Tuesday, December 29, 2009

Pair of Peer-Reviewed Journal Reports Are Critical Of FDA's Medical Device Approval Processes

Significantly, one of the two is co-authored by a current FDA science staffer -- in the Medical Device division.

To be clear, there are important differences between the approval processes for drugs, as distinguished from devices -- such as coronary stents, and pacemakers. Even so, the similarities (and common sense) would tend to suggest that an at least equally robust process be employed, if a device is to be approved, and then permanently implanted inside a patient's body.

Both the Wall Street Journal, and The New York Times have reports out tonight on the two studies -- the small excerpt in blue below, is from the WSJ version; the green, the NYT:

. . . .Jeffrey Shuren, acting director of the FDA's device division, acknowledged weaknesses in clinical trials used to approve some cardiovascular devices. One of the studies was co-authored by an FDA scientist. Dr. Shuren said the FDA has begun toughening standards for device approvals and intends to do more. . . .

One of the articles, published Tuesday in the Journal of the American Medical Association, or JAMA, says many cardiovascular devices are approved based on a single study; most drugs go through several layers of testing.

Many heart devices are implanted in patients and are essential to keeping them alive. They are subject to the FDA's most stringent review process, but the JAMA study said the standards are still weaker than those used for drugs.

"The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can," the researchers said in the JAMA paper. . . .


. . . .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 study’s findings demonstrate that submitted studies frequently lack important details, including information about subjects and study end point definitions,” researchers reported in the review, which was posted Tuesday on the site of The American Journal of Therapeutics.

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed. . . .

Do go read all of both, but FDA had already formally-indicated -- at about the time the existence of these (then-ongoing) studies were becoming public -- it would bolster its internal standards and processes, for determining all future approvals of medical devices.


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