


I’ve Turned Off My Ad Blocker
Edit Story

Federal Regulation Could Redefine The Word 'Organ,' Jeopardize Bone Marrow Donations

Institute For Justice
This article is more than 6 years old.
Doreen Flynn.

Three of Doreen Flynn’s children were born with a rare, debilitating blood disease.  Desperate to save her children’s lives, she challenged a decades-old, outdated ban on compensating bone marrow donors.  She won in federal court.

But now a new rule proposed by the federal Department of Health and Human Services (HHS) would undo this landmark decision and jeopardize this life-saving treatment.

Doreen’s first daughter, Jordan, was born with Fanconi anemia, a devastating genetic disorder that can lead to bone marrow failure.  One-fifth of Fanconi anemia patients do not reach adulthood.

Jordan’s best chance at a bone marrow match was from her siblings.  But none of her two brothers was a match.  Doreen, and her then husband, conceived another child to provide marrow for her sister.  But in a cruel twist of fate, the twins, Jorga and Julia, were both born with Fanconi anemia.

Fortunately, years later, Jordan was finally able to receive a transplant.  Clearly, bone marrow transplants save lives, empowering sick and dying patients to produce new blood cells.

Yet shortages persist.  Like the Flynn family, more than two-thirds of patients who need a bone marrow transplant will not have a matching donor in their own family.  Every year, at least 1,000 people die because they cannot find a matching bone marrow donor.

Under the National Organ Transplant Act (NOTA), offering compensation to all bone marrow donors was a felony, punishable with up to five years in prison.  Congress passed NOTA to combat organ trafficking, particularly the black-market sale of kidneys.  Crucially, Congress explicitly exempted blood from its definition of “human organ.”

When NOTA was first enacted back in 1984, bone marrow could only be transplanted by using long needles to directly suck the marrow from a donor’s pelvic bone.  Thanks to tremendous scientific advances, now 70 percent of bone marrow donations involve a safer method known as apheresis.

Unlike the traditional form of bone marrow donations, no surgery is required while the donor does not have to be anesthetized for apheresis.  In fact, the fatty bone marrow itself is not actually donated.

Instead, apheresis collects blood stem cells, which regenerate (unlike kidneys).  During apheresis, a donor is injected every day for five days with a drug that boosts blood stem cell production.  (To be clear, these stem cells are not the same as the more controversial embryonic stem cells.)

On day five, the donor sits in a recliner and is hooked up to a machine.  This machine separates and collects the stem cells for hours and returns the remaining blood back to the donor.

But unlike donating blood, marrow matches are very hard to find.  There are millions of possible marrow types, while even slight mismatches can lead to complications.

This problem is even more acute for minorities.  For Caucasians who did not have a bone marrow match in their own family, 75 percent are able to receive a transplant.  Among Hispanics and African-Americans, those numbers drop to 45 and 25 percent, respectively.

Since apheresis can be very time-consuming, this deters donors.  At any given time, 98 percent of the U.S. population is not on the national registry.

Indeed, even among those that have signed up to be donors, half of them never follow through with the donations when called upon, according to Rock Center with Brian Williams.

To widen the door pool and encourage donors to show up when they’re a match, compensating donors for their time can be a potent incentive.  One California nonprofit,, sought to do exactly that, by offering a reward of $3,000, in the form of a scholarship, housing allowance or gift to a charity of the donor’s choice.  But under NOTA, even this very limited reward would be illegal.

To fight back against NOTA,, the Flynns and other patients with lethal blood diseases joined forces with the Institute for Justice and sued the government in federal court.

Patients prevailed when the U.S. Ninth Circuit Court of Appeals unanimously struck down the ban on compensating bone marrow donors who undergo apheresis in December 2011.  Since apheresis did not exist back in 1984 and has more in common with donating blood than organs, the court held NOTA does not outlaw compensating donors who undergo this procedure.

Flynn v. Holder legalized such compensation for all those living within the Ninth Circuit, which includes Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon, Washington, and several U.S. territories.

But instead of respecting the court’s decision, HHS is trying to nullify Flynn v. Holder.  HHS has proposed a new regulation that would redefine bone marrow as an “organ,” even if it’s gathered through regenerating blood stem cells. The proposed rule is currently facing an open comment period through December 2, 2013.

If enacted, this would re-impose the ban on compensation, turning some donors into felons.  This regulation defies both the Constitution and common sense.  As Doreen Flynn herself put it, “I don’t think that anybody should go to jail just for trying to save somebody’s life.  If paying donors results in more marrow donations, we should pay them.”

Voluntarily agreeing to give someone bone marrow is worlds apart from having your organs violently harvested against your will.  Medical compensation is hardly unusual.  Blood, egg and sperm donors can earn cash.  Doctors and surgeons are regularly rewarded for their efforts and are paid very well for saving lives.  Why should bone marrow donors be any different?

The HHS should remember to first, do no harm.

