Blood Safety: Resolution - November 1998
DEPARTMENT OF HEALTH AND HUMAN SERVICES
OFFICE OF PUBLIC HEALTH AND SCIENCE
ADVISORY COMMITTEE ON BLOOD SAFETY AND AVAILABILITY
SIXTH MEETING
Tuesday, November 24, 1998
8:39 a.m.
Omni Shoreham Hotel
2500 Calvert Street, N.W.
Washington, D.C. 20008
P A R T I C I P A N T S
Members
Arthur Caplan, Ph.D.
Stephen D. Nightingale, M.D., Executive Secretary
Janice K. Albrecht, Ph.D.
Larry Allen
James P. AuBuchon, M.D.
Michael P. Busch, M.D., Ph.D.
Ronald Gilcher, M.D.
Edward D. Gomperts, M.D.
Fernando Guerra, M.D.
Paul F. Haas, Ph.D.
William Hoots, M.D.
Carolyn D. Jones, J.D., M.P.H.
Dana Kuhn, Ph.D.
Tricia O'Connor
John Penner, M.D.
Jane A. Piliavin, Ph.D.
Eugene R. Schiff, M.D.
Marian Gray Secundy, Ph.D.
John Walsh
Consultants
Richard J. Davey, M.D.
Kristine A. Moore, M.D., M.P.H.
Ex Officio Members
Mary E. Chamberland, M.D.
David Feigal, M.D.
Paul R. McCurdy, M.D.
Capt. Bruce Rutherford, MSC, USN
David Snyder, R.Ph., D.D.S.
Also Present:
Jay Epstein, M.D., FDA
Eric Goosby, M.D., DHHS
Lawrence McMurtry, Deputy Executive Secretary
C O N T E N T S
AGENDA ITEM PAGE
Roll Call, Conflict of Interest Announcement 3
Welcome from the Chairman 9
Centers for Disease Control 16
Food and Drug Administration 56
Interorganizational Task Force on HCV Lookback 87
Blood Recipient Organizations 100
American Liver Foundation 115
Lunch 150
Committee Discussion 151
Motions 178
Adjournment 268
P R O C E E D I N G S
DR. NIGHTINGALE: It is one minute after 8:00 in
the morning. Good morning. I'm Dr. Stephen Nightingale,
the Executive Secretary of the Advisory Committee on Blood
Safety and Availability and welcome to our Sixth Meeting.
The following announcement 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 the Committee
members present no potential conflict of interest when
evaluated against the official agenda.
In particular, as specified in Title XVIII of the
US Code at Chapter 208(b)(2), a Special Government Employee--which all voting Committee members are--may participate in
a matter of general applicability even if they are presently
employed or have the prospect of being employed by an entity
that might be affected by a decision of the Committee,
provided that the matter will not have a special or distinct
effect on the employee or the employer, other than as a part
of the class. The example given in 5 CFR 2640.203, which
implements Title XVIII of the US Code, is as follows:
A chemist employed by a major pharmaceutical
company has been appointed to serve on an advisory committee
established to develop recommendations for 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 the class of all pharmaceutical companies
and other research entities that are attempting to develop
an AIDS vaccine.
Committee members have been given a copy of this
section of the Code. Additional copies are available at the
desk.
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 will be noted for the
public record.
With respect to the other meeting participants, I
ask in the interest of fairness that they disclose any
current or previous financial arrangements with any specific
product or specific firm upon which they plan to comment.
Finally, I will make every effort to see that the
transcript and the summary of this meeting and the final
draft of any recommendations will be posted on our Web site
by the close of business Monday, November 30th. The Web
address is www.hhs.gov/partner/Blood Safety.
Now, would the Chairman and members please signify
their attendance when I call their names? Dr. Caplan?
CHAIRMAN CAPLAN: Here.
DR. NIGHTINGALE: Dr. Albrecht?
DR. ALBRECHT: Present.
DR. NIGHTINGALE: Mr. Allen?
MR. ALLEN: Present.
DR. NIGHTINGALE: Dr. AuBuchon?
DR. AuBUCHON: Present.
DR. NIGHTINGALE: Dr. Busch? Dr. Busch?
[No response.]
DR. NIGHTINGALE: Dr. Chamberland?
DR. CHAMBERLAND: Present.
DR. NIGHTINGALE: Dr. Davey?
DR. DAVEY: Yes.
DR. NIGHTINGALE: Dr. Feigal?
DR. FEIGAL: Yes.
DR. NIGHTINGALE: Dr. Gilcher?
DR. GILCHER: Yes.
DR. NIGHTINGALE: Dr. Gomperts?
DR. GOMPERTS: Yes.
DR. NIGHTINGALE: Dr. Goosby?
DR. GOOSBY: Yes.
DR. NIGHTINGALE: Dr. Guerra?
DR. GUERRA: Here.
DR. NIGHTINGALE: I know that Dr. Haas is unable
to make the meeting. We hope all goes well with him and his
family.
Dr. Hoots?
DR. HOOTS: Here.
DR. NIGHTINGALE: Ms. Jones? Ms. Jones?
[No response.]
DR. NIGHTINGALE: Dr. Kuhn?
DR. KUHN: Present.
DR. NIGHTINGALE: Dr. McCurdy?
DR. McCURDY: Here.
DR. NIGHTINGALE: Dr. Moore?
DR. MOORE: Here.
DR. NIGHTINGALE: Ms. O'Connor?
MS. O'CONNOR: Here.
DR. NIGHTINGALE: Dr. Penner?
DR. PENNER: Here.
DR. NIGHTINGALE: Dr. Piliavin?
DR. PILIAVIN: Piliavin.
DR. NIGHTINGALE: Piliavin. I apologize once
again.
Captain Rutherford?
CAPTAIN RUTHERFORD: Here.
DR. NIGHTINGALE: Dr. Schiff?
DR. SCHIFF: Here.
DR. NIGHTINGALE: Dr. Secundy?
DR. SECUNDY: Here.
DR. NIGHTINGALE: Dr. Snyder?
DR. SNYDER: Here.
DR. NIGHTINGALE: Mr. Walsh?
MR. WALSH: Here.
DR. NIGHTINGALE: Thank you. We'd note that Dr.
Busch is present at the meeting. Also present is Dr.
Epstein, the Director of the Office of Blood Research and
Review of FDA. Dr. Epstein?
DR. EPSTEIN: Here.
DR. NIGHTINGALE: Thank you. The agenda for
today's meeting is the Seventh Report of the House Committee
on Government Reform and Oversight titled "Hepatitis C:
Silent Epidemic, Mute Public Health Response." Dr. Caplan,
the Chairman of the Advisory Committee, will preside.
Dr. Caplan?
CHAIRMAN CAPLAN: Well, we have a busy day this
morning. I want to remind the Committee that we've really
been asked by the Surgeon General to take a look at this
Seventh Report of the House Committee on Government Reform
and Oversight from October 15th. We've sent it to the
Committee, I think, at least four times, in my memory of
mails that have come. So I hope that the message was clear
to pay attention to this.
I want to just look at three findings and three
recommendations in brief. You know, when we've met in the
past, we've had to scramble to the slides and the overheads,
concocting language as we drive toward consensus on certain
matters pertaining to blood safety and availabilty. But in
this case, we've got something to respond to by the end of
the day. It doesn't limit us, but there are some things
we're supposed to say something about.
The findings of this report were as follows: The
Federal response to the hepatitis C epidemic has lacked
focus and energy. Secondly, the proposed HCV lookback is
too limited. Third, private organizations with some Federal
assistance have taken the lead in HCV public education
efforts. I can say that if you read the report, that was
said with a critical edge to it, that private organizations
should not be taking the lead on this. And there are a
series of recommendations, and I'm inside the report on page
2 of it, just to remind you again.
The Secretary of HHS should take the lead in
coordinating the Federal public health response to the
hepatitis C epidemic, including implementation of a research
plan. The Department of Defense should test recruits,
active-duty personnel, and those about to be discharged for
hepatitis C infection. The Department of Veterans Affairs
should conduct additional studies of the prevalence of
hepatitis C in veterans' populations. The hepatitis C
lookback plan should be expanded, and the Federal education
campaign for HCV infection should be launched immediately.
What this report wound up concluding, arguing, was
that they were not convinced that the Government was making
the public health response to the hepatitis C epidemic that
was required, and so we've been asked to think about, listen
to testimony today on those matters, and then to reaffirm or
add or come back and change what we've been told by that
particular subcommittee of the House about this particular
problem.
I want to just note something else that caught my
eye. I collected a couple of things since our last meeting.
Some of them, again, Dr. Nightingale, Mac, did a great job
getting materials out to you. Some of you know there were
articles in the New England Journal last week on combination
therapy for hepatitis C. While far from a cure, they were
optimistic. I'm not going to go through those articles or
the editorial ran, but things are moving fast in the area of
intervention for hepatitis C. That means, I think
personally, that the ante is raised about the importance of
lookback. The ante is raised about the importance of public
education campaigns.
I have a friend who has hepatitis C, and he's been
trying very hard to get access to different forms of
therapy, combination therapies. He believes that the right
response for him with his infection is to try and clear the
virus from his body. And I asked him if he felt that this
Government and our country was doing what we should to
respond to hepatitis C epidemic, and he said no, because
every day he meets people who didn't realize that they might
be infected.
That is not a good situation. So it is, I think,
our mandate to the American people to make sure that if this
problem is out there and if there are steps they can take,
either through the cessation of drinking, watching what they
do with ibuprofen, getting themselves vaccinated against
other forms of hepatitis, not sharing razors, or moving
towards some of these emerging interventions, we have to
make sure that people are aware of what they need to be
aware of, that medical and health communities are able to
answer questions and inform them.
So that's how I see our task, as against that
backdrop of saying, well, if there are steps that can be
taken to reduce infection, if there are steps that might be
taken to reduce the burden of the disease, if, as other
statistics show, we've got 4 million people infected and an
explosion in the number of people getting liver transplants
due to this particular virus, we have to make sure we're
doing all that we can do in terms of a response, both public
and private, to hepatitis C.
I'd just mention one last comment, and then we'll
go to the first witness.
This is a statement from the American Association
for the Study of Liver Diseases. They had a meeting in
Chicago and thoughtfully sent me a statement about one of
the things they are bothered about. And they reported at
that meeting about the challenge of hepatitis C, what it was
doing in terms of cost and burden to the American people.
But this statement caught my eye.
The main reason for the drastic increase in severe
hepatitis C-related liver disease--that means leading to
transplant, leading to death--is that 90 percent of people
with chronic hepatitis C don't know they have it.
Well, that's not an acceptable situation. If
that's what the problem is, then we've got to make sure we
are vigilant in pushing to make sure that that number is
much smaller.
So I'll stop there. That's our charge. We want
to be mindful of the fact that by the end of the day we have
to say something about this report and what we want to tell
the Surgeon General and, through indirection, the other
Federal agencies here and even Congress. I suspect we might
even say if we want them to spend some more money, we might
say they should spend some more money. What the heck? It's
not ours. Well, indirectly. It's so far distant.
So we can move now to the first witness, having
reminded you why we're here and what we're trying to do. I
think we're going to hear from CDC first?
DR. NIGHTINGALE: Hear from CDC.
CHAIRMAN CAPLAN: I don't know who we've got from
CDC. Oh, Dr. Alter?
DR. ALTER: Thank you. Good morning. I'm Miriam
Alter from the Hepatitis Branch of the Centers for Disease
Control and Prevention in Atlanta, and you should all have a
hard copy--most of you should have a hard copy of the
presentation. There may be one or two of you who do not
because we may not have brought enough copies. But if
that's the case, I'll be showing the exact same information
on the slides, and we will get you a hard copy if you need
it.
As the first presentation today, we would like to
review the guiding principles which underlie the
recommendations made by this Committee last year.
Identifying transfusion recipients at potential
risk for HCV infection can be accomplished with two
approaches: targeted lookback, which is the direct
notification of prior recipients of donors who later tested
positive for HCV, and how we define positive may, in fact,
be the major crux of all the issues we're dealing with; and
general lookback, which includes public notification through
broad education campaigns about the need to be tested, as
well as education of health care professionals to routinely
ascertain transfusion histories of their patients and test
those with such a history.
Targeted lookback for transfusion recipients at
potential risk for HCV infection has several advantages. It
focuses on a specific group known to be at risk. It reaches
persons unaware they were transfused. And it is perceived
as proactive.
This approach also has several disadvantages.
Many notifications may be based on false positive results
because supplemental or confirmatory testing is not
available on donors who tested repeat reactive for the anti-HCV. This approach will not reach recipients from donors
testing falsely negative unless sensitive tests or donors
who were never tested because they donated before testing
was available. Records might not be available as far back
as 1988, which is the current time frame for the lookback.
Many individuals are untraceable, and based on limited
evaluation, there has been a poor response on the part of
recipients to programs such as this in the past as well as
in other locations.
General lookback or notification for transfusion
recipients at potential risk for HCV infection also has
several advantages. It is not dependent on donor status or
record availability, and it reaches at-risk persons who
would not otherwise be identified--that is, recipients who
receive blood from donors who tested falsely negative on the
less sensitive test or who received blood from potentially
infected donors before testing was available.
The disadvantages of this approach is it might not
reach some individuals who are unaware they were transfused,
it is perceived as not proactive, and there is no
substantial data on its effectiveness.
In order to maximize the advantages and minimize
the disadvantages of notifying transfusion recipients at
potential risk for HCV infections, the Committee made its
current recommendations for identifying these individuals,
which includes a combination of both approaches:
Direct notification of prior recipients of donors
who later tested confirmed positive by multiantigen assays,
which were widely implemented by July 1992. In the guidance
provided by FDA, this is further clarified, and, in fact, it
will include a small number of recipients who received blood
from donors who had repeat reactive antibody tests that were
not confirmed in order to include the entire time period
that encompasses multiantigen testing.
The current recommendation also provides for
general notification of all persons transfused before July
1992.
By using both of these--this slide illustrates the
components of this comprehensive strategy using both
approaches. Now, if we start--actually, Jean, can I borrow
your...
If we start here in 1998, for donors who have
donated previously and come back to be tested--and have come
back to be tested after multiantigen tests were widely
implemented, which is from July 1992 forward, lookback will
be triggered for their recipients if they donated
previously, those previous donations--if they donated
previously, back to 1988 or as far as--or as far back as
records are available.
So keep in mind that if a donor who is--let's say
a donor donated in 1992 and was negative on the first
generation--first-version screening test, this donor then
comes back to donate again in June of 1996 and is now found
to be positive on both the multiantigen screening and
supplemental assays, lookback will be triggered for the
prior donations from that individual. This individual might
have donated not only back in 1992, but perhaps back in 1989
as well.
So that the time period actually refers to when
the donor is tested, not when the recipient was transfused.
So that the targeted lookback refers to prior transfusion
recipients of donors who donated previously and came back to
be tested with a multiantigen assay.
General lookback will encompass all individuals
transfused prior to 1992, which will include recipients of
donors, of repeat donors who tested repeat reactive but
unconfirmed on the first version of the assay. So you'll
notice that, in fact, there is considerable overlap between
the two approaches.
In discussing the public health issues of these
approaches, we are not considering costs or any other
measures of outcome other than the immediate impact of the
notification on the recipient. This slide shows the
estimated number of transfusion recipients for notification
using the time period specified in the recommendation made
by this Committee last year.
We have updated the numbers based on our
understanding of the availability of supplemental or
confirmatory results on a small percentage of donors testing
repeat reactive on the first version assay. Although the
absolute numbers may have changed from previous versions,
the magnitude of the relationship between each category has
not.
Now, let's look at the column labeled single
antigen. Single antigen testing was first introduced in May
of 1990 and spanned about a two-year time frame. The total
number of recipients for notification based on repeat donors
who tested repeat reactive for anti-HCV by the single
antigen assay has been reduced by about 30 percent from the
previous estimate because we have recently been informed
that about 30 percent of these were tested by RIBA, and
those results are available, and about 25 percent of those
are expected to be positive--are estimated to be positive by
RIBA, and that's why--and that reflects this number of those
who have been tested by RIBA and found to be positive as
well as those who have not been tested.
So of the 500,000-plus recipients estimated that
will require notification based on single antigen testing,
about a third will be recipients of true positive donors.
This includes donors who were tested by RIBA and found
positive, plus the estimated number of RIBA positive donors
among those not tested. So a true positive donor for the
purposes of this presentation is defined as someone whose
antibody is a true positive.
The percentage of individuals who receive a false
notification--that is, their donor was not infected with HCV
and their antibody was not a true positive--is about 68
percent, or over 300,000. Now, of all those notified, we
expect, based on survival rates for persons transfused five
to ten years ago, about 10 percent of these individuals will
be alive. We will miss through a targeted lookback about
43,000 individuals because their donors tested falsely
negative on this assay.
Now, if we look at the second version--I'm sorry.
If we look at the second time period, which is after
multiantigen testing was widely implemented, we find that a
little over 300,000 recipients will be triggered for
notification. Of these, because most have RIBA testing
results, 90 percent of the notifications will be based on a
true positive donor and only 10 percent on a false positive.
Again, based on survival rates for individuals
transfused in the past, about 18 percent of these are
expected to be alive, and because the sensitivity of these
tests were greater, only about 10,000 individuals would be
missed through a direct notification.
Based on these calculations, we can summarize the
consequences of performing targeted lookback for all
recipients since screening was implemented in 1990 based on
their anti-HCV screening results, without regard for whether
or not confirmatory testing was done--that is, if
confirmatory testing is done, the notification would be
based on that. If confirmatory testing was not done, then
the notification would be based on the screening test
results.
The estimated target population, which is a
combination of the two groups I showed you on the previous
slide, is about 850,000. An average of 53 percent of these
notifications would be made to recipients at potential risk--that is, their donors were truly anti-HCV positive. This
ranges from a low of 32 percent for recipients of donors
tested by single antigen assays to a high of 90 percent for
recipients of donors tested by multiantigen assays.
Now, as we stated previously, this approach
fulfills the right to know. It provides the opportunity for
the individual to determine their infection status and to
obtain, if they're positive, follow-up or evaluation for
clinical disease and possible treatment, recognizing that
most, or 80 to 90 percent of these individuals, are already
deceased from other causes.
On the other hand, 47 percent of these
notifications will be made to recipients not at risk. Only
10 percent would be falsely notified using multiantigen
assays, but as many as 68 percent would be falsely notified
if we based notification on single antigen testing.
These false notifications would be made to as many
as 400,000 individuals or their families, and certainly the
right to know is an underlying principle of this program.
But this principle also demands that the information
provided have a high level of diagnostic certainty so that
this activity does not generate more harm than good.
Providing false information might be detrimental
and will certainly require additional counseling for
reassurance. Furthermore, an additional 50,000 recipients
at risk would not be notified through this approach because
their donors tested falsely negative.
As I said before, these estimates have been
revised based on the availability of supplemental or
confirmatory testing of a small proportion of version 1.0
donors, information that was not known a year ago.
Keeping with the guiding principles of trying to
notify as many recipients as possible who received blood
from a true positive donor, we can estimate the number of
transfusion recipients for notification based only on donor
testing status without regard specifically for the time
frame in which the donor was tested, not when the recipient
was transfused.
If we look at the number of notified recipients--the number of recipients who will be triggered for lookback
based on donors tested by the single antigen screening assay
with no supplemental or RIBA testing, then we have about
480,000-plus recipients, of whom about 25 percent are
estimated to have received a donation from a donor who later
tested truly positive. Seventy-five percent did not receive
a unit from a donor who was infected. Again, the rest of
the calculations remain the same as previously.
If we base targeted lookback on both single and
multiantigen-tested donors who were also tested by RIBA,
then about 360,000 recipients would be notified directly, of
whom 91 percent received blood from a donor who later tested
truly positive, and only 9 percent would be notified when
they were--would be notified but had received blood from a
donor whose test result was later--was actually a false
positive.
Thus, we believe that by modifying slightly the
original recommendation that this Committee made for
identifying transfusion recipients at risk for HCV infection
will retain the spirit of the original recommendation,
maximize the direct notification of individuals at risk, and
minimize the number of false notifications. This would
include targeted notification based on supplemental testing
results without regard for time period, including all of the
provisions that are currently included in the FDA guidance.
General notification for all persons transfused
before July 1992, and this would accomplish reducing the
false notifications from a potential high of 400,000 to a
low of 32,000, and minimizes the number of recipients missed
due to donors testing falsely negative.
This approach differs very little from the
previous one, except to take advantage of all the
supplemental or confirmatory testing that's available,
thereby minimizing the number of false notifications; so
that recipients transfused from donors who later came back
to be tested and tested positive using either single or
multiantigen screening assays, plus the results of
supplemental assays, would be directly notified. This would
include all recipients of multiantigen-tested donors as well
as about 30 percent--as well as a small proportion of
recipients from donors who came back during first version
testing.
In addition, we again go even further with general
lookback to include all recipients tested before--who
received blood before July of 1992.
Now, in order to encourage individuals with a
history of transfusion to be tested, as well as to ensure
that these individuals receive the right follow-up, our
major focus in terms of education has been the health care
professional because they need to be able to adequately
address the patient's needs. Education of the health care
professional started well before the Committee's
recommendations for lookback for transfusion recipients.
In March of 1996, the NIH issued a consensus
statement on the management of hepatitis C. In November
1997, the CDC, in collaboration with the Hepatitis
Foundation International, broadcast an interactive, live
teleconference by satellite on diagnosis, clinical
management, and prevention of hepatitis C, targeting primary
care physicians, which was broadcast to more than 2,000
downlink sites.
Then in January 1998, Secretary Shalala agreed
with the recommendations of this Committee calling for
lookback--two approaches, targeted and general--to identify
recipients of HCV-infected blood.
In February of 1998, a Hepatitis Summit was
sponsored by the American Digestive Health Foundation and
focused on providing health education messages to minorities
as well as information to health care professionals on
hepatitis C.
In March of 1998, and revised in September of
1998, the FDA issued guidance for industry for both
quarantine of units found to be positive for anti-HCV as
well as notification of blood collection--as well as
notification in order to carry out directed or targeted
lookback.
In April of 1998, the CDC convened a meeting of
representatives from the American Red Cross, America's Blood
Centers, the American Association of Blood Banks, and the
Council of State and Territorial Epidemiologists to discuss
implementation issues for lookback and coordination of
efforts.
The American Association of Blood Banks formed its
Interorganizational Task Force on HCV Lookback to coordinate
efforts nationwide, and the CDC updated its Web site in
order to include current information on this effort as well
as information in general about hepatitis C.
Between June and September 1998, educational
materials and screening guidelines were mailed to more than
250,000 physicians and other health care professionals,
including members of the American Academy of Family
Practitioners, the American Academy of Pediatrics, the
American College of Physicians, the American College of
Obstetricians and Gynecologists, and the American College of
Surgeons.
A similar mailing was made when the
recommendations for prevention and control of HCV infection
and HCV-related chronic disease was published in an MMWR in
October of 1998. These guidelines, a copy of which should
have been--either you received by mail from us or was
provided to you by Steve Nightingale, includes guidelines
for preventing transmission of HCV, identification,
counseling, and testing of persons at risk, including
transfusion recipients, and providing appropriate medical
evaluation and management.
Between October 1998 and January of next year, we
will be distributing education materials to transfusion
services, including a brochure or pamphlet for transfusion
recipients specifically which is entitled "Get Tested for
Hepatitis C," and you have a copy of it that I provided to
you this morning.
These educational materials include letters that
CDC has worked with the AABB Interorganizational Task Force
on that transfusion services can use to notify both patients
and physicians, which explains the risks involved, why
they're being notified, what they can do about it, and where
they can get tested.
Early next year, we will be finalizing the
protocol to evaluate the effectiveness of our lookback
activities, and we'll also be providing software to
transfusion services to assist in targeted lookback.
By March of 1999, CDC's public advertising
campaign will be launched to notify the public about the
need for testing of transfusion recipients for hepatitis C.
We will also have established a Web-based training site for
health care professionals on HCV prevention, including
testing of transfusion recipients. And by the middle of
next year, we hope to begin evaluation of the effectiveness
of these lookback efforts.
As promised, in the January 1998 memo from
Secretary Shalala, we have gone forward in collaboration
with the Agency for Health Care Policy Research and FDA with
the development of a plan to evaluate the effectiveness of
both the targeted and general lookback efforts. The
objectives of this plan are to evaluate the effectiveness of
both approaches for identifying persons infected with HCV,
encouraging persons found positive to obtain appropriate
medical follow-up, and its effectiveness for promoting
healthy lifestyles and behaviors among those found to be
infected, such as decreasing or eliminating alcohol
consumption. In addition, we will collect cost data in
terms of dollars and personnel resources so that we can
evaluate the cost-effectiveness of these programs.
This evaluation plan includes two national
surveys, one of blood collection establishments and the
other of transfusion services, to collect the basic
information about all of the donors who are triggering
lookback as well as the recipients who are eligible for
notification. It will also include follow-up studies of a
sample of transfusion recipients presumed to have been
notified and/or who have obtained HCV testing to determine
the outcome and impact of the notification process on the
transfusion recipient, including those who test negative;
and for the general notification efforts will include a
survey and study of private and public health care services
to determine the extent of HCV testing of persons with
transfusion history.
As a result of this evaluation, we will determine
if our efforts need to be expanded in order to more--to
identify a larger number of transfusion recipients who may
be at risk of HCV infection.
We believe that, with a slight modification, the
recommendations that this Committee made represent good
public health practice and minimize the negative impact on
individuals who are not at risk of acquiring this infection.
We also believe and feel have demonstrated that the
Department of Health and Human Services has actively gone
forward with a variety of programs to achieve this
important--to achieve a successful outcome to this important
public health program.
Thank you.
CHAIRMAN CAPLAN: Thank you, Miriam.
First, let's take some time for questions. I
wanted to lead off with just one question about the public
health campaign that you've undertaken for physicians and
health care professionals, which I've been following very
closely and I think is great.
I noticed an editorial in the British medical
journal, The Lancet, although I've seen these around, too,
and I just wanted to get your opinion about the public
health campaign. Basically what it said is how much money
would be needed to do a thorough public health campaign.
The current CDC budget for HCV is about $10 million. It's
far too little. It's far smaller than the amount to do the
job than the CDC asked Congress for, which you'll recall we
had some discussion here about it being more than a $48
million level. It's only a portion of what the American
Liver Foundation has told us might be necessary for a
campaign.
What I'm asking is, as we get the materials out,
begin the education campaign, are the resources there, in
your opinion, to really push the materials that are being
developed aggressively, adequately, to the health care
community? Can we get the message out given what the
commitment is?
DR. ALTER: I think given--do you want to, Kris--
DR. MOORE: Go ahead, but I have a comment on
that, too. Go ahead.
DR. ALTER: Although Hal Margolis might want to
add to this, I think we have actually very widely
disseminated this information. In terms of the education of
health care professional, I don't know how much more we
could saturate the market with our current materials. What
I think would be important is resources to evaluate whether
or not what we have done is effective and whether or not we
need to do something additional.
DR. MOORE: As someone who works in a state health
department, I think CDC has really done an excellent job in
trying to get information out; but I also think that there's
this conception that if you put out an MMWR article, people
read it, people absorb it, people learn that information.
And having worked with community--
CHAIRMAN CAPLAN: Is that not true?
DR. MOORE: Well, I'm beginning to believe it's
probably not fully true, with work in this area but also in
a number of other areas related to immunizations, and take
pneumococcal vaccination, for example, where we're doing a
number of other kinds of projects, or GBS guidelines. I
mean, there are so many different levels where this has been
demonstrated over and over again.
But I really think there is a very strong need to
have people at the state level that can really help to push
this information. For example, in Minnesota, because we've
been interested in this, we've done four or five provider
conferences. We've met with the Association for
Practitioners in Infection Control several times. We've
sent information to all the hospitals in the state. We've
worked with the blood banks, and we've done a lot of other
steps that I think if you really want providers to change
practice, you have to have somebody at the local level at
them, you know, just kind of putting the messages out over
and over again.
And I would really advocate for resources to CDC
so that they could then put some categorical funding out to
states. I just think without those resources, it just
doesn't happen to the level that we would like to see. And
I know that this is something that's been discussed at CDC,
and the resources just simply haven't been there. I'd
strongly advocate for that.
DR. ALTER: You're absolutely right, Kris, and the
resources that Dr. Caplan referred to were part of the CDC's
overall nationwide campaign--excuse me, nationwide plan for
HCV prevention and control, which includes not only primary
prevention activities but the identification of everyone at
risk, of which, as we all understand, the transfusion
recipients are very important, but as small component of
that. So Kris' comment is well taken and extremely
important.
In terms of some of the broader issues, however,
the resources--we have actually dedicated--I think had
sufficient resources to deal with both the--at least the
educational programs directed at the health care
professional and will have for the public. But we need to
direct some of those efforts at a very local level in order
to get the message across.
DR. EPSTEIN: Miriam, I have a technical
questions. When you looked at EIA 1.0 RIBA tested to
develop the numbers for recipients, were you including
indeterminate results of RIBA 2?
DR. ALTER: For the purposes of these estimates, I
didn't. I assumed an overall rate of positivity of about 25
percent, recognizing that RIBA 2.0 indeterminates might be
included in there. I looked at some of the--Steve
Kleinman's publication, looked at the percentage who were
indeterminate in that group, and I imagine since that was a
relatively--it's only 40,000 or so donors, you know, that
the range of indeterminates probably varies widely. But I
didn't include them because it was a little too difficult to
estimate.
DR. EPSTEIN: But it would drive the numbers up?
DR. ALTER: The number who would get notified,
yes, it would, and it would drive the number of false
notifications up as well. But the magnitude of the
relationships, again, would remain the same, and I think
that that's--in principle, the principle here are the number
of individuals who would be falsely notified, and since we
have an approach to deal with that, the numbers could change
tomorrow of next week, but the magnitude would remain the
same.
DR. PENNER: With respect to the first-generation
hepatitis C antigen testing, that was the 1990 to 1992--the
1990 to '92 assays?
DR. ALTER: That's correct.
DR. PENNER: If I'm reading this correctly, you're
saying that you'll have to notify 54,000 live recipients, to
let about a third of them know that they were truly exposed
to the live virus?
DR. ALTER: No. The number of notifications that
would have to be made is over 500,000.
DR. PENNER: However, 54,000 of those are alive,
you're saying?
DR. ALTER: Expected to be alive, right. But a
lot of them, they won't know that at the time that they send
out the notification.
DR. PENNER: So it's really 54,000 that you're
concerned about who--
DR. ALTER: No, because--I'm sorry.
DR. PENNER: About two-thirds of those which would
be receiving false positive testing.
DR. ALTER: You could look at it that way. On the
other hand, keep in mind their families receive these
notifications as well.
DR. PENNER: And so the agency is saying that you
prefer to make the decisions for them so they don't get
upset by this?
DR. ALTER: No--
DR. PENNER: And those individuals who happen to
have been--really received the live virus would not be
notified in this way.
DR. ALTER: We feel that it's just as important
for people not to receive false notification as it is for
people to receive notifications based on a high level of
certainty. And since these individual--since we're using
two approaches of notification--it isn't that we're not
notifying people. It's that we're using two different
approaches. And everyone who was transfused before July of
1992 will be encouraged to be tested through very aggressive
public education campaigns. The fact that they won't
receive a specific letter of notification will need to be
evaluated to determine whether or not we need to go further
with efforts to get individuals tested.
DR. PENNER: We already heard from an expert that
spoke at this Committee that direct notification by mail
would be much more effective than a general announcement to
the public.
DR. ALTER: If I remember correctly, it was a
marketing individual who spoke and who did an excellent job
at presenting that. And, yes, this--that might be a slight
overstatement of what he said, and you know what? To be
quite honest, I don't think we know what the impact of these
two approaches is going to be. I think in the next
presentation you're going to see some examples of other
notification programs and the responses to them. And I
think that our plans for evaluation will help us answer
that.
DR. PENNER: There's one other issue, though.
Many patients do not know that they've been transfused,
including those who are in prenatal situations or at least
newborns, as well as a number of patients who have undergone
surgical procedures. They're completely unaware that
they've ever received any blood transfusion. What about
those individuals?
DR. ALTER: Well, as I mentioned early on, there
are advantages and disadvantages to each approach, and
neither of them is perfect. And, yes, you can miss some of
the individuals who are not aware that they were transfused.
I think in some studies of HIV it was estimated
it's about 12 percent of those transfused. However--and
some of them, you're right, will be missed.
However, you know, to somewhat alleviate that
number, we will be encouraging--we will be--part of our
messages will be risk factors for transfusion so that people
will be made aware that they could have had a transfusion,
they should find out about it, as well as the same types of
messages to physicians when they're looking at their
patients' histories. Neither of these approaches is
perfect. We feel that the combination of the two maximizes
the advantages of both of them and minimizes the
disadvantages of both of them.
DR. PENNER: The disadvantage is being frightened
by the fact you received the letter and it may not--
DR. ALTER: And you're not at risk.
DR. PENNER: And you're not at risk.
DR. ALTER: That's correct.
DR. PENNER: And despite the fact the British and
the Canadians have already gone through this and have
accepted the fact that the first-generation testing was
worthwhile notifying the individual recipients?
DR. ALTER: You're going to hear some of those
results, I think in Dr. Mied's presentation.
CHAIRMAN CAPLAN: We're going to take two more
comments. We'll do one from Marian, and then I think I have
one pressing question that I was holding in reserve, and
then we've got to get to the FDA testimony, but the themes
will stay here.
DR. SECUNDY: I want to try to bring this down to
the level of the most simplistic. As I heard you--
CHAIRMAN CAPLAN: Hit that mike a little.
DR. SECUNDY: You indicated that at some point in
time--and I guess I need to know what time period would be
involved--that you would look at your results using these
approaches and make a determination of whether or not they
had worked sufficiently or if you were going to need to step
up efforts.
I've got one comment and a question related to
that. It would appear to me, from what I'm understanding,
that with the exception of some minor incremental changes,
we've been at this for two years, and we have looked at
those results, and it seems to be somewhat mixed in terms of
a sense of whether or not any of that has worked.
But the question that I have is: What time frame
are you suggesting for this approach to be used and at what
point will you evaluate and what criteria are you using to
determine whether or not it has worked? And then, finally,
what do you anticipate might be involved in stepping up
efforts?
DR. ALTER: Okay. Everything that's been done in
the last two years has led up to the notification process,
whichever approach is involved, because the education had to
be laid as groundwork before we could aggressively pursue
testing of individuals at risk. That's number one.
As provided for in the current FDA guidance,
transfusion--notification of transfusion services of
recipients who need to be notified must begin by March of
'99. Some of this has begun already, as I imagine you'll
hear from some of the other speakers today.
However, the bulk of the notification will begin
in March of next year, and it is an ongoing process. Given
the hundreds of thousands of people involved, it will take
time to complete notification of everyone. In the same
month, we will begin our public education campaign.
We will need to give both the public education
campaign, as well as the notification process, time to
settle in, time for people to hear the message or receive
the message in the mail and take some action. So I would
think that in terms of evaluation, we wouldn't begin to
really look at it until, let's say, the end of '99. In
other words, we'd have to implement the procedures to look
at it at the time the notification--both the public and
direction notification begins, and then at the end of the
year or the beginning of 2000, we might have sufficient data
to take a preliminary look at it.
DR. SECUNDY: Well, what will you--
DR. ALTER: Okay. What will we be measuring? We
will be specifically measuring the proportion of recipients
identified who are ultimately tested, the proportion of
those tested who are identified as positive, the reasons
persons do not receive notifications, and the reasons
persons, upon being notified, do not get tested. That will
be some of the basic information upon which we will
initially evaluate both approaches.
We will compare them and see if we think one has
had a substantial impact over the other based just on the
differences in the percentage of individuals we can estimate
got tested using both approaches.
CHAIRMAN CAPLAN: Dr. Alter, let me--I said I was
going to take one more question, but you're hitting an area
that's got Dr. AuBuchon and myself ready to ask a question.
I'm going to ask you to be as succinct as possible because
we've got to get over to the FDA testimony. But, quickly,
just two quick questions from me, and then Jim, and then
we'll let you out of there. You've been up there a while.
Do you think it's possible to send out a
notification to these 54,000 people, risking--
DR. ALTER: It's not 54--
CHAIRMAN CAPLAN: --false notification of many
people to find them that won't frighten people? In other
words, is the issue as we look at this gap of the single
antigen testing, can we avoid a panic? Can we avoid undue
distress? Is there a way to reach out to that 'tweener
group as we try to do a lookback without unduly frightening
them, saying you've got a problem, perhaps, but you'd better
come in, or there's a reason for concern? Is the issue
really--
DR. ALTER: Some individuals are going to get
letters like that because there is a certain percentage of
individuals who received blood from donors who came back to
be tested by multiantigen assays where the donor was not
confirmed, and they're included in the guidance issued by
FDA, and that's fine. You know, it does represent a small
percentage, and we have constructed what we think are
reasonable letters to these individuals explaining what this
means.
But you're talking about doing that to 400,000
people or their families, and although I can't predict what
an individual's reactions will be, I can tell you
anecdotally--well, I'd rather not. The Canadians have some
experience with this, but I--
CHAIRMAN CAPLAN: The reason I ask--
DR. ALTER: I don't--you know, it's just our
opinion on whether that letter frightens you or not.
CHAIRMAN CAPLAN: The reason I ask this, in part,
is I'm sitting at an institution that has ties to many
outfits that are proposing to do general population
screening for breast cancer, gene testing for depression,
and they're saying we're going to look at entire ethnic
groups or X, Y, and Z, and they're not hesitating because
the yield will be tiny, much less than what we're talking
about here. They are trying to be careful how they market,
let's say, genetic testing, looking for probability and risk
factors.
So I'm a little--you don't have to answer this.
I'm just watching sort of--
DR. ALTER: But keep in mind that we're not
notifying one group in favor of another.
CHAIRMAN CAPLAN: I understand that.
DR. ALTER: I think that's a very important
principle. We're notifying everyone, but in different ways.
And I don't know that there's really an answer for your
question.
CHAIRMAN CAPLAN: Back-of-the-envelope
calculation, if there's 50,000 people out there in, again,
this 'tweener group who might be benefited by a direct
notification, perhaps might be found as opposed to a general
lookback, general notification, public education campaign,
if we figure that there's $100,000 per head on a liver
transplant and--I don't know--a tenth of them convert to
liver failure and maybe 30 to 40 percent of them could have
been helped by available or emerging therapies, that's a
pretty good chunk of change on the therapy end, forgetting
the education campaign and so on. So if I just do a quick
back-of-the-envelope, I come out with a question that says:
Isn't it cost-effective to find some percentage of those
50,000 if we are now moving toward a position where we could
prevent morbidity and mortality?
DR. ALTER: Dr. Caplan, I appreciate that
perspective. I think, however, that we've been criticized
in the past for even the perception that we might be
considering cost as an issue here. And since cost--if you
want to look at cost-effectiveness, you would also have to
look at the resources required to notify the over 500,000
people or, you know, the almost 500,000 people that would
result in the 50,000 alive getting testing. Okay? Of which
only a small percentage of them would actually get tested.
So it's not that you're identifying 50,000 people who are
alive. Then you have to take into account how many of them
can be found, how many of them will respond to the test--to
the call to be tested, and all of that. And we did not go
into those calculations because we did not feel that that
should be a part of this particular decision.
CHAIRMAN CAPLAN: Jim, you're going to get the
last question.
DR. AuBUCHON: A comment, Mr. Chairman. I just
wanted to take this opportunity to publicly thank the
Centers for Disease Control and Prevention, and particularly
Dr. Alter, for their efforts and for her efforts in making
information available to the blood banking community and
making materials available for us to use in this
notification process.
As a physician in a transfusion service who's
deeply embroiled at the moment in conducting these
notifications, I greatly appreciate having this information
available, Miriam, and I thank you and the CDC for all of
the efforts, because without this information, blood bankers
who are not hepatologists, who are not counselors, who are
not public health experts, would not have the information
that we need to conduct this in the most thorough manner
possible and to have the greatest possible outcome.
Thank you.
DR. ALTER: Thank you, Jim.
CHAIRMAN CAPLAN: Thanks, Dr. Alter.
We're going to watch the time carefully because we
do have--I know that many on the Committee want to ask
questions, and I'm going to ask people to try and keep their
prepared remarks succinct so that they leave time for
questions. Otherwise, Steve will be breaking off various
appendages of mine in unseemly fashion here if we go way off
schedule.
So let's try and keep our prepared formal
presentation as brief as possible because I know the
Committee wants to put questions. Who do we have? Dr.
Mied?
DR. NIGHTINGALE: Yes.
CHAIRMAN CAPLAN: From the FDA.
DR. MIED: Thank you, Dr. Caplan.
I am Paul Mied from the Division of Transfusion
Transmitted Diseases in the Office of Blood in the Center
for Biologics Evaluation and Research, or CBER. I'm going
to summarize the actions taken by FDA to implement HCV
lookback following the statement of a Department position by
Dr. Shalala in January 1998, and I'll focus especially on
the sequence of events that led to the change from the March
guidance to the September guidance:
On September 23, 1998, FDA issued a Revised
Guidance for Industry Document on HCV lookback. The FDA
recommendations contained in this revised guidance document--and I think you'll find this in Tab E--are provided to
enable quarantine and disposition of units from prior
collections from donors with repeatedly reactive screening
tests for anti-HCV. Additionally, FDA recommends that
consignees of certain blood and blood component units
collected since January 1, 1988, which were anti-HCV
negative or untested, be notified when donors subsequently
test repeatedly reactive for anti-HCV in a licensed
multiantigen screening test and reactive in a licensed or
investigational supplemental test. This notification would
enable recipients to be informed that they had been
transfused with units that may have contained HCV so that
they may obtain further medical counseling. This document
was provided on the CBER home page for comment and
implementation on September 23rd and published in the
Federal Register with a notice of availability on October
21st. Additionally, this guidance document was mailed to
all blood establishments on November 20, 1998.
Now, since the comment period never really closes
on guidance documents, comments on the revised guidance will
be evaluated by FDA as they are received and changes made as
warranted.
The September 23rd revised guidance document
replaced the March 20, 1998, Guidance for Industry
supplemental testing and the notification of consignees of
donor test results for anti-HCV, which had undergone major
revision by FDA in response to comments received from the
industry and the public during the 60-day comment period
following its issuance in March.
Now, as a result of these significant changes in
the guidance, FDA made known its intention to reissue
comprehensive guidance on HCV lookback at a public meeting
of the Blood Products Advisory Committee in June 1998, and
these significant changes encompass several major issues.
First of all, due to difficulties surrounding the
availability of the investigational RIBA 3 supplemental
test, the blood banking community requested that the time
frame to complete prospective notification of consignees be
lengthened from within 30 days to within 45 days following
the donor's repeatedly reactive screening test.
Secondly, since the retrospective lookback is
expected to involve an estimated 500,000 components and
difficult lookback situations may be anticipated for some
blood establishments, the blood organizations requested an
extension of the time period to complete the retrospective
lookback from within 18 months to within two years from the
date of the original guidance. The revised guidance states
that consignee notifications should be completed within 18
months of the date of publication of this guidance or by
March 23, 2000, thus providing a full two years from the
date of the original guidance as requested.
The time frame to complete recipient notification
by transfusion services has been clarified. Due to the
large number of notifications which are anticipated,
industry requested that transfusion services be given a year
to carry out notifications of recipients identified in the
retrospective review of records rather than eight weeks, as
provided for prospective notifications.
In the revised guidance, FDA recommends that
prospective notifications be completed within a maximum of
12 weeks and that retrospective notifications be completed
within one year of the date on which the hospital or
transfusion service received notification from the blood
establishment.
The use of an EIA 3.0 test following an
indeterminate RIBA 2 test result is another significant
change.
Now, due to difficulties surrounding the
availability of investigational RIBA 3 kits, the blood
banking community suggested, for RIBA 2 indeterminates, that
the lookback be waived if an EIA 3.0 test is performed and
the result is negative. Data has been obtained to confirm
the validity of this approach, and so the revised guidance
document permits the use of the EIA 3.0 to resolve RIBA 2
indeterminates if the original screen had been performed
with an EIA 2.0.
Now, I'd like to emphasize that the revised
guidance document was ready for CBER clearance when these
changes were completed in July. However, additional
comments and suggestions for changes were received
belatedly. These includes the recommendation that FDA, in
accordance with good guidance practices, incorporate the
previous recommendations on product retrieval from the July
1996 memo to blood establishments. Thus, the revised
guidance document supersedes that memo. This major
revision, which brought the agency's recommendations
regarding the two parts of lookback--product retrieval and
recipient notification--into one comprehensive guidance
document necessitated a major rewrite of the guidance
document in August.
Now, other change which were made following the
June BPAC meeting included the extension of the time frame
for beginning notification of consignees. The March
guidance recommended that notification of consignees
following the retrospective review of records should begin
within six months of publication of the guidance, that is,
by September 20, 1998. The revised guidance states that
blood establishments should begin notification of consignees
as soon as feasible and no later than six months from the
date of issuance of this guidance, that is, the revised
guidance, or by March 23, 1999.
Now, I'll address the need for this extension in
just a moment.
The revised guidance document includes specific
recommendations on labeling of products released from
quarantine for consistency with existing regulations on
product labeling. Flow chart diagrams were also provided to
assist industry in implementing the complex set of
procedures which are specified in the recommendations.
To permit easier, more rapid notification of the
recipient, the blood organizations requested that
establishments be permitted the option of notifying the
patient directly as an alternative to notifying the
patient's physician of record that the patient was
transfused with a unit that potentially contained HCV. The
revised guidance states that when the patient is notified
directly, the physician should be informed concurrently.
Now, in addition, during this time, June through
July, we were quite heavily involved in the process of
drafting a proposed rule on HCV lookback, and the
bureaucratic process of reconciling the proposed rule with
the revised guidance document and getting it cleared through
general counsel was a major accomplishment during this time
period.
The March 20th guidance was withdrawn on September
8th by a notice on the CBER Web site. The revised guidance
was issued on September 23rd, 15 days later. FDA withdrew
the September--excuse me. FDA withdrew the March 20th
guidance so that blood establishments would not be compelled
to implement the previous outdated guidance which
recommended that notification start by September 20, 1998.
And I should point out that the blood industry was aware
that this action did not signal discontinuation of the
lookback initiative.
The reasons we extended the implementation
deadline for consignee notifications to start were, first of
all, that the wholesale changes we had made in the guidance
required time to implement and that such an extension was
necessary to allow time for the physician education to be
completed. The six-month period from the date of issuance
of the revised guidance for blood establishments to begin
notification of consignees was provided to more closely
coincide with the rollout program for physician education,
ensuring that counseling messages would be available for use
in notification of recipients.
Indeed, now that the MMWR recommendations for
prevention and control of HCV infection and HCV-related
chronic disease, which contains guidelines on counseling and
treatment, was issued on October 16, 1998, some of the
larger and independent blood banks are beginning to notify
consignees.
So you can see that the first nine months of this
year has been a period of intense, basically non-stop effort
at FDA in the implementation of HCV lookback, with the
development of the initial guidance document, the revised
guidance document, and rulemaking on HCV lookback. And
FDA's role in HCV lookback implementation is going to
continue.
Here's an outline of FDA's plan with the time
frame for accomplishing each part of that plan.
Now that the revised guidance document has been
published, we will continue to establish policy by guidance
by responding to comments on the revised guidance document
and conducting inspectional surveillance of lookback
activities. We're also going to be assisting other DHHS
components in evaluating the effectiveness of the public
outreach and the targeted lookback programs.
FDA is also committed to establishing requirements
for HCV lookback through the rulemaking process. As I
mentioned, a draft proposed rule is awaiting DHHS and OMB
clearance. FDA will respond to public comments on the
proposed rule, issue a final rule, and conduct oversight of
implementation of HCV lookback procedures by the industry.
Now, with respect to implementation of HCV
lookback by the industry, the time frames for the
retrospective lookback and the revised guidance document
issued on September 23, 1998, are as follows:
Blood establishments should begin notification of
consignees as soon as feasible and within six months from
the date of issuance of the revised guidance, that is, by
March 23, 1999.
Blood establishments should complete all
notifications of consignees within 18 months of the date of
issuance of the revised guidance, that is, by March 23,
2000.
A transfusion service should begin notification of
the recipient when notified by the blood establishment and
should complete all notifications of recipients within one
year following receipt of notification from the blood
establishment, that is, by March 23, 2001, for the last of
the notifications received.
I'm going to shift gears a little bit and share
with you some of the operational experience with HCV
lookback driven by EIA 2.0 and 3.0, that is, what people are
doing now and how effective it's been.
According to AABB, now that the MMWR has been
issued, some of the larger and independent blood banks are
just beginning to notify consignees. The American Red Cross
is preparing to begin notifying consignees. I should point
out that some of the smaller blood banks actually had
started to notify consignees before the MMWR was issued.
Some blood establishments are doing the lookback and the
notifications in stages: first, the RIBA 2 positives, then
RIBA 2 indeterminates, with additional testing as needed.
At the AABB meeting earlier this month, Dr. Mindy
Goldman presented the experience of the Province of Quebec
with HCV lookback. They initiated targeted lookback in
March 1995. Out of 1.75 million donations collected from
March 1990 to March 1997, they identified 561 repeat donors
who were anti-HCV positive. Their prior donations totaled
3,197 components. The information they received from the
consignees on 2,329 of these components was that, for many
of the components, the patient had died or was not
traceable, but that 355 recipients, or 11 percent, were
located and were tested for anti-HCV. Of these, 217, or 61
percent, were positive, and of those, 103, or 47 percent,
learned of their infection for the first time.
Surprisingly, 114, a little more than half,
already had been tested and knew they were positive.
However, in the preceding six months, there had been a lot
of publicity and special education efforts in Canada about
hepatitis C and blood transfusion. So one lesson here is
that public outreach messages do work.
Also, they found more cases than expected. The
yield rate after three and a half years of the lookback
effort was 355, or 11 percent, of the target population that
was tested.
Contrast this with the experience of the blood
center of southeastern Wisconsin as presented at the AABB
meeting by Drs. Becker and McFarland. They initiated
lookback in August 1997 on 304 RIBA 2 positive donations,
which were traceable to 34 repeat donors, with prior
donations made after January 1987 which were not discarded;
319 products from prior collections were identified that
required notification. Information was obtained on 120 of
those components, leading the tracing and notification of 9
recipients, of whom 5, or 56 percent, tested positive. A
comparable percentage to that in the Canadian study.
However, the yield rate of 2.8 percent of tracing
living recipients who were willing to be tested was about
one-fourth of the 11 percent found in the Canadian study.
Now, there currently are evaluations underway to
determine the utility of first-generation EIA lookback,
going back to EIA 1.0 in the targeted lookback effort. The
military and some private sector blood banks have indicated
they are considering doing lookback on EIA 1.0 repeatedly
reactive donors.
Now, there's divided opinion over whether
attempting to locate and recall EIA 1.0 repeatedly reactive
donors is appropriate. Most feel if you have a sample, do a
RIBA to determine whether to notify. I'd like to emphasize
that while there are no outcome data available yet from any
of these efforts.
I'm going to just be summarizing the limited
information that we've been able to obtain so far. You will
see, though, that lookback based on EIA 1.0 is being
approached in a variety of different ways.
The military's experience is that many of their
donors are first-time donors, with no prior donations to go
back and look for, so the number of lookbacks they have to
do is considerably lower compared to the civilian
population. They are doing lookback based on unconfirmed
1.0 repeatedly reactives. They have no supplemental test
results.
Now, the services have been given the option to do
additional testing if they want to, that is, RIBA 2 or RIBA
3 with the Red Cross or EIA 3.0 if they want to, but none of
them have taken that option because they don't have frozen
samples back that far, and it's difficult to call donors
back in for additional testing. Most of their facilities
have begun the retrospective review of records.
The American Red Cross presently intends to do
lookback for EIA 1.0 repeatedly reactives, but only for
those with supplemental test results, investigational RIBA
2. Their projections are that, because of extending the
lookback to first-generation EIA, the number of repeat
donors to do lookback on will increase from 28,000 to
37,000, an increase of about a third; the number of
components will increase from 242,000 to 320,000, an
increase of about a third; and the number of recipients to
be traced and notified will increase from 50,000 to 60,000.
Blood Systems, Inc., of Scottsdale, Arizona, is
doing lookback for all unconfirmed EIA 1.0 repeatedly
reactives. They no longer have stored samples, but they're
searching records and they're sending out letters to
consignees covering 14,000 donations.
The Community Blood Center in Kansas City,
Missouri, has stored samples for their EIA 1.0 repeatedly
reactives, and they are preparing to do consignee
notifications based on EIA 2.0 and RIBA 2 results on those
stored samples. Extending the lookback to first-generation
EIA has nearly doubled the volume of their lookback effort.
If we would attempt to answer the question of what
should be the scope of lookback for HCV, we may be able to
draw on the experience from the Canadian and the Wisconsin
studies I've cited and from previous lookback efforts. One
option that we might discuss would be a lookback effort of
contacting and testing all transfusion recipients.
In the general lookback effort for HIV in the San
Francisco area, the number of persons who could be
recontacted after 6 to 12 months was very low, and only 4.4
percent of the 17,331 persons notified by individual letter
who were transfused during the risk period prior to
screening for HIV actually sought testing.
Now, shortly after anti-HCV kits were licensed in
1990, one blood center initiated a pilot study of general
HCV lookback, a transfusion recipient education program
about hepatitis C. Following the widely publicized, large-scale targeted community education and notification
campaign, a very small proportion, only an estimated 1 to 5
percent, of the transfused population living in the area
were tested, and only 6.2 percent of recipients who actually
sought testing had a positive test result on a supplement
test.
Therefore, based on these two studies, targeted
and general efforts to notify all transfusion recipients
have limitations similar to targeted lookback based on donor
testing.
I think I'll stop there and take any questions you
might have.
CHAIRMAN CAPLAN: Thanks, Dr. Mied.
Let's open the floor up for questions, comments?
MS. O'CONNOR: With the two studies you cited
here, were there any general education efforts that went
along with that?
DR. MIED: I think there certainly was in the Zuck
study, the HCV study. There was a widespread community
education and notification campaign. The first study is Dr.
Busch's study. Maybe he can comment on the scope of the
education that was--
DR. BUSCH: Right. These are two different
formats. The first study involved particularly UCSF, but
also several other regions in the Bay area. The hospitals
searched their transfusion records and sent letters,
individual letters, to all patients who they had information
they had been transfused in the prior risk period. And you
see that only about 5 percent of those letters ended up
triggering recipients to come in and get tested.
The second study did not include specific letters
to recipients. It was exclusively a large general public
education campaign approach with free testing available.
DR. PENNER: No combined?
DR. BUSCH: Right. There was no--to my knowledge,
in the states there's no experience where--I mean, there
was--in addition at the same time San Francisco sent
letters. That was coincident with when CDC put out their
broad recommendation that transfused recipients should be
tested for HIV.
CHAIRMAN CAPLAN: Yes?
DR. GOMPERTS: This is a question for Dr. Mied as
well as Dr. Alter. To what extent has the procedure for
testing been evaluated as a barrier to this overall public
health campaign?
DR. MIED: The procedure for testing?
DR. GOMPERTS: Yes. Where is testing being done?
DR. MIED: Where is testing--testing is being done
by the blood establishments, or oftentimes they will send
samples out and receive back the results.
Are you talking about the donors or the
recipients?
DR. GOMPERTS: I'm talking about recipients.
DR. ALTER: My understanding is that the American
Red Cross and many--I know that the American Red Cross plans
to, in their letter to the recipient, offer testing to them
at whatever each local area sets up as a testing site, free
of charge. That's my understanding. And other blood
centers I think will be varying their approaches, but in the
letter of notification it will tell the recipient where they
can be tested and under, you know, what conditions.
So I don't think that testing, at least for the
targeted recipient, is--is an issue that will be very
clearly stated in their notification letter. In terms of
general notification, these individuals will be told to go
to their regular source of medical care for such testing.
DR. GOMPERTS: Do you see this as a barrier?
DR. ALTER: For people who lack any source of
medical care, it could be. It will be important that our
current programs, such as Medicare and Medicaid, cover this
testing.
DR. GOMPERTS: Can I just ask one additional
question? Any possibility, any thoughts from a point of
view of opening up the HIV testing centers to HCV?
DR. ALTER: In terms of our overall plan for
testing people at high risk for HCV, which would include
transfusion recipients, we have taken a variety of
approaches for testing, including the use of HIV counseling
and testing sites, to provide HCV follow-up as well. I
don't know that those are the best places for people with a
history of transfusion to seek testing. In fact, they might
not--they might be discouraged from seeking testing if that
were the designated place, and one of the areas that we're
working on with state and local health departments is to
establish testing places in which people who fall outside,
you know, high-risk groups for HIV would be comfortable to
be tested, and that's part of the plan that we submitted
last April to the Department.
CHAIRMAN CAPLAN: Dr. AuBuchon?
DR. AuBUCHON: I would just note, without comment
that to my knowledge the last statement from Health Care
Financing Administration was that they had not yet decided
whether or not to require the Medicare carriers to pay for
HCV testing subsequent to notification as part of targeted
lookback.
A question. Can you give us an update on the
status of the licensure, potential licensure of RIBA 3.0?
This supplemental test would correspond to the most
sensitive EIA testing that's available and the one that is
generally used blood-collecting agencies but for which there
is not a corresponding licensed supplemental test.
DR. MIED: I wish I could give you an update.
Unfortunately, I'm not able to do that. We would like to
see the test get licensed. We recognize the benefits of
having it out there, and we hope that licensure can be
accomplished soon.
DR. BUSCH: Paul, just one clarification and then
one issue. The clarification, you reported for Blood
Systems, Incorporated, that they were triggering lookback on
all first-gen repeat reactives, and I know for a fact that
is not correct. Their program is similar to the Red Cross'
proposed program, triggering lookback on first-gen repeat
reactives for which confirmatory data was available and
which were confirmed positive. And that began approximately
a year and a half into screening. So they have confirmatory
data beginning basically when the Chiron (ph) reference lab
opened in July of, I believe, '91.
DR. MIED: I don't know how many samples they do
have prior confirmatory results for. The impression I got
was that it was a very small proportion of the total number
of the 1.0 repeat reactives, and that when they changed
their facility, many of the samples they had that they could
now go back and retest were not stored properly, and they
had to discard them all. So I think you're correct, but
it's probably a small proportion of the total repeat
reactives from 1.0 that they have.
DR. BUSCH: If they have confirmatory, again. So
the only program that's actually proposed to trigger
lookback on repeat reactives in the absence of confirmatory
data is the military program.
The other point is extending the first gen--for
those samples for which one has confirmation on first gen,
extending it to indeterminates I don't think is warranted.
And the numbers that result are dramatically increased. You
nearly double the number of notifications that would be
triggered if you include RIBA 2 indeterminates. And I think
we know, similar to the policies that are currently approved
by FDA, if you have a better confirmatory assay, such as the
third-gen RIBA for second-gen reactives, you're not
requiring notification of indeterminates. And I would think
that same policy could and should apply here. If we have
first-gen repeat reactives and we have second-generation
RIBA, among the second-generation RIBA indeterminates only a
very small fraction would be confirmed positive. I think
that's a group that there's a very, very low probability of
true infection.
DR. MIED: But you're absolutely right, Mike.
Point well taken. There's quite a difference in doing it on
positives versus positives and indeterminates.
CHAIRMAN CAPLAN: Let me try a different line of
questioning to you about speed of lookback and
implementation of policy. Let's see. What are we in?
We're at the end of November. I think the Committee was
hoping at one point that lookback would have started. I
remember a lot of discussion here of not worrying too much
about the pre-'92 group in the hope that we'd be underway.
And I understand, Dr. Mied, that the revisions and reactions
and input from other sources led to the revised rule and
rulemaking as well.
I guess what troubles me a little bit is, as I
look out there and see some lookback campaigns, some are
going to be launched in a different direction, and some are
out there by private companies, which are now able to
directly market things they think might be efficacious, and
you can see a certain kind of education campaign. I've seen
some advertising copy and some ads that have me worried that
the American people will find out that if they're breathing
and have blood they ought to go out and have a hepatitis C
test. I would rather hear that message coming from
government agencies, authoritative sources, physicians,
health care professionals. So that leads me to be nervous
about speed.
The question that I have for you is: Can we be
assured, given that we're in November, that we are going to
start in March, that the timetable will be firm, that we're
not going to see ourselves set back further? I mean, the
context here is not simply one of letting people know about
their risks, about ways to reduce morbidity or harm and
infectivity, but also that as you look on the therapy side,
the ante goes up and messages are going to start to be
coming out from many sources, some of which may--how can I
put this?--have a spin on that message.
So what I'm looking for is some assurance that we
were here once before and we're not looking back yet, and I
know we're getting ready to look back again. I saw the
slide. I understood what the story was. But I'd like to
have some assurance that we won't be sitting here in April
wondering what's up.
DR. MIED: Dr. Caplan, I think that the good news
is that many small blood establishments have begun their
notification process, and no doubt some of them have
completed their notifications. The larger and independent
blood establishments or blood organizations are notifying
consignees now, and I think that our recommendations state
that you don't have to wait until March, that blood
establishments should begin notification of consignees as
soon as feasible, and for many blood establishments, that's
now.
In fact, it has been feasible for them to notify,
and they have done so, but that they complete all
notifications by March 23, 1999, and that's a firm date,
that they begin notifying by that time. So that's a firm
date, and certainly the counseling materials are out there.
CDC has done a wonderful job in getting those out, and now
that they're widely available, you know, I think that that
can proceed and that date is easily accomplishable.
CHAIRMAN CAPLAN: David, I see your--
DR. FEIGAL: I just wanted to comment that I think
as soon as this Committee made its recommendations, even
before Secretary Shalala made her statement, we're aware of
the fact that the blood centers were beginning to identify
the products that needed to be traced. And one of the
things that's difficult to appreciate in terms of the
magnitude of this is the amount of it that's invisible
before the letter goes out.
You saw some of the trees that start with the
millions of units, and then whittle it down to the number of
recipients, and then expand back up to the number of
components. So I think it's that first part that is well
under way.
Some of the comments will adjust some of that, but
I think the industry knew that there were certain people
that were going to be part of the lookback no matter what.
We're arguing about some of the margins. And I think that
process is well under way.
DR. SECUNDY: The congressional report made
comments about the failure--the lack of a monitoring or
enforcement mechanism for FDA relative to the industry and
the lookback. Can you speak to that issue relative to what
you have presented? How are you going to know that it's
being done? What processes exist formally or informally?
DR. MIED: We have inspectional surveillance of
blood establishments. Now that the revised guidance is out
there with its firm dates by which they need to begin
notification and complete notification, our inspectional
surveillance activity of blood establishments will see that
that, in fact, is accomplished.
Once the regulation is out there, then we will
conduct surveillance to see that the regulation is complied
with, not just the guidance. So we have that oversight now
with the guidance by inspections, and we will have it with
the rule when it is published.
DR. GUERRA: A couple of comments. I think, you
know, as we have seen in our own community and in other
communities around at least the State of Texas, the initial
efforts are certainly underway with any number of the blood
centers that have initiated that in their communities and I
think are being very good about trying to be appropriate in
the way they have taken the information to the recipients of
those units where they have identified individuals that have
been positive.
The greater concern for us has been that there is
certainly some lag in reporting to us, at least from a
public health standpoint where we're trying to maintain some
surveillance in the community, and the other is that we are
getting now an increased number of calls from the people
that are worried because they have had some contact with
those that have been found to have received a blood
transfusion from somebody that's hepatitis C positive.
So I think that somehow we have to bring those two
systems together of public health at the local and state
level and the blood center industry.
CHAIRMAN CAPLAN: All right. Thank you, Dr. Mied.
Let's go right into our next presentation. This
is the Interorganizational Task Force on HCV Lookback. It's
the AABB, America's Blood Centers, ARC. I'm not sure who
actually is doing the presentation on this one. All right.
xx DR. TRIULZI: Thank you, Dr. Caplan. Good
morning.
My name is Dr. Darrell Triulzi, and I am an
associate professor of pathology and medicine at the
University of Pittsburgh and medical director of a large
multi-hospital transfusion service in Pittsburgh that
supports the largest liver transplant program in the nation.
Since our transfusion service does account for
two-thirds of all the blood transfused in Pittsburgh, I have
abundant experience in the lookback process for HIV, HTLV,
and CJD, and it is anticipated that our transfusion service
alone will receive a list of more than 3,000 components
implicated in the HCV lookback in its current form.
From this background, as one in the trenches, I'm
speaking to you this morning on behalf of the AABB
Interagency Task Force on HCV Lookback, and I'm thankful to
have the opportunity to speak to you on this important
issue.
Following the recommendation of this Committee to
conduct targeted lookback for recipients of prior components
from donors determined by testing after May of '92 to be HCV
antibody positive, the AABB formed an interagency work force
to coordinate efforts with the health care community. This
task force is comprised of representatives from the American
Association of Blood Banks, America's Blood Centers, the
American Red Cross, and has liaisons with the FDA, CDC, and
HCFA. The task force represents all facets of blood
banking, including blood collection centers and also
hospital transfusion services.
This task force has taken a very active role in
seeing that HCV lookback is effectively implemented and that
state-of-the-art information about HCV is immediately
available not only to blood banks and transfusion services,
but also to physicians and patients.
The Advisory Committee has received updates from
Dr. Jim AuBuchon, who is a member of your Committee, and has
also been provided with a copy of a letter from the AABB to
Representative Shays which discussed some of the task force
activities in detail.
Targeted lookback is a massive endeavor. The time
and effort required by the entire health care community
should not be underestimated. In the Canadian HCV lookback
experience, they reported two hours of physician time and 12
hours of technologist time were necessary to identify the
recipient of each blood component. Three years into the
process in the Canadian experience, they are only one-third
of the way to completion of their HCV notification effort.
There have been several key developments in the
HCV lookback effort in the United States. First, the CDC,
with input from the blood banking and transfusion medicine
community, has developed sample letters for both patients
and physicians and a patient brochure to be used nationwide
in the HCV lookback program. Second, on September 23rd, the
FDA issued a revised comprehensive guidance document. And,
finally, recipients obviously cannot be notified in a
vacuum, and we have worked diligently to provide education
and counseling materials for notifying the physician and the
recipient.
The task force developed a physician script for
use by the notifying physician and also the CDC published an
MMWR on recommendations for prevention and control of
hepatitis C on October 16th. These educational materials
were provided to all AABB members.
HCFA has not yet published guidance for hospitals,
and we remain concerned that the hospital community is not
aware of the significant resources needed to conduct HCV
lookback. Further, HCFA has not acted to ensure
reimbursement for testing of Medicare recipients. A
specific recommendation from this Committee may be helpful
in accomplishing those actions.
Since the publication of the draft FDA guidance
document, blood-collecting agencies have been working
diligently to identify involved donors and work toward
notification of hospitals. We appreciate the FDA's
understanding of the importance of coordinating the patient
notification effort from hospitals and physicians with
public and physician education about the importance of this
effort.
We estimate that the approximately 300,000
components are subject to lookback investigation in the
current form of guidance document. Records for many of
these units have been identified, and consignee letters are
now going out. Now that all the educational pieces have
been provided, including the recent MMWR, we anticipate that
hospital notification of individuals will proceed at a rapid
pace.
We support the concept of recipient notification
and the extension of previous recommendations to include
donations from donors found to be repeat reactive with the
1.0 HCV test who have been subsequently confirmed with RIBA
2.0. New information indicates that there are some blood
banks that do, in fact, have such confirmatory test records,
and this extension will provide useful information to some
individuals.
On the basis of information presented to this
Committee, including the problems associated with false
positive tests, lack of sensitivity, and the Canadian
experience with HCV lookback, we believe that the most
effective way of notifying recipients with repeat reactive
HCV 1.10 and confirmatory test has not been done is the
general notification plan presented by the CDC.
However, if lookback is extended to HCV 1.0, the
Committee should understand it would be impossible to
accomplish the targeted notification of an additional
536,000 individuals within the current time frames and that,
in fact, it would be years.
At the same time, we support the CDC evaluation of
the effectiveness of targeted and general notification and
stand ready to assist in these efforts.
In closing, I would ask that the Committee
consider the following five points to increase the
effectiveness of HCV lookback:
One, that if the Committee elects to recommend HCV
lookback to 1.0, that adequate time be allowed to perform
this task;
That there be licensure of the confirmatory test,
meaning RIBA 3.0, to resolve donor status in regard to
infectivity, so that way we may minimize unnecessary
notification of recipients;
Three, that there be assistance from the Social
Security locator service to find patients so that we may,
indeed, in the shortest time frame possible get notification
to those individuals;
Four, that there be assistance from the state
government, such as Bureau of Vital Statistics, in sharing
information on patient vital status, such as whether they
are alive or dead, so that we don't need to unnecessarily
notify families;
And, five, that there be coverage of testing costs
by HCFA for Medicare and Medicaid patients.
Thank you for the opportunity to speak today. The
Interagency Task Force remains committed to the public
health effort embodied in the HCV targeted lookback and
general education campaigns.
CHAIRMAN CAPLAN: Thank you. That was a paradigm
of succinct presentation.
DR. PENNER: Since there's a reliance on the
Canadian data, as I recall, the Canadians did not use the--or apply ALT elimination of donors prior to their lookback,
and this I think would eliminate a lot of the repeat donors
that would be applying. So I don't know that their data
really is applicable here.
DR. TRIULZI: Okay.
DR. BUSCH: Just to respond to that, it, in fact,
goes the other direction; i.e., that in the States where we
introduced anti-core and ALT, that resulted in deferral of a
large number of infected donors who would have presented and
been found in triggered lookback. So the Canadian program,
in fact, would have a much higher yield because they didn't
defer those doors. They were detected in the context of
first-generation and second-generation screening.
DR. PENNER: What I'm proposing, though, is that
many of those ALT donors that would have been repeat donors
are now excluded, so, therefore, you have a population of
more single donors who are first-time donors.
CAPTAIN RUTHERFORD: Concerning changing the law
to allow us to go to the Social Security Administration, I
know that the DOD has tried unsuccessfully, wants to have
the law changed to allow us to do that. For those of you
who do not know, there is a law written using the Social
Security Administration and the IRS to allow the state
health departments and the District of Columbia and
commonwealths to go to the Social Security Administration.
Well, if your state health department does not sign the MOU,
then you are blocked from going to the Social Security
Administration.
So the law is really written to allow us to do
that, but it neuters us if you do not sign the agreement
from the local health department. So I think it's an
outstanding idea. If we are really sincere on trying to
locate recipients, then this is one way to do it.
CHAIRMAN CAPLAN: We've flagged an issue here that
is near and dear to my heart. Remember the recent debate,
too, that took place when Congress mandated the identifier
number be put forward, and I don't think the American people
understand the public health consequences of not being able
to trace through public records identifier numbers that
face--that challenge people who want to do this kind of
lookback or other similar sorts of public health
interventions. So maybe the Committee will be able to speak
on that in the discussion period later.
I think it's quite possible to protect privacy
without sacrificing public health, but I don't think we've
made a good case about that, and these kinds of things are
obstacles. So I understood what you were asking for about
help in that area.
DR. TRIULZI: Can I just make a comment? That's
especially true, because going back to 1.0, you're talking
about donations between '90 and '92 and may extend back into
the '80s when people have moved two and three times, and
their vital status and their location may be unknown.
DR. AuBUCHON: Dr. Penner's comments about the
inapplicability of the Canadian experience may be true, but
in a different direction related to being able to find
recipients. In the Canadian health care system and also in
Finland, where they have reported a similar experience with
HCV lookback, they have universal health care; they know
where their recipients are; they know where their patients
are; and they provide them free testing and free follow-up
service. So any concerns about insurability would not deter
someone from getting tested. Therefore, the issue of
establishing some system to identify patients over time is
extremely important. Unfortunately, it did not begin 15
years ago in such a way that it would allow us better
probability of finding recipients we're looking for in HCV
targeted lookback.
DR. GILCHER: Darrell, have you considered
recalling the HCV 1.0 donors and retesting them and then
with a 3.0 test? That's what we intend to do, and that
actually will eliminate a lot of the false positives that we
first found.
DR. TRIULZI: Right. Did everybody hear the
question? It was about recalling the donors who were tested
with 1.0.
The blood center that provides us with blood
recalled the donors from the 1992, the 2.0, on. About 20
percent was the response, the ability to recall donors. So
80 percent, you could not get them back. I suspect that
number of 20 percent would be even lower for people who
donated between 1990 and '92.
The other problem is that RIBA 3 is not widely
available to all blood centers in this country, and I think
that's a problem. It's not a licensed test, and there are
availability issues, and that's one of the reasons why we
bring that up to the Committee, that at least having the 3.0
would allow us to resolve as many of these donors as
possible.
DR. GILCHER: My comment is not RIBA 3. My
comment is EIA 3.0.
DR. TRIULZI: That would be widely available. EIA
3.0 could be used to the same intent.
CHAIRMAN CAPLAN: All right. Why don't we push
on? Maybe the thing to do at this point is to take a break.
We can go to the recipient blood group organizations, COTT,
Hemophilia, IDF and so on, after the break. We can also
hear from the American Liver Foundation at that point.
So let's break for 15 minutes and reassemble
pretty promptly at about 10:15.
[Recess.]
CHAIRMAN CAPLAN: We are going to hear next from
representatives of some of the blood recipient
organizations; following them the American Liver Foundation,
Alan Brownstein.
Terry, why don't you launch us?
MR. RICE: Good morning. My name is Terry Rice,
and I'm a member of the Board of Directors at the Committee
of Ten Thousand.
I had a few overheads for us to enjoy today which
would have made my presentation a little longer, but they
ended up in Manhattan somewhere yesterday, and I haven't
gotten them back yet. So I put together a little bit of
what I could recollect my presentation was, and I'll present
it to you today. It'll be shorter, so it's probably better
for everybody.
First, I'd like to thank the Blood Safety and
Availability Committee for inviting us to speak today on the
subject concerning HCV lookback. We are pleased that the
Federal Government and the blood banking industry are
finally taking the initiative and moving to notify those
exposed to hepatitis C through blood transfusions.
The history of HIV and HCV is one of regulatory
failure and industry inaction, an explosive combination that
resulted in the devastating AIDS epidemic in the hemophilia
community, as well as the HCV infection of potentially
hundreds of thousands of American citizens, a history that
is in large part preventable and avoidable. It is from this
perspective that we address the proposed lookback
initiative.
Prior to the availability of early inactivated
factor concentrates and improved donor screening techniques,
virtually all persons with hemophilia were infected with the
hepatitis C virus. While today we may view this as some
historical matter of fact, it still gives me pause to
reflect that this reality emerged within the world's best
medical care delivery system and regulatory structure.
Believe it or not, there was a time when the medical
community and the regulatory structure considered it normal
or acceptable for persons with hemophilia to be infected
with non-A/non-B hepatitis and for the industry to ship
knowingly lot after lot of adulterated product. Simply put,
there may not be another community more devastated by
hepatitis C than the hemophilia community.
Suffice it to say we've experienced the emotional
and physical suffering which accompanies chronic HCV
infection, as well as a sense of abandonment from those
responsible to warn and inform.
Recently, CDC estimates indicate that some 4
million Americans are now infected with HCV, and this number
is growing. HHS has estimated that the yearly total society
cost of hepatitis C approximates $600 million. Since an
estimated one million of these infections are considered a
result of blood and blood product transfusions, it would be
reasonable to rationalize that society is bearing some $150
million in negative externalities from the production
processes of these products. That's not a bad subsidy for
industry. Society seems to have made a substantial down
payment on whatever it may cost to carry out a humane and
ethical lookback initiative.
One might ask why are we here. Why is hepatitis C
lookback important? At the core of a free society is the
right to self-determination. Americans have a right to know
critical medical information that can substantially impact
the quality of life as well as one's longevity. It is
commensurate with an individual's right to informed consent.
Treatment options are available to persons infected with
HCV. Many of these therapies work best if intervention
occurs in the early stages of disease.
Changes in lifestyle, such as eliminating alcohol
intake, can have a positive effect on an infected person's
well-being and disease progression. Americans should be
informed if they are at risk so that they might seek
diagnosis and treatment options. One would hope that we
would try to reach as many people at risk as possible
through the most effective method of communication--direct
notification.
The scope of the current lookback is too limited.
Proponents of this plan want to begin notification with the
introduction of the second-generation HCV antibody test in
1992. This test was not only more sensitive than its
predecessor, but had an increased specificity. It also
coincided with an available confirmatory test to eliminate
more false positives. While supporters advocate saving
these dollars by limiting this lookback, we would be leaving
out a number of Americans who might benefit from this
notification.
We support at the Committee of Ten Thousand
extending the lookback cutoff date to 1990 with the
availability of the first-generation HCV antibody screening
test, as other countries who have already carried out their
HCV lookback initiatives have done. It is estimated that if
we do carry this HCV lookback back to 1990 and the first-generation test, an additional 700,000 persons might be
identifiable as potentially at risk. Although there will be
a number of reductions in that number based on mortality and
perhaps only 10 percent of these individuals still being
alive today, still there may be as many as 50,000 to 70,000
individuals who can benefit from this additional public
health lookback and information for their own personal
health.
Essentially, if the current lookback proceeds with
the 1992 cutoff date, we will limit our availability to
notifying approximately 300,000 of the one million
potentially infected Americans. To coin a phrase, if it's
good enough to screen with, it's good enough to look back
for.
Another troubling exclusion is that users of blood
products which were made from donors who were infected with
HCV have not been included in this lookback. Although I am
troubled by this, I am not surprised. The hemophilia
community is still waiting for an HIV lookback to be carried
out by industry, as we would presume is required by law.
This statute was ignored with respect to blood products
users although it was carried out with respect to whole
blood recipients who had a lookback conducted in the late
'80s.
But in the lookback, users of plasma products,
such as hemophilic factor, we're being expressly exempted.
Decisionmakers have explained that this exemption was based
on good economic cost/benefit considerations. Since all
persons with hemophilia typically have good medical care,
they would already be advised that it's time to be tested,
and there may not be a serious benefit in identifying those
individuals.
I think that from our perspective it just seems
that every time there is a lookback, persons with hemophilia
are excluded. Is it just because we happen to have such a
breadth of infection that we all just assume that we should
be tested? But we think that there is a pattern that's
developing, and we hope that every time there is a lookback
that we're not expressly exempted from that particular
initiative.
Let's not be naive. We feel that industry is--although I'm sure that the leaders in industry want to do
the right, moral, and ethical thing and are probably
committed to notifying as many persons as possible, we have
to realize that in most cases the decisionmaking is led by
legal advice. And that legal advice is going to in most
cases try to restrict the potential exposure and legal
liability that notification processes can create for
organizations.
Therefore, we believe that the leadership for this
entire initiative must rest with and be carried out by the
HHS since we believe that leaving it to industry to take it
upon themselves to conduct this would not be in the best
public interest.
Lastly, I'd like to thank the Committee and the
Secretary for taking the time to address this issue.
Special thanks should be given to Chairman Shays of the
Human Resources Subcommittee for continuing to make this
issue a forefront issue, and I'm sure that there are going
to be many lives not only preserved but enhanced by his
efforts and the efforts of the members of that committee.
Finally, we strongly support the seven
recommendations as published by the Government Reform and
Oversight Committee.
Thank you.
CHAIRMAN CAPLAN: Jan, do you want to go next?
MS. HAMILTON: Good morning. Thank you for
inviting us once again. My name is Jan Hamilton. I'm
Executive Director of the Hemophilia Federation of America.
I'd like to thank the Chairman and Dr. Nightingale and
everyone for allowing us this opportunity.
If Hollywood were having a casting call for a new
superhero to portray the watchman for safety in the blood
industry, they might look no farther than Congressman
Christopher Shays. Congressman Shays has kept his finger on
the pulse of the blood products industry for quite some time
now and usually points out shortcomings of government and
industry in this field with startling clarity and accuracy.
Congressman Shays has once again sounded the
trumpet for concern and, yes, even alarm in the shortcomings
regarding the silent epidemic of hepatitis C infection
posing a threat to the public health in our country.
However, it has seemed to fall on deaf ears in some of our
Federal public health arenas.
The Centers for Disease Control and Prevention
sources tell us that HCV has now spread to an estimated 4
million Americans. Eighty-five percent of those infected
develop chronic liver disease, and about 10 to 20 percent
develop cirrhosis of the liver within about 20 years after
the onset of infection, to say nothing of those who convert
to cancer. Deaths from hepatitis C are amounting to be
8,000 and 10,000 per year in the United States and within a
decade or so should triple, without more effective programs
for prevention and treatment.
In July of 1995, after an almost two-year study,
the Institute of Medicine released a comprehensive report
entitled "HIV and the Blood Supply: An Analysis of Crisis
Decisionmaking." This report doesn't address problems of
hepatitis in our population, but it does address with great
detail and clarity what needed to be done to prevent another
health crisis like the one with which we have become all too
familiar in regards to HIV.
Some of the recommendations that you will find in
this comprehensive report are: establishment by the Public
Health Service of a Blood Safety Council with a Blood Safety
Director, and we know that's been done; a call for other
Federal agencies to understand, support, and respond to
CDC's responsibility to serve as the nation's early-warning
system for threats to the health of the public. Is anyone
listening? The FDA should periodically review important
decisions made when uncertain about the value of key
decision variables. Who is reviewing these HCV decisions?
In response to lookback, the IOM determined that
earlier action on lookback in regards to HIV might have
reduced secondary transmission of HIV. We have to ask if
we're falling into the same trap here.
When issues instructions to regulated entities,
the FDA should specify clearly whether it is demanding
specific compliance with legal requirements or merely
providing advice for careful consideration. The FDA should
tell its advisory committees what it expects from them and
should independently evaluate their agendas and their
performance. The FDA should develop reliable sources of the
information it needs to make decisions about the blood
supply. The FDA should have its own capacity to analyze
this information and predict the effects of regulatory
decisions, and an expert panel should be created to inform
the providers of care and the public about the risks
associated with blood and blood products, about alternatives
to using them, and about treatments that have the support of
the scientific record. And this is all from the IOM report
recommendations.
It is true that only 25 percent of hepatitis C
transmissions occur through the blood supply. However,
attention to these could and would spill over to other areas
of concern, and the educational component can certainly
apply to all.
Additionally, infection in 40 percent of the cases
cannot be attributed to a known risk factor which alerts us
to the fact that there could be another road to transmission
of HCV of which we are unaware. What is it? Where are
these dangers? And why isn't more being done to find these
answers?
Of the some 4 million Americans now infected with
HCV, as previously stated, 85 percent develop chronic liver
diseases and between 10 and 20 percent of those develop
cirrhosis of the liver and up to 10,000 a year will die from
this so-called silent epidemic. Most of those who have been
infected are unaware of their infection. While there is no
vaccine against hepatitis C, there are effectiveness
treatments of which patients should be made aware. Of
course, they must know to be tested for HCV first in order
to avail themselves of treatment.
A look at the time line of discussion and
decisions, or lack thereof, on the part of our government
agencies is frightening at best. In 1996, Congressman
Shays' committee recommended HHS take steps to notify
300,000 or more Americans known to have been infected with
HCV through blood before 1990. To date, this has not been
done. More than two years have passed, and the numbers have
skyrocketed, and now we're told we're up to a million.
On seven occasions between October 31, 1989, and
December 16, 1994, BPAC considered whether patients
receiving HCV-infected units of blood or blood products
should be notified. Even though treatment options were
available, BPAC chose on each occasion not to act.
October 12, 1995, Donna Shalala committed that HCV
lookback notification would be the first issue considered by
this new committee. This issue was reviewed and discussed
two years later, in April and August of 1997. At the August
meeting, the Committee recommended lookback on patients
testing positive on second generation screening, though some
Committee members wanted more.
There was a steady line of Committee and agency
discussion leading to a statement on March 5th by Surgeon
General David Satcher, who announced an HCV lookback and
education plan and stated his intention to reach
"effectively as many people at risk as we can."
March 20, 1998, the FDA responded with publication
of a guidance to industry in the Federal Register
recommending that blood banks identify past donors of blood
who tested positive for HCV on the 1992 second generation
test and notify hospital blood banks and transfusion
services that they should notify either at-risk patients or
their doctors by September 20, 1998, more meetings and more
workshops on plans for education and implementation of
lookback procedures, and then on September 8, 1998, FDA
withdrew the March 20, 1998, guidance for industry and
didn't say anything about another guidance being issued.
The very next day, September 9, 1998, at a hearing
of Congressman Shays' committee, both Acting FDA
Commissioner Michael Friedman and Jay Epstein gave answers
to questions posed by the Congressman regarding the lookback
campaign and at no time indicated that the lookback had been
withdrawn the day before.
Blood collection organizations were notified by
FDA of the impending withdrawal by telephone on August 28,
1998. However, consumer groups were not notified in
advance, and no written notices were sent by the FDA to
blood banking organizations and no written records kept of
these exchanges.
While on September 23, 1998, FDA issued a revised
guidance for industry, current good manufacturing practice
for blood and blood components, the guidance suggests but
does not require that individuals who receive potentially
HCV-infected blood and blood products should be notified by
March 23, 2000.
Of the almost 1.2 million persons who have
received potentially HCV-infected blood or blood products,
only 25 percent would be directly informed with the lookback
program instituted by HHS. Why? Because HHS has decided
the first generation test had a high false positive rate,
even though the sensitivity rate was 84 to 89 percent, while
the second generation test was 92 to 95 percent.
Estimates are that only 22 percent received units
from an individual with a false positive test. This doesn't
seem to be a number significant enough to leave this at-risk
group uninformed.
The CDC has developed a comprehensive, nationally
focused plan for prevention and control of HCV infection
entitled "A Prevention and Control Plan for Hepatitis C
Virus Infection," referred to earlier today. Components
include counseling and testing, professional and public
education, surveillance, epidemiology and laboratory
investigation and evaluation. The plan was submitted to HHS
on April 14, 1998, but was not discussed by HHS's Blood
Safety Committee due to HHS' refusal to commit requested
funds to this CDC program; and since HHS didn't include the
plan in its budget, Congress was never given the opportunity
to review it.
I would like to refer once again to the Institute
of Medicine report, "An Analysis of Crisis Decisionmaking."
This prestigious panel stated that management of a public
health risk requires an evolving process of decisionmaking
under uncertainty. It includes interpretive judgment in the
presence of scientific uncertainty and disagreement about
values. Public health officials must characterize and
estimate the magnitude of the risk which involves
considering both the likelihood that infection might occur
in various circumstances and the costs and benefits
associated with each of the possible uncertain outcomes.
They must also communicate with the public about the risk
and strategies for reducing it.
We at the Hemophilia Federation of America highly
recommend reviewing the pages of the Institute of Medicine
report. Learn from the mistakes of the past. Help us to
protect our citizens from additional risks.
The powers that be need to build energy, obtain
focus, expand the lookback to a more realistic depth, and
increase the educational components several-fold. Take
advantage of all the consumer agencies that wish to be of
assistance in spreading the word. If we join the hands of
government, industry, and consumer advocacy organizations in
providing education and utilize all the resources that are
available, the silence can be removed from this epidemic.
Thank you for listening to our concerns.
CHAIRMAN CAPLAN: Thank you. Let's hold on to
questions until we get all the presentations. Then we'll
come back to the Committee.
Let's see. Don? Don Colburn is up next.
MR. COLBURN: Good morning, everyone. My name is
Don Colburn. I'm a volunteer for the National Hemophilia
Foundation, and I'm pleased to be here before you again.
I wish I was here on a little bit better of a
topic, though, because as I reviewed the material for this
meeting and we looked at our concerns, we have a number of
issues that everyone thinks the hemophilia community is all
wrapped tightly and secure and everything is okay.
We have approximately 25 to 30 percent of people
with hemophilia who are not seen by our hemophilia treatment
centers. They are outside that wrapped system. These folks
may not know--they're usually mild folks with hemophilia or
von Willebrand's disease. If we take a look at those folks
who have been treated with a plasma product or whole blood
product at that point, you're talking about a large number
of people.
There is a real concern we have when we listen to
things that were said this morning. I cannot believe that
it actually takes 14 hours of a tech and a doctor's time to
discover whether or not someone has actually become a
recipient of a transfusion product. I guess my world of
computerization is a little bit better.
There's also some other concerns that we have,
too. I guess the economic concerns I've heard expressed
here, I can understand it, I can agree with. But it strikes
me that it might be a fair task, easier, just to notify
everyone who's received a transfusion and let them be
notified that they need to have a test for hepatitis C.
Now, one of the biggest challenges we have in the
United States is the collection of blood. There are
seminars held constantly on how to increase donors. What a
better way to educate the public and let them know that they
may have been infected and at the same time, when they do
come in for their test, they can be told about the
importance of blood.
We have opportunities here that we don't seize
upon, and when we talk about a disease, one cannot help but
go back to the early 1980s. And I guess all of you are
going to have the opportunity this weekend for probably a
long weekend, and I am certainly not comparing you to this
group, but I would just ask you to draw your own
conclusions. I might ask that you rent "The Band Played On"
and watch the section where the government panel debates
what they should do with HIV. It's kind of scary. We have
read the same type of things for HCV.
Now, the reasons that we were given back then were
a little bit different. Well, we don't know what causes
AIDS. Well, we know what causes hep C. Well, we don't have
any treatment for AIDS. Well, we have treatments for hep C.
You know, there are just some parallels here that
I'll ask you in your wisdom to give stronger consideration
to and not to give consideration to the economic concerns of
those who feel that reaching out and touching past
transfusion recipients is bad to do.
The other thing that I'm concerned about is I
guess I feel very lucky as I approach Thanksgiving because
when I was a youngster, I received a lot of whole blood
transfusions, and based on the statistic I heard this
morning, if you go in a hospital and have a transfusion, you
have a 90 percent chance of being dead in ten years. I feel
very good.
With that, I would just like to encourage the
Committee to go for a more direct approach and insist upon
it, that people be notified, and, you know, let's not worry
about the false negatives. What better gift a person could
have than to be notified you might have a viral disease and
then to receive the information that you don't.
Thank you.
CHAIRMAN CAPLAN: And Miriam O'Day.
MS. O'DAY: Good morning. I'm Miriam O'Day, and
I'm Vice President of the Immune Deficiency Foundation, and
if you'll bear with me, I'll give the overview of the
organization once again.
The primary immunodeficiency diseases are a group
of nearly 80 different disorders that are intrinsic to the
immune system and result in immunodeficiency. Most patients
present clinically with an increased susceptibility to
infection. These infections are marked by unusual severity
and are generally chronic or unremitting, a point especially
relevant to today's discussions since patients with primary
immunodeficiency diseases may suffer severe complications
from liver viral infections such as hepatitis C.
The Immune Deficiency Foundation was founded in
1980 to further education and research into the primary
immunodeficiencies and thereby improve clinical care and
prognosis of these patients. The foundation is comprised of
over 20 chapters and represents nearly 50,000 U.S. patients.
The foundation's medical advisory committee is comprised of
20 leading clinical immunologists who specialize in the care
of patients with primary immunodeficiencies. Their function
is to advise the foundation on its many medical programs and
develop position statements on issues related to the care
and treatment of this disease. It is on behalf of the IDF
medical advisory committee that I'm making today's
statement.
Of the nearly 50,000 U.S. patients who have
primary immunodeficiency diseases, we have estimated from
our survey data that some 20,000 to 30,000 currently receive
IGIV antibody replacement therapy. Since the introduction
of these products, these patients can look forward to a
normal or near-normal life span. However, adverse events
associated with the administration of IGIV have occurred and
have forever changed or ended the lives of some of our
patients.
Most recently, some of our patients have
experienced an outbreak of hepatitis C due to the use of
IGIV. In July 1994, there were 112 reported cases of
hepatitis C, but this was just the first wave within this
community. Because of the lack of surveillance, we do not
yet know how many people were ultimately infected.
This has obviously been a tragedy for the
individual patients, but it's also unfortunate that we have
not learned anything about the management and natural
history of hepatitis C in the vulnerable population. And as
recently as October of 1998, the CDC's MMWR Volume 47
neglected to mention IGIV recipients during the period from
1993 to 1994 as high-risk individuals who should be screened
for HCV, although the MMWR does mention the transmission via
IGIV.
The establishment of a national registry of these
cases would allow for comprehensive surveillance and, thus,
we could learn about the natural history of hepatitis C
within the primary immunodeficiency diseases. Physicians
are currently unable to counsel their patients concerning
the best treatment, relate the disease severity to immune
function, give an estimate of the number of cases who have
needed liver transplantation, or give any results about the
outcome of this procedure and for which patients it proved
the most useful.
A national registry would be the most valuable
scientific resource for physicians who are dealing with the
aftermath of this outbreak and for scientists who want to
learn more about this common disease.
While it is presumed that transmission of
hepatitis C through IGIV is no longer a threat to our
patient population due to additional viral screening and
viral inactivation steps, we should not fail patients who
may be unaware that they have contracted this disease or to
improve the management of those already diagnosed.
In summary, the IDF medical advisory committee
makes the following recommendations:
Number one, the FDA, NIH, or CDC should establish
a sufficient lookback and registry program to determine how
many cases of hepatitis C occurred in the United States in
recipients, both with and without primary immunodeficiency
disease, of intravenous immune globulin during the relevant
years;
Number two, a retrospective notification of
primary immunodeficient patients and physicians should be
conducted to alert these individuals to the possibility of a
past hepatitis C transmission;
And, number three, determine if the type of
primary immunodeficiency disease which the patient has
determines the clinical presentation, clinical course, and
eventual outcome of the hepatitis C infection;
Number four, determine what antiviral drugs have
been efficacious and to what degree they've been useful;
And, finally, number five, determine the degree of
liver disease that developed if liver transplantation was
done and its outcome.
Thank you for the opportunity to make these
comments today.
CHAIRMAN CAPLAN: I'm going to--I know we've got
the American Liver Foundation coming, but why don't we stop
here? Miriam, don't go too far away because I may have
questions for you. Hang up there. Let's open the floor to
some comments. Jim?
DR. AuBUCHON: A clarification, please. Two of
the speakers mentioned that 25 percent of hepatitis C in
this country was attributable to transfusion. Data that I
remember from the CDC would place that proportion more in
the range of 5 percent. Could we get clarification from CDC
on that, please?
DR. ALTER: Of the estimated 3.9 million Americans
who have been infected with HCV, approximately 7 percent
might have acquired their infection from blood transfusion.
CHAIRMAN CAPLAN: Miriam, does that include blood
products, too?
DR. ALTER: Sorry. I don't know.
CHAIRMAN CAPLAN: Dr. Alter, one Miriam, both
Miriams--
[Laughter.]
DR. ALTER: Do you mean in terms of the hemophilia
community?
CHAIRMAN CAPLAN: Yes.
DR. ALTER: That would not--it didn't, but it
would not increase that percentage substantially. Not that
it isn't an important group.
CHAIRMAN CAPLAN: The mike.
DR. ALTER: Sorry. The question is what
percentage of persons with hemophilia are infected with HCV.
Of those who received--of those who were treated prior to
1987, it may be as high as 90 percent. But my question is:
Why haven't all these individuals already been tested?
CHAIRMAN CAPLAN: Okay. Let's go to--
DR. HOOTS: Actually, in at least two large
studies, it's probably, prior to 1987, as high as 98
percent. So it's almost universal infection if you received
a clotting replacement product prior to 1987.
I think a couple of issues that were raised are of
consequence by several of the hemophilia presenters which
has to do with individuals who don't access comprehensive
care. I think part and parcel--and it goes along with what
Ms. O'Day was talking about, primary immune deficiencies.
Clearly, for people who are not accessing the
system, for whatever reason, it's incumbent on us to make
sure we get the message out that they must be tested,
because if they are at risk--and for hemophilia it's pretty
straightforward. If they were alive and bleeding before
1987, they are at extraordinary risk--
CHAIRMAN CAPLAN: Keith, can you just say a word
on this just for my clarification? The people who aren't
accessing the system, they could be mild hemophilia.
DR. HOOTS: Correct.
CHAIRMAN CAPLAN: There could be obstacles by
geographic access to providers.
DR. HOOTS: Yes, or they could be accessing
medical care through primary care because primarily--and the
data is now available, looking at what percentage do access
care, outside of the comprehensive centers, and by and
large, it's people who are mild or moderate, but not
exclusively so. And those people are probably the ones who
are least likely to be aware, perhaps, of their relative
risk, perhaps because of a combined issue of not having been
exposed very often because they're very mild, and also
because their primary care physician may not have that--except in the context of the most recent CDC educational
program, may not have that high on their agenda.
So I think, particularly in regards to what Miriam
O'Day said, we do need to make sure that we keep out front
the context that anyone who is an at-risk group be tested.
I think it's just--from my opinion, it's straightforward.
They should just be tested because the idiosyncracies of
trying to find out when, where, and why they were exposed,
we've got to find out--we just have to assume that they were
exposed and test that group because they're at such very,
very high risk.
DR. PENNER: Keith, 100,000 von Willebrand cases
out there?
DR. HOOTS: I think any patient with von
Willebrand's who was exposed to a replacement product or to
a blood product should be tested. I think that's part of
the education. I absolutely agree.
I think we kind of got at this, but probably not
into this detail, in our previous discussions. One of the
things that we continually want to make the case about is
that if one has been exposed or at risk, particularly
disease processes where there's a likelihood of repeated
exposure, the need for testing probably supervenes any need
for trying to ascertain exactly when or how they were
exposed, and I really think that we should assume that they
were exposed until we prove otherwise.
CHAIRMAN CAPLAN: Dr. Schiff?
DR. SCHIFF: Yes, I think it's important to keep
in mind when we say that only 7 percent of this pool of C
has it on the basis of transfusion, that the transfused
patient who acquired C seems to disproportionately have more
severe disease. There's published data that would support
that they are more likely to evolve to cirrhosis in a given
period of time. Perhaps it's related to the initial viral
load. So they may be relatively sicker than many of these
people who shared a needle when they were a teenager.
CHAIRMAN CAPLAN: Jay?
DR. EPSTEIN: Thank you. I just wanted to clarify
that it is the position of the Public Health Service that
persons who received clotting factor concentrates prior to
1987 should be screened. That has been understood for quite
some time and is part of the current MMWR recommendation.
I also wanted to comment, you know, by way of
trying to keep focused. The debate is not whether persons
at risk should be notified or informed. The debate is what
is the most effective vehicle to do that. And I would just
hark back to Miriam Alter's comments in her presentation
that there is an overlap of the strategies dealing with the
population transfused prior to July 1992, and it's a false
argument to argue that that population is being neglected.
It's simply that the current proposal is to reach that
population through outreach messages as opposed to targeted
notification, and really, that should be the proper focus of
the debate.
CHAIRMAN CAPLAN: John?
DR. PENNER: I don't think we have any data at all
saying what happens when you use the combined effects of
both an outreach and a directed approach. And as you look
at the Wisconsin data, which is about nine years ago, this
was certainly a different context than a national referendum
or at least information speaking to the fact that it's a big
problem out there and it has to be followed up. That
coinciding with a direct letter approach on lookback I think
is going to be very powerful, but we do not have any
examples of that being offered at this point.
CHAIRMAN CAPLAN: I'm not going to be overly
optimistic about general lookback. I have my doubts. But I
do think from my point of view, looking at the data from the
past, it isn't the same situation, in part because of the
emergence of more interventions and more understanding about
control of infectivity. I'm put in mind of the degree to
which people were willing to step forward and talk about
impotency once there was a cure. You didn't hear much about
it before, but when you had a treatment that was useful,
then I think people began to speak more about it. We may
see a different approach to general lookback in the current
context.
So I don't know. It's hard to assess how those
strategies will go, even though we have some data from '90
and '91.
Other questions, other comments? Larry?
MR. ALLEN: Actually, a few comments.
First of all, we're hearing 4 million people,
approximately, in the United States, approximately 100
million globally. Is that correct? Is that about the right
percentage at this point in time?
CHAIRMAN CAPLAN: About.
MR. ALLEN: Okay. First of all, to the members of
the CDC and FDA, as an individual with two members of my
immediate family who will be part of this initial lookback
and probably five or six members of my family, additional
members, who would also need to be tested, I can tell you
firsthand that they would rather get a notification that at
some point turns out to be negative versus not being part of
the process at all. That's just basic kindness that I think
you should afford these people, because whether or not
they're sent into an initial panic or not, the actual final
results are what they are counting on, and they need to be
part of that program. And that's just something that has to
be done.
Part of the reason for this committee is trust,
and we can't arbitrarily decide who should be notified and
who should not. I don't see that as being any one person's
job here. I think anyone who potentially has--could
possibly have this disorder, this disease, should be
notified.
Also, what are we doing--what kind of programs are
we talking about with the other 3 million plus who did not
contract this through a transmission, but who may ultimately
pass this on to someone else? What are we doing to notify
these people and their family members? What kind of
educational program or process are we working on with that?
DR. ALTER: I think actually at your last meeting
you were made aware of the nationwide plan that CDC
developed for not only primary prevention but the
identification of everyone at increased risk or most at risk
for HCV infection in the U.S. And as part of that, this
MMWR that was published on October 16th lays out the
recommendations for the groups at large, not just the
transfusion recipients.
In addition, as part of that plan, we gave a--we
outlined the activities that would be required to identify
individuals in high-risk settings other than the transfusion
setting, which, again, includes a combination of education
of the health care professional and the public as to who's
at risk and who needs to be tested, as well as what activity
or what measures people can take to prevent getting
infected. All of this has been outlined both in a plan that
was given to the Department as well as this comprehensive
MMWR, which will be disseminated in a variety of ways and in
a variety of venues.
It will be important to establish state and local
health department programs to accomplish these activities in
the public sector as well as in the private sector, and
that's what we're working towards.
CHAIRMAN CAPLAN: Before I got to Dana, who I keep
not seeing out of the corner of my eye here, I want to ask
Dr. Alter, while she's up there, and maybe, Hal, if you want
to get in on this, you can. The patient groups that talked
to us said time and again: Don't ignore those of us who
have used blood products, the lookback for blood recipients
is great, but you want to make sure that you don't forget
us, too.
Dr. Hoots has pointed out that anybody basically
using blood or blood products before, say, '89, '88, needs
to be tested, just presume a risk.
And Larry's commenting on the fact that we have
other people at risk for other reasons, and we have to get
to them.
Are you prepared to go back in and work with
Congress on making sure that whatever the budget is to push
this education campaign, physician education campaign, state
coordination is really there? I mean, I feel like I want to
broker a thing here. I think there is some interest in
Congress in making sure that we do this right, but I think
they're looking for the appropriate plan. I think
Congressman Shays and others are eager to think about making
sure we've got the infrastructure.
So where are we on this? Are we going to get this
comprehensively laid out and then budget it appropriately?
MR. MARGOLIS: It's always hard to talk about
who's writing the check when you're a Federal agency.
The issue of the plan--and, again, I think as was
stated early on, the issues around lookback, both general
and targeted, at least from the CDC perspective, are
currently being funded at a level that we think is moving
forward, you know, in terms of the various activities. No,
it has not been a congressional line item, but it's within
the CDC budget as of today.
The issues about the future, which include working
with other patient volunteer organizations and professional
societies, has been that to some degree we have had the
expectations that they would frame their messages to their
constituent groups, and we are very glad to provide either
the technical support, and, if, in fact, there are requests
for resources, we'll try and deal with those. And we would
welcome that they would, you know, help garner the resources
for the larger hepatitis C prevention plan.
We at CDC have put forth budget estimates, and our
greatest concern, as Dr. Moore pointed out, is how to get
resources to the state and local level, which, in fact, is
not happening this fiscal year but we hope will begin to
happen next fiscal year. I mean, that's the vagaries of the
budget process. But, again--and I think you'll hear other
numbers in terms of what those are.
So, again, I think for the various groups that
have patient populations for whom they have access, at least
in the past, they have done much better at crafting those
messages for their own patient populations in terms of
testing and the need to be tested and to get to the
physicians that are caring for those populations.
We are glad to work with them and very much
welcome working with them, and, again, if there become
resource issues, we need to know about that. But I think
that's all I can.
CHAIRMAN CAPLAN: The only reason I'm really
pounding this particular nail is I just look at the budget
for the public health challenge of HIV-AIDS, and then I look
at the budget for the public health challenge of hep C. And
I don't have the number right in my head, but they're
considerably different.
MR. MARGOLIS: Oh, they're very different, and one
of the things--just to bring the Committee up to date, we
have to do some of these within house. Within CDC, we now
have an inter-center group, so the HIV people and the
hepatitis people are meeting and working together to try and
integrate hepatitis C prevention messages, both training,
the counseling message, what is hepatitis C, into current
HIV activities. And that, in fact--the training and that
integration--should go on this year.
But let me say, as others have pointed out, that
we don't know that just by putting this into the HIV testing
and counseling arena that we're going to find the
appropriate HCV-infected individuals. The plan right now,
we think probably by the end of this fiscal year, will be
that there will be several demonstration sites up and
running to look at that, because, again, it's part of this
evolution of the public health process that has to go on.
We've never done--none of us has done this before.
So that's actually happening at CDC right now.
But remember that, again, most of HIV dollars are not all
coming from the Federal Government. A lot come from the
state and local funding, and, in fact, again, that has begun
to happen, at least as hear it from state health
departments, that they're beginning to request HCV dollars
in their budgets, too.
So, again, I think it's all beginning to move.
CHAIRMAN CAPLAN: Dana?
DR. KUHN: I guess it's--it might change a little
bit of the subject here, but it was pressing on my mind.
First of all, I want to thank the consumer groups
for doing a well-presented and processed concerns to this
Committee. One of the questions I had that I heard in this
whole presentation was a concern for legal liability. And
I'm wondering if there is any reason for resistance to a
lookback prior to 1992 for any legal liability reasons. And
I think I heard Terry Rice speak to this, and I'm not sure
if he wants to address it and bring that point up, if there
is any validity to that. And then I may have a follow-up
question I wanted to ask.
MR. RICE: Why I mentioned it is that when it
comes to causational-type things, to actually have a
notification from a manufacturer or blood center that they
indeed are saying you may have received a product that was
tainted with HCV from us, it makes it a much clearer case
for the person to perhaps exercise their legal rights than
if someone just is told.
That is why I think the hemophilia population has
been handled in a generic sense because, if the infection is
so widespread within a community, people can say, "Well,
let's not waste any money identifying them specifically with
a piece of paper. Let's just tell them generically that
they are all infected or likely to be, so go get tested."
That is why industry prefers that modality of communication
as opposed to the specific notification because, once you
have got that piece of paper in your hand, that may increase
your ability to prove your case in a court of law, which is
why I said there may be many people within the blood centers
and even in the fractionation industry who are morally and
ethically good people who would like to do this right, but
it is going to be the lawyers of these organizations that
are going to basically adulterate whatever information there
might be within the legalese that they can do to thwart that
notification from going out.
I mean, I am not a lawyer. So I cannot give legal
advice about that specifically, but I would say that from
the case trials that we have had in our community, we have
experienced the fact that it would be a much easier burden
for the individual if they had the specific letter notifying
them from a specific manufacturer or organization which, of
course, they do not want to give.
DR. KUHN: If this is perhaps a reason for
resistance to look back prior to 1992, do you believe that
if there was a development of, say, a blood products
compensation program, similar to a Vaccine Injury Act, do
you think this could remedy that problem or that concern?
MR. RICE: Well, I think it would greatly diminish
the "legal beagles" of these various organizations and
companies, whereby they already know that it has been put in
the cost structure of the products that they have sold and
that there has been a funding mechanism put aside, that they
would be less likely to be reticent about going through a
formal notification procedure. I think it would go miles to
creating this distortion between what is good public health
and what is a legal liability risk for the manufacturers and
blood centers.
CHAIRPERSON CAPLAN: Jane?
DR. PILIAVIN: These statements about legal
liability, I would like to put a slightly different spin on
this in that we know with the tests that were being used
between 1990 and 1992 that there are both high false
positive and high false negative rates.
This, to me, makes it very reasonable, logical,
and sane for the organizations that were collecting blood at
that time to be resisting, identifying people who received
products, because so many of the people who received those
products will have received products where there were false
positives, false negatives. It completely muddies the issue
of responsibility.
Of course, I think that something should be done
along the lines of taking it out of the hands of the lawyers
because so much money is indeed wasted in that way, but that
is another issue.
I also want to comment on the comment over here
about the 93 percent of people who are infected with HCV who
did not get it through blood donation. I think it is
absolutely criminal that we are worrying so much about the 7
percent, not that they are not of great concern, and so
little apparently about the 93 percent, and I really want to
urge people to put pressure on wherever they can put
pressure for us to become more concerned about education
campaigns and end the provision of free testing and free
treatment for those people who, of course, are, as is always
the case, more likely to be poor and uninsured.
MS. HAMILTON: I had a couple of comments I wanted
to make, and then Dana brought up the legal issue and
brought up a question that is also referred to in the IOM
report.
One of the recommendations is to come up with a
compensatory mechanism for these kinds of issues. The other
two points were there was a discussion about the people who
are seen in the HTCs and those who are not, and I think
sometimes we tend to forget that there is a huge population,
mostly west of the Mississippi, but some east of the
Mississippi, that are just totally geographically removed
from being able to access frequent care at an HTC. And they
are relegated to smaller clinics and even individual
physicians who see them. That is one thing.
Another thing I wanted to say on the point of
notification, I think a lot of it is in the wording. It is
the old thing about my glass if half empty, my glass if half
full. I think if you present it in such a way as: "We are
not saying that you are infected with HCV, but you have
possibly been exposed to it at some point in time.
Therefore, in order to access treatment, if it is necessary,
then perhaps you might want to go get tested." And I think
that can be done a lot in a public information campaign, if
organized well.
CHAIRPERSON CAPLAN: Alan, why don't you move up
here.
Chris, why don't you make your comment. We will
go let the Liver Foundation make their remarks, but quickly.
DR. MOORE: A couple of points I wanted to make
that echo some things that have been said, one is that I
really honestly believe that everybody in this room is very
concerned about making sure that people who have been
exposed get tested, and I very much appreciate the comments
of the consumer groups and the advocacy groups around that
issue.
So the first point is I think we all agree that we
want to be tested, and this echos what Jay had said, but the
point here that I think is the critical point is what is
good public policy. Basing decisions on a test that is
simply not a good test does not make sense to me in terms of
good public health practice and policy.
One of my concerns that was brought up just now by
Jane is the issue of false negative testing. We have talked
about false positives, but the other issue is the concern of
false negatives.
As someone who is very much involved in public
policy, I am concerned that we are going to get a false
sense of security out there if we drop the date back to 1990
that people who were transfused between '90 and '92, but
don't get notified, are going to be more complacent, are
going to be less concerned, and I think it confuses our
message.
As someone also involved in educating both the
public and providers over the last 10 years, good policy
means simple, clear messages, and I think that sticking with
the date of 1992 is very critical to our success. What
becomes the challenge to me is the issue of how do we assure
that those people transfused prior to '92 get the
information that they need to make choices about their
health care. I think that should be the focus of this
decision going back to what both Jay and Miriam have said.
The issue is not that those people should be
tested. It is how we go about doing that, and I think that
our resources would be much better served in the public
health arena if we push our efforts to consumer and provider
education and make sure that that message is out there,
rather than basing decisions on a test that is not a good
test and confuses our public health message.
One of the things I, for example, would advocate
for is having a health educator in every State health
department that can do local networking, that can work with
local provider communities, provider organizations, that
knows who the key players are, who the champions are in
their community. That is how you get those changes made,
and that, I think, is a much more effective strategy that
trying to go back and basing decisions on the first-generation EIA test.
CHAIRPERSON CAPLAN: Let me let Alan Brownstein
come up here from the American Liver Foundation.
* MR. BROWNSTEIN: Thank you very much.
Good morning, Dr. Caplan and members of the committee. I am
Alan Brownstein, president and chief executive office of the
American Liver Foundation. Joining me today is Dr. Adrian
Di Bisceglie. He is the American Liver Foundation's medical
director and chairs our Hepatitis Council. He is also the
professor of Internal Medicine and associate chairman of the
Department of Internal Medicine at Saint Louis University
School of Medicine.
The American Liver Foundation is a national voluntary health
organization dedicated to the prevention, treatment, and
cure of hepatitis and other liver and gallbladder diseases,
and we do this through education and research.
We have 26 chapters nationwide covering about 70 percent of
our population, and we provide information to people beyond
our chapters. In fact, some 200,000 patients and families
receive our information throughout the United States, as do
70,000 physicians, including primary care practitioners and
liver specialists and scientists who also receive
information regularly from us.
The membership of ALF is composed of scientists, clinicians,
patients and family members, and others who are affected by
liver diseases.
Hepatitis C is a disease that goes well beyond the Beltway.
Every month, ALF receives approximately 11- to 12,000 calls
to our hotline requesting information about hepatitis and
other liver diseases. Ninety percent of those phone calls
are about hepatitis, and over 75 percent of those calls are
specifically about hepatitis C. The distribution of calls
that we receive represents that this is truly a significant
threat that affects our entire Nation. We get monthly
printouts by each area code where those calls are coming
from. I know that 24.2 percent of the calls come from
California, for example, and we have printouts that reflect
that every month our calls come from 50 States.
Through our hotline, we know that the public is deeply
interested in learning more about hepatitis C and concerned
about its impact on them. The media has become increasingly
concerned about this issue as well.
Over the past several months, there have been several cover
stories, cover stories in the U.S. News and World Report,
the New Yorker, the Washington Post, and even Penthouse. In
fact, I had a tough time explaining to my wife when I got
the August issue of Penthouse that I was buying it for the
article.
It has also been featured on the news on all the national
networks and highlighted on shows such as "Nightline,"
"20/20," "Oprah Winfrey," "Good Morning America," "Today,"
and "Sallie Jessie Raphael." In fact, for the committee
members, there is a little display that shows the major
national media coverage and how this is reaching across
America.
Through our hepatitis and liver disease hotline, we hear
from people from all walks of life and every State in the
Nation. The face of hepatitis truly mirrors America. It
represents people from all walks of life, and clearly, there
are those populations that require more emphasis, those who
are at higher risk, but it does mirror America.
Every time there is a major story in the media, calls to our
hotline increase. Last June, when ALF mounted a nationwide
advertising campaign to increase the awareness of hepatitis
C, we received a historic high of 19,000 phone calls in one
month.
ALF strongly supports your August 12, 1997, recommendations
that the Department of Health and Human Services initiate a
targeted lookback and a general notification and public
education campaign to alert blood transfusion recipients and
others at high risk of chronic hepatitis C, of their risk
for infection and their need to be tested.
Five months later, Secretary Shalala announced on July 28,
1998--you know what, I am going to skip this portion because
you have heard it all and you know it all.
Basically, to sum up, we are concerned that there has been a
delay in the implementation of this plan, and I know that
you have expressed some of your concerns yourself. We think
we really need to get on with it.
When it was withdrawn and it came back with a 6-month
implementation delay, I think that that was a bit much. We
knew that there had to be some corrections in the notice to
industry, but it is too bad it had to be a 6-month further
delay.
Nonetheless, it is written. Let's get on with it, and I
know you share the urgency that we feel that there is 4
million people who are infected with hepatitis C. You know
the number of deaths that occur each year, and we need to
move on. We believe our message, our major message, is that
Secretary Shalala should make this a top priority of the
Department of Health and Human Services if we are to succeed
in our resolve to fight hepatitis C.
I would like to now introduce Dr. Di Bisceglie, who will
continue our presentation.
* DR. DI BISCEGLIE: Thank you very much.
In addition to being medical director of the American Liver
Foundation, I am a hepatologist and a hepatitis C
researcher.
I think it is very important to echo previous comments to
acknowledge and applaud the efforts made by the FDA to begin
their preparations for the targeted lookback of blood
donation records.
And on behalf of the ALF's Hepatitis Council, I want to
commend the CDC for the tremendous effort they have put in
to the planning and preparation for the general notification
and their broad-based public education campaign,
particularly the "Recommendations for Prevention and Control
of HCV Infection and HCV-Related Chronic Disease."
These initiatives are vital to help people now infected with
hepatitis C to take critical steps to protect their health.
Now there are more treatment options available to these
patients, and the results are steadily improving.
We heard about the recent articles in the New England
Journal demonstrating that about 40 percent of patients are
free of the virus 6 months after stopping treatment,
compared to 15 to 20 percent just a year or two ago.
In addition, the NIH Consensus Conference on hepatitis C has
further recommendations that these patients, once informed
and diagnosed, could put into place, immunization against
hepatitis A and B.
Most significantly, that report also says that the most
important thing patients can do to avoid developing
cirrhosis and permanent liver damage is to stop drinking
alcohol. So, armed with this knowledge of their HCV status,
people can make life-saving decisions.
So the recommendations, then, of the American Liver
Foundation are that this committee consider expanding the
planned targeted lookback, to extend the targeted lookback
to donors testing positive between 1990 and 1992.
While we recognize that these tests produced a high rate of
false positive results, we believe this step is essential to
protect the public health.
I think that if one were to poll the recipients of those
blood donations, they would say uniformly: Give me all the
information you have and let me make the decisions, rather
than let you make the decisions for me because I might be
afraid of what you say.
Here is another important point, I think, that has not come
up. The vast majority of repeat blood donors were probably
screened out of the donor pool between 1990 and 1992 with
that first-generation assay. So, thus, by limiting the
targeted lookback to the post-July 1992 period, we would
only be identifying HCV donors, then, who slipped through
the cracks for this reason.
We believe that the Government has a moral imperative to
notify every individual who has given blood from a donor who
is on record with a positive HCV test during this time
period, and we believe that every effort must be made to
identify as many pre-1992 recipients as possible because
they have the basic right to know about their health status
so that they can make these important life-saving health
decisions.
A second aspect of this would be to explore the feasibility
of extending the targeted lookback to patients receiving
blood prior to 1988. We believe that HHS should study the
feasibility, not necessarily implement, but study the
feasibility of extending this targeted lookback to people
who received blood from HCV-positive donors prior to 1988.
During the AIDS epidemic, our awareness was sharpened of the
potential to transmit deadly diseases through blood products
and transfusions, and transfusions were very widely
performed at that time. Because of the fear of HIV
infection, then this practice began to be curtailed in the
mid to late 1980's.
CDC's recommendations for prevention and control of HCV
infection states that during 1985 to 1990, cases of
transfusion-associated non-A and non-B hepatitis declined by
more than 50 percent. So, by cutting off notification in
1988 at a time when the use of transfusions was already
substantially reduced, this targeted lookback would then
exclude a significant segment of people infected with HCV
through transfusions.
We understand, again, that many blood centers do not keep
records for that length of time, but for those that do,
serious consideration should be given to reaching those
patients for whom records exist.
We questioned the effectiveness of a targeted lookback that
automatically excludes consideration of a block of patients
whose risk of HCV is substantially higher than those being
notified. HHS should explore the existence of pre-1988
transfusion records and estimate the potential numbers of
people infected prior to 1988 who could reasonably be
notified.
The other aspect that we have talked about today goes beyond
these blood transfusion recipients to broad-based general
notification. Of the nearly 4 million people who have
chronic hepatitis C, the CDC estimates that about 300,000
became infected through blood products. Many of these
people will not be able to be identified because the donors
of the blood they received did not return later to donate
blood. Further, many of the patients identified as
receiving blood from HCV-positive donors will not be able to
be located.
The Secretary of HHS supported your recommendation that the
remaining people at risk of HCV from transfusions must be
notified through a broad-based general notification program
that alerts the public to the risk from blood transmissions
and advises individuals who may have been transfused to get
tested. We strongly support this initiative.
So another recommendation, then, would be to launch the
broad-based general notification immediately. This campaign
should not be delayed. The large numbers of people at risk
of hepatitis C through transfusion who will not get notified
directly must be given an early warning of their risk and an
equally early opportunity to get themselves tested.
The success of ALF's public awareness campaigns, which I
referred to previously, amply demonstrates that people will
take notice and respond to these messages.
We understand that CDC has already prepared a plan to
undertake these initiatives. Their Prevention and Control
Plan for HCV Infection contains implementation
recommendations. It is now undergoing the Secretary's
review.
Therefore, we need to implement a general notification
program to complement the existing targeted lookback and to
inform as many of these pre-1992 blood recipients as soon as
possible about the risks of HCV exposure and the importance
of being tested. We urge the Secretary to move swiftly on
this plan and enable implementation to begin.
Let me talk a little bit about an example of an issue that
demonstrates the point about pre-1988 testing as well. This
is to explore special outreach to women transfused during
caesarian section. This issue is a concrete example of a
large high-risk group that would be excluded from the
targeted lookback's cutoff date of 1988; that is, women
undergoing caesarian section during the 1970's and '80s.
This is one of the most common abdominal operations done in
the United States, conducted in approximately 20 percent of
births each year.
During that previous era, as many as 20 percent of women
undergoing caesarian section were transfused, and they may
well have been unaware of receiving transfusions because of
sedation or general anesthesia. HHS could use this group as
a model, then, to explore how best to identify and notify
these women of their risk of hepatitis C, perhaps through
their obstetricians.
Let's talk about a comprehensive nationwide public health
hepatitis C education campaign because that has been raised.
Your recommendation of August 1997 also called for such a
campaign regarding the risk of hepatitis C beyond
transfusion recipients.
Secretary Shalala and Surgeon General Satcher both made
commitments to the American people to follow through on this
recommendation as well. On January 28th, when announcing
the adoption of the Advisory Committee's recommendations,
Secretary Shalala stated, "...these steps are only the first
phase of a comprehensive plan to address this significant
public health problem. It is my intention to reach
effectively as many people at risk as we can."
The Surgeon General reiterated the Secretary's pledge at the
House Committee on Government Reform and Oversight hearings
on March 5 when he announced that CDC would develop
educational programs to support recognition, diagnosis,
counseling and testing of those at risk for hepatitis C. He
said, "I want to underscore these words. Everyone we
believe to be at risk of having hepatitis C will be targeted
by the Department's plan."
This is a clear commitment to launch the comprehensive
nationwide public health campaign that your committee
envisioned in its recommendations to reach out not only to
those people infected through blood products, but also those
who contracted HCV in other ways such as injection drug use.
Our recommendations in this area, then, are to include
outreach to all groups at high risk of HCV. This
comprehensive public health campaign must include targeted
outreach to groups who are known to include a high
proportion of people at risk of HCV, such as low-income
groups, injection drug users, veterans, prisoners, as well
as others known to have higher rates of infection than the
general population, such as African Americans and Hispanics
among the ethnic minorities.
Launch the nationwide public health hepatitis C education
campaign immediately. The vast number of people estimated
to have chronic hepatitis C must be promptly given an
opportunity to assess their risk and take action. It is
imperative that we begin promptly.
People who are chronically infected with hepatitis C have a
right to be informed that their health has been placed at
risk. Some have urged delay in the past because treatments
are not widely effective, because the information would
cause uninfected people needless anxiety or because the
money was not available to provide testing and treatment.
I believe this rationale does not carry great weight when
the person who may have a deadly disease that could be
monitored and possibly controlled is a family member, a
mother, a spouse, a child, or one's self.
AFL believes this rationale must not be used to obstruct our
imperative to give people the right to know. Those with
chronic hepatitis C must be informed so that they can take
steps to reduce its impact by putting themselves under the
care of a qualified knowledgeable physician, avoiding
alcohol, immunizing themselves against hepatitis A and B,
and exploring whether available treatments could benefit
them or not.
How, then, can we deny this right to the estimated 4 million
Americans infected with hepatitis C? The CDC's plan, "A
Prevention and Control Plan for Hepatitis C Virus
Infection," also contains steps to implement this
comprehensive nationwide public health campaign and would go
a long way toward making this happen.
Thank you very much, and Mr. Brownstein will conclude the
ALF's remarks.
MR. BROWNSTEIN: Thank you.
In conclusion, we believe that what we need to see is a
private and public sector cooperation model. The American
Liver Foundation over the last 3 years has spent $5.8
million to promote an increased awareness about hepatitis C.
We want to stress that given the order of magnitude of
hepatitis C, we need more Federal support, and to implement
the recommendations that have been presented by Dr. De
Bisceglie, it cannot be done without that increased support.
We must face the fact that if the cupboard is bare, there is
little for us to do. We must have the resources there to
accomplish these tasks. CDC estimates the costs of
hepatitis C in medical expenses and work loss at $600
million or more. If intervention is not done, those
currently chronically infected with hepatitis C, those
deaths will triple over the next 10 to 20 years, as you have
already heard. So will the associated costs. So will the
demand for liver transplantation, and we already know that
liver transplants, there is a scarce reservoir of livers
that are available. And a thousand people are dying every
year waiting for livers. So we cannot afford to triple the
demand for liver transplants.
In other words, the costs of indifference to this epidemic
is far greater than the cost of mounting this campaign. We
must avoid repeating the mistakes made during the AIDS
epidemic, but instead to learn from them and to learn what
the investments in a disease can accomplish. Much has been
accomplished during the AIDS epidemic.
We need the same strategies and resources targeted to
hepatitis C that have successfully reduced AIDS deaths
almost in half over the last few years.
We need support to provide assistance for testing and
treatment. We need to assist those in identified high-risk
groups to get tested without regard to their ability to pay.
We also must do more to assist those who are eligible for
treatment, but do not have the adequate health insurance.
We also believe we need to allocate at least $73 million to
the general notification and comprehensive nationwide public
health campaign. We need that at a minimum, $73 million is
needed for an aggressive campaign, including the following
educational and outreach activities.
First, we need a nationwide public health education campaign
that includes advertising, and we recommend $10 million be
spent for that to educate all Americans about hepatitis with
special emphasis on reaching those in the populations at
greatest risk.
An additional $1 million is needed for primary care, for the
education of primary care physicians, and this is absolutely
essential for more effective ways to educate these
physicians.
With all the phone calls we received on our hotline, many of
those calls have become repeat calls because these are
people who have gone to their primary care physicians and
their primary care physicians say there is no problem or
don't worry, you have hepatitis C, but you will die of
something else in 10 or 20 or 30 years, or that there is on
need to be tested when people clearly have some of the risk
factors that are associated with hepatitis C. So, clearly,
more education is needed there.
We need to subsidize hepatitis C testing for those who are
at greatest risk. We estimate $20 million to help support
the cost of testing. We believe that it is important to
have an information referral and counseling support, and, by
the way, this and the testing support, in large measure, we
see going to the various State and local health departments
as being an essential way of getting this message out at the
local grass roots level. So we are estimating $30 million
for that.
We believe that we need to evaluate the various strategies
that are implemented, and that certain models need to be
tested. So the cost of setting up demonstration projects
and evaluating their effectiveness, we put at $10 million.
An additional $2 million is needed over and above the
current CDC level for conducting ongoing surveillance so
that we can sharpen our focus on hepatitis C more
effectively. So that totals $73 million, and as I said
before, additional funds are also needed to provide for
treatment subsidies.
Mr. Chairman, unfortunately, there is only 5- or $6 million
at CDC that could be devoted to these purposes, and we
understand that the FY 2000 budget now under preparation at
OMB, there has not been a request for increased funding to
OMB for this purpose. CDC needs increased funding.
Our next request is that there needs to be support of a
major campaign for hepatitis C research. The American Liver
Foundation has developed a 7-year, $404-million plan for
hepatitis C research that is crafted line by line based on
the recommendations from the 1997 Hepatitis C Consensus
Conference.
We took some of the best scientists to give us guidance as
to what strategies need to be followed for each of the
recommendations, and then based on those strategies, how
much it would cost. Those are the building blocks of a
$404-million, 7-year plan.
In summary, we are all encouraged by improved treatment
outcomes for hepatitis C patients. Now is the time for real
action. We call on the Department of Health and Human
Services to back up these commitments with a significant
allocation of Federal funds. We understand that the
Secretary of HHS has many priorities. However, hepatitis C
needs to be at the top of the list if we are to succeed, not
number four, not number five. It has to be at the top of
this list. With the Secretary's leadership, we are sure
that Congress will respond with the resources so badly
needed.
Now that I have concluded my statements, I have some
statements that I have received from others that I would
like to share with you, and also part of our presentation,
we have a couple of other presenters that would like to
share their views with you as well.
First of all, because of the compelling nature of this
crisis, the American Liver Foundation has joined forces with
the American Digestive Health Foundation, representing the
consumer and medical perspectives of the major
gastroenterological societies in America, combined with the
American Liver Foundation. Together, we have formed a
National Hepatitis Advisory Panel.
One of the members of the panel, Dr. Tony Rodriguez, who is
a board member of the Gay and Lesbian Medical Association,
asked me to share some of his comments with you today.
He talks of the next epidemic, and he says, "As a gay
physician and a physician who treats all types of families
in a suburban family practice setting, I have a special
insight into the worlds of hepatitis. I am constantly
ordering and administering vaccines for my pediatric and
other special risk group patients, and as a member of the
board of directors of the Gay and Lesbian Medical
Association, I want to stress to the recipients of this
letter that this is a disease of all communities, not just
gay and lesbian or the HIV or the men-who-have-sex-with-men
communities. However, because of the insurance guidelines,
it has specific consequences on the lesbian/gay
communities," and he speaks of hepatitis C as the next
epidemic.
"As a gay physician who treats HIV patients, most of our HIV
deaths are preventable opportunistic diseases, and many of
the HIV wards are now filling with hepatitis C patients.
This is a devastating disease. Estimates are that there are
approximately 4 million Americans with hepatitis C." He
concludes, "Hepatitis education and outreach is essential if
we are to prevent the next epidemic."
CHAIRPERSON CAPLAN: Alan, I want to leave you some time for
questions, so maybe one more?
MR. BROWNSTEIN: Okay. We have two guests who have come
with us.
The next is a statement that I received as this committee
was meeting from former Surgeon General, Dr. C. Everett
Koop. Dr. Koop writes to this committee on the imperatives
associated with hepatitis C epidemic, "As the Advisory
Committee on Blood Safety and Availability convenes to
consider the report of the House committee"--you know what
I'm going to do, I am going to skip to the specific
recommendations in his letter, and then I will have it
duplicated.
"Therefore, the imperatives associated with the necessary
public health response to hepatitis C are clear. One, we
must act expeditiously capitalizing on opportunities to
reach the 300,000 Americans we know were infected with
hepatitis C through blood transfusions prior to 1992. In
this regard, it is critical that HHS implement immediately
its targeted lookback to reach persons infected with HCV
through blood transfusions prior to 1992. As it exists, it
will reach only a small portion of these individuals.
Equally critical is that the boundaries of this notification
plan be expanded to include all individuals in this
category, including, for example, pregnant women who prior
to the implementation of improved viral screening and
activation methods in the mid-1980's received units of blood
in conjunction with C-section procedures. Two, we must
share information and provide the medical community and the
public with information they require to make informed
decisions about hepatitis C, and we need this broad-based
HCV education campaign. Three, we must allocate funds equal
to the actual health needs associated with HCV. Government
funding and support of our HCV health policy initiatives are
woefully inadequate and supports increased Government
funding. And last, we must fund aggressive research
initiatives that hold the promise of eradicating HCV.
Increasing funding is needed to support research and to
improve diagnosis, treatment, and ultimately a cure for
hepatitis C." That is from Dr. Koop, and I will share the
full statement for your committee.
Lastly, we have two very important people who have joined
us. One of them is also from our Hepatitis Advisory Panel.
Is Millicent Gorham still here? I guess she had to leave.
Her statement will be shared with you.
We also have Phyllis Greenberger from the Society for the
Advancement of Women's Health Research.
Phyllis?
With that, I will not step up again. So that concludes our
comments.
MS. GREENBERGER: Good morning, and thank you for the
opportunity to make some statements today. A little bit of
what I said has already been covered, but I want to
reemphasize some of the points.
Again, I am Phyllis Greenberger, the executive director of
the Society for the Advancement of Women's Health Research,
an organization to improving women's health through
research. We work closely with public agencies, private
industry, and the academic community for women's health
research gender.
I am here today to voice our concern, which was just briefly
mentioned in passing, I think, for the thousands of women
who may be unaware that in giving birth through a caesarian
section, they also may have been given hepatitis C.
Approximately 1 million babies are born each year via
caesarian sections, and while most of us, including mothers
who have had caesarian sections, think of it as a form of
childbirth, it is actually the most common surgical
procedure performed in this country.
During the 1970's and early '80s, as many as 20 percent of
the women who had caesarian sections were given whole blood
transfusions either through the procedure or afterwards to
replace blood loss or to speed their recovery, and by the
mid-1980's, after blood use had decreased significantly,
approximately 5 percent of C-section patients required
transfusion.
A 1992 study at the University of Southern California found
that 6.8 percent of women were receiving transfusions during
C-sections.
A 1993 study published in the Journal of Reproductive
Medicine indicates that only 25 percent of women who
received blood during a C-section realized that they had
been transfused, and there are a number of explanations for
this phenomenon.
The first is that most people do not think of C-section as a
surgical procedure and are therefore less likely to connect
it with the possibility of blood transfusion, unlike
elective surgery or emergency surgery after an accident.
Additionally, women are at risk for another reason. The
symptoms of hepatitis C are for many people no different
from those of a common cold, and being tired is a "common
complaint," quote/unquote, for the millions of women who
juggle responsibilities for home, family, and job. Women
are still too often told that they should just get more rest
or it is all in their head. Unfortunately, it may be in
their liver and in their blood.
It is believed that the transmission of hepatitis C through
transfusion related to caesarian section was relatively
high. That is true because infective populations were
fairly large during the mid-1980's with as many as 3 percent
of the population infected, and because an NIH study in the
mid-1980's found that between 7 and 10 percent of patients
who received a transfusion developed HCV after surgery.
That is as many as 250,000 women may have contracted the
virus in this way, and most of those infected between the
late '60s and early '80s would just now be developing
serious liver disease.
Mr. Chairman, our concerns at the Society are twofold.
First, we believe that hepatitis C should be treated by the
Centers for Disease Control and Prevention as are other
infectious diseases. We know that public awareness can be
the impetus for professional research.
The CDC should be monitoring and reporting on hepatitis C so
that health professionals and the general public, and I
would add targeted to obstetricians and gynecologists as
well, become aware of the scope of this silent epidemic.
Second, the Federal Government's lookback and public
education campaign should be rapidly expanded. As the New
England Journal of Medicine reported last week, there is now
a treatment for hepatitis C, and women who are on the brink
of developing this life-threatening disease should know that
they have options, and diagnosis is the first step.
Thank you very much, Mr. Chairman and members of the
committee, for the opportunity to make this statement.
CHAIRPERSON CAPLAN: Thank you.
In the interest of time, I am going to thank the presenters
for their comments, and they remind us again and again of
the real human cost and consequences of this particular
epidemic. The Chair and the committee, I know, are very
grateful to all of those who presented testimony.
What I am going to do in the interest of our schedule is
steer the committee with the following marching orders.
I would like to just spend a minute going over some
recommendations that come out of the morning that I think we
may want to consider that I have been jotting down. You may
have others. I just want to sort of list some of those for
you.
Then what I think we will do is we are going to eat lunch
right here, maybe take 20 minutes for that, and then pick up
again. Some of you may have to check out and so forth, but
we will really try to make it into a working lunch and go
right until 3:00. That way, you will be able to get out of
here on time.
Remember, our overall charge, just to remind you, is to
advise the Secretary on what I will start to refer to now as
the Shays report, or Report No. 7. Those recommendations
are in there. We are going to have to say something about
them. So that is a top priority for us, something that I
want you to look at, at this break coming up, the things I
read to you, both findings and recommendations. Take a
look. We are going to vote or say something up/down on that
set of recommendations that the committee gave us.
Secondly, I want to suggest something. I do not know if you
will buy this, but I think it is important that we try to
think this way.
One of the issues that we are spending a lot of time on is
extending the lookback, and I am happy to spend some more
time on extending the lookback, but I would urge us to think
very hard about separating the issue of extending the
lookback from the current commitment to do the '92 lookback
on a schedule done by March and separate the two questions.
In other words, we can have a discussion about extending the
lookback and what we want to do with that separate from the
current commitment that we heard today to get this thing
done, the '92 lookback up to '92, by March, whatever it is,
20, 1999.
I personally would be very loathe to see any delay, any
rewriting, any regulatory change hinder where we are at with
respect to a lookback now. So I would urge us to be
thinking, if we are going to get into a discussion about
expanding or changing, to add other groups. This does not
have to connect to where we are at. It can be done in
tandem or in parallel, and I think it would not be wise to
back away at this point from where we are with a promise to
do the directed lookback by next March.
I am very loathe to open up that can of worms again and see
a setback further from where we are at, even though, as I
said, I am perfectly willing to entertain and talk about
what might be added, supplemented, or put on in addition.
The one should not interfere, if you will, with the others.
So I would like you to be thinking about that. Maybe if we
could even get consensus before lunch, that we will split
those issues in the way I am talking about. Otherwise, I
think the cost could be pretty enormous if we then add
something on, get into a rewrite of what is expected, and
how that all moves. I am very worried that we might be
going down a road that would not be in the interest of the
American people on this matter.
In fact, let me stop there and see if we can just talk about
that for one second. Can we agree that we would split those
issues in that way as a way to talk about this?
David?
DR. FEIGAL: Since so many of the cost figures were cited, I
also wanted to add for the committee's background what the
estimates by the economists who looked at the lookback, what
the lookback would cost the blood and transfusion centers.
That was that the current lookback would cost $100 million
to do.
I think, as you think about expanding it, aside from cost,
the other factor which you have raised up is the issue of
time. It is hard to do things in parallel when the same
people who have to do the first task have to do the second
task.
So the issues of the amount of time, the yield of some of
these efforts, this is a cost that is not an appropriated
cost. It is essentially a tax that is being passed on to
the blood users. I guess we will all pay it as we consume
medical products, but I was struck by the comment that the
Canadians are only a third of the way through it, 3 years.
I guess they will be finished with their lookback in 9
years.
CHAIRPERSON CAPLAN: Marian?
DR. SECUNDY: I want to support your recommendation, and
this may be delayed for our discussion later, but I really
want to hear a breakdown of that cost because my assumption
is that the cost, as specified, is based upon several
assumptions and procedures that I want to question later. I
would like to be able to have you at some point maybe help
me to understand those costs, but I do recommend and support
what you were recommending in terms of a separation, not
giving up on the extension.
CHAIRPERSON CAPLAN: Is everybody in agreement with that?
Mike?
DR. BUSCH: I just have two concerns. One is, in principle,
I agree completely, but I think there are potential
ramifications of a further lookback that could impact the
current policies.
For example, if there was any consideration about going
prior to 1988, this would mean revisiting all of the records
that we have already gone through or are going through for
the current donation. So that is something that would need
to be understood now, or the work would be substantially
increased to repeat it again later.
Also, as we have heard, most of the blood programs have
already gone beyond the current recommended lookback if
confirmatory test data exists for the earlier period, and if
there are issues around how those notifications would
proceed differently from the current procedures recommended
by FDA, we need to understand those; for example, the
indeterminate group in that group. If we are already
proceeding with that activity, we need to have clear
guidance now, I think, from the FDA as to whether certain of
the subtle issues that play out from that.
CHAIRPERSON CAPLAN: It seems to me it may take a little
judicious phrasing, but what we are probably headed toward
is a recommendation that we go full speed on what has been
committed to, and then some sort of recommendation may come
out of us that wants to extend the lookback to identifiable
donors with tracing, under some circumstances, maybe with a
slightly different deadline.
As the Secretary and other policy-makers will have to
wrestle with it, they will have to figure out, if you will,
how to make that efficient in terms of implementation and
what the blood industry itself is trying to do as it
understands this, but if we can get that launched today, we
will heads-up the industry, so to speak, that X and Y may
have different dates and they can try to sort it from there.
Again, it seems to me I see a lot of nodding around the
table that it is possible for us to separate these issues.
I do not think I need a vote on that. I see that there is a
lot of consensus emerging around that. So I think that is
good. I think that will get us head on to the extension of
the lookback issue, without having to worry about
compromising current commitments, and that is probably the
way to address that issue.
I will just tell you what some of the other issues are that
I identified. Then we will break. I may have Steve and Mac
try to write some of these down on an overhead.
One is, first and foremost, to look at the Shays report
recommendations. We will look at those, and that will
trigger a discussion, but we should say something
specifically about what they recommended back to the
Secretary because that is what we have been asked to do
today.
Some items I heard, more budget for CDC and State and local
efforts and encouraging that we take advantage more of State
and local health department resources to handle hepatitis C.
A second one, resources for prompt evaluation of these
lookback efforts, be they generally directed that those be
there and that we keep tabs on what is going on, so we can
back away of something is not cost effective or not working
right.
The addition, if you will, of a coordinator in each State to
start to work on hepatitis C, maybe in the State public
health departments, a recommendation coming into the
infrastructure; that HCFA be urged to pay for testing, a
reimbursement for hepatitis C testing.
That we somehow remember that this committee, and here I
have to follow up with what Jane and others mentioned, is
carrying the ball for the other, whatever it is, 93 percent
of the world that did not get hepatitis C through blood, but
we are it. We are the group that is going to do something.
I do not think there is going to be a recreational needle
exchange committee forum to talk about their needs. I doubt
we are even going to get a C-section committee.
So here we are, and we are it. So we need to make sure that
the effort of the public health lookback starts promptly and
looks back to groups that need to have special information.
We have heard a longer list then we have ever heard before,
by the way, I might say today. I have a feeling if we keep
meeting, we will have this list doubled or tripled, but the
women who gave birth and had C-sections and did not know if
they had transfusions, but may have undergone a C-section,
may be a group.
Some of the blood products groups told us that they do not
want to be ignored and do not want to be forgotten, just
exposure itself that some of the physicians and health care
workers need to know about so that they are talking to those
people.
So extending the lookback to appropriate categories of
individuals who might be at higher than general risk seems
to be something we might want to recommend to the Secretary.
The licensing of RIBA 3, the great mystery of where it is,
but there it is. We might want to say something about that.
Think about strategies that we might use to use current
testing capability to go back as part of our lookback
strategies to make them more efficient, if we extend the
lookback, that is to say, using current testing techniques
where available to try and sort out who might in fact be a
donor who put product at risk.
It seems to me, too, I heard a recommendation that HHS asked
or the Secretary asked Congress to provide supplemental
funds and appropriations to do a public education campaign
to foster public and private partnership, to make sure the
budget for hepatitis C is up to par for what the threat is
of the disease.
Make sure that we have for some groups removed the barriers
to testing, not only HCFA, but free testing, maybe some free
clinic models. I think we can also anticipate the need to
talk about barriers to treatment. We are mounting up an
effort here to warn the American people, let them know about
risk. Many of them may decide that they want to pursue some
of the emerging interventions.
We are going to need some advice about how well they work,
what their risks are, who they might be appropriate for, and
issues of fundings. So we may want to say something about
that. That may be important to say something there.
It seems to me that in the end, if we can get through a list
like that by 3:00, we will be quite advanced in the battle
against the silent epidemic.
So what you are going to do now is we will take that break.
I think lunch will materialize here, maybe, in about 5 or 10
minutes. We will eat it, and then we will get all of these
recommendations endorsed, maybe be out by 1:30, 1:45,
something like that.
DR. EPSTEIN: Speaking from a Government perspective, I
actually think it is important in this entire process for
the committee to endorse the major efforts that have been
made by governmental organizations because there has been
the perception, and I would say misperception, of idleness,
complacency, and inaction.
The fact of the matter is that this is both an enormously
large and complex and endeavor with which the Government has
been directly grappling and with progress made, and I think
that is an important statement to be heard from this
committee.
CHAIRPERSON CAPLAN: Let's do Ed, and then we will do Keith,
but you will each have one sentence.
DR. GOMPERTS: I was going to make that comment.
CHAIRPERSON CAPLAN: Fernando?
DR. GUERRA: I think the public health dimension is
extremely important in all of this as well for several
reasons.
One, there is the need, having identified the population, to
then also protecting against hepatitis A and hepatitis B, at
a time when the national immunization program has had some
major reductions in support for vaccines and for the
delivery systems, et cetera.
And then just one other, so we do not lose it, there is an
enormous population of severely prematurely born infants
that have received many transfusions in the neonatal units,
and they are sort of lost in these discussions.
DR. HOOTS: Will we have an opportunity to query the past
speakers, the ones who have not had a chance to answer
questions yet?
CHAIRPERSON CAPLAN: Yes. In fact, we will even be able to
add to that short list of recommendations that I dragged up.
So do not panic about that if there is something else that
you wanted to get in.
Ten minutes out, then back here for lunch, and then we will
start up again.
[Whereupon, at 12:05 p.m., a luncheon recess was taken, to
reconvene at 12:51 p.m., this same day, Tuesday, November
24, 1998.]
A F T E R N O O N S E S S I O N
[12:51 p.m.]
CHAIRPERSON CAPLAN: Let us reassemble. While we are doing
that, let me clarify something that a couple of people
brought to my attention as a reminder, and that is, even
though I said we have to comment on the report, the Shays
report, Report No. 7, we are advising the Secretary of HHS.
The Secretary of HHS has a certain scope of duties. She
does not control the world. So there are some
recommendations in there that are aimed at the Defense
Department and some other places. I am not sure they quite
fit our focus. So that, we want to be focused primarily on
what the Secretary, Surgeon General, and Assistant Secretary
of Health has asked us to focus on relative to HHS
functions. They may control more than I think they do, but
they do not control everything.
So, when I looked at the Report No. 7 list, the key ones,
then, that we are going to start talking about pretty soon
are the Secretary of HHS should take the lead in
coordinating the Federal public health response to hep C
including implementation of a research plan. The hepatitis
C lookback plan should be expanded. Federal educational
campaigns on HCV infection should be launched immediately.
That is kind of 1A, 2, and 3 on the recommendations in
brief, if you are reading your program. There is a
recommendation there to the Defense Department. There is a
recommendation there to the Department of Veterans Affairs.
They are fine. They are wholesome recommendations. We
probably all like them a lot, but they are probably not what
Dr. Satcher needs to hear from us.
So I suspect that those three that I just mentioned that are
more in the summary form, you can look at them longer if you
wish.
I have been asking Steve and Mac to do a little work on some
of the recommendations that I thought would get us in the
mood of consensus-building, some of the recommendations that
came up that I think will not provoke so much controversy
and discussion. The first one that I just read will, but we
will go back to that. Some of the others may be more
consensus-building, get us in the right spirit for that kind
of exploration.
One that I left out that Dr. Hoots reminds me of is that we
did hear about the need to coordinate or try to minimize
barriers from Government and State databases, so that people
would be able to get timely information on deaths and then
use that as part of lookback. There seems to be obstacles
and hindrances.
I do not know if Mac has gotten to that. I think it was
Recommendation 13 or something. Mac, do you have it?
DR. NIGHTINGALE: I have got it.
CHAIRPERSON CAPLAN: That may be one where we could just
start, even having not quite written the language up on the
overhead. It is coming, but even there, I think I can
paraphrase it pretty well.
Oh, that is the first one. Don't give me that. I will get
there in a second.
I want to do something even less controversial. The one I
am fishing for is to just say something like minimize
barriers to State and Federal databases for lookback. I
think that is the recommendation we are trying to make here;
that the Secretary take steps to minimize barriers.
This is controversial. I understand Americans are concerned
about their privacy and their confidentiality, and I do not
think we are going to work out the details, but what we
heard was that for some purposes for hepatitis C, there are
obstacles to getting efficient use of information in the
testimony. So that is something we are comfortable with
understanding that there is going to have to be a discussion
of how to do that, the specifics, but we would like to see
the barriers lowered as to the degree possible.
DR. SECUNDY: Are you going to list the barriers, or some of
them?
CHAIRPERSON CAPLAN: No.
DR. SECUNDY: We will assume she knows what they are?
CHAIRPERSON CAPLAN: Yes.
I assume that the people who are attempting to do lookbacks
and trying to tap into the State, local, and Federal
databases will inform her of what they are.
Yes.
DR. NIGHTINGALE: This is Steve Nightingale.
I would inform the committee that we have reviewed this
internally, and Mr. Richard Riceberg, who is the counsel to
the Surgeon General, has concluded that if the Federal
database, including the Social Security database, were to be
used for assistance in tracking patients, that additional
legislation would in all likelihood be required.
So, while it is the committee's privilege to recommend to
anyone that they wish, whatever they wish, I think the
recommendation to the Secretary would be to suggest to the
Congress that legislation be enacted to facilitate this.
CHAIRPERSON CAPLAN: Well, having said we did not want to
make recommendations to the Department of Defense, I am
loathe to say that we will recommend to Congress, per se,
but let us--
DR. SECUNDY: No, no. Can't we say that we recommend that
she consider legislative recommendations?
CHAIRPERSON CAPLAN: Yes, that she work with Congress to
lower these barriers. That is roughly what we are getting
at.
DR. SNYDER: I have a question. Is that with respect to the
current lookback as we know it, or is that with respect to
if we changed it?
CHAIRPERSON CAPLAN: Extend it?
DR. SNYDER: Yes.
CHAIRPERSON CAPLAN: What I am thinking about, I am thinking
about any form of lookback that we wind up recommending.
I understand I suffer many slings and beatings about this
national identifying number. So I know the sentiment of the
American people is not to trust prowling in databases, but
for some basic information about deaths and people who have
moved three times that you are trying to find, I think that
the American people could support lowering those kind of
barriers without worrying that their records would be unduly
compromised for other purposes.
So it seems to me, here, it is a duty-to-warn-type situation
that we would like to see efforts made, the Secretary
working with Congress to lower those barriers for a
lookback.
DR. CHAMBERLAND: I just have a question. Does anybody know
if such a request has ever been made before, or would this
be precedent-setting?
DR. NIGHTINGALE: I think the Secretary does make
recommendations to Congress. There are several ways. One
of them is the standard of statement administration policy.
DR. CHAMBERLAND: No. I am asking specifically if anybody
in this Department or elsewhere aware that there has ever
been a request made before to have a non-Government agency
access the Social Security database for locating
information, or is this precedent-setting, and I am just
asking because I do not know.
DR. NIGHTINGALE: We would need somebody who knew the
legislative history of the 1991 Amendment to the Social
Security Act.
CHAIRPERSON CAPLAN: Paul, you know the legislative history
to the 1991 Amendment to the Social Security Act.
DR. McCURDY: I do not have that, but not too long after
that, the National Marrow Donor Program, the registry of
marrow donors for unrelated patients, at least explored the
issue of using that to locate people who had signed up to be
marrow donors and were unable to be found.
That project never went anywhere, and I am not sure exactly
why it was, but at least the question was raised. It did
not fit with the Act as of that time.
MR. McMURTRY: Mary, I would like to add that the Pension
Benefit Guaranty Corporation accesses Social Security
records to locate people on a regular basis. That is one of
those quasi-Government agencies.
CHAIRPERSON CAPLAN: All in favor of this language which we
will fine-tune a little bit?
[Show of hands.]
CHAIRPERSON CAPLAN: Opposed?
[No response.]
CHAIRPERSON CAPLAN: Okay, we got that one out of the way.
What else do we have in the apple-pie category? How about
this attempt to budget adequately for CDC and other agencies
to work with State, local, and public health interventions
to create an infrastructure.
I think you had this merged up, Steve, because I also had a
thing about maybe having a State coordinator. Did you
concoct some language there?
DR. NIGHTINGALE: Let me try this one again. The second
recommendation that you proposed before lunch was that the
Department allocate adequate funds to permit CDC to work
effectively with State and local governments to implement
the hepatitis C lookback.
DR. MOORE: Health departments?
DR. NIGHTINGALE: That the Department allocate adequate
funds to permit the CDC to work with State and local health
departments, too?
DR. MOORE: Implement educational efforts. I think it needs
to be broader than the lookback, or coordinate hepatitis C
prevention efforts at the State and local levels.
CHAIRPERSON CAPLAN: Education.
DR. NIGHTINGALE: To coordinate hepatitis C. What did you
say? Education and prevention and notification efforts?
DR. PILIAVIN: No.
DR. MOORE: "Prevention" sort of encompasses the
notification process and education.
DR. GOOSBY: Did you also want to facilitate treatment?
DR. MOORE: Yes.
DR. PENNER: Similar to the HIV program?
DR. MOORE: Yes.
CHAIRPERSON CAPLAN: Facilitate prevention, education, and
treatment, is that what we are talking about here?
DR. CHAMBERLAND: The Health Department's tree?
DR. MOORE: With HIV, they may facilitate like developing a
list of people that can be referred. They are not going to
pay for people being treated, but they can help facilitate
that process as part of the secondary prevention activities.
DR. CHAMBERLAND: So your recommendation is it extends
beyond the transfusion recipient issue. It is the broader
population?
DR. MOORE: I think that the issue of the lookback that is
not the targeted lookback, but the lookback to make sure
that people get tested if they were transfused before 1992
is such an important educational message, and it will rely
so heavily on educating providers and the public.
If we are going to stay with the transfusion area, it is
that piece, not the targeted lookback, but the more general
lookback. I think there is a huge need for provider
education, and then once providers test people, they kind of
know what the secondary prevention messages are, et cetera.
DR. NIGHTINGALE: Kris, let me try the following wording.
We recommend the Department allocate sufficient resources to
permit CDC to work with State and local health departments
to facilitate education and testing programs for individuals
at risk for hepatitis C infection.
DR. MOORE: That would be fine.
CHAIRPERSON CAPLAN: I do not mind saying "treatment." To
me, you can add that in there. There is nothing
facilitating treatment.
DR. NIGHTINGALE: Then it would be education, testing, and
treatment?
MRS. O'CONNER: How about referral?
DR. NIGHTINGALE: Referral rather than treatment.
Education, testing, and referral.
MRS. O'CONNER: Can we discuss the amount of money?
"Adequate" and "sufficient" seem rather vague.
CHAIRPERSON CAPLAN: The Liver Foundation gave us a set of
testimony about what they thought these costs would be, and
I have seen numbers go by about this matter of cost. I have
tried to ask like a boring, drone all day long, if money was
adequate. I do not think we have to advise the Secretary on
the budget, though.
What we are saying is that we want that in there. There is
some testimony about different ideas and what people think
would be necessary to make this go. That is why I was
trying to enter it on the record. So I am not so concerned
that we put it into the recommendations. That is the honest
answer. We have heard a lot about what people think is
needed by way of testimony, which we will certainly pass
onto the Secretary.
MRS. O'CONNER: My only concern is will this, then, generate
other months and months of discussion as to how much money
do we spend, who decides? Could we at least include this as
something that has been thought out and presented to us as a
point of reference? As lookback gets delayed, it would seem
that you could at least get a communication problem going to
reach people about the concern.
CHAIRPERSON CAPLAN: I understand what you are saying.
MRS. O'CONNER: If we leave it very vague, it just takes a
longer time.
CHAIRPERSON CAPLAN: This may not be the recommendation to
do it, the infrastructure, but I think it would be fine, if
the committee is willing, to make a recommendation that to
the extent possible, the Secretary mount this public
education campaign through CDC and other sources as quickly
as possible.
What we did here about the need to move this fast and CDC
has its plans for roll-out that we heard, there are other
agencies that are involved, to some extent, and public
outreach, some private.
I had a two-parter on this. One was to encourage the
Secretary to seek as rapidly as possible a public education
campaign, which is something they have committed to, but we
want to come back to, and then specifically to foster
public/private partnership.
Some of what has gone on, if you look at the Liver
Foundation or other things, groups have said we have ideas
and we would like to partner them. Some people have said we
have to take advantage of marketing, communication, and
advertising. This may be a place where the Secretary could
be urged to roll out both a public education campaign across
the board.
I mean, we are talking here about our risk groups that we
have heard about, contentiously a little bit, caesarian
section, newborn babies, blood products users. That is what
I am talking about when I say public education across the
board fast, and then partner with appropriate private
resources. That is what I am trying for there.
How is that going, Mac? Does that make it into English?
DR. MOORE: I think the wording of that should be a little
bit careful because there is an awful lot that has been
done, and I think we heard about it this morning. I just
want to make sure however this is worded, it is not like we
are inventing something new because I think CDC has done a
lot. I think we are trying to build on what has been done,
but not start something new. I just want to make sure that
gets in the recommendation, and it does not sound like they
have not done anything and therefore they need to start. A
lot has been done. A lot of educational efforts have been
done.
CHAIRPERSON CAPLAN: There will be no commendation of the
agencies from our committee until we get through all the
other recommendations. It is the reward at the end.
DR. SECUNDY: Would you use perhaps the word "supplemental
funds" or "additional funds"? Because you are swaying there
is already money in the pot, but you want additional or
supplemental.
In relation to your comment, it would seem to me that the
way we are going about this may slightly confuse the issue.
I think, from my perspective, that I would like to make it
clear that we are starting with an understanding that we are
in support of a mandate that says stop planning, stop
delaying, and get on with this in a speedy fashion, and then
everything else follows from that. It is not at all in any
way intended to alter it, change it. The given is that we
do not want any more bureaucratic nonsense.
DR. NIGHTINGALE: Then could I ask both Drs. Secundy and
Moore, if we phrase the resolution, we recommend the
Department allocate sufficient additional resources to
permit CDC to work with State and local health departments
to facilitate education, testing, and referral programs for
individuals at risk for hepatitis C infection? Does that
get it?
Mary?
DR. CHAMBERLAND: I just want a clarification again because,
the way that was just worded, that is broad. That gets at
the entire population of persons at risk for hepatitis C and
goes beyond transfusion recipients, and I thought I heard
Kris talking about a more narrow focus. So I am just asking
for clarity.
DR. MOORE: I can go either way, depending on the committee.
I think it is hard to separate out one little piece of
hepatitis C from the bigger picture.
DR. CHAMBERLAND: I would agree.
DR. MOORE: I think education campaigns targeted to
providers need to include other aspects. So I can go either
way, but it depends on how narrow this committee wants to
focus its efforts.
CHAIRPERSON CAPLAN: My argument on that one is what I said
before the lunch break. I think we are it for the issue.
So we have some kind of duty to carry the ball across the
whole field.
It is not that we could not just recommend about blood. We
can, but I would urge us not to. I think if we push in the
broad sense, we will be doing the right thing.
CAPTAIN RUTHERFORD: This has probably already been said.
Get to as many people who are affected as possible, not just
transfusions.
DR. GOMPERTS: I think there is another issue here, and that
is resources should be allocated over a time frame. This is
not a "oncer." The responses that we have seen by CDC and
also FDA will need to be reviewed, issued identified,
further actions, further resources allocated depending upon
outcomes of these responses.
I think in relationship to public and private interactions,
a major issue, which has not yet been put on the table, is
the development of vaccine. I think the potential for a
vaccine to this virus is there. It is not an easy nut to
crack, but I think it is there, and that is, from a public
health point of view, I think absolutely critical.
CHAIRPERSON CAPLAN: Just so I sort this out, Steve's
recommendation is the one that is targeted more towards
coordinating State and local efforts. Let's go with that
for a second. I think I clouded this by starting to talk a
little bit about public/private. So forget that for the
time being.
Why don't you re-read what you have got now?
DR. NIGHTINGALE: I think what I read is that we recommend
that the Department of Health and Human Services allocate
sufficient additional resources to permit CDC to work with
State and local health departments to facilitate education,
testing, and referral programs for individuals at risk for
hepatitis C virus infection.
DR. MOORE: Maybe you could just add "including those
transfused before 1992," or something like that.
DR. CHAMBERLAND: No, no, no.
CHAIRPERSON CAPLAN: Folks are voting.
By the way, I meant to say this. What I am going to try to
do since we are into the discussion and voting time period,
even though I am normally pretty eclectic about this, I will
try and let the voting members talk a little more than the
non-voting members for this session.
All in favor of that recommendation before it fades away
into somewhere?
[Show of hands.]
CHAIRPERSON CAPLAN: Opposed?
[No response.]
DR. AuBUCHON: Mr. Chairman?
CHAIRPERSON CAPLAN: Yes.
DR. AuBUCHON: Could we continue the discussion of
resources?
CHAIRPERSON CAPLAN: Yes.
DR. AuBUCHON: There was mention earlier about the cost of
the targeted lookback program, and I think it is entirely
appropriate that we as a committee turn to the Federal
Government and say put your money where your mouth is if you
think hepatitis C is an important disease worth treating and
preventing.
My estimation of the cost of the targeted lookback program
as it is currently configured is $250 million. I say that
not because I think that the blood banks and hospital
transfusion services of the country are looking with their
hands out to get money from the Federal Government to
perform this, but I do want to bring to the committee's
attention that as we put a lot of effort into this program,
there are resources time people that are not being spent
doing other things. That is where the cost is coming.
There is where the $250 million is being spent.
There are programs at my hospital right now that we are not
investigating, not developing, that would improve
transfusion safety today or tomorrow because of what we are
doing for hepatitis C lookback.
Would it be appropriate for this committee to consider
asking the Federal Government to put some funds to be
expended to accomplish the targeted lookback that has
already been requested of us?
CHAIRPERSON CAPLAN: That is a fair proposal.
DR. NIGHTINGALE: Would you like to suggest language?
CHAIRPERSON CAPLAN: Would you concoct that into a proposal?
DR. SECUNDY: Could I ask a question for clarification?
CHAIRPERSON CAPLAN: Yes.
DR. SECUNDY: Would that recommendation mean that if the
funds are not provided that the FDA does not do what it is
supposed to be doing?
DR. AuBUCHON: No. What I am saying is that right now as we
are doing lookback, because we do not have additional funds
from any source to do this, that blood centers and hospital
transfusion services are not doing things that they would
otherwise do and want to do to make transfusions safer
tomorrow.
DR. SECUNDY: I would support that, as long as we are clear
that it does not in any way alter the mandate to proceed.
DR. HOOTS: And I support it, too. I think it is really
important for us to do everything we can to ensure that as
resources are applied to whatever recommendations we make,
that we do not draw those resources from strategic
components of particularly blood products.
I am not a blood banker, so I think that I can easily say
this, that donor recruitment and things like that do not
suffer, and we have to come back 5 years from now and
address availability issues that we help create because of
safety issues. So I think we have got to make sure that
every decision, every recommendation we make, is in the
context of both safety and availability.
With regards to what Jim said, I think this is one
particular place that if we are not very careful and do not
provide the needed resources that we might create a
secondary problem down the road, and I do not want us to do
that.
DR. SECUNDY: This is where I wanted to come in earlier with
my question about some assumptions when I raised the
question of money because I think that perhaps I am
operating from a different set of assumptions than some of
the Federal officials are. I am hearing some assumptions
that I am not buying into that involve cost.
One of the assumptions that I think I was hearing was that
in order to do the lookback, the targeted lookback that is
currently in place, that it required an activity of a
treatment component and a specific set of mechanisms that I
am not sure are necessary. There was a phasing and staging
process that was in place.
There is another assumption that I was hearing that one must
guarantee some kind of results, and that assumption is
intention with my assumption that the priority or a goal and
objective that is my priority is the people's right to know.
So I am hearing the people's right to know intention with
cost considerations, and I think that maybe if all of us
think about which assumptions we are operating from, or at
least for me I have got to do that in order to prioritize
where my values lie, I am not going to buy into the
assumption that we have to have a treatment thing that works
before people have a right to know. I am not buying into
the assumption that this has to be staged in a particular
way before people have a right to know.
Others of you may be doing that, and that is your right, but
I need to say that my objective as the ethicist sitting at
this table is to say to you that the value that I am here to
uphold is the people's right to know.
CHAIRPERSON CAPLAN: Go ahead.
DR. NIGHTINGALE: Actually, David is next.
DR. FEIGAL: The costs that I mentioned before did not
include anything with regards to treatment or education
about treatment. It simply was the cost of the process of
identifying the blood samples, tracing the blood samples to
their components, any of the testing that might still be
done to clarify whether it is a false positive or not, and
then the process of the transfusion centers trying to notify
people, including pulling the charts, the repeated efforts
to call.
We have experience with other lookbacks. So we have ideas
of roughly how many hours each of these activities take.
The majority of the cost is actually the labor of just
providing the information to actually have the person come
in and be tested and the cost of that test, but there is
nothing about treatment in any of those assumptions.
DR. SECUNDY: Okay, but that is the assumption. That
process is the assumption, and what I am saying when I talk
about the people's right to know is to send out a letter,
tell everybody who has ever been transfused, that they are
at risk, and that is not going to cost $100 million.
DR. FEIGAL: You are right. It is not the recommendation of
this committee to send a letter to everyone who has ever
been transfused, and so the costs that I am describing are
the costs that are the implementation of this committee's
recommendations to do a targeted lookback. Still, even
though the process of sending a letter to everyone who has
been transfused means pulling the charts and trying to find
a current address on everyone who has been transfused
because there is no central record in a hospital, in most
hospitals, of who has had a transfusion.
So, at some level, you still have to start with the blood
products and begin pulling the charts.
CHAIRPERSON CAPLAN: Yes.
DR. NIGHTINGALE: May I propose language initially to see if
it addresses both the concerns of Dr. AuBuchon and Dr.
Secundy, with the language that states, "We recommend the
Government investigate potential sources of financial
support to facilitate the prompt completion of targeted
lookback for individuals at risk of transfusion-transmitted
hepatitis C virus infection." Would that address both of
the concerns that you have previously stated?
DR. SECUNDY: It would, except with the caveat that if you
do not find the potential sources, you proceed in some
compromised way.
Again, I think I understand clearly what you are saying
about the need to identify the people, but when I talk about
a letter of notification, I am talking about the universal
communication with the American people.
CHAIRPERSON CAPLAN: Let me jump in here because I
understand what the concern is. Why don't we use something
like "supplemental" or "complementary"?
DR. NIGHTINGALE: Supplemental sources?
CHAIRPERSON CAPLAN: I am very sure when we leave here
today, we are not going to back away from a recommendation
that says hit the March '98 completion deadline, come hell
or high water, for an improved lookback.
DR. SECUNDY: It is very important that we get that on the
table.
DR. NIGHTINGALE: Dr. Secundy, does the word "supplemental"
address your concern, "supplemental sources"?
DR. SECUNDY: The wording was fine, Steve.
CHAIRPERSON CAPLAN: She is just worried that if there is no
dough, there is no lookback. That is all.
I am not going to say do not worry about it. I will just
say we will make for the record a statement. Remember what
we said before lunch that we are presuming that the
deadlines that were announced for the lookback that we
directed will be met. That is why I asked for it to go on
the record. We can vote it, if you want, as a
recommendation to the Secretary that this be enforced. I am
happy to do that.
That is why I said, before we broke, to get it on the record
for FDA, that is why I want to split the issue of the
supplemental lookback away, a further lookback from what we
have already gotten to.
Do you want to make a recommendation on that one before we
vote on yours? I just want to know if that is one you feel
comfortable that we should urge the Secretary to make sure
that everything is done to complete the time table that we
have been given by the FDA for the lookback. Do you want
that one? So we will write that one, too. That is coming.
Let's go back to Steve's language which is that we urge the
Secretary explore supplemental funding for the prompt
completion of the targeted lookback.
Does that do what you want, Jim, the spirit of it?
DR. AuBUCHON: Yes, I believe so, although the spirit really
is not looking for money. It is making sure that we do not
have to take resources away from other important activities
in order to accomplish this.
DR. DAVEY: I think that the only supplemental funds that
are going to be available are Federal funds. I do not
anticipate finding funds elsewhere. So I think we had
better call it Federal funding and be clear about it.
Again, just a couple of comments from the Red Cross
perspective, just to give you an idea of the cost and
impact, we anticipate about a--
CHAIRPERSON CAPLAN: Actually, you know what, don't give me
the cost yet. I know that is on the table. It doesn't
matter. We will come back to that in a second.
DR. DAVEY: I was just going to comment a little bit about
the effect.
CHAIRPERSON CAPLAN: I know there is a lust, once there is
one committee that would actually listen to talk about
lawyers and money, to indulge in both. I even heard Jane
describe lawyers at one point in our deliberations. She
followed the description of lawyers with the words
"rational," "logical," and "sane." Do you remember that?
I know you weren't referring to them.
DR. PILIAVIN: I was referring to blood centers, not to
lawyers.
CHAIRPERSON CAPLAN: Hold off on the costing because we will
be smack in the middle of it in a second. I want to see
whether we are going to pursue supplemental sources of
funding and recommendation. We know what is going on here.
We do not want this to be a tax. We want it somehow not to
be taken out of the hide of the existing system, to the
extent possible.
DR. MOORE: I just want to make sure it doesn't also get
taken out of the existing public health dollars.
CHAIRPERSON CAPLAN: Don't even worry about that. When we
say "supplemental"--
DR. MOORE: I just want to be real careful about that
because this is a small piece of a big plan and not a very
efficient piece. So I just want to make sure it doesn't
come out of existing public health resources.
DR. PENNER: The public is going to pay for this, anyway,
whether the blood banks do it or not because it will end up
with increasing the price of blood.
DR. AuBUCHON: My concern is that there are no new health
care dollars period. Blood centers are not free to increase
their charges. Hospitals are not receiving additional
reimbursement from third-party payers or the Federal
Government. That means that in order to do this, we are not
doing something else, and I am concerned that we are missing
opportunities to improve the outcome.
DR. PENNER: Do you mean there is no flexibility at all in
increasing the price of blood, no matter what the costs are?
DR. AuBUCHON: No, I do not believe there is.
DR. NIGHTINGALE: I think one comment in response to Dr.
Moore's concern is that funding is, of course, a constant
dynamic. It will not be stable in the next budget just
because it was stable in this, and a request for additional
funds is often in the course of Government operations
necessary to maintain existing ones. Dr. Moore already
knows that.
DR. MOORE: And they often come out of existing pots of
money, too.
CHAIRPERSON CAPLAN: Let me move on this one. I have a
feeling we are close.
DR. NIGHTINGALE: The preamble recommendation about the
timing, I have suggested wording which should be that we
urge the Secretary to take all necessary steps to ensure
completion of the currently recommended lookback programs
within the currently recommended time frames.
I would ask Dr. Epstein and Dr. Feigal to comment as to
whether or not that language is consistent with the current
status of the lookback as a guidance to industry.
DR. CHAMBERLAND: Just as a point of order or business, I am
confused again, and I am sorry, but do we have a couple of
different recommendations up there at the same time? Should
we deal with one?
CHAIRPERSON CAPLAN: There are two up there right now, and
Steve actually erroneously read his second one, being so
excited about his prose flowing.
DR. NIGHTINGALE: I apologize.
[Laughter.]
CHAIRPERSON CAPLAN: It is the first one, the supplemental
funds that we want to be talking about.
DR. CHAMBERLAND: A question about the recommendation that I
do believe is up there about identifying additional support,
this is support that would go to non-Government agencies.
Do we want to be more specific? It says to identify
potential sources of financial support to facilitate prompt
completion of targeted lookback.
I think the trigger for this were the comments by Jim and
maybe Rick, but that is broadly written. That could be
good, or maybe people might want to focus it.
CHAIRPERSON CAPLAN: It doesn't bother me. There may be
other places besides blood banks that are hoping to get some
supplemental funding to let them do it. I would say I can
live with that.
DR. PILIAVIN: It actually might be a way of getting around
problems with regard to opening up the Social Security
database because the supplemental funding would be to pay
some part of the Government to do the looking for the
private agencies. Then you wouldn't have to let it loose.
DR. NIGHTINGALE: Or a private agency.
Paradoxically, sometimes broader statements flow more easily
through the Humphrey Building than specifically targeted
ones.
CHAIRPERSON CAPLAN: How about a motion on that one?
DR. SECUNDY: So moved.
DR. BUSCH: Second.
CHAIRPERSON CAPLAN: All in favor?
[Show of hands.]
CHAIRPERSON CAPLAN: Opposed?
[No response.]
CHAIRPERSON CAPLAN: All right. I have got one other apple-pie one, and then I think we will take a shot at the actual
Shays recommendation.
The apple-pie one is more money spent, but do we want to say
something that HCFA should start to pay for testing? That
is a pretty succinct recommendation.
DR. SNYDER: A quick question. Are you talking about
Medicare or Medicaid or both?
CHAIRPERSON CAPLAN: For me, anything that HCFA controls,
Medicare, Medicaid, BSRD, Indian Health Service. I don't
know.
DR. SNYDER: No, no. They just do the Medicare or Medicaid.
That is why I am asking.
CHAIRPERSON CAPLAN: I mean, I would say to the extent to
which HCFA can remove obstacles by getting reimbursed for
testing.
DR. SNYDER: That will help anybody who qualifies under
Medicaid is what I am looking at.
CHAIRPERSON CAPLAN: Yes. Who likes that one?
DR. NIGHTINGALE: Actually, I think you would urge the
Secretary to direct the Health Care Financing Administration
to support testing, counseling, and referral?
CHAIRPERSON CAPLAN: Pay for.
DR. SNYDER: They only do payments, but the other thing they
are going to have to check, is whether or not this meets the
test because there is only certain testing procedures that
can be done under current legislation, such as the
mammograms. Other types of testing for Medicare or
Medicaid, I believe get a little more touchy.
DR. GUERRA: Yes, and it tends to be FDA-approved testing.
DR. SNYDER: Of course.
DR. GUERRA: So it would have to be the one or two.
DR. NIGHTINGALE: You are asking them to support payment for
testing of patients identified at risk of hepatitis C virus
infection by current CDC guidelines?
DR. SNYDER: No. I am not making a recommendation.
CHAIRPERSON CAPLAN: I think we should keep this simple.
DR. SNYDER: If they can legally do it, that is the problem.
CHAIRPERSON CAPLAN: We want HCFA to remove financial
barriers to testing.
DR. SECUNDY: And if they cannot legally do it, if there is
a legal issue--
CHAIRPERSON CAPLAN: They will have to figure it out.
DR. SECUNDY: --then it would seem to me that there is
another place that we should say anything about her role in
a legislative initiative.
CHAIRPERSON CAPLAN: My hunch is we do not have to say
anything about this. What we want HCFA to do is to remove
financial barriers to testing and then go at it, legally,
congressionally, check the testing list, whatever we want to
do. It doesn't much matter.
DR. GUERRA: But I think we run the risk, then, of
essentially establishing two tiers of access.
CHAIRPERSON CAPLAN: You mean for different kinds of
testing?
DR. GUERRA: Well, not just that. I think we incumbent in
this recommendation is what the standards are going to be
for testing in terms of reimbursement because otherwise
there can be a lot of tests that probably do not have the
specificity or sensitivity that will really make the cost
beneficial.
The other concern is that population that is out there that
has the same risk and lives in the same communities that is
not going to be eligible for either Medicare or Medicaid.
CHAIRPERSON CAPLAN: I understand that. That one is
tougher.
DR. SECUNDY: Well, that is the removal of financial
barriers. It is not just for Medicaid, Medicare, but for
the uninsured.
CHAIRPERSON CAPLAN: I understand that.
DR. GUERRA: Yes, but the uninsured also includes the
immigrant populations.
CHAIRPERSON CAPLAN: I understand the two-tiered problem,
and I also understand the importance of clarification about
the kinds of tests that will be used, but I will try and
steer this one this way and say before we worry about
others, let's recommend to HCFA that what they control, they
reduce barriers to.
I understand the other problem. I understand there is going
to be a debate about what tests are covered. I don't care.
The issue is: Can we remove financial barriers for
hepatitis C testing? That is the recommendation. It is
pretty straightforward. They can control what they can
control. Then we will get to the uninsured and the lost
souls, the 40 million others who are not in the Medicaid
program.
DR. GUERRA: I guess, then, we probably should add, if you
want to better define the parameters that HCFA has control
over, then I think we also need to see what we can put into
it as covered by the VA system, Department of Defense,
TriCare, and some of the federally supported programs that
are not Medicare or Medicaid.
DR. NIGHTINGALE: If you want generalities, I can most
certainly provide you with them, and would do so by
rewording the statement to say we recommend that the
Department of Health and Human Services remove financial
barriers to testing of individuals identified by current
Government standards as being at risk for hepatitis C virus
infection. Is that too broad?
DR. SNYDER: Personally, I think it is. We came in here
talking about HCFA. The Secretary can talk to DOD, can talk
to VA, but that does not mean anything is going to happen.
So the bottom line is let's stick to what we can work with,
and then as far as the testing, having the community of
migrant health centers, I am acutely aware of what you are
talking about. Even with our system jumping in as
appropriate, it still leaves about another 20 million that
are uninsured.
DR. NIGHTINGALE: Would your concerns, then, be better
addressed if we said the Department rather than HCFA? You
want HCFA.
DR. SNYDER: Why not go with what you started with? It is
much better, and it is succinct. It also does not address
lookback versus you have hepatitis C from some other source.
That is a smart move.
DR. NIGHTINGALE: And we urge the Health Care Financing
Administration to remove financial barriers to testing of
individuals identified by current Government standards as
being at risk of hepatitis C virus infection.
CHAIRPERSON CAPLAN: Motion?
DR. GUERRA: I am not sure. I think the populations get
very blurred out there. I think there has to be in place,
at least for the federally controlled programs that already
deal with entitlement for certain populations, that somehow
we need to have the insurance that if we are seeing a
veteran in a clinic that we can bill that to the VA system,
rather than to Medicare or Medicaid if they are not
eligible.
DR. SNYDER: But, again, that is crossing Department lines,
keep it out of there. You may want to make a separate
recommendation.
I understand what you are saying. I concur with you, but
just the idea of let's stick within the Department, Mary, do
you have any opinion on that?
DR. CHAMBERLAND: In terms of expanding it to Veterans
Affairs and DOD?
DR. SNYDER: No, no. What I am saying is as far as keeping
a recommendation that is just for the Department and then
the Secretary discuss with VA and DOD the other thing under
the separate recommendation. That would seem to make more
sense to me.
DR. GUERRA: Well, if that is what will help it move
forward, I am fine with that, but I think there has to be
some communication.
DR. SNYDER: Can you read it again?
DR. NIGHTINGALE: I most certainly can. I would agree as a
paper bearer, what happens with recommendations of this sort
is the things that are wrong with them bureaucratically
serve as much stronger hooks than the things that are right
with them. So the recommendation right now reads: We urge
the Health Care Financing Administration to remove financial
barriers to testing of individuals identified by current
Government standards as being at risk of hepatitis C virus
infection.
DR. SECUNDY: Second. Moved.
CHAIRPERSON CAPLAN: All in favor?
[Show of hands.]
CHAIRPERSON CAPLAN: Opposed?
[No response.]
CHAIRPERSON CAPLAN: Do you want to try that other language
that you were so excited about that you couldn't restrain
yourself?
DR. NIGHTINGALE: I did so with difficultly.
We urge the Secretary to take all necessary steps to ensure
completion of current lookback programs within the currently
recommended time frames.
DR. GUERRA: So moved.
DR. SECUNDY: Second.
CHAIRPERSON CAPLAN: Approved?
[Show of hands.]
CHAIRPERSON CAPLAN: Opposed?
[No response.]
CHAIRPERSON CAPLAN: That was good language. You were
right.
All right. Maybe it is time, having built a spirit of
conviviality and friendship and amicability, to take a look
at our Report No. 7 here.
Again, the recommendations here are from the congressional
committee, Shays' committee.
The Secretary of Health and Human Services should take the
lead in coordinating Federal public health response to
hepatitis C epidemic.
Just for the record, does anybody have any problem with that
part? I doubt we will find that very controversial.
The hepatitis C lookback plan should be expanded, and the
Federal education campaign on HCV infection should be
launched immediately.
That is, by the way, subtracting the DOD and Veterans
Affairs focus. I know I am summarizing from a summary here.
There is more said about that.
DR. SECUNDY: The committee can support those
recommendations without asking the Secretary to do anything
about them, right?
DR. NIGHTINGALE: Correct.
CHAIRPERSON CAPLAN: Well, there has been advice given to
the Secretary. We are endorsing, if you will. We are
blessing them or something like that.
Discussion?
DR. CHAMBERLAND: Yes. I guess I do want to be clear about
the discussion in terms of endorsing or supporting the
recommendations of Shays' committee.
Clearly, the discussion that we were involved in this
morning has really focussed on recommendations or issues
that pertain to Recommendation 1A and 2 and 3.
The recommendations of the Shays report that deal with DOD
and Veterans Affairs, I would submit that we have not really
had any information or data presented to us that would allow
careful review and consideration.
CHAIRPERSON CAPLAN: We agree. In fact, they are off the
table. Don't even worry about them.
DR. CHAMBERLAND: Oh, I misunderstood.
DR. SECUNDY: I was asking whether or not a recommendation
or a support of the report could not also just be an overall
support of the report without taking them out.
I don't care particularly a whole lot if they stay in or
don't. I was just trying to clarify the question.
CHAIRPERSON CAPLAN: Can we give a general endorsement to
the report and not do what I am about to make us do, which
is to pick a little bit at the substantive key
recommendations?
Mary is trying to be a little nicer than I was. I
highlighted three things for you that I thought you should
be alert to what they said, and if you make a general report
recommendation saying we endorse that report, that is fine.
DR. SECUNDY: I would, in answer to you, say that, again, my
position would be that I don't need data to understand that
the people have a right to know whether they are in the
Veterans Administration or in the Department of Defense, but
I do not really think that this speaks specifically enough
to that for us to be concerned that we should take it out
necessarily.
CAPTAIN RUTHERFORD: I really would prefer that that not be
in. The DOD has a huge number of samples in their frozen
repositories, and we are in the process of responding to
this, I have been told, by pulling out samples from
individuals who have deployed overseas, pre-, during, and
post-testing those samples, and doing some recruit studies
which we had done a number of years ago, and re-pulling
samples and testing those. The first take on that is a very
small number of recruits, like 2 or 3 out of 1,000 or 2,000
or 3,000, were in fact HCV-positive.
So I would prefer that the committee not respond on that
issue.
CHAIRPERSON CAPLAN: Okay. I mean, I think we are in
consensus.
What we are trying to talk about here for the report is the
recommendations that are directed to the Secretary, HHS. We
know there are some recommendations that head in other
directions, DOD, Veterans Affairs, and I think that is fine.
We will keep that focus there.
Let me try this out as a question, just for discussion. Is
the committee comfortable endorsing the general report with
this narrowing to the HHS focus?
We can certainly go after the specifics of expanding the
lookback, and that will be a good time to talk about cost
and some other things, but if you want to, we can just say
we endorse this general spirit of this and what the key
recommendations are to the Secretary and then have a
discussion about what expansion of the lookback would mean.
DR. PILIAVIN: I would be opposed to doing that personally
because the majora focus of everyone on this set of
recommendations has been on the expansion of the lookback.
So, if we were to say in general we favor this report, that
would be taken as agreeing that we think that the lookback
should be expanded.
I think if we want to do something, we should do exactly
what we have been doing, and that is to say yes to this, yes
to this, and, for example, the stuff about the DOD and the
Veterans Administration is not anything that we think is any
of our business. So we are not going to talk about that.
In other words, go point by point, even though it is more
tedious.
DR. BUSCH: I also oppose in any way endorsing the report.
I think the report has a number of inaccuracies both with
respect to general hepatitis C epidemiology, risk groups,
and also very specifically total inaccuracies as to the
understanding of how lookback perceives the issue of dates
and does not appear to accurately discriminate donors from
recipients.
So I think not only in specifics, but I think in flavor the
report is negative about the public health response which I
totally support a motion from the committee that we not only
recommend leadership, but that we acknowledge that the
public health service has taken an aggressive response to
the original recommendations.
So I very much oppose any endorsement of the report as
written.
DR. SECUNDY: I guess this is where the controversy really
comes. I would really want this to go to vote.
I do not agree with you. I think the public health service
has done what it though it could within the bureaucratic
constraints of its organizational structures. I have got
lots of questions, as I said earlier, about the assumptions
and the ideological base from which not so much the public
health service, but from where FDA is coming, or has come.
I am very concerned about where I stand on this committee in
relation to this overall fundamental issue that I am
speaking to because, as I have said here, even though we
have been doing this for a while, it has hit me harder today
than any other time that we are talking about the
possibilities that really resonates the whole discussion
about the prior discussions years ago regarding AIDS.
I am recognizing that we are looking at issues of
bureaucratic delay that I find troubling. We are looking at
questions that I have regarding the attitudes toward
disposable people, the Hispanics, blacks, drug abusers,
homosexuals, hemophiliacs, and I have got to stand and say
that I fully support the Shay report. So I really would
like to take it to a committee vote after more discussion.
MR. WALSH: I think it is inappropriate for the committee to
condemn this report. On the contrary, I think it is totally
appropriate to commend Chairman Shays for making certain
that this issue, again, is brought to the forefront. That
is why we are all here today.
Like the American Liver Foundation has taken a leadership
role in creating a public information program that the
Government is engaged in developing and to hopefully soon
implement, Chairman Shays has brought this issue to the
forefront, and I think we need to extend the courtesy to
support the initiative, if not in fact the specificity of
the report.
CHAIRPERSON CAPLAN: I am actually giving some hand signals
out that I am narrowing this down for a second to the
voters.
Go ahead, Jim.
DR. AuBUCHON: Dr. Busch is entirely correct that there are
many inaccuracies in this report, and I have great concern
about this committee endorsing a report with a highly
politicized content and, in my opinion, motive.
I think our focus should be on the patients that we are all
trying to serve in one manner or another. We should
maintain that focus. We should try to put politics aside.
We should do the best that we can to recommend the best
course of action.
I am afraid that if we get embroiled in whether or not a
particular report of Congress is or is not accurate, is or
is not appropriate, we will be debating this until the cows
come home, and that is well after 3 o'clock where I live.
[Laughter.]
DR. AuBUCHON: I think we should focus on what we want the
Federal Government to do at this point.
DR. KUHN: Are we endorsing the report, or are we endorsing
the recommendations?
CHAIRPERSON CAPLAN: The recommendations.
DR. KUHN: So I do not think we are endorsing the report.
CHAIRPERSON CAPLAN: I mean, what I am moving is that we
talk about the three key recommendations, not bless the
report.
DR. KUHN: Right.
DR. SECUNDY: Well, you did raise the question, though.
CHAIRPERSON CAPLAN: I said whether we want to do it
generally, but I heard a lot of "let's not try that."
MS. JONES: Since we are discussing supporting the
recommendations, from my reading them over, I agree that
some of the information in the body of the report is
incorrect or may be a little bit misleading.
Recommendation No. 1 is something that we have been
discussing all morning, whether HHS is taking the lead. I
think all of us could support that recommendation, and if it
is something that is already taking place, we support it and
ask HHS to continue that role.
The other A and B of that, we decided that it is not an
issue for this committee to address.
Item 2 is one that is going to be the one that is debatable,
but Item 3, I think we have all been saying get on with it.
So we already have consensus on Items 1 and 3. Let's get on
with discussing Item 2, cut the debate here. I think we
have consensus.
CHAIRPERSON CAPLAN: So one way to put this is we could take
a motion that we endorse Recommendations 1 and 3, the key
recommendations to the Secretary that the report makes, and
then we can talk some about lookback expansion. Do you want
to do it that way?
DR. PILIAVIN: I think you mean 1A.
CHAIRPERSON CAPLAN: Excuse me. 1A and 3.
Are we happy with that motion?
DR. NIGHTINGALE: The following language is: We support
the Secretary's leadership efforts in coordinating the
public health response. I throw that out for comment.
DR. SECUNDY: Go back to the report. We have not finished
with that.
CHAIRPERSON CAPLAN: Just on 1A and 3, are we ready to
support the Shays' committee's Report No. 7's
recommendations and say yes, we agree with those two?
DR. SECUNDY: So moved.
DR. PILIAVIN: It sounds okay.
CHAIRPERSON CAPLAN: Mike?
DR. BUSCH: I concur with that, so long as there is the
understanding that we will address and I hope endorse a
separate proposal related to acknowledgement that there has
been a substantial public health response to date because I
think the flavor of this report is that there has not been
an effort undertaken of substance, and I do not think that
is correct.
DR. NIGHTINGALE: So the motion, then, before the committee
is that we support Recommendation 1A and 3 of the 734 of the
House Committee on Government Reform and Oversight?
CHAIRPERSON CAPLAN: Yes.
So moved?
DR. SECUNDY: Yes.
[Show of hands.]
CHAIRPERSON CAPLAN: Opposed?
[No response.]
CHAIRPERSON CAPLAN: Well, why don't we talk a little bit
about extending the lookback since we have tottered our way
toward it. That is Recommendation 2, the hepatitis C
lookback should be expanded.
While we are doing that, someone came in the room who is an
old friend of mine, and I always introduce old friends of
mine.
Dr. Nicki Lewery is here. Actually, I should let you do
this.
DR. GOOSBY: No, that is fine.
Dr. Nicki Lewery is the Principal Deputy Assistant Secretary
of Health, is new to the Department, and has added her
wisdom and input into a variety of areas that the Assistant
Secretary, Surgeon General, and Secretary are dealing with,
and I wanted to introduce her to the committee.
Dr. Lewery?
DR. LEWERY: Thanks. Thanks for giving me the opportunity
to come by. I am sorry I could not come and spend the
entire day, but I had an otherwise extremely tight schedule.
But, Art, it is great to see an old friend, and I am looking
forward to working together. In fact, you should even know
that I called Art on a weekend just a couple of weeks ago,
just to ask him for some advice. So it is good to be doing
this.
CHAIRPERSON CAPLAN: How to shovel her driveway, I think.
We were in Minnesota together.
DR. LEWERY: I think there is more to shovel.
[Laughter.]
DR. LEWERY: Let me just make a couple of comments. I have
been here now 8 or 9 weeks, not very long, but shortly after
I got here, I was introduced to hepatitis C in the sense
that you are describing it and discussing it today.
For a long time as a patient in a safety-net institution, I
have been on the clinical side of this, and so it is not an
issue that is new to me at all.
But I will say that in all the time I have been doing public
health and health policy, I do not think I have ever
encountered an issue that hsa been as emotionally
contentious, and for which the emotion continues to
overshadow the science and the science to overshadow the
emotion.
And one of the things that I am really looking forward to is
a discussion that helps us see our way clear. I gather that
you had a somewhat emotional morning. I am sorry I missed
it, but I would tell you that since I have been here, I have
been working extremely closely with Drs. Goosby and
Nightingale, as well as Dr. Satcher, to move to coordinate
the Department's response and move forward quickly with
getting different parts of it into gear.
Dr. Satcher has asked me to turn a lot of my attention to
doing that with Dr. Goosby. So that is, I think, moving
forward with some renewed energy.
Also, to comment again, and I know that you know this, our
job here and our task is really to work through making a
decision that is science-based and in the best interest of
the public's health. That is really what we are all about
here today.
So I would comment that I really appreciate all of the hard
work that you are putting into this. I am looking forward
to hearing the results of a thoughtful deliberation that is
really based on science here. That will really help us move
forward.
I am eager to hear about the deliberations today. I am
sorry that I could not come and listen all day, but I am
looking forward to your recommendations because I think this
is a time for us to listen and to learn from your synthesis
of the information.
Shortly after I got into this, I had an opportunity to speak
to a couple of people who have been quite emotional about
this, and one of them said to me at the end, science is what
the public health service decides to hide behind when it
does not want to take any action. I was a little stunned by
that, and I thought about that a lot.
I just want to tell you from my perspective and from Dr.
Satcher's perspective--and I am sure I speak for Eric and
Steve--that is not true, okay? We are really here to guard
and protect the health of the public, and we want to make
the best decision in the public's interest.
I am happy to entertain a couple of questions, but otherwise
I will sit and listen.
DR. GUERRA: I guess I am interested in knowing how much
emotional carryover is there from the experience of HIV/AIDS
in dealing with a lot of the same issue that I think have
certainly added a burden to the current state of HCV
discussions.
DR. LEWERY: You know, it is probably hard for me to gage
that because I cannot fully understand the motives and
emotional places that all the different people I have talked
to about this are coming from. I will comment that it
hardly ever comes up in the discussions in the first couple
of layers.
CHAIRPERSON CAPLAN: Nicki, excuse me.
Is there a Jane Baird here? See Mac. He has got a phone
message that you have to get.
Go ahead. I'm sorry.
DR. LEWERY: I have actually been surprised with the degree
to which it has not come up in the discussion, but people
are sort of emotional about this for its own right.
CHAIRPERSON CAPLAN: Yes.
MR. ALLEN: Actually, this is more of a statement or a
question to the entire panel here, but I have read two
reports over the last couple of months that state that 25 to
40 percent of the people that we know have hepatitis C
contacted it somewhere--an unknown source as being listed a
this point in time. If that is 25 to 40 percent of 4
million people, if that is correct so far, then my question
is: How many other people are we missing through this fact
that we do not know how they are contacting hepatitis C?
This leads back to the reasoning for my thinking about the
extended lookback because I am concerned not only about the
people that we are obviously talking about leaving out with
the lookbacks as they are stated now, but I am also
concerned about the fact that there is a seemingly large
percentage of people who have hepatitis C, and we have no
idea at this point in time how they contacted it.
So that bothers me, and I am just concerned how many others
are out there, how conservative is this 4 million, is this a
high or a low that we have been given. I also hear about
100 million globally. I am really wondering whether the
percentages are based on how many of these people have
gotten it through transfusions or through other sources.
DR. LEWERY: Is that a question for me or a question for
people more broadly?
MR. ALLEN: Anyone.
DR. LEWERY: I guess I would only comment that I think the
CDC and the CDC surveillance process probably are the best
people to give you the exact numbers, but for me, your
comments speak to the real necessity for a really aggressive
public education response, which I think has kicked into
here.
MR. ALLEN: But do you understand what I am saying? There
seems to be a large percentage of people that we cannot go
to them and say that we can tell everyone who has it how
they got it.
DR. LEWERY: No. About 90 percent. There is some chunk of
people for whom we do not know how they got it. It has been
the same for lots of other health conditions and for lots of
other problems.
MR. ALLEN: This 4 million, where did this 4 million come
from? That is what I want to know.
CHAIRPERSON CAPLAN: If you want to, Miriam, go ahead. Did
you want to say just a quick word about that?
DR. ALTER: The National Health and Nutrition Examination
Survey is a population-based survey of a representative
sample of the United States population that is conducted
periodically.
The latest one was conducted between 1988 and 1994, and it
represents the civilian non-institutionalized population of
the United States. That is where the 4 million estimate
comes from.
It underestimates it in the sense that it does not include
institutionalized populations such as correctional
facilities which do contain a high percent, which probably
in many instances have a high proportion of HCV-infected
individuals, most of whom acquired their infection from
injection drug use, but regardless of that, the more recent
studies that have been published have shown that about 90
percent of the infections can be accounted for by a known
route of transmission. So that, we are comfortable with our
understanding of the epidemiology of hepatitis C.
DR. LEWERY: You should also know that we are gearing up for
the next version of the National Health and Nutrition
Survey, and so this kind of activity is the kind of activity
around a number of things that we undertake on a periodic
basis to do all kinds of surveillance.
CHAIRPERSON CAPLAN: I am always deeply, deeply troubled
when people think that numbers are going to have more
solidity than values. There is this old problem about what
is that number. Let's go back at this point to something
that will be a policy moral discussion, the lookback,
because we are not going to get there if we don't get there.
So let's go there.
What I suspect we need to ask is I would take it for granted
we have made a recommendation, nothing about the commitment
to the lookback as it stands will change. We are separating
that issue off right now. There may be some issues about
how to implement an extension in tandem with or consistent
with what has been committed to.
I would suggest to you that you just forget about that.
That will work itself out in one way or another. That is
going to be a detail, if you will, but should we decide to
do a lookback further than what FDA and its revised
September guidance proposed and what is already beginning to
take place and that it is supposed to be completed by March
1998? That is what we are talking about.
What it is going to take to talk about this is actually,
believe it or not, a little bit of a proposal or motion, to
put it on the table. So that is what I am sort of fishing
for next is some language that would get us under discussion
about an extension beyond what has been committed to in
terms of a lookback through identified persons at risk, what
that might look like.
DR. SECUNDY: Well, then I guess you are defining the
context of a lookback through identified persons at risk.
What I was going to ask you to do was to clarify and specify
what lookback translates to because that is where, again, I
am continuing to have my difficulty.
I think that the assumptions that perhaps the science
driving the assumptions of a lookback may present the
problem in terms of the disadvantages to doing a lookback.
CHAIRPERSON CAPLAN: David, here is a test for you. Can you
in two sentences say what do you think the September 1998
guidance to the blood industry is for a lookback right now?
Jay can do this, too, but, I mean, I am looking for
something succinct.
We want a general lookback that relies on public education
and outreach to notify all Americans of the possibility of
risk. That is the general lookback.
Then we have a focused lookback, and I am letting you tell
me the language here succinctly.
DR. EPSTEIN: We call it targeted.
CHAIRPERSON CAPLAN: Targeted.
DR. EPSTEIN: Or donor-directed.
DR. SECUNDY: But what does a targeted lookback entail? It
has all those assumptions that exist with the current
guidelines; that there needs to be education before hand,
that there has to be a certain kind of testing procedure and
mechanism, right?
I want to contrast that with kind of general notification.
I want to make the difference.
DR. EPSTEIN: Right, but they are not actually operating
independent of each other.
The background information to health care providers to
support the targeted lookback is just a subset of the
information that is being provided to educate both the
providers and the general public on the importance of
testing and, of course, how to go about it. So they are
really not separate things. The education campaign is
linked to the two efforts.
DR. SECUNDY: But you have got it phrased.
DR. EPSTEIN: Not really.
DR. SECUNDY: You have got one before the other.
DR. EPSTEIN: Not really. They are rolling out
concurrently.
DR. FEIGAL: The only thing that has phased that we may have
made confusing is the fact that, first, you have to identify
the donor that gave the contaminated blood, and the second
phase which is done by a completely different set of people
because it is done at the transfusion center, identify where
that blood went. They are the ones that have contact.
It is a two-step process that is adherent in the way that we
collect blood in one center and we give it in another, and
they do not share their records with each other.
So that is all we meant by phasing. There is not any way
that the people who collect the blood can actually send
letters to the people who get it because all they know is
the institutions that they ship the blood to.
DR. SECUNDY: My question, though, is: Why is it that we
have to do it that way? Why can't there be a general call
out there in the world that says anybody who was transfused
since 1985 needs to go get tested?
DR. FEIGAL: Well, that was not the recommendation of this
committee or the mandate that Dr. Shalala asked us to do.
DR. SECUNDY: I am saying, can't we revisit those
assumptions? I want to hear the reasons that we cannot
visit those assumptions.
CHAIRPERSON CAPLAN: Jay?
DR. EPSTEIN: In point of fact, the recommendation of this
committee and the recommendation of the public health
service is that anyone transfused prior to July 1992 should
get an HCV test.
DR. SECUNDY: I want to go back further than that.
DR. EPSTEIN: That is an infinite regress.
DR. SECUNDY: Okay, I got it. All right.
DR. EPSTEIN: Anyone transfused, ever, before July 1992.
DR. SECUNDY: By self-definition, not by the center.
CHAIRPERSON CAPLAN: Here it the language that I think we
are fishing for here. We have been trying to concoct it.
DR. NIGHTINGALE: I think the issue that we have bene
dancing around for sometime is whether or not the lookback
should be from a donor who subsequently tested positive by a
multiantigen test, which is the current language, or whether
or not the words should be added "single" or "multiantigen
test." That is one of the issues that the committee needs
to address.
CHAIRPERSON CAPLAN: That is the target.
DR. NIGHTINGALE: We are talking about who gets a letter.
DR. SECUNDY: But forget the letter and just talk about a TV
thing, the newspaper.
DR. SCHIFF: I think Mary is trying to say how do you
implement the general awareness program for if you were ever
transfused before 1992 that you are at risk.
Public service announcements are what is going on. Should
it go to the extreme that a letter goes to every person that
was ever transfused before '92 that says you are at risk,
not that you have it, you are at risk, you should be tested?
That would be one extreme versus just PSAs.
Then, the other one that Steve was talking about is the
second targeted lookback between '90 and '92.
CHAIRPERSON CAPLAN: I actually do not mind having a
discussion at some point about whether we should do the
letter-writing campaign, but let me focus us a little more.
We have a campaign underway to notify everybody who was
transfused prior to 1992 by physician education, PSA, and a
variety of other means. We could ask what Mirian has asked,
which is should we write them, too. That is possible, we
might, but put that on hold.
We are supposed to be looking back for everybody who is at
risk.
We have another population that we know got product,
specifically from someone who tested positive to the
multiantigen test. They are looking specifically because
there is a higher reason to think you are infected.
There is the single-antigen test that some people think we
should also be including in that targeted lookback. That is
the issue I want us to talk about right now.
We can come back, if you want, to the more general ways to
toughen the broad lookback, but the specific question I
think that is on the table is, do we want to add anything
about single-antigen testing, that test period of '90 to
'92, that some people believe would require special
notification because it does indicate that the person might
have been with a fair amount of false positive and false
negative associated, compromised as hepatitis C donor source
getting product from that person.
There are some things that have come up, too. Remember,
there were the little discussions where we begin to think
about the targeted lookback--thank you for that word--that
we have some newer tests. Some people have samples. That
might be a way to sort out whether someone really was an
infected donor then as a part of a lookback strategy, but it
is to the targeted lookback, the addition that I want us to
focus right now.
DR. PENNER: Can I give you a motion to work with, and then
we could go from there? My motion would be to recommend
that we expand the targeted lookback to contact the
recipients of donors identified as hepatitis C-positive by
the first-generation hepatitis C assay implemented in 1990
through '92.
DR. SCHIFF: Second.
DR. NIGHTINGALE: Can we get clarification on the term
"positive"?
DR. PENNER: Repeat reactive, as was originally done for so-called positive exclusion.
DR. EPSTEIN: Well, I think that the central point of
controversy really focuses on the need or lack of need for
confirmation of the screening result.
I think we have gone down the primrose path framing this as
EIA-1 versus EIA-2. It is the fact that supplemental tests
were largely available when the multiantigen test was
approved that changed the dynamic.
The problem that we have with the EIA-1.0 is mainly the
absence of confirmatory testing.
If I could just very quickly recap a few of the numbers that
Miriam Alter told us, if you look at a confirm test, the
likelihood that the notification is based on a donor who at
some point later was found infected is about 90 percent. If
you look at an unconfirmed test, it is only 25 percent.
If you look at the time periods involved, if you are tracing
recipients post-'92, 18 percent alive, pre-'92, only 10
percent alive--if you take the Canadian data, if you go all
the way and test the people who you notify, 60 percent of
those who had true positive exposure will be infected, and
that is probably an upper limit. I will not discuss the
reasons.
When you multiply those figures, what you come up to is
putting aside the question of how many living recipients you
find who then wish to be tested. Your maximum possible
yield for the effort is 1.5 percent if you drive it by
unconfirmed testing compared to 9.7 or nearly 10 percent if
you drive it by confirmed testing.
So what is at issue here, if you want to look at it in terms
of effectiveness, you are doubling the size of the program,
but the second half of the program is operating at one-sixth
the efficiency of the first half. In other words, 98.5
percent of all the effort will be wasted, and I think that
is the problem as it presents itself to public health. That
is where we really have to take a very clear view. Do we
really think it is justified at that level of inefficiency?
Remember, it has been estimated that the cost of the
directed program is somewhere between--I don't know. You
hear figures between 48- and $100 million. You are talking
about doubling it, but at one-sixth the efficiency.
DR. DAVEY: I think just to echo a comment earlier by Jay,
it is not whether we are going to test and notify. It is
how we are going to do it. We are debating education versus
targeted lookback. I think it is important to remember that
both of these things are time-sensitive. The further we go
back in time, the more valuable education is because the
tests are lousy, the records are lost, the patients are
dead. The closer we are to present time, targeted lookback
is more effective because the tests are good, the records
are there.
So what has been proposed by the interagency task force, I
think is a very reasonable overlap of those two approaches,
education for the past, targeted lookback for closer to the
present, and a very reasonable interface in my view is 1.0
with confirmatory testing, extending it, 1.0 with
confirmatory testing as the interface, education from '92
back--
CHAIRPERSON CAPLAN: Do you want to say what you mean by 1.0
with confirmatory? What would that mean to the motion on
the floor?
DR. DAVEY: It means that it extends Dr. Penner's motion to
be more specific to not just 1.0 repeat reactives, but 1.0
repeat reactives with a confirmatory test performed that is
positive plus minus in determining.
CHAIRPERSON CAPLAN: Do you want to make that as an amended
proposal, substitute?
DR. NIGHTINGALE: Not until there is a vote.
DR. PILIAVIN: That would be an amendment, not a substitute
motion, I would think.
DR. GOMPERTS: My problem with the first-generation test of
the EIA-1.0 is that if a donor walked into the blood bank in
1990 which tested negative, that donor could be infected and
could be transmitted.
Similarly, if he was tested positive, he may not be
infected. This is a false positive. So, in reality, if we
are looking for solid day, any information obtained during
that period is highly suspect. In order to try and close
the gap, a possibility to close this gap with some good data
would be to say each one of those donors who has only tested
during that period, multiple-tested, be brought back whether
that individual was positive or negative, and if such a
donor, whether it is a one-time donor or multiple donor and
not repeat tested subsequently with a second generation
procedure, if that donor were to be identified, brought
back, whatever the result, tested and found to be positive,
that lookback then occur.
So the target is initially to bring back the donor.
CHAIRPERSON CAPLAN: I would just like to ask a hypothetical
thought experiment philosopher's question here. You have
got a child. It is between 1990 and 1992. You all have
heard again and again and again the false positive/false
negative, lousy test aspect of 1.0 repeat reactive. You
also know that there is a 40-percent chance now if you put
your kid on anti-virals that their liver won't get eaten.
Would you want to know about the test result from '90 to
'92, repeat reactive, if it was positive? Do you want to
know? I just want to know.
DR. PILIAVIN: Art?
CHAIRPERSON CAPLAN: Would you prefer that someone told you
that I told you in a PSA? I am just asking as a thought
experiment. Would you want to know? You don't have to
answer this. I am trying to put it out there as a moral
question because we know what the strengths and weaknesses
are of a bad test.
We can go over the cost. We can go over the weaknesses of
that test, but the question becomes, if we go out to the
American people and say yes, we had something, but we did
not tell you, are we going to be able to go nose to nose
with them and just say it was just too lousy a test, it cost
too darn much, and we relied on general outreach instead of
the tracking? To me, that is it in a nutshell. Where are
we going to be on that? So a little thought experiment just
to ponder.
DR. GOMPERTS: But the answer to that one is if my child was
transfused during that period of time, I would have the
child tested. I am not interested in the donor. I would
have the child tested.
DR. PILIAVIN: Absolutely.
DR. SECUNDY: That is what I wanted to ask. Why are those
of you who are scientists pushing on the donor rather than
the recipient?
DR. BUSCH: We are not. We have always favored the general.
DR. SECUNDY: I do not understand why you are targeting the
donor rather than the recipient.
CHAIRPERSON CAPLAN: Well, it is because in some instances
when you think you have got a positive donor and someone
knows that they received product from a positive donor,
whatever the weaknesses or strengths of that claim, that is
a fact that they would like to know about, more than just I
got transfused.
DR. SECUNDY: But I am the recipient. I just need to know.
CHAIRPERSON CAPLAN: Maybe.
Let's go. Jim, then Larry, and we will swing over here.
DR. AuBUCHON: This committee has wrangled over what to do
with targeted lookback for multiple days worth of discussion
over multiple years.
We ultimately reached an August ago--reached a compromise
that tended to reflect the best way possible, a public
health policy that recognized the seriousness of hepatitis C
infection, as well as the difficulties of informing
individuals about their potential risk of a hepatitis C
transmission through transfusion.
I recognize that some individuals in the general community,
some individuals in Congress, were not happy with the
compromise that we came up with, but I think we came up with
it with the intention of doing the best that we could for as
many patients as we could under the umbrella of sound public
health policy. I think that we should let this play out.
A hepatitis C targeted lookback is just now beginning. We
should recognize that it is a huge and complex process.
Let's have it work through along the lines that have already
been established by the FDA and then decide whether or not
it is worthwhile putting the additional effort in as Dr.
Epstein was talking about.
I would finally like to conclude by noting that several
speakers this morning talked about the IOM report. One of
the things that was mentioned multiple times in the IOM
report was the importance that all of us that have something
to do with blood banking should place on the musings and the
science that comes out of CDC. We should listen to what CDC
tells us and follow them because they are our public health
guardians, and in this case, I think we should indeed listen
to the experts on hepatitis at CDC.
They have no ax to grind. They are not financially involved
in any of this. They are not doing any of the work. Let us
listen to what they have to say about the best way to inform
people about hepatitis C risks.
CHAIRPERSON CAPLAN: Larry?
MR. ALLEN: What I am going to refer back to is the
statements from Secretary Shalala and Surgeon General
Satcher, and basically, I did not hear any dates. What I
heard is that they both wanted to find as many people as
possible, period.
Now, we can talk about dates all we want, but that was their
statement. I believe we should be working along that
premise, and if there is an issue of how many people get
notified, maybe there is a better way of notifying people.
I don't know. Maybe it is some of the issues we talked
about earlier as far as going through Congress, getting
something changed. I do not know at this point, but they
both made the similar set as many people as possible. I do
not want to be part of a committee that has to go to someone
to say that you were part of the compromise portion that we
just did not get to. I am sorry, but we are getting back to
things that happened 10, 15 years ago, and we do not seem to
be recognizing this.
DR. MOORE: Following up on a number of these discussions, I
think that the spirit of what this committee believes is
very similar to what is in the Shays report, which is that
all--and I think we cannot lose sight of this--is to make
sure that every effort is made to notify and educate people.
We are focussing that effort on a test that is not a good
test. We are going to be, in my opinion, diverting
resources that could be used to accomplish what I believe
the Shays report is trying to accomplish, which is to make
sure that people who receive transfusions get tested.
Again, if you look at the person who got transfused in 1989,
we are not talking about that person at all. I think that
the key issue is that our recommendations should be that we
agree with the spirit of the report and that we support
efforts to be sure that the educational campaigns are in
place to notify all those persons, not just those with the
positive test that is going to miss a number of people. I
just think that that should be our recommendation to the
Secretary.
CHAIRPERSON CAPLAN: Jane?
DR. PILIAVIN: Yes. I would like to get back to this issue
of the right to know in regard to just what we are talking
about.
I want us to think about what the phrase "to know" in this
context means, okay? It is not the right to know a
particular item of supposed test information. What your
right to know is whether you are indeed at risk, and I do
not think we should confuse those two things because to know
the test report between 1990 and 1992 is not to know that
you are at risk.
I am particularly concerned about that 25 percent of people,
I guess the estimate is, who were tested by that bad test,
got a negative, said, "Oh, great, I am fine," and weren't,
and their blood was transfused into people who may indeed
now also, if this targeted lookback goes on, not be
contacted and assume because they did not get a letter that
they are fine, and they are not fine, just like their donor
was not fine. They do not now have the right to know
because nobody is telling them, "You got a transfusion, and
we do not know whether that transfusion was any good."
We are behaving if we do this particular suggested targeted
lookback as if we know they are okay, and I think you have
to worry about the right to know of those people along with
the peculiar problem of somebody knowing that the
transfusion he or she got was bad when it turns out it was
not bad. So then they do not know either. They know
something that is not true.
So I am not so worried about this whole idea that we talked
about this morning of are you going to upset people by
sending them this letter. That is not the point. I think
the only fair thing is to put a lot of effort and funding
into finding people who were transfused before 1992 and
forget about this testing thing.
I think in part the concern and the interest in going after
the people who had positive-tested blood in that period is
an image thing. People are trying to say, "Well, you are
not going to look good if you do not do this." I do not
think that should be our concern. I think our concern
should be in reaching all of those people who do indeed have
the right to know that they were transfused with blood that
is at current with standards uncertain.
CHAIRPERSON CAPLAN: John?
DR. PENNER: This so-called bad test really is a very
sensitive test. As we originally learned, it is not really
any much less sensitive than the present test, and there is
in the neighborhood of something like 15-percent false
negative.
What it is really getting down is to the concern of the
false positives, and so far, initially, we learned, as I
recall watching National Public Television, CDC saying it is
less than 1 percent, are true positives with the test. Now
I see that it has been amended a little bit from the speaker
who spoke on national public television to maybe about a
third. I suspect that it is really more in the neighborhood
of about 50 percent of those are false positives and 50
percent are true-positives, or perhaps it is even 30
percent.
At any rate, I think the testing is not the issue. I think
the fact that the test has proven itself that there are true
positives out there that have not been identified.
So, as I look at the arguments against this, I see, first of
all, the argument comes down to: Well, maybe we are not
going to get them all. Maybe we will get 10 percent or 20
percent or 30 percent, or maybe it is only 1 percent we will
find.
So then the decision is, is that 1 percent worth finding, or
what is the level you expect. If it is 100 percent, you
would go for it. If it is 5 percent, you wouldn't.
The other item then was the alarm situation. Well, you are
going to alarm a lot of people. Obviously, they are going
to get these letters, and they are going to go berserk and
start running around. That is going to happen, I think,
with any kind of letter. There is going to be a certain
group who will become very, very concerned and anxious, and
that is, I think, one of the acceptance of having knowledge
about what is going on in your life and what goes in, in
some of the testing that is being done. You have to accept
the fact that you will get some people who will become
alarmed and it will have to be managed.
So, if you look at those two arguments and disregard and
say, well, maybe even a few are enough--and alarm is one of
the aspects that one is going to have to accept, but it can
be managed--and I would much rather get alarmed than not
know, but perhaps the rest of you would rather not know than
get alarmed. That is a decision you have to make.
That leaves one and only one argument, and the argument is
cost. This seems to be what we are dancing around that
there is a cost to all of this, and there are ways of doing
it and they are going to cost us a great deal. You have to
decide whether that is important enough to let the
individual know, the recipient of this blood, that there has
been a good possibility, perhaps 30 percent, he is one out
of three that has been exposed to the disease.
I see with my fellows and my residents probably about one or
two patients who have unknown liver disease expressing
itself and who have had blood transfusions in the last, have
not the slightest concept that this could have occurred as a
result of the blood transfusion.
Now, I am used to seeing my hemophiliac patients because we
have been tracking those for the past 30, 40 years. I know
which have hepatitis C, those at least that are coming
within our jurisdiction, the same with our sickle cell
patients, but there are a lot of the milder ones that we
have already said that are out there that have no idea that
they have been exposed.
I think these people are really entitled to at least make
their own decisions, and I dislike the idea of the
bureaucracy saying we know best for you, we are not going to
let you know the answers to this question, we will let you
find it out as you watch public television.
CHAIRPERSON CAPLAN: Let's see. Ron?
DR. GILCHER: I have been kind of quiet on this subject, but
I support a lot of what has been said here.
What I think is really important is that--and I want to
reiterate the point that was made earlier, and that is that
the current lookback clearly needs to be continued. It
should not stop.
Jane's point on the general lookback on how to reach people
who have been previously transfused is a good one, but very
difficult to do.
I think that we do need, however, to consider ways to
improve the current lookback, and let me give you a couple
of examples. One is the first-time donor who is not a
first-time donor, and an example of that is a first-time
donor in our system who tells they have donated in another
system. We find them positive. We do no lookback. We do
not notify the other system, the Red Cross right up the road
in Tulsa, for example. There needs to be a way to exchange
that information because they may not have identified it.
That would, in fact, pick up a lot of potential donors.
We have had the reverse lookback, as I call it, where we
have had a doctor's wife in our system who turned up
positive. We did the testing, transfused twice in the
distant past, went back to her records in the hospital
because that was the only way to get them. The blood bank's
records no longer existed, but the patient's records exist,
identified the units, found four donors, but now we have the
problem. Obviously, she received four different donors'
blood. We have four donors who were not tested who we
cannot locate.
So, if she did get it from the unit of blood, we have the
situation of three donors who would be untested, and
theoretically, we would be doing a lookback, if you see what
I am saying, on untested donors. We have not resolved that
issue, but these are considerations.
Then the point that you have made, John, which I think is
important, about extending the lookback--and I think this
goes back to, again, what Jay made so valid, the point--that
is, it is the people with Version 1 who in fact had a
positive supplemental test. Those are the individuals on
whom a lookback should be considered. In our own system, we
will do that because we have both repository samples and the
ability to in fact go back and attempt to reach those
donors. There is on reason why that attempt could not be
made as well, go back and actually notify these donors that
you had a repeat reactive even if you did not have a
supplemental test done. Come back in for testing. All of
these are measures that could improve both the current
lookback and a way to do the extended lookback, but not get
it out of control.
DR. GUERRA: I was going to say that there are several
scenarios that play out in local communities that are not so
dissimilar form this in terms of the population concerns for
populations at risk, and one of those is the environmental
exposures to potentially toxic substances and how they
affect a lot of people.
I guess that some of the guiding principles that we
sometimes have to keep in mind--and I just wonder whether or
not they might be relevant for this--obviously, some of this
has been discussed, but it is how you communicate risk, and
that once you do that, some of the burden for the
responsibility for selecting out those individuals that want
to pursue it further has a lot to do with willingness to
pay.
In some instances, I think that becomes a real ethical
dilemma when you are dealing with those groups that are not
able to pay their own way, but I think one has to assume
some responsibility for them. I think so it is with
hepatitis C.
I think to a great extent, it is a willingness-to-pay type
of issue.
DR. CHAMBERLAND: Just a couple of thoughts. The issue that
targeted versus the general lookback, I think a lot of that
discussion is predicated under an assumption that one
approach is better than another or that one is less good
than another.
I think we have tried to get a handle on that by looking at
data that are available to us from other countries, the
limited data that have been collected to date in the United
States.
I would submit that the answer to that is we do not know,
but I would also submit that it is something that can be
empirically evaluated, and that is the point of the CDC and
ACPER plan to evaluate the effectiveness, if you will, of
the two approaches.
I think that is an important piece of information that we
might want to have before we made a recommendation to expand
the targeted approach, exclusive of triggering targeted on
the ability to confirm Version 1 testing, when that data are
available.
The reason I think it is important to do that is we are
going to walk down this road again, dollars to doughnuts.
There will be other pathogens that come along that
potentially threaten the blood supply, and it will likely
play out in a scenario like this, which is where the first
test that comes along is not as sensitive, not as specific
as subsequent tests. Yet, it is put into place to screen
the supply of blood, which is a very different purpose than
using a test for individual diagnosis with the aim of
pursuing treatment and whatever.
So I think people have encouraged us to look back. They
have urged the committee, if you will, to look
retrospectively back at the lessons that we learned from the
HIV epidemic, but I guess I would also say at the same time,
we should be looking forward because we will happen upon
this issue again.
The way we approach it, our recommendations in the end may
be viewed as precedent-setting, and people will say the
committee did it for hepatitis C, then nothing less can be
acceptable for future agents.
So I was a little bit discouraged by Nicole Lewery's
statement about science being used as something that we hide
behind in public health. I guess I was more optimistic
along the lines of what Kris Moore said earlier that we all
want to do the right thing on this committee, and the right
thing is a complicated decision, but I guess I would hope
that factoring into that in a not insignificant way is a
consideration of good public health policy and practice.
CHAIRPERSON CAPLAN: Let's see. Who else is up there?
Keith.
By the way, I am going to do Keith, Eric, and then I am
going to be looking for a motion again.
DR. HOOTS: I think what you just said is extraordinarily
important and what I have really been debating is. First of
all, I think I can honestly say I think what we proposed
before was reasonable and that it was good.
It was based on a premise which I think is still operative,
and you said it. And everyone in this issue wants to do the
right thing. I think that is why we chose what we did. We
didn't always agree on that, but I think the parallel issue
of assessing what is the right thing is extraordinarily
important, and it can be used as an argument for either
side. That is what makes it even more of a crux.
But I think that being said, maybe as I have really tried to
sort out these issues, if we can come up with a strategy
that is bold and study it for this very bizarre little
window in history, at the same time we pursue the strategy
that we all agree to or virtually agreed to before, that it
is going to take some resources to do that.
I absolutely agree with you. We are going to be back at
this--not we, but somebody is going to be back at this table
sometime sorting with this same issue. I think we have got
to do not only what is right for the individuals, but what
is right for the system. Maybe the right thing is to do
some of both, even to a degree that we haven't already
agreed to do that.
It has taken me a long time to reach that point of view
because I think one of the turning points for me is that I
absolutely agree with what Jim said. I think that the
people at the CDC, the people in the blood banks, everyone
is really trying extraordinarily hard, and everybody is
highly committed to this issue.
I think one of the things we are seeing is that even in our
very best efforts and intents, things always take more time,
effort, and energy than we would have ever guessed, and
ironically, what that says to me is because it takes more
time, but not because it takes more energy, that perhaps
doing some of both is not a bad thing and we find out
essentially which is the better way to go.
So I guess what I am coming down to is I am beginning to
flipflop a little bit on this issue, but I would like to see
a strategy that is well thought out, and I am not sure that
we can absolutely do this in the next 10 minutes.
I think to look at ways to address that population is
extraordinarily important not only because those small but
very important individuals need to know--and we all agreed
with that from the beginning, but also because of what it is
going to teach us about this conundrum in the future.
CHAIRPERSON CAPLAN: Eric?
DR. GOOSBY: I actually wanted to reiterate what Mary said
and Miriam with her data earlier and Jay's summary of it.
It is very difficult to know what to do with a test that has
a poor degree of reliability and identifying an infected
individual.
Juxtaposed against an effort to notify the recipients of
blood, of the potential that they may have been at some time
in the past infused with an agent that they are indeed
infected with, I think that the committee has to weigh what
I think are very intangible weights, looking at what is our
obligation as a society and as institutions within it,
Federal Government in this instance? What is our obligation
to pursue and make every effort to notify an individual of a
potential risk versus relying and having it be adequate for
the general campaign to be the adequate intervention?
Mary is right. They are both attempts to notify, and I
think what the committee has to decide is, is it an
acceptable effort to notify in a general campaign for those
individuals between '90 and '92 versus trying to increase
costs significantly, without a doubt, to gain and better
perhaps target individuals who may or may not be positive.
We cannot tell from the science that they are or are not,
but we know that there is a potential that they could be.
It is weighing that, that I think it really gets down to.
This discussion has been over years. It has been hot and
heated within then Department. People who are highly
credible and dedicated have felt very differently about this
issue, and it has, to some degree, precluded a continued
open discussion around this because of the intensity of the
feelings.
It gets down to for me, and I am talking personally now, as
a provider, as a physician, caring for patients, we must
think about what we are doing in that dynamic, that doctor-patient relationship, that patient-institution relationship,
that fosters or detracts from the trust that a patient may
have with a system that they are engaged in and with the
individuals making decisions with them in that system.
If we are in a position where we can no longer say to the
patient that we have done everything we can and every time
we come to a bifurcation and a decision that we are trying
to consistently and repeatedly look after your best
interests in the making of that decision, we will without
doubt erode the trust further, even more than it has gone
now.
It is that difficult juxtaposition that I think that this
committee really is right at the fulcrum of in trying to
help us make that decision.
What is or is not reasonable is really what it gets down to.
The science is not going to give us the answer here, and I
think the discussion has to incorporate some of those other
issues.
CHAIRPERSON CAPLAN: The only other comment that I am going
to take will be a little one by me.
[Laughter.]
CHAIRPERSON CAPLAN: I actually tried to let the committee
express its views on this issue. We have been around and
around with it. It is back again. I hope we are not around
with it anymore. I understand what Keith was saying about
coming up with a strategy, too, but I doubt we will do that.
I suspect we are going to make a recommendation either to
extend and leave it to the Secretary to figure out how to do
it, evaluate it, make sure that it is moving appropriately,
but we will not do the strategy for what that is.
My personal view has been that we should extend, and it
comes from two reasons. One is that the patient groups keep
telling us that that is what they want, and so I listened to
that closely and think that this trust issue is tipping
toward a constant request that if you have information that
you might be at risk, you tell us. I hear that more from
patients than I do from anyone else, and if we do mean what
we say about patients, then that makes me lean that way.
The other is I never think of this particular extension as a
test to find out whether or not somebody is at risk. I
think it is a warning that they have to then go find out if
they are. So I understand what the unreliability is of a
bad test. It is the positive side. Certainly, there is no
exemption and no relief if you are negative, but I guess I
believe that issue is moot.
The question is if you have positive results, then you have
to go get yourself tested to find out if you do have a
problem or not, and this is just a trigger to that.
Certainly, the case that the general outreach hopes to
achieve the same thing, but what drives me more than
anything else here is listening to--I don't think we have
had a patient advocate testify to this committee since we
met who did not say they thought we should extend. I do not
think we have had any.
So that is my little 2 cents on that matter.
DR. FEIGAL: Could I ask as you consider that, would you
also comment on what you think is a reasonable time frame to
accomplish this is, then? Because you are voting on whether
to extend. You are not spending your dollars. You are
spending somebody else's dollars, and the mechanism by which
you are doing it is the regulatory enforcement.
CHAIRPERSON CAPLAN: David, I am going to jump in and say
no, and I will tell you why. We won't do the strategy. We
won't do the evaluation. We won't recommend today a bailout
if we do decide to extend, and we won't even say what time
frame to do it over.
What I suggest we will do if we vote what is up on that
slide, which is what we have to do here, is to ask the
Secretary to come tell us.
DR. FEIGAL: Let me remind you, though, that doing it
through the FDA means that you have to do it through our
enforcement mechanisms, which means that the centers are
unable to accomplish this must close.
DR. SECUNDY: Art, I do not want to vote on that motion--
DR. PILIAVIN: Nor do I.
DR. SECUNDY: --and it is because it does restrict us in a
very specific methodological way that I think partly he is
speaking to.
I would only vote for that if I thought I could not get
notification of recipients because I will vote for anything
that extends the net, but I do think that that puts a cost
of public policy problem before the Secretary that a wider
recommendation of a lookback does not.
CHAIRPERSON CAPLAN: Understood.
DR. SECUNDY: I think that at least if we understand that--and if I vote against that and then we do not get the other
one, I will be upset.
MR. WALSH: Mr. Chairman, I agree with that statement. I am
more worried about the false negatives than the false
positives.
CHAIRPERSON CAPLAN: The reason I said I was not worried
about the false negatives, just to be clear, I think that
the people who might have taken an assurance in their false
negative test from 9 years ago have taken the assurance and
have gone one and we are going to have to find them somehow
or another.
DR. PILIAVIN: But we will not have any money left to find
them.
DR. SECUNDY: We do not have to find them. We just put out
a notice.
MS. JONES: I have been grappling with this all day. I do
not see the benefits of doing a targeted lookback on that
small window period when RIBA-1 or whatever it was, was
used.
I can see along with Mirian and Jane, and I think this is
what they are seeing. If we look at the CDC general
approach to this, I do not think we should be targeting the
collection centers for the lookback. We need to be
targeting the recipients of the blood.
How can we work to expand the CDC approach, the general
approach, either with a letter to the recipients of blood
from '92 back or some other mechanism other than having
these collection centers go back through the records again
and do the same process they are doing for the current FDA-targeted lookback?
CHAIRPERSON CAPLAN: Maybe I misunderstood something here.
Some of you were saying you do not want to vote on that, and
I thought you meant you did not like the language. What you
are doing now is actually continuing the debate.
So what I am looking for is I would like us to do a vote on
that.
CHAIRPERSON CAPLAN: Do you understand what I am saying in
terms of timing? If I killed that--
DR. KUHN: I think maybe if I can express it, my opinion
right now is for this recommendation that is on the table
and has a second, I would have to vote in favor of it
because for fear that it may not address the issue of the
recipients who may be false positive.
That is why I would have to vote for this. I do not know if
anybody else is caught in this same situation.
CHAIRPERSON CAPLAN: Is what is being asked for, then, a
better motion?
DR. DAVEY: Art, I think it is important we consider that--
DR. SECUNDY: We are asking for a better motion, yes.
CHAIRPERSON CAPLAN: Okay.
DR. DAVEY: --the motion that I considered earlier was that
we specify 1.0 repeat reactive with positive confirmatory
tests. That is a huge difference.
DR. SECUNDY: No, no. That is not--
MRS. O'CONNER: As a consumer who will not understand the
test, but who has a child with hepatitis C and would love to
know how he got it, bag the test. Write as many people as
you can who have had transfusions and say you are at risk,
go in and get tested. That is it.
DR. SECUNDY: I think a public service announcement and
notification as widely as possible.
CHAIRPERSON CAPLAN: I understand.
DR. SECUNDY: That is the alternative motion.
CHAIRPERSON CAPLAN: Let me take the prerogative of the
Chair and say we have a question. It is in the Shays
report. Extend the testing this way.
DR. SECUNDY: No.
CHAIRPERSON CAPLAN: If you want to reject it and then put
another motion on the table to say please write to everybody
who had a transfusion or whatever, I am perfectly open to
that, but I think, if you will, the Secretary is asking us
based on what the Shays report said to extend testing by
single-antigen testing, are you for it.
DR. SECUNDY: Did he specify targeted lookback in the Shays
report? Does it say targeted lookback?
DR. SCHIFF: Arthur, ideally, you would want a letter to go
to everybody who received blood, and there would be three
letters. One is the targeted lookback '92 onward and have a
piece in there that is specific. Second would be '90 to '92
that waters it down because of the false positive, and the
third letter would be someone who all you know is they got
blood. They may not have known they got blood, but you know
it from records.
That may not be feasible, but that is what you want. With a
mechanism like that, every recipient of blood would know it,
and you could give more information where you have it, but
what does that mean? That might be very altruistic to send
a letter to everybody who received blood. That means you
would go to every hospital, every transfusion service, and
you just say they got a blood product, send a letter out.
How feasible is that? I just have to know that. Is it
totally unrealistic?
DR. AuBUCHON: It is totally unrealistic.
DR. SCHIFF: It is?
DR. SECUNDY: Why?
DR. GILCHER: It is a great idea. We have been talking
about it over here.
The problem is that about half of the hospitals in our
system, some 72, have destroyed their records in the past.
I am talking about the transfusion service.
On the other hand, the patients' records exist on microfilm.
That is almost an impossible way to approach it.
For those transfusion services that do have their records,
they have the name of the patient, and they have the product
that they received and the unit number to track it back. So
it probably exists for about half the patients as a
guesstimate, in my opinion, in this country.
CHAIRPERSON CAPLAN: Now, remember, when we talk about the
language that Steve is about to read me, what do they say in
that text there to the Secretary?
DR. NIGHTINGALE: The text of the Shays Committee
Recommendation No. 2, italicized: The hepatitis C lookback
plan should be expanded in regular type two paragraphs. HHS
should immediately take steps to ensure notification of all
recipients of blood from donors who have tested positive on
any HCV screening test regardless of date, period.
CHAIRPERSON CAPLAN: Any HCV screening test is 90 to 92
plus. That is what the recommendation is from your Congress
to the Secretary.
So, again, I am going to say, regardless of whether you
think we should have a letter-writing campaign, a doorbell
campaign, sound trucks driving through the streets, which I
am very interested in, the here and now is you must tell the
Secretary whether you concur with the recommendation to look
back that way. You may amend. We can return to this in
terms of doing better outreach, personal visits, letter
writing. I do not much care. This question is still
sitting there.
So are we ready to vote?
DR. BUSCH: The term that was read was positive. What was
just read was positive on first generation, and here we have
got repeat reactor. So, as long as we know what we are
voting on--as I understand it, what we are voting on is if
you are first generation, if the donor was first-generation
react, repeat reactive, irrespective of presence or absence
of confirmatory tests, we should drive lookback.
DR. NIGHTINGALE: That is how I think the members would
interpret the language, and I believe that was the intent of
the language.
DR. SECUNDY: Could I get clarification on what the
gentleman from FDA said again about what the policy was and
what the problem was with this? Somebody said something
about FDA policy.
DR. FEIGAL: I am talking about enforceability. If we say
it is mandatory, you must complete this by this date, then
that means it for you to be an open blood bank. You will
have completed it by that date or you will be in violation
of the regulations, and we can either at that point have
regulatory discretion and ignore the fact that the blood
bank is not complying with hepatitis C lookback or we can
close that blood bank or transfusion service, which would be
our usual operation, would be to close those centers that
are unable to complete the actions in the time that you have
all specified.
There is no other option. We have no money to give them.
We have no other thing.
You are recommending that you make this mandatory to be a
blood bank or transfusion service in good standing, that you
will complete this process by a certain period of time or
you should not be a blood transfusion service. You may feel
that way, but we are a regulatory body that sets standards,
and you have set into motion putting things into regulation
that are requirements. There is not much flexibility about
this.
DR. PENNER: But not that particular--
DR. FEIGAL: We will have to specify a time period, and
there has been concerns about this not dragging on for 4
years or 9 years or whatever, but, again, I would point out
that you are not spending your own money. You are not
looking at your own resources and wisely parceling them out
and making hard choices.
You are saying someone else should find a way to do this,
and I am saying what your logical conclusion is that you
give them an impossible task and we will either be stuck
with a regulation that is irrelevant that we will just have
to exempt because nobody could do it or we will have to
start saying this is an issue that is so important, that
transfusion centers that cannot do this should close.
CHAIRPERSON CAPLAN: Let me move this past timelines and
address how to do it. All I am asking is that we get the
vote, and I am calling it now. I am sick of waiting for
these motions that are not coming. I want you to vote on
that, non-confirmed, just reactive. If someone wants to
jump in and then give me the Mike Busch-amended version of
confirmed reactive--or Dick or Mike, something.
Give me a second so I do not sound like I am Mussolini here
on this thing. All in favor of that, what is up there, that
we endorse this recommendation back to the Secretary to come
up with a strategy to do a targeted lookback?
[Show of hands.]
DR. NIGHTINGALE: Keep your hands up while I check it.
Without counting the chairman, I have 10 votes for, and I
have one abstention.
DR. PILIAVIN: When did you count the against?
DR. NIGHTINGALE: I am counting them right now.
DR. PILIAVIN: I did not vote yet.
CHAIRPERSON CAPLAN: He took the noes.
DR. PILIAVIN: I thought you were doing the ayes. I am a
no.
DR. NIGHTINGALE: You are a no. That is how you were
counted.
For the resolution, I have Dr. Albrecht, Mr. Allen, Dr.
Guerra, Dr. Hoots, Dr. Kuhn, Mrs. O'Conner, Dr. Penner, Dr.
Schiff, Dr. Secundy, and Mr. Walsh.
Against the motion, I have Dr. AuBuchon. I have Dr. Busch,
Dr. Gomperts, Dr. Gilcher, Ms. Jones.
DR. GOMPERTS: I am an abstention.
DR. NIGHTINGALE: Excuse me. Dr. Gomperts is abstention.
Gilcher is an abstention. Thank you.
Is there anybody else who abstained?
Let me read the votes one more time. In favor, I have Dr.
Albrecht, Mr. Allen, Dr. Guerra, Dr. Hoots--that is four--Dr. Kuhn, Mrs. O'Conner--that is six--Dr. Penner, Dr.
Schiff--that is eight--Dr. Secundy, Mr. Walsh--that is 10.
I have two abstentions, Dr. Gilcher and Dr. Gomperts.
Against the motion, I have Dr. AuBuchon--
CHAIRPERSON CAPLAN: No.
DR. NIGHTINGALE: I am sorry. Dr. Gomperts abstained. Dr.
Gilcher abstained.
I have Dr. AuBuchon and Dr. Busch who voted against the
motion. Is that correct?
DR. GOMPERTS: I'm against. Gomperts is a no.
CHAIRPERSON CAPLAN: You keep trying to take away his
franchise there.
DR. NIGHTINGALE: No, that is not my intent.
Dr. AuBuchon, no; Dr. Busch, no; Dr. Gomperts, no; Ms.
Jones, no; Dr. Piliavin, no.
Did I omit anybody?
[No response.]
DR. NIGHTINGALE: In that case, I have got 10 for, 5
against, and 2 abstained. The chairman did not vote. The
motion carries.
DR. GILCHER: Art, I have a concern here, a point of order.
You called for the vote after the second and gave no time
for discussion of th emotion.
DR. SECUNDY: We had been discussing it.
DR. GILCHER: And I am concerned about that because I wanted
to amend that motion or at least make an amendment, which is
why I ended up abstaining. So there was no time for
discussion.
CHAIRPERSON CAPLAN: The Chair thought we had a lot of
discussion, basically an hour. It may be that there is
something that has not been discussed, but you can add it.
Go ahead.
DR. GILCHER: I wanted to amend this to be a confirmed
repeat reactive by a supplemental test, and then I will vote
it for, which is why I ended up as an abstention.
DR. PILIAVIN: I would have also voted for it if he had been
allowed to put the amendment on it.
CHAIRPERSON CAPLAN: It is a different vote. I understand
what is being asked for, and I think there might be more
votes for doing that, for the amended test, if you will, or
the confirmed test, but I think, to put it another way, the
test as it stood with the sort of duty to worn is what
commanded the 10 votes, as I looked at that.
I understand that there are people who want to amend it or
would endorse that. In fact, we might take a second vote
and say that the whole group supports the confirmed test and
so forth. It does not undermine the first vote. If people
what to go on record for that, I understand that.
What we have done with the 10-vote/6-vote--is that how it
is?
DR. NIGHTINGALE: Ten to 5.
CHAIRPERSON CAPLAN: I understand what was the other
alternative to the motion that was up there, but it seems
to me we have charged the Secretary with coming up with a
strategy to implement, make feasible, cost-worthy, timewise,
not close the blood system and all the rest of it, some
system for getting back to individuals who might have been
positive through a targeted lookback. That is what this
says on a weak non-confirmed test. That is going to be an
interesting task. I suspect it is not the last time we will
be on the issue, then, because there are many tough policy
questions about how to bring that forward.
It seems to me that, however, there is a majority here that
wants the test as it was, just reactive, to be the trigger
to something, and in that sense, the report, I think we are
chasing here, 7, does much the same thing.
DR. PILIAVIN: Art, I think you railroaded that vote. I
think the vote was taken quite inappropriately, and I
believe, just from the discussion I have had with a number
of people around, that if they had had the option to vote
for a more restrictive form of lookback, they would have
rejected the first. The only reason they voted on the first
one was because they thought that it was that--it was my way
or the highway, basically. You, indeed, did railroad that,
and I do not appreciate it.
CHAIRPERSON CAPLAN: We can test that one if you want.
DR. PILIAVIN: I can't test it. It's gone.
CHAIRPERSON CAPLAN: The Chair is open to this. If you want
to make a motion to put the other test forward and see if it
shifts the first vote, it would not bother me.
DR. SECUNDY: I think that there is no doubt that she is
expressing the sense of the group over here. I had said
that that was why I would vote for it.
May I put another motion on the table?
CHAIRPERSON CAPLAN: Sure.
DR. SECUNDY: Perhaps we can resolve this, and at least I
will feel comfortable.
DR. PILIAVIN: As someone who voted for it, you can ask for
a re-vote.
DR. SECUNDY: No, I do not want to do that. I just want to
throw what I really want out there which is that I would
urge the Secretary to initiate and support the CDC and the
development of public service announcements to all at risk,
members of this population, using the CDC mechanisms and
strategies, whatever that appropriate language is for so
doing.
DR. PILIAVIN: The money will all be gone.
DR. KUHN: Mr. Chairman, can I just bring up a point of
order? I know parliamentary procedure pretty well, and what
I understand is that Dr. Penner brought up a motion. It was
seconded by Dr. Schiff.
You as the chairman opened up the discussion for questions
and discussion, and then you called for the question which
is parliamentary procedure. Then it was voted upon. It did
pass.
Now, it is proper parliamentary procedure for someone else
to bring up another recommendation if they so choose, and
Marian is doing it, which is proper parliamentary procedure.
CHAIRPERSON CAPLAN: Correct.
DR. SECUNDY: I mean, which Marian? There are two of us,
right?
CHAIRPERSON CAPLAN: This Marian.
DR. SECUNDY: Me, Marian.
CHAIRPERSON CAPLAN: Dr. Secundy.
DR. SECUNDY: My motion is on the floor, okay? I do not
know if anybody seconded it.
DR. NIGHTINGALE: Responsible state one more time, please.
DR. SECUNDY: Okay. We urge the Secretary to use the good
offices of CDC to develop a public service announcement for
all at-risk recipients of blood--you know, I mean, I don't
know the proper language there, but for at-risk recipients
with advice and urging them to be tested.
CHAIRPERSON CAPLAN: The reason I think there is some
hesitancy about this particular motion is I suspect that is
what we think we have got with the general lookback, am I
right?
DR. SECUNDY: We do not. That is not defined that way, and
I kept asking what a general lookback was. I do not hear
anything in the language that talks about notifying the
recipients. We keep talking about donors, and that is in
the context of, quote/unquote, "the public health science."
I really have a lot to say about that.
CHAIRPERSON CAPLAN: So, on the motion, then, Steve, the
language is something like the Secretary direct the CDC.
DR. NIGHTINGALE: Yes, to develop public service
announcements to notify--
CHAIRPERSON CAPLAN: Directly notify.
DR. NIGHTINGALE: --all recipients at risk or recipients of
blood or blood products--or recipients of blood or blood
products of their risk for hepatitis C.
DR. SECUNDY: And public service announcement and other
strategies, other appropriate strategies, you know, because
the CDC has a whole armamentarium of activities that it does
relative to these kinds of things.
I mean, you know, use their good offices to do them.
DR. KUHN: Communications strategies.
DR. BUSCH: I wanted to address not that specific motion,
but sort of a supplemental motion. I think it was passed,
and I recognize it was passed. I do feel some level of
railroading myself, but what was passed was the
recommendation to extend the lookback to first generation.
I think there has not been enough time to review and discuss
our options for fine-tuning that. For example, I have data
that I could present that would show if we simply use the
reactive ratio of the screening test, we could capture 90-plus percent of the confirmed positives and avoid notifying
approximately 70 percent of the false positives.
Strategies like that, that I think need to be explored,
perhaps within HHS, I would recommend be brought back to
this committee, and before proceeding with an explicit plan
that this committee have the option to review and comment
and potentially vote on specific recommended approaches for
implementing a first-generation triggered lookback.
CHAIRPERSON CAPLAN: Is that a motion?
DR. SECUNDY: There is a motion on the floor. Excuse me.
Point of order.
CHAIRPERSON CAPLAN: That is true. There is a motion on the
floor. Let's ask for a second and a discussion, then, of
Marian's motion, if that is the way to move that one along.
DR. SCHIFF: Second.
CHAIRPERSON CAPLAN: All right.
DR. SCHIFF: I would like to raise a discussion. I think if
we are going to have public service announcements which I
think are planned that I would embrace all risk factors for
hepatitis C as the CDC wants to do, not just transfusion
recipients, and I think you have to separate that from
specifically notifying all recipients of blood before 1992.
That is what I was begging the question before. Is that
totally unrealistic?
Because if it is not, I think that ought to be done.
DR. SECUNDY: Could I say something? Because I think I need
to respond, Dr. Mary, in relation to earlier comments that I
think keep surfacing around the whole issue of the
evaluation of the need to take time. I think it also maybe
is speaking, from my perspective, to what you are saying.
I was struck with how emotionally concerned I was when Dr.
Lewery was here and was talking about kind of a dichotomy
between science and emotion, and I finally was able to put
into context for myself what I am really dealing with.
It will help me to explain the importance to me of this
motion. Science for me is also an art. It is value-laden.
The public health policies are value-laden, and we make the
assumption that they are good, but science, hopefully, is
about caring. Caring most effectively in my opinion--and I
think it was said over here earlier, it expresses itself
with emotion and with feeling.
What I am struck with when I hear talk about waiting to
evaluate data, in the context of a situation in which we
know that people are dying and that even if they do not come
forward to do anything about themselves, that they at least
should know that they are at risk, and that we can make them
better if they will come forward. Even if the current
treatment does not work, we know something about changing
lifestyle that can work.
If we do not do that, when we know that we can because we
are evaluating and we are doing controlled studies and we
are doing studies, what it says to me--and this is the
emotional part of it--and I do this with total deliberation,
but it is important that you understand that what that says
to me is the public health service had put health policy
when it did the Tuskegee study, and this is good health
policy. And I must go on record and say I cannot support
this good health policy either.
CHAIRPERSON CAPLAN: I have got a motion and a second. More
discussion on the motion?
DR. NIGHTINGALE: Is that your motion?
DR. SECUNDY: [Nodding head up and down.]
CHAIRPERSON CAPLAN: So what we are talking about is
strategies for recipient notification focus. That is really
what the heart of the thing is.
DR. EPSTEIN: Art, I am confused because what is being
called for is what is already being done. So why is there a
need for this? In other words, the current public service
announcement says if you have got a transfusion, if you were
a recipient prior to July 1992, you should get a hepatitis C
test. That is what you are calling for.
DR. SECUNDY: Where are those public service announcements?
DR. EPSTEIN: I will let the CDC answer that.
DR. CHAMBERLAND: The handout, Miriam Alter outlined in her
presentation, and I hope you got a copy of the slides. They
outlined the time frame and what would be done, what has
been done and what would be done as part of that outreach.
And the kickoff for the more formal PSAs, et cetera, was
given as March of next year.
DR. SECUNDY: That is not, I guess, immediate then. We need
to put immediate. I mean, March of next year--I did not see
a procedure for distribution of these in that, in her
report, but it is perhaps here and I missed it.
DR. CHAMBERLAND: Do you want to say anything else?
DR. MARGOLIS: I guess in this whole debate about general
lookback, everybody is focused on public service
announcements. I would hope that we realized that we are
really going much farther than that.
I guess I can go back to at least what we have done very
effectively in the immunization arena and one that is going
on right now, and that is get your flu shot. How do you
make sure the right people get their flu shots?
Well, there is all types of health systems out there in
which you can identify high-risk individuals, in this case,
individuals who have had blood transfusions. What we see
happening and what we have already had discussions and what
we would clearly push as part of this whole general lookback
issue is that in fact anybody in your practice, be it a
highly specialized one, be it in a large managed care
organization, would in fact be identifying those people so
that they can be given information about testing.
I mean, I think this is public health practice, and what we
have discussed internally and externally through this whole
debate--and it is not just public service announcements.
Yes, the highly motivated individual who happens to read,
who can read, who happens to read or happens to hear the
information may go to their physician, but the other side of
it is that we know the way we make these things happen is
that the practitioner in fact recommends this to the patient
when you are in that 5-minute or 15-minute encounter,
depending on what your own practice situation is, but it can
be done. That is all part of this general lookback.
So I guess that is kind of my--I have been pretty silent
about this, but the fact is, it has been discussed in many
forms about the breadth of this type of activity.
DR. SECUNDY: But I guess my motion does not really speak to
the issue because the practice environment is not the
environment which I am talking about.
The people that I am talking about needing to be targeted
are not in a practice environment. They rarely see a
doctor, and I will say that from my own personal experience,
there are physicians who still have not been affected by
this information and are not sharing it with their patients.
So, when I am talking about public service announcements,
maybe I am not doing it then in the context of traditional
CDC activity. Perhaps I am talking about t he kind of
public service announcements that we see on the media--in
the media, and I do not know how we can then move that
forward.
But I am talking about people who are not going to doctors,
who are not seeing the doctors, the family members of the
deceased people that you are talking about who may not ever
know that they were at risk until they hear this and the
friends.
I am concerned that we are talking about what appears to be
an increasing population of people who are infected with
hepatitis C, and there is not a clear explanation for why
there is this increase.
CHAIRPERSON CAPLAN: Let me--
DR. GUERRA: Art, if I could just try to provide some
reassurance, the National Association of City and County
Health Officers has an ongoing project specifically to do
that at the level of local health departments to target
those populations that are outside of traditional systems of
car whether it is via public service announcements, via
outreach efforts into the communities of risk.
There are some communities that have dealt with it in a
culturally relevant way by developing materials that are
taken to the communities, whether it is IV drug users or
prostitutes or those coming out of jails, for example, to
specifically target those that are not connected to
comprehensive systems of care.
I think that the efforts, especially in larger and center
public health departments, is to link up the public and the
private sectors so that the safety net providers can work
more closely with the private sector for those population
groups that sort of are quite mobile and move across all
systems.
DR. SECUNDY: Would the motion be more appropriate, then, if
it were speaking to CDC working with State and local health
departments? Where should--
CHAIRPERSON CAPLAN: Marian, let me make a suggestion.
DR. GUERRA: But that is happening.
CHAIRPERSON CAPLAN: Let me make a suggestion. I would like
to ask if you would consider withdrawing this motion for now
because we can come back to it. I understand what you are
fishing for in terms of hitting the appropriate communities.
The reason I say that is I would like us to think about one
more thing before we go. I hear people saying on the
targeted lookback vote that, while some are for it and some
are against it, they also do not want to be in a situation
where they wind up saddled with the strategy that would
allow for a complete consensus to emerge on what exactly is
a worthwhile cost-effective, doable, practical way to pick
up and extend a lookback.
So the Chair is understanding of that. I think, if I could,
if I could at least get you to pull the motion back for a
second, I suspect I can get the other comment about
listening to what Mike Busch was talking about, which was
asking the Secretary pursuant to what we voted on here to
present some options, including the confirmatory, that we
would then consider as the way to implement.
I think we voted, and what Dana said I believe to be true
that we had a vote about something to look back, after
plenty of discussion, more than percentage-wise than
anything else.
I also hear the group saying, now, wait, almost all of us
can climb on board here if we are not going to get a
strategy for the extension that is going to be not sensible
relative to picking up 95 percent and 90 percent of what is
out there.
I understand what is being said about that, too. I would
not mind. Can I get you to pull that out for now?
DR. SECUNDY: Yes, absolutely. Again, it just verifies what
I tried to say you about a half-hour ago. I mean, I think
we could have worked with that other one.
CHAIRPERSON CAPLAN: Right, but let's see if we can leave
today, and then we will return to what CDC might do for
recipient notification and non-traditional audiences, what
we are starting to talk about here, how do you get PSA
announcements to the uninsured or the people who do not have
television sets, which I hear about.
Could we agree or could I entertain a motion that would say
we would like to then see from the Secretary strategies for
implementation of an extension that we would then deliberate
about next time? In other words, what I said here is we
have no time frame. There is no cost number. Nothing is up
there except we want to extend it off the trigger, but I
think it would be useful for us, and I think it would
probably get us pretty far if we said okay, then let's hear
the strategic developments and possibilities that are out
there.
I do not think we what to do what Dr. Feigal is warning
about, which is to shut the blood banks down that can't. I
doubt that is our recommendation. At the same time, I
suspect there may be places where the Secretary may say,
"Well, having consulted with experts, this is a strategy to
go for more extended lookback. This is a time frame. This
is what your options are. Think about them."
DR. HOOTS: First, I would like to second Mike's motion, and
I would like to ask--and I do not know quite how to phrase
this--for a friendly amendment to take into consideration
what Mary and I had said previously, which clearly had a lot
of--for me at least, a lot of motivation for how I vote, to
say that whatever final strategy is developed that resources
become available to study the benefits or the efficacy of
that strategy in relation to the broader strategies of at-large education. I think this is a question we absolutely
need to know in a better way than we know today about.
DR. PENNER: Does Ron and Mike want to bring up that if you
repeat test a donor who was positive by the first generation
and find it is negative, you exclude those from lookback, or
do you mean just if those that you gather that you can
repeat the testing, you handle, and then forget about the
ones you cannot find?
DR. BUSCH: It is more complex than that. The current
motion that was approved called for notification of all
prior recipients for repeat reactive donors.
Taken to the extreme, that says even if we have a
confirmation negative, which we have for about a third of
those, one would have to trigger the notification.
In terms of the donors getting them back, I mean, what we
have heard is that only about 20 percent of these donors who
have been lost to the system for up to 10 years will come
back. If they come back now 10 years later and they are
negative, that does not necessarily mean they were in fact
not infected 10 years ago. People serorevert. After they
are cleared of aeremia, they serorevert.
I think all of these issues are relevant for discussion, but
I think it is a lot of time and discussion, both outside and
inside this committee that is necessary to really formally
develop a policy that is based on data and science.
DR. PENNER: I am looking for that motion.
CHAIRPERSON CAPLAN: Did you want to try that one?
DR. BUSCH: Well, what I would move would be that this
recommendation not be implemented until internal PHS debate
has evaluated options, strategies to refine the notification
process, to maximize yield and minimize non-specific
notifications.
DR. AuBUCHON: Second.
CHAIRPERSON CAPLAN: Did you get that down?
DR. NIGHTINGALE: Let me see if I have got it. We moved
that implementation of the prior recommendation be deferred
until public health service has had an opportunity to review
it and present options for its implementation.
DR. BUSCH: Right, to the committee for further vote,
further deliberation.
DR. SECUNDY: Is that not automatic?
CHAIRPERSON CAPLAN: Do you want to try that as a--
DR. SECUNDY: Is that not automatic the way that the agency
works, anyway?
CHAIRPERSON CAPLAN: We are going to do something, but we
would like to hear by, I would assume--when is our next
meeting?
DR. NIGHTINGALE: January 28th and 29th.
DR. GUERRA: So is that the time limit, Art, that we are
going to impose on that?
CHAIRPERSON CAPLAN: Yes.
DR. GUERRA: By the time of the next meeting.
CHAIRPERSON CAPLAN: Yes, right.
We will take that from the Amendment by the next meeting.
DR. NIGHTINGALE: Until PHS has--
DR. GUERRA: What kind of information will we be asking for?
Cost-benefit analysis? Science?
DR. BUSCH: Well, again, I can show you data that I think
would be very convincing that would allow you, I think, to
recommend that we should use the single cutoff on the EIA to
stratify these. If we look at the data, you could catch 90
percent of the confirmed positives and avoid about 75
percent of the false notifications by simply looking at the
single cutoff on the EIA. That kind of data, the issue of
if we have confirmed data, that clearly it is inappropriate
to notify the confirmation negative and I think the
indeterminates. You guys need to see the data that
justifies those.
DR. PENNER: That is by the level of the cutoff?
DR. BUSCH: That is correct.
MR. ALLEN: All I want to know right now is what do you tell
the people that you do not reach, that you decide that are
not going to be notified. What do you tell them? That is
what I want to know because I do not understand this. We
need to notify everyone. I do not understand this. What
are you going to tell the people that you could have
notified, but you did not?
DR. AuBUCHON: We are trying to make public health policy
here. It is difficult to do, obviously, and it is different
than the practice of medicine at the bedside.
MR. ALLEN: Making policy does not mean you do not notify
people that should be notified. There is a difference
there. That is all I want to know. What do you tell the
people that should be notified that you are deciding here
and now will never be notified?
DR. AuBUCHON: It is my interpretation of this committee's
deliberations that we are trying to find the best way
possible within the public health system and the medical
care system of this country to notify as many people as
possible with as much information as we have.
MR. ALLEN: That is not what you are saying. That is not
what you are saying.
CHAIRPERSON CAPLAN: Let me--
DR. AuBUCHON: Could I please complete my comments?
Please understand that any decision that this committee or
public health service or the FDA may make regarding
extending this notification is not going to have an impact
tomorrow on what we are doing.
We are going to be doing lookback on Version 2 and Version 3
for years to come, regardless of the FDA requirements, even
giving our very best efforts. It is going to take years to
complete this.
So whether we include Version 1 today or next January or
next March really is of no consequence in terms of the
actual practical timeline of implementation.
MR. ALLEN: It still gets back to what do you tell the
people who should have been notified that you are now saying
will never be notified. What do you tell those people?
DR. AuBUCHON: I am not saying that any person should not be
notified. I am saying that there are different ways of
notifying different groups of people.
CHAIRPERSON CAPLAN: Let me jump into this and say I think
what we have done with a vote is gone over a certain hurdle
about trying to extend off of the test, that is, the single-antigen test.
If you want, there is now a motion on the floor from Mike
Busch that says we would like to have pretty quick some
implementation strategies for what that is, and if I get a
second on that, I suspect that what Jim AuBuchon said is
true.
Over Christmas, no one will be told anything. By January
28th, somebody should be sitting here with some strategies
where we can then pick up the debate about if we said
trigger the test and tell what dates, what timeline, what
science really makes that cash out.
I doubt anybody will find out anything before January 28th.
I am praying that if we pass this motion that is up on the
floor, we might find out some strategies by January 28th.
So, in that spirit, I am looking for a second.
DR. PILIAVIN: I already heard a second, but I will second
it again.
CHAIRPERSON CAPLAN: Can I move a vote on that? All in
favor?
[Show of hands.]
CHAIRPERSON CAPLAN: All right. Opposed?
DR. NIGHTINGALE: Dr. Secundy.
DR. SECUNDY: I would like to write a dissenting piece to go
along with this.
CHAIRPERSON CAPLAN: Now, you have something you wanted to
tell them about comments.
DR. NIGHTINGALE: Yes. I would ask that the--it is ordinary
practice for committees, including this one, although we
have not practiced it prior, to keep the committee record
open for a period of time afterward so that members of the
committee may, if they wish, add supplemental testimony to
it.
I will be able to find you the CFR, if you want. I cannot
pull it out off the top of my head. I would encourage
members who wish to provide additional written information
for the records of this meeting to do so. They may indicate
to me whether they wish their supplemental comments to be
posted along with the transcript of this meeting on the web
site, which as I said will be posted hopefully no later than
Monday or whether they wish it simply to be maintained in
the records of the committee.
Either way, these additional comments by the committee
members, including all committee members, would serve an
important role in the development of these additional
strategies by the public health service. So I would beg,
rather than just request, that anybody who wishes to make
additional written comments to public health service do so
through that mechanism.
CHAIRPERSON CAPLAN: Dr. Hoots reminded me on the motion
that just passed, for the record of the tape, that we had an
evaluation addition, just a word in there and will we write
that one up about the strategies so that we are watching
what we are doing as we proceed along.
I am going to suggest at this point that we end our business
for today, having worked hard, and emotionally, but, Steve,
I know we are going to be looking to get this options
strategies in front of us, and we will be revisiting yet
again lookback off the antigen test, but there was one other
topic, I think, that you wanted to warn us was coming up at
the next meeting?
DR. NIGHTINGALE: I will be sending the committee additional
information about several matters of interest. One was a
recent vote of the FDA's Blood Products Advisory Committee
on leukodepletion. A second will be a notification of the
outcome of the FDA's TSE Advisory Committee which is meeting
on December 18th. I believe that Drs. Gilcher and Hoots
will both be present at that meeting. Dr. Gilcher will be
present at that meeting.
CHAIRPERSON CAPLAN: They are representing you, by the way.
DR. NIGHTINGALE: If not more.
I think that there will be additional information as it
becomes available about emerging viruses. There has been
stuff about TTV and perhaps about HHV8. Finally, there is
some discussion about re-looking at the national blood
policy. That may be in the remote or in the immediate
purview of the committee.
CHAIRPERSON CAPLAN: You actually did not hit the one I
thought you were going to tell them, IVIG.
DR. NIGHTINGALE: IVIG remains a concern of the public
health service, and you were provided with updates and you
will continue to be provided with updates as they become
available to us.
CHAIRPERSON CAPLAN: So we will have discussion on the
lookback issue strategies, concrete implementation, what are
we really talking about, if we are extending, and then we
have to go back and look at IVIG, just again as the
prerogative of the Chair. There is a lot of reason to be
concerned that production is still not coming online, and
shortage is going to be there.
I know John is eager to at least say one word about this.
MR. WALSH: Yes. Pursuant to my charge, the report on the
IVIG shortage is a continuing report. I have asked the
chairman to present. He has requested that we defer and
forward by mail to all committee members, Dr. Nightingale, a
full report on the IVIG shortage and other plasma derivative
shortages, and would strongly recommend that this committee
be prepared to discuss that in more detail at the next
meeting.
CHAIRPERSON CAPLAN: The manufacturing situation is not
better. It continues to be troublesome, and I think that
some of the issues we talked about, about distribution, are
going to be with us again, talking about things we have to
revisit.
DR. PENNER: The costs have gone up about ten-fold.
CHAIRPERSON CAPLAN: So there is something very still
pressing about that area. So we are going to have to come
back and take a look at the January meeting on that, too.
What are the dates on that one, the 28th and 29th?
DR. NIGHTINGALE: January 28th and January 29th.
DR. CHAMBERLAND: One final parting PSA, I wanted to make
sure that the Advisory Committee members were aware that
part of the packet of information that was awaiting for you
at your desk included an announcement of a workshop that is
going to be held January 14th and 15th in Atlanta that is
sponsored by CDC, FDA, NIH, and the Department of Defense.
The workshop is to look at the potential for transfusion,
transmission of tick-borne agents, and it will be a meeting
that will take place, as I said, January 14th and 15th.
Information is included as to how to register for that, and
I would encourage and invite all of you to try to attend
that.
CHAIRPERSON CAPLAN: Well, have a nice holiday. I will see
you all recharged and ready to talk in January.
[Whereupon, at 3:28 p.m., the meeting was concluded.]
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