Institute of Medicine report on cord blood
The U.S. Congress commissioned an Institute of Medicine (IoM) study on 23 Jan 2004 to make recommendations on the ideal structure of a national cord blood program. The National Academy of Sciences proceeded to assemble an IoM Committee and held a series of meetings on 2 June, 18-19 August, 29 Sept 2004, and 15 Dec 2004. The Institute of Medicine released their report, "Establishing a National Hematopoietic Stem Cell Bank Program", on 14 April 2005 at 4PM.
The background to the IoM report is that legislation was introduced to both houses of Congress in 2003 to establish a "National Cord Blood Program" (see Timeline for 20 Dec 2005). That legislation became bogged down in intense rivalry between the NY Blood Center (NYBC) and the National Marrow Donor Program (NMDP), both of whom wanted to run the program.
In order to sort out the issues, Congress did not pass the Cord Blood Stem Cell Act of 2003 (bills S1717 and HR2852). Instead, Congress modified HR2673, the Omnibus Spending Bill for fiscal year 2004, to include $10 million of appropriations for a National Cord Blood Inventory to be administered by the Human Resources and Services Administration (HRSA). The exact language required that the first $1 million be spent to commission an Institute of Medicine study which would decide how best to distribute the funds. The remaining $9 million could not be released until the study was complete.
The IoM report on cord blood did not side with either NMDP or NYBC, but took a path down the middle. However, history shows that when the National Cord Blood Program was funded, HRSA awarded nearly all the contracts to NMDP, so effectively they won. Eventually the NYBC joined the NMDP network of public banks.
Here is an extremely abbreviated summary (the IoM report is a book):
- The primary goal of the national program is to maximize patient access in the most efficient, cost-effective, and ethical manner possible.
- The U.S. Department of Health and Human Services (DHHS) should establish a new National Cord Blood Policy Board to set rules for the donation, collection, and use of this resource.
- The new National Cord Blood Policy Board should be established at the level of the DHHS Secretary to ensure that it is distanced from other HHS programs (such as NMDP).
- The HHS dept HRSA should solicit proposals for a new Cord Blood Coordinating Center to manage daily operations of cord blood banking and allocation nationwide.
- No current organization has all the necessary capabilities to serve as the Cord Blood Coordinating Center (this implicitly means neither NMDP nor NYBC).
- In particular, techniques of HLA typing and measures of quality control both need to be standardized.
- Cord blood donors must give fully informed consent prior to delivery.
- The FDA should move "promptly" to license cord blood.
- The majority of funding available for the national cord blood bank program should be targeted to expanding the inventories of participating banks.
- According to an economic analysis conducted for the study, the point at which the costs of banking exceed the benefits for the patient population is 200,000 units.