Way back on July 11, 2008, I wrote about physician/editors at  THE NEW ENGLAND JOURNAL OF MEDICINE who had grave concerns about consumers of American medical care, and users of American medical devices, given the often less-than-optimal testing of drugs and devices by the FDA prior to their approval for use on or in patients.  Their concerns extended to the federal preemption addressed in Riegel v. Medtronicand Wyeth v. Levine that would prevent patients injured or killed by defective products from seeking redress in state courts, if the drug or device had been FDA approved.

In the December 11, 2008 issue of THE NEW ENGLAND JOURNAL OF MEDICINE , the war of words continues.  Cardiologist Robert G. Hauser, M.D., and electrophysiologist Adrian K. Almquist, M.D., call out the FDA on its casual and even reckless approach to the testing of new ICDs (implantable cardioverter-defibrilators) .  According to the authors, the overriding concern for the manufacturers of the next generation of ICDs is getting them to market quickly, and for the least amount of money.  To that end, they want to avoid premarket clinical testing because of its cost, and its potential to delay introduction of the product.

Apparently, neither the FDA nor the manufacturers of the ICDs will conduct any premarket clinical testing of the new ICD before it is approved for routine implantation in patients.  Instead, the FDA will rely on engineering tests, and tests in animals.

Drs. Hauser and Almquist write that “the decision by the FDA and industry to forgo premarket clinical testing …is not in the best interests of patients.”  And they go on to explain why such testing is so dangerously flawed, especially in light of what is at stake–the lives of cardiac patients who deserve better than to serve as guinea pigs for the FDA.

We’re here to listen.

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