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The Clinical Trial
Mark Thornton, Wall Street Journal, 2-12-07

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?

Critics of early access also present doomsday scenarios of the impact of success of the Abigail Alliance case on the medical drug development process called "Phase III clinical trials." Over the last 25 years the U.S. has evolved an enormous engine for testing new drugs on patients at hundreds of medical centers in the country. If you have a life–threatening disease like cancer, and you want to try a drug not yet on the market, you better belly–up to a clinical trial, or wait a few years (or six or seven) before your doctor can prescribe it. It is a bloated and slow engine, but it is the best process we have to try to show if a new drug works or not.

Some with a vested interest in maintaining the status quo, such as medical society groups, might feel threatened by a victory by the Abigail Alliance if the perception is that a patient will be able to easily opt out of clinical trials and just get the drug directly. How will we ever get new drugs properly tested if everyone is slipping past the engine? In my opinion this threat is non–existent. One criterion of the patients under consideration by the court is that they cannot even be eligible for a clinical trial. In addition, the FDA will still have enormous authority in deciding who is truly terminal, who is eligible for other clinical trials, and whether other treatment options exist.

For a different perspective, see this article from Jerome Groopman in the New Yorker.

Project FDA.
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