2005P-0411

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

FDA Comment Number :

EC2775

Submitter :

Mrs. Susan Hoots

Date & Time:

02/16/2006 03:02:48

Organization :

Mrs. Susan Hoots

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

While Bio-Identical Hormones may endanger Wyeth's health, they have been proven much safer to human health than hormone replacements touted by Wyeth and other pharmaceutical companies. These drug hormones are not identical to human hormones, and our bodies are not fooled into thinking that they are.

If Wyeth succeeds in their action, millions of women will sicken and/or die (heart disease, breast cancer, other cancers, diabetes) from lack of natural bio-identical hormones. Wyeth is operating under a misconception if they truly believe that women will go back to taking Premarin, Provera, and Prempro, when these drugs have been proven to actually cause the diseases that they were supposed to help prevent. Women will never return to these drugs now that they know the truth.

If you look at all the research done on hormone therapies, you will definitely see that bioidentical hormones do not carry the risks that conventional HRT brings.

I urge you therefore to stand strong in defending the freedoms inherent in our constitution and our free enterprise system, and rejecting without hesitation the Wyeth claims. Women and their doctors need and deserve to have choices regarding their health and medical treatment.

Restriction of bio-identical hormones would indeed be a death warrant for many, many women, as those of us referred to as baby boomers have reached the age when our female hormones have bottomed out. In my own experience, I can assure you that since beginning bio-identical hormone replacement, I have lost some of the weight that I have accumulated over the last 12 years, my blood pressure has returned to normal, my migraine headaches have subsided, I have more energy, I can think more clearly, I look better, and I no longer suffer aches and pains all over my body.

I have faith that you will stand in support of the women of America against their enemies. Help us to help ourselves so that we can continue to live in health with a high quality of life for our future years. Please do not condemn us to live in suffering, weakness, dementia and fear. We really do need your help and support in this, and we are counting on you to do what is right.