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article imageOp-Ed: FDA monitors ‘enemies list’ of scientists, Congress, media

By Paul Wallis     Jul 14, 2012 in Crime
Washington - When you see conservatives howling about regulation, it sounds stupid and delusive. When you see anti-big government rants online, so what? Now uber-regulator FDA has exposed a paranoid culture monitoring its "enemies". Thanks, guys, you're a big help.
The New York Times:
A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.
…Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.
While Federal authorities do have the legal right to monitor communications, both for national security reasons and as a routine part of internal security, the message sent by 80,000 pages of documentation is quite different. The “targeting system” effectively set up monitoring of a range of people whose jobs it is to deal with regulatory issues. Whether the scientists were right or wrong in their complaints and assessments is irrelevant. The point is that the FDA was apparently compiling a list of enemies.
When leaks aren’t leaks
Apparently the idea was to protect “trade secrets”, at least for the purpose of justifying the surveillance. Not a great defence, even in theory. “Trade secrets” have a very short shelf life when products go on the market.
“Proprietary/confidential” materials, for the record, are subject to dispute on exactly whose property they are and what sort of confidence is involved, so that theory doesn’t fly too well or too far. If it was business confidence in relation to a device for public use, any journalist could simply ask an expert for an opinion, and under Fair Use rules, that information is not confidential, even in theory.
The law isn’t too sympathetic, either. Apparently the FDA tried to get approval to investigate a “leak” of a GE device by FDA employees, and was told that
…“matters of public safety” can legally be released to the news media.
Paranoia, the reality health show that’s killing Americans
Mental health is definitely one of the subjects that makes this topic such compelling reading. An interesting, if nauseating, sidelight to the surveillance is the mindset and sales copy of the providers of the surveillance software, a company called SpectorSoft, which tells its wide-eyed prospective customers they can “Catch them red-handed….” What a well-adjusted security firm.
Paranoia is perhaps the best working description of the general situation. The FDA has quite rightly been in the firing line for years over its approvals process in relation to unsafe products being released on to the market. The list of FDA recalls is gigantic, and evidence enough of a regulator that can’t do its job well, if at all. If the procedures work, why the recalls? “Because someone didn’t tell us” loses its novelty after a few decades, guys.
However, you can see why the agency might be a little sensitive/hyper-reactive to the possibilities of yet more documentation of its blundering through its own role as a regulator. Those years of selfless indifference to the apocalyptic failure of the US health system to do anything right could have been at risk if someone pointed out yet another flaw in the FDA’s Nutcase Nirvana. Millions of Americans are affected by the health systems various insanities every year, many fatally and some not so lucky, and like all good musical comedies, the FDA obviously considers The Show Must Go On.
That this procedure was atypical of normal security provisions is pretty obvious. Why target scientists’ communications, in the first place? The agency used key loggers and similar technology, capturing emails, screen shots and content of private correspondence.
The New York Times continues:
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.
If you’re getting an impression of bureaucratic self-interest at work, you’re right. This is a quite familiar pattern of retaliation and “meeting room stir-crazy” behaviour which is regularly seen in other government agencies around the world.
You’ll note that the public interest is apparently not one of the reasons for the FDA’s behaviour as it’s been documented by the NYT. A dispute about things as fundamental as safety and basic review procedures leads to creation of an “enemies list” from the infantile brains at the top of the bureaucratic dunghill.
This affair came to light as a result of a particularly ironic form of justice- The documents were posted on a website by an FDA contractor, apparently accidentally. Nice to see the public/private partnerships working so well.
The NYT documents a memo accusing someone of sending “proprietary documents” to one of its own correspondents regarding colonography reports alleging FDA mismanagement. Elsewhere three people are named as “point men” (nothing like a bit of melodrama in regulation) responsible for filtering materials going to the media.
The FDA is apparently incapable of dealing with professional experts in its own area of regulation on a sane basis:
1. Why did the scientists, regulatory review officers and medical officers have to resort to external sources to deal with internal FDA business operations?
2. Whistle blowing is an extreme action. Despite endless babble that whistleblowers should blow their whistles, they suffer severely from their employers, particularly bureaucratic administrations for doing so. Protection is almost non-existent, in fact. So why did these people feel forced to behave as they did?
Whistle blowing as a blood sport
The most likely answer is desperation. If you’ve never worked in a bureaucratic organization, the situation is that you’re working with a collection of totally self-interested,time-serving, expert de-motivators whose main function is nitpicking and getting paid six figures at least for doing that. They behave the same way whether they’re running a government agency or a hot dog stand- In their own interests. Under the Bush administration, one agency was literally spending hundreds of thousands on their senior executives. It was an all-term party. Whistle blowers weren’t popular at that agency, either, although the administrators were apparently too far gone to do much about it.
Various scientists were fired in the course of the surveillance program, although associations were apparently not directly made between the surveillance and the firings. The scientists are now suing the agency.
Congress members have been less than thrilled, or pleased, to discover that they and their staff are also on the FDA’s list. Democrat and Republican members of Congress have their own files under the surveillance programs, as do media and other people.
What was originally a whistle blowing exercise is now a full size brass band. The FDA surveillance program has backfired 100%. The FDA’s megalomaniacal approach to criticism and refusal to acknowledge expert critiques from the very people appointed to carry out those critiques, is damning. Nor is there any indication of who approved the surveillance program in the FDA, another bureaucratic cover up mechanism well-documented around the world as an indicator of an agency knowing full well it wasn’t supposed to be doing anything of the sort.
The betrayal of the idea of regulation and public trust
Perhaps the worst injury done by the FDA’s extraordinary behaviour is to cast a massive shadow of doubt over the whole idea of regulation. The FDA may be a pathetic, timid and ridiculous regulator by world standards, and it may have been previously castrated by the self-regulation mythos of the 1980s, but it is one of the world’s very highest profile regulators.
People may not believe in the FDA any more than FEMA, that other triumph of clueless authority, but the theory of regulation does ultimately equate to “rule of law”, and that’s what’s been trashed. You have to be a bit mindful of the timing of this self-abusive surveillance program, too. Just at a time when regulation of finance and health is the biggest single issue in the United States, a regulator self-destructs with an act of stupidity on this scale?
What this case says is that a major regulator is able to conduct a surveillance operation, without anyone signing off on authorizing it, targeting critics for no obviously good reason. The word “corruption” is rarely far away from the many cases of approval/recall/ “it wasn’t our fault” which have been cluttering up the headlines for the last 20 years.
To now discover a culture of obsessive surveillance of detractors simply adds a few gigalitres of petrol to the fire. The FDA has done a huge disservice to the American public and to the basic tenets of trustworthy regulation with these blatant actions against professionals doing their jobs properly and drawing attention to faults in the system.
If this train wreck culminates in a “How Not To” handbook for regulators, it might serve some purpose, but until it does, this is a kick in the teeth for regulation around the world. It makes a mockery of the idea of legislation designed to protect the public, and betrays the trust of the people in the basic competence of the FDA.
That trust is going to be damn near impossible to rebuild. Maybe it’s time to replace the FDA with something that actually works, and doesn’t have the culture which created this 360 degree administrative and regulatory disaster.
This opinion article was written by an independent writer. The opinions and views expressed herein are those of the author and are not necessarily intended to reflect those of
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