Larry Kramer, Nathan Kolodner, Dr. Barry Gingell, and singer/songwriter and pioneering AIDS activist Michael Callen finally took their seats across a broad table from Dr. Fauci and fifteen of his selected scientists from FDA and NIH. Throughout that meeting, the advocates found Dr. Fauci both manipulative and “dismissive” of their concerns. According to Nussbaum, these leaders “had said time and again that NIAID was obsessed with AZT, that most of the trials and people with AIDS involved in the trials were on just that one drug.”39 They began by confronting Dr. Fauci with the fact that his own most trusted scientists, Dr. Laurence and Dr. Gallo, had found AL 721 effective in reducing viral loads;40 Dr. Fauci responded with a barrage of misdirection and obfuscation. He cherry-picked a single assay from an obscure laboratory that had found AL 721 ineffective and refused to discuss or acknowledge the two studies by his own agency that supported its use.
They next questioned him about his sandbagging on aerosol pentamidine. According to Nussbaum, “. . . dozens of community doctors and thousands of PWAs [people with AIDS] already knew: that Aerosol Pentamidine prevented AIDS’ most lethal symptom—pneumocystis carinii pneumonia (PCP).”41 Doctors had also found early intervention with Bactrim and Septra to be effective prophylaxis against PCP. The activists presented Dr. Fauci with a modest request: that NIAID agree to make guidelines for physicians who wanted to use Bactrim to treat people with AIDS preventively, or even a statement supporting consideration of the use. An official declaration by NIH that doctors consider these treatments “standard of care” would require insurance companies to cover their costs, making them available to AIDS victims, many of whom were destitute. Dr. Fauci met both requests with refusal. He said he simply could not recommend a drug until he saw “randomized, blinded, placebo-controlled trial” results. That was the “gold standard,” he said. It would be that, or nothing. When they asked him, “Why not?” he shouted, “There’s no data!”42 He told them that the treatment experiences and voluminous case study reports of dozens of community AIDS doctors was not real science. The activists were aware of this increasingly lethal irony: It had been NIAID’s decision to not fund any randomized trials on these unpatented drugs. Dr. Fauci himself had constructed this dead end. This pattern of resourceful stonewalling to obstruct repurposed off-patent drugs with lifesaving potential would become a pattern familiar to Dr. Fauci’s critics during the COVID crisis.
According to Callen, “We asked him—no, we begged him—to issue interim guidelines urging physicians to prophylax those patients deemed at high risk for PCP (pneumonia) [with Bactrim or aerosol pentamidine]. Although it would not have cost the government much to have done so, he steadfastly refused to issue such guidelines. His reason: no data. So, the Catch-22 was complete and many people died of PCP who didn’t have to.”43
When the activists asked Dr. Fauci to at least add AL 721, Peptide D, DHPG, and aerosolized pentamidine to his clinical trials, Dr. Fauci’s refusal was loud: “I can’t do that!” he shouted. “I can’t convene a consensus conference.”44 The choice, he explained, of which compounds would enter NIAID’s clinical trial pipeline was made, not by public agreement, but by a panel of “independent scientists.” Dr. Fauci did not mention that virtually all the members of his “independent panel” were pharmaceutical PIs, with ties to NIAID and Burroughs Wellcome.
Following that meeting, a group of frustrated community doctors raised money from their own AIDS patients to collect data for a randomized trial on Bactrim. It took them two years, and their results strongly supported Bactrim’s effectiveness against pneumonia. AIDS activists lamented that two years of stalling by Fauci on aerosol pentamidine and Bactrim had cost seventeen thousand people their lives.45
Following the NIH parley, the fury of the AIDS patient advocates against Dr. Fauci mounted. In their view, the community doctors were generating plenty of good science. Those treatment experiences—often published—had as much validity as case studies upon which scientists routinely rely. As Nussbaum points out, “There was plenty of data, if only Fauci and the rest of NIH were willing to look at real people in real communities instead of the endless bottoms of their test tubes.”46
Michael Callen told Nussbaum that Dr. Fauci’s single-minded concern seemed to be avoiding the mortification of acknowledging success by doctors outside his agency. “He would not be humiliated even if ‘Fauci’s decision cost the lives of tens of thousands of people with AIDS.’”47
Michael Callen, Larry Kramer, and the other AIDS activists left the NIH sit-down in a fierce rage. In June 1987 at a postmortem at ACT UP’s circus-like New York City headquarters auditorium (where I often spoke on environmental issues during that era), Kramer lambasted Dr. Fauci for his Pharma bias:
“Where are the drugs the government promised?” he asked. “After we got them millions of dollars for their experiments, what do we get? A ten-thousand-dollar drug! What about all the other drugs out there?”48
Congressional Confrontation April 28, 1988
Dr. Fauci had given Kramer and the other activists the bum’s rush. He could not do the same with his congressional patrons. For years, my uncle, Senator Ted Kennedy, the chair of the Senate Health Committee, and Senator Lowell Weicker, who chaired Senate Appropriations, along with their allies in the House, California Congressman Henry Waxman and Manhattan Congressman Ted Weiss, had fought hand-to-hand combat with Ronald Reagan’s tight-fisted budget director, David Stockman, to free up money for AIDS research.
In 1980, Teddy became the first presidential candidate to actively campaign for gay rights. I stumped with him in San Francisco’s Castro District when he shattered political taboos by barnstorming the gay bars, shaking hands, and snapping photos. When the AIDS epidemic broke a year later, Teddy defied convention by hiring Terry Beirn, the first openly gay/HIV-infected Senate aide, to stage-manage the legislative battle against AIDS. Beirn became the leading national advocate for the community-based clinical trials for remedies like Bactrim and aerosolized pentamidine, to which Dr. Fauci had shown such hostility.49 Beirn had hatched the idea for a community research initiative (CRI) with Teddy’s close friend Mathilde Krimm, of the activist group of amfAR, and Martin Delaney of Project Inform. Their proposal was to create a “parallel track” approval system that would allow community AIDS doctors to conduct clinical studies on the off-the-shelf drugs that neither Pharma nor NIAID wanted to test. Delaney, who did not have AIDS but made his bones in the movement smuggling ribavirin from Mexico for the Buyers Clubs, described the parallel track program as “medically supervised guerilla drug trials.”50 Appealing to his friend Senator Orrin Hatch’s Mormon sense of compassion toward the ill, Senator Kennedy had recruited the Utah conservative Republican to cochampion the AIDS issue. Independent-minded Connecticut Senator Lowell Weicker was another key ally. Those three most powerful senators from three different political perspectives worked in tandem and with Waxman and Weiss in the House. Their coordinated bipartisan efforts freed up hundreds of millions of dollars from the White House bean counters, over the objections of powerful Christian conservatives who framed AIDS as God’s just punishment for the homosexual lifestyle.