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To: Zakeet
It would be fine to allow no-other-options patients the access, IF trial lawyers were prohibited from mega-million-dollar judgements when a non-approved medication results in patient side effects or death.

This sounds like a trial-lawyer bonanza waiting to happen.

5 posted on 01/11/2008 3:40:13 AM PST by traditional1 (Thompson/Hunter '08)
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To: traditional1; driftdiver; Gorzaloon

traditional1 is right about the possibility of crazy lawsuites. Allowing patients all out access to non-approved drugs is too much of a liability for the FDA and drug companies.

“However if someone is gonna die why not allow them to get the experimental drug.”

I work in clinical research and patients can get experimental drug without being in the study. Its called Compassionate Use. Yes it takes work on the part of the doctor to go through a few necessary hoops, but many patients can get expirimental drugs this way.

“I intended that by opting out of the placebo, they would be guaranteed to get the experimental drug, instead of wondering and taking the chance.”

More than the drug’s effectiveness is being studied during the research phase. Side effects and other health issues the drug could cause are also studied. Blind studies (not even the sponsor knows which patients are on the drug until after the study ends) are necessary to determine if the drug causes more harm than good. If you have reached the point of opting to be a research subject you are not going to choose to take a sugar pill which you know will nothing to help you. Patient’s have a 50/50 chance of getting the study drug. If you’ve exhausted all other possibilities, those odds aren’t bad and its worth the risk.


12 posted on 01/11/2008 6:00:16 AM PST by EHC Southern Pride (No Shoes, no shirt, no problem)
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