Vioxx News
Merck downplayed death risk of Vioxx: study
Recall of painkiller biggest in history
Mike Segar/Reuters
A new study suggests that drug maker Merck manipulated data about the drug Vioxx. The drug's 2004 recall was the largest in history.
Drug giant Merck & Co. minimized a significant increased risk of death in patients taking its painkiller Vioxx and offered to pay doctors to sign their names to Vioxx studies ghost written by medical publishing companies, according to new research published in the Journal of the American Medical Association (JAMA).
U.S. researchers say Merck's own internal analysis of data pooled from two studies testing the drug for Alzheimer's disease showed a threefold increase risk of death in patients on Vioxx compared to those who had taken a placebo in 2001 -- three years before Merck pulled Vioxx from markets worldwide in the biggest drug recall in history.
The data were not submitted to U.S. drug regulators until 2003, according to the researchers. Instead, they say Merck used a variety of "counting methods" that "minimized the appearance of the mortality risk."
One of the Alzheimer's studies continued for another two years. During follow-up, there were approximately eight deaths in patients taking Vioxx.
"It's certainly possible that if Merck had made these findings public, many patients would have thought twice about taking Vioxx, many fewer patients might have taken Vioxx, and because Vioxx is associated with a risk of cardiovascular events, many fewer patients might have been harmed," said Dr. Bruce Psaty, professor of medicine and epidemiology at the University of Washington in Seattle.
Another study in this week's JAMA charges that Merck worked out a system to make it easier to publish the work of unnamed ghost writers under the names of authors who did not perform the research.
The two studies are based on thousands of documents unearthed in the Vioxx trials, including internal documents that provide a window "into what and when Merck knew about the mortality findings in the Alzheimer's studies," Dr. Psaty said.
All of the authors of the two new studies, except one, served as paid consultants for Vioxx plaintiffs.
In a statement, Merck said the new studies are "false, misleading or lack context." The company said that when it examined the actual causes of death in the Alzheimer's studies in 2001, it found no pattern suggesting Vioxx was to blame.
"There were deaths from all sorts of causes, like car accidents and electric shocks and other things that could not possibly have been drug-related," Merck lawyer Jim Fitzpatrick said.
"While there's no question that there were statistically more deaths on Vioxx than [on] placebo, and Merck disclosed that, ultimately the conclusion was that did not reflect an actual risk of the medicine."
Merck said all of the data were provided to U.S. drug regulators.
Vioxx was pulled from the market in 2004 after a study linked it to heart attacks in some patients. The company recently agreed to pay US$4.85-billion to settle claims involving 47,000 people who allege Vioxx caused their heart attack or stroke.
There are a number of Vioxx-related suits pending against Merck in Canada. A Quebec court approved class-action status for one such action in January of last year, while a consortium of litigators from the other nine provinces have banded together to seek a similar ruling in an Ontario court.
Vioxx was approved for use in this country in 1999. By 2003, it was the 10th best-selling drug in the country with annual sales of $194-million, according to the Canadian Medical Association.
A year after Merck pulled Vioxx from the market, an expert panel convened by Health Canada recommended the drug be reapproved for Canadian use, a move the ministry rejected in 2006.
Two papers published in 2004 and 2005 on the Alzheimer studies concluded that Vioxx is "well-tolerated." But company documents show that, in April, 2001, a Merck analysis showed a fourfold increased risk of death in one study, and a 2.5-fold increase in the other. The pooled data showed 34 deaths among 1,069 Vioxx patients and 12 deaths among 1,078 patients on a placebo.
"These analyses were not submitted to the FDA or made public in a timely fashion," Dr. Psaty said.
In July, 2001, Merck submitted data to the FDA that used a counting method that minimized the appearance of risk. In December, the FDA raised questions about the mortality findings. "Merck dismissed the FDA concerns and was unable to see any compelling or clear safety issue," he said.
"By conventional scientific standards, a threefold increase in death rate is a major safety issue."
If you or a loved one have experienced side effects from taking Vioxx, you may be entitled to compensation. Call the Vioxx attorneys at Ennis & Ennis P.A. or fill out the form on this page for a free case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have about Vioxx side effects, Vioxx lawsuits, or any other Vioxx litigation.
