Healthy Skepticism Library item: 4529

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

UPDATE 1-Wyeth renews push for crackdown on unapproved drugs
Reuters 2006 Apr 25
http://yahoo.reuters.com/stocks/QuoteCompanyNewsArticle.aspx?storyID=urn:newsml:reuters.com:20060426:MTFH84336_2006-04-26_01-02-06_N25226204&symbol=WYE.N&rpc=44

Keywords:
bio-identical hormones Wyeth

Notes:

Ralph Faggotter’s Comments:

See also HS Library No.4916

Wyeth has a fair point here.

The proposition that “because ‘bio-identicals’ come from plants, therefore they are safe” can not be assumed automatically to be true and has not been adequately studied to see if it stands up to real-world scrutiny.

Full text:

UPDATE 1-Wyeth renews push for crackdown on unapproved drugs
Tue Apr 25, 2006 9:01 PM ET

SAN FRANCISCO, April 25 (Reuters) – Drug maker Wyeth (WYE.N: Quote, Profile, Research) on Tuesday renewed its call for the U.S. Food and Drug Administration to crack down on so-called bio-identical hormone replacement therapies the company said could threaten women’s health.

The company has already filed a petition asking the FDA to take action against pharmacies that are unlawfully promoting, manufacturing and selling unapproved drugs under the guise of “compounding.”

Compounded bio-identical hormones are plant-derived hormones that are prepared and packaged as a drug by a pharmacist.

The request targeting such therapies comes as sales of Wyeth’s own female hormone replacement drugs have plummeted in the wake of a study uncovering health risks associated with their long-term use.

Wyeth said bio-identical hormone replacement therapies use chemicals synthesized from plants and other sources and are sometimes marketed to women as safer or more effective than FDA-approved medications.

But L.D. King, executive director of the International Academy of Compounding Pharmacists, said compounded bio-identical hormones are legal, regulated, prescription-only medicines that many women rely on to treat symptoms of menopause.

“Bio-identical hormones are also an alternative to Wyeth’s patented hormone products,” King said in a statement. “Wyeth’s petition isn’t about protecting patient health; it’s about protecting Wyeth’s wealth.”
© Reuters 2006. All Rights Reserved.