Editing Marshall's "Clinical promise, ethical quandry" 1996

*We often use bone marrow to save people from lethal diseases, especially immune deficiency diseases, but it is hard to come by and often causes immune reaction problems.
*Umbilical cord blood seems to offer many of the same benefits, has less immune reaction, and is a little easier to get.
*Cord blood can be transplanted to regenerate bone marrow and therefore all of the other blood cell types.
*There are two leading physicians who say the transplants are going well.
*There are lots of ethical and policy questions that arise however:
**Do you have to obtain consent to collect blood?
**Do you have to tell the donor / donor parents if the blood is found to be positive for diseases?
**How do you regulate comnpanies that will lobby parents to pay for storage of their child's blood as "insurance"?
**''et cetera''
*However, it is not just commercial entities that need regulationg; if we are going to offer transplant material to people, even from within the medical / academic community, it must be from a reputable source.
*So we want the FDA to lay out safe handling rules as well as ethical guidelines.  But we want the ethical guidelines to come around as we're banking--we don't want to wait for a consensus.

==Good and plenty==
*About 200 transplants had been done at the time of publication (1996) and they went well.
*Not much data has been published, however.
*The National Heart, Lung, and Blood Institute plans to fund 24 million worth of research and banking in the coming years.
*Some think that cord blood transplants could be a good medium for gene therapy.  We could, perhaps, add a gene that would allow the transplanted cells to live longer and / or generate more progeny.
*Hal Broxmeyer is from IUSM and is considered a "pioneer of the field''.
*One of cord blood's major advantages over bone marrow is the ease of donation; the bone marrow donation process is invasive.
*Another advantage is the decreased likelihood of immune response.
**With bone marrow transplants, even when patient and donor are matched immunologically, there is a 40% chance of grade 3 or 4 (4 being potentially lethal) '''graft versus host disease''', an immune reaction.
**Over 14 cord transplants, no 3 or 4 GVHDs have been observed (and this was with immune-mismatched donor and recipient).
*Researchers believe cord blood yields fewer immune reactions because an infants immune system is ''naive''.
*Researchers believe cord blood may be safer, too, because the infants immune system weeds out viruses like cytomegalovirus (Epstein-Barr, the most common virus transplanted via bone marrow) before it reaches the umbilical cord.
*Cord blood is cheaper: $3000 for collection and testing versus $20K for bone marrow collection and testing.

==Setting the standards==
*Researchers are hoping the FDA will soon establish standards for collecting and storing blood and testing for bacteria, HIV, hepatitis, and blood-borne genetic risks like sickle cell disease, some immune deficiencies, thalassemia, and perhaps even cystic fibrosis.
*However, this is difficult because you have to get everyone to agree on little things like how to collect the sample.
*There are ethical issues that will make regulation hard, too.  One being that the donor will be a newborn and it cannot give consent, yet testing will result in a load of information, including genetic information, which presents potential privacy risk.
*Transplant researchers seem to agree that parents must give explicit consent for collection, donation, and for each screening test that will be done.  Most researchers believe, too, that parental consent should be obtained for each test performed later.
*The next issue then, is whether or not parents should be told if a genetic test (run by the bank as it will be helpful / necessary to know if a donation has a gene or mutation for things like cystic fibrosis or immune disfunction) returns positive.
**Some say yes, but an IOM report says that adolescents shouldn't be tested for genetic disorders unless there is "an effective curative or preventive treatment that must be instituted early in life."
*Though everyone wants to protect the donor's privacy, while some say we should simply de-identify the donations and their information, other say that the important medical information that may be discovered in the blood must be shared back with the family / donor.

==Private cord blood banks raise concern==
*Lots of people want to start companies to store cord blood.
*Researchers are concerned about this because they think cord blood should be a common property. They want to use it for research. They are afraid it will be stored away (with good intent) but that it will be a waste as it is so unlikely that it will get used.
*The FDA is getting involved and has said it will propose rules for cord blood use and storage and such.
*One company said it would collect and store blood for a one-time fee of $1500 and an annual fee of $95.
*One cord blood researcher from Duke says she does not want to see a family-based bank take away from public banks, especially because a child is unlikely to need their own cord blood even if they do get a disease. (She says that if a person gets a disease, she will not want to transplant their own blood because it may have the progenitors of the disease in it or it may not be able to fight against that disease.)
*Some medical ethicists are vehemently against the cord blood bank services and say that approaching parents at a vulnerable time is wrong.
*"FDA has declared that cord blood will be controlled as a "biologic." Anyone offering the material for therapy will need to obtain an Inve tigational New Drug application from FDA. Thi will enforce minimal tandards and raise new financial barrier to entering the field-and, FDA officials say, focus public scrutiny on it."