Dr. Arthur Caplan is a professor and founding head of the Division of Medical Ethics at the NYU Grossman School of Medicine’s Department of Population Health in New York City.
After years investigating the shadowy world of private drug research companies that test new drugs on marginalized people, one thing was crystal clear: the system is deeply flawed, and the efforts to monitor it are dangerously inadequate.
As a physician and scientist, this worries me, but not for the obvious reasons (well, yes, for the obvious reasons). But what really frightens me is how fragile public trust is, and how hard we have to work to regain it when it’s lost. If our research processes aren’t guarded, the damage to public trust in pharmaceuticals – which save millions of lives each year – could be harmed.
I reached out to Dr Arthur Caplan, a world-famous bioethicist who used to work in a building with a Contract Research Organization, or CRO, to ask him about the problems and potential fixes to a broken scheme that collects shaky data from vulnerable people. He joined me from his office at NYU Langone in New York City.
“I’ve known about these trials for 20 years. They’ve been around a long time,” he says.
CROs are an essential part of how drugs get approved, and how doctors understand side effects and adverse events. But our investigation found that CROs target marginalized people and woo them to participate in new drug trials by offering a range of incentives from money to referral bonuses and loyalty programs – enough that some have taken up the role of professional human guinea pig. For many, the payout is so tempting, they go to great lengths to get into a trial.
“Some people are in multiple trials at the same time to make money, but they don’t admit it,” Caplan told me. “There are zero checks and balances. None. Nothing.”
Caplan’s right, there are no government regulations that restrict dual enrollment. But some research companies are trying. There’s a fingerprint service out there CROs can subscribe to, but it’s not mandatory.
People double-dip in multiple trials, contaminating not only their bodies but the results of the trials as well. Researchers can’t tell which drug is causing which effect. Sometimes, he says, people take part in four or five studies at once.
“I’ve talked to these people as they came in and out of the lobby. I’d ask them if they were honest with the researchers, and the answer was no. Their motive is money, it’s not altruism or increasing human knowledge.”
But with thousands of dollars on the table, you can’t blame marginalized people for gaming the system, says Caplan. As our investigation showed, they are being dishonest to pay the rent.
DON’T ASK, DON’T TELL
“On the sponsor side, if you ask the researcher, they say ‘I’m not the cops, I don’t police these people,’” Caplan explains. “People can lie about drug use, sexual behaviour, smoking, they’ll lie about anything to meet the trial criteria. They are very savvy.”
CROs are also motivated by money. If the CRO can’t recruit people, they can’t fulfill their contract to drug manufacturers.
“There are no secrets about this behaviour. CROs know all this. And there has been no system reform.”
While some professional guinea pigs may conceal their adverse effects so they don’t get kicked out of a trial, others may exacerbate symptoms to get a free hospital stay – shelter and food, he explains..
That makes the question of coercion particularly challenging. With thousands of dollars at stake, and hotel-like accommodations and meals up for grabs, it’s unclear when compensation crosses the line from being fair to being coercive.
Caplan says capitalism often wins. Some people argue that, if you’re poor, who am I to say you can’t earn $20,000 by taking the risk to be in these studies? But we have to be somewhat paternalistic. Ethics boards are already able to determine when risk is too high.”
University ethics boards are known for being too bureaucratic, overbearing and slow, so CROs use private ethics boards that often operate in secrecy. “No one knows what the hell is going on in there. Things seem to get approved.”.
FLAWS WITH STATUS QUO
Caplan told me the current system fails in two big ways.
The first is the integrity of how new drugs are tested and approved.
“If they are not federally sponsored, they aren’t transparent,” he says.
“In phase one trials, if no one dies, researchers are happy. That’s why dirty data is tolerated. People think the details will be worked out in phase 2 and 3 studies. So the motive to reform is weak.”
The second concern is the guinea pigs themselves. “Tighter surveillance and monitoring of who enrolls can help. If you cared, you could do it.” Facial recognition, Caplan says, could fix a lot of the problems of enrolling in multiple studies.
OBVIOUS SOLUTIONS
Caplan believes the fix lies in beefed up regulation.
He views professional guinea pigs much like the professional boxers of the past. “In boxing, they’d get knocked out cold in New York and then show up the next day in Illinois,” Caplan recalls how “tomato cans” – fodder for the champs to beat up – would evade safety rules.
State regulators would bar them from matches after being knocked out to protect their health, but they’d go to the next state and conceal their concussion.
“Eventually, people said, ‘Enough of this, we’re gonna kill these guys,’ – we finally stepped in to protect them by closing the loophole with licensing.”
But the same approach hasn’t happened to protect research subjects or the integrity of drug research.
“They need to keep tabs on how many times someone has shown up in Philly, or Buffalo, or Cleveland, or Allentown, but they don’t. We need to demand better identification of these hobo subjects, who just go town to town on the train participating in trials for money.”
Caplan also wonders why governments aren’t doing their part to regulate phase one trials. “Do audits; send an inspector out every once and a while. See what’s going on. Interview people. Way back when, I just asked people in the lobby to talk.”
Caplan also sees a future where humans aren’t needed for phase one trials. Caplan pointed to my own medical training, where practicing on real people has often been replaced by practicing on mannequins and computer simulations.
“In the future, we’ll see other ways of answering these questions. You can ask families of brain dead patients if they can be test subjects. You can use animals. You can use artificial intelligence. You can do it in the lab.”
Caplan sees hope in the example of the for-profit plasma industry, where people used to go around selling their plasma around town until they fainted or had a stroke. Eventually, the Food and Drug Administration regulated a 48 hour period between donations, and a max of twice weekly.
But letting a company extract your plasma is different from ingesting a pill.
“This whole thing of using marginalized people to be the first, it’s kind of ethically iffy. It’s hard to defend.”
“NO ONE IS MARCHING IN THE STREETS”
“There are areas in healthcare that are very hard to reform when there are for-profit companies and marginal people. No one is agitating to make it better. Who’s there to mount the charge to do better? It’s tough,” Caplan said, with a hint of resignation.
But tough is fine. Tough is what we do.
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