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Feds Reject Complaints of FDA Misconduct in Medical Device Approvals
Feds Reject Complaints of FDA Misconduct in Medical Device Approvals
November 13, 2010 Author: Jonathan Benson Source: Natural News
At least nine current and former scientists at the U.S. Food and Drug Administration's (FDA)
medical device unit have filed complaints against the agency for harassment and intimidation over
their concerns about the safety of FDA-approved medical devices. But for the second time this
year, federal officials have rejected those complaints without even conducting a legitimate
investigation.
According to reports, FDA scientists went public with concerns about the safety of new medical
imaging devices that inflict a heavy load of harmful radiation on patients. Of particular concern are
new computed tomography (CT) scanning machines being used on otherwise healthy individuals to
screen for prostate cancer, which the same scientists say exposes individuals to needlessly high
levels of radiation. And these are the same devices implicated in hundreds of radiation overdoses
throughout this past year.
The scientists say their FDA overseers pressured them to approve the devices despite the health
concerns, and even threatened to retaliate against them if they failed to cooperate. These same
managers actually overrode the scientists' decisions, but without documenting a valid reason for
doing so as is required by law. And according to a recent Associated Press release, three of the
"whistleblowers" had their contracts terminated after finally bringing their concerns before Congress.
But worst of all is the fact that the office of inspector general at the Department of Health and
Human Services (HHS) did not even perform a real investigation into the matter before outright
dismissing it. According to Dr. Julian Nicholas, an Oxford-trained intestinal specialist that had his
contract at the FDA annulled for filing a complaint, the office did not even interview any of the
scientists to hear their side of the story.
"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," Nicholas stated in an interview. "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."
Meanwhile, the FDA continues to insist that the new imaging devices are safe when used according
to proper guidelines.
November 13, 2010 Author: Jonathan Benson Source: Natural News
At least nine current and former scientists at the U.S. Food and Drug Administration's (FDA)
medical device unit have filed complaints against the agency for harassment and intimidation over
their concerns about the safety of FDA-approved medical devices. But for the second time this
year, federal officials have rejected those complaints without even conducting a legitimate
investigation.
According to reports, FDA scientists went public with concerns about the safety of new medical
imaging devices that inflict a heavy load of harmful radiation on patients. Of particular concern are
new computed tomography (CT) scanning machines being used on otherwise healthy individuals to
screen for prostate cancer, which the same scientists say exposes individuals to needlessly high
levels of radiation. And these are the same devices implicated in hundreds of radiation overdoses
throughout this past year.
The scientists say their FDA overseers pressured them to approve the devices despite the health
concerns, and even threatened to retaliate against them if they failed to cooperate. These same
managers actually overrode the scientists' decisions, but without documenting a valid reason for
doing so as is required by law. And according to a recent Associated Press release, three of the
"whistleblowers" had their contracts terminated after finally bringing their concerns before Congress.
But worst of all is the fact that the office of inspector general at the Department of Health and
Human Services (HHS) did not even perform a real investigation into the matter before outright
dismissing it. According to Dr. Julian Nicholas, an Oxford-trained intestinal specialist that had his
contract at the FDA annulled for filing a complaint, the office did not even interview any of the
scientists to hear their side of the story.
"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," Nicholas stated in an interview. "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."
Meanwhile, the FDA continues to insist that the new imaging devices are safe when used according
to proper guidelines.