There are some mysteries I fear I will never be able to solve. who was DB Cooper And what happened to her? WHO Gardner loots the museum 1990’s Vermeer and Rembrandts? And, most pressingly: where Thousands of pancreases In 2021, 2022, and 2023, Americans are exhumed from corpses that have never been transplanted into anyone?
Let me back up. The pancreas (the correct plural of “pancreas”) is one of those organs you can’t live without. Without one, you don’t have the insulin to regulate blood sugar or the enzymes needed to digest food. So all donated pancreases come from deceased people who register as organ donors. In the United States, we outsource the procurement of organs from cadavers to private groups known as Organ Procurement Organizations, or OPOs. Each OPO has exclusive rights over organs in a specific geographic area; there is Total 56 groupsSome of which cover only part of a state and some of which cover multiple states.
For some time, independent analysts and investigative journalists have argued that the OP is using organs from thousands of deceased donors. A report from 2019 estimates every year 28,000 usable organs (mostly kidneys but pancreas, heart, liver, etc.) are not used from deceased donors; do another The number is 75,000. This, while the national waiting list for organs More than 100,000 people long.
Historically, OPOs have faced perverse incentives. For example, they are often evaluated based on how many organs are recovered per “qualified death,” but “qualified death” is a determination made by the OPs themselves. This simplified the statistics, for example, by classifying some deaths as “incompetent” even when the organs were perfectly usable. This results in “recovered organs per eligible death” increasing the number of people not receiving organs. OPO Agreement with the Federal Government quite profitableWhich means OPO executives have ample reason hard battle to hold them.
In 2019, President Donald Trump issued a landmark executive order directing the Centers for Medicare and Medicaid Services, which oversees OPOs, to change the way they evaluate OPOs. This order led to two new metrics that were meant to be harder to play. The rule was finalized in December 2020, and – also after review and approval The Biden administration – Effective March 2021. It came with real teeth: particularly poorly performing OPOs would face decertification, meaning another OPO with a better track record of serving patients would take over their territory.
This rule had the potential to force OPOs to harvest more organs and save thousands more lives each year. But OPO quickly found a new loophole.
Birth of the pancreatic duct
The new metrics of the rules were meant to be based on objective criteria. It asked the OPO to count the number of people who died 75 and younger with causes of death compatible with donation, and then to 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. of the population. The denominator was now something that OPOs could not interfere with. This means, hopefully, that they will be judged based on how many organs they recover and transplant into people – how many thousands of lives they save.
But even though OPOs can no longer joke with denominators, they can still joke with numerators. Being a donor usually means your organs are used in a transplant, but there is a carve-out for one organ: the pancreas. A Narrow 2004 Act It allows researchers conducting clinical trials to transplant islet cells (the part of the pancreas that produces insulin) as a potential cure for diabetes. Because of that law, OPOs can “recover” pancreases for islet cell transplant research and receive credit for recovering more organs under the new rules. But the federal government never sought any proof that these organs were part of FDA-approved research.
Sure enough, the total number of pancreases that OPOs label as “research” increased from 513 in 2020 to 3,238 in 2023. The number of donors whose pancreas was the only recovered organ selected for the study increased from 25 to 429, the Organ Procurement and Transplantation Network. Which is ten times more in three years.
Last year, Lenny Bernstein, a Washington Post reporter who has been following the scandal closely, Pancreas spoke to researchers All of whom reported no sudden increase in pancreatic requirements in the research project. Indeed, if you look A few medical centers For those that use research pancreata for islet cell transplants, you see only 24 transplants performed in 2023: 22 at Chicago Medical Center, and one hospital outside of Los Angeles at City of Hope Medical Center. University of Pennsylvania.
It found 3,238 pancreases were retrieved for islet cell transplant research in 2023, and only 24 actual transplants were performed that year. Where did the remaining 3,214 pancreas go? Where did the nearly 7,000 pancreases taken from dead Americans in the last three years go and not used for transplants?
Waiting list for people who just need a pancreas Barely 800 people. This number can be zero if these organs are better allocated. Where are they?
I asked the Association of Organ Procurement Organizations (AOPO), a sort of trade group for organ procurers, for an explanation. “CMS developed and implemented the current rule governing the use of pancreas for research in 2021. As required, OPO has been in compliance with the rule since then,” AOPO President Dory Diels told Vox in a statement. “OPOs have always followed CMS guidelines and will continue to do so.”
Explain that one. Another is that we are seeing an attempt by OPOs to get around the regulations, and avoid being decertified because they don’t facilitate enough grants. That’s certainly how Senate Finance CommitteeWhere a bipartisan group of senators is investigating the matter, it sees. In a letter sent to the OPO last year, the committee quoted from the list of OPO staff. In a thread discussing the new rules, an OPO staffer wrote, “If you have a donor with only one pancreas for research, that’s an organ donor for the donor rate. Otherwise, a donor is any donor who has at least 1 organ transplanted. Wise (or cruel?) OPOs should immediately initiate a pancreas for research program.”
Clever (or cruel?) indeed! A Reply to CommitteeThe AOPO protested that “OPOs are working according to the rules” and that research donations mean “the organ is not wasted.” Aren’t they spoiled? The committee asked the OPO to report on which specific research studies they have assigned Pancreata; I know of no OPO that has published data formally tying each pancreas to a specific study.
Last January, CMS sent a letter to OPO Remind them that they can only count the pancreas that was actually used for the study. But it should go a step further and do what it should The Senate committee is urging: Clarify that only pancreases donated in FDA-approved research are counted under the rule. That is, OPOs cannot make themselves look better and avoid decertification by simply retrieving the pancreas and then sticking it in a freezer. They actually have to get the pancreas into the hands of scientists.
It’s a very simple change, but it could mean the difference between rules that funnel thousands of organs to people who need them and rules that allow the current system of unaccountable OPOs to continue unabated.
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