Six people are in hospital, two critical, after participating in a clinical trial for a new anti-inflammatory drug in London, according to the Sky News report today. Alongside this report, a Sky News poll asks: should drug trials be banned on humans? One wonders how those who vote in favor of such a ban (a mere 13,6%, with 86,4% voting against a ban) expect to ever have access to new medical drugs that have the potential to ease suffering and save lives if the developers were not permitted to test these drugs on humans.
Nonetheless, this report comes after calls for more transparency regarding drug trial results as it is evident that drug companies are neither legally required nor ethically compelled to make all the data publicly available. In fact, according to an article published in the New England Journal of Medicine last year, several major pharmaceutical companies do withhold important details about clinical drug trials. Although a clinical trial registration website exists to monitor and track clinical trial results, it by no means makes it mandatory for drug companies to make public all findings from such trials.
So what went wrong in this London trial? Was it just a fluke, a drug that may have been safe in animals but evoked a negative reaction in humans? Or were the correct procedures not followed, resulting in the human administration of a drug that had not yet been declared safe for testing in humans? Authorities are now looking into the testing procedures: watch this space.
Thursday, March 16, 2006
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2 comments:
Please give an up date on this story. I can't believe there have not been any follow up stories on this unbelievable error.
The latest (that I am aware of) can be read here:
http://www.bloomberg.com/apps/news?pid=10000100&sid=aG3sg1rIkL4U&refer=germany
(Hat tip to the AJOB guys)
From what I have been able to gather, there appear to have been problems with the consent documents (in that they did not fully disclose the nature of the drugs under investigation nor the extent of prior testing) as well as, perhaps, the actual conduct of the trial. (eg, volunteers in the same room, receiving injections at 10-minute intervals, with the last couple subjects receiving the meds even after those already injected appeared to be having bad reactions).
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