Arlington, Va.—On Tuesday, August 1, the U.S. Department of Health and Human Services (HHS) withdrew an unpopular rule proposed by the Obama Administration that would have barred compensation for donors of blood stem cells, commonly known as bone marrow. This action now clears the way for researchers and entrepreneurs to create programs to determine whether offering modest compensation for blood stem cell donors will encourage more people to sign up as donors and to actually donate when called upon. If successful, these model programs could end the chronic shortage of bone marrow that costs thousands of Americans their lives every year.
In 2012, the Institute for Justice won a federal court victory in Flynn v. Holder against the U.S. Attorney General on behalf of cancer patients across the nation, clearing the way for compensating those who donate blood stem cells through a process called apheresis. More than two-thirds of bone marrow donations are no longer done through an uncomfortable procedure in which bone marrow is extracted from the hip using a large needle. Rather, approximately 70 percent of all bone marrow transplants are now done through a far-less painful and now very common process called apheresis, which is more like donating blood. Through apheresis, bone marrow donors are given a series of shots that prompts their bone marrow to overproduce blood stem cells, which then circulate in the bloodstream. Whole blood is taken out of one arm, the blood stem cells are extracted, and then the remaining blood is returned to the donor in the other arm. The donated blood stem cells quickly regenerate, leaving the donor whole.
In 2013, however, the Obama Administration’s HHS proposed a rule barring such compensation and opened the question up to comment by the public. Typically, such opportunities to comment attract perhaps a dozen responses; this proposed change generated more than 500 comments overwhelmingly opposed to HHS’s ban. Among the many individuals and groups who comment against the ban were two Nobel Laureates in Economics: Daniel McFadden and Al Roth.
The proposed rule was unconstitutional. Jeff Rowes, a senior attorney with the Institute for Justice, said, “Under the proposed rule, HHS sought to do something Congress never authorized it to do: define loose cells floating in the body, such as blood stem cells, as a ‘human organ’ when such cells are not in fact a human organ. HHS does not have the power to make false things true by regulation. If loose cells were an organ, the National Organ Transplant Act would prohibit paying people for platelets or sperm or eggs, all of which is now allowed. Agencies like HHS lack the power to redefine words in order to grant themselves more authority.”
Even if HHS had the power to declare blood stem cells to be an organ, the rule still would have been unconstitutional because such a ban would be irrational. Under the HHS rule, it would have been legal to compensate a donor for providing lifesaving whole blood, providing just red blood cells or providing just plasma. It also would have been legal to compensate a blood stem cell donor if the cells are going to be used for research. It also would have been legal to compensate an entity—such as a registry—for providing blood stem cells that come from someone else. It only would have been illegal to compensate a donor if he or she donates blood stem cells and those cells are going to be used for transplantation into a dying patient.
“It is irrational for the government to criminalize the sale of only one particular kind of blood cell, to criminalize that sale only when the cells will be immediately used to save a human life, and to criminalize that sale only when the seller is the original donor of the cells,” said IJ Senior Attorney Bob McNamara.
“Banning compensation for donors would have eliminated the best incentive we have—money—for persuading strangers to work for each other,” Rowes said. “Predictably, the ban on compensation for blood stem cell donors created chronic shortages and waiting lists. During the past four years, thousands of Americans needlessly died because compensation for bone marrow donors was unavailable. We aim to change that.”
Compensating bone marrow donors holds the power to eliminate America’s chronic shortage of bone marrow, just as compensating plasma donors has allowed America to be the world’s largest plasma exporter. Just as with other medical donations, bone marrow would go through rigorous testing to ensure it is safe. At any given time, more than 11,000 Americans are actively searching for a bone marrow donor. According to the New England Journal of Medicine, Caucasian potential donors are available and willing to donate about 51 percent of the time; Hispanic and Asian about 29 percent; and African-American about 23 percent. Caucasian patients can find a matching, available and willing donor about 75 percent of the time; Hispanic about 37 percent; Asian-American about 35 percent; and African-American patients only about 19 percent of the time. This demonstrates the huge gap between the need for compatible donors and the supply.
The HHS rule caused a dark cloud of uncertainty to hang over patients, doctors and researchers for four years. Since HHS proposed the rule, IJ has continually pushed back against the agency. In August 2016, IJ released an award-winning short film, Everything, that dramatized the story of IJ client Doreen Gummoe, who was Doreen Flynn when the lead plaintiff in Flynn v. Holder. The mother in the film engages in a desperate search to find a bone marrow donor for her daughter. Since its release, Everything has earned laurels from 17 film festivals, but, more importantly, it applied important pressure on HHS during the last days of the Obama Administration as it was pushing through a wave of administrative rules. Owing at least in part to the media coverage brought to bear by the release of IJ’s short film, HHS’s proposed new rule was never imposed.
Now that HHS has withdrawn the rule, IJ’s 2012 legal victory stands. Rowes said, “The goal of our initial lawsuit against the Attorney General was to enable researchers to find out if donor compensation would lead to more donors. Our victory made that possible, and now that HHS has withdrawn the rule that threatened that victory, researchers and entrepreneurs are free to create programs that are sure to save thousands of lives.”