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March 18, 1988

Treatment INDs: Promising, Problematic

JAMA. 1988;259(11):1607-1608. doi:10.1001/jama.1988.03720110001001

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CONTROVERSY AND CONFUSION surround a new regulation that expands the availability of investigational new drugs (INDs) beyond clinical trials.

The rule, known informally as the "Treatment IND," describes procedures for making promising INDs available to patients with serious or immediately life-threatening disease for whom other forms of treatment have been inadequate (JAMA 1987;257:1858). In essence an extension of the "Compassionate IND," it is not a new concept or practice, but a codification and extension of existing procedures. Yet many believe that the consequences of its enactment will be far ranging: that it will threaten controlled clinical trials; make untried drugs available; and create a two-tiered system of care for the critically ill.

Since the regulation went into effect last June, the Food and Drug Administration (FDA) has made three drugs available under its provisions—cytomegalovirus (CMV) immune globulin to prevent CMV infection in patients with kidney transplants; ifosfamide and mesma for