Back in February, I wrote about a disturbing action taken by the FDA under pressure from Wyeth pharmaceuticals, the makers of Premarin and Prempro. (See blog entry titled "Bioidentical Hormone Access Threatened – Act Now" dated Feb. 7, 2008.)
Wyeth took a financial hit after the Women’s Health Initiiative study found some serious adverse effects to synthetic HRT (Hormone Replacement Therapy.) Market share severely affected, they persuaded the FDA to restrict access to bioidentical hormones. Nice!
Briefly, the FDA has stopped compounding pharmacies from dispensing estriol (a naturally occuring estrogen in our bodies) unless they have an investigational drug permit. I don’t have time or space to explain how hard it is to get and implement such a permit. It’s like unraveling a Gordian knot with your teeth.
I’m not a conspiracy theorist and I don’t believe that drug companies in general or Wyeth in particular are evil. They are just protecting their interests in a capitalist economy. We women and health care professionals, however, MUST be vigilant that this normal self-protective mechanism does not infringe upon our health options and liberties.
Fact: Bioidentical hormones have not been extensively studied for safety.
Also Fact: Physicians have been prescribing them safely for decades.
Even if we assume the very best motives on behalf of the FDA and Wyeth, we must vigorously oppose this "regulation" by one of our watchdog agencies. Now is the time to write our congresspeople again to make our voices heard.
U.S. Representatives Mike Ross of Arkansas and Jo Ann Emerson of Missouri have presented a "Sense of The Congress Resolution (H. Con. Res. 342) challenging the FDA’s new policy. The resolution is being co-sponsored by U.S. Representatives Tammy Baldwin (Wisconsin), Michael Burgess (Texas), John Carter (Texas), Sam Farr (California), and Gabrielle Giffords (Arizona); deeming FDA’s policy as inappropriate and requesting reversal of the policy.
What can we do? We can protect our healthcare choices by writing to our senators and congresspeople to protect our access to bioidentical hormones. Even if you don’t personallly use BHRT (Bioidentical Hormone Therapy) like some of the Venuses including myself, speak up loudly for all menopausal goddesses and their trusted health care practitioners.
The Women’s International Pharmacy website makes it easy to find out who your congressional representives are and to submit your comments to them via email. Click on the link below or go to www.women’sinternational.com Do it today. Do it now.
I will take a stab at some letters and will do my best to get some of my lady friends to do so as well. I do have a suggestion. Within the real estate industry, we have some pretty good template letters to use when we need to come together as a force against governmental agencies. This template helps tremendously when encouraging those that are a bit intimidated to write on their own. If we were to put together something along these lines, perhaps we could encourage women to either use them as they are or better yet, enhance with personal experience.
I know you will be out of reach for a couple of weeks but perhaps this is an idea for future efforts.
As a long time user of premarin, i must say it has accomplished wonders during a difficult menopause. Again as i said before, all body chemistry varies. Of course knowing your body and with the support of your doctor, should give a complete picture.So menopause goddesses, make your voice heard! Thank you for all your hard work , Lynette
I'll send a letter too, thanks for the info. I just read two interesting articles about Wyeth — a class action lawsuit filed by two women who hold Premarin responsible for their breast cancer was just given the greenlight to proceed in Canada. And then, I read that Wyeth is getting ready to unroll a new non-hormonal medicine to treat hot flashes (think it's called Pristiq and is technically an antidepressant). In both these cases, I can see why Wyeth would want to quell competition (lawsuit = potential for big pay out and maximum cash resources needed; new drug = need to get rid of competition).