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Merck ignored evidence for four years that Vioxx had deadly heart risks

Tuesday, December 08, 2009 by: S. L. Baker, features writer
Tags: vioxx, heart attacks, health news

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(NaturalNews) Pharmaceutical manufacturers would never knowingly withhold, gloss over or otherwise ignore evidence that any of their drugs could be killing people, right? Wrong. Take the case of Big Pharma giant Merck -- the company kept a dangerous drug, Vioxx, on the market for years as tens of thousands died from taking the pain pill.

In a new study that should be a wake-up call to anyone who blindly trusts their health to the prescription drug industry, investigators concluded that Merck & Co. Inc., should have identified the deadly cardiovascular risks associated with taking Vioxx four years before the company finally pulled the drug from the market. In fact, Merck apparently stopped selling Vioxx only after the body count linked to the drugs kept piling up and the associated lawsuits became too numerous to ignore.

Merck introduced the drug in May of 1999 and Vioxx quickly became a commercial success, with sales climbing to $2 billion annually. However, it turns out Vioxx raised the risk of cardiovascular problems in users, most notably heart attacks and deaths, soon after a person started taking it. And even going off the drug didn't help much -- the risk of dropping dead from a heart attack stayed high for a year or more.

So how many deaths did Vioxx (a nonsteroidal anti-inflammatory drug known generically as rofecoxib) cause while still on the market? No one knows for sure but Dr. David Graham, a whistleblower who tried to alert the medical community to the dangers of the drug while Merck was still pushing it as a great pain-reliever, testified before the US Senate in 2002 and revealed data indicating 88,000 to 139,000 Americans experienced heart attacks as a side effect from the drug, and 30 to 40% of these died. So preventable deaths caused by Vioxx likely ranged from 27,000 to 55,000.

The evidence points to clear dangers of Vioxx

For the just released study, Joseph Ross, MD, MHS, assistant professor of Geriatrics and Palliative Medicine and of Medicine at Mount Sinai School of Medicine, led a team of six investigators who analyzed 30 randomized, placebo-controlled trials of Vioxx that were made available through lawsuits filed against Merck. The researchers published their findings in the November 23 edition of the Archives of Internal Medicine.

In all, the trials involving Vioxx enrolled 20,152 individuals and lasted from four weeks to four years. Research subjects who were given Vioxx took doses ranging from 12.5 milligrams to 50 milligrams. The Mount Sinai scientists analyzed the pooled data from these studies and found that safety concerns arose almost four years before Merck finally took the drug off the market.

Dr. Ross and his colleagues discovered that by December of 2000, after 21 of the 30 studies had been completed, there were already strong reasons to believe that patients taking Vioxx were at a greater risk for adverse events or death from cardiovascular conditions or blood clots. Then data collected through June 2001 indicated Vioxx was linked with a huge 35 percent increased risk of a having a cardiovascular event or death.

But the stats were to get even worse. As more data came in, the association with deadly side effects grew much stronger. Finally, by April of 2002, the analysis of all the studies showed a 39 percent increased risk and, as of September 2004, a 43 percent increase of cardiovascular events (usually heart attacks) or death.

"Because the recently enacted FDA Amendments Act requires public disclosure of trial results within the ClinicalTrials.gov database within 12-24 months of study completion, including both efficacy and safety outcomes, clinical trial data should be available to conduct iterative meta-analyses independent of the FDA and manufacturers," Dr. Ross and his research colleagues wrote in their paper. "Physicians and the public deserve to be in a position to make informed choices about risk and benefits [of pharmaceutical products]. And the early disclosure and dissemination of information about potential risk after its recognition must be required."

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