France’s Minister of Health called the abortion pill recently approved in his country the “moral property” of women, not just the property of the drug company that makes it. That no U.S. public health official has taken a similar stand on behalf of AZT, this country’s only approved antiviral AIDS drug, is a measure of how foreign the term “moral property” is to the U.S. drug development nexus. But the 45,000 AIDS deaths to date in the United States have finally forced a debate that cuts to the heart of this society’s dollar-oriented medical philosophy by focusing increased attention on the Food and Drug Administration, the agency that must approve all drug treatments before they may be marketed.
The AIDS movement, a burgeoning coalition of health care practitioners and mostly gay activists has persistently challenged what it regards as the weak and ineffective role of the F.D.A., a role recently abetted by President-elect George Bush. Scarcely three weeks before his election, in his capacity as chair of President Reagan’s Task Force on Regulatory Relief, Bush recommended streamlining the F.D.A.’s approval process for drugs that treat life-threatening conditions. The result, informally dubbed the “Bush initiative,” has now been implemented by the agency as an interim rule and codifies the expedited procedure by which AZT was tested and released in 1987.
The F.D.A. touted the Bush initiative as proof of its commitment to help people with AIDS. “The procedures,” says Commissioner Frank Young, “reflect a recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening diseases.” Young claims that the new plan shows “that F.D.A. is not ‘part of the problem’ but an integral, aggressive part of the solution to AIDS and other diseases.”
Yet most doctors, legislators and AIDS activists are skeptical. Representative Ted Weiss, chair of the House Human Resources Subcommittee, called the initiative “a politically timed restatement of what the F.D.A. already can and does do”; and Dr. Mathilde Krim, co-founder and chair of the American Foundation for Aids Research (AmFAR), got to the cynical root of the initiative when she said that “without significant dollars, these proposals constitute a public relations ploy…by the Administration in the closing weeks of the presidential campaign.”
Mark Harrington is a member of the AIDS Coalition to Unleash Power (ACT UP), the organization that has spearheaded the attack on the Bush initiative and the F.D.A. He is a gay man in his 20s who has made it his business to know all there is to know about the drug approval process in this country. “We want the drug companies to be more accountable to the public, not less,” says Harrington, who argues that the F.D.A. is not nearly tough enough on the pharmaceutical firms.
At present, a drug must pass successfully through three phases of clinical (human) trials before it is approved. The first phase tests safety and dosage levels; the second, safety and efficacy; and the third, further efficacy by expanding the trial to a wider range of subjects over a longer period of time. The whole process takes eight to ten years, three times the average remaining life span of a person infected with HIV, the AIDS virus.
The Bush initiative, when fully effective, could lop three to five years off this process by eliminating the third phase of clinical testing. To compensate for this it proposes heightening F.D.A. consultation with the drug companies and Federal institutions performing the trials. Commissioner Young has stated, however, that only 20 percent of the drug companies consult with the F.D A., and the initiative offers little incentive for reluctant firms to increase such communication. And even if the F.D.A. is sincere in its proposal to oversee the trials more closely, where, Harrington asks, “are they going to get the resources to do this? There are neither funds nor staff positions to do what they must do now, let alone [carry out] the Bush initiative.”