The case of the nearly 7,000 missing pancreases

There are some mysteries that I fear I’ll never see resolved. Who was DB Cooper and what happened to him? Who robbed the Gardner Museum of its Vermeer and Rembrandts in 1990? And, most pressingly: where are the thousands of pancreases taken out of Americans’ dead bodies in 2021, 2022, and 2023 that were never transplanted into anybody?

Let me back up. Pancreata (the correct plural form of “pancreas”) are one of those organs you can’t live without. Without one, you don’t have insulin to regulate blood sugar or enzymes necessary to digest food. So all donated pancreata come from dead people who register as organ donors. In the US, we outsource the job of collecting organs from dead bodies to private groups called organ procurement organizations, or OPOs. Each OPO has a monopoly on organs in a particular geographic area; there are 56 groups total, some of which only cover part of a state and some of which cover multiple states.

For some time now, independent analysts and investigative reporters have argued that OPOs are underusing deceased donor organs by the tens of thousands. One report from 2019 estimated that every year 28,000 usable organs (mostly kidneys but also pancreata, hearts, livers, etc.) from deceased donors are never used; another put the number at 75,000. This, when the national waitlist for organs is more than 100,000 people long.

Historically, OPOs have faced perverse incentives. For instance, they were most often evaluated on the basis of how many organs are recovered per “eligible death,” but “eligible death” is a determination made by the OPOs themselves. That made it easy to juice the stats by, for instance, classifying some deaths as “ineligible” even when the organs were perfectly usable. That made “organs recovered per eligible deaths” go up without actually getting more people organs. OPO contracts with the federal government are quite lucrative, which means OPO executives have ample reason to fight hard to retain them.

In 2019, President Donald Trump issued a quite good executive order instructing the Centers for Medicare and Medicaid Services, which oversees OPOs, to change the way they’re evaluated. The order led to two new metrics that were meant to be harder to game. The rule was finalized in December 2020, and — after also being reviewed and approved by the Biden administration — took effect in March 2021. It came with real teeth: OPOs that did particularly badly would face decertification, meaning another OPO with a better track record of serving patients would take over their territory.

The rule had the potential to force OPOs to collect more organs and save thousands more lives every year. But the OPOs quickly figured out a new loophole.

The birth of the pancreas loophole

The rule’s new metrics were meant to be based on objective criteria. It asked OPOs to tally the total number of deceased people 75 and younger with causes of death compatible with donation, and then estimate the number of deceased donors each year as a share of that total population, and the number of organs actually used as a share of that total population. The denominator was now something that OPOs couldn’t tamper with. That meant, hopefully, that they’d be judged solely on how many organs they recovered and transplanted into people — on how many thousands of lives they saved.

But while OPOs couldn’t muck with the denominator anymore, they could still muck with the numerators. Being a donor generally means that your organs are used in a transplant, but there’s a carveout for one organ: the pancreas. A narrow 2004 law allows researchers running clinical trials to conduct transplants of islet cells (the parts of the pancreas that produce insulin) as a potential cure for diabetes. Because of 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 never asked for any proof that these organs were part of any FDA-approved research.

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

Last year, Lenny Bernstein, a reporter at the Washington Post who’s been watching this scandal closely, talked to pancreatic researchers who all reported there was no sudden surge in need for pancreases in research projects. Indeed, if you look at the small handful of medical centers that use research pancreata for islet cell transplants, you find that there were only 24 transplants conducted in all of 2023: 22 at the University of Chicago Medical Center, and one each at City of Hope Medical Center outside Los Angeles, and at 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 conducted that year. Where did the other 3,214 pancreata go? Where did the nearly 7,000 pancreata taken from dead Americans’ bodies over the past three years and not used for transplants go? 

The waiting list for people needing just pancreata is barely 800 people. That number could be zero if these organs were better allocated. Where are they?

I asked the Association of Organ Procurement Organizations (AOPO), a kind of trade group for the organ procurers, for an explanation. “CMS developed and implemented the current rule governing the use of pancreata for research in 2021. As is required, OPOs have been complying with the rule since that time,” AOPO’s president Dorrie Dils told Vox in a statement. “OPOs have always followed CMS guidance and will continue to do so.”

That’s one interpretation. Another is that we could be seeing an attempt by OPOs to get around regulations, and avoid being decertified because they don’t facilitate enough donations. That’s certainly how the Senate Finance Committee, where a bipartisan group of senators has been investigating the matter, sees it. In a letter to OPOs sent last year, the committee quoted from a listserv of OPO employees. In a thread discussing the new rules, an OPO employee wrote, “If you have a donor with only a pancreas for research, that is an organ donor for the Donor Rate. Otherwise, a donor is any donor with at least 1 organ transplanted. Savvy (or cynical?) OPOs ought to start a pancreas for research program immediately.”

Savvy (or cynical?) indeed! In a reply to the committee, AOPO protested that “OPOs have been operating according to the rule” and that the research donations mean “the organ does not go to waste.” Have they not gone to waste? The committee asked OPOs to report back which specific research studies they gave the pancreata to; I know of no OPO that has put out data formally tying each pancreas to a specific study.

This past January, CMS sent a letter to OPOs reminding them that they could only count pancreases that were actually used for research. But it should go a step further and do what the Senate committee is urging: clarify that only pancreata donated to research approved by the FDA counts under the rule. That is, OPOs cannot make themselves look better and avoid decertification just by recovering pancreata and then sticking them in a freezer. They have to actually get the pancreata into the hands of scientists.

It’s a very simple change, but it could mean the difference between rules that lead to thousands more organs going to people who need them, and rules that let the current system of unaccountable OPOs continue unabated.

A version of this story originally appeared in the Future Perfect newsletter. Sign up here!