Litigation involving the drug maker Merck has revealed alarming new information. Although Merck pulled Vioxx from the market citing safety concerns in 2004, these new documents show that the company knew about an increased risk of death in the late 90's, when the drug was first tested in Alzheimer's patients.
Company reports indicated early on that Vioxx, an anti-inflammatory drug, carried a life threatening risk but nothing was made public or was reported to the FDA.
Bruce Psaty, M.D., Ph.D., of the University of Washington, says that, "The company found a threefold increase risk in mortality and failed to see a safety signal. By scientific standards this is a major safety issue." He added, "Large clinical trials like these clearly need independent data and safety monitoring committees to protect the patients."
In a published report in 2004, Merck reported that Vioxx is "generally well tolerated by the elderly patients in our study". But an internal company document tells a different story. It reveals that Merck knew about an increased risk in mortality associated with Vioxx and they knew it in 2001.
Dr. Psaty, M.D., Ph.D., said, "If these findings had been made public back in 2001 many fewer people would have taken Vioxx and because it is associated with an increased risk of mortality and of heart attacks, many fewer people would have been harmed."
In 2002, despite knowing the risk, Merck extended one of the clinical trials and even re-enrolled patients. During this time eight deaths were associated with the use of Vioxx.
Dr. Psaty's review appears this week in JAMA, The Journal of the American Medical Association. Dr. Psaty says stricter regulations are necessary not only to avoid selective reporting of results, but to help restore public trust.
Some new safeguards are already in place. The Food and Drug Administration Amendments Act went into effect in October 2007 and requires companies to submit clinical trial findings to a public results database. This is meant to help prevent selective reporting of results from clinical trials.
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