[CONVENE 8:46 A.M.]
M.
STOTO: Good morning, everyone. Welcome to the meeting of the Ranch Hand
Advisory Committee. I’m Michael Stoto;
I’m the Chair of the Committee. I work
at the Rand Corporation although I’m not representing them here. And I’d like to begin by going around and
asking the Committee members to introduce themselves and then we’ll ask the
others present in the room to introduce themselves as well. So Dr. Leffingwell?
S.
LEFFINGWELL: Sanford Leffingwell.
M.
STOTO: And remember you have to put
the — turn the mikes on before they will work.
S.
LEFFINGWELL: Yeah. Sanford Leffingwell with HLM Consultants,
formerly with CDC.
D.
JOHNSON: Dave Johnson with the
Florida Department of Health.
L.
SCHECHTMAN: I’m Leonard Schechtman. I’m the Executive Secretary of the Ranch
Hand ...
M.
STOTO: You’re not on; you’re not
on.
L.
SCHECHTMAN: Okay. Now I’m on.
I’m Leonard — I’m sorry; I should know better. I’m Leonard Schechtman, the Executive Secretary of the Ranch Hand
Advisory Committee and the Deputy Director for FDA’s National Center for
Toxicological Research.
P.
CAMACHO: Paul Camacho from the
University of Massachusetts.
E.
HASSOUN: Ezdihar Hassoun from the
University of Toledo.
R.
TREWYN: Ron Trewyn, Kansas State
University.
K.
FOX: Colonel Karen Fox with the Air
Force Health Study, now Principal Investigator.
J.
MICHALEK: Joel Michalek, formal —
former Principal Investigator, now with the University of Texas.
M.
STOTO: If you want to start over
this way? Just introduce yourself
please. Okay.
M.
MONTGOMERY: Lieutenant Margaret
Montgomery, Deputy Program Manager, Air Force Health Study.
J.
ROBINSON: I’m Julie Robinson. I’m the prior Air Force Health Study Branch
Chief.
M.
STOTO: Julie, would you give the
mike to the gentleman over there?
J.
SILVERS: Sorry. Jonathan Silvers; I’m an independent
producer for ABC News Nightline.
M.
PAVUK: I’m Marian Pavuk with
SpecPro. I work on the Air Force Health
Study, Brooks-San Antonio, epidemiologist, biostatistician.
M.
BLANCAS: Manny Blancas, contractor
with the Air Force Health Study Program Management Team.
J.
MINER: Jay Miner with Operational
Technologies, former Principal Investigator with the study and former Air
Force. And I currently work with the
Program Office at Brooks Air Force Base.
M.
PAXTON: Mary Paxton, IOM Project
Officer for the “Veteran’s and Agent Orange Update Series.”
M.
OWENS: Maurice Owens; I’m with
Science Applications International Corporation.
M.
YEAGER: Meagan Yeager; I’m with Science
Applications International Corporation.
W.
GRUBBS: Bill Grubbs, Science
Applications International Corporation.
J.
GONZALES: Captain Jose
Gonzales. I’m the new Program Element
Monitor with the Air Force staff.
K.
CAMPBELL: Kim Campbell; I’m the
Management Specialist for the Ranch Hand Advisory Committee.
F.
MATSUMURA: Fumio Matsumura from the
University of California-Davis.
P.
FUJIYOSHI: Phillip Fujiyoshi from
the University of California-Davis.
D.
BUTLER: David Butler, National
Academy of Sciences. I’m the staff
officer for the National Academies’ AFHS Disposition Study.
A.
O’CONNOR: Amy O’Connor, National
Academy of Sciences, Institute of Medicine.
M.
STOTO: Okay. Thank you very much, everyone, and again,
welcome. Len, you have some house —
housekeeping items for us?
L.
SCHECHTMAN: Okay, just a few brief
housekeeping items for today’s meeting and for the rest of today. I’d like to
remind everyone to sign in on the sign-in sheet at the front desk. One of them, I think, is being passed
around, but there are other sheets at the front desk. Everyone at the meeting, including the public, the media and
everyone needs to sign in and give their contact information please.
Just
for information’s sake, to remind everyone, our next Ranch Hands Advisory
Committee meeting is scheduled for September 19th and we’re hoping
to have another meeting thereafter, possibly in November. So I’m asking everyone to please start
thinking about their availability in November and to please also start thinking
about agenda items for the September and possible November meeting as
well. We’ll also address this later as
needed.
As
far as the agenda is concerned, we have one hour for public comments that
begins at 10:45 this morning. And we
would also like to recognize those individuals who will be making public
comments at today’s meeting by name.
And if there are any such individuals in the room, if you could identify
yourselves for the record right now and if you have any written public comments
to submit, we would appreciate you turning those into the Chair at this time.
Not
seeing anyone at this time, we’ll just move on and note that the agenda also
allows for a couple of coffee breaks so that we can have some sidebar
conversations where perhaps we’ll get a significant amount of science
accomplished as a matter of fact. We
also have a working lunch scheduled. We
will be working through lunch; please do not leave. The table will be well stocked with food, so you won’t be
disappointed. Okay.
At
this point, I’d like to read the conflict of interest of statement into the
record to give everyone an opportunity to address this if needed. The following announcement addresses the
issue of conflict of interest with respect to this meeting and is made a part of
the record to preclude even the appearance of such. Based on the agenda submitted for today’s meeting, all special
government employees have been screened for their financial interests related
to the topics at hand.
FDA
has determined that all financial interests and firms regulated by the Food and
Drug Administration present no potential for a conflict of interest at this
meeting. In the event that the
discussions involve any other product or firms not already on the agenda for
which a participant has a financial interest, the participants are aware of the
need to be excluded from further participation. Such an action will be noted for the record. In the interest of fairness, all other guest
participants are asked to address any current or previous financial involvement
with any firm whose products upon which they wish to comment. Okay.
M.
STOTO: Okay. Thank you, Len. That’s an — those conflict of interest things are very important
issues, but they often don’t apply to — in the same way to the Ranch Hand
Committee as they do to other FDA committees because we’re not a — we don’t
deal with regulatory matters. But I
think it’s important that we take them very seriously.
Approval of Previous Meeting Minutes
M.
STOTO: The next item on the agenda
is the approval of the minutes from the previous meeting; there’s a copy in
your folder. I believe it was also sent
out in advance for you to look at and I’ve had a chance to review it. I think that my comments have already been
incorporated in this. And we asked Dr.
Michalek to review it from a scientific accuracy point of view and that’s been
done as well. So I’d just like to ask
at this point if there’s any further comments or discussion that people would
like to have about those minutes?
R.
TREWYN: It is possible to make some
editing changes at this point?
M.
STOTO: Sure. We have to approve them.
R.
TREWYN: In which case ...
M.
STOTO: Please go ahead.
R.
TREWYN: Page 7. Since it’s my part, I thought I would
actually look it over.
M.
STOTO: Okay.
R.
TREWYN: First bulleted point, line
3, all the stuff, “particularly substantial increases” adds nothing. The rest of that sentence adds nothing to
that statement and I don’t think it’s necessary. So I would just say let’s remove that part.
D.
JOHNSON: So that’s a full stop
after ...
R.
TREWYN: After “results.”
D.
JOHNSON: “Results.”
M.
STOTO: Okay.
R.
TREWYN: Then at the last bullet,
second line, “literature that cite cacodylic acid and other” — “toxic” should
be in there — “non-dioxin components of herbicides sprayed in Vietnam.” I wouldn’t expect that all herbicides in the
world would be made part of this report, so and only things that have been
reported in the literature as being toxic.
M.
STOTO: How about “herbicides used
in Vietnam?”
R.
TREWYN: That’s fine; that’s
fine. And I have one question on the
next page which isn’t my — well, this is the general part and ...
M.
STOTO: Before we — before we go on,
let me just ...
R.
TREWYN: Okay. Yes.
M.
STOTO: ... see if there are any
objections to that or questions, discussion?
Okay.
R.
TREWYN: The next page, so page 8;
let me count down the number of lines here.
Line 15, in the sentence that it starts, “Second, clarify that the serum
dioxin measurement technique was” and my question is “invented,” if that’s the
right word? It doesn’t — was
“developed” or, you know, I don’t know that “invented” is the right — is the
correct word. So “developed” after the
...
M.
STOTO: “Developed” seems like a
reasonable word to me.
R.
TREWYN: And those are the only
changes.
M.
STOTO: Any other discussion on that
point? Okay, those are helpful changes,
Ron. Thank you. Other comments, suggestions for changes in
the — in the minutes? Okay. Is there — would someone like to move that
we approve the minutes?
R.
TREWYN: Move to approve with the
modifications.
M.
STOTO: Ron Trewyn, okay. A second?
Okay. Thank you, Dr.
Camacho. All in favor, please say yes.
RHAC: Yes.
M.
STOTO: Any not in favor? Okay.
Thank you very much; I think that passed unanimously. And thank you to our scribe for again doing
an excellent job with preparing these minutes and to Dr. Michalek for reviewing
the scientific content. Okay.
M.
STOTO: So now the next item on the
agenda — we’re right on schedule — is to hear a presentation from Dr. Butler
from the Institute of Medicine, National Academy of Sciences.
D.
BUTLER: Good morning. Those of you who’ve been to some of the
earlier meetings will notice some similarities between...
M.
STOTO: Microphone.
D.
BUTLER: There we go; I’m
sorry. Good morning. Those of you who’ve been to some of the
other meetings will notice some similarities between these slides and the
earlier slides. There are two reasons
for that. First of all, I wanted to make
sure to catch anybody up who hadn’t been at the earlier meetings. And a second reason is that I’m somewhat
limited in what I can tell you about the work of the National Academies
committee that’s been addressing the disposition of the Ranch Hand Study.
The
reason for that isn’t anything particular to this study, but rather a general
rule that the content of discussions and conduct of the committees is not
discussed prior to the final release of any National Academies report. So afterwards if you have any questions,
I’ll do my best to answer them. But I
wanted to warn you up front that I have to be a bit circumspect about what I
can talk about in terms of what the committee has been discussing to this
point. I will, to the extent I’m able,
catch you up on what our progress is.
Sorry. This study was one that the Congress
mandated that the Department of Veterans Affairs ask us to conduct, so the
Department of Veterans Affairs is our sponsor for this study. “Sponsorship” in this particular case means
that they give us the money to do the study, but is otherwise uninvolved in any
of the conduct or content of it. The
Congress specified five primary tasks for a committee of the National Academy
of Sciences to address.
The
first was the merit of retaining or — and maintaining the medical records; the
other study data by which we’ve come to understand be the demographics,
socioeconomic status and other non-medical data collected in the course of the
study; and the laboratory specimens that have been collected over the six
cycles of medical exams that the Ranch Hand participants have been potentially
subject for when the study reaches its currently scheduled termination date of
2006.
The
second primary issue was whether or not any obstacles, including and perhaps
primarily privacy concerns, exist to retaining and maintaining those
records. The third is the advisability
of providing any independent oversight of the records, data and specimens and
the advisability of further study of this material, and if so, the mechanism
that would underlie that independent oversight and that further study of the
materials.
The
third is the advisability of extending the study itself, which would mean some
continuation of medical exams or some other continuation of the study as it
presently stands past the presently scheduled termination date, and if so, the
mechanism and mechanics behind that extension.
And finally, the advisability of making laboratory specimens that have
been collected in the course of this study — those would be both serum and
urine samples — available for independent research. In the course of all these is you’ve noted, if you’ve been
reading along, the Congress asked us to try to scope out the costs that might
be associated with conducting any of this work.
In
order to conduct this study, we formed an expert committee, which is being led
by Dr. David Tollerud. Dr. Tollerud is
an environmental and occupational physician who was co-chair of the original
“Veterans and Agent Orange Study,” has since been highly involved in the
National Academies studies of Agent Orange-related health effects and is quite
knowledgeable in that area. Assisting
Dr. Tollerud is a committee of individuals which include epidemiologists, biostatisticians,
a bioethicist and specialist in privacy concerns. And we’ve also added a consultant to the committee who is an
expert in the management of SAS databases since that is the primary means by
which the data are stored electronically.
What’s
the status of this study? Well, so far
we’ve conducted two committee meetings — full committee meetings. At the first of those, we were given our
charge by our sponsor and also had Joel give a presentation, a very detailed
presentation, on the study itself. At
the second committee meeting, we had a workshop for gathering data and I’ll
give you a little bit more information about that in just a moment.
And
just a few weeks ago, a subcommittee of the committee went down to San Antonio
to visit the Air Force Health Study research facilities. I have to emphasize how tremendously
grateful we are for the cooperation that we received in that study. In that visit, we learned a tremendous
amount and along with the complete cooperation that the research personnel had
given us throughout the course of this study.
We’re just tremendously thankful for their cooperation and it’s really
been key to our work so far.
At
our second committee meeting, we had a workshop where we discussed a number of
topics related to the questions that we were asked to address. Dr. Stoto was kind enough to come and speak
to us. In addition, we asked
individuals who were — who’ve been responsible for gathering data in other
epidemiologic studies, and administering the conduct of those studies and the
availability of that data to independent researchers.
We
were fortunate in having the health attaché for the U.S. Embassy in Hanoi, Dr.
Sweeney, who formerly was with NIEHS and who’s worked as a dioxin researcher
for years to speak with us, and also representatives from the Congressional
staff and from veteran’s service organizations come and give their points of
view. We are holding an additional
workshop. I — actually, my first edit
of this, I had “mini-workshop” because we’re convening it just for a morning on
the 20th of June coming up where we’re going to gather a little bit
of additional data regarding administration of data set — data sets for use by
outside researchers.
To
that end, we’ve invited a principal investigator of the VA Normative Aging
Study which allows their data to be used by independent researchers to come and
speak with us. We’ll also have a
representative from the Institute of Medicine’s own Medical Follow-up Agency
which administers a series of databases that have medical and other data on
twins from various conflicts and administers those data. National Center for Health Statistics, which
of course is the NHANES and other data sets at their command.
And
we’ll also have some researchers from a National Academies study that was
recently completed that addressed access to vaccine health research. So we’ll try to learn some stuff from those
folks so we don’t have to go about reinventing the wheel when there are people
around who’ve had a lot of experience on this topic.
As for our future plans, we’re going to be very seriously into report writing for this report over the summer. We’ll have a final committee meeting at the end of the summer and we intend on releasing the report in the fall of this year. It’s a bit early for me to make an