Authority, Ethics, Peer Review, Research, Social Role, Technology, Tools

The FDA Spies On Its Own Scientists — Cloaks and Daggers Emerge When Scientists and Authorities Clash

Spy vs. Spy

Spy vs. Spy (Photo credit: Wikipedia)

Scientists and administrators make bumbling spies no matter which side they’re on, it appears. A recent report from the New York Times details efforts by Food and Drug Administration (FDA) administrators to track the online activities of a group of five dissident scientists, all putatively to protect trade secrets of companies seeking FDA approval for breast and colon imaging devices. Unfortunately, the proprietary information was posted to the Web inadvertently as matters came to a head, remaining openly available until reporters started asking about it.

Perhaps showing how vindictive matters became, four of the five scientists were let go after their activities became known, and they are now suing the FDA.

The absurdity apparently started with concerns that information was being leaked out of the FDA by scientists voicing concerns about how certain devices were being evaluated. This led FDA officials to ask the Department of Health and Human Services’ inspector general to conduct a criminal probe. They were turned down. So, it was time for someone at the FDA to take matters into their own hands. Their next step was to buy SpectorSoft tracking software for a few hundred dollars, and install it on the scientists’ work computers.

SpectorSoft tracks keywords or phrases as they are typed into a computer, and captures emails and instant messages, as well as Web sites.

The scientists being tracked were raising concerns about how the FDA was evaluating radiographic devices used in mammography and colonoscopy. They had concerns that the radiation dangers were being shunted aside or downplayed. And they probably had a point — a confidential review by the Office of Special Council this past May found that the scientists’ medical concerns constituted “a substantial and specific danger to public safety.”

But that didn’t stop some at the FDA from trying to track what these scientists were doing, who they were talking to, and what they were saying — taking it so far as to capture letters to the President and emails from personal accounts to reporters.

Government officials have been shocked by the goings-on. The White House Office of Management and Budget issued a memo last month emphasizing that internal monitoring, while allowed, must be done in ways that “do not interfere with or chill employees’ use of appropriate channels to disclose wrongdoing.”

So, it seems overzealous administrators at the FDA have not been elegant spies — they’ve overstepped their bounds, done things without approval, crossed lines, and triggered lawsuits. And the scientists themselves were not exactly sophisticated, doing much of their whistle-blowing from work computers they knew could be monitored (although, to be fair, they probably had no inkling things might be taken this far).

And, in a charming additional bit of ironic glory, it seems an FDA contractor keeping the 80,000 pages of documents generated by the monitoring inadvertently released them online for all to see. When the documents went up isn’t clear, but they were taken down last Friday after reporters started asking about them.

When science and the public good is put aside for a paranoid hunt for “prime movers” and “ancillary actors” in an imagined bit of espionage, all in an effort to protect proprietary business interests, someone’s priorities have clearly gone awry. Maybe those colonoscopy imaging devices can help those involved find their way out.

Enhanced by Zemanta

About Kent Anderson

I am the Publisher at AAAS/Science. Previously, I have worked as CEO/Publisher of the STRIATUS/JBJS, Inc., a publishing executive at the New England Journal of Medicine, and Director of Medical Journals at the American Academy of Pediatrics.

Discussion

2 thoughts on “The FDA Spies On Its Own Scientists — Cloaks and Daggers Emerge When Scientists and Authorities Clash

  1. The scientists were doing their jobs, so using government computers was not inappropriate, nor was it foolish. Had they copied confidential documents to their private machines, they certainly would have violated security regulations and perhaps even committed a criminal act. The fault here lies entirely with the supervisors.

    Ironically, government record-keeping procedures probably provide a clear electronic trail back to those who tried to suppress the whistleblowers. By staying on government computers, the scientists kept this trail intact.

    Posted by Ken Lanfear | Jul 17, 2012, 9:14 am

Side Dishes by Stewart Wills

Find Posts by Category

Find Posts by Date

July 2012
S M T W T F S
« Jun   Aug »
1234567
891011121314
15161718192021
22232425262728
293031  

The Scholarly Kitchen on Twitter

SSP_LOGO
The mission of the Society for Scholarly Publishing (SSP) is "[t]o advance scholarly publishing and communication, and the professional development of its members through education, collaboration, and networking." SSP established The Scholarly Kitchen blog in February 2008 to keep SSP members and interested parties aware of new developments in publishing.
......................................
The Scholarly Kitchen is a moderated and independent blog. Opinions on The Scholarly Kitchen are those of the authors. They are not necessarily those held by the Society for Scholarly Publishing nor by their respective employers.
Follow

Get every new post delivered to your Inbox.

Join 14,430 other followers

%d bloggers like this: