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Articles Criticize Merck on Vioxx

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Merck and Co., Inc. engaged in a series of deceitful actions that led to an underestimation of deaths caused by its blockbuster drug Vioxx during post-marketing research of the pain reliever, according to two articles in a medical journal that used documents released by Merck in lawsuits against the pharmaceutical giant.

The articles in the Journal of the American Medical Association, or JAMA, stated that Merck failed to disclose damaging information about death rates in Vioxx patients, and paid academic researchers to put their names on papers they did not write. In one case, the company probably should have stopped a trial because of a clear signal that patients on the drug were dying of heart attacks at higher rates, the authors said.

Merck reacted angrily to the articles. In a news release, Merck said that a careful analysis of the data at the time of the studies gave no indication the extra deaths were caused by the drug. It claimed the JAMA report’s conclusions are “false, misleading or lack context.” The company complained that it was unable to comment on the reports before their publication.

Noting that Merck has one of the best reputations in the drug industry, the authors suggested that such practices may be common among pharmaceutical companies. The disclosure of these actions point to the need for changes in the way that drug research is conducted and monitored by the Food and Drug Administration, they wrote. The articles come at a time when the FDA is regarded as critically short of manpower to carry out its regulatory functions.

Image has not been found. URL: /wp-content/uploads/2008/09/vioxx.jpg In an editorial accompanying the articles, the JAMA editor-in-chief Catherine DeAngelis and her deputy, Phil Fontarosa, say the disclosures in the Vioxx case point to widespread problems that threaten to “erode the ethical foundation of medicine and medical research.”

“The profession of medicine, in every aspect—clinical, education and research– has been inundated with profound influence from the pharmaceutical and medical device industries,” the JAMA editors wrote. “Manipulation of studies by the pharmaceutical and medical device industry is either increasing or there has been more exposure of these practices. This has occurred because physicians have allowed it to happen, and this has to stop. Primum non nocere (“first do no harm”) does not hold true only for physicians directly treating patients.’’

Vioxx, one of three major COX-2 inhibitors, which are compounds that used a new biological pathway to fight pain, went on the market in 1999 and earned as much as $5.2 billion a year in sales. Merck pulled the drug off the market in 2004. FDA analysts estimate that the drug caused between 88,000 and 139,000 heart attacks, about a third of them fatal, in the five years it was on the market. Merck in November paid $5 billion to settle most of the tens of thousands of lawsuits.

Controversy has swirled over which company officials, FDA officials and journal authors and editors knew what, and when, about the severity of the drug’s problems. Both JAMA articles were the product of internal documents on drug studies conducted by Merck that it released in discovery for thousands of lawsuits.

In the first article, Bruce Psaty and Richard Kronmal of University of Washington found that in an April 2001 analysis of two trials of Vioxx for the prevention of Alzheimer’s disease, company officials found a three-fold risk of death in the patients who took the drug compared to those who took a sugar pill placebo. The three-fold risk was based on examining records of patients on the drug and those who had used it in the previous two years.

However, Merck did not provide this internal analysis to the FDA, according to the authors. In July 2001 it submitted a different analysis that reviewed only patients still on the drug. This number was believed to have underestimated the drug’s harm because it shortened the time patients were under observation, and missed those who dropped out of the trial after suffering side effects.

In that analysis, Merck reported 29 deaths (2.7 percent) out of the 1067 patients on Rofecoxib, the drug’s technical name, and 17 (1.6 percent) of the 1075 on placebo. Based on these numbers, Merck declared the drug “generally well-tolerated.” In December 2001, the FDA raised questions about the data, but Merck did not bring them to the study’s Institutional Review Board for examination, the authors wrote.

Some of the authors involved in the JAMA reports have worked as expert witnesses for plaintiffs in the Merck lawsuits. “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 the second study, Joseph S. Ross of the Mount Sinai School of Medicine and his co-authors found in a review of Vioxx safety studies that Merck scientists often wrote the articles or hired one of two professional journal writing companies, then paid academics fees of up to $1,500 to review the work and be listed as senior authors. The journal-writing companies were never credited for their roles. The academics never disclosed the fee-for-service nature of their work, and sometimes didn’t even disclose any financial relationship with Merck.

Worse things may be going on at other drug companies, the authors wrote. “Access to industry documents through litigation presents a rare opportunity to explore the relationship between the medical profession and the pharmaceutical industry. Our case-study review suggests that inappropriately attributing authorship was common.”

The authors elaborated a list of 11 measures that would make publication of journal articles more transparent, with more disclosure about who actually did the work or wrote a paper, and requirements for outside statistical analysis in papers funded by industry.

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