The New York Times is reporting that the Food and Drug Administration has now admitted that it approved a faulty knee device because of pressure from four New Jersey members of Congress and the device’s manufacturer, ReGen Biologics Inc.
I wish I could say that I’m surprised and shocked that the FDA would knowingly put patients at risk because of political and industry pressure. Unfortunately, it’s just another example of how the medical device industry and Pharma have corrupted the FDA’s approval process. Public Citizen’s health researchers testified before the FDA in November 2008 recommending that the FDA reject the device — which replaces damaged knee cartilage — on the grounds that a clinical trial conducted by the company conclusively proved that the device has no clinical benefit. Instead of using data from clinical trials, ReGen’s lab tests did not involve testing on humans.
According to Gardiner Harris’ story in the NYT: