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Vioxx study shows complex researcher involvement
April 16, 2008 / 4:42 PM / 9 years ago

Vioxx study shows complex researcher involvement

WASHINGTON, April 16 (Reuters) - Every few months, Stephen Ferris would receive folders of papers with clinical descriptions of patients suspected to have Alzheimer’s disease.

Ferris, the Gerald J. and Dorothy R. Friedman Professor of Psychiatry and director of New York University’s Alzheimer’s Disease Center, would help decide if a patient had developed Alzheimer’s disease.

He never saw a patient. Yet his name is listed as second author on the study in the journal Neuropsychopharmacology in March 2005.

Wednesday’s issue of the Journal of the American Medical Association alleges this is a clear demonstration of “guest writing.”

But Ferris says the journal, popularly known as JAMA, is mistaken.

Ferris’s story shows that the line of names at the top of a report published about a clinical trial does not always reflect the work that went into the study.

JAMA says companies can cherry-pick distinguished authors to lend their names and reputations to work controlled by the firms, making it easy to manipulate data and researchers alike, while Ferris notes that often hundreds of people work on a study and just a few representative names get used.

JAMA says the study, which was testing the Merck and Co (MRK.N) arthritis drug Vioxx to see if it could delay the development of Alzheimer‘s, showed clearly that patients taking the drug were more likely to die than patients taking placebo.

“My role in the conduct of the study was ... we would get binders in the mail on a regular basis over the years the study was ongoing,” Ferris told Reuters in a telephone interview.

“There was a sheet that we would check off with a recommendation and we would fax that in. It was like a vote,” he added.

“We were not paid to be authors,” Ferris said.

SUSCEPTIBLE TO DUPING

He said Dr. Leon Thal, a respected Alzheimer’s researcher at the University of California San Diego, had helped Merck come up with the idea of the trial and helped write the results.

Thal, who was killed in a plane crash in 2007, was not paid, Ferris said. He said they both looked at the first analysis, which was written by a Merck researcher.

“It is typical that the person writing the first draft is some person in the company who knows something about the study,” Ferris said.

Ferris said he had no opinion on whether the data showed the patients taking Vioxx were more likely to have a stroke or to die. “I don’t feel I am competent to have an opinion about that,” said Ferris, who is not a physician.

But he said Thal was, as was Dr. Louis Kirby of Pivotal Research Centers in Peoria, Arizona, another outside researcher whose name is also on the paper.

“I think with regard to this I would have to admit that I could be susceptible to duping given my particular background and expertise,” Ferris said.

In the end, the study carried the names of eight Merck researchers, as well as Thal, Ferris and Kirby.

Vioxx was pulled from the market in 2004, but thousands of lawsuits have been filed against Merck alleging that it knew the drug was dangerous years earlier and kept it on the market without cautioning patients.

Dr. Joseph Ross of the Mount Sinai School of Medicine in New York, and colleagues studied documents presented in the lawsuits, which Merck is trying to settle as a group.

They say researchers like Ferris were part of a “systematic strategy” used by Merck to “facilitate the publication of guest authored and ghost written medical literature.”

“Recruited authors were frequently placed in the first and second positions of the authorship list,” they wrote in JAMA.

Ferris said he was livid about JAMA’s use of his particular paper as an example of guest writing.

“I am sure guest authorship is something that goes on and I neither condone it nor participate in it,” Ferris said.

But Ross said no doctors were being blamed. “No one is going to talk about it. No one is going to admit to it,” he said.

Editing by Julie Steenhuysen and Philip Barbara

Our Standards:The Thomson Reuters Trust Principles.
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