The bizarre pancreas loophole that’s undermining America’s organ donation system
Below is a graph showing a trend that exploded during the 2020s:
What is this depicting? Compute use for AI? Crispr gene edits per year?
No, this is another, much less-known example of massive growth these past several years. This is a chart of the number of pancreases (or, to use the correct plural, “pancreata”) collected each year from dead bodies in the US for research purposes:
How this happened is no mystery. The surge is, by all accounts, due to a regulation that took effect in 2021 focused on groups called organ procurement organizations (OPOs).
You probably haven’t heard of OPOs, but if you or anyone you know has ever received an organ transplant, they’re the ones who procured it. OPOs are nonprofit, nongovernmental bodies to which the US outsources the job of collecting organs from deceased organ donors. Each OPO has a monopoly on recovery of all organs in a particular geographic area; there are 55 groups, some of which only cover part of a state and some of which cover multiple states.
For some time now, critics have argued that OPOs are massively underusing deceased donor organs. One report from 2019 estimated that every year 28,000 usable organs (mostly badly needed kidneys but also pancreata, hearts, livers, etc.) are removed from deceased donors but never used; another put the number at 75,000. This, when the national waitlist for organs is more than 100,000 people long.
OPOs are not paid to collect these organs per se: They are entitled to 100 percent reimbursement of costs they report related to retrieving, preserving, and delivering organs, with ultimate payment coming from Medicare or transplant centers (which in turn charge Medicare and other insurers). This system, critics have long charged, does not provide enough incentive to procure harder-to-retrieve organs from patients who may be older or have certain medical conditions.
To get OPOs to collect more organs, the Trump administration in 2019 issued an executive order calling for new rules governing how the organizations are certified by the federal government, rules that were finalized two years later. This was high stakes: If an OPO loses certification, it has to shut down, and another OPO gets its territory. The rules were meant to more strictly grade OPOs on the share of organs they eventually transplant than the earlier, laxer rules did.
But there was a catch. In addition to organs recovered from deceased donors and transplanted, pancreata recovered and used for research would count toward recertification as well. Not any other organs for research — just pancreata.
What happened next can be see in the chart above: a massive, sudden surge in the number of research pancreata being recovered by OPOs, beginning in 2022, the precise year the new evaluation system took effect.
I’ve long been fascinated by this trend, which OPO critics call the “pancreas loophole” and OPO defenders describe as a perfectly legal response to overly onerous regulations. The numbers represent thousands of real, physical human pancreata, taken from real, recently deceased donors, that wouldn’t have been taken from those bodies without this regulation.
I’ve tried in recent months to make sense of how this happened, and what it means. I’m not the only one; the Senate Finance Committee has been investigating, and released a report in early June on the problem.
There is still plenty that remains unknown about the fate of these pancreata (if you work at an OPO or research center and know more details, please email me). But what is clear is that they represent an approach by the federal government toward increasing organ supply that absolutely no one is happy with. If the point of the regulations is to help people in need — including the millions of Americans with diabetes, a disease of the pancreas — evaluating OPOs based on the number of pancreata they donate to researchers simply doesn’t make any sense.
But to understand how we started judging them this way regardless, you have to go all the way back to an obscure law passed in George W. Bush’s first term.
Pancreata (and why you might need one transplanted), explained
Everyone knows, in broad strokes, what the heart or the lungs do. But the pancreas doesn’t have the same level of fame. Its basic purpose is to excrete enzymes, hormones, and other compounds to both 1) help the body digest food and 2) regulate blood sugar levels.
The latter function is performed by the islets of Langerhans, cells in the pancreas (named after their discoverer, 19th-century German researcher Paul Langerhans) that secrete two different hormones: insulin (to lower blood sugar) and glucagon (to raise it).
In Type 1 diabetes, the ability of the pancreas to produce insulin is impaired and thus blood sugar levels are dangerously elevated; in some kinds of Type 2 diabetes, the body develops resistance to insulin’s effects. Typically, people with diabetes deal with this through injecting insulin directly, a process that has become much more sophisticated in recent decades as finger pricks and needles have given way to insulin pumps that can directly measure and adjust blood sugar levels.
But even with advanced care, diabetes carries lifelong medical consequences, so researchers have long sought a more permanent fix: What if you could replace or supplement the faulty islet cells in patients with diabetes with healthy islet cells? Could you, then, cure diabetes at the source and avoid the need for insulin injections and the risk of long-term health effects altogether?
In the most extreme version of this approach, a complete new pancreas is transplanted into a patient with diabetes, like swapping out a faulty part. This is a proven treatment (© Vox
