FDA Scientists Allege Coercion In Medical Device Approval Process

All I can say here is that this goes back to a earlier post:

The 2 New Hot Words in Healthcare: Algorithms and Whistleblowers

In this case we have a bit of both, algorithms created by the scientists, but a requested change by the clinical side of the table? Sounds a bit like the algorithms run on Wall Street? Algorithms will produce and reveal what the code is programmed to do. Read the paragraph below in bold and it somewhat alludes to this statement.

There have also been reports in the news of recent relating to some potential faulty software operations and perhaps the 2 items are or are not related, but as we all know you just can’t get enough beta testing today to get 100% of the bugs out of software, and this can cause some real areas of concern with implanted devices in particular. BD

The House Energy and Commerce Committee on Monday launched an investigation into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns, CongressDaily reports (Edney, CongressDaily, 11/18). Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee

Chair Bart Stupak (D-Mich.) said that the investigation was prompted by an Oct. 14 letter "written on behalf of a large group of Center for Devices and Radiological Health scientists and physicians who state that CDRH managers have 'corrupted and interfered with the scientific review of medical devices'" (Reichard, CQ HealthBeat, 11/17). The letter to the committee, released publicly on Monday, did not include the names of the FDA scientists or information on which device approvals the scientists questioned (Harris, New York Times, 11/18).

The scientists claim that they were threatened with removal or negative performance reviews if they did not modify their scientific data to obscure unscientific clinical and technical data submitted by device companies and legal violations, including a lack of informed consent from study participants. "This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation," the scientists wrote (CongressDaily, 11/18).

FDA Scientists Allege Coercion In Medical Device Approval Process, House Panel Investigates

Related Reading:

Beware of Geeks Bearing Formulas