Showing posts with label organs. Show all posts
Showing posts with label organs. Show all posts

Wednesday, October 2, 2024

Regulation of Organ Transplantation and Procurement (Chan and Roth in the JPE)

 Here's a new paper (in final form, online ahead of print) on how organ transplants are regulated.  The paper uses an experiment to make several points about the design of current regulations.  One of them is that transplant centers are incentivized to be risk averse, since they are measured only by the outcomes of the transplants they perform, and not on the outcomes for patients they decline to transplant (so they are reluctant to transplant risky kidneys or risky patients).

Regulation of Organ Transplantation and Procurement: A Market-Design Lab Experiment by Alex Chan and Alvin E. Roth, Journal of Political Economy, online ahead-of-print .

 Abstract: We conduct a lab experiment that shows that current rules regulating transplant centers (TCs) and organ-procurement organizations (OPOs) create perverse incentives that inefficiently reduce both organ recovery and beneficial transplantations. We model the decision environment with a two-player multiround game between an OPO and a TC. In the condition that simulates current rules, OPOs recover only the highest-quality kidneys and forgo valuable recovery opportunities, and TCs decline some beneficial transplants. Alternative regulations that reward TCs and OPOs together for health outcomes in their entire patient pool lead to behaviors that increase organ recovery and appropriate transplants.

Here's what transplants look like in our experimental environment:



And our results are robust to big changes in parameters:




Friday, September 20, 2024

HRSA has accepted bids to reform deceased donor organ allocation

 Here's yesterday's HRSA press release. (Item 2, Supporting OPTN IT Modernization, might be of most interest to most readers of this blog.)

In Historic Step, HRSA Makes First Ever Multi-Vendor Awards to Modernize the Nation’s Organ Transplant System and End the Current Contract Monopoly

U.S. Department of Health and Human Services
Health Resources and Services Administration

FOR IMMEDIATE RELEASE

HRSA NEWS ROOM

newsroom.hrsa.gov

Contact: HRSA PRESS OFFICE

Phone: 301-443-3376

Email: Press@hrsa.gov

As part of the Administration’s efforts, for the first time in the program’s nearly 40-year history, HRSA has awarded separate contracts to reform the organ procurement and transplant network. Multiple vendors will support improving quality and patient safety, modernizing IT, bolstering communications with patients, and more

Today, the Health Resources and Services Administration (HRSA) at the Department of Health and Hunan Services (HHS) announced the first ever multi-vendor contract awards to modernize the nation’s organ transplant system to improve transparency, performance, governance, and efficiency of the organ donation and transplantation system for the more than 100,000 people on the organ transplant waitlist.

The Organ Procurement and Transplantation Network (OPTN) has long faced critiques about lack of transparency, potential for conflicts of interest, IT reliability issues and other structural challenges. As part of the Administration’s transformation of the OPTN, for the first time in 40 years, multiple contractors will provide their expertise and proven experience to improve the national organ transplant system. This transition from a single vendor to multiple vendors to support OPTN operations is a critical step in advancing innovation in the transplant system to better serve patients and their families and implements the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act signed by the President in September 2023.

“With the life of more than 100,000 Americans at stake, no organ donated for transplantation should go to waste,” said HHS Secretary Xavier Becerra. “For too long, our organ transplant system has fallen short, mired in monopoly. The Biden-Harris Administration has reformed OPTN to require accountability in the operation of organ procurement that our transplant patients and their families demand.”

“One person is added to the waitlist every 10 minutes. Each one relies on and deserves the best care possible,” said HRSA Administrator Carole Johnson. “Today’s action marks a significant advancement in the Biden-Harris Administration’s commitment to doing what it takes to make sure the nation’s organ matching system works for patients, donors, and the families who depend on the OPTN for that life-saving call.”

HRSA is announcing multiple OPTN modernization awards to support critical actions, including:

  1. Improving Patient Safety - Arbor Research Collaborative for Health will provide support on patient safety and the policy compliance systems and processes overseen by the OPTN Board of Directors and the Membership and Professional Standards Committee to improve oversight of the multiple entities in the OPTN.
  2. Supporting OPTN IT Modernization - General Dynamic Information Technology (GDIT) will focus on the opportunities to improve the OPTN organ matching IT system and inform HRSA’s Next Generation IT procurement and development work.
  3. Increasing Transparency and Public Engagement in OPTN Policy Development - Maximus Federal will advance opportunities to improve public visibility and engagement in the OPTN policy making process, including improving transparency around OPTN policy making committees’ deliberations and actions.
  4. Strengthening Patient-Centered Communications - Deloitte will focus on improvements in communications from the OPTN, within the OPTN and, importantly, with patients and families.
  5. Improving OPTN Financial Management - Guidehouse Digital will address improvements for OPTN’s budget development and management systems and processes.

In August 2024, HRSA announced that the OPTN Board of Directors—the governing board that develops national organ allocation policy—is now separately incorporated and independent from the Board of longtime OPTN contractor, the United Network for Organ Sharing (UNOS). HRSA awarded an OPTN Board Support contract to a new vendor, American Institutes for Research, to support the newly incorporated OPTN Board of Directors.

HRSA launched the OPTN Modernization Initiative in March 2023, including making proposals to reform the decades old OPTN statute and increase funding for the program to better serve patients and families. Within a year, HRSA worked closely with bipartisan leaders in Congress to secure passage of the Securing the U.S. OPTN Act and substantially boost funding to support modernization efforts. Today’s awards represent a key step forward in this work.

###########

Here's the full list (from OrangeSlices AI):

14 Prime awardees named for $440M in HHS HRSA OPTN Operations Transition IDIQs

The total ceiling for Domain 1 is $30M, Domain 2 is $145M, Domain 3 is $235M, and Domain 4 is $40M. The following awardee information is provided for the HRSA procurement:


1. ABT GLOBAL

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1 – $30M


2. ARBOR RESEARCH COLLABORATIVE FOR HEALTH

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1 – $30M


3. GUIDEHOUSE DIGITAL LLC

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1, 2, 4 – $215M


4. MAXIMUS FEDERAL SERVICES

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1, 2 – $175M


5. RAND CORPORATION

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1 – $30M


6. CUSTOMER VALUE PARTNERS

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2, 4 – $185M


7. GENERAL DYNAMICS INFORMATION TECHNOLOGY INC

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2, 3 – $380M


8. KPMG LLP

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2 – $145M


9. UNITED NETWORK FOR ORGAN SHARING

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2 – $145M


10. ACCENTURE FEDERAL SERVICES LLC

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 3 – $235M


11. LEIDOS INC

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 3 – $235M


12. SAPIENT GOVERNMENT SERVICES INC

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 3 – $235M


13. DELOITTE CONSULTING LLP

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 4 – $40M


14. HIGHLIGHT TECHNOLOGIES INC

Total IDIQ Maximum Not to Exceed/Ceiling: Domain 4 – $40M


The IDIQs include a base ordering period of one year staring on 9/25/2024 and 4 option periods.


Solicitation: 75R60224R0008, OPTN Operations Transition Indefinite-Delivery-Indefinite-Quantity (IDIQ)

Agency: HEALTH AND HUMAN SERVICES HEALTH RESOURCES AND SERVICES ADMINISTRATION


Friday, May 31, 2024

Organs, tissues, and medical devices are regulated very differently

 Here's an article in JAMA by a Michigan doctor and his Congresswoman, on the lack of regulation for some substances of human origin.

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products, by Robert P. Dickson, MD; Deborah A. Dingell, MS, JAMA. 2024;331(20):1703-1704. doi:10.1001/jama.2024.6834

" In 2021, an outbreak of M tuberculosis occurred in the US when contaminated bone graft material was implanted into 113 patients, 77% of whom developed clinically apparent tuberculosis.

...

[Again in 2023] "the Centers for Disease Control and Prevention (CDC) had identified additional tuberculosis-infected patients who had received implants of the same product, harvested from the same donor. At final count, 36 patients in 7 states had undergone implantation of bone graft tissue contaminated with M tuberculosis.

...

"Given the rigorous safety testing required of most medical therapies, how could 2 lethal outbreaks of tuberculosis occur in as many years, arising from the same product, distributed by the same company?

"The answer lies in the FDA’s designation of this product as a human cells, tissues, and cellular and tissue–based product (HCT/P) (Table). This class of therapies, which includes bone grafts, skin grafts, and stem cells, is not subject to the same regulatory standards as pharmaceuticals, biological products (such as blood products and monoclonal antibodies), or organ transplants. This designation has profound regulatory and clinical consequences



Tuesday, December 5, 2023

Organ & Body Donations: John Oliver

Laugh through the tears with John Oliver:

Monday, October 23, 2023

Waitlist equity, when not everyone can wait a long time, by Afshin Nikzad and Philipp Strack

 Patients waiting for deceased donor kidneys are given priority in part by how long they have been on dialysis, while patients waiting for livers are prioritized according to how sick they are, sickest first.  When the wait is long, not everyone has an equal chance of surviving long enough to receive an organ. Here's a paper that suggests that service in random order (SIRO) has desirable equity properties. Efficiency depends on how patients' welfare and future prospects change while they wait.

Equity and Efficiency in Dynamic Matching: Extreme Waitlist Policies, by Afshin Nikzad and Philipp Strack, Management Science, forthcoming, Published Online:3 Oct 2023https://doi.org/10.1287/mnsc.2023.01212

Abstract: Waitlists are commonly used to allocate scarce resources, such as public housing or organs. Waitlist policies attempt to prioritize agents who wait longer by assigning them priority points (à la first come, first served). We show that such point systems can lead to severe inequality across the agents’ assignment probabilities unless they use randomization. In particular, deterministic point systems lead to a more unequal allocation than any other rule that prioritizes earlier arrivals, an axiom that ensures that agents who wait longer are treated (weakly) better. Among the policies abiding by this axiom, we show that service in random order (SIRO) leads to the most equal allocation. From a utilitarian perspective, we show that the planner faces no trade-off between equity and efficiency when the flow utility from waiting is nonnegative or negative and increasing over time. In these cases, SIRO is also the most efficient policy. However, when the flow cost of waiting increases over time, then the planner may face an efficiency–equity trade-off: SIRO remains the most equitable policy but may not be the most efficient one.


1. Introduction: Waitlists are a common way to allocate scarce resources, such as public housing,1 organs,2 or services such as call center support.3 There are many ways to decide who among the waiting agents receives an object once it becomes available. Some waitlists operate in a service-in-random-order (SIRO) manner and use lotteries to allocate objects to waiting agents, such as in the Diversity Immigrant Visa Program in the United States4 or Beijing’s license plate allocation.5 Many other waitlists follow designs akin to first come, first served (FCFS), in which whoever has waited for the longest time receives (priority points for) an object. For example, in the national kidney transplant waitlist in the United States, enrolled patients earn priority points for each day that they remain on the waitlist.6 Such rules ensure that an agent who waits longer is not treated worse than an agent with a shorter waiting time and otherwise identical characteristics.

"Prioritizing agents with longer waiting times, however, has a drawback: it implies that an agent with a longer lifetime, that is, an agent who can wait longer for an object, has a higher probability of receiving an object. This naturally leads to inequality in assignment probabilities across agents with varying lifetimes. For example, a first-come, first-served list would lead to many of the sickest patients never receiving an organ as they depart the system before having waited long enough to receive an organ. Such equity concerns, for example, play an important role in the context of organ allocations (Organ Procurement and Transplantation Network 2015). The high-level question we ask here is, what policy induces the least inequality among policies that give priority to agents who arrive earlier? Furthermore, is minimizing inequality aligned with the objective of a planner who maximizes the average of the agents’ utilities, or are there efficiency–equity trade-offs to be considered here?"

Thursday, July 6, 2023

Cryopreservation of organs for transplants, and Sebastian Giwa in Forbes

 Forbes has a long, interesting, somewhat breathless story about the progress and promise of freezing organs for transplants, including not only the usual eight organs, but also bone marrow/blood stem cells. It focuses on one of the entrepreneurs in the field, Dr. Sebastian (Seb) Giwa, and his colleague Jedd Lewis among others

New Breakthroughs In Cryopreservation Poised To Transform Organ Transplantation, by Alex Zhavoronkov, PhD, Jul 5, 2023

"To understand how this came about I delved into the career of the founder and CEO of Sylvatica Biotech, Dr. Sebastian Giwa (called “Seb” by his friends). Seb is credited by many as the chief architect of the surge of scientific interest in cryopreservation over the last several years.

Sebastian Giwa, PhD, MBA 

BRIDGET BENNETT

...

"Trying to donate organs (without cryopreservation) is a lot like trying to donate perishable (non-canned) food: there are certainly a lot of starving people in the world, but good luck finding a recipient for every single ounce before it expires. 

...

"[Organ Preservation Alliance]  partnered ... to publish position papers, including a peer-reviewed article in Nature Biotechnology outlining the need for an organ cryopreservation research effort. The paper was co-authored with all of the major U.S. transplant societies and a star-studded lineup of scientists including Robert Langer, George Church, and Ed Boyden, and even Nobel Prize-winning economist Alvin Roth – whose work has focused on finding new ways to ameliorate the organ shortage. It is currently in the top 1% of the most widely read scientific articles published since its release.

...

"Donor bone marrow is lifesaving for many kinds of  cancers and a variety of other blood diseases. Successful bone marrow transplants have been performed since the 1950s, but the challenge is finding a source of bone marrow to transplant – especially since donors and recipients must be matched for genetic factors even more precisely than some organ transplants.

...

" if bone marrow could be cryogenically banked, why not procure it from deceased organ donors who were already providing hearts, livers, and other organs for transplantation? There are nearly 40,000 such donors worldwide each year, and each could potentially donate enough marrow for multiple patients in need. For many patients, when a transplant was needed the matching bone marrow would already be available in the bone marrow bank.

"From the perspective of the deceased organ donor and the OPOs, this would be like providing an opportunity to donate an additional lifesaving organ. Traditionally, each donor can provide up to eight lifesaving vital organs: a heart, two lungs, two kidneys, a liver, intestines, and a pancreas. In essence, bone marrow would be the ninth. And if a donor could provide bone marrow to multiple recipients, this might even double the number of lives that each donor could save.

...

"Alex: What’s something we haven’t covered that excites you about what cryopreservation can do for the organ shortage?

"Seb: In the long-term, one of the things that I’m most excited about is how these technologies can remove barriers to developing transplant systems in new countries. Most of the world still doesn’t have access to deceased donor transplantation. For instance, Africa has 16% of the world’s population but only 0.5% of transplants are done there. Meanwhile the U.S. has less than 5% of the world’s population but does about 25% of the world’s transplants. Many developed countries, like my father’s home country Ghana, have limited live kidney donation programs. But they don’t have deceased donor programs, which are needed to carry out large numbers of kidney and liver transplants as well as any sort of heart or lung transplantation.

"That’s partly because the logistical demands to source organ donations prospectively require so much infrastructure: a waitlist, rapid matching of donors to recipients, OPOs that need to be overstaffed in order to deal with unpredictable surges in organs available, rushed activities that require tight coordination between donor hospitals, OPOs, transplant centers, and even third party service providers like organ couriers. Many organs have also needed expensive transportation (private jets and helicopters).

"It’s a very different situation when there’s a source of cryopreserved hearts, livers, etc., that can be donated in a much more flexible way and are simply waiting to be matched to patients. Even things like Doctors without Borders and perhaps “OPOs without Borders” become possible for transplantation, helping train and develop new organ recovery, heart, lung, and liver transplant programs. So many more possibilities open up when you don’t need to create every part of a transplant system from scratch and have all of those parts acting in synchrony on Day 1."

**************

Here's the original article referred to:

The promise of organ and tissue preservation to transform medicine 
 Sebastian Giwa, Jedediah K Lewis, Luis Alvarez, Robert Langer, Alvin E Roth, George M Church, James F Markmann, David H Sachs, Anil Chandraker, Jason A Wertheim, Martine Rothblatt, Edward S Boyden, Elling Eidbo, W P Andrew Lee, Bohdan Pomahac, Gerald Brandacher, David M Weinstock, Gloria Elliott, David Nelson, Jason P Acker, Korkut Uygun, Boris Schmalz, Brad P Weegman, Alessandro Tocchio, Greg M Fahy, Kenneth B Storey, Boris Rubinsky, John Bischof, Janet A W Elliott, Teresa K Woodruff, G John Morris, Utkan Demirci, Kelvin G M Brockbank, Erik J Woods, Robert N Ben, John G Baust, Dayong Gao, Barry Fuller, Yoed Rabin, David C Kravitz, Michael J Taylor & Mehmet Toner

Nature Biotechnology 35, 530–542 (2017) doi:10.1038/nbt.3889
Published online 07 June 2017

Abstract: The ability to replace organs and tissues on demand could save or improve millions of lives each year globally and create public health benefits on par with curing cancer. Unmet needs for organ and tissue preservation place enormous logistical limitations on transplantation, regenerative medicine, drug discovery, and a variety of rapidly advancing areas spanning biomedicine. A growing coalition of researchers, clinicians, advocacy organizations, academic institutions, and other stakeholders has assembled to address the unmet need for preservation advances, outlining remaining challenges and identifying areas of underinvestment and untapped opportunities. Meanwhile, recent discoveries provide proofs of principle for breakthroughs in a family of research areas surrounding biopreservation. These developments indicate that a new paradigm, integrating multiple existing preservation approaches and new technologies that have flourished in the past 10 years, could transform preservation research. Capitalizing on these opportunities will require engagement across many research areas and stakeholder groups. A coordinated effort is needed to expedite preservation advances that can transform several areas of medicine and medical science.
************

Friday, February 17, 2023

A tale of two Organ Procurement Organizations, in JAMA Surgery

 Here's a report of two Organ Procurement Organizations with very different rates of recovery of organs:

Variability in Organ Procurement Organization Performance by Individual Hospital in the United States, by Wali Johnson, MD1; Kathryn Kraft, MD2; Pranit Chotai, MD3; Raymond Lynch, MD4; Robert S. Dittus, MD5; David Goldberg, MD6; Fei Ye, PhD7; Brianna Doby, BA8; Douglas E. Schaubel, PhD9; Malay B. Shah, MD2; Seth J. Karp, MD1, JAMA Surg. Published online February 8, 2023. doi:10.1001/jamasurg.2022.7853

"Design, Setting, and Participants  A retrospective cross-sectional analysis was performed of organ donation across 13 different hospitals in 2 donor service areas covered by 2 organ procurement organizations (OPOs) in 2017 and 2018 to compare donor potential to actual donors. More than 2000 complete medical records for decedents were reviewed as a sample of nearly 9000 deaths. Data were analyzed from January 1, 2017, to December 31, 2018.

"Exposure  Deaths of causes consistent with donation according to medical record review, ventilated patient referrals, center acceptance practices, and actual deceased donors.

"Main Outcomes and Measures  Potential donors by medical record review vs actual donors and OPO performance at specific hospitals.

"Results  Compared with 242 actual donors, 931 potential donors were identified at these hospitals. This suggests a deceased donor potential of 3.85 times (95% CI, 4.23-5.32) the actual number of donors recovered. There was a surprisingly wide variability in conversion of potential donor patients into actual donors among the hospitals studied, from 0% to 51.0%. One OPO recovered 18.8% of the potential donors, whereas the second recovered 48.2%. The performance of the OPOs was moderately related to referrals of ventilated patients and not related to center acceptance practices.

"Conclusions and Relevance  In this cross-sectional study of hospitals served by 2 OPOs, wide variation was found in the performance of the OPOs, especially at individual hospitals. Addressing this opportunity could greatly increase the organ supply, affirming the importance of recent efforts from the federal government to increase OPO accountability and transparency.

**********

And here's an accompanying editorial:

It Is Time for the Light to Shine on Organ Procurement Organizations by Robert M. Cannon, MD, MS1; Jayme E. Locke, MD, MPH1 JAMA Surg. Published online February 8, 2023. doi:10.1001/jamasurg.2022.7857

"Many explanations have been put forth as to why some OPOs carry out their mandate more effectively than others. One argument is that mechanisms of death in some parts of the country are more conducive to organ donations than in others. We have refuted this phenomenon as a significant factor in OPO performance variability in our previous work.3 Others have even tried to place the blame for poorly performing OPOs at the feet of “risk-averse” transplant centers, a factor that the data presented in this current study also refute. The cold truth is that we have no good understanding of why some OPOs are better than others, or even what an acceptable level of OPO performance should be, because the environment in which OPOs operate is so completely obscure."

Tuesday, December 14, 2021

The costs of deceased donor organ recovery in the U.S., by Held et al. in the journal Transplantation

 Here's the report of an investigation into organ procurement costs and finances:

Cost Structures of US Organ Procurement Organizations by Held, Philip J. PhD1; Bragg-Gresham, Jennifer L. PhD2; Peters, Thomas G. MD3; McCormick, Frank PhD4; Chertow, Glenn MD, MPH1; Vaughan, William P. BS5; Roberts, John P. MD, Transplantation. 2021;105(12):2612-2619. doi:10.1097/TP.0000000000003667.

Abstract: "Background. The goal is to provide a national analysis of organ procurement organization (OPO) costs.

"Methods. Five years of data, for 51 of the 58 OPOs (2013-2017, a near census) were obtained under a FOIA. OPOs are not-for-profit federal contractors with a geographic monopoly. A generalized 15-factor cost regression model was estimated with adjustments to precision of estimates (P) for repeated observations. Selected measures were validated by comparison to IRS forms.

"Results. Decease donor organ procurement is a $1B/y operation with over 26 000 transplants/y. Over 60% of the cost of an organ is overhead. Profits are $2.3M/OPO/y. Total assets are $45M/OPO and growing at 9%/y. "Tissue" (skin, bones) generates $2-3M profit/OPO/y. A comparison of the highest with the lower costing OPOs showed our model explained 75% of the cost difference. Comparing costs across OPOs showed that highest-cost OPOs are smaller, import 44% more kidneys, face 6% higher labor costs, report 98% higher compensation for support personnel, spend 46% more on professional education, have 44% fewer assets, compensate their Executive Director 36% less, and have a lower procurement performance (SDRR) score.

"Conclusions. Profits and assets suggest that OPOs are fiscally secure and OPO finances are not a source of the organ shortage. Asset accumulation ($45M/OPO) of incumbents suggests establishing a competitive market with new entrants is unlikely. Kidney-cost allocations support tissue procurements. Professional education spending does not reduce procurement costs. OPO importing of organs from other OPOs is a complex issue possibly increasing cost ($6K/kidney)."

...

"CONCLUSION

"In the United States, deceased-donor organ recovery costs total $1B per year and represent approximately one-third the cost of an organ transplant procedure. Direct and indirect costs are reported on CMS required OPO cost reports, confirming that over half of all costs are indirect, such as the costs of organ procurement personnel, professional education, and other personnel expenses. Kidney cost increases over the 5-y study period seem reasonable compared with all medical care cost increases but increased at rates in excess of the cost increases transplant centers experienced for transplant procedures. And, kidney importation (from other OPOs) adds substantially to cost adding $4K-$6K per organ. OPO revenue over expense is largely due to profits from tissue recovery activities. Cost variations of over 100% across areas suggest less than socially efficient cost controls. The strong financial position of OPOs suggests that fiscal limits are not a likely explanation for the shortage of organs for transplantation.

"In considering individual OPOs, 2 levels of kidney costs (>$40K/kidney and <$40K) disclosed both statistically and clinically significant differences. The highest-cost OPOs (>$40K/kidney) are associated with higher direct costs (including more imported organs), higher compensation for support staff and procurement coordinators, higher professional education spending, and lower total assets, fewer organs procured, and lower performance measures-among other factors. Assessment of structural factors such as these may lead to opportunities to decrease cost and improve efficiencies. The US OPO enterprise is substantial, yet future OPO efficiency and performance improvements through competition appear unlikely considering OPO assets, current practices, and regulatory oversight issues. The inefficient financial incentives built into the U.S. OPO structure include both monopoly markets and self-reported cost reimbursement. These characteristics do not compel critical assessment, which could lead to organizational changes and more effective mission capability."

Monday, October 28, 2019

Organ and tissue procurement: back and forth between LA Times and OneLegacy

Even in the era of social media, it remains difficult to conduct an argument with someone who buys ink by the truckload.

The LA Times ran a series of stories on tissue procurement:
Full Coverage: The Times’ investigation into how companies that harvest body parts upend death investigations

This was followed by a press release from OneLegacy, the big S. California organ procurement organization (OPO), disputing a number of points and objecting to the overall tone of the articles:
Inaccurate and Sensationalized Los Angeles Times Article Likely to Cause Unnecessary Deaths and Suffering
"—A highly-inaccurate and tragically sensationalized article in a recent edition of the Los Angeles Times is likely to lead to deaths and suffering while causing severe damage to the donation and transplantation community."

and this in turn was followed by a rejoinder in the LA Times:
OneLegacy issued a statement on an L.A. Times investigation; The Times responds
By MELODY PETERSEN OCT. 27, 2019
"“The Times stands firmly behind these important stories, which were the product of months of meticulous reporting and careful editing,” said Scott Kraft, managing editor of The Times."

Friday, January 25, 2019

Kidney transport: a Tesla and a flat tire

Transporting kidneys can be surprisingly informal.  Here's an account of a Tesla, a flat tire, and hitching a ride.

Good Samaritan drives stranded surgeon, donor kidney to Pa. hospital

"Dr. Martin Wijkstrom had two jobs to perform Wednesday evening: Drive a donor kidney from Pittsburgh to Erie, Pa., then implant the organ in a patient at UPMC Hamot.
...
“I had already picked up the kidney at a Pittsburgh hospital and had just charged my Tesla in Cranberry Township,” said Wijkstrom, a UPMC transplant surgeon. “I was driving to get back on (Interstate 79) to go to Erie when I struck a pothole.”

"The pothole caused one of Wijkstrom’s tires to go flat. He was stuck in the Cranberry Mall parking lot with a donor kidney, 108 miles from the hospital where a patient waited to receive it.

"His Tesla didn’t carry a spare tire. Though the kidney was secured in a refrigerated container in Wijkstrom’s trunk, the surgeon had about 12 hours to implant the organ for the best chances of success.

“It wasn’t an emergency situation but we needed to put the kidney into the patient as soon as possible,” said Wijkstrom, who said he had transported kidneys in his car three or four previous times.
...
"Brad Dostlik was driving his Nissan Sentra near the mall, listening to his portable police scanner.
He heard a dispatcher send police to the surgeon’s car and notify them about the kidney. Dostlik, who was headed to the nearby Field & Stream store, decided to see if he could help.
...
“He asked if I could take him to Erie,” Dostlik said. “I had a full tank of gas, so why not?”
...
“I learned a lot of stuff during the trip,” Dostlik said. “I don’t think I could do what he does.”
...
"The two men shook hands and the surgeon walked into the hospital with the donor organ, just 40 minutes later than expected.

“The surgery was uneventful,” Wijkstrom said. “The patient is doing well, his kidney is making some urine already.”

Monday, December 17, 2018

Australia's parliament reports on organ trafficking

Australia's parliament has published a report on organ trafficking in Australia. They didn't find much trafficking there, but recommend that data be more vigorously collected. They report that only one case of (attempted) paid organ donation has come to the attention of the authorities, but that it was successfully prevented, and the intended recipient died. The report ends with a case study of an anatomical exhibit using human cadavers.

Human Rights Sub-Committee, House of Representatives, Joint Standing Committee on Foreign Affairs, Defence and Trade, November 2018, Canberra

(The above link is the the 178 page pdf version, and here's a link to the table of contents and each chapter separately).

"This report examines the global prevalence of human organ trafficking and the scope of Australian participation within this illicit trade.
...
"2.5...The commercial trade in human organs is near-universally prohibited. Despite these prohibitions and restrictions, the illicit commercial trade in human organs has been estimated by the research advisory organisation Global Financial Integrity to be worth between US$840 million and $1.7 billion globally each year.4 Up to 10 per cent of kidney transplants worldwide may now involve commercially traded organs.
...
"3.15 There has been only one reported case to date of alleged organ trafficking within Australian jurisdiction,
 Alleged case of organ trafficking in Australia
"In 2011, an Australian couple were alleged to have brought a woman from the Philippines to Australia, promising her monetary compensation and a working visa in exchange for a kidney donation.
The woman changed her mind upon arriving in Australia. Medical transplant integrity procedures – a pre-operative counselling session at a Sydney hospital –ensured that the situation was discovered before the removal of the organ.
The potential donor was identified as an alleged victim of organ trafficking, resulting in referral to the Australian Federal Police. Due to the death of the prospective recipient, and limitations of the legislation as then in force, the matter did not progress to prosecution."
...
"3.20 International studies have observed the tendency of patients born in a country where organ trafficking may occur, but living outside of that country, to be at a substantially higher risk of participation in transplant tourism.31 This would appear to be equally true in Australia, as Dr Campbell Fraser observed: "...less than five per cent of Australians who are waiting on organs are likely to even consider going overseas. ...most of the Australians who have purchased an organ overseas have ethnic family connections to the countries or regions where they buy their organs—Pakistani Australians tended to go to Pakistan, Egyptian Australians travel to Egypt, and so on."
...
"Mandatory reporting by medical practitioners
3.41 A large number of submissions and witnesses argued in favour of the establishment of a nationwide mandatory reporting scheme for commercial transplants. A Bill before the Parliament of New South Wales, Human Tissue Amendment (Trafficking in Human Organs) Bill 2016, introduced by Mr David Shoebridge MP, seeks to amend the Human Tissue Act 1983 (NSW). The amendment would, inter alia, require medical professionals to report to the NSW Secretary of Health any reasonable belief that a patient has received a commercial transplant or one sourced from a non-consenting donor.
...
"Case study on alleged human tissue trafficking 
‘Real Bodies’
6.1 The Real Bodies commercial anatomical exhibition, on display in Australia during the course of this inquiry, was brought to the attention of the  Sub-Committee by a number of witnesses and is illustrative of an apparent gap in the current legislation. The Real Bodies exhibition involves the commercial display of 20 plastinated human cadavers, and ‘over 200’ plastinated organs, embryos and foetuses.1
Allegations of the trafficking of organs and other human tissue
6.2Mr David Shoebridge MP of the New South Wales Parliament informed the Sub-Committee as to the nature of the exhibition:...
"[they] are real bodies ... they are displayed in quite grotesque circumstances—some of them literally sawn down the middle and presented as a human standing and divided in two so that you can look into the internal parts of them. There are pregnant women. There are multiple fetuses ... put on display for commercial gain ... it is a grossly exploitative process. The proprietors ... have been asked about the circumstances in which these bodies came into their possession, and they have been unable and unwilling to prove that any of the persons on display ever gave their consent."
**********

Here's an earlier post on repugnance to anatomical exhibits using cadavers:

Saturday, March 28, 2009, Markets for (viewing) bodies

Thursday, November 30, 2017

Organ donation and transplantation data from around the world

The International Registry in Organ Donation and Transplantation  maintains an informative international database.
Here's a list of the files they show...

WORLDWIDE ACTUAL DECEASED DONORS (PMP) 2013
WORLDWIDE LIVING DONORS (PMP) 2013
WORLDWIDE DCD DONORS (PMP) 2013
WORLDWIDE KIDNEY TRANSPLANT FROM DECEASED DONORS (PMP) 2013
WORLDWIDE KIDNEY TRANSPLANT FROM LIVING DONORS (PMP) 2013
WORLDWIDE LIVER TRANSPLANT FROM DECEASED DONORS (PMP) 2013
WORLDWIDE LIVER TRANSPLANT FROM LIVING DONORS (PMP) 2013
WORLDWIDE HEART TRANSPLANT (PMP) 2013
WORLDWIDE LUNG TRANSPLANT (PMP) 2013
WORLDWIDE PANCREAS TRANSPLANT (PMP) 2013
EUROPE ACTUAL DECEASED ORGAN DONORS (PMP) 2013
EUROPE LIVING ORGAN DONORS (PMP) 2013
AMERICA ACTUAL DECEASED ORGAN DONORS (PMP) 2013
AMERICA LIVING ORGAN DONORS (PMP) 2013
ASIA - OCEANIA ACTUAL DECEASED ORGAN DONORS (PMP) 2013
ASIA - OCEANIA LIVING ORGAN DONORS (PMP) 2013
AFRICA - MIDDLE EAST ACTUAL DECEASED ORGAN DONORS (PMP) 2013
AFRICA - MIDDLE EAST LIVING ORGAN DONORS (PMP) 2013

Monday, June 12, 2017

Organ preservation could bring big changes to transplantation

Transplantation would be a lot less hectic if organs could be preserved. Here's a 42-author paper (the biggest coauthorship I've been involved in) that discusses some of the possibilities.

The promise of organ and tissue preservation to transform medicine 
 Sebastian Giwa, Jedediah K Lewis, Luis Alvarez, Robert Langer, Alvin E Roth, George M Church, James F Markmann, David H Sachs, Anil Chandraker, Jason A Wertheim, Martine Rothblatt, Edward S Boyden, Elling Eidbo, W P Andrew Lee, Bohdan Pomahac, Gerald Brandacher, David M Weinstock, Gloria Elliott, David Nelson, Jason P Acker, Korkut Uygun, Boris Schmalz, Brad P Weegman, Alessandro Tocchio, Greg M Fahy, Kenneth B Storey, Boris Rubinsky, John Bischof, Janet A W Elliott, Teresa K Woodruff, G John Morris, Utkan Demirci, Kelvin G M Brockbank, Erik J Woods, Robert N Ben, John G Baust, Dayong Gao, Barry Fuller, Yoed Rabin, David C Kravitz, Michael J Taylor & Mehmet Toner

Nature Biotechnology 35, 530–542 (2017) doi:10.1038/nbt.3889
Published online 07 June 2017
Abstract: The ability to replace organs and tissues on demand could save or improve millions of lives each year globally and create public health benefits on par with curing cancer. Unmet needs for organ and tissue preservation place enormous logistical limitations on transplantation, regenerative medicine, drug discovery, and a variety of rapidly advancing areas spanning biomedicine. A growing coalition of researchers, clinicians, advocacy organizations, academic institutions, and other stakeholders has assembled to address the unmet need for preservation advances, outlining remaining challenges and identifying areas of underinvestment and untapped opportunities. Meanwhile, recent discoveries provide proofs of principle for breakthroughs in a family of research areas surrounding biopreservation. These developments indicate that a new paradigm, integrating multiple existing preservation approaches and new technologies that have flourished in the past 10 years, could transform preservation research. Capitalizing on these opportunities will require engagement across many research areas and stakeholder groups. A coordinated effort is needed to expedite preservation advances that can transform several areas of medicine and medical science.
View full text

Saturday, October 15, 2016

A look into how transplant centers are monitored (and organs are allocated)

Here's a press release saying that the University of Pittsburgh's iconic transplant center has been taken off probation by UNOS. The reason they were on probation is interesting:
University of Pittsburgh Medical Center released from probation

"The Board had placed UPMC on probation in June 2015. Its lung transplant program had an unusually high number of instances where they accepted lung offers for one transplant candidate, then transplanted another candidate at the program. This inappropriately limited opportunity for consideration of other candidates identified on the match run."

Thursday, August 18, 2016

Transplant surgeons meet in Hong Kong amid questions about China's continued use of organs from executed prisoners

The NY Times has the story: Debate Flares on China’s Use of Prisoners’ Organs as Experts Meet in Hong Kong

It discusses a recent article in the American Journal of Transplantation:
Transplant Medicine in China: Need for Transparency and International Scrutiny Remains by T. Trey, A. Sharif, A. Schwarz, M. Fiatarone Singh, and J. Lavee

Here's the abstract of the article:
"Previous publications have described unethical organ procurement procedures in the People's Republic of China. International awareness and condemnation contributed to the announcement abolishing the procurement of organs from executed prisoners starting from January 2015. Eighteen months after the announcement, and aligned with the upcoming International Congress of the Transplantation Society in Hong Kong, this paper revisits the topic and discusses whether the declared reform has indeed been implemented. It is noticeable that China has neither addressed nor included in the reform a pledge to end the procurement of organs from prisoners of conscience, nor have they initiated any legislative amendments. Recent reports have discussed an implausible discrepancy of officially reported steady annual transplant numbers and a steep expansion of the transplant infrastructure in China. This paper expresses the viewpoint that, in the current context, it is not possible to verify the veracity of the announced changes and it thus remains premature to include China as an ethical partner in the international transplant community. Until we have independent and objective evidence of a complete cessation of unethical organ procurement from prisoners, the medical community has a professional responsibility to maintain the academic embargo on Chinese transplant professionals."
************

The NY Times story includes this:
"In an interview conducted on the messaging app WeChat, Huang Jiefu, a senior Chinese transplant official and a former deputy minister of health, appeared to defend the changes but simultaneously acknowledge they were far from perfect.

“We have finished walking the first step of a long march of 10,000 li, the task is heavy and the road far, but we are walking on a path of light,” he wrote. "

Sunday, February 7, 2016

Mishaps while flying transplant organs

This news story stopped with the plane, and doesn't say what happened to the organ...
No one hurt when jet scheduled to pick up donor organ slides off runway in Wheeling

Wednesday, August 26, 2015

Some histories of organ transplantation

I can't vouch for any of these...most are un-refereed internet pages...some starting with events reported from quite long ago, regarding skin and bones, for example.

From organdonor.gov: Timeline of Historical Events Significant Milestones in Organ Donation and Transplantation

http://www.organtransplants.org/understanding/history/


http://optn.transplant.hrsa.gov/learn/about-transplantation/history/

http://www.donatelifeny.org/all-about-transplantation/organ-transplant-history/

https://www.unos.org/transplantation/history/

http://www.mtf.org/news_history_of_transplantation.html


Here's a journal article, whose history begins with kidneys...
Organ transplantation: historical perspective and current practice
C. J. E. Watson1,* and J. H. Dark, 
Br. J. Anaesth. (2012) 108 (suppl 1): i29-i42.
doi: 10.1093/bja/aer384 
"A brief history of transplantation
Kidney transplantation
Since Jaboulay and Carrel developed the techniques
required to perform vascular anastomoses at the turn of
the last century, there has been a desire to treat organ
failure by transplantation. Jaboulay was the first to
attempt this in 1906, treating two patients with renal
failure by transplanting a goat kidney into one and a pig
kidney into the other; in both cases, he joined the renal
vessels to the brachial vessels.1 Both transplants failed
and both patients died. At that time, there was no alternative
to death if renal failure developed, and it would be
another 38 yr before the first haemodialysis machine was
invented. The first use of a human kidney for transplantation
followed in 1936 when Yu Yu Voronoy, a Ukrainian
surgeon working in Kiev, performed the first in a series of
six transplants to treat patients dying from acute renal
failure secondary to mercury poisoning, ingested by its
victims in an attempt to commit suicide. All the transplants
failed, in large part because of a failure to appreciate the
deleterious effect of warm ischaemia; the first kidney was
retrieved 6 h after the donor died.
One limitation to transplantation then, as now, was the
lack of suitable donor organs. The initial pioneers had used
animal organs or organs from long deceased humans. In
the 1950s, there came a realization of the need to avoid
excessive ischaemic injury and kidneys from live donors
began to be used. Some of these were from the relatives of
the recipient; others were unrelated patients having a good
kidney removed for other reasons. The surgical technique
also needed refinement; while a kidney based on the thigh
or arm vessels might be technically straightforward, and possibly
adequate for the short-term treatment of acute renal
failure, it was not a realistic solution for the long term.
That solution came from France in 1951 and involved
placing the kidney extraperitoneally in an iliac fossa, where
the external iliac vessels are easy to access and the
bladder is close by for anastomosis to the donor ureter;
this is the technique still used today.
Having overcome the technical issues of vascular anastomosis
and placement of the kidney, there remained the
problem of the immune response. Medawar’s work during
and after the Second World War studying the rejection of
skin grafts had demonstrated the potency of the immune
system.2 At that time, attempts to control the immune
system using irradiation had proved either ineffectual or
lethal. The first successful transplant therefore came about
by avoiding an immune response altogether, which Joseph
Murray’s team achieved by performing a kidney transplant
between identical twins.3 There then followed a series of
identical twin transplants around the world, with the first in
the UK being performed in Edinburgh by Woodruff and
colleagues4 in 1960."

Thursday, January 29, 2015

New reports that China to stop harvesting executed prisoners' organs

But no word on how they propose to manage the transition from executed prisoners to developing a voluntary source of donated organs for transplant.

Here's a BBC story: China to stop harvesting executed prisoners' organs

China has promised to stop harvesting organs from executed prisoners by 1 January, state media report.
It has said for many years that it will end the controversial practice. It previously promised to do so by November last year.
Death row inmates have long served as a key source for transplants.
China has been criticised for taking their organs without consent, but has struggled to encourage voluntary donations due to cultural concerns.
Prisoners used to account for two-thirds of transplant organs, based on previous estimates from state media.
For years, China denied that it used organs from executed prisoners and only admitted to the practice a few years ago.
The Chinese authorities put more prisoners to death every year than the rest of the world combined - an estimated 2,400 people in 2013 - according to the San Francisco-based prisoners' rights organisation, Dui Hua.
'Fair, just and transparent'
State media reported on Thursday that the head of the country's organ donation committee Huang Jiefu said that by 1 January 2015, only voluntarily donated organs from civilians can be used in transplants.
So far 38 organ transplant centres around the country, including those in Beijing, Guangdong and Zhejiang, have already stopped using prisoners' organs, according to reports.
Dr Huang, who was addressing a seminar, said that every year about 300,000 people in China need transplanted organs, but only 10,000 operations are carried out.
Grey line
Analysis: Celia Hatton, BBC News, Beijing
It's taken years for the Chinese authorities to end their own practice of harvesting organs from executed prisoners.
In 2006, Dr Huang admitted China must reduce its reliance on prisoners' organs. He repeated that again in 2009, when announcing the establishment of a national organ donation network. And finally, in 2012, Dr Huang surfaced in Chinese state media once more with a promise to end all prisoners' donations within a few years.
Why did it take so long? Thousands of people are on China's transplant waiting list in desperate need of organs, with no clear solution in sight. Attempts to address the need, by encouraging public organ donations, have faltered.
But many in China believe that bodies should remain intact after death. China's also home to a thriving illegal trade in body parts, making would-be donors nervous they will contribute to a wider problem.
A 2012 poll conducted in the southern city of Guangzhou revealed that 79% of respondents believed organ donation was "noble". However, 81% were concerned the donations "inevitably feed the organ trade."
Clearly, Chinese health officials have a lot of work to do to change public perceptions.
Grey line
With a donation rate of only 0.6 per 1 million people, China has one of the world's lowest levels of organ donation. Dr Huang compared it to Spain, which has a rate of 37 per 1 million.
"Besides traditional beliefs, one of the major roadblocks to the development of our organ donation industry is that people are concerned that organ donation will be fair, just and transparent," he was quoted as saying.
Dr Huang, who used to be the vice minister for health, had last year pledged to phase out prisoner organ transplants by the end of 2013.
Amnesty International's William Nee told the BBC that halting prisoner organ transplants would be "a positive step forward in China's human rights record", although some challenges remain.
"It will be worth seeing not only how effective a new voluntary organ donation system is, but it will also be crucial that the government becomes fully transparent about the number of people sentenced to death, the number of executions per year, and how the executions are carried out," he said.

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