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Prepared Witness Testimony The House Committee on Energy and Commerce
Assessing Initiatives to Increase Organ Donations
Subcommittee on Oversight and Investigations
Dr. Robert M. Sade MD
The American Medical Association (AMA) appreciates the opportunity to share its views on appropriate strategies to increase organ donation rates and thanks Chairman Greenwood and members of the Subcommittee for holding today's hearing on this important issue. Background In the United States, there is a striking gap between the demand for transplantable organs and the available supply of such organs. Annually, approximately 6,000 patients with end-stage organ failure - the equivalent of 16 per day - die because of the lack of available organs. Successes of solid-organ transplantation have greatly increased the need for organ donors. Unfortunately, donation rates have not kept up with the need for organs which has grown nearly five times faster than the number of cadaveric donors. The annually compounded rate (1990-2000) of increase in number of patients on waiting lists has averaged 14.1% a year. Meanwhile, the rate of increase of donors has averaged only 2.9% a year. Unrealized potential accounts for much of the donation gap, with studies suggesting that each year only 35-50% of potential donors consent to donation. Because the number of potential donors far exceeds current procurement rates, the AMA, like many other groups, has identified the urgent need to develop new strategies to increase donation rates in an effort to alleviate our country's organ shortage. The Need for Innovative Approaches In the past, initiatives to increase organ donation have included vigorous educational campaigns to motivate individuals to become donors. Other efforts have been directed at health professionals urging them to educate patients regarding donation, or legislatively mandating that they present relatives of a newly deceased with a choice to donate. All these initiatives have been expanded through the establishment of the Organ Procurement and Transplantation Network (OPTN), donor card programs and donor registries, and the creation of specialized organ donation teams within hospitals that discuss organ donation with patients and families. Unfortunately, these efforts have failed to increase cadaveric donation rates significantly. The AMA believes that these efforts should be maintained. It is essential that physicians and other organ donation advocates continue to promote voluntary donation of organs. Beyond these programs, however, the AMA supports innovative approaches that are informed by a more comprehensive understanding of what motivates and what hinders individuals' decisions to donate. Reexamining Donor Motivation The AMA applauds recent efforts by various groups to determine best practices in organ donation. Thorough study of these practices and their replication should increase donation rates. The AMA applauds the attention that has been given to the issue of organ donation by the Secretary of Health and Human Services, Tommy Thompson. Under his leadership, the membership of the Advisory Committee on Organ Transplantation (ACOT) has doubled in size, and, it has successfully pursued its mission to enhance organ donation by ensuring that the system of organ transplantation is grounded in the best available medical science, while assuring the public that the system is as effective and equitable as possible. In November 2002, the ACOT issued a set of recommendations to the Secretary, some pertaining to the effectiveness of living donation and appropriate protection of potential living donors, and others relating to increasing the supply of organs from deceased donors. Similarly, the United Network for Organ Sharing (UNOS) convened organ donation and transplantation professionals last month to build a consensus on best practices regarding techniques related to donation requests. Considering that the most common reason for missed donation opportunities is denial by the donor's family, this conference marked a concerted national effort to improve consent rates by examining shared characteristics among professionals who are routinely successful when approaching families and potential donors about organ donation. These findings, once implemented, could lead to increased rates of donation. Creative proposals must continue to be examined for their potential to increase the number of cadaveric donations to help supplement current initiatives and address the shortage. Whether expanding criteria for donation, systematizing the use of asystolic donors, or incorporating organ donation as a specialized form of end-of-life care, ethical strategies should be investigated to establish their effectiveness in raising donation rates. Against this background, the AMA recently considered issues related to donor motivation. We acknowledged the medical profession's obligation to continue to encourage the voluntary donation of organs in appropriate circumstances and also to support innovative approaches. We have noted that financial incentives might be an important motivational factor in the context of cadaveric organ donation but that it remains inadequately explored because of federal prohibition. In our view, such incentives are not intrinsically unethical even though they are counter to current customs, and, if proven effective, could save the lives of many patients suffering from end-stage organ failure. Encouraging the Study of Financial Incentives In June 2002, the AMA adopted a policy encouraging the medical community to support the reexamination of motivation for cadaveric organ donation. In particular, the report explored financial incentives as a possible strategy to increase organ donation, and recommended that the impact of these incentives on donation rates be studied. Theoretical concerns regarding harms that could result from offering financial incentives for organ donation were carefully considered: - Currently, individuals see donation as a gift. To put a financial incentive on cadaveric organ donation might deter some individuals from wanting to be donors. - Financial incentives for cadaveric organ donation might fuel what is considered by some as a disturbing trend towards viewing the human body as a source of profit. - Payments might be unduly coercive to certain segments of the population, interfering with the voluntary nature of donation. - Even if financial incentives initially are permitted for cadaveric organ donation only, pressure might build to allow payments to live donors. Several of these concerns led a panel of experts convened by the American Society of Transplant Surgeons (ASTS), in April 2002, to oppose any form of direct payment for cadaveric organs. The panel was asked to determine whether an ethically acceptable pilot trial could be designed whereby a family would be offered a financial incentive to consent to the donation of organs from a deceased relative. The panel unanimously agreed that such direct payment would violate the standard of altruism in organ donation, leading to a system that would commodify human organs. The panel was divided with regard to the acceptability of other indirect incentives such as funeral reimbursements or charitable contributions, which would convey society's appreciation to a family for their gift of life. For its part, the AMA notes that there is a dearth of scientific data supporting those concerns. Nearly all of the arguments against financial incentives are based on assumptions that can be proven or disproved by objective empirical studies. Factual evidence that would determine the presence or absence of harm to individuals, groups of individuals, or society as a whole could resolve many of the policy debates between those who object to financial incentives for cadaveric organ donation and those who favor such incentives. It is on this basis that the AMA supports the study of motivation, to gain a better understanding of the impact of moderate financial incentives and other motivators on cadaveric organ donation. Whether or not such incentives and other motivators are ethical depends, at least in part, upon the balance of benefits and harms that result from them. In its June 2002 policy, the AMA articulated parameters for research studies investigating the effects of financial incentives for cadaveric organ donation. First and foremost, these studies should apply only to organ donation; the current system of organ distribution, as developed and administered by the United Network for Organ Sharing should be maintained. Also, the studies should be limited to understanding motivation for cadaveric organ donation only, and not its effect on living donors. With respect to their design, each study should be limited to a small population, provide financial incentives at the lowest level that could reasonably be expected to increase organ donation, have measurable outcome variables to assess their effectiveness, and be completed within defined time frames. Altogether, it would be desirable that data be gathered from broad population segments and that they not only help measure the effect of incentives upon donation rates but also on public perception of the transplant enterprise and of the meaning of organ donation. Moreover, studies should be undertaken only after: - A new law is enacted for the purpose of collecting these data which would waive the National Organ Transplantation Act's legal prohibition against providing valuable considerations for organ donation. - Guidance and advice have been sought from the particular population under study to ensure that the proposed research is consistent with their needs, values, and mores. - Protocols that meet ethical standards and are scientifically rigorous have been reviewed and approved by appropriate oversight bodies, such as Institutional Review Boards. All other ethical safeguards that generally guide the participation of human subjects in clinical investigations also should be adhered to when studying the impact of financial incentives on organ donation rates. Models have been proposed by several organizations, including the ASTS and UNOS, whose Board of Directors agreed, days after the AMA adopted its policy, to support legislation that would enable studying the impact of incentives to encourage organ donation and to honor organ donors. Among the suggested models are: future contracts, as was proposed in a bill before Congress several years ago, that would have allowed for the implementation of a tax credit of up to $10,000 on the estate of the deceased donor; reimbursement for funeral expenses, as was passed into law in Pennsylvania, but was never implemented because of the federal prohibition; charitable donations; direct payment; and medals of honor. Moreover, Congressman Greenwood's leadership with this issue was displayed through the introduction of H.R. 5224 during the last Congress which would have authorized the Department of Health and Human Services to carry out demonstration projects to increase the supply of organs donated for human transplantation. The potential benefits to be gained from each proposal discussed above remain speculative and must be weighed against possible harms before any such program is widely implemented. For example, if research shows that little discernable harm to potential donors, their families, or society results from offering modest financial incentives, thereby saving more lives through increased organ donation rate, everyone benefits. But if serious harms are found, physicians and policymakers will need to search for other means of increasing donation rates. A thorough discussion of this matter also must include consideration of the costs of foregoing such studies. Currently patients die each day waiting for available organs. Therefore, a better informed debate is necessary, one that can occur only after the effectiveness of various incentive models has been measured. It is for this reason that the AMA will continue to advocate for the study of financial incentives as a strategy for increasing organ donation. We thank the members of the Subcommittee for initiating a review of this important matter and for inviting the AMA to share its views.
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