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.
I edited the contact information into the stories that I
Three of them no longer work for the FDA
After the three stories, information on the hearing for
I have added (again) the Union of Concerned Scientists
The same can be said of the “unaccountability” that enables this to exist:>
Multiple news releases can be found with the Google search terms;
Dr. Julian Nichola
Feds dismiss misconduct claims at FDA device unit
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 memorandum.
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 radiation scans.
“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 Diego. “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 of “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.
(Note: who is the “private contractor” ?- TK)
Feds reopen probe into medical scanner approvals
Matthew Perrone, Associated Press Health Writer,
On Tuesday September 28, 2010, 4:52 pm EDT
WASHINGTON (AP) Federal inspectors have reopened an investigation into complaints by Food and Drug Administration scientists who say they were pressured by their managers to approve high-tech medical scanners that could pose harm to patients.
The lead inspector overseeing the matter told The Associated Press on Tuesday that the inquiry into the allegations, which were dismissed in February, is being revisited to look at manager misconduct.
“The original intent of the investigation was to look at criminal matters and our agents did that,” said Gerald Roy, deputy inspector general for investigations in the Department of Health and Human Services. “But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective.”
The HHS office of inspector general, which oversees the FDA, closed the case in February after finding there was “no violation of law.”
But the whistleblowers have repeatedly stressed that their grievances involve mismanagement and violations of regulations which don’t fall under criminal law.
Nine FDA medical device reviewers alleged in 2008 that agency management overruled their opinions without supporting evidence and tried to intimidate them when they went public with their concerns.
At issue are CT scanners, MRI machines 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 recent years, hundreds of radiation overdoses have been reported with imaging devices used by hospitals across the country. The whistleblowers say these problems underscore the concerns they raised about such devices.
The new probe comes after prodding from lawmakers and nonprofit watchdog groups, including the Project for Government Oversight. In a letter to the inspector general Tuesday, the group calls the previous investigation a “sham.”
“If these allegations are true, the FDA is failing in its primary mission of keeping people safe,” said Danielle Brian, the group’s executive director.
An agency spokeswoman said she could not immediately provide comment Tuesday.
Since the FDA whistleblowers went public with their concerns in letters to Congress and the Obama administration in 2008 and 2009 at least two scientists have been let go and another has quit after alleged intimidation.
Interviews with the staffers and internal e-mails obtained by The Associated Press provide new details of alleged mismanagement in the FDA’s device division.
Central to the scientists’ complaints is an FDA pathway to approval that allows speedy clearance if a device appears comparable to others already on the market.
Former FDA reviewer Dr. Gamal Akabani repeatedly recommended against clearing radiation-emitting devices used to treat cancer under the accelerated system, saying the devices needed to undergo actual testing to prove their safety and effectiveness. Between 2007 and 2008, Akabani said he was frequently pressured by supervisors to change his opinion, he said in an interview with The Associated Press.
In the final incident, Akabani’s manager asked about the health of his wife, who has cancer, and his son, who was born severely handicapped. According to Akabani, the manager suggested his job and health insurance for his family would be safe as long as he cooperated with his supervisors.
“It shook me to the core because I realized that he was coercing me,” said Akabani, who resigned from the FDA and currently teaches nuclear physics at Texas A&M University.
Dr. Gamal Akabani
Akabani and other whistleblowers say a key problem at the agency is that managers who have often spent decades in government have far less expertise and up-to-date training than the medical reviewers they oversee. Akabani was recruited to the FDA after a decade in the radiology department at Duke University Medical Center.
The whistleblowers also point out that FDA managers are evaluated, in part, on their ability to get speedy reviews of devices, causing them to pressure and sometimes overrule scientists who slow down the process.
In another case of alleged retaliation, an Oxford-trained medical specialist’s contract was not renewed after he repeatedly opposed approving a CT scanner for routine colon cancer screening. Dr. Julian Nicholas said that he objected to exposing otherwise healthy patients to the cancer risks of radiation. He says he was ridiculed by agency managers for “raising the bugaboo of radiation.”
“They conspired against me because I refused to change my expert medical opinion to conform with their desired regulatory outcome,” Nicholas wrote in an e-mail to FDA Commissioner Margaret Hamburg after his termination late last year.
Both Akabani and Nicholas say they were never contacted by the office of inspector general, which they say makes the inspectors’ original report flawed and incomplete.
The inspector general’s office issued a memo to FDA leadership in February when it concluded there had been no criminal violations.
The whistleblowers complain that FDA officials have used the four-page memo to try to dissuade members of Congress from looking into their allegations.
Robert Smith, a former radiology division reviewer who left the agency in July, said FDA leadership assured the whistleblowers that the investigation would be comprehensive.
“It was the FDA’s responsibility to make sure the investigation they requested was properly conducted and reported,” Smith said, “And it was the responsibility of the inspector general to conduct a legitimate investigation which they know they did not.”
Jena Longo – Democratic Deputy Communications Director (202) 224-8374 begin_of_the_skype_highlighting (202) 224-8374 end_of_the_skype_highlighting
Russell Senate Office Building – 253
WASHINGTON, D.C.The U.S. Senate Committee on Commerce, Science, and Transportation announces the following full committee hearing on Transportation Security Administration oversight.
Individuals with disabilities who require an auxiliary aid or service, including closed captioning service for webcast hearings, should contact Collenne Wider at 202-224-5511 begin_of_the_skype_highlighting 202-224-5511 end_of_the_skype_highlighting at least three business days in advance of the hearing date.
For further information about this meeting, contact:
FDA Medical Devices
Simon Choi, PhD, MPH
Contact The Transportation Security Administration
Allied Pilots Association to boycott full body scanners Updated
08 Nov 2010 11:56 | by Andrea Petrou | posted in Security
The Allied Pilots Association has announced that it will boycott full body scanners at airports, citing health risks.
The world’s largest association of pilots has gone to war following the suspension of an American pilot for refusing to be scanned, as well as fears that that scanners could emit twenty times more radiation than that of which was previously announced by authorities who introduced them.
It now has called on its members to demand a “pat down” search rather than expose themselves to the increased radiation from scanners.
The moves have been backed by privacy organisation Big Brother Watch, which warned that scanners were a danger.
Alex Deane, director of the civil liberties campaign group said: “Scanners are dangerous. There’s a reason that the nurse stands behind a screen when you get an x-ray at hospital. Radiation is potentially harmful, even in small doses, and the regularity with which frequent flyers are exposed to potentially cancer-causing radiation.
“If pilots aren’t going to be scanned, why should members of the public? This stance from a professional group, the world’s leading association of pilots, must shake the government out of its absurd position on scanners.
He also warns that in the UK alone you “cannot opt for a pat-down search instead of a scan”
The Inter-Agency Committee on Radiation Safety, which includes the European Commission , International Atomic Energy Agency, Nuclear Energy Agency and the World Health OrganiSation has written a report that states that Air passengers should be made aware of the health risks of airport body screenings.
It also says governments must explain any decision to expose the public to higher levels of cancer-causing radiation as well as noting that pregnant women and children should not be subject to scanning
However according to Mr Deane the British government isn’t doing this. “By making scanning compulsory for all and by failing to publicise this guidance, the British government is failing to do all of these things and is potentially jeopardising the health of vulnerable people as a result. The APA’s stance will hopefully wake our government to that fact,” he said.
This isn’t the first time body scanners have come into the spotlight. Earlier this year campaigners warned that the rapid introduction of full body scanners at British airports threatened to breach child protection laws which ban the creation of indecent images of children.
Last week we also reported that the TSA had rolled out its new Advanced Imaging Technology scanners in 65 airports throughout America. The new technology, which allows security to see through a person’s clothes to reveal any metal bombs, shanks or guns, was questioned for being a violation of privacy rights and posed the question of what would happen if the pictures were leaked.
Alex Deane, of Big Brother Watch, has sent an open letter to the chairman of BALPA – the pilot’s union for the UK’s commercial pilots. It reads:
“You no doubt know that your colleagues in the Allied Pilots Association have issued guidelines recommending that their members do not submit themselves to body scanners at airports.
“This seems sensible given that members of associations such as yours are the most frequent flyers of all, and are therefore already exposed to a higher level of radiation than the rest of the population.
“Furthermore, you are no doubt also aware that Dr David Brenner, head of Columbia University’s Centre for Radiological Research, has concluded in a report which is (as far as I know) entirely uncontested by any scientist or airline body that because the beam from scanners concentrates on the skin – one of the most radiation-sensitive organs of the human body – that the radiation dose from scanners may be up to 20 times higher than first estimated.
“Dr Brenner also concludes that some members of the population are particularly prone to harm from such radiation (he estimates this to be around one in 20 of the population). As far as I know, there has been no research conducted by your Association (or anyone else) to establish whether or not members of your Association fall into that group and are therefore particularly vulnerable as they go through scanners.
“The Inter-Agency Committee on Radiation Safety (which includes the European Commission, International Atomic Energy Agency, Nuclear Energy Agency and the World Health Organization) has written an authoritative report that states that
1) Air passengers should be made aware of the health risks of airport body screenings,
2) Governments must explain any decision to expose the public to higher levels of cancer-causing radiation
3) Pregnant women and children should not be subject to scanning (i.e. at all).
“You will no doubt appreciate that in fact none of this has been done in the United Kingdom. To reiterate the point I have made above, you will doubtless also appreciate that if such risks apply to the population at large then they inevitably apply to your members, at a higher level.
“In these circumstances, I was dismayed to see your Association issue blithe assurances in the media yesterday that the scanners were perfectly safe. I simply do not know how you can have reached such a position on the evidence available, and subsequently cannot help but feel that you are failing properly to serve the interests of your members with this position. Why should British pilots fail to receive guidance which reflects the best available scientific evidence, unlike their American counterparts? The consequences of such a position in future years for some or indeed many of your members are potentially most serious.
“I furthermore point out that your Association is widely viewed as a responsible and authoritative body and that your position is – wrongly, in my view – therefore stifling debate in this country.
“Whilst our American friends are now discussing this openly, the British media remains unwilling to engage with this serious issue because of the false reassurance gained from the approach that you have adopted.
“You will appreciate that all that I have written here is said without regard to privacy concerns about the scanners – suffice it to say that my organisation would suggest that such concerns are significant and that if you would like further information of the numerous abuses of body scanner technology by staff, they can be found on our website, www.bigbrotherwatch.org.uk .
“I finally note that I was also surprised to read that your spokesman told the press that one can opt for a pat-down instead of going through the scanners. As I’m sure you’re aware, in the United Kingdom, this is simply incorrect. Here, alone in the world, if one’s picked out for a scan one has to be scanned – no scan, no fly. I’m sure that this was inadvertent and that your Association regrets unintentionally misleading people on this point.
“I would be delighted to meet with you to discuss these issues further, or to speak via the telephone or on e-mail if that is more convenient to you.”