Infernal Devices
Some scientists at the FDA recently got together and wrote a letter to Congress. In a nutshell, the letter read: “Help us Obi-Wan Kenobi. You’re our only hope.”
I wish them luck. They’re going to need it.
The phantom menace
First a little background…
Two years ago I told you about a shocking survey in which about 180 FDA scientists agreed they could make this statement: “I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.”
Frightening, sad, criminal – use whatever excerpt:encoded you like, it’s probably not exactly the image the FDA wants to present to the general public.
The survey polled about 1,000 scientists who also offered these disturbing responses:
- 20 percent said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.”
- 40 percent said they would fear retaliation if they publicly expressed “concerns about public health.”
- When asked if the FDA “routinely provides complete and accurate information to the public,” less than half agreed.
Many years ago, in a galaxy far far away, these revelations might have prompted Congressional outrage and a thorough FDA housecleaning. But over the past two years, it seems these trends have only gotten worse in at least one FDA division.
A new hope?
Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for “urgent intervention” due to “serious misconduct” by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes “serious misconduct”?
Here’s how the scientists put it: “There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices.”
And: “To avoid accountability, these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.”
And: “These managers at CDRH knowingly continue to make the same regulatory and scientific mistakes over and over again.”
And: “These managers seem far more concerned about ensuring their current positions and protecting and promoting their own careers and those of their cronies, than they are about ensuring the safety and effectiveness of medical devices and protecting and promoting the health of all Americans.”
In mid-November, Rep. Dingell’s committee issued a news release with this statement from Rep. Bart Stupak (Chairman of the Subcommittee on Oversight and Investigations): “Our investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, and now serious allegations have been raised about the scientific integrity of the FDA medical device approval process.
“Although the FDA has launched its own investigation into this matter, no corrective action has been taken. The committee intends to learn what action the FDA plans to take to ensure the integrity of the medical device approval process and prevent retaliation against the scientists who blew the whistle on these activities.”
If you were one of those whistleblowers, would you be the least bit comforted by those words? I mean, how passive aggressive can you get!? No corrective action has been taken, but don’t you worry because the committee “intends” to find out what steps the FDA is taking to police itself.
Reading between the lines, this non-investigation is going to move along at the speed of government. And all those guys who came forward are hung out to dry. Sure, their names have been withheld by Dingell’s committee, but you know their managers must have a pretty good idea of who to put on their hit list, and who to leave off.
If anything at all comes of all this I’ll let you know. Meanwhile, it’s safe to assume that “FDA approved” medical devices just might be bad for your health.
Sources:
“FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns” Union of Concerned Scientists, 7/20/06, ucsusa.org
Letter to Representative John D. Dingell from anonymous scientists in the FDA Center for Devices and Radiological Health, 10/14/08, energycommerce.house.gov
“Dingell, Stupak to Investigate FDA’s Medical Device Approval Process” News Release, Committee on Energy and Commerce, 11/17/08, energycommerce.house.gov
“FDA Scientists Accuse Agency Officials of Misconduct” Gardiner Harris, New York Times, 11/18/08, nytimes.com
