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AIDS Activism Improves Medicine

The Washington Post

Last week, in the waning hours of the 102nd session, Congress passed legislation that permitted the Food and Drug Administration to charge drug companies for reviewing new drug applications.

The legislation looked, on the surface, like a simple bargain between the drug industry and the FDA: If pharmaceutical companies agreed to pay the agency millions of dollars for a variety of regulatory services, the FDA would devote all the new money to expanding and computerizing its drug review operation.

But the real impetus for the reform -- one of the most significant in the agency's history -- came from an unexpected place: the AIDS activists who have been pressuring the FDA for close to a decade. According to FDA officials, it was the FDA's experience in reviewing AIDS drugs quickly, and in devoting extra attention to that disease, that led them to believe they could speed up the review of all drugs if given the necessary resources.

Among policymakers, physicians and legal experts, this has become a familiar story. Ten years of AIDS activism, they say, has had a profound impact on U.S. regulation, law and society far beyond the immediate world of those infected with the HIV virus. The outpouring of grief, expressed so eloquently in the AIDS quilt that was displayed on the Mall last weekend, also has changed the way medical science is conducted, the relationship between doctor and patient, the way Americans talk about sex, the way drugs are regulated and the way civil rights law is written.

"You can look at all of the major cutting edge issues in health law and ethics and you can see how AIDS has had an impact," said Lawrence Gostin, executive director of the American Society of Law and Medicine in Boston. "It is the lens we use to examine all the critical issues."

In the case of user fees, for example, the FDA pledged to cut by almost half the amount of time it takes to review new drugs and to review so-called breakthough drugs in no longer than six months if the pharmaceutical industry paid the FDA $300 million in fees over five years. Agency officials said they were able to make this pledge because of their experience with the AIDS drugs DDI and DDC. Both were approved in record time because of pressure by AIDS activists, showing that extra resources could be translated into faster scientific reviews.

A series of regulatory changes enacted at the FDA this year, in fact, which allow experimental drugs for lifesaving diseases to be made available to patients before they are approved, are all legacies of the demands of AIDS activists to loosen up the drug approval process, which averages 20 months.

"Back in the 1960s and 1970s, post-thalidomide, the agency's mission was to keep unsafe products off the market," FDA Commissioner David A. Kessler said. "But in dealing with AIDS, we have learned in no uncertain terms that our job is not only to keep unsafe drugs off the markets but to get safe and effective drugs to the market. This will carry over to traditional drugs as well. ... The pendulum has swung."

AIDS has had a more subtle, but no less significant, effect in reshaping the face of health and civil rights law. Since the epidemic began, there have been 469 court cases and administrative agency legal actions related to AIDS, on subjects as diverse as education, crimimal law, family law, confidentiality and discrimination.

Consider, for example, how AIDS has changed just one of those areas: the 1990 Americans with Disabilities Act. The law covers areas traditionally associated with disabilities: how facilities must be accessible to those in wheelchairs, how the blind or the deaf cannot be discriminated against in employment or housing. But in one significant respect it differs from previous civil rights legislation. At the insistence of AIDS activists, the law covers HIV infection as a disability.

"If it had followed it's predecessors, the ADA would not have mentioned or barely been applicable to health," said Gostin. "It used to be that if you had cancer or Huntington's disease and someone said, `I'm not going to employ you any more, I'm not going to let you go on a senior management program,' you couldn't do anything. It wasn't because you were a woman. It wasn't because you were black. But what this means is that whenever you are denied a service, excluded from a job or a school, or whenever you have any compulsory power exercised against you because of an illness, you have a remedy. You can go to a federal court and sue for discrimination."

What AIDS activists have done, say medical experts, is to assert the interests and demand of those actually suffering from a disease far more effectively than any previous group of patient advocates. In so doing, they have provided a model for other groups to follow.

"People with AIDS were the first to say that we're not victims and to demand a full partnership with their physicians," said Deborah Cotton, an AIDS physician and researcher at Beth Israel Hospital in Boston. "To me that is the biggest change, and it is spilling over to other patients. Paternalism in medicine was on the way out, but with AIDS it's dead."