As we commemorate World AIDS Day, there’s more to reflect on than support for those people living with HIV and honoring the 40 million people we have lost globally to AIDS-related illnesses.
Despite its devastating impact on patients around the world, the public health efforts surrounding HIV/AIDS set a new bar for self-awareness in healthcare. For example, if you consider the achievements made possible by patient advocacy across a host of disease areas – from access to new medicines, increased global awareness, expanded fundraising, and reduced social stigma – you can thank the HIV/AIDS grassroots advocacy of the 1980s for igniting the modern movement towards more active patient engagement in managing one’s own health and elevating expectations for being an equal partner in decision-making.
Today, an estimated 24 million people are on lifesaving anti-retroviral treatment as a direct result of activism that began in the mid-80s to prioritize the AIDS epidemic as a national health crisis. The story of how the first AIDS drugs were developed sounds a lot like a current-day patient advocacy blueprint. Patients not only educated themselves about the science of the disease and research funding mechanisms but also demanded to be full partners in clinical trial design and conduct, regulatory approval processes, and access policies.[1]
Films like Dallas Buyers Club illustrate the desperate tactics patients used to find alternative treatments and how patient advocacy accelerated the development of effective HIV medications.[2]
The AIDS Coalition to Unleash Power (ACT UP) was an advocacy group that gained notoriety for extreme measures, such as the 1988 protest at FDA headquarters for what “they perceived as an obstructionist drug approval process that was preventing access to possibly useful treatments … and costing patients their lives.”[3] This influential group is also credited with influencing the decision to lower the price of HIV drugs, transforming the U.S. Food and Drug Administration’s drug approval process, and pushing for the inclusion of people with AIDS in drug trials.2
1988 turned out to be a pivotal year for AIDS awareness and responses from national and global organizations. Cases in the U.S. exceeded more than 100,000,[4] and World AIDS Day, the first-ever global health day, was declared on December 1 by the World Health Organization. The U.S. National Institutes of Health (NIH) established the Office of AIDS Research (OAR) and AIDS Clinical Trials Group (ACTG).[5]
By the 1990s, AIDS advocacy led to a new precedent at the FDA of involving patients in the policy-making process. An Office of AIDS and Special Health Issues was created to build relationships with patient communities. The FDA also began including a patient representative on every advisory committee in 1991.[6]
In 2001, the role of patient representatives expanded to serving as consultants to reviewers during review cycles. Following a series of initiatives focused on more active patient participation in drug development and safety reporting, the next major milestone took place in 2012, when the FDA’s Patient-Focused Drug Development initiative was established under The Prescription Drug User Fee Act (PDUFA) V, the legislative funding mechanism for FDA activities. This landmark initiative set in motion a spate of subsequent initiatives, including the formation of the Patient Engagement Advisory Committee in 2015, the launch of Patient Affairs Staff in 2017[7], and drug approvals for diseases with few treatment alternatives.
Since the 1990s, FDA has approved 32 antiretroviral drugs, 1 pharmacokinetic enhancer, and 21 fixed-dose combinations to treat HIV/AIDS patients.[8] Other high-profile approvals shaped by patient advocacy have included eteplirsen for Duchenne muscular dystrophy (DMD), the Maestro Rechargeable System for obesity, and flibanserin for female sexual health.[9] Patient advocacy organizations are now sponsoring drug research in areas such as Parkinson’s Disease and Alzheimer’s Disease.[10]
“Nothing about us without us,” a key message of AIDS advocacy, remains as a unifying rallying cry for today’s patients across virtually every disease area. It’s often repeated at patient-focused events such as the annual Patients as Partners conference that brings patient advocacy, FDA agencies, and the clinical research industry together for best practice discussions of how to include patients in clinical research.
In spite of the progress the medical community has made, World AIDS Day is important because while AIDS is no longer a death sentence, HIV has not gone away – there is still a vital need to raise money, increase awareness, and improve education. The patient’s voice will continue to be increasingly influential in solving unmet medical needs, advancing health equity, and reminding us all of the ever-present need for humanity in research and health care.
[1] https://www.forbes.com/sites/madhukarpai/2019/11/30/aids-activism-a-playbook-for-global-health-advocacy/?sh=7a99b37540a1
[2] https://www.foxnews.com/health/dallas-buyers-club-highlights-patient-advocacys-role-during-hiv-aids-epidemic
[3] https://www.fda.gov/about-fda/fda-history-exhibits/history-fdas-role-preventing-spread-hivaids
[4] https://greensboro.com/news/local/hes-raised-1m-for-aids-hiv-program-see-what-drives-this-greensboro-attorney/article_425c5ff8-69f6-11ed-918a-e7413810794e.html
[5] https://www.kff.org/global-health-policy/timeline/global-hivaids-timeline/
[6] https://www.fda.gov/about-fda/fda-history-exhibits/history-fdas-role-preventing-spread-hivaids
[7] https://www.fda.gov/about-fda/office-clinical-policy-and-programs/evolution-patient-engagement-fda-text-alternative
[8] https://www.fda.gov/about-fda/fda-history-exhibits/history-fdas-role-preventing-spread-hivaids
[9] https://www.washingtonpost.com/business/economy/to-sway-drug-approval-patient-advocates-turn-up-the-heat-on-the-fda/2016/04/23/71bfdd90-07df-11e6-a12f-ea5aed7958dc_story.html
[10] https://www.statnews.com/2021/07/06/patient-advocacy-groups-and-innovators-must-partner-to-advance-new-treatments/
