FDA, Labor / Employment, Privacy, Technology

The FDA Should Probably Leave Spying to, You Know, Real Spies

Why has the FDA been spying on its own scientists?

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Forget the vast right-wing conspiracy. Forget the secret Communists hiding out in America. Over the weekend, the New York Times unleashed a massive article blowing the lid off the scariest conspiracy of them all: the secret Food and Drug Administration surveillance conspiracy.

Apparently, the FDA has been spying on some of its scientists, seeking out “enemies” of the agency, reading scientists’ private correspondence with everyone from journalists to attorneys to Barack Obama, taking screenshots of their personal computers, and more. The agency is facing accusations of privacy and whistleblower violations, and the scandal is so absurd that one senator has called the FDA the Gestapo.

Extra, extra, read all about it…

The New York Times has all the details:

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.

What the hell were these FDA scientists saying that was so dangerous that the department felt it necessary to spy on THE PRESIDENT? I can imagine the scene:

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SCIENTIST #1 looks up from his microscope: Oh my God, Robert, you’ve got to see this.

SCIENTIST #2 shuffles over in his lab coat, looks through viewfinder: No. Way. You have to tell someone.

SCIENTIST #1, getting panicky: We can’t do that! No one will believe us that McDonald’s is the cure to cancer! Our careers will be over.

Of course, in reality it was not so earth-shattering. The FDA was simply angry that scientists released confidential information to the media about medical devices that might’ve been unsafe. You know, because part of the fun of a mammogram is knowing that it might make you sicker:

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.”

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On a more general-interest workplace privacy level, the technology (literally known as “spy” software) used by the FDA to monitor its employees was pretty impressive. If you doubted that your employer would ever have any problem seeing exactly what you’re doing on your computer at any time, well, you are misguided to say the least. Whether or not your employer is competent enough to not accidentally post the information publicly is another issue entirely:

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.

It looks like the FDA surveillance may have gone way beyond the already wide boundaries of permissible employee surveillance. Several of the scientists (some of whom were fired) have filed suit against the agency. And according to the New York Times, it turns out that some very basic information about the program is disconcertingly vague: “the documents do not make clear who at the agency authorized the program or whether it is still in operation.”

Seriously? Now we are leaving the 1984 station and entering the bureaucratic dystopia of Brazil:

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.

Even Senator Charles E. Grassley, an Iowa Republican, is pissed. Emails of one of his former staff members were cataloged in the surveillance database too. According to the Times, Grassley said that “the F.D.A. is discouraging whistle-blowers.” And then he pulled the Nazi card, saying 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.”

I just can’t get over the fact that this scandal is happening at the FDA. The only way it could be more incongruous is if it were unfolding at the National Park Service. Oh wait, maybe it’s not so surprising, because in the great American tradition, the agency was looking out for the interests of medical device companies:

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.)

Never mind that during the original kerfuffle the Inspector General said there was no evidence of a crime because “matters of public safety” were at issue, the FDA purchased and used SpectorSoft, software designed in part for parents to prevent their children from looking at porn.

There’s way too much in the extensive New York Times article to cover here. It’s worth reading for a lot of spicy little details (like, for example the fact that the surveillance may have actually leaked the very corporate trade secrets it was trying to protect).

It will be interesting to see how this pans out. I wouldn’t be surprised if the FDA takes a bad enough beating that it fast tracks a new drug to numb the pain.

Vast F.D.A. Effort Tracked E-Mails of Its Scientists [New York Times]

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