Scientist pressured by FDA abt. CT scans

Unfortunately, the FDA, the public’s drug watchdog, has a history of suppressing opinions the honchos don’t like.  During the Vioxx debacle, David Graham was the prime example of expert opinion ignored and pushed aside.

Now there is a possible new example which has surfaced.

From the Pharmalot blog:


There was a bit of a spectacle yesterday (March 30, 2010)  as Julian Nicholas, a former FDA scientist, told a public hearing that he and other FDA staffers “were pressured to change their scientific opinion” after they opposed the approval of a CT scanner for routine colon cancer screening. Nicholas said he objected to exposing otherwise healthy patients to cancer risks of radiation and his job was eventually eliminated.

After FDA officials proceeded with plans to approve the device, Nicholas, who now works at the Scripps Clinic in San Diego, said concerns were raised last fall with the division director Jeff Shuren. Nicholas does not think there was undue influence by the manufacturer in his ouster, but his stance was opposed by FDA officials, the Associated Press writes. The device is apparently still under review. The issue was also covered here, but for those interested in what jumpstarted the unusual hearing, Nicholas wrote this letter to HHS Secretary Kathleen Sebelius and FDA commish Margaret Hamburg about the episode.

“It is a sad commentary, for the FDA and for all those who work in HHS to promote Public Health, that when I documented and expressed my concerns about the radiation dose and concomitant risk of radiation induced cancer and leukemia, CDRH managers with no knowledge or training in Radiology or Gastroenterology or any other related science, chastised my concerns as ‘raising the bugaboo of radiation.’

via CT Scans & A Former FDA Scientist, In His Own Words // Pharmalot.


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