A leading drug company has been accused of misrepresenting data on the safety of a bestselling drug and persuading academics to lend their names to studies that were ghostwritten for them.

Two papers in the Journal of the American Medical Association (JAMA) have accused Merck, one of the largest drug companies in the world, of questionable practices over its arthritis drug, Vioxx (rofecoxib).

Vioxx was one of the biggest-selling and most heavily promoted drugs until Merck withdrew it after it was linked to a higher rate of heart attacks. Subsequent court cases have brought to light documents that have enabled researchers to trace the drug’s history.

Bruce Psaty and Richard Kronmal, of the University of Washington in Seattle, reported that Merck had not fully disclosed the death rates in trials in which Vioxx was tested in Alzheimer’s patients after there had been some evidence to suggest that drugs of the Vioxx type could slow progression of the disease.

In published papers, the authors said, Merck reported that, as regarding safety, Vioxx was “well tolerated”. But internal company documents showed that patients who were given Vioxx in one trial had been more than four times as likely to die as those given a placebo, and 2.5 times as likely to die in a second trial. When pooled, the two trials showed 34 deaths among about 1,000 patients given Vioxx, and 12 deaths among a similar number given a placebo.

“These mortality analyses were neither provided to the US Food and Drug Administration (FDA) nor made public in a timely fashion,” the two authors concluded in their report.

In a second paper in the journal, a team led by Joseph Ross, of Mount Sinai School of Medicine in New York, studied about 250 documents released to the courts by Merck.

These showed that some of the published trials demonstrating the benefits of Vioxx were planned by the company and ghostwritten by medical publishing companies. External acadamics were recruited to put their names to them. Some of the “authors” were paid honorariums by Merck.

The paper showed two versions of one of the Alzheimer’s trial papers.

In the first, eight scientists from Merck were listed but the lead author was described as “External author?”.

In the published version, three academic scientists occupied the top positions in the list of authors, implying that they had led the research, followed by seven of the Merck authors.

The authors of the paper said that studies drafted by others should make it clear who the authors were, who drafted the article, and who revised it, and make clear any financial tie-ups.

Merck said yesterday that many of the comments in the JAMA were “false, misleading or lack context”.

The company said that the articles were based on analyses of documents conducted by consultants hired by trial lawyers engaged in litigation relating to Vioxx. It added that a “full, unbiased evaluation of the Merck documents” showed significant errors in the conclusions put forward by the authors of the JAMA articles.

“The allegation that Merck misrepresented mortality data from our Alzheimer’s studies is just plain wrong,” said Peter S. Kim, the president of Merck Research Laboratories. He added that the “outside authors” of the papers about Merck’s clinical trials referenced in the JAMA article were intimately involved in the studies.

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