Feature Drug Safety

Battle over popular bone drug Fosamax bursts into court

BMJ 2009; 339 doi: http://dx.doi.org/10.1136/bmj.40024.494213.4D (Published 06 August 2009) Cite this as: BMJ 2009;339:b3155
  1. Ray Moynihan, visiting editor, BMJ
  1. 1Melbourne, Australia
  1. Ray.Moynihan{at}newcastle.edu.au

    A New York judge has revealed internal Merck discussions about a possible link between its widely prescribed drug and dead jaw syndrome, finds Ray Moynihan

    A spring evening back in May 1996 was something of a high point for the folks at the global drug company Merck. Three American television networks ran news stories celebrating Merck’s latest blockbuster to fight brittle bones—Fosamax, whose generic name is alendronic acid (or alendronate sodium).

    Reporters told tens of millions of viewers that the recently approved drug could cut the risk of a hip fracture in half, and one report described this as “almost miraculous.”1The televangelism proved both efficacious and prophetic: in the years since, the drug became one of Merck’s top selling products, with sales in excess of $3bn (£1.8bn; €2.1bn) annually for several years during the past decade.

    Fosamax on trial for the first time

    Next week, in a district court room not too far away from those same network studios, Merck is scheduled to face the first trial involving its golden goose alendronic acid before Judge John Keenan of the southern district of New York. More than 850 cases have joined a mass action, with plaintiffs claiming that alendronic acid caused them to suffer a rare condition called osteonecrosis of the jaw, or dead jaw syndrome, and Merck failed to properly warn them of this devastating complication. A company spokesperson has told BMJ that Merck is vigorously defending the action, arguing there is no proof of a causal link between the drug and the jaw condition, and that timely and appropriate information about its drug has been provided to consumers and to the medical, scientific, and regulatory communities.

    One of the first cases scheduled to be tried involves Shirley Boles, a woman from Florida in her 70s who was first prescribed alendronic acid in 1997 and …

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