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US court rules on donor lung allocation
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A court ruling has suspended existing lung allocation rules for a 10-yearold Pennsylvania girl with end-stage cystic fibrosis, shaking the US organ transplantation system. On June 5, Federal District Court Judge Michael Baylson ordered that she and a 10-year-old boy should receive priority for adult-donor lungs based on lung allocation score instead of having to wait for a donation from a child. Days later, she underwent a bilateral lobar transplantation. But to pre-empt further intrusion by the courts, the US Organ Procurement and Transplantation Network/ United Network for Organ Sharing (OPTN/UNOS) executive committee temporarily changed their rules on June 10, allowing hospitals to petition the national lung review board to have a child assigned a second listing and a lung allocation score, providing the child with additional priority for adolescent and adult lungs. That rule will expire on July 1, 2014— time enough, committee members hope, for a more deliberative reconsideration of the data and existing rules. “The clinical experience in the United States has been limited in using adult donor lungs in younger children”, cautioned Joel Newman (UNOS, Richmond, VA, USA). “It remains an individual medical decision by the transplant team.” Allowing courts to change allocation rules is a “dangerous precedent”, said Stuart Sweet (St Louis Children’s Hospital, St Louis, MO, USA), OPTN/ UNOS board secretary. “The worry was if we didn’t do something, the courts would.” A rapid review of available outcomes data did not yield statistically significant differences between children and other recipient age groups, because of small numbers, he said. “Listing practices and disease processes are not identical for children and other patients”, Sweet said. “Our goal will be to keep to a minimum, www.thelancet.com/respiratory Vol 1 July 2013
situations where we recognise a need for improvement and are forced by circumstances to implement change quickly.” The ruling was troubling, agreed Scott Halpern (University of Pennsylvania, Philadelphia, PA, USA). The judge made “a rash decision without having data to understand what the implications would be for other patients on the waiting list”, he said. “This is where politicians and our courts need to remain objective and help all potential patients”, he added. The news media failed as well, Halpern believes. “The media dropped the ball by continually portraying the allocation policy as discriminatory toward the young—when in fact, its presence makes paediatric lung transplantation possible.” Until 2005, patients of all ages were included on a single waiting list, forcing children to compete with adults for donor lung tissue. Now, children, adolescents, and adults are supposed to be prioritised for receipt of lungs from similarly aged donors. However, others think that a reexamination of the existing allocation rules was overdue. “I think this is an opportunity; it’s healthy to re-explore and see if it needs to be modified”, said Charles Burton, president of the Association for Medical Ethics (Monarch Beach, CA, USA). “This ended with a reasonable resolution and I don’t think the integrity of the US allocation is threatened”, said Arthur Caplan (Langone Medical Center, New York University, New York, NY, USA). “OPTN looked at the data, changed their approach and will take each case of a child under 12 and allow them to appeal to be put in the adult lung pool.” Because of the small numbers of patients involved, there is simply “not enough solid evidence to back up a rigid, unappealable rule”, Caplan said.
Cystic fibrosis is not cured by lung transplantation, Caplan was quick to add. “The 6-year overall survival rate is about 50%. It’s a tough organ to transplant.” Damage done to other organs by underlying pulmonary diseases such as emphysema and cystic fibrosis are not reversed by lung transplantation. And immunosuppression is a more serious concern among lung transplant recipients than patients who receive other organs. Ultimately, the root problem is the scarcity of donors. “Lungs are hard to come by and are very frail”, Caplan said. They’re frequently damaged by lethal trauma or during procurement. Public reporting of transplantation centre outcomes compounds the problem, leaving facilities less willing to work with damaged lung tissue from donors, Halpern noted. “When the public has the ability to evaluate centres on the proportion of patients alive a year after transplantation, that creates a disincentive for centres to take lungs that are anything but perfect”, he explained. More transplantation centres should “get up to speed on the unique logistical and technical challenges of using lungs from cardiac-death donors”, Halpern said. “There’s tremendous opportunity for improvement at intensive care units at identifying potential donors after cardiac death.” Caplan agrees. But he also advocates a policy change to default donation—a presumption of donor consent. Austria, Belgium, Poland, and Spain have such opt-out organ donation policies, he noted. In the USA, state lawmakers in New York, Colorado, and Delaware have introduced similar legislation, but all three bills died in committee. At present, more than 1500 US adults and 70 children and adolescents (31 younger than age 11 years) are awaiting donor lung transplantations.
Michelle Del Guercio/Science Photo Library
US court rules on donor lung allocation
Published Online June 24, 2013 http://dx.doi.org/10.1016/ S2213-2600(13)70082-1 See Spotlight page 368 For more on lung transplantation see Review Lancet Respir Med 2013; 1: 318–28 For more on the OPTN/UNOS executive committee’s temporary rule change see http://optn.transplant.hrsa.gov/ news/newsDetail.asp?id=1598
Bryant Furlow 363
A court ruling has suspended existing lung allocation rules for a 10-yearold Pennsylvania girl with end-stage cystic fibrosis, shaking the US organ transplantation system. On June 5, Federal District Court Judge Michael Baylson ordered that she and a 10-year-old boy should receive priority for adult-donor lungs based on lung allocation score instead of having to wait for a donation from a child. Days later, she underwent a bilateral lobar transplantation. But to pre-empt further intrusion by the courts, the US Organ Procurement and Transplantation Network/ United Network for Organ Sharing (OPTN/UNOS) executive committee temporarily changed their rules on June 10, allowing hospitals to petition the national lung review board to have a child assigned a second listing and a lung allocation score, providing the child with additional priority for adolescent and adult lungs. That rule will expire on July 1, 2014— time enough, committee members hope, for a more deliberative reconsideration of the data and existing rules. “The clinical experience in the United States has been limited in using adult donor lungs in younger children”, cautioned Joel Newman (UNOS, Richmond, VA, USA). “It remains an individual medical decision by the transplant team.” Allowing courts to change allocation rules is a “dangerous precedent”, said Stuart Sweet (St Louis Children’s Hospital, St Louis, MO, USA), OPTN/ UNOS board secretary. “The worry was if we didn’t do something, the courts would.” A rapid review of available outcomes data did not yield statistically significant differences between children and other recipient age groups, because of small numbers, he said. “Listing practices and disease processes are not identical for children and other patients”, Sweet said. “Our goal will be to keep to a minimum, www.thelancet.com/respiratory Vol 1 July 2013
situations where we recognise a need for improvement and are forced by circumstances to implement change quickly.” The ruling was troubling, agreed Scott Halpern (University of Pennsylvania, Philadelphia, PA, USA). The judge made “a rash decision without having data to understand what the implications would be for other patients on the waiting list”, he said. “This is where politicians and our courts need to remain objective and help all potential patients”, he added. The news media failed as well, Halpern believes. “The media dropped the ball by continually portraying the allocation policy as discriminatory toward the young—when in fact, its presence makes paediatric lung transplantation possible.” Until 2005, patients of all ages were included on a single waiting list, forcing children to compete with adults for donor lung tissue. Now, children, adolescents, and adults are supposed to be prioritised for receipt of lungs from similarly aged donors. However, others think that a reexamination of the existing allocation rules was overdue. “I think this is an opportunity; it’s healthy to re-explore and see if it needs to be modified”, said Charles Burton, president of the Association for Medical Ethics (Monarch Beach, CA, USA). “This ended with a reasonable resolution and I don’t think the integrity of the US allocation is threatened”, said Arthur Caplan (Langone Medical Center, New York University, New York, NY, USA). “OPTN looked at the data, changed their approach and will take each case of a child under 12 and allow them to appeal to be put in the adult lung pool.” Because of the small numbers of patients involved, there is simply “not enough solid evidence to back up a rigid, unappealable rule”, Caplan said.
Cystic fibrosis is not cured by lung transplantation, Caplan was quick to add. “The 6-year overall survival rate is about 50%. It’s a tough organ to transplant.” Damage done to other organs by underlying pulmonary diseases such as emphysema and cystic fibrosis are not reversed by lung transplantation. And immunosuppression is a more serious concern among lung transplant recipients than patients who receive other organs. Ultimately, the root problem is the scarcity of donors. “Lungs are hard to come by and are very frail”, Caplan said. They’re frequently damaged by lethal trauma or during procurement. Public reporting of transplantation centre outcomes compounds the problem, leaving facilities less willing to work with damaged lung tissue from donors, Halpern noted. “When the public has the ability to evaluate centres on the proportion of patients alive a year after transplantation, that creates a disincentive for centres to take lungs that are anything but perfect”, he explained. More transplantation centres should “get up to speed on the unique logistical and technical challenges of using lungs from cardiac-death donors”, Halpern said. “There’s tremendous opportunity for improvement at intensive care units at identifying potential donors after cardiac death.” Caplan agrees. But he also advocates a policy change to default donation—a presumption of donor consent. Austria, Belgium, Poland, and Spain have such opt-out organ donation policies, he noted. In the USA, state lawmakers in New York, Colorado, and Delaware have introduced similar legislation, but all three bills died in committee. At present, more than 1500 US adults and 70 children and adolescents (31 younger than age 11 years) are awaiting donor lung transplantations.
Michelle Del Guercio/Science Photo Library
US court rules on donor lung allocation
Published Online June 24, 2013 http://dx.doi.org/10.1016/ S2213-2600(13)70082-1 See Spotlight page 368 For more on lung transplantation see Review Lancet Respir Med 2013; 1: 318–28 For more on the OPTN/UNOS executive committee’s temporary rule change see http://optn.transplant.hrsa.gov/ news/newsDetail.asp?id=1598
Bryant Furlow 363