1 department of health and human services




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15 We know which regions of the country the centers are in. We

16 do not know what the individual centers are. They are

17 reported to us under code. This was to remove any concern

18 about Big Brother, Sister or whatever looking over the data

19 and pointing fingers.

20 [Slide]

21 This is the mid-Atlantic and southeast sections of

22 the country -- eastern section of the country. This is the

23 central section. Presumably, these are in mid-America where

24 the blood supply has traditionally been more stable and less

25 subject to fluctuation, whereas this is in the northeast,


31 1 mid-Atlantic and southeast where there is more fluctuation.

2 I also did this in part because I received a

3 report from the America's Blood Centers that a number of

4 their centers had gone out with appeals in the month of May,

5 toward the end of May and early June. This was earlier than

6 they usually did in the past. It wasn't clear whether this

7 was increased utilization for which we now have no data or

8 whether it was decreased collections. We are not able to

9 detect decreased collections. On the other hand, ours is

10 macro data and individual centers are dealing with their own

11 individual micro information.

12 I think I can stop here. If there any questions,

13 I would be glad to answer them.

14 DR. HOLLINGER: Any questions of Dr. McCurdy?

15 Yes, Dr. Simon?

16 DR. SIMON: I think this information is extremely

17 useful, and I am pleased that the effort is being made to

18 collect it and take a look at it. I know that a lot of the

19 focus is on the fallout in terms of donors from the

20 exclusion from people who have been in the United Kingdom

21 for six months, from 1980 to 1996.

22 I think one of the issues that we are dealing with

23 in both plasma and the blood industry there is that the

24 publicity caused many people to self-defer and not show up

25 so that we can't get accurate data on just how many people


32 1 we are losing because that question was introduced. So, I

2 think the kind of data that Dr. McCurdy is giving us is the

3 kind of data on which we will have to rely, that is, what is

4 the final impact on the blood supply.

5 I would also point out that we have tended not to

6 monitor the supply of source plasma. At our last liaison

7 meeting we discussed this with the FDA but there is now data

8 showing a significant fall-off in source plasma donations,

9 possibly in the range of, you know, 10-20 percent over the

10 last couple of years, which has not yet impacted final

11 product but could. So, I think there are a number of supply

12 issues that may be of importance to this committee and the

13 agency in the upcoming months.

14 DR. MCCURDY: It is hard for me to speak off the

15 cuff on this, but I think that the Institute would be quite

16 willing to listen to proposals that might have a similar

17 type of approach to the plasma industry. I don't know

18 whether there is anything collected in that which is

19 universal but we would at least be willing to talk.

20 DR. SIMON: The main universal is that all new

21 plasma donors are checked through the National Donor

22 Deferral Registry. So, ABRA does have a running total of

23 those checks and of the new plasma donors who have shown up

24 at centers. There has been a bit of a problem getting other

25 sources of data because they are proprietary in nature and


33 1 these centers do compete with each other in similar

2 communities, but I think it is certainly something we need

3 to pay more attention to.

4 DR. MCCURDY: In this, we tried to avoid some of

5 the proprietary issues and so forth by having it go through

6 a so-called neutral party and having us know by code and

7 sections of the country but not by individual center what is

8 going on.

9 DR. HOLLINGER: Dr. Epstein?

10 DR. EPSTEIN: Paul, looking at the last graph, the

11 drop in mid-Atlantic and southeast looks precipitous and

12 large. I just wondered if you could comment on how accurate

13 the data are on that graph and then, secondly, a response to

14 Toby Simon, the Canadians have tried to look at the question

15 of measuring the impact of the U.K. related exposure

16 deferral by doing surveys of donors, including non-returned

17 donors. If, in fact, most centers in the U.S. which have

18 implemented U.K. deferral have only done so in late March

19 and April, it may very well be the case that what we are

20 seeing in May is correlated, but I wonder if there has been

21 any thought in the blood community about doing a survey

22 similar to what the Canadians did to actually find out if

23 that is so. Of course, if the dip goes away we perhaps

24 don't care but if it doesn't go away it might help to know

25 why it is happening.


34 1 DR. MCCURDY: The sample for May which showed that

2 is a sample that had six centers from the east area,

3 northeast, mid-Atlantic and southeast, and four centers from

4 the midwest. There were no centers from the west that have

5 come in with reports yet. And, it is only ten. Ten are

6 extrapolated for the whole 26 sample. I think the closer

7 you get to the 26 the more comfortable I am with that

8 extrapolation. So, I think we need more data and we will

9 certainly share that within the PHS and we will probably

10 ultimately, when we get enough to make it meaningful, try to

11 arrange to share it much more widely.

12 DR. HOLLINGER: Paul, I like your metaphor but I

13 don't think this committee ever wants to look at things with

14 a jaundiced eye --

15 [Laughter]

16 -- but, you know, one of the issues with the

17 apheresis donors -- I think Ron Gilcher commented that he

18 was concerned about how that might make an impact. I know

19 you looked at whole blood and a few other things, but what

20 has happened with the apheresis donors, or have you talked

21 to him? I am particularly interested in that because he

22 said a lot of these people are people who have traveled a

23 lot, extensively, and have been gone.

24 DR. MCCURDY: I have not talked with Ron

25 specifically on this issue. About a week ago we made a


35 1 presentation in front of the TSE advisory committee, and

2 that was focused primarily on what we could learn about the

3 U.K. deferrals and timing.

4 Unfortunately, most of the centers came on fairly

5 late, the largest number, and the others came on

6 intermittently throughout which made analysis a real

7 challenge. We could not detect anything that appeared to

8 happen before and after centers that provided that kind of

9 data came online with U.K. deferral. In that, we looked at

10 the apheresis situation. We are collecting information on

11 platelets and apheresis platelets, and we were unable to

12 detect any real change in the availability of apheresis

13 products in that period of time. But analysis is very

14 difficult and this is macro data. We heard some anecdotes

15 at the TSE advisory committee that there were problems in

16 collections and they did, at least in some instances, seem

17 to be related to U.K. deferral.

18 DR. HOLLINGER: Yes, Toby?

19 DR. SIMON: Just as an anecdotal addition, from

20 our company with 64 centers, the thread that is most

21 consistent is proximity to Air Force installations and a

22 little bit of some of the other services, but it is those

23 centers that draw from that population, either active or

24 retired, that are located geographically in such a way where

25 we have seen the biggest impact. That has been the only


36 1 consistent finding. There has been a little bit also in the

2 plasma industry to correlate with Dr. Gilcher's observation

3 that donors in specialty centers that tend to be higher

4 socioeconomic individuals and travel more, there is a slight

5 tendency to pick up a little more there, but the Air Force

6 one has been the most consistent marker.

7 DR. HOLLINGER: Thank you. Thank you, Paul. I

8 look forward to the next report. The final report is the

9 summary of Transmissible Spongiform Encephalopathies

10 Advisory Committee meeting, which was held June 1st and 2nd

11 of this year, and Dr. Asher will give us an overview and

12 comments about that meeting. Dr. Asher?

13 Summary of Transmissible Spongiform Encephalopathies

14 Advisory Committee Meeting

15 DR. ASHER: Thank you. Good morning.

16 [Slide]

17 The TSE Advisory Committee met on June 1st and 2nd

18 and addressed two issues. First, the issue of potential

19 possible deferral of blood donors with a history of travel

20 or residence in BSE countries other than the United Kingdom,

21 as well as a look back, obviously, concerning the U.K.

22 Second, the possible effects of leukoreduction on reducing

23 the risk of transmitting CJD by blood.

24 As you may recall, although the risk of

25 transmitting CJD via blood and blood products is entirely


37 1 theoretical, the FDA has taken a very conservative position

2 on the issue as recently as November of 1996 recommending

3 withdrawal not only of blood and components but also of

4 plasma derivatives where a donor was belatedly recognized as

5 having CJD or being at increased risk of CJD.

6 [Slide]

7 However, by the end of 1997 it was clear that

8 there was no demonstrated risk, detectable by

9 epidemiological studies, of CJD in implicated plasma

10 derivatives in transmitting disease. The withdrawals were

11 recognized as not substantially reducing the theoretical

12 risk, at least for recipients receiving multiple exposures

13 when at least 25 percent of large plasma pools used to

14 produce derivatives were likely to contain a contribution

15 from at least one donor who would ultimately get sporadic

16 CJD. There was no screening question that could defer such

17 a donor and no laboratory test available to detect the risk.

18 Withdrawals had failed to retrieve most CJD implicated

19 products anyhow, and CJD withdrawals were contributing

20 significantly to shortages of some plasma derivatives. So,

21 in January of 1998 the PHS Advisory Committee on Blood

22 Safety and Availability recommended that the FDA could relax

23 policy sufficient to relieve those shortages without

24 seriously endangering public health.

25 [Slide]


38 1 In August of 1998 the Surgeon General, Dr. David

2 Satcher, announced the new policy which was then elaborated

3 in guidance issued by the FDA in September of 1998. The

4 agency recommended continued deferral of donors with CJD or

5 increased risk of CJD and continued quarantine and retrieval

6 of blood and components, but no longer recommended

7 withdrawal of plasma derivatives prepared from pools to

8 which those donors with classical CJD or increased risk had

9 contributed. However, withdrawal of plasma derivatives and

10 quarantine of intermediates prepared from pools to which any

11 donor who developed new variant CJD -- CJD attributable to

12 infection with bovine a spongiform encephalopathy agent --

13 those derivatives would still be withdrawn.

14 [Slide]

15 The reasons for increased concern about donors

16 during the incubation period of CJD are as follows: First,

17 less is known about the pathogenesis of new variant CJD than

18 sporadic CJD.

19 Second, new variant CJD is an emerging infection

20 not yet recognized in the United States and lymphoid tissues

21 of patients with CJD, and even at the end of the incubation

22 period of new variant CJD, contain detectable protease

23 resistant prion protein while those in patients with

24 sporadic CJD do not, which implies that the blood which

25 contains lymphoid cells might be more infectious in patients


39 1 with new variant CJD than it is in sporadic CJD.

2 Finally, authorities in the United Kingdom decided

3 not to source plasma for preparing derivatives from their

4 own U.K. donors which implied a certain lack of confidence

5 in the safety of the plasma. The FDA then felt compelled to

6 consider the issue of donors who had been potentially

7 exposed to the BSE agent while traveling or residing abroad.

8 [Slide]

9 Following consideration by the TSE Advisory

10 Committee in December of 1998 and June of 1999, the agency

11 recommended deferral of donors who had resided in the United

12 Kingdom for six months or more cumulative between January

13 1st, 1990 and end of December, 1996, and deferral of donors

14 who had received injections of bovine insulin from the

15 United Kingdom, but did not recommend withdrawal of plasma

16 derivatives for U.K. residents at any period or for exposure

17 to injectable bovine products.
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