SALES DOWN 80% FROM PEAK DUE TO “CONCERNS ABOUT LONG TERM SAFETY”
By Timothy O’Brien
November 26th, 2012 2:00pm
For years, Merck’s osteoporosis medication Fosamax was the golden child of the Merck pharmaceutical portfolio. Fosamax’s sales, however, have been hammered by multiple case-control and cohort studies associating spontaneous femur (thigh) fractures in long-term users of the drug. Coupled with a 2011 FDA Joint Advisory Committee inquest regarding who should be on Fosamax and for how long, global sales for Fosamax continue to nose-dive.
Even after Fosamax revenues for Merck initially declined in 2008 because of the availability of alendronate in generic form as well as safety concerns related to osteonecrosis (literally, bone death) of the jaw, sales of Fosamax have consistently declined, year after year, as additional studies were released by independent organizations reinforcing the link between Fosamax and spontaneous, atypical femur fractures.
In 2010, the American Society of Bone and Mineral Research released a major task force position paper calling for stronger warnings relating to the risk of Fosamax-associated spontaneous femur fractures. One year later, Elizabeth Shane, M.D., the President of the American Society of Bone and Mineral Research, speaking on behalf of the organization, testified before the FDA Joint Advisory Committee: “We recommend that bisphosphonates be reserved for patients who are at high-risk of fracture.” This directly departs from Merck’s marketing plan for Fosamax: since 1997, Merck has been marketing Fosamax to be used by lower-risk, non-osteoporotic patients who are estimated to compromise nearly 80% of the patients taking Fosamax.
In addition to the ASBMR recommendation that bisphosphonates such as Fosamax not be used by non-osteoporotic patients, FDA scientists at the 2011 FDA Joint Advisory Committee inquest testified that there was no demonstrated fracture reduction benefit, even for patients at high risk of fracture, from long term use of drugs like Fosamax.
The sales for Fosamax peaked in the mid-2000s at more than $3.5 billion per year. According to 3rd Quarter 2012 Merck financial filings, global sales for 2012 are projected to be less than $700 million, with a remarkable 29% drop in Fosamax revenues from the same quarter last year. Fosamax sales have fallen so precipitously that Merck no longer lists Fosamax as one of its “Top Pharmaceutical Products” in its quarterly financial disclosures. For years, Merck has been racing to develop the next generation osteoporosis drug, odancatib, to replace Fosamax. In April 2012, Merck CEO Kenneth Frazier conceded the connection between the problematic safety issues for Fosamax and its slumping sales: “There’s also declining use of bisphosphonates due to concerns about long term safety.”
Merck employs 84,000 employees worldwide and reports annual revenues of $48 billion.
Timothy M. O’Brien is a senior shareholder in the Levin, Papantonio law firm. He is national lead counsel for the Plaintiffs Steering Committee in MDL No. 1789, In re Fosamax Products Liability Litigation.