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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."
I don't think there is anything shocking about this, especially given the technological climate of the current era when it comes to information systems, data security and patents etc. The tricky part is the managing the human resource of such an operation and dealing with he seemingly infinite intellectual nuances of the human psyche involved in such an operation, at a level like this.
I am prepared to see more and more of these kinds of operations surface, and I am glad to see this kind of quality control is taking place within an organization that is in charge of something as crucial as what they are indeed in charge of securing. The title of this story entry is misleading with it's use of the word 'spied', to me this is just good management / quality control in the information age. When you work for a government agency, there's no way in hell you can expect your activities not to be monitored, especially when you're using government property to perform them.
The FTC should do this. If you are creating a new device, you need to get FTC approval, and it's basically impossible to keep a device secret during the approval process.
Now, they do allow you to charge more, and they will promise to keep it a secret, but if it is interesting, someone will still leak it. That's why Apple announced the iPhone originally before getting FTC approval.
"First they came for the slanderers and i said nothing."
The article mentions no trojans. Why would they need trojans when they can roll out patches to their user' workstations?
That said, I'm really curious as to what software they used, and why (if any) virus scanners didn't pick this up.
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.
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
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.
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?
The management is paid by the companies they approve? So what, this works well elsewhere. Just look at the US Patent Office.
The patent office is paid for by people wanting to patent things, and they continue to carefully check each patent for inventiveness and non obviousness, still.
So just because there's a conflict of interest, it didn't cause the patent office management to jizz patents like a teenage boy with unfiltered internet. No sticky mess to clean up in the patent office, and hence no sticky mess to clean up in the FDA.
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?
---
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.
I remember that the government relinquished a long time ago this Internet to universities and private corporations, I think they should use their own network. I also don't think that government employees should have access to the Internet from their desks.
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!
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.
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.
If you are a govt worker, don't be a whistleblower on your work computer. Do it from elsewhere, as they then need a warrant....at least hypothetically.
How common is it for companies (gov or private) to use key loggers and trojans to monitor employees in the US? Or for that matter monitoring any Internet traffic through the firewall? Does your average IT department provide detailed Internet history to the managers? Will my time spent on Slashdot and Reddit be used against me on my next review :)
Was it on FDA time? If so its their data.
Was it using FDA computers? If so, its their data
Was it using FDA networks? If so its their data
Its pretty simple: if its not your time/equipment, its not your data and it is owned by your employer for and they have a right to monitor/record/restrict it all.
---- Booth was a patriot ----
Ignoring the entire article, and picking on terminology:
It's not FDA approval, it's FDA clearance. ... you get cleared to sell and market your product, not approved.
meh
What, precisely, is the difference between a mole and a whistleblower? What's the difference between a terrorist and a freedom fighter. The FDA most certainly has a responsibility to protect the integrity of the organization. If they didn't, than rampant bribery would make it look like, oh, say, the Republican party. By the way, unless they have special computers, these were like every other one of the fed's computers that has a banner which says that by using the computer, you consent to the monitoring of your communications.
As someone who actually worked at the FDA with the people in question, I'm getting tired of the piss on the FDA attitude here, and I can tell you that TFA is written to sex things up.
The individuals who were "spied" on were parts of teams who reviewed medical products. People on those teams had differing opinions regarding the safety and effectiveness of various products. The leads of those teams and their management had to decide whether to approve the products given the conflicting input from the team, the history of safety and effectiveness of similar products, published scientific studies, etc. When those decisions did not go in favor of the individuals in question, they complained loudly. And when details about the products that they were reviewing were leaked to the NYT, they were suspected of doing so. Note that this product information belongs to the companies that submit the products, and its release by the FDA is against the law.
Anytime that any FDA employee logs into a FDA computer, a big splash window appears that states that ALL use of that computer is subject to monitoring by the US government. This window has appeared on all federal computers for more that 12 years now. Are we supposed to be surprised when the federal government monitors the use of some employees' computers they suspect of violating the law?
Not quite as sexy as the article makes it out, is it?
Obama is a paranoid pedofile.
Yea, this is what we got for a President.
I want my vote back.
Fuck [bomb him back to the Stone Age] Obama and his Unelected Government.
LoL
Data is available but rarely used at my company. Requires special request for logs.
Democracy Now! had an excellent interview today with the attorney for the FDA Whistleblowers, Stephen Kohn. I’d highly recommend it. Check it out here: http://www.democracynow.org/2012/7/17/spying_on_scientists_how_the_fda