Xenotransplantation Science, Ethics, and Public Policy (1996) / Chapter Skim
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4. Ethics and Public Policy
4. Ethics and Public Policy
Pages 57-91
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From page 57... ...
Consideration is given to the value and quality of human life, special problems of informed consent, and the use of animals. The chapter also addresses issues regarding the economic and regulatory impact of xenotransplantation.
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From page 58... ...
The debate about transplanting baboon bone marrow into an AIDS patient in San Francisco prominently displayed this message for two reasons. First, the experiment in question was in the process of being considered for approval by the Food and Drug Administration (FDA)
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From page 59... ...
had received organ transplants. The third person, Evelyn W., was Calvin's mother, who spoke about the issues confronted by families.
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From page 60... ...
of Len K.'s kidney transplant will be paid entirely by Medicare's End Stage Renal Disease Entitlement Program. For many others, no insurance or Medicare program is available, and because of lack of money, many of these patients will die.
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From page 61... ...
Fortunately, protections that encourage, and at points require, patient-physician and patient-researcher communication exist in the form of guidelines for research with human subjects.
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From page 62... ...
In addition, for the patient, the risks are especially great relative to the individual benefits, and for the community, there is a possible public health risk from animal pathogens or new infectious agents. The history of organ transplantation is replete with instances of medical community enthusiasm tending to underestimate risks and exaggerate individual benefits of new medical and surgical interventions (Arnold, 1995; Fox and Swazey, 1992~.
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From page 63... ...
When investigators develop gene therapy protocols for review by the NIH Recombinant DNA Advisory Committee and by the FDA, they are guided by the "NIH Guidelines for Research Involving Recombinant DNA Molecules." One of the appendixes to 3The Federal Regulations for the Protection of Human Subjects (45 CFR 46)
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From page 64... ...
Justice and Fairness Issues: Organ Allocation and Research There are two major questions of justice and fairness that must be addressed in the consideration of xenotransplants: organ allocation and access to research. The United States has already developed a system for allocating human organs.
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From page 65... ...
If they are referred, the transplant center generally requires assurance of payment before placing a patient on the waiting list (Evans, 19893. Transplant centers justify this practice on the grounds that, in order to recover losses, they must charge higher rates to all patients.
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From page 66... ...
Likewise, African Americans represent 33.7 percent of patients waiting for kidney transplants (UNOS, 1994~. Ironically, African Americans experience the longest waiting times for kidneys, once they have been placed on the waiting list.
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From page 67... ...
The situation may become analogous to that immediately before the passage of NOTA, when some families took to the airwaves to dramatize their plight, a practice that has continued over time. More recently, when approval for one of the first xenogeneic bone marrow experiments for AIDS patients was delayed for almost two years, one of the investigators, Suzanne Ildstad, publicly reported being approached by several foreign governments to conduct the trial in their countries.
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From page 68... ...
The public endorses human organ transplantation at least on the surface. There is widespread public acceptance of organ donation and transplantation, as evidenced by a 1993 Gallup survey sponsored by the Partnership for Organ Donation (Spital, 1995~.6 In the survey of more than 400 adults, 85 percent expressed support for organ donation, although the level was somewhat lower for minority respondents.
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From page 69... ...
Transplant surgeons and ethicists also voice concerns that exaggeration of the scientific potential of xenotransplants will actually reduce the number of human organs now being donated. They view public support for voluntary cadaveric organ donation as tenuous enough to be undermined easily.
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From page 70... ...
Such hopes, however, may not be realized if cultural values against the use of animal organs in these countries outweigh values about human life. Alternatively, if xenotransplantation requires special animal facilities and increased expenditures, economically depressed countries may continue exploitative practices to procure human organs.
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From page 71... ...
Even though the scientific community had acted earlier to impose a moratorium until safety guidelines were in place, communities remained distrustful. Citizens of Cambridge, Massachusetts, opposed to recombinant DNA research at Harvard and the Massachusetts Institute of Technology, were successful in convincing their city council to impose a moratorium on the research until a citizen review board could evaluate the problem and recommend action.
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From page 72... ...
It then focuses specifically on the use of animals as a source of organs. The history of attitudes regarding xenotransplantation will be reviewed briefly, followed by modern-day reflections on the use of nonhuman primates and swine as a source of cells, tissues, and organs for transplantation.
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From page 73... ...
Because utilitarian theory requires an estimation of the probability that a certain action will produce a good consequence, if most research produces no useful result, it is morally groundless or problematic. Alternatives to the use of animals in research may include conducting public health research or epidemiological studies instead of using animals.
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From page 74... ...
Elements of utilitarianism are incorporated into this version of the rights theory. The rights ethical view accords with many people's view of animals, insofar as it explains why we should treat animals as individuals worthy of respect.
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From page 75... ...
History of Social Responses to Xenotransplantation Physicians have been interested in using animal tissues to treat human disease for centuries (Lederer, 1995~. In the seventeenth century, transfusion of blood from animals into people was abandoned after limited use.
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From page 76... ...
Questions concerning both the scientific basis for this transplantation experiment and the ethics of research with human subjects were raised. At the time of this experiment it was known that the success of transplantation improved when there was major blood group compatibility, a compatibility that was lacking in this case.
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From page 77... ...
So, according to Walter's analysis, these animals may have higher moral status than some humans. Finally, it is clear that humans, like other animals, are "speciesists," in that we display partiality to fellow human beings, even if some of them lack capabilities possessed by other species.
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From page 78... ...
The fact that annual expenditures for organ transplantation account for only a small proportion of national health care expenditures is explained by the relatively low number of transplanted and surviving patients. Were more organs available, the total expenditures would most certainly be higher.
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From page 79... ...
Organ transplants including bone marrow transplants consistently rank in the top ten most expensive medical treatments, according to data from the Mayo Clinic. Between 1990 and 1992, liver and heart transplants were ranked in either first or second place, based on the billing data for transplant procedures (Evans, 1993~.
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From page 80... ...
Figure 4-2 depicts the hospital charge per case and expected patient survival rates for liver transplants at different hospitals. The charges ranged from a low of $97,852 to a high of $457,522, a difference of more than 300 percent, with seemingly no effect on patient survival.
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From page 81... ...
The demand will come from patients on the waiting list, patients who are not eligible for placement on the waiting list, or patients with conditions that may now benefit from xenotransplantation. It is estimated that nearly 124,000 patients, who could conceivably require a solid organ transplant, might benefit from xenotransplants.
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From page 82... ...
Private insurance usually pays for heart, liver, and bone marrow transplants, but less typically for heart, lung, and pancreas transplants, which are considered experimental by many insurers. The extent of reimbursement varies according to the policy and, as previously described, usually falls short of actual billed charges.
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From page 83... ...
Managed care coverage of transplants is similar to that of traditional feefor-service plans, although the data are somewhat sketchy. For example, surveys reveal that organ and tissue transplants (cornea and bone marrow)
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From page 84... ...
For xenotransplants to be covered by managed care, their cost-effectiveness will have to be demonstrated by carefully designed studies, as was done by comparing kidney allotransplants with dialysis. Most managed care providers and other insurers have decided to cover kidney transplants because research demonstrated that annual expenditures for a patient with a functioning transplant are far lower than those for renal dialysis (Evans, 1993~.
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From page 85... ...
A summary of the regulations pertaining to the committee that reviews research on patients is discussed first, followed by a description of the regulations for the committee that reviews the use of animals and a consideration of reviewing complex protocols such as xenotransplantation. The institutional review board, sometimes known as the human subjects committee, is the committee that reviews protocols that describe proposed research involving patients.
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From page 86... ...
~ The IRB is required to maintain detailed records, which include copies of the protocol and supporting documents, minutes of all meetings, records of continuing reviews, copies of all correspondence with investigators, a membership list, and procedures followed in reviewing proposals. The institutional animal care and use committee (IACUC)
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From page 87... ...
Proposals that fail to receive extramural funding may still go forward, and no attempt is made to suspend projects that do not pass external scientific review. In the case of xenotransplantation protocols, which involve questions concerning the state of current immunological knowledge, human organ availability, technical feasibility, infectious disease risks, and ethical and societal issues, the committees may be very dependent on consultants or may require national review by a committee composed of experts in the relevant fields.
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From page 88... ...
Organ transplantation is considered a surgical procedure conducted in the practice of medicine, an area historically outside the purview of FDA. Likewise, FDA does not require premarket approval of cells and tissues that are unmanipulated.
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From page 89... ...
However, bone marrow purged of T-cells is considered under the current regulatory framework to be manipulated. Premarket approval is therefore required.
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From page 90... ...
Far more stringent and expensive requirements pertain to these phases of human testing. Genetic modifications to xenogeneic organs, tissues, and cells not only require premarket approval by the FDA but also are likely to require review by the NIH Recombinant DNA Advisory Committee (RAC)
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From page 91... ...
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