Former FDA Scientist Claims Radiation Concerns Were SuppressedMar 31, 2010 | Parker Waichman LLP
Critics Of FDA Complain Of Drug Safety Problems
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 “high-grade medical” scanners. Dr. Nicholas was speaking to a group of imaging specialists when he announced that FDA staffers—and he was among a group of nine—“were pressured to change their scientific opinion,” quoted the AP, by managers in FDA’s medical device division. The group alerted Dr. Jeffrey Shuren last September, said the AP.
“Scientific and regulatory review process for medical devices was being distorted by managers who were not following the laws,” Dr. Nicholas said, quoted the AP. It took just one month for Nicholas’ position to be “terminated,” he said, added the AP.
Patients Warned Against CT Scanner Radiation Problem
Dr. Nicholas said that he continually rejected a manufacturers’ 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. “I hope you understand that the failure to include a warning on the label will mean that patients will undoubtedly develop abdominal cancer and leukemia…. It may not happen tomorrow, but yes, sadly it will happen,” wrote Dr. Nicholas, quoted the AP. Dr. Nicholas told the group yesterday that he was mocked by FDA managers for “raising the bugaboo of radiation,” quoted the AP.
As we have previously written, some scientists at the FDA wrote to President Obama’s transition team earlier last year, basically begging for help and outlining a number of problems with an agency they described as “fundamentally broken,” 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 “’an end to secrecy,’ to ‘revive’” the agency.
We also wrote that the AP noted last year that scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” 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 lawmakers—such as Representative Henry Waxman (Democrat-California) and Senator Chuck Grassley (Republican-Iowa)—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 radiation—for instance, the radiation used in medical imaging—to cancer that can show up in the body years after the procedure. “Science must not be ignored, suppressed, or distorted as that endangers the public,” said Dr. Robert Smith, an agency medical reviewer and colleague of Dr. Nicholas. Dr. Smith also presented at yesterday’s meeting.
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