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Akron Univ. School of Law

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Thursday, April 17, 2008

Vioxx Deaths, Merck's Data and Ghostwriters

Guardian reports on the bad data provided by Merck and the New York Times follows up with a review of yesterday's Journal of the American Medical Association piece discussing ghostwriters for medical articles on Merck data and analysis. Sarah Boseley for the Guardian writes,

A multinational drug company that made a painkiller that had to be withdrawn from sale because it was found to cause heart attacks may have hidden the death rate from the authorities for several years, it was claimed yesterday. Internal company documents released during litigation in the US suggest that Merck, makers of Vioxx, gave the US Food and Drug Administration only selected data on deaths in its clinical trials, and failed to include people who had a fatal heart attack soon after coming off the drug. . . . .

Bruce Psaty and Richard Kronmal, from the University of Washington in Seattle, say that internal company records from 2001 give 34 deaths among the 1,069 Vioxx patients from two of the Alzheimer's trials and 12 among the 1,078 on placebo - a threefold increase among those on the drug. But the published data of the first study in 2004 stated there were 11 deaths which were "non drug-related" among 346 Vioxx patients, and two among those on placebo. In the second study published in 2005 there were said to be 24 deaths among 725 Vioxx patients and 15 among the 732 on placebo, with 17 and two more respectively within 14 days of the last dose. But, say the researchers, neither study analysed the mortality data.

In July 2001, Merck had reported mortality data to the FDA. Psaty and Kronmal wrote that "deaths that had occurred more than 14 days after discontinuation of the trial drug apparently were not included". When the FDA questioned the figures, in December 2001, it emerged that there was no independent data. The second journal paper reveals that manuscripts for scientific journals were written by Merck employees. Doctors attached to leading universities would then be invited to take authorship. Some, but not all, declared financial support from industry.

The New York Times provides more details on the ghostwriters for Merck and suggested reforms for medical publishers by the Journal of the American Medical Association,

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?”   . . . .

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. . . . .

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. . . .

One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression.  The draft of the paper, dated August 2003, identified the lead writer as “External author?” But when it was published in 2005 in the journal Neuropsychopharmacology, the lead author was listed as Dr. Leon J. Thal, a well-known Alzheimer’s researcher at the University of California, San Diego. Dr. Thal was killed in an airplane crash last year.  The second author listed on the published Alzheimer’s paper, whose name had not been on the draft, was Dr. Ferris, the New York University professor. Dr. Ferris, reached by telephone Tuesday, said he had played an active role in the research and he was substantially involved in helping shape the final draft.  “It’s simply false that we didn’t contribute to the final publication,” Dr. Ferris said.

A third author, also not named on the initial draft, was Dr. Louis Kirby, currently the medical director for the company Provista Life Sciences. In an e-mail message on Tuesday, Dr. Kirby said that as a clinical investigator for the study he had enrolled more patients, 109, than any of the other researchers. He also said he made revisions to the final document.  “The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting,” Dr. Kirby’s e-mail message said.

The current editor of the journal Neuropsychopharmacology, Dr. James H. Meador-Woodruff, the chairman of psychiatry at the University of Alabama, Birmingham, said he was not the editor in 2005 but planned to investigate the accusations. “Currently, we have in place prohibitions against this,” Dr. Meador-Woodruff said.

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