Ethical issues unresolved surrounding umbilical cord blood banking
Public vs. private bank debate just one sticky issue
Underneath the glitzy marketing materials, promising developments in bone marrow transplants, and piles of consent forms lies a host of unanswered ethical questions surrounding the issue of umbilical cord blood banking.
Ironically, the relatively simple procedure of donating and banking umbilical cord blood (UCB), which is associated with treating a host of malignant and nonmalignant diseases, is creating a list of ethical dilemmas. Consider, for example, the following questions surrounding UCB donation and banking:
• Should the banking program follow the health status of children whose blood is banked?
• Should genetic tests that become available for diseases be used on previously banked blood? If so, who should be informed of the results?
• Should UCB be sold to private companies?
"These issues need to be addressed in advance, along with others, to prevent potential problems down the road with blood banks and fertility clinics," warns Jeremy Sugarman, MD, MPH, MA, associate professor of medicine and medical ethicist at Duke University Medical Center and Health System in Durham, NC.
In a few short years, researchers have realized the value of UCB. The blood is rich in stem cells, which can be used to treat a variety of diseases. Especially promising are advances made in bone marrow transplantation. (For a list of diseases treated with UCB, see above chart.) Traditional bone marrow transplants require painful procedures for donors and patients, time-consuming searches for suitable donors, and costly hospital stays. The New York Blood Center in New York City, for instance, estimates they can cost an average of $113,000, compared with $31,000 for UCB. And unlike the National Marrow Donor Program, which consists of a list of prospective donors, the UCB donation and banking procedure requires testing blood like any other blood bank procedure, but with a twist. "Unlike traditional methods where blood is drawn from adults," Sugarman says, "This procedure uses blood from infants whose future health risk is unknown."
Sugarman and colleagues formed a working group to examine the ethical issues of UCB. The suggestions were published in the Sept. 17 issue of JAMA.1 The following are their conclusions regarding UCB banking:
• UCB technology has promising results, although there are several investigational aspects.
• The identity of the donor of the stored UCB should be secure during the investigational phase.
• More uncertainty is being associated with autologous use than allogenic use.
• UCB marketing tactics in the private sector should require closer attention.
• More data are needed to ensure that recruiting and banking practices of UCB are fair.
• The process of obtaining informed consent for collection of UCB should begin before labor and delivery.
The collection and storage of UCB is gaining momentum across the nation as private blood banking companies bombard expectant mothers with marketing information.
Some of that information may promote the procedure as a "safety net" against the future need of bone marrow by a parent or family member. Additionally, the storing of UCB might protect children from future genetic disorders, according to the marketing materials.
"Most of the obstetricians and gynecologists I talk to say they discourage patients to donate to private companies because they don’t approve of how the private industry is making money off of playing on someone’s fear," explains Richard Moldwin, MD, PhD, director of the Chicago Community Cord Blood Bank. The Chicago bank, which began collecting UCB in 1993, is one of about seven public banks in the country, he adds.
The potential uses of UCB also have peaked the interest of officials at the National Institutes of Health in Bethesda, MD. Duke, for example, is one of two confirmed participating organizations in a national study funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health, to collect UCB for testing at a later date. The study eventually will grow to a third participant, says George Nemo, coordinator of the study.
"Our goal is to collect and cryogenically preserve 15,000 units of UCB for transplant studies to determine if stem cell blood is as effective as traditional blood donation methods," Nemo adds.
Consensus on issue of consent
One area where providers, researchers, and ethicists agree, however, is informed consent. Debate still remains as to when the process should begin and whether anyone other than the mother should be involved. Participants in the institute study at Duke, for example, can choose to include the father in the consent process, but it is not required, Sugarman notes.
Dorothy E. Vawter, PhD, associate director of the Minnesota Center for Health Care Ethics in Minneapolis, has proposed a framework for collecting UCB. "There are logistical and practical resource questions involved in when consent should be obtained. Private banks usually start the process well before labor and delivery; and on the other hand, some public banks often don’t have the leisure or opportunity to get consent before delivery," she says. Vawter’s framework addresses the following fundamental ethics and policy objectives:
• respect infant cord blood donors;
• protect infant cord blood donors;
• respect/protect the infant’s closest relatives;
• maintain or enhance public trust in organ and tissue donation;
• protect and benefit recipients;
• improve fair access to stem cell transplants;
• increase number and diversity of donations.
Perhaps the area where more work needs to be done is in recruiting donors from diverse backgrounds, say Sugarman and Moldwin. "The informed consent process has worked well for well-educated or informed patients, but not so well for others. In some cases, we have to obtain verbal permission right before delivery, then see the mother again following delivery to obtain written consent and draw the blood. That’s very labor-intensive for us," Moldwin explains.
Lower-income women, for example, may not receive adequate prenatal care and often are not informed of the UCB procedure.
"We’ve had several revisions already to our [informed consent] policy, and as of now, we only inform the donor of any positive results to the standard blood bank tests. That means the physician is not informed of the results. One ethical issue that is in the back of our minds, however, is if a donor tests positive for HIV. Do we then revisit the policy because there’s a child in danger?" he asks.
Ultimately, hospitals may have to assume closer scrutiny of private banks to ensure that patients are well-informed of the risks involved. Estimates range from one in 3,000 to one in 20,000 that there will be negative tests results from collected UCB, Moldwin says.
Perhaps ethics committees should take a closer look at the companies hospitals permit to collect UCB in their institutions, Sugarman suggests. "I think the committee might want to ask itself what kind of business arrangements are acceptable for the hospital to engage in, and should the hospital represent one company over another."