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.<\/p>\n
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.<\/p>\n
Apparently<\/a>, 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n So how would this panel have known to be more cautious?<\/p>\n But maybe I’m being too cynical—I’d love to be proven wrong.<\/p>\n","protected":false},"excerpt":{"rendered":" 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. Read more<\/a> Continue reading