for Covid-19 could hardly arrive soon enough. Level
heads agree, however, that a vaccine will only be ready, in
the best case, by autumn of 2021. Vaccines take
time. They require an infrastructure to mass-produce and deliver on a large
scale. Before they can be bought and sold, companies have to trudge through the
first three of the four phases of the U.S. Food and Drug Administration’s
approval process. And to get FDA approval, companies need a raw material
essential for any drug or vaccine to go to market: healthy human bodies.
studies, also called Phase I studies, are the riskiest of clinical trials. The
studies are designed simply to figure out what a medicine does to a normally
functioning body (does it make you vomit, cause a headache, make your heart
stop?). The healthy body is the steady instrument through which scientists
learn whether a drug or vaccine hurts you. The aim is not primarily to figure
out whether it helps. (Later stages do this.) In May, the first Phase I trial
ended for a vaccine to protect against Covid-19. Days later its developer,
Moderna, announced the vaccine to be safe by the most brute measures of
first-in-human trials, and the FDA cleared it for the next phase of testing.
those people who served in the riskiest studies for the first vaccine against a
new virus? To the extent that the participants have been allowed to talk,
journalists have politely
focused on people’s (no doubt sincere) sense of
duty and patriotism. They have not asked about the money. The FDA, for its
part, queries the race and gender of people in any trial, as required by law.
The agency does not ask how often or how recently people have enrolled in a
Phase I trial, which, in addition to being the riskiest type of study, is also
the most lucrative.
Sociologist Jill A. Fisher does ask, in her new book, Adverse Events, and the answers she gets from first-in-human test subjects show how systemic anti-Black racism in the United States maintains the clinical trials industry and how the industry circles back to hold people of color disproportionately in positions of economic precarity.
The conventional wisdom is that people of color are underrepresented in clinical research because of well-justified mistrust of the medical establishment. They are also underrepresented because of federal law enacted, paradoxically, to protect vulnerable populations—particularly Black Americans—from medical exploitation, after public exposure of the horrific Tuskegee Syphilis Studies. (Women also tend to be underrepresented.) On this basic story line, there is no dispute. But while people of color are indeed underrepresented in research overall, Fisher shows that Black men are hugely overrepresented in the most dangerous phase of research, in which there is no possibility of medical benefit to the participants.
In Adverse Events, Fisher reports her discoveries traveling across the U.S. to go inside the “hidden world” of Phase I testing facilities. Fisher interviewed more than 200 healthy human subjects in Phase I trials and the staff who managed, castigated, and cared for them in six facilities evenly distributed across the East Coast, Midwest, and West Coast. She hung out for days or weeks in the facilities, which she and her interviewees described at different points as prisons, frat houses, and quirky cruise ships, depending on your tastes (meals catered by IHOP in a clinic with no kitchen, Jackass on TV). Either way, you could not easily get out. Phase I testing clinics are often lock-in, windowless, residential clinics. At security screening, along with outside food and illicit toiletries, staff confiscate anything with a camera. Think airport security, but worse.
Phase I testing is a liability nightmare. It is little surprise, then, that companies that develop new drugs and vaccines rarely test the medicine themselves. As with the vaccine for Covid-19, the pharmaceutical company typically contracts out to other companies to do the testing. These private contractors are companies dedicated to running clinical trials, and many exclusively run the most profitable Phase I trials. Some are academic centers that take contracts from drug developers to make ends meet, itself a sad comment on the state of health care and health education in the U.S.
“Phase I trials can be read as protocols designed to produce harm in healthy volunteers in order to document investigational drugs’ safety profile,” Fisher writes. In the trials industry, these harms are euphemistically referred to as “adverse events,” the phrase Fisher, with one eyebrow raised, takes for the title of her book. When she talked to people, she found that those who identified as White were most likely serving in their first trial. Few would do it more than a time or two. Yet the people who had served in more than five studies typically identified as Black. Several people had served in more than 50 trials. All of them were Black men. One African American man estimated he had served in more than 100 trials.
There is an important difference between the life circumstances of occasional human subjects and those of serial participants. Unlike the (predominantly White) people who serve in Phase I trials once or maybe a few times, serial participants are dealing with multiple, reinforcing life disadvantages. They may be unemployed or in debt, or have a prison record or a low level of education. There is not a perfect correlation between race and serial participation. Nonetheless, it is the case that in the U.S., Black people are unusually and unjustly more likely than White people to face any given disadvantage because of racism in education, employment, health care, and criminal justice, as the ongoing call for Black lives to matter is showing right now. Adverse life events, as Fisher puts it, expose people unevenly to adverse health events.
These “serial participants” work a grueling circuit. They load up their cars, which for some double as their homes, and drive to testing facilities with a new contract. They swap tips with each other and develop preferences for the more luxe facilities. They learn to be selective about studies. (To be avoided: lumbar punctures.) Some think of starting a union.
But a union would expose a gig economy that reproduces its labor force by keeping people in “persistent economic insecurity.” In this corrupt economy, the pharmaceutical industry is the culprit and the U.S. government, through craven regulation, is its alibi. In the waning days of the Obama administration, the U.S. government accepted landmark new rules for regulating research on human subjects. It was the first substantial update to the rules in 40 years and came after six years of work between experts, industry, and the public. The proposed rules had originally extended regulations to privately funded clinical trials, which had been able to slip the golden handcuffs of federal funding that forced most trials also to follow federal rules. By extending the regulations, privately funded trials would have been required to have readable consent forms, to have basic accountability for how contractors treated participants, and to be open to federal audits. Cowering from industry pushback, the federal government ultimately decided not to extend regulations to private industry, saying that the problem of “unregulated clinical trials would benefit from further deliberation.”
Unlike the Covid-19 vaccine trials, there are few heroics in the studies Fisher describes. Serial participants actively work to keep their involvement secret among their intimates. Long-term relationships are already hard to maintain and participants’ secrecy is a beacon of the shame that the industry reinforces. “If healthy volunteers believe there is some shame in enrolling in Phase I trials, subpar facilities, in which they are made to feel as though they were in jail or less than human, might just confirm this belief,” Fisher writes.
Additionally, some interpreted their own or others’ willingness to participate in studies at clinics with poor accommodations and untrained staff as a sign of financial desperation; to return to those places meant that someone was truly out of better options, which made enrollment all the more shameful.
Though the style and upkeep of the facilities varied substantially, the list of building types has a brutal clarity: “former warehouse,” “former factory,” “suite in an office park.” Staff “fine” participants for infractions during studies—being minutes late for a blood draw, for example—which reduces their take-home pay. With a ready supply of people willing to earn any money in its next trial, the industry has little incentive to improve its facilities or up its stipends.
You would be hard-pressed to earn $20,000 per year working full time as a human subject. The average earning per night is $250, and for any given study it can be hard to qualify. It helps to know the staff, to get there early, and to have a reputation for docility and giving good data. Like the participants, staff members are in precarious positions. While the nurses, cooks, and managers are demeaning and punitive toward participants, they are also tasked to do work not in their own job descriptions and to labor on punishing schedules. To keep their jobs, they have to keep their employers in business. In order to ensure profit for their employers, the staff in Phase I trials have to deliver data that will convince the FDA that the latest R&D project is safe.
This arrangement of the clinical trials industry is not only an offense to social justice. It is also bad science. Bald fabrication of data is likely rare. Instead, staff coach and aid participants to get their bodies to yield data, such as lower blood pressures, in line with the funder’s desired outcome. Fisher explains, “[H]ealthy volunteers, clinics, and the pharmaceutical industry are all incentivized to make investigational drugs appear safe.” The outcome is all but written before the study begins.
Fisher’s access to these facilities is impressive, and it was also hard-earned. Staff members were wary of her presence; no doubt executives were wary, too. And to get such unparalleled access, Fisher likely had to assure them that her aim, as a professor at the University of North Carolina with the backing of a prestigious National Institutes of Health grant, was not to produce a journalist’s exposé but a social scientist’s even-handed analysis. “This is not a story about Big Bad Pharma,” she tells us, “although it could be.” Other writers have published effective and important takedowns of Big Bad Pharma, including David Healy in the UK, Joseph Dumit in the U.S., Kaushik Sunder Rajan in India, and Adriana Petryna for the many “offshore” locales of multinational companies.
Adverse Events damns the industry with simple description, but Fisher’s analysis has a bigger concern. The industry is a symptom of the American problem of racist capitalism, and in the book, Fisher documents how a racist, wildly unequal economy leads people who are already in precarious positions to take part in first-in-human trials. Ten years ago, when she started her research, she could hardly have predicted its immediacy.