Discordant organ transplants

While the media celebrates the first pig-to-human transplant, over 100,000 patients await organs from the nation's dysfunctional human organ donation system

While celebrating what hopefully will become the first-ever successful transplant of an animal organ into a human subject, let’s not forget that the U.S. human organ donation system is in shambles and badly in need of an overhaul.

Two weeks ago, surgeons at Massachusetts General Hospital transplanted a kidney from a genetically-modified pig into Richard Slayman, 62, who left the hospital this week with a functioning kidney. Bioengineered to avoid the human immune system, Slayman’s new kidney hasn’t been rejected, as least, not yet.

The good news is that if all goes well, he will no longer needs dialysis, unlike the 550,000 other Americans with total kidney failure. Over 100,000 of them qualify for organ transplantation and are awaiting kidneys from human donors. Patients on dialysis, about 80% of whom lost kidney function after decades of poorly managed diabetes and hyperension, must endure four-hour sessions three days a week during which they are hooked up to dialysis machines that mechanically cleanse their blood.

Patients aren’t the only ones hoping that something will shorten the timeframe for replacing their failed kidneys. Medicare, which pays for dialysis for anyone who needs it, spent $51 billion a year on the “end stage renal disease” program in 2020, which was about 7 percent of its total budget.

Photo by Adobe stock

Targeting the transplant network

Unfortunately, those awaiting kidneys and other organs have been poorly served by the federally-funded system for managing human organ donations. Since 1984, it has been run by the non-profit United Network for Organ Sharing (UNOS), whose network manages to generate just 25,000 human kidneys or nearly half of the nation’s annual transplants. Organize, a patient advocacy group, estimates “28,000 organs donated each year are thrown away because of the inefficient organ transplant system.”

In recent years, UNOS and its Organ Procurement and Transplant Network (OPTN) have come in for repeated criticisms from Congressional committees. OPTN is comprised of 55 regionally-based, non-profit Organ Procurement Organizations (OPOs), which are responsible for obtaining organs from recently deceased donors and transferring them to hospitals where patients are awaiting transplants. The OPOs are awarded sole-source contracts for their regions by the Health Resources and Services Administration (HRSA), which contributes about 10% of the network’s funding with the rest coming from government and private health insurance payers.

Two years ago, the Senate Finance Committee finished a two-year investigation that documented at least 70 unnecessary deaths after organs managed by an OPO had been abandoned at airports, never picked up or mistakenly discarded. The committee also blasted the network’s computer and information exchange systems as “outdated, mismanaged and insecure.” Its report estimates 6,000 people a year die awaiting transplants.

A year ago, the Biden administration announced plans for a complete overhaul of how HRSA awards its contracts to UNOS and the OPOs. HRSA administrator Carole Johnson called for the creation of a new data dashboard where patients and surgeons could find information about waitlists, organ availability and the operations of individual OPOs.

A new law

Last July, Congress unanimously passed the Securing the U.S. Procurement and Transplantation Network Act, which the president signed last September. It allows HRSA to award multiple contracts within OPTN regions; allows competitive bidding for the different functions performed by UNOS; and called for the Government Accountability Office to conduct a study documenting how much the government spends on OPOs and how they use the funds.

A spokesperson for UNOS said in response to emailed questions that the organization welcomes HRSA’s plan for a more competitive bidding process. “Given the system’s complexity, the lives that depend on it, and UNOS’ unique level of experience, we believe UNOS should continue to play a critical role in the nation’s organ donation and transplant system.”

Irritated Congressional leaders from both sides of the aisle aren’t done yet. Two weeks ago, the House Energy & Commerce Commitee launched another bipartisan investigation into the operations of UNOS and the OPTN. It also announced it will seek information from HRSA about how it plans to implement the reforms in the new law.

“UNOS has been the sole organization managing the OPTN, during which time concerning reports have emerged that the organ donation system has become unsafe, inequitable, self-dealing, and retaliatory,” the committee press release said. It was signed by Chair Cathy McMorris Rodgers (R-WA), Ranking Member Frank Pallone, Jr. (D-NJ), and four subcommittee chairs and ranking members. “The Committee supports HRSA’s proposed reforms to make the contracting process truly competitive to help ensure patients are served by the best contractors for each function.”

Over on the Senate side, Chuck Grassley (R-IA) and Ron Wyden (D-OR) are demanding answers for a UNOS data breach last fall that left the medical records of 1.5 million organ transplant patients and donors open to outsiders. Numerous reports, including one in September 2022 by the HHS Office of the Inspector General, have called on HRSA to improve its oversight of cybersecurity at the OPTN.

Minor improvements underway

UNOS is taking some steps to clean up its act. It recently revamped how it handles sensitive patient data. The recent breach was caused by improper redactions when sharing information with outside users of the system’s data.

The Associated Press this week reported how the organization two years ago ordered hospitals to use only race-neutral tests when adding patients to the kidney waiting list. For decades, nephrologists used a scientifically inaccurate test that calculated higher values for Black transplant candidates than white candidates regarding their ability filter toxins and waste from the blood. The test was based on false assumptions about racial differences in muscle mass and diet.

As a result, more than 14,300 Black kidney transplant candidates had their wait times shortened by an average of two years, with 2,800 already having received a transplant, according to UNOS. Blacks, already overrepresented on the transplant waiting lists, have historically been underrepresented in the group that actually receives a donated organ.

And that gets at the larger problem facing the U.S. transplant system. There simply aren’t enough organs available for transplantation. It will be years before animal-to-human transplants are tested in clinical trials and approved for widespread use.

Organize CEO Greg Segal, who started the patient advocacy group in 2014 after his father had to wait five years to get a heart transplant, lays blame for that situation squarely at the feet of UNOS and the regional OPOs, which have failed to set up a system that could potentially harvest far more organs from recently deceased humans.

“Hospitals are legally required to refer all deaths to an OPO, whether they have the heart donor designation on their driver’s license or not,” Segal said. “The OPO’s job is to show up on the case. If the deceased is a registered organ donor, the OPO has the legal authority to procure the organs. If not registered, he or she can ask the family to authorize it. Whether that happens is a function of how well the OPO is run and if it is well staffed.”

From his perspective, they are collectively falling down on the job. “The waiting list has grown to 100,000 from 40,000 a decade ago. There’s a huge supply-demand gap. The OPOs put out press releases all the time saying they’re having a record year. But transplants haven’t kept pace with population growth.

“We have more donors per capita because we have far more opioid deaths and gun deaths, car accidents and suicides than any other country,” he said. “The OPOs know they have to do better.”