Dollars for donors

More than 9 million people in the United States and about 19 million worldwide are registered as bone marrow donors. Yet, doctors sometimes struggle to find donors compatible with their patients. About 70 percent of people who need a bone marrow transplant don’t have a compatible donor in their extended family, according to the National Marrow Donor Program.

A nonprofit corporation has proposed that offering financial incentives for bone marrow donors may lead to an increase in donations. But bone marrow is a human organ, as defined by the National Organ Transplant Act, and that means marrow – like other human organs – cannot be sold.

A recent court decision, however, has opened the door for financial compensation of marrow donors and left many people wondering what the legal, medical and ethical implications may be.

Developments in medicine, law

Doctors used to harvest marrow primarily by aspiration – using a needle to draw marrow directly from the donor’s bone. While that method is still in use today, about 20 years ago peripheral blood stem cell apheresis was introduced allowing doctors to stimulate the production of peripheral blood stem cells in the bloodstream and extract them with a machine that filters the cells out of the blood.

MoreMarrowDonors.org argued in its complaint against United States Attorney General Eric Holder that the ban on bone marrow extraction was a

violation of the Equal Protection Clause. The nonprofit contended that bone marrow extraction is not materially different from blood donation or the harvesting of a human ovum – both of which are legal. The corporation argued that it should be permitted to offer $3,000 in incentives for marrow donors, in the form of housing allowances, scholarships and donations to the donor’s favorite charity, if a donor signed up for and followed through with marrow donation.

The 9th Circuit rejected the Equal Protection Clause claim. But, the court did agree that PBSCs cannot be classified as an organ, as defined by NOTA.

Holder has since filed a petition for an en banc review of that decision.

The debate

Jennifer Girod, attorney for Hall Render Killian Heath & Lyman, was a nurse and assistant professor of bioethics before she attended law school. She said her interpretation of NOTA is that it intended to prevent a market for human organs. And while supporters of the 9th Circuit opinion have argued that NOTA, enacted in 1984, could not have predicted the process of peripheral stem cell apheresis, amendments to the act in the past decade have.

“(Holder) is saying Congress knows what bone marrow is, and they may not have explicitly said it when they passed NOTA, but they did say it when they passed the amendments,” she said. “It doesn’t seem to matter at all that this is a less dangerous procedure, or less painful, or similar to blood donation. It just matters whether Congress intended to prevent a market.”

Fred Cate, co-director of the Center for Law, Ethics and Applied Research in Health Information for the Indiana University Maurer School of Law, sees a subtle distinction between financial incentives and direct payment with regard to organ donation.

“Compensation rarely means I’ll give you $25,000 for a kidney. It’s rather the thought of modest financial incentives and recognizing that everyone is getting paid for this, why can’t I,” he said, in reference to the high cost of medical care.

Cate is licensed to practice in the 9th Circuit, and he thinks the court’s decision in Flynn could be a sign of progress.

“I have the greatest respect for the attorney general, but I think he’s dead wrong on this issue,” Cate said.

Cate doesn’t see how compensating bone marrow donors could ultimately result in a black market for organ peddling.

“I don’t buy it as a justification for not paying. There’s always going to be wrongdoing and for perfectly good reason. If you were watching a loved one die, you too would say, can I buy an organ? Can I go to Mexico? Can I go to China? Can I save my mother?” Cate said. “I think you can say we’re going to regulate a market – just like we do with pharmaceuticals – to protect vulnerable and ill people from being taken advantage of.”

The National Marrow Donor Program, which oversees the world’s largest donor-matching program, said Holder’s argument is that if the court’s decision about compensation stands, it will create a potential for serious health risks to patients and donors. The NMDP is not a party in the suit but supports Holder’s appeal.

;were we worried about nothing? Should we try this with solid organs?’”

Risks and rewards

The NMDP reports that about 76 percent of the time a patient’s doctor requests a PBSC donation, and about 24 percent of the time a patient’s doctor requests a marrow donation. But Dr. Paul Haut, chief medical officer for Riley Hospital for Children at Indiana University Health and director of its pediatric stem cell transplant program, said whether one method of marrow donation is better than the other is a difficult question to answer.

“Peripheral stem cells have become more popular over time. It is generally safe,” he said. “A lot of donors would rather do that than harvest. The cells that you collect that way tend to grow back faster.”

But in pediatrics, Haut said, research suggests that PBSCs may be more likely to cause graft-versus-host disease, when transplanted stem cells attack the patient’s body.

Recent research suggests a similar pattern may be occurring in adults.

“It may be that in the next few years we see the pendulum swinging back” toward a preference for marrow aspiration, he added.

“The implication from this lawsuit in part is about the donors, but primarily it’s about making the best choice for my patient,” he said. Haut wonders if offering compensation for PBSC donation could cause fewer people to donate by aspiration. If so, Haut may have even more difficulty in finding a good match for his pediatric patients.

The process

For four or five days preceding PBSC donation, donors receive injections to stimulate the production of stem cells. In rare occasions, this medicine can cause the body to produce too many white blood cells too quickly, which can increase the risk of stroke or cause the spleen to rupture, Haut said.

“Ninety-nine percent of the time, it goes fine,” he said. “But it’s definitely not like going to donate blood, where you get hooked up to an IV, and an hour later you walk out with a cookie and juice.”

PBSC donation may offer quicker recovery time for patients. Aspiration generally requires patients to be off work for about a week as the body works to restore its own stem cells.

Unknown outcomes

“Having people die or living lower-quality lives when we could improve the quality of their lives if only we had an organ is a big issue,” Cate said. “These are very longstanding fights, and they are often waged by people of enormous goodwill on both sides, and I guess that’s why I don’t understand why the attorney general would be getting involved in this case.”

Cate thinks that an issue of statutory interpretation would be more appropriately addressed by Congress, the Department of Health and Human Services, and individual states.

Girod said that one of the traditional arguments against compensation for organ donation is that the process must be voluntary. And Haut said that in compensated blood donation, people have been dishonest about medical conditions that would make them ineligible to donate blood, so he could see that being a problem in compensated marrow donation, too.

If the 9th Circuit’s decision stands, it may lead to a new way of thinking, Girod said.

“So far, people have been making proposals that we pay people for kidney donations for 30 years or more, and there’s just tremendous resistance to it because nobody knows what it’s going to do to the voluntary market,” she said. “But I think people might be willing to see how it plays out in the bone marrow transplant context and say, were we worried about nothing? Should we try this
with solid organs?