Open the Vioxx Files

The news is out that Merck has agreed to settle 27,000 Vioxx lawsuits for $4.85 billion. Plaintiffs who claim they or their family members suffered injury or died after taking the anti-inflammatory drug will, on average, receive just over $100,000 before legal fees and expenses, reports the New York Times’ Alex Berenson.

The Vioxx debacle is an example of how not to interpret clinical trials data. Even before the FDA approved the drug, there was extensive evidence that taking Vioxx increased the risk of a cardiovascular event. Yet the FDA approved it and an estimated 20 million Americans took the drug. As a result, between 88,000 and 140,000 people suffered heart attacks, according to an estimate by FDA scientists.

What went wrong? How did the drug get through the FDA approval system? The documents that served as the foundation for the Vioxx litigation could help the medical community understand what happened.

Before a judge signs off on the settlement, I’d like to see her press Merck and the plaintiff attorneys to release to the public all the relevant documents.


Too often, settlements in tort cases include confidentiality orders, with both sides agreeing not to reveal the contents of sensitive documents. The Project on Scientific Knowledge and Public Policy examined this and related problems at a conference entitled Sequestered Science: The Consequences of Undisclosed Knowledge. The papers have been published in the Summer 2006 issue of Law and Contemporary Problems.

The general case against sequestering documents in litigation involving hazards is addressed by Daniel J. Givelber and Anthony Robbins their paper “Public Health Versus Court-Sponsored Secrecy”:

The public health case against the secret resolution of lawsuits involving dangerous products and practices is straightforward. Suppressing information about the dangers inherent in corporate behavior and consumer products deprives regulators, litigants, and consumers of knowledge relating to safety. Regulators might have acted earlier with respect to the dangers posed by asbestos, the Dalkon Shield, and Bridgestone/Firestone tires had they been aware of the number of lawsuits, the settlements, or information revealed in pretrial discovery. Other potential litigants might have been encouraged to sue earlier and in greater numbers had they been aware that their injuries were not unique. These suits, in turn, could well have affected the manufacturer’s calculus of when the liability generated by continuing to produce or market a particular product outweighed the profit flowing from product sales.

The free flow of information might advance public health in a more straightforward fashion. Consumers armed with information about the dangerous attributes of a product might well choose not to consume it. Cigarette smoking declined significantly in this country long before any cigarette smoker succeeded in holding a tobacco company liable for disease.

We don’t need the papers from the Vioxx litigation to protect against more harm from Vioxx, since that drug is no longer on the market. But releasing them might help prevent the next drug safety debacle.

Comments

  1. #1 Frank Mirer
    November 11, 2007

    This critique is correct, but could also have focused on a deeper point. (By way of conflict of interest, I was prescribed and consumed Vioxx for a week several years ago, for treatment of pain arising from tendinitis of the foot)

    The problem is that clinical trials for effectiveness are hardly ever adequately powered to detect adverse side effects from common disorders such as heart disease. The trials won’t detect cancer arising from short duration exposure, and of course can’t detect effects of any kind from years long dosing. I suspect the Vioxx trials were for pain relief, stomach aches and maybe worse GI problems.

    One palliative for this is post introduction surveillance. One serious candidate for post introduction surveillance would be the statins, which are carcinogenic (or would be shown to be if tested) in mice and rats because they are peroxisome proliferators.

    However, post introduction surveillance would at best limit the damage. The fundamental question is whether to approve a trial of “me-too-azine” at all, assuming that a safe and effective drug of the class already is in use, with some post introduction surveillance putting an upper bound on adverse effect risk. Especially since “me-too-azine” is being introduced to compete, at higher cost, with existing remedies and “crapazine” which already got through the net.