Experts Debate Extent of FDA Reform in Wake of Whistleblower Testimony/ Medscape

From the April 5 Medscape:

... The testimony repeated charges that Dr. Nicholas made in a letter last December to HHS Secretary Kathleen Sebelius and FDA Commissioner Hamburg. He disclosed that he had sought an FDA warning label on the CT scanner in question that would highlight the risk for radiation-induced cancer, noting that between 1.5% and 2% of all cancers "are directly attributable to radiation exposure from CT scanning."

"You could imagine the appalling consequence," Dr. Nicholas wrote Ms. Sebelius and Dr. Hamburg, "of clearing a device that may not be as effective as [optical] colonoscopy, that may be misused to actually prevent patients from being studied with colonoscopy, and that may also cause radiation-induced cancer."
"I was continually harassed and pressured to change my review by managers, but because of my commitment to the public, I could not in good conscience do so, absent a valid scientific reason. I was intimidated and ultimately suffered the most severe form of retaliation against any employee engaged in whistleblowing activity — termination..."

Dr. Nicholas's allegations were riveting, but they are not new. In a series of group letters to Congress and the White House going back to 2008, FDA physicians and scientists depicted the FDA as a broken, corrupt institution more beholden to medical device manufacturers and the politicians that lobbied on their behalf than to the public it was supposed to protect.

An April 2 letter to President Barack Obama stated that despite new leadership at the very top, the agency still abounded with veteran managers who have "violated laws, rules and regulations; who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out." The letter recommended disciplinary action against such employees, adding that some cases might need to go to the US Attorney General's office...

Steven Findlay, a senior health policy analyst at Consumers Union (the publisher of Consumer Reports), noted that the agency's tilt toward drug and device makers began before George W. Bush became president. "The culture at the FDA has been problematic for many years," he said. "But it became more acute during the Bush administration," he noted...