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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. Abraham Shaked MD
Chairman Greenwood, Ranking Member Deutsch, and distinguished Members of the Subcommittee: On behalf of the American Society of Transplant Surgeons ("ASTS"), thank you for the opportunity to testify before this Subcommittee on the important issue of assessing initiatives to increase organ donation rates. My name is Abraham Shaked and I am Chief of Transplantation Surgery at the University of Pennsylvania, Department of Surgery. Today marks my first day as President of ASTS, an organization comprised of over 900 transplant surgeons dedicated to promoting and encouraging education and research with respect to organ and tissue transplantation so as to save lives and enhance the quality of life of patients with end stage organ failure. As this Subcommittee assesses initiatives to increase the rate of organ donation in this country, we would like to offer comments on four topics: 1. The use of organ coordinators in what is often referred to as the "Spanish model"; 2. The ethical use of financial incentives to increase organ donation rates; 3. Honoring the donor's wishes, what is sometimes referred to a "donor rights"; and 4. The importance of living donor liver transplantation and related research. Background Mr. Chairman, as you well know, one of the most pressing problems in the field of organ transplantation is the lack of available organ donors. This creates long waiting lists of potential candidates for organ transplants. Every individual who needs an organ transplant should be able to receive one in a timely manner but, as a nation, we are not even close to achieving this goal. The Bush Administration is providing strong leadership in this area, both in terms of funding of the programs under the Division of Transplantation within the Health Resources and Services Administration and with the assistance of his Advisory Committee on Transplantation ("ACOT"). Secretary Thompson, in particular, deserves great credit for his personal commitment to the organ donation issue. Along with a concerted effort in the transplant community and with the private sector, we are starting to turn the corner on this national problem, but there is much more progress to be made. ASTS is very encouraged by the Bush administration's support for increased organ donation activities. In April 2001, Secretary of Health and Human Services Tommy Thompson first announced a five-point initiative to encourage organ, tissue, marrow, and blood donations. More recently, the Department of HHS has been working to implement the 18 recommendations of the ACOT. In past years, the third week in April was designated as "National Organ and Tissue Donor Awareness Week." This year, however, the Administration changed this to a month-long observance. Thousands of people have already recognized the importance of giving the "gift of life" to others. In 2002, 22,741 organ transplants and more than 46,000 corneal transplants were performed in the United States, and an average of 173 transplants were facilitated each month by the National Bone Marrow Donor Registry. The need, however, is still enormous. Close to 81,000 individuals are on the waiting list for organ transplants, and thousands need tissue and corneal transplants each year. About 30,000 people per year are diagnosed with blood diseases that may be cured by a marrow/blood stem cell transplant. And each day, approximately 32,000 units of blood are needed, yet only about 5 percent of eligible blood donors give blood regularly. Sadly, more than 6,000 people die unnecessarily each year because they did not receive the organ they needed. Currently, sixteen people die every day waiting for a donated organ-that is one death every 91 minutes. And the problem is getting worse, not better. Regrettably, in the past ten years, the number of registrations on the waiting list has quadrupled. Mr. Chairman, there are many strategies to combat this problem, some more controversial than others. More often than not, simple awareness by patients and their families about the facts of organ donation can make the difference between life and death. Studies have shown that over 95% of families would consent to organ donation if they knew it was the wish of their loved one. As recent increases in organ donation rates demonstrate, education and awareness can be an effective tool in saving the lives of patients needing transplants. Consequently, the ASTS strongly favors initiatives that foster education and public awareness efforts. The commitment of federal resources to address the nationwide shortage of donated organs is essential to both increase the success rate in organ transplantation and increase the number of organ donors available. While additional spending is critical on public awareness, grants for organ coordinators, grants for studies to eliminate disincentives to organ donation, and other programs, ASTS also supports changes in public policies to encourage donation. Several years ago, ASTS worked with a number of transplant-related organizations to craft a set of organ donation proposals for Secretary Thompson's consideration, and ultimately for the consideration of Congress. Now the bulk of these recommendations are represented in legislation introduced by Senate Majority Leader Bill Frist, who, as you know, is a transplant surgeon. This legislation, S.573, the "Organ Donation and Recovery Improvement Act," has widespread support and we hope to see it serve in the Senate as a vehicle to enact an organ donor bill into law this year. The Use of Organ Coordinators There has been significant U.S. interest in the potential promise that organ coordination programs, such as the program utilized in Spain, may offer. In fact, grants to fund organ coordination activities are proposed in Senator Frist's organ donation legislation, S. 573. In the House, Congressmen Wilson (R-SC) and Inslee (D- WA) have each sponsored similar legislation in the past. The so-called "Spanish Model" has been outlined as a structure of national, regional, and local or in-hospital efforts to increase organ donation. The management structure consists of a front-line in-hospital transplant coordinator who is fully involved and accountable for the donor recruitment effort. Furthermore, transplant donor coordination has been "professionalized" and most coordinators are qualified doctors, mainly intensive care specialists and nephrologists, who have dedicated time allocated to transplant coordination. Moreover, the Spanish system adheres to the principles of decentralization of the donor coordination effort through the use of regional coordinators and the establishment of organ procurement as the main priority for national, regional, and hospital coordinators. In an attempt to assess and study whether organ coordination models could be effective for the U.S. in raising organ donation rates, the ASTS organized and funded a study group in the late 1990's to investigate methods of maximizing organ donor potential and improving the recovery of organs from these donors. The study group consisted of three transplant surgeons (John Roberts from the University of California San Francisco, Bruce Rosengard from the University of Pennsylvania, and myself as chair of the group) as well as four representatives from the Association of Organ Procurement Organizations (AOPO). The study group spent two days in Madrid, Spain at the Organizacion Nacional de Transplantes (ONT), that country's national transplant program. Since the creation of the Organizacion Nacional de Trasplantes (ONT) in 1989, the organ donation rate in Spain has doubled. This effort has been so successful that it produced a 28% decrease in the size of the waiting list for kidney transplantation in Spain between 1991 and 1997. During this same time period, the US kidney waiting list nearly doubled in size. Although often attributed to improved donor recruitment efforts, the increase in donor rates in Spain may also represent higher utilization of marginal donors. Recently, a study examined age-related donor recruitment in Spain and the U.S. Chang, George J., MD, Mahanty, Harish D., MD, Ascher, Nancy L., MD PhD, Roberts, John P., MD, "Expanding the Donor Pool-Can the Spanish model work in the United States?" (Division of Transplantation, Department of Surgery, University of California, San Francisco). Data from the ONT, the US Scientific Registry of Transplant Recipients (SRTR), the US Census Bureau, and the Tempus databank of Spain's Instituto Nacional de Estadistica (INE) were analyzed. Between 1989-1999, the number of donors in Spain increased from 14.3 to 33.7 per million population (pmp), (136% increase) compared to an increase in the US from 16.2 to 21.5 donors pmp (33%). The largest difference between Spain and the US in the increased number of donors was in the =45 year old group representing 30.3% of donors in Spain in 1999 (44 donors pmp). If the U.S. increased its older donor rates to match Spain's, an incremental 1235 donors per year would be realized. The high Spanish organ donation rates are largely attributable to increased use of older donors. Utilizing similar proportions of older donors in the US would increase the donor pool by almost 40%. As already stated, there has been significant interest in implementing a "Spanish Model" for organ donation in the US and other countries. Calls for funding similar types of organizational structures have been made on the grounds that this change will result in an increase in organ availability. ASTS supports legislation that would create such organ coordination programs in the U.S. and believes that such a model can be effective, along with the practice of expanding the donor pool by utilizing older donors. The Ethical Use of Financial Incentives to Increase Organ Donation The use of financial incentives to increase organ donation rates can be quite controversial and, of course, payment for organs is prohibited by current law under the National Organ Transplant Act (NOTA). NOTA prohibits the exchange of "valuable consideration" for the use of a person's organs. 42 U.S.C. 274e. To do so would run the risk of turning what is now often referred to as the "gift of life" into a commodity to be bought and sold. This potentially cheapens the sanctity of human life and raises profound moral, ethical and religious questions. These questions, however, must be weighed against the morality of tolerating huge organ donor waiting lists with thousands of people dieing each year unnecessarily. The ASTS clearly opposes payment for organs. The United States must not send a signal to the international "black market" that the United States tolerates the commoditization of human organs. However, ASTS does not oppose efforts to study various methods and programs to increase donation rates that may have a financial component. For instance, ASTS would support a demonstration project that assessed the effectiveness of providing a modest funeral expense benefit to the family of a decedent donor, not as a payment for a donated organ, but as a token of thanks. ASTS also supports initiatives to eliminate financial disincentives to donation such as the provision of travel and subsistence expenses for living donors and similar initiatives. Mr. Chairman, ASTS is well aware of your bill introduced in the 107th Congress, H.R. 5224, that addressed the issue of financial incentives without permitting such incentives to override the provisions of NOTA. Senator Frist's bill in this Congress, S. 573, takes a slightly different approach by stating that demonstration projects on financial incentives may be conducted "Notwithstanding [the provisions] of NOTA..." This language appears to open the door to financial incentive demonstration projects that may not be considered permissible under current law. However, Senator Frist's bill contains two important provisions that help ensure that such demonstrations will be ethically sound before being funded by the Department of Health and Human Services. First, the Secretary is required to submit a report to Congress before funding any initiatives that evaluates "the ethical implications of proposals for demonstration projects to increase cadaveric donation." Second, the bill requires the Secretary to provide "ongoing ethical review and evaluation." While ASTS would prefer that this review be provided by an entity that is independent from HHS, such as the President's Council on Bioethics, and will continue to work in the Senate to accomplish this goal, ASTS supports S. 573 and looks forward to the day that an organ donation bill will be signed into law. ASTS Supports Donor Rights ASTS recently formally endorsed a policy of honoring donor wishes in the donation decision, notwithstanding familial objections. This policy is consistent with current federal law but many states are currently considering "donor rights" laws of their own. Formal endorsements of donor rights by AOPO and the Advisory Committee on Transplantation preceded ASTS's decision, all of which have occurred in the last several weeks. It is ASTS' hope that raising the awareness level of donor rights will have an impact on the number of people who take affirmative steps to witness their intent to donate their organs upon death. ASTS and NIH Partnership ASTS and the NIH have a solid history of partnering on projects that will increase the rates of organ donation, improve existing transplant protocols, and provide basic research into transplantation. This year, the NIH announced, in coordination with ASTS, the Adult to Adult Living Donor Liver Transplant Cohort Study (A2ALL), to take place at 10 U.S. transplant centers over the next seven years. ASTS has committed over $2.1 million over a seven year period for this joint project. The national project will investigate the experience of a group of patients eligible for living donor liver transplantation, focusing on the factors influencing outcomes of living donor liver transplants for both donors and recipients. Researchers will compare outcomes of this new procedure with the outcomes for patients who receive donor livers from cadavers. The goal of the study is to gather accurate data in a disciplined, careful way so that liver transplant patients and potential donors have reliable information about the risks and benefits of living organ donation. In addition to vital clinical issues, the A2ALL will investigate important research issues such as liver regeneration, liver cancer, and infectious hepatitis. Liver transplantation is the only cure and a life-saving measure for people with end-stage liver disease. Although liver transplants have become relatively common in the U.S. in recent decades, in 2001 some 17,000 patients waited for livers to be donated, while fewer than 5,000 cadaveric livers were actually transplanted that year. The shortage of cadaveric organs has led physicians and researchers to look to live donors to close that gap. The liver is a large segmented organ that can potentially be split without harm to the donor and with benefit to the recipient. Because the liver, unlike most organs, has a remarkable ability to regenerate, the donor's remaining liver grows to its original size within weeks. Likewise, the donated lobe will also grow in the recipient's body. For children in need of liver transplantation, living donor transplantation from an adult has been very successful and has become an accepted medical option. Adults in need of liver transplantation require a larger segment, as much as half or more of the donor's liver. This requires a more extensive and complex surgery, with potentially greater risks for the donor and the recipient. The procedure has evolved so rapidly that over half of the living donor transplants performed to date have occurred since 2000. Evaluation of donors as well as surgical procedures vary from one transplant center to another. Although the large majority of living donor liver transplants have been successful, there are few data to inform potential donors about risks. Post-surgical problems for donors can include infection, pneumonia, and leaking bile, which can require further surgery. Because the procedure is expanding across the country, a group of concerned physicians recently called for more research on the risks and benefits of this procedure as well as an outside regulator to certify hospitals that would perform the procedure in the New England Journal of Medicine (April 4, 2002). They also asked for uniform medical criteria in selecting donors and recipients. Mr. Chairman, transplant surgeons place a great deal of importance on the well-being of both donors and recipients. ASTS's partnership with NIDDK should give us credible data for the high quality patient care we all want to provide. Conclusion Thank your, Mr. Chairman, for the opportunity to present the views of the ASTS before this Subcommittee. Please do not hesitate to contact me in the future if I can be of any further assistance. Thank you.
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