Six thousand people have died from lack of suitable bone marrow donations in the two years since Doreen Flynn, the mother of three daughters whose rare genetic disorder has left them in need of bone marrow transplants, filed suit challenging the constitutionality of the National Organ Transplant Act. The Ninth Circuit handed down its unanimous decision on December 1 that the product of a new method for bone marrow donation is not an “organ” under the statutory definition set forth in the Act, and thus may be donated in exchange for monetary compensation.

The National Organ Transplant Act

The National Organ Transplant Act, approved in 1984, outlawed the sale of human organs in the United States and made violators punishable by up to five years in prison. The intended purpose of this act was to promote Congress’ belief that “human bodies should not be viewed as commodities.” Congress feared that incentivizing organ donation with compensation would effectively diminish patient autonomy and induce prospective donors to inaccurately perceive the medical risks attendant to such donations.

Proponents of this Act insist that allowing organ sale would also unfairly benefit the rich at the expense of the poor. They fear that poor, desperate people could be influenced into turning their bodies into organ farms to save the lives of wealthier patients, and could imperil their own lives in the process. The Act also seeks to quell any further motivation for already existent organ thieves, and to avoid inequitable bartering and extortion through the organ-money exchange.

The Act defines a “human organ” as including a human “kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, skin, and intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.” The statute further emphasizes that the restrictions cover organs and the “subparts thereof.” Significantly, neither the statute nor the regulation defines “human organ” to include blood, and the government has conceded that the statute does not prohibit the common practice of compensating blood donors.

The new bone marrow extraction procedure

Historically, bone marrow donation has involved an excruciating and risky procedure, called aspiration, involving anesthesia and intimidatingly long needles inserted directly into the donor’s hipbone to extract the marrow. Over the past twenty years, however, doctors and researchers have developed a significantly less painful and invasive procedure called “peripheral blood stem cell apheresis.” Under this method, the donor receives injections of a medication called “granulocyte colony-stimulating factor” over five days prior to the actual procedure, which works to accelerate blood stem cell production in the donor’s bone marrow, causing the excess stem cells to leak into the blood stream.

During the actual donation procedure, the donor undergoes a process similar to normal blood donation, whereby he is hooked up to a machine that extracts his blood, passes it through a filtration machine to separate out the marrow stem cells, and then returns the filtered blood back to his body. The extracted marrow stem cells are then grown into bone marrow in vitro, while the donor’s body regenerates the extracted cells over the next three to six weeks.

By this method, the donation is not of bone marrow itself, but rather its regenerative by-products, hematopoietic stem cells. It is this differentiation that allowed the 9^th Circuit to circumvent the statutory limitations of the Organ Transplant Act and permit compensated bone marrow donation.

Marrow apheresis is not an “organ” donation

Bone marrow produces both blood cells and bone marrow stem cells. Thus, were the statutory definition of “organs and subparts thereof” interpreted to include the materials bone marrow produces, it would necessarily prohibit compensating blood donors. Yet, the government has made clear that compensating blood donors is legal under the Organ Transplant Act because blood is not an organ or subpart thereof. By the same token, the 9^th Circuit reasoned that hematopoietic stem cells, when extracted from the blood stream rather than in concert with developed bone marrow, are akin to blood cells and do not fall under the statutory definition of an organ. In this way, the court did not need to address the constitutionality of the Act, because the procedure at issue is not prohibited by the terms of the statute.

Proposed bone marrow donor compensation

Bone marrow transplants are needed for people undergoing cancer treatments, as well as for those suffering from leukemia or a host of genetic disorders. Unfortunately, unlike blood, which only has four types, there are millions of types of bone marrow, making donor-recipient matching extremely problematic, especially for patients with mixed racial heritage. The available bone marrow donor base is infinitesimal when compared to the urgent need for suitable donors. The plaintiffs in this case are hopeful that incentivizing bone marrow donations with monetary compensation will help to increase transplant availability.

A pilot project promoted by a Californian non-profit offered to provide $3,000 scholarships or housing payments to compensate bone marrow donors using the apheresis procedure. The organization explained that this dollar amount would be enough to incentivize donations without fostering the development of a black market or promoting the other seedy side effects Congress sought to avoid by banning organ sales. The donors and recipients would give and receive the bone marrow through a centralized bank that will not share each party’s information with the other, an effort that the organization believes could protect against extortion.

While these $3,000 payments would initially be funded by charitable donations, the pilot project hopes to eventually enlist insurance companies in providing some of the payments. Successful donor-recipient bone marrow matches will ultimately save insurance companies significant money over the costs of complications and expensive follow-up care that often follow less suitable matches. This pilot program must wait to take effect, however, until after the Supreme Court has issued its ruling if the Department of Justice petitions for a writ of certiorari, which it likely will do.

Policy implications

The 9^th Circuit’s decision to characterize bone marrow stem cells outside the statutory definition of a human organ prompts much concern on the U.S. government’s part. The defendants in the case are concerned that redefining parts or by-products of organs could be a slippery slope to allowing people to sell parts of regenerative organs, like the liver. The government fears that by mincing terms, the 9^th Circuit has opened the door to future circumvention of Congress’ intent in enacting the ban on organ sale.

Beyond this concern, one might argue that, by taking a few steps backward in the physiological development process, future donors could sell any of their organs by donating pluripotent stem cells, which are capable of becoming any type of cell or organ. More conservatively, if scientists are able to develop limitedly invasive procedures for extracting the stem cell precursors to livers, kidneys, or hearts, the 9^th Circuit’s reasoning in the present case would easily allow compensated donation of these cells without violating the Organ Transplant Act, thereby obviating any need for the Act at all.

The Department of Justice will most likely appeal this decision to the U.S. Supreme Court, not out of a desire to prevent deserving patients from receiving compatible organ matches, but rather in an effort to seek a definitive ruling on what physiological matter Congress intended to protect when it signed the Organ Transplant Act into law. In the meantime, Ms. Flynn's daughters must patiently wait for altruistic donors with compatible bone marrow types.