Protect Your Right to Bio-Identical Hormones

Bio-identical hormones are prescription drugs that are produced by compounding pharmacies as customized products. With the serious health concerns over prescription hormone replacement drugs reported in the 2002 Women’s Health Initiative (WHI), many doctors and patients have since turned to custom compounded bio-identical hormones for safer estrogen, progesterone, and testosterone replacement with fewer side effects and risks than mass manufactured versions.

Unfortunately, Wyeth Pharmaceutical is now putting its marketing, public relations and lobbying muscle behind a huge effort to try to prevent you from being able to get bio-identical hormones. Not surprisingly, Wyeth’s motivations appear to be self-serving -- they are makers of Premarin -- the conjugated estrogen made from PRegnant MAre's UrINe -- and Prempro, the conjugated estrogen and progestin drug. In just the past few years, sales of both Wyeth mass manufactured drugs have fallen dramatically -- by almost 70%! -- in light of the serious health implications -- including risk of breast cancer, blood clots to the lungs, heart attacks and strokes -- linked to taking these Wyeth drugs.

To try to undermine the market for bio-identical hormones, Wyeth filed a "Citizens Complaint" with the FDA in October of 2005, asking that the FDA prohibit compounding pharmacies from providing bio-identical hormones to patients. If Wyeth is successful and eliminates the availability of bio-identical hormones prepared by compounding pharmacies, your practitioner will no longer be able to prescribe "compounded" bio-identical hormone prescriptions, in the dosages that meet your medical needs. AND…Wyeth will have forced women who need hormone replacement to take their products.

Why aren’t you hearing about this on the news, and from various patient and medical groups? Well, Wyeth, like most drug companies, contributes large amounts of money to these groups and organizations, which is why you are not hearing the outcry. These groups are afraid to bite the hand that feeds them!

Right now, the FDA is soliciting comments from the public and medical professionals regarding bio-identical hormones. This is a critical step in the process, and the FDA will decide in part based on input from consumers and practitioners. The comment period ends on April 4, 2006, at which point the FDA will make its decision.

Luckily, the FDA has an easy, online form where you can submit YOUR comment and have it go directly to the FDA. Protecting the availability of bio-identical hormones depends on each and every patient sharing comments with the FDA. To protect your right to use bio-identical hormones, post your comments!

SEND YOUR COMMENTS TO THE FDA TODAY!!.

Sample letters are included here to help you.

Sample Letter from Someone Taking Bio-Identical Hormones

RE: Docket 2005P-0411

My name is (name) and I have been taking bio-identical hormones for (time). The benefits to me have been significant reduction in (symptoms).

My physician has determined that the bio-identical hormones are most appropriate to resolve my symptoms, and they are prepared by my pharmacy. If I were unable to obtain this medication (describe what symptoms you would experience, or what would change about your life if you were unable to get your bio-identical hormones).

I am seriously concerned about Wyeth’s petition (Docket # 2005P-0411) that would limit or even prevent the ability of my practitioner and pharmacist to continue to prescribe and prepare the individualized these individualized bio-identical hormones for me. I strongly urge that the FDA reject Wyeth’s petition.

Sincerely,

(Name)
(City, State)

Sample Letter of General Support for Availability of Bio-Identical Hormones

RE: Docket 2005P-0411

My name is (name) and I am writing to express my strong opposition to Wyeth’s petition (Docket # 2005P-0411) that would limit or even prevent the ability of my practitioner and pharmacist to continue to prescribe and prepare bio-identical hormones.

As a thyroid patient, I am very aware of the fact that one-size-fits-all medications are not suitable for everyone, and customized, compounded hormone replacement drugs must remain on the market, in order for all hormone replacement patients to have suitable options.

I strongly urge that the FDA reject Wyeth’s petition.

Sincerely,

(Name)
(City, State)

Mary Shomon, About.com's Thyroid Guide since 1997, is a nationally-known patient advocate and best-selling author of 10 books on health, including "The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss," "Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You...That You Need to Know," "Living Well With Graves' Disease and Hyperthyroidism," "Living Well With Autoimmune Disease," "Living Well With Chronic Fatigue Syndrome and Fibromyalgia," and the "Thyroid Guide to Fertility, Pregnancy and Breastfeeding Success." Click here for more information on Mary Shomon.