Probe of Medical Scanner Approvals Reopened by FDA

US health regulators are taking another look at approvals for CT scanners, MRI machines and other medical devices that use radiation to detect or treat diseases. Such devices carry a higher risk from radiation than older scans such as X-rays.

We’ve previously reported on charges made by whistleblowers – all Food & Drug Administration (FDA) scientists – who claimed they were pressured by agency managers to approve high-tech medical scanners that could pose harm to patients. Since the FDA scientists made their allegations public -in letters to Congress and the Obama administration in 2008 and 2009 — at least two scientists have been let go and another has quit after alleged intimidation, the Associated Press said.

In one such incident, FDA managers sought to approve an application by General Electric to allow the use of CT scans for colon cancer screenings over the repeated objections of agency scientists. After the managers made the recommendation, Dr. Julian Nicholas, a gastroenterologist who trained at Oxford University and the Mayo Clinic and worked under contract with the agency, responded by e-mail that he felt strongly that approving the application could “expose a number of Americans to a risk of radiation that is unwarranted and may lead to instances of solid organ abdominal cancer.”

Dr. Nicholas claims his concerns were dismissed at a May 2009 meeting by a manager who said, “We don’t need to be reinventing a big bugaboo about radiation.” But Dr. Nicholas said he refused to back off his concerns. He was ultimately terminated, as the FDA allowed his contract to expire in October 2009.

According to the Associated Press, those charges and others were dismissed in February by the Department of Health and Human Services office of inspector general. However, Dr. Nicholas, and at least one other whistleblower say they were never interviewed by the inspector general during that probe. The whistleblowers also claim that the agency has used the four-page memo the FDA issued after investigation to try to dissuade members of Congress from looking into their allegations, the Associated Press said.

Now the Associated Press is reporting that the the investigation is being reopened to look into manager misconduct.

“The original intent of the investigation was to look at criminal matters and our agents did that,” Gerald Roy, deputy inspector general for investigations in HHS told the Associated Press. “But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective.”

Robert Smith, a former radiology division reviewer who left the agency in July, told the Associated Press that FDA leadership assured the whistleblowers that the first investigation into their allegations would be comprehensive.

“It was the FDA’s responsibility to make sure the investigation they requested was properly conducted and reported,” Smith said, “And it was the responsibility of the inspector general to conduct a legitimate investigation — which they know they did not.”

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