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505


UNITED STATES OF AMERICA


DEPARTMENT OF HEALTH AND HUMAN SERVICES


FOOD AND DRUG ADMINISTRATION


CENTER FOR BIOLOGICS EVALUATION AND RESEARCH


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TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE


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9th Meeting


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Thursday,


June 28, 2001

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The Advisory Committee was called to order at 8:30 a.m., in the Versailles Ballrooms I and II, of the Holiday Inn-Bethesda, 8120 Wisconsin Avenue, Bethesda, Maryland by Dr. David C. Bolton, presiding.

MEMBERS PRESENT:

DAVID BOLTON, Ph.D., Chairman

JOHN C. BAILAR, III, M.D., Ph.D.

ERMIAS D. BELAY, M.D.

DONALD S. BURKE, M.D.

DEAN O. CLIVER, Ph.D.

STEPHEN J. DEARMOND, M.D., Ph.D.

BRUCE M. EWENSTEIN, M.D., Ph.D.

MEMBERS PRESENT: (continued)

LISA A. FERGUSON, D.V.M.

PETER LURIE, M.D.

J. JEFFREY MCCULLOUGH, M.D.

PEDRO PICCARDO, M.D.

SUZETTE A. PRIOLA, Ph.D.

SHIRLEY JEAN WALKER

ELIZABETH S. WILLIAMS, D.V.M., Ph.D.

WILLIAM FREAS, Ph.D., Executive Secretary

GUESTS PRESENT:

RICHARD DAVEY, M.D.

DR. LOUIS KATZ, M.D.

DR. HARVEY KLEIN, M.D.

STEPHEN PETTEWAY, JR., M.D.

CONSULTANTS PRESENT:

PAUL R. MCCURDY, M.D.

KENRAD E. NELSON, M.D.

STANLEY B. PRUSINER, M.D.

C O N T E N T S

PAGE

I. Administrative Remarks by Dr. William Freas 4

II. Opening Remarks by David Bolton, Chairman 10

III. Presentation by Dr. David Asher 12

IV. Presentation by Dr. Joachim Kreysa 37

V. Presentation by Jean-Hugues Trouvin 59

VI. Presentation by Christl Donnelly 71

VII. Presentation by Antonio Giulivi 95

VIII. Presentation by Alan Williams 124

IX. Open Public Hearing 196

XI. Committee Discussion, Conclusions, Votes 252

XII. Topic 2, Introduction, Charge,

and Questions by Dorothy Scott 402

XII. Presentation by Robert Rohwer 361

XIII. Presentation by Henry Baron 399

XIV. Presentation by Jeff Davies 420

XV. Presentation by Gordon Busenbark 429

XVI. Presentation by Christopher Healey 439

XVII. Open Public Hearing 474

XVIII. Committee Discussion, Conclusions, Vote 482

XIX. Adjournment for Day One 507

P R O C E E D I N G S

(8:00 a.m.)

DR. FREAS: I would like to welcome everybody to this, our 9th meeting of the TSE Advisory Committee. I am Bill Freas, the Executive Secretary for the Committee, and both days of this meeting will be entirely open to the public.

At this time, I would like to go around to the head table and introduce those that are seated at the head table. Would the members and guests please raise their hand when I call out their name.

At the end of the table is Dr. Donald Burke, Director for the Center for Immunization Research, Johns Hopkins University.

The next chair is occupied by a standing member of this committee, Dr. Elizabeth Williams, Professor, Department of Veterinary Service, University of Wyoming.

Next is Dr. Jeffrey McCullough, a standing committee member, and he is a Professor in the Department of Laboratory Medicine and Pathology, University of Minnesota.

The next is an empty chair, which will soon be filled by Dr. Stan Prusiner, Professor of Neurology, University of California Institute of Neuro Degenerative Diseases; and Dr. Prusiner will be a temporary voting member for this meeting today.

The next individual is a standing committee member, Dr. Peter Lurie, a medical researcher for the Public Citizen's Health Research Group, Washington, D.C.

And in the next chair is our consumer representative, Shirley Walker, Vice President of Health and Human Services, Dallas Urban League.

Next is a standing committee member, Dr. Dean Cliver, Professor, School of Veterinary Medicine, University of California at Davis.

Around the corner of the table is a new committee member, and I would like to welcome all our new committee members, the first one being Dr. Stephen DeArmond, Professor, Department of Pathology, University of California, San Francisco.

Next is another new committee member, Dr. Suzette Priola, Investigator, Laboratory of Persistent and Viral Diseases, Rocky Mountain Laboratories.

We will soon be joined in the empty chair by a temporary voting member for today, and he is Dr. Kenrad Nelson, and he is also Chairman of the FDA Blood Products Advisory Committee, and he is a Professor in the Department of Epidemiology, Johns Hopkins University School of Hygiene and Public Health.

Next is the Chairman of this Committee, and he is Dr. David Bolton, head of the Laboratory of Molecular Structure and Function, New York State Institute for Basic Research.

Next is another new committee member, Dr. John Bailar, Professor Emeritus, Department of Health Studies, University of Chicago.

Next is a standing committee member, Dr. Ermias Belay, a medical Epidemiologist, Centers for Disease Control and Prevention.

Around the corner of the table is a standing committee member, Dr. Lisa Ferguson, Senior Staff Veterinarian, U.S. Department of Agriculture.

Next is Dr. Pedro Piccardo, Associate Professor, Indiana University Hospital; and next is a temporary voting member, Dr. Paul McCurdy, Consultant to the National Heart, Lung, and Blood Institute.

Next is a standing committee member, Dr. Bruce Ewenstein, Clinical Director, Hematology Division, Brigham and Women's Hospital of Harvard Medical School.

Next is a guest for today from industry, Dr. Stephen Petteway, Director of Pathogen Safety and Research, Bayer Corporation.

Next is a guest, Dr. Richard Davey, and he is a representative from the Public Health Service Blood Safety and Availability Advisory Committee, in Washington, D.C.

Next is an invited guest, Dr. Lou Katz, Vice President for Medical Affairs and Medical Director for the Mississippi Valley Regional Blood Center, Davenport Iowa.

And at the end of the table is a guest, Dr. Harvey Klein, Chief, Department of Transfusion Medicine, National Institute of Health. Welcome to everybody.

Dr. Pierluigi Gambetti is a new member of this committee who could not be with us today. I would now like to read into the open public record the conflict of interest statement for this meeting.

The following announcement is made part of the public record to preclude even the appearance of a conflict of interest at this meeting. Pursuant to the authority granted under the committee charter, the Director for the Center for Biologics Evaluation and Research has appointed Drs. Paul McCurdy, Kenrad Nelson, and Stanley Prusiner, as temporary voting members for the meeting.

Dr. Lester Crawford has been appointed as a temporary voting member for tomorrow's session. Based on the agenda made available, it is has been determined that the agenda addresses general matters only.

General matters waivers have been approved by the Agency for all members of the TSEAC Advisory Committee, as well as consultants for this meeting.

The general nature of the matters to be discussed by the committee will not have a unique and distinct effect on any members' personal or imputed financial interests.

In regards to FDA's invited guests, the Agency has determined that the services of these guests are essential. The following reported interests are being made public to allow meeting participants to objectively evaluate any presentation, and/or comments made by the participants.

Dr. Richard Davey is employed by the Georgetown University. He is also a member of the PHS Blood Safety and Availability Advisory Committee.

Dr. Christl Donnelly consulted with Oxford Biologica. Dr. Lou Katz is employed by the Mississippi Valley Regional Blood Center. Dr. Harvey Klein is employed by the Department of Transfusion Medicine, National Institute of Health.

Dr. Stephen Petteway is employed by the Pharmaceutical Division of Bayer, and consults with Intersouth Investors, and is an advisor for Biologic Science Board.

Dr. Robert Rohwer consults widely on TSE issues with both blood industry and gelatin industry, for which he receives compensation. His laboratory research program receives support from the Gelatin Manufactures of Europe. Dr. Rohwer is an advisor and has equity positions in several companies related to TSE.

Dr. Michel Schoentjes is employed by SKW Gelatin and Specialties, France. He also is the vice president of the Gelatin Manufacturers of Europe.

Dr. Jean-Hugues Trouvin is employed by the Department of Biologics, France.

In addition, listed on the agenda are speakers making industry presentations. These speakers were not screened for conflict of interests because they are employed by industry, and are invited here to present industry's point of view on this topic.

In the event that the discussions involves specific products or specific firms for which FDA's participants have a financial interest, or participants are aware of the need to exclude themselves from such involvement, then their exclusion shall be noted on the public record.

A record of waivers are available upon written request under the Freedom of Information Act. With respect to all meeting participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose products they wish to comment upon.

Dr. Bolton, I turn the meeting over to you.

CHAIRMAN BOLTON: Thank you, Bill. I won't say much this morning in my opening remarks as we have a very full agenda. I want to do a couple of things. I want to welcome the new members of the committee.

We are very happy as I am sure the FDA are very happy that you have agreed to serve on this committee. I consider and have for the last few years a privilege to serve as a member of the committee, and now I am doubly honored to serve as the Chairman of the Committee, although you may have to check back with me this evening to see if I am still in that mood.

I would also like to thank the returning members of the committee for their continued service. I think it is a very important thing that you do, and you have done it, and know how difficult it can be at times.

We do provide an important service both for the FDA and obviously for the nation at large, in trying to help them come to an understanding of some very difficult issues, and often times with very little information, and not as much as we would like to have, but as much as is available.

And I guess with that, I think we will move on to the first topic of the day, which is -- oh, and I have one more thing actually. I want to thank also the former members of the committee who are now serving as consultants, and in particular, Stan Prusiner, my former mentor.

And I have the gavel, and so I have an opportunity now to overrule.

DR. PRUSINER: Couldn't we read something into the record.

CHAIRMAN BOLTON: And that is another thing. Those who are returning members of the committee recall our usual set-up with the microphones that have switches on them.

I think that these may be live all the time. So just be aware that you may have a live microphone sitting in front of you.

DR. FREAS: Could I just comment on that? The microphone is turned down right now. So if you start talking, the microphone may not be very loud. But please don't put down this microphone, and try to pick up a microphone next to you.

Keep talking and the gentleman at the sound board will then turn up the volume. But, please, your microphone should be working. Just pause a little bit until the volume has been turned up.

CHAIRMAN BOLTON: Okay. Well, the first topic for this morning is topic one, the suitability of blood donors who have lived or traveled in various countries based on recent information concerning new-variant Creutzfeldt-Jakob disease, and bovine spongiform encephalopathy.

And our first presentation will be the introduction, charge, and questions by Dr. David Asher of the FDA.

DR. ASHER: Thank you, David. Good morning. Today we are asking the committee to review for the third time the issue of blood donors potentially exposed to the BSE agent, and hence having some probability, presumably very small, of incubating Creutzfeldt-Jakob disease.

There is a theoretical risk that their blood might serve as a vehicle to transmit the effects to recipients. The FDA has already recommended a limited deferral policy for some potentially exposed donors, and the committee previously advised a modest extension of that policy.

Much less is known about variant Creutzfeldt-Jakob disease in other forms. As you may recall, unlike sporadic vCJD and variance CJD, the abnormal protease-resistant prion protein accumulates to substantial levels of lumpohoid tissues, and of course some lymphoid cells normally enter blood.

That raised a concern early on that the relatively reassuring epidemiological evidence suggesting that blood was unlikely to be an important vector for other forms of CJD might not be predictive for variance CJD.

Then came reports last year that BSE had been transmitted by blood of experimentally infected mice, and finding that not uncommon in other rodent TSC models; and then by transfusion from an experimentally infected sheep, a unique isolated and preliminary finding, but one that is troubling nonetheless.

Now there is concern not only about donors exposed to BSE in the U.K., where cases of variant CJD continue to rise to 104 at my last count, but also about people who ate U.K. beef products in continental European countries.

The three French patients with variant CJD had no history of travel to the U.K. France may have imported at least five percent of its supply of beef products from the U.K. during some years of the epidemic. So there were ample opportunities for exposure there.

Other European countries also imported U.K. beef. There is also concern about the spread of BSE into other national cattle herds because U.K. meat-and-bone meal was exported to many countries, and possibly used in cattle feed.

In just the last year, four new European countries have recognized BSE in native cattle. So BSE may have spread more widely in European cattle than previously thought.

Now there is in addition to the risk from U.K. beef an additional risk to humans from indigenous BSE in cattle of continental Europe. Regarding variant CJD itself, there is both bad news and good news.

Rates of variant CJD have continued to rise in the U.K., although fortunately not in France. Two other cases have been reliably diagnosed outside the U.K. and France, but both were in long-time U.K. residents.

Attempts to transmit TSE to mice and monkeys from blood of patients with variant CJD have apparently been negative, but the total volume of blood tested has been small.
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