Right to try, right to buy, right to test
(Dr. Sally Satel, who has guest-blogged here before, was kind enough to write up this item on a topic that has long interested me; I'm delighted to pass it along: -EV)
In 2007, Eugene Volokh, the host of this site, published an essay in the Harvard Law Review titled "Medical Self-Defense, Prohibited Experimental Therapies, and Payment for Organs" in which he argued that the government should need "a very good reason" to prevent sick people from saving their own lives.
That insight impels the Right to Try movement, which seeks to give terminally ill patients the right to try drugs that show promise but not have received FDA approval and which has received sympathetic hearings from President Trump and Vice President Pence. One of the leaders of Right to Try reform, the libertarian Goldwater Institute, said it best: "We just fundamentally do not believe that you should have to apply to the government for permission to try to save your own life."
That principle has vital implications for patients needing bone marrow and kidney transplants.
Each year, 2,000 to 3,000 individuals with leukemia and other forms of bone marrow disease die while waiting to receive another person's bone marrow cells. It's not that strangers are indifferent to their plight, but that suitable biological matches are hard to find. And even when a match is found, there is a 1-in-2 chance that the needle-in-a-haystack donor either can't be located by registry personnel or, incomprehensibly, refuses to donate even though he had earlier volunteered to be tested.
We can enlarge the pool of potential donors while increasing the likelihood that compatible donors will follow through if they are paid—or if sick patients (or charities acting on their behalf) have the Right to Buy, as I call it.
But there is an obstacle to buying. The 1984 National Organ Transplant Act, or NOTA, bans exchange of "valuable consideration"—that is, anything of material worth—for solid organs, such as kidneys and livers, as well as for bone marrow.
The Institute for Justice, a libertarian public-interest law firm, fought the prohibition. It sued the Justice Department on behalf of families afraid their ill loved ones would die because they couldn't get a bone marrow transplant.
In a unanimous 2012 ruling, a three-judge panel of the U.S. Court of Appeals for the 9th Circuit rejected the federal government's argument that obtaining bone-marrow stem cells through a needle in a donor's arm violates NOTA. The judges based their decision on the fact that modern bone-marrow procurement, a process known as apheresis, is akin to drawing blood. Indeed, filtered stem cells, they held, are merely components of blood, no different from blood-derived plasma, platelets and clotting factors, all of which are replenished by the body within weeks of a donation. Because it's legal to compensate blood donors, it's also legal to pay bone marrow donors, the court ruled.
Unfortunately, the Department of Health and Human Services rejected the court's ruling. In 2013, it proposed a rule that would extend the NOTA prohibition to bone marrow stem cells. Under the proposed regulation, anyone who accepted material gain for giving bone-marrow stem cells would be subject to NOTA's penalties, facing imprisonment for up to five years. According to HHS, compensation runs afoul of NOTA's "intent to ban commodification of human stem cells" and to "curb opportunities for coercion and exploitation, encourage altruistic donation and decrease the likelihood of disease transmission."
The solicitor general could have asked the Supreme Court to review the 9th Circuit's bone-marrow decision, but he declined. Perhaps he grasped the central folly of HHS's position: How could the agency justify its worry about "opportunities for coercion and exploitation" and the "likelihood of disease transmission" when it came to bone marrow cells, yet not apply those same concerns to plasma?
For three years, HHS has been silent on its proposed rule. Meanwhile, people are dying because nonprofits that want to begin paying donors on behalf of needy patients can't move forward until they are assured that the agency can't shut them down. The Institute for Justice is considering a legal challenge over the HHS delay, which is causing needless deaths.
But perhaps the lawsuit can wait. With a new administration that is skeptical of overregulation, HHS Secretary Tom Price could withdraw the proposed rule. Ideally, Congress would thwart future regulatory blockades by amending NOTA to stipulate that marrow stem cells are not organs covered by the act.
Changes to NOTA should also be made for other organs. I feel strongly about this on fundamental grounds of liberty but also because, in 2005, I needed to save my own life. I developed kidney failure but could not find a donor. Thank goodness, an angel, or as some readers know her, Virginia Postrel, heard about my predicament and gave me a kidney. And this summer another living saint, Kimberly Hendrickson, who saw how desperate I was many years ago, offered me one of hers when the first transplant began to fail. Every day, 12 people die because no one was able to come to their rescue and, had a patient offered money for an organ, both the patient and the donor who accepted the money would face felony charges.
Congress could take the bold step of revising NOTA to permit donors who are willing to save the life of a stranger through kidney donation to receive valuable consideration from governments or nonprofit organizations. Or, lawmakers could take the intermediate step of creating a pilot program allowing doctors to study the effect of such measures, as proposed last May by Rep. Matthew Cartwright (D-Pa.), who introduced the Organ Donor Clarification Act of 2016.
Rather than large sums of cash, potential rewards could include a contribution to the donor's retirement fund, an income tax credit or a tuition voucher, lifetime health insurance, a contribution to a charity of the donor's choice, or loan forgiveness. Only the government, or a government-designated charity, would be allowed to disburse the rewards. Consequently, all patients, not just those with financial means, could benefit. The funds could potentially come from the savings from stopping dialysis, which costs roughly $80,000 a year per person.
The pilot programs, to be designed by individual medical centers, could also impose a waiting period on prospective donors, thereby cooling any impulsivity. Prospective donors would be fully informed about the risks of surgery and carefully screened for physical and emotional health, as all non-compensated kidney donors are now.
The idea of the government standing between a dying person and his salvation is deeply troubling. I know. We need to at least test better ways to recruit more marrow and kidney donors.
Dr. Sally Satel is a resident scholar at the American Enterprise Institute and editor of "When Altruism isn't Enough: The Case for Compensating Kidney Donors."