Is the FDA Using Weak Clinical Studies to Approve Cardiac Implants?

02 Jan

The short answer is: Yes.

The longer answer is, of course, more complicated. It seems that the relevant experts can’t agree on whether the standards that apply to clinical trials of drugs can or should be applied consistently to medical implants. That would then, it seems, signal that it’s time to develop strong standards that are more appropriate for trials of this class of medical device.

John Timmer of Arstechnica writes – The significance of the FDA’s approval is made clear by the authors of one of the evaluations, which was published yesterday by the Journal of the American Medical Association. As is the case with drugs, many physicians view the FDA’s acceptance as an indication that a device is safe and effective, as do many insurance companies. The makers of the implants, for their part, often view approval as a sign that it’s safe to begin a direct-to-consumer advertising campaign for their product.

And, to a certain degree, the implant makers are right. Last year, the Supreme Court ruled that FDA approval of a medical device prevents consumers from suing based on claims that the device is poorly designed or unsafe. In short, FDA approval confers an important validation on an implant.

For drug approval, randomized, double-blind trials have become the gold standard. However, the authors of the JAMA study recognize that blinding people to a physical implant can be difficult and, for some of the devices studied, completely impossible.

The issues, however, extend beyond even the lack of double blind studies.

Barry Meier of The New York Times writes – The F.D.A.-sponsored study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study. In addition, that study also found that about 25 percent of trials had failed to adequately follow the outcomes of a sufficient number of patients, a level the review defined as 90 percent or more of patients initially enrolled in a trial.

The substantial agreement between the two reports [JAMA – conducted by researchers at the University of California, San Francisco, and the F.D.A. – researchers from the Beth Israel Deaconess Medical Center in Boston] suggests that there’s a real problem with obtaining clinical data of sufficient quality for a thorough evaluation of cardiac medical implants, and quite probably medical implants in general. If the FDA intends to improve the situation, the common conclusions of the two reports would give that effort added weight.

You can read the Arstechnica article written by John Timmer here.

You can read The New York Times article written by Barry Meier here.

American Journal of Therapeutics, 2009. Publication in progress. JAMA, 2009. Vol 302, No. 24. DOI unavailable.

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Posted by on January 2, 2010 in Health


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