Earlier last year we wrote that many critics of the U.S. Food and Drug Administration (FDA) had long complained of food and drug safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA.
Now, says The Associated Press (AP), Dr. Julian Nicholas, a former scientist with the agency just said that his position was eliminated after he brought up the matter of exposure to radiation from <“https://www.yourlawyer.com/practice_areas/defective_medical_devices”>â€œhigh-grade medicalâ€ scanners. Dr. Nicholas was speaking to a group of imaging specialists when he announced that FDA staffersâ€”and he was among a group of nineâ€”â€œwere pressured to change their scientific opinion,â€ quoted the AP, by managers in FDAâ€™s medical device division. The group alerted Dr. Jeffrey Shuren last September, said the AP.
â€œScientific and regulatory review process for medical devices was being distorted by managers who were not following the laws,â€ Dr. Nicholas said, quoted the AP. It took just one month for Nicholasâ€™ position to be â€œterminated,â€ he said, added the AP.
Dr. Nicholas said that he continually rejected a manufacturersâ€™ marketing request for a CT scanner developed for colon cancer screening, said the AP. Dr. Nicholas, in a letter last year to senior managers, wrote that patients should be warned of the risks of radiation exposure from CT scanning procedures, explained the AP. â€œI hope you understand that the failure to include a warning on the label will mean that patients will undoubtedly develop abdominal cancer and leukemiaâ€¦. It may not happen tomorrow, but yes, sadly it will happen,â€ wrote Dr. Nicholas, quoted the AP. Dr. Nicholas told the group yesterday that he was mocked by FDA managers for â€œraising the bugaboo of radiation,â€ quoted the AP.
As we have previously written, some scientists at the FDA wrote to President Obamaâ€™s transition team earlier last year, basically begging for help and outlining a number of problems with an agency they described as â€œfundamentally broken,â€ reported The Wall Street Journal previously. Dr. Steven Nissen, a prominent cardiologist with the renowned Cleveland Clinic in Ohio, was one of those who offered opinions. In his piece, said TheHeart, Dr. Nissen called for â€œâ€™an end to secrecy,â€™ to â€˜reviveâ€™â€ the agency.
We also wrote that the AP noted last year that scientists under former medical device head, Daniel Schultz, claimed, â€œthey were pressured to approve certain productsâ€ against their best judgment. It was the nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakersâ€”such as Representative Henry Waxman (Democrat-California) and Senator Chuck Grassley (Republican-Iowa)â€”called on the FDA to investigate the alleged corruption, reported the AP. Schultz ultimately resigned saying that his resignation “would be in the best interest of the center and the agency.” Schultz managed the division for five years, said the AP.
Hundreds of studies, said the AP, have been published linking some types of radiationâ€”for instance, the radiation used in medical imagingâ€”to cancer that can show up in the body years after the procedure. â€œScience must not be ignored, suppressed, or distorted as that endangers the public,â€ said Dr. Robert Smith, an agency medical reviewer and colleague of Dr. Nicholas. Dr. Smith also presented at yesterdayâ€™s meeting.