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Blood Safety: Resolution - November 1998



Tuesday, November 24, 1998

8:39 a.m.

Omni Shoreham Hotel

2500 Calvert Street, N.W.

Washington, D.C. 20008



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


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



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


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 Safety.

Now, would the Chairman and members please signify their attendance when I call their names? Dr. Caplan?


DR. NIGHTINGALE: Dr. Albrecht?

DR. ALBRECHT: Present.


MR. ALLEN: Present.


DR. AuBUCHON: Present.

DR. NIGHTINGALE: Dr. Busch? Dr. Busch?

[No response.]

DR. NIGHTINGALE: Dr. Chamberland?








DR. NIGHTINGALE: Dr. Gomperts?






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. KUHN: Present.


DR. McCURDY: Here.


DR. MOORE: Here.





DR. NIGHTINGALE: Dr. Piliavin?

DR. PILIAVIN: Piliavin.

DR. NIGHTINGALE: Piliavin. I apologize once again.

Captain Rutherford?









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. 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?


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. 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. 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.


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.


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. 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.


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.


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--


DR. ALTER: Do you mean in terms of the hemophilia community?


DR. ALTER: That would not--it didn't, but it would not increase that percentage substantially. Not that it isn't an important group.


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.


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.


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.


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?


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.


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.


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.


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.


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?


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.


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?


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.


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.]


[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?


DR. SECUNDY: We will assume she knows what they are?


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.


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: 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.]


[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.


DR. NIGHTINGALE: To coordinate hepatitis C. What did you say? Education and prevention and notification efforts?


DR. MOORE: "Prevention" sort of encompasses the notification process and education.

DR. GOOSBY: Did you also want to facilitate treatment?


DR. PENNER: Similar to the HIV program?


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?


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.]


[No response.]

DR. AuBUCHON: Mr. Chairman?


DR. AuBUCHON: Could we continue the discussion of resources?


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?


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.


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.


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.


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.


[Show of hands.]


[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?


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.


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.


[Show of hands.]


[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.


[Show of hands.]


[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?


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.


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.


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.


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?


So moved?


[Show of hands.]


[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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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. 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.


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.


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.


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.


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. 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--


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?


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?


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.


DR. SECUNDY: I mean, which Marian? There are two of us, right?


DR. SECUNDY: Me, Marian.


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.


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.


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?


DR. GUERRA: By the time of the next meeting.


We will take that from the Amendment by the next meeting.


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.


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. 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.]