Two studies appearing today in the Journal of the American Medical Association have prompted the journal’s editors to call for “drastic actionâ€? to prevent drug manufacturers from misleading patients by misrepresenting data from clinical trials.The two papers, based on internal Merck documents that surfaced during litigation over its withdrawn painkiller Vioxx, accuse the company of questionable practices over the drug. Vioxx was one of the biggest selling and most heavily promoted drugs Merck withdrew in 2004 after it was linked to a higher rate of heart attacks.Bruce Psaty and Richard Kronmal, of the University of Washington reported that Merck had not fully disclosed the death rates in trials in which Vioxx was tested on Alzheimer’s patients after there had been some evidence to suggest that drugs of the Vioxx type could slow progression of the disease.Merck reported in the first place that Vioxx was “well tolerated,â€? according to Psaty and Kronmal, but internal company documents revealed that patients given the drug 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. The two trials resulted in 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 U.S. Food and Drug Administration nor made public in a timely fashion. There was a threefold increase in the risk of death for these patients. Our study raises questions about the wisdom of allowing drug study sponsors like Merck to control the data and analyses,â€? the two authors concluded in their report.“The drug industry appears to treat scientific data as if they were a marketing tool. That’s not appropriate,â€? Psaty added.The second paper accusing Merck involved a team led by Joseph Ross of Mount Sinai School of Medicine in New York who studied about 250 documents released to the courts by Merck. The documents showed that academics were recruited to put their names to them in turn being paid by Merck.“This is a very serious transgression and the medical community needs to agree that it’s wrong…and figure out a way to discourage it,â€? Dr. Ross said.Merck officials denied the accusations that the company misrepresented data. Peter Kim, Merck’s research chief criticized the JAMA reports saying, “the allegation that Merck is misrepresenting mortality data from our Alzheimer’s studies is just plain wrong. We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal,â€? Kim said in a statement, according to Reuters.Merck’s lawyer James Fitzpatrick of Hughes, Hubbard & Reed called the allegations a “trial brief masquerading as scientific debate.â€?“These are allegations that haven been made and rebutted in the litigation. Merck thoroughly disclosed these data both to the FDA and to the scientific literature. And, in fact, Merck looked carefully at the mortality data from all of its studies and concluded across the body of data they didn’t see any difference in mortality related to Vioxx,â€? Fitzpatrick said.Sen. Charles Grassley, R-Iowa, as chairperson of the Senate Committee on Finance personally addressed a letter to Merck on Tuesday in which he demanded answers to his questions about the trials.

“These reports reveal just how far a drug maker might go to market its product and try to bury information that might hurt sales when that information directly affected the health and safety of the people taking their medicine,� Grassley said, according to USA Today.