Edward Scolnick's testimony is front and center now. Scolnick is the former president of Merck Research Laboratories. His testimony can't help Merck, in my opinion.
Scolnick testified about two studies where Alzheimers-diagnosed patients ingested various dosages of Vioxx. In both studies, the clinical trial patients evidenced higher death rates than those in the control group who ingested only a placebo. The two studies were commenced to find if Vioxx would serve to delay the onset or worsening of the devastating effects of Alzheimer's.
Merck & Co. never notified physicians or its sales representatives of this result. He also admitted that the information regarding deaths among Alzheimer's patients was never mentioned or included in info cards that Merck sales reps used to answer potential queries by doctors.
Scolnick was asked to admit that the death data was important to doctors, and he said
"It's data the physician should know."
To access FDA information, go here. From that site:
In April 2002, FDA approved extensive labeling changes to reflect the findings from the VIGOR study. FDA also approved a rheumatoid arthritis indication at the 25 mg dose based on separate efficacy trials. The new label provided additional information to the Clinical Studies, Precautions, Drug Interactions and Dosage and Administration sections to reflect all that was known at the time about the potential risk of cardiovascular effects with Vioxx. These labeling changes included detailed information about the increase in risk of cardiovascular events relative to naproxen, including heart attack. It also included data from the ongoing placebo controlled Alzheimer's study at the 14 month time point which did not show an increase in CV risk. The new labeling change also noted that Vioxx 50 mg was not recommended for chronic use.
