SEARCH

SEARCH BY CITATION

News and issues that affect organ and tissue transplantation

Two Children Added to Adult Lung Transplant Waitlist

Case captures national spotlight as judge overrules transplant policy

In a case that captured national attention this spring, a lawsuit and subsequent ruling by a district court judge resulted in two pediatric patients receiving increased priority for lungs from adolescent and adult donors.

“What these cases have done, in terms of the judge intervening, is threaten the integrity of the OPTN [Organ Procurement and Transplantation Network] distribution system,” says bioethicist Arthur Caplan, MD, director, division of medical ethics at New York University Langone Medical Center in New York City.

While Dr. Caplan and other critics loudly argued that the courts have no business interfering in organ transplant policy, the Executive Committee of the OPTN/United Network for Organ Sharing (UNOS) met in an emergency session June 10, 2013 to approve a revision to national lung allocation policy affecting transplant candidates aged 11 or younger. The change keeps decision-making in the hands of doctors, rather than the courts, by providing a mechanism by which lung transplant programs can request additional priority for these young lung transplant patients, for whom the transplant team would consider transplanting lungs from an adolescent or adult donor. The policy would expire on July 1, 2014, pending reconsideration by the full OPTN/UNOS board of directors and additional study and recommendations.

The current lung allocation policy gives children aged 11 and younger first priority for organs from donors aged 11 and younger, and gives patients aged 12 and older priority for adolescent or adult lungs. Since 2007, there has been only one case of a transplant from a donor older than age 18 to a recipient younger than 12. On June 12, following the district court ruling, 10-year-old Sarah Murnaghan of Pennsylvania—one of the patients at the center of the lawsuit—received a lung transplant from an adult donor.

OPTN/UNOS Committees Respond

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference

The legal case began in June when the families of Murnaghan and 11-year-old Javier Acosta of New York hired attorney Stephen Harvey. At first, the families and their lawyer appealed to U.S. Department of Health and Human Services (HSS) Secretary Kathleen Sebelius, who refused to intervene in the lung transplant allocation, but requested that OPTN conduct a review of the lung allocation policy. Harvey then filed a lawsuit in Federal District Court, where Judge Michael M. Baylson ordered HHS to put both Murnaghan and Acosta on the adolescent/adult waiting list.

In a report to the OPTN/UNOS Executive Committee, Stuart Sweet, MD, PhD, director of the Pediatric Lung Transplant Program at Washington University in St. Louis, said that the avalanche of publicity and the judicial ruling has put the U.S. transplant system at risk. “We cannot undo the dangerous precedents set by the judiciary as a result of this case, but we can take steps to ensure that the next time this question arises the case can be heard in a more appropriate venue.”

KEY POINTS

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference
  • A district court judge ordered that two children on the pediatric lung transplant waitlist be added to the adult waiting list, overruling OPTN policy.
  • OPTN/UNOS met in an emergency session to approve a revision to lung allocation policy that would allow transplant programs to request additional priority for specific young patients.

Also commenting to the Executive Committee on the lung allocation policy were the OPTN/UNOS Thoracic Organ Transplantation and Pediatric Transplant Committees and the Ethics Committee. Representing the thoracic and pediatrics committees, Steven A. Weber, MBChB, said, “The data show that the waitlist mortality for children is not significantly higher than it is for adults waiting for lungs.” The committees “concluded that this was not an appropriate solution to implement on an urgent basis outside of standard policy development processes, and that potentially unintended consequences to other candidate groups awaiting lung transplantation would need to be carefully reviewed.”

The Ethics Committee noted that “the circumvention of organ allocation through judicial appeals or other mechanisms is likely to undermine the main ethical directive of an equitable allocation system to maximize the public good and achieve justice.”

Does the Policy Discriminate?

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference

“That a federal judge intervened in this case because of the emotionally compelling stories of two suffering children is just incorrect,” says nephrologist Benjamin E. Hippen, MD, clinical associate professor in the department of medicine, University of North Carolina, Charlotte. “The salient issue is whether or not the current allocation system discriminates against a subset of patients based on age. The existing evidence does not support age alone as a suitable variable for predicting clinical outcomes, and therefore a straightforward age cutoff for allocation purposes may not be appropriate.”

Dr. Hippen cites the pediatric and thoracic committees, which said there was no finding of a systematic, disproportional, imminent threat to pediatric lung candidates by the current lung allocation policy. “In the context of very low numbers, finding a systematic, disproportional, imminent threat to pediatric lung candidates is a nearly unachievable standard of proof, and certainly so if statistical significance is the bar to be met here,” Dr. Hippen says. “The current system does not permit consideration of individual candidates for inclusion in the LAS [lung allocation score] for purposes of allocating a very small number of patients who might otherwise be clinically similar, and this may be reasonably assumed to have outcomes similar to 12-year-old candidates. The policy change approved by the OPTN/UNOS Executive Committee fixes that deficiency.”

Additional Lawsuits

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference

“There's always a danger that others will watch this, think that they are being treated unfairly, and file a lawsuit,” Dr. Caplan says. “This is the worst possible outcome. It would destroy the system. Hopefully, by building this small path for appeals, you can stave, off the. resort to the courts.”

Dr. Sweet says, “It is impossible to predict the future. One of the main reasons this case was so difficult is that we had no mechanism in policy for a review board to hear the center's appeal on behalf of the patient. The federal court chose to hear that appeal instead. In response, we put in place such a review path. I anticipate that the OPTN will review all of its policies looking for similar areas where an appeal process might be helpful. But it is difficult to anticipate all potential challenges to the fairness of the system, and the precedent set by the federal court in this instance will not go away.”

“We cannot undo the dangerous precedents set by the judiciary as a result of this case, but we can take steps to ensure that the next time this question arises the case can be heard in a more appropriate venue.”

—Stuart Sweet, MD, PhD

New Guideline for Disease Transmission Includes Hepatitis

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference

This summer, the U.S. Department of Health and Human Services (HHS) released a new guideline designed to improve safety in organ transplantation with major changes from previous U.S. Public Health Service (PHS) guidelines including:

  • Screening donors for hepatitis B virus (HBV) and hepatitis C virus (HCV), in addition to screening for human immuno deficiency virus;
  • Using new, more sensitive laboratory testing;
  • Using a revised set of risk factors with updated information.[1]

To update the guidelines, the Centers for Disease Control and Prevention (CDC) led an HHS workgroup consisting of experts on evidence-based guidelines and a multidisciplinary group that included transplant and infection prevention experts. Representatives from the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) were among those consulted.

“ASTS shares the PHS commitment to two overarching principles,” says AlanLangnas, DO, president of ASTS. “We want to minimize unanticipated transmission of diseases through transplantation. But at the same time, and this is the challenge, [we want] to be sure the guidelines do not exacerbate the terrible shortage of organs for transplantation.”

To begin this process, he says, it's important to identify what the problem is. “The actual numbers of diseases that have been transmitted to patients in the 19 years since the initial guidelines is remarkably low. If we're going to create new guidelines, they need to be appropriate to the current identifiable problem. So it's not clear what the net benefit would be to transplant recipients.”

More Sensitive Tests, Such as NAT

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference

“The tension that we recognize is that one has to have a balanced view of risk in order to understand how transplantation really works,” says Daniel Salomon, MD, president of AST. “There is a risk of creating a sense that ‘x’ amount of testing has to be done before we can take any donor. The end result may be losing otherwise perfectly good donor organs.”

While noting that nucleic acid testing (NAT) is sensitive and rapid, and has been successfully implemented for infectious diseases, both presidents note that NAT is expensive and time consuming and can be associated with false positives. “If you want to do this on every patient, then it becomes an issue,” says Dr. Langnas. “While NAT can be reassuring when there is a known high-risk donor, we've also experienced failure of the test, requiring the lab to repeat, leading to hours of delay.”

Critical Implementation Process Begins

  1. Top of page
  2. OPTN/UNOS Committees Respond
  3. KEY POINTS
  4. Does the Policy Discriminate?
  5. Additional Lawsuits
  6. New Guideline for Disease Transmission Includes Hepatitis
  7. More Sensitive Tests, Such as NAT
  8. Critical Implementation Process Begins
  9. Reference

“AST would point out that the guidelines, in the legal framework of federal law, are guidelines, not regulations,” says Dr. Salomon. “Therefore, a critical step in going from guidelines to practice is the final certification and implementation by UNOS in a process involving the Disease Transmission Advisory Committee (DTAC). Both AST and ASTS will work with the DTAC in the implementation phase, which we feel is critical.”

Because organ donation is so dependent on an efficient process that is impacted by time, “there a re real concerns that in the implementation phase we need to be careful that we don't do anything that will significantly diminish the number of available organs,” says Dr. Salomon. “These are the kinds of questions that the AST and ASTS will work on with UNOS during the implementation phase.”

“At its core, I would say our two major concerns with the final document remain the same as they were two years ago,” says Dr. Langnas. “We don't believe that the PHS was able to balance the issue of disease transmission with preserving access to organs for transplantation. I think the guidelines fail to address how this will impact the supply of organs. That's our big disappointment. We have worked very hard in a partnership, but at the end of the day, I think we were unable to come to a strong agreement.” AJT