(ATN) Untold History: Activism and Growth Hormone

(ATN) Untold History: Activism and Growth Hormone

AIDS TREATMENT NEWS Issue #212, December 03, 1994
John S. James

A glimpse of a largely untold history was published November 25 in the BAY AREA REPORTER, a gay newspaper in San Francisco. The article, "Activists Zap FDA Over Growth Hormones," by Jeff Getty of ACT UP/Golden Gate, looks at one treatment (recombinant human growth hormone for wasting syndrome) but illustrates a larger story -- the real determinants of whether or not critically important medicines ever get studied, and whether they get to doctors and patients who want them even when the studies have found that they work. The case of growth hormone shows how much effective medical care depends on quiet, behind-the-scenes work of activists from such organizations as ACT UP/Golden Gate, Healing Alternatives Foundation, and Project Inform in San Francisco, and others elsewhere.

Before activists got involved, the major trial of human growth hormone was failing because it could not recruit patients. Activists diagnosed the problem -- the trial's exclusion criteria, which kept out the very people who needed the treatment in the first place. They got the criteria relaxed, and the trial filled quickly.

Now the study has been successful, but red tape is keeping the drug from patients. A major problem today seems to originate in international political struggles around the European Economic Community, with patients being used as pawns. The plant to manufacture the drug is in Switzerland, and it is currently under construction to increase capacity. Apparently the FDA no longer accepts Swiss inspection, due to international politics, but must inspect the plant itself -- and it does not inspect plants under construction, leaving U.S. access to this particular source of drug on hold. (There are other potential sources, but they have problems of their own.) As we go to press, activists have forced meetings to try to get the plant-inspection problem resolved.

These kinds of problems happen all the time. What is most astonishing is that there is no established system in place to deal with them. Still, after almost ten years of the epidemic, no one is responsible. The impact of this responsibility gap not only on AIDS, but on medical research for cancer, Alzheimer's, and other serious or life- threatening diseases, must be unimaginable. The opportunities to improve medical research for the benefit of everyone, just by applying the most basic principles of effective management which have long been developed for industry, must be immense.

The November 25 article is the first in a series by ACT UP/Golden Gate in the BAR AREA REPORTER. We hope to see more on the hidden history of activism in drug development, so that the public will understand the importance of this work.

Note: For a copy of "Activists Zap FDA Over Growth Hormones," send a self-addressed stamped envelope to: Bay Area Reporter, 395 Ninth St., San Francisco, CA 94103.

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