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Just Saying No to NOTA: Court Permits the Sale of Hematopoietic Stem Cells
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Just Saying No to NOTA: Court Permits the Sale of Hematopoietic Stem Cells Robert Steinbuch, JD, MA
Keywords: law n organ donation J Natl Med Assoc. 2012;104:219-220 Author Affiliations: University of Arkansas at Little Rock, William H. Bowen School of Law. Correspondence: Robert Steinbuch, JD, MA, Professor of Law, University of Arkansas at Little Rock, William H. Bowen School of Law, 1200 McMath Ave, Little Rock, AR 72202, Little Rock, AR ([email protected]).
I
n a recent case decided by the US Court of Appeals for the Ninth Circuit, we see another struggle to work within the confines of poorly designed healthrelated laws.1 The case concerns the unintended sideeffects resulting from laws that prohibit payments to “donors” of lifesaving biological material.2,3 Recently, a medical school professor, parents of some sick children, an African American leukemia patient, and a nonprofit corporation—which sought to pay for bone marrow donations—all sued the federal government to have declared invalid a law that interfered with bone marrow and stem cell “donors” from receiving exceedingly modest compensation for their efforts.1 The controversy concerned the nonprofit plaintiff’s desire to give $3000 in scholarships, housing allowances, or gifts to charities for bone marrow or blood-borne stem cells.1 The program was initially designed to direct payments to minority and mixed-race donors of bone marrow cells, due to the greatest medical need in this cohort.1 The proposal to pay donors was simple: induce more donors through compensation. The question that the court faced was whether such payments ran afoul of the National Organ Transplant Act (NOTA), which criminalizes payment for organs.1 The statute defines human organ as a kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin, and any other organ specified by regulation.1 Until fairly recently, stem cells for cancer treatment were taken from bone marrow.1 A newer technique obtains the same cells from blood.1 The blood is filtered to extract the stem cells, and the remainder transfuses back into the donor.1 Notwithstanding the greater ease of extraction, matching remains a problem.1 Unlike simple blood types, there are millions of marrow cell types, JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
making matching difficult.1 “African Americans have especially great difficulty finding a compatible unrelated donor, as they tend to have a mix of African, Caucasian, and Native American genes, and fewer potential donors are registered in the national civilian registry.”1 Plaintiffs—in their efforts to get the court to approve the $3000 stipend for stem cell donation—argued: (1) that NOTA violates the US Constitution, and (2) that NOTA does not govern stem cells taken from the blood instead of from bone marrow.1 For the constitutional claim, plaintiffs had to demonstrate that no “rational basis” existed for distinguishing permissible from prohibited activities under NOTA.1 In other words, plaintiffs had to show it irrational to prohibit the sale of organs and bone barrow, on the one hand, while permitting the sale of blood, sperm, and eggs, on the other—as NOTA does.1 This legal standard starts with the presumption that laws such as NOTA are constitutional.1 (Since NOTA expressly prohibits compensating bone marrow donors, plaintiffs could not argue that it did not apply to bone marrow stem cells—as they did for the blood-borne stem cells.1) As for whether NOTA’s distinction between compensable and noncompensable bodily substances has a rational basis, the court answered in the affirmative.1 And while such a justification could be hobbled together, perplexingly, an inchoate effort was never consummated by the court. Indeed, the court took pains to reject the commonly asserted, but wholly incorrect, basis that compensation is permitted for body parts that regenerate and prohibited for those that do not.1 NOTA makes no such claim, and the prohibition on the sale of part of a liver (which regenerates) and the permissibility on the sale of eggs (which do not regenerate) belies this post hoc rationalization.1 Equally, the claim that the law allows the sale of biological material whose transfer poses little risk or discomfort is contradicted by, among other examples, the sale of human eggs—which is moderately dangerous and onerous.1 Nonetheless, the court held that a rational basis exists and ruled NOTA constitutional. Although the court failed to spell out the rational basis, that does not necessarily mean one does not exist. A rational basis, however, should not be confused with a good one. For VOL. 104, NOS. 3 & 4, MARCH/APRIL 2012 219
Court Permits the Sale of Hematopoietic Stem Cells
example, the Supreme Court upheld an Oklahoma law that prohibited opticians from, among other things, adjusting eyeglass frames—restricting such behavior to licensed ophthalmologists and optometrists—on the ground that it rationally could be supported by the government’s concern for the safety of its citizenry.4 While the Oklahoma law was constitutional, ie, it had a rational basis, it also was undoubtedly foolish—as is much of NOTA. Regarding the second question—whether selling blood-borne stem cells is prohibited by NOTA itself— the Department of Justice (DOJ), the defendant, argued that allowing compensation for the donation of bloodborne stem cells is prohibited by NOTA. The DOJ generally argues in court for the clear dictates of a challenged federal law, regardless of whether the administration agrees with it. Thus, for example, even though the Obama administration disagreed with the “don’t ask, don’t tell” law that covered gays in the military, it defended that law.5 Where a law is not clear, however, an administration is free to choose any reasonable interpretation. And here, the law was, at best, not clear on the question of the applicability of NOTA to hematopoietic stem cells. Nonetheless, the government argued for the lessplausible and more-damaging-to-public-health position: that blood-borne stem cells should be treated as bone marrow, not blood, because these cells originated in bone marrow.1 This view is curious because the more intuitive interpretation would be to equate blood-borne stem cells with blood, not bone marrow. Indeed, as the court recognized, a variety of components of blood originate in bone marrow, and NOTA permits the sale of blood and these other components.1 The government’s reasoning seems to have been that paying for stem cells would result in poorer minorities, among others, improperly feeling “pressure” to commodify themselves.1 I have previously advocated against such paternalism, particularly when no similar ban exists on mining coal or other employment opportunities far more dangerous than “donating” biological material that saves lives.2,3 Indeed, the government argued that the court should prohibit acts that would be wholly permissible if done for free. Thus, asking a poor person to donate marrow for free is perfectly OK, but helping that extremely kind donor with modest compensation is somehow bad.2,3
220 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
That logic seems confused. Moreover, this overprotectiveness harms the very cohort that the avowed policy is asserted to benefit, as many minorities particularly need scarce biological material from other members of their relatively small, genetically similar group.1-3 Further, in evaluating this philosophical conundrum, consider why an act considered laudable becomes, according to some, dangerous or improper when accompanied by payment. True, the motivation of the “donor” will change with compensation, but does the act’s underlying virtue and inherent benefit become so corrupted that we should prohibit it? If you answered yes, consider whether you might change your mind if you daughter needed the transplant. And while it is absolutely correct that difficult decisions are better made without the duress of a loved one’s illness, the sterile analysis of life-and-death situations made in the abstract may result in principles that work well in a law school debate, but not in a hospital or for a family. Notwithstanding these philosophical questions, the court simply rejected the argument that NOTA banned the sale of blood-borne stem cells based on the language of the statute and after the government admitted that paying ordinary blood donors is permissible under NOTA.1 While the court interpreted the law well enough, the underlying question remains: Why should we continue to be subjected to a law that all but arbitrarily prohibits payment for some biological materials, but not others? The inherent contradiction in NOTA highlights that the time has arrived to take a new look at this old law. And though the broader issue of payment for organs requires further discussion, the current regime, which haphazardly permits small efforts to induce greater donation of biological material in some instances, but not others, simply does not make for good health law or policy.
References
1. Flynn et al v Holder. 2011 WL 5986689 (9th Cir 2011). 2. Steinbuch R. Improving the health and welfare of the historically underprivileged. J Natl Med Assoc. 2010;102:40-43. 3. Steinbuch R. Kidneys, cash, & kashrut: A legal, economic, and religious analysis of selling kidneys. Houston Law Rev. 2009;45:1529-1607. 4. Williamson v Lee Optical. 348 US 483 (1955). 5. Gura D. Obama administration defends ‘don’t ask, don’t tell,’ a policy it wants to repeal. NPR News, October 14, 2010. www.npr.org/blogs/thetwoway/2010/10/14/130575512/obama-administration-defends-don-t-askdon-t-tell-a-policy-it-wants-to-repeal. Accessed December 7, 2011. n
VOL. 104, NOS. 3 & 4, MARCH/APRIL 2012
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Just Saying No to NOTA: Court Permits the Sale of Hematopoietic Stem Cells Robert Steinbuch, JD, MA
Keywords: law n organ donation J Natl Med Assoc. 2012;104:219-220 Author Affiliations: University of Arkansas at Little Rock, William H. Bowen School of Law. Correspondence: Robert Steinbuch, JD, MA, Professor of Law, University of Arkansas at Little Rock, William H. Bowen School of Law, 1200 McMath Ave, Little Rock, AR 72202, Little Rock, AR ([email protected]).
I
n a recent case decided by the US Court of Appeals for the Ninth Circuit, we see another struggle to work within the confines of poorly designed healthrelated laws.1 The case concerns the unintended sideeffects resulting from laws that prohibit payments to “donors” of lifesaving biological material.2,3 Recently, a medical school professor, parents of some sick children, an African American leukemia patient, and a nonprofit corporation—which sought to pay for bone marrow donations—all sued the federal government to have declared invalid a law that interfered with bone marrow and stem cell “donors” from receiving exceedingly modest compensation for their efforts.1 The controversy concerned the nonprofit plaintiff’s desire to give $3000 in scholarships, housing allowances, or gifts to charities for bone marrow or blood-borne stem cells.1 The program was initially designed to direct payments to minority and mixed-race donors of bone marrow cells, due to the greatest medical need in this cohort.1 The proposal to pay donors was simple: induce more donors through compensation. The question that the court faced was whether such payments ran afoul of the National Organ Transplant Act (NOTA), which criminalizes payment for organs.1 The statute defines human organ as a kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin, and any other organ specified by regulation.1 Until fairly recently, stem cells for cancer treatment were taken from bone marrow.1 A newer technique obtains the same cells from blood.1 The blood is filtered to extract the stem cells, and the remainder transfuses back into the donor.1 Notwithstanding the greater ease of extraction, matching remains a problem.1 Unlike simple blood types, there are millions of marrow cell types, JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
making matching difficult.1 “African Americans have especially great difficulty finding a compatible unrelated donor, as they tend to have a mix of African, Caucasian, and Native American genes, and fewer potential donors are registered in the national civilian registry.”1 Plaintiffs—in their efforts to get the court to approve the $3000 stipend for stem cell donation—argued: (1) that NOTA violates the US Constitution, and (2) that NOTA does not govern stem cells taken from the blood instead of from bone marrow.1 For the constitutional claim, plaintiffs had to demonstrate that no “rational basis” existed for distinguishing permissible from prohibited activities under NOTA.1 In other words, plaintiffs had to show it irrational to prohibit the sale of organs and bone barrow, on the one hand, while permitting the sale of blood, sperm, and eggs, on the other—as NOTA does.1 This legal standard starts with the presumption that laws such as NOTA are constitutional.1 (Since NOTA expressly prohibits compensating bone marrow donors, plaintiffs could not argue that it did not apply to bone marrow stem cells—as they did for the blood-borne stem cells.1) As for whether NOTA’s distinction between compensable and noncompensable bodily substances has a rational basis, the court answered in the affirmative.1 And while such a justification could be hobbled together, perplexingly, an inchoate effort was never consummated by the court. Indeed, the court took pains to reject the commonly asserted, but wholly incorrect, basis that compensation is permitted for body parts that regenerate and prohibited for those that do not.1 NOTA makes no such claim, and the prohibition on the sale of part of a liver (which regenerates) and the permissibility on the sale of eggs (which do not regenerate) belies this post hoc rationalization.1 Equally, the claim that the law allows the sale of biological material whose transfer poses little risk or discomfort is contradicted by, among other examples, the sale of human eggs—which is moderately dangerous and onerous.1 Nonetheless, the court held that a rational basis exists and ruled NOTA constitutional. Although the court failed to spell out the rational basis, that does not necessarily mean one does not exist. A rational basis, however, should not be confused with a good one. For VOL. 104, NOS. 3 & 4, MARCH/APRIL 2012 219
Court Permits the Sale of Hematopoietic Stem Cells
example, the Supreme Court upheld an Oklahoma law that prohibited opticians from, among other things, adjusting eyeglass frames—restricting such behavior to licensed ophthalmologists and optometrists—on the ground that it rationally could be supported by the government’s concern for the safety of its citizenry.4 While the Oklahoma law was constitutional, ie, it had a rational basis, it also was undoubtedly foolish—as is much of NOTA. Regarding the second question—whether selling blood-borne stem cells is prohibited by NOTA itself— the Department of Justice (DOJ), the defendant, argued that allowing compensation for the donation of bloodborne stem cells is prohibited by NOTA. The DOJ generally argues in court for the clear dictates of a challenged federal law, regardless of whether the administration agrees with it. Thus, for example, even though the Obama administration disagreed with the “don’t ask, don’t tell” law that covered gays in the military, it defended that law.5 Where a law is not clear, however, an administration is free to choose any reasonable interpretation. And here, the law was, at best, not clear on the question of the applicability of NOTA to hematopoietic stem cells. Nonetheless, the government argued for the lessplausible and more-damaging-to-public-health position: that blood-borne stem cells should be treated as bone marrow, not blood, because these cells originated in bone marrow.1 This view is curious because the more intuitive interpretation would be to equate blood-borne stem cells with blood, not bone marrow. Indeed, as the court recognized, a variety of components of blood originate in bone marrow, and NOTA permits the sale of blood and these other components.1 The government’s reasoning seems to have been that paying for stem cells would result in poorer minorities, among others, improperly feeling “pressure” to commodify themselves.1 I have previously advocated against such paternalism, particularly when no similar ban exists on mining coal or other employment opportunities far more dangerous than “donating” biological material that saves lives.2,3 Indeed, the government argued that the court should prohibit acts that would be wholly permissible if done for free. Thus, asking a poor person to donate marrow for free is perfectly OK, but helping that extremely kind donor with modest compensation is somehow bad.2,3
220 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
That logic seems confused. Moreover, this overprotectiveness harms the very cohort that the avowed policy is asserted to benefit, as many minorities particularly need scarce biological material from other members of their relatively small, genetically similar group.1-3 Further, in evaluating this philosophical conundrum, consider why an act considered laudable becomes, according to some, dangerous or improper when accompanied by payment. True, the motivation of the “donor” will change with compensation, but does the act’s underlying virtue and inherent benefit become so corrupted that we should prohibit it? If you answered yes, consider whether you might change your mind if you daughter needed the transplant. And while it is absolutely correct that difficult decisions are better made without the duress of a loved one’s illness, the sterile analysis of life-and-death situations made in the abstract may result in principles that work well in a law school debate, but not in a hospital or for a family. Notwithstanding these philosophical questions, the court simply rejected the argument that NOTA banned the sale of blood-borne stem cells based on the language of the statute and after the government admitted that paying ordinary blood donors is permissible under NOTA.1 While the court interpreted the law well enough, the underlying question remains: Why should we continue to be subjected to a law that all but arbitrarily prohibits payment for some biological materials, but not others? The inherent contradiction in NOTA highlights that the time has arrived to take a new look at this old law. And though the broader issue of payment for organs requires further discussion, the current regime, which haphazardly permits small efforts to induce greater donation of biological material in some instances, but not others, simply does not make for good health law or policy.
References
1. Flynn et al v Holder. 2011 WL 5986689 (9th Cir 2011). 2. Steinbuch R. Improving the health and welfare of the historically underprivileged. J Natl Med Assoc. 2010;102:40-43. 3. Steinbuch R. Kidneys, cash, & kashrut: A legal, economic, and religious analysis of selling kidneys. Houston Law Rev. 2009;45:1529-1607. 4. Williamson v Lee Optical. 348 US 483 (1955). 5. Gura D. Obama administration defends ‘don’t ask, don’t tell,’ a policy it wants to repeal. NPR News, October 14, 2010. www.npr.org/blogs/thetwoway/2010/10/14/130575512/obama-administration-defends-don-t-askdon-t-tell-a-policy-it-wants-to-repeal. Accessed December 7, 2011. n
VOL. 104, NOS. 3 & 4, MARCH/APRIL 2012