Those Who Paved the WayCelia Wasco's discusses the role of patient advocacy in medical research, focusing on the impact of the ACT UP movement and the inclusion of patients' voices in clinical research and drug development.
As the fourth participant in the Personal Genome Project, Dr. Misha Angrist is experienced in paving the way in which the public interacts with scientific research. He voluntarily chose to have his entire genome sequenced and made public.
In his professional life, he continues to explore and share the way we govern and regulate research with human beings. At Duke, he teaches a class on patient activism and advocacy where he takes his students through the research process from “guinea pigs to pink ribbons” (or from wet lab research to treatments for breast cancer).
During the seminar, he shared a core patient advocacy movement that permanently changed clinical research and the drug approval process. It seems natural to include patients in the way that their medical condition is researched and treated, whether it’s a diagnosis of diabetes or ALS. However, the involvement of patients in the medical research process is a rather novel development. We have ACT UP (AIDS Coalition To Unleash Power) to thank for the presence of patients’ voices in clinical research and drug development. In 1987, the group formed to bring attention to the AIDS epidemic and advocate for an overlooked and underserved patient population. They battled the FDA to expedite the process of testing and approving AIDs drugs.
Dr. Angrist examined the problems that arise with three different stakeholders in the drug development process. The FDA’s primary goal is to ensure that all drugs available to the public are safe and effective. This often means lengthy clinical trials and years of waiting before a drug is available to the public. Patient’s want the FDA to accelerate the process of testing and approving drugs so that they can have access to potentially life saving medication as soon as possible. Pharmaceutical companies are supportive of rapid drug approval because it means they will spend less money on further clinical trials and have more time on their patent in the market. If a balance between efficacy testing and speed is not found, patients may desperately pay high costs for drugs with no proven benefits and potential side effects. The FDA must evaluate safety and efficacy but also incorporate patient health and bodily autonomy into their decision-making process.
In the case of the AIDS epidemic, the FDA was not effectively testing and approving promising treatments. This led many people to protest outside the FDA headquarters for withholding AIDS drugs safely used in other countries and blocking patients from life saving medication. At the time, the only available drug to treat HIV, ATZ, was not entirely effective and was toxic. With over 140 potential drugs identified by the FDA as potential treatments for HIV, ACT UP demanded that the FDA accelerate their research and “get drugs into bodies”.
ACT UP set the blueprint for activism and advocacy and set a new precedent in which patients had a voice in decision-making processes at the FDA. The movement started a conversation on how to include patients in clinical research. In the 1990s, the FDA began to include patient representatives on every advisory board. There is no doubt that ACT UP helped accelerate the process of finding an effective treatment for AIDS. Fast acting drug approvals of the past helped to prepare the FDA to rapidly approve covid-19 vaccines.
Patient voices are crucial for health equity and optimal medical care. As we advance patient advocacy in the present, we must acknowledge that our ability to do so is a legacy of ACT UP.
Celia Wasco, Huang Fellow ’26
Celia Wasco is a first-year student from Neenah, Wisconsin, pursuing a Program II major in bioethics with a minor in computer science.