Thursday, July 26, 2007

FDA Scientists Grade Their Agency: 5/10=F for Failure

There is yet more kill-the-messenger posturing going on at the FDA, the federal agency staffed with dedicated, reality-based individuals--scientists--but managed by parties whose pro-small-government ideology, not to mention undeniable fealty to corporate paymasters (Big Pharma), translate to downsizing and privatizing. Both of which, as I've discussed extensively, mean even fewer inspections of food imports (currently the rate is about 1%, if that) and even more fast-tracking of drug approvals despite contraindicative study results and red flags aplenty. From Wednesday's Washington Post:

WASHINGTON -- Two lawmakers alleged Wednesday that a top Food and Drug Administration official began a campaign of intimidation and retaliation against employees who gave the agency failing grades in its efforts to police the nation's food supply.

None of the FDA field employees gave the agency more than a 5 on a scale of 1 to 10, in grading its food safety efforts when they testified at a congressional hearing July 17. Two days later, the FDA's associate commissioner for regulatory affairs, Margaret Glavin, wrote an office-wide e-mail saying she was "deeply saddened" by the ratings, which she considered inaccurate.

"I know many of you were also disappointed, and perhaps even angry, at this erroneous assessment," Glavin wrote to employees of the agency's regulatory affairs division.

I don't understand how Ms. Glavin could possibly misread plain data--the testimony of numerous FDA field employees that the agency, at best, rated a 5-out-of-10 for its food safety efforts--as "erroneous assessment" that must surely have rendered many FDA personnel "disappointed, and perhaps even angry".

To my mind, those ratings and testimonies before congress represent the sincere concerns of scientists and field personnel who are right there on the front lines, doing the work required to protect the American public.

To my mind, the disappointment and anger should be directed at those who are behind all the lab closures and general downsizing of vital staff. And, certainly, at those who learn of scientists' assessments and genuine concerns and then turn around and blithely label them "erroneous".

Thankfully, some congressmen are well aware of FDA management's anti-science attitude as well as its unwritten policies of retaliation toward question-raisers, critics, and whistleblowers:

Reps. John Dingell and Bart Stupak, both Michigan Democrats, said the electronic note violated agency policy and regulations against retaliation _ and perhaps even a federal law that prohibits interfering with the rights of federal employees to give Congress information. They asked FDA Commissioner Andrew von Eschenbach to disavow the e-mail, discipline Glavin and evaluate her future as head of the agency's field staff. In a later statement, Stupak said she should be removed.

"Ms. Glavin's central message appears to be that dissent within the ranks will not be tolerated. This is tantamount to retaliation for her employees' sworn testimony to Congress," the lawmakers wrote in part.[...]
One employee who testified said no one in the FDA's field offices took the poor grades as a "slam on their efforts."

"It's not because we are doing a bad job," said Ann Adams, director of the FDA's Kansas City district laboratory in Lenexa, Kan. "We are doing an incredible job with what we have available. The problem is we can't be doing everything we should be doing. We just don't have the people. We just don't have the money."[...]

Another employee who testified said Glavin's note took their comments out of context.

"What we were all saying was FDA needed to do more and needed more resources to do a good job in looking at the number of imported products coming into the country," said Richard Jacobs, a chemist and toxic element specialist in the FDA's San Francisco district laboratory in Alameda, Calif. "It was just a statement, to me, of fact that we weren't doing what we need to do in finding bad products entering the country."

It was just a statement, to me, of fact...Ah, but you're thinking and talking like a scientist, Mr. Jacobs, and as we've been reminded over and over again these past six-plus years, those who currently wield the Bunsen burners of power feel in their guts that the jury is still out on all that sciencifying fact stuff.

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