10. A very united blood system and a blood center near the Pacific ocean say that they will follow the FDA recommendations exactly. These centers will neither accelerate dates of implementation nor expand the deferral criteria in response to ARC's policy, which they feel is not scientifically justified.

11. A blood bank administrator commented that his center has not embraced the American Red Cross as the standards-setting organization for the U.S. nor does his center have any intention to do so! His center will follow the FDA recommendation and timetable. He had sharp criticism for the process by which the ARC seems to be developing its donor deferral policies. He says that it remains to be seen whether the ARC vCJD policy will become the de facto standard of care. He personally doubts it.

12. Coincidentally, the following was distributed on Oct. 5 by the list server for ARCNET-L@SENTINEL.REDCROSS.ORG. The quoted article addresses some very real additional concerns about the future impact vCJD testing may have on the availability of blood.

Blood supplies 'could be halved' as donors fear results of vCJD tests. Oct. 2, The Guardian (London), by James Meikle.

Britain could lose up to half its blood supplies within the next two years because of donors' fears that they might find they have the human form of BSE. NHS officials warn that a million of the nation's 2m volunteer blood donors might drop out with the introduction of a test for the fatal variant CJD, which is expected to become available in the near future. They fear that huge numbers could decide they do not want to donate, since they would have to be tested for a condition which is incurable, despite some hopes for treatment on the horizon. The national blood service, which collects 2.2m donations a year from 1.9m volunteers in England and north Wales, is preparing radical contingency plans which would lead to huge changes in the way operations are conducted and post-operative care is organised. These include the increased use of recycled blood, either donated by the patient before operations or collected during operations and then transfused back; the wider use of synthetic blood substitutes; and more use of oxygen masks for patients after operations. NBS officials outline the scale of the impending problem in information being sent to hospital consultants and blood bank managers this week, saying 'The unknown risk that vCJD may be transmissible via the blood supply is probably the largest single challenge that the blood services in the UK have had to face.' Safety measures have already been introduced over the past three years - including the removal of white cells thought most likely to transmit vCJD and the importation of plasma from the United States - but further strategies are said to be essential to mitigate the unquantified risk. A government advisory committee will consider later this month whether anyone who has received a transfusion should now be allowed to donate blood - a measure that might in itself lead to a 10% fall in donors, according to the latest NBS estimate. This follows the results of experiments in sheep which suggest that the deformed prion protein linked to vCJD can be transmitted through blood. But now the service is anticipating the fallout from advances in detection of vCJD. A blood test is expected in about 12-18 months' time, and once it has been proved reliable, potential donors are likely to be screened compulsorily before they can give blood. Liz Reynolds, the national blood service's director of public and customer services, writing in the quarterly information sheet Blood Matters, says: Should a test for vCJD be introduced, it is possible that some donors will not wish to know the outcome. And, if it transpires that a donor knows they might have an incurable disease and not have access to life insurance, mortgages, etc., the likelihood of a large scale defection in the blood donor base must be considered. Here the scenario planning around a worst case option of 50% reduction in blood donors may become a plausible option.' Twenty-two people have so far been identified as having received transfusions using blood from 13 donors who later exhibited vCJD, and thousands of others have received vaccines and clotting factors in which donations from those possibly contaminated volunteers were used. None of those who received whole transfusions has been told, and there is still widespread debate on the ethics of doing so while there is no treatment or cure. It is likely that patients who were told their donation was not needed would suspect the worst. The NBS says any test would have to be robust and reliable' before it could be introduced. Future measures would continue to take into account the delicate balance between safety and sufficiency of supplies. Several countries have already imposed restrictions on donors who have lived in Britain and Europe. A total of 101 Britons have died from vCJD , with six suspected victims still alive."

ADDENDUM Oct. 6, 2001

13. A blood banker in central California commented that his facility will follow the FDA guidelines when they are effective. In the meantime, they will comment on the draft guidelines and they encourage others to do so, too. Regarding the ARC policy to defer donors based on geographic criteria, the responding blood banker suggested (hopefully tongue in cheek) that the ARC should defer those who have been to Japan per the finding of a BSE cow there, and perhaps 300 more too. If the US military follows suit, they will lose even more potential donors too. Both should think about travel to Canada too; a cow with BSE was identified there in 1993! If they are going to have more extensive geographic exclusions than the FDA, both the ARC and the military should be consistent. The responding blood banker wonders what they will do when the first case of BSE is identified in the USA? In the meantime, both should defer people from Western US states with Chronic Wasting Disease (CWD) of deer and elk, or all hunters, especially if they have ever eaten venison! That's the problem with these geographic exclusions, where do they end?

CWD References: Report on CWD, Dept. of Agriculture, Province of Alberta, May 2001

ADDENDUM Oct. 8, 2001

14. A blood banker from Connecticut says "In regard to FDA guidance relating to donor deferral and vCJD, in the August 2001 issue of the AABB Regulatory Update, it states:  "The FDA advises that anyone who wishes to use more stringent geographic donor deferrals must establish a pilot program to ascertain the potential impact of establishing a more stringent program than that recommended by the FDA. Establishments must devise a carerfully structured plan that:...." The required elements of the plan are then stated. That should discourage (as appears the intent of the FDA) some of those responding who are choosing to follow the ARC which has, once again, taken upon itself (although being only a manufacturer) of making a medical decision, although having no authority to do so, in an attempt to set a standard of practice."

15. Dr. Paul Holland says that for those of you interested in the discussion surrounding vCJD and donor deferral policy, there will be a RAP session at the AABB entitled "Mad Cows or Mad Regulators". Anyone interested in addressing any aspects of this issue is welcome to contact Dr. Holland about speaking. The general rules are that you can show up to 4 slides and speak for 5 minutes, unless there are not that many speakers or the chair permits more extended remarks. Dr. Holland will start the session and he has some speakers already lined up, including Alan Williams of the FDA and Robert Jones of the New York Blood Center. Dr. Holland can be reached at abotogo@earthlink.net.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator