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The FDA Spied On Its Own Scientists

retroworks writes "The New York Times has an interesting article about efforts by the Food and Drug Administration to locate a source of 'leaks' within the agency. The search became a slippery slope involving trojans, keyloggers, screenshot captures, and an investigation that eventually became an allegory for management overkill. The article describes how the investigation of one employee expanded to five, and how the investigation of five led to other staff (including the interception of correspondence to President Obama). The Agency struggled with the gray area between protecting trade secrets of drug companies (which had applied for FDA approval) and censoring researchers with legitimate questions about the Agency's approval process."

11 of 95 comments (clear)

  1. Re:This is understandable by Anonymous Coward · · Score: 5, Insightful

    Don't employ scientists then. Just employ more bureaucrats.

    Science needs to be open and dissent needs to be encouraged. If you want to lock it up in secrecy, then call it something else. It would not be science, and the researchers would not be scientists.

    For the FDA, where public safety should be a priority, you would want to have the process be as open as possible. If you feel there is a need to spy on your scientists in order to prevent leaks then it is obvious that public safety is not particularly high on the agenda.

  2. Re:This is understandable by Anonymous Coward · · Score: 5, Insightful

    Routing out whisteblowers isn't quality control. And science does just fine without bureaucrats performing quality control. Reproducibility, falsifiability, and peer review (which means an independent review--not your boss) do that better than bureaucrats ever could.

    And just in case you are wondering why this is important, RTFA. The scientists felt that the FDA approved medical imaging devices that allowed patients to be exposed to dangerous levels of radiation. The FDA was worried that trade secrets were being released, so they decided to hunt down the whistleblowers. Quality control, right?

  3. Re:FTC by jma05 · · Score: 4, Informative

    > but if it is interesting, someone will still leak it. That's why Apple announced the iPhone originally before getting FTC approval.

    Your iPhone example doesn't hold here. The targeted personnel are responsible scientists communicating with proper whistle blowing channels regarding impropriety, not some lower-tier techies leaking shallow trinket tidbits for cash to rumor web sites.

    > The FTC should do this.

    No, they should not. They can certainly act if the leak question was on leaking to competitors and such. But these were issues of public concern and they were clearly told to not investigate... and then they went ahead and did it anyway.

    "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."

  4. it's no longer an public agency by smoothnorman · · Score: 5, Insightful

    the slippery slope of having big-pharma pay for the FDA's testing (as a "cost cutting" maneuver), which then became having the industry itself doing the testing of its own trial products, and by now the FDA is a watch-dog for the industries secrets and guarding their IP, the FDA has become essentially just contract research for the private sector. add that there are good indicators that big-pharma is behind pulling in "campaign contributions" to continue the war on drugs (there's proprietary money in xanax there's none in marijuana) and it's time to just tear down the remains and start a new agency. ...has that ever occurred? i don't think so.

  5. "protecting important secrets" by harvey+the+nerd · · Score: 4, Interesting

    The FDA has to protect many important pharma secrets, like payoffs for the bosses and the new drugs that maim and kill. Really. Of course they want to keep an eye on the grunt scientists, one might get disgruntled and spill the beans, again.

  6. Re:On the one hand by Anonymous Coward · · Score: 5, Informative

    Theres is also a chain of command to be respected, john douche going to the new york post over a finding without informing anyone is also wrong

    there is 2 sides to this coin, your only looking at the shiny one

    How do you think the FDA knew who to monitor? The scientists used the chain of command and were told to STFU. Then they leaked the information and contacted Congress. A special investigation determined that their concerns were valid and that an investigation would be needed due to "a substantial and specific danger to public safety".

    Four of the scientists were fired. See, that is what the chain of command does. It makes it easy to put together a complainers list.

    The end result: four scientists had to lose their jobs in order to protect the public from faulty medical imaging devices. Would you prefer that nobody leaked anything and that the faulty medical imaging devices were released to hospitals?

  7. Re:This is understandable by rohan972 · · Score: 5, Informative

    Anyone working for any government department has the moral right to act in the interest of the public to the best of their ability. If you read TFA you'd know that:

    "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 government wide 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,"

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

    While you may have to do what the boss says, when you're a public servant and the White House as well as members of Congress from both parties come are on your side and your actions are specifically protected by law, you ARE doing what the boss says.

    And to cap it off: 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."

    They were doing the right thing.

  8. Don't expect privacy if you work for the Fed. by PerlPunk · · Score: 5, Informative

    Sorry, as someone who has worked for the fed and has held a security clearance, I don't sympathize with the journalist who wrote the WP article. If you work for the federal govt, then you have absolutely no expectation of privacy for communications sent using federal equipmentt. It's in the U.S. laws, and HR in all the places I worked where the fed was involved made sure you knew that. And yes, there is a legitimate public interest for the government to find out who is leaking confidential information. Lives, reputations, and public confidence is often at stake in these matters.

    1. Re:Don't expect privacy if you work for the Fed. by Anonymous Coward · · Score: 4, Informative

      Sorry, as someone who has worked for the fed and has held a security clearance, I don't sympathize with the journalist who wrote the WP article. If you work for the federal govt, then you have absolutely no expectation of privacy for communications sent using federal equipmentt. It's in the U.S. laws, and HR in all the places I worked where the fed was involved made sure you knew that. And yes, there is a legitimate public interest for the government to find out who is leaking confidential information. Lives, reputations, and public confidence is often at stake in these matters.

      '... Lives, reputations, and public confidence is often at stake in these matters.'

      FTA

      '...

      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.” ...

      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. ...'

  9. Re:This is understandable by rohan972 · · Score: 5, Insightful

    It doesn't matter if congress or the white house got mad. They are not the boss, they are the boss's boss.

    Not when your actions are protected by legislation. Then you have no obligation to follow instructions from your boss to the contrary.

    If someone takes a job as a scientific researcher for the government they are definitely entitled to follow proper scientific processes. They are putting their name and professional reputation to their work. I'm not a scientist but I have worked in quality control and been pressured to sign off product that did not meet specification. Now I work as a tradesman and I've been pressured to do work that doesn't meet relevant standards. The answer is both cases was no. How could it be otherwise? What's the point of hiring scientists if you don't want them to do science properly?

    Read again: 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."

    Their job as scientists was to identify that danger to public safety. When the boss didn't want to listen they went to the "boss's boss" and to the public (the boss's boss's boss) via the media, action that is legally protected for this very reason. They were doing their job.

  10. Re:This is understandable by demachina · · Score: 4, Informative

    I think the laws at issue here are Lloyd - La Follette Act of 1912 and the Treasury and General Government Appropriations Act of 1998.

    It is explicitly forbidden for Federal agencies and managers to interfer with whistleblowers trying to contact Congress to report abuses. One caveat is the whistleblower can't usually divulge classified information to people not authorized to recieve it as part of the whistle blowing but I doubt there is any classified information in an FDA dispute.

    Garcetti v. Ceballos has nothing to do with whistleblowing to Congress, it wasn't whistleblowing at all really. Its not whistleblowing when you report an issue to your boss. I can see no way it applies to this case. A DA disagreed with and disputed a warrant, Sherrif's office was furious and his boss overruled him and proceeded with the case. DA thought he was passover for a promotion over it.

    Manning wasn't whistleblowing to Congress and he was divulging classified information without authorization to people not authroized to receive it so his case has NO relevance to this case either.

    Not sure why you are bringing up cases that have no particular bearing on this case and pretending like they do. You kind of sounded impressive there for a second until you acutally parse what you said.

    --
    @de_machina