Change at the FDA One Can Believe in (versus feel-good morale builders) : Neuron Culture

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I write articles on science, medicine, nature, culture and other matters for the New York Times Magazine, The Atlantic, Slate, National Geographic, Scientific American Mind, and other publications, and am working on my fourth book, The Orchid and the Dandelion, which expands on my recent December 2009 Atlantic article. In August 2010, I'll be moving to London for a year to work on the book. I'll also serve as a senior fellow at City University London's MA science journalism program.

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Worth Noting

Change at the FDA One Can Believe in (versus feel-good morale builders)

Posted on: January 8, 2009 8:31 PM, by David Dobbs

This post by Science's Jennifer Couzin at ScienceInsider suggests how much serious overhaul the FDA needs.

Looks like some scientists at the Food and Drug Administration are doing what they can to influence president elect Obama's choice of their new boss. Nine scientists have written to Obama's transition team pleading with him to restructure the agency and lamenting manipulation of scientific data there. The biggest worry cited in the letter is around review of medical devices. Obama reportedly has his eye on some candidates who would likely shake up the FDA, including agency critic Steven Nissen and Joshua Sharfstein, who was the Obama staffer who received the letter, reportedly.

The letter, sent to Obama transition team leader John Podesta, said "There is an atmosphere at FDA in which the honest employee fearrs the dishonest employee," according to the Journal story. The letter particularly emphasized concerns about the agency's review of medical devices -- a sector whose growth is expected to replace flagging drug sales, and which lately has been aggressively pushing neuromodulators as treatments for almost everything.

"The scientists appear to hope that their concerns will pressure Mr. Daschle to quickly change leadership at the FDA," according to the story, and appoint someone like the above-mentioned Nissen or Sharfstein.

In lieu of real change, the agency has apparently been trying to boost morale through some rather elaborate cheerleading.

But even as FDA scientists seek change, the agency is finding itself in hot water for a pricey effort to boost morale. Members of Congress are fuming about the agency's decision to fork over $1.5 million to a consulting company to improve battered morale, following an independent review citing this as a serious problem at FDA. A slideshow designed by the consultants and shown at an FDA retreat reportedly compared senior FDA official Janet Woodcock to Golda Meir, a former prime minister of Israel, and Ghandi, the Wall Street Journal reports. A call to the FDA for comment went unreturned. A congressional committee has opened an investigation into the spending choice.

It's hard to overstate the importance of a healthy overhaul at the FDA. The agency's poor oversight of the drug and device industry the last few years has added to the public's -- and many doctors' -- loss of confidence in the integrity of drug-efficacy evidence and testing. A turnaround at the agency is badly needed to set things aright.