Organ donations are in trouble: thousands of pancreases are missing

There are a few mysteries I fear will never be solved. Who was DB Cooper and what happened to him? Who robbed the Gardner Museum of its Vermeers and Rembrandts in 1990? And, most urgently, where are the thousands of pancreases that were removed from the corpses of Americans in 2021, 2022, and 2023 and never transplanted into anyone?

Let me back up a bit. The pancreas (the correct plural of “pancreas”) is one of those organs that is hard to live without. Without a pancreas, you don’t have insulin to regulate blood sugar or enzymes to digest food. So all donated pancreas comes from deceased people who register as organ donors. In the U.S., we outsource the task of harvesting organs from dead bodies to private groups called organ procurement organizations, or OPOs. Each OPO has a monopoly on organs in a certain geographic area; there are 56 groups in total, some with organ procurement in only part of a state and some with organ procurement in multiple states.

For some time now, independent analysts and investigative journalists have been claiming that OPOs are underusing deceased donor organs by the tens of thousands. A 2019 report estimated that 28,000 usable organs (mainly kidneys, but also pancreases, hearts, livers, etc.) from deceased donors are never used each year; another put the number at 75,000. This, while the national waiting list for organs is over 100,000 people long.

Historically, OPOs have faced perverse incentives. For example, they were most often judged on the number of organs retrieved per “eligible death,” but “eligible death” is a determination made by the OPOs themselves. This made it easy to inflate the statistics by, for example, classifying some deaths as “ineligible” even when the organs were perfectly viable. This caused “organs retrieved per eligible death” to go up without actually obtaining more organs for people. OPO contracts with the federal government are quite lucrative, which means that OPO administrators have ample incentive to fight hard to keep them.

In 2019, President Donald Trump issued a pretty neat executive order directing the Centers for Medicare and Medicaid Services (CMS), which oversees OPOs, to change the way they are evaluated. The order created two new metrics that were harder to manipulate. The rule was finalized in December 2020 and went into effect in March 2021, after it was also reviewed and approved by the Biden administration. It had real teeth: OPOs that were doing particularly poorly would face decertification, meaning that another OPO with a better track record of serving patients would take over their territory.

The rule had the potential to force OPOs to harvest more organs and save thousands more lives each year. But OPOs quickly discovered a new loophole. And now, a little over a week after this story originally published, federal regulators are stepping in to close it.

The rule’s new metrics were to be based on objective criteria. It asked OPOs to count the total number of deceased people 75 and younger with causes of death compatible with donation, and then estimate the number of deceased donors per year as a percentage of that total population, and the number of organs actually used as a percentage of that total population. The denominator was now something OPOs could no longer tinker with. That meant, hopefully, that they would be judged solely on how many organs they had recovered and transplanted into people — on how many thousands of lives they had saved.

But while OPOs could no longer fiddle with the denominator, they could still fiddle with the numerators. Being a donor generally means that your organs will be used in a transplant, but there is an exception for one organ: the pancreas. A limited 2004 law allows researchers running clinical trials to perform transplants of islet cells (the parts of the pancreas that produce insulin) as a possible cure for diabetes. Under that law, OPOs could “recover” pancreases for islet cell transplant research and get credit for recovering more organs under the new rule. But the federal government has never asked for any proof that those organs were part of any FDA-approved research.

Indeed, the total number of pancreata that OPOs designated as “for research” grew from 513 in 2020 to a whopping 3,238 in 2023. The number of donors whose only organ retrieved was a pancreas designated for research grew from 25 to 429, according to the Organ Procurement & Transplantation Network. That’s a more than tenfold increase in three years.

Last year, Lenny Bernstein, a Washington Post reporter who has been following this scandal closely, spoke to pancreas researchers who all reported that there had been no sudden increase in demand for pancreases in research projects. If you look at the handful of medical centers that use research pancreata for islet cell transplants, you see that in all of 2023, only 24 transplants were performed: 22 at the University of Chicago Medical Center, and one each at City of Hope Medical Center outside Los Angeles and the Hospital of the University of Pennsylvania.

That’s 3,238 pancreata recovered for islet cell transplant research in 2023, and only 24 actual transplants that year. Where did the other 3,214 pancreata go? Where did the nearly 7,000 pancreata that were removed from the bodies of dead Americans over the past three years and not used for transplants go?

The waiting list for people who only need pancreata is barely 800 people. That number could be zero if these organs were better distributed. Where are they?

I reached out to the Association of Organ Procurement Organizations (AOPO), a trade association for organ procurators, for clarification. “CMS developed and implemented the current rule governing the use of pancreata for research in 2021. As required, OPOs have been in compliance since then,” Dorrie Dils, president of AOPO, told Vox in a statement. “OPOs have always followed CMS’s guidance and will continue to do so.”

That’s one interpretation. Another is that we could be seeing an attempt by OPOs to skirt the regulations and avoid losing their certification for not facilitating enough donations. That’s certainly how the Senate Finance Committee, where a bipartisan group of senators has been investigating the issue, sees it. In a letter to OPOs sent last year, the committee quoted from a listserv of OPO staff. In a thread discussing the new rules, an OPO staffer wrote: “If you have a donor with only a research pancreas, that’s a Donor Rate organ donor. Otherwise, a donor is any donor with at least 1 transplanted organ. Smart (or cynical?) OPOs should start a research pancreas program immediately.”

Savvy (or cynical?) indeed! In a response to the committee, AOPO protested that “OPOs have complied with the law” and that the research donations mean “the organ is not wasted.” Were they not wasted? The committee asked OPOs to report back to me which specific research studies they donated their pancreata to; I am not aware of any OPO that has released data formally linking each pancreas to a specific study.

Last January, CMS sent a letter to OPOs reminding them that they could only count pancreata that had actually been used in research. But the Senate committee urged them to go a step further: clarify that only pancreata donated to FDA-approved research count under the rule. That is, OPOs can’t make themselves look better and avoid decertification by simply harvesting pancreata and then sticking them in a freezer. They have to actually get the pancreata into the hands of scientists.

On August 29, CMS accepted the Senate committee’s recommendation and issued a memorandum clarifying that “pancreata are considered ‘research used’ if they are accepted for use in bona fide islet cell research conducted by a qualified investigator, such as research approved by the National Institutes of Health.” That is, the 24 islet cell transplants in 2023 will count when CMS evaluates OPOs; the other 3,214 pancreata recovered that year may not.

It is a very simple change, but it means greater accountability for OPOs, an accountability that could result in thousands more organs going to people who need them.

Update, August 30, 10:00 am: This story was originally published on August 21, 2024, and has been updated with new information that CMS has issued a memorandum updating its policy on pancreata.

Correction, August 22, 1:20 PM: An earlier version of this story misrepresented whether someone can live without a pancreas. It is possible, but difficult.