Merck hid Vioxx dangers prior to recall

One of the major controversy in the Vioxx recall drama is if Merck knew whether Vioxx was a dangerous drug. Merck continues to deny that it knew that Vioxx was killing people and claims that it recalled the drug as soon as it came to know that. Everybody else disagrees. Since the recall of Vioxx in September of last year, several disclosures have been made that clearly show that Merck may have known as early as 2000 that Vioxx was killing arthritis patients. Rather than doing something about it, Merck advertised the drug even more aggressively and engaged in a sophisticated campaign to hide the facts. (Related article: Vioxx side effects confirmed in yet another study)

Drug company-funded research and naive journalists who publish the findings are making thousands of people sick and causing hundreds more to die, says Arthur Schafer, a philosophy professor and medical ethicist at the University of Manitoba. The study that made Celebrex a household name in 2000 was rigged, Schafer claims. "I want to warn you, a lot of studies aren't real studies. They are drug company ploys to get doctors to prescribe their drugs," Schafer said to a roomful of scientists and students attending a symposium in Winnipeg last week, as quoted by Rochelle Squires in the newspaper Winnipeg Sun. (Related article: Merck and Pfizer ignored safety, focused on profits)

In papers published in academic journals and information provided to the FDA, Merck simply did not disclose the deaths from Vioxx. Last month, The New York Times disclosed that based on copies of Merck emails, it is very clear that Merck scientists knew that Vioxx was killing the patients but the senior-level management instead decided to hide the facts.

Looks as if the controversy caused by the NYT article and comments of Arthur Schafer are having its effect on academic journals. The Annals of Internal Medicine, a highly respected journal in the medical community may soon publish a correction to a Merck-sponsored study of Vioxx. The corrected version will show that Vioxx had a higher risk of heart attacks than originally reported by Merck scientists.

In a note posted on the Annals of Internal Medicine website, the editors write, "On 24 April 2005, The New York Times carried an article that discussed the ADVANTAGE trial, a Merck-sponsored study that compared rofecoxib (Vioxx) with naproxen in patients with arthritis. Annals published the primary report of this trial. The New York Times states that the Annals article reported only 6 of a total of 9 cardiac events that occurred in study subjects. Annals published the number of cardiac events (5 myocardial infarctions in the rofecoxib group and 1 in the placebo group) that the authors reported in their manuscript. The editors will try to verify the number of cardiac events reported in The New York Times article. We will print a correction if we confirm that Lisse and colleagues reported patient outcomes incorrectly."

In an interview with Bloomberg News, Annals editor Harold Sox said, "Corrections happen all the time, but corrections that materially change the message of the article are pretty uncommon." He added, "If they had told us it was 8-to-1, it would have been much different than 5-to-1." The paper was written by Jeffrey Lisse, head of Rheumatology and professor in the Medicine/Rheumatology Section at the University of Arizona College of Medicine. He was quoted in the Times story as saying that while he is listed as the study's author, Merck actually wrote the report.

There are several other instances in which Merck threatened its own scientists and others who questioned the safety of Vioxx. These findings are important since these will be crucial in the arguments by Vioxx plaintiffs that Merck knew about the dangers of Vioxx and failed to disclose them in a timely manner. Most attorneys intend to make this a central argument in Vioxx lawsuits currently in the courts.

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