Bioidenticals & Compounding Pharmacies Under New Attack

Once again the FDA is cracking down on compounding pharmacies.  These are the folks that customize all of our bioidentical hormones for us.  This newest threat is yet another part of the continuing debate on whether bioidenticals are as safe as the synthetic variety.  Wyeth, the largest maker of synthetic hormones, is constantly stirring this pot because they see their revenues going down as more women switch over to bioidentical hormone replacement therapy.

Over 70,000 comments were sent to the FDA defending these pharmacies. This is encouraging and shows how those of us using bioidenticals want to continue using them. The longer this contentious debate goes on the more these numbers will grow. The North American Menopause Society estimates 6,000 women reach menopause every day which comes to approximately two million each year.

The FDA warned seven pharmacies to stop using the term bioidentical and that they couldn't sell hormone mixtures containing estriol. It is important to realize that there are three different types of estrogen, each playing a different role in the body.

Estradiol is the principal estrogen found in a women's body and helps to relieve menopausal symptoms. It is protective against heart disease, osteoporosis (by slowing bone loss), and Alzheimer’s disease. It also improves mood by increasing serotonin and endorphin levels. Estriol is the estrogen that increases tremendously during pregnancy and is essential for successful gestation. It is useful in protecting the urogenital region and promoting its health. Estrone is the weakest of the three estrogens and estradiol  has benefits of protecting against osteoporosis by opposing the breakdown of bone.

A Wyeth spokesman said they support the FDA's actions.  No kidding.  They want to increase their revenues, even if their synthetic hormone replacement could harm the women they say they want to protect.

If you want to read more about how you can help support the compounding pharmacies please click here.

Comments

[Jacqueline]

It's interesting that this is happening at the same time that I just read a study showing that an increasing number of older women are choosing not to use HRT. The study didn't even say what these women were doing instead of HRT, just gave the blanket term, "natural rememdies". But -- obviously -- that's enough for Big Pharma to don its battle gear! I'm enjoying all the blogs about this topic (natural vs. HRT) and will pass along a site I've found to be a true blessing for me: womentowomen.com -- great alternative medicine info. Here's a "Test Your Menopause I.Q." that I especially like: http://www.womentowomen.com/community/survey/testyourmenopauseiq.aspx

[linda z franklin]

after 6 years of loestrin 5.0 to control heavy bleeding from "fibroids") (I am 51) I decided to see if infact I might be in menopause. I couldnt see if I was on the pill because there was always a period. So I went the bioidentical route. Amazingly, My periods stopped and no heavy bleeding for 5 months.I hooked up with Medicine in Balance, I stopped the synthetic hormones, started chastetreeberry, all of the sudden my periods stopped! My fear was that I would bleed forever because my dr. said I had bleeding fibroids, now after trusting in the bioidenticals I am now period free, and bleeding fibroid free. Thank you Jesus!

[jeffrey dach md]

It is obvious that the FDA has been waging a war
against bioidentical hormones because of a citizen's petition from Wyeth.

Wyeth makes the synthetic hormone, prempro, a drug found to cause cancer and heart disease in the WHI study published in JAMA July 2002.

Wyeth has lost 2 billion in sales since millions of women have switched away from the Wyeth product to compounded bioidentical hormones, a safer and more effective alternative.

Wyeth wants to use the FDA to eliminate its competition.

The problem is that the FDA does not regulate compounded bioidentical hormones, the states do the regulation.

And the FDA's actions have only demonstrated that the agency is completely inept and corrupted by special interest groups in the drug industry.

To read more about this click here,

FDA Declares War on BioIdentical Hormones by Jeffrey Dach MD

http://jeffreydach.com/2008/01/11/fda-declares-war-on-bioidentical-hormones-by-jeffrey-dach-md.aspx

Jeffrey Dach MD
www.drdach.com