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Fraud studies made by drug company { March 2008 }

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Merck Masked Vioxx Risk, Hired Study Ghostwriters, Records Show
By Michelle Fay Cortez

April 16 (Bloomberg) -- Merck & Co. conducted its own studies on the pain pill Vioxx, then hired companies to ghostwrite reports for medical journals that appeared under the names of scientists who didn't do the majority of the research, court records show.

In many cases, Merck's involvement in producing the data wasn't disclosed, according to two articles in the current Journal of the American Medical Association relying on court papers. The documents disclosed by Merck in two Vioxx lawsuits also suggest the company's control of the data allowed it to downplay the risk of death from Vioxx in patients with Alzheimer's disease, the journal's editors said in an editorial.

About 250 documents show Merck employees worked alone or with publishing companies to write manuscripts and later recruited academic medical experts to put their names as first authors, according to an analysis by researchers from medical schools at Harvard, Brown and Yale Universities, and the Mt. Sinai School of Medicine in New York.

``The academic authors are supposed to be the most objective members of the team,'' said Joseph Ross of Mount Sinai, who led the analysis, in a telephone interview. `To have them involved in the very last stage, and give the impression that they've been involved from the very beginning, is distorting. This is not acceptable.''

Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said.

Pulled Off Market

Merck, based in Whitehouse Station, New Jersey, pulled Vioxx off the market in 2004 after a study linked it to heart disease. The company has agreed to pay $4.85 billion to settle tens of thousands of patient claims that Vioxx, used by 84 million people worldwide, caused heart attacks or strokes.

Merck fell 18 cents to $41.22 in New York Stock Exchange composite trading yesterday, and has dropped 18 percent in the past 12 months.

``We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal,'' said Peter Kim, president of Merck Research Laboratories, in a statement. The company also said it wasn't given the opportunity to respond to the allegations before publication.

Positive Spin

The Vioxx case shows that pharmaceutical companies often design and conduct research, analyze and interpret data and start writing a manuscript before academic investigators are involved, said Ross of Mt. Sinai. When companies prepare the report, the results are spun more positively, he said. For the academic authors, publication of large studies in major medical journals is prestigious and often opens doors for other roles, including lucrative consulting.

``Lots of companies are collaborating with academic physicians this way,'' Ross said. ``The profession really needs to take a look at itself and decide this isn't the way science is conducted. When you put your name on a manuscript, you need to be involved from the very beginning.''

Dozens of studies, including one involving Alzheimer's patients, were written by people hired by Merck and subsequently attributed to researchers at major universities, a review of the documents in JAMA found. An invoice for one report targeting a cardiovascular audience, involving 20 pages, six charts and two revisions, from Health Science Communications totaled $23,841, according to the court documents.

Delphine Dubois, president of the New York-based company, didn't return phone calls or e-mails seeking comment.

`External Author?'

A draft version of the Alzheimer's trial, called study 078, had ``external author?'' in the spot where the lead author's name typically goes. The final version listed three academic researchers, in addition to the eight named Merck employees. There were minor differences in the final publication, though the results presented were identical, according to the analysis led by Ross from Mount Sinai School of Medicine.

The lead author on the final, published report was Leon Thal, chair of neurosciences at the University of California, San Diego School of Medicine. Thal died last year when a small airplane he was piloting crashed in California.

Jim Fitzpatrick, an attorney with Hughes, Hubbard and Reed who helped represent Merck in its Vioxx litigation, said all authors on Merck studies had input on them. It is part of the scientific process to list authors with varying degrees of involvement, he said in a telephone interview.

``Merck's expectation is if a scientist is an author on a paper, then he or she agrees with the paper, has had the opportunity to comment and make revisions,'' Fitzpatrick said. ``I think it does give the paper more credibility if there is a respected outside author that has reviewed and edited the content of the paper.''

Consultants to Plaintiffs

All six authors of the two reports in JAMA, except Bruce Psaty, served as consultants to plaintiffs suing Merck because of Vioxx.

A review of the court documents found that a separate company analysis in April 2001 showed Vioxx tripled the risk of death in Alzheimer's disease patients. The documents show Merck denied the danger to regulators and concluded when findings were published years later that Vioxx was ``well tolerated.''

``By any conventional scientific standard, a threefold increased risk in the death rate is a major safety issue,'' said Psaty, the lead author of the study evaluating Vioxx risks for Alzheimer's patients, and a professor at the University of Washington. ``Had this been reported in April 2001, it's possible that many fewer patients may have decided to take Vioxx,'' he said in a telephone interview.

Ethics Questioned

In July 2001, Merck submitted a drug safety report to the U.S. Food and Drug Administration detailing deaths in Alzheimer's disease patients while they were taking Vioxx, leaving out those that occurred more than two weeks after the last dose of the drug. Even with the reduced numbers, FDA staff members asked about the ethics of continuing an Alzheimer's disease study because of the increased death rate.

The company replied to the FDA that the numbers were small and likely due to chance, and disclosed that there was no independent review group designed to monitor the trial for safety. Merck didn't disclose the death rates to individual researchers because the company determined there was no ``compelling and clear safety issue,'' the documents show.

``Our study raises questions about the wisdom of allowing the sponsor to control and analyze the data,'' Psaty said. ``This is a major safety concern that remained unreported.''

Unrelated Causes

The death rates in the Alzheimer's studies are misleading because some patients died from causes unrelated to the drug, such as a car accident or electric shock, said Fitzpatrick, the Merck attorney. There were 21 deaths from heart disease in patients getting Vioxx, compared with 6 of those getting a placebo. In all, there were 57 deaths in the Vioxx group and 29 in the placebo group, the documents showed.

``There is a pretty clear disclosure that there were more deaths in the Vioxx arm,'' he said. ``The data were very fairly discussed.''

Senator Charles Grassley, an Iowa Republican, said the reports on ghostwritten articles about Vioxx ``reveal just how far a drugmaker might go to market its product and try to bury information that might hurt sales even when that information directly affected the health and safety of the people taking their medicine.''

``Revealing this kind of activity is very important in building pressure on the Food and Drug Administration to regulate, not accommodate drugmakers,'' Grassley said in an e- mailed statement.

$4.85 Billion Settlement

Lawyers who represent consumers who sued Merck over Vioxx said the revelations won't change the $4.85 billion settlement reached to resolve litigation over the drug in November.

`This has absolutely no effect on the settlement,'' said Arnold Levin, a Philadelphia-based lawyer for former Vioxx users who helped negotiate the accord. ``It's in effect and all the parties will follow the agreement. People would be crazy to even think of pulling out of it.''

Last Updated: April 16, 2008 00:00 EDT

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