The FDA approved Vioxx in 1999, and physicians frequently prescribed the drug for acute or chronic pain like that which accompanies arthritis. Unfortunately, the drug proved to be fatal the entire time that it was on market, according to Pharmalot blogger Ed Silverman. Eight years after Merck withdrew the drug and thousands of lawsuits later, Merck is still under fire for information that was not disclosed to the public.
Silverman says this secrecy was recently proven in a paper written by authors who did extensive research on three Vioxx trials conducted over a decade ago. Merck initiated the trials to see if Vioxx was useful in treating or preventing Alzheimer’s disease. According to Jerry Avorn, a professor of medicine at Harvard Medical School and one of the authors of this paper, Merck used on-treatment analysis as opposed to intent-to-treat analysis. Intent-to-treat analysis is widely used by drug makers in order to discover a drug’s potentially harmful side effects.
Since there was no data safety monitoring board for the three experiments, Merck was free to present the data it chose to reveal to the public. The company has denied any knowledge of the dangerous side effects that resulted in the death of many patients.
According to Silverman, Avorn and several of his colleagues recently performed intent-to-treat analysis on the same three trials that Merck conducted. Results showed significant disparities from the on-treatment analysis that Merck used. Specifically, the analysis showed that Vioxx had a substantial amount of risks that would have forced Merck to take the drug off the market much sooner.
“If we could do this from the same data they had, why didn’t they, especially given all the prior concern about possible cardiovascular toxicity? The company certainly should not have gone around and cited these very trials as ‘proof’ that the drug was safe,” Avorn reportedly said.
Rather than prevent thousands of deaths, Merck instead pocketed the $2.5 billion it made by keeping dangerous drug Vioxx on the market.