Wednesday, July 18, 2012

New York Times Reports that FDA Spied on Agency Scientists Who Disagreed with Established Positions and Tried to Quell Collaboration Between Dissenters

According to a July 14 article in the New York Times, the Food and Drug Administration (FDA) spied on a number of agency scientists who expressed disagreement with established agency positions by secretly capturing their emails, analyzing them, tracking their computer keystrokes in real-time, and creating directories of communications organized by the names of sympathetic public officials with whom they were communicating.

According to the article: "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." ...

"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.”" ...

"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." 

The Rest of the Story

While the FDA claims that these efforts were intended only to prevent the release of confidential, proprietary information, it seems quite clear that the scope of the agency's spying efforts goes way beyond that narrow aim. The number of scientists who were monitored, the nature of the spy effort (including intercepting emails and tracking keystrokes in real-time), and the analysis of information that is protected under whistle-blower  laws all indicate that the agency far exceeded its discretionary authority.

The most concerning aspect of the story is that it exposes an attempt on the part of the FDA to quell dissent by intimidating scientists from expressing disagreement with agency decisions that they felt put the safety of public at risk. In fact, an independent review confirmed that the concerns of these scientists about the approval of devices that exposed patients to dangerous levels of radiation were warranted: these devices represented “a substantial and specific danger to public safety.”

The integrity of science depends on the ability of scientists to express disagreement. In fact, most of the great scientific advances have come from scientists who have been willing to challenge conventional thinking. Quelling dissent destroys the integrity of the scientific process and ensures that agency decisions will be made on political, rather than scientific grounds.

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