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Merck Admits Errors with Vioxx Reports
In September 2004, Merck announced the withdrawal of Vioxx from all worldwide markets after a long-term study was halted because of an increased risk of serious cardiovascular events including heart attack, stroke, blood clots and other cardiovascular complications among study patients taking the drug Vioxx. In September 2004, the Food and Drug Administration (FDA) acknowledged Merck’s voluntary withdrawal of Vioxx and issued a Public Health Advisory directed at patients who were prescribed Vioxx.
Some reports indicate that Merck was fully aware of Vioxx side effects and risks as early as March 2000 and that there was a concerted effort by the company to bury negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies. It has been claimed that the effort was done in an attempt to “mask” the rate of cardiovascular problems for Vioxx patients and that the pharmaceutical company put profit making before consumers' health. Millions of Americans have taken the drug and the FDA estimates that more than 27,000 patients have suffered heart attacks or have died as a result of using Vioxx.
In May 2006, Merck publicly stated the company erred when it reported in 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of use. The test does not support Merck's former theory that only after 18 months of usage were there any serious heart risks for individuals who used Vioxx and that these risks were not apparent if patients took it for less than 18 months.
Scientists outside of Merck claim that Merck's admission, when considered along with other clinical trials of the drug and studies tracking real-world Vioxx use, supports longstanding claims that Vioxx caused heart problems quickly. The 18-month issue is crucial for the 20 million Americans who took Vioxx. Merck currently faces at least 11,500 lawsuits, covering 23,000 people, from patients who say that Vioxx caused their heart attacks and strokes. Merck cited the 18-month theory when it withdrew Vioxx from the market.
In defending Vioxx lawsuits, Merck has consistently taken the position that Vioxx can cause heart problems only if it is used continuously for more than 18 months. However, in the five Vioxx court cases in which juries have reached decisions so far, Merck has lost three times. In two of the cases, the heart attack victim had taken the drug for fewer than 18 months.
Merck has based the 18-month theory largely on data from the Approve Study, in which the company tracked 2,600 patients in a test to see whether Vioxx could prevent colon polyps. In the Approve study, twice as many patients taking Vioxx suffered heart attacks or strokes as those taking a placebo. After the company submitted new data to the FDA as part of a one-year follow-up study of patients in the trial company, critics raised new questions about the Approve trial's overall results. Some outside scientists have stated that the new data indicated that Vioxx's dangers became evident after four months of use. Merck has disputed that interpretation and has stated that its newly discovered mistake was unrelated to that new data. Some reports indicate the company's disclosed mistake is yet another example of Merck’s mishandling of the data to make Vioxx appear safer to the public.
An individual that believes they may have been harmed or suffered adverse heath effects from the usage of Vioxx should seek the advice of an attorney who specializes in pharmaceutical litigation.
