Implications in Challenging the OPTN
Part Two of a Three-Part Series
Last week, in my very first Presidential blog post, I urged us to consider the implications of the message, "it's organ donation stupid." Supply falls short of demand. There are not enough organs to save every patient who needs one to survive. Yet despite the OPTN's system to regulate the allocation of organs, issues arise that publically contest the system. And the most recent issue became my first challenge as President of the Society.
A few weeks ago our nation took notice of a 10-year old girl with cystic fibrosis, Sarah Murnaghan, who had been denied access to adult lung transplant donors simply as a result of her age based on OPTN lung allocation rules. If she were 12 years old, she may have been at or near the top of the adult lung transplant list. As you know, the girl's family challenged the rules and petitioned both the courts and U.S. Secretary of Health and Human Services (HHS), Kathleen Sebelius, to exercise her authority under the law to mandate a variance and allow the lung transplant to go forward. In their initial response, the OPTN stated that it "cannot create a policy exemption on behalf of an individual patient, since giving an advantage to one patient may unduly disadvantage others." Several noted medical ethicists supported that position, but we all realized that this was a very challenging and complicated situation. Ultimately, a Federal judge agreed with the family, took the decision out of the hands of the OPTN and issued a court ruling instructing Secretary Sebelius to direct the OPTN to cease application of the under 12 age rule.
The U.S. House of Representatives also became involved. The Republican Physicians Caucus sent a letter to HHS Secretary Sebelius requesting that she "exercise (her) existing authority pursuant to Section 121.4(d) of the OPTN regulations to suspend policies under review when there is 'risk to the health of patients or public safety.'" The letter further stated, "We believe the current OPTN age policies are discriminatory and as physicians, they pose a risk to health and safety of children." In response, Secretary Sebelius has called for the OPTN to review its policies surrounding lung allocation and availability of organs to children.
The entire issue rapidly evolved into a major legal and public political event. And in the process, the underlying and very real transplantation issues were colored by current partisan Washington politics over Federal oversight and regulations.
The first challenge for me as President of the AST was to consider how to constructively respond as the crisis evolved. First and foremost, as individuals and as an organization, the AST recognizes the difficult situation that the family and the patient were facing. Their passion, advocacy and calls for a rule change are respected and understandable. Indeed, our democratic process guarantees these remedies. On the other hand, the AST also strongly supports the current OPTN system and the critical importance of the expert process of formulating and constantly reviewing policies that is federally mandated by NOTA. Ultimately, the patient received her lung transplant - a wonderful result for this particular patient. But many questions still remain, not the least of which is how to maintain the operational integrity of our current process of OPTN rule making. We all understand it is not a perfect process, but I sincerely admire the professionalism, dedication and immense amount of work done by all those that engage in this process. I honestly do not see how our patients would be better served by having government regulators, Federal judges, or politicians taking the process over now and certainly not in case-by-case dramas in the public media.
However, in thinking about other ways for the AST to contribute, I keep going back to the one thing that could address all of these issues and make it unnecessary for rules and restrictions that prevent some from receiving a lifesaving donor organ: "it's donation stupid." The AST and ASTS have stated the rationale simply: "No policy can guarantee that all patients receive donated organs when the rate of organ donation does not match the number of patients who desperately need this life-saving treatment." At the time of Sarah's lung transplant there were 118,023 candidates awaiting an organ transplant... with 1,628 of those candidates awaiting a lung transplant.
I have spent some time contemplating the primary ways that AST can begin exploring to move this issue forward and will discuss them in the next blog post. Be sure to watch out for the post next week and I encourage you to weigh in with comments below.