SID&T Responds to flawed Vox “news” story on so-called missing pancreas.

Dear Dylan Matthews and Julia Longoria Vox Media:

We are responding to your piece, The case of the nearly 7,000 missing pancreases Organ companies are getting up to pancreas hijinks.

We respect Vox’s standing as a news platform but this story does not reflect the growing body of peer-reviewed science, published abstracts on the Centers for Medicare and Medicaid Services (CMS)’ Final Rule for Organ Procurement Organizations’ Conditions for Coverage, and the inability of CMS to admit a course correction is clearly indicated before chaos ensues in 2026 in the organ donation and transplant system.

At a minimum, we expect that the organ transplant community be treated no differently than the subject of any other healthcare story of this nature. The story makes a number of statements that should have been put to a factual test. There are qualified spokespersons for Organ Procurement Organizations, transplant centers, donor families, and the scientific researchers who have published peer-reviewed papers covering many of the topics raised in in the Vox article.

Science in Donation & Transplant is a repository of peer-reviewed science helpful to media inquiries of this nature. Many of the mistakes in your coverage could have been avoided if fact checking had been honored instead of ignored.

Following is our response to some of the key points of the story.

Overall, the piece seemed to follow the talking points of Organize, the big tech funded special interest intent on gaming the system.

Patients deserve those organizations’ performances to be judged based on peer-reviewed science, not special interest scheming or baseless media slanders.

The misunderstandings in Mr. Matthews’ article start at the title, “7,000 missing pancreas” and continue throughout.

There are no “missing” pancreases. Any organ recovered for research needs to be sent to researchers or research organ distribution agencies such as International Institute for the Advancement of Medicine (IIAM) and the National Disease Research Interchange (NDRI). Validation is the job of Centers for Medicare and Medicaid Services (CMS), and they will conduct that validation in their 2026 certification surveys of OPOs.

• No research nor audits have ever found that OPOs, “juice(d) the stats by, for instance, classifying some deaths as “ineligible” even when the organs were perfectly usable.” In fact, UNOS researcher, John Rosendale studied the impact of the policy improvement that removed the subjective donor rule-out criterion “Multi- Symptom Organ Failure” and replaced it with a published policy requirement that OPOs identify lab values and specific diagnoses for each organ that was non-viable. Only after all organs were ruled out, could a prospective donor be determined to be non-Eligible. This change caused virtually no difference in the number of eligible donors ruled out by OPOs. Subsequent CMS OPO audits did not report evidence of this practice.

• The “quite good” Trump Executive Order that the article extols was the basis for CMS’s Final Rule for OPO’s Conditions for Coverage. This rule has been found to be replete with statistical failings, mis-rankings, and unreliable fragility in 20 peer-reviewed, published articles and abstracts by the country’s leading donation and transplant biostatisticians, including the federally contracted SRTR: https://sidandt.org/the-science/ peer-reviewed-science.

• OPOs could “muck with the numerators” in the reporting of pancreata recovered for research. In fact, CMS’s change to its OPO certification methodology on 2022 elevated the importance of recovering pancreas for research by specifically including this in the primary metric of OPO performance. Previously it had been an ineffective tertiary measure since CMS issued its OPO certification rules in 2006. The insinuations concerning the OPO’s using pancreata to rig their results is false, insulting, and should have been the subject of an interview request. It would have been easy for Matthews to learn that OPOs are fulfilling an Act of Congress that calls on them to recover and provide these organs to researchers.

• “This past January, CMS sent a letter to OPOs reminding them that they could only count pancreases that were actually used for research.” However, CMS has recently identified that their rules incorrectly referred to “pancreas for research” rather than “pancreas for Iselt Cell research.” OPOs will update their reporting of research pancreas that meet the islet cell requirement but cannot do so until CMS and HRSA issue guidance and reporting tools to do so.

Bottom line, 1) there are no “missing pancreas”, 2) OPOs have never been shown to have “juiced their stats”,

3) the Trump-era OPO metric is the methodologically weakest and least reliable ever issued by CMS, and 4) OPOs have stepped up admirably to fulfill CMS’s guidance and following the federal law and regulations that were occasioned by efforts of the diabetes research community to help identify treatments and cures for this devastating disease.

A DEEPER AND FAR MORE TROUBLING ISSUE

 The misinterpretation of the pancreata issue is but a symptom of a far greater problem in the current public policy debate on organ donation and transplant.

1. The American Transplant Congress is the Joint Annual Meeting of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST) and one of the most significant public health gatherings on the current best research on donation and transplant. The most recent Congress was held in Philadelphia in June.

    

   At the June meeting, as the Boston Globe reported, transplant surgeons’ concerns grew when,  CMS unexpectedly ordered researchers from the Scientific Registry of Transplant Recipients (SRTR) and the Organ Procurement and Transplantation Network (OPTN) to withdraw six peer-reviewed papers that directly or indirectly raised key questions about the CMS rule’s flawed metrics and the potential to skew outcomes. Among many key findings, these peer-reviewed studies said that if CMS goes forward with its rule, well-performing organ procurement organizations would be ranked below poor-performing OPOs, and that large OPOs were at a structural disadvantage against smaller OPOs.

   Presentations of six key papers at the American Transplant Congress were abruptly canceled, but conference participants had already downloaded abstracts of each paper, so the 1,000 transplant surgeons, researchers, lab directors, vendors, and other US organ transplant system leaders in attendance could see exactly what CMS was doing to protect its rule from critical scientific scrutiny.
   
   Here is a link to the censored research.
   

2. Congress funded and mandated what resulted in a landmark study by the National Academies of Science, Engineering and Medicine (NASEM, entitled “Realizing the Promise of Equity in the Organ Transplantation System.” * https://doi.org/10.17226/26364.

   Both CMS and the Senate Finance Committee have ignored this truly expert peer-reviewed study. It noted among many other unassailable conclusions that the metrics for judging OPO performance were out of line as the law gives OPOs no role in the number of transplants in each donor service area. NASEM concluded what many other researchers have in that a key problem is a much higher discard rate of usable organs by transplant centers that in other developed countries. However, CMS’ Final Rule downgrades OPOs for each organ they procure that is not subsequently utilized by a transplant center.

3. Vox is a well thought out, well-written news site but we ask a simple question. When was the last time a United States Senate or House hearing didn’t have the press release written before the hearing was held? There is no “fact finding”. There were, and continued to be, hand-picked witnesses, ignoring the peer reviewed science (NASEM and the censored abstracts) and the current currency of Washington, ad hominem attacks on those who raise a dissenting voice no matter how credible.

We are not interested in propping up failing OPOs or any health care facility. We do want performance to be judged on medically and scientifically sound bases. Your “monopolies”, a favored Organize phrase are Federally certified community based non-profit organizations with dedicated staff appointed to approach families at the most sensitive time.

We are hopeful these facts will inspire a keener desire on Vox’s part to see the whole picture before publishing further content on organ transplantation. Articles like this that don’t represent even a fraction of the truth do damage to the organ transplant system in a fundamental way, by raising doubts in the minds of potential organ donors and their families, doubts that could affect the final judgments about a donation. That is why we ask for an opportunity for rebuttal, along with your commitment to reach out to the organ transplant community for verification the next time a story or column about our industry is under consideration.

We request the opportunity, in the sake of fairness,  to turn our response into an article or op-ed on your site. Thank you.

Please reach out to John Samerjan over email at jns@sidandt.org or over the telephone at 1 (609) 306-2933 with your follow-up.

Thank you,

Anthony Pizzutillo
Science In Donation and Transplant
www.sidant.org
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