A 19-Year-Old Dropout Who Helped Save Millions of Lives

A playwright. A bond trader. A college dropout. A teenager. These are the people who walked into the FDA in the late 1980s and early 90s and came out having redesigned how drugs get approved in America.

This is Part 2 of "How Queers Saved Modern Medicine," and it focuses on the activists who didn't just protest, they taught themselves virology, pharmacology, and clinical trial design in their living rooms. Then they sat down with the scientists, argued with them, and won.

Spencer Cox was one of them. He was nineteen years old, had dropped out of school, and was working odd jobs when he joined ACT UP and started reading everything he could find about HIV treatment research. Within a few years he was helping redesign the parallel track system for drug trials, an innovation that allowed people with life-threatening illnesses to access experimental treatments while trials were still ongoing. That system is still in use today. It helped speed the development of cancer drugs and COVID vaccines long after the activists who built it were gone.

Mark Harrington. David Barr. People who refused to accept that expertise was something that belonged only to people with the right credentials.

This is what radical intelligence looks like in service of survival.

Watch the video version: https://youtu.be/4_ThEj30aIQ
Stay in touch: https://thisweekinqueerhistory.com/subscribe
Website: https://thisweekinqueerhistory.com

Transcript

SPEAKER_00 0:00

What if I told you a playwright, a bond trader, and a college dropout redesigned the entire FDA? Hi there, I'm Chris with a K, and welcome back to this week in Queer History, where we find hope-filled, inspirational, and strategic moments from queer history that we can use today. This is episode two of our series, How Queers Save Modern Medicine. And if episode one was about the rage and the fury, this one is about the brains. Because here's something they absolutely did not teach you in school. The reason modern drug trials include diverse patients, the reason you can access an experimental treatment before final approval, and the reason COVID vaccines reached your arm as fast as they did. Well, it all traces back to a group of queer activists who taught themselves pharmacology in their living rooms and then walked right into the FDA and out-argued the experts. Let's get into it. So here's where we left off. Act Up had crashed the FDA. They'd stormed the stock exchange, and the doors were starting to open. But the activists realized something that changed everything. Protests alone can't redesign a broken system. You have to understand the system well enough to rebuild it from the inside. And that's exactly what they did. That turning point was Iris Long. She had a PhD in chemistry from the University of Connecticut and had spent 11 years at Memorial Sloan Kettering, developing nucleosides, the very class of compounds that included AZT. Heterosexual, married, living in Queens, no connection to the gay community, but she walked into an act-up meeting around 1987 and told a room full of desperate activists something nobody wanted to hear. Your strategy of importing unregulated drugs from Mexico is going to get you killed. Instead, learn how clinical trials work, beat the agency at its own game. And that message fundamentally reoriented the entire movement. Iris helped form the Treatment and Data Committee, known internally as the Science Club. She gave its members something no one else could: a rapid, robust education in clinical science. And the committee's opening principle became its credo. Know your shit, knowledge is power. And every significant gain won by Act Up was because they knew their shit. Now here's the lineup of who was in that room. Jim Igo was a playwright. Mark Harrington had a Harvard humanities degree. Peter Staley was a former bond trader. Spencer Cox was a college dropout who'd studied theater. David Barr was a lawyer. Garens Frank Ruda was just 16 years old, and none of them had formal medical training. And within months, they'd mastered virology, pharmacology, and regulatory procedures well enough to sit across from Anthony Fauci, yes, COVID Fauci, and propose changes that career scientists hadn't imagined. Harrington absorbed the material so fast that Larry Kramer said, right away, Mark digested, as by osmosis, everything. Within weeks, he'd come up with a glossary of AIDS treatment terms. Fauci was reportedly so dazzled by Harrington's brilliance that he tried to hire him. By 1992, Harrington was delivering a keynote speech at the International AIDS Conference in Amsterdam, and he used slides of his own HIV-infected lymph nodes to illustrate unanswered questions about HIV science. He dedicated his remarks to 14 colleagues who had died since the previous conference. He named every single one. And then there was Jim Igo's invention, the one that changed everything. In April 1988, Igo presented a concept called the parallel track. The idea was deceptively simple: allow patients who were ineligible for clinical trials to access experimental drugs outside of those trials while the trials continued, save lives without compromising the data needed for approval. In June 1989, Fauci publicly endorsed it at the Montreal AIDS Conference. And he hadn't warned the FDA or his other colleagues, this move was borderline insubordinate. But he told the crowd there was a moral obligation to make experimental therapies available earlier. The first drug distributed through the framework was DDL, and over 23,000 people received it before formal approval. Think about that, what that number means. 23,000 people who have been told to wait, who instead got to try the drug that might just save their lives. And at that same Montreal conference, Act Up presented its 15-page National AIDS Treatment Research Agenda, the first comprehensive plan for AIDS research written by anyone, activist or scientist. Peter Staley recalled, everyone was buzzing about Act Up's report. We not only demanded a seat at the table, we had earned it. And the policy wins started to cascade. A huge thank you to the members that you see on screen right now. Your support makes this all possible. And it helps me keep digging through archives and sharing the queer history that inspires us. If you'd like to join them, there's a link up above and in the description down below. And if membership isn't in your budget right now, no worries. Subscribing and hitting the bell helps more than you know. Most of all, thank you for being here. Ten days after the FDA protest, the agency published Subpart E regulations, creating expedited pathways for life-threatening conditions. On December 11th, 1992, the FDA formalized accelerated approval, allowing drugs to be approved based on surrogate endpoints like CD4 counts rather than waiting years for survival data. That single change cut the timeline from 8 to 12 years to as little as three. Harrington and Greg Gonzalvez authored a critical NIH review that led to the NIH Revitalization Act of 1993. Harrington received a MacArthur Genius grant in 1997. Gonzalez earned one in 2018. College dropout to Yale Professor. The community advisory board model was revolutionary. In July 1990, Fauci announced that the activists would have representation on all AIDS clinical trials group committees. And that was unprecedented. And as he later said, before AIDS and before Act Up, all experimental medical decisions were made by physicians. Now here's the part that makes this everyone's story. The accelerated approval pathway has been used to approve 278 drugs since 1992, and 85% of those between 2010 and 2020 were for cancer. Herseptin, the breakthrough breast cancer drug, was approved in 1998 through the very pathway these activists created. The National Breast Cancer Coalition explicitly modeled itself on Act Up. And the COVID-19 emergency use authorization framework? Yeah, built on parallel track and accelerated approval infrastructure. David Kessler, who finalized Accelerated Approval in 1992, co-chaired the Biden COVID Advisory Board. Average FDA review times dropped from over 31 months before these reforms to under 10 months today. Every person who has ever benefited from accelerated drug approval, every cancer patient, every Alzheimer's patient, every person who got a COVID vaccine in record time owes a debt to a community that was told its lives didn't matter. But we have to highlight Spencer Cox. He arrived at ACTUP in 1989 at 19. He was a college dropout, diagnosed HIV positive almost immediately. He taught himself clinical trial design so thoroughly that he created the study protocol for Reznovar, the protease inhibitor, whose trial showed that half mortality rate of the placebo. That drug was approved in February 1996, and US and European AIDS death rates dropped 70% within two years. Doctors called it the Lazarus effect. Patients at death's door stood up and walked out of the hospital all by themselves. Mark Harrington said, Spencer single-handedly sped up the development and marketing of the protease inhibitors, which currently are saving 8 million lives. But Spencer struggled with addiction and depression. He stopped taking his medications, and on December 18th, 2012, he died of AIDS-related pneumonia at the age of 44, killed by the disease he had helped to make survivable. Harrington wrote, he saved the lives of millions, but he couldn't save his own. But they turned AZT into a blueprint, and that blueprint eventually led to something that would have felt like science fiction in 1987, a pill that could stop HIV taking root. But that story and why it's under threat right now is all in episode 3, so you're just gonna have to wait. But a little something more. We're so lucky we live when we live. When I was researching this episode, I was thinking about timing a lot and how when something happens, it can be beautiful, but it can also be brutal and mathematically cold. The way a few weeks can be the difference between a funeral and a future. And when I was learning about parallel tracks for this episode, it kept hitting me. There were people who were right there, right on the cusp. The medicine existed. It was sitting in a lab or stuck in a bureaucratic queue, and someone died waiting just for a signature. And then I think about the people who fixed that. People who didn't have PhDs, but decided that that wasn't going to stop them from walking into rooms full of people who did have PhDs. People who taught themselves virology in their living rooms because no one else was going to fight for them. That is a kind of strength that I don't think gets talked about enough anymore. And I came up in a generation that benefited from this education. I had all the condom talks, the safe sex campaigns, all of the infrastructure that was already built on top of unimaginable loss. I can still remember when prep was so new and being a part of an early study, sitting in clinics, filling out adherence questionnaires, and it felt so routine at the time, but looking back through the lens of history, I realized what a profound thing it was to be included in a study. To have researchers actively want my data, my experience. That didn't happen by accident. That happened because activists bled for it. And without them, there would be no parallel track, no accelerated approval, no community advisory boards, no prep. No me sitting here protected and comfortable enough to tell you this story instead of living in fear of it. And so many of them never benefited from what they built. They fought for a future that they didn't get to live in. I'm so grateful for them and for that. But the thing about this system that is currently built, yes, it was rebuilt and yes, it was reformed, but it can also be rolled back. The access that I have right now isn't guaranteed. It was fought for and it can be taken away. And again, that's not fear talking, it's it's history. It's asking us to pay attention, to be aware, to stay active. Now it's your turn. I want to hear what you think. Have you ever been on a trial or received a medicine that happened because it was an accelerated drug? Please drop your thoughts in the comments. I read and respond to all of them. And the final episode of this series, where we bring this story into 2025 and talk about what's at stake today with prep and art, it'll be out next week. But in the meantime, you can get some more queer history by clicking this video right over here. And you can also join our circle community where we keep these conversations going and alive together, sharing history, asking questions, and building more connections. The link is up above and in the description down below. Until next time, stay strong, stay bold, and keep making history.