America's drug agency, the Food and Drug Administration (FDA), is in the throes of an embarrassing enquiry after a group of whistleblowers reported alleged wrong-doing over the approval of a medical device.
The whistleblowers, scientists who work for the FDA's Center for Devices and Radiological Health, say their managers 'corrupted the scientific review process' and approved a device in gross violation of federal law.
The scientists first reported their concerns to the then FDA Commissioner Andrew von Eschenbach, but they were told to 'move forward' after an initial investigation failed to find any wrongdoing.
Undeterred, the scientists wrote to two Congressmen, who, in turn, wrote to Eschenbach and urged him to make immediate changes to the way medical devices are approved within the FDA, and to ensure they are safe and effective.
(Source: Journal of the American Medical Association, 2009; 301: 152).