There is no doubt that the FDA of the 1970s and 1980s was sclerotic, slow and conservative. The tempo and trajectory of how we developed drugs—even ones not designed for public health emergencies such as the AIDS epidemic—were not fit for purpose. That’s why ACT UP “seized control of the FDA” in our first national action in 1988. The central motivating force of our campaign in those early years was to speed up the government’s regulatory pipeline so that we could actually use drugs that we hoped and believed could save our lives if the FDA approved them faster. This is the point that many of the patient groups today hearken back to in invoking the work of ACT UP.
The flaw in their thinking, though, is that this is only part of the story—and in simply grabbing hold of the notion that “drugs into bodies” is the only thing that matters, they do a disservice to our legacy and to the future of patients today.
You see, for HIV back then, as for many diseases now, the lack of effective treatments wasn’t only about the FDA. It was also that the treatments going into the regulatory cascade simply did not work, or work well enough. That’s why, even as we pressured the FDA, we also fought ferociously to reform the way clinical trials were designed and conducted, forcing our way to a seat at the table with researchers and academics. We devoted considerable effort to the National Institutes of Health, figuring out how to jumpstart biomedical research on HIV—to prime the pump, so to speak—and to get new ideas for treating this virus from the bench to the bedside.
At the FDA, while we pushed for proposals such as accelerated approval (yes, that was us), we also quickly realized that access to drugs alone was insufficient to save our lives, we needed rigorous evidence that they worked. We became experts in clinical trial design and were mentored by biostatisticians to help us understand how to evaluate these studies. We proposed the “parallel track,” a mechanism by which drug companies could offer new drugs for free to patients in “expanded access”, while the critical randomized, controlled studies to assess their efficacy continued. Several early drugs, such as ddI and d4T, were offered to tens of thousands of patients, while others enrolled in studies of the drugs as well. “Access AND answers” was our mantra.