Merck refutes allegations of false data, ghostwriting

CHICAGO According to a report in the Journal of the American Medical Association, Merck purposely gave the Food and Drug Administration incomplete clinical trial data from its painkiller drug Vioxx in an effort to get the drug on the market and keep it there, according to the Washington Post.

The report also said that Merck used “guest authorship and ghostwriting” to make it appear that research done by its employees or contractors was the work of scientists at medical schools and universities. In turn, this made the findings of the research more credible and therefore boosted the drug’s profile.

The clinical trials in question involve deaths appearing in patients taking the drug who were experiencing mild dementia. Originally, the FDA said that 29 people taking Vioxx died in a clinical trial that was testing whether the drug could slow the progression of dementia. In that same trial, 17 people died while taking a placebo. Actually, the report should have stated that 34 people died while taking Vioxx and only 12 deaths occurred in the placebo group.

Merck stated in its FDA filing that, it only reported deaths that occurred while patients were “on treatment” and up to as long as three months. But, in-house documents had results of patients had results of patients who died while on the drug as well people who stopped taking the drug and yet still died. Eventually, the company reported all the data to the FDA, two years later.

In response to the “ghostwriting” accusation, Merck’s lawyer James Fitzpatrick said: “It is correct that Merck would sometimes use an outside company to compile the literature in a field and do the first draft, much the way a professor would use a research assistant to do the same thing.”

JAMA though believes the articles were completely written by Merck scientists and that doctors and researchers were paid off to use their names on the papers. One scientist though came in defense of Merck and said that he was, “directly involved in a very substantive way” in a paper that JAMA said was done by Merck and not outside authors.

To date, the drug has cost the company $4.85 billion in lawsuits, which the company paid off in a joint fund.