Scott D. Halpern, MD, PhD
This article was published at www.annals.org on 25 June 2013.
Disclaimer: The author is a member of the Scientific Registry of Transplant Recipients Technical Advisory Committee and the Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability. The views expressed in this article are his own and do not necessarily reflect the views of these committees or the United States government.
Acknowledgment: The author thanks Vivek Ahya, MD; Nancy Blumenthal, CRNP; Edward Cantu, MD; Robert Kotloff, MD; David Lederer, MD, MS; and Peter Reese, MD, MSCE, for comments on an earlier draft of the manuscript.
Grant Support: The author was supported by a Greenwall Foundation Faculty Scholar Award in Bioethics.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1487.
Requests for Single Reprints: Scott D. Halpern, MD, PhD, University of Pennsylvania, 719 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104; e-mail, firstname.lastname@example.org.
Author Contributions: Conception and design: S.D. Halpern.
Drafting of the article: S.D. Halpern.
Critical revision of the article for important intellectual content: S.D. Halpern.
Final approval of the article: S.D. Halpern.
Obtaining of funding: S.D. Halpern.
Administrative, technical, or logistic support: S.D. Halpern.
Halpern SD. Turning Wrong Into Right: The 2013 Lung Allocation Controversy. Ann Intern Med. 2013;159:358-359. doi: 10.7326/0003-4819-159-5-201309030-00684
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Published: Ann Intern Med. 2013;159(5):358-359.
Insufficient supply prevents many Americans from receiving health care services they might benefit from. Sometimes, as in the case of transplantable organs, both the processes and outcomes of allocating limited resources are highly visible. In other contexts, allocation proceeds more opaquely, as when physicians discharge patients from intensive care units to open beds for other patients (1). The ethics of both rule-based and “bedside” rationing hinge on how well each process promotes fairness, maximizes benefit, and gives priority to patients who are the worst off. Unfortunately, inevitable tensions arise when trying to balance equity, efficiency, and priority. Consequently, some people will feel mistreated.
Such perceived mistreatment fueled recent controversy surrounding Sarah Murnaghan, a 10-year-old girl dying of cystic fibrosis at the Children's Hospital of Philadelphia. As her condition deteriorated, Murnaghan's family and friends organized an impressive media campaign claiming that a policy preventing Murnaghan from receiving priority for lungs from adult donors discriminated against children.
This policy, enacted in 2010 by the Department of Health and Human Services (DHHS) Organ Procurement and Transplantation Network (OPTN), states that children younger than 12 years receive highest priority for lungs from donors younger than 12, secondary priority (behind adolescents aged 12 to 17 years) for donors aged 12 to 17, and lowest priority for donors 18 years or older.
Spurred by the Murnaghans’ public relations blitz, U.S. Senator Patrick Toomey (R-Pa) (2) and media outlets echoed the claim that this policy discriminated against children, and District Court Judge Michael Baylson imposed a 10-day restraining order against the DHHS. With Murnaghan (and ultimately, another child at the same hospital) thus given equal priority as adults for receiving lungs from adult donors, Murnaghan received a double-lung transplant from an adult donor before a full hearing could ensue.
This intervention sets a troubling precedent. The court did not seek evidence to assess the merit of the age-discrimination claim. Measuring this policy's impact on different age groups requires careful consideration of the numbers of adults, adolescents, and children awaiting transplantation; the availability of donors in each group; and the expected benefit when patients receive donor lungs outside of their age range. Preliminary analyses presented by the United Network for Organ Sharing 5 days after the court decision showed no evidence that existing policy reduced lung access for children (3). Had expert testimony been allowed, it may have also become clear that absent the policy, far more adults would become recipients of children's lungs than vice versa.
The rule undoubtedly disadvantaged Murnaghan, but the court's response exalted her and another child above a national policy, suggesting either failure to recognize that preferential treatment for some recipients will adversely affect others (who may not be much older than 12) or that the court considered these 2 children's lives more valuable than others’. Neither of these explanations is satisfying. Further, by showing willingness to put national policies on hold to benefit individuals, the court established a broad tolerance for intervention. It might seem comparatively easy to issue restraining orders against individual physicians who must routinely deny chemotherapy due to drug shortages or establish queues in emergency rooms.
Sarah Murnaghan's parents, who were fulfilling their duties to their own child, cannot be blamed for this circumvention of due process. Blame falls on the legal and political leaders who neglected their responsibility to protect the interests of all potential patients. These leaders bent the rules in favor of a well-resourced family that generated enormous media attention. The transplant community would be wise to heed this case as a clarion call for improving the supply and allocation of transplantable organs.
First, existing OPTN review committees should use more sophisticated modeling tools, such as the Scientific Registry for Transplant Recipients’ simulated allocation models (4), to compare access to lungs and outcomes after transplantation under the present and alternative age-stratification policies. If such models suggest that the population of patients awaiting lung transplantation would fare better by altering age-based prioritizations, then the policy should change accordingly.
Second, this case should motivate transplant physicians to more earnestly adhere not only to their duties to their own patients, but to their equally compelling duties to just distribution of resources (5). Current imbalance in these duties is evidenced by the practice of listing most patients with idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease for double-lung transplantation (6), despite the absence of benefit relative to single-lung transplantation for most patients with idiopathic pulmonary fibrosis (7) and evidence showing that double-lung transplantation for chronic obstructive pulmonary disease yields more deaths on the waiting list without increasing life-years gained overall (8). New policies that set explicit, evidence-based criteria for listing patients for double-lung transplantation would enable more patients to receive a transplant with the same supply of lungs.
Third, the transplant community should work to expand the lung supply by making better use of donors after circulatory determination of death. A population-based cohort study in the same region in which Murnaghan resides showed that the lung supply could be increased by as much as 50% (9) if more transplant centers used these organs.
Finally, this case should spur transplant centers to reconsider how they choose to accept donor lungs with blemishes, such as those from moderate smokers. Although such lungs may produce shorter survival than pristine organs, some patients may prefer to receive an imperfect organ sooner rather than waiting for a better one (10). Indeed, had Judge Baylson acted more assiduously, he might have heard evidence that many children listed for lung transplantation have multiple organs offered to them (3). If so, changing the allocation system may be a less effective solution than changing practices that influence transplant centers’ acceptance of available organs. To this end, public reporting of transplant center outcomes should be modified to reward, rather than to penalize, centers for taking risks on behalf of well-informed patients.
By embracing such changes, the transplant community can turn the political and legal wrongs of the Sarah Murnaghan case into a strong dose of right. Not only would these steps provide more patients with access to life-extending interventions, but by being more proactive the transplant community can protect the system it has worked so hard to build from future judicial intervention.
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Stephen G. Harvey
Pepper Hamilton LLP
June 28, 2013
Conflict of Interest:
Stephen G. Harvey was lead counsel for the plaintiffs in the federal court lawsuits in Philadelphia involving Sarah Murnaghan and Javier Acosta.
A RESPONSE TO CRITICISM OF LEGAL SYSTEM IN PEDIATRIC LUNG ALLOCATION CASES
In his June 25 opinion piece in the Annals of Internal Medicine, Scott D. Halpern, MD, PhD, refers to the temporary restraining orders issued on June 5 and 6 by Judge Michael M. Baylson, a federal judge in Philadelphia, as “a troubling precedent,” “circumvention of due process,” and “legal wrongs.” He says that the TROs suggest “either failure to recognize that preferential treatment for some recipients will adversely affect others (who may not be much older than 12) or that the court considered these 2 children's lives more valuable than others'.”
With all due respect to Dr. Halpern, his assertions are incorrect. I assume that he is aware that a specific federal regulation, a binding law, requires that organs be allocated based on medical urgency, with no exception for children under 12 years old. He may not know that the legal complaint filed on behalf of Sarah Murnaghan and Javier Acosta asked only that they be given access to adult lungs based on the medical urgency of their conditions, and that they sought no special preference. Certainly there was no suggestion made at any time that their lives were more valuable than others. Quite to the contrary, their parents took the position that each life is equally valuable and that Sarah and Javier should be treated equally with persons over 12 absent some compelling reason to do otherwise. They questioned whether there was any compelling reason for treating their children differently from persons 12 and over, when it would likely result in the deaths of both children. As it turned out, we never learned through the legal system whether there is any compelling reason for differential treatment of children in the circumstances of Sarah and Javier – that is, children under 12 who are closer to 12 than infancy and who suffer from fatal diseases that present in children and in adults where their doctors have expressed confidence in a lobar transplant procedure -- because, four days after the second TRO, the Organ Procurement and Transplantation Network authorized the OPTN Lung Review Board to waive the “Under 12 Rule” in certain cases and the Board decided to waive it in Sarah’s and Javier’s case.
We can all agree that organ allocation systems are difficult and that we don’t want to engage in frequent second guessing of the doctors responsible for the organ allocation system. But we do have a legal system that provides for review of OPTN’s policies by the Secretary of Health and Human Services and by a court if necessary. The possibility of baseless claims is not a reason to reject meritorious claims. In this case, the failure of the system to allocate adult lungs to persons under 12 in the circumstances of Sarah and Javier based on the medical urgency allocation principle presented an important legal issue that deserved the attention of a federal court authorized to decide it. There is no question that one or both children could have died before that decision could have been thoughtfully made. Under these circumstances, the court acted appropriately and well within its power to prevent the possible death of two children pending the outcome of the OPTN’s decision.
Scott D. Halpern, MD, PhD
University of Pennsylvania
July 8, 2013
Stephen Harvey raises issue with my characterization of the judicial review process in the cases of Sarah Murnaghan and Javier Acosta due to a specific rule, commonly referred to as the Organ Procurement and Transplantation Network Final Rule (or 42 CFR 121),(1) dictating that medical urgency be a basis for organ allocation. The relevant sections of this rule state that “transplant candidates shall be grouped by status categories ordered from most to least medically urgent,” and that “criteria for status designations shall contain explicit thresholds for differentiating among patients and shall be expressed, to the extent possible, through objective and measurable medical criteria.(1)” Current lung allocation policies in both adults and children meet these criteria. Existing policies categorize children as Priority 1 or Priority 2 based on explicit criteria reflecting medical urgency.
The Final Rule is silent on the question of what, if any, special priority ought to be accorded to patients of different ages. Thus, the fact that the urgency-based prioritization in children differs from the urgency-based prioritization in adults in no way violates the Final Rule. Indeed, the multivariable prediction models included in the Lung Allocation Score (LAS), which gauge both urgency and anticipated benefit in ranking adults on the waitlist, cannot be applied with any confidence or statistical precision to children because the paucity of children requiring lung transplantation led to their exclusion from the development of these complex models.(2) Applying these models to children might therefore cause inequitable prioritization, conflicting with the Final Rule's mandate.
These facts raise serious questions regarding the merits of the case brought by Mr. Harvey. Mr. Harvey is correct that as it happened, the step in the judicial process where the merits of the Murnaghan case would be considered was never reached because Murnaghan was transplanted within the 10-day window of the temporary restraining order. He is also correct that Murnaghan might have suffered irreparable harm without the restraining order. In most legal circumstances, this would make issuance of a restraining order appropriate until the merits could be fully evaluated. However, issuing a restraining order that interferes with national organ allocation policy is very different from nearly all contexts in which restraining orders have been used to date because the order protects one identifiable person while causing direct disadvantage to on one or more other Americans awaiting lung transplantation. This conflict creates unusually broad responsibilities for Judge Baylson in contemplating a restraining order, making him ethically (if not also legally) obliged to give serious consideration to the merits of the claim prior to intervening. Had such prudent steps been taken, it is unlikely that the claims could have been sustained that existing policies violated the Final Rule or discriminated against children. There may indeed be ways to improve upon the existing allocation system, but granting one-off waivers to well-resourced patients and families is not the path to such improvement.
1. Department of Health and Human Services. The Final Rule. Accessed at: http://www.gaonet.gov/special.pubs/organ/appendd.pdf on July 1, 2013.
2. Egan TM, Murray S, Bustami RT, Shearon TH, McCullough KR, Edwards LB, et al. Development of the new lung allocation system in the United States. American Journal of Transplantation. 2006;6(5):1212-27.
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