MS. GREGORY: Good afternoon.

I'd just like to come up here rather than try and fix that microphone to my height.

The American Association of Blood Banks is the professional society for over 9,000 individuals involved in blood banking and transfusion medicine and represents roughly 2,200 institutional members including community and Red Cross blood collection centers, hospital-based blood banks, and transfusion services as they collect, process, distribute and transfuse blood and blood components and hematopoietic stem cells.

Our members are responsible for virtually all of the blood collected and more than 80 percent of the blood transfused in this country. For over 50 years, the AABB's highest priority has been to maintain and enhance the safety of the nation's blood supply.

The association operates a wide array of programs to meet the safety priority and is proud to have played a key role in ensuring that the nation's blood supply is safer today than ever before.

The AABB appreciates this opportunity to comment on the potential deferral of donors who have traveled to Great Britain as a means of reducing the theoretical risk of transmission of nvCJD through transfusion of blood and blood products.

The AABB wishes to reiterate its previous position stated at the last meeting of this committee that any measures taken to decrease a theoretical risk must not impact safety by decreasing the availability of the blood supply.

The AABB points out that classical CJD has been the subject of intensive study and notes that current opinion is moving toward a position that transfusion does not transmit this disease. AABB recognizes that data from classical CJD cannot be extrapolated to new variant CJD.

Nevertheless, there are no scientific data to support deferral of donors for new variant CJD. AABB considers it very important to continue to gather and assess data about new variant CJD and was pleased to be able to participate in the survey you heard about earlier today to determine the magnitude of donor loss should donors be deferred based on travel to Great Britain.

In December, when you met last, this committee recognized that 11 percent of donors, as estimated by AABB and other presenters, would not be tolerable. And you asked for more data to evaluate the impact of imposing different deferral criteria on blood availability.

The AABB would like to call your attention to recent data obtained from the National Blood Data Resource Center on current trends in blood donation and utilization, and you've heard this already this morning. Data obtained from the 1998 blood collection and utilization survey indicate that in 1997 12.6 million units were collected and 11.5 million units were transfused.

For allogeneic units, 93 percent were transfused. Between 1994 and 1997, total blood collections decreased by 5.5 percent, while the total number of whole blood and red cell transfusions increased by 3.7 percent during the same period.

Extrapolating recent trends, the National Blood Data Resource Center predicts that demand will exceed supply by the year 2000 if no changes in deferral criteria are applied. Therefore, even with no changes in deferral criteria, it is becoming increasingly difficult to maintain an appropriate level of supply.

Spot shortages during holiday periods and during the summer will be even more difficult to alleviate. Any new deferral criteria for donors will decrease the number of donations available. Thus, a policy that defers even a very small percent, such as one to two percent, of available donors will have a detrimental effect on blood availability.

Furthermore, donors deferred for travel to Great Britain would, of necessity, be replaced at least in part by first time donors, a population which has shown to have higher behavioral risk and a higher incidence and prevalence of infectious diseases known to be transmitted by blood.

Therefore, it is possible that the change in the donor base that might occur as a result of donor deferral or travel to Great Britain might increase the risk of transmission of other known or unrecognized transfusion transmitted pathogens.

Another issue that merits consideration is the potential psychological impact of deferring donors who have traveled to Great Britain. A person who is excluded from donation based upon concerns of transmitting nvCJD may react by becoming anxious about whether he or she might develop nvCJD at a later date.

This is especially worrisome, in that the risk is theoretical, there is no short term intervention or resolution available for the donor, and there is no intervention that can be taken on the donor's behalf to alleviate such concerns.

In conclusion, AABB notes that there is no evidence that nvCJD is transmitted by blood transfusion. There are no cases of nvCJD in the United States. It is unknown whether travel to Great Britain correlates with exposure to or infection with the agent of BSE.

And there is no evidence that any proposed criteria will decrease the theoretical risk of acquiring nvCJD from transfusion. In contrast, there is good evidence that even a one to two percent loss of donors due to new deferral criteria will have a significant impact on blood availability and, hence, on the safety of those transfusion recipients who cannot tolerate a delay in receiving blood products.

The country should contemplate nvCJD deferral criteria only when it is apparent that such a policy would improve blood safety more than the loss of donors and the associated decrease in blood availability would compromise blood safety.

Thank you.

CHAIRMAN BROWN: Thank you, Ms. Gregory.

The word theoretical has been used many, many, many times this morning and will continue to be used, and it's being used correctly. I'd just point out that, for ten years, between 1985 and 1995, the risk of new variant CJD from BSE was also theoretical.

The next speaker is Dave Cavenaugh from the Government Relations Committee of Ten Thousand.

MR. CAVENAUGH: I'm the government relations person at the Committee of Ten Thousand. The organization is the Committee of Ten Thousand.

CHAIRMAN BROWN: Yes, that's fine. Thank you.