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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."
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.
So because you're a scientist executing work in the name of science for the FDA there's shouldn't be any supervision, quality control or oversight of what you're doing? Provided that I might be arguing the wrong side of the field here, I'm just failing to see why this could possibly be a problem.
In any large, well establish organization your activities are monitored and reviewed on a consistent basis, when it comes to what you're doing work-wise...why should scientists being employed at the FDA be any different?
I don't feel this is about trying to lock down the openness of science, I feel this is about quality control.
There is a difference between employers monitoring workstations to prevent waste, fraud, and abuse, and the employer monitoring workstations to search for whistleblowers. A big fucking difference.
No employer has a right to hunt down employees who disclose illegal or unethical acts, especially if it is the federal government. The fact that messages to Congress were monitored is also a major issue. Federal law states:
The right of employees, individually or collectively, to petition Congress or a Member of Congress, or to furnish information to either House of Congress, or to a committee or Member thereof, may not be interfered with or denied. - 5 USC 7211
There are also numerous whistleblower protections. Pooh-pooh it if you want, but it is highly likely that numerous federal laws were broken by the FDA in this spying operation.
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?
> 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."
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.
Uh, answering my own post with a counter-argument, spying on your employees really isn't a very good way to accomplish this though. It creates distrust, bad morale, etc. I think there must be a better way to accomplish the same goal, of secrecy.
The issue is not distrust, bad morale, etc. Again, you are only looking at this from a mundane office perspective. That's just an issue of productivity. This is a much bigger issue than that. This is an inquisition on whistle blowers. It is an issue over the very soul for FDA and unlike your average office spying, is very much a headline article.
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.
"Windows is like the faint smell of piss in a subway: it's there, and there's nothing you can do about it." - Charlie Br
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.
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?
Honey bees are in decline across the world, including the UK, and it has been attributed to everything from pesticides to mites so is probably a combination of things. And I don't know of any drug, FDA approved or otherwise, which turns you into an orangutan..
Perhaps we should take a more serious look at the contents of the article with a bit less hyperbole?
// MD_Update(&m,buf,j);
What's wrong with a little hyperbole?
As for being turned into an orangutan - I just thought is sounded funny. (For some people, that would actually be beneficial, I think.)
The bees? True - no one knows for certain yet what is causing honey bee colony collapse. But, an awful lot of credible evidence points to pesticides. Both pesticides that are applied to crops, as well as pesticides produced by genetically modified crops. Bayer's pesticide is the leading suspect, at this point in time. Bee colony collapse is global, but pesticide usage is also global.
"Windows is like the faint smell of piss in a subway: it's there, and there's nothing you can do about it." - Charlie Br
> "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."
Yes, that sounds to me like the bad guys are in control, and they are winning the battle. Stupid me thought that the FDA should be acting in the public interest...
I had to deploy some software that did just this not too long ago. I forget which version or manufacturer we used, but it came with a signed certificate from an regular authority and the antivirus simply ignored it unless you boosted the heuristics up to the point about anything would trigger an alert.
Anyways, not too many people check their antivirus to see if someone placed a few exceptions in it. This is especially true when there is an IT department taking care of most of the computer related stuff. Even if the software was detected by the antivirus, the agency had control over the systems and could have placed exceptions for it. and of course this is assuming they used windows systems (we did) and not Linux or something where the Antivirus would probably see it as just another daemon running.
Oh yea, in my case of using it, we caught a person who was funneling bid information to a competitor for a commission and attempting to pad his own sales to scam bonuses.
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.
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.
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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.
Would you prefer that nobody leaked anything and that the faulty medical imaging devices were released to hospitals?
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Yes.
Litigiously,
-United States Trial Lawyers Association
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Strat
Progressivism (aka US 'Liberalism'): Ideas so good they need a police/surveillance-state to enforce.
Um. There's a difference between Federal Law and "chain of command."
Come on. The FDA bureaucrats blew it. RTFA.
I can see the fnords!
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.
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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.
The FDA only regulates pesticides as they relate to residues left on human-consumed food (because they then become a food contaminant.)
Regulation of the pesticide's environmental impact is the EPAs job.
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.
There's nothing like $HOME
Let me call a halt to this "failed organisation", "in pockets of big pharma" circle jerk.
If you want a pharama company in this country (UK) to shit their pants, tell them they are about to be inspected by the FDA. No other organisation we have to deal with (we deal with the equivalent of the FDA from every country we market product to) instils such down right fear in the factory manager to the quality assurance through the scientists to the cleaner mopping the floors as they do. The FDA know they have been caught with their pants down on more than one occasion, and are out for blood. Also, now there is no longer a Republican in the white house, they feel able to do their job. Don't believe me? Take a look at the number of warning letters and recalls (the way by which the FDA assert their power on the companies) issued by the FDA to drug companies over the past few years:
I hate to use websites obviously pushing an agenda, but there is a graph from 1996 to 2006:
http://mgdservices.com/wp-content/uploads/2010/12/fdacloudgraph21.png
And from 2004 to 2011
http://marginalrevolution.com/wp-content/uploads/2012/06/FDA-letters1.png
Notice the (political) trend?
They are also the single most paranoid organisation we have dealings with, which most likely explains this spying incident. The FDA have also had a lot of trouble lately with scientists leaking information on drug trials to the stock markets. This makes a lot of people very wealthy at the expense of others. Doesn't justify what they have done, but does explain why.
But then again, these are just my experiences, I don't work for an american big pharma company and their is always an element of national-why aren't you making the drug in *our* country-protectionism within every one of these organisations.
Posting anonymously for obvious reasons.
They were doing the right thing.
They did the right thing by raising concerns about the devices' safety. But there are two problems with some of their other actions.
First, just because they disagreed with the conclusions about the safety of the devices doesn't mean the FDA was wrong a they were right. Apparently there were plenty of studies and the conclusion was that the risk posed by the devices was small enough. But this group didn't want to accept that answer. Which leads to...
Second, a federal employee is protected by whistle-blower laws. But there's a proper way to pursue that option, these scientists went about it the wrong way and got in trouble.
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?
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