A Bad Break: FDA Continues Review Of Bone Drugs
4 CommentsBy Ed Silverman // March 11th, 2010 // 8:42 am
Two years after issuing warnings about a group of meds known as bisphosphonates, the FDA has determined there is no link between the drugs and thigh-bone fractures (see here). These meds include Merck’s Fosamax, Novartis’ Zometa and Reclast; Procter & Gamble’s Actonel, and Boniva, which is marketed by Glaxo and Roche.
The matter, however, isn’t quite settled. The agency is continuing to work with outside experts, including the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more info. And two new studies released this week at the annual meeting of the American Academy of Orthopaedic Surgeons found bones of some post-menopausal women who take the meds on a long-term basis to prevent osteoporosis can stop rejuvenating and become brittle (see here).
“These drugs are good drugs. They strengthen bone and protect you from fractures for a while,” Melvin Rosenwasser, chief of orthopedic trauma surgery at Columbia University Medical Center in New York, tells USA Today. “But in some people they can become deleterious after a period of time.” This may become a bad break for drugmakers - the meds reportedly generate about $3.5 billion in annual sales.
Justice in MI
Oh, the agony! Can you imagine if Sally Field fell off the dock? Well, she’d probably be rescued by the Flomax Kayak Team.
But seriously….I’m still wondering why ABC did this as a lead story a few nights ago, and in unusual detail. Clearly, they got a head’s up on the AAOS presentations. But I don’t recall quite this kind of “preemptive” (pardon my phrase) coverage of an issue when no drug withdrawal involved.
Is Diane Sawyer making a difference? Perhaps her 60 Minutes background? Personally, I think the program is improved since she stepped in.
David, Health Blogger
This is shocking news.
The last I looked at these medications they were viewed as effective for preventing bone fractures. Now?
Things change so fast in the world of pharmaceuticals.
patrons99
I would really like to see a prospective, double blind, placebo controlled study comparing high dose Vitamin D3 versus the bisphosphonates. There may well need to be a new medical practice guideline for the treatment of osteoporosis.
DocLemmon
I’m never surprised by these sorts of things.
The bisphosphonates were hyped and oversold.
If your severely osteoporotic, T-score -2.5 or worse, Fosamax will cut relative risk (the deception) of hip fractures 56% over 4 years. Absolute risk is cut only 0.3% per year, 1.2% total over 4 years. Bottom line, 80 women take it for 4 years to prevent 1 fracture at a cost of over $300,000.
And it only works if patients are compliant enough to take their calcium and vitamin D every day. No benefit from taking Fosamax longer than 5 years.
Now we see there is a downside.
Nice post Ed.
I think I will write a blog post on this topic in a few days.