by Matthew Perrone
AP Health Writer
November 9, 2010
For the second time this year, federal
inspectors have dismissed allegations by
Food and Drug Administration
scientists who say they were pressured and harassed by their
managers into approving medical devices against their judgment.
The office of inspector general for the Department of Health and
Human Services, which oversees the FDA, concluded there is "no
evidence of retaliation" against the employees, according to a
one-page memo obtained by The Associated Press.
The memo, dated Oct.
14, concludes "this case is closed."
The inspector general reached a similar finding in February, but
agreed to reopen the investigation at the request of federal
lawmakers and advocacy groups, including the Project on Government
Oversight. The groups complained that the previous investigation was
too narrow and did not look into allegations of misconduct that fell
short of criminal violations.
A spokesman for the inspector general declined to comment beyond the
Nine current and former FDA medical device reviewers have alleged
since 2008 that agency managers improperly overruled their opinions
and tried to intimidate them when they went public with their
concerns. At issue are
CT scanners and other medical
devices that use radiation to detect or treat diseases.
Many of the devices allow lifelike
pictures of the human anatomy, but carry a higher risk from
radiation than older scans such as X-rays.
In the last year, hundreds of radiation overdoses have been reported
with imaging devices, particularly CT scanners, used by hospitals
across the country. The whistleblowers have argued that these
problems underscore the concerns they raised about such devices.
But in a separate announcement Tuesday, the FDA said it has
concluded that CT scanners are safe when used properly. After more
than a year of investigation, the agency said, the overdoses
probably resulted from improper use by imaging technicians.
The agency recommends several manufacturing changes to make scanners
safer to use, including automatic warnings that alert machine
operators when radiation doses exceed recommended levels.
The FDA whistleblowers point to multiple occasions in which managers
overruled their rejections of medical scanners, without properly
documenting the reason, as required by FDA regulations. At least
three of the whistleblowers have left the agency in the last year,
saying their contracts were terminated after they sent letters of
complaint to Congress, the administration and other outside groups.
One of those whistleblowers, Dr. Julian Nicholas, said he has
never been interviewed by the inspector general's office.
Nicholas, an Oxford-trained intestinal
specialist, said that his contract as a medical reviewer was
terminated after he repeatedly opposed approving a CT scanner for
routine colon cancer screening. Nicholas said that he objected to
exposing otherwise healthy patients to the cancer risks of routine
"It's hard for me to believe this
was a bona fide investigation when they haven't even contacted
the people who reported these violations," said Nicholas, now a
practicing gastroenterologist at the Scripps Clinic in San
"Such a huge amount of money is at
stake and so many people are affected, that for the (office of
inspector general) not to conduct a credible investigation is
criminal in itself."
FDA's device leadership shared the
results of the latest investigation with employees last week,
according to a Nov. 5 e-mail obtained by The Associated Press.
The e-mail was written by Dr. Jeffrey Shuren, head of the
FDA's Center for Devices and Radiological Health, to members
of his staff.
In it he said the investigation found no
evidence of retaliation against the scientists who complained nor
"material violation of rules with
respect to documenting significant decisions."
Shuren pointed out in his e-mail that
the FDA hired a private contractor last spring to review the device
unit's structure and make recommendations for improving relations
between scientists and management.
The contractor recommended changes in
internal communications and training opportunities, Shuren said.