Douglas Hanto, a transplant surgeon at VA St. Louis Health-Care System, told me his research on using carbon monoxide to improve kidney transplants has been stymied. While toxic in high doses, carbon monoxide at low doses seemed to improve kidney function in pigs. They never got to test it in human donors, he says, because the company interested in carbon monoxide realized such trials would be impossible to do. It didn’t help that carbon monoxide is usually known a poison.
In contrast, the handful of donor-intervention trials that have gone through, like the hypothermia trial, have been minimal-risk. Usually, they have involved drugs already used in live patients. These trials are obviously not controversy-free, but if researchers are serious about testing new drugs that could radically change the quality of organs, Feng says the United States definitely needs a better system for ethical review.
For example, what if a new drug preserves the lungs but could potentially damage other organs? Would you need consent from the heart, kidney, liver, pancreas, intestinal, and tissue recipients, too? Would you need each recipient’s hospital IRB to approve the trial? Organs are not even allocated until after the drug would need to be given. It would be nearly impossible to go to each individual IRB in the time the organ is viable for transplant.
One solution is a central IRB, whose decisions would be accepted by every hospital in the country or at least in a region. That would logistically simplify a donor-intervention trial. IRB members also tend to be generalists, not experts on transplants. “This is a sufficiently niche area of research that there are compelling arguments for establishing donor-intervention research IRBs that could regulate all donor-intervention trials around the country,” says Scott Halpern, a doctor and bioethicist at University of Pennsylvania.
In the fall, the National Academy of Medicine—a nonprofit group that advises the federal government—is expected to issue a report on how to handle the ethical and regulatory issues of donor-intervention research. A national IRB is one of the recommendations it is considering.
To doctors like Malinoski, clear guidelines for donor-intervention research—guidelines that can cut through the mess of diverging opinions—can’t come soon enough. He and Niemann had planned a follow-up trial. Cooling the donor’s body did appear to improve kidney transplant success, and now they wanted to compare it to an alternative technique that uses a machine to pump liquid through the kidney outside the body.
But after the Public Citizen letter came out, potential collaborators were suddenly shaky. “When there’s controversy, people don’t want to touch it with a 10-foot pole,” says Malinoski. “It really set our study back over a year, year and a half.” After a lot of meetings and consultations, UCSF eventually gave them the go-ahead. The National Academy of Medicine can provide an authoritative answer for the whole country.
“We’re looking forward to clarity,” he says, “Whatever is decided, we’re happy to follow it.”