Blood Safety Transcripts

DEPARTMENT OF HEALTH AND HUMAN SERVICES
ADVISORY COMMITTEE ON BLOOD SAFETY AND AVAILABILITY

Twenty-Seventh Meeting
Volume II
Tuesday, September 20, 2005
9:05 a.m.
Bethesda North Marriott Hotel
and Conference Center
5701 Marinelli Road
North Bethesda, Maryland 20852

P A R T I C I P A N T S

• Mark Brecher, M.D., Chairman
• Jerry A. Holmberg, Ph.D., Executive Secretary
• Judy Angelbeck, Ph.D.
• Celso Bianco, M.D.
• Arthur W. Bracey, M.D.
• Paul F. Haas, Ph.D.
• Jeanne Linden, M.D.
• Karen Shoos Lipton, J.D.
• Gargi Pahuja
• Susan D. Roseff, M.D.
• S. Gerald Sandler, M.D.
• Merlyn Sayers, M.D., Ph.D.
• Mark Skinner, J.D.
• Pearl Toy, M.D.
• Wing Yen Wong, M.D.
• Non-voting Government Representatives
• Jay Epstein, M.D.
• James S. Bowman III, M.D.
• CDR Michael Libby

C O N T E N T S

• Call to Order - Mark Brecher, M.D., Chair 4
• Roll Call - Jerry Holmberg, Ph.D. 4
• Committee Discussion 5
• Break 74
• Committee Discussion 74
• Lunch 114
• Committee Discussion 115
• Adjournment 129

1 P R O C E E D I N G S
2 Call to Order
3 DR. BRECHER: Okay. I'd like to call this
4 second day of the meeting to order. We're going to
5 start with a roll call. Jerry?
6 Roll Call
7 DR. HOLMBERG: For the second day of our
8 meeting, September 20th, Judy Angelbeck?
9 DR. ANGELBECK: Here.
10 DR. HOLMBERG: Celso Bianco?
11 DR. BIANCO: Here.
12 DR. HOLMBERG: Art Bracey?
13 DR. BRACEY: Here.
14 DR. HOLMBERG: Mark Brecher?
15 DR. BRECHER: Here.
16 DR. HOLMBERG: Paul Haas?
17 DR. HAAS: Here.
18 DR. HOLMBERG: Andrew Heaton is absent.
19 Jeanne Linden?
20 DR. LINDEN: Here.
21 DR. HOLMBERG: Gargi Pahuja?
22 MS. PAHUJA: Yes.
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1 DR. HOLMBERG: Karen Shoos Lipton?
2 MS. LIPTON: Here.
3 DR. HOLMBERG: Susan Roseff?
4 DR. ROSEFF: Here.
5 DR. HOLMBERG: Jerry Sandler?
6 DR. SANDLER: Here.
7 DR. HOLMBERG: Merlyn Sayers?
8 DR. SAYERS: Here.
9 DR. HOLMBERG: Mark Skinner?
10 MR. SKINNER: Here.
11 DR. HOLMBERG: Pearl Toy?
12 DR. TOY: Here.
13 DR. HOLMBERG: John Walsh is absent. Wing
14 Yen Wong?
15 DR. WONG: Here.
16 DR. HOLMBERG: James Bowman will be here
17 late. Jay Epstein?
18 DR. EPSTEIN: Here.
19 DR. HOLMBERG: Harvey Klein is absent.
20 Matt Kuehnert is absent. Mike Libby?
21 COMMANDER LIBBY: Here.
22 Committee Discussion
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1 DR. BRECHER: All right. We have a lot of
2 discussion time today. We have a major charge.
3 There are three documents I'd like to call
4 everyone's attention to before we begin. One is a
5 set of questions that Jerry has put together
6 basically outlining what HHS would like from us.
7 It begins by saying: Does the committee
8 believe there is a need for the Department to
9 develop a strategic plan for detecting and
10 preventing transfusion-transmitted complications in
11 the 21st century? If a new strategic plan is
12 recommended by the committee, what scope of issues
13 does the committee believe that the plan should
14 address? What role should the Advisory Committee
15 and its subcommittees play in the development of
16 the strategic plan? And then there are a whole
17 series of questions that relate principally to the
18 presentations that we heard yesterday. So I would
19 encourage everyone to look this over because this
20 is going to be our game plan for discussion.
21 The second document I'd like to call your
22 attention to is, in your books, right in front of
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1 the orange tab is the subcommittee report. Jeanne,
2 maybe you could talk us through that. This is from
3 your subcommittee; is that correct?
4 DR. LINDEN: Sort of, yes.
5 DR. BRECHER: Sort of, yes?
6 DR. LINDEN: Yes. I don't think of
7 anything to add other than what I said yesterday.
8 DR. BRECHER: Okay. So why don't we just
9 take a look at this. This basically summarizes
10 what the subcommittee concluded.
11 The third item is on the other side of the
12 orange tab. It's an e-mail from Paul Haas, our
13 resident economist, with some thoughtful words
14 about the last meeting. Maybe, Paul, you could
15 just say a few words about what you concluded.
16 DR. HAAS: I think the fundamental message
17 is that nothing happens anywhere without the use of
18 resources. And as we go through our deliberation
19 to come up with recommendations and have no concept
20 of the resources necessary to do that, one, I don't
21 think that's wise; and, secondly, I don't think
22 it's politically wise. And so what I just want us
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1 to do is try and keep the use of resources in mind,
2 but not so constrain ourselves in the sense of
3 saying we don't have it so we don't want to do it.
4 I think we ought to push the envelope, but we
5 better keep the resource question or issue there.
6 DR. BRECHER: Okay. Thank you, Paul.
7 So let's kick off--
8 DR. BIANCO: Mark, there is another issue
9 that I'd like you to add to the agenda. The
10 charter of the committee expires a year from now,
11 next October, and it takes two to three years to
12 write a new charter, as we all know. Maybe that's
13 the opportunity to sharpen up or focus some of the
14 questions. It's very vague, very unclear. And as
15 we think strategically and all that, I think we
16 should at least ask the question whether some of
17 the things that are there in the charter should be
18 revised or not and make that suggestion to the
19 Assistant Secretary.
20 DR. BRECHER: Well, maybe we can be more
21 specific and pull the charter for the next meeting
22 and go through it and see what we think needs to be
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1 changed.
2 DR. BIANCO: It's in our books, and it's
3 way in the back close to where Jerry's report was.
4 In front of the blue tab it was. I moved it, but I
5 think that's where it was.
6 DR. HOLMBERG: It's actually following
7 part of the supporting document for Dr. McClellan's
8 response. If you go to, I think it's the lavender
9 tab, Dr. McClellan's May 13th letter, and at the
10 end of that is the letter to McClellan from Dr.
11 Beato, and behind that is the charter for the
12 Advisory Committee.
13 DR. BRECHER: I think that's--I'll just
14 take a moment for everyone to take a look at the
15 charter, and maybe we can discuss that briefly.
16 DR. BIANCO: I don't think we need to at
17 this meeting. I think that as we think strategically we
18 should have it mind.
19 DR. BRECHER: Jerry?
20 DR. HOLMBERG: As the Executive Secretary,
21 I'd like to make a comment. As we go through this
22 process today, I want to make sure that people
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1 understand that their role on the committee is as
2 subject matter experts and that their position here
3 is to provide recommendations to the Secretary of
4 Health and Human Services; and that sometimes we
5 have personal agendas and we have to make sure that
6 we put maybe our personal agendas aside and look at
7 the well-being for where we feel the blood
8 community should go.
9 So I just throw that out, that, you know,
10 your role here is as a subject matter expert on
11 this and not as a lobbyist for a special group.
12 DR. BRECHER: All right. Let's start with
13 the easier questions. Should our committee
14 recommend that a strategic plan for improving blood
15 safety and availability in the 21st century be a
16 goal of HHS? Does everyone agree with that? Okay.
17 Because if we had said no, then we could have gone
18 home.
19 [Laughter.]
20 DR. BIANCO: You should have told us
21 before.
22 [Laughter.]
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1 DR. BRECHER: No, that would have been
2 biasing you.
3 Okay. So the second question is: What
4 scope of issues should that strategic plan
5 encompass?
6 DR. EPSTEIN: Mark?
7 DR. BRECHER: Yes?
8 DR. EPSTEIN: Back on the first question,
9 whereas we have consensus, I think that in any
10 recommendation we make it will fall to us to
11 provide the rationale, and that may warrant a
12 little bit of discussion.
13 DR. BRECHER: Okay. Fair enough. Jerry?
14 DR. SANDLER: The first question, as it's
15 worded, says "detecting and preventing trans-
16 fusion-transmitted complications." That's not the
17 same as saying transfusion-related complications,
18 and I'm wondering, are we excluding the whole
19 subject area of errors, for example, from our
20 discussion by limiting it to what looks like a
21 discussion of infectious diseases.
22 DR. BRECHER: I would think if we inserted
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1 the word "related" that it would include errors.
2 DR. SANDLER: Thank you.
3 DR. BRECHER: Now--go ahead, Jeanne.
4 DR. LINDEN: Just to clarify, that was the
5 intent of the subcommittee. I agree that wording
6 is suboptimal. I believe "related" would equally
7 reflect our thoughts.
8 DR. BRECHER: Is it "complications" or
9 "adverse events"?
10 DR. SANDLER: I think "adverse events."
11 We've got TRALI. We've got errors. We've got a
12 whole bunch of things. So I think "adverse events"
13 is probably better. That would include immune
14 modulation, whatever is coming along.
15 DR. BRECHER: Okay. Jay?
16 DR. EPSTEIN: Well, this also leaves out
17 supply, unless you very indirectly consider, you
18 know, shortages to be itself an adverse event,
19 which is a reasonable point of view. But I think
20 we actually had earlier wording, Jerry, about
21 improving safety and availability, which is a
22 broader construct. But I just think that it
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1 shouldn't be so focused on adverse event.
2 DR. BRECHER: Did you want--you agree with
3 that? Okay. Karen?
4 MS. LIPTON: I know this opens up sort of
5 a can of worms, but we talked yesterday briefly
6 about National Blood Policy and is there one still
7 in existence, and, you know, in some ways if
8 you--we don't have it in front of us, but if you
9 look at it, that really is sort of a backdrop of
10 what you're trying to achieve through the strategic
11 plan. I think it's another way of saying what Jay
12 is saying: What are we trying to accomplish
13 through a strategic plan? But I guess what I'd ask
14 is: Do we know if that still has any force and
15 effect on what we do, the National Blood Policy?
16 DR. BIANCO: It's still on the books, and
17 you were the last one to address it--I don't
18 know--ten years ago?
19 DR. HOLMBERG: I'll remind people that in
20 January 2004 we went back and we reviewed the
21 National Blood Policy.
22 DR. BRECHER: See how memorable it was.
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1 MS. LIPTON: So it is still in effect.
2 DR. HOLMBERG: Yes.
3 MS. LIPTON: So should we not in some ways
4 also be using that to look at the strategic plan?
5 I'm sorry. I didn't even think about it until now.
6 But we just want to make sure it's consonant with
7 the National Blood Policy.
8 DR. HOLMBERG: The recommendation at the
9 time, 2004, the consensus from the transcripts was
10 that it was still pertinent, and that although
11 there were some words that could be refined to
12 reflect today's language, it still covered the
13 concerns of safety and availability of products.
14 You know, it dealt with issues such as the
15 different testing that was limited at that time.
16 But it still brought in all the parameters of blood
17 safety and availability.
18 MS. LIPTON: So would we want to reference
19 it somehow and in discussion of a strategic plan?
20 I mean, it almost seems as if we have this policy
21 over here and then we're talking about elements of
22 the strategic plan for blood. And somewhere we
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1 probably want to put the two together, or at least
2 reference it.
3 DR. BRECHER: We still, I think, need to
4 get back to Jay's comment that we've had three
5 meetings that have touched on this subject, and so
6 we ought to conclude that there needs to be an
7 improvement over what is currently in place based
8 on those presentations. Jay?
9 DR. EPSTEIN: I think what this is about
10 is setting priorities and communicating a vision of
11 where we are versus where we want to be, and the
12 key levers, if you will, to get us from Point A to
13 Point B.
14 I'm not sure it's the same thing as the
15 National Blood Policy because I think that that
16 dealt a lot with the question of the underlying
17 structure of our system. And I'm not convinced
18 that the strategic plan needs to take on the
19 question of restructuring, although that is, of
20 course, open to debate. I think we have adequate
21 structures and that, you know, we have our
22 respective roles in a largely privatized system,
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1 albeit regulated and publicly funded. And I think
2 that what this is about instead is where should we
3 be putting energy and effort. In other words, what
4 are the big issues that we should be focused on?
5 Again, there may be others who feel that,
6 well, we really can't do that without restructuring, but
7 personally I think that that's not
8 what's needed now.
9 MS. LIPTON: Well, I actually thought the
10 policy wasn't so much about structure. I think
11 that there was a lot that the private community did
12 afterwards. I thought the policy really was about
13 accessibility and supply. It was about availability,
14 safety, and accessibility.
15 DR. EPSTEIN: Yes, but that was at the
16 level of a statement of principles but--and I agree
17 that it's important to have a statement of
18 principles, and I also agree with the earlier
19 conclusion that the principles articulated in 1974
20 remain sound. But I think that the underlying
21 issue at the time that the National Blood Policy
22 was promulgated was whether the American blood
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1 system should be nationalized. And the conclusion
2 was, no, we can do okay with a privatized system.
3 And I think, you know, from my point of view, then
4 there's the key structural question, and my answer
5 is, well, it's still working okay, let's leave that
6 part alone.
7 So I agree with you that the National
8 Blood Policy also dealt with certain values and
9 that they remain sound but that, therefore, I don't
10 think they're the subject matter of any new
11 strategic plan. We're not trying to change the
12 values of accessibility, affordability--
13 MS. LIPTON: I think maybe that's what I
14 was asking. Shouldn't we just say--you know, the
15 strategic plan we're creating is really--it's
16 supports the National Blood Policy or the values of
17 the National Blood Policy.
18 DR. BRECHER: Maybe what we should do is
19 lay out what we think are the priorities for the
20 country and then decide how best to make them
21 happen. Jeanne?
22 DR. LINDEN: Can we clarify again exactly
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1 the role of this committee? I haven't looked at
2 the National Blood Policy recently, but my
3 recollection is, as has been said, it's the values
4 of how we would like the structure to be, you know,
5 volunteer donors and that sort of thing.
6 Jerry, is our role here to talk about the
7 strategic plan, this is what we're advising the
8 Secretary in terms of the public health approach
9 and really what the Department should be
10 doing--right?--as opposed to telling the blood
11 centers and transfusion services what they should
12 be doing. Can you just clarify a little bit our
13 role?
14 DR. HOLMBERG: Right, and I think that
15 that goes right back to what Karen was referring
16 to. You know, I think that two years ago we did
17 look at the National Blood Policy. The structure
18 is there, the privatization of the blood community,
19 that we are not moving to a nationalized blood
20 program. And so the purpose of this is to lay
21 direction on where the government's role should go
22 in blood safety and availability and what should be
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1 the strategic plan that government needs to put
2 into place to make sure that we are detecting and
3 preventing related transfusion-transmitted adverse
4 events. And if, you know, Jay wants to--I realize
5 that we've sort of included, but omitted, the blood
6 safety and availability, you know, we can work that
7 in there, too, in that question. But the question
8 is designed just to get you thinking about that.
9 DR. BRACEY: I think that one of the
10 things that the committee has a duty to do is to
11 ensure that for the public, accessibility is
12 something that is real. If we, in essence, look at
13 a snapshot of today's picture and assume that the
14 private set-up is adequate, that doesn't
15 necessarily ensure accessibility for the long term.
16 I mean, we're looking at an era when there are a
17 number of blood products that will have very
18 intense resource requirements, and I think that it
19 would be our duty as a committee to make sure that
20 there's not only availability but to focus also on
21 accessibility and through the policy perhaps.
22 MS. LIPTON: And we spent the entire day
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1 yesterday basically talking about access to care in
2 certain settings. So I think that is an important
3 issue to include.
4 DR. BRECHER: Jerry?
5 DR. SANDLER: Yes, and I'd very much
6 support the drift that we're going on. We started
7 with a document that refers to preventing
8 transfusion-transmitted complications, and we're
9 drifting toward the subject of blood availability
10 and accessibility as a priority and safety. To me
11 there's a mountain and a molehill.
12 The mountain is the 45 million people in
13 this country who don't have insurance, which means
14 they don't have real access to blood. We've heard
15 about all kinds of people that don't have access to
16 blood. And availability to me is a mountain.
17 The molehill to me, relative to this, is
18 the fact that HIV, hepatitis C, hepatitis B, and
19 West Nile virus were handled fantastically by the
20 United States Public Health Service, at least
21 relative to--relative to--the way the Department
22 has handled reimbursement and availability. If I
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1 had my druthers, the first thing I'd say is we
2 would like to change the name to the Committee on
3 Availability and Safety of Blood so that we
4 prioritize the mountain and put the molehill where
5 it belongs.
6 DR. BRECHER: Other thoughts? Merlyn, is
7 your light on?
8 DR. SAYERS: Yes, it is, but I'm not going
9 to be able to say anything evangelical in follow-up
10 to what Jerry had to say. The light was on because
11 I was going to go on a slightly different tack. So
12 let this just be a short intermission.
13 You had mention of developing a big-item
14 list where strategic attention might be devoted,
15 and the last big-item list was the Blood Action
16 Plan. And certainly there were strategic elements
17 there, and there was a to-do quality to the Blood
18 Action Plan.
19 I was just going to ask Jay how that Blood
20 Action Plan was developed, who were the authors,
21 because I think that was really an excellent
22 product, which has served us in good stead since
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1 1997, and there may well be elements of that Blood
2 Action Plan which could be incorporated, because
3 they are ongoing concern items, could be
4 incorporated into a strategic plan.
5 So I'm just wondering, Jay, who were the
6 authors of that.
7 DR. EPSTEIN: Well, first of all, the plan
8 was initiated within the FDA in July of 1997, and
9 the Acting Commissioner at the time, Mike Friedman,
10 directed a group of us to develop a strategic plan.
11 A small working group actually wrote it. I was a
12 participant.
13 The reason for it was that we were, if you
14 will, very beleaguered, you know, an agency under
15 fire over blood issues. There was lack of consumer
16 confidence on account of issues related to HIV and
17 hepatitis C. And there had bee a series of
18 incidents involving plasma fractionators related to
19 breakdowns of GMP, very frequent product
20 withdrawals and recalls. And there were a set of
21 large issues that just cry out for resolution in
22 terms of the donor standards and transparency in a
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1 sense of notification issues, things like lookback.
2 And so there was a general sense that the
3 only way to deal with that sort of broad set of
4 problems would be to develop a plan and to bring it
5 to public knowledge through, you know, communication and so
6 forth. And we realized very early on
7 that it would not be possible to effect this plan
8 without very high-level interagency cooperation,
9 for example, gathering of epidemiologic data by the
10 CDC or funding of specific studies by the NHLBI.
11 And so we approached the Department about
12 ownership of the plan, and I believe it was under
13 David Satcher's watch that the plan was adopted in
14 March of 1998--actually, I guess it was Donna
15 Shalala. It was adopted as a departmental plan,
16 and then it was modified once in November '99 under
17 David Satcher. It was modified to add the whole
18 issue of vCJD. And that issue itself triggered the
19 need for closer supply monitoring because we for
20 the first time were going to recommend donor
21 deferrals, geographic-based deferrals that were
22 going to have a very large and very rapid impact on
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1 supply for which there was no antecedent
2 experience. And so a commitment was made to
3 initiate blood supply monitoring concomitant with
4 the implementation of the vCJD-related risk
5 deferrals.
6 So, you know, the history in a nutshell is
7 that a small working group at FDA wrote it, and
8 then it became adopted by the Department and then
9 was amended over time. And we didn't come prepared
10 to discuss it, but I can tell you that there have
11 been hundreds of deliverables under that plan in
12 the way of workshops, guidance documents, and
13 rulemaking, in addition to simply organizing some
14 of the effort of the agencies toward specific
15 problem solving.
16 DR. BRECHER: For the committee's
17 information, third tab from the back is the FDA
18 Blood Action Plan.
19 DR. EPSTEIN: Right, but it lacks a
20 summary of all the outputs.
21 DR. SAYERS: Some of the items on the
22 Blood Action Plan, monitoring and increasing the
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1 blood supply, emerging infectious diseases, I mean,
2 still are big items for any strategic plan. You
3 know, the comments that Jerry made earlier could
4 well be another bit item to add to son or daughter
5 of Blood Action Plan, however one wants to describe
6 the follow-up.
7 DR. BIANCO: I see and I agree with what
8 Merlyn just said, but those were the priorities in
9 1997. I think that as we look through it, most of
10 the regulatory goals that were the agency goals or
11 the public health goals were achieved. We have
12 lookback. We have--all the items that were outside
13 the agency were not achieved in terms of, yes,
14 there is an increase in availability but there was
15 a compensation of the losses that happened with the
16 vCJD deferral. But there was nothing that was
17 effectively performed--and I don't want to sound
18 bad about it because I recognize the effort that
19 was put into that. But that was the burden of the
20 private sector. It was not the burden of the
21 government. And that's why we have to ask the
22 question, that is, what should be the role of the
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1 government in those things, be it monitoring, be it
2 increased availability, and other items that we can
3 add to our priority list from which there was no
4 funding. There was even limited funding for
5 monitoring that didn't last too long, and I don't
6 know where it is. But it was a success in terms
7 of--in regulatory terms, in terms of compliance, in
8 terms of safety. We have to recognize that.
9 DR. BRECHER: Jay?
10 DR. EPSTEIN: Well, I think that the
11 funding issue always comes to the fore. When the
12 Blood Action Plan was first envisioned, we had this
13 concept that we could garner funds, rather
14 significant amounts of funds, for certain of the
15 issues, for example, the scientific re-examination
16 of donor deferrals. Those funds never
17 materialized, and I think instead the plan served
18 the role of a road map in organizing our effort
19 toward certain objectives within our existing
20 structures and our existing funds. And I guess my
21 view of the current situation is that we ought to
22 be thinking in the same terms because I think the
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1 likelihood that there would be any significant
2 redirection of funds toward a current strategic
3 plan or action plan is not likely. But, on the
4 other hand, having a vision of where we're trying
5 to go and a sense of how to get there can be very
6 productive.
7 DR. BRECHER: Jerry?
8 DR. SANDLER: I want to pick up on that
9 word, Jay, the vision, because that's exactly what
10 I think that our job will be. Once we figure out
11 what our priority is, we do have to put some things
12 onto the strategic plan. The two that I would put:
13 number one would be the development and evaluation
14 of pathogen inactivation as an approach (versus
15 business as usual). And the second one under that
16 would be the development and evaluation of
17 alternatives to human blood products, to human
18 blood components to be perhaps more specific.
19 The intent here is that I don't see as a
20 strategic direction from the Department initiatives. I
21 think that investors and companies that
22 want to do something come up to the FDA with some
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1 studies and FDA tells them what's not meeting
2 there. But I don't see a national strategy versus
3 where we are now, which is an impossible situation
4 of ten or more laboratory tests, et cetera, as the
5 strategy.
6 DR. BRECHER: That may be a little too
7 specific. Maybe just develop--encourage the
8 development and evaluation of alternatives to
9 present methodologies.
10 DR. SANDLER: You're on the right track.
11 I mean, this is the kind of thing I think that
12 we're supposed to be doing today once we get our
13 priority sorted out as the mountain and the
14 molehill, and we're going to have to look at the
15 molehill a little bit, at least relatively, and
16 that's the kind of thing I think we have to do.
17 DR. BRECHER: Jerry?
18 DR. HOLMBERG: Well, I think that the
19 subcommittee did a great job in identifying some of
20 the elements that they thought and put forward for
21 a potential strategic plan. And one of those items
22 was the element of research, and so I think that
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1 many of the things that you just--the two items
2 that you mentioned could be under that research
3 element.
4 DR. BRECHER: Art?
5 DR. BRACEY: Perhaps, though, as we heard
6 yesterday, you know, IVIG is not considered a blood
7 product. I don't know where Factor VII sits. I
8 don't know where Factor XIII, which is in
9 development now, sits.
10 I think that rather than to have these
11 things all in sort of wide-ranging, unorganized
12 boxes, if we could consider the broad spectrum of
13 blood-related products and make them inclusive,
14 it's research, but yes, there are products that are
15 here now that aren't labeled as blood products that
16 I think the committee could do a job in bringing
17 them into the fold.
18 DR. BRECHER: What I'd suggest we do is
19 make a list of what we think are maybe the top ten
20 priorities. Maybe then we can even narrow that to
21 the top six priorities. So I'd encourage people to
22 just take a minute to think about what should be
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1 the priorities for the country. Let's put them on
2 the table, and then we can think about how we can
3 try to make them happen and what's the best
4 structure to try to make them happen.
5 MS. LIPTON: So do you want us to actually
6 use the list that we developed as possibly saying,
7 well, we think that this is a high priority? Or
8 are you just--
9 DR. BRECHER: Well, I think the list may
10 be the starting point.
11 MS. LIPTON: Yes, okay.
12 DR. BRECHER: And I think looking at the
13 FDA Action Plan may bring to mind one or two
14 others. But let's try to come up with a complete
15 list and prioritize them as to what we think is the
16 biggest priority, the second biggest priority?
17 Jay?
18 DR. EPSTEIN: Mark, I think that's a
19 useful exercise, but I think we need to get very
20 clear whether we're trying to draft the strategic
21 plan or action plan as a committee or whether our
22 real objective is to request that the Department do
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1 it. Because I'm not sure what the feasible quality
2 of the output will be in, you know, a part-day
3 meeting of this group. I mean, I think it's fair
4 for us to call attention to certain areas, but
5 wouldn't we want, you know, some body to be
6 convened to do this in very thoughtfully?
7 MS. LIPTON: That's my thought, too, Mark.
8 When I think about this, I think--I mean, the most
9 that I believe I could say at the end of the day is
10 well, I think that we should--there should be a
11 process to develop a strategic plan. I'd like to
12 figure out what our role is, if any, in it. I
13 think we would have to say things like we think it
14 needs to be broader than this group, it needs to
15 include other stakeholders, because we have done
16 some fact finding, but I don't think we really have
17 a grass-roots--we haven't, you know, undertaken a
18 grass-roots fact-finding initiative, and that might
19 be part of it.
20 But I don't know that beyond that I could
21 sit here and say, well, this is the most important
22 thing. I think I could say here are all the things
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1 we think we need to address. Or maybe we could say
2 availability is maybe the most important thing.
3 DR. BRECHER: Well, I think if we
4 accomplish that, then I think we would have done
5 our jobs. I worry also about trying to draft a
6 strategic plan in this committee today. I don't
7 think it can happen. But what we can do is, as
8 Karen says, recommend that a strategic plan be
9 developed and that that strategic plan should
10 address the following points.
11 MS. LIPTON: And here's what we think our
12 role might be in that. As Jeanne just said, that's
13 kind of what our subcommittee recommended.
14 DR. BRECHER: Okay. Maybe we can put up
15 on the screen for everybody the list. Is that
16 possible, Jerry?
17 DR. BIANCO: Yes, the questions that were
18 developed are questions that could be synthesized,
19 at least in part, as that list of big issues that
20 remain unresolved.
21 DR. BRECHER: Right. There are a lot of
22 questions here, and I don't know that we can answer
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1 them all, but if a committee is put together to
2 make a strategic plan, they would need to address
3 all these questions or make recommendations
4 regarding these questions.
5 DR. LINDEN: Mark, if I can just clarify,
6 the questions--we really do not have any intention
7 of anybody specifically answering them, and
8 especially not us today. It was really just some
9 issues for people to think about that might, you
10 know, trigger some additional thoughts of really to
11 add to the priority list that we made or to clarify
12 things or possibly delete things. That was really
13 all.
14 DR. BRECHER: Okay. So what I've heard so
15 far this morning is that the committee feels that
16 we've heard enough to say that a strategic plan
17 should be developed--should not be developed here
18 in this room today--and that there are several
19 items that we think that that strategic plan should
20 specifically address and here's the list. So let's
21 look at the list. Is that fair? Jay?
22 DR. EPSTEIN: Well, strategic planning
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1 generally starts with what's called a situation
2 analysis. And I think that really the next stage
3 here is for someone to do an objective analysis of
4 sort of the strengths and the weaknesses of the
5 current system. And I think it's reasonable for
6 this committee as a group of experts to comment on
7 where we think the gaps are. So I think we could
8 go that one additional step if we wish. In other
9 words, as we identify an issue area and say it
10 belongs under the plan, we could provide some
11 commentary on what we think is the matter.
12 Again, it is along the same lines of
13 rationale. In other words, why do we think that
14 element belongs in a plan? There must be some
15 reason. There's something that's bothering us. I
16 think we ought to try to state it concisely.
17 DR. BRECHER: Okay. I think that's a good
18 suggestion. So under each item, we'll put a couple
19 of points as to why we think it needs attention.
T1B While Jerry's putting it up there, I will
20
21 throw out one for discussion. When we talk about
22 surveillance of adverse events, I know one item
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1 that keeps recurring at these meetings is
2 discussion of errors, and the biggest or the most
3 fatal error that we're aware of is identification
4 errors.
5 We know there's a potential solution out
6 there, which is electronic identification of the
7 patient, the sample, and the blood component.
8 That's a complete circle. The government has said
9 that they want an electronic system tracing drugs
10 from start to finish, and it seems to me that we
11 could come out and say that there should be some
12 timeline for electronic traceability of samples and
13 blood products in this country.
14 Does that sound reasonable? Sue?
15 DR. ROSEFF: It's definitely reasonable.
16 I think it would be very helpful to hospitals to
17 have that as a mandate because then we would have
18 to do it. But what I've heard, too, from our
19 hospital is because the mandate is for pharmaceuticals in a
20 few years, we'll include blood at
21 that time. So once that's in place for the
22 pharmaceutical industry, we will have the
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1 resources. So I don't know if it's necessary to
2 have a separate mandate because, at least from my
3 perspective, it's going to happen through the back
4 door, almost.
5 DR. BRECHER: Jay?
6 DR. EPSTEIN: Well, the rule on bar coding
7 does include blood products. The requirement for
8 blood products is machine-readable code. The rule
9 does not require the same codification scheme for
10 the blood product as for the pharmaceutical, which
11 was largely at the request of the industry, not to
12 be forced to use the particular scheme specified
13 for the pharmaceuticals. So there will be the need
14 for dual systems, in other words, readers that can
15 read one or the other.
16 That doesn't quite get to the level that
17 Mark is addressing, which is that the sample from
18 the recipient needs to also be electronically coded
19 and to ensure that there's a system of matching at
20 the time of dispensing and at the time of
21 administration. And we know that electronic
22 solutions exist. Progress in that field has been
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1 expectant in the sense that we wait for manufacturers to
2 bring forward candidate products and then
3 we review them for their safety and efficacy, and
4 we have approved one such system.
5 Jerry is actually an expert in this, and I
6 think lectured on it even at the transfusion
7 medicine symposium. We're talking about the need
8 for establishing electronic traceability of the
9 patient sample and the unit to ensure the proper
10 match and whether that's a strategic issue because
11 of the relationship to mismatch as a chief source
12 of fatal error.
13 DR. SANDLER: The only comment I would
14 make is that even a simple bar code system for a
15 small hospital like Georgetown of 500 beds starts
16 with an outlay of $1 million. The way to do it is
17 to add a blood-tracing system as one of three new
18 items on a medication-dispensing system. So as we
19 look at blood-tracing systems with either
20 electronic bar codes or radiofrequency transponders
21 or tags, the way it's going to happen in the United
22 States will be that the medicine-dispensing system
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1 will go bar code, and once it's bar code, then you
2 just take three empty slots on your medicine thing
3 and you have red cells, plasma, platelets. And now
4 you've put the blood-tracing system into your
5 hospital piggybacked on medication.
6 That's where I see this field going, and I
7 would like to see that as one of the strategic
8 things to be looked at.
9 DR. BRECHER: Well, that doesn't
10 necessarily link the patient sample into the
11 electronic loop, though.
12 DR. SANDLER: Oh, sure. Yes, I mean, once
13 you've got the bar code on the patient's wristband,
14 and once the provider, the nurse, has a portable
15 system, whether it's a scanner or whether it's a
16 PalmPilot type of PDA, that can be beamed to a
17 printer you make bar coded sticky labels right in
18 the room. I mean, that's peanuts into the whole
19 picture. Yeah, I mean, it's easy to do.
20 DR. BRECHER: See, what we're doing,
21 Jerry, is we're saying that if we're going to
22 generate a list and we can say addressing errors is
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1 a major priority, we should have some justification
2 for why we're saying that. And we would say that
3 it is recognized that the largest cause of
4 fatalities due to errors is identification and that
5 an electronic system would address most of these
6 errors. And so we would go through each point,
7 point by point, saying that this is a problem and
8 this is why we think it's a problem.
9 DR. SANDLER: I love it.
10 DR. BRECHER: So we have the list on the
11 screen. So my question to the committee: Is this
12 the list that we would like to submit, or do we
13 want to change it? Art?
14 DR. BRACEY: The one piece that I think
15 that's missing gets back to the appropriate use of
16 blood, and so I would add a bullet that would
17 address--yeah, we had it there before, but--yeah.
18 Improving the clinical practice.
19 DR. LINDEN: Practice guidelines was on
20 the list.
21 DR. EPSTEIN: Clinical practice standards
22 for transfusion was actually on our original list.
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1 DR. HAAS: While he's typing that,
2 although it might be implied, we've been consistent
3 over the last several years of also making sure we
4 have recombinant and log issues up there, too. I
5 don't think that's clear there.
6 DR. BRECHER: We'll work that in there as
7 well. So if we have these items--Jay?
8 DR. EPSTEIN: I think that the discussions
9 that we've had about IGIV availability have once
10 again reminded us that we have a large issue of
11 ensuring adequate reimbursement for indicated blood
12 products. And that issue has come up every time we
13 have technology innovation. Our system doesn't
14 readily provide for paying for it. So I think
15 there is a missing element, if you will, about
16 something along the lines of ensuring, you know,
17 funding for needed products and technologies,
18 something like that.
19 MS. LIPTON: Yesterday we used the words
20 "what's stable and sustainable," and maybe what
21 we're talking about is stable and sustainable
22 reimbursement policies that support--
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1 DR. BIANCO: Actually, that has to go
2 beyond that, Karen, to include the new
3 technologies. That is, why aren't we at 100
4 percent leukoreduction? I think that money is the
5 issue and things like that.
6 MS. LIPTON: Okay.
7 DR. BRECHER: So we need to get the point
8 across that reimbursement is tightly related to
9 access, and that without adequate reimbursement,
10 access is not going to be a reality.
11 Jerry?
12 DR. SANDLER: I continue to see pathogen
13 inactivation as a whole strategic topic of even
14 greater importance than some of the other topics
15 that are up on this list. I don't see it as
16 another research item. The concept of doing
17 hemovigilance and surveillance and then chasing
18 after another test and adding another test I think
19 is an overburden on the entire system, and I think
20 strategically we have to look at pathogen inactivation in
21 its broadest sense, maybe not even with
22 current products. But it would seem to me it's a
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1 bullet.
2 DR. BRECHER: I think it is a research
3 item. It may be the first priority as a research
4 item, and to be honest, it's not a reality now so
5 we can't do it in this country at the moment. And,
6 two, it may actually be more costly than doing all
7 the tests.
8 Merlyn?
9 DR. SAYERS: Help me with this one. I can
10 really only see three bullets there which are truly
11 strategic. It's the first one, what strategies
12 might you uncover to structure that process; the
13 second one, how strategically might you consider
14 the value of integrating those systems; and then
15 the other one which looks strategic has to do with
16 Jerry's point about reimbursement, what are the
17 strategies there. Everything else is a to-do list.
18 DR. BRECHER: Yes, or examples--right,
19 examples that would fall out from those three.
20 Jay?
21 DR. EPSTEIN: I think risk communication
22 is strategic, but I think you could easily fold it
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1 into a structured policy and decisionmaking process
2 because it is linked.
3 DR. BRECHER: Okay. Jerry?
4 DR. SANDLER: I'll go back to the point of
5 alternatives to blood components as a strategic
6 item. It seems to me that those aren't minor
7 research items. It seems to me that it's strategic
8 that we look at alternatives to platelets, red
9 cells, and perhaps preservative solutions or plasma
10 solutions from a government initiative point of
11 view rather than waiting for investors to be hit
12 upon by someone with a hot idea, which is the
13 catch-as-catch-go system we have right now.
14 DR. BIANCO: What about a research agenda
15 for new products, not just a research agenda?
16 DR. BRECHER: Jay, you look like you've
17 been thinking about--
18 DR. EPSTEIN: Yes, well, perhaps--Jerry
19 was just starting to write the last bullet. If
20 it's ensuring funding for promising new technologies, that's
21 broader than saying pathogen
22 reduction technology, but that could be the lead
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1 item.
2 DR. SANDLER: I can compromise to that,
3 but it doesn't really put it to the strategic
4 concept of--you know, we're going in the wrong
5 direction. You know, we're just going in the
6 wrong--I mean, that might mean we found a way to
7 fund Chagas' disease, and that's not what I'm
8 thinking about. I'm thinking about a way to end
9 all of this.
10 DR. BRECHER: Pathogen reduction would get
11 rid of Chagas' disease.
12 DR. EPSTEIN: I think the problem here,
13 Jerry, is you don't have consensus that we want to
14 make a sea change to move away from screening and
15 testing to inactivation. As you well know, that
16 has been debated scientifically, and the lead
17 experts in pathogen reduction do not think that you
18 could do away with testing, at least for certain
19 agents.
20 DR. SANDLER: Absolutely. There's no
21 question about that, and we want the belt and we
22 want the suspenders. But when the new virus comes
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1 along, if it's in place, it's going to be good. I
2 mean, the milkman is doing a wonderful job with
3 pasteurization, and I think it's a great model for
4 us to look at strategically. I just don't think
5 that the half a dozen companies who have failed to
6 get a product license have exhausted the strategic
7 value of pathogen inactivation as a concept. And
8 we did have a product on the market that was really
9 terrific--Plas Plus--and for lack of money the
10 thing just died. The stuff was fabulous, and it
11 was a very, very good--a better product than the
12 alternative.
13 DR. BRECHER: Well, there were other
14 issues with that product than lack of money. To be
15 fair, there were concerns about the size of the
16 pools. There were concerns about coagulation
17 problems with the product. So it wasn't quite as
18 simple as lack of money.
19 Mike?
20 COMMANDER LIBBY: I think what I hear is
21 two things: one is you're looking at technologies
22 that are emerging; and the other thing, if you look
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1 at research, you would think research that we
2 haven't done yet or where we need to go.
3 DR. BRECHER: Art?
4 DR. BRACEY: Getting back to what Jerry
5 was saying, you know, I think that we are assuming
6 that blood will remain an important--and it
7 probably will--element in medical care. But, on
8 the other hand, if you do sort of strategically
9 say, well, let's look and see if we can really
10 focus on taking care of people using alternative
11 therapies, I mean, you know, that I think is really
12 strategic. It's not let's do pathogen inactivation. But
13 let's look at strategies that will allow
14 us to get an end product of a patient who is taken
15 care of without the need to use components. I
16 think that might be something to consider.
17 DR. BRECHER: All right. What I would
18 propose is that we lay out the three or four
19 strategies that we want to emphasize, and then
20 underneath each of those we put a few bullet points
21 as to why we think they're important and examples
22 of areas that need attention. Does it sound fair?
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1 Because the list right now--I think Merlyn's point
2 was well taken--is they're not all strategies, and
3 so we could reduce the list down to maybe four
4 items.
5 [Pause.]
6 DR. BRECHER: Merlyn, help us here. Which
7 items would you see as the major strategy items?
8 DR. SAYERS: Have we lost some bullets
9 there, Jay?
10 PARTICIPANT: They're combined. He's lost
11 some carriage returns.
12 DR. SAYERS: Let's go with a strategic
13 approach to research.
14 [Inaudible comments off microphone.]
15 DR. SAYERS: Mark was talking about
16 reducing this down to--yeah, so let's take that
17 strategic research agenda as one of those four
18 major categories.
19 [Pause.]
20 DR. BRECHER: Let's take them one at a
21 time and flesh them out. Is that fair? Gargi?
22 MS. PAHUJA: I have a suggestion for a
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1 sort of different approach just based on the
2 experience we've had with how our messages are
3 taken. The more focused and more concise the
4 message, the better it's received. And I sort of
5 see three main topics in which these could fall
6 underneath those topics: increasing availability,
7 increasing access, and increasing transfusion
8 safety.
9 So, for example, under increasing
10 availability, we would have increasing supply,
11 donor retention and recruitment. Under increasing
12 transfusion safety would be surveillance of errors,
13 new research initiatives, alternatives to blood
14 transfusion development. And under increasing
15 availability, reimbursement issues and access
16 issues--sorry, under increasing access,
17 reimbursement issues. I feel like that might
18 be--these are kind of subsets under sort of three
19 main strategies or concerns that we have to
20 address.
21 DR. BRECHER: I like that. I think that
22 that's a nice simple structure. Other people,
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1 everyone agree? Okay. So we're going to go with
2 that there are three major priorities, and then
3 we'll flesh each of those out. So let's do
4 availability.
5 MS. PAHUJA: So under availability would
6 be increasing supply, donor retention and
7 recruitment, which could even be seen as a subset
8 of that, but I think should be a separate point.
9 PARTICIPANT: It should go under retention
10 separate?
11 MS. PAHUJA: No. Donor recruitment and
12 retention is fine. I'm saying it could be a subset
13 of increasing supply, but...
14 DR. BRECHER: Under safety, you would want
15 error reduction.
16 MS. PAHUJA: Right, surveillance of--
17 DR. BRECHER: Adverse events?
18 MS. PAHUJA: Adverse events.
19 DR. LINDEN: Should infectious disease
20 issues be under transfusion safety, or do we want
21 to look at product safety and then safety of the
22 transfusion process as separate issues? In other
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1 words, all the infectious disease things would fall
2 under here also.
3 DR. BRECHER: Right, so preventing
4 infectious disease.
5 DR. LINDEN: Yeah, I'm just asking, is it
6 enough to be a whole separate item or is it a key
7 subset?
8 DR. BRECHER: I think it's a subset.
9 MS. PAHUJA: I think my concern is that if
10 we have too many sort of strong points, then we
11 kind of lose the focus and the attention span, you
12 know, as we've noticed, is only so great.
13 DR. BRECHER: Say prevention or error
14 reduction. There have to be more bullets for
15 access than reimbursement.
16 MS. PAHUJA: Yes.
17 DR. BRACEY: Include alternative therapies
18 under safety?
19 DR. BRECHER: Oh, yes.
20 MS. PAHUJA: Research and alternative
21 therapies.
22 DR. BRECHER: I think it's therapies and
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1 methodologies.
2 What about for access?
3 MS. PAHUJA: We could clarify what we mean
4 by reimbursement, I mean, which is really--you
5 know, for example, the problem that we talked about
6 yesterday with--
7 DR. BRECHER: E.g., the current IVIG--
8 MS. PAHUJA: Right, or stress the
9 coordination of, you know, CMS policy with current
10 blood practices or current standards of clinical
11 practices.
12 DR. BRECHER: I think that an example for
13 each of these items might be helpful to the reader,
14 a specific example.
15 MS. LIPTON: Under increasing transfusion
16 safety, I guess two things: Art's clinical--I
17 don't know if it's safety or availability, but the
18 clinical guidelines. Development of those clinical
19 guidelines I think is important. And then the
20 other thing is this whole issue of the Public
21 Health Service and really the way we--I mean,
22 really the Public Health Service and the robustness
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1 of the Public Health Service and how we interact
2 and relate to them. I think that was a topic that
3 we talked about a lot. I think it's of concern to
4 us, but we need to capture it someplace up there.
5 I guess under safety.
6 DR. LINDEN: Well, it goes beyond that.
7 That almost could be like an introductory
8 statement, I think.
9 DR. BRECHER: Well, let's go to the top of
10 this list and let's begin drafting an introductory
11 statement, something like: The committee concludes
12 that a strategic plan for--how did we phrase it
13 originally? The committee believes that there is a
14 need for the Department to develop a strategic plan
15 for improving safety and availability for the
16 transfusion of blood and blood derivatives in the
17 21st century. Something like that.
18 The committee believes that there is a
19 need for the Department to develop a strategic plan
20 for improving safety and availability for the
21 transfusion of blood and blood derivatives.
22 MR. SKINNER: Can we add there "and their
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1 recombinant analogues"?
2 DR. BRECHER: Yes, we can say
3 "/recombinant analogues in the 21st century."
4 "...for improving safety and availability"--
5 MS. LIPTON: Do you like the word
6 "increasing" better than "improving"? I mean, it's
7 hard to improve on safety right now.
8 DR. BRECHER: That's fine. "Increasing"
9 instead of "improving."
10 MS. LIPTON: Should we add to that initial
11 statement access, since we have it identified as a
12 topic here, safety, availability, and access?
13 DR. BRECHER: Well, we could argue about
14 access is part of availability.
15 Jay?
16 DR. EPSTEIN: Yes, I wanted to make that
17 point. I think that those are so tightly linked
18 that I would put them together as one of the topic
19 issues, increasing availability and access. But
20 I'm saying additionally in the bullets that are
21 below, the topic headers that are below, I'm
22 inclined to merge availability and access because
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1 they always go together when you try to solve a
2 problem.
3 Also, I would ask the group, you know,
4 what happened to the strategic issues on
5 policymaking and on public health integration.
6 They seem to have gotten lost here when we
7 restructured the list. I think we have to find a
8 way to bring them back.
9 MR. SKINNER: The other issue that's
10 missing is having an integrated risk communication
11 system under safety. Some of the broader issues
12 that override all of this, as Jay was saying, fall
13 out of this structure.
14 DR. BIANCO: Actually, what I suggest,
15 Mark, that we do is we take the questions that are
16 here. There are several things that we didn't put
17 under the categories, like disaster, that I would
18 put in increasing access. And the definition of
19 roles of each one of the governmental agencies, I
20 would also--
21 DR. BRECHER: Okay. I think that's good,
22 but I think we're running ahead of our list. So
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1 let's slow down for a minute.
2 DR. BIANCO: It's the excitement.
3 [Laughter.]
4 DR. BRECHER: Jay?
5 DR. EPSTEIN: I think in the opening
6 sentence you really only need to say safety and
7 availability, because those are the title heads of
8 the committee and more or less everything related
9 in some way or another to them. Because where
10 you're headed by starting to enumerate is you're
11 going to end up enumerating the whole list, and
12 that's really not what you want to do.
13 DR. BRECHER: Say "plasma deriva-
14 tives/recombinants."
15 DR. EPSTEIN: Well, derivatives are blood
16 products, so if you want to say blood products
17 including plasma derivatives or including analogous
18 products. Blood product is already the biggest
19 header.
20 DR. BRECHER: Yes, okay. Blood products
21 and derivatives/analogues? I mean--
22 DR. EPSTEIN: Synthetic platelet isn't a
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1 derivative. I mean, it's blood products and their
2 analogues.
3 DR. BRECHER: Okay, blood products and
4 their analogues. But if we have a synthetic
5 platelet, I'm out of business.
6 DR. SANDLER: That's a strategic plan.
7 DR. BRECHER: To get me out of business?
8 [Laughter.]
9 DR. SANDLER: A safer product.
10 DR. BRECHER: Gargi?
11 MS. PAHUJA: So since we've sort of moved
12 increasing access up to availability, perhaps a
13 third could be that increased coordination where
14 you could include the public--integration of the
15 public health system, a coordinated risk communication
16 effort.
17 DR. BRECHER: Coordination of the public
18 and the government--public, governmental, and
19 private sectors? Something like that?
20 DR. LINDEN: I'm not sure that's a
21 separate item, though. I mean, wasn't the whole
22 point that all of this should be coordinated
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1 between public health and the private sector? I
2 mean, that's why I'm suggesting this be sort of an
3 overarching approach as well as Jay's, you know,
4 concern about the structured process. I mean,
5 don't all of these things sort of fall under both
6 of those?
7 MR. SKINNER: Could we make those two
8 concepts, the first two bullets, the structured
9 process and the integration, part of our preamble
10 and kind of as our overriding goals and then say as
11 a part of that then we want to achieve these within
12 that kind of framework of integration and--
13 DR. BRECHER: Yes, I like that so we're
14 going to move that up to the preamble, put it as
15 the second sentence.
16 Mark, how would you want to word that?
17 DR. LINDEN: I mean, I think we can really
18 include what we said, that the decision-making
19 process should be structured, open, and include
20 collaboration between public health agencies and--
21 DR. BRECHER: So is it open, structured,
22 and inclusive of all interested parties? Something
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1 like that?
2 DR. HOLMBERG: Of all parties?
3 DR. BRECHER: For all parties?
4 DR. LINDEN: "Stakeholders" works, but
5 it's awkward to include.
6 DR. : Yeah, not "open," but open.
7 DR. EPSTEIN: See, I think we're
8 losing--Mark, if I could comment.
9 DR. BRECHER: Yes.
10 DR. EPSTEIN: I think we're losing the
11 strategic issue here about policymaking in a
12 structured process which is about the use of
13 analytical tools--in other words, doing formal risk
14 assessments, doing formal risk analyses, engaging
15 in a more formal way in risk communication. So I
16 think simply to say that these processes should be
17 open and structured is fine, but it's not
18 highlighting it as one of the strategic issues,
19 something that we're trying to transform about how
20 we do business now versus how we should do
21 business.
22 DR. BRECHER: So that they should be
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1 factually based.
2 DR. EPSTEIN: Well, that's, again, part of
3 it, you know, that it should be scientifically
4 based, that there should be outcome evaluations.
5 It's a whole package of things. And I think simply
6 putting it in the preamble misses the point that
7 you really want to elaborate on it as one of the
8 strategic issues.
9 DR. BRECHER: Okay.
10 DR. EPSTEIN: Again, I think the tension
11 here is being too explicit in the preamble. A
12 short point in the preamble might say that this
13 should include an overview of decision-making and
14 integration of blood policy with public health
15 policy. And then you still have room to highlight
16 it later. It shouldn't substitute for highlighting
17 it as a strategic issue, I don't think.
18 DR. BRECHER: Okay. Say that again, Jay.
19 "...including..."
20 DR. EPSTEIN: That this plan should
21 include a review or attention to--just say "a
22 review" of the process of decision-making for the
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1 blood system and its integration with the larger
2 public health system.
3 DR. SAYERS: Jay, when you first said
4 that, though, you referred specifically to the
5 integration being at a policy level. That sounded
6 good.
7 DR. EPSTEIN: Oh, well, I think it's both,
8 see. I think that we need to make blood safety
9 decisions within the context of public health
10 decisions. For example, when we talked about
11 smallpox immunization, it became necessary for us
12 to advocate quite strongly to get on the agenda the
13 notion that if you started vaccinating people, you
14 might also be deferring vaccinees for awhile and
15 that could affect, you know, blood availability.
16 And similar issues could be raised about pandemic
17 flu; you know, if people start getting sick, how
18 are you going to sustain the blood supply? What
19 are your strategies?
20 So I do think that there's a need--and,
21 you know, you could give other examples for
22 emerging disease or error management, where the
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1 decision-making about the blood system should be
2 well integrated into the public health
3 decision-making.
4 So I agree with that, but I also think
5 that we're talking about structuring the blood
6 system in such a way that there's better
7 integration with the public health infrastructure.
8 In other words, where is blood collected, how is
9 blood delivered, should you get your IGIV in an
10 outpatient physician setting or in a hospital
11 infusion clinic? So I think that both things are
12 integration issues.
13 DR. BRACEY: On another topic, I'd be
14 interested in hearing from the folks from the
15 consumer side here. We haven't really addressed
16 enhancing or engaging the consumer so that that
17 individual would be more informed and involved in,
18 you know, transfusion decision processes. You
19 know, this is the era of information, this is the
20 era of patient involvement in terms of informed
21 consent, et cetera. I'd be interested to see know
22 what the consumer folks think about engaging the
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1 public would be.
2 MR. SKINNER: I think that's an excellent
3 point. I mean, the notion, when we talked about
4 stakeholders or--I have a hard reading that because
5 the print's awfully small, but whatever we said at
6 the beginning about all the relevant parties. I'm
7 not sure it's intuitive to everyone that the
8 patients have a role or the consumers have a role,
9 the end users, at each stage in the process; and
10 somehow that that would be communicated.
11 Some of that comes under risk
12 communication. And I like the way it was presented
13 yesterday, talking about an integrated and
14 interactive process, because communication has to
15 be two-way, which then naturally involves hearing
16 from the patients and having their feedback/return.
17 So I don't know whether our plan--I wasn't wanting
18 to get ahead of the discussion--is whether we're
19 going to go back and make these complete sentences,
20 each of the individual items under them, because I
21 think some of these words just by themselves aren't
22 going to communicate what we're talking about.
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1 I had written down a sentence here
2 somewhere, that we needed "an integrated and
3 interactive process for timely risk communication,"
4 which implies that it has to occur with all of the
5 stakeholders, which we define earlier; that it has
6 to be a two-way dialogue; and that it has to be
7 timely, that it's not just telling them at the end,
8 after the government makes its decision that it's
9 actually a risk. And somehow we have to embed
10 those concepts in what we produce. The word
11 "interactive" is not there. If you're integrated
12 and interactive--
13 But I don't know where that falls in the
14 final document. But I agree with you: That's
15 missing, and I just don't know where it fits and
16 what our discussion is. But I think each of these
17 need to become sentences.
18 DR. LINDEN: I had a comment along that
19 line, if I may speak.
20 We have things that are topics, and then
21 we have basically our opinions of what the
22 attributes should be or what some of the goals are.
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1 And I don't know that we want full sentences,
2 but--you know, say there's an issue--you know, risk
3 communication. That is a topic. And then our
4 thought is that it should be, you know, integrated
5 with recipients, and so on and so forth. And even
6 "blood policy is to develop a structured process."
7 Well, the topic is really blood policy. We believe
8 it should be structured process, and we should use
9 analytical tools that include--you know, may
10 include this, that, and the other thing.
11 So just a suggestion that maybe we can
12 develop a sort of format we really want to use of,
13 you know, topics versus goals to achieve.
14 My other, minor, comment is our frequent
15 reference to the blood system. I don't know that I
16 know what that is. The collectors in the blood
17 banks, clearly, but does it include the donors,
18 does it include the ordering physicians, does it
19 include the nurses administering the blood, does it
20 include the patients, the recipients? So we either
21 might want to be more specific or define that
22 somewhere.
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1 DR. BRECHER: Or substitute for the word
2 "provision of blood."
3 DR. : Provision of blood?
4 DR. BRECHER: Yeah.
5 DR. LINDEN: Could we also add "outcome
6 monitoring"--I'm sorry, back under this process?
7 DR. BRECHER: Back under where?
8 DR. LINDEN: Analytical tools.
9 DR. BRECHER: What was that again?
10 DR. LINDEN: Outcome monitoring. It just
11 seems that was a big piece that we don't always do
12 very effectively and we thought that would be an
13 important part, good decision-making.
14 [Pause.]
15 DR. LINDEN: Well, just on my point, I'm
16 not sure "provision of blood" is really inclusive
17 enough. I don't think we need to say anything.
18 The first sentence, we already said what we're
19 talking about, in terms of the safety and
20 availability. Can't we just say "decision-making"?
21 I mean, it's obvious what it relates to. Or you
22 could say "related."
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1 DR. BRECHER: This includes a review of
2 the process of decision-making and integration with
3 the larger public health system. Just kick that
4 middle piece out, for the provision of blood. Just
5 get rid of that.
6 DR. LINDEN: What's the larger public
7 health system? As opposed to the public health
8 system?
9 DR. BRECHER: Or is it the national health
10 systems?
11 DR. LINDEN: Yeah. I mean, you're saying
12 you want to include the state and local agencies as
13 well as the federal? I mean, is that what that
14 means?
15 DR. HOLMBERG: Can you just say public--
16 DR. BRECHER: With the health system?
17 DR. HOLMBERG: With the public health
18 system. If you want to then maybe put
19 parenthetically, local, state--
20 DR. LINDEN: You could say--I mean, I
21 consider myself to be part of the public health
22 system, personally, but--
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1 DR. SANDLER: Nation's health system?
2 DR. BRECHER: Is that sort of like
3 NationsBank?
4 DR. SANDLER: Lower-case n.
5 DR. LINDEN: National?
6 DR. BRECHER: Unless you want to say
7 public and private health system? Which I don't
8 think we want to say.
9 DR. EPSTEIN: I don't think the issue,
10 again, is structure; it's function. Of course you
11 have local, state, and national entities involved
12 in blood and its, you know, preparation and
13 delivery. The point here is that the
14 decision-making process as it concerns blood policy
15 should be well-considered with other public health
16 policy.
17 So let me give you one example. Should
18 you practice public health in the donor room?
19 Should there be a national policy to offer things
20 like, you know, cholesterol screens and PSA
21 screens? Should there be more proactive medical
22 referral? Should you link donor recruitment to
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1 providing, say, advice on healthy lifestyles?
2 That's an example of the thought that I
3 have. And that would be transformational. That's
4 not what we do now. We don't look at the donor
5 from the standpoint of an opportunity to practice
6 public health. We have a reductionist idea. We
7 exclude all the people who are ineligible, we do
8 nothing to make them more eligible, like, you know,
9 give iron to people who may need iron.
10 So I think that's the transformation that
11 I'm talking about. And I've been using the word
12 "transformation" because I think that, if this is a
13 strategic plan, as opposed to simply an action
14 plan--in other words, a punch list--then we ought
15 to be thinking about what are the big-picture
16 changes that we think are needed for our country
17 and how it looks at blood? And all these things
18 are important, but I'm not sure that they're all
19 transformational.
20 So, for example, the whole mindset of
21 being more prevention-minded; you know, to
22 anticipate problems and address them and fund
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1 initiatives in prospect rather than being reactive.
2 And Jerry was making this point about pathogen
3 reduction, because what you're saying in essence is
4 let's get it in place before the next EID. And
5 that's right. That's an example of being
6 proactive, but it would be a transformation of our
7 system. We don't think that way. We wait for the
8 next EID and then we try to address it. And we do
9 that pretty well, but we're always doing it in the
10 reactive mode.
11 So, again, I think that there may be other
12 large ideas for transformation of the system that I
13 haven't focused on. But those are the things that
14 are strategic. Everything else is an action item.
15 DR. BRECHER: Mark?
16 MR. SKINNER: I think it's the word
17 "system" that maybe is troubling. I wonder if what
18 Jay is talking about is public health policy, and
19 then we need to define who we think are parts of
20 that. Because in my mind, the word "system" also
21 includes, you know, all the voluntary health
22 organizations, which include the patient
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1 organizations and all the nonprofit organizations,
2 not just government institutions. And I think the
3 word "system" is left for people to define. I'm
4 wondering if we could change it to the word
5 "policy," and then add a sentence that defined who
6 all the players are that we should be thinking
7 about integrating with.
8 DR. BRECHER: I like the word "policy." I
9 don't know that we need to define it up there. I
10 think if we keep the preamble short, it will be
11 more easily absorbed by the reader.
12 Jeanne?
13 DR. LINDEN: I think we're getting very
14 hung up on the term "strategic plan" and is this
15 strategic and is that strategic. I mean, that was
16 a term that the subcommittee came up with, but I
17 wonder if we just call it "a plan" and--because we
18 didn't set out to write a strategic plan. What the
19 committee as a whole has really done is identify
20 issues of concern where there needs to be
21 additional work over the past few years. And we
22 were trying to just synthesize a list of those that
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1 continue to need attention. So I'm just wondering
2 if we should just call it "a plan."
3 I agree with Jay. I mean, some of these
4 are really action items. And that really was the
5 point, that these are areas that need to continue
6 to be looked.
7 DR. EPSTEIN: So then we're talking about
8 an updated action plan. Because we have an action
9 plan. It's still in effect, albeit nearly
10 completed. So we're talking just about a new blood
11 action--
12 DR. BRECHER: Well, except it may be
13 broader than the FDA action plan, which was--
14 DR. EPSTEIN: Well, again, mind you, it
15 started as an FDA action plan but it became a
16 departmental action plan and many of its elements
17 were inter-agency and, indeed, involved the private
18 sector. So I wouldn't--I mean, to characterize it
19 as FDA's action plan, we had a very large partner,
20 to be sure, but it wasn't just FDA's action plan.
21 But be that as it may, I think what we're
22 talking about is an updated or a current blood
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1 action plan.
2 DR. BRECHER: Well, could you--
3 DR. EPSTEIN: But I think we lose
4 something--again, it's not that I'm against having
5 an action plan dealing with many of these issue
6 areas. I do think we need it to focus attention.
7 But I think that if we go that route, we are
8 perhaps losing the opportunity to think
9 strategically about transforming our current system
10 and its processes. Because I do think that we need
11 some of that.
12 DR. BRECHER: Do we have any--
13 DR. SAYERS: If I could just--
14 DR. BRECHER: Go ahead.
15 DR. SAYERS: Sorry. I'd like to endorse
16 that. I'd feel happier about what we're doing now
17 if we just called it something simple, like "a wish
18 list." Because we've lost looking at the issues
19 that confront us from a higher altitude, which
20 would be an opportunity to think strategically. So
21 if we do call this, what did you say?, an action
22 plan, I'd stop complaining about where is the
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1 strategic element here. Maybe looking at the
2 industry strategically is something we should do at
3 a different sitting at a different time, but it
4 would give us an opportunity to talk about what is
5 the role of the blood program in promoting public
6 health. That certainly is a strategic issue. And
7 there are other issues that we could develop an
8 agenda for which would be exclusively strategic.
9 But this is not.
10 But it's important. I'm not belittling
11 this list at all. But it's not a strategic list.
12 DR. HOLMBERG: Let me just sort of go back
13 and give you a little overview of some of the
14 things that have transitioned within the Department
15 of Health and Human Services since Secretary
16 Leavitt has come on board, and that is that there
17 is a 500-day and a 5,000-day plan. There's a
18 vision, and then there's plans and products that go
19 into that plan. And so I think what we're talking
20 about when we talk about an action plan, we're
21 actually talking tactical--how do we move forward
22 with this. And strategic is an opportunity to give
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1 an overview, a high level.
2 And I really--I like what Jay is saying,
3 and I think that we may miss the opportunity to
4 really lay out a high-level strategy of how are we
5 going to transform. First of all, do we need to
6 transform? Secondly, what is that strategic plan?
7 And then we can work down into the tactical aspect
8 of it, which would become an action plan.
9 DR. BRECHER: All right, it's now after
10 10:30. Why don't we take our scheduled 15-minute
11 break and we'll come back and discuss becoming
12 transformers.
13 [Break.]
14 Committee Discussion (Continued)
15 DR. BRECHER: If everyone will take their
16 seat.
17 DR. HOLMBERG: Can we all get back to our
18 seats, please?
19 DR. BRECHER: Okay. It was suggested
20 during our break that what was really missing from
21 our statement is justification for us making a
22 statement, and so that what we need above is
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1 statements of fact that there are current problems.
2 So we need a couple of Whereas statements before we
3 launch into our recommendation. So I wrote the
4 first two, which we can wordsmith, but I think
5 we--there are lots of problems and I think we could
6 list them. But it would be nice if we had at least
7 five Whereas's before we launched into our
8 proposal.
9 Oh, yes, and Jerry has a quick comment to
10 make.
11 DR. HOLMBERG: Actually, two comments. I
12 was reminded this morning, when I was talking to
13 Karen, about some of the comments that were made
14 yesterday. And maybe as we're thinking through
15 this strategic approach, we should keep this in
16 mind. I think that--and somebody mentioned this
17 yesterday, but in my words, I think we're victims
18 of our own success. We've done things very well.
19 And so, you know, maybe 25 years ago it wasn't done
20 as well, but I think we've learned our lessons and
21 we've moved forward.
22 And I have to say that even the Assistant
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1 Secretary for Public Health, the emergency
2 preparedness, had five questions that he routinely
3 asked. And the fifth question was always, How is
4 the blood supply? Okay? So there is an awareness
5 of what is the blood supply.
6 The other thing I wanted to say--and maybe
7 we could work into the--in this whole structure and
8 the justification and that, and the mantra that I
9 try to get across down to the people down at the
10 Humphrey Building, is that blood is a critical
11 element of health care infrastructure. And so
12 trying to get that message across, I think, is very
13 important. Because everybody just assumes that
14 it's going to be there. And, you know, they think
15 of maybe respirators and things like that as
16 support items, but blood definitely is a support
17 item.
18 DR. BRECHER: Well, maybe that should be
19 one of our Whereas's. Whereas blood is a critical
20 element of modern medicine. You could add--
21 DR. BIANCO: That should be--and while
22 this is done, this has triggered another thought.
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1 I think that we have to admit, as one of the first
2 Whereas's, that there has been an incredible
3 progress over the years. And so there have been
4 many positive things done before this committee and
5 through this committee, but there's still a lot of
6 work to be done. And then--
7 DR. BRECHER: That may be our closing
8 statement on this resolution, acknowledging that
9 progress has been made but that more can be made,
10 something like that. Should be made. Will be
11 made. Shall be made.
12 DR. SANDLER: I'd like to see one of the
13 Whereas's say that Whereas blood shortages continue
14 to occur in the United States. Or just "continue
15 to occur."
16 DR. BIANCO: They occur in Washington,
17 Jerry. They don't occur in other places.
18 DR. BRECHER: But that's intentional.
19 MR. SKINNER: I don't want to appear lost,
20 but can you clarify for me? What are we doing
21 right now? Are we developing an action plan or a
22 strategic plan? Because even the Whereas's makes a
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1 difference with what we're drafting and where we're
2 leading. I mean, it would be helpful if we could
3 just make a decision which is it that we're doing
4 so that we're all moving in the same direction. Is
5 there consensus, or do we need to take a vote so
6 that we know what we're actually trying to achieve?
7 DR. BRECHER: Well, yes, we've had
8 arguments for both. So a vote, I think, is
9 appropriate.
10 So the question before us: Are we
11 proposing a strategic plan or are we proposing an
12 action plan? What's the committee's pleasure?
13 All those in favor of a strategic plan?
14 DR. LINDEN: Can I just ask a question?
15 Are we proposing that we recommend--
16 DR. BRECHER: Yes.
17 DR. LINDEN: --that the Department develop
18 one of these?
19 DR. BRECHER: Yes. That's correct.
20 DR. LINDEN: And are we identifying who
21 would do it? I mean, there was discussion about
22 the existing action plan.
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1 DR. BRECHER: We haven't discussed that
2 part, whether we would make a specific
3 recommendation as to who would do it.
4 DR. LINDEN: Because I think there was
5 discussion that we are not able to do this and
6 there probably would not be funds to hire somebody
7 outside. So are we suggesting that the agency do
8 it?
9 DR. BRECHER: It may be some sort of
10 inter-agency group with some liaisons from the
11 outside. I think that's at HHS's discretion as to
12 how they would want to do this. We could--
13 DR. LINDEN: Well, my concern--I mean, we
14 can recommend that something be done, but it's
15 going to cost funds and we don't have anything
16 definitive. It may just be listened to as much as
17 some of our previous recommendations.
18 DR. BRECHER: I guess we could pass the
19 hat around the table.
20 DR. BRACEY: I thought what we're doing
21 right now is basically laying the groundwork for
22 why a strategic plan needs to be developed.
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1 Because we can't develop one within the room; we
2 don't have the resources to do so. But we can kind
3 of lay out why one is needed.
4 DR. BIANCO: Before you go to the book, I
5 think that we cannot have an action plan without
6 having a strategy and knowing where we want to go.
7 So I think both are linked, Mark. And I think that
8 we have to have what some people--Jerry, I
9 remember, the last one--talked about, the vision
10 and what are the major issues we want to address.
11 And then, the action plan derives from that. And
12 actually, a good action plan will only come out
13 after we have--after the strategic plan is
14 developed.
15 DR. BRECHER: Well, we could even say,
16 Whereas this committee does not have the resources
17 and the time to develop the strategic plan."
18 DR. BIANCO: That's pessimistic.
19 DR. BRECHER: Okay. All right, we won't
20 do that.
21 DR. BIANCO: We can it nicer.
22 DR. HAAS: I guess I'm still not clear,
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1 that when we say "strategic plan," is that
2 referring to all issues relating to blood? Or are
3 we talking about what this committee's strategic
4 plan would be?
5 DR. BRECHER: I think we've been taking
6 the larger picture, and that's why we've given a
7 little punch list at the bottom to say that any
8 such plan would, at a minimum, include the
9 following items. So it's a bigger picture that
10 we'll take.
11 DR. EPSTEIN: I think the greatest service
12 we can provide to the secretary is to outline what
13 we think are the deficiencies of the current system
14 that need to be addressed prospectively. And I
15 think they're things like the fact that we continue
16 to have periodic disruptions in supply availability
17 and access; that we have persisting gaps in the
18 development of products for small patient groups or
19 narrow, albeit critical, indications; that we are
20 slow and not directive in funding technology
21 developments that could offer substantial benefits
22 either to supply or safety; that we do not have a
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1 comprehensive system to monitor the current safety
2 and availability within our system; that we do not
3 routinely monitor the outcome of decisions and
4 actions affecting blood products; that we are slow
5 to respond to certain recognized threats that have
6 available interventions, for example, the
7 misidentification of the unit and patient; and that
8 we have had difficulty in optimizing risk
9 communication to maximize public confidence and
10 trust on the basis of honest communications.
11 So, I mean, we could go on. But I think
12 that if we fail to suggest where the problems lie,
13 there's sort of no point in the plan. I mean,
14 there's still a point in having action items
15 because the world's not perfect and there's certain
16 work to do, and that's fine. Again, I'm not
17 against an action plan. But it's the vision of why
18 we need to be more strategic that's the issue. And
19 unless we can say what's the matter with the
20 system, then there's no point calling for this.
21 DR. LINDEN: So did you write those down?
22 DR. EPSTEIN: Yeah.
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1 DR. LINDEN: Okay, so why don't we start
2 there? I mean, I think what we were talking about
3 was trying to go through some of these
4 presentations and identifying weaknesses, and it
5 seems to me you've captured virtually all of them.
6 So can we start--
7 DR. HOLMBERG: If I can just say, when my
8 subcommittee met, the idea of doing a SWAT analysis
9 was really brought up, and the fact that, in the
10 presentation of the material, how do you present.
11 And the challenge that the subcommittee members
12 were given was how to put those SWAT-type questions
13 together to get the committee to be thinking. So I
14 think that this is right online.
15 DR. BRECHER: Okay, Jay, slowly from the
16 top.
17 DR. EPSTEIN: Well, I'm happy to do that,
18 but also we could be more systematic. If we accept
19 that the list of bulleted points in the
20 subcommittee report is a good starting point, we
21 could systematically go through them one-by-one and
22 simply state what we think is the underlying
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1 problem or set of problems that makes that an
2 issue.
3 But that said, you know, a sort of the
4 back-of-the-envelope stab at it is:
5 Periodic disruptions in supply
6 availability and access.
7 Gaps or, if you will, unmet needs in
8 development of products for small patient groups or
9 rare indications.
10 Inadequate funding for implementation of
11 new technologies.
12 DR. BRECHER: Implementation or timely
13 implementation?
14 DR. EPSTEIN: Well, you can say "timely,"
15 sure. Again, this is a crude cut. We're going to
16 polish all this.
17 Lack of adequate data to support
18 monitoring of the blood system. That's the whole
19 surveillance--
20 DR. LINDEN: Actually, you put it a
21 different way before, which I thought was better,
22 which is lack of a comprehensive system to monitor
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1 blood safety and availability. Or, put another
2 way, fragmented systems. That's really what we
3 identified. We have a lot of different systems,
4 but they're not coordinated.
5 DR. EPSTEIN: Right. You could say
6 fragmented systems for monitoring--
7 DR. LINDEN: Safety and availability.
8 DR. EPSTEIN: --safety and availability.
9 And then we have this issue of failures in
10 monitoring outcomes of policies or interventions.
11 Then we have the slowness in responding to
12 recognized threats such as blood misidentification,
13 errors.
14 DR. LINDEN: I think you said before "for
15 which there is available technology," which I think
16 is a good way of stating it.
17 DR. EPSTEIN: Recognized threats for which
18 there are available technology solutions. Or they
19 don't have to be technological, you know, just
20 interventions.
21 DR. LINDEN: Solutions or interventions.
22 DR. EPSTEIN: Right.
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1 DR. LINDEN: And what was your risk
2 communication one, Jay? You had one.
3 DR. EPSTEIN: It was just "difficulties in
4 communicating risks in a manner that can sustain
5 public confidence and trust."
6 DR. LINDEN: Do we want to put "lack of
7 integration" into the public health system as one?
8 DR. EPSTEIN: I think we ought to go back
9 over each of the subject areas where we had a
10 presentation, where we have a bullet, and ask
11 ourselves to articulate what is the core problem.
12 Where's the gap? What do we think needs fixing in
13 that domain?
14 DR. : What comes after risk
15 communication?
16 DR. EPSTEIN: In order to sustain public
17 confidence and trust. That would sustain public
18 confidence and trust.
19 I mean, I think this is also an issue of
20 missed opportunities for public health in the
21 management of blood donors.
22 DR. BRECHER: Provision of public health?
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1 DR. EPSTEIN: Yeah, for practice of public
2 health, or For enhancing public health, through the
3 management of blood donors.
4 DR. LINDEN: And then maybe we want to put
5 the absence of, you know, uniform clinical
6 guidelines, put something in there about that.
7 DR. BRECHER: Evidence-based.
8 DR. LINDEN: Ah.
9 DR. BRECHER: Evidence-based.
10 DR. SANDLER: If I understand Dr.
11 Epstein's suggestion, it's that we now reorder his
12 order according to the list we've made. I'd like
13 to suggest that his order is the one that I would
14 have picked and that, if we just took his items and
15 numbered them--in other words, Whereas 1, 2, 3, 4,
16 5--we would be able to cut and paste the things
17 that we've done and put them in the paragraph below
18 it to match his list. His prioritization is just
19 great, as far as I'm concerned.
20 DR. BRECHER: Jeanne?
21 DR. LINDEN: The other item that had been
22 on the list was insufficient disaster planning--do
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1 we want to retain that?
2 DR. EPSTEIN: Yeah, I think we need to
3 just say something about each bullet. We haven't
4 said anything about the research agenda, disaster
5 planning, funding promising new technologies,
6 stable reimbursement. Again, I was just sort of
7 sketching the idea of where we need to go here,
8 which is to give some description of what we're
9 trying to fix in each area.
10 DR. BIANCO: The reimbursement issue, Jay,
11 is it should --[?]-- things because a lot of it you
12 could trace back to reimbursement, or funding.
13 DR. EPSTEIN: Again, the problem--you
14 can't just say "research agenda." What's the issue
15 about the research agenda? The issue about the
16 research agenda is that A) we don't have a
17 consensus agenda based on a collective sense of
18 priorities, and B) that it needs to become more
19 proactive, future thinking. In other words, we
20 want to--as you were saying, Jerry, right now we're
21 waiting for the private sector to develop remedies.
22 Right? Instead, we could say we have a national
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1 priority to develop this technology because of its
2 great promise, so we're going to--you know, we're
3 going to have a Manhattan Project that delivers it.
4 That's the difference. That's the transformation.
5 It's not that we have no research agenda. There
6 are lots of funded projects. It's that we don't
7 have one that is directed toward certain goals.
8 DR. BRECHER: --the word "targeted" up
9 there?
10 DR. SANDLER: I think that since the
11 initiative comes from investors, which is really
12 where it gets out to the market, whereas the
13 initiative for research is not strategically
14 directed toward public health issues but
15 short-term--or primarily by economic or fiscal
16 issues.
17 DR. EPSTEIN: Well, this is the biggest
18 issue of all, is the, if you will, the rough edges
19 between the privatized model, right, and the
20 government-driven model. And I think that each
21 time that we reexamine the national blood policy,
22 we decide we don't want to nationalize the blood
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1 system in America and that any such movement cannot
2 be isolated from the broader question of national
3 public health. And, you know, we always take a
4 step back and say, well, we'll just do better with
5 the system that we have and, you know, we trust the
6 marketplace and we trust innovation. And I don't
7 have a problem with that, but I think that we have
8 to, at the same time, if we accept that model,
9 recognize where it doesn't work and have strategies
10 to deal with those, if you will, boundary issues.
11 And a perfect example of such an issue is
12 generating products for rare disorders. There just
13 isn't a market incentive. And, you know, you just
14 can't expect that the market's just going to solve
15 that problem. You have to do something more.
16 DR. BRECHER: Jerry, let's take this list
17 and break them out into points, each one having its
18 own line.
19 DR. SAYERS: While Jerry is fracturing
20 this list, as far as the research agenda goes, what
21 it lacks is any sense of appropriate priority. So
22 we don't have a research agenda which encourages
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1 development of solutions to those problems where
2 the most benefit could be achieved.
3 DR. BRECHER: We could say proactive,
4 prioritized, and targeted research agenda.
5 DR. LINDEN: Are we saying lack of
6 proactive and targeted research agenda?
7 DR. BRECHER: Yes, lack of. It's a lack
8 of.
9 DR. EPSTEIN: I think the issue is a
10 goal-oriented research agenda. Lack of a
11 proactive, prioritized, and goal-oriented.
12 DR. BRECHER: Okay. Goal-oriented. You
13 mean besides publications?
14 DR. EPSTEIN: They're secondary, as you
15 know, Mark.
16 DR. BRECHER: Fortunately, we have all the
17 speakers from yesterday around the table, who made
18 their presentations. Are there any items that you
19 presented and discussed that we don't have on the
20 list?
21 DR. HOLMBERG: Where's the policy?
22 DR. BRECHER: What do you mean the policy?
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1 PARTICIPANT: The decision making is not
2 there.
3 DR. HOLMBERG: Yeah. Decision making.
4 And integration of the proper tools--the open
5 transparency.
6 DR. BRECHER: Well, right now we're
7 stating what the problems are, so we have to phrase
8 it as that there's a current problem.
9 DR. BRACEY: Well, one of the things that
10 I was thinking about from the clinical piece is our
11 ability to impact practice. It sort of has been
12 inef--well, I won't say ineffective, but it's been
13 sub-optimal--limited. Limited ability to impact
14 clinical practice or clinical use of blood.
15 DR. LINDEN: That's separate, though, I
16 think.
17 DR. BRECHER: Okay. Other items? Okay.
18 So now, we need to smooth this list so that it
19 basically as, whereas, the following problems
20 exist--yeah, so--
21 DR. BIANCO: The other item that we didn't
22 put there was going through, because I don't know
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1 if still we put the policy question that Jay raised
2 about decision making? That is, we lack a clear
3 mechanism for decision making in--
4 DR. BRECHER: Clear path? Or
5 PARTICIPANT: How about a clear process?
6 DR. BRECHER: Yes.
7 DR. LIPTON: I thought we had a path, but
8 we didn't have--but some of the elements of good
9 decision making I thought--we thought were absent,
10 like us of analytical tools and--we do have the
11 outcomes measurement.
12 DR. BRECHER: So it's path and for
13 evidence-based decision making?
14 DR. LIPTON: Well, we could say decision
15 making does not uniformly utilize--or follow good
16 decision making practices or something like that.
17 DR. BRECHER: Yeah.
18 DR. LIPTON: Or recognized decision
19 making.
20 DR. EPSTEIN: I think the gap as I see it
21 is underutilization of formal analytical tools in
22 our decision making process. I don't think we lack
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1 a process. We know what our process is, but we
2 don't commit ourselves to routine use of formal
3 tools--you know, cost-benefit analysis,
4 risk-benefit analysis, cost effectiveness, risk
5 assessment, risk management, et cetera. We do that
6 ad hoc, and we don't always do it. But we're not
7 committed to it.
8 DR. BRECHER: Underutilization of formal
9 decision making tools--
10 DR. EPSTEIN: In policy and decision
11 making. I wouldn't say in creation of policy, but
12 in policy and decision making.
13 DR. BRECHER: Yeah. We're not in the
14 business of creation.
15 DR. EPSTEIN: Pardon?
16 DR. BRECHER: We don't--we're not in the
17 business of creation.
18 DR. BRACEY: Yeah. Well, one of the
19 things, and I think it fits partly under
20 insufficient disaster planning, but I wonder
21 whether it is something that ought to be stated and
22 that's the lack of a strategic blood reserve.
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1 Those, you know, that might be seeing that would
2 perhaps--
3 DR. BRECHER: Or a minimum supply?
4 DR. BRACEY: Right. Exactly.
5 DR. BRECHER: I mean, for example, just to
6 toss something out. You know, to be licensed as
7 blood center. I mean the FDA may require that you
8 have to have a minimum of six days supply, 95
9 percent of the time in the year. You can imagine a
10 mandate like that.
11 Just tossing that out.
12 DR. BIANCO: Since you're talking
13 about--that was one of the questions that we
14 discussed yesterday. What is the ideal blood
15 supply? And the other one is that we left aside a
16 little bit--I tried to raise yesterday, but
17 probably didn't communicate it well--was that I
18 don't think that it's clear the responsibility of
19 each one of the segments, be it the private sector,
20 the transfusion service, the third-party payer, or
21 the government, or the several agencies, and the
22 whole blood availability scene in the donor
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1 availability scene; that is, is this entirely a
2 private sector, since Jay likes to put that. Since
3 we are privatized, is this an entirely private
4 sector activity or does the government play a role?
5 And what is that role besides the regulatory role?
6 DR. EPSTEIN: So, Celso, are you saying
7 that the issue is the lack of clarity of the
8 respective responsibilities?
9 DR. BIANCO: With the lack of clarity
10 comes the lack of involvement or the lack of
11 demand. But, yes, I agree. The lack of clarity is
12 the best way to express it.
13 DR. BRECHER: Jerry?
14 DR. SANDLER: I'd like to make an effort
15 to clarify the underutilization of formal decision
16 making tools in policy and decision making for
17 systematic changes in blood products and
18 transfusion practices. In other words, I think
19 what we're talking about is all of sudden we get
20 universal leukoreduction or all of a sudden we're
21 testing for HTLV-1, and there is a lack of
22 utilization of formal decision making tools for
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1 such systematic changes that occur. Now, that's
2 what I think it's intended to say, but I wanted to
3 make it a little clearer.
4 DR. BRECHER: Is that okay now? So does
5 that work for you, Jay? Systematic changes?
6 DR. EPSTEIN: Yeah. I have another
7 comment; that I would quarrel with the examples
8 because I think, you know, leukoreduction is an
9 example where we did it up the wazoo, but that's--
10 DR. BIANCO: And the HTLV-1 is Jerry's
11 fault.
12 DR. EPSTEIN: Yeah. I wasn't going to say
13 that.
14 [Laughter.]
15 DR. BRECHER: We don't need to be that
16 specific. Okay. Mark?
17 MR. SKINNER: I've lost what's at the top
18 of the list that we're remembering, since we've got
19 so far down, but did integration of the public
20 health infrastructure; is that on that list
21 somewhere? The decision making within the public
22 health infrastructure?
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1 That's a blood donors. No, I'm thinking--
2 DR. LIPTON: Part of it is under
3 monitoring, because--well, how do we use the public
4 health? Well, one could be in monitoring, you
5 know--
6 MR. SKINNER: Yeah. But the issue I'm
7 thinking of are issues like where the FDA approves
8 a product as safe and efficacious, but CMS doesn't
9 approve it for reimbursement purposes. And the
10 integration between what the FDA is doing and what
11 CMS is doing in terms of authorizing reimbursement
12 and where do we--I mean if we're looking at
13 creating a--
14 DR. BRECHER: Or even categorization--
15 MR. SKINNER: --a transition-
16 DR. BRECHER: Or even categorization of
17 products?
18 MR. SKINNER: Yeah. Exactly. I mean if
19 we're looking at creating a transition or a new
20 beginning, I mean that's--one is perhaps a--to at
21 least look at is how do we--do we want better
22 integration between the HHS agencies--
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1 DR. BRECHER: Right. So lack of
2 integration between government agencies.
3 MR. SKINNER: Well, that was what I had
4 interpreted and understood was part of yesterday
5 was the second bullet--integration in the blood
6 system within the public health infrastructure
7 incorporated all of those kinds of issues. But.
8 DR. BRECHER: Lack of integration?
9 DR. EPSTEIN: I see it as part of the
10 previous point. Inadequate funding for timely
11 implementation of new technology that includes new
12 products.
13 DR. BRECHER: No, but I think what he's
14 saying is that you may all IVIG a blood product,
15 but CMS might call it something else. So that's
16 lack of integration. Alternative universes?
17 MR. SKINNER: Maybe it's more a part of
18 fragmented systems? I mean maybe it's--'cause
19 fragmented is, you know, we have a fragmented
20 system or a non-integrated system, and that affects
21 availability because it's an access issue. I mean
22 maybe it's there. We're just not using the word
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1 integration.
2 DR. BRECHER: I think it's--you know I
3 agree. It probably--you could probably put it
4 under fragmented, but it's not just for monitoring
5 safety and availability, but it's also for
6 classification and reimbursement--safety,
7 availability, classification, and reimbursement?
8 DR. LINDEN: Didn't we mention
9 reimbursement as an item, though?
10 DR. BRECHER: We did--
11 DR. LINDEN: I mean because that would
12 link to--
13 DR. BRECHER: We said reimbursement as a
14 function of access. But what we've neglected is
15 that we have a fragmented reimbursement system.
16 It's not just CMS. There are all these insurers
17 out there. And they're--everybody does things a
18 little different.
19 DR. LIPTON: So it's fragmented
20 reimbursement policies and failure to integrate
21 those with decision making?
22 DR. BRECHER: Yeah. So make it separate.
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1 DR. LIPTON: Decisions made around blood
2 safety and availability?
3 MR. SKINNER: I like that.
4 DR. LIPTON: I wish I could say it again,
5 but I'll never in my life.
6 DR. BRECHER: Reimbursement policies.
7 DR. LIPTON: Oh, what did I say? Failure
8 to integrate--
9 DR. BIANCO: I'd like to include not just
10 reimbursement, but funding. That is, even what
11 comes from an NHLBI or from CDC and other agencies
12 that impacts blood is not coordinated.
13 DR. LIPTON: Okay.
14 DR. BIANCO: And so it's the funding of
15 research; it's the funding of surveillance, or the
16 development of clinical processes, conferences--
17 DR. LIPTON: Can I just put--I think and
18 failure to integrate those policies with decisions
19 affecting blood safety and availability. Those
20 policies.
21 DR. EPSTEIN: Just suggest that
22 fragmentation in our system then it seems to me
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1 appears to be one of the strategic concerns. In
2 other words, if you look at the extent to which
3 fragmentation underlies many of the problems that
4 we're talking about, you'll find that it's a
5 pervasive theme. So I think that's one--emerges as
6 a strategic issue; is should we transform ourselves
7 to a less fragmented system?
8 DR. SAYERS: And against that background,
9 this is becoming a mea culpa more than anything
10 else. But I think somebody reading this could
11 be--for assuming, given these comments, that we're
12 running a blood industry which is based on a Third
13 World model. And, you know, what we've really
14 identified here are opportunities for improvement.
15 And the fragmentation and the recognition of that
16 is something for a strategic think tank approach.
17 But we could just as easily say given
18 these opportunities for improvement, systems for
19 monitoring funding. I just worry that we are
20 labeling all this--all these items as faults,
21 deficiencies, and sins on our part, 'cause a couple
22 of you have said we've done pretty well, given some
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1 challenging circumstances. And reading this
2 lengthy apology makes it sound like we haven't.
3 DR. BRECHER: I guess some of our
4 colleagues in New Orleans might think we are in the
5 Third World. All right, Jeanne?
6 DR. LINDEN: Well, yeah, that was sort
7 of--I think our thought originally, yes, we can
8 identify the weaknesses or gaps, but you could
9 also make it a positive thing that you'll--that
10 these are things that we think could be worked on.
11 We can improve, you know, continuity of supply, you
12 know, as opposed to--that the disruption is a
13 concern.
14 Just as a suggestion, the other comment
15 just specific to the part about reimbursement. I
16 don't think we want to say the blood policy should
17 be driven by the reimbursement; that we're reacting
18 to CMS. I think it should be the other way around.
19 The reimbursement should really be following the
20 blood policies. I mean even if that's not going to
21 happen.
22 DR. LIPTON: So this may be failure of
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1 those policies to support decisions affecting blood
2 safety and availability?
3 DR. BRECHER: So it sounds like we need a
4 preface sentence; something like overall, blood
5 safety availability in the United States has been
6 largely successful. However, we recognize that
7 there are the following opportunities for
8 improvement. Something like that?
9 DR. SAYERS: And then could you just go to
10 the beginning, because it doesn't take all that
11 much of a re-write. So then the first opportunity
12 for improvement might be in the supply and access
13 of blood products and their analogs rather than
14 mentioning anything about periodic disruption.
15 And then the next one would the
16 opportunity for improvement--would be development
17 of products for--what was that?--small patients.
18 DR. BRECHER: Put a colon here.
19 DR. EPSTEIN: Small patient groups and
20 rare indications.
21 DR. SAYER: Yeah.
22 DR. BRECHER: What was the first one? I'm
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1 sorry.
2 DR. SAYER: The opportunity for
3 improvement is in the supply and access of blood
4 products and their analogs.
5 DR. BRECHER: It's minimizing disruptions.
6 Minimizing disruptions. Disruptions. And here's
7 the small patient groups. Meeting the needs of
8 small patient groups for the development of
9 products. For the development of--put in there
10 products--or specific products.
11 DR. LIPTON: Can we say meeting the
12 product development needs of small patient groups?
13 DR. BRECHER: Yeah. I like that. Product
14 development.
15 DR. LIPTON: It gets so complicated then.
16 PARTICIPANT: The product development?
17 DR. BRECHER: Needs of small patient
18 groups. Yeah. The product development needs.
19 DR. SAYER: Is there something other than
20 small patient groups? I keep thinking of people
21 that are stature challenged.
22 [Laughter.]
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1 DR. LINDEN: Yeah. Can we talk about
2 frequency? Infrequent or--you know, or rare
3 disorders or--
4 DR. SAYERS: Rare disorders.
5 MR. SKINNER: Rare disorders really
6 doesn't cover it, because rare disorders--anybody
7 with 200,000 or less, at least as it's defined.
8 And we're talking about smaller than that. We're
9 talking about groups, you know, of a few hundred or
10 less.
11 DR. BRECHER: Well, but they're still in
12 that group.
13 DR. SAYERS: Yeah.
14 DR. BRECHER: They're just a subset of
15 that.
16 DR. SAYERS: They're included in the rare.
17 DR. BRECHER: Okay.
18 DR. SAYERS: And the other--the next
19 opportunity would just be funding for timely
20 implementation of new technology.
21 So I don't think you need the inadequate,
22 because the opportunity is funding. Right.
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1 Reducing fragmentation. In system--reducing
2 fragmentation in systems for monitoring safety and
3 availability.
4 DR. LIPTON: What about instead of
5 reducing fragmentation to make it more
6 positive--integrating. To use a positive word.
7 You know, integrating systems for monitoring safety
8 and availability and then integrating reimbursement
9 and funding.
10 DR. LINDEN: Integrating or coordinating?
11 DR. LIPTON: It could be both.
12 Integrating again, and Jeanne just said maybe
13 integrating and coordinating just for these--
14 DR. BRACEY: One of the things that we may
15 not want to include this in the preamble, but to
16 think about is again focusing on the importance of
17 blood as a resource in the provision of medical
18 care. It's somewhat self-serving, but Jerry
19 mentioned that it's--we hear that all the time.
20 DR. BRECHER: Yeah. I think it's down on
21 the list.
22 DR. BRACEY: It's down below?
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1 DR. BRECHER: Yeah.
2 DR. BRACEY: Thanks.
3 DR. LIPTON: Should it just be integrating
4 and coordinating reimbursement and funding?
5 We have to change the next part, too.
6 DR. LINDEN: I would propose coordinating
7 reimbursement funding policies and integrating
8 decisions on blood policies into those
9 reimbursement policies or practices in a timely
10 fashion.
11 DR. EPSTEIN: How about aligning
12 reimbursement policies. I don't think you need the
13 word funding. Aligning reimbursement policies.
14 Aligning reimbursement policies with decisions on
15 blood products and technologies with safety
16 and--well, just with decisions on--yes.
17 DR. LINDEN: Should the reimbursement vary
18 with availability? That makes it sound like a
19 supply and demand thing.
20 DR. EPSTEIN: Well, the idea is you're
21 trying to make a product available, but it won't
22 get paid for.
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1 DR. BRECHER: Okay. Let's do the--how are
2 we going to make the next one opportunity.
3 DR. EPSTEIN: Decisions on blood products
4 and technologies. I'm back to aligning
5 reimbursement policies with decisions on blood
6 products and related technologies. I'm trying to
7 get away from the availability thing. Just with
8 decisions on blood products and related
9 technologies.
10 DR. LIPTON: When we say--don't we want to
11 suggest somehow that those decisions improve blood
12 safety and our availability?
13 DR. BRECHER: You could say and to
14 optimize blood safety and availability.
15 DR. LIPTON: Well, it would be decisions
16 that optimize blood safety and availability. Can I
17 make a suggestion about this editing. I mean if we
18 capture it, you know, one or two of us went
19 through, and kind of did the grammar and everything
20 run during lunch, because it just seems so--it's
21 very hard to read up and down and unless we're all
22 looking at it all; maybe rather than doing a
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1 group--as long as we have the concepts.
2 DR. BRECHER: I tell you what. Why don't
3 a small group stay here for the next 23 minutes and
4 wordsmith it, and we'll take until 1:00 o'clock for
5 lunch. That gives us an hour and 20 minutes?
6 Okay.
7 DR. DUBIN: We don't want to forget a dose
8 of humility. We're not doing everything right, and
9 if we soften the entire document, the Secretary is
10 going to say everything is fine. We just need to
11 integrate a little more.
12 What I heard yesterday is if I'm a patient
13 with primary immune deficiency, I'm fighting the
14 same battle I was fighting in 1998. That doesn't
15 tell me everything is okay.
16 And while I agree, Dr. Sayers, that we
17 have done a good job in safety and availability and
18 improved immensely from the heyday of the '90s, I'm
19 concerned that if you take all the strong language
20 out, all of out, no one is going to hear you.
21 I think they still need to see there are
22 areas where people are really hurting, be it in
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1 primary, immune or elsewhere. And I think we as
2 Americans tend to think we're the best at
3 everything, and sometimes we forget to have the
4 humility to know we're not so great. The good
5 example recently is the 1,500 Cuban doctors that
6 were to be sent here, and you notice the New York
7 Times, the Washington Post, and the L.A. Times had
8 banner headlines that say the U.N. believes the
9 Cubans are the best at disaster relief from
10 hurricanes in the world.
11 I think sometimes we got to step back. I
12 agree with most of the document, but I don't want
13 to make it so soft that the Secretary or the new
14 ass coming in doesn't see the problem. Jerry it's
15 what you were saying to me earlier about preparing
16 for a new Secretary--a new Assistant Secretary.
17 I'm hopeful that Secretary reads that and says,
18 well, here's some areas we really have to work on.
19 DR. BRECHER: Maybe we can compromise.
20 Why don't we say--instead of saying for--
21 DR. DUBIN: That's all I wanted to add.
22 DR. BRECHER: --opportunities--
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1 DR. DUBIN: Thank you.
2 DR. BRECHER: --why don't we say
3 significant opportunities at the top?
4 We recognize that there--that the
5 following--yeah. Recognize the
6 following--opportunities for improvement. Does
7 that capture that thought somewhat?
8 DR. LINDEN: Do you want to get something
9 maybe across of these areas need improvement, you
10 know, for needed improvement or rephrase the whole
11 thing the strengthen?
12 DR. BRECHER: Yeah. We can say--
13 DR. LINDEN: Not just that we can tweak,
14 but that we really need some fundamental changes in
15 some cases.
16 DR. BRECHER: Yeah. We can say for a
17 needed improvement. Does that get to it, Corey?
18 Okay. Merlyn?
19 DR. SAYERS: How about prompt attention?
20 DR. BRECHER: Prompt attention. So needed
21 for prompt attention rather than needed
22 improvement--well, we've already reworded
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1 everything for improvement. We've already sort of
2 reworded things for improvement. Plus the
3 following--to these--for needed improvement or say
4 prompt attention? I guess we could do that.
5 DR. LINDEN: Or in a timely fashion.
6 DR. BRECHER: Okay. Jay?
7 DR. EPSTEIN: Since we're phrasing each of
8 the issues as an opportunity, maybe we don't have
9 to call them opportunities in the opening
10 paragraph. Maybe the opening paragraph can just be
11 strengthened so it--recognize the following needs
12 for improvement. But then the way we phrase them
13 doesn't, you know, damn ourselves. But that would
14 strengthen it.
15 DR. BRECHER: Needs for improvement and
16 prompt attention.
17 All right. It's--Celso.
18 DR. BIANCO: Yeah. I recognize that half
19 an hour will be great for a group to wordsmith it.
20 But I don't think that it's going to take us more
21 than half an hour after that to wrap it up.
22 DR. BRECHER: So you'd rather work through
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1 it and skip lunch or?
2 DR. BIANCO: Well, either that or take our
3 half an hour break and do it and then go for lunch.
4 DR. BRECHER: Yeah. We could do that.
5 Okay. You want to take a half an hour break and
6 then we'll re-adjourn let's say at 12:15 p.m.?
7 Okay. And let's--the group who's interested in
8 wordsmithing it, come up here and let's do it.
9 Is that okay with everyone or you guys
10 want to have lunch and then finish it? That's the
11 Committee's pleasure. All for having a lunch
12 before we finish it, raise their hands. Three.
13 All those who rather skip lunch? Okay.
14 Take an half an hour break, and if anyone wants to
15 come up here and anyone wants to come up here and
16 help wordsmith it, let's do it.
17 [Luncheon recess.]
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1 A F T E R N O O N S E S S I O N
2 [1:17 p.m.]
3 Committee Discussion (Continued)
4 DR. BRECHER: So we could get this done
5 before everybody comes--gets back from lunch. We
6 do.
7 DR. SAYERS: I move adoption. I move
8 adoption.
9 DR. BRECHER: Do we hear a second? Let's
10 read it into the record first.
11 Jerry, you want to read it into the
12 record?
13 DR. HOLMBERG: Blood is a critical element
14 of modern medical care and ensuring an adequate
15 supply of safe blood is a national responsibility.
16 Although there have been dramatic
17 improvements in blood safety and availability in
18 the United States in the last two decades, the
19 Committee finds that there are compelling needs for
20 improvement in some areas: minimizing disruption in
21 the supply of and access to blood products and
22 their analogs; meeting the product development
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1 needs for patients with rare disorders; timely
2 findings--funding--I'm sorry. I can't see. Yes.
3 I only have one contact. Timely funding to ensure
4 appropriate utilization of new technologies;
5 integration or--I'm sorry--integrating presently
6 fragmented systems for monitoring blood safety and
7 availability; aligning reimbursement and funding
8 policies with product approvals; and other
9 decisions intended to optimize blood safety and
10 availability; modifying reimbursement policies as
11 needed to sustain access to blood products and
12 their analogs for all patient groups, e.g., IGIV;
13 reassessing policies and their related
14 interventions based on evaluation of their impacts;
15 intensifying efforts to influence clinical
16 practices related to blood transfusion and
17 alternate therapies based on scientific evidence;
18 accelerating responses to threats, e.g., patient,
19 specimen, unit misidentification for which there
20 are available interventions; utilizing formal risk
21 communication strategies targeted to blood donor,
22 patients, and care providers to enhance scientific
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1 comprehension and public trust; pursuing
2 opportunities to enhance public health in the
3 management of blood donors; promoting comprehensive
4 disaster planning, including sustaining the
5 inventories necessary for an effective crisis
6 response; establishing a proactive, prioritized,
7 and goal-oriented research agenda; utilizing formal
8 assessment tools more routinely and policy
9 development in decision making; further clarifying
10 the respective roles of government agencies and
11 their private sector and management and oversight
12 of the blood system.
13 Therefore, the Committee believes that the
14 Department should develop a strategic plan for
15 increasing safety and availability for blood
16 products and their analogs. This plan should
17 include a review of the process of policy and
18 decision making for blood issues and its
19 integration with broader health policy
20 making--public health policy making.
21 Such a plan should encompass structured
22 process for policy and decision making, integration
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1 of blood systems within the public health
2 infrastructure, surveillance of adverse events
3 related to blood donations and transfusions, risk
4 communication, error prevention in blood collection
5 centers, transfusion services, and clinical
6 transfusion settings, donor recruitment and
7 retention, clinical practice standards for
8 transfusion and strategic research agenda.
9 DR. BRECHER: Comments? Jerry?
10 DR. SANDLER: My compliments to the
11 Writing Committee. I think it's a superb document,
12 and I think we should endorse it.
13 DR. BRECHER: Okay. So we have a motion
14 to accept? Second?
15 DR. SAYERS: Second. Can I amend that?
16 DR. BRECHER: Mm hmm.
17 DR. SAYERS: And add to the endorsement
18 the instruction to require that the Chairman submit
19 this document as correspondence to the Secretary?
20 DR. BRECHER: Yes. That's the way all
21 these resolutions are passed to the--well,
22 actually, to the Acting Assistant Secretary. Jay?
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1 DR. EPSTEIN: I think just for parallel
2 structure, it would help to indent the first set of
3 bullet items just the way you've indented the last
4 set of bullet items.
5 DR. BRECHER: Yeah. We'll work on the
6 formatting.
7 DR. HOLMBERG: There is one area here that
8 I thought as I was reading the--there was something
9 singular and something plural, and I don't know if
10 anybody else caught that?
11 DR. LINDEN: What the process thing is
12 sort of awkward, but technically, that's singular.
13 But it might be able to be rewritten to be clearer.
14 DR. HOLMBERG: What one is that?
15 DR. LINDEN: It may be in the conclusion
16 paragraph. I don't recall the--we had the process
17 for something or other. Oh, yeah. This--to
18 include a review of the process?
19 DR. HOLMBERG: Review of the process?
20 DR. LINDEN: And its integration?
21 DR. HOLMBERG: Is that okay?
22 DR. LINDEN: It's okay as it is. It's
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1 just a little awkward. I don't know if that's what
2 you were thinking of or not.
3 But I think grammatical changes, minor
4 tweaking, you can do offline?
5 DR. BRECHER: Yes. I think--if the
6 Committee is agreeable to that, we'll tweak it a
7 little bit. Mark and then Jay.
8 MR. SKINNER: I mean I'm sorry. I missed
9 the--is this the top of the resolution?
10 DR. BRECHER: Correct.
11 MR. SKINNER: I mean there's one thought
12 that's just somehow missing to me in here. I mean
13 we don't define the players or the stakeholders.
14 And I'm thinking about this recommendation. We're
15 asking the Secretary to do it, but we're not
16 suggesting anyway in how they do it. So the role
17 of this committee to me after this point is unclear
18 and the fact that the Secretary should do it in a
19 broadly representative stakeholder group that
20 includes all the various interests isn't clear.
21 I mean I'm a little bit concerned if this
22 becomes purely an internal process within the
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1 Department to address these issues, and a group
2 like this that's broadly representative of all the
3 stakeholders is not a part of the process.
4 And nowhere in here do we seem to indicate
5 that this needs to be developed in an open and a
6 comprehensive and an inclusive manner.
7 DR. BRECHER: Well, if we were to do that,
8 that would be in the paragraph down below, where we
9 make our recommendation.
10 Jay?
11 DR. EPSTEIN: In our discussion yesterday,
12 we decided that there were two additional
13 categories for the strategic plan. In my notes, I
14 indicated them as stable and sustainable
15 reimbursement, and funding for promising new
16 technologies. So, you know, what we've copied here
17 is the original list, but we did add those two
18 items yesterday.
19 DR. BRECHER: Funding for new
20 technologies.
21 DR. EPSTEIN: It was funding for promising
22 new technologies.
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1 PARTICIPANT: Oh, here. I'm sorry. Here
2 it is.
3 DR. EPSTEIN: Ah, there they are.
4 DR. BRECHER: Okay. We're ahead of you.
5 Let's go up to the paragraph.
6 DR. EPSTEIN: Yeah. They're there.
7 DR. LINDEN: And the thought was just that
8 the second list of items is going to parallel and
9 order the first list?
10 DR. BRECHER: It could or it could not. I
11 don't--personally, I don't feel strongly that it
12 needs to parallel it. I think more importantly is
13 addressing the openness of the--how this will be
14 done. So, Mark, what would you propose we change
15 to this paragraph?
16 MR. SKINNER: I mean this is saying that
17 the Department should develop, and I guess these
18 are--either they need to, you know, commission the
19 development or the Department needs to develop in
20 collaboration with or something that indicates that
21 I mean this is an external--this is a process that
22 includes all of the external stakeholders or an
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1 alternative would be to ask that some of this be
2 tasked back or that we have a, you know, an
3 oversight or a monitoring role or some kind of, you
4 know, we provide feedback for the strategic
5 planning process. But I'm not comfortable leaving
6 it all to an internal government process.
7 I mean that's the way it reads now is the
8 Department is going to do it.
9 DR. LINDEN: Should you just say should
10 develop comma in collaboration with stakeholders
11 or, you know.
12 MR. SKINNER: That would be fine.
13 DR. LINDEN: Interested parties or
14 affected parties, whatever comma.
15 DR. BIANCO: Or even with this committee.
16 In essence, that's how we see ourselves.
17 DR. BRECHER: Stakeholders.
18 MR. SKINNER: I don't want us to make a
19 recommendation putting ourselves out of business.
20 DR. BRECHER: And interested parties.
21 Yeah. Does that work? All right. To go back to
22 the motion. We had a motion. It was seconded, and
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1 we've tweaked it just a bit. Is everybody
2 comfortable with this? All those in favor?
3 [Show of hands.]
4 DR. BRECHER: Thirteen in favor. All
5 those opposed? None. This resolution carries, and
6 I will forward it to the Acting Assistant
7 Secretary. Jerry?
8 DR. SANDLER: I'd like to suggest that
9 when Jerry Holmberg writes the cover letter that it
10 is going to say something to this effect: one,
11 that, of course, you're transmitting two
12 recommendations that were developed at the
13 Committee meeting the 19th and 20th of September;
14 but the second one is to highlight that one of
15 these recommendations includes a guidance for an
16 emergency plan or an emergency action for a highly
17 urgent problem that requires immediate attention.
18 I think if we just leave it as it stands,
19 that we're sending two recommendations, we don't
20 get the sense in that communication that's going to
21 really direct his attention to what we did
22 yesterday, which was something very, very urgent
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1 that has to be taken seriously and has been I think
2 not appreciated at the highest levels for its
3 urgency. I can work that into my letter, as well as
4 capital letters, bold, underlined, urgent.
5 All right. In terms of other business.
6 Are there any other business we need to address
7 other than when our next meeting is? Do you have
8 the date?
9 DR. HOLMBERG: Captain, do you
10 have--Captain McMurtrey, do you have the dates for
11 the next meeting please?
12 DR. BRECHER: You know, we're breaking new
13 ground for this committee. We've never finished
14 this early before, and we're going to go out with a
15 bang.
16 CAPTAIN MCMURTREY: I have a pretty
17 definite date for the January meeting, which will
18 be the 5th and 6th of January. That's the first
19 Thursday and Friday of the month. The other dates
20 I don't have finalized yet.
21 I'm sorry. The meeting will be in
22 Virginia at the Crystal City Marriott, and I'll
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1 provide you all with the address. I just don't
2 have it with me right this minute.
3 DR. BRECHER: Jeanne?
4 DR. LINDEN: Jerry, when will we find out
5 if we're being replaced or need to plan on
6 attending that meeting for those us scheduled to
7 rotate off?
8 DR. HOLMBERG: I hope within the next two
9 months, we'll be able to get you some definitive
10 information.
11 DR. BRECHER: It's possible that some
12 members may be re-upped for a second term. But I
13 don't know that it's clear who will be. I'm sorry.
14 Paul?
15 DR. HAAS: I'm--much, much in the same
16 regard, I had planned coming in today to either
17 individually or do it collectively saying that I've
18 really enjoyed being part of this process since the
19 beginning, and I think this group has done a lot.
20 But yet, during today's meeting, especially given
21 that we had some time to talk with other members of
22 the Committee, I guess as one that knows he is
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1 rotating off officially at the end of this meeting,
2 but who knows what happens in January, I'm really
3 concerned about what appears or what we're hearing
4 via the rumor mill, I guess, that there's going to
5 be a rather massive change of personnel in the
6 Committee. We have just spent a lot of time
7 talking about trying to set a direction for the
8 future, and if those rumors are correct, who of
9 this group is going to be sitting around the table?
10 What's causing this rather significant change in
11 the composition of the group?
12 And I guess, as I'm leaving, that's a
13 concern.
14 DR. BRECHER: Well, I guess part of the
15 question is because two charters ago--or one
16 charter ago--the term of office was a four-year
17 term. And then the most recent charter, it went to
18 three years, and so it happens that two waves now
19 come together, and so a large percentage of the
20 Committee is coming to the end of term, and
21 so--it's a question of HHS whether they want to
22 re-up some of those people to enhance continuity at
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1 their discretion.
2 DR. HAAS: And I guess it's in that spirit
3 that at least if the information I'm getting is
4 accurate--and I don't know--that a lot of folks who
5 could be re-upped apparently are not going to be.
6 And that's much more of a concern. Someone like
7 myself, it's time for me to rotate off.
8 DR. BRECHER: Any comments, Jerry? None?
9 DR. HOLMBERG: Well, the process is not
10 just one person's decision. And the slate that is
11 put forward has to go through several offices to
12 get final approval. So, you know, I wish I could
13 say that, you know, my office made all the
14 decisions on it, but my office doesn't make all of
15 the decisions. My office is an office with a small
16 "O," so--
17 DR. HAAS: Jerry, let me interject. In
18 the spirit of a comment you made last night at the
19 PPTA meeting, I'm not making this comment as a
20 direct hit on you. It's a general systemic thing
21 that I'm concerned about.
22 DR. HOLMBERG: Sure. And I appreciate
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1 that, and that's one of the things that we are very
2 concerned about is the continuity and making sure
3 that we do have continuity of members already--I
4 mean the people that have joined--committee members
5 that joined this--Art and Susan, this is your
6 second time. And for Pearl, this is her first
7 time. It is a learning curve, and there's a lot to
8 take in, and so we're very much aware of that, and
9 we are considering that very issue is that we need
10 to have the consistency on that. It's just at this
11 point in time, I cannot say anything really.
12 DR. BRECHER: And I guess in my role as
13 Chairman, I'd like to thank all of those members
14 who will be departing. I think, while we may not
15 have accomplished all that we wanted to accomplish,
16 I think over the last couple of years, we have
17 accomplished quite a bit. Thank you. With that,
18 this meeting is adjourned.
19 [Whereupon, at 1:35 p.m., the meeting was
20 adjourned.]
21 - - -
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