Big Bone Business - Fablyn for Osteoporosis?

On Sept. 8, a panel supplying the FDA with expert opinion decided that Pfizer's not-so-new drug for osteoporosis will bring more good than harm to those who take it. I say not-so-new because while today the drug is called Fablyn, it has been rejected by the FDA under a different brand name twice before. This time, Pfizer says, their "new data" proves that the drug is safe to take. Fablyn is a SERM, as is Eli Lily's Evista.

Final approval for Fablyn will be determined by the FDA, probably in October. The panel stopped short of recommending Fablyn, and suggested that its use be restricted to high-risk individuals and those who have not benefitted from other bone building treatments. Pfizer's marketing of Fablyn will likely target post menopausal women.

The generic name for Fablyn is lasofoxifene tartrate.

What I notice, however, is that this bit of news is all over the business and financal pages, but nowhere to be found (until now) in media outlets that talk health, such as the Back and Neck Pain Site. And in the financial coverage that I've read, I found little mention of the clear benefits Fablyn might offer to consumers. Here are the two I found:

• as an "alternative to other osteoporosis treatments, some of which have multiple side effects". But Fablyn comes with side effects of its own such as the risk of dangerous blood clots, and possible death.
• for patients who don't tolerate biphosphates

According to a press release from Reuters, "Pfizer, the world's largest drugmaker, is looking for new medicines to help it survive ...competition". It seems that some of Pfizer's best selling patents are due to expire soon, creating a need to replace revenue from sales of drugs such as the highly successful Lipitor. CNN Money says, "A rejection of Fablyn would be a setback for Pfizer, as analysts estimate the drug could bring in peak sales of $1 billion".

Doctor's are often well-wooed by drug companies, from beautiful pens and drug samples to weekend get aways at fancy resorts, and if Fablyn is approved for market, yours may be no exception. So, if this medication is suggested or prescribed for you, please ask the hard questions about blood clots, death and other possible problems.

Although overall the panel voted "yes" on Fablyn, its members walked away confused: it's possible that the risk of death associated with taking Fablyn is higher than it should be for a medication to be given the go ahead from the FDA. But the research Pfizer provided did not go so far as to prove or disprove this important side effect. CNN Money reports that panel member Clifford Rosen, senior scientist at the Maine Center for Osteoporosis said, "I'm really dismayed that we don't have a head-to-head trial of Fablyn with other FDA-approved drugs. Without head-to-head trials, we really can't make absolute definitions about what drugs work and don't work."

CNN Money also reports that "Cindy Pearson, executive director of the National Women's Health Network, a consumer advocacy group, said there isn't enough information presently for women to make decisions on whether this drug is good for them".

It's well known that osteoporosis and osteopenia are related to spinal fractures. With or without drugs, a healthy lifestyle that includes weight bearing exercise to build bone mass can help prevent or manage this disease.

_{Sources:
FDA Panel: Pfizer Osteoporosis Drug's Benefits Outweigh Risks. CNN Money. Sept 8, 2008.
UPDATE 2-US FDA panel backs Pfizer osteoporosis drug. Reuters.com Sept 8, 2008.
FDA Panel Endorses Pfizer’s Fablyn, With Reservations. Wall Street Journal Health Blog. Sept 8, 2008.
Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices}