It's now high noon. And I had been reading the agenda from a draft and inadvertently left out a presentation by Dr. Stephen Nightingale about the meeting held by the Advisory Committee on Blood Safety and Availability about the reserve capacity of U.S. blood supply.

He will speak next, and he will be followed by Dr. Penny Chan. Both speakers have kindly agreed to limit their presentations to 20 minutes so that we can remain on schedule.

Dr. Nightingale.

DR. NIGHTINGALE: And if possible, less.

Dr. Brown, members of the committee, and ladies and gentlemen, what I will try to do, and do in the next ten minutes, is to summarize the meeting of the Advisory Committee on Blood Safety and Availability that was held on April 29th and 30th of this year to examine the reserve capacity of the United States' blood supply and to recommend how it might be strengthened.

But before I change that slide, since Dr. Freas and Dr. Brown raised the issue, let me briefly, within 30 seconds, go over the jurisdiction of the Advisory Committee on Blood Safety.

It was chartered on October 9th to advise the Secretary and the Assistant Secretary on a broad range of issues which include: implications for blood safety and availability of various economic factors affecting product cost and supply; definition of public health parameters around safety and availability of the blood supply; and finally, broad public health ethical and legal issues related to blood safety.

So I would say, Dr. Brown, yours is, by no means, the only committee which has jurisdiction with which ours overlaps. I am sensitive to the concerns that you raised in your earlier comments and will take them to the Surgeon General.

The committee -- could I have the next slide, please?

Dr. Satcher opened the April 29th meeting of the Advisory Committee by noting what is on the slide here, "that it may be necessary, at some time in the future, to defer, at least temporarily, some portion of the donor pool in order to maintain the integrity of the blood supply."

Dr. Satcher emphasized the need that this be done in a way that would minimize the impact of this action on those who depend on blood transfusions for the health and even their lives. He charged the Advisory Committee to review the state of the reserve capacity of the United States' blood supply and to recommend how it might be strengthened.

He further charged the Advisory Committee to do so before, and not after, circumstances might require use of this reserve capacity. And he concluded his charge by reminding the Advisory Committee that we should never be in a position, as some have suggested we may have been in the past, where we would feel obligated to release a unit of blood if we had any doubt whatever about its safety.

Could I have the next slide, please?

After introductory comments about the current safety profile of the blood supply, Ms. Marian Sullivan of the National Blood Data Resource Center, which is an affiliate of the American Association of Blood Banks, then described the current availability of the blood supply on the basis of data available to her.

She stated that, in 1997, about 12.6 million units of blood were collected and about 111/2 million units of red cells were transfused; 93 percent of allogenic units were transfused; 2 percent were discarded because of screening test results; 4 percent became outdated; and 1 percent were unaccounted for.

However, as shown on this slide here -- leave that right where it is. Turn that slide back on, please. Okay, shown on this slide, total blood collections have decreased by 5.5 percent between 1994 and '97, while the total number of whole blood and red cell transfusions increased by 3.7 percent during the same time.

And extrapolating from the current trends and making the assumption that Ms. Sullivan reiterated several times, the available blood supply in the year 2000 would be 11.7 million units of red cells, and total demand would be 11.9 million units.

There were three substantive comments made during the discussion that followed this presentation. The first was that most outdated units are Group AB blood donations which can only be transfused, I think everybody in the room knows, into a Group AB recipient.

The second comment was the fact that while the overall supply of blood exceeded overall demand during 1997, that did not mean that there were not local shortages during the year. And indeed, there were.

The final comment was that one factor contributing to the trend that Ms. Sullivan described is the aging of the population. About half of all transfusion recipients are over 65. As a result, as the population ages, there will be proportionately fewer donors and proportionately more recipients.

After that -- you can just leave that there for a while -- Dr. George Schreiber of Westat and National Heart, Lung and Blood Institute sponsored retroviral epidemiology donor study, then discussed how donor retention might influence the reserve capacity of the blood supply.

He began by noting that, while almost half of the adult population of the United States has donated at some time, only about 5 percent donate during a given year. In 1995, about 32 percent of roughly eight million blood donors were first time donors.

Half of these donors never returned, and two thirds of those that did returned during the first year after their initial donation. Dr. Schreiber estimated that if the rate at which first time donors returned for a second donation within one year could be increased by 15 percent, the blood supply could be increased by 10 percent.

The discussion that followed focused on the suitability of these donors that might be induced to return. Dr. Schreiber has found that individuals who had donated only twice had no greater incidence of HIV or hepatitis C than individuals who had donated more than twice.

A similar observation has been made about paid plasma donors. Paid plasma donors who return only once, regardless of the interval after their initial donation, appeared just as suitable as those who returned more often and/or more frequently.

After that, Dr. Alan Williams of the American Red Cross Holland Laboratories discussed some preliminary data on the use and effectiveness of incentives to increase blood donation. Again, Dr. Williams emphasized that his data was preliminary, and I will emphasize that again for him.

What he did report was he found that the number of donors who report receiving some non-token compensation had increased from 26 percent in 1995 to 62 percent in 1998. And in a survey of blood donors, Dr. Williams found that future blood credit is the incentive that would most strongly encourage them to give blood.

However, donors indicated that lottery tickets might actually discourage them from making future donations, and that cash incentives might tempt some donors not to disclose a deferrable risk.

Dr. Busch then spoke of the Blood Centers of the Pacific, and he discussed differences of risk factors among blood donors. Dr. Busch, I think, will be speaking this afternoon in the public comment period, and Dr. Busch will speak on his own behalf on that point.

However, I would note that Dr. Busch's presentation was consistent with the observation of Dr. Schreiber and the plasma industry that single repeat donors are as suitable as multiple repeat donors. And Dr. Busch's presentation supported the suggestion of Dr. Schreiber that we focus efforts to expand the reserve capacity of the blood supply on efforts to increase retention of first time donors.

Dr. Gilcher, who is also in the audience and on the committee, did discuss new technologies that might increase yield per donation. He said, however, that because of the increased cost, the increased interval between donations, that this was unlikely to be a significant -- provide a significant addition to the blood supply.

Now, in the public comment and the Advisory Committee discussion that followed, the consensus emerged that retention of more first time donors, as Dr. Schreiber suggested, was the strategy most likely to increase the capacity of the United States blood supply and least likely to increase its risk.

There was also consensus that it would cost a substantial amount of money and incentives, direct or indirect, to retain these first time donors, and that blood banks could not fund these additional costs from current revenues.

However, no consensus was reached on what, if any, incentives, up to and including paid donations, would be effective, how much they would cost, or who would pay for them.

With that in mind, the Advisory Committee then addressed the issues of what, if anything, individuals with hemochromatosis or the blood substitute industry could contribute to the reserve capacity of the blood supply.

There was substantial discussion on that issue in the long run. The most substantive discussion was by Dr. Al Grindon, who presented a range of estimates of the potential contributions of therapeutic phlebotomies from individuals with hemochromatosis.

These estimates range from 300,000 units per year, or 2.5 percent, of the current blood supply to three million units, or 25 percent, of the blood supply. Dr. Grindon's own estimate was on the lower side.

After further discussion, the Advisory Committee did unanimously approve a motion that since blood products obtained from persons with hemochromatosis carry no known increased risk to recipients attributable to hemochromatosis, per se, they may be a valuable resource to augment the diminishing supply.

The Advisory Committee recognized the obligate need for phlebotomy can constitute undue incentive for blood donations due primarily to financial considerations. For this reason, the Department of Health and Human Services, they recommended, should create policies that eliminate incentives to seek donation for purposes of phlebotomy, and that, as such undue incentives are removed, the Department should create policies that eliminate barriers to using this resource.

Finally, the Advisory Committee heard presentations from representatives of the blood substitute industry on the potential contribution of blood substitutes to the reserve capacity of the blood supply.

The consensus of these presentations was that proof of principle had been established for these agents, but unequivocal demonstration of safety and efficacy in adequately powered Phase III clinical trials had not yet been accomplished.

For this reason, it appeared to the committee unlikely that any of these agents would be able to make a meaningful contribution to the reserve capacity of the blood supply within the next two years, but quite possibly they could do so at a later time.

Let me have my last slide, which is a summary of the recommendations that the -- the summary is that demand for blood is increasing at about 1 percent per year and supply is decreasing at about the same rate. The extrapolation from the current trend says demand is expected to exceed supply in the year 2000.

The strategy that appears most likely to increase the reserve capacity of the blood supply -- and again, least likely to increase the risk of blood transfusion -- is to increase retention of first time blood donors.

However -- and these are important. However, there is no guarantee that this goal could be achieved. No firm estimate of how much it would cost and no certainty who would pay for it.

And finally, the complementary strategy to increase the reserve capacity of blood supply is to eliminate undue financial incentives for blood donations by individuals with hemochromatosis. And as such undue incentives are removed, to create policies that eliminate barriers to this use.

However, the potential contribution of this resource, while it may be substantial, is again there is no guarantee that this potential will be realized.

(Applause.)

CHAIRMAN BROWN: Thank you very much, Dr. Nightingale, for a lucid and concise presentation of the Advisory Committee's deliberations and conclusions.

Unless there are questions for Dr. Nightingale, we will proceed then directly to Dr. Penny Chan, who will report on the Canadian viewpoint which, as I understand it, is in flux with two meetings bracketing this one as though the Canadians want to see what we're going to do before they make up their mind.