Girl Prompts Small Change to Organ Transplant Policy

June 11, 2013— -- The Organ Procurement and Transplantation Network voted to keep the so-called Under 12 Rule, but it created a mechanism that would allow doctors to request exceptions for their pediatric patients. A national lung review board would then approve these children for transplant consideration as adults case by case.

The transplant network convened an emergency meeting of its executive committee to evaluate the Under 12 Rule, a little-known organ transplant policy that a Pennsylvania couple brought to national attention after arguing that it had been pushing their dying 10-year-old to the bottom of the adult lung transplant waiting list.

Lawyers for Sarah Murnaghan, who is dying of cystic fibrosis, convinced federal Judge Michael Baylson on June 5 that the Under 12 Rule was discriminatory, prompting a temporary restraining order against Health and Human Services Secretary Kathleen Sebelius to prevent her from enforcing it for Sarah.

Read about the Murnaghans' battle to save Sarah.

Baylson's ruling forced OPTN to create a second database entry for Sarah with a fake birthday to trick the organ transplant system into thinking she was 12. The following day, another child in Sarah's hospital, Javier Acosta, 11, won the same reprieve.

Read about how Javier's brother died waiting for a lung transplant when he was 11.

But the OPTN decision doesn't mean Sarah's and Javier's cases need to go before a national lung review board immediately to keep their transplant database entries in the system. Since the courts forced OPTN to create these entries, a hearing scheduled for June 14 will determine whether they can stay where they are on the list or whether their cases need to be evaluated by the review board.

Sarah's mother, Janet Murnaghan, took to Facebook following OPTN's decision.

"We consider this a tremendous win for Sarah and all kids waiting for lungs!!!" she wrote. "I hope Sarah's story moves people to become organ donors, because more than any ruling it is the heroes who donate their organs that save lives."

Part of the OPTN meeting, which convened via teleconference, was dedicated to the ethics of judicial intervention in organ allocation and the fear that transplant candidates would sue to increase their likelihoods of getting the organs they need.

"Politicians and judges who intervene in a complex allocation algorithm may be well-intentioned but fail to consider all the moral variables that must be balanced at the macro level rather than through an individual candidate's experience," the OPTN ethics committee concluded. "The message that lawsuits are a mechanism for more favorable organ allocation runs the risk of disrupting a stable system based on public trust. For patients waiting for transplantation, the resulting lack of predictability may have unintended and lethal consequences."

Several medical, legal and health experts had condemned Baylson's ruling before the OPTN decision, arguing that existing lung allocation practices –- including the Under 12 Rule -- are based on medical evidence, and that allowing Sarah and Javier to be given special priority without OPTN approval was unfair to other candidates on the list.

"It is unlikely that the courts are the best place to make these decisions," said R. Alta Charo, a law and bioethics professor at the University of Wisconsin-Madison. "The reasons for giving priority to one category of patients over another are usually due to a complicated combination of factors."

Charo said she had not heard of any other court rulings overriding an OPTN decision, but she hoped Baylson's ruling would not set a precedent. (Courts have intervened in medical decision-making before, Charo said, citing the Terri Schiavo case in which doctors, lawyers and family members battled for more than a decade over whether to remove Schiavo's feeding tube and let her die.)

A joint statement by the American Society of Transplant Surgeons and the American Society of Transplantation last week said that the existing policy was formulated from the best information available, and to change or obfuscate it would be "unwise" without the calculative approach mandated in the National Organ Transplantation Act.

As it stands now, lung transplant candidates older than 12 are assigned a lung allocation score, or LAS, based on a complex mathematical formula that includes the patient's age and size. For transplant patients younger than 12 -- of which there are 20 nationally compared with about 1,600 adults -- the LAS is not used. Instead, patients are broken into "priority 1" and "priority 2." It's this difference that has been called discriminatory in court.

"I don't think that it's reasonable to call them discriminatory if they're established based on medically relevant facts," said Dr. Margaret Moon, a pediatrician and bioethicist at Johns Hopkins Berman Institute of Bioethics. "We can't ask the judge, and we can't ask Congress to determine medical facts."

Children get priority for lungs donated from children younger than 12, but they have to wait for children between 12 and 17 to decline lungs donated from 12- to 17-year-olds before they get a chance at them. Lungs donated by anyone older than 18 are offered to all candidates older than 12, depending on their LAS. Only if all local matching candidates 12 and older decline the adult lungs can they be offered to children within 500 miles of the hospital where the lungs were harvested.

Since Sarah and Javier now have two transplant database records -- one with their actual birthdays and one with fake 12-year-old birthdays -- they can be considered for child lungs based on their priority level and adult lungs based on their LAS.

OPTN's rule amendment provides for this dual consideration to be available to children who have been approved for an exception to the Under 12 Rule by a national lung review board. The amendment takes effect immediately, but it expires on July 1, 2014, when OPTN can re-evaluate it.

Moon said she supports the decision to take another look at the Under 12 Rule, but that an adult lung transplant would likely do Sarah and Javier more harm than good.

Dr. David Cronin, a transplant surgeon at the Medical College of Wisconsin in Milwaukee, said most adult donor organs are not suitable for child recipients. Resized lung transplants -- called lobe transplants -- are not commonly performed on children.

"Is this prolonging [Sarah's] suffering in a way that's dangerous?" Moon asked.

Cronin said he "totally" disagreed with Baylson's ruling.

"The allocation system is transparent, equitable, fair and represents evidence-based medicine," Cronin said. "We have come a long way in fine-tuning the system and improving access and equity."

Moon said the children's parents can't be faulted for fighting the organ allocation system, because it's their job to put their children first. Even though Moon is a pediatrician, she said she takes her children to another doctor when they're sick because she can't be objective about their medical care.

"How is that helping?" she asked of granting a potentially harmful lung transplant to a child. "Is that medicine or is that just acquiescing to a parent's anxiety? It's a harsh thing to say, but parents don't get to drive medical choices for that reason."