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Experimental Treatments? Unapproved But Not Always Unavailable

The Intervention of AIDS

Before the 1980s, a more paternalistic medical community argued that it was the government's job to protect patients from possible harm by withholding experimental drugs until there is proof that they work and are safe.

AIDS helped alter that view. Not only did that lethal disease spread with terrifying speed, but it struck a patient population capable of mounting a political response that grabbed the nation's attention and galvanized public health policymakers to reconsider long-held beliefs.

Experimental treatments should be available, The Washington Post quoted one activist at the time, "so people would be able to choose for themselves, working with their doctors, whether they want to risk taking a drug because of the possible benefits."

Critics accused FDA of denying dying patients access to possibly lifesaving drugs. To drive home the point, in October 1988, more than 1,000 gay activists staged a protest outside FDA's Rockville, MD, headquarters, trapping the agency's staff inside.

"FDA is the nexus between the government, the private sector and the consumer," the spokeswoman for one of the protest organizers told the Post. "That's why we're targeting (the agency)."

The protest had an effect. The agency, already focused on the issue by the urgency of AIDS, accelerated its reexamination of the way people with serious and life-threatening diseases could gain access to unproven remedies. Although the treatment IND regulations were finalized in 1987, FDA put in place additional mechanisms to make experimental drugs available to seriously ill patients earlier in the drug development process.

With the activism around AIDS and the demands of people with other serious illnesses for access to unproven treatments, the medical community, including FDA, began to appreciate that the traditional risk/benefit models may have been inappropriate for people with serious and life-threatening diseases. Dying patients were willing to take bigger risks for even the slenderest hope of benefit.

"The hope part of it is that it might work and keep them alive a little longer," says Theresa Toigo, Associate Commissioner for the Office of Special Health Issues. "Even if it is only two months, by then there might be a cure. It is a wonderful survival instinct."

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