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The FDA Spied On Its Own Scientists 95

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."
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The FDA Spied On Its Own Scientists

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  • by Anonymous Coward on Sunday July 15, 2012 @02:21AM (#40653681)

    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.

  • by Anonymous Coward on Sunday July 15, 2012 @02:51AM (#40653807)

    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?

  • by smoothnorman ( 1670542 ) on Sunday July 15, 2012 @02:55AM (#40653825)
    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.
  • by Runaway1956 ( 1322357 ) on Sunday July 15, 2012 @03:05AM (#40653857) Homepage Journal

    It seems like the FDA is a failed institution, anyway. It seems that almost every year, some "approved" medical treatment is recalled. It turns out the drug in question has serious side effects, from turning you into a corpse, to turning you into an orangatan. Meanwhile - other "drugs" such as quinine, which have been in use worldwide for millenia are suddenly regulated, and taken off the market, so that some bunch of freaks can properly "research", then market quinine.

    I'm glad that you're happy, and feel secure, about the FDA doing all this "quality assurance". I'd rather see them doing real QA on the products brought before them. Screw all those trade secrets, and "intellectual property".

    As things stand right now, the FDA is a failure. How 'bout all that food on the market, full of growth hormones, antibiotics, pink slime, and genetically engineered crap? Failure, after failure, after failure. The FDA isn't there to protect fools like you and me. It's there to protect corporations, and government. You and I mean less than nothing to them. That's NOT how it was supposed to be.

  • by Anonymous Coward on Sunday July 15, 2012 @03:54AM (#40654057)

    I guess you should then go work for a university or something. No one is making you work at the FDA or for them for that matter. If you take the check, then prepare to be put under the control of whatever the FDA or whatever boss you have at the time decides is necessary for them to ensure whatever it is they need to ensure. You are not entitled to anything.

    People like you are the reason coverups happen. I have no doubt that you think whistleblowers are scum. The FDA bosses probably felt the same. And that is the problem. The fact that you don't recognize it is fairly disturbing.

    Fortunately, federal law disagrees with you. Whistleblowing is the right of a worker, not an entitlement. And retaliating against a whistleblower is a crime.

  • by rohan972 ( 880586 ) on Sunday July 15, 2012 @06:04AM (#40654453)

    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.

  • by Anonymous Coward on Sunday July 15, 2012 @06:25AM (#40654519)

    The FDA is much stricter than other country's regulatory agencies when it comes to not approving medications. But it's easy for you to complain about recalls because the sample size is so large and you can just ignore all the drugs that are shown to be safe. Many are calling for the FDA to relax their strict guidelines for approving medications as it is a trade-off between making available potentially life-saving medicine and protecting people from medications that don't work / have unexpected side-effects.

  • by Schmorgluck ( 1293264 ) on Sunday July 15, 2012 @07:01AM (#40654623)

    And the sad part is an organization like the FDA is actually all about transparency. Transparency is its core purpose, being it by enforcing accuracy on food ingredients lists, or by checking out what a drug actually does. It's all about information, and sharing it, and ensuring it's accurate.

    So the only thing such an organization could possibly have to cover up is a regulatory capture. I can't think of anything else.

  • by Anonymous Coward on Sunday July 15, 2012 @10:38AM (#40655577)

    Screw all of this legal talk. All that WE need to know is whether it was ethical or not. Let us stop talking in technicalities and focus on the big picture.

    If a scientist feels that something is going to hurt public safety, they have a moral duty to do everything they can to prevent that.

    To do the job they were hired to do. It really is that simple. If I hire an electrician to put extra outlets in a room, I'm not paying them to discover and rewire another room just because they think it should be done. I hired them to do a specific job and they should do that specific job, If they notice the other room, they can inform me and I will decide if they are going to repair it or someone else or not.

    It doesn't matter whether they pan out or not. It matters if there is a reasonable suspicion. Five scientists thought there was a reasonable suspicion that public safety would be impacted. The IG agreed. Look up chilled environment. I'm not a passive observer here. I quit working in nuclear power partially because I was always required to be 100% correct in every safety issue I questioned. In my previous job for every safety issue that I could justify away and keep a reactor online I was given a pat on the back. For every safety issue that I brought up that could potentially cause a shutdown I was looked at like I was an asshole. Every issue was investigated, of course. Nuclear power is good at ensuring there is a paper trail that shows they investigate problems. Everything was nice and legal. Every check box was filled. They just socked it to me on my performance evals and bonuses and let me know in no uncertain terms that what I was doing was undesired. I was only investigating potential issues with nuclear safety. No biggie, right?

Man is an animal that makes bargains: no other animal does this-- no dog exchanges bones with another. -- Adam Smith