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Lichtblau and Shane report: "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."

File photo, FDA building. (photo: The Daily Caller)
File photo, FDA building. (photo: The Daily Caller)



Vast Effort by FDA Spied on E-Mails of Its Own Scientists

By Eric Lichtblau, Scott Shane, The New York Times

15 July 12

 

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.

The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists' claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists' medical claims were valid enough to warrant a full investigation into what it termed "a substantial and specific danger to public safety."

The documents captured in the surveillance effort - including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails - were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists' communications.

With the documents from the surveillance cataloged in 66 huge directories, many Congressional staff members regarded as sympathetic to the scientists each got their own files containing all their e-mails to or from the whistle-blowers. Drafts and final copies of letters the scientists sent to Mr. Obama about their safety concerns were also included.

Last year, the scientists found that a few dozen of their e-mails had been intercepted by the agency. They filed a lawsuit over the issue in September, after four of the scientists had been let go, and The Washington Post first disclosed the monitoring in January. But the wide scope of the F.D.A. surveillance operation, its broad range of targets across Washington, and the huge volume of computer information that it generated were not previously known, even to some of the targets.

F.D.A. officials said that in monitoring the communication of the five scientists, their e-mails "were collected without regard to the identity of the individuals with whom the user may have been corresponding." While the F.D.A. memo described the Congressional officials and other "actors" as collaborating in the scientists' effort to attract negative publicity, the F.D.A. said that those outside the agency were never targets of the surveillance operation, but were suspected of receiving confidential information.

While federal agencies have broad discretion to monitor their employees' computer use, the F.D.A. program may have crossed legal lines by grabbing and analyzing confidential information that is specifically protected under the law, including attorney-client communications, whistle-blower complaints to Congress and workplace grievances filed with the government.

Other administration officials were so concerned to learn of the F.D.A. operation that the White House Office of Management and Budget sent a governmentwide memo last month emphasizing that while the internal monitoring of employee communications was allowed, it could not be used under the law to intimidate whistle-blowers. Any monitoring must be done in ways that "do not interfere with or chill employees' use of appropriate channels to disclose wrongdoing," the memo said.

Although some senior F.D.A. officials appear to have been made aware of aspects of the surveillance, which went on for months, the documents do not make clear who at the agency authorized the program or whether it is still in operation.

But Stephen Kohn, a lawyer who represents six scientists who are suing the agency, said he planned to go to federal court this month seeking an injunction to stop any surveillance that may be continuing against the two medical researchers among the group who are still employed there.

The scientists who have been let go say in a lawsuit that their treatment was retaliation for reporting their claims of mismanagement and safety abuses in the F.D.A.'s medical reviews.

Members of Congress from both parties were irate to learn that correspondence between the scientists and their own staff had been gathered and analyzed.

Representative Chris Van Hollen, a Maryland Democrat who has examined the agency's medical review procedures, was listed as No. 14 on the surveillance operation's list of targets - an "ancillary actor" in the efforts to put out negative information on the agency. (An aide to Mr. Van Hollen was No. 13.)

Mr. Van Hollen said on Friday after learning of his status on the list that "it is absolutely unacceptable for the F.D.A. to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies."

Senator Charles E. Grassley, an Iowa Republican whose former staff member's e-mails were cataloged in the surveillance database, said that "the F.D.A. is discouraging whistle-blowers." He added that agency officials "have absolutely no business reading the private e-mails of their employees. They think they can be the Gestapo and do anything they want."

While national security agencies have become more aggressive in monitoring employee communications, such tactics are unusual at domestic agencies that do not handle classified information.

Much of the material the F.D.A. was eager to protect centered on trade secrets submitted by drug and medical device manufacturers seeking approval for products. Particular issues were raised by a March 2010 article in The New York Times that examined the safety concerns about imaging devices and quoted two agency scientists who would come under surveillance, Dr. Robert C. Smith and Dr. Julian Nicholas.

Agency officials saw Dr. Smith as the ringleader, or "point man" as one memo from the agency put it, for the complaining scientists, and the surveillance documents included hundreds of e-mails that he wrote on ways to make their concerns heard. (Dr. Smith and the other scientists would not comment for this article because of their pending litigation.)

Lawyers for GE Healthcare charged that the 2010 article in The Times - written by Gardiner Harris, who would be placed first on the surveillance program's list of "media outlet actors" - included proprietary information about their imaging devices that may have been improperly leaked by F.D.A. employees.

F.D.A. officials went to the inspector general at the Department of Health and Human Services to seek a criminal investigation into the possible leak, but they were turned down. The inspector general found that there was no evidence of a crime, noting that "matters of public safety" can legally be released to the news media.

Undeterred, agency officials began the electronic monitoring operation on their own.

The software used to track the F.D.A. scientists, sold by SpectorSoft of Vero Beach, Fla., costs as little as $99.95 for individual use, or $2,875 to place the program on 25 computers. It is marketed mainly to employers to monitor their workers and to parents to keep tabs on their children's computer activities.

"Monitor everything they do," says SpectorSoft's Web site. "Catch them red-handed by receiving instant alerts when keywords or phrases are typed or are contained in an e-mail, chat, instant message or Web site."

The F.D.A. program did all of that and more, as its operators analyzed the results from their early e-mail interceptions and used them to search for new "actors," develop new keywords to search and map out future areas of concern.

The intercepted e-mails revealed, for instance, that a few of the scientists under surveillance were drafting a complaint in 2010 that they planned to take to the Office of Special Counsel. A short time later, before the complaint was filed, Dr. Smith and another complaining scientist were let go and a third was suspended.

In another case, the intercepted e-mails indicated that Paul T. Hardy, another of the dissident employees, had reapplied for an F.D.A. job "and is being considered for a position." (He did not get it.)

F.D.A. officials were eager to track future media stories too. When they learned from Mr. Hardy's e-mails that he was considering talking to PBS's "Frontline" for a documentary, they ordered a search for anything else on the same topic.

While the surveillance was intended to protect trade secrets for companies like G.E., it may have done just the opposite. The data posted publicly by the F.D.A. contractor - and taken down late Friday after inquiries by The Times - includes hundreds of confidential documents on the design of imaging devices and other detailed, proprietary information.

The posting of the documents was discovered inadvertently by one of the researchers whose e-mails were monitored. The researcher did Google searches for scientists involved in the case to check for negative publicity that might hinder chances of finding work. Within a few minutes, the researcher stumbled upon the database.

"I couldn't believe what I was seeing," said the researcher, who did not want to be identified because of pending job applications. "I thought: ‘Oh my God, everything is out there. It's all about us.' It was just outrageous."

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+16 # Erdajean 2012-07-15 10:28
It used to be that America was the prime haven from tyranny, for scientists and other thinkers with conscience. Times have changed.
In this day, doubtless such good citizens as these researchers at FDA are wondering, "Where in this WORLD can we go, that brains, honesty and humanity are not a scary liability?"
A thought not limited to these scientists, I am saddened to say.
 
 
+25 # Adoregon 2012-07-15 10:47
This article begs the question, for whom does the F.D.A. work, the citizens of the U.S. or the corporations it is intended to oversee? As with so many parts of the government,it appears the F.D.A. has been co-opted by corporations.

Now, it is not just young blacks and Latinos being subjected to "Gestapo and frisk" in N.Y.C., but also scientists and congresspersons and their staffs are being subjected to cyber "Gestapo and bend over" by an government agency overly zealous in its desire to protect its patrons.

Who is running the show? You know.
 
 
+14 # paloda8705 2012-07-15 11:15
I long ago concluded that the FDA operates in its own self interest at the expense of the American people - just learn the history of how aspartame (essentially a poison) was approved by the FDA. It was virtually a criminal act orchestrated by none other than Donald Rumsfeld, when CEO at G. D. Searle (later acquired by none other than the rotten to the core Monsanto).
Sadly, this article just further confirms what I have already come to believe.
 
 
+8 # Gwat 2012-07-15 11:28
This is not surprising. Gary Null has just released a great new movie on the FDA: "War On Health". The entire movie can be seen on YouTube: http://youtu.be/h0CQrL5nzwo
 
 
+9 # carolsj 2012-07-15 12:15
This is the tip of another iceberg. Most scientists are truth seekers who are not getting rich on their craft. Our scientists, our best and brightest, are being defamed, coerced and criminalized by the powers that do not want the truth to come out. Al Gore had the right phrase for it--inconvenien t truth. Also unprofitable truth, about climate change, the gulf spill, safety of food and drugs, frakking and much more. Admitting that there is corruption going on in our country is not unpatriotic. It is the highest form of patriotism to do the hard work of exposing it and ending it. We need to enforce the high ideals we learned in school to remake and keep this the country we can be proud of.
 
 
+9 # Bob P 2012-07-15 13:16
I spent my whole career in quality control in the human food, animal feed, and pharmaceutical industries. My experience is that the FDA has a long history of real benefits to society. We bemoan the problems associated with examples of their current poor performance. Without an FDA, the examples we bemoan would be perfectly legal. We don't want to get rid of the FDA, we want to get rid of the management that weakens their mission and the influence of the money buying their counter productive behavior. Business, industry, and wealth all seem to be working in concert to prove the necessity of government regulation, even as they strive to buy its demise.
 
 
+7 # Adoregon 2012-07-15 14:55
In short, we want all government and its agencies to work for the benefit of all U.S. citizens --impartially-- the way they are supposed to.
 
 
+3 # JessJuan-d-Ring 2012-07-15 15:20
Yes, FDA certainly has (had?) a valid mission and purpose. But there have been so many examples over the last many years in which the agency has clearly violated that mission due to a skewing of its policies towards corporate interests. Instead of protecting public health, they seem more often to be colluding to put it at risk. I'm sure that's not the fault of the scientists, but of the political appointees who demonstrate the corrupting influence of the revolving door between private indusry and government agency employment.
 
 
+5 # JessJuan-d-Ring 2012-07-15 15:23
If Obama wants a chance to demonstrate that he is NOT the tool of corporate interests, he should make an internal inquiry and fire the parties responsible for this suppression of whistle-blowing , and maybe replace them with the wronged honest scientists who appear only to have been looking out for the public.
 
 
+1 # Gwat 2012-07-15 22:56
This is what Dr. Graham, who works for the FDA in drug safety has to say: "As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured. Within the Center for Drug Evaluation and Research about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about five percent. The “gorilla in the living room” is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug. So you have that conflict as well". Dr Graham blew the whistle on Vioxx, a drug that killed 60,000 Americans. Congress, bought and paid for by Big Pharma, is the real issue.
 
 
0 # JessJuan-d-Ring 2012-07-16 10:20
Thanks for posting that... though it won't surprise many, it provides further inside confirmation of what we've observed from the outside. And reminds us that the corruption of government by concentrated capital is widespread and its tentacles reach through all branches.
As with so many issues, it points out that truly representative democracy will grow more and more elusive until we can get eliminate capital's political control.
 
 
+1 # Bob P 2012-07-16 12:18
We used to call buying government officials bribery. Now we call it free speech so now it is constitutional.
 
 
+5 # Secular Humanist 2012-07-15 15:08
The first priority here is to identify the miscreants who conducted this illegal and idiotic spy operation. My firs thought was that they were Bush appointees, embedded into the civil service ranks at the end of his administration. My second thought was that Bush appointees wouldn't do anything to protect the reputation of the Agency as their primary mission was almost universally to make federal agencies dysfunctional. My third thought is that that's just what these idiots were doing, and accomplished, and they did so as part of an effort to protect corporations over the public interest. So I'm back to my first thought. These were likely embedded Bush appointees. I want names.
 
 
-9 # davehaze 2012-07-15 15:17
Who is to blame for this? Ralph Nader? Georgie Bush? What administration hired or kept on and protects the FDA officials responsible? Who sets the agenda and oversees the agency?

Oh, the Obama administration. .. never mind.
 
 
+4 # brianf 2012-07-15 18:58
I wonder, are the FDA officials doing this appointees of GW Bush or of Obama? Either way, they should at least be fired, and probably prosecuted.
 
 
+1 # Bigfella 2012-07-15 19:40
Some thing to be siad about good old snail mail....and it's protection by law!
 
 
0 # db4635 2012-07-16 08:03
As a federal whistleblower, I am baffled as to why any whistleblower, or "digruntled employee," would use office computers for this.
 
 
0 # gzuckier 2012-07-17 14:47
This ought to prove to everyone that government agencies can show the same kind of effective processes that private industry does.
 

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