Bone Marrow—NOTA Challenge

Introduction

Every year, tens of thousands of Americans are diagnosed with deadly blood diseases. Just one of these—leukemia, a cancer of the blood—will strike 44,000 people this year, 3,500 of them children, and eventually kill half the adults and about 700 of the children.

For many, the only hope for survival is a bone marrow transplant: taking blood-producing marrow cells from a donor’s bones and putting them in a patient’s body. Tragically, tens of thousands have died because there are not enough marrow donors and thousands more have died or suffer terribly after gambling on an incompatible donor. Minorities, who tend to have the rarest marrow types, are hardest hit.

It is time to confront an obvious truth.  More people would donate marrow if we did one simple thing:  compensate them.  Strategic but modest financial incentives represent the only realistic way to alter the sobering reality that African-Americans find an unrelated marrow donor only about 25 percent of the time.  Hispanics and Asians find a donor less than half of the time.  Even Caucasians, who have the best odds, find a donor only about 75 percent of the time.  People who are multi-racial, whose numbers increase every day, are the worst off because their genetically diverse family trees make finding a perfect donor like finding the proverbial needle in a haystack.  Nearly 3,000 Americans die each year because they cannot find a matching donor.

MoreMarrowDonors.org is a California nonprofit that intends to use privately contributed charitable funds to reward the most needed donors, especially minorities, with a $3,000 scholarship, housing allowance or gift to the charity of the donor’s choice. MoreMarrowDonors.org’s plan is an effective, safe and ethical way to save lives right now by encouraging more people to become bone marrow donors.

There is, however, only one problem: federal law makes MoreMarrowDonors.org’s efforts to attract more bone marrow donations a serious crime. Under the National Organ Transplant Act (NOTA), giving a college student a scholarship or a new homeowner a mortgage payment for donating marrow would land everyone—doctors, nurses, donors, patients along with the staff and financial supporters of MoreMarrowDonors.org—in federal prison for up to five years. Federal criminal law treats this commonsense plan as though it were black-market organ sales.

That makes no sense. Throwing ordinary people into prison for trying to save lives is irrational and the public gains nothing from stripping doctors and grown adults of their ability to make informed medical decisions. The only thing the bone marrow provision of NOTA appears to accomplish is unnecessary deaths.

That is why, on October 28, 2009, Plaintiff MoreMarrowDonors.org and its co-plaintiffs—adults with deadly blood diseases, the parents of sick children and a world renowned medical doctor who specializes in bone marrow research—joined with the Institute for Justice to bring suit against the U.S. Attorney General to put an end to this ban on a promising effort to save lives. ¹ Their legal claims are simple.  NOTA’s criminal ban violates equal protection because it arbitrarily treats renewable bone marrow like nonrenewable solid organs instead of like other renewable or inexhaustible cells—such as blood—for which compensated donation is legal.  That makes no sense because bone marrow, unlike organs such as kidneys, replenishes itself in just a few weeks after it is donated, leaving the donor whole once again.  The ban also violates substantive due process because it irrationally interferes with the right to participate in safe, accepted, lifesaving, and otherwise legal medical treatment.   A victory in this case will not only give hope to thousands facing deadly diseases, but also reaffirm bedrock principles about constitutional protection for individual liberty.

The Plaintiffs

The plaintiffs in this landmark legal challenge are of diverse backgrounds, but share a common conviction that no one else should have to die because of the federal criminal ban on compensation for bone marrow donors.

Doreen Flynn is a compelling example of the courage and determination parents must exhibit when their children are struck with a deadly blood disease. Doreen is from Lewiston, Maine, and is a single mother of five children—James (13), Jordan (11), Jacob (8), and twins Jorga and Julia (5). Jordan, Jorga and Julia have Fanconi anemia, a serious genetic disorder whose sufferers often need a bone marrow transplant in their teens. The Flynns’ story is one of love and tragedy. Jorga and Julia were conceived after Jordan was diagnosed with Fanconi anemia because Doreen desperately hoped they would be able to save their sister’s life someday by providing her with lifesaving marrow. But in a cruel twist, not only were the twins not a match, they too were also born with the same disease. Each of the girls will need a bone marrow transplant one day, and Doreen wants every option on the table to save her daughters. If more bone marrow donors were added to the pool, parents would not have to go to the lengths Doreen did in hopes of saving their children. Although we will never match everyone who needs a donor, adding substantially more donors to the rolls through incentives will without question save lives.

Joining Doreen is John Wagner, M.D., an internationally recognized expert in marrow cell transplantation at the University of Minnesota. He has treated thousands of patients in need of marrow transplants, and he has been forced to watch hundreds of them die after they were unable to find a matching donor. He believes it is time to try the most promising strategy for bringing in more donors—providing potential donors with an incentive to donate.

This promising strategy will actually be carried out by MoreMarrowDonors.org, a California nonprofit corporation that educates the public about the need for more marrow donors. MoreMarrowDonors.org also intends to compensate marrow donors in order to increase the amount of available donor marrow. MoreMarrowDonors.org is run by a team of three healthcare and bone-marrow activists.

Shaka Mitchell chairs the board of MoreMarrowDonors.org. He is of African-American and Puerto Rican heritage. Shaka has joined this fight to ensure that more patients, especially minorities and people who are multi-racial, can find the donors they need.

Akiim DeShay is also on the board of MoreMarrowDonors.org. He is an African-American leukemia survivor from Irving, Texas, who received a bone marrow transplant from his sister in 2004. Although she was a good match, he suffers from persistent medical complications and nearly died in February 2009. Akiim is an advocate for African-American bone marrow issues and runs a website called BlackBoneMarrow.com.

MoreMarrowDonors.org’s third board member is Mike Hamel. Mike is a Caucasian lymphoma patient in Colorado Springs, Colo. He recently underwent a transplant of his own stored marrow cells in an effort to avoid a transplant from someone else. Mike is a former pastor and currently a professional writer with, among other things, a book series to his credit. He runs a blog called Open Mike (http://mikehamel.wordpress.com) that chronicles his daily battle with the disease.

Two more clients round out the coalition, both of whom have experienced firsthand the special difficulties ethnic minorities face in seeking unrelated marrow donors. Mark Hachey and his family live in Puyallup, Wash. Mark is Caucasian and his wife is of Filipino heritage. Their teenage son, Greg, who is multi-racial, is a leukemia survivor. Greg had a mismatched transplant more than one year ago because there was no matching donor. Greg continues to experience serious medical complications as a result of his transplant.

Kumud Majumder and his family are of Indian descent and live in Saddle River, N.J. Kumud’s 11-year-old son, Arya, has leukemia and underwent a transplant from an unrelated donor in April when a matching donor was identified at the last moment. Arya continues to suffer medical complications from his transplant.

The ABCs of Bone Marrow Transplantation

Bone marrow is a spongy, fluid-filled tissue inside bones. ² There are special “marrow cells” inside the hollows of the marrow that produce the body’s blood supply. ³ Marrow cells accomplish this by doing two things. A marrow cell either divides into new marrow cells or matures into a blood cell and passes out of the bone marrow cavities into the blood stream. This process ensures that healthy people have a stable population of marrow cells in their bones and a steady supply of fresh blood. Marrow cells are just immature blood cells.

Diseases like leukemia kill by altering the process through which marrow cells divide and grow into blood cells. For many, the only hope for survival is a bone marrow transplant, but finding a matching donor is very hard, so hard in fact that only 30 percent of patients will have a matching donor in their own family. The remaining 70 percent need a transplant from strangers.

Matching unrelated marrow donors and patients is incredibly complex and far more difficult than matching ordinary blood donors. Although there are only four basic blood types and millions of potential donors of each type, ⁴ it is the opposite for marrow: literally millions of marrow types and only a handful of potential donors for each type. ⁵

Marrow cell donors and patients must have matching types because an imperfect match can cause a very serious complication called graft-versus-host (GVH) disease that can kill the patient or cause a lifetime of pain and suffering. ⁶ GVH arises when the new blood being produced in a patient by a marrow-cell transplant goes to war against the patient’s body. In a nutshell, a patient’s new white blood cells, which are genetically related to the donor and not the patient, mistakenly attack the patient’s body, confusing the patient’s own cells for foreign objects like bacteria. In other words, the marrow-cell transplant “rejects” the patient’s whole body. This is the opposite of the kidney transplant problem in which the patient’s body “rejects” the donor organ.

The deep genetic compatibility required for matching unrelated donors and patients means that it is essentially impossible for doctors to find donors on their own. The only practical way to match donors and patients is through a search of the national marrow registry which has marrow cell information on about seven million people. ⁷

Unfortunately, even a database this large has persistent gaps.  Caucasians can find matching, available and willing donors only about about 75 percent of the  time and chances are far bleaker for minorities:  about 45 percent of Hispanics, about 40 percent of Asians and only about 25 percent of African-Americans ⁸ can find matches. People who are multi-racial face even worse odds.  At least 3,000 Americans die each year because they cannot find a matching bone marrow donor.

Donating marrow cells is considered safe and is just a different kind of blood donation. The donation experience is a bit like getting wisdom teeth pulled: safe but unpleasant. A typical donation requires less than five percent of a donor’s marrow cells and these lost cells regenerate in a few weeks. ⁹ Doctors collect marrow cells two ways, either by drawing them directly out of the bones using a long needle ¹⁰ or by drawing ordinary blood out of a donor’s arm and skimming out the marrow cells with a special machine. ¹¹ The national registry has facilitated more than 35,000 unrelated marrow-cell donations without a single donor death.

Addressing the Shortage of Donors

The stubborn shortage of donors is a complex problem, but one glaring factor is that donors get no compensation. Donors get no remuneration despite having to undergo confirmatory testing after being contacted as a potential donor, subsequent physical examination, injections and an unpleasant, though safe, medical procedure. ¹²

It is common sense that the absence of compensation is a decisive reason why only two percent of the population is on the national bone marrow registry and why so many people on the registry cannot be found or will not donate when asked.  As it stands now, only 65 percent of Caucasians on the registry are available and willing to donate, 47 percent of Hispanics, 44 percent of Asians and only 34 percent of African-Americans. ¹³ It is also common sense that offering some compensation, especially to the rarest marrow cell types, will increase the number of matched, available and willing donors.

The plaintiffs want to put this commonsense idea into action. MoreMarrowDonors.org is a nonprofit that intends to compensate donors with rare marrow cell types. This incentive will take one of three forms: (1) a scholarship; (2) a housing allowance; or (3) a gift to a charity of the donor’s choice. By making more options available, more donors will be willing to donate.

These options are expected to affect donor decision-making in three critical ways: (1) more people will sign up to the national registry; (2) more people will keep their information updated with the registry so they can be found if they turn up as a match; and (3) more people will go through with the donation process when they are actually matched with a patient. MoreMarrowDonors.org is not arguing for mandatory compensation. It simply wants to implement a pilot program to determine whether strategic incentives would work for donors with the rarest marrow-cell types.

MoreMarrowDonors.org—and not patients—will provide the awards using funds raised from third-party philanthropists. MoreMarrowDonors.org will have absolutely no involvement in the transplant process, which is strictly the purview of medical professionals. Nor will MoreMarrowDonors.org attempt to determine the identity of patients or put donors in touch with patients. By law, donors and patients are matched anonymously and must remain unknown to each other for a year after any transplant. ¹⁴ Finally, the award is fixed at $3,000 and MoreMarrowDonors.org will not negotiate with any donor. Operating in this way, pressure cannot be applied to donors and recipients cannot be held hostage for greater compensation.

An award for donating could be the difference between life and death for patients with rare marrow cell types. For example, if an African-American is lucky enough to find a match on the registry, there is an 80 percent chance that that donor is the only match on the registry. ¹⁵ When you have only one matching donor, that person must be available and willing to donate if the patient’s life is to be saved. Compensation would go a long way to ensuring that that would happen.

Compensating Marrow Cell Donors Is a Felony under Federal Law

The National Organ Transplant Act (NOTA) treats granting a scholarship to a college student—or any other award MoreMarrowDonors.org wants to offer—as a black-market organ sale. ¹⁶ As a result, everyone involved in such a transplant could go to federal prison for five years; this includes doctors, nurses, the patient, the donor, the staff of MoreMarrowDonors.org and its financial supporters. This is true even if MoreMarrowDonors.org operates under the strictest medical and ethical supervision and ensures that everyone who participates has given informed consent.

That makes no sense. Congress outlawed organ selling in 1984 to prevent markets in kidneys and other nonrenewable organs. ¹⁷ Organ selling became a public issue in the early 1980s because a new anti-rejection drug called cyclosporine ¹⁸ suddenly made widespread organ transplantation possible as long as there is a steady supply of donor organs.

Recognizing the potential of cyclosporine, a disgraced Virginia doctor named H. Barry Jacobs decided to bring in kidney donors from the developing world and broker transplants with American patients. ¹⁹ This was a plausible business model because tens of thousands of Americans desperately needed a kidney transplant and healthy people have two kidneys but need only one. ²⁰

But this also bothered many people and Congress enacted NOTA’s ban on organ-selling in direct response to Jacobs’ scheme. There were three things in particular that Congress did not like about for-profit kidney brokering: (1) kidney surgery is invasive; (2) a kidney donor loses an irreplaceable body part; and (3) market-bought organs would flow from the poor to the rich. Congress also seems to have believed—quite naively in retrospect—that the problem of organ shortages would disappear in a few years because so many people would become volunteer organ donors. ²¹

Whatever one thinks about banning kidney markets, it is clear that none of these considerations applies to marrow cells. Donating marrow cells is safe and donated cells regenerate. And there is no plausible prospect of a highest bidder market for marrow cells because donors and patients are matched anonymously through the national registry on the basis of complex genetic factors. Finally, the past 25 years have proved that there are not enough people willing to undergo the pain and inconvenience of marrow donation for free.

Congress actually appears to have included marrow cells in NOTA by mistake. In more than 1,500 pages of detailed legislative history, there was no discussion of bone marrow or why it was included in the statute. The words “bone marrow” showed up for the first time in a late Senate draft of the NOTA bill and did so without any explanation. ²² “Bone marrow” was then included in the next House version, also without explanation. ²³ The inclusion of bone marrow in NOTA is even stranger in light of the fact that the Conference Report of the Senate and House of Representatives on the bill Congress sent to President Reagan for his signature expressly stated that the ban on organ selling was not intended to include renewable cells such as blood cells. ²⁴ But that is precisely what marrow cells are: immature blood cells.

NOTA Violates the Constitution

NOTA’s irrational ban on compensation for marrow cell donors violates the rights to due process and equal protection found in the Due Process Clause of the Fifth Amendment, and the plaintiffs have brought suit to strike down that ban and save lives by encouraging more marrow cell donations. This lawsuit does not challenge the provision in NOTA that prohibits compensation for solid organs and this lawsuit will not open the door to solid organ markets. Rather, this lawsuit challenges only the provision of NOTA that bans compensation for marrow. The premise of this legal challenge is that there is a fundamental biological distinction between renewable marrow cells and nonrenewable solid organs.

Adults have always had the right to participate in safe, accepted and lifesaving medical treatment. That right has never been conditioned on medical goods or services being provided for free. When NOTA was enacted in 1984, it was the first time in American history in which grown adults—doctors, patients, nurses and whomever—were forbidden from participating in otherwise safe and legal medical treatment just because one of the participants earned compensation.

Second, whatever the precise limits on the power to regulate or even deny a particular right, the government never has the authority to do so for arbitrary or irrational reasons. This important principle has been reaffirmed in a number of cases before the United States Supreme Court. ²⁵

Yet that is exactly what Congress has done: exercise its power arbitrarily. This violates the plaintiffs’ right to equal protection because there is no rational reason to treat marrow cells like solid organs. Congress enacted NOTA to prohibit markets in solid organs and tissues because, in Congress’ view, the non-renewability of solid organs creates such special problems that compensation must be outlawed.

But none of the problems with compensation for solid organs that Congress worried about has anything to do with marrow cells, which are renewable. Indeed, NOTA does not ban compensation for other renewable cell types—such as blood cells or reproductive cells like sperm or eggs—and people provide compensation for these cells literally every day. Because there is no rational reason to single out marrow cells for special treatment (and single out people who need marrow cell transplants for special suffering), NOTA is arbitrary and, therefore, unconstitutional.

Given that Congress had no actual reason to ban compensation for marrow cells, the constitutional analysis need not proceed any further. But it is worth pointing out that there are not even hypothetical justifications for the law that are rational. The two most likely to be invoked—(1) compensating marrow cell donors will lead to the same problem as compensating blood donors (indigent blood donors wanting to get paid would lie about their risk of having hepatitis), and (2) compensating donors “coerces” them—are also arbitrary and antithetical to basic principles of liberty.

With respect to blood, although the blood banking industry no longer purchases blood from donors, it is perfectly legal to do so and blood banking centers sell blood every single day to hospitals for hundreds of dollars per unit. If it is legal to pay for blood, how can it be rational to ban compensation for marrow cells on the basis of problems with paid blood? Even beyond that obvious logical point, there are two independent reasons why compensating people for donating marrow would not give rise to any of the problems arising out of paying blood donors.

First, there is no need to compensate blood donors because enough blood donors donate for free—something that is not true in the marrow context, where a chronic shortage of available donors is killing people every day. Second, there are only four blood types and millions of donors for each type, so it makes no sense to tolerate even a small risk that some paid blood donors will lie about their health history to get paid. But in the marrow context, there are millions of donor types and only a few donors each for the rarest types, and the patients who need marrow cells are facing death or terrible, lifelong suffering if they do not get a well-matched donor. Facing these risks, a patient and her doctor might very reasonably decide that the best course is to use a compensated marrow cell donor (especially when every possible medical precaution would be taken to ensure that the donated marrow cells are free of infections).

With respect to concerns about donor “coercion,” no one can persuasively argue that NOTA protects a marrow cell donor from being “coerced” by a $3,000 college scholarship. ²⁶ Donors, of course, would always be free to decide not to donate marrow cells or to refuse compensation. A $3,000 scholarship no more coerces a college student to donate marrow than a $3,000 merit scholarship coerces her to get an “A” in class. The true coercion, of course, is NOTA itself, which threatens doctors and charities with federal prison sentences for trying a commonsense plan to save more lives by encouraging more marrow cell donations.

The bottom line is that there is no rational reason for NOTA to interfere in the effort of the plaintiffs to save the lives of people confronting deadly blood diseases. The provision of NOTA that bans compensation for bone marrow donation is, therefore, unconstitutional as applied to the plaintiffs because the government may not irrationally interfere in the rights of citizens, especially when the right is as foundational as the right to participate in lifesaving and safe medical treatment.

The Institute for Justice Team

The lead attorney from the Institute for Justice is Senior Attorney Jeff Rowes. He will be joined by IJ President and General Counsel William Mellor, Senior Attorney Dana Berliner, Staff Attorney Robert McNamara, and Paralegal Kyndra Griffin. Justin Sobodash will join them as local counsel in Los Angeles, Calif., where the case was filed.

For more information, please contact:

John Kramer (Vice President for Communications) or Bob Ewing (Assistant Director of Communications) Institute for Justice 901 North Glebe Road, Suite 900 Arlington, VA 22203

(703) 682-9320 [email protected]

[email protected]