What on earth has been going on at the FDA? The agency has engaged in a large and long-running surveillance of its own staff. This story was broken earlier this year by the Washington Post, but a mistake by a contractor gave the New York Times (and others) access to many more intercepted files. And things seem to have gotten out of hand pretty quickly:
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.
A good old-fashioned enemies list! The agency used key-logger and screenshot capture software on the government laptops of several employees, and the whole thing started over an internal dispute:
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.
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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 FDA is insisting that these actions had nothing to do with rooting out whistleblowers or tracking down critics of its regulatory decisions. Not at all - they were just making sure that no one was leaking proprietary documents. The rooting out of whistleblowers and identification of critics, those were just side effects. Not everyone is buying that explanation:
Representative Chris Van Hollen, a Maryland Democrat, sent a letter on Monday to Kathleen Sebelius, the secretary of health and human services, calling on her to conduct a full investigation into whether the surveillance program violated federal employee protections and whistle-blower laws.
“The tactics reportedly used by the F.D.A. send a terrible message to those who are prepared to expose waste, abuse or wrongdoing in government agencies,” wrote Mr. Van Hollen, whose staff communications were monitored by the F.D.A.
He's got a point. If a company does something like this to its own disgruntled employees, it exposes itself to a great deal of legal jeopardy. I'm not a lawyer, so I don't know what applies to the FDA itself, but I hope that there's a thorough investigation indeed. The agency takes a lot of flack, from every direction: groups on the left of the political spectrum, among others, blast them for having sold out to industry and not protecting the consumer, drug companies complain about arbitrary decisions and regulatory delays, and the more libertarian types would like big chunks of the whole apparatus to just disappear somehow.
But when I say "the agency", I'm talking about its people, its employees, many of whom are doing very difficult work for not all that much money. The people who authorize this kind of thing, well. . .they're in another category. Now, I understand that people inside the FDA (and other regulatory agencies) need some oversight. They're the referees in this business, and quis custodiet ipsos custodes? is always an appropriate question to ask. The recent insider trading scandal at the agency is just one example of what can happen when someone in a rule-making department goes astray.
But that doesn't mean that you can't go astray while chasing such things. You start reading people's mail and keylogging their passwords, and all sorts of ideas can come to your mind about what you're doing and why. So, who had these ideas at the FDA this time, and just what were they thinking?