The final scheduled presentation is Dr. Richard Davey, who is the Chief Medical Officer for the American Red Cross.

DR. DAVEY: Thanks, Dr. Brown. Just before I start, I'd like to correct perhaps one misperception from Mike's presentation. He said that half of patients who get transfused eventually die.

Actually, all patients who get transfused will eventually die.


DR. DAVEY: So, Mr. Chairman, the American Red Cross does welcome the opportunity to speak to this committee on this important subject. The Red Cross supplies almost half of the nation's blood supply through the generosity of over four and a half million volunteer blood donors.

We serve over 3,000 hospitals through our national network of 37 blood regions. The Red Cross regards the safety of the blood supply as its highest priority. As such, the Red Cross is currently conducting nucleic acid testing for HCV and HIV throughout our system under an IND application.

In addition, Red Cross scientists are actively investigating possible emerging threats to the blood supply such as Chagas disease and Babesiosis. We've also supported research in the TSEs through direct research conducted by Dr. William Drohen at our Jerome Holland Laboratory, as well as through -- as well as with collaborative research with both Dr. Brown and with Dr. Rohwer.

The Red Cross actually has devoted more resources than any other private organization to understanding the relationship, if any, between TSEs and blood transfusion. While the safety of the blood supply is our highest priority, the Red Cross also has an additional responsibility to ensure an adequate supply of blood and blood products for the American people.

Indeed, an inadequate supply of blood poses a major safety hazard, as critical blood and blood components may not be available when needed. We view with considerable concern, therefore, any proposal to defer donors who have lived in or traveled to Great Britain during the peak years of the BSE epidemic in that country.

This deferral is being considered because of the theoretical risk of transmitting new variant CJD from individuals who may have consumed beef products in Great Britain during those years. As we know, new variant CJD has not been reported in the United States, and there are no documented cases of this disease being transmitted by blood or blood products worldwide.

Now this morning Dr. Alan Williams presented data gathered through the REDS and ARCNET systems on the impact on the American blood supply if donors who lived in or traveled to Great Britain between 1980 and 1996 were deferred.

In brief, the percentage of donor travel to the UK varied from 0.4 percent for those who resided in the UK for five years or more to 22.6 percent who were in that country for three days or fewer.

The estimated annual blood resource lost by deferral of donors visiting UK between 1984 and 1990 varies from over 35,000 units lost annually for deferral for a five year visit to 1,939,000 units lost for deferral for a one week visit.

That's just an annual loss, not a cumulative loss, which would be larger if we looked at it over a two or three or four year span.

Now the blood supply today is marginal, at best, with shortages often occurring over the holidays and summer months. A variety of recruitment strategies have been implemented with encouraging results, but the donor base remains barely adequate to meet increasing clinical needs.

Our blood supply actually is not very elastic. Increased recruitment efforts, however strenuous, may not be able to overcome the deficit caused by deferrals of the magnitude being considered by this committee.

New donors would have to be found to replace the deferred donors. As these new donors, as we've heard, would be first time donors, most of which would be first time donors, a group with a higher incidence of deferral risk and disease markers, it's quite possible that these new variant CJD deferrals would actually decrease the safety of the blood supply.

In addition, deferred donors may face possible stigmatization for being somehow unsafe, and may have undue concerns about being at risk for a dread disease. Also, and I think this is important, the message that the committee will send to the public with these deferrals is that Mad Cow Disease is a current blood transfusion safety risk in the United States.

Can we say the new variant CJD will never be shown to be transmitted by blood transfusion? Of course we can't. That would be asking us to prove a negative when we can't do that. But we must act rationally using the best science and professional judgement in considering these options.

Research must continue in this important area. Periodic evaluation of our national strategies on blood safety issues must take place. However, given the present body of scientific and epidemiological data, and considering the known impact on our nation's blood supply, any deferral at this time for this theoretical risk cannot be justified.

Now I may just digress from my written comments for a moment. I think this committee clearly has a very important issue in blood safety and it's considering it very, very carefully, to its credit. But I think it's important for us to realize that not having enough blood is a very, very unsafe thing.

In the National Blood Data Resource Center data that wasn't presented today, 8 percent of the hospitals in the United States in 1997 -- 8 percent -- had to defer or cancel surgery because there was not enough blood.

That's a lot. That's within the Red Cross system and across the nation in the independent blood centers, 8 percent of hospitals deferred surgery.

We just don't have enough elasticity to make up for a further major deferral. In the Red Cross system, we are actually increasing donations. Our donations are up, but the demand is up even further.

We also have to consider again the first time donor issue. We're going to be replacing these deferrals, if we can replace them at all, with first time donors primarily.

And we've seen that they have an increased risk of deferral risk factors three times over repeat donors, increased risk of disease markers of twice that of repeat blood donors, a safety issue of concern.

Also, I think we have to ask is it in the public interest, as Mike pointed out just a few minutes ago, to have to convey a message to our donors, most of whom are dedicated pheresis donors and repeat donors, that we no longer wish to have them as participants in the national blood supply.

We will develop a group of hurt, angry and scared donors. And whether deferral is permanent or temporary, it's going to be very hard to give these folks the message that they're deferred for a risk that really we know nothing about and is purely theoretical.

It's up to the blood centers to have to deal with these donors. It's up to the blood centers to have to get new donors, and that's going to be tough indeed. And again, I think it's important to realize that public perception of the safety of the blood supply is also at question here, and deferrals will indeed raise the public perception of risk of TSE in the American blood supply.

So I ask the committee to think very carefully about these proposals and to base their decisions on the best science and epidemiology available. Consider the impact of blood safety that may result from significant erosion of both our blood donor base and of public confidence in the safety of the blood supply.

The American Red Cross will continue to conduct and support research on the possible transmissibility of new variant CJD, and we will honor our commitment to help ensure both a safe and an adequate blood supply for the American people.

Thank you.

CHAIRMAN BROWN: Thank you, Jay.

If there is anyone in the room who wishes to make a statement, this is the time to do it.

Oh, I'm sorry, did you -- Peter, a question for the last speaker or a comment?

DR. LURIE: To the assertion that the development of travel restrictions would signal to the public that Mad Cow Disease is a problem, I guess I have two comments. The first is the Institution of Travel Restrictions for Malaria does not seem to have communicated to the American public that malaria is a problem in the blood supply.

What I think the message the American people will take from this is that a group of people have wrestled with the problem and have done the most they can to protect the blood supply from Mad Cow.

CHAIRMAN BROWN: I must say the Chair agrees with Dr. Lurie on this. I don't think it probably is too smart to go that far afield and make a decision on the basis of something which really is a question of education.

I mean, if someone is going to take a decision to defer, let's say, a small number, let's just say, of donors who have lived in Britain as evidence that Mad Cow Disease exists in the United States, I just don't think there's much we can do about it.

That's just a question of not understanding. In any case, we had a question or a comment from the floor.

DR. FREAS: Please identify yourself.

MS. McMILLAN: Certainly.