There are some mysteries I fear I will never be able to solve. D.B. Cooper And what happened to him? Who They robbed the Gardner Museum. When was the exhibition of works by Vermeer and Rembrandt held in 1990? And the most urgent one is: Thousands of pancreases What will we do with the genes that are taken from dead Americans in 2021, 2022, 2023 and not implanted into anyone?
But back to the point. The pancreas (the correct plural of “pancreas”) is one of the hardest organs to live with. Without a pancreas, you don't have the insulin to regulate blood sugar levels or the enzymes needed to digest food. So all donated pancreases come from deceased people who register as organ donors. In the United States, the task of collecting organs from cadavers is outsourced to private groups called organ procurement organizations (OPOs). Each OPO has a monopoly on organs in a particular geographic area, Total 56 groupsSome cover only parts of the state, some cover multiple states.
Independent analysts and investigative journalists have long alleged that OPOs are underutilizing tens of thousands of deceased-donor organs. A 2019 report found that 100,000 donors are being treated annually. 28,000 available organs Organs from deceased donors (mainly kidneys, but also pancreas, heart, liver, etc.) are never used. 75,000 numbersThe national organ waiting list More than 100,000 people.
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Historically, OPOs have faced unfair incentives. For example, OPOs have most often been evaluated based on how many organs were retrieved per “eligible death,” but “eligible death” is determined by the OPO itself. This made it easy for them to inflate statistics, for example by classifying some deaths as “ineligible” even though the organs were perfectly usable. Thus, the “number of organs retrieved per eligible death” increased without actually retrieving more people's organs. OPOs' contracts with the federal government Quite profitableSo OPO executives have good reason to believe Fight Hard To hold them.
In 2019, President Donald Trump issued a remarkable executive order directing the Centers for Medicare and Medicaid Services (CMS), which oversees OPOs, to change how they evaluate OPOs. The order introduced two new metrics that make them harder to manipulate. The rule was finalized in December 2020, Biden Administration — Effective from March 2021This came with stiff penalties: particularly poorly performing OPOs could be subject to decertification and another OPO with a better track record of serving patients could take over their jurisdiction.
The rule would have forced organ donors to collect organs, potentially saving thousands of lives each year, but organ donors quickly found a new loophole — and now, just over a week after this article was first published, it's finally here. Federal regulators are moving to shut it down.
The birth of the pancreatic loophole
The new criteria for evaluation in this rule were based on objective criteria. It required OPOs to tally up the total number of people under 75 who died from causes that allowed for organ donation, and estimate the number of deceased donors in that total population, and the number of organs actually used in that total population. The denominator was something that OPOs could not tamper with. This meant that OPOs would be evaluated only on how many organs they retrieved and transplanted into people, i.e., how many thousands of lives they saved.
But while OPOs can no longer tweak the denominator, they can tweak the numerator. Becoming a donor generally means that your organs will be used for transplantation, although there is an exception for the pancreas. Narrowing the 2004 law The law allows researchers in clinical trials to transplant islet cells (the part of the pancreas that produces insulin) as a potential treatment for diabetes. Thanks to the law, OPOs can “harvest” pancreases for islet cell transplantation studies, and get credit for harvesting more organs under the new rules. But the federal government never required proof that these organs were part of FDA-approved research.
Sure enough, the total number of pancreases labeled by OPOs as “for research” increased from 513 in 2020 to a whopping 3,238 in 2023. The number of donors who retrieved only pancreases designated for research increased from 25 to 429. Organ Donation and Transplant NetworkThis is more than a ten-fold increase in three years.
Lenny Bernstein, a Washington Post reporter who has been following the scandal closely, said last year: I spoke with a pancreatic researcher. There were no reports of a sudden increase in demand for pancreases for research projects. A small number of medical centers A study of pancreatic research samples for islet cell transplants found that only 24 transplants were performed 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 the Hospital of the University of Pennsylvania.
So, in 2023, 3,238 pancreases were collected for islet cell transplant research, but only 24 of those were actually transplanted that year. Where did the other 3,214 pancreases go? Where did the roughly 7,000 pancreases that were harvested from dead Americans in the past three years go that were not used for transplant?
The waiting list for people who just need a pancreas is Only 800 peopleIf we allocated these organs better, that number could go down to zero. Where are the organs?
I reached out to the Association of Organ Donor Organizations (AOPO), a trade group for organ donors, for clarification. “CMS developed and implemented the current rules governing the research use of pancreases in 2021, and OPOs have been in compliance with the rules since then, as required,” AOPO president Dorie Dills told Vox in a statement. “OPOs have always followed CMS guidance and will continue to do so in the future.”
That's one interpretation. Another is that OPOs may be trying to circumvent regulations and avoid decertification for not facilitating enough donations. Senate Finance CommitteeThat's how a committee of bipartisan senators looking into the issue sees it. In a letter it sent to OPOs last year, the committee quoted from a listserv of OPO officials. In a thread discussing the new rules, an OPO official wrote, “If we have a donor who only donates pancreases for research purposes, then that's a donor-rate organ donor. Otherwise, a donor is one who has received at least one organ transplant. Prudent (or cynical?) OPOs should immediately initiate a pancreas donation program for research purposes.”
How clever (or ironic?)! Response to the CommitteeAOPO protested that “OPOs operate by the rules” and that donating organs for research means “organs are not going to waste.” Are organs not going to waste? The committee asked OPOs to report which specific studies they donated pancreases to. To my knowledge, no OPO has produced data formally linking pancreases to specific studies.
This January, CMS sent letters to OPOs I reminded them that only pancreases that were actually used in the study could be counted. The Senate committee called for further action.Clarify that only pancreases donated to FDA-approved research are subject to this rule, which means OPOs can't just collect pancreases and put them in a freezer to boost their reputation and avoid decertification — they have to actually get the pancreases into the hands of scientists.
On August 29, CMS, acting on the advice of the Senate committee, Issue a memorandum It clarifies that “a pancreas is considered 'used' for research if it is approved for use in bona fide islet cell research conducted by qualified investigators, such as research approved by the National Institutes of Health.” This means that the 24 islet cell transplants in 2023 will be counted when CMS evaluates OPOs, but the other 3,214 pancreases retrieved that year may not be counted.
This is a very simple change, but it means that organ transplant organizations will have greater accountability – and this increased accountability could mean that thousands of organs are not available to people who need them.
Update August 30, 10am: This article was originally published on August 21, 2024 and has been updated to reflect new information that CMS has issued a memorandum to update its pancreatic policy.
Correction, August 22, 1:20 p.m.: An earlier version of this article incorrectly stated whether a person can live without a pancreas. It is possible, but it is difficult.
