Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees.
Here it is!
Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well “honest communication” with doctors.
“In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,” according to the amended code. “We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.”
Merck withdrew Vioxx in 2004 after a study showed it doubled the risk of heart attacks and strokes. The company won 11 of 16 Vioxx suits at trial before agreeing in 2007 to create a $4.85 billion settlement fund to resolve thousands of injury claims over the drug. Plaintiffs’ experts said Merck distorted the health risks of Vioxx in medical literature, advertisements and statements to doctors by sales representatives.
The settlement, which won preliminary approval from a New Jersey state judge yesterday, would resolve all so-called derivative lawsuits, which are for the benefit of the company rather than just shareholders. An approval hearing is scheduled for March 22 in Atlantic City, New Jersey.
‘Most Appropriate Way’
Merck “believes this is the best and most appropriate way to resolve these suits and enable the company to put this matter behind it,” said Ron Rogers, a spokesman for Merck, based in Whitehouse Station, New Jersey.
The settlement, which covers federal and New Jersey state shareholder cases, isn’t an admission of wrongdoing on the part of Merck or the executives named in the suit, Rogers said. The company will be required to make corporate governance changes and “supplement existing policies and procedures,” he said.
In testimony videotaped in 2006 for the Vioxx trials, Harvard Medical School professor Jerome Avorn said Merck failed to conduct adequate studies of Vioxx’s risks before launching it in 1999 as an alternative to painkillers that caused more stomach bleeding. Merck also misled doctors about a 2000 study that showed Vioxx caused five times more heart attacks than another painkiller, naproxen, he said.
“There was a pattern of what I would characterize as systematic distortion that rose almost to the level of grotesque,” Avorn said in a tape played in federal court in New Orleans. “It was an embarrassment for me as a member of the medical profession that this was going on in presenting information to doctors in such a one-sided and lopsided way.”
Marketing Tool
One Merck study designed to show Vioxx was easier on the stomach than an older painkiller was actually a marketing tool to boost sales, according to a 2008 report in the Annals of Internal Medicine. The study, known as Advantage, was a trial of 5,557 patients started in 1999, just as Vioxx was cleared for sale.
The study, which recruited 600 doctors, was crafted by Merck’s marketing department, according to researchers who reviewed 100 internal company memos and reports.
The Advantage study “was marketing masquerading as science,” the lead author of the Annals report, Kevin Hill of Harvard Medical School in Boston, said in a 2008 interview. “They went about this in a very analytic way, picking doctors who would be most influential, who will talk to other doctors and recommend Vioxx to them, and thus increase prescriptions in the area, planting the seeds of additional Vioxx use.”
Under the settlement announced today, Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party.
The chief medical officer would have an “executive voice” on product safety issues independent of Merck Research Laboratories. The appointee would serve as Merck’s “medical ambassador,” report to the chief executive officer and serve on the executive committee.
Bloomberg
1 comment:
I can't possibly understand how Vioxx killed tens-of-thousands of people before it was eventually pulled from shelves... I wonder if we'll see any further suits in the future..?
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