Food and drug administration national institutes of health advisory Committee on: transmissible spongiform




НазваниеFood and drug administration national institutes of health advisory Committee on: transmissible spongiform
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FOOD AND DRUG ADMINISTRATION



NATIONAL INSTITUTES OF HEALTH


Advisory Committee on:


TRANSMISSIBLE

SPONGIFORM




ENCEPHALOPATHIES




December 18, 1998


Holiday Inn

8120 Wisconsin Avenue

Bethesda, Maryland


Proceedings by:


CASET Associates, Ltd

10201 Lee Highway, Suite 160

Fairfax, Virginia 22030

TABLE OF CONTENTS

Page


Opening and Administrative Remarks - Dr. Freas 1


Introductory Remarks - Dr. Wykoff 9

NEW VARIANT CREUTZFELDT-JAKOB DISEASE AND BOVINE SPONGIFORM ENCEPTHALOPATHY: Issues Relevant to the

Safety of Blood, Blood Components and Plasma Derivatives



Background - Dr. Jacobs 11


nvCJD: Characteristics and Demographics 19

  • Dr. Will


Experimental Studies of Blood Infected with 48

TSE Agents - Dr. Rohwer


Role of Circulating Lymphocytes in Pathogenesis 68

of TSEs; BSE, nvCJD and Blood: A European View

  • Dr. Aguzzi


Current Status of the BSE Epidemic in Europe: 101

USDA Perspective - Dr. Ferguson

BLOOD DONOR DEFERRAL, PRODUCT WITHDRAWALS AND

PRODUCT SHORTAGES



US Blood Donor Deferral Policies - Capt Gustafson 104


Current Regulatory Policies in the United Kingdom 120

Regarding TSEs and Safety of Blood Components

and Plasma Derivatives - Dr. Metters


Current Regulatory Policies in Canada Regarding 135

TSEs and Safety of Blood, Blood Components and

Plasma Derivatives - Dr. Kennedy


REDS Study - Dr. Williams 155


Effects of Withdrawal and Recall Policies on the 169

Supply of Plasma Derivatives in the U.S.

  • Dr. Weinstein


Open Public Hearing 176


Committee Discussion and Votes 216


Dura Mater Allograft: Update - Dr. Witten 333

PARTICIPANTS:


EXE. SEC: WILLIAM FREAS, PhD, CBER, FDA, Rockville, MD

MGMT SPEC: SHEILA D. LANGFORD, CBER, FDA, Rockville, MD


MEMBERS:

CHAIRMAN: PAUL W BROWN, MD, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD

DONALD S BURKE, MD, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland

DEAN O CLIVER, PhD, School of Veterinary Medicine, University of California, Davis, California

LINDA A DETWEILER, DVM, US Department of Agriculture, APHIS/Veterinarian Services, Robbinsville, New Jersey

BARBARA W HARRELL, MPA, Consumer Representative. Montgomery, Alabama

DAVID G HOEL, PhD, Medical University of South Carolina, Charleston, South Carolina

WILLIAM D HUESTON, PhD, University of Maryland, College Park, Maryland

STANLEY B PRUSINER, MD, University of California, San Francisco, California

RAYMOND P ROOS, MD, University of Chicago, Chicago, IL

LAWRENCE B SCHONBERGER, MD, Division of Viral and Rickettsial Diseases, CDC, Atlanta, Georgia

EDMUND TREMONT, MD, University of Maryland, Baltimore, MD


TEMPORARY VOTING MEMBERS:

F BLAINE HOLLINGER, MD, Baylor College of Medicine, Houston, TX

SUSAN F LEITMAN, MD, Department of Transfusion Medicine, NIH, Bethesda, MD

KENRAD E NELSON, MD, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland

PETER G LURIE, MD, MPH, Public Citizen's Health Resource Group, Washington, D.C.


GUESTS:

LOUIS KATZ, MD, Davenport, Iowa

MERLIN SAYERS, MD, PhD, Carter Blood Care, Bedford, Texas

DONALD GILCHER, MD, FACP, Oklahoma Blood Institute, Oklahoma City, OK

W KEITH HOOTS, MD, Gulf States Hemophilia and Treatment Center, Houston, Texas


CONSULTANT:

ROBERT G ROHWER, PhD, VA Medical Cntr 151, Baltimore, MD P R O C E E D I N G S (8:07 a.m.)

AGENDA ITEM: Opening and Administrative Remarks.

DR. FREAS: Good morning. Mr. Chairman, members of the committee, invited guests and public participants, I would like to welcome all of you to this, our fourth meeting of the Transmissible Spongiform Encephalopathies Advisory Committee.

I am Bill Freas, the acting executive secretary for today's meeting.

Today's presentations will be open to the public.

At this time, I would like to go around and introduce to the public the members seated at the front table.

Starting on the audience's right-hand side of the room, in the first seat is a committee member, and also a consumer representative, Ms. Barbara Harrell from Montgomery, Alabama.

In the next seat is Dr. Susan Leitman, chief of blood services, Department of Transfusion Medicine at NIH.

In the next seat is Dr. Lawrence Schonberger, assistant director for public health, division of viral and rickettsial diseases, Centers for Disease Control.

In the next seat is Dr. Stan Prusiner, professor of neurology, University of California School of Medicine.

In the next seat is Dr. Edmund Tremont, professor of medicine, University of Maryland.

In the next seat is Dr. Raymond Roos, chairman, department of neurology, University of Chicago.

In the next seat is the chairman of FDA's blood products advisory committee, who will be working with us today, serving as a temporary voting member of this committee, and that is Dr. Blaine Hollinger, professor of medicine, virology and epidemiology at the Baylor College of Medicine.

In the next seat is committee member, Dr. David Hoel, professor and chairman, department of biometry, epidemiology, at the University of South Carolina.

Coming around the corner is a temporary voting member for today, Dr. Peter Lurie, Public Citizen's Health Resource Group, Washington, D.C.

Next is a committee member, Dr. Donald Burke, director, Center for Immunization Research, Johns Hopkins University.

Next is our chairman of this TSE advisory committee, Dr. Paul Brown, medical director, laboratory of central nervous systems studies, National Institutes of Neurological Disorders and Stroke.

Next is a new member to this committee, and I would like to welcome Dr. Dean Cliver, professor, School of Veterinary Medicine, University of California, Davis.

Dr. Kenrad Nelson, who is a member of the blood products advisory committee, will be joining us very shortly, and he will be sitting in the seat next to Dr. Cliver.

The next committee member is Dr. Linda Detweiler. She is senior staff veterinarian, U.S. Department of Agriculture.

Around the corner of the table is a committee member, Dr. William Hueston, associate dean, Virginia-Maryland Regional College of Veterinary Medicine.

In the next seat, Dr. Rohwer will soon be joining us. He is not here. That will be his seat. He is director, molecular neurovirology unit, at the VA Medical Center. He is a consultant for today's meeting.

Our next seat is occupied by a member of the Health and Human Services Advisory Committee on blood safety and availability. Today he will be joining us as a guest at this committee meeting. That is Dr. Ronald Gilcher, president and CEO of the Oklahoma Blood Institute.

Next is another guest, Dr. Merlin Sayers, director of the blood bank at the Carter Blood Care in Bedford, Texas.

In the last seat is Dr. Louis Katz, vice president for medical affairs and medical director for the Mississippi Valley Regional Blood Center.

There are two committee members who were not able to join us today. They are Dr. Katherine O'Rourke and Dr. Leon Fatek.

In addition, Dr. Keith Hoots, another member of the Health and Human Services Advisory Committee on Blood Safety and Availability was to attend this, but at the last minute, he had a medical emergency and will not be here this morning.

I would now like to read into the 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, Center for Biologics Evaluation and Research, had appointed Drs. Blaine Hollinger, Susan Leitman, Peter Lurie and Kenrad Nelson as temporary voting members for this meeting.

Based on the information made available, it has been determined that the agenda addresses general issues and matters only.

General matters waivers have been approved by the agencies for all members on the TSE advisory committee.

In addition, a waiver has been approved for Dr. Robert Rohwer to participate as a non-voting consultant.

Furthermore, it has been determined that all financial interests in firms regulated by the Food and Drug Administration, which have been reported by the participating members, consultants and invited guests, as of this date, present no potential for an appearance of a conflict of interest at this meeting.

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

In regard to FDA's invited guests, the agency has determined that the services of these participants are essential.

The following reported financial interests are being made public to allow the meeting participants to objectively evaluate any presentation and/or comments made by the guests and speakers.

These interests will be as followed:

Dr. Katz is employed by the Regional Blood Centers.

Dr. Merlin Sayers is employed by a non-profit community blood center.

Dr. Robert Will is a science advisor on CDJ to an FDA-regulated firm.

Dr. Alan Williams is employed by the American Red Cross.

In the event that the discussions involve specific products or specific firms for which FDA participants have a financial interest, the participants are aware of the need to exclude themselves from such discussions, and the discussions will be noted for the record.

A copy of the waivers are made available by written request under the Freedom of Information Act.

With respect to all other meeting participants, we ask, in the interests of fairness, that they address any current or previous financial involvement with any firm whose products they may wish to comment upon.

So ends the reading of the conflict of interest statement. Dr. Brown, I turn the microphone over to you.

DR. BROWN: Good morning. I think today's meeting should be interesting, possibly more interesting than any of the previous three, for the reason that we are being asked to consider answers to questions concerning blood safety and new variant Creutzfeldt-Jakob disease without a shred of direct evidence about infectivity in the blood of patients with new variant Creutzfeldt-Jakob disease, which you would think would be enough to dissuade us from considering the question.

It is compounded by the fact that we haven't got a clue how many people are walking around incubating new variant disease to begin with.

With these two complete holes in our scientific knowledge, we will make a valiant attempt, early this afternoon, to come to policy decision recommendations.

Having said that, I would like to turn to our first speaker. Is Dr. Wykoff here? Dr. Wykoff will provide an introduction from the standpoint of the Food and Drug Administration. Dr. Wykoff?

AGENDA ITEM: Introductory Remarks.

DR. WYKOFF: Thank you, Dr. Brown. I am Randy Wykoff, the associate commissioner for operations at the Food and Drug Administration.

On behalf of Commissioner Haney and my many colleagues and coworkers at the FDA, it is my privilege to welcome all of you today.

I welcome not only the members of the committee and our guests, but also members of regulated industry, the media and the general public.

I would like to extend a particular welcome to our colleagues from Canada and Europe who have been able to join us today.

I have had the pleasure of speaking to this group in the past. As Dr. Brown has implied, I think today's meeting will be as challenging and as complex, and hopefully as rewarding as any meeting you have had in the past.

The issue before us today is, we are trying to determine what additional actions, if any, the FDA should take, to help assure the safety of the blood supply, in the face of a theoretical risk of new variant CJD.

As with so many questions that this committee deals with related to TSEs, this issue is made more complex by the lack of information.

We do not have all the information we might like to have about new variant CJD, particularly its etiology and transmissibility.

This lack of information in no way absolves us of our responsibility to take the most appropriate actions to promote and protect the public health.

To deal with this issue, the FDA has brought together a truly exceptional group of experts. This group of experts, the advisory committee and the invited guests, will hear a series of scientific presentations this morning and then, this afternoon, will discuss in open session this issue, and ultimately will make recommendations to the FDA.

These recommendations are to be impartial and are to be balanced, and are to reflect both the sophisticated scientific capability that you bring to this issue, and also your understanding of the public health ramifications of any recommendations you might make.

To assist the committee in this process, there will be an open public comment period this afternoon. Members of the general public and others not on the agenda will have the opportunity to make sure that their ideas, their thoughts and their suggestions are heard by the committee.

Additionally, to assist the committee, the FDA has developed a series of questions that will be posed to the committee.

We hope that by your deliberating on these questions, that you will find it easier to give us recommendations.

It is very important for the committee to understand that they can go beyond these questions if they wish to. The committee may explore other ideas, other suggestions, other recommendations if they believe they are appropriate.

Our charge to the committee is simple. What additional actions or activities, if any, should the FDA take to help assure the safety of the blood supply in the face of a theoretical risk from CJD.

As Dr. Brown said, this is a complicated issue. It is going to require all of your scientific capability and your thoughtful deliberation.

It will probably also require the full amount of time allocated on the agenda. In fairness to that time, I will conclude my comments by reiterating our welcome to all of you.

Because I will not be here at the end of the day, let me thank the committee for your thoughts, your deliberations and your recommendations. Thank you and welcome.

DR. BROWN: Thank you very much, Dr. Wykoff. Some further background to this issue will now be presented by Dr. Mary Elizabeth Jacobs, in the CBER section of FDA. Dr. Jacobs?

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