RUTHFULLY YOURS

Modern medicine has produced many high-tech miracles, among them gene therapy, electrical stimulation devices that restore significant function after traumatic spinal cord injury, and robot-performed surgery.

Another sector of medicine that needs a breakthrough is transplantation of solid organs. More than 100,000 Americans are waiting for transplants, and due to a shortage of hearts, lungs, livers, and kidneys, at least 17 die each day. Currently, donor organs – from a living person or a cadaver – must match the recipient’s tissue type and size, and often, the match is not perfect. By one estimate, approximately half of transplanted organs are rejected by recipients’ bodies within 10-12 years. Compounding the shortage, the organ procurement system in the U.S. is inefficient, inconsistent, and unaccountable – in short, a mess that causes preventable deaths.

A high-tech approach that uses organs from genetically engineered pigs for transplantation, xenotransplantation, might both eliminate the need for human organ donors and reduce the risk of tissue rejection.

Researchers at the University of Alabama at Birmingham reported in JAMA Surgery earlier this month that they had transplanted a pig kidney with 10 gene edits into a brain-dead man, where it functioned normally – producing urine and evading rejection – during a seven-day study.

That experiment was made possible by a milestone that occurred in December 2020 when the FDA approved “a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs” called GalSafe, which may be used for food or human therapeutics. The IGA in the animals eliminates the gene that makes α-Gal, a sugar molecule found naturally on the surface of porcine cells. It is the source of allergy in some people when they consume certain meats, and it is also involved in tissue or organ rejection after transplantation into humans. That was the first IGA in an animal approved by the FDA for both human food consumption and as a potential source for therapeutic uses.

Another limited success occurred this month, when a kidney from a pig with only a single edited gene was transplanted at NYU Langone Health in New York City into a brain-dead human recipient.  That kidney has functioned for upwards of five weeks.

These are very exciting advances. We are nearing a time when the FDA will permit clinical trials in living patients. Within the next 10 to 20 years, xenotransplantation may well be mainstream practice for kidney failure. But that is too long to wait for people languishing on dialysis today.

Therefore, we propose a federal tax credit for living kidney donors willing to save the lives of strangers. The value of the reward should be between $50,000 and $100,000, which physicians and others who endorse donor compensation believe would be sufficient to address the shortage. Currently, only friends, relatives, and the occasional “good Samaritan” donor can donate kidneys. Under section 301(a) of National Organ Transplant Act of 1984 (NOTA), it is a federal crime for “any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.”

An economic analysis published last year estimated that a reward of $77,000 could encourage sufficient donations to save 47,000 patients annually.

The credit would be universally available – refundable in cash for people who do not pay income tax, not phased out at high income levels, and available under the alternative minimum tax. There would be no change in NOTA’s restriction on payments by organ recipients and other private individuals and organizations – it would still be illegal for recipients to buy organs.

A qualified organ donation would be subject to stringent safeguards. Prospective compensated donors would be carefully screened for physical and emotional health, as all donors are now. A minimum six-month waiting period before the donation would filter out impulsive donations of the financially desperate.

In addition to saving lives, the credit would save the government money – about $14 billion (according to an analysis that examined disincentive removal; providing incentives would probably yield considerably more). Thus, donors would receive financial compensation from the government for both contributing to the public good and for bearing the risk of a surgical operation to remove the organ. This would be compassionate and pragmatic policy.

Moreover, it could be implemented immediately, rapidly clearing much of the backlog of Americans waiting for organs in advance of the longer-term high-tech approaches.

The organ shortage kills thousands of Americans every year. We must do all we can to alleviate it now.

Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA’s Office of Biotechnology. Sally Satel, a psychiatrist and senior fellow at the American Enterprise Institute, is a kidney recipient. She and economist Alan Viard developed the tax proposal in depth.