Health Team

Lawsuit: Drug-Maker Knew About Risks of Vioxx

Posted April 15, 2008

Vioxx, the anti-inflammatory drug, was pulled from the market four years ago over safety concerns. Since then, material revealed during litigation indicates the drug's maker, Merck, knew about life-threatening risks that were never made public.

In the late 1990s, Merck tested whether Vioxx could prevent cognitive decline in patients with Alzheimer's disease. Testers discovered an increased risk of death that was never reported to the Food and Drug Administration or the public.

“The company found a three-fold increase risk in mortality and failed to see a safety signal. By scientific standards, this is a major safety issue,” said Dr. Bruce Psaty with the University of Washington.

Researchers reviewed legal documents from lawsuits involving Merck and Vioxx. In 2004, the company reported the drug was "generally well tolerated by the elderly patients in our study."

However, an internal company document revealed Merck knew about an increased risk of death and heart attacks as early as 2001. Psaty says Vioxx should have been removed from the market then, rather than three years later.

“Fewer people would have been harmed,” he said.

Despite knowing the risk, Merck extended one of the clinical trials and enrolled new patients in 2003. During that time, eight deaths were associated with the use of Vioxx.

“Large clinical trials like these clearly need independent data and safety monitoring committees to protect the patients,” Psaty said.

Psaty's review appeared in the Journal of the American Medical Association. He says stricter regulations are necessary to avoid selective reporting of results and to help restore the public trust.

Some new safeguards are already in place. The FDA Amendments Act went into effect last fall, and it requires companies to make all clinical trial findings available to the public instead of just those results that may appear favorable.


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  • DrJ Apr 17, 2008

    8 deaths from Vioxx? There are probably 8 deaths associated with every drug on the market every year. There are probably more deaths associated with people NOT taking the drugs they should.

    People die one way or the other. It's unfortunate a few die earlier than they should. But all the lottery sized judgments, and lottery sized payoffs to lawyers will never bring about a medication that's totally safe. Never. We may as well quit pretending like it will, because all we're doing is driving up all the prices of medications to create a few "compensated" family members, and a bunch of filthy rich lawyers.

  • raleighwakenative Apr 17, 2008

    my father died of a sudden heart attack and was on Vioxx. May this type of cover-up never happen again.

  • ts807 Apr 16, 2008

    And the Supreme Court is trying to give immunity to drug companies WHY? This is why drug companies should NOT have immunity.

  • 5-113 FA Retired Apr 16, 2008

    Big egos, greed and impatience are a death sentence for the human guinea pigs used to test drugs. A local company uses dogs and monkeys for case studies. If they don't die during the tests, they release them for experiments on us.

  • live_the_truth Apr 16, 2008

    I took Vioxx for about 2 weeks before it was pulled off the market. My feet and ankles swelled up like balloons. My doctor finally decided the swelling was from the Vioxx, after trying other treatments, and I stopped taking it. I never had a swelling problem again after I stopped taking this product.

  • clintoflannagan Apr 16, 2008

    I don't see what the big deal is. The drug company was just trying to make a profit. If they had published all the bad studies on the drug there's no way they could have made any money.

  • Mad Baumer Apr 16, 2008

    I took this garbage for 6 months to treat a back injury. I stopped taking it after having variances in my heart rate that I could feel at night when I laid down to sleep. My doctor actually put me on blood pressure meds as he thought it was another issue. I researched it myself on the internet, ah I am NOT a scientist, and I saw where it had issues. Nice that the drug company took longer than me to pull it. I feel horrible for the people who lost their lives following the drug companies suggested use, and doctors orders. I say go get em'!

  • jlr31933 Apr 16, 2008

    I was the lead research assistant auditing all of the study files for Vioxx. Let me put it this way, they knew exactly how deadly this drug was. After I finished auditing it, I told all my family and friends to avoid this drug at all costs.

  • hi_i_am_wade Apr 16, 2008

    Want to lower drug prices? Ban all drug ads of all kinds, including the samples, pens and paper given, and all bribes to doctors includes "informative" vacations. This will lower drug costs because all that stuff isn't cheap.

    And you can lower your drug costs by ignoring the commercials. They make it seem like you must have a drug when, in fact, you probably do not or can do just as well or better with a generic. Consumer Reports quite often exposes the lies in drug commercials.