27 Jun You will have a choice in the assignment this week. You can either do a case analysis or respond to the questions below from Chapter 25. Please select one and not
You will have a choice in the assignment this week. You can either do a case analysis or respond to the questions below from Chapter 25. Please select one and not both to complete.
1.Can we confine our arguments about health care efficiency to organ transplants, or can one argue that other types of medical treatments and health care services are also scarce?
2.Is the shortage of organs available for transplant one health care problem that could be solved by unlimited funding of the health care system?
3.What is the justification underlying laws restricting or offering payment for transplant organs?
4.What legal distinction is there between selling organs versus human tissues, blood plasma, ova, and sperm?
5.What practical considerations support or detract from legally regulating organ procurement and transplants?
6.Would it be permissible to remove the organs of healthy, deceased prisoners to save the lives of five to eight others who need organ transplants?
7.Under what circumstances might palliative sedation facilitate organ transplants?
Chapt 25
Organ and Tissue Procurement and Transplantation
Lecture Overview
Principles and Applications
Types of Transplanta tions and Limitations
Organ Transplants
In Reality: How Organ Procurement and Transplant Occurs
Tissue Transplantation
Xenotransplants
Alternative Strategies for Developing Organ and Tissue Replacements
Moving Altruism Forward
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Organ and tissue procurement and transplantation. In Health care management and the law: Principles and applications (pp. 517-542). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Principles and Applications
Needs for Body Parts:
Primary: transplantation of organs, tissues, and cells into humans
Transplantation has the greatest potential to treat:
Acquired conditions
Replacing tissues
Chronic conditions
Congenital conditions
Hemophilia
Gross organ failure
Secondary: : medical research in regenerative medicine,
stem cell and gene based therapy
Treatment needs for organ failure and tissue loss are expected to increase as the average age of the population increases, including the need for:
Mechanical devices
Surgical reconstructions
Transplants
Acquired Conditions such as cancer (by replacing the removed cancerous tissues with ecternally grown health tissue)
Chronic conditions like diabetes (
Discussion
An 8 year old child had a genetic disorder known as Maple Syrup Urine Disease
Could only be cured with a liver transplant
Missouri Medicaid insurance program declined coverage for liver transplant argued diet could control disease
Medical community split over the medical necessity of a liver transplant
Thoughts?
Children with this diseases must restruct their intake of natural proteins, replacing them with a special amino acide formula
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Types of Transplants and Limitations: Autotransplants
3 Types of Transplants:
Autotransplants
Allotransplants
Xenotransplants
Types of Transplants and Limitations: Autotransplants
Autotransplants
human material is harvested from one and transplanted form one part of a patient’s body to another.
Autographs
Material used in autotransplants
Difficulties: availability of human material and donor site materials
Litigation
Insurance coverage for bone marrow transplants
Autotransplants involve a process through which human material is harvested and transplanted from one part of a patient’s body to another.
The limitations associated with autografts include:
Availability of human material
Donor site diseases
The most litigated issue in this type of transplant involved insurance coverage for bone marrow autotransplants.
Types of Transplants and Limitations: Allotransplants
Allotransplants
human material is harvested from one individual and transplanted into another individual.
Allogeneic grafts: cells, tissues, or organs involved in allotransplants
The challenges associated with allogenic grafts include:
Damage to donor organs and tissue during the transport process
Donor recipient blood type compatibility
Donor recipient physical compatibility
Rejection of immunologically incompatible organs and tissues
Shortage of organs and tissue
Transmission of donor site diseases to recipients
Use and long term cost of immunosuppressive drugs to circumvent transplant immunorejection
Autotransplants involve a process through which human material is harvested and transplanted from one part of a patient’s body to another.
The limitations associated with autografts include:
Availability of human material
Donor site diseases
Types of Transplants and Limitations: Xenotransplants
Xenotransplantation is the use of animal materials to replace human cells, tissues, or organs.
A central limitation is the risk of transmission of novel viral and microbial pathogens from donor xenografts form to human recipients.
Rejection is a more significant issue with interspecies transplants.
The Campaign for Responsible Transplantation has been engaged in the federal courts for freedom of information demands for proprietary information about the FDA’s regulation of xenotransplants.
https://caselaw.findlaw.com/us-dc-circuit/1176695.html
https://www.fda.gov/vaccines-blood-biologics/xenotransplantation
Man with HIV receives Babboon Heart
https://web.stanford.edu/dept/HPS/transplant/html/frequently_asked_questions.html
Organ Transplants: Current Context
Critical Shortage of Kidneys
More than three-quarters of the waitlist population of the National Organ Donor Registry comprises patients suffering from renal failure.
A central financial authority could pay for these kidney transplants from tax revenues.
Demand Exceeds Supply
About 7,700 Americans unnecessarily die waiting for transplant operations each year.
Relaxing the restrictions on who can donate, clarifying the misunderstandings surrounding organ donation, and compensating donors or their families could alleviate this shortage.
Other Organ Shortages
The number of patients who need transplants is growing 5 times faster than the rate of donations.
Kidney Donation: Kindney donor exchange, a deceased donor kidney can last 10-15 years, a live kidney donation can last 15-20 years.
Discussion
What legal distinction is there between selling human organs versus human tissues, blood plasma, ova and sperm?
https://health.usnews.com/health-news/blogs/on-women/2009/07/28/women-sell-their-eggs-so-why-not-a-kidney
Organ Transplants- In Theory: How Organ Procurement and Transplants Occur
The National Organ Transplantation Act provided for the establishment of the Organ Procurement and Transplantation Network, which administers the retrieval, distribution, and transplantation of organs.
The network also standardizes the criteria for placement on distribution lists and maintains a National Organ Donor Registry for organ matching.
Several studies have revealed that nearly every organ procurement agency is in violation of at least one government policy on the distribution of organs.
There are many different health care professionals on a patient’s transplant team.
In response to violations more federal regulations were adopted allowing the government additional control and further limitations over how organs are allocateed
Transplant Developments
Uniform Anatomical Gift Act of 2006
Legalized donating tissues and organs
National Organ Transplantation Act
Rendered it unlawful to ‘knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplants if the transfer affects interstate commerce’.
Organ Procurement and Transplantation Network
Sets standards and regulates organ transplant centers across the country
Establishes the process and policies for allocating organs.
Transplants are severly constrained by ythe failure of regulatory policy to keep pace with technological advances in medicine. Cadaveric organ procurement policies in the US and other countries have failed to effectively respond to the growing demand for transplantable organs.
There is a chronic and growing shortage of human organs available for transplants.
12
Current Context
Critical Shortage of Kidneys
National Organ Donor Registry: patients suffering from renal failure
Other Organ Shortages
Although more than 450,000 transplants have been performed in the US
The number of patients who need transplants is growing at a 5x the rate of donations
How to alleviate the shortage:
Relax the restriction on who can donate
Clarifying the misunderstandings surrounding organ donation
Compensating donors or their families
Organ Transplants: United Network for Organ Sharing
Many factors affect how long a patient may be on the National Organ Donor Registry’s waitlist:
Number of organs available for donation
Patient’s blood type, tissue type, height and weight
Size of available organs
Transplant center’s criteria for accepting donated organs
The United Network for Organ Sharing encourages physicians to consider nonmedical factors such as whether patients have:
Caused their organ failure by their own behavior
Compiled with and adhered to their treatment regimen
Had or might have success with treatment other than a transplant
Received prior organ transplants
With improved medical technologies, cold ischemic times have been extended to allow for truly national allocations.
Organ Transplants: Nongovernmental Networks
Cofinity Institute of Excellence
comprises facilities that manage heart, lung, simultaneous heart/ling, kidney, liver, and stem cell.
Developed by Aetna
All of the transplant centers in the Aetna network have met quality, volume, and outcomes standards.
Regulatory policy decisions determining who receives the limited number of organs have crucial consequences for patients.
These are medical decisions that might be better made by the medical community as opposed to the government.
There is an ideological and practical divide between the United Network for Organ Sharing and the medical community concerning the procedures and criteria for allocating organs and for reviewing the organ allocation system.
Organ Transplants: Donation Criteria
Donors must usually be 18 years of age or older unless a parent or guardian of a deceased minor consents to donation.
Donors must also have written documentation of their wish to donate.
Relatives may deny permission even when deceased patients did consent prior to death.
Even if a culture or religion does not expressly forbid organ donation, some are under the false impression that their culture or religion does forbid it.
Many among the Jewish community believe organ donation is a desecration of the body.
Organ Transplants: Zero Antigen Mismatch Rule
The question of how to distribute scarce organs presents a classic conflict between utility, which seeks to provide the greatest good for the greatest number, and equity, which seeks fairness for all individuals.
A zero antigen mismatch meant the antigens all matched up between the transplant patient and the donated organ, meaning the transplant patient’s body was much less likely to reject the organ.
Because more Caucasians donate organs than any other race, this resulted in more Caucasians receiving organs.
The zero antigen mismatch rule has been relaxed
Carey v. New England Organ Bank
Uniform Anatomical Gift Act may provide grounds for a donor’s family to sue when donated body parts are used for a purpose other than their specified purpose of transplant, although organ and tissue banks maybe excused from liability by good faith protections
Organ Transplants: Limited Property Interest in Human Biological Material
Even as scientific advances lead to increased use of and demand for human organs, the body continues to take on the functional characteristics of property in the law.
Most courts refuse to overturn traditional notions of a limited property interest in the human body as demonstrated by the landmark Colavito case.
Colavito v. New York Organ Donor Network, Inc.
Woman donated kidney to Colavito
The kidney donated to Colavito had been damaged; the other kidney was transplanted to someone else.
In Reality: How Organ Procurement and Transplants Occur
Historically, organs were recovered from patients who suffered cardiac death.
This meant that by the time their organs could be transplanted, they could no longer be used because they would be unlikely to function in the recipients.
In 1968, the medical community redefined death to include brain death.
The use of brain death has led to the rampant misunderstanding that patients who might otherwise survive might be killed for their organs.
Factors that contribute to the short supply of usable transplant organs:
Some transplant centers still do not consider transplanting organs from patients who are older than 65 or who might have high blood pressure.
Deaths occurring outside of a hospital setting
In Reality: How Organ Procurement and Transplants Occur – Access to Organs
Kidney Transplants
The most frequently performed and least expensive organ transplant procedures
Most individuals with end-stage renal disease are covered under Medicare’s end-stage renal disease program
Kidney transplants are generally accepted as the best treatment both for quality of life and cost effectiveness
Heart Transplants
Many patients could be saved if transplant centers were less particular about the quality of donor hearts
Alternate heart programs provide lower quality hearts to older and sicker patients
In Reality: How Organ Procurement and Transplants Occur – Anencephalic Neonates
One of the earliest controversies surrounding organ donation involved anencephalic neonates.
Anencephalic neonates are babies who are born nearly brain dead.
They have no possibility of living a life beyond a vegetative state
Most die within days of birth
Cannot be declared dead
If their life support machines are turned off and death occurs naturally, their organs cannot be used.
The American Medical Association was originally of the opinion that it was ethically acceptable to transplant the organs of such infants even before they were technically dead, with parental consent.
In Reality: How Organ Procurement and Transplants Occur: HIV-Positive Transplant Candidates
There is public controversy over whether HIV-positive transplant candidates should receive organs, even is they have no symptoms and are not in the end stage of the disease.
HIV-positive patients argue that their status is at least equal to other transplant patients who:
Previously received transplants but whose bodies rejected the organs
Have other diseases such as hepatitis or diabetes
Are elderly
With the advent of antiretroviral drugs, those infected with HIV are now living longer and dying from illnesses other than Acquired Immunodeficiency Syndrome (AIDS)
Some transplant centers often refuse to list HIV-positive patients in the National Organ Donor Registry’s wait list.
This has led to the suggestion that potential survivability should be the only criteria for selecting transplant recipients.
There have been HIV+ to HIV+ donor and reeiver- there were concerns over the drugs for HIV and if it would influence the success of the transplant as well as the long term effects of HIV drugs on organs. Lastly, little was known about the conducting transplants with different strains of the virus
Alternative Procurement of Organs
Presumed Consent or Opt-Out
Assumes everyone wants to be a donor unless then indicate otherwise
Often called an opt-out plan because persons who do not wish to donate their organs must opt out during life
Mandated Choice
Forces everyone to choose whether or not they want to be a donor
Places the burden on individuals to think about organ donations
Internet Solicitation
Involves communication between potential donors and recipients through Internet-based chat rooms and websites.
Alternative Procurement of Organs: Live Organ Swaps and Paired Living Donations
There are organizations, such as LifeSharers, designed to improve transplant candidates’ chances of receiving an organ by requiring members to agree to donate organs to other members before the general public.
Kidney-paired donation is a process that connects an incompatible donor-recipient pair with another incompatible donor-recipient pair.
The slow initial growth of paired organ donations reflected concerns that trades might violate a federal ban on selling organs.
Today, computer experts are optimizing matches to enable the greatest number of organ transplants.
To serve as an inducement, some states propose requiring all organ donors to have lifetime insurance coverage or that Medicare insurance cover all organ donors.
Alternative Procurement of Organs: Compelled Donations
Compelled living donations from children and incompetent persons are the least desired forms of organ donation
Incompetency is defined as a lack of legal ability in some respect.
Cognitively impaired children are considered legally incompetent if born severely cognitively impaired or if born healthy but become so before age 18.
The practice of procuring tissue and organ from children drastically changed when it became possible to use assistive reproductive techniques primarily for the purpose of a child becoming an organ donor.
Stem cells from the child’s umbilical cord blood can be harvested from the newborn at birth and transplanted into the older sibling.
Limiting the pool of incompetent donors will necessitate and hopefully force a reconsideration of the altruistically based procurement regimen.
Every year organs are harvested from minors and mentally incompetent adults who haven’t volunteered nor consented to the surgical procedure
Alternative Procurement of Organs: Lengthening Post-Transplant Organ Survival
A variety of techniques prevent injury that results from temporary arterial blockage and restoration of blood flow to transplanted organs.
Transplant patients who lose their insurance coverage are more likely to stop taking necessary antirejection drugs.
If families cannot afford immunosuppressive drugs, it can mean losing the transplanted organ or even death.
There are black market drugs available through an underground network run by transplant patients with the cooperation of sympathetic health care workers and overlooked by law enforcement.
Tissue Transplantation: U.S. Navy Tissue Bank
Human tissue
is anything donated from the human body that is not a vital organ.
The first tissue bank was established by the U.S. Navy in 1949 to deal with war injuries.
Scientists at the Navy Tissue Bank pioneered many of the commercial standards followed today:
Cryopreservation, free drying, and irradiation sterilization of tissue
Documentation and clinical evaluation of tissues
Establishment of a graph register
Identification of appropriate donor criteria for tissue donation
Immunological principles of tissue transplants
Procurement and processing methods
Tissue Transplantation: Current Context
With the growth of tissue transplants, it has been easy for human tissue to be commoditized and turned into valuable medical products.
The typical tissue donation chain is as follows:
Organ procurement agencies meet with the donor’s family in order to get consent
Organ procurement agencies then give the recovered tissue to a processor and collect recovery fees
Tissue processors process the transplantable tissue into marketable tissue products and the distribute the processed tissue products to marketing agencies and collect processing fees
Marketing agencies sell the processed tissue products to hospitals and physicians for transplantation and collect distribution fees
Hospitals and physicians then transplant the processed tissue products into patients and collect medical fees
The tissue bank industry is not thoroughly regulated by the government.
The American Association of Tissue Banks has its own voluntary regulations and accreditation guidelines for all tissue banks.
Tissue Transplantation: Biosynthetic Tissues
Biosynthetic tissues are viable alternative to traditional human transplant materials.
Synthetic skin
Bone substitutes
Numerous restrictions currently limit their use outside major teaching hospitals.
Technical limitations associated with engineering complex tissues so as to duplicate their innate function in vivo.
The leading potential solution to this shortage for the foreseeable future is xenotransplantation.
Xenotransplants
Fewer than 5% of the human organs needed are actually made accessible for transplant.
Strictly regulated by the FDA, xenotransplantation involves any procedure that transplants, implants, or infuses one of the following into a human:
Live cells, tissues, or organs from a nonhuman animal source
Human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs
Xenotransplantation are used to treat certain diseases such as neurodegenerative disorders, liver failure, and diabetes where human body parts are not usually available.
These technologies are expensive and have lower success rates than human organ donations.
Tissue Transplantation: Oversight of Safety and Effectiveness
For over 20 years, the National Institute of Health publicly disclosed summary safety and effectiveness data for studies related to xenotransplants.
In 2001, proposed rules were made to extend this same level of disclosure to the FDA’s regulation of xenotransplants.
Concerns about protecting animals and humans from cross-species diseases, known as zoonoses.
A number of potential methods are under consideration and are being pursued:
Modification of the donor to increase its compatibility with the recipient
Organ and clone T-cell deletion
Transplant of bone marrow
The goal is to create partially humanized organs
Tissue Transplantation: Xenotransplant Tourism
Xenotransplants occur in countries with no regulatory oversight.
Patients seeking xenotransplant procedures visit countries like Mexico, Cambodia, Laos, and Myanmar for controversial treatments that can be exceedingly dangerous.
Xenotransplant tourism by patients willing to pay for unproven interventions in countries without adequate controls risks global dissemination of new pathogens.
May undermine this fledgling field just as it is emerging
Alternative Strategies for Developing Organ and Tissue Replacements
Current research efforts can be divided into four areas:
Development of new organs,
taking advantage of advances in stem cell biology,
genetic engineering, and tissue engineering
Improvement in medical devices to replace organ functions
Methods for improving organ and tissue preservation during transport from donor to recipient
Procedures for lengthening postimplantation survival of the organ and the recipient
While engineering of replacement tissues now uses large-scale tissue cultures, research is extending relatively crude current cell and tissue culture techniques to better determine the conditions required to create organ systems in vitro.
Moving Altruism Forward
As medical advances have made organ transplants easier and more successful, questions arise:
Are living donations ethical?
Should organ donors be compensated similarly to those who donate plasma or reproductive material?
Which patient should be the priority when an organ becomes available: the sickest and the ones suffering the most, or the healthiest and the most likely to survive, or the one who has been waiting the longest?
Who should receive the limited supply of transplantable organs?
If basic economic concepts are not an an appropriate way to distribute scarce transplantable organs, what is the best way to do so?
While altruistic procurement of organs is not meeting the growing demand for transplantable organs, there is not sufficient moral certainty to warrant allowing marketplace approaches to organ transplants → material gain makes patients uneasy
Management and Law Issues
Can we confine our arguments about health care efficiency to organ transplants, or can one argue that other types of medical treatments and health care services are also scarce?
Is the shortage of organs available for transplant one health care problem that could be solved by unlimited funding of the health care system?
What is the justification underlying laws restricting or offering payment for transplant organs?
What legal distinction is there between selling organs versus human tissues, blood plasma, ova, and sperm?
What practical considerations support or detract from legally regulating organ procurement and transplants?
Would it be permissible to remove the organs of healthy, deceased prisoners to save the lives of five to eight others who need organ transplants?
Under what circumstances might palliative sedation facilitate organ transplants?
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