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


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.

Nat Hentoff Laid Off After 50 Years

Hentoff
When I lived in NYC and had the Village Voice close at hand, I loved reading Nat Hentoff, whether it was on jazz, politics, or whatever else excited him.
He got laid off yesterday, at 83. His farewell column makes it clear he’s got more left to say.

Around the country, a lot of reporters are being excessed, and print newspapers may soon become collectors’ items. But over the years, my advice to new and aspiring reporters is to remember what Tom Wicker, a first-class professional spelunker, then at The New York Times, said in a tribute to Izzy Stone: “He never lost his sense of rage.” Neither have I. See you somewhere else. Finally, I’m grateful for the comments on the phone and the Web. It’s like hearing my obituaries while I’m still here.

I hope he finds a place to broadcast it.
For some enjoyable relevant context, read Louis Menand’s wonderful history of the Voice in the New Yorker.
Hat tip: Mediabistro

The walkable city

Woman walking in city
Walking Firenze
Leon Krier, from “The City Within the City”.:

THE QUARTERS.
A city can only be reconstructed in the form of urban quarters. A large or a small city can only be reorganized as a large or a small number of urban quarters; as a federation of autonomous quarters. Each quarter must have its own center, periphery and limit. Each quarter must be A CITY WITHIN A CITY. The quarter must integrate all daily functions of urban life (dwelling, working, leisure) within a territory dimensioned on the basis of the comfort of a walking person; not exceeding 35 hectares (80 acres) in surface and 15,000 inhabitants. Tiredness sets a natural limit to what a human being is prepared to walk daily and this limit has taught mankind all through history the size of rural or urban communities.

One of the attractions of my own city, Montpelier, is that I can walk across it comfortably in well under half a day — and can walk out of it and into the countryside in about 10 minutes, which is also how long it takes me to reach the city center. Despite that we have little mass transit, I rarely use a car.
Krier’s point about quarters — that they must integrate all daily functions of urbain life — seems spot on to me when I think of the cities (and parts of cities) that I’ve found most agreeable.
For more along these lines, check out James Howard Kuntsler’s website and Steven J. Dubner’s Freakonomic’s blog entry on the future of suburbia.

You don’t smell any better, but you sure act hot

From Mind Hacks: Deodorants boost sexiness by getting men in the groove:

I keep running into fascinating articles that The Economist ran over the Christmas period and this one is no exception – it covers research that suggests that men’s deodorants do increase sexual attractiveness, but by increasing confidence and hence the behaviour of the wearer. The smell alone seems to have little impact on women.

Defense Dept hopes to offer virtual parents

Yikes. “Creepy” only starts to get at it. Will Saletan at Slate describes a program DOD hopes to develop that will give the children of soldiers sent away a sort of avatar parent to replace the one Uncle Sam is busy using:

For ages, we’ve been telling children that ghosts aren’t real. But DOD has just put out a request for proposals to create what are, in effect, virtual ghosts. Another truism of parenting is about to become untrue.

Continue reading →

The dangers (?) of public funding of drug trials

Ezra Klein relays Jim Manzi’s worry that public funding of drug trials

exposes you to the inverse problems of the current system. Namely, “bureaucrats and politicians tend to have enormous career risk from an unsafe drug introduction, but almost none from a rejected drug that would have been effective had it been introduced…[it] would likely result in fewer new drugs being brought to market.”

There’s a bit to this. But it misses something important: The biggest problem with the present system may not be that deeply unsafe drugs are approved but that too many drugs that carry modest safety issues (and most drugs carry some safety issues) but little if any benefit are approved because their benefits are overstated. The risk-benefit ratio gets misrepresented, in other words, not so much because risks are understated (though that is done too) as because the benefits are oversold.

Continue reading →