Untold History: Activism and Growth Hormone

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Untold History: Activism and Growth Hormone

AIDS Treatment News (12/02/94) No. 212, P. 5
James, John S.

A largely untold story, "Activists Zap FDA Over Growth Hormones," by Jeff Getty of ACT UP/Golden Gate, examines recombinant human growth hormone as a treatment for wasting syndrome. The larger story it illustrates, however, is the real determinants of whether critical medicines ever get studied and whether they are ever made available to the doctors and patients who want them--even when studies have shown that they work. A major trial of human growth hormone was failing until activists determined that the exclusion criteria eliminated the people in need of the treatment. Once the criteria was relaxed, the trial filled with participants and was able to proceed. Located in Switzerland, the plant to manufacture the drug is currently under construction to increase capacity. Due to international politics, the Food and Drug Administration (FDA) no longer accepts Swiss inspections and must inspect the plant itself. Because the United States does not inspect plants under construction, however, U.S. access to this drug source is on hold. Although they happen frequently, there is still no established system to deal with such problems and no one is responsible.

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