San Francisco Chronicle - Wednesday, June 28, 1989
Randy Shilts, National Correspondent

FDA spokesman Brad Stone, noting that the secret studies are being conducted without "FDA approval or sanction," said, "We're looking at the operation to determine whether there have been any problems or violation of the law."

Stone said it was "too early to speculate" whether the agency will proceed with criminal prosecutions.

Among scientists, meanwhile, controversy continued yesterday over the secret Compound Q tests, which are based in San Francisco.

Researchers at San Francisco General Hospital said community organizers of the underground trials recklessly endan- ger the lives of AIDS sufferers and undermine their government-approved studies of the substance. LEGALITY ASSERTED

Organizers of the clandestine study - conducted wholly outside the normal channels of AIDS research - countered that their work is "entirely legal," and they pledged to continue the trial of the promising treatment.

Yesterday's disclosure of the unofficial trial, in which 42 people across the nation are being given the unapproved drug, underscored a long-running dispute about the speed at which AIDS drugs are tested and approved.

Officials at the National Institutes of Health declined to comment publicly on the trial yesterday, even as the elaborately designed study became the major subject of discussion among AIDS researchers nationwide.

"These people are encouraging the use of a drug in unknown standards in apparently unsafe doses," said Dr. Paul Volberding, director of San Francisco General Hospital's AIDS Program and a leading AIDS researcher.

"In the interest of supposedly accelerating research, they are threatening the development of it because they are bypassing safety considerations," he said. APRIL ANNOUNCEMENT

Study organizers began plotting their study in April after researchers at the University of California at San Francisco announced that their drug, GLQ 223, a derivative of fresh Chinese cucumber root, appeared to selectively kill HIV-infected immune system cells.

With the prospect that Compound Q, as it became known among AIDS groups, could be a virtual cure, a network of physicians, community organizers and people with AIDS organized their own clinical trial, which was run out of private doctors' offices in San Francisco, Los Angeles, New York and Miami.

Study organizers said that the Food and Drug Administration-approved study of possible toxicities of GLQ-223 was moving too slowly and that their work could demonstrate that such studies can be conducted much more rapidly.

"We expected an investigation and we welcome it," said Martin Delaney, the key organizer of the study. "We have nothing to hide. All of the normal precautions and controls were used here."

Attorney Curtis Ponzi said an FDA investigation would find that "these doctors practiced very good medicine. There was nothing illegal about monitoring patients who had decided to take a drug."

Ponzi said that under FDA rules patients can import their own medications and take the drugs under a doctor's care. "This study was entirely legal," he said. NEED FOR SPEEDY TRIALS

In a statement released yesterday, the American Foundation for AIDS Research did not condemn the testing, saying it only showed the need for speedier drug trials.

"Private-care physicians and their patients are desperate to participate in the search for effective treatments," the statement said. "Unless we provide the resources to channel those energies, we can expect to see more reports of unauthorized experimentation."

The FDA statement also said it will study "the exact circumstances surrounding the death" of a San Francisco man who was participating in the study. He was one of two San Francisco men to die while taking the drug.

Mount Zion Hospital spokeswoman Pat Newman identified the man as Robert Parr, a 44-year-old real estate broker. He was one of 14 men who started the experiment in San Francisco.

Parr, who had suffered from HIV-related brain disorders and brain damage from a 1981 hammer assault, went into a coma last week after his second injection with the drug, according to his physician, Larry Waites, one of the doctors working on the unapproved study.

Parr had come out of the coma on Friday and appeared to be regaining his health when he choked on his own vomit at Mount Zion Hospital on Saturday morning. He died after the family forbade physicians from taking any extraordinary measures to save his life, Waites said. Study organizers said the death was unrelated to the drug's use. DRUG TOXICITY

Volberding, the director of the first-phase research on Compound Q, said yesterday that it is too early to disregard the role that the drug's toxicities may have played in the man's demise.

"Deaths on a drug study - any drug study - are reported as related unless proven otherwise," Volberding said. "It's hard for me to believe that a patient who becomes comatose isn't suffering from a drug toxicity."

Such severe reactions, particularly as they are seen on AIDS patients, require researchers to move slowly in the first stages of drug research, Volberding said.

The underground study's organizers disagreed. "They're just saying that because we're moving ahead outside of the systems they have control over," Waites said. "They can look at the medical records and see the facts for themselves."

Dr. Alan Levin, another physician working on the unofficial study, said preliminary data has shown what appears to be a beneficial impact of the drug on the immune systems of the study subjects.

"Things are happening," he said.

The last injections of Q in the San Francisco branch of this study are slated to be administered today in Levin's office.

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