DR. PENNER: Yes.
DR. MARGOLIS: In
other words, all of the data I've shown you so far is for version two,
for the second generation. And so for us, for the evaluation, it has to
be added to the questionnaire that will go out in 2001.
DR. PENNER: So
you're really not sure what that part of the look-back is--
Don't have any data on that.
DR. PENNER: Mike,
do you have any idea what that might be, just offhand?
DR. BUSCH: Well,
just I remember when we looked at this there was data from Stanford that
indicated that their actual incremental pick-up with the version
one-driven look-back was quite low just because of the tracing issues,
the lack of records, the number of patients alive.
In terms of the
first-gen look back, I think most programs have implemented it. There's
actually not a formal final FDA recommendation, in terms of exactly how
to conduct it. But sort of verbally, I think BPAC meetings, et cetera,
FDA has indicated their position. So most programs have initiated it and
I think probably completed it.
DR. PENNER: With
the first part, but the other part--
DR. BUSCH: No, I'm
talking about the first-generation-driven, BIA-driven look-back programs
have, to my knowledge, been implemented and are probably well on the way
MS. LIPTON: If I
can just, the difficulty we don't know. I mean, we're pretty confident
about what the blood centers have done. When you get into more problems
is trying to ascertain whether the hospitals have actually been able to
make the contact. I think most blood banks got on it right away because
if you were going to go through the records once, you just wanted to
accomplish it. But as to how, you know, finding patients who were back
much further I think was a very different issue. And there are time
lines. I think everyone is working diligently. But, Kay, you don't know,
do you? I just don't think we know right now. And we periodically send
out surveys, but we don't have one on the--and it's really the hospitals
we need to hear from.
Harold, a couple of public health questions and concerns.
Most states now
are doing universal screening for HIV and Hepatitis B in their
populations of women that are being taken care of in labor and delivery
room suites or during their prenatal care, and it must be documented. It
is a requirement, at least prior to dismissal of the infant from the
hospital because of certain therapeutic decisions perhaps that have to
Are we anywhere
close to considering that as a universal recommendation for prenatal
populations, given what obviously is a tremendous increase or at least
the suspected increase in serum prevalence rates is one question. And
the other is within some of the efforts that are taking place, are we
also doing something to try to dispel the myths and misperceptions about
Hepatitis C? We often get questions about household members being in
contact with somebody that is identified as being Hepatitis C. And it's
almost a real stigmatization that occurs in infants or children in day
care settings, where a parent has declared themselves to be Hepatitis C,
and it becomes a matter of public concern.
CHAIRMAN CAPLAN: I
just wanted to piggyback something that I forgot to ask onto that
question. We had a big battle, which you're aware of, Hal, in
Philadelphia about firemen getting infected with Hepatitis C. And I got
a lot of calls about this casual contact transmission, bleeding contact,
that sort of thing.
DR. MARGOLIS: I
would venture to say we spend 50 percent of our time, professional time,
both public inquiries and actual time "doing the studies," to dispel
some of the myths, actually maybe working from the fire fighters back.
Again, unfortunately, there are a lot of things that go wrong out there,
so incorrectly reported data, which turns into somebody's political
agenda, which doesn't serve anybody. And as you saw, we moved pretty
quickly to test old data sets, analyze data, get an MMWR out and try and
answer and at least hopefully set the information platform straight.
The same goes on
with the question of transmission. I think there are, again, good data,
and those get handled both through hotline and a lot of calls, and, no,
we don't have a pamphlet that says what do you do in a day care center.
That's on the list that needs to be written. And so that's where, and
again, we try and clearly work with our partners to identify certain
groups or information areas in some of these cooperative agreements that
we do. I mean, that's frankly how we work is to let them put that
information together and get it out. And so some of that type of, you
know, those areas where we're getting a lot of inquiries, we then try
and generate, you know, some written information or put something on the
website and go that way with it.
So it's kind of
both, if we need the data--you know, tatoos is, again, still one of the
big issues. So there are RFAs out there, there are awards that have been
made for looking at tattooing in various settings to, again, look at
risks. So sometimes we need to generate the data, which is the research
side. Other times it's just communicating it that we try and deal with.
The question about
perinatal transmission and screening pregnant women, there is a CDC
study that's being presented now and is in the process of being written
up for publication that showed, again, that the rate of perinatal
transmission is low. It's about 3-3.5 percent. Transmission only
occurred in an HCV RNA-positive woman. But, in fact, since this was
actually a prospective multicenter study, it showed two additional
One, it showed
that there was an increased risk for internal fetal
monitoring--somewhat, you know, that's kind of a logical thing, but it's
never been looked at before; and the other that there was increased risk
with prolonged rupture of membranes greater than 6 hours. And actually
those in the multi-variant analysis part of it actually became the only
dominant risk factors, in fact, over HCV RNA titer in the mother.
It raises the
question of, given that kind of information, is there something we ought
to be doing differently in terms of identifying HCV-positive pregnant
women because in the past there wasn't anything you could actually do as
an intervention. And, again, going back to how you make things happen in
practice, we're currently working with ACOG, and their Fetal Medicine
Committee, and their Infectious Disease Committee to review those data
and see if it warrants such a recommendation for screening because that
gets back into that issue of, you know, identification of all of the
issues and what one might do.
So those are new
data that, as I say, have been presented, and several meetings now are
being put together for publication and are being worked on by the groups
that would be most affected by it. So we are trying to move in that
DR. GUERRA: But
beyond, obviously, the port of transmissions or just they're serving the
purpose of identifying the Hepatitis C women in child-bearing years,
that obviously could then be put into a registry for tracking and for
doing the other kinds of preventive measures.
Again, it goes back to a bit of the question that Dr. Caplan asked,
which turns out that actually in that age group, if you just did it
uniformly, you're identification rate is actually very low because
that's actually one of the lower-prevalence areas. We do have
recommendations that if women have risk factors, they should be
screened. And, again, if you go around and talk, especially to large
inner-city OB-GYN and delivery services, many of them are screening,
some of them now to the point of routine. They're definitely asking
And, again, ACOG
has put that in one of their, you know, in their newest screening
questionnaire. So, again, it's this issue of, you know, should you do
everybody or should you do some, and some of the new data on possible
intervention for the infant may change the equation in terms of should
we do all. And that's where are right now. And as I say, this is just in
the last couple of months. So we're trying to deal with it with various
DR. GILCHER: A
couple of comments from a large regional blood center that might be
With respect to
first-time donors, it's 95 percent of our HCV hits are in first-time
donors. It's actually 95.4 percent at our blood center. We've gone back
and queried these individuals. There are not a lot, but we've queried
them. And what we have found is that, number one, they were not seeking
tests. They really did not know they were infected. What we did find,
though, was that about 50 percent of them did admit, even though they
had denied this at the time of the donor screening, they did admit that
they had tried IV drugs even one time.
We then added
another question, and this is really a comment that I'd like you to
comment on. We said, "Do you have any friends that are Hepatitis C
positive?" And almost every instance, they have friends. And, in fact,
when we query, it's those friends with whom they tried IV drugs even one
interesting finding that we have now from our NAP data, and I can only
speak for my own center, is that roughly--and this is a donor
population, not a general population, is that about 25 percent of the
donors who are RIBA-positive appear to have cleared the infection.
That's higher than what has been found in the general population. But of
that group, interestingly, about 30 percent of the women have cleared,
but only about 17 or 18 percent of the men appeared to have cleared the
infection. I'd appreciate your comments.
Starting with the last one, when we looked at the NHANES data, 25
percent were, in fact, RNA negative, realizing that's a one-time RNA
test. But only 75 percent were positive. The younger you were, the more
likely you were to be RNA negative. And, again, that gave us some pretty
wide confidence intervals, but there are other data that kind of keep
coming out that way. And, again, in that data set, as you recall that
African Americans had the highest chronic infection rate, at about
almost 90 percent. And, again, those data and other studies have been
seen that way. So that when you put that together, I think that's
probably what we're seeing, what you're seeing, and it's part of, I
guess, better knowing the biology and the natural history of the
The issue that an
HCV-positive individual may have another positive individual either in
their family or close to them, we're now seeing again, in a number of
data sets that we're analyzing, and where again I can just give you from
the NHANES that we're looking at, for instance, in families actually
close to 30 percent of the families had more than one HCV-positive
person in it. But when you actually look genetically, these aren't the
same viruses. So it wasn't that they were transmitting to each other
because, unfortunately, NHANES didn't have all of the risk factor data
we would have liked in NHANES 3, but from what we have, it seems they
had similar risk factors. And, again, I think that is beginning to be
noticed, and we just need to get a little more precise with how common
that is and how we can use it to identify individuals. It's not that
this is, you know, intrafamilial transmission, but it's shared risk
factors. And I think, frankly, we need to figure out better how to use
that information so we can identify people.
But, yes, we've
seen that in the NHANES, we've seen it now in a couple of other data
sets, and we're trying to, again, figure out ways I guess really to best
understand it so we can use it for identifying people.
DR. DAVEY: Dr.
Margolis, I think we can all agree, and the comments have reflected
this, that the toughest group to approach is the IV drug-abusing
community. Probably over 50 percent, I believe, of infections are
thought to be by that route, as Ron and others have pointed out.
Could you comment
on the CDC's efforts to link their control measures on Hepatitis C with
other government agencies that have responsibility for managing drug
abuse. And secondly, specifically, what's the CDC policy on clean
needles and providing clean needles for a prospective management of this
infection in that community?
DR. MARGOLIS: I
think probably the best indicator of what the Public Health Service--how
we view this was this meeting in May in Baltimore called Drug Use,
Hepatitis, and HIV--or I can't remember which way they had it--bringing
it all together, in fact, sponsored by the agencies who have
responsibility both for prevention, treatment, and control of substance
When you then
really start talking to drug treatment center directors as well as the
research investigators and trying to--how do we figure this out, I think
everybody's well aware and I think now is beginning to believe that the
paradigm for prevention of infections among injection drug users, while
HIV has been the focus, it's really HCV because it's there immediately,
and, in fact, I think it's made us all--and, again, based on data that
was done in syringe and needle exchange programs, actually sponsored by
CDC, show that it's probably things other--I mean, the syringe and
needle are extremely important, but transmission also goes from the rest
of the activity, and to put it kind of quite bluntly and frankly, you
need universal precautions in a drug use setting, then reflect on that
and realize how difficult that is. But that's, in fact, what the issue
becomes. It's everything else that's transmitting, and, in fact, we've
done studies to ferret out those other things, including blood on the
hands and all those things that go on with drug use.
So you still got
to get at the prevention side. You have to figure out how to interdict
in terms of those who are using. And let me tell you, one of the things
that I've seen--and I'm kind of new to this--is that in the states where
we have now seen hepatitis C coalitions from a state perspective put
together, it has heavily driven the issue of drug treatment. So that,
again, several states now have moved drug treatment actually into
clinical public health settings instead of that "over there" kind of
situation. And these people are now talking to each other. And, you
know, there's been real changes in total philosophy. Yes, CDC recommends
that syringe and needle exchange should be carried out. The Federal
Government doesn't fund it. So that's, you know, where there's some
But, in fact, it's
very effective, and most recently some involvement we've had with
vaccinating drug users in exchange programs shows that it's highly
effective, can be done, and you can access people.
So I think things
are changing, and the people who are supposed to be dealing with this
are talking to each other a lot. Is there money? That's what Fernando
asked earlier. Unfortunately, no, there's not a lot of money that's
coming together with this. But I think at least we're finally talking
about it and realizing what the issues are.
So, you know,
that's kind of--this is new and this is evolving, and evolving pretty
Maybe what we will do is take one more question from the Committee. I
might look to see if there's one question out in the audience. Then I
will finally relieve Hal from standing up here so long.
DR. HAAS: It's
impressive the amount of work that you have done, and I have to believe
it's also very frustrating in terms of how slow the information comes
out. And this part might be the wild part, but I'm listening to this and
thinking of watching these ads now showing up on TV for different types
of pharmaceutical drugs and the awareness it has, I suppose, given the
patient showing up at the doctor's, probably asking for the drugs for
the wrong purpose, but at least they're aware that it's out there.
wondering, now that we do have treatment for hepatitis C, whether some
of those drug companies might be willing to start funneling dollars in
to help the continued promotion that you're doing.
DR. MARGOLIS: In
fact, the PSAs, you know, the TV PSAs, which are very expensive, were
funded through the CDC Foundation and a drug company consortium. We just
didn't have the resources directly from what we had. And so we haven't
gone to the subliminal advertising yet, but we're clearly partnering.
And I think it's been working well. And it's also including
immunizations. So when I talk about, you know--because again, as Dr.
Guerra said, this is the whole thing.
I mean, I don't
know if you've heard me say it here, but our buzz word around CDC
now--and this is with the AIDS groups and others--is one-stop shopping.
I mean, the reality is you've got to think of these all together, and
all the bloodborne infections are together, and we've got to start
talking about it that way. And so we've been trying to do that with
Could I just ask you to identify yourself for the record?
MS. JACOBS: Yes,
Mary Beth Jacobs from FDA. I have a follow-up question to the last one.
About a year ago,
I saw an ad in the Washington Post directed toward women from a company
saying: The next time you go to your gynecologist, why not ask if you
should be tested for hepatitis C?
Has CDC evaluated
the effectiveness of that type of direct ad to consumer, not the
approaching of having companies fund the PSAs, but the comparison
between that kind of approach in someone who has not yet been diagnosed?
DR. MARGOLIS: No,
Dave Cavanaugh, Committee of 10,000. The occasion for this presentation
is the letter, which is stopped. There are several barricades to the
letter going out. We understood kind of elliptically from Dr. Satcher
that a sentence is being changed, and I don't know if that means the
letter's been pulled back or never went to other Congressmen. And even
with the ban, is there any kind of assurance that something will happen
that any number of the 435 members will be sending it when they come
back in January?
Just for the record, I spoke to Mr. Slobodan of the House Commerce
Committee yesterday. We do have a plan, and we'll be in touch with you.
There are separation--because of the separation of powers, I'm not going
to say anything else right now, but I will say for the record that we
continue to work actively with the Congress and fully respectful of
We will come back, undoubtedly, to the letter with, I'm sure, other
illuminating responses. But let's stick with Hal for now. I'm going to
take one more question, if that's to Hal, and then we'll take--we're
getting ready for a break, although Steve has one comment to make before
DR. SAYERS: Merlyn
Sayers from Carta (ph) Blood Care, which is the community blood program
for Dallas-Fort Worth. Heaven forbid I should delay getting into the
break, but some comments that relate to remarks by Dr. Satcher, Dr.
Busch, Dr. Gilcher, and Dr. Margolis.
It's not all that
long ago that community blood banking was a lot simpler. All we really
needed to do was recruit donors, collect blood, test the blood, make
components, and distribute it. But whether we like it or not, the role
for community blood programs to become centers of community and public
health is increasing dramatically, and that's understandable. Something
like 40,000 volunteer donors a day are scrutinized by an extensive
health history and extensive serological testing. So our role in
community and public health then immediately relates to counseling those
individuals that have been identified as potentially worthy of
That community and
public health role then gets extended with targeted lookback, and I have
no doubt that that role is going to be extended even further when this
letter comes out announcing to the nation at large what the risks are of
hepatitis C, the silent epidemic. And whether we like this or not, I
have no doubt that even though individuals will be cautioned against
going to their blood program to donate to get tested, I would not be at
all surprised if we do not see a small surge in individuals who are
found to be reactive in HCV because simply they're one of the many
millions that do not have health care coverage.
So at every point,
the cost of doing business at blood programs is increasing, and a
significant element of that increased cost has to do with the fact that
we now have a community and public health role.
Now, we cannot
exactly pass those costs, understandably, on to the individuals that we
sell blood to. Goodness knows they can't get reimbursed for the
additional testing that we're doing. So, Dr. Margolis, you posed the
question just a couple of minutes ago, is there the money? And what I'm
wondering is, if there is the money which is going to recognize that
community blood programs are now a very valuable and very important
source of community and public health, could there be creative ways to
fund these public health programs which are centered at the blood
End of sermon.
Well, let me just tell the group, the Committee, because it's public
record, you know, our budget through this year, the end of this fiscal
year, is about $13 million. So that pays for all these things you're
hearing about and some things you're not hearing about, like the
sentinel counties, the NHANES, all of those things, and also pays for
some staff. Congress, in the current President's budget for 2001, the
estimate mark is an additional $5 million, and that's kind of where we
are, and that's how we put it together.
testimony in a number of hearings as to what the estimates might be for
a program that would fund counseling and testing and support of the
various community activities that you're describing, and that's in the
range of $40 to $60 million per year. So we're a long way and, you know,
we're trying to be as creative as we can.
Yes, we think it
ought to be a part of the mix, and if you look at HIV, you know, some of
those types of things do occur. But we don't have that for hepatitis C.
Merlyn, in response to your statement, something that we have done for
over 12 to 15 years is offered what is called non-donor testing. We
clearly found out that there is a segment of the population who wants
anonymous testing not at a doctor's office but are willing to pay for
it. And we believe that that has actually enhanced the safety of our
blood supply and has removed test seekers from donating blood because we
now offer this kind of program through our system, which is really in a
sense a public health maneuver.
Okay. Thank you, Hal.
Steve, you wanted
to say a word about the WHO issue that the Secretary brought up, I
DR. NIGHTINGALE: A
word or two, and about several subjects. I am taking over Dr. Snyder's
obligation to be brief before the break. I'm not sure that I will
Hal said that you
had to hear a message seven times before you really understand it. This
will be the tenth time that the Committee will have heard either in full
or slightly abbreviated fashion the conflict of interest statement.
Relative to what
we're up to, I would ask you to listen to it at least as carefully as
you have on the previous occasions because there are some very important
things in it, and it reads as follows:
statement is made as part of the public record to preclude even the
appearance of a conflict of interest at this meeting. General
applicability has been approved for all Committee members. This means
that unless a particular matter is brought before this Committee that
deals with a specific product or firm, it has been determined that all
interests reported by Committee members present no conflict--potential
conflict of interest when evaluated against this agenda.
specified in Title 18 of the United States Code at 208(b)(2), a special
government employee, which all Advisory Committee members are, may
participate in a matter of general applicability, for example, advising
the government about its policies on the hepatitis C epidemic, even if
they are presently employed or have the prospect of being employed by an
entity, including themselves if they are self-employed, that might be
affected by the decision of the Committee--and here is the key
point--provided that the matter will not have a specific or distinct
effect on the employer or the employee other than as a member of that
The example give
in 5 C.F.R. 2640.203 is as follows: A chemist employed by a major
pharmaceutical company has been appointed to serve on an Advisory
Committee established to develop new standards for AIDS vaccine trials
involving human subjects. Even though the chemist's employer is in the
process of developing an experimental AIDS vaccine and, therefore, will
be affected by the new standards, the chemist may participate in
formulating the Advisory Committee's recommendations. The chemist's
employer will be affected by the new standards only as part of a class
of all pharmaceutical companies and other research entities that are
attempting to develop an AIDS vaccine.
In the event the
discussions involve a specific product or a specific firm in which a
member has a financial interest, that member should exclude him- or
herself from the discussion, and that exclusion should be noted for the
With regard to the
other meeting participants, we ask in the interest of fairness that they
disclose any current or previous financial arrangements with any
specific product or any specific firm on which they plan to comment.
The point here,
the tenth time, is that conflict of interest is an extremely important
issue in a democracy. The process of regulation--it's very important
that we do this right on several different levels. We have and will
continue to talk about issues where the advice--we cannot get the advice
we need as a government unless we get it from people who will have a
conflict of interest. This Committee is intentionally much more
inclusive than some of the other Advisory Committees, and I think that
has been one of its strengths. And one of the things that--perhaps my
personal agenda is to try to make other committees stronger by being
I believe that we
have in the statement that I just read, and, as you can see, I deeply
respect, a principle analogous to the principles that we will be trying
to elucidate--to gather from you today on the broader issue of blood
safety that goes part of the way but not all of the way. And that's why
I wanted you to focus on it. The principle for conflict of interest
works extremely well, I think, for individuals. Does it work as well for
aggregate committees? That's where we fall short.
I saw the lawyer
to my left give a knowing smile. I think there are a few others.
For example, it is
perhaps not quite in our technical capacity yet to clone the chemist
that I mentioned earlier and several times previously, but clearly a
committee that was made up of 10, 18, or 24 clones of the chemist would
not be an ideal committee. We really don't have the principles quite yet
for aggregates as we do for individuals in regard to conflict of
interest. How we develop a committee that is not collectively biased is
something we haven't figured out yet. We have some standards, though,
and I think you should look--when we make our disclaimers or our
proactive statements that we encourage members of minorities, women to
apply, that geographic diversity is indeed a criteria for membership on
the committee, these are perhaps sentinels that we would use to see
whether--as a first pass, but they're clearly not sufficient.
So as you are
thinking today about either the certain matters or the principles,
however we formulate the statement, I would encourage you to consider
that we've come part of the way towards that but not all of the way.
Now, in that
context, one other thing that I think we have that we don't use
perfectly but I think use well is the charter that we have for this
committee identifies people--the class from which we wish to draw
nominees, and, in fact, this is my segue to the comments on our request
for nominations for membership in the committee.
Our charter does
not identify specific people who have chairs on the Committee other than
that there are six non-voting governmental representatives. There is
somewhat of a split between people on the left, people on the right, and
people in the center. That is not cast in stone. That's something we're
still working on, and comments on that either now or sometime in the
future from the Committee would be helpful. But as we actively solicit
nominations for membership in the Advisory Committee, we would be
interested in nominations that make the whole Committee stronger rather
One final point,
of course, is that the Committee, while it might be the people around
the table, we have made and will continue to make a deliberate attempt
to act as much as we can as a Committee of the Whole. Dr. Caplan has
been superb--and I would like to make that compliment for the record
right now--in including members of the audience. The audience has been
equally superb in their contribution, and for the record, thank you for
your continued support.
With that, then,
on May 31st, notice was published in the Federal Register, Volume 65,
No. 105, page 34705, soliciting nominations of individuals to serve on
the Advisory Committee in accordance with its charter. As Dr. Satcher
noted, the terms of five members will expire on September 30, 2000.
Appointments will be made for a term of four years, and it is now
necessary to renominate individuals previously nominated.
In accordance with
the Committee's charter, persons nominated for membership should be from
among authorities knowledgeable in blood banking, transfusion medicine,
bioethics and/or related disciplines. Members shall be selected from
state and local organizations, blood and blood products industry
including manufacturers and distributors, advocacy groups, consumer
advocates, provider organizations, academic researchers, ethicists,
private physicians, scientists, consumer advocates, legal organizations,
and from among communities of persons who are frequent recipients of
blood and blood products.
Membership is by
secretarial appointment, and I can assure you that it is by secretarial
and not by staff appointment.
A copy of the
announcement is available at the back of the room. We have attempted to
make the nomination process as simple as possible. We need to know who
the nominee is, how to reach her or him, which of the very broad
categories I just mentioned the nominee fits into, and that is only
because of the requirement of the Committee charter, and a written
statement of the nominee that, if appointed, he or she will serve.
We need a copy of
the nominee's C.V. Additional supporting materials are welcome but not
necessary. Individuals may and are encouraged to nominate themselves. In
accordance with well-known Department policies regarding
nondiscrimination and diversity, women and members of minority groups
are encouraged to apply. If someone other than the nominee is the
nominator, we need that person's name and address. If the nominator is a
corporation, we need a human contact in that organization.
Finally, we need
to receive the materials by 4:00 p.m. on August 31, 2000, which will be
the 92nd day since the notice was published on May 31, 2000.
If anyone has any
questions, please contact CAPT McMurtry. His direct telephone line is
202-260-1351, and it will not be changed until after the close of
business on August the 31st.
Now, to the statement of issue for the meeting, at your request you are
meeting to discuss the role of various considerations in decision making
related to new and additional safety measures. Dr. Satcher suggested the
alternative but not contradictory title of what are the principles on
which a blood policy to assure a safe, available, and affordable supply
should be based. This is meant to encourage rather than to limit
comment. I think one of the uses, perhaps the immediate use of the
comments will be as the Department considers how best to support the
efforts of Dr. Emmanuel, who you met at the last meeting, and certainly
Dr. Epstein, who has made huge contributions to this process, to the
meeting in Geneva on November 13-17 by WHO, the first Global
Collaboration for Blood Safety. A copy of the announcement was
distributed with your briefing memoranda.
We approach this
with an open mind, with, as you heard from Dr. Satcher, a desire to
participate in a constructive manner both in regard to the needs and the
policies and the political conflicts of developed countries as well as
made that comment about the immediate purpose, that is, of course, not
the only purpose of the meeting. The Department is aware, in part
because of its response to your previous recommendations, of the issue
of reimbursement for blood products and reimbursement for the services
that are incorporated into the provision of blood products, many of
which economists would call externalities. The issue of what the market
recognizes and what it doesn't is one of which we are aware, but do not
mind being reminded once again at this meeting.
The agenda for
today's meeting is much less structured than it has been in the past and
much less structured than I anticipate it will be in the future. The
reason we have done this is to provide the members of the Advisory
Committee and the members of the public in attendance an opportunity to
say whatever they want to say on this issue and to do so in an unbiased
context as possible. The one request I have, although I may not have
honored it myself, is to keep it short.
Steve, just for the record, some members of the Committee have asked me,
having perhaps not been as intimately acquainted with the charter of
this Committee as you are, with a new election how does that affect if
there's a turnover at HHS, with the Secretary, how does that affect our
business, our charter, what goes on?
On November 9th, all bets are off. At the same time--I've actually--I've
never gone through a government transition, particularly not being kind
of in the--I don't want to call it "the bunker," but in the Secretary's
What I do
anticipate, however, is that there would not be a complete change of
administration. I am aware of very broad bipartisan support for this
Committee. It's been incorporated into report language in the past. It's
been expressed to me privately, and I communicated it to you because,
folks, it's your work that has been recognized.
Where are we
going? The speech that Dr. Satcher said was this Committee, I believe
very successfully, has addressed six very complex issues. The burden of
Dr. Satcher's--at least the text of his message was that these problems,
while addressed, remain, have not gone away, and if we let them drop,
they could become problems again very soon.
To give a little
bit of my political feel for this, it is that the establishment of this
Committee and the maturation of this Committee was a very labor and
emotionally intensive process. I know of no one in the government or I
think in the private sector who wants to start all over from scratch.
DR. DAVEY: Steve,
one quick question about membership. Assuming the Committee continues, I
would recommend--and I think we've discussed this--that we include a
representative from the Health Care Financing Administration as a
representative on the Committee joining our other government
Noted. Also, I think membership on the Committee by a nongovernmental
individual who may have expertise in that area would also merit
consideration and will be considered.
Dr. Davey did
remind me to say one of the many things that I wanted to say and didn't
say when I was reading my text real fast: Membership on this Committee
is a membership of individuals in accordance with the charter. We
nominate, the Secretary approves individuals for membership in the
Having said that,
I would say something else. The Committee needs new blood. You get tired
of listening to me read that conflict of interest after a while, and you
get tired of listening to some of the other things. At the same time the
Committee needs continuity. These are issues for which we don't have
good guidelines. We make it up as we go along. But I think in a
government, the more, first of all, that the public participates in the
process and the more--the better the road map, the easier it is to
govern with the consent of all who are being governed. That's what we're
Okay. Unless there are any other questions about our membership and what
to do to put people forward, why don't we take a 15-minute break? Then
what I would propose is we come back and follow up on the issues raised
by Dr. Satcher and Dr. Margolis in terms of hepatitis C lookback,
notification, that area. Then I think we have some public comment to do,
which I suspect is going to take us toward the values and principles
issue about increasing efforts at safety relative to cost and
practicality, which I know members of the Committee want to talk about,
and that should get us up through lunch.
So let's plan on
thinking about what we heard this morning, going to the lookback issue
and notification and public awareness, and spend some time with that and
then move on to the public testimony as a way to move us toward the
consideration of continued efforts to push for safety.
Could I have a show of hands about how many members of the Committee
wish to make statements? One, two, three, four, five, six, seven, eight,
nine, ten, eleven, twelve, thirteen.
Well, forget it.
On that note...
We have time, so we will go there. Did you want to do that sort of
pre-public testimony? You want to go around that way?
All right. We'll do it that way. Maybe we'll get us into that and then
move into the public testimony side after lunch, if that's how that's
going to work. Okay.
Could we take our seats back here, please?
What I'd like to
do is have the members of the committee spend whatever amount of time
they want, but just a few minutes on the presentations we heard this
morning on hepatitis C on the look-back. I know we've had discussions
about, and requests about this matter of sending the letter. I
understand that this is a subject under discussion, and has legal and
even constitutional issues in play, but you may want to say a bit more
about that in terms of advice to the Secretary.
One idea that I
had which I can toss up in front of the committee is that we might want
to say if something hasn't happened by a certain date, than we would
hope that monies would be appropriated to make sure that something
happens by another date, but that's just my particular thinking about
But let me open
the floor and see if, based upon the presentations, we have any
discussion, comment that you want to make about the hepatitis C, the
look-back, the notification issue.
One thing I think
we might want to urge, if not recommend, is that there be, with
acknowledgement to Dr. Nightingale's comment about intensity versus
duration, some effort to coordinate the letter with CDC efforts, patient
and foundation activities in private sector activities. It seems to me,
whether you want to commit to an intense effort or make sure that
something is there that's going to go on over time, it's just important
to get the ducks lined up so that you get a maximum impact of sending
the letter. Plus, if the Secretary--if you remember what he said, he
said in part, we're not sure we're ready for a response that might be
large, to sending out a letter. Other organizations and other groups
need to be on board here in terms of knowing what's going on, being
ready to both field questions, but also perhaps to bring pressure to
bear to make sure that the infrastructure for an adequate response, if
not right after the letter goes back, that at some point in the future
is there. So that is of concern to me, that we try to push that they
coordinate on this kind of thing, and that we urge everybody to try and
work together, all the interested parties here. Jim?
DR. AuBUCHON: I
certainly agree with you that coordination would appear to be helpful,
although we have no data to know exactly what is going to work, and that
is an unfortunate impediment, as Dr. Margolis identified, but even
beyond coordination, I would urge the federal government to identify
resources to put toward this problem.
If I could make
a--what will probably be perceived as a cynical observation--when this
committee began its existence several years ago, there was a great push
on from the Congress that we had to address this hepatitis C problem
immediately, and we have addressed it from a transfusion point of view,
but as Dr. Epstein pointed out, that is a very small piece of the
puzzle. The larger piece of the puzzles is not getting the attention and
the resources it deserves. One might suggest that some in the federal
government--and I do not mean those around this table--directed
attention to hepatitis C through transfusion as a cheap means of
addressing what they thought was the hepatitis C problem, because the
federal government didn't have to pay for hepatitis C look-back,
primarily. They foisted it off on someone else. I think it's time, and
the situation deserves additional resources from the federal government
to address the larger part of the problem.
DR. GUERRA: I
think as we continue to take the hepatitis C national effort to the
scale, we need to somehow--and I'd be interested in Dr. Margolis's
response--we need to build that onto the efforts that have been in place
for HIV/AIDS, the national campaign, and not take away from that,
because that continues to pose a very significant threat in communities.
Well, perhaps we can come back after we listen to committee
presentations up until the lunch period, to what we want to say, if
anything, about both budget resource commitment and coordination in
general. Since we've been around for the three years, I continue to find
it somewhat surprising that the total budget to send out the letter is
bigger than the CDC Hepatitis Office budget, but all right.
Okay. I guess the
way to go on this, we have a lot of people who took the request for
comment very seriously, and that's great, and I am now in the
unfortunate position of trying to steer a group, in terms of time, that
I have learned to be unruly about these matters. But I think we have a
5-minute aspiration on presentations and statements, and what I'd like
to do, is instead of organizing us by height or alphabet or something,
I'm going to start down with John over there. I tend to--these people
have accused me of looking to the left first, so let me go over there,
and then we'll just move right around the room for committee members to
make their presentations. I didn't watch all the hands, so not everybody
has one, but if you do have one, let's start there and just come down.
So, John, I give
you the first 5-minute opportunity.
MR. WALSH: Thank
you. I'm used to being at the end of the alphabet.
First of all, I'd
like to express the appreciation on behalf of the alpha one community to
this committee for taking the shortage situation with respect to A1PI
products as seriously as we have. The Alpha One Foundation is dedicated
to providing the leadership and resources that will result in increased
research, improved health, and worldwide detection, and ultimately a
cure for alpha one. AAT is a single-gene defect leading to loss of one
serum protein, and there is currently only one product available,
manufactured by one manufacturer, naturally, to provide augmentation
therapy for patients with alpha one.
that I would like to report on in the form of an update that helped us
through a crisis that lasted some 24 months with supplies decreasing for
allocation between 40 and 80 percent throughout our population.
On April 28, 1998,
resolution: "The Department of Health and Human Services should explore,
in collaboration with industry, health care providers and appropriate
consumer groups, methods to optimize and standardize allocation of
available products in an equitable manner, including management of
emergency supplies and programs that distribute products directly from
manufacturers to registered consumers."
issue was addressed by the Alpha One Association, the alpha one
community, in conjunction with the foundation and the medical and
scientific advisory panel. We did address it, and a direct distribution
strategy was developed to respond to the request for direct consumer
allocation, and deliver prolastin directly to the consumer. Prolastin is
no longer sold to distributors. It is allocated directly from the
manufacturer to the consumer, ensuring that the fully-prescribed dosage
is available to each alpha as long as there's product available, which
includes issues related to lot releases and ultimate supply issues.
in the program has received their full prescription at 28-day intervals,
resolving the need for reduced dosages or increased intervals at this
time. In addition, over 200 consumers that did not have access prior to
November '99, are currently on augmentation therapy. So a controlled
direct distribution in the case of a one-product-one-manufacturer
community like ours has definitely resolved the inequities and directly
related to decrease and severe shortages.
April 28, 1998,
the committee made a recommendation that industry should explore with
the FDA strategies for reallocating partially processed plasma materials
from one manufacturer to another, you know, to optimize production of
alpha1-antitrypsin deficiency and other plasma derivatives.
We are able to
work very closely with industry, and again, on behalf of the Alpha One
community, I'd like to thank the American Red Cross and Baxter for
working very closely with Bayer in a cooperative relationship that
ultimately provided enough 401 paste to optimize production capacity at
both of Bayer's manufacturing facilities.
So for now we have
enough raw paste to produce at maximum capacity. That does not mean
we're going to have enough end product or throughput to be able to
April 28, 1998,
again the NIH and industry should immediately evaluate alternative
dosing schedules and alternative delivery systems for alpha one therapy,
including prophylactics strategies and strategies for treatment during
acute exacerbations of disease, and accelerate the development of
gene-based products and gene-directed therapies for alpha one.
supported the evaluation of new delivery technologies. The advisory
committee recommendations for expedited development of new and
non-plasma derived options helped break the logjam for aerosol or
inhaled development of A1PI, and we currently have three manufacturers
that are in various processes of development for an aerosol product,
including one transgenic product, will be the first recombinant product
available to our community, potentially available to the community,
obviously, pending trials and licensure, but it's already gone through a
situation, with only one manufacturer and one product, with limited
production capacity, it is inevitable that demand will exceed supply. In
fact, I believe we're there right now, where we're going to see, within
the next two months, the inability to be able to dispense 100 percent of
prescribed dosages to patients, so we've already hit the wall in
optimizing the distribution. We need another product. This will
ultimately affect every consumer. The product will continue to be
shipped in sequence with no prioritization given to reimbursement
issues, which was one of the problems in our distribution that's
corrected by this, effectively, or clinical triage. There's been no
determination by medical and scientific advisory committee that clinical
triage is possible, let alone appropriate in relationship to
augmentation therapy for alpha one. It failed in Europe. The European
Respiratory Society tried to implement one in 1999.
The future IV
products--there are two IV products currently under different stages of
development. One is finished the Phase III and delayed in PLA
application for numerous reasons. The other is in Phase III now. It's
fully recruited for enrollment in the trial and should be completed, and
once their data is analyzed, will obviously get to the FDA for expedited
There are three
initiatives, as I said, with respect to the aerosol delivery, which
would--we hope, would make a more efficacious process to deliver the
drug directly to the lung. It's hoped that aerosolized products will
provide increased access to more consumers, being able to take care of
up to five times as many consumers with the same raw material, and also
be more cost effective.
The Alpha One
Foundation will continue to work closely with industry and the FDA to
promote the development of new therapies. Alpha One has a meeting
scheduled with the FDA and CBER, which has been very cooperative in
addressing the issues related to clinical trial design and the IND
issues. One of the issues we're discussing is a recommendation to form a
working group between the FDA, the NIH and the Alpha One Foundation
Medical and Scientific Advisory Group, to be able to actually look at
some of the surrogate marker endpoint issues and other impediments to
design of clinical trials and approval of products.
And the foundation
is organizing and HR CT scan, using high resolution CT scanning to look
at the progression of lung disease as a potential surrogate marker, and
also an animal model study workshop, which will be conducted in Sienna
There's just a
couple other comments that I would like to make to the committee.
Regards HCFA, the committee's action, I think HCFA had more response to
the outpatient prospective payment issues. The APC code change, where
there would be a direct path to plasma derivatives, definitely made it
possible so that all of our HCFA consumers would not be cut off from
product and create a real problem for access. So we thank the committee
for the support in that.
We've taken the
responsibility to communicate directly with all of the distributors, all
of the providers for HCFA treating alpha one patients, and let them know
how to actually do the billing, and we're working closely with HCFA to
The transition to
recombinant is a result of this committee's strong recommendation,
although I notice that the--in the final recommendation that was
published, it only mentioned hemophilia factor products. I believe the
committee discussed that in the broader context of plasma derivatives,
and I'd like to state for the record that I think that very much helped
the PPL Therapeutics out of Scotland to focus their attention on alpha
one, and not just cystic fibrosis.
Finally, I'd like
to thank the members of this committee for their support for the Five
Points of Life, speaking of donor awareness, and the Surgeon General's
remarks earlier, the Five Points of Life event is to raise donor
awareness for organ tissue, DNA, plasma pheresis, obviously, donations
country-wide. Dr. Gilcher, his group has a rider involved with that
program that raises a lot of awareness, and I think it's just a ripple
and we need to do more, as much as possible, we're committed to. ARC,
AABB, ABC and ABRA have all contributed to sponsor the event, and there
will be an activity here in Washington, a reception for congress people.
And even the insurance industry is involved. State Farm, I think, is the
only one I'm aware of so far that's embraced this, but I think it's
important for us all to take on the responsibility to get involved with
creating more donor awareness.
I would also like
to thank the organizer of the ride, Life South, for all their efforts,
and to thank our committee's Executive Secretary, Dr. Steve Nightingale,
for his ongoing participation and support throughout the process. Dr.
Nightingale is actually riding the first week, from Bar Harbor, Maine to
So again I thank
the committee on behalf of our community, and look forward to making
more progress in the future.
Thank you. Unless it seems--I mean if someone--I'll take a minute to see
if there's a question or a comment after each speaker, but you don't
have to feel compelled to do so, comment or--that's a polite way of--
All right. Jerry?
Well, I was unprepared. I'm usually last alphabetically, so thank you
Well, I wanted to
make two comments. The first is in the form of a thank you, which is
heartfelt, and the second is in the form of a proposal for a future
Now, the first is
a thank you, and if you will remember, one and two years ago I presented
information to this committee when I was not on the committee, but a
member of the audience, about the shortage of IV gamma globulin and the
many patients with primary immune deficiency diseases. I'll remind you
that well over 10,000 patients receive IV gamma globulin, and it is the
only thing for primary immune deficient patients which is
therapeutically beneficial. There's no substitute for the IV gamma
globulin. But during the past few years there had been a very
significant shortage of IVIG for these patients, which was impacting
very significantly on their health status.
Now, the part of
the thank you is that through the efforts of this committee, a similar
committee advising the FDA, the Immune Deficiency Foundation, and under
the leadership of Dr. Epstein, the FDA itself, all of these groups
developed a realistic and achievable clinical protocols which will speed
the licensing of new IV gamma globulin preparations from a number of old
manufacturers and new manufacturers. One such protocol, my understanding
is, nearing completion, if not been completed, from the patients' point
of view at least. Another clinical protocol has begun to enter patients
over this summer, and two other manufacturers are developing clinical
protocols as we speak. I believe that the availability of these new
preparations will help very significant in alleviating the shortage. So
my thank you is that I would like to publicly thank both this committee
and the FDA for their efforts to alleviate the shortage. I do believe it
made a difference, and I think we're seeing the results of that even as
I speak. So if you ask yourself if the committee has done anything
worthwhile, which I had to ask myself before I joined the committee,
rather than sit around, I can give you evidence that you made a
significant difference for these patients.
Now, my second
point relates to asking your advice as to whether or not there should be
consideration for a new agenda item over the next number of months or
year, and I'd like you to consider whether this is an appropriate agenda
item. Now, as you know, patients with primary immune deficiency diseases
are the only long-term users of IV gamma globulin, one of the plasma
products. Many of the patients have been on for decades. In fact, there
are patients entering their third decade of use of licensed IV gamma
globulin in this country, and most of them will remain on IV gamma
globulin for a period of four, five or six decades if the therapy is as
good as we think it is. From that point of view they're quite unique,
and represent, if you will, a canary population for patients receiving
IV gamma globulin and many other disease states in the short term. These
long-term patients receive it for decades, as I said.
Now, in recent
years, there's been a growing suspicion that long-term consequences have
not been well documented. There are at least two articles of anecdotal
case reports of patients with primary immune deficiency disease, who
have received IV gamma globulin, presenting with unexplained central
nervous system diseases. In addition, there are some other problems
associated with the use of this material, as there would be with any
pharmacologic or biologic material. Renal disease, immediate adverse
events, and the consequence of long-term use have been looked at, but
not in a formal way.
And so what I'm
wondering is whether or not this committee should consider adding a
future agenda item which would include presentations on the value of a
formal assessment or prospective study of the long-term and short-term
adverse effects of IVIG. Obviously, I would hope then that they would
endorse such studies because these studies are not being done currently.
Whether that's a role for this committee or not, I'm young on the
committee, and so I'm not sure, but I did want to bring it to your
DR. NIGHTINGALE: I
would comment briefly that there are many ways to view the role of the
committee and many readings that you can make of the charter, but one
that I think that would encompass not only your statement but the
statements that I anticipate from the other side of the room here, would
be that this committee very fundamentally addresses what economists call
externalities. For those of you who are not either economists or
children of same--and I am in category B--and externality is a cost of
producing a good or product that the market for one reason or another
does not recognize. So I think I've answered your question
Then my impression would be that this would be an appropriate agenda
item, depending on priorities of the committee.
DR. PILIAVIN: I
was under the impression that our remarks were supposed to be addressed
to the precautionary principle. So of course, as soon as I start to
talk, my voice acts up. And I guess I'd like to start by referring to
the article that you included in our voluminous materials for this
meeting, entitled, "Will Blood Transfusion Ever Be Safe Enough?"
And that's the
point that I guess my remarks are all oriented around that. Whether that
puts me on the left or on the right, I don't know, because I don't know
where that dimension goes from to. I also want to note that we were just
handed out a bunch of new stuff, one of which is a memo from Merlyn
Sayers about leuko-reduction, which just ties in with this same issue.
First I want to
say that I read everything you gave us about the precautionary principle
and I still don't know what it is. That's because very early on in the
material it says that it's not going to give a definition of it, and
then as you read the examples, clearly, the precautionary principle goes
everywhere from saying if something has any kind of potential harm to
the environment, to human health, you shouldn't do it, to a very basic
kind of risk cost benefit analysis on the other hand, that says when it
comes to new technological things, you should be really, really careful
and think about the concerns for human health. So I don't know what the
precautionary principle is.
I think we all
have been trying to be careful, and if the precautionary principle says
"Be careful", then we've been following it. I get the sense that because
of the examples they use about the European community, there's more
attention in regard to this principle to new developments than to
long-standing situations, and I'm wondering whether that's appropriate.
Is it only about new technological things or is it about any kind of
dangers? And I'm going to deal with it more as if it's any kind of
Okay. I kind of
liked one of the things I read in here which said that when dealing with
data under the precautionary principle, you need less than a
preponderance but more than a scintilla of evidence of harm. I just love
the word "scintilla" anyway. And I'm wondering to what extent we in the
past and other committees have been dealing with scintillas or less
rather than with preponderances, and that we should take that into
account. I'm specifically referring to the NBCJD issue, which strikes me
as having less than a scintilla of evidence. As you all know, I have
been opposed to that regulation regarding people who have been in Great
Also in the
materials on the precautionary principle, one of the things that they
said--and this was clear--is that you should deal comparably with
things, that you should not have one sort of reaction to one problem and
a different kind of reaction to another problem, that things should be
dealt with in some equitable kind of way. And again, referring to the
response to NBCJD, I would like to ask why did we respond that way to
that issue and have not responded to what struck me as more evidence
about Chagas Disease, and certainly lots more evidence about problems
with errors, simply blood matching and other kinds of errors. Now,
these--I mean, the latter is of course not technological in the usual
sense and it's not new, but if we're going to apply this principle to
concerns about risk, I think we have to look at having comparable
responses to issues, and certainly there are far more people who die
from errors of the sort we talked about last time than have, obviously,
NBCJD--nobody's died--and Chagas Disease, I don't think anybody's died
from transmission, and certainly there's all sorts of things that could
come down the pike.
In terms of equity
issues of a different sort--no, I think I'm going to skip over that
because I know I don't have that much time here.
I want to get back
on my usual hobby horse of safety equals availability. At the level of
infectivity that we now have in the blood supply, the idea of adding
leukocyte depletion and individual NAT testing strike me as
inappropriate use of money for a variety of reasons. Of course it's
going to drive the price up, which will lead to both a decrease in the
number of people who can afford the product, and a decrease in money
that's available for other things. Certainly it will lead to an increase
in medical premiums. It will put an excessive drain on the public
funding, Medicare, Medicaid, and from what I saw in terms of the
estimated dollars per year of quality adjusted life that will be added
by the individual NAT testing, this struck me as really inappropriate
use of money.
I want to think,
in terms of other uses of money and how much life could be saved, things
of the sort of child immunization, sex education and HIV prevention,
prenatal care, visiting nurse programs and even cancer research, and
certainly putting in funds for getting more information to more people
about Hepatitis C would come under better uses of money.
In regard to
availability then, these things also have the impact of further
decreasing the availability of blood, but also the possibility of
bankrupting the blood centers. Because it's more or less guaranteed, I
think we all know, that reimbursement for the Medicare/Medicaid patients
won't be sufficient.
As a social
scientist, I was thinking about this as I was reading the materials, I
would love to get a survey of all of the blood centers in the United
States to see where they are financially. I mean, it's conceivable to me
that all of a sudden a good proportion of these organizations, which are
mainly nonprofit, are just going to go belly up, and they're not going
to do it one at a time so we can see a trend going. There's going to be
a bunch of them who are going to say, "This is the straw that breaks the
camel's back. We can't do it. We have to quit." And that can be a
It would be very
nice to know where they are, how close to that point these organizations
are. Because if anything like this disaster scenario were to happen, we
would be in deep trouble.
It's clear, also,
from the materials that this message we've been trying to send, that we
want a no-fault coverage for people who do, indeed, get injured by these
very, very, very few people who get injured by infectivity in blood,
that nobody is paying any attention to this. The secretary says they
can't do it, and I'm sure that they can't. And the Congress, who
mandated this committee, seems uninclined to do anything. I think the
best precaution against the very small known risk would be accepting
that risk at this point and providing that kind of relief for people who
are, indeed, harmed, as we do for people, the very few people who are
harmed by vaccines.
I'm trying to
think of a comparison that would be apt in terms of the number of people
who are injured in this arena, as compared to other arenas.
Unfortunately, I was late reading my material, and therefore did not
have access to even the Internet to check anything. But I know that we
lose many more people on the highway in one day than from
transfusion-transmitted diseases in the last 15 years. And so that
struck me as apt. Why aren't we putting a lot more money into educating
people about safe driving and so on?
lose more mothers and babies from inadequate prenatal care, to put it in
the same arena, but the people that we're losing are probably, for the
most part, from groups that aren't powerful enough to lobby Congress for
Why aren't we
doing cost-benefit analyses comparing the things that we spend our money
on? Now, obviously, this committee as a committee can't do that. But you
asked us to give you our opinions, and this is my opinion. I think that
the next HHS secretary should ask Congress to appoint a committee to
assess how our medical dollars are spent across the spectrum of things
that endanger the health of our populations--how much bang for our buck
are we, indeed, getting?
I want to end with
sort of the old simile about, in terms of where we're spending money,
are we like the drunk who drops his keys while trying to open his front
door, but looks for them under the streetlight because he can see better
over there? Are we pursuing technological and bureaucratic fixes for
smaller and smaller risks very expensively simply because we can, while
ignoring much more critical problems because we can't?
DR. NIGHTINGALE: I
need to make a couple of brief procedural comments. First of all, Jane
asked, very legitimately, what is the precautionary principle. It was
included in your packet because it is one of the many approaches to the
answer of the question not because it was a preferred approach. If it
has any primacy, it is because it is, in fact, the law of a very large
chunk of land with which we have trade, in which we have biologic trade,
and it is not something that I think that we are free to ignore,
although we are, by no means, required to accede to it. And if my own
personal take on it snuck in, in that last comment, so be it. I realize,
also a comment to Jane's why was the precautionary principle put in, in
something this big, it was put in because this is a very complex
And I think one of
the things that the government can do wrong when it runs a committee
like this is to try to dumb it down so you can get an answer. And one of
the things we have not done here is to try to dumb this committee down.
And along those comments, when Jane finally asked are we getting our
bang for our buck, this meeting costs about $25,000 to put on. Most of
it goes to plane tickets and most of the rest goes to the Hyatt. Not
much goes to food, as you tell.
But I would say, so far, we are getting advice at about a thousand bucks
a pop, and so far it is the judgment of the government that we are very
much getting our money's worth, and I thank you.
Steve, I wasn't talking about this committee. I was talking about the
medical budget of the United States.
No, no. But I was trying to say thank you.
It's easier to say that to some people than others.
CHAIRMAN CAPLAN: I
do think the precautionary principle is used by some outside the United
States, and their policy is for new things, so it doesn't really set
itself up for comparative risk assessment.
DR. PENNER: It
seems to me that the recurring theme of our deliberations is what price
safety. And I'd like to reemphasize the fact that I don't believe blood
is an industrial product. I don't think it's comparable to a drug or a
medication. I think it's unique, it has no alternative, and you do not
have a dose ratio of efficacy to safety. In other words, exposure and
the occurrence of any viral effects to that exposure are not reversible.
It's all or none. You can't just reduce the dose and reduce the side
effects or complications associated with this item, which we call blood.
If we had a
situation whereby a medication I think was put up for approval and would
produce a death rate of, say, 1 percent or 1/2 percent or so on in every
recipient that received it, I don't think that drug would be expected to
be approved. And we do have that situation with blood, that it does,
once it's administered, produce an effect that is not going to be
reversed in those individuals who are exposed to whatever the
contaminants are. And since there is no alternative, I think we're put
into a very unique situation that is not comparable to what we find with
other manufactured medications.
And then lastly, I
think the public expects safety with this product. The donor population
is particularly sensitive to this issue and always will respect the fact
that if the blood is not considered to be safe, we will probably
continue to have problems on recruitment of donors. It will have an
impact. So it would seem, therefore, to me that cost will have to
respond to these requirements. And despite the fact that the cost effect
may be considerable, I don't think we really have a lot of choices if we
want the public to respect the fact that we are providing them with
something that they don't have to fear.
MS. LIPTON: I just
had a few short comments. And we're going to have more of an opportunity
later on the precautionary principle, so I was going to leave that aside
I wanted to let
you all know, some of you knew, I actually had an opportunity to
participate as a blood safety and availability committee member in the
fourth annual meeting of GAIN. And GAIN is the Global Aviation
Information Network. It's a very interesting organization. It sort of
takes off from where we talk domestically about air and accident
reduction. And the whole purpose of GAIN is to really improve aviation
safety worldwide by promoting the exchange of information by and among
members of the aviation community.
When you get into
the details of what GAIN is, it's truly a remarkable partnership between
government, FAA in particular, but other government regulatory agencies
around the world, and the airline industry globally. And the whole
purpose is really to share information about near misses, and deviations
and problems that come up--I mean, to share it in a way that really is a
no-fault exchange and really does improve safety.
The FAA provides
technical support, but the aviation industry is truly in partnership
with the FAA because, together, they have constructed a data base that
everyone has access to. Now, interestingly, they have the same barriers
that we identified in our last meeting, the principle barrier, of
course, being legal obstacles. There's fear of discovery of the
information that's in the database, and there's also fear of the
punitive action that might be taken as a result of the information in
that they've been able to solve those problems. They've been able to
solve it both through international treaty and through an international
organization that's very interested in promoting this and has gotten
different countries to sign on to their principles. FAA itself I think
we saw by the regulations has agreed that they will not use the
information that's reported through the system to take punitive action.
Some of the other
obstacles they reported will sound familiar--lack of support from people
within their own profession, that cultural shift that needs to be made,
and also from the CEOs' perspective in the airlines, demonstrating
cost-effectiveness. But they are making some headway there.
I wanted to
comment about this conference and tell you about it because, at the end,
the conference came up with five guiding principles. They were consensus
statements. And I only want to talk about the first two because they do
relate to our discussions later today, whether it's on precautionary
principle or blood safety issues. One is that the first guiding
principle is that the safety of passengers and workers is of paramount
concern to this industry. My guess, as they stated, it's because
generally the airline pilot is first at the scene of an accident. But
that being said, I think there are some things that we can take into our
own community from that.
But the second was
very, very intriguing to me, and that is that the public perception of
safety, of airline travel, is as important to them as absolute safety.
And this is a principle that, excuse the pun, they live and die by. They
don't have a problem incorporating that into the actions that they take
to improve safety, even when they think that airline travel, if you look
at it, is safer than it's ever been. We've heard that before. You know,
your chances of really dying in an airline accident are quite small. But
they don't care, they are continually trying to drive down the number of
accidents. So I just wanted to bring that up, and perhaps we could get
back to that again when we talk about our own decision making.
The second issue
is to talk about reimbursement, and again to thank this committee for
its support, and HHS in particular. We did achieve some beneficial
changes to outpatient reimbursement. We're now really working diligently
and very hard on trying to change reimbursement for inpatients for
people who will require transfusions in the hospital.
We've been greatly
encouraged by the interest of congressional members in this issue. They
clearly appreciate that both safety and availability, as Jane pointed
out, are really tied to reimbursement issues.
I think, at the
same time, we've frankly been I guess challenged and maybe somewhat
disheartened by the lack of uniform appreciation and support within the
health care community itself for the need to fix reimbursement for blood
and blood products. There's a general need to say we need to fix
hospital issues. But getting the attention focused on blood and blood
products continues to be a dilemma. After all, we compete with a lot of
other issues that hospitals are concerned about, and we're critical, but
we're small. But, again, we are critical, and I think that we lose a
real opportunity if we don't keep this committee's attention on the
reimbursement issue and if we don't keep pushing.
I guess we're
going to hear a little bit later from Paul on some adequacy data. But,
again, related to reimbursement, adequacy remains a critical issue in
this country. But to my mind, adequacy, again, it's not related to a
lack of good ideas, it's not related to the fact that we don't have good
professionals or very motivated people. The real issue is it all comes
down to costs. It costs money to recruit donors, and we have not been
paying enough attention to putting money into that side, and that will
raise the cost of blood.
I think, frankly,
as a government and as a society, we've been kind of content with
supplying just about enough blood--80 to 95 percent. We could easily get
to 100 percent, where there aren't shortages, where there aren't
surgeries that are postponed. But it all comes down to reimbursement and
comes down to the cost of what that last unit will be. And it really
isn't, in most cases, to the individual patient, it's what we as a
society and we as government or, you know, part of the government today
are willing to pay for.
DR. Au BUCHON: If
I could just second Karen's note about the importance of public
perception of safety and commend to the committee's attention an article
that appears in this month's issue of Transfusion, entitled,
"Public Perception of the Risk of Blood Transfusion." And in that
article they note that about two-thirds of individuals in a national
telephone poll noted that blood transfusion was associated with images
of safety or high levels of safety, but one-third did not. And they
regarded blood transfusion as risky or very risky.
And the authors
went on to note that the perception of an individual about the degree of
safety in transfusion today was closely correlated with their perception
of safety of other technologic matters and that even for those
individuals who did not regard blood as being unsafe today, it wouldn't
take a whole lot to sway them in the other direction should something
And in their
conclusion they note that it is better to spend resources
prophylactically on this issue because the consequences of not averting
potential concerns about real or imagined risks, and thus losing public
confidence, can be extremely costly. We've seen that in blood banking
many times over.
DR. KUHN: Mr.
Chairman, I really don't have a comment unless we're not going to
revisit the "Dear Citizen" letter. I still had some questions that have
been left unresolved, and hopefully, I'm not sure if we're going to come
back to address that issue.
You can do it now. We can come back. We should say something more about
DR. KUHN: I think
that I understand that there is a dilemma about allocating resources to
inform the public versus the resources to handle the requests for
testing, once that letter is out. And that brings me to the question has
that letter gone out. I seem to have, maybe I'm interpreting things
wrong, but it seems to me what I have been hearing is there's kind of
some elusive answers to whether or not it has officially gone out, the
letter. Has it gone out? In what capacity has it gone out to the public?
Has it been funded? And to what extent has it been funded to go out? Did
the House Administration Committee request the funding for it? Has it in
this budget year? Is it there?
And the other
question I have, has it perhaps not gone out because of the 90-day rule,
and will it go out after the 90-day rule is complete? The question I
have, I was hearing that it had gone out, is that I happen to be a
constituent of Congressman Bliley, and I have not seen a letter come to
me notifying me of anything of the kind. The time I saw it, the first
time, was when it was sent to us in a packet. So there are a lot of
questions I think are still unresolved that I would like to hopefully
have answered to know more about whether or not or what this committee
may be able to do. If the funding is not there, does the committee have
the power to request the secretary somehow, some way, maybe--as we all
know, the elusive budget or member of the budget is usually the HHS
bill. And I'm not sure if it could be attached onto there, the funding
to do it adequately in getting out this letter.
I'm still, there
are a lot of questions that I would like to see if there are ways,
perhaps in the time we have today, these could be answered.
Let me try to do a better job than I did the last time. The letter had
been the subject within the Department long before I arrived. When I
arrived, it got a formal hearing. In fact, after Dr. Kuhn asked Dr.
Margolis a question in February of 1999, is this still on the table, and
Hal said, yeah, it's still on the table. And following that meeting, I
made a second investigation of the cost. I had made one actually in
August of 1999, and the cost that I had gotten some bids from private
manufacturers was far in excess of $30 million. What I found was that
the post office charges 13.5 cents to send a letter. And if you're going
to send $100 million letters, that's going to be $13.5 million.
The printing of a
letter--if it was going to be on official stationery, something that
would make you look at it, would probably be two-color with the surgeon
general's letterhead, it's blue, it says, "Public Health Services," it's
the letterhead we use--would probably be in the range of 11 cents. And
one of the issues, of course, is you put it one side English and one
side Spanish, where do you stop, where do you start? Probably low end
will be about 11.5 cents for English only, two color.
In addition to
that, there are costs for sorting the letters. You've got to put 100
million labels on there. That's going to be about 4 cents a letter. And
you've also got to deliver it. So while I might, until right now,
privately peg the thing at about 26.5 cents per letter sent out, I don't
know if we could do it for 26.5 cents. A hundred million is a round
number, but that's the number I've gotten from a couple commercial
suppliers. So there is real money involved in that.
This is 20th
century technology. There are other ways of delivering letters right
now. They may be in the process of development, but the Internet is not
necessarily the best way to deliver mail to the targets of this--to many
of the targets of the letter. But a third way that came up in private
conversations that went on for several months between the Department and
the House was inclusion of this into a congressional mailing. The idea
was not to have a separate letter, you know, a separate envelope on with
Bliley's frank on it, but Congressman Bliley or anybody else in the
House who had a teenager who knew how to use Adobe
that's presently unemployed--and I think there are others in that group
that what we thought we could do is get the same message out at less
than $30 million.
I think that there
are the problems, the objection to the separation of powers, was not one
that was anticipated by either side at the time that we had the press
conference. We weren't going to do the press conference. The thing came
up. Hey, I was in Ely, Minnesota, when I got word of it, came back and
have this being dealt with. Max has been dealing with it, and we'll be
dealing with the issue next week. We did review this with Dr. Satcher on
Monday morning. Max had the conversation with Al, and I've had a
conversation with Mr. Slobodan. And we're going to proceed as quickly as
we can to resolve the issues.
The one thing that
I have to emphasize, and this is a very direct order from the surgeon
general of the United States to his employee, is respect the
Constitution, the autonomy of the House. And that is the sole limitation
on what I have to say right here. I think I've probably said as much as
I can. But if you want to try to pry some more out of me, go right
ahead, and I'll try to open up.
The issue still, however, remains, and we can get back to it later, of
whether we want to say anything about how to proceed with the letter in
terms of should things not go well, in terms of the autonomy and
privileges of the Congress looming larger than the surgeon general's
mail opportunities. Do we want to say something about what should happen
then or, as I said, put a date forward and say if it doesn't happen by
X, then let's ask for Y, appropriate monies, et cetera, et cetera.
DR. KUHN: Yeah, I
think we need to be specific in asking for a date. I guess what I'm
hearing you say, Steve, is that the letter is not going to go out.
Did I say that?
DR. KUHN: Has it?
Well, I guess the question I'm asking, has it gone out?
If you go to www.surgeongeneral.gov, you will find the letter. It's one
of the four little blue lines up at the top. It's on the CDC's website.
Before we received the concern of the House Management Office, a
photo-ready copy of the letter that was underneath, not on top of, but
underneath the press release by Congressman Bliley was hand-delivered to
every office of the House of Representatives. I believe that the
American Liver Foundation was provided with some copies of the letter,
as well, these being at taxpayer expense. This was what I was doing
between the time the letter went out and between the time I mailed it to
you guys. So it was something being done, yeah. It's being done.
DR. KUHN: And I
understand it can go out on the Net, but then there's not a whole lot of
access to the American public to the Net and then even finding where it
is on the Net. I guess, and I'm understanding also that it probably went
to each member in Congress, this letter?
It was a copy in a white manila--well, in a manila-colored manila
folder--was, in fact, delivered by--we hired a temp, a really good guy.
CAPT. McMurtry: It
went to every member of Congress, every voting member of Congress, every
nonvoting member of Congress, the representatives from the trust
territories and the District of Columbia. If there was an office in any
House building, it got a copy.
And it got a copy the day after. And that copy--actually, it was 2 days
after, because we spent a day having the temp run the letter through the
autopen, so it would have the same signature--the original legal
signature and not just a rubber stamp.
I'm going to go over to Larry in a second. But so far we know that the
Congress has been notified about Hepatitis C. So anybody else besides
MR. ALLEN: I guess
a couple of things that I wanted to know about. First of all, it's been
passed on to members of Congress. Do they have an obligation, from that
point on, to send a letter out?
MR. ALLEN: Beyond
the fact that the surgeon general has written this letter, who is
actually in charge now? Who do we go to to find out where the next steps
are going to be taken for this?
Well, I think it was suggested earlier that the Advisory Committee might
wish to make some statement on the subject. I have not been told by my
boss, the surgeon general, to discourage such a statement. Did you see
DR. BUSCH: I think
this is an interesting discussion because all of us, at the initial
discussion, the idea of sending out a letter to notify the public, said
it sounds like a reasonable thing to do. But then hearing the costs to
me, $100 million, in the context--
DR. BUSCH: In the
context--or $30, depending on, you know, how it's structured, et
cetera--is extraordinary. And I really would question whether the
concept of a letter to the public, particularly one focused, in part, on
transfusion recipients or even on HCV is an appropriate--this is an
appropriate mechanism to raise this issue. I think you've done the
correct thing in putting the brakes on this and asking is this the
mechanism. And I'm not so sure it is. And certainly if there is going to
be a letter, I think it perhaps should be framed with much broader
implications than certainly transfusion recipients or Hepatitis C
specifically. I think 99 percent of these are going to end up in the
Dr. Busch raises--we didn't come to the 99-percent in the trash can
letter--but if I could quote, without hopefully misquoting Dr. AuBuchon
in another context, I think I heard him once at a public meeting say,
"If this cost five bucks, we wouldn't be talking about it." That was in
September of 1998. Jim recognizes the allusion and doesn't fight me too
There are a lot of
things that we could do with $30 million. Dr. Margolis just talked about
a couple of them. If time was not an issue, I could go on for a number.
There is a--yes, I'm saying it--a finite amount of money here, and what
we're trying to do is to make the best use of the available money that
we have. In that context, however, I would say one thing that gives me
an opportunity to respond to Jane and perhaps anticipate a response that
I might want to make to some of the other members of the committee,
there is a very common assumption among noneconomists that many economic
issues are zero sum gains.
We spend so much
money on a letter, we don't have the money to spend on something else.
That assumption is not, in many economic domains, true. For example,
those of you who got through EC 1 heard of the multiplier effect.
Hopefully, you remembered it when it came to the final exam. The
recruitment of funds from a government source to a nongovernmental
source is another. In a simple world, we do simple things. At the risk
of dumbing down to the committee, this ain't a simple world.
Does anybody care to comment on the impact/effectiveness of the previous
Koop letter? I mean, we did have an experiment on letter writing from
the surgeon general about something.
DR. PENNER: I
think that issue that Koop proceeded with on the tobacco? No. On the
HIV? Or the HIV--yeah, both had surfaced very effectively I think in the
media. So I don't think it would be as startling as the Hepatitis C.
maybe we should send this out with the income tax forms. That would be
There were several formal studies done of the America Responds to AIDS
letter. Basically, about half of the households recalled getting the
letter. Those who recalled getting the letter, and this was again with
some pretty wide sampling, of those who recalled getting the letter, it
was probably around half of those individuals used it to discuss issues
about HIV. Now that letter was focused on transmission issues, not a
call-to-action to do anything. And, in fact, it was quite variable of
what was looked at as to whether anything happened.
Now, you have to
realize that what was in place at that time were hotlines not only at
the CDC or the national hotline, but also essentially every state was
funded for an HIV hotline. And some states saw increases, some didn't
see any change. So it was kind of inconclusive as to whether it changed
anybody's behavior, but it was clear that it did change or had people
discussing it. I mean, that was kind of the focus group or the context
of it. But, again, it was a very different at least
thought-to-be-purpose. That was clearly to talk about transmission
issues. And I know much of the issue for this letter is to, again, get
people to do something; namely, to get tested. And so, again, we have no
experience with whether these types of things do that.
MR. ALLEN: I hear
a couple of things. I hear Dr. Busch say something about it might have
been right to put the brakes on. I know I missed the morning session
here, but have we put the brakes or has someone put the brakes on this
letter? That's the first part.
MR. ALLEN: Okay.
Secondly, in my opinion, I see this committee having an obligation to at
least continue what we've done, you know, up until now, which is
continue to push for some form of notification. I don't see how we can
get around that being on this committee, that we go ahead with that
beyond things like the Internet or PSAs. I think we need to continue to
push for some type of a letter to go out and find a means of doing it,
so that if it is $30 million, maybe there's a way of getting it out
cheaper than $30 million. But I just see that that is an obligation of
this committee to make sure that as many people as possible are notified
in the proper manner.
Well, one thing we could do, if we're amenable, is ponder this a bit
more and return to it this afternoon. It's somewhat disquieting to me
that we may get the letter rolling without coordination, and the
involvement of other things that might want to accompany the mailing of
the letter. I know the Surgeon General would like to probably put his
health indicators thing into any mailings that he does so you can find
out you should get tested and you're fat, too.
But that's my personal animus about this thing. The fact is, without
coordination, I worry about impact here. It is expensive, although one
thing we can also ponder if we're going to return to what we want to do
on the letter business is: Has Congress really taken hepatitis C
seriously, the challenge of it in terms of budgeting and so forth? I
remind you, again, we're spending more on the letter than the CDC office
budget, so that's an issue. And maybe we should spend a lot more on
both, but we may want to say something about rising to the challenge
here in terms of adequate funding for this public health problem.
That was a way of
saying why don't we table the discussion, but come back to it, and go to
DR. HOOTS: Well,
even though it's the heat of the summer, this is kind of, as I
understood it, our January meeting and the fact that we were looking
backwards where we've come from and perhaps forward where we ought to
go. And so I thought it might be an appropriate time both in reality and
philosophically to look at a couple microcosms. John has already looked
at one. I thought I'd look back at the hemophilia issue, particularly in
the context of what Jane alluded to, which we've been over many times,
which is that safety is intrinsically linked to adequate supply, and
also alluding to what Karen was talking about with regards to the
in that is being ever vigilant to not only do what we perceive to be the
precautionary way, with all the precautionary pattern, but, in fact, to
continue to monitor the fact. And that, of course, leads into the
principles of aviation safety, error management, which we spent the last
two meetings talking about.
So I thought I
would give you just a little bit of an example of how I think some
things have worked in this Committee related to one microcosm, supply of
clotting factor concentrates, but also to point out the fact that it is
an ever present danger and it's always hanging on the precipice, and
give you some examples in real time of things that could actually
influence that availability versus the demand for that product.
I should start by
saying that if--I'm putting myself in the ever present proverbial
pharmaceutical chemist role, that some of the things I will say, which I
won't--first of all, time won't permit, but I won't offer opinions about
what the solution should be. But were I to do that, I would have to
change my lab coat about five different times for conflict of interest
reasons. But I want to point out some of the things that have been going
on behind the scenes, and before I do that, I would be remiss if I
didn't acknowledge really a lot of people who worked very hard on all
the elements we talked about today, but particularly this microcosm: the
FDA, the pharmaceutical industry, the consumer groups and interests,
this Committee, and particularly its Executive Secretary and its staff,
all of whom have been involved on all these issues on both very
high-level, superior sort of policy roles, but also at the very
If I could have
the first--I have two slides just because these issues are so complex
that I thought if I tried to even remember them all, I'd probably use up
all my time. And I'm not going to go into great details, but what I want
to tell you is that right now, as you all know, as a direct outgrowth of
the discussions that took place on May 8, 1988, and August of 1988, we
have had consecutive reports from PPTA on clotting factor concentrate
availability. We, all members of this Committee, plus all the consumer
and governmental agencies, get these data. We've been following them
very closely, and I think it's fair to say that we made it through some
stormy times in late 1988, but now in early--or mid-2000, entering late
2000, we're probably back very close to where we may have been in 1988.
And that's the reason I thought we should visit some issues.
So what could--I
should tell you the data shows that at the very best of times between
those two periods, we've had about 9 weeks' worth of inventory, up to 9
to 11 weeks. We're now back down to 4 weeks of inventory for clotting
factor concentrates overall.
Why is that? Well,
these are the issues, at least as I can identify them, having spent some
time about it.
production. There have been, as you know, as we've talked about, new
production capacities that are coming online, new bioreactors by certain
pharmaceutical companies that are scheduled to come on. Overly
optimistic projections on the time line in terms of FDA approval in some
cases have compressed our more optimistic projections and put us a
little bit more precarious than we thought we might be if everything had
gone according to the best projections. But, again, those are moving
As recently as
yesterday, we got notification that one of the newest products is now
FDA licensed, and, again, to be applauded is the FDA for having moved
this along very quickly. But because of some of the last issues I'll
talk about, which are international relationships and the companies'
inability to really meet their own projected time lines, we won't have
this product available next month as we had originally hoped. And, in
fact, it's now projected to be available in 2001. So all these things
are part of what go into making a projection model in terms of supply.
issues are continuously, as with all the issues this Committee has taken
up, are howling around us all the time. Most recently, one that has
particular imminent import is actions related to reimbursement of HCFA
programs, particularly--specifically Medicaid and Medicare, and the
reaction by states' attorneys general to average wholesale pricing, a
collective impression on their part that these AWPs on which
reimbursement was based were too high and, therefore, categorical
decisions but not--many times they were unilateral, those categorical
decisions, to modify those adjustments.
What has been the
outcome of that is that certain of the private sector distributors, like
home care companies, have been put in tenuous binds about being able to
get adequate reimbursement for their services, and in cases of patients
that they supply who are HCFA-supported, Medicaid or Medicare, have at
least to my knowledge on a few cases actually said they could no longer
do it because they were losing money. So, clearly, even though that's
not a direct supply issue on a national basis, it has localized
geographical significant import.
have been--to say discussions is probably to be euphemistic. There have
been discussions going on about a prime vendor program which we
discussed once upon a time, and I don't expect anybody around this table
to remember that discussion unless they're in hemophilia. But
essentially HRSA was charged by the original act that created lower
federal pricing for factor concentrates to look for a way to make sure
that all this pricing could be accessed by all hemophilia treatment
providers and patients around the country.
Well, that also
has created discussions about whether that really is anti-trade and all
kinds of issues. If that were to be--if that were to really go at this
particular point in time to a confrontation between, say, PPTA and HRSA,
to where both threw down the gauntlet and said we're going to fight this
out, whether legally or otherwise, that could have an imminent impact on
important, I think, to draw from the analogy of the aviation industry
where we learned very quickly that when weird things happen in
multiples, things that shouldn't happen, that's when they happen. I
mean, that's when you are most vulnerable, and that's the reason I
decided to point out these issues, because at this point in time I think
we're vulnerable to each of these issues.
The next slide,
There have been proposals. Some of the newest technologies that are
coming on, recombinant technologies, are just--one of which has been
delayed, as I just told you, but another one that's coming online
imminently, there have been proposals that it be provided on an
allocation basis based on certain individuals who opted that they wanted
to just go that route and put their names in, it would be a first-come,
A number of us
have argued strongly that that takes the flexibility out of the system
in terms of the end-user level, if I've allocated Product A for little
Johnny and little Sammy has a bleed that's acute and little Sammy is not
part of that allocation system, if they do that, I can't borrow from
little Johnny to help little Sammy. So it takes our flexibility as
treaters out of play.
So those are all
issues, I think, that in a time where a shortage is imminent or where
supply is marginally adequate, where we have to continue to argue all
the facts, because keep in mind that these decisions in many cases are
made irrespective of issues of supply. They're made for economic
reasons. They're made for political reasons or any other kind of
reasons. And so it's our job collectively, both as, you know, members of
this constituency but also as broader--this whole Committee, I think, to
have people around who are continually--and we do have them--continually
monitoring along with the federal agencies like the FDA.
The other thing
about it, as everyone knows, we recommended on this Committee that
clotting factor concentrate use in the United States moved to an all
recombinant supply. Well, clearly, the biggest impediment to that is the
supply itself, and the less available recombinant there is, the more
likely that people who would otherwise move are not going to be able to.
Which leads me
into the last point, and I think I'm probably right at the end of my
five minutes, to say that as we've talked about before, that's not just
a U.S. issue. That's an international issue because these are
multinational producers, and they're also chains of suppliers that are
multinational as well, along with supply routes. And so I'll take the
example of the most recent product that got delayed until January 2001.
In that case, that
product was licensed in Europe first, and right now the demand in Europe
is so great that there has been a reluctance, not to divert because
there was never any intention to divert from that supply, but I'm sure
it's influencing the availability, how quickly they can come online to
provide a North American supply to this, which would help ameliorate the
recombinant shortage, which then finally kicks down to the
plasma-derived supply piece, which I want to end up with by saying--to
remind ourselves--and it's already been alluded to multiple times--that
this is a domino effect. So that if we don't have the recombinant supply
in the developed countries, we're going to draw on the plasma-derived
supply that is intrinsic to providing the care for the developing world.
So all of these
issues are exceedingly complex, as you all know or you wouldn't be here,
but I think they're things that indicate why we need to be ever mindful
as we go along not only what we should recommend for our government and
our policymakers to do, but to kind of stay on the case to make sure
that, as we go along, as new contingencies occur, which they inevitably
will, that we're there ready. Because the one thing I, as a member,
personally--as a member of this Committee, I would want to think that
when someone says, well, why didn't somebody think of this, we can say
we did think of it and we tried. Even if we fail, we at least thought of
it and we tried.
Let's go to Paul.
DR. HAAS: I guess
I'm going to ask you to indulge me as an academic for five minutes. And
as I was putting these thoughts together, I had several titles running
through my head, but I guess I ended up with "Economics and Blood
Products: Do They Mix?"
The two most
common economic terms, supply and demand, are probably the most commonly
misused terms. Supply and demand reflect dimensions of both price and
quantity. Supply and demand flow from the concepts of competition, which
is built on the assumption that there are a large number of sellers of a
homogeneous product, that buyers and sellers are well aware of the
properties of that product, and that the entry into a market is free and
Furthermore, it is
assumed that products are manufactured in a single plant producing a
single product. Right away we should understand or see the complications
with these assumptions related to the so-called market for blood
products. While there's a significant homogeneity within various blood
products, there are multiple products included in the blood product
category. Depending on the product and the timing, there may or may not
be many sellers. And we heard from John that there's one seller of his
product. And the concept of a single plant producing a single product
Entry is not free
and easy. While some of the general forces of competition might exist,
the distinction of real conditions from those in the competitive market
cause alterations, often significant alterations, in the expressed
In addition, the
so-called market for blood products is complicated by the role played by
government. Also, the term demand depends upon a large set of
assumptions that rarely are met in medical economics. For example, the
demand concept is compromised by the existence of third-party payers,
which themselves are compromised by the existence of privately purchased
insurance, fee-for-service and managed care, government-provided,
insurance and charity.
When demand for
blood products is considered, are we really talking about, one, the
willingness and ability of patients to pay for the product? I don't
think so. Two, the decision to provide blood products with or without
the payment by individuals or insurance? Or, three, simply a measure of
quantity devoid of any concern about price?
The first option
is the definition of demand under conditions of a free market, which, of
course, do not exist in the market for blood products. The last view
doesn't make any economic sense because the cost to provide the products
always exists. Even if the society were to supply the blood products
free of charge, there are still the taxes and the opportunity costs
associated with using the resources to supply that blood and not
Obviously I could
become very pedantic, but the fundamental point is that economics is
very much a discipline that's concerned about choices, but its models
must be used carefully or the choices offered by the model will not be
equitable or efficient.
applied to the public sector must use supply and demand reasoning very
cautiously. Since society has determined that one's income should not
determine one's access to health, then health care and blood products
move out of the private domain of demand and supply and into the public
sector. Yet this movement doesn't avoid the problems associated with
cost or rationing, as those of us on the Committee read that article
about rationing. Rationing is there because there's a trade-off.
decision is a rationing decision. The controversy isn't about rationing
but how the rationing should be accomplished, and Jane and Karen were
really saying similar type things.
given us cost/benefit analysis and cost-effectiveness analysis to
approximate the forces of demand and supply. Cost/benefit analysis
attempts to determine the most efficient way of accomplishing a given
activity. Cost-effectiveness analysis attempts to broaden the scope of
the analysis by including other dimensions such as pain, suffering, and
disability, that is, value judgments, again referencing another article
we have in the packet.
is the more appropriate analysis because value judgments are an
essential part of the process. If we could rely upon the existence of a
competitive market, then we could rely more heavily on the concepts of
demand and supply or cost/benefit analysis, which under conditions of
competition provide results that are both efficient and equitable. Since
the competitive market for blood products does not exist, use of
cost/benefit analysis is likely to provide deceiving results.
As the article
"Cost-Effectiveness Analysis in a Setting of Budget Constraints--Is It
Equitable?" points out, lack of measures of demand and supply leads to a
form of cost-effectiveness, equity does matter, equity matters in
competition. But the competitive assumptions are unrealistic in the
blood market. If we are not careful, then efficiency concerns dominate
equity concerns in economic decision making.
The supply problem
associated with the blood supply are complicated by the desire to
provide only the best--and I think that means safest--blood product. If
we truly believe in market forces, then blood products with many
different degrees of safety would exist at a variety of prices. The
safest blood products--and that includes getting the blood product
safely to the bedside--would have the highest price. Because of equity
concerns, society would want blood to be as safe as possible, but often
forgetting the costs associated with that desire.
Yet we don't know
what safe really means. Is a blood product safe if the probability of
transmitting the disease to a typical blood product recipient is one in
a million? What if that same product is given to a heavy user of the
product, such as hemophilia, alpha 1, immune deficient patients, would
the probability of transmission of one in a thousand or one in ten
thousand be considered safe?
Is it possible to
provide a variety of varying qualities of blood to different groups? I
don't think so. Yet, as an economist, I'm supposed to present options.
I'm supposed to--but as soon as we move away from the conditions
necessary to permit an effective use of the concepts of demand and
supply, economists are subject to concerns other than efficiency and
profitability. In a perfectly competitive market, efficiency,
profitability, and equity happen naturally. No human interference is
necessary or even desired. Unfortunately, no one has ever seen that
competitive market, certainly not in the health and blood areas.
Unless we or
society are willing to define what is meant by safe blood and what is
meant by the demand for and supply of blood products, then this
Committee will always be facing the impossible task of deciding what
error we are willing to accept: error one, very safe blood but
inadequate supply and high cost of production; or error two, less safe
blood, more supply, and lower cost. And, yes, I know there are many
other options, but I'm not going too far over my five minutes.
In the article
"Cost-Effectiveness Analysis in a Setting of Budget Constraints--Is It
Equitable?", the options are clear. Of course, with a little bit of
creative thinking, there are additional options, such as increasing the
budget. And, again, a couple of other people have mentioned that. This
approach is harder to achieve, but failure to think outside of the
so-called box limits our ability to assess all options.
If we and society
want an adequate supply of the safest blood products, then more
resources need to be devoted to this area, and some other area--who
knows what?--education, defense, environment--again, Jane mentioned some
of these--will lose resources.
refrain of Tans Stoffel (ph), "There ain't no such thing as a free
lunch," never goes away. With this thought in mind, I personally prefer
to push the envelope on safety and search for resources to accomplish
this goal. I take this stand in spite of Dr. Klein's editorial in JAMA
pointing out the trade-offs between safety and equity. I argue that we
need to set the safety standard according to the needs of those who use
the product on a regular and continuing basis. I do not argue that blood
products need to be 100 percent safe. I know that goal is unrealistic.
But I do, however, argue that until the blood industry restores its
reputation, safety has to be the dominant concern.
Okay. Thank you. Let's go to Fernando. Then we'll get to me, and then I
guess we'll get to lunch and then we'll pick up with Ron and go around.
I'm sort of hopping over our ex officio and non-formal members in the
presentations, and I thought we could hear them, open that up for
discussion, and then swing back around to reconsideration of anything
that others who are observers or ex officio members might want to say,
and then come back to the letter issue and whatever else is on the
table. So that's my rough tactic here.
DR. GUERRA: I
think Ron had a comment to make. I saw his hand up. No? Okay.
Thank you for the
opportunity, and certainly being privileged to serve on this Committee
has given me a real-time opportunity to see for the first time what I
consider some interfaces of public health and the blood industry and
blood banking and those enterprises, especially as that interface plays
out in large urban centers.
But I think that
in the first instance there are clearly some overlapping obligations,
responsibilities, and opportunities, and those are certainly for
surveillance, for prevention, for screening, for testing, for
communicating, for tracking, for doing a lot of things that maybe we
have not always thought about in the context of that interface, and
where I think the collaboration certainly in the future could open up
some incredible opportunities for how we convey to the general public
those issues, those concerns related to the transmission of disease
beyond hepatitis C, HIV/AIDS, but any number of other conditions that
perhaps in one way or another, directly or indirectly, come very close
to the nation's blood supply.
I think that there
is a real need for being able to better communicate what is real versus
perceived risk, which, again, is very much a part of what public health
does on a regular and ongoing basis because of so many conditions that
we're faced with and that we have to somehow communicate to communities
that today are very diverse and that at times their grasp of information
is limited, and so one has to develop some very creative types of
strategies, especially for dealing with populations at risk, as some of
the targeted populations, the populations that are homeless or those
that engage on a regular basis in a variety of risk-taking behaviors.
I think that an
area where there is a real strength in trying to more clearly define
that interface--and I hope that it is an opportunity for the future in
terms of some of the agenda items--that public health probably has a
much greater access to population data, linking data sets, looking at
vital records, what birth and death rates are, what the number of
C-sections are, how or what the utilization of blood is, what inventory
is. I mean, some of that is tracked because of other public health
responsibilities that one has.
But there is an
emerging natl information system called the Health Alert Networks, where
I would think that it is possible to link into some of those information
technology networks, some of the issues, concerns, and opportunities
related to the blood banking industry and the populations that are
Public health in
the instance of accessing the political arena, in particular elected
public officials, especially in local communities and at the state
level, where that access could perhaps be a very powerful one for the
blood banking enterprise in both the public and the private sectors. On
a regular basis one is faced with having to access that arena for either
allocation of resources, for concerns for development of legislation,
for ordinances, et cetera.
hopefully--even though I think we heard from Dr. Satcher on any number
of occasions, and certainly we've heard it in some of our discussions,
we don't always have the capacity and/or the support for that capacity
for tracking populations. But there is some expertise that could be
expanded, and I think that there perhaps could be some additional
support brought into it for such things as outreach and case management.
The DIS staff, for example, in public health departments that
track--that does the contact investigation when there are a number of
infectious diseases could certainly be called into play for some of
these other efforts.
I think the
interface would allow really for the expansion on both sides of the
leadership role in first responder type of activities. There's no
question but that the nation's blood supply faces the same threat that
especially large population centers face related to weapons of mass
destruction, bioterrorism. Contamination of the nation's blood supply
could be a tremendously serious situation that I think all of us would
be concerned about.
I think public
health has at times had some special initiatives, some that are just
emerging related to environmental concerns. This is an area that really
needs to be linked very closely to both the supply of blood, the donor
supply, et cetera, related to environmental pathway exposures. We don't
always understand, for example, the exposures to potentially toxic
chemicals, insecticides, pesticides, or dietary substances or heavy
metal exposures--any number of things, radiation, et cetera, that I
think perhaps could pose some additional threats that certainly have to
be looked at and addressed.
I think if there
is an opportunity to deal with some of the issues of disparity and
social justice, it is in the interface of public health with the blood
banking industry. We've learned in public health, in keeping with some
of the finest traditions--and I think we've seen it certainly in the
list that Dr. Satcher handed us. But there's an even longer list that
deals with disparities across population groups and communities by race,
ethnicity, and socioeconomic status, and I think we see that play out
every day within the blood banking industry and the populations that are
served or not served or those that have particular conditions that have
to be recognized as part of a greater social justice discussion.
Then, finally, in
the instance where there is potential harm to large numbers of people,
it is public health in keeping with, again, the authority that is placed
within that system, and in particular those individuals that carry the
designation of local health authority that have to sometimes issue
quarantines and/or shut down operations if they pose a threat to groups
of individuals. And so I think that it is very clear, as I have been on
this Committee now over several years, that somehow we need to better
define and forge the relationship at the interface between public health
and the blood banking industry.
Thank you, Fernando.
I think I'm last
up and headed for lunch, so I will keep to my five minutes, although
somebody can yell at me if I start to lurch over.
I tried to think
hard at the beginning of this summer about values and principles. I got
asked to write something about leukocyte reduction and some of the
issues that came up there, and I never got it done because I got caught
up in brokering this peace treaty between the private sector and the
public sector on who is going to figure out what to do with the human
genome. But I still have been thinking about it, and I hope to write
about it, and it led me to reflect on a couple of things which, I guess,
in the spirit of Paul's remarks, I could call it bloody ethics.
looks like a nuisance here. I think overall when I try to think about
competing social goods that we have to wrestle with, spending money on
blood versus other things, what I find myself thinking about this
Committee is that our mandate is blood safety and availability, and the
advice we should give, as I see it, is to figure out how to get a safe
and available supply of blood, but it is not always to weigh other
things that are important to do or good to do.
If I had more
confidence in the political system, I'd feel better about that. But,
nonetheless, I find myself thinking the job is to figure out, given many
choices and options and expenses and opportunities, what do you do to
get a safe and available blood supply?
I have always
found it interesting that our Committee is called Blood Safety and
Availability. It's not Blood Availability and Safety, and a lot of our
debates go have we gone too far down the safety road and jeopardized the
availability part. So we sort of took safety as our starting point.
Safety in some ways triggered our existence. Safety has been the driving
force behind a lot of what I think the congressional or the public
concerns are. And, ironically, availability often takes second place.
I'm not sure that is true. But I don't worry as much overall in a sense
of justice about trying to weigh childhood vaccination or a better
highway system or more seat belts or better tires. I think it is our
mandate to think about blood safety and availability, and then Congress
and the politicians will think about all the rest of the things.
So that's how I
sort of think about the large picture of competing goods when we ask
questions about $30 million letters or is it worth doing that testing or
leukocyte reduction. It may be that we shouldn't even have a Blood
Committee. We should have the Surgeon General send out a letter saying:
Do you know you don't have health insurance? And that would be the most
politically adept thing we could with mailings, but, all right, it's not
about blood so there we are.
context, then, I always find myself thinking not so much about
principles as about values. And one thing I know--and Jane's knows this
better, but I have read her book and I've talked to her about it off and
on--is that this is a wacky area because it is not about economics since
the provision of the substance that is at issue is a gift, and it always
is rooted in this ethics problem of how do you cement public altruism to
give this substance, blood, that then gets a cost put on it and then
gets into distribution.
I do know for sure
that if the public perceives that the distribution is not fair and that
the cost or price that's being charged is too high, then altruism as the
basis of collecting the substance is in jeopardy. It just becomes
tremendously put at risk. I know that because I've studied for a long
time the organ and tissue worlds, and nothing dries up altruism faster
than a perception of inequity in the distribution of a gifted item.
I also know that
this is a weird area, as Paul was hinting at, because in terms of
values, if we are going to commit to altruism, we have certain
obligations to watch distribution that aren't market-driven because we
are trying to get everybody to give, in theory, and that makes for a
problem as opposed to those who could pay.
The second thing I
know is that the use of the substance is involuntary. So it's not
something that you go and get; it's something that you have to--very few
people have said to me, Boy, I hope I get to use blood anytime soon.
Most people, the majority of users, I would venture, don't want to. They
have to for various reasons.
That, of course,
puts them in a position then of feeling exposed to risks or dangers that
might be different if somebody said I'm going to drive real fast and
have many deaths on the highway every day, but I chose to do that, as
opposed to here's the safety that I have to face if I must use this
thing, which I don't want to, but it's foisted upon me.
I think sort of
the first value that's out there that we have to be alert to is
altruism. The second is the involuntary nature of the use and what that
means in thinking about safety. I think it means something different
than when you voluntarily assume risk or voluntarily do certain things
vis-a-vis behavior that can be pretty risky.
that plays a role here is what I would call privacy and stigma. If you
look at blood and blood transfusion, blood product use over the years,
we can't even talk about hepatitis in this country without a lot of
people worrying that they're going to be typed as a particular lifestyle
or having a particular background. And HIV certainly has plenty of that,
and most of the infectivity in the blood supply carries stigma. It also
carries the very real prospect of discrimination. So that values about
privacy and confidentiality loom large because of the connection to
stigma and discrimination.
So here we have to
not only account for what's efficient, we have to make sure we're
building privacy and confidentiality protections in as we think about
safety and availability at all points, just because of the nature, the
controversial nature of the substance.
I have to say,
too, even though it makes me sound almost like Martin Boober (ph) for a
second, that blood is symbolic. There are a fair number of people who
still say that the way they define kinship with one another is through
blood. And I could go on about the symbolism here, but when you have an
entity that is not seen as an oxygen-carrying fluid but a mystic
substance of life or other types of things that different cultural and
ethnic groups have, then it imposes even more limits on what you can do
vis-a-vis safety and purity.
I once mentioned
to someone in the biotech industry that were I to start making
genetically modified foods, my first one would not have been milk. Blood
has this problem, too. It's just fraught with symbol, and, therefore,
people have expectations about purity and safety not consistent with
what they might expect from other arenas of their lives. That's a
reality that we have to struggle with.
I'd say one other
thing. As I watch this group function and listen to different voices, I
come to understand that blood is one of the few ways Americans can seem
to be a community. There's almost nothing that makes them seem to be a
community. We don't even have baseball anymore. But we do have blood
collection and blood drives, and not-for-profit voluntary organizations
that pull the community together, and we make appeals to one another to
pull society together.
This may be a
funny social glue, but there it is. And we could shift the ideology of
it. We could be less concerned about gifting. We could be less concerned
about altruism. We could be less concerned about community. But if you
look at the blood organizations, the blood banks, the kinds of things
that they talk about, it is very clear that the value of community is
trying to be exemplified at all points in what takes place with respect
disappointed when we hear about blood donation rates dropping, not just
because it means that we're at risk, it's because it says something
about society. I've had that said to me as I've left this room, whenever
we see that little curve, somewhat in dispute about how bad the dip is.
But when you put up a curve that looks like it might be a dip in supply,
people sort of say, Boy, this country's going to hell. They don't say
I'm at risk. They say this is bad. This is a bad thing about America.
So the value of
community is there, and I might add it's reflected in another two
special areas: the liability on the product is different from what
happens in the market normally, so it's got special status and
protection because of this altruism community set of values; and you've
got in play something about the modulation of the cost since a good deal
of the blood industry moves under the banner of not-for-profit. We can
dispute whether that's true. There are certainly segments that are
for-profit, I understand, but generally speaking, I think the American
people have said a gifting, altruistically driven, community-based
system should try to reflect a not-for-profit ethos in terms of what
makes it tick and function.
So what I would
say by way of my pre-luncheon reflection is I don't know how yet--I
still don't understand exactly how issues of fairness, compensation,
precaution, and risk avoidance play out. But I would say this: It
becomes very tough, I would agree with Paul, to just take cost/benefit
or cost-effectiveness analyses or efficiency as the sole value here
because you've got this other set of values that you're constantly
trying to mix with this notion of efficiency.
I think it's also
true that even though it irritates us all the time about trying to say
how important is it to get marginal safety or marginal increases on risk
avoidance, to some extent the symbolism, the history, the sort of moral
status that blood donation plays for us, is reflected in what people are
willing to pay to get that marginal utility. It doesn't make sense. If
you just toted up the numbers, there's no sense at all. But it's
probably playing roles other than that, and to change that--I'm not
saying that's the correct ethical outlook, but if you want to change it,
you've at least got to say you want to modify these other value
dimensions I've been talking about, you want to shift them, they don't
make sense, or they're not worth preserving. They cost too much,
literally, if you want to put it that way. But I think that's why we're
not so efficient in what we do. That's because we're doing a lot of
other things with blood that have nothing to do with who's going to get
a safe unit transfused to them, or at least a reasonably safe unit, and
it's why people I think are so concerned and maybe even why Jim's
article comes out the way it does that you've got one of the safest
things going, and yet a third of the people who hear about it are still
not sure that it's safe enough, and a lot of others could shift their
attitudes about it. It probably tells you what they think about their
neighbors, what they think about stigma, what they think about symbol,
as much as it does what they think about somebody's safety analysis.
So there are some
big thoughts to launch us off to lunch. I will take no questions on
these truths, and--
And then the game plan is, however, to swing back around over to this
side, stop, talk about what we've heard from the members add other
people in who are here, who may want to say something, observers in the
ex officio role, and then revisit what we need to revisit.
I think the dream
today--I mean, I'm amenable to hanging around as long as people want to
hang around, but the target goal might be to maybe get us out by 4:30,
but I mean, if we go longer, I'm here. However, if we're going to do
that, you really have to get back from lunch in an hour or less, so one
hour. It's now about 12:30, so I'm going to try to kick this off at
1:25, and that should give us enough time to keep moving here. Okay.
DR. HOOTS: Can I
have a autographed copy of the stone tablets?
12:30 p.m., there was a luncheon recess.]
A F T E R N O O N
S E S S I O N
Can we reconvene?
You will recall
the moving final statement by the Chair before lunch left us in a
position to now move to a more concrete insight. Ron, I think you're up
next if you want to, for comment.
DR. GILCHER: Thank
you. It is interesting that the comments about--which I will make in a
moment from a prepared statement that I prepared before coming to the
meeting--are very similar to comments that have been made already by Dr.
Penner, by Karen, supporting those views, but in somewhat of a
contradistinction to what Jane Piliavin said. And the statement relates
to blood safety, blood supply and cost, and it is from my perspective as
the director of a large regional blood center and the impact that the
initiatives that we have put in place have had in our system. So I'll
read this statement and try to stay below 5 minutes, Mr. Chairman.
The safety of
blood products is regarded by the recipient patient as being of such
critical importance that the inherent and perceived risks should
approximate zero risk as closely as possible. The receipt of a blood
transfusion is analogous to flying as a passenger in an airplane, which
we've heard from you, Karen. Specifically, zero risk or zero defects,
even though realistically not possible, remain the goal.
medicine we have approached the safety of blood products in three
general ways, and these are not the only ways. Number one is pathogen
detection. Number two is pathogen removal, and number three is pathogen
pathogen detection, that is, testing, now uses the state-of-the-art
testing, nucleic acid testing, to approach zero risk for specific
pathogens, again, HCV and HIV. In a low-risk system for HIV, such as in
our system in Oklahoma, the estimated cost to detect and prevent a
window transmission for HIV will probably be around $7 million, with one
detection estimated to occur over and above our current systems, using
that about once every nine years. For HCV this cost is about $1 million
per detection in our system. Theoretically, these are the costs to
detect one HIV or one HCV positive unit, yet nobody knows which unit
that is until it happens.
pathogen removal, which includes macro and micro-filtered blood for
removal of clots, aggregates and other debris, has been used for decades
to prevent theoretical embolic risks and other risks, and now we are
using leukocyte reduction, which has the ability to remove
cell-associated pathogens for which we do not, cannot, or will not test.
At the Oklahoma Blood Institute we adopted universal leuko-reduction as
of July 1st, 2000 for all red cells and platelet transfusions. We had
had that in place for platelets already for over five years. From
hospital surveys which we did, we estimated that approximately 40
percent of all red cell transfusions in our system went through a
micro-aggregate filter, for which the cost of that was about $380,000
per year, and average cost of $9.85 per filter. Universal
leuko-reduction has removed the need for micro-aggregate filters, but
has added about 1.9 million or a net increase, if you look at that in
our system, of about 1.54 million in 96,000 red cell transfusions, and
interestingly, that comes out to about $16 per red cell unit, and that
is applied to every single blood product that goes through the system,
in contradistinction to NAT, which is only picking up the two.
Longer term cost
effective studies are now in progress at two of our major hospitals, and
the preliminary data is very interesting because one of the hospitals
was a nay-sayer, and in fact, they have the data that supports
leuko-reduction even more so than the hospital that was in favor.
pathogen inactivation is the newest safety initiative for blood products
with much of it being research based, although it has been used for
plasma derivatives, and now a pool form of fresh frozen plasma, where it
has doubled the cost, with some questions regarding safety enhancement
in the face of the advanced pathogen detection technology, that is, NAT.
approaches, pathogen detection, pathogen removal, and pathogen
inactivation, at times clearly overlap, and there's a significant cost
to that overlap. Identification and subsequent removal of the
unnecessary overlap can result in cost savings so that the goal of zero
risk and the approaches toward zero risk, can be economically, ethically
and medically justified.
The perception and
reality or working towards zero risk or zero defects for blood products
is--and this is in my experience and opinion--also very important to
blood donors, and ultimately influences the donation rates and
availability of the blood supply. We have clearly focused on that in our
system, and as you know, it is one of the systems that generally always
has enough blood.
In summary, zero
risk, although not achievable, should remain the goal in transfusion
medicine. To do less will continue to fuel the fears of patients and the
distrust, mistrust of both donors and patients. The end result is then
an inadequate blood supply and ultimately a less safe blood supply.
Questions, comment? Thanks, Ron. Rick?
DR. DAVEY: Well,
Steve, I took you at your word fairly concretely when you suggested that
we as a committee identify a set of intellectually consistent and
politically acceptable principles on which a coherent and durable policy
to assure safety, availability and affordability of blood and blood
products can be established. And so I did look over some of the
readings, do some thinking about this, and thought that I might just
have a condensation of some of the principles that were in the
precautionary principle paper, as well as some of the thoughts on papers
by Ubel and others, and maybe suggest a template that might have been
useful for us to use in the past on some of our deliberations, that
might be also useful for us to consider when further actions of this
committee might be considered, and again, just putting this in the
context of some of the comments that Art made about our special gift
relationship, the altruism, that we have to consider the
confidentiality, the privacy, also the political, scientific and
financial environment that we specifically have to deal with in blood
and transfusion medicine.
But with those--in
that context, I'd like to suggest seven evaluation parameters from the
readings and some elaboration that I've had on them that we might want
to consider. I guess I would consider them evaluation parameters, and
maybe think of these seven things almost as a template. Whenever a new
action is considered, are we going to think about each of these seven
items and consider them before we decide on what to do.
Again--and this is
in some of the readings--but the seven are as follows. Number one:
Whenever we want to consider an action that affects the blood and blood
supply, is it proportional to the chosen level of the protection that we
want to have? For instance, we knew we were going to need to tailor
measures to be appropriate for the level of protection that we're
looking at, and again, we might want to think of the appropriateness of
the UK ban here. Is that proportional to the level of protection? That's
Number two: Is the
action equitable? Is it something like in consideration of what Jane was
saying earlier and in consideration of the paper by Ubel, is it
something that can be equally applied to all people that the action
affects? I think the paper by Ubel is very interesting, if you read it,
where there was a evaluation of two different ways to screen for colon
cancer. One was more cost effective and one was more equitable, if you
will, and it was the equity that carried the day in terms of when
ethicists and medical professionals reviewed the two opportunities.
So proportional to
the chosen level of protection, equitable. And three--I think this is
what Jane was looking at--is it comparable? Can comparable situations be
looked at comparably? Can we look at Chagas Disease and New Variant CJD
and say, "Look, are we dealing with these two issues in a comparable
fashion or not?" So is our action--is the consideration of the action
Fourthly: Is it
consistent with other similar measures that have already been taken? The
actions we might want to consider should be of the scope and nature of
those that have already been done, that we're not going off on some kind
Fifth: The actions
should be based on cost benefit analysis. There should be a evaluation,
not only maybe of the economic cost benefit analysis of a particular
action, but maybe some of the non-economic considerations also. Is this
an acceptable action for the public to consider? So cost benefit
analysis for sure. That's five.
Six: Is the action
really subject to review? Is it something that can be periodically
reevaluated, and if necessary, reviewed in the light of new scientific
progress, amended if necessary? Can it be reviewed?
And lastly, and
maybe related to the subject of the review, can responsibility be
assigned for getting the scientific evidence so that it can be
reevaluated and amended? Can we assign responsibility to follow up on
And I think when
we think of 100 percent leukocyte reduction and HCV look-back, many of
these, I think, principles, could have been perhaps better utilized in
our deliberations. So, again, I would very briefly suggest that we have
a template, that we think of these seven things when we review our
actions, that they might have been good in some cases in the past.
Again, let me
quick review them again. Number one: Is the action proportional to the
level of protection? Is it equitable? Is it comparable to other
situations that have occurred in the past? Is it consistent with similar
measures we've already taken? Is it based on cost benefit analysis? Is
it subject to review? And can we assign responsibility for producing
Simple, but it
might be seven little principles that would be useful as a template
whenever we think of something new. Those are my comments.
DR. BUSCH: Just a
follow up. I know both Steve and Jay and I were involved in a WHO
program that I guess is going to play out in the next meeting as well,
but similarly attempted to define a process, you know, a really on-paper
consensus process of issues that needed to be addressed in terms of
making decisions. I know Jay has been much more involved than I, but I
think what you've done in terms of trying to lay out concrete elements
of decision making is what I hope we end up talking a lot about and
working a lot on.
DR. HOOTS: I just
wanted to make a comment in terms of one of the articles. I think one of
the--where the rubber meets the road and where the complexities comes
in, as is pointed out in the cost efficacy versus equity discussion. And
perhaps what we need to do in addition to--and I applaud your effort to
organize the thought process--but to look at really where the
conflicting components almost inevitably come into play, and then also
then further sub-stratify or sub-strategize, perhaps is a better word,
how you deal with those issues, because that's really where we always
kind of end up.
DR. PENNER: Maybe
one other comment, and that is a question. Is it relevant with respect
to other costs that are involved in therapeutic and medical care? As I'm
recalling, we were paying, I think, something like about $45 20 years
ago for a pint of blood at that point, and now it's something like
about, what 92? So it's--over 20 years it's increased, doubled. And
what's happened to the antibiotics and the other therapeutic agents that
we're using cost-wise? I think I'd still make the point that we are
probably under selling or under costing our blood products in comparison
to many of the other products that are being used as therapeutics, and
that kind of mindset has been hard to dislodge, that we should just
maintain that level of pricing for those products just because they're,
supposedly, initially, voluntary. I think we have to really look at it
in terms of market, and market value on everything else has gone sky
high. If we're paying $1,000 a day for some antibiotic regimens in our
intensive care unit, and we're still giving two units of blood at maybe
$140. It sounds like there's a discrepancy there in relationship to the
significance of the product that we're giving that is being overlooked.
DR. BUSCH: Yeah. I
presented about two months ago a talk that Steve was at at CDC that he
thought maybe some of this would be useful, and a lot of this is stuff
we kind of know, but I think could make some points sort of relevant to
the decision process, particularly as it's evolved in my area of focus,
which is in the testing side of blood safety.
If you could turn
on the first slide, please. Yeah, this is just sort of a strong backdrop
of how much safety we've achieved, and I think there were earlier
comments about sort of the perception of the public. And I remember a
colleague from CDC, who worked in blood safety only for a few years,
Lyle Peterson, five or six years ago made the comment that, "You guys
are completely missing the aim. You should be out there emphasizing what
an incredible success story the elimination of transfusion-transmitted
infections is to the public." Instead, all the focus is down on the
incredibly minute residual risk, and we're not adequately educating the
public about the extraordinary safety of blood.
Next slide. One of
the other things that I think we've struggled to do, and it's kind of
bit us, is we've spent a lot of time and a lot of energy trying to
estimate risk, the residual risk. And it's required--you know, we've
moved away from simple ways to measure the risk to recipients, following
recipients and measuring sero-conversion rates or doing special testing
of donor units to find rare residual infections. We've moved away from
those because you just can't do studies big enough to quantify the
extremely low levels of residual risk.
So what we've done
in the last, you know, five to ten years is develop model strategies
that estimate the rate of window-pair period donations, the potential
sources from variant viruses, unusual people who don't sero-convert, and
testing errors, and this has been a sort of building process over the
last, you know, ten years, that have come down with numbers that are
extremely low and essentially unmeasurable in the range, for example, of
HIV of, you know, 1 per million anticipated transmission event. And the
problem again is how do people weigh, in a risk analysis sense, these
extremely low numbers? In general, my sense is that people take any
quantifiable number as a problem, instead of having some way to balance
the risk of these remote transfusion events compared to other risks that
But in any event,
we have put numbers on risks and have developed strategies that we
thought were pretty reasonable to estimate risk. These model projections
of risk and value of new tests have been criticized in the past. For
example, after the debate over antigen testing, where we presented
estimates of the yield of antigen screening, Congress came back and
criticized those as gross underestimates of the yield without a lot of
data. So I think one of the questions that is important is, as suggested
a few minutes ago by Rick, is coming back to our estimates and trying to
benchmark and confirm that those were reasonable. And we'll come back to
that in a minute, because I think the introduction of nucleic acid
testing has really very adequately confirmed these estimates that are
laid out here.
Because the window period, as you saw on the prior slide, has been the
major theoretical source of residual risk, there's been a lot of work
that's gone on to estimate, understand the dynamics of virus during the
window period, and estimate the ability of various new tests, be it
antigen, NAT, either applied to small pools or single donations, to
further close the window period. We don't have time to go into that, but
I think there's an enormous amount of strong data that allows us to
estimate how many additional days of closure could be achieved by adding
this test or that test, and that's both for HIV, and on the next slide,
for hepatitis C there's a similar large body of data that's over the
last few years been generated to understand the duration of the viremic
period prior to antibody, and the ability of various test strategies to
interdict these window period donations.
that--next slide--we've been able to estimate how much these nucleic
acid tests, which are now in place, have been able to reduce the window
period, and one of the big issues that I'm focused on is what the
potential additional benefit that we would achieve in terms of window
closure or yield, and at what cost would the transition from mini-pool
screening to individual donation NAT achieve?
And you can see
here that the mini-pool screening, because of the dynamics of the window
period for each virus, detects the vast majority of the overall window
period for HCV, and a less proportion of the window period for HIV and
HBV. But it's--what I'm trying to emphasize is I think the scientific
efforts to get empiric data to help make these decisions is a first step
in the decision process.
Next slide. And
the other point that I wanted to emphasize is, again, that I think we
have to always ask whether our prior predictions, be they in this arena
for NAT yield, or risk, or issues like in HCV look-back, where there was
all the controversy over how effective would it be, how many infections
would we actually identify? And I think it's very valuable and important
that CDC undertook the effort to try to quantify what the real impact
was, so that we can then use the knowledge, and I think in HCV, as with
HIV--I'm sorry--in HCV look-back as with NAT, what we've discovered is
that our estimates were really very accurate. The yield of HCV look-back
was a very small fraction of the total proportion of infected
recipients, let alone infected people. And it's important to go back to
that, because I think that question of whether those estimates were
accurate was a major driver in the decision to do something that some of
us argued would not be very effective.
Here again we
say--if you just look at the yield of nucleic acid testing over the
first year of screening, we picked up 42 HCV and 4 HIV window-phase
infections. Some of these actually would have been detected by other
screening measures like ALT, but these were all antibody-negative yield
cases. And if we then estimate--derive from this yield the observed rate
of detection, we can actually then compare the yield that was observed
with the predicted yield from those model estimates I presented earlier.
And again, the big message here really is that our predictions were
really pretty close. We actually slightly over estimated the yield,
implying that we probably over estimated the risk.
In addition, for
HCV, we can look at what kind of yield we picked up in terms of
window-period versus error versus these silent carriers, and again, it's
really quite comparable to our predictions.
So, to me, I think
we have in place now a strong surveillance program and strategy for
making these projections, and I think it's very important that we use
that to reassure the public that we know what we're talking about and
use these data to frame future questions.
Next slide. Just
in terms specifically about moving to individual donation testing, we
can then use these window-period closure estimates, the further closure
that could be achieved by taking this next step of testing every unit
individually, and given the incidence in the donor pool, we can estimate
the yield, and these are per 10 million donations. So these are the
projected number of additional infected donations that we will detect
essentially per year in the United States. So we're talking really about
two or three additional HCV and HIV infections, and with HBV, the
incremental yield of individual donation NAT would be greater, but HBV
is much less important in terms of most patients who are exposed clear
the infection, resolve it completely.
And the next slide
is coming to a conclusion, just puts this into the cost effectiveness,
and these are numbers that were generated with Jim, and for important
comparison purposes--and I'll come back to this at the end--what I've
done here is to juxtapose the cost effectiveness, kind of the cost, the
number of infections detected, and then the cost effectiveness in the
formal dollars per quality calculation, of the basic antibody assays
with these, you know, sort of next-generation high-tech window closure
detection methods. And what you can see is the basic antibody test for
HIV and HCV, that because they detect the vast majority of infected
donors, the prevalent infections, and are relatively inexpensive,
they're actually extremely cost effective. In fact, for HCV, it's
actually a negative dollars per quality, which means that we save a lot
more health care cost by screening the donor units and preventing the
transmission than it costs to screen.
So these are
very--you know, these are sort of "gimmes." And one of the things I'll
close with is the big problem is that these tests are not being done in
many parts of the world. In strong contrast to that, we can see that
these window closure assays, because the yield of additional infections
that are being detected, are so low, and the costs are relatively
higher, you know, the cost per quality is just--from a cost
effectiveness, economic perspective, you know, out of control. Whether
these still justify, in terms of safeguarding the US blood supply and
public trust, et cetera, is, I think, perhaps being defined.
Next slide, just
final. This is just a compilation again with Jim of the cost
effectiveness of various blood safety initiatives. These are the
mini-pool and individual donation NAT testing. You have some of the
viral inactivation methods over here, and you know, basic antibody
testing and other generally accepted medical practices come in under
50,000 per quality. We're talking about measures in blood safety in the
millions of dollars per quality, which there's nothing comparable, I
think, perhaps, except for airplane safety in terms of public health
And finally, next
slide. Just a point that although, you know, you can argue negatively
that these direct virus detection methods like NAT are perhaps
inappropriate or cost ineffective. I think they are important for one
reason, which is that the perpetual discovery of new viruses that are
coming now every year, one of these is eventually going to prove to be
clinically important, I suspect, and having a direct virus detection
platform like NAT in place is going to be a very important safeguard at
some point in the future, and should cause us to revisit the whole
paradigm of screening in terms of, you know, perhaps getting rid of some
of the older antibody tests, antigen tests, obviously P-24, but probably
surface antigen, and relying more on the high-sensitivity direct virus
assays. Certainly as we look at new agents, I think our first decision
or first choice will often be to add a system to the NAT screening
Next slide. Just
wanted to make one comment about international safety and close. I
mentioned this earlier. These are slides from Luke Noel at WHO, but what
we sort of ignore is the fact that a large proportion of the world, and
nearly, you know, a third of the global blood supply, is collected and
transfused in developing countries, and in these settings, almost half
of the blood is untested.
Next slide, again
from WHO. They estimate that in the range of 10 million units that are
transfused annually that are not tested for HIV, 15 or so million for
HBV, and probably in the range of 25 million not tested for HCV. And
much of this is in regions of the world where the prevalence of these
viruses are extraordinary compared to here.
So, finally, the
last slide is sort of a new slide that we built as part of a group that
I'm involved with, which is called the International Consortium for
Blood Safety, which is trying to get resources toward the international
safety arena. And what this just illustrates is the point that that sort
of cost effectiveness slide also emphasized, which is that the basic
first generation--or relatively standard antibody tests, are able to
interdict, you know, probably at least 95, and probably closer to 99
percent of all potential infectious donations, and that these
technologies are really relatively inexpensive on a per donation basis
and very cost effective, because they do detect such a high proportion
of the transmitting units, and you know, what's sort of our of
equilibrium on a global level is the extraordinary expenditure that's
being applied to these sort of asymptotic residual risk infections in
the US and other developed countries. And although, clearly there's a
mandate to this committee and to us to try to do what we can to maximize
safety, I think we also should consider our responsibility globally to
make sure that basic screening tests are brought into play throughout
the world. That's it.
MS. LIPTON: Just
one comment. Mike, when you were talking about risk perception, you were
really focusing on, well, you know, we have a good story, and we do, and
so we should try to change the public's perception. And that's really
not my point, and I just want to make that clear. From my dealings with
the FAA, they accept what people's perceptions are, and they're not
trying to change them. You don't hear the FAA talk about how safe
airline travel is. What they say is any accident is bad, and our goal is
to get rid of those.
And so I think
that we think that if we just educate the public enough they're going to
get the point. And I think what we have to do is say to ourselves, if we
educate ourselves enough, we will get their point. And so I would turn
it a little bit on its head.
I absolutely agree
with you, too, about the international issue. And you know at AABB we've
been working a lot in the international field. I think testing is
critically important and technologies. But the other thing that we've
found in working in countries is it's not just the testing technology.
You must work to build infrastructures there and systems that can
actually use the tests appropriately, maintain them on an ongoing basis
and training. And I think there are a lot of initiatives going on right
now that are very good and I think are coordinated more and more. And I
know, again, our obligation is here, and I don't bemoan what we spend in
this country, but I do think we could look outside of our borders more
DR. HAAS: Mike,
were you using cost benefit or cost effectiveness? Because at least as I
was hearing you, I was hearing cost, and I was hearing prevention of
disease. And that would put, in my mind, more the cost benefit rather
than cost effectiveness.
DR. BUSCH: Well,
these are numbers that, in terms of those specific numbers that Jim
derived, and he's saying cost effectiveness.
DR. HAAS: I'd like
to see some background on--not today.
DR. Au BUCHON: The
process by which societies, their governments and skilled technocrats
make decisions about safety have fascinated me for many years. I'd like
to make a few preliminary comments on the issue in general and then
proceed to discuss a specific illustrative example.
This committee has
considered many issues of pressing medical, social and political
importance over the first 3 years of its existence. Although a more
rational approach might have been to first lay out the framework by
which decisions related to blood safety should be made, I can readily
understand that action was first required on the issues of the day
before we could take a collective step backwards, draw in a deep breath
and develop a plan by which future issues should be addressed. I'm glad
that we're now at that point.
In considering how
this committee should address the often conflicting issues of safety and
availability, I believe it would be prudent to recognize that health
care resources are limited. It was the federal government that first
created a prospective payment system for senior citizens in our country,
and it is that same largest of all health care payers that has, on
multiple occasions over the last 10 years, reduced payments to hospitals
for care that is increasingly more complex, sophisticated, costly and
This committee was
specifically charged to consider the cost of its recommendations, along
with other important implications. While efforts through and beside this
committee to obtain additional resources for hemotherapy are of course
welcomed and encouraged, we cannot kid ourselves into thinking that the
pot of gold from which these resources come is boundless.
I believe it is
the task of this committee to identify the risks, benefits, costs and
alternatives in critical blood safety decisions. We should highlight
what can be done with the resources available and highlight where the
commitment of additional resources will lead to further improvements in
hemotherapy. Where the people indicate a desire to pursue efforts beyond
a point that may make sense from a health benefit point of view,
implementation of these strategies should be pursued if, one, the
commitment of the public is reflected in the commitment of additional
resources to the effort so that, two, no net detriment to health will
rise through the implementation.
will, hopefully, continue to provide insights into how we can improve
transfusion in this country. However, I believe the decision-makers
should be made well aware of the facts about yields and costs of
proposed programs and that such considerations are an important part of
our deliberations. When resources are limited and choices have to be
made, this committee may be of invaluable assistance by saying to
society or its elected or appointed representatives that certain issues
deserve attention first and that more resources are necessary to
accomplish all that could be done to make transfusions safer or to
Now I would like
to turn my attention to the issue of universal leuko reduction as an
example of the kinds of situations that we will find ourselves in in the
future, an example of the dilemmas that our intentions and our
limitations lead us. I do not do this to speak for or against universal
leukocyte reduction, but merely to use it as an illustrative case.
As a former
medical officer at the national headquarters of the American Red Cross
and as a physician dedicated to providing the best hemotherapy to the
patients I serve, I'm always on the lookout for new means to achieve
safer transfusion. For example, my institution uses only apheresis
platelets and donor retested plasma in an attempt to reduce the inherent
risks of allogeneic transfusion. And to my knowledge, we are the only
hospital in the country that routinely cultures all platelet units to
detect bacterial contamination and one of the few to employ a mechanical
barrier system to prevent mistransfusion.
What is best for
our patient should always be paramount in the minds of health care
providers, and our institution has an admirable record of directing its
resources to that end. I would hope that those around this table and in
this audience can accept that my intentions are those supposed by
Hippocrates and not Adam Smith.
DR. Au BUCHON:
Some would apply the precautionary principle to require that something
be done just in case leukocytes are harmful to transfusion recipients. I
do not believe the data are yet available to conclude from an academic
point of view that the safety of transfusion will be advanced by
universal leukocyte reduction. In fact, there's a reasonable possibility
that diversion of resources, including our attention, toward universal
leuko reduction will prevent transfusion services from addressing issues
that have already been documented as causing more facilities than the
presence of leukocytes in allogeneic blood components; namely,
mistransfusion and bacterial contamination. That would be a mistake.
I have been told
by more than one blood center official in confidence that the push by
many blood centers toward universal leukocyte reduction is driven by the
economics of their finances and the inability of many facilities to
maintain operations with their current red cell pricing structures. If
this is the case, it should be addressed directly and not through
diversion of additional funds, amounting to approximately half a billion
dollars per year, to an effort of unproven consequence.
We need, as a
society, to pay for the safety improvements already implemented. And the
push toward universal leukocyte reduction, at least by some blood
centers, may be derived really from a perverse approach to the problem
of economics and is a sad commentary on how we have attempted to pay for
past improvements in blood safety.
Is it wise to
force hospitals to spend precious limited resources on an unproven
technology? When the potential for harm is great, the trigger for action
should be easier to squeeze. However, in my medical opinion, there does
not appear to be the horrendous threat to transfusion recipient safety,
about which some are raising the alarm with respect to allogeneic
leukocytes. If clinical harm were indeed evident, then it should be
If the public
wishes to spend additional resources on an unproven technology, I will
be happy to implement it, providing it does no harm. But to ask me to
direct limited resources to an arena where I can predict no benefit and
in doing so deplete the resources needed to address more well-documented
and larger problems, is to ask me not to deliver the best health care I
can to my patients. As a physician, I have difficulty accepting that
directive. A federal directive to implement universal leuko reduction
takes the decision how to treat patients out of my hands.
We have an
opportunity today to gather the technical resources of those trained in
the field with the representatives of society charged with overseeing
them and the associations of those who are the beneficiaries of the
efforts of the first two groups to define how this society should make
decisions about blood safety in the future.
substantial part of my academic career has been based on
cost-effectiveness analyses, I would be the first to acknowledge that
there is more to decision making than determining the
cost-per-quality-adjusted-life-year saved. At the same time, we as a
society cannot continue to demand a risk-free blood supply at Wal-Mart
prices. This committee is the perfect forum for considering options and
opportunities, and I hope that we will explore them honestly and openly.
Much has been
accomplished over the last 15 years to make transfusions safer. We have
many significant and important opportunities open to us to improve
further the safety of a transfusion. To the extent that existing or new
resources are available to advance toward the mutual goal of safer
transfusion, let's direct them towards the biggest problems. Although
universal leuko reduction has garnered the limelight recently, this is
not the biggest problem we face.
The patients that
I treat every day expect me to do my best to make their transfusion an
event they will not regret. To meet their expectation, I need to direct
the resources available to me toward the largest risks that they face.
Although emotion and rhetoric can be powerful, helping patients should
be our goal. And directing resources, time and money toward the largest
problems is the way to improve the health of patients.
We do need more
resources to make transfusion as safe as it could be, and we need to
direct these to the problems that cause the greatest morbidity and
DR. HOOTS: In
light of what you said and what Karen said earlier, it seems to me that
one of the things we don't have that might be useful here is cost
utility because one of the things that's critical for this whole
decision process is what are people willing to pay if they're given all
the facts. And that's what cost utility is supposed to measure.
And I wonder,
maybe you can--I mean, you would know, I'm sure, if anybody is doing
cost utility related to transfusion events and are they doing general
population or are they starting--if they are doing it, are they starting
with more people--people who are more sophisticated in terms of risk
analysis? But it seems to me that that's part of the equation that we've
always been missing.
But as Karen was
saying in terms of aviation safety, the perceptions are incredibly
important. And if people, I mean, it's obviously a major undertaking
just to educate this committee to all of the subtleties of the data that
might just show, much less the whole population, but it seems like, at
some point in time, we have to at least try to get some data on that
side of the equation that's collected in a scientifically appropriate
fashion and also probably could be put side-by-side with cost benefit
and cost efficacy.
DR. Au BUCHON: A
willingness to pay I think is a problem in health care analyses often
because the patient usually does not see the bill for what their health
care really is. And when their health is on the line or when they're
about to step into an airplane, they want an absolute assurance of
safety. But yet when taken out of that immediate threat context and put
in the framework of do you want to pay more income tax in order to make
sure that there's enough resources in the system to provide the very
safest blood, well, then people say, well, what am I really getting for
this? And that question is answered differently when they're about to be
transfused versus some unknown person at the other end of the country is
about to be transfused.
DR. HOOTS: Yes,
and I understand that. And maybe the targeted population initially then
should be people who are getting ready to undergo the transfusion and
also have an experiential base for other risks that they're undertaking
related to their medical care as well. So at least they'd have some
basis of comparison to what risks on other medical-related issues
compared to transfusion-related issues and relative costs of each.
DR. HAAS: If I may
just jump in very quickly, I agree with the concept that the ability to
measure that is almost nonexistent because you are playing with two
different fields of information. You're asking someone to say what would
I do if, and there have been some economic studies on uncertainty, and
it comes out saying people have to make decisions. And I think that's
why these discussions around here become very important. Where we have
slight differences, one of our jobs I think is to say, as a committee,
what do we recommend here because we're not going to get the data.
DR. EPSTEIN: Jim,
although you discussed universal leuko reduction, for example, you kind
of took a position on the issue. And I would just ask you, just at a
technical level, do you feel that there has been an adequate assessment
of cost effectiveness or cost benefit for universal leuko reduction? And
if so, where do you put it on a scale on the kind of graph that Mike
displayed? Because I think that a lot of the underlying debate, even if
we can put aside the reimbursement problem, which is, of course, real,
it really focuses on the difference between immediate benefit to
patients without known indications versus long-term benefit to the
population as a whole. And one of my concerns is that that issue has not
been framed adequately scientifically, and it tends to confound the
debate and is the underlying reason why opinion is so polarized on this.
So could you just
comment on whether there has been an adequate cost-effectiveness or
cost-benefit assessment and what did it yield.
MR. ALLEN: I don't
feel we have seen that yet in the literature. There have been several
economic analyses of the effects of providing leukocyte reduction, in
terms of potentially reducing length of stay or antibiotic usage or
other such benefits. The studies to which those analyses have been
attached have had some difficulties in terms of their structure and in
their interpretation, although some adherence of the concept of
universal leukocyte reduction I firmly believe that it will be cost
saving. It's very difficult to document that because most of the studies
have been retrospective. And with the rapid change in health care and
the pressures to reduce length of stay, it's hard to construct a
longitudinal study to answer the question.
Like many others,
I'm anxiously awaiting the results of the study that has recently been
concluded at Massachusetts General Hospital, where for the first time in
a U.S. hospital situation patients were prospectively randomized between
receiving leukocyte-reduced blood, when they had no specific
indications, versus receiving nonleukocyte-reduced blood. And
specifically the end points that are being sought in that study are
economic or have economic implications, such as length of stay.
So I'm hoping that
that study will provide some very useful information to try to guide
decisions as to exactly what economic benefit we will see. In order to
really conduct a cost-effectiveness analysis, one would need to
determine what the effectiveness is, and I have great difficulties
projecting what the yield of universal leukocyte reduction will be.
MS. LIPTON: I
think, and then to add, you know, if you look at this from a different
viewpoint, and some people are struggling with another concept, and that
is that if you accept that there are certain subsets of patients who
would benefit from this, we are unfortunately in a situation in our
society where I don't believe we can effectively identify accurately, in
every situation, those patients who do need them.
And the way the
DRGs are structured, and the way you go into a hospital, and the limited
medical history you get, and you go in on a specific service, and it's
their job to get you off of that service as fast as possible, really
doesn't have us treating patients, you know, from birth to death. We
treat events. And I think that there is some anxiety on the part of
people who think if we accept this principle of selective, you know,
doing selective leukocyte reduction, that really, in the long run, as
Jay said, when you look at a lifetime of these issues, that you don't
have a way of measuring that, but you've totally discounted that as a
potential good effect.
Jim, I'd like to follow up on Karen's question with the following one.
One of the things that skilled technocrats do, and I think there's
several people around the table who would self-identify themselves as
skilled technocrats do when confronted with a problem and having the
resources, is to throw money at the problem. And I said that not just--I
wanted to get a laugh out of it to diffuse the situation, but to ask you
a very, very serious question. One of the frustrations of us
technocrats--skilled or otherwise--when dealing with issues of blood, is
whether or not money that we would throw at a problem would actually
Do you have any
suggestions as to how any such money that we might throw at this
problem, which is the problem of limited resources for blood
establishments, broadly, limited reimbursement at the level of the blood
establishment, how would you suggest rectifying that problem? If you, in
fact, feel it is one.
DR. Au BUCHON: I
could think of a number of approaches, not all of them, probably none of
which, actually, are politically viable, at least in this country. But,
Yeah, but don't stop trying.
DR. Au BUCHON:
Okay. No. For example, the blood collection and delivery service could
be directly funded by the government. And, in fact, in most countries,
most developed countries, that is indeed what is done. So if the society
then decides that they want a new test, society would couple that
decision with putting more money into the blood supply system. It would
directly go to those who are expending the money to buy the test kits
and do the test. That would be one way to do it.
Another way that
has been discussed recently, as we've been considering how best to try
to get society to reflect their interest in increased safety with a
willingness to pay for it, would be to have a separate payment category
for blood transfusion. Right now blood transfusion is rolled into the
diagnosis-related groups through which federal government pays for
Medicare patients and that there is, indeed, no guarantee that
increasing reimbursement through the Medicare system as a whole will be
identified by hospitals as due to increased costs of blood.
If one were
charging out blood directly, then it would be easier to have that
recognized. It would at least be hoped that with the amount of
attention, amount of press at least within the health care community
that the cost of blood is currently getting, that any increased
reimbursement through Medicare to hospitals would be able to be used by
hospital transfusion service directors when internally negotiating with
their administrators to say this additional money should be allocated to
our budget in order to bring about additional blood safety initiatives
in the hospital.
If I could have a follow-up question then, one of the problems that we
have in this country in dealing simplistically with this issue is that
we don't have a national blood supply, we don't have a nationalized
payer. I think it's 22 percent of health care expenditures, last I
checked, and it's in the packet that I prepared for you, are Medicare.
So simply if the government were to set a price for blood, it would only
account for 22 percent of the benefits.
I guess the
question I would ask you to consider is, is there a way that the
government could set a price for blood without nationalizing the blood
business? We've tried, as you know, with the outpatient--APCs.
MR. ALLEN: I do
not have a direct answer to your question. Maybe I could defer to the
economist among us, but I would say that the federal government, while
obviously not having control over all health care expenditures or paying
for all health care, has incredible power to cause things to happen in
the marketplace and particularly in health care reimbursement. So if the
federal government were to, for example, indicate that a particular
avenue was appropriate and the federal government were willing to put
more resources into that to pay for that, I believe that private
insurers would probably follow suit.
DR. HAAS: Steve,
can I just add on to that? I agree with what Jim has said, but I don't
think there's any reason to assume the federal government would put more
money. They could put less, as Jim already indicated in his comments, so
that's a pretty dangerous route.
The federal government has stated on April 7th that the price it is
willing to pay for a unit of leuko-reduced blood, when used in an
outpatient hospital setting, is $137.21. That's a provocative statement
by the government. It's a policy that's in place right now. It's clearly
not an adequate policy by itself. It can be viewed, at least as I view
it, as a noble experiment, but it is one of the potential responses to
the very legitimate issues that you just raised.
MR. ALLEN: My
understanding is we will get back to the "Dear Citizen" letter, so I
basically just have a comment. As was mentioned earlier about the blood
industry and the issue of safety insofar as the perception goes,
basically what I wanted to say was that we do have a long way to go in
terms of educating consumers about how low the risk is now through
transfusion, as far as contamination. However, when consumers, such as
some of us here at the table, go out into our communities, we don't talk
about the numbers like we do here. We talk about the individuals and the
effect that these issues have on their families and these people.
So I'd just,
because of some of the things I hear and we're talking about numbers, I
just think it's important that we remember that we are talking about
people here and that these issues have a great impact on not only their
lives, but their families' lives. And we also heard earlier about the
possibility of blood banks going under. I mean, I just want to emphasize
that we have families that go under as well. So we just need to, I
think, keep all of that in mind when we have these discussions.
What I hear or take away from the committee comments might be lumped
into four categories. There's an interest in talking about
correspondence that people might send around. That's come up. There's
interest in talking about do we want to have a template of principles or
considerations that we might agree are relevant, even if we don't agree
on their application or how to interpret any one of them, but just
factors to consider when you're looking at an issue and sort of leave
saying, yep, that's a rough outline of what we'd like to have.
We were reminded
by a number of people that there are groups who rely heavily on blood
who are still concerned about supply and equitable access, whether it
was IVIG or alpha or hemophilia and asking whether we could put that on
the agenda or keep maintenance going on those areas to make sure that
they get done. And then there's a discussion out there about what we
want to say and do on issues of safety, continued safety, both
here--I'll call it the marginal safety issue--and then overseas, the
sort of impact on global safety. I may have not lumped them up
completely. But, anyway, those are areas that I heard kind of presented
I was going to
suggest to sort of not illuminate it, but I think it is our
responsibility to keep an eye on the supply and access issues for the
populations heavily dependent. So on that one I suspect we can just
direct ourselves to return to these issues. We may want to go to IVIG
and hear about that in terms of a sentinel study or something, but to
devote parts of future meetings to that topic. So I don't think there
shouldn't be too much controversy about that I would imagine.
And then I'm open
to going in whichever direction you all want to go to. Are people--well,
let me throw open the floor and see. Do people want--what they would
like to pursue, if I've got those categories straight, is there an
interest in discussing the letter a bit further and trying to do that
DR. EPSTEIN: Art,
were you going to entertain 5-minute presentations from--
What I was going to do is let them comment a bit on this and then go to
the 5 minutes. But it sounds to me like you think your 5 minutes is
DR. EPSTEIN: I
think before we, you know, cone down on one of the four topics, it might
be helpful. At least it speaks to one of them. It speaks to one of them.
All right. We'll do your 5 minutes because it may be relevant to one of
them. All right.
DR. EPSTEIN: Okay.
Well, as a hopefully skilled technocrat, I took literally Steve's charge
for this meeting, that we hope to identify a set of intellectually
consistent, politically acceptable principles on which a coherent and
durable policy to assure the safety, availability and affordability of
blood and blood products can be established.
And so what I
sought to do in my 5 minutes was to look at the different paradigms of
decision making that have been in use as a framework for trying to think
about underlying principles. And my first observation is that I think
that there are two large categories that tend to get confounded. You
need to go backwards to the first slide. One is how we deal with known
threats, and the other is how we deal with potential threats.
So with respect to
known safety threats, some of the paradigms that have been in operation,
and we could talk about which cases were addressed when and how, have
dealt, particularly in the post-AIDS era, with a zero risk concept,
which is intervene at any cost. And what I've tried to do is rank these
in some order of what one might call stringency, and I would say that
that's the least stringent because it requires the least reflection
about benefits and costs or tradeoffs.
which I think is a little bit less more stringent than zero risk is
looking at whether there's a favorable benefit-to-risk ratio. However,
that's also a limited framework because it implicitly is at any cost. As
long as sort of the gains outweigh the losses, then it's good and you
should do it. But that's independent of whether it costs too much.
I think that a
larger framework which begins to encompass cost has been the concept of
cost-effectiveness is favorable and that that should drive decision. But
there's been criticism that at least the FDA shouldn't look at the world
that way. We should be cost neutral from our purview.
that has been utilized in other domains, not particularly in the blood
area, but has been a successful paradigm, is the notion of trying to
have risk as low as reasonably achievable, so-called ALARA, and that's
yet another way that one can look at the problem integrating all of the
different ways of framing benefits.
And then lastly I
think the most global point of view is something that's been called
public health or wellness, which is to try to look at a possible
intervention and rate its value for wellness amongst all alternatives,
including things that aren't of a like kind; in other words, tradeoffs
for, say, different parts of public health--money into the vaccine
versus marginal blood safety, for example.
Now, as hard as
these decisions obviously are dealing with known risks, they usually are
made in the face of unknown risk and/or unknown benefits of particular
interventions. And yet once again I think it's possible to recognize
that there have been a range of strategies with, again, varying
stringency as to how much scrutiny is applied as the basis for decision.
And so in the
approach for potential safety risks, I think that the most stringent
framework, and here I'm going in reverse, has been to withhold all
action pending scientific certainty. And I think that that's the
paradigm that we had in place approximately 20 years ago, where we
waited until the data were conclusive and essentially all fair-minded
scientists were convinced. Short of that was the idea that we would
withhold action pending a scientific consensus, which basically meant
that the decision-makers, whoever they happened to be, tried to figure
out if there was sort of a dominant scientific view and then they would
go with it.
than that is what has been called the precautionary principle. And here
I'm pretty much describing it as it has been explained in the recent
document from the European Commission, which is to adopt precautionary
measures based on a consideration of options considering the underlying
factors of proportionality, nondiscrimination, consistency, and cost
And I think we
need to recognize that we have also had operating in some situations a
precautionary principle, but one which has been even less stringent than
as articulated by the European Commission, which is to adopt
precautionary measures, but in the absence of a full consideration of
impacts and alternatives, and that part of the problem has been that
some of our decisions have been on that paradigm.
Now, I guess I had
hoped that at this meeting or perhaps as possible topics for future
meetings, we might try to examine some of the upcoming decisions in
blood safety and availability or, alternatively, I suppose we could
adopt the retrospective model, look at cases where we've already made
decisions and ask what paradigm were we on and did it have value or
didn't it have value.
But I thought it
useful to at least note some of the pending decisions. And these fall
also into two bins: potential added safeguards and potential relaxations
of existing standards. In the area of potential added safeguards, we
have, you know in the near horizon, things such as implementation of the
minipool nucleic acid test for Hepatitis C, for HIV, which of course are
well along in development. But then a big question mark about Hepatitis
B, which is a subject of current debate.
Shortly over the
horizon, lies the question of whether there should further be
single-unit nucleic acid testing. And there's a question of whether that
should supersede minipool NAT or whether it should be seen as following
minipool NAT as an additional incremental safety benefit. And Mike
showed us what that would mean in terms of yield and cost and likewise
for the same agents.
Again, echoing Ron
Gilcher, we look forward to an era where there will be infectious agent
and activation technologies for cellular components. And the current
paradigm would layer them onto existing testing, and I think that the
challenge is whether we can deal with the overlap and perhaps not do
Likewise, we have
the challenge of dealing with emerging infectious agents, and Chagas
disease has been mentioned, as well as perhaps the inconsistency of how
we've been approaching Chagas versus other things. But the list doesn't
stop. It goes on: Human herpes virus type 8, human parvovirus B19,
Hepatitis A virus, and other things which are less-well characterized.
Then, of course,
we have the question of whether to expand the exclusions for TSE risk
not only related to Mad Cow disease, but potentially related to other
TSEs of mammals that may also be consumed in the food supply, and as has
been already mentioned, the questions of routine use of leuko reduction.
So under the
heading of "Relaxation of Standards," again, I would echo Jane
Piliavin's comment that we shouldn't only be looking at the new
technology and the new safety threat. We should concurrently and perhaps
always be reexamining existing policies and standards and reassessing
their benefit in a current scientific light. And I would put on this
list such considerations as the voluntary discontinuation of ALT, the
movement toward relaxing the restriction on donation by persons with
hereditary hemochromatosis as to the current requirements for unit
labeling and restricted donor frequency, and we've already discussed the
fact that FDA has moved toward permitting exceptions, whether to
discontinue HIV 1P24 antigen testing in the era when we can approve
minipool NAT and perhaps single-unit NAT, relaxing potentially the
current exclusion criteria based on behavioral risk of males who have
sex with males, whether there is continued utility of the serologic test
for syphilis and what is the continued utility of the test for
antibodies to the core antigen of Hepatitis B. These are just ones that
are already under consideration, not even getting into the question of
things that may come down the road.
So what are the
key issues then in terms of the decision-making process? My concept is
that the issue of the day is to talk about a process by which blood
safety availability and affordable cost decisions can be made in the
post-AIDS era based on some appropriate set of underlying principles
that should govern that process.
My own notion of
those principles is shown on the next two slides, and fundamentally they
conform with the recent statement of the European Commission regarding
application of the precautionary principle. However, again, I would
point out that the underlying principles really are not limited to the
situation of threats of unknown risk or unquantified risk; that the same
principles really should underlie consideration in the case of known or
quantifiable risk, as well as reconsideration of existing measures.
So what are these
principles? Well, I would put way to the top of the list that I think
acceptance of risk is a political decision. And what I mean by political
is that ultimately it's a matter of social choice, however the society
goes about that. Related to that, I would agree with what was stated, at
least by Dr. Gilcher, that zero risk should remain a goal, but it cannot
be viewed as a mandate. Regarding it as a mandate in any given situation
may lead to irrational actions, even if we continue to embrace as a
reality public fear and the public goal of zero risk.
Secondly, I would
say that just as acceptance of risk requires political decision,
acceptance of cost is a political decision. Why? Because in the end
there are finite resources, and it is up to the society where to place
its resources and for whatever gains or perceived gains.
Thirdly, in a
democracy, I think it's inevitable that decision making must be
transparent. But I think that this is also a necessary feature to obtain
a public endorsement, both of the process and its outcome.
Fourth, I concur
with the EC statement that any effective decision-making process in this
domain must be structured and must include the elements of risk
assessment or risk management; that is to say, well-defined strategies
of known or presumed effectiveness, and additionally, risk
communication, however effective or ineffective that might be.
Further, I believe
that there has to be ongoing scientific input; that this has to be both
prospective and retrospective in any situation.
And I would add
two dimensions that are part of the WHO thinking, but are not really
echoed in the EC document, which are that in this global village, blood
safety decisions need to be considered in an international framework
because they have international repercussions bi-directionally from the
U.S. point of view, and that additionally it's my personal view that
wherever possible, the decision makers nationally should attempt to
independently articulate the scientific basis, economic basis and
political basis of blood safety decisions because I think that that
effort contributes to clarity and creates increased freedom for national
governments and societies to make different decisions in the face of the
same available scientific data.
And so that's my
stab at trying to frame what I think are the underlying problems in
examining decisional paradigms, as well as my view of the basic
principles we might wish to discuss.
All right. We can move toward principles and a matrix discussion or we
can move toward some discussion of the correspondence issue. Anybody
want to take us in a direction? I'm going to see which way the comments
DR. KUHN: I'd like
to give a stab at the correspondence issue, and hopefully it can be
addressed pretty quickly.
After listening to
much of the discussion this morning, it seems like we do have a
correspondence that was sent out to congressional members. They did get
it in some kind of a packet, but they are not under any obligation to
mail it to their constituents. And it seems like there probably
is--funding is probably not available in the 2000 budget for trying to
address the correspondent issues.
But I believe that
in the spirit of what the committee accepted and their recommendations
of August 13, 1997 and November, 24, 1998, regarding Hepatitis C
look-back notification and education, and also seeing that the surgeon
general deemed the "Dear Citizen" letter most important, I would offer a
recommendation, hopefully, that could be considered, and that would be
that the committee actively supports the surgeon general's effort to
inform the American public of the risks that Hepatitis C or HCV
infection and transmission. Moreover, the committee strongly urges the
secretary to seek adequate supplemental fiscal year 2001 funding in
order to provide the CDC with the most efficacious and widespread means
of informing the American public, including the consideration of sending
a "Dear Citizen" letter to the American public by March 31st, 2001.
That sounds like a proposal. Why don't we have a little discussion.
MR. ALLEN: Would
it make sense to consider possibly asking HHS to allocate the funds
directly to the surgeon general? No? Why not?
DR. NIGHTINGALE: I
think--we don't--not that much money passes through us, and there's a
reason for it. I don't think that where the money goes is essential the
perf--is material to the performance.
MR. ALLEN: I guess
what I'm concerned about is obviously I'm one of the people that would
like for this letter to go out. But my concern, one, is if it comes from
a congressperson who may feel obligated to send it out, but really
doesn't want to send it out, and then once the constituents get this
letter, they're more than likely going to call that congressperson's
office, and they may or may not have the right information to give them.
So I'm a little concerned about doing it that way. So that's one of the
If this is a
letter that the surgeon general feels strongly about, I want to back him
in getting this letter out.
DR. NIGHTINGALE: I
apologize. Larry, while you were talking, I was looking over my shoulder
to see if the window that was blocking the text of the statement had
been obliterated. So I misunderstood what you said.
Could you repeat
it once more for me. I know it's already in the record.
MR. ALLEN: I just
wanted to know whether or not we could ask that funds be given directly
to the surgeon general for the purpose of sending out this letter
Oh, here, I just have to speak personally, and this is from the heart.
The administrative staff of the surgeon general is limited. You are
looking at them.
DR. NIGHTINGALE: I
think, given that reality, there are more administrative staffs in
agencies where such programs are usually based, and there is a reason
MR. ALLEN: Okay.
Well, then besides letting Congress do this is what I guess I'm getting
to here. I'm just concerned about the letter coming from congresspeople
that might, you know--
If the money were to be allocated, I cannot anticipate problems spending
allocated money. But if I could anticipate a problem, it is one person,
contrary to public belief, in the government can only spend so much
money so fast. It takes more of us to spend all of that tax money.
DR. HAAS: I guess,
listening to some of the discussion before lunch, I guess before the
discussion I wanted a letter out. Listening to the discussion, I'm not
so convinced. I just don't know. And the way the proposal is written, it
doesn't say, "Send a letter." It says, "Let's get appropriate
information out there." And in the spirit of some of the discussion we
have just had, I guess I'm a little reluctant this afternoon to say the
letter is the absolute most important thing to do or the best way to do
it. So I guess I'd prefer to keep it the way it is, and then figure out
a way to put the nice gentle pressure and say, "This is extremely
important", and the intent of that letter's got to go out there whether
it's the letter or not. So, again, I guess my fundamental point is I'm
not right now in favor of tying anybody's hands.
Again, I'm just speaking as a grammarian here, not as an official of the
government, if that is possible--and it probably isn't. But I don't see
anything up on the board that would tie our hands.
DR. HAAS: I agree.
That's what I'm saying, I like it the way it is.
MR. WALSH: Mr.
Chairman, on the contrary, I think our hands are shackled right now
And Larry, maybe
that you weren't here earlier this morning for the discussion of--the
entire discussion, but the letter is a letter signed by the Surgeon
General on his original letterhead. It's not as if it's coming from a
member of Congress, advising a constituent of a potential health
problem, so I think that hopefully they would look at the Surgeon
General's letterhead and not the Congress person.
DR. GUERRA: I
certainly agree with trying to get information to the greatest number of
people in the shortest period of time, but I think incumbent in the
process is also the need to have some capacity in place to serve the
general public that is going to have the questions, and that is going to
need to be counseled and screened and tested, and then connected to
resources, and I think that that is a moral and ethical obligation that
we will have, but I think it's part of this process.
Again, I have to phrase this more carefully than perhaps I phrased some
of the things that I've put into this microphone. But there are several
proposals currently before Congress, of which I am aware, that address
the point that Dr. Guerra just raised.
What are they?
DR. GUERRA: Yeah.
What are they and how far along are they in the process, because there
are very few resources out in the field right now.
DR. NIGHTINGALE: I
understand. Rather than just telling everybody to go to Thomas dot LOC
and search for hepatitis, that's one way to do them. To answer your
question--and I haven't done that search recently--I am aware of one
proposal that is an authorization rather than a dollar amount to spend
money for this purpose--a children's health insurance plan. Just kind of
a for instance, because that's the one that I looked at yesterday.
Just for the record, I haven't really had any involvement with the
development of the letter at CDC. That's something that Hal Margolis and
others, as you heard this morning, have been working on.
I guess before we
vote on anything, my sense from the comments that I heard this morning,
Steve, is that the letter is not a dead end, and that as I understand
it, there has been a very public announcement by the Surgeon General and
Congressman Bliley to put out a letter using Congress and its mailing
capacity to do so, to its individual constituents. And, yes, there is no
obligation for each individual congressman or woman to do that. And it
has hit a snag, a couple of snags, in terms of the separation of powers
issue and this 90-day moratorium on mail-outs prior to an election.
But what I heard
this morning is that what is under way is--actively under way, is to try
and work through those two implementation issues, and--
And furthermore, if you--excuse me--to search for alternative means of
distribution that would not subvert the purpose of the message, changing
the letterhead, say, to a commercial entity signed by the Surgeon
General is not on the table, but--
We could discuss it, I suppose.
Right. So--and I understand there's this whole other discussion that's
been going on this morning about the merits of a letter and how
effective, whatever it could be. And I guess I'm just wondering if such
a vote is a little premature. Perhaps we should--you know, if the
committee wants to make some statement, recommendation about their
support for such a letter and that it be sent out, and that Congress,
individual members of Congress, support this effort, because I guess I'm
believing that this is eventually going to be worked out, that there
will be a way for Congress and the Surgeon General to work together to
get a letter out, but it can't be until after this 90-day period that
has to be paid attention to. And that, really, we should maybe be
supporting efforts to see that that does happen once these sort of
implementation issues can be worked through.
This is Steve Nightingale. I agree with Dr. Chamberland. Let me restate
that while I can't predict the future, I can state my own intentions,
and I can state the result of a conversation that we had on Monday with
the Surgeon General, was to proceed on the basis of our private
discussions with congressional staffers that the issues were
prudentially resolvable, and also to proceed with other avenues for
distribution of the letter. Also in the context of support for the
overall CDC program report. I think it is important here for me to state
that it is not our view--this is not the only component of the CDC's or
the government's effort in this area. It is not our intent to get into a
discussion of the relative importance of this or other initiatives,
because, frankly, we don't care. We want to get the job done, and
successful as possible, with the--and make--I should find a better
word--the minimum amount of mess in the process of doing so. This is a
messy issue. At the same time, since we are certainly open to
alternatives to distribution, we are certainly open to getting the
maximum amount of effect for the money that we spend. I think it's fair
for me to say that I don't--I didn't see anything up here, as I said
earlier, tied our hands on this issue, but that's because I'm not
looking at it right now. I'm looking at the committee, and if somebody
else sees something that would tie our hands, please let me know.
CHAIRMAN CAPLAN: I
see something that will tie our hands. If anybody thinks--this is my
opinion--that they're going to sneak a $30 million expense under the
franking privilege around the lawyers that are now paying attention to
this, forget it. So my hunch is that unfunded, this may not fly. You
betting me? All right. I'll bet the lawyers. I'll take it.
So if you want to
be risk averse and follow the zero risk principle, you might want to
look at something like that as a ace in the hole of the letter, finding
a way to send out a efficacious letter. I'm assuming here, that as we
deliberate about this, it might turn out that putting it all on TV was
better than sending a letter, but that's my outlook on things. But
whatever, some way to get that message out. That may be our safest
course, it would seem to me.
DR. EPSTEIN: I
just wanted to propose some rewording that might be a little bit better
received by the Secretary. What I'm suggesting is that the part
directing the Secretary what to do simply be omitted, and that the date
certain be omitted because that would increase flexibility. So if we do
that, it would read, "The Committee actively supports the Surgeon
General's efforts to inform the American public of the risk of the HCV
infection and transmission", and then jump down, "including the
consideration of sending a "Dear Citizen" letter to the American public
as soon as feasible."
I think the virtue
of that is that you have the committee endorsement, but you really have
not dictated how the message should be conveyed. You've suggested the
sense of urgency, but you've not, you know, put a burden on the
Secretary should it not be feasible by that particular date. So it's a
little bit softer, but I think it gets our message across. Let me just
reread what I'm saying.
Basically what it
would be, deletion from the word "moreover" through "American public."
So it would say--yes. And then I would strike "by March 31st", and
substitute "as soon as feasible." So this version would read: "The
Committee actively supports the Surgeon General's efforts to inform the
American public of the risk of HCV infection and transmission, including
the consideration of sending a "Dear Citizen" letter to the American
public as soon as feasible."
And that way we're
not telling the Congress what to do, we're not telling the Surgeon
General what to do. We're just saying that something should be done and
as soon as feasible.
DR. KUHN: I
thought about the wording very carefully, and I think it--and that the
logic or rationale I had behind that was, number one, I think it
fulfills Congress's concern that they have had on this issue for quite
some time. I think it addresses that, number one. Number two, I think it
also addresses the urgency of many of the decisions that this committee
has made, and also the encouraging ways that the CDC is trying to get
this information out to persons. I think, number three, it supports the
Surgeon General's--I believe his wishes of trying to get the
communication out as quickly as possible in a widespread manner. And
also when you're dealing with Congress, I think we all know, you have to
have money. And I think it has to be mentioned in there in order for
this to fly.
And I also thought
about putting--when I put this together, that we needed to make it
flexible enough--a directive, but a soft directive, and flexible enough
so that there is latitude to be able to accomplish the objective. It
doesn't mean that it has to be a "Dear Citizens" letter. That is the
direction that the Surgeon General proceeded in in having that letter
written, but it doesn't necessarily mean that is going to be the most
effective way to accomplish it. I think the goal is accomplishing it.
How do we make the American public aware in a widespread way? And it's
going to take funding, and I don't think--I think if we ignore
mentioning the funding, I think this will get lost someplace in the
budget process that's going to be taking place in the next month here.
MR. ALLEN: I agree
with what Dana's saying. My concern is leaving it open-ended like that.
I think maybe if we could ask that they get--give us some response back
by the next meeting in terms of where we're at with--where they're at
with this letter, the timeline that they feel maybe that will give them
enough time to have some answers, because right now, you know, if we
leave it the way it is now, look at how long it's taken us to get to
this point. By the time they finally get a letter out, it might not mean
So I'm concerned
about that. I would like some kind of language in there that at least
ask someone within HHS to get back to this committee by the next meeting
with a timeline on what's happening with this issue here.
Being somewhat befuddled about my parliamentary procedure here, we have
two proposed statements with nothing moved yet, so somebody could move
one or the other, or we can have a little more discussion.
DR. KUHN: Mr.
Chairman, I move that the first proposal or recommendation that I had
submitted by put on the floor.
Did you save that one, Mac, in your--
Discussion? About amendments to this short of Jay's amendment. We could
do it that way. Any other language clarification as soon as it
DR. BUSCH: Just
that the "infection and transmission", I'm trying to understand what
those--how they're different. One thought would be to, instead, have
"infection and disease" instead of "transmission."
DR. EPSTEIN: I
thought the point of that was to deal with the issue of secondary
transmission. In other words, your own infection and the risk to
transmit to others. Your modification would be correct, of course, but
would lose that conflict. That's how I read it.
DR. AuBUCHON: From
time to time the Executive Secretary of this Committee offers us
valuable insights into the workings of the government. Might he offer
some comments as to which two versions that have been discussed would
provide the intended outcome? And I do not perceive that there is really
any difference around the table in terms of what we would like to see
happen, but how best to make it happen is not entirely clear.
DR. NIGHTINGALE: I
can obviously live with either one, because it's my job to live with
each other one, appearances sometimes to the contrary. I--this is a gut
feeling, something that comes from the committee, particularly if it is
very strongly endorsed by the committee, will have more force, because
believe me, if they want to get a hold of me or Jay, they have our phone
numbers and they can get our advice--well, not for free, but at a
relatively discounted price to the market.
So for that
reason, I suspect that the more potent one would be the one from the
committee. Did I walk the fine line?
DR. AuBUCHON: Very
MR. ALLEN: Steve,
what would be your opinion then on how long of a time before we got a
response from the Secretary?
DR. HAAS: Maybe we
could ask Steve to turn off his mike.
DR. NIGHTINGALE: I
think that the--obviously, the Secretary's FY 2001 budget is in. At the
moment, what happens with the budget that begins on October 1st is in
the hands of Congress. Yes, there is a lot of discussion going back and
forth, but really, most of that discussion at this point is White House,
sort of is White House coordinated. I'm not speaking in absolute terms.
I'm trying to give the committee information based on what I know
general processes are, but specifically, what I know the processes for
the health budget are.
The Secretary has
not had problems in the past saying, "Thanks, but no thanks" or "Thanks,
but reconsider." And if she or the senior staff were to disagree, we're
not in a confrontational mode here because we're all trying to do the
same thing. That's why I made the suggestion that I did. I wouldn't
sweat the small stuff here right now, because it's not going to offend
anybody, I think, or put anything off track. I think you've heard from
me what our consensus within this administration is, which is we
consider that a component of what we're trying to do, we're trying to
make it happen. We've also--there's a lot of other things that we would
like to do with 30 million bucks, and if we can do this for less than 30
million or get somebody else to pick up the tab, we'll be--we could
still use the money.
So I mean, given
that bias, if yours is not--if yours, the committee, is not identical to
that--and I think to some members of the committee, it is not identical
to the one that i just articulated--then if you wish to articulate your
own position very clearly, this would do it. Again, I'm really--and not
just for the record. I think people understand, I'm not trying to talk
you into one position or another. These are easy sells for me one way or
another because the distinctions--I mean, these are tactics rather than
strategy. Everybody wants to get to the same place here.
There is some discussion. I just heard in fact one mention of there
being lots better ways to spend $30 million. Speaking now as a social
scientist, which I don't get to do specifically very often here, I think
we should think about the response that was made by the gentleman who's
no longer here, to how effective the last Surgeon General's letter was,
and it didn't sound as though it was very effective.
You mentioned the
use of television. I think you mentioned it, perhaps not seriously, but
you could get a lot of spots in very high-profile places. John mentioned
the Super Bowl. It only costs $500,000 for a spot in the Super Bowl,
which in comparison to--I always used to think that was a lot of money,
but in comparison to $30 million, it's a drop in the bucket.
In terms of the
persuasive power that we know different media have, television has a
whole hell of a lot more than a letter that comes in the mail, that if
it has got a congressional stamp on it, is most likely to end up in the
waste basket, because a lot of people don't think very highly of the
Congress, and a communication from them is unlikely to be seen as
terribly valuable, whereas a communication--
CHAIRMAN CAPLAN: I
hope you have the data to back that up.
DR. PILIAVIN: I
don't, but I could probably find it.
it's clear that this is what the Surgeon General would like to do. I
think a spot with him saying this on television, that could be put on 15
times for a third of this money, even in extremely high-profile places,
would reach more people with more effect, and I would suggest that maybe
it would be good to have some social scientists who are more expert in
persuasion than I am--and I could give you a list of people--speak to
him about alternative ways of doing the very same thing.
Well, just two quick comments. One, there will be many television
marketing people available after November 9th who might want to work on
this, and there are also--I think the language that I like about this is
to try and figure out the most efficacious and widespread means of
informing, including the letter, because it does make a window there to
have it taped, read, broadcast, and, as I was trying to indicate, my
concern is coordinated. There are a lot of other things going on, and I
hope that the way that language reads would get a coordinated effort
going with the letter. I too am not so sanguine about the fate of the
letter actually, even though I was joking about it, but I'm not
impressed that a letter alone is going to get us where we want to be,
and I think that was the lesson of the Koop thing.
So now, how about
a call for vote? Yes, I see some sentiment for that. All in favor of the
Kuhn proposal on encouraging correspondence?
[Show of hands.]
Eleven votes in favor.
DR. NIGHTINGALE: I
see no votes.
[A show of hands.]
DR. NIGHTINGALE: I
CHAIRMAN CAPLAN: I
got two abstain.
We have two abstentions? The motion has 11 votes in favor and no votes
against, two abstentions. Motion carries.
All right. Now, I'm in a mild dilemma here. I want to leave some time
for public comment, and I want to leave some time for consideration or
talk about further comment about the matrix principles, whether there's
something we can do. I know we don't have to settle that one, but I'd
like to at least--since we had people kind of turn in homework
assignments that covered some of this, it would be useful to give some
opportunity for a little bit more comment on that.
So my proposal is
this: How many people do we have who want to make public comment? If I
could get hands way up. Okay. What I'd like to do then is ask you, as I
often do, to limit it to two minutes, come to the mike. We're going to
do it in the order in which you arrive at the microphone. There's
someone going first. I like that. Yet again, let me ask you to identify
who you are, and give me your last name and that will give me the clue
about who's coming next.
Okay. My name is Jan Hamilton. I'm Executive Director of Hemophilia
Federation of America.
When the IOM gave
its report on crisis and decision making in July of 1995, it considered
the nation's blood supply a unique, life-giving resource. They said the
safety of the blood supply is a shared responsibility of many
organizations, including the plasma fractionation industry, community
blood banks, the Federal Government, and others. The precipitating event
for the findings of the IOM was contamination of our nation's blood
supply by the HIV virus and all that it entailed.
In the ensuing
years, we've heard much rhetoric about who failed to do what and when
and what should be done about it. We've also discussed the same things
today. Thousands of lives have been lost, and even more families' lives
turned upside down because of the lack of a systematic process in the
The charge from
the IOM was that we learn from the past and prepare for the future, and
that's what I hope I hear coming out of this Committee.
We would like to
urge that we continue the charge from the IOM. Several of the charges
have been addressed by Dr. Satcher as he mentioned them this morning.
There are still some areas that need to be visited and some that need to
Please continue to
monitor foreign bodies in the blood supply: CJD, HIV, hepatitis C,
hepatitis XYZ, whatever, and even such things as bacteria and/or mold in
the manufacturing process.
We appreciate the
proactive stands in these areas, including, but not limited to, NAT
testing and leukocyte reduction. Continue to monitor problems of supply.
Dr. Hoots mentioned it earlier today, and we have been very concerned
about the decline in the recombinant supply and are speaking with
industry directly. But we could use a little help from our friends.
address errors and accidents. Some of these have proven to be disastrous
and cost dear lives. We've been pleased about the Committee's stand on
the prospective payment system issues, and now we would request some
assistance in addressing looming inequities on AWP for coagulation
products, and especially recombinant products for Medicaid and Medicare
patients. There should not be a double standard for these patients, or
of this Committee has been a bright light on the horizon, and we're very
pleased to be able to attend, learn, and put in our two cents' worth of
comments on issues heavily impacting the coagulation disorder
population. We hope you will continue to be vigilant in the areas of
blood and blood product safety and continue your strides towards
Thank you for
allowing us a few minutes to comment.
Thank you. Questions? No? Okay.
Again, I'll ask
you to state your name for the record.
MS. FOSS: Thank
you. I'm Mary Foss from Mayo Clinic, Rochester. Dr. Brendan Moore and I
would just like a few minutes to talk about costs and benefits related
to leuk reduction.
I would like to
start with just a little bit of data to give you an idea of the scope of
our practice in Rochester so that you can kind of compare our costs with
In 1999, we
transfused about 39,000 red cells, about 46,000 platelet unit
equivalents, close to 14,000 fresh frozen, and about 6,000
If I could have
the next slide, please?
inventory comes from the blood we collect at Mayo Clinic, Rochester. We
collect, test, process, as well as transfuse, and we also receive
supplemental blood supplies from the St. Paul Red Cross. So about 56
percent of the red cells that we transfuse at Mayo Clinic, Rochester,
are collected at Mayo. And the other 44 percent come to us from St. Paul
Red Cross provides
29 percent of our platelet unit equivalents, and about 71 percent are
collected by us at Mayo. Of those 71 percent platelet unit equivalents
that we provide, about half of them, a little more than half come from
apheresis donations and the other half are random donor platelets made
from whole blood donations.
So you can see we
rely heavily on the random donor platelets made from whole blood
donations. So, consequently, we feel that if and when we go to 100
percent leuko reduction, leuko-reduced blood supply, we will need to
continue to manufacture random donor platelets from whole blood
If I could have
the next slide?
You can see that
when we calculate what that's going to mean to us when we switch from
our current situation, which was that we were at 17 percent of our red
cells being leuko-reduced and 70 percent of our platelets. If we go to
100 percent, we will go from a supply cost of $15.50, approximately, to
a supply cost of $40. This is exclusively due to the need to switch than
to a new collection set with the in-line filter.
If I can have the
last slide, please?
I wanted to just
show you the incremental cost for us to switch from our current
situation to 100 percent leuko reduction at Mayo Clinic, Rochester. When
we look at the increased cost for us for the blood we collect as well as
the increased charges from the St. Paul Red Cross for all of their blood
to be leuko-reduced, for us at Mayo Clinic, Rochester, the incremental
cost is $1.2 million. And when we saw those big costs, we knew we needed
to step back and better define the benefits before we made the final
decision. We thought we wanted to go to 100 percent leuko reduction. We
saw a lot of reasons why we probably should. But $1.2 million in our
institution is a lot of money, and we needed to be able to justify that
So now I'd like to
turn it over to Dr. Moore to have him give you some of his thoughts and
ideas about those benefits and this conundrum that we find ourselves in
in making the decision.
DR. MOORE: I'm Dr.
Brendan Moore. I'm the Chairman of the Division of Transfusion Medicine
at Mayo Clinic.
This is a figure
that's been shown recently looking at the total number of blood
collections in the United States, and it's available to anyone to look
at, but there's clearly a down trend, which is a national problem.
If you just look
at the question of benefits and concentrate on certain areas of benefits
for leuko reduction, one of the areas that stands out in my mind as
being potentially where the money is is post-operative infections. If
you look at the number of surgical procedures annually in the United
States, there are 18 million, and post-op infections are either surgical
site, catheter-related, pulmonary, or general sepsis.
Now, if you just
look at surgical site infections alone, by the best estimate about 2.7
percent, or 486,000, surgical site infections per year. Approximately 50
percent of the transfused blood in the United States goes to surgical
patients, and there are data to support this. You'll see where I'm going
with this in a moment.
These are the data
from the Vamvakas' study of surgical versus medical use, and they're
approximately the same in Olmstead County. So we think it's probably the
same nationally, about 50 percent. And, of course, if you're going to
use surgical site infections, then you're only looking at the benefit
from half of the blood that you leuko-reduce.
Here's a study by
Kirkland, et al., from Duke, I believe. They did a matched cohort study
of surgical site infections on 255 pairs in inpatient surgery. Now, the
main point of this slide is to show that mortality was different. Those
requiring ICU admission was different. The median hospitalization,
translate that to dollars, and median direct costs were different if
they got a surgical site infection or they didn't. And we've all known
this for years.
If you then looked
at the survivors requiring readmission, you now look at 41 percent of
those with surgical site infection versus 7 percent, excess
hospitalization of 12 days, and in this one study alone of just 255
matched pairs, the incremental cost attributable to surgical site
infections alone was $1.9 million--255 patients, $1.9 million, surgical
site infection alone.
So if you
extrapolate from that--and I know that economists and maybe
epidemiologists would shudder if they saw how I did this, but if you
just take those figures and extrapolate them to the national data, one
is potentially looking at a cost of surgical site infection alone in
this country annually of $3,764.1 million. Now, that's real dollars.
proportion of inpatient surgery which is associated with transfusion is
not known, so it's not clear that all inpatient surgery, even major
surgery, is indeed now associated with transfusions. You can see where
have demonstrated that there are various risk factors for surgical site
infection, depending on the type of surgery, the age of the patient,
whether it's spinal surgery, whether they have a high admission
hematocrit, and whether they're allogeneic transfusions, and those
contain white cells. This is non-leuko-reduced. So transfusions are only
one of the factors that may well have affected the surgical site
infection or other infections. But it probably is one.
contribution of allogeneic transfusion to the risk of SSI is actually
unknown for most surgical operations, and this is clear--and I'll come
back to this point. We don't know enough yet.
If you look at the
study of post-op infections, localized or systemic, in 120
patients--this is from Heiss' study--having colorectal cancer surgery,
those getting allogeneic transfusions had an odds ratio of 2.84 by a
multivariate regression analysis. So, in other words, in that study it
appeared to make a difference.
If you look at
Vamvakas' study, retrospective analysis of nearly 1,000 colorectal
cancer patients at MDH, allogeneic transfusions were associated with a
relative risk of 1.07 for post-op infections. In other words, there was
a 7 percent increase in those transfused with allogeneic blood. And
another study from Vamvakas in the same institution, this time looking
at just CABG and pneumonia, which is a common occurrence after CABG, the
allo-exposed versus the unexposed had a clear difference, and the risk
was related to the length of storage of the blood. None of these were
prospective, randomized studies.
If we weren't
looking at this unfortunate situation, none of us, as was mentioned
earlier, would even bother discussing this question. We'd all have
universal leuko reduction a long time ago. But, unfortunately, we are
dealing with large dollars.
So, in summary,
what I would like to say is that allogeneic transfusion exposure appears
to be one of many significant factors in post-op infections. The result
of multiple studies, in fact, appear to implicate the white cells in
that blood, hence, leuko reduction. The potential savings to society are
enormous if the post-op infection rate can be significantly reduced.
And, remember, transfusions may only be one factor, but it may be an
The final comment
I would make is really a plea that before we make significant
decisions--and this Committee makes significant decisions relative to
blood safety in the United States--that there be more data obtained so
that the decisions that are made are based on some sort of analysis that
gives you a balance. And I think most experts would agree that there
really is a need for large, multi-center, prospective, randomized
clinical trials to assess the role of white cells, red cells, and even
plasma, free hemoglobin, and maybe even iron content in post-op
infections, because there are data supporting the role of each one of
these, but we don't know the full answer yet. So before we spend the
money, let's figure out what it's likely to--what the bang is likely to
Questions? Larry? Dr. Moore, do you want to stay up there?
MR. ALLEN: I was
just curious. In the best of both worlds for you, what would you prefer
to have? What would you like to see happen?
DR. MOORE: Well,
to make life very simple, I would like the FDA to mandate leuko
reduction. Number two, I would like the government to then recognize
this is going to cost an enormous amount of money, and before the
mandate is done, more data are obtained, and they're obtained in decent
studies with large numbers in a fashion similar to what the TRAP study
attempted to do and did very well some years ago for a totally different
issue. So that everybody would arrive at the same point and say we have
a consensus, we don't need a mandate that people fight over, it's very
obvious that we have cost-effectiveness, let's do it. Because there are
multiple medical reasons for giving leuko-reduced blood, but not
necessarily to everyone. That's the problem.
Dr. Moore, on your cost estimates, do you use a micro-aggregate filter
at the ward? And did you eliminate that as part of your cost estimate?
DR. MOORE: No, we
don't use micro-aggregate filtration, and, in fact, if you look at the
data on micro-aggregate filtration over the years, it really hasn't been
effective in taking out the numbers of white cells that one needs to get
to. And, in fact, recent data from Europe particularly would indicate
that the level that we should be aiming at is not 5 by 106
per unit, it's really 1 by 5 by 10--1 times 106 per unit. And
that is achievable with modern filters, but not at the bedside and not
micro-aggregate. They'd have to be done in the lab with proper QC.
I'm not sure--the question was more pointed to how you're currently
using them, and would you eliminate them with ULR?
DR. MOORE: Oh, no,
we don't--we have never used them. For those patients who need
leuko-reduced products in our practice--and you saw the figures for the
numbers--we use third and fourth generation filters. They're not
Last one to Jerry.
DR. WINKELSTEIN: I
noticed that the increment between pre- and post-leuko reduction cost
estimates was incrementally in terms of percent greater for the Mayo
Clinic than the American Red Cross. I think the Mayo Clinic went from
400,000 to 900,000, and the American Red Cross from 1.6 million to 2.1.
Is that a real
difference? Are there cost savings that differ from provider to
provider, or what?
DR. MOORE: Mrs.
Foss might want to make a comment about this since she pulled the data
together and put it together. But it seems to me that what we did was a
fairly rough and ready estimate as to what our own cost difference was
going to be based upon the materials--not the blood itself, the
materials that we would have to buy, the filters, for example, the bags,
the new bag systems, in order to do it in our establishment. We really
can't compare that to anybody else's cost where scale may be different,
for example, at Red Cross, et cetera.
The contracts that
we have with the manufacturers of blood bags and filter systems might be
quite different from the contract that the Red Cross would have. So it's
apples and oranges, and I wouldn't like to compare more than that.
Mary, do you want
to say anything?
Thank you. I'm going to move us along here. Please tell me who you are
for the record.
DR. FANG: Thank
you, Mr. Chairman and members of the Committee. My name is Chyang Fang,
and I am Director of Scientific Affairs of Chiron Corporation's Blood
The purpose of my
comments today is to update you on the impact of Chiron's genomic
Nucleic Acid Testing (NAT) capabilities.
Since March of
1999, Chiron and its strategic partner Gen-Probe, Inc., has been supply
NAT reagents, instrumentation, training, and technical support to U.S.
blood centers performing NAT under FDA-approved Investigational New Drug
HIV-1/HCV assay is currently utilized to screen approximately 75 percent
of all volunteer blood donations in the U.S. under IND. Blood banks from
the civilian blood collection sector and, most recently, the Armed
Services Blood Program are now routinely screening blood donations using
this highly sensitive and new technology.
estimate that NAT may reduce the window periods of potential HCV
infection by 70 percent and by nearly 50 percent for HIV.
Working with all
blood centers in the United States, by June of this year NAT assays have
identified 62 HCV-positive donors and four HIV-positive volunteer donors
whose infectious units would have been transfused but for NAT testing.
In addition, NAT
assays are responsible for identifying three HCV-positive donors that
were initially HCV EIA negative due to laboratory errors.
In addition to
interception of infected donors, NAT has demonstrated other public
health benefits. NAT can identify infected persons at the early stage of
infection for more effective antiviral treatment.
In addition, NAT
results are an important tool for counseling of volunteer blood donors
and also paid plasma donors. NAT can enhance diagnosis and treatment and
prevent secondary infections.
Outside of the
U.S., the Chiron NAT assay has been specifically approved for blood
screening in France, Germany, Spain, Australia, and Singapore. The
Australian Red Cross began routine screening in May 2000. Various
European countries are finalizing plans for full implementation of
nucleic acid testing.
Blood is a
national resource that must be preserved and maintained. Each person in
the U.S. shares equally in the potential need for blood and the
resulting potential for contracting transfusion-associated illness, such
as hepatitis and AIDS. Therefore, we must strive to protect and maintain
both the safety and availability of the nation's blood supply. There are
still cases of transfusion-transmitted HIV and hepatitis in the United
States and other countries. We can substantially reduce these infections
by adopting new technologies, such as NAT, in order to improve detection
of these infectious agents. NAT testing ensures that our nation's blood
supply is truly as safe as it can be.
Do we have any questions? Are there any questions from the committee
If not, thank you very much, doctor.
Merlyn? I'm sorry,
Merlyn, could you identify yourself in the microphone?
DR. SAYERS: I
still am Merlyn Sayers. I'm going to be speaking on behalf of America's
Blood Centers, and we really do appreciate this opportunity to address
Centers is an association of some 75 diverse community blood programs
that are responsible for about half of the nation's volunteer donor
ABC has many
concerns that really reflect the division of opinion, both within the
organization and nationally, regarding the justification for universal
leuko-reduction. While some ABC blood programs have embraced universal
leuko-reduction as appropriate, those who point to the lack of medical
consensus on the topic also consider that the selection of such
components is an expression of the practice of medicine. ABC members
are, however, in agreement that if FDA does go forward with a
recommendation for universal leuko-reduction, the agency must proceed
with formal rule making, rather than allowing implementation to proceed
until a standard of care has been established, followed by regulation
under CGMP. Only through formal rule making will there be consistent
quality control and licensure requirements.
regard to licensing, this ponderous process must be streamlined before
the expected surge of universal leuko-reduction linked applications, and
to these ends we ask this committee to urge the FDA to continue
considering creative, effective and efficient methods, as the agency
outlined in a June concept paper, to assure the quality of leuko-reduced
components and the pace of their licensing.
that as we move towards universal leuko-reduction some other unforeseen
issues are going to arise, such as the problems currently being seen
with leuko-reduction of red cells from donors with sickle cell trait.
And finally, we
ask this committee to exhort the FDA, even as that agency proceeds with
rule making, to cooperate with PHS, health care agencies and hospital
organizations to help remedy reimbursement deficiencies. And while we
recognize that FDA is not charged with solving reimbursement problems,
it no longer is acceptable for regulation to be divorced from
reimbursement. And in this context, America's Blood Centers applauds
members of this committee for their resolution of April the 26th, which
recommended legislation to provide funding for blood-related costs, and
we respectfully solicit this committee to persist in encouraging steps
that put an end to unfunded mandates. Thanks.
Thank you. Before Ms. Gregory approaches the microphone, are there any
questions from the committee for Dr. Sayers?
If not, Kay.
MS. GREGORY: Some
disadvantage to being short.
My name is Kay
Gregory, and I'm here with two separate statements. First of all, I want
to speak--when I get the microphone fixed--on behalf of the new multiple
organizational task force that the AABB has developed, to evaluate and
develop recommendations to simplify the uniform donor history
questionnaire, including consideration of an abbreviated version for
The task force
appreciates the opportunity to make this advisory committee aware of its
activities. We hope that this meeting will also provide an opportunity
to let the public and those with a special interest in donor screening
know of our activities. So we're here to tell you about a concern, but a
way in which we're going to address the concern, instead of just letting
somebody do something.
The task force was
formed in response to information from the FDA that the agency would
like to see a simplified questionnaire developed, perhaps sometime in
2001, and would prefer to have a single initiative supported by the
entire blood banking community. The task force, chaired by Dr. Joy
Friday, is composed of representatives from the AABB, ABC, ABRA, ARC,
CDC, and the FDA, and we will shortly be joined by representatives from
NHLIB and the Armed Services Blood Program Office as well.
The task force is
intending to be the core group guiding the effort, but each organization
will be active participants, assisting the task force with things such
as identifying member centers to pilot questions and generate additional
information or data as needed. It is vital that we include everyone in
this effort including donors.
The task force
charges are to reevaluate the scientific validity of all FDA required
infectious disease questions in view of the most recent scientific data,
including current testing technology, to identify and reword questions
for which the wording may represent comprehension difficulties for
average individuals, to identify questions that can logically be grouped
together and simplified, and to reorder questions as appropriate, and
finally, to evaluate methods and develop recommendations for
administering the questionnaire. These would be things like oral,
written, computer-based questioning methods, how to handle recurring
questions, et cetera. And then lastly, when we complete our task, submit
it to FDA to be sure that it meets their approval.
It's an active
task force. It was only organized in June. We've already had three
conference calls where the entire task force and numerous conference
calls for the subcommittees that are working.
I just want to
list for you some of the activities that are currently under way. First,
we're working with the FDA, planning a joint workshop, which will be
held October the 16th, and information about that will be posted on both
the AABB and the FDA web page and will be announced in the Federal
Register shortly. Secondly, we've distributed a survey to obtain
information about questions currently in use to selected blood centers,
hospital blood banks and plasma collection facilities. Third, the AABB
members have specifically begun to review which of the AABB added
questions need to remain and which we might do something about. We're
not going to blame it all on the FDA. The AABB has made this
questionnaire somewhat complicated as well. And then, finally, the FDA
is busy compiling information about questions that are most frequently
cited in error and accident reports, and they're also looking to give us
some direction about those questions or those errors where they're
non-negotiable, that is, they're going to need to stay on the
questionnaire in some format, maybe not the exact wording we use now,
but at least so we're not spinning our wheels on things that we can't do
I thank you for
the opportunity to speak today. The task force is excited about the
opportunity to accomplish meaningful change, and we plan to keep giving
you regular, progress reports.
Thank you, Ms. Gregory. Are there any questions? Dr. Penner?
DR. PENNER: Just a
quick question. Will there be a first-time donor questionnaire as
opposed to those repeated donors, or is all going to be strictly a
MS. GREGORY: We
really haven't gotten quite that far into it yet. That is one of the
things we're considering, is, you know, can the first-time donor be
different from the repeat donors? Are there local issues that need to be
addressed? So I can't really give you an answer yet.
DR. PENNER: Yeah,
because I'm sure it's a nuisance to continue to answer the same--
That's one of the things that we hear is, "I've already answered this,
and if I said I never did it, why do you keep asking me?"
Are there any other questions from the committee for Ms. Gregory? Is
there anybody else in--I'm sorry. Kay, you've got another one. You don't
have to identify yourself again.
MS. GREGORY: This
time I'm speaking on behalf of the American Association of Blood Banks,
and we would like to take this opportunity to recognize the activities
of the advisory committee on blood safety and availability.
We note, however,
that the committee charter indicates that the committee would cease to
exist on October 9th unless renewed by appropriate action prior to its
expiration date. Even though we've not always agreed with all of the
committee recommendations and conclusions, we believe the committee has
served, and should continue to serve, a vital function. Although there
are other public forums for discussing scientific matters, this
committee is the only public forum for addressing other important issues
such as availability, cost, other economic issues, reimbursement.
Further, the committee has been remarkably successful in obtaining
action in response to its recommendations. Clearly, your voice is being
heard in the right places.
In keeping with
the general approach of the committee to enunciate positions in the form
of a resolution, the AABB makes the following recommendation: Whereas,
the Advisory Committee on Blood Safety and Availability provides a
public forum for discussing issues of concern to the blood banking
community and the public, and whereas the committee has successfully
formulated recommendations presenting potential solutions to the issues
it has discussed, the AABB recommends that the committee charter be
renewed and that the committee continue to provide this valuable service
to the blood banking community and the public. In short, we urge the
Secretary to take appropriate steps to allow for the committee's ongoing
work to provide patients with a safe and available blood supply. Thank
Thank you, Ms. Gregory. Would you state for the record that my mother
did not write that statement?
MS. GREGORY: I
will state that I wrote the statement.
Then I would state more formally for the record, that we have completed
the process of applying for a two-year continuance of our charter, and
that we anticipate a favorable response from the Secretary. The process
is such that she does not sign the reauthorization, I believe, until
after the conclusion of the current committee, but CAPT McMurtry is the
administrator who understands this far better than I. Comment, Mac?
CAPT. McMURTRY: We
expect the Secretary's signature right around the end of September.
We, nevertheless, appreciate the kind words very much.
We have approximately, I would say, 30 minutes before we start losing
airplane travelers. My suggestion would be that we take advantage of
that time to think about--and this is just a suggestion; I'm open to
other suggestions--but my suggestion is that we take advantage of that
time to think about not resolving the issue of what matrix or dimensions
to use, but perhaps to direct the staff to take under advisement what
Dr. Epstein presented, what Rick presented, some other comments, in the
formulation of a matrix of points and factors to consider.
The reason this
becomes important, that we give some direction to a matrix, if you will,
is that with this international meeting coming up, the Secretary, I
suspect, could use some advice about what framework to bear into that
meeting in Geneva. What's that, November?
November 13th--14th, 15th, 16th and 17th, I believe.
CHAIRMAN CAPLAN: I
mean, I may be wrong, but I think we're going to today, arrive at the
framework, but I think we probably have enough material here to assemble
what starts to look like a series of points to consider or principles to
consider, and sort of use that as the outcome of our trying to struggle
to do this on a case-by-case basis, but saying that it jumped out of
there. So anyway, that's my thinking about where we might go with
principles, but the floor is open for other business and other
DR. AuBUCHON: I am
pleased to see that we're not going to try to come up with that
framework in the next 28 minutes. I was very impressed with Dr.
Epstein's enumeration of the different approaches, and I think Dr.
Davey's distillation of similar concepts to a template format could
indeed be useful.
I would like to
suggest that we consider hearing from Dr. Salmi [ph], who produced the
template that was utilized at the WHO meeting in March, which now has
had some practical application, at least within that meeting, to see
another approach from another country, but one that has had some
international application, and it may help move us toward understanding
the factors that really push us to make certain decisions.
In light of Dr. Caplan's comments, I'd like to add some input for the
staff when we start formulating that or they start working on that.
We have the
advantage of being one of the largest organizations in the nation that
collects, manufactures, processes, and transfuses blood products, and so
we get to see the global perspective. We now have more U.S military
deployed throughout the world than ever before. In every instance of
that deployment during this time of peace, we have had to collect blood,
fresh whole blood, and transfuse it untested to treat either U.S.
casualties or local national casualties or accident victims.
This presents us a
unique problem in safety and availability challenges because the charter
of our office is to continue to maintain and supply safe, compliant
blood to all U.S. forces deployed throughout the world. Each additional
test makes it more difficult to do this.
We now have
multinational forces supported by multinational medical forces and a
multinational hospital being built in Kosovo. Adhering to the policy of
the United States that U.S. deployed forces will receive FDA-licensed or
equivalent blood becomes much more difficult in these situations.
everything, and it appears we have actually timed something
appropriately. November 9th and 10th we will have the NATO
Civil-Military Blood Committee meeting here in Washington, D.C.,
immediately after the American Association of Blood Banks meeting and
immediately prior to the meeting in Geneva.
The topic and
focus of the NATO meeting is interoperability and harmonization of
international blood supplies. In order to achieve those goals, we need
our federal regulatory agencies of each nation and our blood committees
and blood bank organizations of each nation to work together in Geneva
to try and harmonize the requirements and the donor selection criteria
and infectious disease testing criteria in order to make support for
these multinational forces more possible, because as each nation draws
its military down, we will have more multinational events.
Costs continue to
be a major factor, and as I have mentioned before at this Committee,
every time a new test is required, it takes us two years to accomplish
budgeting to do that test. Because of that, reallocation of resources is
required, and in the military medical health care system we do have to
take from some other pot to put into the infectious disease testing pot,
and some factor of health care suffers for those two years.
So I would just
ask the Committee to continue to keep in mind the aspect of funding for
the Department of Defense blood program when a new test is required, and
that we feel the development of a template or cost/risk/benefit model
which will provide a framework for making these decisions and
discussions extremely important in our strategic planning and the
world's strategic planning in keeping a safe and available blood supply.
I want to thank
HHS for allowing DOD to be a part of this Committee, and we hope that we
can continue to contribute. Thank you.
DR. DAVEY: I have
a couple of comments, first about the international meeting coming up,
Mr. Chairman. I spent a year with WHO working with their blood program
and spent a lot of time in Africa, and I can only second I think what
Karen was saying earlier for those who are going to be at the meeting
that the testing techniques have been there and have been available for
10, 15 years, mini-pool testing, cartridge tests. The technology has
been there, and the funds, almost, to provide the testing has been
there. What is lacking, again, which Karen pointed out, is the training
and infrastructure and also the importance--and, again, this was brought
out--of each country developing their own blood program based on their
own needs and their own culture and their own customs.
There have been a
lot of mistakes about moving technology in in a Western fashion with
Western technology and Western thinking, and it hasn't worked. So
there's been a lot of experience. We're at another threshold, I think,
of consciousness raising, and perhaps we can move this forward now with
the experience, and I think the program at WHO has really gotten funded
with some good people, so there's a good opportunity now to move it
On another topic,
I fully support the Chairman's recommendation that staff go ahead and
work on a matrix and see what we can come up. I think Jay has had some
good ideas. Perhaps my seven points might be considered.
Also, I think it
would be useful as maybe a preamble, since this is a turning point for
the Committee, we're looking backward, looking forward, that a listing
of some of the pending issues and actions--again, Jay had a good one, I
think Mike and others have pointed out some very key issues--that that
be kind of a preamble. These are things that are facing this Committee
and the country, and this is a template that we can use to address them
in the future. It would be a useful piece to put in the minutes.
We did mention that one of the things that might be useful to add to our
agenda was a consideration of changes of unnecessary or out-of-date
safety measures, and we haven't sort of gone at that systematically, and
that might be an important agenda item to flag for the future, too,
using the matrix approach to help us think about that.
Yes, I appreciate Dr. Davey's comments. In response to the anticipation
of future agenda items, while the process might appear somewhat
undirected, I hope it's appeared to be transparent. We have tried to use
the Committee to identify problems that, bluntly, we thought might be
resolvable. This is a very useful instrument of government, but it's by
no means the perfect--better still, it's not the only instrument of
government. You saw that, for example, when the TSE scientific debate
went to the TSE Advisory Committee rather than to this Committee, not
something that everybody agreed with but, nevertheless, if I'm a little
reticent to commit to the next year or even to the next meeting's
agenda, it is because blood is a complicated business. And it's also
because blood is a high-level business. I think there were some kind
words spoken about what happens after resolutions are made here, but
that's really only possible when there is consensus within the
Department about the topics and the expected outcomes before the
decisions are made.
I mean, we can
perhaps--an analogy I've used elsewhere--keep the river from flooding
the village, but we can't make the water go back uphill here. And I
think that that's been one of the strengths of the Committee.
So while I take it
under advisement, there is a clearance procedure that I would have to go
through, and I'll at least try to keep that clearance as transparent as
possible to the members.
MS. LIPTON: My
only comment, I absolutely support looking at what we could do to reduce
or eliminate some of these things, but I think there is a process here,
and the process begins with FDA. And if they have that on their
agenda--I mean, I don't think--I certainly don't feel qualified to sit
here and evaluate scientific data. So anytime something comes up to this
Committee, I would hope that we have, you know, some kind of
deliberation before BPAC or some other body that we can then add those
other factors. I would hate to see us bypass that route before it got
And if I may second that, I believe I'm on the record repeatedly as
supporting that, and possibly to simplify what Ms. Lipton just said, you
know, if there's science on which to base a decision, it shouldn't be
here. We don't get the hanging curves. So far we haven't got them, and
if a hanging curve shows up here, it probably should have been somebody
else who had a chance to hit it out.
DR. AuBUCHON: I
understand what you're saying, Steve, but at least today in blood safety
I don't see many issues where the scientific conclusion or the
scientific consensus alone creates a slam-dunk situation. And there are
clearly other factors, particularly economic, that need to be factored
in. Furthermore, Blood Products Advisory Committee or other Advisory
Committees may not be in a position to take into account all of the
availability discussions, which are part of an ultimate conclusion of an
So I would like
to, as we look at how decisions are made, discuss not only the factors
that should be considered in making a decision but which arms of the
Federal Government in its Advisory Committee structure can be utilized
and how they should interact with one another.
It's fair to say that the Chair occasionally gets from the people
that--even though we sometimes think of ourselves as advising the
Secretary, occasionally e-mails arrive at my desk asking about things
that the public wants to know about. Some I pass to Steve. Some which
are more acerbic I don't. But one thing that comes up a lot is the issue
of male sex and the rule about donation. I've heard a lot of
communication about that. People are interested in that.
My point in
getting us to some issues that might be considered by us was not so much
to jump ahead of where the science might be but to act as a prod to make
sure that the science gets done if it doesn't seem to be getting done
because we've grandfathered in a lot of things that may make no sense or
may be sort of up for reconsideration.
Jay's list is
pretty good. I didn't get the sense that the FDA was asleep about these
things, but it's sort of pushing more than it is saying, oh, okay, well,
we can set the standards here about all those things.
DR. EPSTEIN: Yes,
I think--I presented a list of things that are in the hopper. I mean,
these are happening now. We are considering them. But I resonate very
strongly to both what Karen Lipton said and what Jim AuBuchon said,
which is, you know, we start with an FDA process, but we have an
underlying problem of divided responsibilities. And the reason for that
is that the lines have been drawn in a certain way over areas of
responsibility. I mean, FDA is not supposed to look at cost. We're
supposed to look at, you know, safety, effectiveness. We can go as far
as to look at, you know, public health, risk/benefit, but not the C
You know, that
creates a problem in an era of limited resources and very difficult
trade-offs. And on the one hand, I think that we have evolved to a
system where we do have fora to vet related issues, global concerns. But
the process by which we decide which issues surface, how they surface,
where they go, when the decision should get made, what is linked to
what, that's the part that's ill-defined.
I mean, we
recognize, for example, that the issue of safety advances and how to pay
for them is linked to the reimbursement system. But, on the other hand,
it's been pointed out many times, and correctly, that that isn't really
FDA's charge. But then whose charge is it, and what system do we have to
ensure the integration? And I think that's really where the challenges
lie. I think we do have a pretty good idea what the particular concerns
are, but we don't have a system that decides which is the correct
paradigm to address that issue.
You know, I guess
we aren't going to do it at this meeting, but my notion was that we
might want to go through that list and ask ourselves what paradigm are
we applying now and is it the right one, kind of issue by issue. Now,
that doesn't mean that we want to take on all issues in this forum, but
I think thinking along those lines is what's needed.
You know, there
are some people who would say, well, you know, you're doing the right
thing about HHVA wanting to have proof of transmission before you
attempt to intervene. And there would be other people who say, But
that's not following the precautionary principle. You know, you've
already got enough reason to be concerned because it's
So, you know, the
whole problem is where should you be and how do you decide where to be.
How do you measure the relative importance of the different issues? I
think part of the problem is that at least to the FDA, they each present
as an entity in their own right, because we're really not charged with
trading them off against each other. We're charged with dealing with
them all at once.
And so, again, my
feeling is, yes, it starts at FDA and, yes, we don't bypass FDA. But
there is a dilemma related to divided responsibilities.
To follow up that, I think that the issues we've had over the last three
years, the six that I enumerated--hepatitis--or the Surgeon General did,
I'm sorry--hepatitis C, CJD, plasma shortages, blood shortages,
reimbursement, and error management--were issues that came to us.
We're at a nice
time right now, as the Surgeon General said this morning. We may not
have put them to bed, but we've made constructive progress on them. It
may very well signal a transition not only for the Committee but for the
blood community as a whole that we are in a position to start acting
proactively rather than reactively. And if that, in fact, is the case,
that's a good thing.
I also think if
that is the case, we've made a really good start this afternoon. We do
not give door prizes out at the meeting for the best talk, and that's
good because, not to offend anybody, but the last two speakers would
have had to fight over the door prize, not because they happened to have
the right words, I think, but because I think both of them--and if
you'll forgive me, particularly Dr. Epstein--captured where the
Department is right now. Dr. Epstein's is not exhaustive--it was not an
exhaustive analysis. It was a useful framework, and what he said there
very much reflects what we were--the internal discussions of the
Department over the last month after we set on this agenda.
This is a process,
a discussion--what we wanted to do was find a place to start where
hopefully there was some consensus outside not only of the Humphrey
Building but outside of the FDA, CDC, Humphrey, NIH axis. And that's the
reason why I brought up the analogy of the door prize because that was a
tricky thing to do.
It is my
impression from reading the body language, if you will, that Dr.
Epstein's formulation of the position has fairly wide support. And if it
does--for what it was intended to be, a formulation of talking points, a
set of principles that we realize are not the final answer to a very
complex question, but a point of departure. And if that is--if my
perception is shared, it would be of some assistance, I think, to Dr.
Epstein and the others involved in planning for, say, the Geneva meeting
to have some expression of that support, if, in fact, that's there.
DR. PENNER: Jay
brought up the "C" word, which I presume is cost. And at this point I'm
getting a little confused inasmuch as I pay something like a thousand
dollars a day for antibiotics on a patient in the intensive care unit,
and $3- or $400 worth of blood may be life saving. And I don't quite
understand how the price of blood is being set by HCFA, at this point,
which then sets the pace for the rest of the reimbursement situation.
Our movement from
some $48, as I mentioned, 20 years ago to the 90-some-dollars now seems
to be rather negligible in comparison to other drugs that are being used
and employed very effectively at very, very high levels of cost. Does
this need more attention or have we spent as much as we can on our
energies in getting that area taken care of?
No. I think the one last point that I would want the committee to recall
is something I said earlier, on November 9th it's a new ball game. The
issue of reimbursement for blood products I suspect we have taken it as
far as we can take it in the isolated context of blood alone. And while
I'm not suggesting that we have failed because I don't think we have, I
think that to get beyond where we have gone with our recommendations and
actions resulting from them, we're going to have to look more carefully
not only as to how blood fits into the current reimbursement framework,
but perhaps into limitations of the current reimbursement framework. And
a new administration is a convenient place for that to happen. I said
far more right there than I perhaps should have.
DR. PENNER: Blood
is cheap in comparison, and I think we all fail to look at that because
we are left over with the years of getting blood, and it's donated, and
therefore it should be free concept in our minds, and that I think has
got to be altered.
Just to respond to Steve's point and see if we can get agreement perhaps
on a recommendation or suggestion to the staff on this one. Jay's
framework I don't think is a basis for consensus about decision making.
It's a good matrix, however, of points and approaches to consider. I'm
not a particular fan of the precautionary principle, for example. So I
know it's on the list, it's a way to go. It wouldn't be my way to go. I
can't imagine capitalist-mad America deciding that it's going to be risk
averse in the way that the precautionary principle suggests, but
maybe--I doubt it. That's why we'll be eating GMO and everybody else
However, there is
enough there to set out a matrix of points to consider ways to approach,
and that's what I would like us perhaps to recommend that the staff
develop for us. Can we perhaps even take a vote so I can get a formal or
a second or a motion or something? A motion. I'm making a motion that we
direct the staff to develop a matrix out of the presentations we have of
points to consider. We then might move on with that matrix to some
weighting or what we in the trade would call a prescriptive position
about which is better or which is worse or which we want to go with. But
first we need to get the whole thing in front of us.
Since I would--Mac and I would have to be the people to do what you're
directing us to do, are you directing the staff to develop a matrix from
the presentations--plural--made at the committee as a basis for further
discussion about principles--
--that would underlie safe, effective and portable blood supply?
That's my idea.
That's eminently doable, and thank you for the opportunity if that's
what you choose to do.
DR. HOOTS: Kind of
implicit in that, but would you consider, as a friendly amendment, that
essentially this draft would then--we would kind of commit ourselves to
applying it, as it's already been implied, that we apply it to certain
models, whichever ones we prioritize in the next few meetings, to see
how it works; in other words, we actually commit ourselves to seeing if
we can use this paradigm to develop policy?
While my own enthusiasm for Dr. Epstein's and Dr. Davey's presentation
is there, I think that the presentations require further public
discussion before there is a commitment to them. And I think not because
of any inherent weakness in them, but because these are new ideas to get
into the public--
DR. HOOTS: I
didn't mean to imply that we would do it for all times. I mean just
experiment with trying to use that thought process as we go through a
problem and learn as we go. That's what I meant, not that it would be
the end all and be all.
Beta testing, in other words.
DR. DAVEY: So
All in favor?
[Show of hands.]
[Show of hands.]
That's a fairly innocuous recommendation I suspect.
I'm going to take
the last few minutes here to thank the people who have served on the
committee whose service is now over. When is our next meeting? January
DR. NIGHTINGALE: I
was afraid you'd ask. Mac? The next meeting of the committee? The last
Thursday and Friday in January. We've had a mix-up with days before. But
if anybody has a 2001 calendar, it's the last Thursday and Friday.
Of January 2001, right.
January 25 and 26; is that the last? January 25-26?
Let me state for the record that you will be informed through the
Federal Register, and personally and on the committee's
website of the next meeting of the Advisory Committee. We do have a
contract with this hotel, but to the extent that we can minimize
conflicts with our I don't know if I want to say sister organization, we
will certainly strive to do so.
So still hang onto the last Thursday and Friday date until you're told
The other thing
that obviously is going to happen is elections come, Steve has used the
word "new ball game" a couple times. There could be changes, not by the
time we meet next, but changes could come in the administration, and the
people that we talk to at HHS and so on, and the secretary's office. So
it'll be an interesting time for us to transit. My hope is, however,
that our work has been such that we will sail on, despite new winds in
the air, potentially, or for certain--actually, there will be no winds
for certain no matter what goes on--and that whoever is in Congress,
whoever is in the White House, whoever winds up at HHS is going to see
the value of having this group here.
that the floor is open for nominations to membership. And I think you
have to get it in by the end of the month, and Mac will accept by phone
or e-mail or letter names and ideas, and so that is very important that
we get the right people to replace the good people that we're losing.
Unless there's new
business, I'm going to suggest that we now adjourn.
Okay. We stand adjourned.
4:19 p.m., the proceedings were adjourned.]