2005P-0411

Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

FDA Comment Number :

EC1728

Submitter :

Dr. Sophia Burns

Date & Time:

02/13/2006 01:02:29

Organization :

Dr. Sophia Burns

Category :

Health Professional

Issue Areas/Comments

GENERAL

I am always surprised and profoundly disappointed when obvious politics enter into the area of health care. There are many years of research and data that support the safety and efficacy of bio-identical hormone therapy. The WHI study was flawed in its very design, and to take those results, using horse estrogen and synthetic progestin, and say that all hormones cause heart disease, strokes and cancer is ridiculous. A recent article in December 2005 Fertility and Sterility also supports this statement. Compounding pharmacies have been providing a vital service to patients and physicians in this country for many years. Mainstream pharmaceutical companies in their quest for profits created synthetic hormones for patent/profit purposes, thinking that they could not make money selling a product they couldn't patent. Wyeth has been the most successful company in this area, with over 40 years of dominating the HRT market. Now that their product has been shown to be harmful, their profits have dramatically dropped. They are now going after the compounding pharmacies, who have been quietly providing a safe, natural alternative for years. Their thinking is, again, flawed. Getting rid of bio-identical hormones and the pharmacies that provide them is not going to make people by Premarin/Prempro again! I would be happy to provide you with hundreds of references documenting the safety and efficacy of bio-identical hormone therapy. Countless women would be childless or would have suffered repeated miscarriages without the compounding pharmacists providing micronized progesterone to correct luteal-phase defects or topical estrogen creams to overcome to correct similar deficiencies.

I just glanced up at the title for this comment section. Are they (Wyeth) kidding?! Hormone replacement drugs that endanger public health?! Wyeth, with their Premarin/Prempro line should be at the top of the list! It is amazing to me that their product is still on the market. Vioxx was pulled from the market, but if you crunch the numbers from the studies, Prempro has a higher incidence of causing stroke and cardiovascular related events than Vioxx does. Wyeth, I guess has a stronger lobby/presence in the FDA circle than Merck did. It's all such dirty politics, with no regard for the public you serve. But Wyeth's claim is ridiculous, with no basis in fact. Evidence based medicine and research clearly shows the safety and efficacy of BIHT and the dangers of the Premarin/Prempro products. If your own natural hormones caused the problems that the WHI studies revealed for the synthetic products, then all women everywhere would get breast cancer or have heart attacks and strokes when puberty hit, and for sure during pregnancy, when hormone levels go off the charts. But we all know that this isn't the case. Please do the right thing and prevent any loss of our freedom to choose and to have available safe, effective medicines. Read Dr. Joseph Kassirer's book "ON THE TAKE" or books by Fran Hawthorne or Ray Moynihan exposing big drug companies and their complete lack of interest in providing or contributing to true health and wellness.