Issues in Science and Technology, Online A Publication of National Academy of Sciences National Academy of Engineering Institute of Medicine University of Texas at Dallas
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Update

Crisis in U.S. organ transplant system intensifies

More than 10 Americans die each day while awaiting organ transplantation. The U.S. organ transplant system has been in "crisis" for decades, but recently its systemic failures have become more glaring. Indeed, the crisis has worsened since I wrote "Organ Donations: The Failure of Altruism" (Issues, Fall 1994), in which I argued that voluntary organ donation should be replaced with a system of compensated presumed consent. Although continuing advances in transplant technology have made it possible for many people to benefit from transplants, the number of organs available for donation has remained stubbornly insufficient. In 1997, only 9,235 donor organs were recovered. Yet since 1994, the number of individuals waiting for an organ has risen from 36,000 to 59,000. In addition, the limited number of organs that are available are not always allocated equitably. A recent study in the Journal of the American Medical Association reported that "blacks, women, and poor individuals are less likely to receive transplants than whites, men, and wealthy individuals due to access barriers in the transplantation process." These twin problems of organ scarcity and inefficient, inequitable organ allocation are, in part, a result of the largely private and unregulated system of organ transplantation that the United States has chosen. Until the American people and the U.S. government develop the moral and political will to deal decisively with the structural flaws in the U.S. organ transplant system, many individuals who could benefit from organ donation will die needlessly.

In December 1997, the U.S. Department of Health and Human Services (HHS) proposed a new National Organ and Tissue Donation Initiative, with the goal of increasing organ donation by 20 percent within two years. This national partnership of public, private, and volunteer organizations will provide educational materials and hold workshops to promote public awareness about donation and to encourage people to donate their own or loved ones' organs. In addition, on April 2, 1998, HHS issued a final rule under the National Organ Transplant Act of 1984 (NOTA) to improve the effectiveness and equity of the nation's transplantation system. NOTA established a national system of organ transplantation centers with the goal of ensuring an adequate supply of organs to be distributed on an equitable basis to patients throughout the United States. NOTA created the Organ Procurement and Transplantation Network (OPTN) to "manage the organ allocation system [and] to increase the supply of donated organs." OPTN is operated by the United Network of Organ Sharing (UNOS), a private, nonprofit entity under contract with HHS to develop and enforce transplant policy nationwide. All hospitals performing organ transplants must be OPTN members in order to receive Medicare and Medicaid funds.

Under the new rule, which was four years in the making, an improved organ transplantation system with more equitable allocation standards will be developed to make organs "available on a broader regional or national basis for patients with the greatest medical need consistent with sound medical judgment." Under the rule, three new sets of criteria for organ allocation would be developed by OPTN: 1) criteria to allocate organs first to those with the greatest medical urgency, with reduced reliance on geographical factors; 2) criteria to decide when to place patients on the waiting list for an organ; and 3) criteria to determine the medical status of patients who are listed. These criteria will provide uniform national standards for organ allocation, which do not currently exist.

The rule was scheduled to take effect on October 1, 1998. However, responding to intense lobbying by the rule's opponents, including then-House Appropriations Committee Chair Robert Livingston (R-La.), Congress imposed a year-long moratorium on the rule as part of the FY 1999 Omnibus Appropriations Act. UNOS and certain organ transplant centers argued that adoption of the rule would result in a single national list that would steer organs away from small and medium-sized centers and lead to organs being "wasted" on very sick patients who were too ill to benefit from organ transplantation. HHS responded that the new rule does not require a single list and that doctors would not transplant organs to patients who would not benefit. The congressional moratorium charges the Institute of Medicine (IOM) to examine the issues surrounding organ allocation and issue a report by May 1999. It also encourages HHS to engage in discussions with UNOS and OPTN in an effort to resolve disagreements raised by the final rule, and it suggests mediation as a means of resolving the dispute. Congress has also demanded that OPTN release timely and accurate information about the performance of transplant programs nationwide so that the IOM and HHS can obtain complete data for their decisionmaking.

While the federal government is reconsidering its organ transplantation policy, many states are becoming more involved with organ donation and transplantation. In 1994, Pennsylvania became the first state to pass a routine-referral organ donor law. Routine-referral laws require hospitals to notify their federally designated Organ Procurement Organization (OPO) whenever the death of a patient is imminent or has just occurred. It is then the OPO's job to determine the patient's suitability for organ donation and to approach potential donor families, with the goal of increasing the number of positive responses. New York, Montana, and Texas have adopted similar legislation. Some states have enacted legislation that appears to directly conflict with HHS's goal of allocating organs on the basis of medical urgency rather than geography. Louisiana, Oklahoma, South Carolina, and Wisconsin have passed laws mandating that organs harvested locally be offered first to their own citizens, regardless of their medical need. Such laws raise classic problems of federalism and preemption. Under the new HHS rule, the federal government seeks to ensure that patients with the greatest need will receive scarce organs on the basis of medical necessity alone, without regard to where they live or at what transplant center they are awaiting treatment. Louisiana, Oklahoma, South Carolina, and Wisconsin want to reward local transplant centers and doctors if they are successful in increasing organ donation by ensuring that organs donated locally will remain there. HHS recognized this

conflict and resolved it in favor of federal preemption. However, this provision in the final rule will remain in abeyance until the end of the year-long moratorium.

The crisis in U.S. organ transplantation is moral and political, not technological. It will not be resolved until Congress and the states move beyond localism to develop a uniform nationwide approach to increase organ donation; identify medically appropriate criteria for transplant recipients; and remove racial, gender, and class barriers to equitable organ allocation. While the IOM studies these problems and individual states try to promote organ donation, more than 4,000 people on a transplant waiting list will die.

LINDA C. FENTIMAN

New radon reports have no effect on policy

Indoor radon poses a difficult policy problem, because even average exposures in U.S. homes entail estimated risks that substantially exceed the pollutant risks that the Environmental Protection Agency (EPA) usually deals with and because there are many homes with radon concentrations that are very much greater than average. In 1998, the National Research Council (NRC) released two studies that redid earlier analyses of the risks of radon in homes. As expected, both found that there had been no basic change in the scientific understanding that has existed since the 1980s. More important, neither study addressed much-needed policy changes to deal with these risks. As I argued in "A National Strategy for Indoor Radon" (Issues, Fall 1992), a much more effective strategy is needed. It should focus first and foremost on finding and fixing the 100,000 U.S. homes with radon concentrations 10 or more times the national average.

One NRC committee study [Health Effects of Exposure to Radon (BEIR VI, February 1998] revisited the data on lung cancer associated with exposure to radon and its decay products. It is based primarily on a linear extrapolation of data from mines, because lower indoor concentrations make studies in homes inconclusive. The panel estimated that radon exposures are involved in 3,000 to 33,000 lung cancer deaths per year, with a central value around 18,000, which is consistent with earlier estimates. Of these deaths, perhaps 2,000 would occur among people who have not smoked cigarettes, because the synergy between radon and smoking accounts for most of the total radon-related estimate.

The estimated mortality rate even among nonsmokers greatly exceeds that from most pollutants in outdoor air and water supplies; however, it is in the same range as some risks occurring indoors, such as deaths from carbon monoxide poisoning, and is smaller than other outdoor risks, such as those from falls or fires. On the other hand, the radon risks for smokers are significantly greater, though they are still far smaller than the baseline risks from smoking itself, which causes about 400,000 deaths per year in the United States.

No one expects to lower the total risk from radon by a large factor, except perhaps Congress, which has required that indoor concentrations be reduced to outdoor levels. But the NRC committee implicitly supported the current EPA strategy of monitoring all homes and remedying those with levels a factor of three or more times the average, by emphasizing that this would lower the total risk by 30 percent. This contrasts with the desire of many scientists to rapidly find homes where occupants suffer individual risks that are 10 or even a 100 times the average, then lowering their exposures by a substantial factor.

A second report, Risk Assessment of Radon in Drinking Water, released in September 1998, creates a real policy conundrum. Here too, the picture changes very little from earlier evaluations, except that the estimated 20 stomach cancer deaths due to direct ingestion of radon (of the total of 13,000 such deaths annually in the United States) is smaller than earlier EPA estimates. The main risk from radon in water is from release into indoor air, but the associated 160 deaths are only 1 percent of the total (18,000) from airborne radon and are less than the 700 resulting solely from outdoor exposures to radon.

The difficulty is that the legal structure for regulating water appears to compel EPA to set the standard for a carcinogen to zero, or in this case at the limit of monitoring capability. This would result in spending large sums of money for a change in risk that is essentially irrelevant to the total radon risk. At EPA's request, the NRC committee examined how an alternative standard might be permitted for water districts that reduced radon risks in other ways. But Congress would have to act to permit EPA to avoid this messy and ineffective approach and to simply set an exposure limit at what people receive from outdoor air.

All of this avoids the principal need, which is to rapidly reduce the number of homes where occupants are exposed to extraordinary radon concentrations. Related needs are to emphasize the reliability of long-term monitoring (as opposed to the tests lasting several days that currently prevail) and to develop information and programs that focus on, and aid in solving, the problem of high-radon homes. These were compelling needs in 1992 and they remain compelling today.

ANTHONY V. NERO, JR.