Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
3 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 raig rWEn 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.
4 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.
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3<br />
OPENING STATEMENT OF SENATOR LARRY CRAIG<br />
Senator CRAIG. Well, to the Chairman and to you, the Ranking<br />
Member, let me thank you for bringing this hearing together.<br />
I will ask unanimous c<strong>on</strong>sent that my full statement be a part<br />
of the record, Gord<strong>on</strong>. Let me say-<br />
Senator SMITH. Without objecti<strong>on</strong>.<br />
Senator CRAIG [c<strong>on</strong>tinuing]. Just <strong>on</strong>e thing..<br />
One of the expectati<strong>on</strong>s, I believe, that Americans have of their<br />
Government is, in part, to keep them safe. This is especially true<br />
in a protecti<strong>on</strong> from pharmaceuticals whose potential negative side<br />
effects outweigh their potential benefits. Americans want to know<br />
they can take a drug that is prescribed by their physician with the<br />
knowledge that this drug will treat or cure what ails them.<br />
However, like all other governmental resp<strong>on</strong>sibilities, we must<br />
balance our obligati<strong>on</strong> to protect with our resp<strong>on</strong>sibility to allow individual<br />
freedoms. That is a rather precarious balance at times<br />
that we especially try to achieve in the area of medicine, certainly<br />
in the area of pharmaceuticals.<br />
So-I keep wanting to say, Mr. Chairman. Senator Smith-Gord<strong>on</strong>.<br />
Senator SMITH. "Senator" works fine.<br />
Senator CRAIG. OK.<br />
That is why I think this hearing is important; that you come<br />
back to this issue, as you should, in an area where we may not be<br />
as aggressive or as resp<strong>on</strong>sible as we should be.<br />
Thank you.<br />
The prepared statement- of Senator raig rWEn<br />
PREPARED STATEMENT OF SENATOR LARRY CRAIG<br />
Mr. Chairman, I know that we have a lot of witnesses that we want to hear from<br />
today, so I will be brief in my comments. First of all, I want to thank you for holding<br />
this hearing today. <str<strong>on</strong>g>Bioidentical</str<strong>on</strong>g> horm<strong>on</strong>es are a part of the lives of many Americans<br />
and I think the questi<strong>on</strong>s surrounding them bear further examinati<strong>on</strong>. This hearing<br />
brings together a cross-secti<strong>on</strong> of issues: individual freedom to choose alternative<br />
therapies vs. ensuring drug safety.<br />
One of the expectati<strong>on</strong>s that Americans have of their government is that we keep<br />
them safe. This includes protecti<strong>on</strong> from pharmaceuticals whose potential negative<br />
side effects outweigh their potential benefits. Americans want to know they can take<br />
a drug that is prescribed by their physician with the knowledge that this drug will<br />
treat or cure what ails them. However, like all other governmental resp<strong>on</strong>sibilities,<br />
we must balance our obligati<strong>on</strong> to protect with our resp<strong>on</strong>sibility to allow individual<br />
freedom.<br />
Many Americans utilize various alternative drug therapies or dietary supplements<br />
as a significant part of their health care regimen. They want the freedom to have<br />
more c<strong>on</strong>trol of their health and to utilize what they believe are more natural drug<br />
treatments. It is important that we do not eliminate that opti<strong>on</strong>.<br />
As C<strong>on</strong>gress, our challenge is to strike the proper balance between these resp<strong>on</strong>sibilities.<br />
We must ensure drug safety without infringing up<strong>on</strong> pers<strong>on</strong>al freedom and<br />
choice.<br />
When I first became aware of the c<strong>on</strong>cerns surrounding bioidentical horm<strong>on</strong>es, my<br />
first inclinati<strong>on</strong> was to keep the government out of the issue. Women should have<br />
the freedom to choose natural treatments that may work better for them. However,<br />
as I have learned more about this issue a few items raised some red flags in my<br />
mind.<br />
Many Americans, and I suspect many American women, are aware of the results<br />
of the Nati<strong>on</strong>al Institutes of Health (NIH) Women's Health Initiative relating to<br />
horm<strong>on</strong>e replacement therapy. Unfortunately, the general public does not fully understand<br />
the nuances of the findings. The story people heard was that horm<strong>on</strong>e replacement<br />
therapy was bad for you. And as the witnesses will testify, there was a<br />
significant drop in the number of women using horm<strong>on</strong>e replacement therapy. How-