Every week, 2,000 - 3,000 Second District residents write to me about the issues pending before Congress, and I work hard to respond to each person as promptly and thoughtfully as possible.  On this "Letter of the Week" blog, I highlight constituent letters that are of general interest.  If you'd like to share your own views, please feel free to e-mail me at any time!

Dear Nancy,

As a pharmacist and one of your constituents, I strongly urge you to co-sponsor a Sense of the Congress resolution supporting my ability to fill doctors' prescriptions for medications that contain estriol. Hundreds of thousands of women are prescribed these medications to treat the painful symptoms of menopause.

H. Con. Res. 342 has been introduced in the House by Reps. Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.), and S. Con. Res. 88 has been introduced in the Senate by Sens. John Cornyn (R-Texas) and Jim Bunning (R-Ky.). These resolutions declare that a new FDA policy that restricts patients' access to estriol is "not in the public interest."

The FDA's policy is not based on legitimate safety issues, and they cannot document a single adverse event with estriol over the past three decades. Instead, the FDA is catering to a request by Wyeth Pharmaceuticals to eliminate medications that compete with Wyeth's synthetic hormones.

The FDA says that my patients can still get estriol if their doctor files an investigational new drug application (IND). This is simply not true. Requiring an IND will have the same effect as banning estriol.

While supposedly "independent" women's groups are supporting the FDA, you should know that most of these groups are funded by Wyeth. I'm your constituent, I oppose the FDA action, and I'm not paid by Wyeth. Please listen to your constituents on this issue.

Hormone treatment decisions should be made by a woman and her doctor, not by the federal government. I simply ask that you help preserve women's options to take the medicine that they and their doctor determine is most appropriate for them.

I urge you to send FDA a clear signal that this policy must be reversed, and I ask you to co-sponsor the resolution to protect women's access to estriol. I look forward to your response.

Most of the women for which I compound hormone replacement have tried and failed on commercially available medications. This allows them another option for the treatment of their symptoms. Compounding is already regulated at the state level, by the Kansas Board of Pharmacy. If I remember my history correctly, Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938 because of concerns over the quality of manufactured drugs and NOT compounded medications.

Paul from Manhattan, KS.

Dear Paul,

Thank you for contacting me about compounded hormone replacement therapies.  Since the Food and Drug Administration (FDA) announced its crackdown in January, I have heard from dozens of concerned Kansans, and I want to let you know that I have signed on to a resolution, H. Con. Res. 342, opposing the FDA’s decision to ban estriol.

On January 9, 2008, the FDA announced that it was responding to citizens’ petitions and cracking down on pharmacies that were compounding hormone replacement therapy (HRT) pills and creams for the treatment of menopause.  The FDA announcement had three effects:
•    A ban on the use of the term bio-identical in marketing HRT drugs; and
•    A ban on making claims that compounded HRT drugs are safer or more effective than the HRT drugs produced by the big pharmaceutical manufacturers; and
•    A ban on compounding drugs containing estriol.
The more that I looked into this announcement, the more concerned I became.

Big Pharma Protecting Big Profits
As you may know, in my first career, I worked for a pharmaceutical company developing new drugs.  That experience showed me both the good and the bad that Big Pharma brings to our society.  It showed me, up close, how the FDA works.  It also instilled in me a deep appreciation of how important local pharmacists are to our health care net.  Because of that experience, I can say, with confidence, that the FDA was wrong.

The concerned “citizen” that filed the petition with the FDA wasn’t a neighborhood doctor or druggist.  It was Wyeth Pharmaceuticals, the maker of the best-selling HRT drug Premarin.  Premarin has been a cash cow for Wyeth for over six decades, but early this decade, a major study of Premarin showed that women taking the drugs were getting more serious illnesses than those not taking the drugs.  Wyeth’s sales plummeted.  Some women quit taking HRT drugs entirely, and some switched to compounded HRT drugs.  Almost immediately, Wyeth filed the petition with the FDA to force the compounding pharmacists out of the market.

The Difference Between The Estrogens
HRT drugs, whether they’re made by Wyeth or compounded by a pharmacist, contain chemicals that are intended to replace the hormones (hence, “hormone replacement therapy”) that women’s bodies make less of after menopause.  Usually, this includes one or more drugs from the class of chemicals called “estrogens.”

The three major estrogens produced by a woman’s body are estriol, estradiol, and estrone.  Premarin got its name because the estrogens in it are isolated from a pregnant mare’s urine.  Since horses’ chemistry is slightly different than chemistry of humans, Premarin’s estrogen ingredients are slightly different: equilin, equilenin, and estrone.  Compounded HRT drugs use estrone too, but they combine it with actual estriol and estradiol (which can be made in a lab).

Restrictions on Marketing
Because compounded HRT drugs contain the same estrogens as the human body makes, some pharmacies started calling their products “bioidentical” hormone replacement therapy (BHRT).  The FDA says that the pharmacies have to stop using the term because “bioidentical” sounds safer or better for you, but there’s no evidence that BHRT actually is safer or better.  The FDA also took action against seven pharmacies that were making explicit health claims that BHRT can treat or prevent cancer, strokes, Alzheimer’s and other diseases. 

I agree with the FDA on this.  The FDA has the authority to take action against false and misleading advertising, and the FDA’s power over prescription drug advertising was expanded by this Congress in 2007.  I would like to see even more restrictions on prescription drug advertisements.  I think that the FDA actions on marketing are reasonable.  Prescription drug health claims require hard science to back them up, and no big studies have been run here. 

FDA’s Unfounded Attacks on Estriol
The final step taken by FDA here was mind-boggling.  The FDA said that pharmacists should no longer compound drugs containing estriol because estriol is not part of any drug approved by the FDA.  In reaching this decision, the FDA blatantly exceeded its authority and seriously misrepresented the laws regarding pharmacy compounding.

If you go to the FDA’s webpage on compounded drugs, you can read section 127 of the FDA Modernization Act of 1997 and see for yourself that pharmacists can compound drugs if those drugs 1) are a component of an FDA-approved drug or 2) have a monograph in the United States Pharmacopoeia (USP). Estriol has a USP monograph.  It can be compounded.  All of the FDA’s talk about estriol not being part of an FDA-approved drug is as misleading as the BHRT advertisements they are looking to ban. 

What’s Next
The Resolution I am cosponsoring says “the FDA should reverse its policy that aims to eliminate patients’ access to compounded medications containing estriol that their physicians prescribe for them.”  I wholeheartedly agree with that, but I don’t expect the FDA to do so.  I expect that this battle will be decided in the judicial system, and I hope that the resolution comes quickly so that women are able to continue to have access to HRT that suits their needs. 

This situation brings together two of my highest legislative priorities in Congress: promoting women’s health and protecting community pharmacies.  You can be sure that I will continue to monitor this issue.  I know you will too.  As a woman, I certainly understand the personal nature of these important decisions.  Please don’t hesitate to contact me if there’s anything else I can do help you on this or any other issue.

Sincerely,

Nancy Boyda
Member of Congress