Bozelko column: Clinical trials in prisons are a good idea
Columns share an author’s personal perspective.
Debate has erupted over how to prioritize prisoners in the COVID-19 vaccine rollout. Six states have promised to put them ahead of other groups, according to the Prison Policy Initiative. The remaining states are either not prioritizing them or staying silent on what their plans are.
Like the decarceration debate that’s endured since April when the spread of the novel coronavirus started tearing through these places, there’s little consensus on what to do, despite the fact that illness in prison threatens all of us. On Dec. 15, Prison Policy Initiative reported that mismanagement of COVID-19 inside prisons led to at least 500,000 cases in the community over summer 2020 alone.
We could have resolved this earlier - and possibly saved lives inside prison and out - if pharmaceutical companies had conducted some of the COVID-19 clinical trials in correctional settings. In fact, some inmates might have been vaccinated by now.
What slowed Operation Warp Speed, the federal government’s public–private partnership to accelerate development of the COVID-19 vaccine - and admittedly not that much - was trials’ ability to enroll minority subjects. Pharmaceutical company Moderna’s trial population was 37% minority, The Washington Post reported in October. For the Pfizer vaccine testing, it was about the same: 9% Black and 28% Latino, according to WCIV.
That really isn’t enough. Because COVID-19 disproportionately affects racial minorities, public health experts wanted at least half of enrollees to come from these groups. Director of the National Institute of Allergy and Infectious Diseases, the famed Dr. Anthony Fauci, aimed even higher; he said minorities should make up at least 66.4% of study populations. The surging infection rates weren’t going to wait for more people to sign up.
Even if they are minorities, study participants can’t just be anyone. Subjects must face “high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure” to qualify to volunteer, says clinicaltrials.gov.
The ideal place to achieve this racial balance among people in downright danger of coronavirus infection is prisons.
Prisons satisfy both requirements. The prisoner coronavirus infection rate is five times higher than the general public and their death rate from COVID-19 is three times higher, reported a published study by researchers from Johns Hopkins University and the University of California Los Angeles’ COVID-19 Behind Bars Data Project. And, according to the Bureau of Justice Statistics 59% of approximately 1.3 million state prisoners are Black or Latino. Correctional facilities contain more than enough racial minorities at appreciable risk.
And they’re probably more likely to join a trial; the same hesitance to jump into guinea pig status doesn’t seem to hold inmates back. In a 2013 survey by Brown University of 70 inmates who had participated in clinical trials, 65 participants disagreed that the study they were involved in exploited them. Over 75% of the respondents agreed that there should be more research opportunities for incarcerated populations.
Of those 70, 27 - or 38% - were minorities, and that’s without targeted recruitment. In many ways, prisons are ideal for clinical human research.
Not everyone agrees though, as the history of clinical trials in these settings prove. When Joseph Califano, former Secretary of Health, Education and Welfare under President Jimmy Carter, announced his intention to ban all human research in prisons and urged the FDA to do the same in response to pressure from advocates - the ACLU had already passed a resolution supporting the ban of biological research on inmates - a group of Michigan inmates sued to protect their right to participate in clinical research. Califano’s ban never fully materialized; it’s been officially stayed for 39 years because of the litigation.
The limbo likely explains why there’s no central repository of data on clinical trials on prisoners that would help companies like Moderna or Pfizer make better recruiting decisions. In 2006, the Institute of Medicine (now the National Academy of Medicine) issued a report that recommended improving access to clinical trials for inmates, but it had little effect.
Starting studies in prisons shouldn’t be an insurmountable challenge for large pharmaceutical companies; such trials are completely legal and have only one additional requirement: creating a separate Institutional Review Board to include at least one inmate member to certify the study to the Office of Human Research Protections of the Department of Health and Human Services. That’s easy for companies like Moderna and Pfizer.
It’s been done relatively recently. Drug maker Alkermes ran a randomized double-blind trial of its injectable Vivitrol in correctional facilities between 2011 and 2014. Eighty-five percent of participants were Black.
The idea that investigators would focus recruitment for clinical trials in a target-rich environment almost makes too much sense - which begs the question of why none of these endeavors have included prisons so far.
The simple answer is that protectors of prisoners thwart it. The outcry over the Bureau of Prisons’ $60,000 order of hydroxychloroquine in April was a decent enough indication that entering prisons for this research will face public backlash. Even though the BOP admitted that it purchased the drugs for incarcerated COVID patients who were started on hydroxychloroquine in local hospitals, it wasn’t enough to convince people that the purchase wasn’t the second coming of the Tuskegee Syphilis Study.
Whatever the motivation is behind it, preventing quick and ethical recruitment of minority study subjects is just further politicization of the vaccine process. If a path to a shot’s safety and efficacy winds through a willing, minority-heavy, high-risk population, then it shouldn’t matter who they are, where they live - or what they did.
Of course, advocates are right to pay attention to voluntariness of participation in prisons. Experts have debated an inmate’s capacity to consent for decades.
Prisons are generally coercive; offers that appear to be choices aren’t always so.
But not so much that we should ignore prisons as clinical trial sites, especially when our lives are on the line. It will take guts on the part of the drug companies, but that temerity will be the only difference between a trial in prison and one on the street. We’d be in better shape now if they’d taken this risk earlier.
Chandra Bozelko writes the award-winning blog Prison Diaries. You can follow her on Twitter at @ChandraBozelko and email her at email@example.com.