Much of what Dr. Anthony Fauci, the esteemed head of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), learned about clinical trials for the novel coronavirus disease (COVID-19), he learned from sparring with HIV community activists.
The ethical thing to do
In the 1980s, during the early days of the HIV pandemic, American and Canadian activists, mostly gay men and their allies, were furious with the slow pace of drug research and approvals. We felt alone and stigmatized, first for our sexuality, then as vectors of disease. Our battle cry was “Drugs in Bodies”, “Silence = Death” and “Nothing about us without us!” Despite the urgency, we recognized and insisted that new drug approvals be expedited while ensuring their safety, as far as humanly possible. We also recognized that novel therapies not only needed government approval, but also needed to be paid for.
It came as no surprise, therefore, when the NIAID announced that a small randomized control trial of remdesivir, a potential antiviral treatment for COVID-19, was being stopped early and those in the placebo arm switched to remdesivir. It was the ethical thing to do because remdesivir was shown in early analysis to shorten the recovery time for COVID-19 patients at a statistically significant reduction. In other words, the effectiveness of remdesivir was sufficiently demonstrated to warrant stopping the trial and giving it to all of the 1,063 participants in both arms of the trial.
The right to safe and effective treatments
When threatened by a pandemic like HIV or COVID-19, university and industry researchers begin by searching their cupboards for existing drugs that might prove effective against the virus. Drugs such as remdesivir, originally developed (though never approved) for use against Ebola, become “placeholders” while the search continues for novel and more effective treatments. That’s what we saw in the early days of the HIV epidemic with the redeployment of azidothymidine (AZT), a drug that was originally developed for cancer.
Dr. Fauci, confronted by HIV activists, learned in those early days that when lives are at risk, the right to safe and effective treatment for patients is more important than the regulatory approval system itself. This meant that early access to potentially life-saving treatments and preventive vaccines required small trials of short duration, early trial stoppages where results showed success, and timely access through emergency and compassionate programs.
Following the HIV playbook
In Canada, HIV activists convinced Health Canada to bring in expedited approval based on 24-week data, instead of the customary 48 weeks. They argued that market approval in any form should be followed by the collection of “real-world data” about side effects, as well as unexpected benefits.
In the U.S., Dr. Fauci announced remdesivir would become the “standard of care” for COVID-19. This should not be interpreted to mean offering remdesivir injections to every patient, but as a reminder that future trials be conducted as a comparison with the best existing treatment, as opposed to a placebo. In other words, we have a duty to offer treatment in both arms of a clinical trial if an effective treatment already exists. This concept is an important legacy of HIV activism, as is the clear and comprehensible informed consent we insisted must be obtained from all participants prior to enrolment in any clinical trial.
Dr. Fauci will most likely follow the playbook he developed by listening to HIV activists during the HIV epidemic for guidance on COVID-19. In Canada, we count on the leadership of Dr. Theresa Tam at the Public Health Agency of Canada, and on Health Canada to ensure that while we wait for a vaccine, any treatments developed for COVID-19 get to the people who need them as quickly and safely as possible.
At the same time, we must ensure that the various agencies along the Health Canada regulatory pathway are coordinating their efforts, specifically those that ensure access to public reimbursement programs.
The complicated patchwork of reimbursement
Yet reimbursement in Canada, whether private or public, remains a complicated patchwork. In Ontario, for example, the HIV activist community succeeded in convincing the government to bring in the Trillium Drug Program in the early 1990s, the public reimbursement program now in place for all working Ontarians lacking private coverage and with high drug costs in relation to their income. Most other provinces and territories offer similar (or better) programs to help offset out-of-pocket costs for people with limited or no private coverage. More needs to be done to reduce the deductibles associated with these programs, particularly for individuals and families experiencing financial hardship as a result of the COVID-19 pandemic. Among the proposed solutions is a national pharmacare program, but that deserves a separate article.
Federal and provincial governments deserve credit for the actions they are taking to bring the COVID-19 pandemic under control. If, however, they are slow to approve and reimburse novel treatments and vaccines, we have the tools and lessons learned from the HIV activist community over the past 35 years to remind governments how to ensure timely access to treatments and vaccines in these perilous times.
Louise Binder is a lawyer who co-founded the Canadian Treatment Action Council (CTAC) in 1996, which advocated for better access to HIV treatments and quality care. Louise is presently Health Policy Consultant for the Save Your Skin Foundation. Louise has received an honorary doctorate of laws from her alma mater Queen’s Law School, the Order of Ontario and two Queen Elizabeth II medals.
Ron Rosenes is a community health advocate and served as vice-chair of CTAC from 1997 to 2011. He is currently chair of the Canadian HIV/AIDS Legal Network. Ron has received an honorary doctorate of laws from his alma mater Carleton University, a Queen Elizabeth II medal and is a member of the Order of Canada.