Vicious infighting among FDA employees puts consumer safety at risk

Rollin’ & Tumblin’

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.”

Intriguing? Sure. Inflammatory? Absolutely. But what does employee friction at the FDA have to do with you?

Plenty – especially if you’re a woman scheduled to have a mammogram.

Fear & Loathing at the FDA

We saw this one coming a mile off.

In the e-Alert “Infernal Devices” (12/11/08), I told you about a letter sent to Congress from a group of very unhappy FDA scientists. The letter was a plea for “urgent intervention” due to “serious misconduct” by managers of the FDA’s Center for Devices and Radiological Health (CDRH).

Here’s just one of the infuriating claims made in the letter: “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.”

Of course, consumer safety is the casualty here. As the letter notes, CDRH managers seem more concerned with protecting their careers than ensuring the safety of medical devices.

In response to the letter, representatives of the House Committee on Energy and Commerce issued a somewhat half-hearted promise to investigate the situation.

Probably understanding that the House committee wasn’t going to drop everything to immediately tear things up at CDRH, the gang of dissidents fired off another letter – this one addressed to the Obama transition team. Unfortunately it was sent just a few days before last week’s inauguration – a very tough moment to get the President-elect’s attention.

So the transition team didn’t issue a response, but the FDA did. A spokesperson told the Associated Press: “The agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

Well that sounds pretty reasonable, taken at face value. But if you’re an FDA employee who’s just stuck his neck out to expose corruption, I’ll bet that comment reads like an ominous threat.

Bring on the mothballs

The dissidents’ letter is very specific about a new technology in which mammogram images are rendered on a computer screen rather than on film.

I told you about this mammogram innovation last year in the e-Alert “Compression Obsession.” Hailed as a great leap forward in mammography, it’s actually a great leap nowhere. Two reasons: 1) Unlike alternative breast cancer detection techniques, computerized mammography still requires breasts to be painfully and dangerously pressed on the imaging surface, and 2) The computer mammograms are difficult to read, prompting follow-up exams that are costly to patients (not to mention terrifying), and often produce false positives, which lead to unnecessary biopsies.

The AP reports that FDA scientists recommended AGAINST approval of the new technology not once, not twice…but FIVE times! And yet, CDRH managers approved the computerized mammography technique last March.

And it appears this process was nerve-wracking for all concerned.

The dissidents’ letter charged that the managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along.”

The gloves are off at the FDA!

I’ll be following all this to see what happens, and I’ll report back to you. Meanwhile, CDRH employees might find this information useful: Mothballs and sulfur powder are useful for driving away snakes.

Sources:
“FDA Scientists Complain to Obama of ‘Corruption'” Ricardo Alonso-Zaldivar, Associated Press, 1/8/09, ap.org
“FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns” Union of Concerned Scientists, 7/20/06, ucsusa.org