Wyeth has long fought pharmacies trying to convince women to buy compounded hormone replacement therapies in lieu of Premarin. The company now has a new nemesis: Oprah Winfrey.The television celeb devoted an entire show last month to bioidentical hormone therapy, announcing that she was “opening a national conversation” about HRT. The dialogue continued two weeks later with guest and perennial pitchwoman Suzanne Somers, a long-time advocate of bioidentical hormone replacement therapy.
The February issue of Oprah Magazine also includes an article on the topic (the cover has the teaser “Hot Women! The stuff nobody’s telling you about hormones”) and a column by Oprah in which she describes her own experience with the treatment.
“After one day on bioidentical estrogen, I felt the veil lift,” she writes. “After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step.”
Oprah’s endorsement cast a spotlight on bioidentical HRT as an alternative treatment for menopause symptoms, and has garnered attention far, far outside her typical audience: the New York State Bar Association’s annual meeting. At the meeting, attorney Irving Wiesen said her endorsement would draw an avalanche of attention to compounding.
That comment prompted Geoffrey Levitt, Wyeth’s chief regulatory counsel, to acknowledge: “It’s really hard to go up against Oprah.”
Several years ago Wyeth filed a citizen petition with FDA asking the agency to take enforcement action against compounding pharmacies that were manufacturing or dispensing bioidentical hormone replacement therapy. And Wyeth won: FDA sent warning letters to seven compounding pharmacies for producing these products with unapproved ingredients and making false and misleading promotional claims (you can read all about that here).
Oprah acknowledged FDA’s concerns about the therapy. FDA said in a statement to the show that it does not recognize the term bioidentical. “Many compounding pharmacies use ‘bioidentical’ as a marketing term to imply that drugs are natural or have effects identical to those from hormones made by the body,” the agency said.
“FDA is not aware of credible scientific evidence to support these claims. There are potentially serious adverse effects associated with long term use of these products--even when consumers use FDA-approved hormone therapy drugs that have been proven safe and effective.”
Blah-de-blah-blah-blah. This is Oprah we're taking about. The woman elected a president, for goodness' sake! She's got far more power than FDA and Wyeth combined!
(Oprah photo courtsey of flickr user radiant guy)
-- Brenda Sandburg
She should be ashamed.
ReplyDeleteCome to think of it, Wyeth should be ashamed too, for downplaying the risks of HRT:
ReplyDeletehttp://hcrenewal.blogspot.com/2009/01/paying-more-for-worse-outcomes-wyeth.html
Thanks for the background story and the link. When I was watching the show I was actually thinking, oh boy, the pharmaceutical companies are going to freak out about this. Funny how Wyeth admits up front that it's difficult to go up against Oprah. In my quest to find balanced info about bioidenticals, I haven't found much, but this article HRT alternatives is pretty informative.
ReplyDeleteIt is not just the drug companies that are to blame for the situation where dangerous drugs are offered up to the American public. There is also blame attached to the FDA for allowing these drugs to still be manufactured and sold even with the knowledge of their dangers.
ReplyDeleteSomehow the link between drug company financing of the FDA needs to be broken. Maybe this can be done via some form of excise on companies and their sales of FDA approved drugs with these funds going into general government coffers and the FDA being funded appropriately from general tax revenues rather than from charges for companies wishing to go through the approval process.