Organ donation problem: Thousands of pancreases unaccounted for

There are some mysteries I fear will never be solved. Database Cooper What’s wrong with him? Robbery of the Gardner Museum Where were the Vermeers and Rembrandts in 1990? Most pressingly: Thousands of pancreases The cells taken from the bodies of Americans in 2021, 2022, and 2023 were never transplanted into anyone?

Let me review. The pancreas (the correct plural form of “pancreases”) is one of those organs that’s hard to keep alive. Without it, you don’t have insulin to regulate your blood sugar, nor the enzymes you need to digest food. For this reason, all donated pancreases come from deceased people who are registered as organ donors. In the United States, we outsource the collection of organs from cadavers to private groups called organ procurement organizations (OPOs). Each OPO has a monopoly on organs in a specific geographic area; there are Total 56 groupssome only cover some states, while others cover multiple states.

Independent analysts and investigative journalists have argued for some time that OPO is underutilizing tens of thousands of deceased donor organs. A 2019 report estimated that 28,000 available organs (mainly kidneys, but also pancreas, heart, liver, etc.) Organs from deceased donors are never used; another way of saying it is 75,000 people. Currently, the national organ waiting list More than 100,000 people.

Historically, OPOs have faced perverse incentives. For example, OPO evaluations are often based on the number of organs recovered per “qualifying death,” but “qualifying death” is determined by the OPO itself. This makes it easy to skewer statistics by, for example, classifying some deaths as “ineligible,” even though the organs were perfectly usable. This results in an increase in the “number of organs recovered per qualifying death,” without actually obtaining more organs from more people. OPO contracts with the federal government Quite profitablewhich means that OPO executives have good reason to Strive hard To keep them.

In 2019, President Donald Trump A pretty good executive order was issued Directed the Centers for Medicare & Medicaid Services (CMS), which oversees OPOs, to change the way they are evaluated. The order resulted in two new metrics designed to make manipulation more difficult. The rule was finalized in December 2020 and — after review and approval — Biden Administration — Effective March 2021The rule has real binding force: OPOs that perform particularly poorly face decertification, which means another OPO with a better record of serving patients will take over their turf.

This rule could have forced OPO to harvest more organs and save thousands of lives each year. But OPO quickly found new loopholes. Now, more than a week after this article was published, Federal regulators are moving to shut it down.

The rule’s new metric is designed to be based on objective criteria. It requires OPOs to count the total number of deceased people aged 75 and younger who died of causes suitable for donation, and then estimate each year what percentage of the total population are deceased donors, and what percentage of the total population are actually used. The denominator is now something OPOs cannot tamper with. This means that, hopefully, OPOs will be judged solely on the number of organs they recover and transplant into people — on how many lives they have saved.

But while OPOs can no longer interfere with the denominator, they can still interfere with the numerator. Being a donor usually means your organs will be used for transplantation, but there is one exception: the pancreas. 2004 Narrow Law The law allows researchers conducting clinical trials to transplant islet cells (the part of the pancreas that produces insulin) as a potential treatment for diabetes. Under the law, OPOs can “restore” pancreases for islet cell transplant studies and receive credit for restoring more organs under the new rules. But the federal government has never required any proof that the organs were part of any FDA-approved research.

Sure enough, the total number of pancreases the OPO has labeled “research” increased from 513 in 2020 to 3,238 in 2023. The number of donors whose only organs recovered were pancreases designated for research increased from 25 to 429, according to the OPO. Organ Procurement and Transplantation Network. It has increased more than tenfold in three years.

Lenny Bernstein, a Washington Post reporter who has been following the scandal closely for the past year, Talk to Pancreas Researchers They all report that there has been no sudden surge in demand for pancreases in research projects. In fact, if you look at Few medical centers Using research pancreas for islet cell transplants, you’ll find 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.

This means that in 2023, there were 3,238 pancreases available for islet cell transplantation research, but only 24 transplants were actually performed that year. Where did the other 3,214 pancreases go? And what about the nearly 7,000 pancreases that were removed from dead Americans over the past three years and were not used for transplants?

The waiting list for patients who need only a pancreas is Only 800 peopleIf these organs were better allocated, that number would probably be zero. Where are they?

I reached out to the Association of Organ Procurement Organizations (AOPO), a trade group for organ purchasers, for an explanation. “CMS established and implemented the current rule governing the use of pancreases for research in 2021. As required, OPOs have been in compliance with that rule since then,” AOPO President Dorrie Dils told Vox in a statement. “OPOs have always followed CMS guidance and will continue to do so.”

That’s one explanation. Another explanation is that we may be seeing OPOs trying to circumvent regulation and avoid being decertified for not facilitating enough donations. This is certainly Senate Finance CommitteeA bipartisan group of senators who have been investigating the matter see this. In a letter sent to OPO last year, the committee cited an OPO staff mailing list. In a post discussing the new rule, an OPO employee wrote: “If you have a donor who has donated only one pancreas for research, then that person is a qualified organ donor. Otherwise, any donor who has at least 1 organ transplanted is a qualified donor. A savvy (or cynical?) OPO should start a pancreas research program immediately.”

Astute (or cynical?) indeed! Reply CommitteeAOPO protested that “OPOs have been operating as directed” and that research donations meant “the organs were not wasted.” Were they not wasted? The committee required OPOs to report the specific studies to which they donated pancreases; to my knowledge, no OPO has published data formally linking each pancreas to a specific study.

In January this year, CMS Letter to OPOs Remind them that only pancreases used for research can be counted. Senate committee urges further action: Clarify that only pancreases donated for FDA-approved research qualify under this rule. That is, OPOs can’t just recycle pancreases and put them in a freezer to make themselves look better and avoid decertification. They have to actually get the pancreas into the hands of scientists.

On August 29, CMS adopted the Senate committee’s recommendation. Release Memo Clarify that “a pancreas would be considered ‘used in’ research if it was accepted by a qualified researcher for use in bona fide islet cell research, such as research approved by the National Institutes of Health.” That is, the 24 islet cell transplants in 2023 would count toward CMS’s assessment of OPOs; the other 3,214 pancreata recovered that year may not be counted.

It’s a very simple change, but it means greater responsibility for the OPO — responsibility that could mean thousands more organs get to people who need them.

Updated: August 30, 10am: This story was originally published on August 21, 2024 and has been updated to reflect new information from CMS’s memorandum updating its pancreas policy.

Correction, August 22, 1:20 p.m.: A previous version of this story incorrectly stated whether a person can survive without a pancreas. It is possible, but difficult.