No Free Trials


Image: Phil Roeder via Flickr

At first, what everyone wanted to know about the highly anticipated COVID-19 vaccines were basic things: whether they were safe, whether they were effective, who could get them and when, how to get a coveted appointment. Once that was resolved, we wondered whether one shot offered better protection than another and for how long, whether everyone at the party had one, whether we needed a booster. In all cases, when the answers came, they seemed to materialize out of thin air. The science seemed to take place behind the closed doors of hospitals, in other people’s bodies. I couldn’t leave my house or open my phone without seeing a clip-art syringe on some billboard or banner ad, but the experimental trials generating the numbers were relatively invisible.

When the trials did show up in the news, I paid close attention. Specialty news outlets published lionizing interviews under headlines like “COVID-19 Vaccine Trial Participant Tells Healthline: ‘It’s the Right Thing to Do.’” The message these articles offered to readers (at least until the Delta variant came along) was clear: keep your chin up, because participants’ antibodies are the harbingers of the end of the pandemic. Test subjects were objects of curiosity. They were portrayed as our mediums, oracles of immunity. The interviewees told reporters about their own high hopes for vaccine development, and how glad they were to be a part of the process. They understood that they were doing something good. They’d made themselves useful.

I both am and am not one of these people. In January of this year, I signed up for a trial testing two doses of the “one and done” Johnson & Johnson vaccine. It was a decision made less out of altruism than self interest: I was scared for myself and the people around me. I wanted a shot, and I wanted one now, and if I could get some money in return, even better. Taking part in a trial wasn’t new to me — my preschool permitted developmental psychologists to use its students as guinea pigs. With my parents’ consent, grad students put three-year-old me through multiple psychometric tests per week. In elementary school, I made my allowance through trial payouts from a major longitudinal study and its side gigs, despite being afraid of needles. I played Pokémon on the nurse’s Gameboy Color during my first blood draw, trading my fluids for a carton of grape drink, a popsicle, and $75, which, to my eight-year-old brain, was the most money anyone could possibly have. I cried when the nurse stuck the needle in my arm. “You’re doing a good thing!” she said.

The trial I am enrolled in is running in parallel to a one-dose trial. We are 30,000 test subjects; they are 45,000. Both have cute names: Their trial is called ENSEMBLE; ours is ENSEMBLE 2. Whoever named them is right that a chorus is probably a better metaphor for the trial than a legion of oracles: we are using our COVID-free lungs to sing the praises of our Sponsor’s vaccine for the FDA. Documents and staff refer to Johnson & Johnson, which received $456 million in federal funds for these two trials, as “the Sponsor,” which makes it sound like a powerful paternal figure who’s here to provide for us. This, of course, is the same corporation being forced to pay $5 billion to settle opioid lawsuits while claiming to be a proponent of public health. From the beginning, I am uncomfortably aware that my contribution to curbing the virus creates intellectual property for the largest pharmaceutical company in the world.

When I enrolled, this trial struck me as less urgent than the others I knew were going on: even if the double dose was better, it was hard for experts to justify why someone should get two shots of an unequally distributed vaccine that does the trick in one. So I didn’t think I should get to feel especially useful, even if I let myself believe that “helping science” counterbalanced selfishly skipping the line. I didn’t know at the time that J&J would have a lower efficacy than Pfizer and Moderna, or cause blood clots. But in the midst of isolation, it was worth the risk: the ability to frequently leave my home to go somewhere where I felt wanted, a place where participation was styled as altruism. Everyone at the trial site was very nice and cared about how I was doing; they were eager to thank me for showing up and doing my part. Every trial staff member I talked to told me they were proud to be doing this work “for science,” an eternal refrain haunted by old abuses. The staff at my trial site were working ten- or twelve-hour days in the spring to get desperately needed vaccines into the world, and this is what kept them going: a generous economy of pats on the back.

* * *

The COVID-19 crisis resists localization: The year before I joined the trial, it was always elsewhere, in emergency rooms and others’ homes, until it was dangerously close, in your body or the body of someone you loved. Once I enrolled, the trial site became, in my mind, the location of the pandemic. I housed the crisis in the clinic’s storefront on the North Side of Chicago, a thirty-minute drive from my home. COVID was playing out over there, in that exam room, waiting room, and laboratory, and I could now have the tiniest hand in getting rid of it. I was the anti-pharma grouch singing under my breath in the back row of ENSEMBLE 2’s recital, but I was making a sound! And in addition to $100/visit and a 50-50 chance of vaccination (as I initially understood it), the trial offered a return to the cold clinicality that to me — an insured white girl raised in trials — had once felt like a form of care.

At my first appointment, Dave, a likable coordinator in a white lab coat, ushered me and two other people into a conference room. (I’m using pseudonyms to protect the jobs of staff members I interviewed.) For an hour or so the three of us sat around a big table and filled out dozens of pages of paperwork, detailing our lifestyles and medical histories, while Dave explained what would happen next. He was the only vaccinated person I had met at the time, and his loose, partially untied mask reminded me how I used to be able to ignore the bodies of strangers, how I used to sit in rooms with people unaware of the droplets passing in and out of their respiratory tracts. All three of us enrollees glowed in his presence, seduced by the thought that soon, people might feel similarly safe around our bodies.

We quickly learned it wasn’t quite that simple. Half of ENSEMBLE 2 got the so-called “investigational drug,” which at the time had no emergency use authorization. The other half got the placebo. Our trial was double blind: we wouldn’t know what we were getting, and the staff wouldn’t either. The site’s pharmacist was the only person on site who was not blind. He worked in a room sequestered from the rest of the building, rolling the algorithmic dice and loading up the syringe, dozens of times per day.

But before we could get any kind of syringe, there was the consent form, thirty-three pages of documentation that provided basic information about what the study was trying to measure and how it was trying to measure it. The document’s narrator was the authoritative voice of science, and its protagonist was not the trial participant but the Sponsor. “The Sponsor is paying for this research study,” the form clarifies at one point. “Your study doctor will be paid by the Sponsor.”

Institutional Review Boards (the committees that oversee human subjects research, usually known as IRBs) recommend that the language of informed consent be kept at an eighth-grade reading level or below, so the lawyers squash legally binding material into a middle-school lexicon. It gets weird: the FAQ reads, in inexplicable capital letters, “WHAT IF SOMETHING GOES WRONG?” Later, there is a section about data privacy regarding our bodily fluids. Above all, the mantra: “Taking part in this study is your choice. You may choose to not participate in this study…There will not be any penalty if you decide not to take part.”

The signing is a kind of bioethical ceremony. Trial ethics gravitate around this important but limited moment of consent — the ceremonious affirmation of choice that releases trial administrators from legal consequences. Consent makes risk your problem: if you know what you’re getting into and you choose to get into it and it kills you? Well, it was your choice.

* * *

Trials do and do not provide care to their participants. There is a huge difference, history shows, between collecting data from a body and treating a person. Clinical trials have been, and continue to be, abusive and exploitative; researchers behaved as if they were owed access to the bodies of others, especially racialized bodies, or bodies belonging to those who could not pay for their own treatment. Testing veered between being dehumanizing, inadequate, and protracted (as with antiretroviral drugs in the 1980s, which took years to get to market despite the urgent need for them). For most of the twentieth century, the US had virtually no human subjects regulations. Politicians repeatedly blocked laws and policies for fear of hindering science until the call-and-response of scandals and minor regulations reached a fever pitch, culminating in the National Research Act of 1974. The act created a commission, which produced the Belmont Report, a notoriously philosophical document of brain-in-a-jar ethics that eventually led to informed consent requirements. As bioethicist Jill Fisher points out, the report totally ignores the material conditions that made people vulnerable to exploitation, notably racial capitalism and its institutions.

If you don’t have health insurance, trials are one way to get medical attention without accompanying medical debt. You might get tests, you might get treatment — or you might not, if you get the placebo. But you’re a subject, not a patient: the people attending to you are harvesting data. They may care — Dave, at my trial, definitely cares — but they are not explicitly responsible for caring. Sometimes caring conflicts with their jobs, Fisher notes. Because recruiting is the hardest part of running a trial, the trials industry actually benefits from barriers to getting medical healthcare in the US. Trials are a way for people to access care that’s otherwise out of their reach. Ethically speaking, as Fisher points out, it seems doubtful that an informed signature on a consent form can hold water without universal healthcare, when people arrive at trial sites deprived of medical attention, having already made up their mind to take what the trial can give them.

Some participants treat clinical trials as a gig economy unto themselves, in the vein of selling plasma. Studies almost always pay well above minimum wage, and many people are in it for the pay. For some staff, subjects who seek remuneration undermine their fantasy of research as commitment to progress. Coordinators’ and investigators’ dream subject, historically, is a well-informed person altruistically volunteering their body for science. Anthropologist Adriana Petryna interviewed a study doctor who referred to these ideal subjects as “normal people” — people who already have care, housing, and enough money. Dispossessed trial subjects were desirable back when trials could exploit them without compensation; once trials pay people for their time, anyone who needs that pay is no longer considered particularly worthy of taking part in the noble enterprise of research.

Before regulations, the mid century was a really bad time for human subjects research, even after the US tried Nazis involved in human experimentation at Nuremberg. In the ’50s and ’60s, Chester Southam injected live cancer cells — cells stolen from Henrietta Lacks, a young Black mother who had died of cancer three years prior — into unknowing prisoners and chronically ill patients. Around the same time, government-funded researchers at Willowbrook State School in New York deliberately infected children who were institutionalized for their disabilities with hepatitis A, claiming they would have gotten it from the horrible conditions regardless. And from 1932–1972 an infamous study in Tuskegee denied four hundred Black men treatment for syphilis, and lied to them about it.

That trial was a case of scientific racism in both its concept and method: it centered the hypothesis that syphilis would play out differently in white bodies and Black bodies, impacting delicate white minds, while merely destroying the nervous systems of Black patients. One hundred twenty-eight men died, along with many of their infected, unstudied family members, despite the invention of penicillin in the ’40s. For decades autopsies were required to diagnose syphilis, and at a certain point the study coordinators’ jobs were to keep tabs on these men and wait around for them to die. As one study doctor put it, the men were “cadavers that have been identified while still living,” three hundred of whom were convinced to undergo nontherapeutic spinal taps under the guise of “treatment.” The study was prestigious and made illustrious careers for many of the white doctors involved.

By the ’50s it had become common practice to use patients from the public wards for research without their knowledge — patients unwittingly paid for their care with their own bodies. A century prior, scientists were expected to first submit themselves, their own families, and their students to experimental treatments. Reluctance to try things on the people most dear to them before trying them on strangers was cause for collegial criticism. But the prohibition only extended to white strangers, according to research by C. Riley Snorton and Harriet Washington, who both write about forced experimental procedures on enslaved women in the 1850s—deeply racialized field-founding scenes for gynecology. The family-first norm wholly dissolved by the 1950s and 60s, when prisons were especially prized trial environments. In the ’00s, Adriana Petryna interviewed an industry leader who described how prisons had provided his then-colleagues with reliable subjects leading a “controlled lifestyle.” They couldn’t get paid, but supposedly volunteered (assuming they weren’t coerced) so as to get reprieve from the chain gang, and “more regular food.”

After the regulatory sea change of the 1970s, trials became less spectacularly horrific: people stopped performing tests on prisoners, and lying to subjects became illegal. But, according to the anthropological research of Petryna and Kaushik Sunder Rajan, the corporations running the trials continue to exploit subjects; they just usually do so far away from their markets.

Since the US finally managed to regulate its pharmaceutical companies’ research practices, testing sites have been inching offshore, increasingly residing in the Global South. Research conducted outside of the US is subject to only a portion of national regulation, which makes trialing domestically more pricey. The ENSEMBLE trials are taking place at 339 different sites, in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, and the UK. Mine is one of the largest in the US. One well-publicized reason for testing in various locations is to catch different variants. Another reason is that it’s cheaper per subject. Pharmaceutical companies look for places in the world with decent medical infrastructure, underpaid doctors, and test subjects who won’t expect high stipends. Petryna describes how poor subjects are also desirable because they’re often “treatment-naïve,” having never had access to care for the disease under investigation. They’re clean slates, some of whom will get a placebo.

Cost-per-patient becomes ever more important as the scale of trials balloons: testing a drug on a massive population lets you cull the slightest statistically significant margin of efficacy to get a barely effective drug to market. Countries “compete to convince the pharmaceutical industry” that they can provide ideal economic and legal conditions for trials — the lowest possible cost per patient in terms of labor and supplies — even when residents would never be able to get access to investigational drugs meant for a rich, Western market after the trial’s completion. Even in the era of informed consent, some people’s bodies are used as testing grounds for treatments meant for other, more powerful people’s bodies.

* * *

I got my first shot at my second visit, way back in February. That morning I paged feverishly through the Phase 1/2a results, looking for antibody counts to compare to Pfizer’s and Moderna’s, crunching numbers to cope with my nerves. When I arrived at the trial site, they whisked me straight to the lab to pee in a cup. They took my blood, and then took me to an exam room. A physician assistant arrived with an unmarked vial in a plastic baggy labeled with my participant number, 0320. There it was, my own personal shot. “I’m terrified of needles,” I choked out. “Imagine the beach,” she said kindly, preparing the syringe. She listed random details about this imaginary beach invented for my comfort while I wondered when travel would next be possible.

“Ow,” I said after the injection, doing arm circles.“It hurts a lot.”

“Maybe you got vaccine,” the PA said, smiling. “I hope you got vaccine.”

During the observation period, I finally read the news articles about how adenoviral vaccines work, to try to visualize what may or may not be happening inside me. The vaccine, AD26.COV2.S, contains 5×1010 particles of a neutralized husk of a common cold virus, full of DNA that codes for the famous coronavirus spike protein. Right about then, the adenovirus molecules would be breaking into my cells, co-opting their machinery to manufacture imitation spike proteins. Over the coming days, my body would learn to recognize and destroy the proteins — assuming the shot wasn’t salt water.

On the way out, we got swag bags: a pulse oximeter, a thermometer, a swab to collect a nasal sample in case we develop symptoms, a ruler to measure and report swelling, documents, ads for other trials, a face mask emblazoned with the trial site’s logo, and a sticker that says “I’m Doing My Part!,” all bundled up in a starchy tote bag with “ENSEMBLE 2” emblazoned in rainbow letters.

I had no side effects, which was disappointing, suggesting it hadn’t been vaccine after all. They wouldn’t tell me until I was eligible to get vaccinated through the usual channels, months later. On the upside, if at any point I get COVID, I’ll present for extra observational visits, for which I can make up to $400 extra. They might deliver supplies to my home and pick up samples via courier service. It’s nice to feel like if I get sick, someone will give me special attention, and pay me for data about my pain.

On Mondays and Thursdays, we fill out “diaries” through an online portal affirming that we’ve seen no signs of COVID. Dave warns that reporting symptoms triggers an extensive protocol that creates a lot of work, and involves staff springing into action to collect information, so it’s best to avoid logging a runny nose after you’ve been out in the cold.

We present at the trial site at routine intervals for assessment. Some visits are just “temperature checks,” which seem to exist to make sure we haven’t gotten COVID and failed to notice or report it. Our visits are numbered and will take place over two years, much longer than I’d expected. They’re distinguished from one another by which fluids they take when. Visit 1, urine; Visit 2, urine, mucus, blood; and so on. I drink a lot of water the mornings of, drive thirty minutes up the highway along Lake Michigan, and come home feeling literally drained.

These fluids — 2.7 tablespoons of blood, a nasal swab, and three little cups of urine — are the only way they know what’s going on inside our bodies. Matthew, the lab director, spins the blood down into a coagulated gel in a centrifuge, aliquots it out, freezes it, and ships it out to the central laboratory (also a contracted company), usually the same day. I imagine a scientist peering at my blood under a microscope but I don’t think anyone actually does that. For all the colorful geometric diagrams of adenovirus molecules, no one ever sees my antibodies. They just put my blood into a machine with a whole lot of other blood and run numbers. Somewhere, in some database that neither I nor Matthew will ever access, is the number of antibody particles my body made per milliliter of blood. When they publish the results, that number will exert the tiniest prod of influence on the averaged-out immunogenicity of tens of thousands of samples.

The urine is for pregnancy tests, which they run in-house immediately to make sure they’re not exposing a fetus to an experimental drug. “Do not get pregnant within 3 months of receiving study vaccination,” the informed consent tells me. People who can bear children are sore spots for trials generally — in the 1950s the anxiety drug thalidomide went to market without data on its effects on pregnant women, and at least ten thousand people were born with resulting disabilities. Babies are a hot site for litigation, and for years “women of childbearing age” were wholly disallowed from most clinical trials, leading to a scarcity of research on how drugs impact pregnant people, and on women’s health in general. To participate, I am required to be on one of six approved birth control methods. I heard a rumor about a girl in a trial who convinced her reluctant boyfriend to be abstinent for months so she could do it.

* * *

The trial site is in a white, affluent neighborhood, and the people I’ve seen here seem to be mostly white professionals. We were told the Sponsor has put “a lot of effort” into “ensuring all races, ethnicities, ages, and medical backgrounds are represented.” J&J lists the racial demographics of the one-dose trial on its website; at US sites, white people are overrepresented by about 14 percent, compared to the census (which undercounts people of color). I imagine the people who wanted to participate in these trials were those who trusted scientific practice to treat them right, and maybe felt a bit entitled to be protected before other people. But the limits of this are clear: While the pandemic might eventually leave Chicago’s North Side, it will remain, at least for much longer, in the places that are priced out of vaccines, the countries whose leaders aren’t buddies with the CEO of a major vaccine company, the countries that can’t offer $30 a dose, or are unable or unwilling to bend to the contract’s stipulations.

If you attempt to shame the pharmaceutical industry for hoarding its intellectual property or scold it for its price tags, the CEOs chant in unison: “Research and development!” Trials, they say, are a grueling and costly process. If innovation gets any less profitable, they’ll have to stop prioritizing it. They present research as the pro bono of pharmaceuticals, suggesting that new drugs happen out of the goodness of industry hearts. In truth, as many have pointed out, research is not a huge portion of pharmaceutical budgets. Much of it is federally funded, and much of it simply attempts to mimic other companies’ drugs in order to get a slice of those products’ profits. Besides, trials aren’t mere precursors to pharma having something to sell: they serve as performances of trustworthiness: “high-cost, high-value marketing tools,” as two MIT medical engineers put it.

What is less obvious, though, is that clinical trials are themselves a profit-making industry. As regulations cemented, research went private: new types of businesses helped trials migrate out of academic settings into the market, and an implementation industry sprung up to be hired by various Sponsors on a per-trial contract basis. This is when for-profit trial sites like mine popped up, as well as other types of businesses with jargony acronyms (CROs, SMOs) that mediate between pharmaceutical giants and individual trial sites. J&J’s scientists come up with a drug, come up with a protocol for testing that drug, and then executives turn to one of a handful of huge companies and say, “Here’s millions of dollars, go test this for us.” J&J has been using a CRO to find trial sites and laboratories, recruit subjects through targeted advertising, provide online diary platforms, and shoulder some of the liability. Much of the rest of it falls to the doctors who oversee trials. Doctors often take this on because overseeing trials pays pretty well; these contracts let their clinics survive in the face of skyrocketing malpractice insurance rates. A lot of the time they sign on for the liability and hand off the work to someone like Dave.

Like other sites, mine merely conducts protocols passed down from on high, the word of the Sponsor. Failing to execute them to the word has legal consequences. Trials are subject to “neoliberal audit culture,” as Fisher puts it — mediating companies send monitors around to ensure compliance with protocol. After all, the contracting intermediaries are selling a service: clean, compliant, efficient execution of protocol-as-law. Pharmaceutical companies look for CROs that produce “clean data” in high quantity, as if it’s a strange kind of agriculture, and CROs in turn give contracts to sites that churn out high quantities of quality data. You have to keep getting contracts to stay in business — a staff member at my site explicitly expressed reluctance to say anything that could upset the Sponsor.

* * *

In March, as more and more people became eligible for the vaccine, J&J decided to unblind the whole study so that every participant could get vaccinated without having to drop out of the trial. This involved giving everyone who got the placebo one dose, and changing the study protocol to compare one dose with two doses instead of two doses with nothing. All 600 of the site’s participants were called in to sign a new informed consent and get our shots.

The trial site was packed and euphoric. They sat us down in a large lounge room full of enormous faux-leather armchairs. Staff members were ecstatic, running around with manila folders yelling “Vaccine!” or “Placebo!” Lab techs were rushing to take fluids and give shots — I had my blood drawn at my armchair, gripping the upholstery and staring intently at the aquarium screensaver of a flatscreen TV, on which pixelated blue tang fish were swimming on loop. The woman next to me was angry about having gotten the placebo. “Does this mean I get to stop doing the darn diaries, now that we know?” she asked Dave.

“Sorry,” he said to her, and then peered into my own folder. “You got vaccine!” he exclaimed. “You’re basically superhuman!” He turned to the room: “She’s a bionic woman!” He’d been saying some version of this to everyone with two doses while I cringed, thinking about how a not insignificant percentage of Americans believe the vaccines are literally making them bionic. But there I was, beaming. I’d been immune for months! I was safe the whole time! I was safe right now! Every single person in this room was safe or about to be safe. We were glowing with newfound immunity, ready to go out into the world and relate to people again. “Thank you!” we were all saying to one another. The most satisfying part of the job, the lab director told me, is telling people they’ve been vaccinated for weeks without knowing. “You can see a wave of relief pass through their entire body.”

Together in our anonymity, we were statistically significant. But at the moment of unblinding, we were more ourselves than we’d been in a year, dumbstruck by our freedom to go out into the world and be with other individuals. The trial clinic was suddenly home to mass personal apotheosis.

I have so far been paid the value of sixty doses to make my body a conduit for intellectual property. But as variants proliferate, it’s clear that surviving the virus will rely on this opaque, privatized infrastructure for a long time: government funds will keep flowing through the bureaucracies of pharmaceutical companies, emerging as papers and patents. In the nooks and crannies of these bureaucracies, trial employees perform gestures of care for trial participants, and people like me contemplate their personal usefulness. But all this is a distraction at best: in a laboratory, right now, our blood is being processed into numbers that will be abstracted into averages that will help to keep unthinkable numbers of people alive. Meanwhile, unthinkable numbers of people live beyond the reach of the pharmaceutical industry’s particular form of “care.” Its absence is a different kind of trial.

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