Thursday, March 29, 2018

How is volunteering for a Phase I clinical trial like fighting maniacs in a living hell?

Matt Lamkin and I explain in the latest issue of the Journal of Law, Medicine and Ethics:

In the early 1960s, two prank comedy pioneers approached a stranger on the street and made him an unusual offer. Posing as the hosts of a radio program called “Job Opportunities,” Jim Coyle and Mal Sharpe explained that they needed an employee for a new tourist attraction. In this attraction, the employee would be confined to a flame-filled pit where he would try to fight off bats, snakes, and maniacs. “What we’re trying to do, really, is create a living hell,” Coyle explained. “Have people pay admission; they look down in the pit; they see you down there; the flames are all around you. There will be four maniacs with you and you’ve got to control them.” Then Sharpe asked the prospective employee, “Have you ever worked with maniacs before?” “No, never,” the man said.

In exchange for spending twelve hours a day fighting maniacs, the employee would be paid $46 a week, plus one meal a day — bat meat, which the employee would be expected to grill in the flames. The job would carry some risks, Coyle explained. “I had an employee before, and I will tell you this directly and honestly, he was a little careless and incautious — I gave him specific instructions — and he perished,” Coyle says. “Now I want you to understand this before we get any further. He did perish.” The man was undeterred. “Yeah, I’d like to try it,” he said, sticking with his decision even when Sharpe reminded him that the death index for the job was 98%. “In other words,” Sharpe said, “if you took this job the odds would be 98% in favor of your perishing.” The man replied, “It’s a chance. I like to take chances.”

Part of what made this offer to fight maniacs unfair is the same thing that made it funny. It is not just that Coyle and Sharpe offered the man an absurdly dangerous job, but that the job paid practically nothing. Even if the job of maniac-fighter could be made reasonably safe, fairness would demand a higher wage. Surely it would be better for Coyle and Sharpe to offer the man $4,600 a week rather than only $46.

To most of us, this sounds like common sense. But when it comes to paying subjects for taking part in medical research, many ethicists argue precisely the opposite. The dominant view is that it is better to keep payment low, because larger sums might tempt prospective subjects to take risks to their health. On this view, it would be better for Coyle and Sharpe to pay the man $46 because a larger sum might constitute an “undue influence” and undermine the voluntariness of his consent.

The issue is most acute in Phase I clinical trials, which are typically done to determine whether experimental drugs are safe. Subjects in Phase I trials must often check into a clinical trial site for several weeks, where their diet, vital signs, and health status will be closely monitored as they are given an experimental drug. Sometimes they must undergo invasive procedures, such as endoscopies or lumbar punctures.

Although most Phase I trials are relatively safe, some of them have resulted in disaster, such as the notorious TeGenero TGN1412 study at NorthWick Park Hospital in England, which sent six healthy, paid volunteers into multisystem organ failure in 2006. Since subjects in Phase I trials get no medical benefit from the studies, their primary motivation for enrolling is the payment. IRBs typically attempt to keep payment to subjects low, on the grounds that money might unduly influence the subjects, yet the subjects themselves naturally feel they deserve to be paid well.

For the full article, try here or here.

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