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To: William Tell
do we delay the testing on behalf of one patient and thus deny thousands the timely delivery of the drug?

Put that way, the answer is no. But cynic that I've become, I would want to know that NO ONE has gotten to use the drug. Or if the child could be put on the trial.

45 posted on 03/11/2014 11:09:46 AM PDT by grania
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To: grania
grania said: "But cynic that I've become ..."

I have relatives in the medical device field. Every part of any such device is tracked and accounted for. If you don't know where any part has been or where it came from, it CANNOT BE USED. There's no exception.

I would imagine that drugs are the same way. A numbered lot is manufactured and the items in that lot are accounted for. They're just not going to create a surplus beyond what is needed to do the testing. This may even include amounts needed to restart the testing if something is found to be wrong with the drug at the start.

One would also have to wonder what the drug company would be expected to do with any information that is generated due to compassionate distribution. If the boy gets the drug and then dies mysteriously, what obligation does the drug company have to find out why the boy died? None? Unlimited? Can such an occurrence disqualify the results of the controlled clinical trials?

Imagine going into a McDonalds and asking for an uncooked hamburger because you need the food right away and can't wait for it to be cooked. If a person doesn't eat, they die. But McDonalds can't address that problem by selling uncooked products.

54 posted on 03/11/2014 1:48:03 PM PDT by William Tell
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