Do People Have a Right to Take Part in Medical Studies?
"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."
"In the parents' view, it's better than nothing ... the last hope," Annas tells WebMD. "That's cruel, because the trials don't offer much hope. I've spoken of this before, mutual self-deception: Dying patients and their physicians -- both parties want to see this as treatment. But the truth of the matter is, it's not."
It's the intractable, expensive medical problems that draw the most controversy, says Annas. "We're never going to solve the problem of death with medicine," he says. "But the fact that medicine has had some success is what makes us hungrier for more, makes us want to believe that if we just knew more, had more research, that we would be able to do more."
That's just one reason it's hard for Americans when the FDA closes clinical trials, Annas says.
"We don't like anybody to prohibit us from doing anything," he says. "As long as it doesn't hurt other people, we say, 'What's the deal, why are you prohibiting me from exercising this choice?'"