The drug maker Merck & Co. drafted dozens of research studies for a best-selling drug and then lined up prestigious doctors to put their names on the reports before publication, according to an article in a leading medical journal.
The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look at the industry practice of ghostwriting medical research studies that are then published in academic journals.
The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as "External author?"
Vioxx was a best-selling drug before Merck pulled it from the market in 2004 over evidence linking it to heart attacks. Last fall the company agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.
The lead author of the article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry's published research, because the ghostwriting practice appears to be widespread.
"It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician," said Ross, whose article, written with colleagues, is being published in today's issue of The Journal of the American Medical Association.
Merck acknowledged that it sometimes hires outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But it disputed the article's conclusion that the authors do little of the actual research or analysis.
And at least one of the doctors whose published research was questioned in the article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that an article bearing his name was ghostwritten was "simply false." He said it was "egregious" that Ross and his colleagues had done no research besides mining the Merck documents and reading the published medical journal articles.
In an editorial in today's issue, JAMA said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.
"It is clear that at least some of the authors played little direct roles," the editorial said, "yet still allowed themselves to be named as authors."
