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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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« AstraZeneca Admits It Spent Too Much Money | Main | Qnexa Approved? Someone Seems To Know. . . »

July 17, 2012

Employee Surveillance at the FDA

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Posted by Derek

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?

Comments (9) + TrackBacks (0) | Category: Regulatory Affairs


COMMENTS

1. Hap on July 17, 2012 9:53 AM writes...

If data say that upper management's decisions were wrong, than clearly it must be the data (and the people who were evil enough to gather and analyze the data and make it known) who must be wrong.

I didn't think that big pharma had laid off enough of its upper management for the FDA to hire them. If not, I suggest that someone find an exorcist to send the spirit of Nixon to...wherever in the hell it belongs.

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2. NoDrugsNoJobs on July 17, 2012 10:30 AM writes...

And all this time I thought all the bad guys were in big pharma only, please don't complicate my simple worldview.

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3. Another Kevin on July 17, 2012 1:47 PM writes...

Actually, your idea that protection is stronger with a private employer is wrong. If it's an employer laptop, there is no expectation of privacy, and the employer is free to implement whatever surveillance measures are deemed appropriate. The employee has no recourse against the employer for invasion of the employer's own property, unless there are contractual terms that say otherwise.

There may or may not be stronger protections against the government doing the same thing. I know that private employees can be fired for speaking against their companies' perceived interests. Employment is "at will", and can be terminated for any reason or no reason (except for some narrowly defined exceptions relating to race and gender discrimination). By contrast, government employees enjoy First Amendment protection in their private utterances. But I suspect that the Fourth Amendment doesn't protect anyone from having the government search its own property.

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4. JAB on July 17, 2012 2:18 PM writes...

The standard verbiage in the gov domain is something like this:

You are accessing a U.S. Government information system, which includes (1) this computer, (2) this computer network, (3) all computers connected to this network, and (4) all devices and storage media attached to this network or to a computer on this network. This information system is provided for U.S. Government-authorized use only. Unauthorized or improper use of this system may result in disciplinary action, as well as civil and criminal penalties.

By using this information system, you understand and consent to the following:

You have no reasonable expectation of privacy regarding any communications or data transiting or stored on this information system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this information system. Any communication or data transiting or stored on this information system may be disclosed or used for any lawful Government purpose.

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5. Hap on July 17, 2012 2:43 PM writes...

At least some of those surveilled, though, were not FDA employees and had no reason to expect that their emails and computers would be monitored by them (for example, the staff of the House Representative quoted in the post).

In addition, I don't know how broadly one would interpret "employer" - I don't think the NSA spying on Congress would be considered kosher, for example, even though they are both parts of the federal government (or, perhaps for a more accurate analogy, NSA spying on the Dept. of the Interior). The FDA would seem to have an even narrower purview over employees of other gov't agencies than NSA is likely to have.

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6. matt on July 17, 2012 4:02 PM writes...

I predict smartphone usage at the FDA to increase sharply. Mail, communications, etc.

Including the leaking of private documents and whistleblowing.

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7. Anon on July 17, 2012 6:42 PM writes...

Derek,

"Disgruntled" is a bad term to use. It has negative connotations towards the employee.

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8. Captain Ned on July 17, 2012 7:10 PM writes...

Whistleblowing on your employer-issued computer is just plain stupid.

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9. Spiny Norman on July 18, 2012 12:18 AM writes...

JAB et a. -- It's been reported that the surveillance software wormed its way onto personal (privately owned) computers as well. There is every reason to believe that crimes were committed by the watchers.

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