Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
S.F.-based group reports on underground compound Q tests
San Francisco Chronicle - Wednesday, September 20, 1989
Randy Shilts, National Correspondent
Organizers of a clandestine trial of the AIDS drug Compound Q made their first public announcement of the study's results yesterday as renewed controversy swirled around the unorthodox research. Leaders of Project Inform, the San Francisco-based AIDS information group that organized the study, and doctors involved with the tests said preliminary data from the 4-month-old study indicate that the drug has a "significant" effect thwarting the AIDS virus. Meanwhile, debate flared among AIDS organizers and researchers about the propriety of the underground study after the death of a New York man who had taken the compound, a derivative of Chinese cucumber root, as part of the research. Results from the study had been eagerly awaited both in the scientific community and among people working on the AIDS epidemic ever since news of the once-secret trials was reported in June. The four-city study has rocked the scientific community because it has been conducted by volunteer physicians working outside traditional regulatory agencies and research institutions. DETERMINING TOXICITY Dr. Mathilde Krim, board co-chair of the American Foundation for AIDS Research, said that "this is not the way" to do studies and that the Project Inform research should include an outside monitoring board of medical experts to ensure the safety of the research for patients. "I am very much in favor of accelerating to every extent possible the speed with which clinical research is done," said Krim. "But I think this is serious business, and it has to be done with a number of built-in safeties and protections." In releasing the first results of the study at a crowded public meeting in San Francisco last night, Project Inform co-director Martin Delaney cautioned that the purpose of the research was to determine the drug's possible toxicities rather than establish definitive proof of its effectiveness, a task typically carried out in larger, longer trials. Nevertheless, Delaney said the drug showed evidence of stopping the AIDS virus among study participants. Nine of 15 San Francisco patients, for example, experienced a "significant reduction" in levels of the p24 antigen, a viral protein whose presence is believed to be a marker of HIV activity, according to Delaney, a key organizer of the research. Of patients whose blood had more than 100 T-4 lymphocytes, the immune cells attacked by HIV, all experienced a "substantial reduction" in p24 antigen levels, he said. On the average, p24 antigen levels dropped by 51 percent in these patients, he said. "You can't use the word dramatic to describe the results of such a preliminary, early study," Delaney said, "but you can say it had a significant effect. This is significant stuff by any standard that's out there." HIGHER T-4 CELL COUNT The drug also had a pronounced effect in bolstering the immune systems of study subjects, particularly those who were healthier, as evidenced by the presence of 100 or more T-4 cells. The numbers of T-cells more than doubled among patients with low T-4 levels who received a high dose of the drug, the study found. Meanwhile, a low dose of the drug was most effective on patients with 100 or more T-cells, increasing their T-cell counts by an average of 88 percent. "Clinically, the patients overall have improved," said Dr. Larry Waites, a San Francisco physician who worked on the study. Twelve of 19 San Francisco patients reported a return of energy and nine of 19 gained weight that had been lost because of the disease. By comparison, ddI, the drug currently drawing the most excitement at the National Institutes of Health, was found in recent studies to have reduced p24 antigen levels in about the same proportion of patients. It increased T-4 cell levels in comparatively fewer study subjects. Last night's data was drawn among patients from San Francisco and New York City. Test results have not yet been tabulated for patients participating in the Los Angeles and Miami branches of the study. MORE STUDIES NEEDED Delaney cautioned that more studies will be needed to offer evidence compelling enough to warrant release of the drug. He also warned that given the drug's potential toxic side effects, people should not attempt to use this drug "in a home remedy or self-treatment situation." "There is a class of patients for whom the drug is clearly very dangerous," Delaney told the 350 people at the Project Inform meeting last night. "This is chemotherapy -- it's not herbal tea," he said. " This has benefits and this has risks." Of 72 patients participating in four cities, Delaney said that seven experienced neurological problems. The most severe was that of a San Francisco man who lapsed into a coma. He was revived but later died when his family ordered that no extraordinary measures be taken to save his life. A second San Francisco man also experienced neurological problems that were successfully treated, although he dropped out of the study and later died. A New York man, Scott Sheaffer, died in August after experiencing disorientation that may have been connected with his participation in the study six weeks earlier. DEBATE OVER TRIAL'S SAFETY The disclosure of Sheaffer's death yesterday stirred up a maelstrom of controversy in New York about the research. Scientists worried that although the traditional approach of established studies approved by the Food and Drug Administration might be more time-consuming, they also provide more safeguards for the research subjects. ETHICS OF HUMAN TRIALS "The whole principle of regulation is to make sure that people aren't exposed to one ounce of risk more than absolutely necessary," said Michael Callen, the founder of New York's People With AIDS Coalition. "This is the ethical principle of the protection of human subjects." However, playwright Larry Kramer, founder of the AIDS Coalition to Unleash Power, supported the study, saying, "We've got to do something to increase the pace of AIDS research. I hope there are more studies like these." Delaney said there was no evidence yet that Sheaffer's death was related to his participation in the study, although he said he had appointed a committee to investigate the case. "People are forgetting how many died in the suramin, ribavirin and AZT studies -- and those were all official studies," said Delaney. "When you do studies on very sick people, some die. But all the official studies operate under a total press blackout, so people didn't scrutinize every death on them." At last night's meeting Delaney drew a standing ovation when he said the group would continue to push for faster tests of AIDS drugs. One of the participants in the trial vociferously objected to the idea that the study might be unethical. "I belive I have the right to do what I want do in regard to my health care." said Bob Barnett. " The health care I got on this study was the best I've gotten since I've been diagnosed."
Keywords: ORGANIZATIONS; AIDS; MEDICINE; DRUGS; TESTS; SECRECY; REPORT; SF; COMPOUND Q (DRUG); PROJECT INFORM
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