Former FDA Officer Testifies at Fosamax Retrial
June 16, 2010, the penultimate day of the plaintiff’s case, began with the continuation of Dr. Curt Furberg’s testimony, concerning Merck’s research on Fosamax. Dr. Furberg testified that he believed the primary article upon which Merck relies to try to prove that Fosamax has benefit for women with osteopenia, authored by Dr. Qundt, was widely misleading and deceptive.
The second witness of the day was Dr. Suzanne Parisian, a former FDA medical officer. Dr. Parisian worked at the FDA for four years in the early 1990s. After her tenure there, she published a book, “FDA Inside and Out,” and has made a living explaining the workings of the FDA to outsiders. Dr. Parisian’s testimony illustrated how the FDA has no real authority, that it is basically a shadow organization primarily funded by the drug companies to approve their drugs for marketing to the American public. She testified that the FDA has no power to force a drug company, such as Merck, to change its label or recall a drug once it is on the market. She also testified that the FDA is under a mandate to approve drugs in less than ten months. She further explained that the FDA is woefully understaffed, with only five workers reading the more than 400,000 adverse event reports sent to the FDA each year. Dr. Parisian’s testimony specifically rejected defense attorney Strain’s point in his opening statement that because the FDA had approved Fosamax, it could not be defective.
Tomorrow will be the plaintiff’s final day of witnesses, and will feature the plaintiff herself, Ms. Shirley Boles.