In response to pressure from such groups as ACT-UP, the Food and Drug Administration has grudgingly speeded up approval for some AIDS drugs, including AZT and DDI. But while many activists are content to continue wringing concessions from the FDA, others are advocating a broader and more permanent solution.
Direct Action for Treatment Access, a new organization based in Palo Alto, California, wants to make it easier for all patients with serious illnesses to get drugs that could prolong or save their lives. DATA is backing a bill proposed by Rep. Tom Campbell (R–Calif.) that would order the FDA to streamline its approval process for drugs aimed at treating life-threatening diseases.
Campbell's bill would require the FDA to approve a drug once there is credible evidence that its benefits outweigh its risks. Under current policy, the FDA can spend years proving that a drug is both safe and effective—precisely measuring its therapeutic value—before allowing it to be sold. Meanwhile, victims of AIDS, cancer, Alzheimer's, and other diseases are dying.
"It is patently ridiculous to use the same safety standard for a 5-year-old child with the rest of their life in front of them as [for] a 65-year-old with cancer and 5 months to live," writes DATA President Steven Fowkes. He says a legislative solution is necessary because the FDA's incentives work against rapid approval: "A young child on TV with a drug-induced birth defect is worth more than 1,000 cancer patients or high-blood-pressure patients dying in anonymity."
In addition to supporting the Campbell bill, DATA helps fund treatment research and distributes information on nonapproved drugs such as hypericin and peptide T—information that the FDA will not allow pharmaceutical companies to publish. DATA also runs a referral program to help members obtain treatment products and services.
This article originally appeared in print under the headline "Uneasy Access".