Merck tries to put its defense on track in Vioxx case

In one of those rare instances when the FDA employees were actually doing their job (they have clearly not done it in many cases) - ensure drug safety in America - they were blasted by Merck executives who called them "grade D high school students" and used four-letter words to describe them. The Merck folks were incensed that FDA was actually worried that Americans could die, while the company was more concerned about beating Pfizer's drugs Celebrex and Bextra.

It was clear yesterday that when Edward Scolnick apologized for his choice of words, and said, "My language was clearly, clearly inappropriate and was not respectful to the FDA," he was not really changing his opinion of the drug regulatory agency as an evil to deal with, he was merely trying to help Merck.

While analysts and legal experts are confounded by Merck's reasoning that it was OK to ignore trial data and rely instead on the beliefs of scientists, the jury is likely to think otherwise. When a company statistician, Joshua Chen, found that rate of deaths from Vioxx was 3X that from a placebo, his colleagues not only decided to ignore the evidence but also report fabricated data to the FDA.

According to the FDA estimates, as many as 60,000 Americans have died due to Vioxx.

Related article: Merck tactics show that it expects a defeat in the Humeston case