Dr. Andy

Reflections on medicine and biology among other things

Friday, March 17, 2006

Not good

Not good at all
Four men left seriously ill after taking part in a drug trial have regained consciousness, say doctors.

Another two are in a critical condition and under sedation but have shown early signs of responding to treatment, said Dr Ganesh Suntharalingam.

The men suffered multiple organ failure within hours of taking the TGN1412 drug at a research unit based at Northwick Park Hospital in north-west London.
TGN1412 is an antibody that blocks a key molecule on the surface of T-cells called CD-28, thereby causing changes in the immune system which can apparently be either pro or anti-inflammatory (as evidenced by it being studied for both cancer and rheumatoid arthritis).

Usual protocol for new drugs is to administer them to healthy volunteers after extensive animal testing, which was apparently done in this case and showed no evidence of toxicity. Why the medicine caused such a violent reaction when given to humans is unclear, but it sounds like it was horrible.

I would not discount the possibility that the medication given was somehow adulterated. If not, it is probably just an example of very bad luck.

That said, why 6 people were given the medicine simultaneously is not clear. It would seem safer to give it to one at a time, so at least 5 of the 6 might have been spared. Additionally, the practice of testing new drugs first on healthy volunteers seems odd; wouldn't it make more sense to test it on someone suffering from one of the diseases for which the med is being studied? I know that might confuse the outcome as for some adverse outcomes it might be unclear whether it was the medicine or the underlying condition that was causitive. That said, at least the participants would have an incentive beyond money.


At 9:59 PM, Anonymous Anonymous said...

TGN1412 is a superagonist of CD28, not an antagonist.


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