Approval Trial Prompts Vioxx Withdrawal

Although concerns about COX-2 inhibitors go back to the mid-1990s, Merck did not pull its own painkiller Vioxx off the shelves until September 30, 2004. In a press release that day, Merck stated that its decision was based on “new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial.”

The study was investigating if Vioxx was an effective way of preventing colorectal polyps in high-risk groups. Although these polyps are mostly harmless on their own, left untreated they can lead to colorectal cancer, the second leading cause of cancer death in the United States behind lung cancer. Clearly this would have offered huge health advantages to those who suffer from recurring polyps, including fewer uncomfortable colonoscopy procedures, and a lowered risk of colorectal cancer.

However Merck stated that during the APPROVe trial “there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo.” This was the first public admission by Merck that Vioxx can be directly linked to heart problems.

The Lancet, a respected medical journal, at first commended Merck in its decision to voluntarily remove Vioxx from the market in light of these new findings. But it later said that its praise was “premature” when it published its own findings, showing that the data was already present to prove that Vioxx presented “unacceptable cardiovascular risks.” In an earlier editorial, the journal questioned why it took this relatively small study for the company to realize the dangers, and suggested that larger safety trials looking specifically for hazardous side effects should have taken place years before.

Questions have also been raised about Merck’s awareness of heart-related problems previous to this clinical trial and press release. Documents dating back to at least 2000 suggest that the company was aware of the risk and may have been looking to reformulate the drug to counteract it. Merck fully maintained until it pulled Vioxx from the market that it believed its drug to be safe and effective, and that studies showing otherwise were not conclusive or flawed in some other way.

Lawsuits had already been filed regarding the drug before September 2004 – was Merck simply trying to promote goodwill and do pre-emptive damage control before the suits reached the courts? Perhaps the answer to that will come out during trial. But what is certain is that Merck is fully responsible for the safety of its products; many experts agree that the company should have found any connection between Vioxx and heart problems years ago.

If you have suffered heart problems while taking Vioxx, contact a Jim S. Adler & Associates personal injury lawyer for a free case review. We’ll let you know what your rights are, and help you fight for them. You could be entitled to compensation to cover your medical bills and lost work as well as pain and suffering. Click on the link below to make sure your rights are protected.

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Approval Trial Prompts Vioxx Withdrawal

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Approval Trial Prompts Vioxx Withdrawal