9. Paying Up Front for Human Tissue: Bone Marrow, Eggs, and DNA

Bone marrow: Flynn v. Holder¶

Given a capitalist culture where everything can be commodified and corporations can act as individuals (Citizens United v. Federal Election Commission), it is paradoxical that the US federal government allows for the barter and sale of gametes (egg and sperm), yet, does not support the compensation of bone marrow donations designed to diversify existing bone marrow stem cell banks (Flynn v. Holder). The National Organ Transplant Act of 1984 (NOTA) “prohibits the transfer of any human organ for valuable consideration for use in a human transplantation if the transfer affects interstate commerce.” However, this act does not prohibit the sale of bodily reproductive tissue such as eggs and sperm, which is left to the private sector and market-driven economy.

In 2009, the US Attorney General, Eric Holder was sued for prohibiting payment for bone marrow stem cell donations by plaintiffs represented by the Arlington-based libertarian nonprofit Institute for Justice. The plaintiffs included California nonprofit MoreMarrowDonors.org (MMD), parents of children living with disease, and a physician. At the state court level, the case was decided in favor of the government based on the policies associated with NOTA. The plaintiffs took the decision to the US 9th Circuit Court of Appeals, where the decision was reversed in favor of the plaintiffs on December 1, 2011. The decision in Flynn v. Holder permits compensation for bone marrow donations via apheresis (peripheral blood draw) in the form of scholarships, housing allowances, and charitable donations, but not direct cash payment. Patients can now also ask their insurance providers to cover the costs of such compensation (Barnes, 2012)

Video: Snyderman, N. March 15, 2013. A Mother’s Fight. Rock Center with Brian Williams. NBCnews. (Producers, Amy Schmitz and Stacey Naggier).(7:56min) Link

The stakeholders in this groundbreaking case were all interested in diversifying the bone marrow stem cell supply, but their approaches and philosophies differ. MMD is a nonprofit that seeks to broaden the diversity of existing hematopoietic stem cells (HSC), which are collected from bone marrow to treat a variety of blood and genetic disorders and reestablish blood cells following cancer. Because individuals from mixed-race populations are more genetically diverse, and the number of donors in the registry from mixed-race backgrounds is low, immunological matching proves challenging for non-Caucasian recipients (Brown, 1996; NMDP). Though the US National Marrow Donor Program (NMDP) is one of the most ethnically diverse in the world with over 11 million donors registered, it estimates that less than 3% of donors self identify as mixed race.

Video: NBC. March 15, 2013. Man Starts Organization to Compensate Bone Marrow Donors. Rock Center with Brian Williams. NBC.com. (1:39’) Link.

Currently, those of mixed heritage can identify a bone marrow match about 25% of the time as compared to Caucasians who match 66% of the time.

Slide Show: BET July is African-American Bone Marrow Awareness Month. Bet.com. Link

The matches consider the presence of over 600 million possible combinations of HLA surface proteins on haemopoeitic blood stem cells (Brown, 1996; NMDP). For those regions with a scarcity of bone marrow donations from diverse backgrounds, MMD has proposed a pilot program to pay immunologically matched donors up to $3,000 in non-cash payments to promote donors of mixed-race backgrounds to provide bone marrow stem cells (Shay, 2010).

Though all plaintiffs sought to broaden the diversity of the pool of bone marrow stem cells as the current national registry only contains donations from 2% of the population, the involvement of the MMD and their proposed compensation program speaks to the larger notion of “just participant selection” and community based approaches designed to address health inequities in the US. With this proposed program, the donor and recipient both belong to the community of underrepresented minorities that lack representation in bone marrow stem cell banks. However, the $3000 compensation scheme could present opportunities for exploitation, which is a concern of the NMDP. That the program would provide donors with educational scholarships, housing allowances, or contributions to a charity of their choice also raises ethical concerns regarding paternalism. It could be argued that the non-profit decided what is of value for the donor, but this may not be in line with the values of the donor or the community that they represent.

The idea of paying donors who possess HLA combinations that are not well represented in the current registry has also been deliberated by economists who use mathematical models to determine the probability of matches across races and countries. They argue that altruism alone may not be sufficient in addressing those populations in greatest need. The group most affected by low matches are African Americans because of the wide range of HLA genetic diversity within this racial group. Though their models are based on generalizations, they conclude that to meet the demands of the African American population, the US would need to increase donations from this group by tenfold. Bergstrom et al. are careful to point out that all races would benefit from increased participation in the registry, but that payment for donation should only apply for those populations in greatest need (Bergstrom et al., 2009).

Doreen Flynn, another plaintiff in the case, and mother of three daughters living with Fanconi Anemia (FA) believes that payment to all donors, regardless of race, is in order. Flynn is in a unique position as a mother, as she gave birth to one daughter with FA, but then conceived two more using IVF and PGD in hopes of birthing children without FA. Due to errors in her PGD diagnosis, both siblings also live with FA, but she has not had success in matching donors in the NDMP for her children. Flynn’s argument is based on the use of new technologies that reduce risk and harm to the donor, but provide incentives to those with unique HLA profiles. Currently blood stem cells can be expanded in vivo through the administration of granulocyte-stimulating factor five days prior to donation. Due to the stimulation, an increased number of HSCs in marrow results in a larger number of stem cells migrating to the peripheral blood supply (PBSC) where they can be collected without the painful procedure of bone marrow aspiration (Cohen, 2012). Because 70% of bone marrow donations are currently collected from the peripheral blood supply, the plaintiffs argued that the prohibition of payment under NOTA violated the constitutional Equal Protection Clause, because donors could regenerate their own supply of bone marrow stem cells and would experience little harm through a procedure not dissimilar to sperm and blood donation (Barnes, 2012). Based on the precedent of this court case, a similar proposal regarding cord blood donation and incentives to diversify it was proposed by Seema Mohapatra (Mohapatra, 2013).

The NMDP and the Justice Department both expressed concern regarding exploitation of the impoverished and the vulnerable. The 9th District Court panel deliberated on the notion of “blood for money” exchanges in which very ill patients might be financially depleted in trying to secure a bone marrow stem cell match, but ultimately decided in favor of the plaintiffs (Williams, 2012). The decision in the case is in line with a trend in which economic rewards are used to motivate donations of bodily tissues (Lacetera et al., 2013; Klein, 2013). There are also several studies that suggest compensation increases the rate of provision for sperm, eggs, and blood (Ikemoto, 2009; Klitzman & Sauer, 2009; Egli et al., 2011). These policies are careful to avoid language that would indicate the purchase of a biological product and, rather, express a desire to recognize the efforts associated with providing a product or service. Though some argue that these policies place society on an ethical slippery slope, others present evidence for proposals that would move towards the payment for bodily goods, as appeared in a New England Journal of Medicine editorial titled “Made-To-Order Embryos for Sale – A Brave New World?” (Cohen & Adashi, 2013).

On March 28, 2012, rehearing the case on behalf of the government resulted in a unanimous vote to uphold the Appeals Court decision, and US Attorney General Eric H. Holder Jr. decided not to bring the case to the Supreme Court. Had the case gone to the Supreme Court, it would require analysis of the constitutional question of equal protection (Williams, 2012). The decision has led to much debate surrounding the buying and selling of living tissues and organs (Park, 2012).

Egg Procurement: NY ESSCB and CA Bonilla Bill¶

This decision echoes Ellison and Meliker’s position paper regarding payment for oocyte provision, published in the American Journal of Bioethics in 2011 (Ellison and Meliker, 2011). They argue that paying people to provide oocytes, despite the potential and unknown health risks, is not different from current practices of employment in which agricultural workers and miners are exposed to toxic materials. What their argument fails to account for is the disproportionate health risk that is being outsourced to marginalized populations for the benefit of those with privilege in agricultural, reproductive medicine, and energy markets. The “choice” to engage in labor that may harm one’s health is not normalized across different socioeconomic strata. Ellison is a member of the Empire State Stem Cell Board’s Ethics Committee that deliberated for over a year before arriving at the decision to provide people with up to $10,000 for oocytes provided for stem cell research purposes (ESSCB 2009).

Unlike other states, where decisions regarding oocytes in stem cell research were made through ballot initiatives, or other democratic means, New York declared this policy without public input. Much of the opposition to state initiatives for oocyte compensation centers on the informed consent process and the ways in which it may minimize, exclude, or provide unclear language about potential harm. In New York, the proposed informed consent forms underwent several rounds of revision by members of Ethics Committee before being approved (NYSTEM Model Consent Forms; Roxland, 2010; Roxland 2012). Some see the resulting form as a step in the right direction, because it highlights the lack of existing data on long-term health and lists the limited physical and psychological risks known to date. Additionally, a bill that would require pharmacists to distribute Lupron, an ovarian stimulation protocol drug, with the following warning label: “Caution: This drug could cause adverse reactions including, but not limited to heart attacks, diabetes, convulsions, excessive bleeding, and could lead to death” has been deliberated by both the NY Senate consumer protections and affairs committee and the higher education committee, with a decision still pending as of January 2012 (Open Legislation, 2012).

Robert Klitzman, bioethicist and NYSTEM Ethics Committee member, has argued that long-term health data for oocyte providers should be collected, and that compensation for participation in oocyte provision for stem cell research is socially just. He proposes that the NY provision permits underrepresented minorities, who are not typically recruited by privately run IVF clinics, the opportunity to receive the current rate of up to $10,000 should they choose to provide oocytes for state-funded stem cell research (Klitzman & Sauer, 2009).

In 2013, California Assemblyperson Susan Bonilla presented a bill that was sponsored by the American Society for Reproductive Medicine, seeking to compensate oocyte providers for their services. Although the billwas passed by the State Congress, Governor Jerry Brown vetoed the bill saying that “not everything in life is for sale, nor should it be.” This decision was in line with provisions within the California Institute of Regenerative Medicine that prohibit compensation that is above reimbursement for medical expenses (Benjamin, 2013a; Lifscher, 2013).

Although these compensation policies can be contextualized within a responsive justice framework because they seek diverse and equitable representation of participants and stem cell products, it can be argued that these policies propagate injustice. Opponents of payment for tissues destined for stem cell research claim that the compensation schemes described here could reaffirm the very disparity they seek to minimize. They argue that by providing compensation for living tissues in a society with an inequitable distribution of resources, we remove the option of “choice” and create scenarios where the disadvantaged must sell their body parts to gain the same privileges as those who seek their bodies as sources of biological goods (Hyun, 2006; Ikemoto, 2009; Chamany, 2011; Park, 2012; Chamany, 2015).