1
FOOD ADVISORY COMMITTEE AND
DIETARY
SUPPLEMENTS
SUBCOMMITTEE
THE ROLE OF GLUCOSOSAMINE AND
CHONDROITIN
SULFATE IN OSTEOARTHRITIS
Monday, June 7, 2004
8:03 a.m.
Bethesda Marriott
5151 Pooks Hill Road
Bethesda, Maryland
2
P A R T I C I P A N T
S
Sanford A. Miller, Ph.D., Chair
Linda Reed, Acting Executive Secretary
Douglas L. Archer, Ph.D.
Patrick S. Callery, Ph.D.
Annette Dickinson, Ph.D.
Goulda A. Downer, Ph.D.
Johanna Dwyer, D.Sc., R.D.
Jean M. Halloran
Norman I. Krinsky, Ph.D.
Daryl B. Lund, Ph.D.
Margaret C. McBride, M.D.
Mark F. Nelson, Ph.D.
Robert M. Russell, M.D.
Carolyn I. Waslien, Ph.D., R.D.
Edward Blonz, Ph.D.
Edward D. Harris, Ph.D.
Harihara M. Mehendale, Ph.D.
Steven Zeisel, M.D., Ph.D.
Temporary Voting Members
Steven Abramson, M.D.
John J. Cush, M.D.
Luis Espinoza, M.D.
David Felson, M.D., M.P.H.
Scott A. Kale, M.D., J.D., M.S.
Nancy E. Lane, M.D.
Also Present:
Jeanne Latham, Executive Secretary,
Dietary
Supplements Subcommittee
3
C O N T E N T S
AGENDA ITEM PAGE
Call to Order, Introductions - Dr.
Miller 4
Administrative Matters and Conflict of
Interest
Statement - Ms. Reed 9
Opening Remarks, Robert E. Brackett,
Ph.D.,
Director, Center for Food Safety and
Applied
Nutrition (CFSAN) 20
Background and Questions to Committee -
Laura M.
Tarantino, Ph.D. 22
Questions and Clarifications 30
Overview of Legal Framework, Louisa Nickerson,
Office of General Counsel, FDA 33
Questions and Clarifications 38
Overview of petitions: FDA's Review Process and
Issues - Dr. Craig Rowlands, Biologist,
FDA/ONPLDS/CFSAN 42
Questions and Clarifications 57
Petitioner: Weider Nutrition International, Inc.,
Luke R. Bucci, Ph.D., Vice President of
Research,
Weider Nutrition Group 69
Questions and Clarifications 105
Petitioner: Rotta Pharmaceutical, Inc.
- Dr. Lucio C. Rovati, Executive Medical
Director,
Rotta Research Laboratory 136
- Dr. Roy D. Altman, Professor of
Medicine and
Rheumatology, University of Miami and
University of
California-Los Angeles 156
Questions and Clarifications 174
Lunch 207
Questions and Comments 250
4
C O N T E N T S
(Continued)
AGENDA ITEM PAGE
Current State of the Science on Etiology
of OA and
Modifiable Risk Factors for OA - Dr. Lee
Simon,
Harvard University 209
Questions and Clarifications 250
The Role of Animal and in vitro Models
in OA Risk
Reduction - Dr. James Witter, Center for
Drug
Evaluation and Research, FDA 256
Questions and Clarifications 287
Public Comment 291
- Jason Theodasakis, M.D. 291
- Gayle E. Lester, Ph.D. 299
- Robert Arnot, M.D. 304
- Jose Verges, M.D. 317
- Todd Henderson, D.V.M. 332
- Chuck Filburn, Ph.D. 334
Questions and Clarifications 341
Adjournment 352
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1 P R O
C E E D I N G S
2 DR. MILLER:
Good morning. I want to take
3
this opportunity of welcoming you to this meeting
4
of the Food Advisory Committee.
Today and tomorrow
5
the committee is going to deal with two topics, one
6
dealing with the role of glucosamine and
7
chondroitin sulfate in osteoarthritis, and the
8
other having to do with furan contaminants in
9
foods.
10 For that reason, in order to expand the
11
expertise of the committee, we've invited some
12
temporary members to join the committee, several
13
dealing with the glucosamine and chondroitin
14
sulfate issue and several having to do with the
15
issues concerned with furans.
16 As always, we have much too full a
17
schedule, and as always, I'm going to insist that
18
we stick to our time. We have to
give everybody an
19
opportunity to speak and speak for the time limits
20
that they've been assigned, and we also have to
21
provide enough time for us to discuss the issues to
22
the extent that the committee needs and feels that
6
1
discussion is needed. Towards
that end, as you
2
make your presentations and you have exceeded your
3
time, I'll let you know. And I'm
not sure exactly
4
what I'll do if you continue to talk, but--
5 [Laughter.]
6 DR. MILLER:
The very least would be to
7
turn off your microphone and ask questions
8
concerning the meaning of your data.
9 To begin the meeting, I'd like to
10
introduce--or have them introduce themselves, the
11
members of the committee. This
morning we will
12
deal with the glucosamine and chondroitin sulfate
13
issues, and tomorrow we'll deal with furans.
14 I'll begin by introducing myself. My name
15
is Sandy Miller. I'm a senior
research associate
16
at the Center for Food Nutrition Policy at Virginia
17
Tech University.
18 DR. RUSSELL:
I'm Robert Russell. I'm
19
director of the USDA Human Nutrition Research
20
Center on Aging at Tufts.
21 DR. DICKINSON:
Annette Dickinson,
22
president of the Council for Responsible Nutrition.
7
1 DR. ARCHER:
I'm Doug Archer, professor,
2
Food Science and Human Nutrition at the University
3
of Florida.
4 DR. CALLERY:
Patrick Callery,
5
pharmaceutical chemist, from West Virginia
6
University.
7 DR. DOWNER:
Goulda Downer, president and
8
CEO, Metroplex Health and Nutrition Services,
9
Washington, D.C.
10 DR. McBRIDE:
Margaret McBride, child
11
neurologist at Akron Children's Hospital.
12 DR. BLONZ:
Edward Blonz, nutritional
13
biochemist, from Kensington, California.
14 DR. ABRAMSON:
Steve Abramson, Director of
15
Rheumatology at NYU and the Hospital for Joint
16
Diseases and Dean for Clinical Research at NYU.
17 DR. FELSON:
David Felson, rheumatologist,
18
from Boston University.
19 DR. ESPINOZA:
Luis Espinoza, Chief of
20
Rheumatology, LSU, New Orleans.
21 DR. KALE:
Scott Kale. I'm a
22
rheumatologist at Rush Presbyterian and St. Luke's
8
1
in Chicago.
2 DR. LANE:
Nancy Lane, rheumatologist,
3
University of California-San Francisco.
4 DR. ZEISEL:
Steve Zeisel. I'm professor
5
and Chair of the Department of Nutrition at the
6
University of North Carolina at Chapel Hill.
7 DR. MEHENDALE:
Hari Mehendale, professor
8
of toxicology at the University of Louisiana at
9
Monroe.
10 DR. HARRIS:
I'm Ed Harris, professor of
11
biochemistry and nutrition, Texas A&M University.
12 DR. NELSON:
Mark Nelson, Vice President
13
for Scientific and Regulatory Policy, Grocery
14
Manufacturers of America.
15 DR. WASLIEN:
Carol Waslien, Chair and
16
professor, Nutritional Epidemiology, University of
17
Hawaii.
18 DR. LUND:
Daryl Lund, University of
19
Wisconsin-Madison, Food Science, and Executive
20
Directors of the North Central Regional
21
Association.
22 DR. DWYER:
Johanna Dwyer, professor at
9
1
Tufts University, and Director of the Frances Stern
2
Nutrition Center and New England Medical Center,
3
and I'm spending the year in Washington.
4 DR. KRINSKY:
Norman Krinsky, emeritus
5
professor of biochemistry, Tufts University School
6
of Medicine.
7 MS. LATHAM:
Jeanne Latham, Food and Drug
8
Administration, Executive Secretary of the Dietary
9
Supplements Subcommittee.
10 MS. REED:
Linda Reed, Acting Executive
11
Secretary of the Food Advisory Committee.
12 DR. MILLER:
Next we have certain
13
administrative things that we need to go through,
14
and Linda Reed, who is the Acting Executive
15
Secretary of the Food Advisory Committee, will
16
present those rules of the road and issues
17
concerning conflict of interest.
18 MS. REED: Good
morning, everyone. As
19
you've heard, I'm Linda Reed, the Acting Executive
20
Secretary of the Food Advisory Committee. I was
21
asked to take a few minutes to refresh everyone's
22
memory about a few rules of the road, if you will,
10
1
in terms of Advisory Committee operations.
2 It is my understanding that all of the
3
committee members have been provided a copy of a
4
Committee Member Guide to FDA Advisory Committees.
5
There is a copy of the Member Guide at the
6
registration desk for anyone who may be interested
7
in looking through it. The
Committee Member Guide
8
is in need of updating, but, by and large, it does
9
provide good operational review.
10 FDA relies on Advisory Committees to
11
provide the best possible scientific advice
12
available to assist us in making complex decisions.
13
Our goal is to do that in as open and transparent a
14
manner as possible. Part of that
openness carries
15
with it a request that the members try to avoid
16
even the appearance that issues are being decided
17
or conclusions are being reached outside of the
18
meeting.
19 We understand that issues raised during
20
the meeting may well lead to conversation over
21 breaks and during a meal. In fact, we hope the
22
discussions are thought-provoking.
11
1 We have had instances where members have
2
come back from a break and said, "You know, we were
3
talking over the break, and we would like to
4
request that the FDA provide us with some
5
additional information so we can better understand
6
thus and such." That is
perfectly acceptable.
7 What we don't want is to have a situation
8
where, after the break, the members come back and
9
say, "We were talking over the break and decided
10
that an answer to a question is..." From our
11
perspective, that would be particularly troublesome
12
because neither the agency nor the public would
13
have had the benefit of listening to the entire
14
discussion, the question raised, and the responses.
15 In fact, FDA has adopted a policy that
16
only the matters can be reached by a show of hands,
17
procedure matters, for example--I read all that
18
wrong. Excuse me.
19 In fact, FDA has adopted a policy that the
20
only matters that can be decided by a show of hands
21
are procedure matters, for example, break times.
22
All other votes and comments must be placed on the
12
1
record, attributed to the member making that
2
statement. The policy goes even
further. If a
3
member has to leave the meeting early, the member
4
waives that right to vote. You
may wonder why the
5
person may lose their right to vote, but the answer
6
is fairly simple. FDA believes
that all parts of
7
the meeting and discussions are important.
8
Consequently, voting on issues without having the
9
benefit of the discussion would be premature.
10 The issue of openness is larger than what
11
transpires during the course of the meeting. I
12
would like to call your attention to the section in
13
the Member Guide titled "Member Interaction Before,
14
During, and After a Meeting."
In essence, this
15
section underscores the fact that all
16
communications with the members should be routed
17
through the committee's Executive Secretary. That
18
would be myself. No one, not
even FDA staff, with
19
the exception of the Executive Secretary, should be
20
contacting the members about upcoming meetings,
21
topics, et cetera. This same
guidance applies to
22
consultations between members prior to a meeting.
13
1 If a member receives an inappropriate
2
contact, the member should feel free to notify
3
myself and/or refer the person making the contact
4
to me. Our goal in having all
contacts routed
5
there the Exec. Sec. is to minimize any situations
6
that could be misinterpreted.
7
Appearance issues are always
difficult,
8
because, as is true of many things, appearances can
9
be deceiving. We ask that our
members, guest
10
speakers, liaisons, and everyone attending the
11
meeting be mindful of how an interaction between a
12
member--and anyone, for that matter--might be
13
perceived.
14 Please let me be clear. It is not my
15
intention to question anyone's integrity or
16
motives. But I'm very sensitive
to the issue
17
because I have--and I imagine you all have, too--seen highly
18
respected individuals become an object
19
of negative attention based on a misperception.
20
And I certainly wouldn't want anyone in this room
21
to become such a target.
22
I'm confident that everyone
here today is
14
1
sensitive to these issues and can appreciate that
2
my comments are intended as a gentle reminder.
3 Lastly, as you settle in, please take this
4
opportunity to silent any cell phones or other
5
devices that ring, beep, or play show tunes. And I
6
appreciate your attention for that statement.
7 Now I'd like to read the conflict of
8 interest statement into the record.
9 DR. MILLER:
Just to be certain that there
10
are no mistakes, does anybody need any
11
clarification?
12 [No response.]
13 DR. MILLER: If
not, why don't we go on.
14 MS. REED:
Okay. As Dr. Miller mentioned,
15
we have the pleasure of having two of our
16
subcommittees and several members of our sister
17
center Advisory Committee serving throughout the
18
meeting, and we thank you for being here.
19 And with that, I would like to read the
20
conflict of interest statement into the meeting
21
record. And as with the rules of
the road, this is
22 a
rather long one, so please bear with me.
15
1 The authority to appoint temporary voting
2
members to the Food Advisory Committee is granted
3
to the Center Director. Relying
on that authority,
4
Dr. Robert Brackett, Director, Center for Food
5
Safety and Applied Nutrition, has signed letters
6
appointing Dr. Luis Espinoza, Dr. Scott Kale, and
7
Dr. Nancy Lane as temporary voting members of the
8
Food Advisory Committee of the June 7-8, 2004,
9
committee meeting. These members
will serve on the
10
committee for the first portion of the meeting, the
11
subject of which is osteoarthritis.
12 The authority to grant permission to