The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.
The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in 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 took it off 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 Wednesday’s 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 Dr. Ross, whose article, written with colleagues, was published Wednesday in JAMA, The Journal of the American Medical Association. and posted Tuesday on the journal’s Web site.
Merck acknowledged on Tuesday that it sometimes hired outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article’s conclusion that the authors do little of the actual research or analysis.
The final work is the product of the doctor and “accurately reflects his or her opinion,” said a Merck lawyer, James C. Fitzpatrick.
And at least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was “simply false.” He said it was “egregious” that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published journal articles.
In an editorial, 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 in the study or review, yet still allowed themselves to be named as authors,” the editorial said.
The editorial called upon medical journal editors to require each author to report his or her specific contributions to articles. “Journal editors also bear some of the responsibility for enabling companies to manipulate publications,” the editorial said.
JAMA itself published one of the Vioxx studies that was cited in Dr. Ross’s article.
In that case, in 2002, a Merck scientist was listed as the lead author. But Dr. Catherine D. DeAngelis, JAMA’s editor, said in a telephone interview on Tuesday that, even so, it was dishonest because the authors did not fully disclose the role of a ghostwriter.
“I consider that being scammed,” Dr. DeAngelis said. “But is that as serious as allowing someone to have a review article written by a for-profit company and solicited and paid for by a for-profit company and asking you to put your name on it after it was all done?”
Although the role of pharmaceutical companies in influencing medical journal articles has been questioned before, the Merck documents provided the most comprehensive look at the practice yet, according to one of the study’s four authors, Dr. David S. Egilman, a clinical associate medical professor at Brown University.
In the Vioxx lawsuits, millions of Merck documents were supplied to plaintiffs. Those documents were available to Dr. Egilman and Dr. Ross because they had served as consultants to plaintiffs’ lawyers in some of those suits.
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This article was posted: Thursday, April 17, 2008 at 11:54 am