Research ghostwriting common, insiders say

The news this week that Merck & Co. conducted research on its own drug and paid prominent scientists to lend their names to the studies came as no surprise to many people in medicine.

Researchers and ethicists say scientists are often paid to be listed as authors of ghostwritten studies in scientific journals, a practice they say undermines the public's already sagging confidence in research.

"We've got to stop this," said Dr. Catherine D. DeAngelis, editor of the Journal of the American Medical Association, which had an article on the topic this week. "People are being hurt. We've given away our profession."

DeAngelis, a pediatrician who was vice dean for academic affairs at Johns Hopkins School of Medicine, said she was often approached while on the faculty to put her name on research that she hadn't conducted.

In some cases, callers representing drug companies assured her little work would be required and said she could refer to a draft by a professional writing firm.

"I was approached many times until they realized I wasn't biting," DeAngelis said.

Articles in JAMA this week charged that Merck conducted its own studies on the pain pill Vioxx, then hired a company to ghostwrite reports for medical journals that appeared under the names of scientists who did little of the research.

Merck didn't disclose the involvement of the ghostwriters, according to the articles, which were based on company documents that surfaced in Vioxx lawsuits. The arthritis drug went on the market in 1999 and became a blockbuster before Merck withdrew it in 2004 after studies showed it was linked to a higher risk of heart attack and stroke.

In an editorial, DeAngelis and deputy editor Phil. B. Fontanarosa wrote that the practices of ghostwriting and "guest authorship" are examples of how the medical profession has been "inundated with profound influence from the pharmaceutical and medical device industries."

Merck defended the research and criticized JAMA for not allowing Merck to respond to the allegations before publication.

"We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal," the company said in a prepared statement.

One of the scientists listed as an author has disputed the contention that he did little work - saying that he reviewed the records of almost 200 patients.

An industry group, the Pharmaceutical Research and Manufacturers Association of America, said that "it is essential for clinical trials to be conducted as ethically as possible" but disputed any inference that company-sponsored studies are inherently biased.

The group said the U.S. Food and Drug Administration acts as a check by reviewing protocols, data and conclusions.

It's understandable that drug companies sponsor studies on drugs they developed, DeAngelis said in an interview. "It's the drug companies that discover these drugs, and thank God somebody does," she said.

But she said it's dishonest for companies to hire doctors to lend prestige to studies they had little role in, and to hide the participation of outside firms that do much of the writing and apply the drug company's spin.

The editorial proposed that all authors disclose their contributions and that anybody who helped write the article but didn't qualify for authorship be listed in acknowledgments. It also proposed that any editor who allows for-profit companies "to manipulate his or her journal must be relieved of the editorship."

The articles struck a chord with Dr. Jean Sealey, a retired professor from Weill Cornell Medical College in New York. Last year, she said, a London-based consulting firm that helps drug companies publish research invited her to "author" an article for a coming conference of the American Society for Hypertension.

Sealey, a noted authority on hypertension, said two things surprised her about the offer: The conference was only a week away, and she had never heard of the drug, much less conducted any research on it:

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