AIDS Underground : Drug Tester: Hero or Just a Renegade?

In contrast to millions of Americans who moved to California in search of new lives, Martin Delaney came here from Chicago in 1980 contemplating death.

Chronic hepatitis was eating away at his liver, and doctors advised him the prognosis was grim.

Then hope appeared in the form of an experimental drug program at Stanford University. Delaney signed up and underwent six months of arduous treatments. The medication halted the destruction of his liver but at the cost of a severe side effect: a permanent condition called neuropathy that causes sharp, burning pain in his feet.

Drugs Not Marketed

The trial was shut down in 1982 and the two drugs Delaney took were never marketed. Five members of Delaney’s support group for chronic hepatitis sufferers who came down with the disease after the trials had ended have since died.

“None of them was allowed to choose, as I was, between an early death and living a useful life with sore feet,” said Delaney, who must take methadone daily to control the pain. “The decision should have been theirs, not some pinhead bureaucrat’s in Washington.”

The experience propelled Delaney, a 43-year-old advocate of AIDS patients, to take action.

In 1985, he put his successful consulting business on hold and co-founded Project Inform. The group’s chief goals are to gather information about--and speed access to--promising treatments for AIDS “without being victimized by profiteers or the endless delays of bureaucracy.”

Most recently, Delaney put his philosophy to work by recruiting patients and doctors for the underground trial of a touted Chinese drug called Compound Q.

Works in Two Worlds

Delaney represents a new breed of AIDS activist who battles the epidemic by straddling two often-incompatible worlds. In one of them, he acts as “the field general” of a growing AIDS underground treatment movement, said nurse Jim Corti of Los Angeles, who brought thousands of doses of Compound Q out of China at Delaney’s direction. In the other, Delaney travels comfortably through official Washington, maintaining good relationships with--and constantly prodding--key officials of the U.S. Food and Drug Administration and National Institutes of Health.

Some fret that those relationships may be sorely tested as a result of the unsanctioned Compound Q trial, which was designed to test the drug’s safety and efficacy more quickly than an FDA-approved trial of a similar drug at San Francisco General Hospital.

Last week, the FDA, which insists that it already is expediting AIDS drugs, announced a probe of the Compound Q study after one patient died, possibly from side effects of the drug, a second committed suicide and a handful suffered serious complications. Many of the other patients have shown improvements, although Delaney said it still is too early to draw conclusions about the drug.

The heart of Delaney’s argument is that patients with AIDS and other life-threatening illnesses should be permitted to assume greater risks in trying unproven therapies. “Society must rethink the risk-benefit ratio when the patient has so much to lose by doing nothing,” he said.

A former Jesuit seminarian who is gay, Delaney defends his activities against AIDS in fiercely moral terms. “This is our holocaust,” he said. “We only have one chance to live through it with dignity and a clear conscience that we did all we could.”

Into the Establishment

While other AIDS activists take to the streets, Delaney has used guile, persistence and sheer intellect to insinuate himself into the highest levels of the federal research and drug regulatory establishment.

He confers frequently with FDA Commissioner Dr. Frank Young and National Institutes of Health AIDS research chief Dr. Anthony Fauci, lobbies for greater access to experimental medicines in such prestigious forums as the Journal of Infectious Diseases and sits on the National Academy of Sciences Institute of Medicine’s Roundtable for the Development of Drugs and Vaccines Against AIDS.

“He makes the case for patients in an intelligent, articulate and non-hysterical way,” said Fauci, who serves with Delaney on the panel.

In doing so, Delaney has become part of an informal brain trust of AIDS activists that is changing the face of research into AIDS and other life-threatening illnesses. Other members include ACT UP’s Mark Harrington and Jim Eigo, attorney Jay C. Lipner and a small number of congressional staff members and federal agency officials. Together, they are slowly pushing the federal drug approval process and presenting an unprecedented challenge to the traditional medical establishment.

In recent weeks, for example, the FDA announced the early release of a pair of drugs to prevent AIDS-related blindness and anemia and Fauci unveiled a new way of testing drugs that could increase access to experimental compounds. Beyond AIDS, the National Cancer Institute said it would make the drug levamisole available for colon cancer before results of clinical trials are published.

By speeding the release of AIDS treatments, the activists have raised hopes that the disease will some day become a chronic but manageable illness, like diabetes, rather than a death sentence. Still, some advocates of regulatory reform worry that Delaney’s audacious compound Q experiment went too far and could spark a backlash.

Delaney responds that the only difference between the Compound Q experiment and the many instances of patients gulping other unapproved drugs in the past “is the professionalism and scientific integrity” of the Compound Q experiment. “This event and the threat of future ones like it will be a powerful lever for reform-minded bureaucrats.”

The Compound Q trial has also reignited the long-simmering debate over desperately ill patients’ access to experimental therapies and has led to deep soul-searching by medical ethicists and others.

Scientists performing FDA-sanctioned experiments on the official version of the drug, known as GLQ-223, criticized Delaney’s renegade research, and medical ethicists and some doctors scored Delaney for moving ahead without studying the drug’s toxicity in humans.

“I have grave concerns when he starts playing doctor and superseding the responsibilities of the FDA,” said Dr. Shelley M. Gordon of San Francisco. One of Gordon’s patients was injected with Compound Q in the underground trial by another doctor and had to be hospitalized with neurological problems. Gordon suspects the drug.

Others applauded Delaney’s action. “He is a hero,” declared Larry Kramer, a New York playwright and AIDS activist. “Talk does not save lives, but action might,” added Hank Wilson, a San Francisco hotel manager who has AIDS.

Delaney said the debate is long overdue. “These were terminally ill patients who had exhausted all other options,” he said. “The problem with the ethicists in their ivory towers is that none of them is personally threatened by this disease.

“The voices I hear in my heart, the people I answer to, are the people with AIDS and the people with this virus.”

One such voice belongs to Robert Pitman, a 48-year-old San Francisco playwright with AIDS. Pitman just completed a three-week course of infusions with Compound Q in the Project Inform trial.

“I could care less about the FDA investigation, or what the ethicists say,” said Pitman. “I went into this fully aware that death was a possible side effect. I faced my fear of death a long time ago, and I decided that I wasn’t just going to fold up my tent.”

Pitman said his energy level has increased considerably since the treatments and his lab tests are encouraging. “If Q doesn’t work and something else that is promising comes along, I’ll try it,” he said.

The Project Inform study, which is being conducted by a team of nine doctors, has now enlisted 60 volunteer AIDS patients in San Francisco, Los Angeles, New York and Miami. Physicians conducting the study strongly warn AIDS patients against trying to self-administer the drug.

Even with those warnings, National Institutes of Health AIDS research chief Fauci argued Project Inform’s underground trial of Compound Q is “a serious mistake” because of the precedent it sets. “What if the next time somebody less knowledgeable and altruistic than Marty--or even a fraud artist--comes along and tries something like this? You could have a real disaster on your hands.”

But Delaney claims the AIDS underground treatment movement has grown so sophisticated that it can distinguish between valid hope and wishful thinking. Besides, he added, it was only a matter of time before Compound Q, a form of trichosanthin refined from the root tuber of a Chinese cucumber, found its way into this country.

“The same thing happened with ribavirin from Mexico and dextran sulfate from Japan,” he noted. (Both drugs have proven ineffectual in the oral versions available through the underground, although research is continuing on intravenous dextran sulfate.)

“If the community is going to go out and use it, we felt it was far better to take some risks with a small group of willing people, and to get answers as quickly as possible,” Delaney said.

“The system never counts the tens of thousands of patients who are hurt by delays in drug development. There must be accountability on both sides of the ledger.”

Critics argue that even if Project Inform’s Compound Q experiment is being conducted in strict adherence to scientific principles, Delaney has too much personal involvement for the research to be objective.

“A scientist is trained to construct a study so that his personal biases do not get in the way,” said Gordon, the San Francisco doctor whose patient suffered neurological complications.

When Gordon wrote in the patient’s chart that he had been administered a “relatively impure” version of GLQ-223, Delaney wrote a letter to the head of her medical center demanding a correction.

Delaney noted in his letter that the drug had been “tested to be better than 99% pure by the most knowledgeable protein chemistry laboratory in the United States.”

Gordon replied by letter that “even trivial contaminants” can cause “irreparable damage . . . as a physician I am obligated to consider all possible causes of my patients’ illnesses.”

In an interview, she added: “I was appalled that Martin Delaney was reading my patient’s chart and asking me to forgo my objectivity.”

Dr. Donald Abrams, deputy director of AIDS activities at San Francisco General Hospital, said he fears that “self-educated medical scientists like Martin Delaney may shatter the confidence many people have in their physicians.”

“It is all well and good for people who are not trained to try to pick up the science,” Abrams continued. “But it is important to realize that there is an art to medicine which is much more difficult to acquire.”

Delaney acknowledges that he has no formal scientific training. “I learned AIDS and the science of AIDS about the same time as everybody else did, including the doctors,” he said.

“As a child and into high school days, I was pursuing a scientific career, but as the son of a good Catholic family I was shuffled off to the Jesuits to become a priest instead.”

‘Higher Truths’

Delaney left the seminary shortly before his ordination, but friends and business associates say the training left its mark. “He is willing to give of himself to the point of martyrdom,” said Lois Pryor, who worries about Delaney’s health. As a result of the hepatitis, his liver retains only 10% of its function.

“Clearly, this is a man who believes in higher truths,” she added.

“If he feels something is wrong, he will pursue it tenaciously,” added Ronna Jacobsen, a former girlfriend who taught elementary school with Delaney in a Chicago suburb after he left the seminary.

Delaney faults the old system of medicine in which “the physician is a god-like figure with healing powers,” he said. “Healing occurs out of a collaborative process between patient and physician. That is especially critical in a life-threatening illness.”

To help AIDS and HIV patients to make informed decisions about their health, Project Inform operates six toll-free hot lines and publishes a newsletter that it sends, free, to anyone requesting it. The nonprofit organization has two full-time employees, two part-time employees and 60 volunteers.

Project Inform’s basic message--that people who are at risk for HIV should find out whether they are infected and seek treatment before the virus causes AIDS--stirred controversy when it was first issued in 1985.

Doctors frequently were reluctant to initiate treatment before patients became sick, preferring “the old wait and see,” as Delaney puts it. And some AIDS organizations vacillated on HIV testing because they worried about possible discrimination and the psychological impact of a positive test result.

Last month, Project Inform’s message was vindicated when the U.S. Public Health Service issued guidelines urging HIV testing and early treatment with such drugs as AZT and aerosolized pentamidine to prevent the often-fatal pneumocystis carinii pneumonia that kills most people with AIDS.

“At this point, anyone who suggests that testing is a neutral question is inviting people to walk blindly into an AIDS diagnosis when the medical reality is that we can prevent or delay it,” Delaney said.

Now that his once radical message on the early treatment of HIV infection has been accepted by the mainstream, Delaney said he feels an obligation “to push the system further.”

“The challenge of AIDS was, is and for the near future will remain to act in the face of uncertainty, and not to be immobilized by denial or imperfect solutions,” he added.