AMERICAN RED CROSS STATEMENT TO THE FOOD AND DRUG ADMINISTRATION'S TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE RE: VARIANT CREUTZFELDT-JAKOB DISEASE JUNE 28, 2001

Mr. Chairman and members of the Advisory Committee: Discussions about the deferral of donors at risk of transmitting variant Creutzfeldt-Jakob Disease (vCJD) have once again elevated the critical public health issue of blood availability. Historically, improvements in blood safety have been balanced against concerns regarding availability. In fact, some have suggested that "safety is availability." The American Red Cross believes that safety does not have to be compromised to achieve availability. For over a decade, the blood banking community has accepted mediocre performance as the approach to availability, while facing steadily increasing national need for blood. Only 5% of those eligible to donate do so. Just as we have made and continue to make the necessary investments in blood safety, we must now invest aggressively to ensure availability. The American Red Cross has learned time and time again, that when called upon, the American public responds. We are pleased to share with you our efforts to stabilize and expand blood collections to ensure a consistent and adequate supply of blood whenever and wherever needed. By taking steps to develop a consistent supply, the Red Cross will not only be able to address the theoretical risk of vCJD, but also risks posed by future unknown pathogens and other threats to availability. During last year's unprecedented blood shortages, the Red Cross recognized that new donor recruitment and more effective blood collection strategies were needed to achieve a sustainable and expanding blood supply. After a successful investment of more than $2 million in pilot advertising programs, valuable lessons were learned from last year's successful donor recruitment campaigns, which helped us overcome the shortages. Since the need for blood is always growing, any successful effort to increase blood collection and do so on a sustainable basis will help ensure that safe blood is available for every patient who needs it. Expanded vCJD Deferrals: As requested by FDA, I will first outline the Red Cross plans for expanded donor deferral related to the risk of vCJD. We strongly support the leadership of the FDA in developing the current policies governing the deferral of blood donors who have resided in or traveled to the United Kingdom, and the avowed need to expand the deferral in the wake of the spread of BSE in Europe. Given the scientific uncertainty surrounding vCJD and the need to do everything possible to protect the blood supply, in mid-September 2001, the Red Cross will implement a new donor deferral policy to reduce the theoretical risk of transmission of vCJD through blood products. This policy was developed with serious consideration and deliberation involving leading scientists and epidemiologists from the U.S. and around the world. The Red Cross will defer: Donors who have spent time in the United Kingdom for a cumulative total of three months or more since 1980 or Donors who have spent time in any other European country for six months or more since 1980 or Donors who have received a blood transfusion in the United Kingdom. Based upon modeling available to us by our scientists in January 2001, and subsequently used by FDA in its communications with Red Cross on March 30, 2001, this policy will result in an estimated 85% reduction in risk. The FDA has recently incorporated other assumptions into this model. The calculations in the original model used by FDA and Red Cross and FDA's revised model with regard to risk reduction and donor loss are based on the recognized incidence of the disease in cattle, as measured by reported levels of infectivity in cattle. It is recognized that the testing of cattle has been spotty, and the slaughter of cattle less than 30 months of age may be obscuring the occurrence of BSE during the incubation period. Further, the models do not take into account the porous borders between European countries, and therefore underestimate the number of people at potential risk of exposure. Both the American Red Cross and the FDA recognize the donor exclusion must include European exposure. The difference between FDA's current proposal and the Red Cross planned deferral is about the incremental donor loss of 3% regardless of the model used, not a donor loss of 8%. Based on the magnitude of the threat, we believe that our deferral is cautious and prudent. Irrespective of the additional assumptions incorporated into the revised FDA model, the Red Cross has based its deferral policy upon the more conservative assumptions captured in the original model. New Efforts to Increase Blood Availability As stated in our commitment before the HHS Committee on Blood Safety and Availability in April, the Red Cross has accelerated its plans to increase blood availability, starting with the goal to make up for donors who may no longer be eligible. Even prior to implementation of our new policy we have launched substantial efforts to more aggressively recruit, retain and recognize blood donors. We are cultivating and expanding the next generation of volunteer blood donors. The Red Cross is developing a long-term strategy to meet patient needs for blood that uses the latest technology; maximizes our existing donor base; effectively brings in new donors; and leverages our unique network of more than 1,000 Red Cross chapters in communities nationwide. We are confident that with dedicated resources, we can effectively address availability issues. A blood collection model is now being implemented that is based on actual patient needs. This effort will enable us to expand collections using daily blood collections and inventory data. We have established a plan to grow blood collections from 6.5 million to 9 million units annually within the areas served by the Red Cross over the next five years. In order to meet this goal the Red Cross has several specific initiatives underway: Leveraging Technology We are currently using double red blood cell collection technology in four of our regions and plan to implement this collection capability throughout our national system by the end of the year. It is estimated that this technology will increase the number of units by 300,000 annually. The Red Cross has the know-how and is prepared to immediately expand our capacity to freeze red blood cells for type "O", "B", and Rh-negative donations. The latest technology for freezing is currently under FDA review, awaiting final approval. We know that the Red Cross could freeze at least 25,000 units of type "O" blood each year. Maximizing our Existing Donor Base and Bringing in New Donors The Red Cross is investing $4.5 million in direct mail and advertising nationwide in a campaign that began in May and will continue through July. Throughout the summer, more than 2 million type O blood donors, the universal blood type, will be contacted and asked to give blood. Current Red Cross donors donate an average of 1.7 times per year. We are now sending letters to current and lapsed donors to remind them of the need for blood and encourage them to donate if they are eligible. Increasing donations by these donors to 2 times per year will add 1.2 million available units. Energize Red Cross Nationwide Chapter Network Working with our national network of chapters, the Red Cross has the ability to mobilize volunteers in communities across the country. The importance of blood availability and the chapters' vital role in contributing to donor recruitment was a major focus at our recent annual National Convention. National Blood Reserve The Red Cross is establishing a national blood reserve - a strategically located reserve supply of blood supported by a state-of-the-art logistics and distribution system. Part of this reserve would incorporate the frozen units previously mentioned. Conclusion This month marks the 20th anniversary of the first report of HIV. As with the debate over how to protect the blood supply from HIV in the absence of a screening test, deliberations concerning vCJD have once again been framed as a trade-off between safety and availability. Then as now, some are arguing against aggressive donor screening measures because of the perceived impact on availability. Until we have a test and can better assess risk, donor exclusion by designated behavior is the only way to protect the blood supply. We believe this will be an interim action, hopefully soon eclipsed by more scientific information and a blood screening test. Moving beyond yesterday's paradigm, it is incumbent on the blood banking community to address the need for availability and establish a sustainable, consistent blood supply based upon patient needs. Consistent with our mission to alleviate human suffering, the Red Cross is committed to ensuring that the right blood product is available every time, for every patient. If we are wrong in our more cautious deferral criteria, the only consequence will be a more determined and effective approach to blood collection. If we are correct, the consequence of a less cautious deferral policy cannot be corrected.