New York Times Reports FDA Spying on its own Scientists
From The New York Times - full story HERE.
WASHINGTON — A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.
What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.
Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.
While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.
The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show....
"RK [Ronald Kavanagh, FDA drug reviewer]: During development, if reviewers say things that companies don't like, they will complain about the reviewer or they will call upper management and have the reviewer removed or overruled. On one occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which I then saw happen. On another occasion a company clearly stated in a meeting that they had 'paid for an approval.'
MR [Martha Rosenberg]: That is shocking. Wouldn't the FDA managers want safety risks investigated?
RK: Just the opposite. Sometimes we were literally instructed to only read a 100-150 page summary and to accept drug company claims without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review certain sections of the submission, but invariably that's where the safety issues would be. This could only occur if FDA management was told about issues in the submission before it had even been reviewed. In addition, management would overload us with huge amounts of material that could not possibly be read by a given deadline and would withhold assistance. When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document."
http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety
Posted by: Carol | July 30, 2012 at 10:45 AM
You still wonder how this very corrupt agency behaves.
This agency is below salvation.
Corrupt and dangerous to the core.
Posted by: tony | July 16, 2012 at 07:39 PM
Keep in mind that Facebook is also monitored by government officials. Therefore, always be mindful of everything you type and the limits of free speech. I find this whole thing creepy!
Posted by: Heidi N | July 16, 2012 at 05:44 PM
No doubt that the corruption extends to the CDC and the industry puppets that sit on the CDC approval boards. These people should all be fired if not put in jail for endangering public health. I hope this scandal will finally shine a light on what's really going on at the FDA and the CDC.
Posted by: Sarah | July 16, 2012 at 03:23 PM
Belwo is a letter of complaint from FDA scientists to Rep John Dingell alleging serious misconduct by managers at the FDA.
http://www.whistleblowers.org/storage/whistleblowers/documents/FDAwhistleblowers/letter2repdingell.pdf
Rep. John D. Dingell, D.-Michigan, is a senior member of the House Committee on Energy and Commerce, which has jurisdiction of the FDA. He also is the author of H.R. 1483, the Drug Safety Enhancement Act, which would give the FDA more authority and funding to oversee the U.S. drug supply.
Another article about the scandal--
FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations
January 30, 2012 ~ What’s going on inside the FDA?
Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market. You may recall as President Obama was taking office on January 7, 2009, nine scientists alerted him to the internal problems, accusing the agency of acting illegally by approving flawed and defective medical devices for sale even when others within the FDA objected because of safety issues. One medical device cited as problematic was the computer-aided breast mammograms, “the FDA approved the devices anyway in a flawed process that ignored the science. This had led to significant harm to large numbers of women and significant unnecessary costs to the public.”
After that the staffers said the FDA spied on their private emails, harassed them and in some cases fired the whistleblowers. Internally the group was known as the “FDA Nine”.
The federal lawsuit filed in the District of Columbia charges the agency with 12 counts and names FDA chief Margaret Hamburg, M.D., Jeffrey Shuren, M.D., William Maisel, M.D., and HHS chief Kathleen Sebelius accusing them of retaliation, among other things:
“Defendants have taken and converted private emails without due process or just compensation in violation of the 5th Amendment of the United States Constitution. Defendants have initiated searches and seizures in violation of the 1st and 4th Amendments. Defendants have conducted searches and seizures of a scope that violates the 1st and 4th Amendments. Defendants have violated the 1st Amendment by chilling free speech with searches and seizures. Defendants have violated the 1st Amendment by chilling Plaintiffs’ and the public’s right to associate with whistleblowers. Defendants have violated plaintiffs’ right to representation. Defendants have chilled plaintiffs’ protected 1st Amendment right to free speech.”
http://meshmedicaldevicenewsdesk.com/featured-articles/fda-whistleblowers-sue-agency-claim-retaliation-over-unsafe-medical-device-revelations/
Posted by: Sarah | July 16, 2012 at 03:14 PM
What an incredible double standard! Here the media can come up with the emails and "undisclosed records." They can reveal “a substantial and specific danger to public safety.”
The Wash Post:
"The Food and Drug Administration secretly monitored the personal e-mail of six employees after they warned Congress and the White House that the agency was approving medical devices that posed unacceptable risks to patients, according to a lawsuit filed this week. These selected e-mails and memos were compiled by Kohn, Kohn and Colapinto, the law firm representing the whistleblowers, on behalf of the National Whistleblower Center as part of the lawsuit."
Where is the New York Times or the Washington Post when it comes to corruption, collusion, and cover-up at the CDC? Why does the media accept, without question, any denial that vaccines are linked to serious health problems in our children--most notably, the exponential rate of autism? Why are pharma-funded studies on vaccine safety considered honest science? Why do members of the press close their eyes to massive conflicts of interest when it comes to those charged with protecting the health of our children?
If the issue is vaccine side effects, no reporter is willing to look into Simpsonwood, the Danish study, Poul Thorsen, the IOM study of 2004, Eli Lilly and thimerosal, Thomas Verstraeten etc.etc.
My question is, if this is what goes on at the FDA, why should we believe that CDC isn't covering up huge "undisclosed records" too?
Anne Dachel, Media
Posted by: Anne McElroy Dachel | July 16, 2012 at 02:55 PM
wow...this has huge scandal potential. These scientists who blew the whistle are heros in my book.
The link below shows the actual emails from the FDA scientists who wrote complaints to President Obama. These emails were published in the Washington Post.
FDA surveillance of whistleblowers document set- Washington Post
http://www.washingtonpost.com/wp-srv/national/documents/fda-whistleblowers-set.html
Posted by: Sarah | July 16, 2012 at 12:32 PM