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December 08, 2006

The new drug lord

If you read our year-end issue, you know that we voted Andrew von Eschenbach "least likely to succeed" as the FDA's new chief.

But who asked us? After months of dilly-dallying, the Senate yesterday confirmed von Eschenbach as the new commish. Not that this is a plum job. The last chief, Lester Crawford, lasted exactly two months before he abruptly resigned--which all became more clear when a federal court charged him with lying about his shares in drug companies.

What the FDA needs is someone tough and smart, with enough integrity to stand up to drug companies and a clear plan for dealing with all the messy conflict-of-interest issues, not to mention the urgent scientific questions--like the one the new British panel will tackle.

It's a lot to handle, and I'm just not sure von Eschenbach is the man for the job. This is after all the same man who, as director of the National Cancer Institute, famously declared that we would cure cancer by 2015.

Overall, this has been a terrible year for the FDA. I hope it didn't just get worse.

December 07, 2006

Waxing nostalgic about 2006

Yes, yes, I know, it's not quite over yet. But for us here at Nature Medicine, it already feels like the new year because we're busy putting together our January issue.

December, and with it 2006, is history for us. But to bid the year a proper farewell, we've compiled the year's best, worst and most ridiculous moments. We've given out awards in the style of American high school yearbooks, charted a timeline of events, highlighted the absurdity of some things in numbers and asked scientists what they thought made the biggest difference in 2006--and what they think might happen in 2007.

The fun all begins here.

The Brits' new watchdog

Speaking of doses, there is news today from across the pond that the UK will set up a special panel to look at high-risk studies of drugs.

You'll remember that in March, German company TeGenero tested its monoclonal antibody TGN1412 on six healthy volunteers. Within hours, all six ended up in intensive care. Hindsight being 20/20 and all that, critics said later that the company should have given the drug to just one guy and proceeded with caution.

Apparently, this new panel will make sure those kinds of blunders don't happen again. A bit late for the men, one of whom swelled up to look like an 'elephant man', but a good move nonetheless.

Here's the thing, though: some of these ill-considered studies make it through because the reviewers are overburdened and don't have time for the details, or because they have conflicts of interest, or simply because science is unpredictable.

In the case of this drug, the preclinical work, which included data from monkeys, gave no hint that the trial might end disastrously. After all, this was not a 'first in class' drug.

So how would this panel have known to be more cautious?

But maybe I'm being too cynical--I'd love to be proven wrong.

Your first dose...

Hello everyone!

Welcome to 'Spoonful of medicine', where we hope to enlighten, entertain and occasionally exasperate you with our comments on biomedical research and public health.

We hope you'll be active participants as well, letting us know when we've made sense and, of course, when you think we're stark, raving mad. We hope the proportion is at least slightly more of the former.

Initially, at least, most entries will be posted either by me, Apoorva Mandavilli, or by my colleague, Charlotte Schubert. I am the news editor and am responsible for pretty much everything you read in our news section. You can read more about me here.

Charlotte edits the News & Views section, which involves much editing of copy written by scientists. She'll say hello soon... you can read more about her here.

Let the games begin...

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