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Acceptable Risks.

How two gay drugrunners changed the FDA

There is nothing in the heterosexual experience that remotely coincides with being gay in America today. The experiences that come closest are mercifully rare: seeing your entire platoon wiped out before your eyes, say, or answering the telephone on a Friday night to hear that your children have been killed by a drunken driver. Multiply one of those horrors by 10 and you get a glimmer of what life has been like for many gay men during a decade of watching their friends and loved ones succumb to a hideous death. As horrifying as the death itself is the inevitability that precedes it, waiting for the end while scientists and doctors search for a cure they might never find. But as Jonathan Kwitny shows us in this book(*), not everyone has been willing to watch and wait.

By the time AIDS struck at the beginning of the eighties, many of this country's gay men had migrated to its biggest cities. Educated and affluent beyond the norm, they counted among themselves not only doctors and scientists but businessmen, entrepreneurs, lawyers, scholars, politicians, and other professionals who had grown distrustful of the straight establishment during the gay rights battles of the seventies. Driven by what appeared to be the impending extinction of their tribe, they set out to learn as much about the thing that was killing them as the doctors and scientists knew. And they succeeded, to the extent that a diner in a San Francisco restaurant is now likely to overhear a more lucid discussion of immunology or blood cell biology than can be found in many scientific labs.

AIDS, nearly everyone agreed, was caused by a virus called HIV. There exists a class of drugs, called antiviral agents, that were designed to combat such diseases. These compounds, which had names like ribavirin, isoprinsosine, and dextran sulfate, were freely available in Mexico, the Far East, and Europe. But there was no way of knowing whether they might be effective against AIDS because none of them had been approved by the U.S. Food and Drug Administration (FDA). By law, no drug can be sold or prescribed in this country until the FDA has declared it both safe, meaning that it doesn't cause serious adverse side effects, and effective, meaning that it does what it is supposed to do. But the FDA hadn't seen any evidence that ribavirin and the other drugs available outside the United States were either safe of effective. For all the FDA knew, they might be dangerous, even deadly.

Deadly to whom? Jim Corti wondered. To Corti, a Los Angeles nurse, it seemed the height of perversity that those dying of AIDS were being denied drugs like ribavirin that could be obtained for a few dollars in any Mexican farmacia. There was some evidence that ribavirin interfered with the reproductive cycle of ordinary viruses. But even if this didn't include the AIDS virus, how could the FDA prevent a dying person from trying a drug that might prolong, if not actually save, his life? And if ribavirin should somehow cause that life to end sooner rather than later, who should make that decision? As Corti watched his friends sicken and die, he realized that the words "safe and effective" meant something quite different to someone with a few months, or weeks, to live.

Thus it was that Corti, at the wheel of his yellow-and-white microbus, blazed the trail for what would become the ribavirin run to Tijuana. From those weekend trips to fill orders for friends arose a thriving industry, a loose national network of illicit "buyer's clubs" whose organizers scoured the planet for drugs that might combat AIDS. No one who took ribavirin or any of the other underground drugs ever got well. Indeed, there is no case on record of even a single AIDS patient actually recovering from the disease, and the FDA remains unconvinced of the therapeutic value of ribavirin. Kwitny presents anecdotal evidence, as others have before him, that some lives may have been extended by ribavirin and a few of the other underground drugs that followed it across the border. Persuasive clinical evidence for most of them is lacking, but the FDA recently approved the use of one previously bootlegged compound, ddC.

As told by Kwitny, Corti's story reads like a rewrite of Snowblind starring Albert Schweitzer. Despite the gravity of his mission, Corti no doubt had a certain amount of fun jetting around the world, putting together big-money "drug deals" with a variety of colorfully shady characters, and running circles around the customs police of several nations. Still, the possibility remains that he might be a genuine hero. The case for Kwitny's other protagonist, a former San Francisco banking consultant named Martin Delaney, is less clear. While Corti played tag with the border patrol, Delaney took on the FDA. Arguably the most important federal regulatory agency, the FDA was a disaster area long before Delaney discovered it. In recent years, scandals at the agency have come to light involving generic drugs, breast implants, sleeping compounds and more. (Next on the list may be the FDA's decision to permit the nation's blood banks to continue using a seriously flawed AIDS screening test during most of 1986.) But none of these can match the FDA's heeldragging in approving so-called "investigational" drugs, and its obdurate insistence that even terminally ill AIDS patients need the full protection of federal regulation.

Crossing Delaney

Delaney and I have our disagreements, as Kwitny makes clear, but the performance of the FDA in the post-thalidomide era is not among them. Nor are the underground experiments (now called "community-based trials") set up by Delaney and his followers to test the drugs that Corti and others like him were smuggling into the country. The scientific establishment detested these trials, not least because Delaney was field-testing drugs in ways that real scientists, who had to play by the FDA's rules, could not. What if, the scientists wondered, one of these weird compounds actually proved to be the magic bullet that cured AIDS? Would Corti and Delaney win the Nobel Prize for medicine? A more reasoned criticism concerned the absence, in most of the underground trials, of any controls. If 100 AIDS patients took ribavirin and all of them got better, scientists still wouldn't believe ribavirin worked unless another 100 patients who had been given a placebo were dead. Controls, the scientists argued, were needed to show that it was ribavirin alone that made the difference. But the FDA didn't seem to understand that one couldn't ask a dying man to take part in a drug trial in which he had a 50-50 chance of being given nothing. Apart from the ethical considerations, at those odds there simply wouldn't be many volunteers. And if the trial subjects got better, what more did the FDA or anyone else need to know?

Once it was clear that the AIDS community included people like Corti and Delaney who were not afraid to play by their own rules, the FDA and the giant pharmaceutical companies began paying attention. Once Delaney, a natural organizer and skilled negotiator, got through the door he was able to rewire parts of the federal bureaucracy simply by networking among confused, bickering bureaucrats. Not long after he forced the first grudging concessions from the FDA on the use of investigational drugs, Delaney found himself appointed to scientific committees and boards, becoming the AIDS community's self-nominated ambassador to the scientific establishment.

Profits and saints

Kwitny, an unusually good writer for an investigative reporter, has twined the stories of Corti and Delaney into a book every bit as compelling as any adventure novel. Because it is so uplifting, I would like to believe that Kwitny's story is true. Unfortunately, this book should be subtitled The Jim Corti-Martin Delaney Story as Retold by Jonathan Kwitny. Kwitny acknowledges, in an afterword, not only having fashioned composite scenes from events separated in time, but having reconstructed (i.e., fabricated) the direct quotes that give the story much of its narrative force. He attributes his decision to do this to a "reader preference for detailed dialogue," and it is true that time compression and made-up dialogue can make a book more fun to read, or a dramatization more fun to watch: Acceptable Risks is reportedly "in development" as a film at Warner Brothers. Bit if we are unsure whether the story told by Kwitny is completely true or merely incomplete, we can be sure it's the story Corti and Delaney want us to believe. Kwitny's afterword states that, although the author remained "the final arbiter" of the book's contents, both Corti and Delaney reviewed the manuscript prior to publication and will share 40 percent of the book's profits. Moreover, Kwitny apparently took most of what Corti and Delaney told him at face value. "I felt I could rely enough on their accounts," he writes, "not to clutter the book with attributions for statements based on the word of two people who are effectively colleagues as well as sources." The relatively small number of instances

V in which Kwitny notes any disagreement with his colleagues' version of events are neatly tucked away in footnotes where they do not interfere with the book's dramatic flow.

Even a commissioned, fictionalized biography does not have to be one-sided. In this one, however, the reader will search in vain for a single unflattering reference to either Delaney or Corti. This is especially remarkable considering that politics in the gay community is more convoluted than in the former Yugoslavia. On any given day, it's nearly impossible to know who speaks for whom. And while one would never guess it from Kwitny's book, Delaney's opponents are as vocal as his supporters. Although the San Francisco newspapers have quoted other gay leaders calling Delaney dictatorial, messianic, and worse, Kwitny does not even raise the question of Delaney's tactics and style, much less whether he has been co-opted by government access and pharmaceutical industry grants.

Whether Delaney is a nice guy is ultimately beside the point, because he has dedicated himself to saving lives, not being nice. But Kwitny's credibility suffers when he ignores the many members of the AIDS community who do not think Delaney is yet a candidate for sainthood.

Far more serious are the unsubstantiated allegations of profiteering that have been leveled at both Corti and Delaney. In a recent incendiary letter to the FDA, Delaney's most outspoken critic, a rival gay leader and Shakespearean scholar named Jim Driscoll, accused Delaney and Corti of a variety of deceptions and abuses, among them that Corti sold at least one AIDS drug, the now-legal ddC, on the underground market for several times its cost. Such allegations, which include rumors of secret foundations and Swiss bank accounts, have been heard on the streets of San Francisco and Los Angeles for some time. Disproving them should have been a piece of cake for a reporter like Kwitny, who made his reputation investigating the CIA and the mob. By steering sharply away from those charges or anything else that might diminish the cinematic superhero aura in which he cloaks his two characters, Kwitny does not do those heroes, or himself, any favors.

Earnest or Dubious Gallo

Kwitny's selective reporting is harder to accept because of the strictness with which he judges other writers, including Gina Kolata of The New York Times and myself. Kwitny devotes pages of footnotes to various putative errors in Kolata's reporting of Delaney's activities, principally the underground trials of a drug called Compound Q. Kolata may well be a sloppy reporter--her recent story on DNA fingerprinting required a rare front-page acknowledgment that the Times had erred. But in writing about events of which I have firsthand knowledge, Kwitny himself makes errors, large and small, that he should have avoided.

I speak of what has, inappropriately, come to be known as the "Gallo case," my reporting of which happens to be the source of Delaney's--and by extension Kwitny's--unhappiness with me. The Gallo

V story is generally perceived as a squabble between French and American scientists over who discovered the AIDS virus. It isn't. Everyone, Gallo included, now admits the French are the true discoverers of the virus. The story is really about what looks like phony science, patent fraud, perjury, obstruction of justice, a fatally flawed AIDS test, the safety of the blood supply, illegal experiments on African children, and a Reagan-Bush administration coverup of abuses flowing from the recognition that the S in AIDS is actually a dollar sign.

So hideously complex has the Gallo case become that it is now fully understood by only seven people in North America, none of whom is Kwitny or Delaney. (Unhappily for NIH, one of the seven, Suzanne Hadley, the agency's former chief investigator, has just been reassigned to Rep. John Dingell's subcommittee on investigations.) In rising to Gallo's defense, however, Kwitny nevertheless makes claims in Gallo's behalf that even Gallo doesn't make, such as the assertion that Gallo had more than 25 isolates of the AIDS virus when he was accused of "expropriating" in AIDS virus sample sent to him from France. NIH investigators may also notice, two pages later, that Kwitny's recounting of Gallo's explanation for failing to publish his experiments with the French virus contradicts crucial portions of Gallo's own testimony.

Complexities aside, Kwitny and Delaney's point is that people with AIDS don't care who discovered the cause of this disease or how much credit they gave one another. They are waiting for somebody to discover a cure for AIDS, a process with which Delaney thinks the multiple ongoing investigations of Gallo's activities have somehow interfered. Near the end of the book, for example, Kwitny recounts Delaney's trip to Japan to talk to a pharmaceutical executive, Mr. Osada, about a drug that Gallo thought might cure Kaposi's sarcoma, a kind of cancer that afflicts some gay men with AIDS. When Delaney urged the company to make the drug available to Gallo for further testing, Osada mentioned that Zaki Salahuddin, the Gallo assistant involved in testing the drug, had just pleaded guilty to accepting illegal kickbacks. Kwitny writes:

Without stating the final decision, Osada

changed the subject to Gallo. Given the

Salahuddin problem, the last thing Delaney needed

V

that day was just what had happened--publication

of another story in the American press

that Gallo was going to be investigated yet

again over the Crewdson charges. And

Delaney was left to learn about it from Osada,

who added gratuitously that all these

newspaper articles aroused further caution about a

joint research agreement. Thanks a lot,

Crewdson, Delaney thought.

Gallo wasn't fired, the joint agreement was signed, and the testing of the drug has now begun, although it does not appear as promising as initially thought. And Delaney must know that the company's reluctance to go ahead primarily involved patent considerations and its belief that the number of gay men with Kaposi's sarcoma did not constitute a profitable market. But anyone who suspects that the NIH and congressional investigations have kept Gallo from his test tubes need only to look at his government travel records. And given the track record of Gallo's lab for mixing up and misidentifying viruses, the chances aren't particularly good that any of the scientists there could find a cure if somebody left it on his front porch.

Does it need to be said that people without AIDS share Delaney's wish that AIDS be quickly erased from the earth? Apparently it does. But is that incompatible with concern about the corruption in science and government the AIDS industry has spawned? Still, it is important for us to remember that it is Martin Delaney's platoon, not ours, that is being wiped out.

(*)Acceptable Risk. Jonathan Kwitny. Poseidon, $24.

John Crewdson is a senior writer for The Chicago Tribune based in Washington.
COPYRIGHT 1992 Washington Monthly Company
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Author:Crewdson, John
Publication:Washington Monthly
Article Type:Book Review
Date:Oct 1, 1992
Words:2653
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