Here is a draft letter to the Dept. of Health and Human Services (DHHS) on this issue. It is provided here for review:

"We wish to alert you to a serious threat to patient care in the United States. The American blood supply is facing a major shortage that may jeopardize the health of the millions of Americans who require the transfusion of blood and blood products each year. A series of proposed blood donor deferrals because of the theoretical risk of blood borne transmission of vCJD (bovine spongioform encephalophy or "mad cow disease") will dramatically reduce the supply of blood, rendering an already marginal blood supply completely inadequate to meet critical patient care needs. The American blood supply is now extremely safe because of a successful effort by the FDA, blood transfusion specialists and commercial companies to develop and introduce highly effective blood donor screening procedures and technologies. The vigilance of the Department of Health and Human Services and the Department of Agriculture has prevented the introduction of bovine spongioform encephalopathy (BSE) into the United States. In Europe BSE has been controlled but not eradicated. Over 100 human cases of vCJD (the human variant of BSE) have been reported and the extent of the epidemic remains unclear. It is reassuring that there has never been a reported case of vCJD being transmitted by blood transfusion. Recipients of blood transfusions from patients who subsequently developed vCJD have not developed the disease. Transmission by blood transfusion, therefore, remains theoretical. The mode of transmission and the incubation period of the disease are not well established, however, so continued vigilance and prudent precautionary measures are warranted. Precautionary measures, however, should be based on a careful analysis of the science and an evaluation of the impact of these measures. The Transmissible Spongioform Encephalopathy Advisory Committee (TSEAC) of the FDA has carefully evaluated these options. They have considered the impact of limited blood donor deferrals and have recommended some targeted deferral policies that identify those donors who may have the highest risk for harboring and/or transmitting vCJD, if any risk exists at all. While these deferral measures are arbitrary and will stress the blood supply, they can probably be managed by aggressive donor recruiting and donor retention measures. Unfortunately, the American Red Cross (ARC) has greatly expanded the donor deferral policies recommended by the FDA Advisory Committee. The ARC proposes that all donors who have resided in the United Kingdom for three months or more, or who have resided for a cumulative total of six months or more in any other European country since 1980 be indefinitely deferred from donating blood. This policy would result in a devastating loss of blood donors. Military personnel, students, businessmen, international workers and others, many of whom are dedicated repeat blood or platelet donors, can no longer give blood. The national loss of blood donors is estimated to be between 7% and 10%. The loss in New York City will be especially severe, with up to a 30% loss in available blood for transfusion. There is no way that this loss can be effectively managed. Approximately 8% of hospitals currently report surgery being canceled because of lack of blood. This number of canceled surgeries will greatly increase. There is great danger of patients in critical need of blood not having this vital material available when needed. We must balance a theoretical risk with a real and present danger to the American blood supply and to the patients who require blood transfusion. We urge continued surveillance of the vCJD issue. New science must be immediately brought before appropriate government and professional organizations as it becomes available. However, it is clearly not safe to have an inadequate blood supply. The drastic deferral policies proposed by the American Red Cross cannot be supported by current science and will have a major negative impact on American public health. The donor deferral recommendations of the TSEAC are already quite conservative as there is no defined risk of vCJD being transmitted by transfusion. We strongly recommend that DHHS urge that these recommendations not be exceeded and that TSEAC and the DHHS Advisory Committee on Blood Safety and Availability be the clear focal points for the determination of national vCJD donor deferral policy."

In response to the above concerns and draft letter, the following discussion has ensued:

1. Reply #1 was submitted by a medical director of a free-standing blood center: "From what I can tell, ARC is going "full steam ahead" with their deferral policy, effective this September. It will not matter what FDA says or does. It is my perception that we may all be dragged along with them, regardless of the consequences on blood supply. If anyone has a thoughtful and effective way to derail this steamroller before September, please share it with the rest of us.

2. Reply #2 was also submitted from a blood banker who works at a free-standing blood center: "Other than one typo, the draft letter is an excellent, rational response to the situation. As a personal comment, I might add that Dr. Healy's faith in the ARC's ability to increase donations in the face of significantly higher deferral rates is most unreasonable. After all, it's the ARC that seems to have been experiencing the most difficulty recruiting donors these past couple of years. If those of us running independent blood centers are concerned about the prospects of devastating shortages with this new deferral policy, then the ARC should be scared out of its wits. I would not be surprised if many of the rank and file are!"

3. Reply #3 was submitted by a medical director within the ARC system: "If the absence of data regarding transmission by transfusion in humans turns out to be wrong and vCJD is shown to be transmissible by blood transfusion, then we will have spread TSE/vCJD throughout the country (a country that so far, to this date as best as anyone can tell, does not have a BSE/vCJD problem in the food supply). With such a long incubation period of infectivity before symptom onset, this would mean that healthy-appearing, prion-carrying donors may have many years of donation before we realize they are infected and have passed on the infectious agent through transfusion of their donated products. Since only 5% of those eligible to donate blood actually donate, we have the rest of the eligible donors (the "other 95%") to ask to step up to the plate and meet their community obligation (and to help replace the donations lost by the deferral of some previously loyal blood donors) while everyone is helping to maintain the safety of the blood supply (at a time when major doubts continue to exist over whether TSE/BSE/vCJD is transmissible by blood transfusion). Although the research is still being done, the early animal data on transfusion transmission of TSE (sheep to sheep where the blood donor was infected with prion but was asymptomatic and the recipient became infected and symptomatic with TSE, Lancet 2000; 356: 999-1000 and Implications of Study Reporting Transmission of TSE by Transfusion in Sheep) should definitely make us cautious. Another recent paper involving primate transmission of TSE (intravenous injection of a brain homogenate, PNAS 2001; 98: 4142-4147) gives some more cause for concern. Even though the intravenous injection of brain homogenate is not the same as the intravenous injection of infected blood, the similarities between intravenous injections of liquid infectious sources are sufficient to justify caution. From the proposed letter: "While these deferral measures [by FDA] are arbitrary and will stress the blood supply, they can probably be managed by aggressive donor recruiting and donor retention measures." I guess we are assuming that the ARC suggested deferral and donor loss percentage cannot be offset by "aggressive donor recruiting and donor retention measures." That is an assumption that has not been proven either. American citizens step up and are counted when they are needed (natural disasters, man-made disasters, bombings, etc.). Experience has shown this time and time again. If they know they are needed, the American public steps up and meets the need. It is a matter of letting the American public know they are needed. The "other 95%" (or even the "other 85%, if the predicted additional loss of donors does actually turn out to be 10%) must be reached and in a way that they understand they are now needed more than ever. It may be expensive to come up with ways to reach the "other 95%," but it can be done. And they will come.

4. Reply #4 was from a blood banker in Northern California who suggested developing a consensus letter to be signed by influential blood bankers, similar to what Dr. Larry Petz did re: universal leukoreduction. This fourth reply went on to say: "I think this is a well-written letter and I would be happy to sign it. In addition to direct loss of donors implicated by these expanded criteria, we will have "fall out" loss of donors who don't understand the deferral, and of friends and associates of "appropriately" deferred donors who convey their negative reaction to no longer being eligible to give blood. In addition, it is likely the military will feel compelled to follow the most conservative (ARC) deferral policy, and will close US bases to non-military blood collection. which could add 1-2% additional donor loss. Also persons transfused (past or future) in England will be deferred. Since the proposed ARC deferral includes residence in Britain (3 months) or Europe (6 months) from 1980 on (rather than the current policy that ends the risk period in 1996), this includes visits in the future which could have an adverse impact on not only donation but the travel industry. It will also have major implications for source and recovered plasma and derivatives, since it is irrational to not accept blood donations from donors with moderate exposure in Europe, yet still accept derivatives manufactured from European or mixed-source donor plasma, or indeed from US donor plasma processed in plants that have also processed European donor plasma. The ramifications of this are enormous, given the current admixture of donor sources in pools and intermediate pastes. The supply of several derivatives is already precarious.

5. Reply #5 is also from an independent blood bank: "The letter is very good, but if the ARC doesn't change their guidelines, I think many blood centers will follow suit, and it will become the Standard of care. Maybe the letters should be going to Dr. Bernadine Healy instead. This whole situation is very frightening to me, and it doesn't seem like the FDA has any power to stop the drastic measures the ARC seems bent on doing, so I don't know what our letter will do, but it is worth a try!"

6. Reply #6: "The letter is a good idea but it is too long. I understand that most legislators will not read something more than 1 page long. I agree with the sentiment, however. "

7. Reply #7: I think its a good and valid letter. Tell them there is a typo 8 lines from bottom where the word "will" is spelled "with"

(Editor's NOTE: The typo has been corrected in this web version of the draft letter.)

8. Reply #8 was from a blood banker who wants the e-network to be aware of the upcoming Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) meeting. According to this individual, if clinical transfusionists are able to attend and present statements during the open public hearing, it would be of value. The meeting will be held on June 28, 2001, 8:00 a.m. to 5:00 p.m.; and on June 29, 2001, 8:00 to 11:30 a.m. at the Holiday Inn, Versailles Ballroom I and II, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000. The Contact Person to make arrangements to give a public statement is William Freas, Ph.D., or Sheila D. Langford, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12392. Please call the Information Line for up-to-date information on this meeting. Agenda: On June 28, 2001, the committee will review and discuss the suitability of blood donors who have lived or traveled in various countries based on recent information concerning new-variant Creutzfeldt-Jakob disease (vCJD) and bovine spongiform encephalopathy (BSE) in those countries. In the afternoon the committee will discuss the safety of FDA-regulated plasma derivatives prepared in establishments proposing to use on the same manufacturing line, plasma which does and plasma which does not comply with current U.S. standards,

With regard to donor deferral for vCJD risk factors. On June 29, 2001, the committee will discuss the interim results of a new study on the inactivation of TSE agent by the manufacturing process for gelatin. Oral Presentations: Between approximately 10:50 and 11:30 a.m., and 2:30 and 3:10 p.m. on June 28, 2001; and between 10:00 and 10:30 a.m. on June 29, 2001, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before June 15, 2001. Closed Committee Deliberations: On June 28, 2001, from 4:30 to 5:00 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b (c)(4)). This portion of the meeting will be closed to permit discussion of this material.

ADDENDA May 29, 2001

9. Reply #9: A highly respected blood banker in Cleveland had the following opinion regarding the vCJD issue: "I share the concerns of the many who worry about the adequacy of the blood supply with the new deferral policy. Those of us on the front-lines of transfusion medicine practice have all witnessed, in the past few years, an increasing number of days when blood and blood components are in very short, and sometimes inadequate supply to meet patient needs. Indeed, my biggest fear in recent years has been coming to work one day and learning that there is an insufficient supply of blood or blood components to treat acutely bleeding patients. Mindful of the theoretical risks from blood-transmitted nvCJD I am nonetheless perplexed that a policy to markedly increase the number of donors deferred has apparently been promulgated without careful analysis, planning and coordination to insure an adequate supply of blood. Safety of the blood supply certainly includes an adequate blood supply and this should be a priority focus of the FDA and other governmental agencies/individuals in leadership positions. A more subtle prospect is to create an environment of fear surrounding blood such that doctors and patients, loathe to give and receive blood modify or possibly cancel treatment plans, possibly to the detriment of good patient care. All in all, a decision of this magnitude - to markedly reduce the number of currently enrolled and eligible blood donors - in my view, should be achieved by consensus of all those agencies charged with providing and protecting a safe and adequate supply of blood."

10. Reply #10:The following reply was submitted from the Chief of a Transfusion Medicine Service in Michigan, who says that he is in complete support of the draft letter and wishes to add his name to the signatures. Here is what he has to say:

"I have already written Dr. Healy about this ill-conceived deferral policy and the immediate clinical impact resulting from a theoretical risk. The patient seems to have been forgotten in a policy that appears to be driven by lawyers. This is not HIV; there is no evidence of transfusion-transmission of this disease in the country with the highest density of cases. The paper by Houston, et al, "Transmission of BSE by blood transfusion in sheep," Lancet 2000; 356:999-1000, cannot be cited as "proof" of transfusion-transmission. One event in a non-human species is reason to review our current practices, not to become hostage to a plan to decimate the blood supply.

There are real, measureable risks of transmission of hepatitis, CMV, HIV and, even, malaria and Babesia, not to mention bacterial contamination. This deferral of travelers to the British Isles is a ludicrous detour on the road to increasing the safety of the blood supply. The impact will be greater than expected but still hard to measure: self-deferment by healthy donors who think they are part of the deferral population will result in lower-than-expected deferrals at the blood centers because of fewer attempts, not because the population does not exist. Not a good way to start the summer and enter our annual critical mismatch of need with supply. In fact, I am afraid that this ludicrous policy will only be reversed when there are some well-publicized cases of death from exsanguination because of depletion of existing blood stores. When Congresspersons have major surgery delayed because of lack of blood inventory, interest will increase, not before."

ADDENDUM Aug. 30, 2001: See FDA's draft revision on this subject.

N.B. SUPERSEDED by Revised FDA Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (PDF file) Jan. 10, 2002.

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