18 Months Missing from Merck Tape

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It's not a beautiful morning for Merck & Co., as one of its key claims in defending against Vioxx lawsuits—that the drug's negative effects on the hearts of some patients did not occur before 18 months of usage—disappears. The New England Journal of Medicine has corrected an earlier article on the Vioxx APPROVe study, revising the window from first use to negative effects down to three months.

Merck says it stands by the results of the original study, whatever that means. If the company is saying the heart effects don't show up in all patients and there's still some lag time between initial use and medical risks (for example, that 60 Minutes is still wrong in claiming a woman died after a mere month of usage), then that's probably true. And [libertarian boilerplate alert] this doesn't mean people who decide to take the risks with Cox-2 inhibitors shouldn't be allowed to do so. But Merck (and Reason) argued that many of the pending Vioxx lawsuits were frivolous because they involved people who had not been taking the drug for a year and a half. Obviously, this change will open the company up to many more lawsuits, and will not help its credibility. (So far, Merck is three for six in Vioxx suits.)

NEXT: Smoke on the Water

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  1. Good post on this from Derek Lowe today.

  2. Discovery should help us get to the bottom of what Merck knew and didn’t know here. I am glad the suits are non-frivolous enough to get to that discovery phase in a number of trials commensaurate with the size of the VIOXX market.

    I hope Merck wasn’t hiding anything from the FDA, but, if they were, then the tort plaintiff’s bar will have done us a great service as a society and they will get rich for doing it.

    Really it’s win-win!

  3. Markus Merk is the one that should be put on trial

  4. Markus Merk is the one that should be put on trial

  5. Just think, if we bankrupt all the drug companies by suing them, then all drugs would effectively be off-patent soon enough and no new ones will be created. Our health care costs would fall by a lot. Woooooooo Hoooooooo!!!!!!!!

    Of course, you can kiss new medicines good bye and have zero hope for your nephew or niece or mother or whatever if they get sick with something currently untreatable that would have been easily treated were it not for these lawsuits.

    No, I don’t own any drug stocks. I am not that foolish.

  6. Those who say lawsuits will stop drug company research make so much sense!! They really understand how insurance works, and how excess policies work, and how reinsurance works.

    Get the picture folks? It’s a crappy argument to link responsibility for a company’s products with a reduction in R&D or capital spending. Both are relatively easy to estimate, and both are a part of doing business. These companies are in business for a profit, and they will make a profit even if a few of their products kill some people. This isn’t cynical, this is true. Save the “kiss medicine goodbye” argument for the truly stupid.

  7. Lamar, there is a serious chance Merck will be forced into bankruptcy over this issue. The same thing happened to my company over an even more frivolous set lawsuits, and let me tell you that there can be no doubt that my company laid off lots of people, hired few, and did substantially less R&D (and everything else) for around ten years. A few years ago, when we came out of bankruptcy, things started to pick up and we are doing pretty well now.

    From the reports I have read, I cannot see what Merck did wrong. They followed the law, and the data, even with a lot of hindsight and scrutiny, is still quite inconclusive. We need to completely re-vamp our legal system in this matter. It is becoming more and more obvious every day.

  8. Judges for such cases should be required to have degrees in statistics or a related field.

  9. Forget the degree requirement, but they should have to demonstrate the knowledge one way or another.

  10. All drugs have side effects in some people. There is no drug that doesnt.

    There is absolutly no way to create a drug that is 100% safe for all people all of the time under all conditions.

  11. You are right, Kara. Aspirin has killed far more people than Vioxx. It has also saved many. And helped millions.

    The minor risks that Vioxx seem to cause could easily be offset by the benefits it brings people. It should be an individual decision.

    As for Merck, they did what was required by law and did not lie. There should be no liability whatsoever for this situation.

    Frankly, our entire tort system should boil down to just that – any company that follows the relevant laws, and does not lie to its consumers, should be all but immune to lawsuits.

  12. “any company that follows the relevant laws, and does not lie to its consumers, should be all but immune to lawsuits.”

    Agreed, though I will point out that “lying to its consumers” is one of the things Merck has been accused of doing, with regard to Vioxx.

    Full disclosure: I am a plaintiff against Merck in a pending Vioxx lawsuit. I’m not exactly a disinterested party…

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