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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.

Comments

You're not cynical enough, Apoorva. Here's a scenario:

Multiple levels of regulatory process in the US and UK lead to an increase in offshore drug trials and to use of postmarketing data from developing countries as de facto Phase II information. The people who suffer the greatest adverse consequences of new drug development will be those in countries where there is less public scrutiny (fewer medical journalists, for instance) and less regulatory protection. Our future increases in health and longevity will come at their expense. I don't see any way around this.

You may find this story in Nature enlightening on this subject :)

'New test could weed out dangerous drug trials'
http://www.nature.com/news/2006/061204/full/061204-13.html

how on earth will this help? tgn1412 wouldn't have looked like a "high risk" drug - so it wouldn't even have been given special scrutiny. but people seem to agree that a little bit of common sense would have gone a long way; they just shouldn't have dosed everyone at the same time.

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