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Do People Have a Right to Take Part in Medical Studies?

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An FDA official says that even people who may think they are excluded from a particular study of a drug or other method have some options.

"Patients can petition [the FDA] for access to a drug after a trial has ended, or if a drug trial is not being conducted in their geographical area. Also, the drug company may make a single-patient exception if a clinical trial has not yet begun," Terry Toigo, RPh, the FDA's associate commissioner for special health issues, tells WebMD. A single-patient exception allows patients who do not qualify for the study, but who have a clear medical need, to get the drug being tested.

"So people do have some control over their access to these drugs," says Toigo. "But the real control is often with the pharmaceutical company offering the drug. If the company is not willing to provide the drug, the FDA's OK doesn't help the patient."

But is getting permission to use an experimental drug or take part in a trial really what's best for the patient? Not always, Annas says.

Some have referred to these FDA exceptions as "compassionate use exceptions," he says. "That's a weasel word, compassion," he says. "You think it's compassionate to put somebody in a research [program] when they think it's treatment? Is it really better than nothing? The truth is, we won't know until after the research is completed. The truth also is, it could be worse than nothing; it could make dying worse."

Annas warns that "dying in a research protocol can be pretty bad. The University of Chicago very sensibly requires that in phase 1 [or early phase] cancer studies, everybody be told that their alternative is good hospice care, that they won't die in pain in a hospice program, whereas the phase 1 trial is really not for [the patient's] benefit. It's probably not going to help them."

The reality is that the choices open to terminally ill patients are usually not good ones -- and that's what creates the controversy, Annas says in his book, Some Choice. "To the parent whose child is dying, it feels that their child is being denied treatment," he says. "In truth, there is no treatment available for their child. They're being denied access to a research protocol that could have some effect or none. Some choice."

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