Claris Law Legal Blogging Community

Editor: Tim O'Brien
Profession: Attorney at Law

Category: Fosamax News

Rather than warn patients, and despite knowledge known by Merck about the increased risk of osteonecrosis of the jaw on patients using Fosamax, Merck has yet to issue a "Dear Doctor letter" to prescribing physician, and continues to defend Fosamax by minimizing unfavorable findings through statements such as those made in the Wall Street Journal: "'The cause of osteonecrosis is not well understood and is likely to include a number of conditions.'"

Additionally, while there has been no Merck clinical study directed to the relationship of osteonecrosis of the jaw and Fosamax use, Merck infers that the fears of ONJ are unfounded by arguing "'in all our controlled clinical trials, including the 10-year data with Fosamax, which have included more than 17,000 patients, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax.'"

However, in direct contrast to that statement, Merck has informed the American Dental Association that it is aware of at least 170 reports of osteonecrosis in Fosamax users. So, how has Merck been able to avoid the problems with Fosamax that it faces with Vioxx? And will it continue to be able to do so?

When examining this issue, we should consider the following factors:
(1) The peer-reviewed literature appearing in dental and oral surgery journals clearly establishes the relationship between Fosamax and ONJ;
(2) Most physicians who prescribe Fosamax do not read dental and oral surgery journals;
(3) In its prescribers information, Merck has not issued any warnings about Fosamax and the risk of ONJ to prescribing physicians;
(4) Merck has done no "Dear Doctor" letter to prescribing physicians advising them of the risk of ONJ linked to Fosamax use;
(5) Merck has made public statements inferring to prescribing physicians that there is no risk of ONJ with Fosamax;
(6) Merck previously has been rebuked by the Food & Drug Administration for misleading the public about the risks of another Merck blockbuster drug, Vioxx.
(7) Merck has been rebuked by the FDA for overstating the efficacy of its drug Fosamax.

The time has come for Merck to acknowledge what the leading dental organizations have already acknowledged: Fosamax causes osteonecrosis of the jaw.