The recent session was notable for two reasons: for the first time, it included a patient, Jean Burns, who is participating in an NIH study of Parkinson’s disease. And the guest discussant this time around was lawyer Kenneth Feinberg, who, as administrator of the September 11 Victim Compensation Fund of 2001 and of One Fund Boston, the compensation program following the Boston Marathon bombings, may be the world’s foremost authority on victim compensation.
It was a riveting session that included not only Burns’ emotionally wrought testimony about the need for some kind of safety net when patients allow experimenters to do such things as bore holes in their heads but also Feinberg’s unsentimental elucidation of the hard facts when setting up any kind of compensation fund.
“The first thing you have to do is get your dictionary and tear out the words ‘justice’ and ‘fairness,’” he warned. Compensation funds might show evidence of mercy, he allowed, but they almost never attain the other virtues.
Burns, who was diagnosed with Parkinson’s in 2003, has not been injured during years of participation in more than a dozen clinical trials. But she did consult the CC ethics department prior to a procedure that involved brain surgery and its attendant risks, including stroke.
Current rules at many U.S. institutions say patients injured during research are eligible for up to 30 days of medical care, after which they are on their own dime. Burns thought it might be fairer if research organizations offered, as a matter of course, long-term/catastrophic care insurance—not necessarily a compensation program—to those who volunteer for studies. After all, many patients are so desperate to get better that they barely note the minutia of consent forms and often blow past due consideration of the risks, or remedies.
“I came to the bioethics office to spur change,” she said, noting that she had received “superb care” since coming to NIH about 4 years ago.
Feinberg urged caution before undertaking a national compensation program.
“Be prepared to break it down,” he said. “Do policymakers want such a fund? Who are they? Where is the money coming from? Taxpayers? The NIH budget? Who wants it? Who’s promoting it? How much money is involved is what drives everything.”
Patient Jean Burns (l) is interviewed at the outset of the Grand Rounds session by Dr. Scott Kim of the CC bioethics department. Burns credits Kim with having carefully explained to her the difference between studies and trials.
Dr. Dave Wendler (l), chief of the CC bioethics office, poses with Feinberg, Burns and Kim.
Photos: Ernie Branson
A fund prepared to disburse a check for $1.60 won’t serve anyone, he quipped. “Is there enough money, even if you want to do it?”
The 9/11 fund, created by Congress, was open-ended, he noted. The fund to compensate those harmed by the BP oil spill in the Gulf has $20 billion. The One Fund raised $61 million in only 60 days.
“Be careful when you say that [those injured in the course of research] deserve a fund,” Feinberg counseled. “Bad things happen to people every day and there is no fund to protect them…You need an end-game, an objective. Why this particular area? What long-term goals would justify a compensation program?” This kind of philosophic overlay must be considered beforehand, he said.
The questions only get tougher, and more specific, if you forge ahead. Feinberg offered examples, each of which took advantage of his long experience, going back to his membership on a Clinton commission focusing on biomedical testing during the Cold War of terminally ill patients who did not give their consent to radiation therapy, and beyond that, to Feinberg’s first victim’s comp case 35 years ago—how to settle the claims of those exposed to Agent Orange during the war in Vietnam.
- Who is eligible to receive compensation? What do we mean by “research-related?” What are the criteria?
- What is the methodology for establishing compensation? What is the basis for calculating a remedy?
- What are the proof requirements for the victim? “How do you prove ‘My illness is a consequence of research’ vs. pure fortuity? Was it 100 percent of the cause? Ten percent of the cause?”
- What are the consequences of taking the compensation? What rights, if any, are relinquished if you decide to compensate? What is the scope of the release?
Feinberg was frequently funny when he wasn’t being deadly clear. He noted that no one in his long experience ever took the cash then went and hired another lawyer to seek more compensation. “But you could,” he noted whimsically. “You could.”
- What are the due-process requirements for a compensation fund, the procedural details? Is there an appeals process?
“In my programs,” said Feinberg, who also is involved in the GM ignition litigation and other high-profile victim comp cases, “there is no appeal. If you don’t like it, don’t take it.”
|Feinberg made very clear that compensation programs have little to do with fairness or justice.
Feinberg said infrastructure is a big issue in establishing a program. “How adversarial is it? Do you need a lawyer? Who processes claims?
“We could spend a whole year around the table at NIH, trying to get answers to these questions. But it all starts with the money.”
Feinberg said he likes the idea of a national system of compensation for those injured during research. “But beware of being Goody Two-Shoes here—you are opening a can of worms. Fairness and justice have nothing to do with these kinds of programs.”
During the Q&A, Feinberg noted that the U.S. differs significantly from nations already having compensation programs for research participants: “No country on Earth has a litigation system like the U.S. And no country on Earth is as generous…Never underestimate the charitable impulse of the American people. I’m glad to look at conceptual models from abroad, but here the focus is on dollars.”
He said any prospective compensation program would have to benefit the public, the victim and the researcher. “You better be careful about programs affecting only the chosen few.”
Two potential models for a new national system drew Feinberg’s reactions:
- The current system for addressing adverse responses to vaccinations should not be touted as a stunning success, he said. “It’s fraught with adversarial strife and, procedurally, it’s a nightmare. There’s no closure.” The hallmarks of the programs Feinberg endorses are speed, certainty and efficiency, “not long-winded dispute.”
- On the other hand, the audience member who proposed a program akin to the VA assuring veterans—out of gratitude for their service—long-term health care prompted Feinberg to dub the gentleman the new chair of any new national effort to protect research subjects.
But with one caveat. “Forget gratitude,” said Feinberg. “Victims won’t do that. I’ve never seen that.” He added, “Be careful when you substitute long-term medical care for a check. Medical care will be 10 times more expensive.”
A video of the session is archived at http://videocast.nih.gov/summary.asp?Live=15593&bhcp=1.