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Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com.

Protection to paranoia for FDA’s surveillance program

Published: July 27, 2012

Reports of the FDA spying on their own scientists who’ve been critical of the agency‘s medical review process, and then ranking them on an enemies list is shameful at best and downright frightening at worst.

While public agencies have a right to monitor their employees‘ computer use, there are boundaries, and it appears the FDA may have gone into illegal territory by accessing and analyzing confidential information that is specifically protected under the law, including attorney-client discussions and whistleblower complaints to Congress.

The FDA reportedly used specially designed software that can capture screen images from government laptops while they are used at work and home. The software can track keystrokes, intercept personal emails and follow messages line by line as they are being written. This allowed the FDA to gather at least 80,000 pages of computer documents through its employee monitoring program. All of this so it could counter any negative information about the agency.

The excessive surveillance apparently started as a narrow look into possible leaks in the agency, but it eventually grew into a massive effort to rebuff any outside criticism of the department’s medical review procedures.

The enemies list crafted by the FDA included not only its own employees, but also names of journalists and members of Congress sympathetic to the scientists’ concerns.

This is the agency in charge of making sure new drugs and medical equipment are safe for the public. If scientists involved in the testing have concerns, their opinions should be heard and considered — not squelched.

And certainly those same scientists should not fear losing their jobs because they brought up potential safety issues.

Much of this mistrust had apparently stemmed from a long-lasting dispute between a group of scientists and their bosses at FDA regarding the safety of certain medical imaging devices for mammograms and colonosopies. The FDA approved the devices but the scientists countered that the machines would expose patients to dangerous levels of radiation.

As it turns out, the scientists’ claims were deemed valid enough in May by the Office of Special Council to warrant a review.

The FDA defended its employee surveillance program by saying that monitoring employee computers “was consistent with FDA policy” and that emails were collected “without regard to the identity of the individuals with whom the user may have been corresponding.”

That response is not very comforting, and it still doesn’t explain why the monitoring program focused on those critical of the FDA.

The FDA should be a reassuring agency. When a drug or medical device is approved by the FDA, people believe it is safe.

Now that belief may be in jeopardy.

If the FDA is more concerned with protecting itself from negativity than it is with public health and safety, there is something dangerously wrong.