The FDA Spied On Its Own Scientists 95
retroworks writes "The New York Times has an interesting article about efforts by the Food and Drug Administration to locate a source of 'leaks' within the agency. The search became a slippery slope involving trojans, keyloggers, screenshot captures, and an investigation that eventually became an allegory for management overkill. The article describes how the investigation of one employee expanded to five, and how the investigation of five led to other staff (including the interception of correspondence to President Obama). The Agency struggled with the gray area between protecting trade secrets of drug companies (which had applied for FDA approval) and censoring researchers with legitimate questions about the Agency's approval process."
This is understandable (Score:1, Flamebait)
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
Re:This is understandable (Score:5, Insightful)
Don't employ scientists then. Just employ more bureaucrats.
Science needs to be open and dissent needs to be encouraged. If you want to lock it up in secrecy, then call it something else. It would not be science, and the researchers would not be scientists.
For the FDA, where public safety should be a priority, you would want to have the process be as open as possible. If you feel there is a need to spy on your scientists in order to prevent leaks then it is obvious that public safety is not particularly high on the agenda.
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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 diff
Re:This is understandable (Score:5, Insightful)
Routing out whisteblowers isn't quality control. And science does just fine without bureaucrats performing quality control. Reproducibility, falsifiability, and peer review (which means an independent review--not your boss) do that better than bureaucrats ever could.
And just in case you are wondering why this is important, RTFA. The scientists felt that the FDA approved medical imaging devices that allowed patients to be exposed to dangerous levels of radiation. The FDA was worried that trade secrets were being released, so they decided to hunt down the whistleblowers. Quality control, right?
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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.
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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.
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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. G
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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
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This article has a sub-issue of 'who is watching the watchers' to it.
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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 (Score:5, Informative)
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 (Score:5, Informative)
"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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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 (Score:5, Insightful)
It doesn't matter if congress or the white house got mad. They are not the boss, they are the boss's boss.
Not when your actions are protected by legislation. Then you have no obligation to follow instructions from your boss to the contrary.
If someone takes a job as a scientific researcher for the government they are definitely entitled to follow proper scientific processes. They are putting their name and professional reputation to their work. I'm not a scientist but I have worked in quality control and been pressured to sign off product that did not meet specification. Now I work as a tradesman and I've been pressured to do work that doesn't meet relevant standards. The answer is both cases was no. How could it be otherwise? What's the point of hiring scientists if you don't want them to do science properly?
Read again: A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists' medical claims were valid enough to warrant a full investigation into what it termed "a substantial and specific danger to public safety."
Their job as scientists was to identify that danger to public safety. When the boss didn't want to listen they went to the "boss's boss" and to the public (the boss's boss's boss) via the media, action that is legally protected for this very reason. They were doing their job.
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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.
Only to the extent their job duties and dep
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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 env
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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 dat
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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
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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 sc
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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? N
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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
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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
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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 d
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To give the appearance of doing proper science. Duh!
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Wish I had mod points for you today. (+1, Informative)
Re:This is understandable (Score:4, Insightful)
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.
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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
The actual story (Score:1)
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,
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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 ab
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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 t
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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 (Score:4, Insightful)
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.
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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!
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Perhaps we should take a more serious look at the contents of the article with a bit less hyperbole?
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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 col
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General decline of melliferous bees /= Colony Collapse Disorder.
Perhaps you should not disregard every fact associated with hyperbolae?
That's because it's the EPAs job (Score:4, Informative)
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.
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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 man
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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.
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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.
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,
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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
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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.
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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
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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.
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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 s
FTC (Score:2)
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.
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Re:FTC (Score:4, Interesting)
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 (Score:5, Informative)
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."
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> "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...
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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.
Trojans? (Score:1)
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? (Score:4, Informative)
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.
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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 highl
Re:On the one hand (Score:5, Informative)
Theres is also a chain of command to be respected, john douche going to the new york post over a finding without informing anyone is also wrong
there is 2 sides to this coin, your only looking at the shiny one
How do you think the FDA knew who to monitor? The scientists used the chain of command and were told to STFU. Then they leaked the information and contacted Congress. A special investigation determined that their concerns were valid and that an investigation would be needed due to "a substantial and specific danger to public safety".
Four of the scientists were fired. See, that is what the chain of command does. It makes it easy to put together a complainers list.
The end result: four scientists had to lose their jobs in order to protect the public from faulty medical imaging devices. Would you prefer that nobody leaked anything and that the faulty medical imaging devices were released to hospitals?
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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
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Um. There's a difference between Federal Law and "chain of command."
Come on. The FDA bureaucrats blew it. RTFA.
it's no longer an public agency (Score:5, Insightful)
Well it works in the patent office (Score:1)
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
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Yeah, the Office of Strategic Services was replaced with the Central Intelligence Agency over a period of a couple of years.
https://en.wikipedia.org/wiki/Office_of_Strategic_Services#Dissolution_into_other_agencies [wikipedia.org]
"protecting important secrets" (Score:5, Interesting)
Don't expect privacy if you work for the Fed. (Score:5, Informative)
Re:Don't expect privacy if you work for the Fed. (Score:4, Informative)
Sorry, as someone who has worked for the fed and has held a security clearance, I don't sympathize with the journalist who wrote the WP article. If you work for the federal govt, then you have absolutely no expectation of privacy for communications sent using federal equipmentt. It's in the U.S. laws, and HR in all the places I worked where the fed was involved made sure you knew that. And yes, there is a legitimate public interest for the government to find out who is leaking confidential information. Lives, reputations, and public confidence is often at stake in these matters.
'... Lives, reputations, and public confidence is often at stake in these matters.'
FTA
'...
The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.
A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed “a substantial and specific danger to public safety.” ...
F.D.A. officials went to the inspector general at the Department of Health and Human Services to seek a criminal investigation into the possible leak, but they were turned down. The inspector general found that there was no evidence of a crime, noting that “matters of public safety” can legally be released to the news media.
Undeterred, agency officials began the electronic monitoring operation on their own. ...'
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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.
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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.
As somebody who has to work under FDA oversight (Score:3, Interesting)
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: (Score:1)
Who owns the data? (Score:2)
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.
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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.. (Score:2)
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.