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Two years ago, Doreen Flynn of Lewiston, Maine, won her case against the U.S. government, successfully arguing that bone-marrow donors should be able to receive compensation.
Flynn, a mother of three girls who are afflicted with a rare, hereditary blood disease called Fanconi’s anemia, has a strong interest in bone-marrow transplantation. At the time of the court ruling, her oldest daughter, Jordan, 14, had already received a transplant, and one of the younger twins, Jorja, was expected to need one in a few years.
Locating a marrow donor is often a needle-in-a-haystack affair. The odds that two random individuals will have the same tissue type are less than 1 in 10,000, and the chances are much lower for blacks. Among the precious few potential donors who are matched, nearly half don’t follow through with the actual donation. Too often, patients don’t survive the time it takes to hunt for another donor.
Allowing compensation for donations could enlarge the pool of potential donors and increase the likelihood that compatible donors will follow through. So the ruling by a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit was promising news for the 12,000 people with cancer and blood diseases currently looking for a marrow donor. (James F. Childress, an ethicist at the University of Virginia, and I submitted an amicus brief in the case.)
Soon after the verdict, Shaka Mitchell, a lawyer in Nashville, Tennessee, and co-founder of the nonprofit MoreMarrowDonors.org, began collecting funds to underwrite $3,000 donor benefits, which were to be given as scholarships, housing allowances or gifts to charity.
Mitchell also invited a team of economists to evaluate the effects of the ruling on people’s willingness to join a registry and to donate when they are found to be a match. The researchers were to specifically assess whether cash payments would be any more or less persuasive than noncash rewards or charitable donations.
Now comes the bad news. On Oct. 2, the U.S. Department of Health and Human Services proposed a new rule that would overturn the Ninth Circuit’s decision. The government proposes designating a specific form of bone marrow — circulating bone-marrow stem cells derived from blood — as a kind of donation that, under the 1984 National Organ Transplant Act, cannot be compensated. If this rule goes into effect (the public comment period ends today), anyone who pays another person for donating these cells would be subject to as much as five years in prison and a $50,000 fine.
The problem with this rule is that donating bone marrow is not like donating an essential organ. Indeed, the Ninth Circuit based its decision on the fact that modern bone-marrow procurement, a process known as apheresis, is more akin to drawing blood. In the early 1980s, when the transplant act was written, the process was more demanding, involving anesthesia and the use of large, hollow needles to extract marrow from a donor’s hip. But today, more than two-thirds of marrow donations are done via apheresis. Blood is taken from a donor’s arm, the bone-marrow stem cells are filtered out, and the blood is then returned to the donor through a needle in the other arm.
The Ninth Circuit panel held that these filtered stem cells are merely components of blood — no different from blood-derived plasma, platelets and clotting factors, for which donor compensation is allowed.
The strongest opposition to compensation comes from the National Marrow Donor Program, the Minneapolis-based nonprofit that maintains the nation’s largest donor registry. Michael Boo, the program’s chief strategy officer, says of reimbursement, “Is that what we want people to be motivated by?”
The problem with this logic is that altruism has proven insufficient to motivate enough people to give marrow and, as a result, people die.
HHS is presumably under pressure from the National Marrow Donor Program. The department does not otherwise explain its proposed rule except to claim that compensation runs afoul of the transplant act’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.”
But how could such concerns plausibly apply to marrow stem cells and not to blood plasma? The process of collecting plasma is safe: No serious infection has been transmitted in plasma-derived products in nearly two decades, according to the Plasma Protein Therapeutics Association. Strenuous screening and testing in a robust regulatory environment, coupled with voluntary industry standards and sophisticated manufacturing processes, have created what has been called the “safest blood product” available today.
Outlawing compensation for stem blood cells but not mature blood cells might even violate the constitutional guarantee of equal protection of the law, according to Jeff Rowes, a lawyer at the Institute for Justice, which represented Flynn.
HHS should withdraw its proposal. Ideally, Congress should thwart future regulatory mischief by amending the National Organ Transplant Act to stipulate that marrow stem cells are not organs.
Each year, 2,000 to 3,000 Americans in need of marrow transplants die waiting for a match. Altruism is a virtue, but clearly it is not a dependable motive for marrow donation.
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