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2 advisory committee recommended that HCFA promptly distribute

3 guidelines for coding and billing for its outpatient

4 prospective payment system. I believe that you will have

5 seen in the papers that the implementation of that system

6 has been delayed for 30 days so that recommendations, such

7 as this one for appropriate implementation, can be effected

8 before the outpatient PPD is implemented.

9 The final recommendation of the advisory committee

10 in April was that, recognizing the significant economic

11 issues currently affecting the blood system, the advisory

12 committee seeks to review the role of various considerations

13 and decision-making related to new and existing blood safety

14 measures. Underneath that somewhat opaque language is a

15 further discussion of the realities of the transfusion

16 business -- using that word intentionally -- and what the

17 government can do to provide relief not only for the

18 business but for the people for whom that business is

19 intended to help. We will meet for a single day on August

20 24th. I would be glad to answer any questions.

21 DR. HOLLINGER: Steve, there was a lot of

22 discussion at this meeting on compensation of people who

23 perhaps may develop some diseases from blood products and so

24 on, as well as reimbursement for these very expensive items

25 which we discuss frequently. In terms of the one about

13 1 compensation, was there any discussion about similar ideas

2 as to what is done with vaccines where so much of a vaccine

3 product goes into a pool to pay for that so that, for

4 example, any blood product that is given a certain portion

5 would go to make up some money available for problems that

6 develop?

7 Secondly, how does this work? I mean, I know this

8 goes to the Secretary of Health but what committee does this

9 go to in terms of reimbursement and how does this finally

10 get into the Congress where it perhaps can be acted upon?

11 DR. NIGHTINGALE: In response to the first

12 question, the discussion about no fault was really lead by

13 Mr. Justice Krever's presentation to the committee. When I

14 spoke to you in March I noted that there would be a jurist.

15 I didn't have in writing Horace Krever's acceptance and I

16 just did not feel at liberty to say there is a 99 percent

17 chance that Mr. Krever, now retired, would be there. So, I

18 wasn't holding back from the committee; I just didn't have

19 it on paper at the time.

20 The committee and those in attendance were very

21 taken up by Mr. Justice Krever's presentation, in particular

22 taken with his very clear demarcation of the line between

23 what tort can accomplish and what tort cannot accomplish.

24 Mr. Justice Krever was very clear and articulate in his

25 views of the limitation of tort systems in his home country

14 1 to deal with the tragedies that can ensue in the course of

2 attempts to make people better, and it was on the basis of

3 the limitations of the tort system that he strongly

4 advocated a no-fault system. He did note, however, that in

5 his own country that had not by any means been completely

6 implemented.

7 The second recommendation, which was for such a

8 system in the States, can be seen in the transcripts to come

9 fairly directly from the persuasiveness, at least to the

10 committee, of his recommendations, but there are clearly

11 political and real-world details to be worked out.

12 The answer to the second question as to where do

13 these things go, our charter is fairly clear. We advise the

14 senior management of the Department of Health and Human

15 Services -- we, being the Advisory Committee on Blood Safety

16 and Availability. In practice, both of these

17 recommendations come to the blood safety director who takes

18 that advice and makes his own recommendations to the

19 secretary. That is what is on paper. In the real world, a

20 lot of people are interested in blood safety. For example,

21 the agenda item on errors and accidents was driven to some

22 extent by interest in the House Commerce Committee in that

23 issue, although we had separately been anticipating that

24 issue for some time before the Commerce Committee or the

25 Institute of Medicine got wind of it.

15 1 I think as a courtesy we distribute the

2 transcripts and the summaries to anyone who is interested

3 directly. We post them on the web. The interest right now

4 is in the House Commerce Committee, the Subcommittee on

5 Oversight Investigations which is chaired by Mr. Fred Upton,

6 Republican, Michigan, is particularly interested in this

7 issue. In this election year, it is unclear whether the

8 presence of election will promote or slow down progress on

9 these issues.

10 DR. HOLLINGER: Yes, Dr. Simon?

11 DR. SIMON: Just a couple of comments on this

12 report. First, in my previous life I was involved with the

13 issue of no-fault compensation for transfusion-related

14 injury, first on behalf of AABB and then subsequently on

15 behalf of ABC. And, in fact, all the blood banking

16 organizations tried hard to get a model program in the State

17 of Arizona, when I was with Blood Systems out there, and I

18 think it never did finally come into being. But over the

19 years this has been an issue that the blood banking

20 organizations have been very interested in and have tried to

21 push for progress.

22 From time to time the model of the vaccine injury

23 program comes up, as you mentioned, and we bring this up on

24 Capitol Hill. The two comments that are made by

25 congressional staff people to dissuade us from moving in

16 1 this direction are, number one, when this was put into

2 effect people like Congressman Waxman and Senator Kennedy

3 made it very clear that this was a one-time exception to

4 tort law that they were willing to make and take on the

5 trial lawyers in this area, but it was clearly a one-time

6 exception.

7 Secondly, it was explained to me that the logic

8 behind the vaccine injury program and a special exception

9 for this is that the parents vaccinate their children not so

10 much for the benefit of that child but for herd immunity to

11 protect society as a whole. So, it is reasonable for

12 society, through a tax measure, to assure the parents when

13 they vaccinate their children that, should anything happen,

14 society will take care of that. But it wasn't felt that

15 this same principle applies to transfusion where someone is

16 being transfused for their own benefit, just like any other

17 medical form of therapy. So, I just thought I would add

18 that to this discussion.

19 The second point I just wanted to make on errors

20 and accidents is that it seemed to me, in reviewing this,

21 that that is kind of right down the middle of the plate for

22 this committee and FDA. I think it is certainly an area

23 where we would be interested in further progress and would

24 hope that FDA, as they presumably evolve in their internal

25 discussions on this, might at some point bring some

17 1 suggestions to the committee.

2 DR. NIGHTINGALE: Dr. Hollinger, could I make a

3 response to that?

4 DR. HOLLINGER: Yes, please.

5 DR. NIGHTINGALE: I am aware of those previous

6 discussions and, in fact, I have been in contact with Dr.

7 Sherman, who is going to prepare for me a summary of those

8 deliberations, and I have also spoken to the AABB about this

9 and I anticipate that there will be further discussion of

10 what the blood community had accomplished in the past and

11 the question about what should be accomplished in the

12 future.

13 One of the comments that has been made, and it is

14 not a comment that I made and attribute to somebody else but

15 is certainly one that I share, is that the legs of such an

16 enterprise are vastly strengthened when they include active

17 participation either by those who will be directly affected

18 by that or their representatives. When you talked about

19 errors and accidents being right down the plate of FDA,

20 within FDA's current budget there is a proposal for funds to

21 assist in the implementation of error and accident systems

22 and, honestly, we will have to see what happens on or about

23 September 30th of this year.

24 DR. HOLLINGER: Yes, Dr. Schmidt?

25 DR. SCHMIDT: I think for those on this committee

18 1 who are not involved in or keep up with these things, it is

2 worthwhile mentioning -- you had Justice Krever from Canada,

3 but the events over the last few years have forced the

4 Canadian Red Cross to declare bankruptcy for its entire

5 operation and a complete revision of the blood collection

6 and distribution system in Canada. So, this is a mighty

7 effect of this tort problem.

8 DR. HOLLINGER: Thank you, Dr. Nightingale. The

9 second update is a summary of a workshop that was held on

10 plasticizers: scientific issues in blood collection,

11 storage, and transfusion, held on October 18, 1999, and Dr.

12 Vostal will give us an update on that.

13 Summary of Worship on Plasticizers: Scientific Issues in

14 Blood Collection, Storage and Transfusion

15 DR. VOSTAL: Good morning. Thank you very much

16 for giving me the opportunity to review our workshop.

17 [Slide]

18 We had a workshop last October, and it was

19 entitled Plasticizers: Scientific Issues in Blood

20 Collection, Storage and Transfusion. It was jointly

21 sponsored by the Center for Biologics and the Center for

22 Devices.

23 The objectives of the workshop were to provide an

24 open forum for discussion of scientific data on the use of

25 plasticizers in blood collection and storage, and to examine

19 1 the risks and benefits of currently used plasticizers and

2 other available plasticizers and plastics for blood

3 collection and storage.

4 [Slide]

5 So as a little bit of a background, you are all

6 well aware that blood components are collected and stored in

7 soft, pliable and gas permeable plastic bags. Now, the

8 characteristics that are given to these bags are that the

9 plasticizers are actually dissolved in the plastics, the

10 main plastic that the bags are made of. Plasticizers are

11 not covalently bound to plastics, and can leach out into the

12 stored blood and be transfused along with the blood

13 components. One of the main plasticizers that has been

14 debated over the years has been di(2-ethylhexyl) phthalate

15 or DEHP. The problem with this plasticizer is that it has

16 demonstrated toxicity in rodents. It has been a 30-year

17 debate or longer than 30 years whether this type of toxicity

18 can also be extended to humans.

19 [Slide]

20 DEHP does have some demonstrated benefits. It

21 actually incorporates into the red cell membrane as it

22 leaches out of the plastic bags and extends the storage

23 dating of red cells from 21 days to 42 days. This was

24 actually demonstrated by Dr. Jim au Buchon at the NIH Blood

25 Bank, in the early '80s.

20 1 However, these are some of the risks that have

2 been demonstrated in animals. In rodents DEHP leads to

3 carcinogenicity, and the mechanism of this is peroxisomal

4 proliferation. There are also new data coming out showing

5 that DEHP has negative effects on reproduction, and this is

6 both in male and female adult rodents. There is new

7 evidence coming out that shows that there is testicular

8 toxicity in developing animals, and this was done in

9 rodents. So, again, with these types of things the question

10 is whether these effects could be taking place in human

11 after they have been exposed to DEHP through transfusion.

12 [Slide]

13 In the workshop there was a great deal of debate

14 on alternatives to phthalate plasticizers. For platelets,

15 manufacturers have actually moved away from phthalate

16 plasticizers and they now use citrated plasticizers with PVC

17 or polyolefin bags which don't require plasticizers. So the

18 amount of plasticizers reaching out into platelet products

19 has been greatly decreased.

20 For red cells, there has been a lot of research

21 for plasticizers also and, actually, Baxter came out with

22 citrated plasticizers in PVC for storage of red cells. That

23 was cleared by the FDA and introduced to the market in the

24 early '90s. However, it was not well received by the

25 transfusion community. There were problems with labels not

21 1 sticking to the bags. There were reports of an unpleasant

2 odor to the bags, and there was also an increased cost. So,

3 after about two years these bags were taken off the market

4 and we were back to using bags that have DEHP.

5 The major concern that was discussed in the

6 workshop is that any new type of plasticizer that is
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1 department of health and human services icon1 department of health and human services

1 department of health and human services iconDepartment of health and human services

1 department of health and human services iconDepartment of health and human services

1 department of health and human services iconDepartment of Health and Human Services

1 department of health and human services iconDepartment of health and human services

1 department of health and human services iconU. S. Department of health & human services

1 department of health and human services iconDepartment of health and human services

1 department of health and human services iconU. S. Department of health and human services

1 department of health and human services iconU. S. Department of health and human services

1 department of health and human services iconDepartment of health and human services

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