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Ghostwriters were used in Vioxx studies

The Baltimore Sun

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."

The editorial called for immediate changes in the practice, calling upon medical journal editors to require each author to report his or her specific contributions to articles.

JAMA itself published one of the Vioxx studies that was cited in Ross' 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 that, even so, it was dishonest because the authors did not fully disclose the role of a ghostwriter.

"I consider that being scammed," she 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 magnitude of the practice, said 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 Egilman and Ross because they had served as consultants to plaintiffs' lawyers in some of those suits.

Ross said the concerns go beyond the authorship of drug research studies, raising questions about the validity of the clinical trials on which the research is based.

Combing through the documents, Ross and his colleagues unearthed internal Merck e-mail messages and documents about 96 journal publications, which included review articles and reports of clinical studies. In some cases, Merck's marketing department was involved in developing plans for manuscripts, the article said.

The Ross team said it was not necessarily raising questions about all 96 articles. But for many of the papers, their document searches found scant evidence that the recruited authors made substantive contributions.

For example, in 16 of 20 papers that reported on clinical trials, a Merck employee was designated as the author of the first draft of the manuscript. But an outside academic scientist was listed as the lead author when the study was published.

Merck said yesterday that any outside authors named in its studies were involved in the research, as well as drafting and reviewing of the papers bearing their names.

While the company sometimes hires professional writers to formulate early drafts of scientific articles, the final work is the product of the doctor, the company said.

"Ultimately that doesn't change the fact that the work accurately reflects his or her opinion," said a Merck lawyer, James C. Fitzpatrick.

Today's issue of JAMA also included another Vioxx-related paper that drew from the same cache of documents.

In that paper, Dr. Bruce Psaty and Dr. Richard A. Kronmal of the University of Washington concluded that in the years leading to the Vioxx recall, the company was not fully candid in submitting data to the Food and Drug Administration about the drug's heart attack risk.

Merck said that the Psaty and Kronmal analysis was misleading, saying the FDA had been aware of concerns over cardiovascular risks associated with Vioxx and had been engaged in continuing discussions with the company.

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