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Merck still facing Vioxx scrutiny 8 years after withdrawal

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The FDA approved Vioxx in 1999, and physicians frequently prescribed the drug for acute or chronic pain like that which accompanies arthritis. Unfortunately, the drug proved to be fatal the entire time that it was on market, according to Pharmalot blogger Ed Silverman. Eight years after Merck withdrew the drug and thousands of lawsuits later, Merck is still under fire for information that was not disclosed to the public.

Silverman says this secrecy was recently proven in a paper written by authors who did extensive research on three Vioxx trials conducted over a decade ago. Merck initiated the trials to see if Vioxx was useful in treating or preventing Alzheimer’s disease. According to Jerry Avorn, a professor of medicine at Harvard Medical School and one of the authors of this paper, Merck used on-treatment analysis as opposed to intent-to-treat analysis. Intent-to-treat analysis is widely used by drug makers in order to discover a drug’s potentially harmful side effects.

Since there was no data safety monitoring board for the three experiments, Merck was free to present the data it chose to reveal to the public. The company has denied any knowledge of the dangerous side effects that resulted in the death of many patients.

According to Silverman, Avorn and several of his colleagues recently performed intent-to-treat analysis on the same three trials that Merck conducted. Results showed significant disparities from the on-treatment analysis that Merck used. Specifically, the analysis showed that Vioxx had a substantial amount of risks that would have forced Merck to take the drug off the market much sooner.

“If we could do this from the same data they had, why didn’t they, especially given all the prior concern about possible cardiovascular toxicity? The company certainly should not have gone around and cited these very trials as ‘proof’ that the drug was safe,” Avorn reportedly said.

Rather than prevent thousands of deaths, Merck instead pocketed the $2.5 billion it made by keeping dangerous drug Vioxx on the market.

4 Comments

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  1. Penny Lane says:
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    If some Merck executives were put on trial and served some time, it maybe wouldn’t happen again. Lying to the New England Journal of Medicine and to doctors and to the public was very wrong.

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    Hello Penny,

    Thanks for commenting!

    I agree with you on putting some of these Merck executives on trial, but I don’t know if that will prevent it from happening again, at least by another company. There is definitely something that is going on behind the scenes and it may involve money, lots of it. That is just my opinion though, but there is something more to this whole incident than just the facts that are being reported. I don’t like to deal much with anything outside of the facts, but just because we know what Merck was doing, that doesn’t necessarily mean that we know the entire truth on this matter.

    What we do know is that, sadly, while the medical field is in the business of healing people, it is a practice (a business) and that means making money is always the main concern.

  3. Bill Avioxx says:
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    I used Vioxx from 6/99 through 12/00: about 18 months. Merck initially told the public that Vioxx’s effects wore-off after one month. The lawyers I consulted said I had to: see a doctor or ER immediately after the first event, appear to be severely affected, etc. I have had to take Aggrenox and enteric aspirin ever since. I have had migraines ever since (although now diminishing). I had at least ten TIAs and two strokes from 9/2001 through 7/2008. My HMO (really the entire population) has had to absorb these costs. Yet Big Pharma and Gilmartin pay nothing. Shareholders bear the legal costs; patients bear the medical after-effects. What a country!

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    Hi, Mr. Avioxx:
    My intern, Joe, has returned to college, so I thought I’d reply on his behalf.
    First, I’d like to thank you for reading and commenting. I’m sorry about all the trouble you’ve been through, and I sincerely hope things get better for you.
    I can’t give legal advice, and your previous lawyers may have been spot-on in their advice, but you may want to get a second opinion. I’m not sure where you live, but many law firms throughout the country offer free consultations, so it couldn’t hurt.
    Please take care of yourself.
    Miranda
    Marketing Manager at Spangenberg