2005P-0411

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

FDA Comment Number :

EC7826

Submitter :

Dr. Mark Deramo

Date & Time:

03/07/2006 03:03:08

Organization :

Dr. Mark Deramo

Category :

Health Professional

Issue Areas/Comments

GENERAL

My name is Dr. Mark Deramo (MD, ABFP), and I am writing to support further research on bio-identical hormones and to vehemently oppose Wyeth's Citizen petition to ban the same.

I am a family physician with an interest in complementary & alternative medicine, and to the best of my knowledge studies of bio-identical hormones have never shown inferiority to synthetic hormones, and have in some studies shown superiority. An example is that natural progesterone does not have the negative impact on lipoproteins that synthetic progesterone does (medroxyprogesterone).

I am infuriated at this example of what I see as corporate greed directly harming patients in general and my patients in particular. Bio-identical hormones should be undergoing further testing in double-blind randomized placebo-controlled trials, not outlawed. For Wyeth, or anyone, trying to legally outlaw or block any treatment with no evidence of inferiority and some evidence of superiority is unethical and deplorable. I also find this hypocritical of Wyeth, given that Premarin and PremPro increases the risk of MI, stroke, and breast cancer in the Women's Health Initiative study. While studies of bio-identical hormmones have never been powered to detect this, I am not aware of any data even suggesting that this may be the case.

Please support bio-identical hormone research and oppose Wyeth's petition. My mission is to serve my patients (I work in a residency program and provide direct medical care to the poor and underserved); people before profits. Apparently the same cannot be said of Wyeth.

Sincerely,

Mark Deramo, MD