idaho.

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OPENING STATEMENT OF SENATOR LARRY CRAIG 

Senator CRAIG. Well, to the Chairman and to you, the Ranking 

Member, let me thank you for bringing this hearing together. 

I will ask unanimous consent that my full statement be a part 

of the record, Gordon. Let me say——

Senator SMITH. Without objection. 

Senator CRAIG [continuing]. Just one thing. 

One of the expectations, I believe, that Americans have of their 

Government is, in part, to keep them safe. This is especially true 

in a protection from pharmaceuticals whose potential negative side 

effects outweigh their potential benefits. Americans want to know 

they can take a drug that is prescribed by their physician with the 

knowledge that this drug will treat or cure what ails them. 

However, like all other governmental responsibilities, we must 

balance our obligation to protect with our responsibility to allow individual freedoms. That is a rather precarious balance at times 

that we especially try to achieve in the area of medicine, certainly 

in the area of pharmaceuticals. 

So—I keep wanting to say, Mr. Chairman. Senator Smith—Gordon. 

Senator SMITH. ‘‘Senator’’ works fine. 

Senator CRAIG. OK. 

That is why I think this hearing is important; that you come 

back to this issue, as you should, in an area where we may not be 

as aggressive or as responsible as we should be. 

Thank you. 

[The prepared statement of Senator Craig follows:] 

PREPARED STATEMENT OF SENATOR LARRY CRAIG

Mr. Chairman, I know that we have a lot of witnesses that we want to hear from 

today, so I will be brief in my comments. First of all, I want to thank you for holding 

this hearing today. Bioidentical hormones are a part of the lives of many Americans 

and I think the questions surrounding them bear further examination. This hearing 

brings together a cross-section of issues: individual freedom to choose alternative 

therapies vs. ensuring drug safety. 

One of the expectations that Americans have of their government is that we keep 

them safe. This includes protection from pharmaceuticals whose potential negative 

side effects outweigh their potential benefits. Americans want to know they can take 

a drug that is prescribed by their physician with the knowledge that this drug will 

treat or cure what ails them. However, like all other governmental responsibilities, 

we must balance our obligation to protect with our responsibility to allow individual 

freedom. 

Many Americans utilize various alternative drug therapies or dietary supplements 

as a significant part of their health care regimen. They want the freedom to have 

more control of their health and to utilize what they believe are more natural drug 

treatments. It is important that we do not eliminate that option. 

As Congress, our challenge is to strike the proper balance between these responsibilities. We must ensure drug safety without infringing upon personal freedom and 

choice. 

When I first became aware of the concerns surrounding bioidentical hormones, my 

first inclination was to keep the government out of the issue. Women should have 

the freedom to choose natural treatments that may work better for them. However, 

as I have learned more about this issue a few items raised some red flags in my 

mind. 

Many Americans, and I suspect many American women, are aware of the results 

of the National Institutes of Health (NIH) Women’s Health Initiative relating to 

hormone replacement therapy. Unfortunately, the general public does not fully understand the nuances of the findings. The story people heard was that hormone replacement therapy was bad for you. And as the witnesses will testify, there was a 

significant drop in the number of women using hormone replacement therapy. HowVerDate 0ct 09 2002 09:09 Sep 28, 2007 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 H:\DOCS\37150.TXT SAGING1 PsN: JOYCE
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ever, as Dr. Wartofsky points out, many women went straight to what they thought 

were natural alternative treatments. Many women are not fully aware of the differences, and more importantly, the similarities between bioidentical hormones, 

compounded hormones, and those hormones used in the Women’s Health Initiative. 

It concerns me that women who think they are choosing a natural alternative may 

not have all of the facts. 

That is why this hearing is so important. Hopefully it will shed more light on 

compounded bioidentical hormones so that not just Congress, but consumers, are 

more educated about the products that are out there. With that said, I want to welcome our witnesses and I look forward to hearing from them.

Senator SMITH. Thank you, Senator Craig. 

Our first panel consists of Dr. Jacques Rossouw, who is the chief 

of the Women’s Health Initiative branch of the National Heart, 

Lung and Blood Institute at NIH. Dr. Rossouw will discuss findings 

from the Women’s Health Initiative and its implications for the 

current approach to hormone therapy. 

He will be followed by Dr. Steve Galson. He is the deputy director for the Center for Drug Evaluation and Research at FDA. We 

look forward to hearing about FDA’s suggestions for legislative and 

regulatory initiatives. 

Eileen Harrington is the deputy director of the Bureau of Consumer Protection at the FTC. Ms. Harrington will discuss the 

FTC’s enforcement efforts regarding online sales of hormone products. We look forward to hearing FDA’s future plans for oversight 

in the area. 

So with that, Dr. Rossouw, take it away. 

STATEMENT OF JACQUES ROSSOUW, CHIEF OF THE WOMEN’S 

HEALTH INITIATIVE BRANCH, NATIONAL HEART, LUNG AND 

BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH, 

BETHESDA, MD 

Dr. ROSSOUW. I am pleased to appear before this——

Senator SMITH. Hit your button there on the microphone. 

Dr. ROSSOUW. Yes. 

I am pleased to appear before this committee. I am here to tell 

you about the Women’s Health Initiative, which used conjugated 

equine estrogens. I will also briefly comment on other forms of estrogen therapy. 

Recall that, prior to 1990, the main use of hormone therapy in 

post-menopausal women was to treat the symptoms of menopause 

and prevent osteoporosis. During the 1990’s, there was increasing 

use for prevention of coronary heart disease. In fact, that was the 

standard recommendation at that time. 

This recommendation was based on preceding observational studies indicating benefit for cardiovascular disease in particular in 

hormone users compared to nonusers. 

NIH felt that this recommendation was an example where the 

policy was exceeding the science basis and mounted the Women’s 

Health Initiative to test the very hormones—conjugated equine estrogens and medroxyprogesterone—which were suggested to be associated with benefit in preceding observational studies. 

The expectation was that we would show benefit for hormone 

therapy—either estrogen alone or in combination with a progestin. 

What we found was that the estrogen alone and the estrogen with 

progestin did not protect against coronary heart disease. 

5

In fact, for the combination therapy, the trial was stopped early 

because of an excess risk of breast cancer and heart disease and 

stroke and blood clots. These harms exceeded any potential benefits. 

The estrogen-only trial was also stopped prematurely because of 

an increased risk of stroke and no benefit for the primary outcome 

of coronary heart disease. 

As a result of these findings, the prescriptions for hormone therapy dropped by about 60 percent after 2002. 

Now, because the primary findings were what they were—in a 

negative direction—certain questions then arose which would not 

have arisen if the findings had been as expected: that is, of benefit 

for coronary heart disease. But because there was no benefit, these 

secondary questions gained importance. 

First of all, would the result have been different if the hormone 

therapy had been started at an earlier age, closer to the menopause? In the Women’s Health Initiative, the age range was 50 to 

79 because those are the women to whom hormone therapy was 

being prescribed for prevention of coronary heart disease. So that 

is what we tested. Would it have been different if most of the 

women had been closer to the menopause? First question. 

Second question, would the result have been different and more 

beneficial if we had used a different kind of estrogen, such as estradiol, the estrogen produced by the human body? 

So I want to get straight to the heart of the matter, if I may—

pun intended—and direct your attention within your packet to 

these posters here, because to understand these questions one has 

to know a little bit about the science. 

Atherosclerosis, which is the precursor of heart attacks and 

stroke, is an age-related disease. You can divide it into stages. Of 

course, that is artificial. I mean, it is a continuum. But for the purposes of understanding this, I have divided it into some stages. 

There is the initiation phase, which occurs in the young adult. 

This is a process that involves the lining of the artery, the endothelium, and it then leads to fatty streaks. 

At middle age, there is the increasing prevalence of raised lesions—progression to raised lesions. 

From then onwards into old age, there is an increasing prevalence of complicated lesions, some of which will eventually rupture 

or erode, and a blood clot will form. This leads to the heart attack 

or stroke. 

Now, these are age-related changes. Some of it is due directly to 

the aging of the arteries. Some of it is due to the increasing prevalence of risk factors, such as high blood pressure and high blood 

cholesterol as people age. 

Now, we cannot stop aging. We haven’t figured out how to do 

that. But we can treat the risk factors. 

That is what we mean by ‘‘prevention.’’ You are not preventing 

age, but you are treating the risk factors associated with age, and 

thereby you are preventing the complications of age. Or, you are 

not preventing them totally, but you are decreasing them. 

So one example of such a prevention is lowering of the high blood 

cholesterol—lipid lowering. I will use the example of statins because there is an awful lot of data on statins. Statins will interfere 

6

with every stage of the disease: from the initiation, to the progression, to the treatment of the complications—that is, people who 

have already had heart attacks. 

Statins are effective at every stage, OK? So, therefore, one can 

assume that if you start statins at a young age and continue them 

lifelong, they will continue to have benefit. That is an assumption 

because that trial is not feasible, as it is also not feasible to do a 

really long-term lifelong trial of hormone therapy. 

So statins represent a favorable or an acceptable prevention 

strategy. There are no known long-term complications. 

The situation is different with estrogens, be they Premarin, conjugated estrogens or estradiol. 

There is increasing evidence that estrogens, generally, may retard the earliest stages, the initiation, of atherosclerosis. There will 

be more evidence in the next coming years that may or may not 

be consistent with that idea. But at the moment there is reasonably good evidence that that is the case, including from the Women’s Health Initiative, the recent publication. 

However, once there are established raised lesions, established 

atherosclerosis, there is good evidence that estrogen in any form, 

be it conjugated estrogens or estradiol, does not prevent further 

progression. There is also good evidence that once there are complicated lesions, estrogens actually trigger events and make matters worse. 

So estrogens do not represent a good prevention strategy. We 

cannot assume that if you start it early, and there is potential benefit, that that benefit will persist into older age. 

Again, that is an assumption. We cannot do that trial. But knowing what we know, that would be a very far stretch of the imagination to imagine that if you start it early and use the right estrogen, 

you will get a different outcome than we found in the Women’s 

Health Initiative. 

So, again, we don’t think that there is any essential difference 

between estradiol and conjugated equine estrogen as far as heart 

disease is concerned. We don’t believe that this window of opportunity is anything but a window into the present. There is a reasonably safe period to use hormone therapy close to the menopause, but it is not necessarily a window into the future if you 

start then and persist that that benefit will persist. 

With that, I will close and thank the committee for addressing 

them on this very important issue to women’s health. I am happy 

to entertain questions. 

[The prepared statement of Dr. Rossouw follows:]

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Senator SMITH. Thank you, Doctor. 

Steve Galson. 

STATEMENT OF STEVE GALSON, DIRECTOR, CENTER FOR 

DRUG EVALUATION AND RESEARCH, FOOD AND DRUG 

ADMINISTRATION, ROCKVILLE, MD 

Dr. GALSON. Thank you. Mr. Chairman and members of the committee, I am Dr. Steven Galson——

Senator SMITH. You need to hit your microphone. 

Dr. GALSON. OK. I am Dr. Steven Galson. I am the director of 

the Center for Drug Evaluation and Research at FDA, and a Rear 

Admiral and Assistant Surgeon General in the United States Public Health Service. 

I am really very pleased to be here to discuss FDA’s role regarding the compounding of so-called bioidentical hormone products. 

FDA has increasingly seen these products prepared and marketed by pharmacists as part of a practice called drug 

compounding. FDA regards traditional drug compounding as combining or altering of ingredients by a pharmacist in response to a 

licensed practitioner’s prescription, which produces a medication 

tailored to an individual patient’s needs. 

Traditional pharmacy compounding enhances patient treatment 

with individually tailored drugs when a health-care provider decides that an FDA-approved drug is not appropriate for that particular patient’s care. 

Traditional compounding may involve reformulating a drug, for 

example, by removing a dye or preservative in response to a patient allergy. Or it may involve making a suspension or a suppository form for a child or an elderly patient who has difficulty swallowing a tablet. 

Sometimes, however, the risks associated with compounded 

drugs outweigh their benefits. Improper compounding has caused 

patient harm and death. 

Although many pharmacists are well-trained and well-equipped 

to compound certain medications safely, not all pharmacists have 

the same level of skill and equipment, and some products may not 

be appropriate in the first place for pharmacy compounding. 

In addition, compounding large volumes of standardized drugs 

and copying FDA-approved drugs circumvents important public 

health requirements. These practices undermine the drug approval 

process, which is the evidence-based system of drug review that 

consumers and health professionals rely on for safe and effective 

drugs. 

My written statement that you have describes FDA’s statutory 

and regulatory authority over compounded drugs. FDA has regulated compounded drugs consistent with its Compliance Policy 

Guide on pharmacy compounding, or CPG. 

This CPG explains that FDA generally exercises enforcement discretion toward traditional compounding. But when a pharmacy’s 

activities raise concerns normally associated with the drug’s manufacture and result in significant violations of the Food, Drug and 

Cosmetic Act, FDA considers enforcement action. The CPG identifies some of the factors that FDA evaluates in deciding when and 

how to act. 

16

FDA is aware that a growing number of pharmacists compound 

hormone products for treatment of symptoms of menopause. These 

pharmacists often promote their products as so-called bioidentical 

to the hormones produced by a woman’s body. The phrase ‘‘bioidentical hormone replacement therapy,’’ or BHRT, has been used to describe these products. 

Compounded BHRT products typically contain various forms of 

estrogen and progesterone and, in some cases, testosterone and 

dehydroepiandosterone. 

Some compounding pharmacists claim that their BHRT products 

are a ‘‘natural alternative’’ to FDA-approved drugs because the 

compounded hormones are identical to the hormones produced in 

the body. These pharmacists may also claim that their natural 

compounded products are safer and more effective than FDA-approved hormone replacement drugs. 

FDA is not aware of any credible scientific evidence supporting 

these claims. Nor is FDA aware of sound evidence showing that the 

side effects or risks of compounded BHRT products are different 

than those of FDA-approved hormone replacement drugs. 

Because many claims regarding the safety, efficacy and superiority of compounded BHRT products have not been substantiated, 

FDA is concerned that they mislead patients and practitioners. 

In 2003, FDA began a focused public awareness campaign about 

the risks and benefits of hormone therapy for indications including 

the symptoms of menopause. This outreach campaign has two 

parts. 

Part one included the development of partnerships and educational materials. In implementing this, FDA’s Office of Women’s 

Health formed a working group that included members from NIH, 

the Agency for Healthcare Research and Quality, and 25 women’s 

health and professional organizations. 

The working groups identified a target audience, women aged 40 

through 59, and developed core messages, such as ‘‘Get informed’’ 

and ‘‘What can you believe?’’ The working groups supplemented 

these messages with campaign materials and strategies for disseminating key information. 

Part two was a national media outreach effort. Campaign materials developed in part one were publicized through the media and 

community outreach, Internet, and print advertising and direct email. The materials developed as part of this campaign continue to 

be requested and distributed, and are available on our Web site. 

FDA has not focused only on compounded BHRT drugs. Hormone 

replacement therapy products are also marketed as over-thecounter drugs and dietary supplements, often on television and on 

the Internet. 

In the fall of 2005, the FDA worked with FTC to address the 

marketing of unapproved hormone replacement products. FDA sent 

warning letters to 16 dietary supplement and hormone cream marketers who were making unproven claims that their ‘‘alternative 

hormone replacement therapy’’ products were useful in treating or 

preventing cancer, heart disease, osteoporosis and other serious 

diseases. 

In closing, I assure you that FDA is aware of and attentive to 

the many concerned voices about hormone replacement therapy 

17

products, including compounded so-called bioidentical drugs. As 

these products have become increasingly prevalent, so has our attention to them. 

I am happy to answer your questions. 

[The prepared statement of Dr. Galson follows:]

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Senator SMITH. Thank you very much. 

Dr. GALSON. Thank you. 

Senator SMITH. Eileen Harrington. 

STATEMENT OF EILEEN HARRINGTON, DEPUTY DIRECTOR, 

BUREAU OF CONSUMER PROTECTION, FEDERAL TRADE 

COMMISSION, WASHINGTON, DC 

Ms. HARRINGTON. Good morning, Ranking Member Smith. I am 

Eileen Harrington, the deputy director of the FTC’s Bureau of Consumer Protection. 

The commission’s written testimony has been submitted for the 

record. My oral statement and answers to any questions you may 

have represent my views. 

You have asked us to discuss the FTC’s efforts to address the 

misleading online advertising of alternatives to hormone replacement therapy, as well as our work to combat all types of Internet 

fraud. 

Among its many benefits, the Internet provides consumers with 

access to a vast array of information and products, including 

health-related items. Unfortunately, it also provides an opportunity 

for irresponsible marketers to prey on consumers, making false or 

misleading claims, causing economic injury, and posing potentially 

serious consequences for consumers’ health. 

For over a decade, the FTC has been on the forefront of efforts 

to protect consumers from online fraud. In doing this, we use a 

three-pronged strategy. 

First, we take law enforcement action to stop deceptive practices 

and obtain redress for victims of fraudulent schemes. 

Second, we conduct consumer education campaigns, often in partnership with colleagues like the FDA, to help consumers spot and 

avoid online scams in the first instance. 

Third, we educate businesses to help them comply with the law 

and avoid engaging in deceptive practices. 

The FTC’s work to address deceptive online health and safety 

claims exemplifies our use of this strategy. We have aggressively 

enforced the law, bringing 229 enforcement actions challenging online false and misleading health and safety claims for products 

ranging from weight-loss pills to cancer cures. 

For example, last November, following a fierce trial, the FTC 

won a Federal court order requiring the sellers of the Q-Ray Bracelet to refund up to $87 million to consumers who had purchased 

the product based on false claims that the bracelets would significantly reduce their pain. 

On the consumer education front, the FTC provides consumers 

with useful, creative and timely information to help them avoid 

falling victim to false claims for everything from cure-alls to diet 

and fitness products. We provide all of these materials on our Web 

site. We spread the word offline, as well, often partnering with 

private- and public-sector organizations to distribute publications 

and our messages. 

Our efforts involving alternative HRT products are a good example of our use of the third prong of our strategy: educating business 

about their legal responsibilities. 

34

Our staff identified 34 Web sites with claims that alternative 

natural progesterone creams and sprays were safe or would prevent, treat or cure serious cancer, heart disease or osteoporosis. We 

sent a warning e-mail to each of those site operators; the e-mails 

putting them on notice that they must have substantiation for any 

health claims that they make about their products and urging 

them to review their product claims to make sure they complied 

with the law. 

Our staff recently conducted a follow-up review of those Web 

sites and has continued working with companies to clean up their 

claims. Fifteen of the 34 Web sites have either removed the claims 

or no longer sell the products. 

As I said, we are continuing to follow up directly with the remaining sites, and our staff will be making appropriate enforcement recommendations about those that do not comply with the 

law. 

The FTC’s efforts to halt deceptive health-related claims online 

are part of its larger program to combat Internet fraud. Since 1994, 

the FTC has launched 538 law enforcement actions, garnering 

nearly $1 billion in judgments against those who have used the 

Internet to prey upon American consumers. 

Online deception generally falls into two categories: old-fashioned 

schemes that have simply migrated online and new high-tech 

schemes that are unique to the computer age. 

Spam presents a hybrid of the two. Spammers use low-cost new 

technology e-mails to carpet consumers with old-fashioned deceptive claims about everything from miracle cures to bogus investment opportunities. 

The FTC has pounded the pavement on the spam beat for over 

a decade. Since 1994, we have litigated 89 actions against 241 defendants in which spam was an integral element of the scheme, 

and 26 of those cases use the relatively new Can Spam Act. 

As technology and scams change over time, the FTC continues to 

shift its resources and adjust its priorities, targeting those frauds 

that cause the most harm to consumers. 

False and misleading claims that affect consumers’ health and 

safety are prime targets, and they will remain prime targets, of the 

FTC’s enforcement efforts. We will continue our efforts to ensure 

the truthfulness and accuracy of advertising for health-related 

products, regardless of the medium in which those ads appear. 

Thank you, again, for inviting us. I am happy to answer your 

questions. 

[The prepared statement of Ms. Harrington follows:]

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Senator SMITH. Thank you very much, Eileen. 

Ladies and gentlemen, I am holding in my hand a jar called 

Products of Nature Natural Woman Progesterone Cream. 

Dr. Rossouw, my staff purchased this on the Internet just a few 

days ago. It comes with certain claims, specifically that, if applied 

topically, it will greatly decrease a woman’s risk of breast cancer; 

that women who have previously had breast cancer will have little 

or no reoccurrence if using natural progesterone cream. 

In your scientific opinion, are there any studies that would support such claims? 

Dr. ROSSOUW. No. There are no studies that support such a 

claim. I would make two further points. 

First, that, you know, the dichotomy between natural and synthetic—which this kind of product plays on—appeals to an idea 

amongst the public that natural is somehow better than synthetic. 

From the scientific standpoint, there are either drugs that work 

and are safe or drugs that don’t work or are not safe. Their origin 

is quite irrelevant, firstly. 

Second, if you look at the risk factors for breast cancer 

epidemiologically, they are all related to the levels and duration of 

exposure to the natural human hormones estradiol and progesterone, such as the earlier the onset of the menarche or the later the 

delay in the menopause; with longer exposure the greater the risk 

of breast cancer. 

So I think the evidence would be, though inferential, to the contrary. There is no evidence that progesterone prevents breast cancer. I suspect that, in combination with estrogen, it probably increases the risk. 

Senator SMITH. It increases the risk. 

Dr. ROSSOUW. From what we know, the likelihood is that it increases the risk. 

Senator SMITH. Topically applied, I mean, does that—there is no 

value——

Dr. ROSSOUW. Well, there is a question of how much is absorbed. 

My colleague from the FDA can address that. But if it is absorbed, 

and a woman has circulating estradiol, then I would not regard 

this as a favorable scenario. 

Senator SMITH. You know, on the Western frontier, they had a 

lot of snake oil salesmen. Do we have that in the 21st century, if 

those claims are being made? 

Dr. ROSSOUW. Well, I would just go so far as to say that these 

claims are unsubstantiated. 

Senator SMITH. Ms. Harrington, I am wondering why my staff 

was able to purchase this on the Internet off a Web site that was 

one of 34 companies that you sent warnings to in November of 

2005. 

Two weeks ago, this company was still in business. As far as I 

know, they still are. As far as I know, this is still—I could get it 

today, or a woman could get it today if she sought it. 

Of the 34 companies that received warnings from the FTC in 

2005, 32 of them still had Web sites up and running as of 2 weeks 

ago. 

48

Now, you have identified in your testimony that 19 of these sites 

are still selling hormone products that make unsubstantiated 

health-related claims. 

I guess what I am asking is, what revisions is the FTC going to 

be making to enforce its policies to ensure that this type of egregious enforcement lapse does not reoccur? 

Ms. HARRINGTON. Senator, we, as I said, will be receiving enforcement recommendations on companies that are not in compliance. I can’t say, in a public setting, precisely when and what the 

nature of those will be. 

I think we could have moved faster here, and we should have. 

Senator SMITH. Well, I don’t mean any personal embarrassment 

to you. But, I mean, I am just saying that, in this senator’s opinion, 

the American people are owed better by the FTC than what the 

evidence shows by my staff’s being able to buy this with these kind 

of claims on the Internet; something that may be harmless, it may 

be dangerous, but it is unproven and ought not to be out there as 

modern-day snake oil. 

Ms. HARRINGTON. Point well-taken, Senator. 

Senator SMITH. After the early termination of the Women’s 

Health Initiative study, the FDA issued a black box warning indicating that estrogens with or without progestin should be prescribed at the lowest effective doses for the shortest duration. 

However, it is my understanding that when the FDA issued the 

guidance, there were no studies indicating at what dose women 

faced the lowest risk of serious side effects. It seems to me that the 

Federal Government is playing a guessing game with women’s 

health, and I think they deserve better. 

So, Dr. Rossouw and Dr. Galson, without studies indicating at 

precisely what dose women will see less risk of serious side effects, 

why did the FDA take such an extreme position? 

Dr. GALSON. Well, let me make a few points. 

The first is that, with any area where there is a lot of scientific 

information, the data available to physicians and patients changes 

month by month with more publications by Dr. Rossouw’s group 

and others around the country. The challenge we have at FDA is 

interpreting this information, deciding which of that information 

warrants changing the instructions to patients and physicians. 

At any one moment, when we are convening, when we get together at advisory committees, and we meet internally and we 

make a decision about how to change a label and change the instructions, we base it on the best information that we have available at that moment. 

We are aware, as we were when we most recently changed the 

labeling, that there are many ongoing studies on hormone products. 

So we anticipate continuing to make changes in these instructions. 

But at the point which we put on those warnings, that was the best 

information we had. 

We do know that the news is not all bad. There are some women, 

at some times in their life, depending on their symptoms, who may 

benefit from short courses of these hormones. It wouldn’t be right 

for us to completely shut the door and say they are never indicated, 

never appropriate. 

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Senator SMITH. So that brings me to the obvious question: 

Should the FDA then require black box warnings for compounded 

products containing hormones? 

Dr. GALSON. The issue there and, you know——

Senator SMITH. There are none now. 

Dr. GALSON. We really share your concern about this. One of our 

major problems with compounded products, be they prescription 

compounded products or over-the-counter hormone products, is that 

they don’t contain the same sort of comprehensive labeling that 

FDA-approved products have. 

For example, the information available on the Web site for the 

product you mentioned—although I haven’t looked at it personally, 

I can see it up there—and other products just doesn’t match what 

we think the state of the science indicates patients and physicians 

should have. 

So we share your concern about that. 

Senator SMITH. Well, it needs to match. 

It is my understanding that when asked by my staff for a full 

written accounting and summary of enforcement actions taken 

against compounding pharmacies in general, and bioidentical products in particular, the FDA proffered a mere three examples of enforcement activity. 

Specifically, (1) was a 2001 limited survey of compounded drugs; 

(2) 16 warning letters issued in 2005; and (3) an assertion that the 

FDA may inspect a pharmacy on a for-cause basis. 

Given that, by your own policy, compounded pharmaceutical 

products are unapproved new drugs subject to enforcement under 

the Food Drug and Cosmetic Act, why has the agency done so little 

to regulate this industry and to protect consumers from bad actors? 

Dr. GALSON. As you know, there are tens of thousands of these 

pharmacies, and we have a lot of other compliance activities that 

are going on throughout the agency not related to compounded 

drugs. So, at any one moment, we have to balance the resources 

that we have available with the largest risks to public health. 

We have taken regular action against compounded pharmacies. 

Sure, you can argue that we should do more. We have to, at any 

moment, balance what we can do with the information out there. 

We do think it is important to continue to take these compliance 

actions, and we are going to do that. 

Senator SMITH. Well, I know you are under a lot of pressure from 

a lot of different angles. I am just simply aware in the press and 

best-selling books out there now, a lot of things are being pushed 

right now that really do demand, I believe, a more vigorous response from the FDA. 

I am very troubled by the thousands of Web sites touting bioidentical products as natural and safe, in light of the fact that 

there is no regulation regarding the term ‘‘bioidentical.’’ What precisely that term means, I don’t know. I don’t know that there is a 

definition out there. I think there needs to be one. Medical doctors 

have one definition, yet marketers use the term in a myriad of 

ways. 

The FDA has indicated to my staff that, ‘‘The term ’bioidentical’ 

has no defined meaning in any medical or conventional dictionary 

and is not accepted by the agency as a substantiated labeling 

50

claim.’’ Therefore, since the term ‘‘bioidentical’’ has become commonplace in the industry, shouldn’t the FDA develop guidance with 

respect to the term that could be used both on over-the-counter and 

prescription products? Is there any effort to do that, to define this? 

Dr. GALSON. The term, you are correct, does not mean anything 

to us. 

I was just talking to Dr. Rossouw before the hearing got started 

about the fact that in my remarks I was very careful to say ‘‘socalled bioidentical’’ hormones. Dr. Rossouw didn’t mention the term 

at all. 

We hate this term. We don’t think it means anything. We are not 

sure that it should mean anything. 

It implies, by the very words ‘‘identical’’ and ‘‘bio,’’ that it is 

something that patients should like and should use. We just don’t 

think—we think these are drugs, and they deserve warning labels 

like the drugs that we approve. 

Senator SMITH. So you have a problem with all the Web sites out 

there using this term that holds out medical promise and hope? 

Dr. GALSON. I certainly do. 

Senator SMITH. I certainly hope that the FDA will define the 

term ‘‘bioidentical’’ or at least repudiate it; and that then the FTC 

will do its part in getting these Web sites down. It just shouldn’t 

be happening in this day and age. 

Do you have any comment about the term ‘‘bioidentical,’’ Dr. 

Rossouw? 

Dr. ROSSOUW. Except to agree with my colleague. It is not a medical term. It is a marketing term. 

Senator SMITH. Yes. That is the same kind of marketing they 

used to do in the 19th century. 

Let me thank you all. This is, I am sure, not pleasant for you, 

but it is important to the American people that we highlight what 

is out there and that they not just be told, ‘‘Buyer beware,’’ because 

we are dealing with people’s health here. 

So, please regard this hearing as done in the spirit of trying to 

get information out there so that people aren’t just told to beware, 

that they actually have the opportunity to buy products that have 

health benefits to them and are not scammed by things that may 

actually be harmful to their health. 

So, with that, I thank you for your attendance. 

We will call up our next panel. 

On our second panel, we are pleased to welcome medical experts 

and industry representatives to further outline these issues. 

Our first witness will be Dr. JoAnn Manson, who is the Chief of 

preventive medicine at Brigham and Women’s Hospital in Boston. 

She is also the Elizabeth F. Brigham professor of Women’s Health 

and professor of Medicine at Harvard Medical School. Dr. Manson 

is a recognized medical expert in hormone therapy and has published a substantial body of work on the topic; and has recently 

served as a medical consultant for the ‘‘Today’’ show. 

That is why I recognize you. 

She will be followed by Dr. Leonard Wartofsky, who is the chairman of the Washington Hospital Center’s Department of Medicine 

and is the president of the Endocrine Society, an internationally 

recognized association of 11,000 members from over 80 countries. 

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He will be followed by Dr. Loyd Allen. He is here representing 

the International Academy of Compounding Pharmacists. Dr. Allen 

also serves as the editor-in-chief of the International Journal of 

Pharmaceutical Compounding, among several other pharmacy-related posts. 

Our final witness will be T.S. Wiley, who is a researcher, published author, creator of the Wiley Protocol, a bioidentical hormone 

regimen that she has developed for women seeking an alternative 

to conventional hormone therapy. 

Dr. Manson, we will start with you. 

STATEMENT OF JOANN MANSON, CHIEF OF PREVENTIVE MEDICINE, BRIGHAM AND WOMEN’S HOSPITAL, PROFESSOR OF 

MEDICINE, HARVARD MEDICAL SCHOOL, BOSTON, MA 

Dr. MANSON. Thank you. 

Ranking Member Senator Smith, thank you for the opportunity 

to speak to you today about bioidentical and custom-compounded 

hormones. 

Because of the risks of conventional hormone therapy that you 

have heard about, identified by the Women’s Health Initiative, including stroke, venous blood clots, breast cancer, and other health 

problems, there has been a growing interest in bioidentical and 

custom-compounded hormones as potentially safer alternatives. 

The key question is: Are these products indeed safer or more effective than conventional hormone therapy, as proponents of these 

treatments claim? 

Unfortunately, there is little evidence, as you have heard, to support this assertion. Moreover, women are not getting accurate and 

unbiased information to help them make an informed choice about 

the use of these hormones. 

In addition, what is the rationale for a different policy about 

FDA regulation of bioidentical hormones when they are manufactured en masse and sold by retail pharmacies, where there is full 

FDA regulation, and not for bioidentical products that are customcompounded by pharmacists? There is no clear rationale for a difference in regulation. 

Advocates of bioidentical hormones, particularly custom-compounded ones, assert that these products are more effective at relieving menopause symptoms, have fewer side effects, and offer a 

better balance of long-term health benefits and risks than other 

hormone options. 

However, the truth is, we simply don’t know that these claims 

are valid. Large-scale, scientifically rigorous studies of bioidentical 

hormones have not been conducted. 

Until we have solid data to indicate otherwise, virtually all medical authorities and professional societies agree that a conservative 

and prudent approach is to assume that all hormone formulations 

confer a similar balance of benefits and risks. 

The following are specific concerns about custom-compounded 

hormones due to their lack of FDA oversight. 

As you have heard, quality control is problematic. Preparation 

methods can differ from one pharmacy or pharmacist to another, 

so patients may not receive consistent amounts of hormones. In addition, inactive ingredients vary, and contaminants may be present. 

52

Such quality control problems have been demonstrated by a government study in 2001. The government purchased and tested 29 

products, including hormone preparations from 12 compounding 

pharmacies, and found that 34 percent of the samples failed one or 

more standard quality tests. Ninety percent of the failing samples 

contained less of the active ingredient than advertised. 

In contrast to this 34 percent failure rate, the failure rate for 

FDA-approved drug therapies was less than 2 percent. 

Another problem is that the value of saliva or blood testing of 

hormone levels to guide dose adjustments for these hormones is unsubstantiated. 

Before custom-compounded hormones are prescribed, a saliva or 

blood test is often performed to measure a woman’s natural hormone levels. The belief is that the test can guide the dose of hormones to prescribe. 

However, the value of these tests is highly questionable and not 

supported by scientific evidence. Hormone levels fluctuate throughout the day, as well as from day to day, and these levels are not 

clearly linked to severity of menopausal symptoms or to the dose 

of hormones needed to control symptoms. 

Expense and cost are also important issues. Many custom-compounded hormone products, as well as the associated blood or saliva testing, which must be done every few weeks or months until 

hormones are ‘‘balanced,’’ are expensive and not covered by health 

insurance. 

Some women’s out-of-pocket costs, which can add up to thousands of dollars per year, tend to be higher with custom-compounded hormones than with bioidentical hormones or other hormones that are covered by health insurance—the traditional hormone therapy. 

Consumers lack reliable product information and can fall prey to 

misleading advertising claims. Unlike retail pharmacy prescriptions, compounded products are not required to have a warning 

package insert with information about benefits and risks, and as 

you have heard, do not have a black-box warning and are subject 

to fewer checks on their advertising claims. 

Some women may request bioidentical or custom-compounded 

hormones because they are misled by the following claims often 

made by their proponents. 

One claim is that bioidenticals are not drugs. This is false. Bioidentical products are indeed drugs that provide hormone doses 

that are not usually experienced by women after menopause. As a 

result, they cannot be considered natural. These are not natural 

levels that women experience during the post-menopause. 

It is important to consider that even a woman’s natural estrogen 

can confer some health risks, as Dr. Rossouw mentioned. For example, women with higher natural estrogen levels after menopause, 

as seen with obesity, have a higher risk of breast cancer. Also, 

women’s natural estrogen levels climb during pregnancy. This rise 

is linked to a higher risk of blood clots in the legs and lungs. 

So the assertion that bioidentical estrogen has no risks because 

it is natural is untrue. The assertion that bioidentical estrogen confers less risk than synthetic forms of estrogen is unproven. 

53

How can we determine whether bioidentical hormones are safe 

and effective? By conducting well-designed clinical trials which are 

scientifically rigorous to gauge the safety and effectiveness of these 

medications. 

Unfortunately, for many bioidenticals, and for custom-compounded bioidenticals specifically, such trials have not been done. 

Without clinical trials, we simply don’t know how safe or effective 

these drugs are. 

Trials of a relatively small size and short duration could prove 

or disprove whether such hormones are effective in treating hot 

flashes, night sweats or other symptoms of menopause. These trials 

would have to be placebo-controlled. 

However, larger-scale trials, even more than 25,000 women—the 

scale of the Women’s Health Initiative, the both hormone trials—

would be needed to substantiate or refute the claim that bioidentical or custom-compounded products are safer than conventional 

hormone therapy in terms of clinical outcomes such as heart attack, stroke, or venous blood clots, or breast cancer. 

Mid-size studies can be done to look at intermediate end-points 

such as blood markers of clotting or inflammation and also noninvasive imaging of atherosclerosis. Some trials, such as the Kronos 

Early Estrogen Prevention Study and the ELITE Trial, are in 

progress looking at those issues. But they cannot address whether 

there is a difference in clinical outcomes such as cardiovascular 

events or breast cancer. 

In summary, the prudent policy, in the absence of scientific evidence to the contrary, is to assume that all post-menopausal hormone formulations confer similar risks and benefits. However, 

many proponents of custom-compounded bioidentical hormones are 

making unsubstantiated claims of superiority that run directly 

counter to this policy. 

Given this pervasive and misleading marketing, I have a deep 

concern that women, and even some of their doctors, are not getting the objective information necessary to make well-informed 

choices about hormone therapy. 

There is an urgent need for increased regulatory oversight of custom-compounded bioidentical hormones as is done for traditional 

hormone therapy, including assessment of purity and dosage consistency, the inclusion of uniform patient information about risks 

and benefits in the packaging of these products, mandatory reporting by drug manufacturers and compounding pharmacies of adverse events related to these hormones, and clinical trials testing 

the safety and efficacy of these products. 

Thank you very much. I would be happy to answer any questions. 

[The prepared statement of Dr. Manson follows:]

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Senator SMITH. Dr. Manson, I wonder if you would agree with 

the conclusion of some on the first panel that ‘‘bioidentical’’ is a 

marketing term and it has no medical definition? 

Dr. MANSON. I would agree. I think that there is a great difference between the way the term ‘‘bioidentical’’ is used by scientists and the way it is being used by alternative medicine practitioners and in the mass media. 

The scientists use it for hormones that are chemically identical 

to those produced naturally by the body. 

There are three types of natural estrogen that women make. In 

addition, there is progesterone, as well as testosterone, and other 

hormones. Many of these hormones, as we have discussed, these 

bioidentical hormones, are available through FDA-regulated medications that are produced en masse and available in retail pharmacies. 

These custom-compounded hormones, often we don’t even know 

what is in them. They do not have any clear advantage over the 

bioidentical hormones that include the estradiol or progesterone 

that are available through a retail pharmacy. 

Senator SMITH. Do you know of any head-to-head studies between traditional hormone therapy versus bioidentical hormone 

therapy? 

Dr. MANSON. That is an interesting question. The only current 

trial is the Kronos Early Estrogen Prevention Study, and it is ongoing. The results are not yet available. It is a head-to-head comparison of oral conjugated equine estrogens, which were tested in the 

Women’s Health Initiative, but a lower dose is being tested in the 

Kronos trial, and a transdermal estradiol patch. 

Senator SMITH. Who is doing that test? 

Dr. MANSON. It is being done by the Kronos Longevity Research 

Institute, a private foundation. It is not a drug company-sponsored 

trial. 

Senator SMITH. Do you think the Federal Government ought to 

take the lead in it, or participate in it, or——

Dr. MANSON. I think it would be helpful for the Federal Government to get involved in providing some support so that women can 

get answers to these questions. So it will be comparing the oral 

conjugated estrogens in low dose with the transdermal bioidentical 

form of estradiol. 

Senator SMITH. You spoke in your testimony about the role of the 

physician in prescribing bioidentical hormones. Do they have 

enough information to prescribe them? Are they doing that? 

Dr. MANSON. Yes. Some of them are. 

I do not think that, with how busy physicians are these days and 

all of the other issues that they have to attend to, that most have 

really gotten the information that they need about what bioidentical hormones are, what custom-compounded hormones are—all of 

these issues and concerns that we have been discussing this morning—and that they really have a full understanding of what they 

are prescribing for their patients because of just a lack of available 

information. 

Senator SMITH. I mean, the obvious conclusion is some of them 

may unwittingly be practicing some form of quackery by getting 

into this area. 

66

Dr. MANSON. Well, I think that more information is necessary. 

I think that some physicians consider that they have adequate information. 

But given the paucity of information out there, it is hard to understand how a rationale can be given for prescribing these hormones over the retail pharmacy-available hormones, unless there is 

a specific reason, such as a patient is allergic to peanuts and there 

is peanut oil in the natural micronized progesterone that is available in retail pharmacies. 

Senator SMITH. Maybe a message of this hearing ought to be 

‘‘Doctors beware.’’ 

Dr. MANSON. Absolutely. 

Senator SMITH. Thank you, Dr. Manson. 

Dr. Wartofsky, please. 

STATEMENT OF LEONARD WARTOFSKY, PRESIDENT, THE 

ENDOCRINE SOCIETY, CHEVY CHASE, MD 

Dr. WARTOFSKY. Senator Smith, thank you for the opportunity to 

testify today. My name is Leonard Wartofsky. I am chairman, Department of Medicine at the Washington Hospital Center, and Professor of Medicine at Georgetown University. 

But today I am here as President of the Endocrine Society, the 

world’s largest professional organization of endocrinologists, representing over 14,000 members. 

The Society is deeply concerned about the safety of these socalled bioidentical hormones and believes the Federal Government 

should increase regulatory oversight of these compounds. 

As you mentioned in your opening comments, Senator, bioidentical hormones have been touted inaccurately, by high-profile individuals with no medical training, as being safer and more effective 

than traditional hormone therapies. 

You have raised the question of the definition of ‘‘bioidentical.’’ 

As Dr. Manson said, scientists describe compounds as bioidentical 

that are identical to similar compounds produced naturally in the 

body. 

We do not oppose the use or prescribing of FDA-approved bioidentical hormones, which have been available to the public for 

years. Rather, our concern is with custom-compounded bioidentical 

hormones. 

The WHI study uncovered risks to women taking hormone replacement, as we heard this morning. We caution physicians and 

patients alike against the unfounded presumption that 

bioidenticals would be any safer. 

In fact, no study as comprehensive as the WHI has assessed bioidentical hormones. Until authoritative clinical trials of bioidentical 

hormones are conducted, patient safety is best assured by assuming these hormones carry the same benefits and the same risks as 

those studied in the WHI. 

Claims about safety and efficacy come from the belief that compounded hormones are precisely and individually custom-formulated. While theoretically appealing, such customization is difficult, 

if not impossible, to achieve. 

Perhaps most alarming, compounded preparations, as you again 

mentioned this morning, are not required to have the black-box adVerDate 0ct 09 2002 09:09 Sep 28, 2007 Jkt 000000 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 H:\DOCS\37150.TXT SAGING1 PsN: JOYCE
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visory warning, as required for FDA-approved hormones. This is a 

serious concern for women and their doctors. 

Compounding pharmacies are not required to adhere to the strict 

manufacturing processes governing FDA-monitored facilities, raising concerns about purity, potency and quality. 

In one FDA-conducted post-market survey, 4 out of 11 compounded hormones failed tests for potency and/or uniformity. 

Our concerns are shared by the broader medical community, including multiple other professional medical organizations. The 

AMA recently adopted a policy in support of our society’s positions. 

In conclusion, the society supports legislative action to standardize regulation of compounded hormones to include requirements 

for: (1) surveys for purity and potency; (2) mandatory reporting of 

adverse events; (3) a registry of these events; (4) inclusion of uniform patient information in the packaging; and finally and (5) limits on the use of this term, ‘‘bioidentical hormones.’’ The fact is that 

scientific evidence is lacking at this time to either negate or support claims that bioidentical hormones are safer and more effective 

than other commonly prescribed hormones. Until conclusions are 

based on science, the Federal Government must ensure patients receive safe and effective drugs with accurate information. 

That concludes my personal remarks, Senator. I would be happy 

to answer any questions. 

[The prepared statement of Dr. Wartofsky follows:]

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Senator SMITH. Thank you, Doctor. 

I am going to let Dr. Allen testify, and then I have a question 

for the both of you. 

STATEMENT OF LOYD ALLEN, EDITOR-IN-CHIEF, INTERNATIONAL JOURNAL OF PHARMACEUTICAL COMPOUNDING, 

SUGAR LAND, TX 

Dr. ALLEN. Thank you, Senator Smith. I appreciate and share 

your dedication to improving the health of Americans. I thank you 

for the opportunity to speak to you about my profession, pharmacy 

compounding, and the role that we play in preparing compounded 

hormone treatments. 

In the way they are prescribed, prepared and regulated, compounded hormones are just like all other compounded medicines, so 

I will first address pharmacy compounding overall briefly. 

Most of the time, when patients need pharmaceutical treatment, 

doctors prescribe mass-produced, off-the-shelf drugs. But for some 

patients, those drugs are inappropriate. When they are, doctors 

may prescribe compounded medications, which are then customcompounded by licensed and trained compounding pharmacists. 

Compounded medicines are most commonly prescribed for a 

number of reasons. Sometimes patients are allergic to the inactive 

ingredients that are in off-the-shelf products. Other patients require personalized dosage strengths or delivery forms. Also, many 

times pharmaceutical manufacturers discontinue drugs because 

they aren’t profitable but patients still rely on them and can have 

doctors prescribe compounded versions of them. 

Hospice care patients, cancer patients, dental patients, especially 

pediatric patients, HIV and AIDS patients, ophthalmology patients 

all tend to have individual medical needs and, thus, tend to rely 

on compounded medicines. 

State boards of pharmacy, State medical boards, the Food and 

Drug Administration, the Federal Trade Commission, the Drug Enforcement Agency, and other Federal and State agencies each have 

some degree of oversight over pharmacy compounding. The United 

States Pharmacopeia and the Pharmacy Compounding Accreditation Board all play critical roles. Together, they have constructed 

a web of regulations and standards that protect patients. 

State boards of pharmacy license pharmacists and pharmacies 

and enforce laws that cover the processes and equipment pharmacists use to prepare these medicines, including sterile medicines, 

recordkeeping, and labeling, among other aspects of pharmacy 

practice. 

Since 1820, the United States Pharmacopeia has been the national standard-setting body for pharmaceuticals and pharmaceutical ingredients, and recognized by Congress as such. It, too, 

has strong enforceable standards for pharmacy compounding of 

both sterile and non-sterile medications. States are increasingly 

codifying USP standards. 

The profession is also taking action. Most notably, the United 

States Pharmacopeia, American Pharmacists Association, National 

Community Pharmacists Association, National Boards of Pharmacy, and other associations have launched the Pharmacy 

Compounding Accreditation Board. 

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The FDA also regulates aspects of compounding, including the 

suppliers of the ingredients that pharmacists use to compound. 

FDA also has authority to inspect any pharmacy’s facility, equipment and ingredients. Federal laws also prohibit the making of unsubstantiated claims of safety and efficacy. 

A fundamental question is, what is the difference between compounded and manufactured medicines? 

First, compounded medications are always prepared pursuant to 

a doctor’s prescription. Second, compounded medicines are retail 

only, sold directly to the patient. 

Third, they are not copies of commercially available drugs. They 

are significantly different, as determined by the prescriber, whereas manufactured medicines are produced well in advance of any 

prescription and distributed at wholesale. 

So how does this relate to hormone therapy? As I said, like compounded medications overall, by definition compounded hormones 

are always prescribed by doctors, prepared pursuant to those prescriptions, and dispensed directly to patients at retail. 

Compounded hormones meet the needs of patients that are otherwise unmet by manufactured hormone products. For many patients, these products are effective, but for some, they are not. That 

may be because the manufactured drugs simply don’t relieve the 

symptoms of menopause. It may also be because doctors determine 

that their patients need a lower dose than what is available commercially. The Women’s Health Initiative recommended that 

women in search of relief from menopause symptoms take the lowest effective dose. 

Doctors may find that some patients respond better to different 

delivery forms or drug combinations. Also, some drugs are made 

with peanut oil, and patients allergic to peanut oil may need the 

active ingredient to be compounded without it. 

Each and every time, though, that doctors prescribe compounded 

hormones, they do it because they determine that their patients 

have needs for medications that are significantly different from 

what is manufactured. 

Compounded hormones, like compounded medicines overall, are 

regulated by State boards of pharmacy. The U.S. Pharmacopeia 

and Pharmacy Compounding Accreditation Board set standards for 

their preparation. FDA regulates the suppliers of the ingredients 

that pharmacists use to compound these medicines. the FDA and 

the Federal Trade Commission regulate the marketing practices of 

pharmacies. 

In conclusion, millions of women have been prescribed manufactured hormone products. Many of them have found relief from the 

torturous symptoms of menopause. Some have not and, instead, 

have been prescribed compounded hormones by their physicians, 

and they have found relief. 

I would respectfully urge the members of this committee, and 

Congress overall, to consider the impact of any new policies that 

they would have on them. 

Thank you. 

[The prepared statement of Dr. Allen follows:]

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Senator SMITH. Dr. Allen, as I have listened to your testimony, 

it seems to me that you are saying the doctor just recommends a 

certain compound and sends that to the pharmacy, and then that 

is a kit made just for that particular patient. 

What guidance do they have? I mean, is it just based on their 

training as a physician, or is there something deeper that they 

know that traditional therapies don’t have? 

Dr. ALLEN. Pharmacists will only fill a prescription from a licensed physician or a health-care practitioner. It is the responsibility of the health-care practitioner to care for the patient and to 

prescribe appropriate medications. 

So, yes, you are correct. When the physician determines that a 

specific patient needs a compounded medication, then it is originated at the physician’s office. 

Now, in some cases——

Senator SMITH. Well, I assume, because they are doctors, they 

are very well-trained, but I don’t know if their training goes this 

deeply into how all these things interact. 

I am not a physician. I was trained in law. But I would think, 

based on my training in law, they are out there on their own, if 

they are doing this, if there is some ill effect from it. 

Dr. ALLEN. That is correct. They are trained. 

Basically the physician will prescribe, first of all, the drug, the 

dose, the dosage form, the frequency of administration, and the 

quantity. That would all go on the prescription. Then they work 

with the pharmacist in order to compound the medication specifically for that patient. 

Senator SMITH. Is there any ever very ill effects from this pioneering method that each physician would take? 

Dr. ALLEN. Well, there are obviously ill effects from almost any 

medication that may be prescribed across the board. But with clinical experience, the physicians, you know, continue to prescribe 

medications for these specific patients. 

Senator SMITH. So it is sort of an ad hoc building block. What 

has worked in the past? Let’s try this and do that? 

Dr. ALLEN. Yes. It is very similar to just the standard practice 

of medicine. Not everything works for everybody, and so the physicians will try a drug product until they find something that that 

specific patient will respond to. 

Senator SMITH. I appreciate the education you are giving me. 

Dr. Wartofsky and Dr. Allen, your two organizations have two 

very different positions as to who ought to regulate bioidentical 

hormones made by compounding pharmacies. The International 

Academy says States are best to regulate it. The Endocrine Society 

believes that the FDA, the Federal Government, is best to regulate 

it. 

I wonder if you can each tell the committee how your groups 

have reached their very different positions, including what evidence 

or information you found to support the conclusion of your academy 

or society. 

Specifically, did you consider mortality and morbidity rates, consumer complaints, State statutory and regulatory provisions regarding compounding? How did you come to such different places 

on that? 

83

Dr. WARTOFSKY. In the case of the Endocrine Society, I mentioned our professional organization of endocrinologists, the specialty of medicine that deals with hormone therapies. Our members 

brought to our attention that they were getting questions from 

their women patients about these bioidentical hormones. They were 

lacking information. They were concerned about the claims that 

were being made about these bioidentical hormones—custom-compounded hormones. 

Although Dr. Allen is correct that pharmacists should not prescribe anything without a prescription written by a physician, our 

information is that there are large pharmacy chains that sell these 

products on the Web; that one can get these mail-order; that they, 

in fact, will provide the names of physicians who will write prescriptions for these compounds. 

We believe these physicians are acting without a basis in science, 

as you alluded to, that they are perhaps on the fringe of medicine 

and do not represent our mainstream endocrinologists. 

Senator SMITH. These pharmacies—we call it ‘‘forum shopping’’ 

in the law—do they doctor-shop to find physicians who——

Dr. WARTOFSKY. I am sure that is the case, yes. 

Our concern about the need for a Federal regulation is because 

the degree of regulation by the States is highly varied. From State 

to State, there is no consistency. 

The National Association of State Boards of Pharmacy has issued 

guidelines for compounding which, as of recently, were adopted and 

codified by less than a quarter of the States in the U.S. So these 

guidelines are not uniform. 

We have heard this morning how difficult it is for the FDA, given 

everything that is on their plate, to do the kind of enforcement and 

regulation that Dr. Allen indicates that they do do, because this is 

not happening. It just is not feasible, given the broad practice of 

the dispensing of these bioidentical hormones. 

So we believe there should be some greater oversight at the Federal level with more formal guidelines for regulation under which 

the State boards of pharmacy would operate; that there would be 

consistency throughout the country; and importantly, that there 

would be more teeth put into the regulations with enforcement. 

Senator SMITH. Dr. Allen, obviously, if these products are being 

sold on the Web and somebody in Oregon can get it from a doctor 

in Arkansas on a Web site, that is clearly an interstate commerce 

issue. That is where the Federal Government comes into play. So 

I wonder how you reach a conclusion that the States ought to do 

it. 

Dr. ALLEN. Well, basically the individual States recognize professions—medicine, pharmacy, nursing, et cetera—in their State professional acts. In addition to that, they establish certain laws governing that profession and State boards to regulate those and enforce those. 

The State boards, then, enact regulations to govern the practice 

of pharmacy. So the practice of pharmacy and medicine is something that should be regulated at a State level. 

Now, from the pharmacy standpoint, if a pharmacy sends a compounded preparation into another State, they are required to be 

registered with the State board of pharmacy in that State. 

84

Now, when you are talking about the other aspects of it—the 

physician’s prescription—that is getting into marketing, and that is 

a different story. Probably should be under the FTC or whatever. 

But the pharmacies—any State that a pharmacy sends a compounded prescription to, they must be registered in that State. 

Senator SMITH. Well, the lack of concrete evidence on the whole 

issue of bioidenticals is what has led me and my staff to conclude 

that we need some more information. That is why I have asked the 

Congressional Research Service to prepare a report on the status 

of laws across all 50 States. 

It seems to me that before we can assess who is in the best position to regulate this industry, we need to know more than we now 

know. 

I guess a further question is, does each State track adverse related events in pharmacy-compounded products? In other words, 

does the Oregonian who gets the prescription out of Ohio—how do 

they track it, what it has done to them? 

Dr. ALLEN. Currently, there is no requirement for pharmacists to 

report any adverse reactions for either a commercial manufactured 

product or a compounded preparation. 

Now, the USP in our chapter—it is either 795 or 1075—there is 

a statement that adverse reactions should be reported to the USP 

MedMarks reporting system. That is something, I think, that can 

very easily be adapted to this so that it becomes a standard of 

practice. 

Senator SMITH. Without the information, though, how do we 

know that people aren’t being harmed? Shouldn’t the States or the 

FDA track the information? 

I mean, it does seem to me that this is an area where the Federal Government really ought to get involved and play a role. 

Dr. ALLEN. Currently, the success of therapy or any adverse responses to therapy should be picked up by the physicians and 

changes in therapy made. I would think that a physician would—

it would be incumbent upon them, if the patient is not responding 

or is responding adversely, that there would be a change in the 

therapy of that patient. 

Senator SMITH. Do you feel like there are some physicians out 

there that will prescribe anything for a fee? That this may not be 

being done at the highest standards of science? 

Dr. ALLEN. I can’t really answer that question. 

Senator SMITH. Dr. Allen, you are going to feel like I am picking 

on you, and I am not trying to. I am asking these questions for the 

record of the U.S. Senate and for my own understanding of this 

issue, because there is reason to be concerned. 

It leads me to my next question. 

Some of the biggest criticisms against compounded products that 

I have heard are their variability in composition, the fact that physicians and patients may not know exactly what is in the final 

medication, and the lack of warning labels and patient information. 

So, as to the labeling issue, I understand the International Academy of Compounding Pharmacists has developed a suggested label. 

That label, however, as has been suggested, does not mention the 

potential risks, any side effects, any contraindications of medications that may be present. 

85

If so, why not? It seems to me like the most basic kinds of labeling that consumers ought to have. 

Dr. ALLEN. You are exactly right. 

Now, to address that issue, the USP standards for compounding 

are currently looking at incorporating additional labeling standards 

for all compounded preparations to at least incorporate the level of 

information that you just mentioned. 

In addition to that, you have referred to black box warnings and 

things like that previously. The U.S. Pharmacopeia has had a set 

of reference books called the ‘‘USP Drug Information.’’ There have 

been three volumes: Volume One, Drug Information for the Health 

Care Practitioner; Volume Two, Drug Information for the Patient; 

and then Volume Three, which is basically the FDA orange book, 

et cetera. 

What is feasible is to take the information, the data, from Volume Two and put that in a data base in the pharmacy 

compounding computer system software, so that as prescriptions 

are filled for specific drugs, like progesterone or whatever, it will 

automatically print out the information for the specific patient, just 

like the commercial products is being done today. So that is something that we are looking at. 

Senator SMITH. Well, thank you. I think it is very important. 

I think the most vital consumer information is what customers 

ought to be given, and it ought to include the risks, the side effects 

and what kind of consequences there may be for using these products. So, I don’t think we have that yet. 

But thank you, Dr. Allen. 

Dr. ALLEN. You are welcome. 

Senator SMITH. Ms. Wiley, your testimony, please. 

STATEMENT OF T.S. WILEY, WRITER/RESEARCHER, CREATOR 

OF THE WILEY PROTOCOL, SANTA BARBARA, CA 

Ms. WILEY. Mr. Chairman, members of the committee, I am T.S. 

Wiley, and I thank you for inviting me to address you on the subject——

Senator SMITH. Can you hit your microphone button? There you 

go. 

Ms. WILEY. I thank you for inviting me to address you on a subject to which I have devoted over a decade of my life. 

I have no formal training or indoctrination in the world of medicine. I am a writer and a researcher in the areas of endocrinology 

and women’s health. 

Over 47 million women in menopause in our country are facing 

the same dilemma we are in this room today: what to do. 

At the turn of the century, women died on average by 47. But 

life expectancy is now well over 80. That means a great many of 

us must go on perhaps 30 years or more without the hormones that 

our minds and bodies have always had. 

The Women’s Health Initiative, now the gold standard regarding 

hormone replacement therapy, interestingly enough never looked at 

hormones at all; only drugs with hormone-like effects that were 

dosed in a regimen that in no way resembled replacement in 

human beings. 

86

The only thing the WHI proved was that static doses of synthetic 

hormone-like drugs caused cardiovascular harm in women over 65. 

This information was not pertinent to women 40 to 60 looking for 

answers. Thirteen years ago, I was one of those women. 

To me, the answer seemed simple. Since women’s hormones are 

rhythmic with ups and downs across the 28-day cycle, I decided to 

copy nature precisely with a bioidentical regimen based on a model 

of hormone replacement seen in Type 1 diabetics who use bioidentical insulin—you may argue with the term—biomimetic insulin—

taken through the skin and fat in doses their bodies would have 

produced it. 

That is all there is to the Wiley Protocol. It is a simple, logical 

model using bioidentical compounded estrogen and progesterone in 

variable dosing. 

I arranged for the reporting of adverse events. We use a patient 

insert with contraindications and warnings, and we test for purity 

and potency quarterly in the pharmacies I work with. 

I have standardized the production, the methods and materials, 

of the compound so it could merit study on a large scale in clinical 

trials, of which there are none right now, except, I believe, the one 

we are planning at the University of Texas. 

Menopausal women are orphans in the health-care system in this 

country. There is no one to take care of us. Doctors prescribing the 

standard of care, HRT, or even bioidentical hormones have little 

support or education in the matter. 

Big pharmaceutical companies and the compounders are now at 

war over who gets to make a fortune on us women. 

Instead of modeling hormone replacement like diabetes care, 

women were given a once-a-day-dose pill of synthetic drugs, instead 

of hormones, because that was easier for the pharmaceutical company and the doctors to monitor. 

The last pronouncement from the NIH was just that quite simply 

the drugs—and they weren’t hormones—studied by the WHI don’t 

work. They are, in fact, dangerous, now that you have bothered to 

look 20 years later. 

So now women just can’t have any hormones because big pharma 

couldn’t get it right in the first place. That is unacceptable. 

The majority of Western medicine has been on a wild goose chase 

for the elusive proof that being completely hormoneless will save 

our lives in the face of massive evidence with all of our estrogen 

blocked at every turn we still keep dying of cancer. Logically, if 

high circulating estrogen caused cancer, all young women would be 

dead; all pregnant women would be dead. 

Now, the most recent move to keep us hormoneless is the debate 

over the value of compounded bioidentical hormones. 

The National Institute of Neurological Diseases and Strokes sees 

the value in compounded hormones. 

A national clinical trial designed to see if high doses of compounded progesterone can protect the brain from destruction is 

planned for military use and because 78 million voters are in their 

peak years for stroke and degenerative brain disease. 

Each year, 700,000 Americans suffer strokes and 500,000 more 

are diagnosed with neurodegenerative disease. 

87

Dr. David Wright at Emory University Medical School in Atlanta 

has been testing compounded progesterone for head injury. In a 3-

year trial of 100 such patients, 80 received high-dose progesterone 

over 72 hours after trauma and 20 did not. 

The study on young men—not women—found that those receiving compounded progesterone were 50 percent less likely to die. 

There was less disability at the 1-month mark than would normally be expected considering the severity of their head injuries. 

Marcus Baskett of Commerce, GA, was one of those patients in 

a head-on automobile collision just 3 weeks shy of his high school 

graduation. Early tests of his brain function suggested massive and 

disabling head injury. 

He spent almost 3 weeks in a coma. Then, 4 weeks later, Baskett 

was released with lingering physical injuries but little evidence of 

the severe head trauma. Three years later, a 21-year-old Baskett 

is back 100 percent. 

There are uses for compounded bioidentical hormones that none 

of us have ever even imagined. To consider eliminating them is to 

limit the researchers’ imagination everywhere. 

[The prepared statement of Ms. Wiley follows:]

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Senator SMITH. Thank you very much, Ms. Wiley. You have given 

us another view, and we respect that. 

I guess the thing that leads to my questioning of you is clearly 

the FDA gives a black box warning for hormone therapy when even 

the slightest amounts or smallest amounts of hormones are used. 

They tell you to do it for a short duration. 

You, however, developed a protocol that uses higher amounts and 

for longer periods, as I understand it, recommended for lifetime 

usage. We have heard differing views at this morning’s hearing. 

I wonder, your protocol’s approach contradicts that held by the 

larger—the greater—medical community on hormone therapy. You 

have said you are not a medical doctor. Can you explain how your 

proposal doesn’t put women at greater risk? 

Ms. WILEY. Yes. Hormones, as I am sure Dr. Wartofsky could 

agree, are dose-dependent in their effects on cellular systems and 

different in every organ in the body. 

The normal menstrual rhythm, or the normal production of hormones over the course of 28 days in a healthy young woman who 

does not have breast cancer, heart disease, Alzheimer’s, arthritis, 

osteoporosis—we could go on for days—in those healthy young 

women, is a rhythmic production with a crescendo of estrogen on 

day 12 and a crescendo of progesterone on day 21. 

In using bioidentical transdermal hormone creams, it is possible, 

through justification with blood work, to recreate a dosing schedule 

that mimics those normally rolling hormones that provoke something called apoptosis, which is cell suicide, in the progesterone 

phase, that in the estrogen phase on day 12 provoked the progesterone receptor so that apoptosis can happen. 

Endocrinology is about pulsatility and amplitude. A diabetic, for 

example, would never take the same amount of insulin day-in and 

day-out. The diabetic responds to the meal the diabetic ate with the 

appropriate amount of insulin that his body might have produced 

could he produce it. I only suggest that women are treated the 

same way. 

Senator SMITH. You obviously believe that the bioidentical products ought to have a medical definition. 

Ms. WILEY. Yes, I do. 

Senator SMITH. OK. It is not just a marketing term. 

Ms. WILEY. No. Well, I think ‘‘bioidentical’’ is a marketing term. 

I think ‘‘biomimetic’’ is more accurate. But there are differences in 

the effects of the molecule of estradiol versus conjugated equine estrogens, very big differences, certainly on inflammatory response in 

cardiovascular events. 

Senator SMITH. Thank you. 

Dr. Manson, have you reviewed the Wiley Protocol? 

Dr. MANSON. Yes, I have. 

Senator SMITH. Do you have any problems or concerns? 

Dr. MANSON. I think it is an interesting theory, and I would like 

to see it tested. 

But I think we have to note that in the post-menopausal woman, 

there are not these levels of estrogen and progesterone that are 

achieved with this treatment, so it is not a natural state that is 

being induced. 

137

We just don’t know what the health effects are, especially of very 

long-term, indefinite use. We don’t even know the short-term effects. 

I would like to see funding of trials to look at hormone regimens 

that do more closely simulate what happens in a woman’s natural, 

pre-menopausal state. I think that is very important to have that 

research and to do those studies. But at this point in time, I don’t 

think we can reassure women that this is any safer, any more effective, without rigorous science. 

I would ask the question, why would any woman agree to spend 

so much out-of-pocket to pay for the hormones, to pay for these 

blood or saliva tests, if she really understood that there was no evidence that these treatments were any more effective than treatments that could be covered by her health insurance; that there 

was really no rigorous evidence that these tests were useful in 

guiding her hormone therapy treatment, and also if she were 

aware of the concerns about dosage consistency and impurities? 

So I think it is clear that women are not getting the information 

that they need, or else it seems very unlikely to me that this would 

become as popular as it has become. 

Senator SMITH. Ms. Wiley, would you welcome a Federal scientific test of these things? 

Ms. WILEY. Oh, absolutely. 

Senator SMITH. A vigorous——

Ms. WILEY. Absolutely. 

Right now, the University of Texas at Tyler, through the nursing 

school, is entertaining giving us an IRB number, an Internal Review Board number, so that we can be watched—the women who 

are on the Wiley Protocol now—in a longitudinal observational 

study. We would love to go head-to-head with the commercial products. 

Senator SMITH. Are you tracking occurrences of any adverse effects? 

Ms. WILEY. Absolutely. Dr. Julie Taguchi in Santa Barbara, CA, 

is in touch with all the doctors who will report to us. We track 

them not only through the doctors but through something——

Senator SMITH. There are adverse events? 

Ms. WILEY. We have seen two blood clots in I would say we have 

watched over 1,000 women almost face-to-face in Santa Barbara. 

There are many more that report to us from Santa Fe, NM, for example. There are pockets of women all over the country——

Senator SMITH. What do you do with the information, you know, 

of an adverse event? 

Ms. WILEY. Dr. Taguchi chronicles it and keeps it. 

We right now have reported on cancer patients who have taken 

the Wiley Protocol post-diagnosis without active cancers. That was 

reported to a large group of doctors at the American Academy for 

the Advancement of Medicine, ACAM. 

Senator SMITH. I understand that you require pharmacies to be 

certified——

Ms. WILEY. Well, I——

Senator SMITH [continuing]. Before they can dispense drugs. 

Ms. WILEY. I found that for the Wiley Protocol I expected a certain rigor in compounding. I perceived that there is a process that 

138

makes these hormones uniquely standardized. In other words, a 

woman in New Mexico can pick up the same Wiley Protocol as a 

woman in New York City if, in fact, she goes to a pharmacy that 

has agreed and committed to make them in this certain way. 

I went for standardization because, obviously, it removes variables for the doctors in discerning what is going on with their patients. More importantly, I was aware that no large pharmaceutical 

company is going to sponsor clinical trials for the Wiley Protocol, 

and that clinical trials would be useless without a standardized 

compound. 

So by engaging enough pharmacies and asking them to donate 

a percent of their volume that they do in the Wiley Protocol, ultimately, to a national trial, I would have a standardized product 

that could be looked at. 

Senator SMITH. Do you have any relationship to the FDA? Do 

they monitor what you do? 

Ms. WILEY. No. Other than they monitor the bulk substances 

that the Wiley Protocol, you know, derives from. 

Senator SMITH. But they have investigated your products, I assume, and——

Ms. WILEY. I believe they only investigate the bulk material that 

pharmacists use, and then that is, as Dr. Allen said, a pharmacyto-pharmacy case, whether or not FDA inspects——

Senator SMITH. Those women who sign up for the Wiley Protocol, 

you have found overwhelmingly good results? 

Ms. WILEY. Surprisingly good results. 

I don’t know what I anticipated. I was just interested. The 

oncologist I have worked with for over 7, 8 years, and a very large 

group of doctors both in Santa Barbara and around the country, we 

are all surprised at how remarkably well the women seem to do. 

Senator SMITH. Dr. Allen, how does the Wiley Protocol fit within 

your academy’s view of things? 

Dr. ALLEN. Well, I can address it from the formulation standpoint. 

Physicians in prescribing a compounded preparation may want a 

certain effect, and so the pharmacist has some leeway in the different excipients, or non-active ingredients, that can be included. 

So for the Wiley Protocol, it is, as was explained, a set formulation 

so that it can be compared——

Senator SMITH. Which would be different from your members 

who might be coming up with their own formulations and having 

pharmacies produce them? 

Dr. ALLEN. Yes. The individual physician, based upon what they 

want in their specific prescription for their specific patients, they 

have some flexibility in the different excipients that can be used, 

yes. 

Senator SMITH. Dr. Manson and Dr. Wartofsky, if compounded 

products could be standardized, as Ms. Wiley has done with her 

products, would that alleviate your concerns? 

Dr. WARTOFSKY. I would have——

Senator SMITH. Push your button there. 

Dr. WARTOFSKY. Sorry. I would have residual concern. The concern with compounded products is that they may not be of suffiVerDate 0ct 09 2002 09:09 Sep 28, 2007 Jkt 000000 PO 00000 Frm 00142 Fmt 6633 Sfmt 6633 H:\DOCS\37150.TXT SAGING1 PsN: JOYCE
139

cient content, quality, purity, so that women might be either 

underdosed or overdosed. 

So Dr. Allen’s comment that the doctor should pick up these adverse effects really doesn’t apply because some of these effects may 

take years, if not decades. For example, if an estrogenic compound 

is underdosed and leads to bone mineral loss and osteoporosis, that 

will show up 10, 20 years later. The doctor will not pick that up. 

Ms. Wiley’s standardization of her formulation that is going out 

across the country to different pharmacies to me is counterintuitive 

to customization. If she is customizing the dosage for the individual 

patient, how does this fit a standard protocol? 

Her analogy to diabetes and insulin doesn’t hold. In the case of 

diabetes, we have a very specific marker to follow in terms of the 

efficacy of insulin: the blood sugar. 

As Dr. Manson mentioned, the test to measure hormones by saliva or blood tests are notoriously inaccurate and thrown off. So it 

is really impossible, as I mentioned in my statement, to truly customize to an individual woman what her estrogen levels or progesterone levels should be by some standard formulation analogous 

to insulin and blood sugar. 

Ms. WILEY. May I respond? 

Senator SMITH. Yes. Let me get Dr. Manson. Then we will give 

you the last word, like Bill O’Reilly. [Laughter.] 

Dr. MANSON. I agree with all of the concerns expressed by Dr. 

Wartofsky. But I also want to emphasize that some of the risks of 

having an inadequate dose of the progesterone are very serious. 

Women who have a uterus who are taking estrogen have increased growth of the lining of the uterus. It is very important that 

they receive an adequate dose of a progestogen, whether it is natural or synthetic, in order to avoid uterine cancer, endometrial cancer. So if there is an inadequate dose of the progestogen, then they 

are at an increased risk of uterine cancer. 

So I think there are some very serious concerns about not having 

uniformity of dose or consistency, knowing exactly what doses are 

there. 

Also, if women are being told about the lack of scientific studies, 

the lack of evidence that these custom-compounded hormones are 

any safer or more effective then, again, it seems unlikely that they 

would be paying as much out-of-pocket for them and having these 

tests done that have not been proven to have validity. 

Senator SMITH. Ms. Wiley? 

Ms. WILEY. Well, first of all, I am flattered that anyone could insinuate low doses with the Wiley Protocol because we use quite a 

bit at the Wiley Protocol. 

I don’t ever involve myself with individual patient response. That 

belongs to their doctor. 

However, by testing potency four times a year at the registered 

pharmacies to make sure what is on the label is in the syringe—

and we use syringes—by following these women with what seems 

to be a standardized dose—it is one dose not fits all, but starts 

all—the customization actually is true. 

These women are all on a rhythm. I am very concerned about the 

curves in the rhythm. However, their doctors customize this—because it is a compounded product and not FDA-approved—they cusVerDate 0ct 09 2002 09:09 Sep 28, 2007 Jkt 000000 PO 00000 Frm 00143 Fmt 6633 Sfmt 6633 H:\DOCS\37150.TXT SAGING1 PsN: JOYCE
140

tomize the Wiley Protocol by raising or lowering the dose a couple 

of lines, maintaining the curves which conceptually was my concern. 

As far as tests, we never use saliva. I, too, agree with all of you. 

It is not reliable. 

However, we do use blood testing that has been standardized and 

considered a reasonable approach in medicine since the early 

1950’s—blood tests. We test for estradiol blood levels on day 12 and 

progesterone both, and then we test again for both on day 21. Now, as far as expense goes, the Wiley Protocol is $75 a month, 

and most insurance companies do cover it, OK? 

The testing is not onerous either. In the first 3 months, the woman’s levels are checked to make sure she has optimum response, 

and her doctor can adjust it to her needs given symptoms, matching numbers. 

So I think we have created something that is standardized and 

simultaneously customized for the first time in compounded medicine. 

Senator SMITH. Well, thank you, Ms. Wiley. 

Thanks to all of our witnesses. We respect your time and don’t 

hesitate in telling you that you have each contributed, I think, 

wonderfully to the understanding of this Senator and to the U.S. 

Senate record. 

This is an important issue, and what is at stake is women’s 

health. That matters to this committee and it certainly ought to be 

of concern to Federal agencies charged with consumer protection 

and legitimacy in medicine. 

This hearing has been most enlightening, and for that we thank 

you. We wish you all a very good day. 

We are adjourned. 

[Whereupon, at 11:47 a.m., the Committee was adjourned.] 

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1 Ravdin PM, Cronin KA, Howlader N, Berg CD, Chlebowski RT, Feuer EJ, Edwards BK, 

Berry DA. The decrease in breast-cancer incidence in 2003 in the United States. New England 

Journal of Medicine 2007; 356:1670–4. 2 Breen N, K AC, Meissner HI, Taplin SH, Tangka FK, Tiro JA, McNeel TS. Reported drop 

in mammography: is this cause for concern? Cancer 2007 [e-published on 14 May 2007] 3 Jemal A, Ward E, Thun MJ. Recent trends in breast cancer incidence rates by age and tumor 

characteristics among U.S. women. Breast Cancer Research 2007; 9:R28. 

A P P E N D I X 

RESPONSES TO SENATOR SMITH QUESTIONS FROM JOANN MANSON

Question What does the April 19, 2007 New England Journal of Medicine report1

mean for hormone therapy and women’s health in general? 

Answer. This study compared time trends in breast cancer incidence with time 

trends in hormone therapy use in the United States. The researchers speculated 

that the 7 percent decline in the incidence of breast cancer that occurred from 2002 

to 2003 in this country was most likely a result of the dramatic reduction in the 

use of hormone therapy following the publication of the WHI estrogen-plus-progestin 

trial results in July 2002. However, studies of this type (i.e., time-trend ecologic 

studies, which compare variations in aggregate exposures and outcomes over time 

within a population) cannot definitively establish the existence of cause-and-effect 

relationships. We need more research to tease out the factors causing the drop in 

breast cancer rates. Declining use of hormone therapy is likely part of the answer, 

but the decreasing prevalence of use of screening mammography may also play a 

role.2 If so, some of the apparent decline in breast cancer rates could simply reflect 

underdiagnosis, because fewer women are getting screened for the disease. A key 

question is whether deaths from breast cancer will also decline, and it will take 

years to answer this definitively. Additionally, another recent study suggests that 

breast cancer rates have been declining since 19993—that is, well before the mid2002 drop in hormone therapy use. 

Nonetheless, the results of the New England Journal of Medicine report underscore the importance of adhering to current clinical guidelines regarding the use of 

hormone therapy. To minimize the increase in breast cancer risk associated with 

hormone therapy, use of such therapy, particularly estrogen plus progestogen, 

should be limited to no more than five years (and ideally no more than two or three 

years). It should be noted that available data, including the WHI trials, more 

strongly implicate estrogen plus progestogen than estrogen alone in raising breast 

cancer risk. (Indeed, the WHI estrogen-alone trial found no increase in risk of breast 

cancer after 7 years of estrogen use among women with hysterectomy.) Some data 

suggest that less frequent use of a progestogen (e.g., as in cyclic regimens, where 

the progestogen is taken for only 10–14 days per month, or even less frequently) 

may carry less risk than more frequent use of a progestogen (e.g., as in continuous 

regimens, where it is taken every day), but more research is needed on this topic. 

Question. Can you clarify for the record your position on the use of the term ‘‘bioidentical’’—in what circumstances would its use be appropriate or accurate? 

Answer. ‘‘Bioidentical’’ hormone preparations properly refer to medications that 

contain hormones that are an exact chemical match to those made naturally by 

women’s bodies. Bioidentical preparations fall into two broad categories: (1) FDAapproved medications that are available at commercial pharmacies in a range of 

standard doses, and (2) custom-compounded medications prepared according to an 

individualized prescription from a doctor by compounding pharmacies. This distinction must be made clear to women who are considering the use of bioidentical products. A growing number of bioidentical products have FDA approval and are widely 

available through retail pharmacies, so most women have no need to take on the 

unique risks of custom-compounded products to satisfy their preference for bioidentical over traditional hormone formulations. Another important point is that no type 

of menopausal hormone therapy, including bioidentical products, should be called 

142

‘‘natural,’’ because all lead to substantially higher blood levels of estrogen and/or 

progesterone than the levels that occur naturally in women after menopause. (also 

see response to question #3) 

Question. Could you clarify for the record your position on the use of FDA-approved bioidentical versus custom-compounded hormone therapy products? 

Answer. Provided that they are appropriate candidates for hormone therapy, 

women who prefer to use FDA-approved bioidentical hormone preparations (such as 

estradiol and micronized progesterone) rather than traditional hormone products 

(such as conjugated equine estrogens and synthetic progestins), or transdermal over 

oral delivery systems, can be encouraged to do so, as these products may offer some 

advantages over traditional ones. That said, until we have solid data from randomized clinical trials that indicate otherwise, the conservative and prudent approach 

is to assume that all FDA-approved hormone formulations confer a roughly similar 

balance of benefits and risks. 

There is no evidence that custom-compounded bioidentical hormone products are 

safer than FDA-approved bioidentical products, and healthcare providers should 

clearly convey this message to their patients. Indeed, custom-compounded bioidentical products carry unique risks—insufficient quality control; unreliable information 

about benefits and risks; misleading advertising claims; and are often accompanied 

by unreliable and expensive saliva and blood tests;—and should not be used by most 

women. Few women have a legitimate need to select a custom-compounded hormone 

product over other hormone options. The main valid reasons for a woman to choose 

a custom-compounded hormone product are allergies to certain ingredients (e.g., 

peanut oil in Prometrium) or intolerance to doses of commercially available products. With the recent availability of many different dose levels, there should be even 

less need than in the past to select a custom-compounded hormone product. 

Question. When you spoke of the need for clinical trials on bioidentical hormones, 

did you mean head-to-head studies between FDA-approved bioidentical hormone 

products and traditional conjugated equine products, or did you mean custom-compounded bioidentical hormones and traditional products? If you were referring to 

custom compounding, how could you have a controlled trial without having a ‘‘standardized’’ compound preparation? 

Answer. There are two types of double-blinded randomized clinical trials that 

need to be done. First, we need clinical trials that directly compare FDA-approved 

bioidentical hormone products to traditional hormone therapies such as conjugated 

equine estrogens or other synthetic products. These studies should compare different 

hormone formulations, as well as routes of delivery (such as pill, patch, or cream), 

with respect to their effects on blood-based biomarkers (including levels of cholesterol, C-reactive protein and other markers of inflammation, and markers of thrombosis), intermediate endpoints (such as noninvasive measures of atherosclerotic 

build-up or mammographic density), and, eventually, hard clinical endpoints (such 

as heart attack or breast cancer). Second, we need clinical trials that directly compare FDA-approved bioidentical hormone products with custom-compounded bioidentical hormones to determine which type of therapy, if either, is more effective 

at relieving menopausal symptoms and improving quality of life and sleep. In the 

FDA-approved bioidentical hormone arm of such a trial, the dosing should be determined in the usual way—i.e., start with the lowest possible dose and then adjust 

the dose based on the symptoms subsequently reported by the participant. In the 

custom-compounded bioidentical hormone arm, the initial and subsequent dosing 

would be based on results of ongoing blood and saliva tests until hormone levels are 

‘‘stabilized’’ according to a preset protocol. Both types of clinical trials are affordable 

and feasible; they can be conducted with relatively few women and in a short time 

span, providing answers to many of the research questions in 6 to 12 months of follow-up. If initial trials look promising, then serious consideration should be given 

to mounting a large-scale clinical trial to compare the effect of these various hormone products on clinical events. 

RESPONSES TO SENATOR SMITH QUESTIONS FROM LEONARD WARTOFSKY

Question. In your testimony you referenced internet pharmacies going beyond 

proper professional bounds and doctors on the ‘‘fringe’’ who were prescribing compounded bioidenticals. Can you give the Committee any further information on 

these problems you’ve identified, i.e. where and how frequently this is happening? 

Answer. Unfortunately, no hard data exists detailing how frequently physicians 

in the broader medical community are prescribing compounded bioidentical hormones. However, the vast majority of The Endocrine Society members support our 

position statement, providing evidence that most endocrinologists do not prescribe 

143

* An invented ‘‘syndrome’’ by a Florida physician, Dr. Wilson, to promote sale of his products. 

these. Opportunities do exist for patients to obtain compounded bioidentical hormones without a prescription from their regular physicians. We have attached links 

to three websites that provide women with the names of physicians who are willing 

to prescribe bioidentical hormones for them if their primary physician is unwilling 

to do so. Although compounding pharmacies claim that they are only filling the prescriptions that are generated by physicians, pharmacies such as these provide the 

means for women to get a prescription without the assistance or oversight of the 

physicians with whom they have a medical relationship. 

http://www.gethormones.com/physicians.html 

http://www.womensinternational.com/resources.html 

http://www.naturalwoman.org/

Question. In your testimony you mentioned the National Association of State 

Boards of Pharmacy had guidelines on compounding that were only adopted by a 

quarter of states to date—is that statistic available in a report or paper you could 

share with the Committee? 

Answer. The National Association of State Boards of Pharmacy issued ‘‘Good 

Compounding Practices Applicable to State Licensed Pharmacies,’’ which may be 

viewed through the link below. The model code provides State Boards of Pharmacy 

with a framework for developing requirements for compounding pharmacies. As of 

2003, only 10 states had adopted this code, which was identified through the 2003 

testimony of Steven Galson, Acting Director, Center for Drug Evaluation and Research, FDA, before the Senate Committee on Health, Education, Labor, and Pensions, ‘‘Some of the stakeholder groups with whom we have interacted are engaged 

in activities intended to provide greater confidence in the quality of compounded 

medications. For example, the NABP has a model code governing pharmacy 

compounding that substantially has been adopted by ten states. The model code provides State Boards of Pharmacy with a framework for developing requirements for 

compounding pharmacies.’’ 

(http://www.fda.gov/ola/2003/pharmacycompound1023.html) Current statistics 

on the number of states that have adopted this code were available. 

http://www.nabp.net/ftpfiles/NABP01/ModelActFINAL.doc 

Question. You have mentioned some concerns about compounded products that 

can be attained over the internet. Could you explain those concerns and share any 

examples of bad actors known to the Endocrine Society? What more needs to be 

done to ensure product quality and safety the area of internet available compounded 

products? 

Answer. As we mentioned above, there are compounding pharmacies that will provide women with the names of physicians who have already agreed to provide prescriptions for compounded hormones, even if they are not regular patients. In my 

work on thyroid conditions, I have come across a number of websites that are providing questionable advice and medical supplements for ‘‘Wilson’s Syndrome.’’* We 

have attached links to a few websites as examples that can easily be accessed 

through a Google search. 

http://www.wilsonstemperaturesyndrome.com/index.html 

www.netriceuticals.com/

www.naturalhealthconsult.com 

However, we cannot say with any certainty whether the practices of these organizations or those mentioned in Question #1 go beyond the bounds of the ethical or 

legally allowed practices of the medical community. We do believe that the decision 

about the best hormone therapy for a patient should only be made by the patient 

and her physician. Only when this happens can a woman be assured that she is 

receiving the best therapy for her individual needs. In order to ensure that women 

have access to safe and effective treatments, greater regulation of the production 

and marketing of compounded bioidentical hormones is needed.*An invented 

‘‘syndrome’’by a Florida physician, Dr. Wilson, to promote sale of his products. 

RESPONSE TO SENATOR MCCASKILL QUESTION FROM LEONARD WARTOFSKY

Question. What are the growth or development risks to children of exposure to 

bioidentical hormones their parent or caregiver is using? 

Answer. A small number of cases of children’s virilization have been reported 

since 1999 as a result of exposure to topical testosterone preparations used by their 

fathers. The articles referenced below provide case reports of the effects of these testosterone preparations on small children. In the study conducted by Kunz, et al, 5 

of the 6 caretakers obtained the products through Internet sites or interstate pharVerDate 0ct 09 2002 09:09 Sep 28, 2007 Jkt 000000 PO 00000 Frm 00147 Fmt 6601 Sfmt 6601 H:\DOCS\37150.TXT SAGING1 PsN: JOYCE
144

maceutical commerce, often without a prescription. The children suffered from 

masculinization of the genitals and enlargement of the clitoris or penis, rapid linear 

growth and bone maturation, development of pubic hair and acne, and aggressive 

behavior. In almost all cases, the symptoms regressed after the men ceased use of 

the topical preparations. 

Brachet C, Vermeulen J, Heinrichs C. 

Children’s virilization and the use of a testosterone gel by their fathers. 

Eur J Pediatr. 2005 Oct;164(10):646–7. Epub 2005 Jul 16. 

Kunz GJ, Klein KO, Clemons RD, Gottschalk ME, Jones KL. 

Virilization of young children after topical androgen use by their parents. 

Pediatrics. 2004 Jul;114(1):282–4. 

RESPONSES TO SENATOR SMITH QUESTIONS FROM LOYD V. ALLEN

Question. In your testimony, you discussed the issue of labeling compounded products and expressed that you were generally supportive of a labeling requirement. 

I understand that there is potential for developing a centralized database for pharmacists to use in order to provide a patient printout that provides uniform information about his or her medication. Can you share with the Committee how this would 

work, why it would be helpful, and when nationwide availability of such a database 

could be feasible? 

Answer. The U.S. Pharmacopoeia (USP) has developed the USP–DI, or USP Drug 

Information database. The database was developed by physicians and pharmacists 

over several years and is very comprehensive. It consists of three volumes: Volume 

I is Drug Information for the Health Care Professional; Volume II is Advice for the 

Patient (Drug Information in Lay Language); and Volume III is Approved Drug 

Products and Legal Requirements. These are currently being published by ThomsonMicromedex. 

The specific database that can be of benefit for compounding pharmacy and patients is Volume II Advice for the Patient. This database is at the USP offices in 

Rockville, MD and can be modified to meet the needs for pharmacy compounding. 

The database can be reformatted and licensed to the various software vendors that 

supply the software programs to compounding pharmacists. As the label for a compounded prescription is printed, the patient advisory leaflet information that is 

given to the patient can also be printed. This is similar to what is currently used 

for commercially manufactured prescriptions that print the patient advisory leaflet 

for the commercial product along with the label for dispensing to the patient. 

This is a workable solution and could be implemented relatively quickly as the 

database is already available. 

Question. There was considerable discussion in the hearing about the use of the 

term ‘‘bioidentical’’ when describing that particular type of hormone therapy. What 

is your opinion on the use of bioidentical as a descriptive? 

Answer. The word ‘‘bioidentical’’ is a contraction of the worlds ‘‘bios,’’ meaning 

‘‘life,’’ and ‘‘identical,’’ meaning ‘‘the same as’’. Therefore, ‘‘bioidentical’’ means ‘‘the 

same as life’’ or identical to what is in the living body. This is in contrast to those 

substances that are not the same as those that naturally occur in the human body, 

such as synthetic conjugated hormones. The term bioidentical is descriptive of reality but has been misused. 

To resolve this, since we commonly use the official term ‘‘Human Insulin’’ for insulin that is identical to that which occurs in the human body, it may be better to 

use the term ‘‘Human Hormones’’ to designate those that are identical to those in 

the body. The non-human hormones (conjugated estrogens, etc.) could not use this 

designation. (This is appropriate because human insulin is derived from non-human 

sources but is altered to be chemically identical to that in the body, just like bioidentical hormones are derived from yams and soy but are chemically altered to be 

identical to those in the body, i.e. bioidentical). The American Diabetes Association 

and the American Medical Association both use the term ‘‘Human Insulin,’’ and the 

official name in the USP is Human Insulin USP. 

The term ‘‘natural’’ is another term that has been used in a confusing manner. 

Human hormones are those that occur naturally in the body. However, the starting 

point for the chemical preparation of some of these human hormones is the naturally grown soy beans, yams, etc. The precursor chemical is extracted from these 

plants and is then chemically modified to the hormones that are bioidentical to 

those human hormones that are naturally in the body. This tends to be confusing 

to many people. If one also looks at the marketing of some low dose progesterone 

products available in the market place, they use the term natural, generally referring to the source of the hormone. So, the term ‘‘natural’’ can refer to either the 

145

human hormones that occur naturally in the body or to the natural source from 

which they are derived. 

Question. How safe is ‘‘bioidentical’’ hormone therapy from a pharmacist’s viewpoint? 

As a pharmacist, many things that occur naturally in the body are used therapeutically, including water, electrolytes (sodium, potassium, etc.), thyroid, pancreatic 

enzymes and insulin. We are simply replacing what the body has lost. 

Bioidentical hormones are available in commercially manufactured (e.g., 

Prometriuim, Estragel, Androgel) and compounded forms. These have been recognized as safe and effective by the Food and Drug Administration. Since these hormones are the same as what the body has been producing for years, they should 

be safe, effective and without adverse problems provided the dosing is done properly, which is worked out between the physician, patient and the pharmacist. So 

yes, in my opinion they are safe and effective when properly used. 

Question. We have discussed how you believe that the states are in the best position to regulate the practice of pharmacy compounding. I am told one of the challenges facing state boards of pharmacy is the lack of sufficient staffing (and funding) 

to do the type of inspections and investigations that could provide a higher level of 

oversight.How many additional staff members would each state need to start making a greater enforcement impact, and how much would it potentially cost to provide 

the personnel and training that they need? 

Answer. The practice of pharmacy should be regulated by the state boards of 

pharmacy. As pharmacy practice changes, the state boards adapt to these changes. 

The standards of the USP related to pharmacy compounding are being implemented 

by the states, either directly or by rewriting them on a state-by-state basis. Enclosed 

please find a document prepared about three years ago, entitled ‘‘Reasons the FDA 

Should Not Be Involved In Pharmacy Compounding.’’

The individual state boards of pharmacy may need some supplemental funding for 

additional inspectors, depending upon the needs of the individual states. This may 

range from 1 to 5 additional inspectors per state with an overall average estimate 

of 2 per state, or 100 new inspectors. At salary plus benefits of about $100,000 per 

year per position this amounts to $10 million dollars. This could be provided initially in the form of grants for the first few years, similar to other programs provided by the Federal Government, as the states eventually assume funding for these 

and the federal funds are decreased and eventually eliminated as the program becomes totally supported at the state level.

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