Journals Criticize FDA Trials

Journals Criticize FDA Trials - WSJ.com,

Two leading medical journals found weaknesses in how the Food and Drug Administration approves cardiovascular medical devices, saying some products reached the market based on tests that were inadequate and open to bias.

The studies come as the FDA is facing intense pressure to overhaul the medical-device approval process following several incidents in which the agency acknowledged missteps, including the case of a knee device that was approved a year ago under political pressure.

FDA approval of medical devices based on complete science fraud
The Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) have both published papers criticizing the way in which the Food and Drug Administration (FDA) approves medical devices. Citing a lack of legitimate safety and effectiveness studies, the papers allege that the FDA is approving medical devices without proper scientific evidence proving that they work and will not harm patients.

Researchers from the University of California, San Francisco, pored over seven years worth of FDA public summaries concerning approved medical devices. Researchers from Beth Israel Deaconess Medical Center in Boston wrote the AJT piece, concluding that the FDA's safety and effectiveness data for medical devices is inconsistent and unreliable. William Maisel, one of the researchers, indicated that the FDA needs to improve its clinical trial standards for medical devices.

List of Device Recalls
List of Device Recalls