In the recent bellwether trial of Scheinberg v. Merck & Co., Merck’s Associate Vice President for Clinical Research Dr. Arthur Santora revealed that Merck’s drug Fosamax does not have any evidence of fracture reduction benefit for patients without osteoporosis. In the label for Fosamax, Merck affirmatively indicates that Fosamax prevents fractures for patients for both osteoporosis patients and pre-osteoporosis patients (often called “osteopenia patients”).
Dr. Santora’s trial testimony reveals that Fosamax does not, however, prevent fractures the patients without osteoporosis. Under examination by Levin, Papantonio shareholder Timothy O’Brien, Dr. Santora admitted that there was no evidence of fracture reduction benefit for those patients without osteoporosis:
Q: It’s my understanding, Dr. Santora, based on the clinical trial evidence that Merck had and presented to the FDA, Merck cannot say that for those patients without osteoporosis that the use of Fosamax prevents fractures, right?
A: That’s correct, it doesn’t – – what you said is correct.
Q: Because there’s no evidence that it does, right?
A: That’s another way of saying the same thing, that’s correct.
Q: And in terms of Fosamax, the bottom line for efficacy of Fosamax is fracture reduction, right?
A: That’s what is important to patients and physicians.
Merck, however, continues to sell Fosamax to those non-osteoporotic patients for whom Fosamax has shown no fracture reduction benefit. Prescriber data reveals that 75-80% of all patients who are prescribed Fosamax are non-osteoporotic. Further, Merck’s internal sales documentation revealed during the New Jersey trial of Sessner v. Merck & Co. illustrates that Merck’s Fosamax went from approximately $1 billion in annual sales to $3.5 billion in annual sales in the 2000s, based largely on the sales to non-osteoporotic women, for whom there is no fracture reduction benefit.
Farron Cousins is the executive editor of The Trial Lawyer Magazine, a contributing writer at DeSmogBlog.com, a producer of Ring of Fire. Follow him on Twitter @farronbalanced.