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The Clinical Trial
Mark Thornton, a former FDA staffer, argues in favor of the Abigail Alliance's lawsuit seeking expanded access to experimental drugs for cancer patients with terminal illnesses who have run out of options:
Other critics of Abigail Alliance also claim that at the threshold for early approval for the terminally ill, i.e., post–Phase I testing, the safety of the drug is still very much a concern; many more years of snuggling with the data will still be necessary before the FDA will feel things are just right. The fact is that all drugs, no matter what stage of development, have the potential to evolve new safety concerns. Since a drug is safe enough for the hundreds of patients in the "Phase II" of human testing, how is it not safe enough for a patient whose only option is the terminal progression of his disease?
For a different perspective, see this article from Jerome Groopman in the New Yorker.
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