Leading Global Cell Therapy Organizations Support DOJ Appeal of Ruling on Donor Compensation
February 02 2012
A coalition of eight leading international health organizations today issued a statement supporting the U.S. Department of Justice’s appeal of the Ninth Circuit Court ruling that allows certain marrow donors to be compensated. Filed Jan. 17, the Justice Department’s appeal cites the potential for serious health risks to patients and donors if the ruling stands.
Approximately 5,000 patients each year in the United States receive marrow transplants from unrelated donors to treat leukemia, lymphoma and a number of other diseases. The marrow is a source of stem cells that are critical to restoring the immune system for these patients. Two techniques are used to extract these stem cells. The first draws marrow directly from the donor’s hip bone and the second moves the stem cells out of the bone marrow and into the bloodstream using a stimulating hormone, and then collects peripheral blood stem cells (PBSCs) in a procedure similar to the collection of platelets from blood donors.
Since 1984, the National Organ Transplant Act (NOTA) has banned payment for all marrow stem cell donations. However, a Dec. 1, 2011, Ninth Circuit Court of Appeals ruling legalized compensation for PBSC donations, but upheld the ban on compensation for marrow donation through aspiration.
“The world’s leading cell therapy organizations oppose compensating people who sell their stem cells, however collected, and believe the Ninth Circuit made an erroneous distinction between marrow stem cells extracted directly from bone or from blood,” said Jeffrey W. Chell, M.D., chief executive officer of the National Marrow Donor Program® (NMDP), a coalition member that operates the Be The Match Registry®, the world’s largest listing of volunteer marrow donors. “We fully support the Justice Department’s decision to protect patients and their donors by challenging the ruling. Those motivated by self-gain are more likely to withhold health information that would make them unsafe donors. The blood banking experience in the United States shows that this results in donations that are unacceptable from a clinical standpoint.”
The coalition includes the nonprofit NMDP, the World Marrow Donor Association, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society of Histocompatibility and Immunogenetics, International Society of Cellular Therapy, The Transplantation Society and the Worldwide Network for Blood and Marrow Transplantation. Those seeking to overturn the ban against selling stem cells argue that payment for donors might increase patients’ access to bone marrow; however, the coalition asserts the opposite is true.
Paying for stem cells also would mean the U.S. no longer follows standards recognized throughout developed countries in Europe and Asia, which use volunteer donors in cell therapies. As a result, patients may not be able to use the worldwide search process. These international partnerships are vital to helping increase patients’ access to potential donors. In 2011, nearly half of the transplants facilitated by the NMDP involved either an international donor or patient.
The coalition cites the following reasons in its position against donor compensation:
- Protecting Recipient and Donor Safety
A complete and truthful health history is critical to ensure that individuals are eligible to donate and that donated cells are free from infectious diseases. There is substantial scientific evidence that people wanting to sell their blood or body parts are more likely to withhold medical details and information that could harm patients.
- Ensuring Physicians’ Ability to Provide Quality Care
The decision of whether the donation occurs through the traditional method of bone marrow extraction or PBSC donation should be based on the best clinical judgment of the patient’s physician and will vary from patient to patient. While the donor always has the last say on whether and how to donate, PBSCs may not be in the best interests of the patient in many cases. Paying for PBSCs may cause donors to choose this method instead of a marrow extraction recommended by the recipient’s physician.
- Maintaining Altruistic Motivations
Compensating donors could deter those who are willing to donate for purely altruistic reasons. The more than 9.5 million members of the Be The Match Registry, as well as an additional 9 million potential donors available on international registries, are proof positive that people do not need financial incentive to save a life.
- Avoiding the Creation of Markets in Marrow Donation
Patients may promote donor drives with the promise of compensation, appealing to those with financial need, and not fully disclose the risks associated with the donation. For profit organizations also have an incentive to exploit their donors over a patient’s unique needs. In addition, markets put physicians in the morally dubious position of carrying out medical procedures solely for monetary profit.
For these reasons, the members of the coalition remain opposed to the selling of stem cells.
About the Coalition
The coalition includes the NMDP, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society for Histocompatibility and Immunogenetics, International Society of Cellular Therapy, The Transplantation Society, the World Marrow Donor Association and the Worldwide Network for Blood and Marrow Transplantation .