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The FDA Spied On Its Own Scientists

Soulskill posted more than 2 years ago | from the your-tax-dollars-at-work dept.

Censorship 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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This is understandable (1, Flamebait)

tryptogryphic (1985608) | more than 2 years ago | (#40653663)

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.

Re:This is understandable (5, Insightful)

Anonymous Coward | more than 2 years ago | (#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.

Re:This is understandable (2)

tryptogryphic (1985608) | more than 2 years ago | (#40653717)

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.

Re:This is understandable (5, Insightful)

Anonymous Coward | more than 2 years ago | (#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?

Re:This is understandable (1)

sumdumass (711423) | more than 2 years ago | (#40653923)

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.

Re:This is understandable (2, Insightful)

Anonymous Coward | more than 2 years ago | (#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.

Re:This is understandable (1, Interesting)

sumdumass (711423) | more than 2 years ago | (#40654135)

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

You probably will want to review this information personally and not trust the idiot who told you that ever again.

Federal law in whistle blowing only covers certain subjects pertaining to certain parts of those subjects. There have been several cases in the last 10 years where people who thought as you do ended up on the losing side of the argument. Garcetti v. Ceballos come to mind off the top of my head, and we are still in the process of prosecuting Private Manning for what he calls whistle blowing and it doesn't look like he has any defense at all.

Re:This is understandable (1)

sphealey (2855) | more than 2 years ago | (#40655023)

Your legal knowledge appears extensive. Perhaps you could give us a briefing on the federal law that prohibits interfering in communications between any federal employee and a member of Congress.

sPh

Re:This is understandable (1)

tryptogryphic (1985608) | more than 2 years ago | (#40655125)

Interfering, and monitoring are two totally different things here.

This article has a sub-issue of 'who is watching the watchers' to it.

Re:This is understandable (1)

sphealey (2855) | more than 2 years ago | (#40657591)

You are free to argue that standing over a person's shoulder, watching what they type, and saying "feel FREE to send that e-mail to the Senator" is just monitoring and not interfering. I suspect you'll also be free to make that argument when (1) under oath in front of a Senate Committee (2) to a jury.

sPh

Re:This is understandable (4, Informative)

demachina (71715) | more than 2 years ago | (#40656655)

I think the laws at issue here are Lloyd - La Follette Act [wikipedia.org] 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.

Re:This is understandable (5, Informative)

rohan972 (880586) | more than 2 years ago | (#40654119)

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.

Re:This is understandable (0)

sumdumass (711423) | more than 2 years ago | (#40654185)

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

The comment was directed at the op's claim of "Routing out whisteblowers isn't quality control" expressing the desire to want science without bureaucrats performing quality control". "and peer review (which means an independent review--not your boss)". If you want that, go work someplace that provides it. You are not entitled to it by default or anything.

Re:This is understandable (5, Insightful)

rohan972 (880586) | more than 2 years ago | (#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.

Re:This is understandable (0)

Anonymous Coward | more than 2 years ago | (#40654499)

I feel sad for future scientists. No doubt big farma is going to legislate and manipulate, "scientists duties to the public" with "hurting profits".

Re:This is understandable (1)

sumdumass (711423) | more than 2 years ago | (#40655261)

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

I guess you better make damn sure your actions are covered by law then. Not all whistle blowing is, and i see little indication that this was. See Garcetti v. Ceballos who found that out first hand.

If someone takes a job as a scientific researcher for the government they are definitely entitled to follow proper scientific processes.

Only to the extent their job duties and department policies allow. You do not get hired to do your own thing, you get hired to do their thing. There is nothing special about a scientist or scientific researcher that excludes them from all the customary rules others have to follow.

They are putting their name and professional reputation to their work

If you are not comfortable with working within the confines of your employer, seek employment somewhere else. It really is that simple. No one has a right to any specific job or a right to ignore department policy or set rules and guidelines of the job. If you don't like it, move on to some place you do like.

I simply do not understand this mentality that just because you get hired, you are all the sudden entitled to anything you want or to do anything you want to do. Whoever told you that was the case, was probably trying to take the job you were looking at and decided to steer you wrong so even if you beat them out of it, you wouldn't keep it long and they would get another chance at it.

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?

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.

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."

What is so special about that? It says they wanted an investigation, not that the devices were a danger. Just that the claims represent their might be a danger and an investigation is warranted. For all we know, it could be a couple of bad scientists trying to find a way to become protected from being fired by making claims and accusations that do not pan out in reality. They certainly are not the only scientists there.

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.

You keep saying their actions were legally protected, tell me what specific law protects them? Don't say whistle blowers laws because I have yet to find one that covers employees at the FDA within their official duties.

Whether you want to believe it or not, not all whistle blowing activities are covered or protected by law and some, can actually be criminal.

And this is besides the point that you don't know their bosses didn't want to listen. I certainly do not respond to every subordinate under me who brings something to my attention. However, my failure to light hoops on fire and proceed to jump through them immediately in their presence does not mean i am ignoring their concerns or whatever they are bringing to my attention. I may have already knew about it and could be in the process of taking steps on it, I may be referring it to another employee or even an outside consultant to take care of it. Then again, I might review the situation and determine it is not that big of a problem at the particular stage of events we might be at with it. I certainly do not have to explain any of that to them.

So we simply do not know if the management were doing anything about it or not. We do know they informed President Obama about their concerns and as the boss's boss's boss, the people in question felt left out once again when Obama didn't feel the need to call a national emergency and mobilize the national guard to correct the situation on the spot. It seems that his only public objection to date on the topic was about the spying and to that extent, he claimed it was allowed but shouldn't be done in a way to discourage whistle blowing.

Do you really think Obama as the head of the executive who has implicit power to address the situation was sitting on his hands keeping this information secret to protect G.E. or friends he put in the FDA? Or the congressmen who were informed decided to sit on the information until election time or something? You know congress likes to grill government departments in televised hearings because everyone can see them fighting for the little guy helping their perpetual incumbency. Or perhaps all these other people were either already doing something or reviewed the situation and realized it was exaggerated or something.

Re:This is understandable (2, Insightful)

Anonymous Coward | more than 2 years ago | (#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?

Re:This is understandable (1)

sumdumass (711423) | more than 2 years ago | (#40657651)

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.

It was ethical to bring it to the attention of their supervisors or follow in house reporting procedures but not much more then that. It is not a matter of if something is going to hurt public safety, it is a matter of 5 scientists saying something did hurt public safety and things need to be done the way they want it done then throwing a fit when it wasn't.

Here is the problem with your concept concerning the FDA. It's not a situation where you have 5 employees and they are the only ones who will ever see the device or data. The FDA is required by law to work through advisory committees that consist of experts in the fields in question, industry advocated experts and consumer advocate experts or representatives who determine the scientific and technical relevant procedures, processes, and guidelines that are in place in order to test in the first place. After all tests are done and everything is evaluated, the information .collected is passed to one or several of these advisory committees depending on the subjects at hand (there are something like 50 of them in total which have several divisions under them and task forces or subcommittees who review the information before being sent to them). After the advisory committees view and comment on it, recommendations are sent from each, the industry advocate, the consumer advocate, the neutral expert advocates, to yet another FDA office where it is reviewed once again with the recommendations and concerns from the advisory committees, then an official pass or fail and/or why is issued or further investigation is ordered and the process starts again but on a fast track sort of path.

How the FDA evaluates something, the methods, tests, scientific qualifications and so on for each is pretty much dictated by the advisory committees. Threats to public safety can be overlooked if the good of the device or drug or whatever meets a greater need for the public to halt an existing harm. If the amount of harmful radiation patients are exposed to happens only one in 1000 times and randomly meaning not even that much and all those advisory committees advocates said undetected breast cancer and so one is a greater concern, then it could be approves according to guidelines. If the harmful radiation exposure is using OSHA levels for occupational hazards, brief exposures for medical purposes might provide an exception to that guideline making it not applicable to the specific evaluation criteria for the devices. That type of determination is not up to these five scientific researchers, it is up to the advisory boards and the FDA ultimately.

Re:This is understandable (1)

Rich0 (548339) | more than 2 years ago | (#40668457)

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.

Suppose a scientist thinks that vaccines are dangerous to public safety. Should they be allowed to block approval of any new vaccine, and use government power to harm vaccine manufacturers and get current vaccines off the market? How many people would that harm?

The fact that they are a scientist doesn't make them infallible. Sure, they should raise concerns when they have them, and as a society we should establish regulatory agencies that are responsive to these concerns. However, in the end individual scientists aren't appointed dictators - they are just government employees. Whether they have a moral duty or not does not give them the authority to go on a crusade. Society could not function if anybody who felt they had a moral duty to do something were free to pursue that duty without interference. What happens when your neighbor feels you are imprisoning your poor pets and likely to repeat offend so they feel that killing you in your sleep is the best solution, for the greater good?

Re:This is understandable (1)

demachina (71715) | more than 2 years ago | (#40656829)

Seriously dude, stop spewing this crap about "Garcetti v. Ceballos" all over this thread. It totally doesn't apply to this issue. That was a free speech issue where a DA complained to a supervisor about a warrant, the supervisor overruled him, DA claimed he was passed over for a promition because of it.

The issue here is Federal managers trying to interfer with employees whiste blowing to Congress which is quite explicitly prohibited by Federal law, has been since at least 1912, some of the protections date back to the Civil war.

Re:This is understandable (1)

sumdumass (711423) | more than 2 years ago | (#40657713)

lol.. Does it show that not all whistle blowing is protected? That was my claim, not that it was identical to this situation.

And no, whistle blowing to congress has only been explicitly illegal since the mid 1990's (1994 I think) when congress amended the 1989 whistle blower protection act with the one of the purposes of making that explicit. Previously, whistle blowing to congress was only protected when concerning certain specific matters. But the people involved did not just tell congress now did they? No, they told news outlets and even disclosed trade secretes which is explicitly excluded from whistle blower protections.

Re:This is understandable (1)

Anonymous Coward | more than 2 years ago | (#40657489)

I modded you up, even though you're completely wrong. This is worth reading carefully, because you make mistakes that get to the heart of the matter.

A scientist gets hired to do his job as a professional. If you're an employer, that's what you're hiring.

There is something special about a scientist. Their customary rules are a commitment to truth and disclosure.

When you're a professional, like a scientist, your first responsibility isn't to your boss, it's to your professional obligations. Doctors and nurses lose their professional licenses because they followed orders that they knew would harm their patients. They also refuse orders.

I've talked to government employees (and doctors) who worked on public safety. A lot of them had the attitude, "My first responsibility is to protect lives. Fuck my career, fuck the law."

Generally, the law backs them up. But even if it doesn't, that's not the point.

In this case, they're FDA employees, so they've got a better case. Their mandate is to protect the public. Their first responsibility is to the public, not to some device manufacturers' stockholders.

Re:This is understandable (1)

sumdumass (711423) | more than 2 years ago | (#40657933)

I'm sorry but this just isn't true and isn't relative to the situation being discussed. I know many of scientists who have restrictions on them due to work place rules. Some of these restrictions is about disclosing information only to certain people, some are about using data only from certain sources, some are about reviewing and or evaluating specific parts of something and they are expected to ignore the others. They do not like these restrictions, but they take the work and get compensated for it.

When you are a professional seeking employment, your first responsibility is to do your job the way it was described when you agreed to employment. If during that time, you find something wrong happening or something illegal, perhaps dangerous to the public or even workplace safety, you have a duty to report it to the proper authorities. You do not have a right to disclose confidential documents or trade secretes or anything outside of the extent of reporting the claimed offenses to the proper authorities.

If you get fired for using data from some university study that has not been validated against the testing protocols or for disclosing trade secrets when you run to the press and describe enough information about a device or process that enables a competitor to reverse engineer it, claiming "but I'm a scientist" will do squat for you in trying to get your job back or seek compensation for being terminated. Disclosing trade secrets by the way (as well as several other things) is explicitly exempted from federal whistle blower protections.

Now this is outside of the current situation with the FDA, but if you must insist on viewing the concept through the eyes of the situation, then we know that the scientists involved complained to several congress members (who unassumingly had power to do something or at minimum pressure those who did) and even President Obama himself who by nature of his office as the head of the executive, explicitly has the ability to do something, and nothing was done. Is that because congress as well as the President of the United States do not care about public safety? Or is it because something was being done, just not broadcasts to the people complaining? Could it be that the concerns of the involved scientists were exaggerated or misleading? Or could it be that they wanted to wait until the election so they could claim they were doing something important and get reelected?

Re:This is understandable (1)

Rich0 (548339) | more than 2 years ago | (#40668407)

There is a problem with risk - if you release a drug people die who wouldn't otherwise, and if you don't release a drug people die who wouldn't otherwise.

The FDA as an institution has to create policies around what kinds of risks are appropriate and what kinds are not. That is a matter of public policy, not personal conscience.

Now, a scientist can evaluate data and say whether it supports the drug being an appropriate risk or not (or is inconclusive), as long as those policies are all well-defined. That doesn't mean that random scientists should be given a veto over the approval of individual drugs, or any reason of personal conscience. That isn't their decision to make - they aren't setting policy, they are informing policymakers and determining how particular decisions should be made in light of these policies.

I would say that stuff like this needs to be kept in the open as much as possible. However, if you give somebody the role of a quality inspector and let them operate however they want, then generally from a personal self-interest standpoint their optimum strategy is to never approve anything, and clearly that doesn't serve the interest. Decisions to not approve something tend not to be questioned as closely as decisions to approve something that later turns out to be dangerous. That is why it can't be up to individuals.

Re:This is understandable (1)

randyleepublic (1286320) | more than 2 years ago | (#40669287)

>> What's the point of hiring scientists if you don't want them to do science properly?

To give the appearance of doing proper science. Duh!

Re:This is understandable (1)

bughunter (10093) | more than 2 years ago | (#40654277)

Wish I had mod points for you today. (+1, Informative)

Re:This is understandable (3, Insightful)

Schmorgluck (1293264) | more than 2 years ago | (#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.

Re:This is understandable (2)

tomhath (637240) | more than 2 years ago | (#40655189)

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.

The actual story (1)

Anonymous Coward | more than 2 years ago | (#40658725)

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?

Re:The actual story (1)

rtfa-troll (1340807) | more than 2 years ago | (#40659199)

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.

thanks for declaring up front.

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.

You talk as if there were only two possibilities; "yes" or "no". That's extremely scary and seems to me to show that there is something horribly wrong in the FDA. There is also a third option: "data is currently insufficient to make a clea tr decision". If the input was conflicting, then the team leads responsibility is to identify the reasons behind the conflict, decide what further study would be needed to make a decision and make a temporary rejection with information about what further research needs to be done.

When those decisions did not go in favor of the individuals in question, they complained loudly.

Again, you are scaring me. These are not personal favours. This is not about something going for or against the scientists. They believed that these systems were endangering and possibly killing people. If they believed that then their duty to push their belief forward. The FDA should have a system which accepts or even encourages that. As long as the scientists work within their professional duty it should be no problem at all if they believe and act on something, even if it is actually wrong. If that isn't true then the FDA is a danger to patients.

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.

Let's give a car analogy. Imagine you park your car and leave it to work for the day. I come along to it and put a sticker on it saying "this is rtfa-troll's car and will be removed soon". Does that then make it okay when I subsequently break into it and steal it? No. Illegal activity is lawbreaking, whether you announce it in advance ro not.

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?

You've completely missed the point. Just monitoring is not the problem. The problem is what you do when you realise that you have no legal right to the information you have been monitoring? That is the point that they realised they were monitoring privilaged communications with members of congress or attourneys? They should have done several things: a) immediately destroy the information b) desist from further monitoring until their systems are updated c) ensure that in future similar information will not be captured d) inform those people who were illegally monitored at the first possible opportunity and give an apology and appropriate compensation. If you continue to monitor, gather, classify and use those communictions after realising what they are, then you switch from having made an understandable mistake to deliberate and wilful criminality.

If the FDA, the organisation responsible for approving medicines and medical equipment in the USA and a lead organisation in this area for the entire world, is a criminal organisation then that is a deep concern.

Re:The actual story (0)

Anonymous Coward | more than 2 years ago | (#40661755)

You talk as if there were only two possibilities; "yes" or "no". That's extremely scary and seems to me to show that there is something horribly wrong in the FDA. There is also a third option: "data is currently insufficient to make a clea tr decision". If the input was conflicting, then the team leads responsibility is to identify the reasons behind the conflict, decide what further study would be needed to make a decision and make a temporary rejection with information about what further research needs to be done.

Yes, there are only two possibilities, and no, it's not scary. "Data insufficient to make clear decision" is the same as no, the product is not approved. If some people say there is enough data to make a decision and anothers says there is not, someone has to make a decision. And no, making everybody happy with every decision is not possible, not even at the FDA. If you think it is, you're living in a fantasy world. If everyone had to happy with every decision, no decisions would ever be made.

Again, you are scaring me. These are not personal favours. This is not about something going for or against the scientists. They believed that these systems were endangering and possibly killing people. If they believed that then their duty to push their belief forward. The FDA should have a system which accepts or even encourages that. As long as the scientists work within their professional duty it should be no problem at all if they believe and act on something, even if it is actually wrong. If that isn't true then the FDA is a danger to patients.

Apparently the real world is a big frightening place for you. As you point out scientists are often wrong, including me. If everything came to a standstill everytime a scientist was wrong, nothing would get done.

Let's give a car analogy. Imagine you park your car and leave it to work for the day. I come along to it and put a sticker on it saying "this is rtfa-troll's car and will be removed soon". Does that then make it okay when I subsequently break into it and steal it? No. Illegal activity is lawbreaking, whether you announce it in advance ro not.

Let's give a car analogy. Image you park your car in front of a sign that says, "If you park your car here, it will be towed." Then you are _shocked_ when you come back three hours later and your car has been towed.

You've completely missed the point. Just monitoring is not the problem. The problem is what you do when you realise that you have no legal right to the information you have been monitoring? ... If you continue to monitor, gather, classify and use those communictions after realising what they are, then you switch from having made an understandable mistake to deliberate and wilful criminality.

No, you missed the point. The federal government monitors EVERYTHING that happens on their computers and networks. EVERYTHING. They tell you that up front. If you do not consent to have EVERYTHING that you do monitored, don't use their computers or networks.

Re:This is understandable (1)

hey! (33014) | more than 2 years ago | (#40655547)

Like any other virtue, obedience to proper authority can be taken to such an extreme it becomes a vice. A democracy can't exist for long without a certain modicum of civil disobedience. It is only dictatorships that demand *absolute* obedience, even against the demands of reason.

If a law enforcement agency participates in a cover-up, the workers in that agency should disobey their superiors.

If a medical device regulatory agency has policies that a reasonable person would consider egregious, the workers in that agency should blow the whistle.

We could reasonably look at a whistleblower's claims, decide they are baseless, then fire or prosecute him. But we can't reasonably take that stance *before* we've examined the claims, based on some kind of duty obedience to the bureaucratic hierarchy. There *is* such a duty, but there is also a duty to the public. The public is paying the whistleblower's salary, and that of his superiors.

Re:This is understandable (1)

jellie (949898) | more than 2 years ago | (#40655771)

The irony is that the FDA, through the investigation of its own scientists, released companies' trade secrets. An FDA contractor had compiled a report, and one of the fired scientists came across it by doing a search online.

Also, spying on members of Congress and making an "enemies" list of them is certainly a great way to piss off some powerful people...

Re:This is understandable (3, Insightful)

Runaway1956 (1322357) | more than 2 years ago | (#40653857)

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.

Re:This is understandable (1)

Runaway1956 (1322357) | more than 2 years ago | (#40653879)

Oh - did I mention that pesticide, marketed by Bayer, which is very strongly suspected to be responsible for the honey bees dying off? That's one of the best examples of the FDA failing to do QA on a product brought before them. No scientist outside of Bayer and/or it's contractors ever did any research on the pesticide. And, the very limited research done by Bayer was so flawed, a junior high school student who can properly define what "science" is, could have spotted the flaws!

Re:This is understandable (2)

kestasjk (933987) | more than 2 years ago | (#40653913)

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?

Re:This is understandable (2, Interesting)

Runaway1956 (1322357) | more than 2 years ago | (#40653973)

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.

Re:This is understandable (0)

Anonymous Coward | more than 2 years ago | (#40662547)

What's wrong with a little hyperbole?

What's wrong with a little hyperbole? I'll tell you. Hyperbole is the worst thing ever to have happened!

Re:This is understandable (1)

hoboroadie (1726896) | more than 2 years ago | (#40655341)

General decline of melliferous bees /= Colony Collapse Disorder.
Perhaps you should not disregard every fact associated with hyperbolae?

Re:This is understandable (0)

Anonymous Coward | more than 2 years ago | (#40654553)

Oh - did I mention that pesticide, marketed by Bayer, which is very strongly suspected to be responsible for the honey bees dying off? That's one of the best examples of the FDA failing to do QA on a product brought before them. No scientist outside of Bayer and/or it's contractors ever did any research on the pesticide. And, the very limited research done by Bayer was so flawed, a junior high school student who can properly define what "science" is, could have spotted the flaws!

The FDA doesn't approve pesticides. The EPA does.

That's because it's the EPAs job (3, Informative)

sirwired (27582) | more than 2 years ago | (#40654565)

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.

Re:This is understandable (1)

sjames (1099) | more than 2 years ago | (#40653989)

I can't agree more. I believe we DO need a regulatory agency focused on the safety and efficacy of drugs, but that is not the FDA. They have no business trying to get very old and well understood drugs out of grandfather status. They are already proven safe and effective by decades (or centuries) of practical data.. They SHOULD be avoiding granting exclusivity to reformulations that fail to demonstrate any significant benefit over an existing formulation.

They could stand to learn how risk assessment and management work as well. Currently, they, in cooperation with the DEA are actively increasing the risks and costs to legitimate patients in order to "prevent" prescription drug abuse. Of course, rather than actually preventing abuse, they are just increasing the risk of liver damage or driving users to more dangerous street drugs.

Re:This is understandable (2, Insightful)

Anonymous Coward | more than 2 years ago | (#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.

Re:This is understandable (1)

ColdWetDog (752185) | more than 2 years ago | (#40655767)

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.

While others are calling for increased scrutiny because a number of recent drugs that have gone through 'fast track' have turned out not to be so useful or safe. It's a very, very difficult question and while the FDA often doesn't do a good job of it, I'm not sure that any extant or mythical regulator will. It depends critically on how 'safe' something is. Nothing is perfectly safe, no action, no drug, no treatment. There is a huge body of literature devoted to reasonable levels of safety and basically, it's arbitrary and any one level is guaranteed not to please everyone.

Personally, I think that the FDA has caved to the manufacturers and Big Pharma. If you have a revolutionary new treatment that expands opportunities and actually prolongs or improves life to a significant extent, you can afford some side effects or problems. If it's just another 'me too' drug or treatment or one that cures a disease 30 minutes faster than the old one, not so much.

And the case of Quinine is interesting. The FDA never banned Quinine. They just asked that studies be done on what amounts to a significant off label use (leg cramps). That was done because of quite a bit of (bad) data indicating possible health problems [webmd.com] with the drug and unclear benefits. Nobody took them up on it. You can still buy branded Quinine for $3.00+ dollars a pill and use it for malaria treatment. You just can't get the generics.

I'm not up on the exact level of data the FDA used, but it appears they made a reasonable (not necessarily correct) decision. Like every other Federal regulatory agency, the FDA is heavily politicized. It isn't supposed to be, but that's reality. Politics and Science make strange bedfellows. Add the Law and you have a menage-a-trios that would made the Marquis de Sade happy.

Re:This is understandable (1)

Rich0 (548339) | more than 2 years ago | (#40668489)

I'm not sure we should be so hard on me-too drugs. People like to bash them, but nobody is forced to buy them, and they're good because they create competition in the market which lowers prices and gives doctors alternatives. Many doctors start with the drug that has the best clinical data, but are forced to switch to some other drug because a patient doesn't tolerate the first-line drug - clinical data is all about averages, and the average person isn't really very average. Without me-too drugs doctors would be forced to make all-or-nothing decisions, and patients are unlikely to continue on some of these therapies.

I think the fundamental issue is that drug safety isn't that easy to measure - especially as the bar has gotten raised higher. We also have so many trials out there it is hard to recruit patients into them. I think there are many reforms that could help, but ultimately you can never expect a trial of 10,000 people to spot all the issues that will arise when millions of people take a drug. Even with millions of people you can't always be sure the issues triggering recalls are real.

As has been pointed out - people die whether you approve or reject a drug, so there needs to be a risk-based balance. Simply slowing down drug approvals results in death sentences for anybody who could have been treated but wasn't due to delay. I'm all for reform, but that can't be translated into simple risk-aversion...

Re:This is understandable (0)

Anonymous Coward | more than 2 years ago | (#40655559)

That's not a function of the system; that's a function of statistics. You're not going to see most serious side effects show up in studies of less than 10,000-20,000.

What the FDA HAS dropped the ball on is its third-party inspections of manufacturers and food processors overseas. In a lot of countries where generics are produced, most notably India and China, corruption is the norm in business -- and the FDA does nothing relevant to address it. It's why one-third of all malaria drugs worldwide are fake. We haven't seen the shit hit the fan in the U.S. with it, but it'll happen eventually. (IIRC, they developed this regulation in response to the 2008 melamine crisis.)

FWIW, this is why I buy name brand drugs. The FDA's useless, and extra money I spend is money spent locking down supply chains.

Re:This is understandable (1)

ColdWetDog (752185) | more than 2 years ago | (#40655783)

FWIW, this is why I buy name brand drugs. The FDA's useless, and extra money I spend is money spent locking down supply chains.

Guess where they make most 'brand named drugs'.

The same factories that make the generics with the same feedstocks.

Oopsie. Good thing that the human body is pretty robust.

Re:This is understandable (1)

ChromeAeonium (1026952) | more than 2 years ago | (#40656103)

It seems that almost every year, some "approved" medical treatment is recalled.

Out of how many that are not? And what alternative would you like, testing them so thoroughly people call them a failed institution for never allowing anything through (which I've heard people say)? You are dealing with substances that are biologically active in humans and given to thousands of people, and you expect the law of large numbers to never crop up? Medical science is not perfect, and nothing the FDA does is going to make it so. It sounds a bit callous to say that, but it is the truth.

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.

And why should they get a free pass, if they're going to be sold as medicine? And it isn't like they did it at random (23 people died [archive.org] it seems...hey, weren't you just complaining about drugs that hurt people?)

How 'bout all that food on the market, full of growth hormones, antibiotics, pink slime, and genetically engineered crap?

Antibiotics I'll give you. The other three just creep you out. FDA shouldn't be there to 'protect' you from fears and creepiness.

Re:This is understandable (1)

bill_mcgonigle (4333) | more than 2 years ago | (#40656677)

You and I mean less than nothing to them. That's NOT how it was supposed to be.

Force everybody to pay for a monopoly and then expect good results. Somehow this pattern never works but keeps repeating.

Re:This is understandable (1)

Rich0 (548339) | more than 2 years ago | (#40668357)

The issue is whether they can breach confidentiality agreements.

Suppose an FDA scientist knows that next week the FDA is likely to recommend that some drug be approved. They tell their friend the stock broker and they buy a few million shares of stock in the company at issue. Then a week later they make a fortune when the price rises. No doubt the friend takes good care of them in return.

This isn't about keeping science secret - this is about trade secrets and insider information. We WANT companies to share info with the FDA so that they can make a well-informed decision. When there are leaks it encourages companies to hide info from the FDA which actually interferes with their ability to look after public safety.

I certainly agree that info that has a bearing on public safety should be disclosed. However, things like manufacturing processes or info on how drugs are labeled to prevent counterfeiting, or other info that has no bearing on the safety of the drug itself should not be made public except as provided by law.

That said, I'm not a big fan of witch hunts either. There needs to be a balance. We need scientists who can evaluate scientific evidence, but that doesn't mean they're working free of constraints.

Re:This is understandable (0)

Anonymous Coward | more than 2 years ago | (#40653683)

The title isn't misleading. Installing trojans and keyloggers is surveillance, aka spying. TFA also suggests that this is done for the purpose of intimidating whistleblowers.

Re:This is understandable (0)

Anonymous Coward | more than 2 years ago | (#40655925)

Indeed. Leaking people tend to go insane.

FTC (1)

phantomfive (622387) | more than 2 years ago | (#40653671)

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.

Re:FTC (1)

phantomfive (622387) | more than 2 years ago | (#40653677)

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.

Re:FTC (0)

AssOfDeliciosoness (2682321) | more than 2 years ago | (#40653763)

Can I lick your snap?

Re:FTC (3, Interesting)

jma05 (897351) | more than 2 years ago | (#40653843)

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.

Re:FTC (4, Informative)

jma05 (897351) | more than 2 years ago | (#40653817)

> 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."

Re:FTC (2)

thsths (31372) | more than 2 years ago | (#40653985)

> "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...

Re:FTC (1)

Grygus (1143095) | more than 2 years ago | (#40656077)

I suspect that you misread that; the IG declined to investigate the leak, which was (ostensibly) made in the public interest. This is how the good guys would act. The FDA is out of line, but the system as a whole seems healthy in this case.

Re:FTC (0)

Anonymous Coward | more than 2 years ago | (#40654605)

Your argument might carry more weight if you knew the difference between FCC and FTC.

Trojans? (1)

detritus. (46421) | more than 2 years ago | (#40653687)

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.

Re:Trojans? (0)

Anonymous Coward | more than 2 years ago | (#40653945)

The article mentions no trojans. Why would they need trojans when they can roll out patches to their user' workstations?

I'm assuming they're to infect the old laptop-that-goes-onto-my-home-network..

That said, I'm really curious as to what software they used,

I'm curious too, and would like to know which agency supplied them with said software, as it would have a bearing on the answer to the next question you asked

and why (if any) virus scanners didn't pick this up.

Call me a cynic, I postulate a mechanism whereby AV software peddlers are told by Government that they must write in a 'if software contains a government ID tag as supplied by us, it ain't a virus, it *is* a false positive, your software *will* ignore its presence, otherwise your business *will* suffer.

Pet conspiracy theory asides, why didn't whatever AV scanners that are installed pick this stuff up?, from experience (based on the last batch of viruses and Trojans I harvested from the p2p networks around 5 months ago) it took just over a month after harvesting for all the major AV players to correctly detect one of my samples as a rather nasty trojan.
I regularly get laptops to have a look at (both domestic and corporate), usually with fully up to date (and legal) versions of the top selling AV software packages, in most cases where the user/owner has identified that 'something funny was going on', I've found Trojans.

The most worrying case I've had was a machine which spends over half its working time on a large (one of the Forbes Global2000 top 40) corporate network. When back at the home location it connects back to the corporate network via a VPN over the usual ISP connection, and at this point it was also attempting to send large encrypted blocks of data back to one of several 'unallocated' IP numbers at a 'technical institute' in China. Normal behaviour for a Trojan, the really worrying part was the contingency provisions for blackmail that the writers had included, without going into details, the implied threat of exposure even if you could *eventually* prove your complete innocence would be a career killer.

Re:Trojans? (3, Informative)

sumdumass (711423) | more than 2 years ago | (#40654017)

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.

Re:Trojans? (1)

tiznom (1602661) | more than 2 years ago | (#40654289)

The article mentions the spying software on the third page. Curiously, working out the math for the individual vs bulk prices reveals that math is still hard for most people. 1 machine = $99.95 25 machines? No, not 2498.75 silly. 25 machines = $2875. Anyone else find this odd?

Re:Trojans? (0)

Anonymous Coward | more than 2 years ago | (#40654507)

The tax, my good sir, the tax.

On the one hand (-1)

Anonymous Coward | more than 2 years ago | (#40653711)

While at work, you are consuming your employer's time, equipment and other resources, so you have very little right to privacy.

On the other hand, managers copy the dishonesty of their boss. When the US president advocates spying without judicial process, all his underlings will do the same.

Re:On the one hand (3, Interesting)

Anonymous Coward | more than 2 years ago | (#40653775)

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.

Re:On the one hand (0)

Anonymous Coward | more than 2 years ago | (#40653809)

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

Re:On the one hand (5, Informative)

Anonymous Coward | more than 2 years ago | (#40653871)

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?

Re:On the one hand (2)

BlueStrat (756137) | more than 2 years ago | (#40654247)

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
---

Strat

Re:On the one hand (2)

bughunter (10093) | more than 2 years ago | (#40654309)

Um. There's a difference between Federal Law and "chain of command."

Come on. The FDA bureaucrats blew it. RTFA.

Re:On the one hand (0)

Anonymous Coward | more than 2 years ago | (#40656989)

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.

SPYING ?? THAT"S NOT A SOLUTION !! (-1)

Anonymous Coward | more than 2 years ago | (#40653749)

Firing is !! Toss them all !! Hire anew !! Preferably H1Bs !! Trust me !! What's good for China is good for the FDA !! And Amerika !!

it's no longer an public agency (5, Insightful)

smoothnorman (1670542) | more than 2 years ago | (#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.

Well it works in the patent office (1)

Anonymous Coward | more than 2 years ago | (#40653875)

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.

Re:Well it works in the patent office (1)

only_human (761334) | more than 2 years ago | (#40654321)

+1 Posting here to delete my mod down. An irony detector finally pinged.

"protecting important secrets" (4, Interesting)

harvey the nerd (582806) | more than 2 years ago | (#40653859)

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.

Don't expect privacy if you work for the Fed. (5, Informative)

PerlPunk (548551) | more than 2 years ago | (#40654157)

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.

Re:Don't expect privacy if you work for the Fed. (4, Informative)

Anonymous Coward | more than 2 years ago | (#40654333)

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. ...'

Re:Don't expect privacy if you work for the Fed. (0)

Anonymous Coward | more than 2 years ago | (#40656411)

Hooray for the Most Transparent Administration Ever(tm)!

Re:Don't expect privacy if you work for the Fed. (1)

Anonymous Coward | more than 2 years ago | (#40654439)

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

The people who value reputation and success above the lives of regular people only reaped what they sowed. All i see are the people with morals doing what they can to help the public and those without morals trying to instill fear.

Re:Don't expect privacy if you work for the Fed. (1)

Grygus (1143095) | more than 2 years ago | (#40656121)

I have also worked for the federal government, and I do see the problem here; the scientists in question used the chain of command properly, and that chain failed to act appropriately. There is no law or moral code that requires them to submit to incompetence or corruption, and shame on anyone who would have them do so.

ARPANET (0)

Anonymous Coward | more than 2 years ago | (#40654273)

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.

As somebody who has to work under FDA oversight (3, Interesting)

Anonymous Coward | more than 2 years ago | (#40654709)

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 [mgdservices.com]

And from 2004 to 2011
http://marginalrevolution.com/wp-content/uploads/2012/06/FDA-letters1.png [marginalrevolution.com]

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.

Re:As somebody who has to work under FDA oversight (1)

randyleepublic (1286320) | more than 2 years ago | (#40669343)

So, in this one area, we are not as corrupt as the governments of Europe. Whoopy! How exciting to hear that. Doesn't mean that there isn't any corruption, BTW.

moral of the story (0)

Anonymous Coward | more than 2 years ago | (#40654955)

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 "big brother" type stalking in US. (0)

Anonymous Coward | more than 2 years ago | (#40655053)

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 :)

Re:How common is "big brother" type stalking in US (0)

Anonymous Coward | more than 2 years ago | (#40662765)

Data is available but rarely used at my company. Requires special request for logs.

Who owns the data? (1)

nurb432 (527695) | more than 2 years ago | (#40655775)

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.

Re:Who owns the data? (1)

Grygus (1143095) | more than 2 years ago | (#40656139)

Yes, because when public safety is the issue, what's important is ownership of the data. It's hard to believe that all these people can't see what's really on the line here: profits. Get some perspective, you capitalism-haters!

Pedantic.. (1)

bigattichouse (527527) | more than 2 years ago | (#40656379)

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.

On Par for Obama (0)

Anonymous Coward | more than 2 years ago | (#40659187)

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

FDA whistleblower's attorney (0)

Anonymous Coward | more than 2 years ago | (#40674049)

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

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