Minutes
Review of SoPs concerning chronic multisymptom illness, and Gulf War
syndrome
Date: Wednesday, 16 December 2015 – Start Time 10.00 QLD time
Location: 4th Floor, 259 Queen Street, Brisbane
Participants
Presiding Councillor:
Associate Professor David Newman (Presiding)
Councillors:
Professor Dino Pisaniello
Dr Bradley Ng
Professor Andrew Grulich
Associate Professor John Waterston
Secretariat:
Jan Bowman – Registrar
Anthony Fuster
DISCUSSION
1.
Welcomes & Introductions
A/Professor Newman welcomed participants and outlined the purpose of the
meeting.
2.
Purpose of meeting
To provide an overview of the function and role of the review council.
To consider the application to this review and the scope of the review.
3.
Role of Council
An overview for the legal context for the review was provided and the Council
was referred to the Members Handbooks.
Members confirmed that they understood the function of the Council and the
two statutory tests.
4.
Scope of the Review
Council agreed to consider the applications and submissions in detail before
drafting the scope of the review at the next meeting.
5.
The Information
The 'available' information is that information that was in fact used by the RMA. It
does not include information that may have been available for the use of the RMA at
the time but was not accessed by the RMA.
Address all Communications to:
The Registrar, SMRC, PO Box 965, Brisbane, QLD 4001
Tel (07) 3223 8420
Email: xxxx.xxxxxxxxx@xxx.xxx.xx
Web site: www.smrc.gov.au
1
6.
New information
‘New information’ is information the RMA advises was not available to it when it
made the decision under review. This may include relevant information published
before or after the date that the RMA determined the SoPs under review, including
during the time the SMRC undertakes the review.
Jan advised that there is ‘new’ information identified by the applicant in submissions
to the RMA and to the SMRC.
Actions
The Council discussed the selection of the sound medical-scientific evidence relevant
to the contended factor. The following actions were agreed.
a. Of the 38 page list of papers relied on by the parties to the review, councillors
will divide their preliminary reading as follows:
David, pp1-8
John, pp 9-15
Andrew, pp16-23
Bradley, pp 24-31
Dino, pp32-38
b. Of the list of papers attached the Applicant’s submission to the RMA, councillors
will divide their preliminary reading as follows:
•
Dino and Bradley, papers 1-41
•
John and Andrew, papers 42-81
Comments on papers will be discussed at the next meeting.
Jan will advise of any additional ‘new’ information.
7.
The next meeting
Two hour teleconference. Date to be confirmed.
8.
The meeting was closed by A/Professor Newman at 15:00. Duration of meeting – 5
hours.
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2
2
Minutes
Review of SoPs concerning chronic multisymptom illness, and Gulf War
syndrome
Date: Wednesday, 3 February 2016 – Start Time 14.00 EST
Location: by teleconference
Participants
Presiding Councillor:
Associate Professor David Newman (Presiding)
Councillors:
Professor Dino Pisaniello
Dr Bradley Ng
Professor Andrew Grulich
Dr John Waterston
Secretariat:
Jan Bowman – Registrar
Anthony Fuster
Medical/Science Writer:
Dr Kate Claydon-Platt
DISCUSSION
1.
Welcomes & Introductions
A/Professor Newman welcomed participants and outlined the purpose of the
meeting as:
o Reconfirming the Council’s Tasks
o Settling the Scope of Review
The Council confirmed the minute of the previous meeting with one minor
amendment.
2.
Council’s Tasks
The Council considered a background paper clarifying its role in determining what
constitutes a disease or injury as set out in the legislation.
3.
Scope of Review
The Review Council decided that subject to legal advice the scope would be as
follows:
The Council has decided that it will have particular regard to whether there was
sound medical-scientific evidence (SMSE) on which the Repatriation Medical
Authority could have relied to:
Address all Communications to:
The Registrar, SMRC, PO Box 965, Brisbane, QLD 4001
Tel (07) 3223 8420
Email: xxxx.xxxxxxxxx@xxx.xxx.xx
Web site: www.smrc.gov.au
3
a. create Statements of Principles for Gulf War Syndrome (SoPs) (or Illness) that
would include factors for:
environmental hazards such as, depleted uranium, oil well smoke, chemical
and biological weapons medical countermeasures (such as pyridostigmine,
and vaccinations for anthrax, plague, pertussis), contaminated food and
water, pesticides exposure (including DEET)
psychological stressors
b. amend either or both of the SoPs for Chronic Multisymptom Illness in any or all
of the following ways:
the possible inclusion of a factor or factors as contended, for exposure
to environmental hazards such as, depleted uranium, oil well smoke,
chemical and biological weapons medical countermeasures (such as
pyridostigmine, and vaccinations for anthrax, plague, and pertussis),
contaminated food and water, pesticides exposure (including DEET).
There was some question of whether to include clarification in the scope that the
Council would not be limited to the listed factors.
Actions:
Jan to ask Legal Adviser to review the draft scope before the Council writes
to the Applicant.
Draft letter to Applicant to be circulated to Council before being set.
4.
Discussion of papers as agreed at the last meeting.
The Council discussed the selection of the SMSE relevant to the contended factor as
agreed at the first meeting.
Action: Jan to circulate a list of selected papers.
5.
Managing additional new information
Jan reminded Councillors that there is additional new information in the
Council’s Folder in FILEForce for consideration. “List of Binns papers -
available and new” in FILEForce – FF ID 31471.
Action: Deferred for future discussion.
6.
The next meeting
Council agreed to have a two hour teleconference in March. A decision on the date
and location for the oral hearing will be made at the next meeting.
Action: Anthony to send a Doodle Poll to settle meeting date.
7.
The meeting was closed by A/Professor Newman at 16:00. Duration of meeting – 2
hours.
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2
4
Minutes
Review of SoPs concerning chronic multisymptom illness, and Gulf War
syndrome
Date: Wednesday, 20 April 2016 – Start Time 14.00 EST
Location: by teleconference
Participants
Presiding Councillor:
Associate Professor David Newman (Presiding)
Councillors:
Professor Dino Pisaniello
Dr Bradley Ng
Professor Andrew Grulich
Dr John Waterston
Secretariat:
Jan Bowman – Registrar
Anthony Fuster
Medical/Science Writer:
Dr Kate Claydon-Platt
DISCUSSION
1.
Welcomes & Introductions
-
Review progress on the reading of identified papers
-
Discuss grouping papers by factor
-
Agree on approach to analysis
-
Plan for the Oral Hearing
2.
Council’s Tasks
-
The Council Reviewed progress on the reading of identified papers.
3.
Structuring its approach to Council’s analysis task
-
The Review Council agreed to group papers by factor and using the RMA
grading criteria for overall assessments
Action:
Jan and Kate to structure a consolidated excel reading list with drop-down
boxes for papers by factor and grade and make available to councillors.
Address all Communications to:
The Registrar, SMRC, PO Box 965, Brisbane, QLD 4001
Tel (07) 3223 8840
Email: xxxx.xxxxxxxxx@xxx.xxx.xx
Web site: www.smrc.gov.au
5
4.
Structuring and drafting the Reasons
Jan outlined the structure of the Reasons document (as provided) and brought
members’ attention to those aspects that will require Council input.
5.
Oral Hearing
Council agree that the Oral Hearing should be held in Melbourne in late
August or early September.
Action: Jan to advise Applicants and look for suitable dates
6.
The next meeting
Council agreed to have a two hour teleconference in July.
Action: Jan to send a Doodle Poll to settle meeting date.
7.
The meeting was closed by A/Professor Newman at 16:00. Duration of meeting – 2
hours.
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2
6
Minutes
Review of SoPs concerning chronic multisymptom illness, and Gulf War
syndrome
Date: Wednesday, 17 July 2016 – in conjunction with Oral Hearing
Location: Melbourne
Participants
Presiding Councillor:
Associate Professor David Newman (Presiding)
Councillors:
Professor Dino Pisaniello
Dr Bradley Ng
Professor Andrew Grulich
Dr John Waterston
Secretariat:
Jan Bowman – Registrar
Steven Dare
Medical/Science Writer:
Dr Kate Claydon-Platt
DISCUSSION
1.
Welcomes & Introductions
Review progress on the reading of identified papers
Discuss grouping papers by factor
2.
Council’s Tasks
The Council Reviewed progress on the reading of identified papers
Secretariat Actions:
complete the transfer of councillor comments from the spreadsheet into
FILEforce.
Once all available comments are on FILEforce, councillors will check those
papers marked “yes” and “maybe” (these papers can then later be grouped by
factor and grade).
circulate the most up-to-date list of new papers provided by Mr Watts in his two
submissions to the SMRC (see attached).
circulate papers provided by Mr Watts at the Oral Hearing:
Address all Communications to:
The Registrar, SMRC, PO Box 965, Brisbane, QLD 4001
Tel (07) 3223 8840
Email: xxxx.xxxxxxxxx@xxx.xxx.xx
Web site: www.smrc.gov.au
7
Craddock TJA, Fritsch P, Rice MA Jr, del Rosario RM, Miller DB, Fletcher MA, et
al. (2014) A Role for Homeostatic Drive in the Perpetuation of Complex Chronic
Illness: Gulf War Illness and Chronic Fatigue Syndrome. PLoS ONE 9(1): e84839.
doi:10.1371/journal.pone.0084839
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0084839
Rayhan RU, Stevens BW, Timbol CR, Adewuyi O, Walitt B, VanMeter JW, et al.
(2013) Increased Brain White Matter Axial Diffusivity Associated with Fatigue,
Pain and Hyperalgesia in Gulf War Illness. PLoS ONE 8(3): e58493.
doi:10.1371/journal.pone.0058493
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058493
The other paper contained correspondence between TGA and Defence about
the importation of drugs for ‘prospective combat zones’.
3.
The next meeting
Next meeting face-to-face in Brisbane, December.
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2
8
Minutes
Review of SoPs concerning chronic multisymptom illness, and Gulf War
syndrome
Date: Wednesday, 27 July 2016 – 11.00am – 13.00pm EST (10.30am SA)
Location: Teleconference
Participants
Presiding Councillor:
Associate Professor David Newman (Presiding)
Councillors:
Professor Dino Pisaniello
Dr Bradley Ng
Professor Andrew Grulich
Dr John Waterston
Secretariat:
Jan Bowman – Registrar
Steven Dare
Medical/Science Writer:
Dr Kate Claydon-Platt
DISCUSSION
1.
Welcomes & Introductions
Review progress on the reading of identified papers
Discuss grouping papers by factor
2.
Council’s Tasks
The Council Reviewed progress on the reading of identified papers
Secretariat Actions:
re-circulate the RMA’s Levels of Evidence Paper
add “Multiple Factors” and “Disease Definition” to the Factors dropdown list at
column R
identify the papers in the meta-analysis by Gwini et al 2016
Councillors to continue to identify papers for further reading
Kate will organise papers by factor/grade based on Councillor feedback
Kate to prepare a summary of the history of approaches to disease definition for
CMI/GWS for Council consideration
Address all Communications to:
The Registrar, SMRC, PO Box 965, Brisbane, QLD 4001
Tel (07) 3223 8840
Email: xxxx.xxxxxxxxx@xxx.xxx.xx
Web site: www.smrc.gov.au
9
3.
Preparation for Oral Hearing
Jan provided an overview of the Oral Hearing process and plans for 17
August meeting
4.
The next meeting
Oral Hearing, 17 August in Melbourne
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2
10
Minutes
Review of SoPs concerning chronic multisymptom illness, and Gulf War
syndrome
Date: Tuesday, 6 December 2016
Location: Brisbane
Participants
Presiding Councillor:
Associate Professor David Newman (Presiding)
Councillors:
Professor Dino Pisaniello
Dr Bradley Ng
Professor Andrew Grulich
Dr John Waterston
Secretariat:
Jan Bowman – Registrar
Medical/Science Writer:
Dr Kate Claydon-Platt
DISCUSSION
1. Finalising Council’s evaluation of the SMSE by Factor:
The Council finalised its consideration of the relevant SMSE by factor
2. For GWS - Preliminary decision on Applicants’ contentions re GWS:
The Council agreed that the literature (SMSE) does not provide sufficient
evidence to support separate SOPs for Gulf War Syndrome/Illness
Andrew Grulich will draft reasons for this decision for all members to consider,
that will include comment on post war syndromes generally
The Reasons will acknowledge Gulf War veterans’ experiences, but Council
considers that the symptoms are not sufficiently distinct from other post-war
syndromes to support separate SoPs.
3. For CMI – Preliminary decisions on Applicants’ contended new factors:
Andrew Grulich to consider the definition of CMI as used in the SoPs against the
SMSE
Kate has already documented the various definitions for GWS and CMI which is
available as a guide
Each councillor to draft sections for all members to consider, on a factors basis
as listed and provide to Jan and Kate for circulation by 30 March 2017.
Address all Communications to:
The Registrar, SMRC, PO Box 965, Brisbane, QLD 4001
Tel (07) 3223 8840
Email: xxxx.xxxxxxxxx@xxx.xxx.xx
Web site: www.smrc.gov.au
11
Factor
Decision
Who
Depleted Uranium
David
Oil well Smoke
Dino
Sarin
Dino
pyridostigmine
SMSE does not
John/Bradley
support a factor –
no biological
plausibility
Vaccinations
John/David
Pesticides
Dino/David
Psychological stressors
Bradley
Contaminated food and water
No SMSE
Secretariat Actions:
Provide Andrew Grulich with the legislative definition of a ‘disease or illness’
along with the RMA reasons.
Circulate the updated list of papers from the meeting – ensuring it matches
Image silo
Kate to update and circulate the EndNote library – by factor
Kate’s to update and circulate summary paper by factor
Jan to summarise Applicants’ contentions and note the relied on papers
specifically referred to in submissions for Councillors’ reference and for inclusion
in the Reasons.
4. The next meeting
Council agreed to hold a face-to-face meeting in June 2017.
Action: Jan to send a Doodle Poll to settle meeting date.
2
12
MINUTES: SMRC Review - Council Meeting
For:
CMI and GWS
Date:
Thursday 29 June - 09.00 – 16.30
Venue:
Lorne Meeting Room, Parkroyal, Melbourne Airport
ATTENDEES: Associate Professor David Newman (Presiding), Professor Dino Pisaniello, Dr Bradley Ng, Professor Andrew Grulich, Dr John Waterston, and Ben Dube
(Legal Advisor) Dr Kate Calydon-Platt (medical writer) and Jan Bowman (SMRC Secretariat).
1.
Welcomes and Introductions –
David Newman
2.
Legal Questions–
Ben Dube
Council has been asked to review two decisions of the RMA which refer to two different sections of the Veterans’ Entitlements Act (VEA), it is
therefore appropriate to make two separate decisions.
That the RMA was not satisfied that GWS/I is a particular kind of disease within the meaning of the VEA
(see VEA s. 5D), and so did not create
a SoPs;
That the RMA was satisfied that CMI is a particular kind of disease within the meaning of the VEA, and so created SoPs and formulated factors.
Section 196W sets out the powers of the SMRC.
The test of whether GWS/I is a particular kind of disease within the meaning of the VEA is on the Balance of Probabilities, having regard to the Sound
Medical Scientific Evidence (SMSE).
Council can have regard to diagnostic criteria, but the condition in question does not need to meet diagnostic criteria.
Council needs to arrive at a majority decision. Presiding Councillor has a deliberative vote.
Council reminded that its decisions need to be in respect to the material available to the RMA.
There is potential in respect to CMI, to ask the RMA to include a statement that CMI could be contracted through participation in the Gulf War.
13
3.
Draft reasons for GWS - ALL
Discussion
Action
By Whom
By When
Conclusions of Council
Insufficient SMSE
Wording for Paragraph 1 (declaration)
Draft new wording
Ben
Completed
Overarching summary
Draft summary, with any pertinent observations. E.g., about Andrew
14 July
the extent of reported illnesses/ill health in this cohort of
veterans; the availability of data on exposures; reliance on
self-report; animal studies; proposed biological
mechanisms, the extent and quality of papers etc.
Explain any issues re reliance on factor analysis
New information provided by Applicant:
Retain Kuehn only, and consider the other papers for
All
Completed
apart from Kuehn, those cited in draft
inclusion in CMI Reasons
reasons not relevant to the question.
Include Steele et al in CMI Reasons in reference to PB
Council Review
All members to read decision with care for content, and
All
28 July
provide feedback using ‘track-changes’.
Legal Adviser to review
Ben
Secretariat to Finalise
Jan
4.
Draft reasons for CMI - ALL
Council’s Tentative Conclusions on Factors
Factor
Council’s Conclusion
Depleted uranium
Insufficient SMSE
Oil well smoke
To be confirmed
Chemical and biological weapons (in Sarin)
To be confirmed
Medical countermeasures (such as pyridostigmine)
Insufficient SMSE
Vaccinations
Insufficient SMSE
Contaminated food and water
To be confirmed
Pesticides Inc. Deet
To be confirmed
Combined Exposures
To be confirmed
14
Council reminded that its decisions need to be in respect to the symptoms for CMI as described in the SoPs.
Discussion
Action
By Whom
By When
Sarin
Separate new papers from discussion
Jan/Kate
14 July
Dino to review/finalise draft with focus on CMI symptoms
Dino
21 July
Pay particular attention to the Japanese studies
John W/Dino
Insert section into Reasons
Jan/Kate
11 Aug
Pesticides
Separate new papers from discussion
Jan/Kate
14 July
David/Dino to review/finalise draft with focus on CMI
David/Dino
21 July
symptoms
Insert section into Reasons
Jan/Kate
11 Aug
Oilwell Smoke
Separate new papers from discussion
Jan/Kate
14 July
Dino to review/finalise draft with focus on CMI symptoms
Dino
21 July
Insert section into Reasons
Jan/Kate
11 Aug
Combined Exposures
Identify papers on the effects of combined exposures for:
Kate/Jan
21 July
Sarin and PB, and
Organophosphates and PB.
“
Prepare draft on combined exposures for Sarin & PB, and
Bradley
11 Aug
Organophosphates and PB
All other factors and draft Reasons
All subject matter experts to review their sections and
All
11 Aug
ensure all relevant OR’s and CI’s are included for those
papers relied on by the Applicant (refer to Comment Boxes)
Available Papers - subject matter experts
All subject matter experts to review their sections and ensure all
All
21 July
to ensure all relevant papers have been
relevant available SMSE has been reviewed
identified.
Circulate lists to members
Jan
Members to check lists and advise Jan
All
New Papers - subject matter experts to
All subject matter experts to review their sections and ensure all
All
21 July
ensure all relevant new papers have been
relevant new papers provided by the Applicant have been
identified
reviewed:
15
Discussion
Action
By Whom
By When
Check new papers included in the draft reasons
Check lists of new papers – Jan to send
5.
Finalising reasons
Discussion
Action
By Whom
By When
Overarching summary
Draft summary, with any pertinent observations. E.g., about
11 Aug
the extent of reported illnesses/ill health in this cohort of
veterans; the availability of data on exposures; reliance on
self-report; animal studies; about proposed biological
mechanisms, the extent and quality of papers etc.
Council Review
Circulate final Draft
Jan
18 Aug
Legal Adviser to review
Ben
25 Aug
All members to read decision with care for content, and
All
25 Aug
provide feedback using ‘track-changes’.
6.
Other matters - Jan
Reasons for Decision: The SMRC is required to make a declaration and give reasons for its decision
s (see VEA s. 196W). A statement of reasons is
intended to explain to an applicant and other relevant parties to a Review how the decision/s were made. Reasons:
o explain the basis for the Council’s ultimate conclusion(s) by setting out the evidence it considered and how it applied that evidence to the
legislative test it was required to apply.
o provide transparency
o allows those affected to understand the matters taken into account by the Council; and
o enables affected persons/organisation to identify grounds of appeal if they decide to exercise their review rights.
SMRC Declarations are published in the Government Gazette, and the associated Reasons are provided to all parties to a review, and also
published on the SMRC website.
7.
Next Meeting – 3.00pm, Friday 1 September, by phone.
16
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
17
MINUTES: SMRC Review - Council Meeting
For:
CMI and GWS
Date:
Friday 1 Sept - 15.00 – 17.30
Venue:
Teleconference
ATTENDEES: Associate Professor David Newman (Presiding), Professor Dino Pisaniello, Dr Bradley
Ng, Professor Andrew Grulich, Dr John Waterston, and Dr Kate Calydon-Platt (medical writer) and
Jan Bowman (SMRC Secretariat).
1.
Welcomes and Introductions – David Newman
2.
Draft reasons for GWS – ALL
Members confirmed their decision of 29 June that there is insufficient SMSE to support
new Statements of Principles for Gulf War Syndrome/Illness
Andrew will:
o review the comments provided by members in the current draft
o draft an overarching summary
o add comments about the existing SoPs for CMI and the use of interchangeable
terminology
o add comments acknowledging the health experiences of Gulf War veterans
o add one or two paragraphs on ALS (Motor Neurone Disease) – possibly as a
footnote.
Timeframe:
All changes to be provided to the Secretariat by 30 September (sooner if possible) for
circulation to full council.
3.
Draft reasons for CMI - ALL
•
Members confirmed their tentative decisions on the contended factors:
Factor
Council’s Conclusion
Depleted uranium
Insufficient SMSE
Oil well smoke
Insufficient SMSE
Chemical and biological weapons (in Sarin)
To be confirmed once
summary completed
Medical countermeasures (such as pyridostigmine)
Insufficient SMSE
Vaccinations
Insufficient SMSE
Contaminated food and water
Insufficient SMSE
Pesticides Inc. Deet
To be confirmed once
summary completed
Combined Exposures
Insufficient SMSE
Tasks:
All member to review and finalise their summaries:
o paying particular attention to the symptoms described in the papers and the
SoPs definition of CMI
18
o ordering papers with the best quality/most persuasive listed first, giving
reasons for the assessment of papers, quality of study, and any flaws etc.
(giving particular attention any positive studies cited)
o ensuring all relevant OR’s and CI’s are included for those papers relied on by
the Applicant
o adding final conclusions where this has not been done
o checking that all relevant papers have been cited
o Andrew to prepare general comments on odd ratios and how data is
evaluated by epidemiologists.
Timeframe:
All changes to be provided to the Secretariat by 30 September (sooner if possible) for
circulation to full council.
4.
Next Meeting – TBA if required
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2 | P a g e
19
MINUTES: SMRC Review - Council Meeting
For:
CMI and GWS
Date:
Wednesday 31 Jan - 11.00 – 13.00
Venue:
Teleconference
ATTENDEES: Associate Professor David Newman (Presiding), Professor Dino Pisaniello, Dr Bradley
Ng, Professor Andrew Grulich, Dr John Waterston, and Dr Kate Calydon-Platt (medical writer) and
Jan Bowman (SMRC Secretariat).
1.
Welcomes and Introductions – David Newman
2.
Decisions available to the Review Council
The Council may find that:
the Sound Medical Scientific Evidence (SMSE) is sufficient to direct the RMA to amend the
SoPs to insert a factor(s) – and would go on to draft the relevant factors
there is no, or there is insufficient SMSE (ie
, the SMSE is not convincing enough) to direct
the RMA to amend the SoPs to insert such a factor(s)
there is information to support remitting the matter to the RMA for reconsideration in
accordance with any directions or recommendations the SMRC may make.
3.
Review Decisions on factors in scope – ALL
Members reviewed and confirmed their decisions on the contended factors:
Factor
Council’s Conclusion
Depleted uranium
Insufficient SMSE
Oil well smoke
Insufficient SMSE
Chemical and biological weapons (in Sarin)
Insufficient SMSE
Medical countermeasures (such as pyridostigmine)
Insufficient SMSE
Vaccinations
Insufficient SMSE
Contaminated food and water
Insufficient SMSE
Pesticides Inc. Deet
Insufficient SMSE
Combined Exposures
Insufficient SMSE
Members commented that for all contended factors:
the SMSE generally lacked statistical power, is inconsistent, and too limited in
quality or quantity to make firm conclusions.
problems with the SMSE included:
o reliance on self-reported and hypothetical exposures in the absence of
definitive exposure data
o limited, or on many cases no, evidence that matches the SoPs definition for
CMI, making interpretation and extrapolation difficult.
More details are on the attached table.
20
Members agreed that:
there is insufficient SMSE to support new factors for CMI for all exposures in scope,
and also agreed
there was insufficient evidence in the new information provided by the Applicants to
recommend a fresh investigation by the RMA.
TASKS
The Secretariat will:
o Circulate an updated draft based on comments received to date, with sections
reorganised into a more logical order
o Reduce the section on new information to include commentary only on papers
identified by councillors (if any).
Members will:
o review the comments provided by members in the current draft
o review each section, revise, and refine conclusions.
Timeframe:
All changes to be provided to the Secretariat before the next tele-conference to be held on
Wed 21 February.
4.
Next Meeting – Wed 21 February 2018
Minute taker: Jan Bowman
s 47F(1)
Presiding Councillor: David Newman
2 | P a g e
21
3 | P a g e
22
SUMMARY
Chronic Multi-symptom Illness
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Chemical Warfare,
Conclusion:
Discussion Points:
No evidence that
Update section at para
References re chemical
inc Sarin
Insufficient SMSE
No evidence of acute exposure, lack of exposure
matches the SoPs
188 on chemical alarms.
alarms.
data
definition of CMI, making
Aust, GW veterans’
Grade 4
The chemical alarms produced a lot of false
interpretation and
Review section, revise,
Health Study
positives - not a good measure of exposure –
extrapolation difficult.
and refine conclusions.
US DoD
made for sensitivity, rather than specificity, and
Others
could be set off by containments such as oilwell
There is some evidence
smoke and dust.
that exposure causes
Literature does not detail base-line exposure
something, but not
Aust GW veterans’ Health Study – none of the
enough evidence that,
alarm logs had positive results
that something can be
US DoD no confirmation by secondary testing
described as CMI.
Problem with Japanese studies that exposure was
classified on a measure of severity
Illness in Japanese
Lack of human evidence – lot of reliance on
studies does not equate
animal studies
to CMI.
No evidence that long-term chronic exposure
causes illness in the absence of an acute
cholinergic episode
So many variable, complex.
Summary and Conclusions The evidence of long-term health effects occurring
after acute exposure to sarin gas during the Gulf war is
circumstantial and there is no evidence to support the
hypothesis that chronic toxicity can occur in the
absence of acute exposure symptoms. Much of the
evidence is based on self-reported and hypothetical
exposures in the absence of any definitive exposure
evidence.
The evidence is inconsistent and the studies are
limited in quality or quantity.
23
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Pesticides
Conclusion:
Discussion Points:
Some biological
Review section, revise,
Golomb – letter to RMA
Insufficient SMSE
Similar to above.
plausibility, but can’t
and refine conclusions.
Literature inconsistent, reliance on self-reports,
be extrapolated to
Spencer paper – best
Grade 4
no one really knew what they were exposed to –
CMI.
quality, in terms of
no objective data.
definition – looks at
No or limited exposure data
exposure variables, and
Often no distinction made between unique
clusters of exposure
chemical agents, ie reference is to pesticides and
variables - case definition
a generic term
in papers relatively good,
The studies leave open the possibility of pesticides
but exposure analysis has
(Ops) making a contribution (Golomb – not the
not been done.
answer, but may make a contribution).
The available SMSE does not suggest a clear and
unequivocal association between pesticide use and/or
exposure and the multifactorial multi-symptom
illnesses reported in Gulf War veterans.
The evidence is inconsistent and the studies are
limited in quality or quantity.
2
24
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Depleted uranium
Conclusion:
Discussion Points:
No studies related to
Review section, revise,
Insufficient SMSE
CMI?
and refine conclusions.
Overall, the study samples have been small and there
Grade: 4 or 5b
are limitations with measurements or records to
quantify the amount of depleted uranium Gulf War
veterans were potentially or actually exposed to.
There is also relatively little information available from
epidemiologic studies concerning veterans' exposure
to depleted uranium and its possible link to chronic
multisymptom illness.
Overall, the weight of SMSE suggests that depleted
uranium has not been shown to be a factor in the
development of symptoms of chronic multisymptom
illness.
Combined Factors
Conclusion:
Discussion Points:
Review section, revise,
Spencer
Insufficient SMSE
Problems with the other literature is magnified in
and refine conclusions.
the attempt to combine factors.
Grade 4
Spencer – BP & pesticides with relatedly close
match to SoPs definition found that there wasn’t
an interaction.
3
25
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Contaminated Food
Tests –
The quality of the available evidence concerning
Only one paper specific
Review section, revise,
and Water
Reasonable
exposure to contaminated food and water and the
to CMI?
and refine conclusions.
Hypothesis
development of chronic multisymptom illness is
Balance of
limited. The Council noted that of the SMSE identified,
Probabilities
only one paper by Unwin et al(27) used the CDC
definition for chronic multisymptom illness to examine
Conclusion:
the association between exposure to contaminated
Insufficient SMSE
food. Unwin et al(27) demonstrated a non-significant
association of eating local food and chronic
multisymptom illness.
Grade: 4
Overall, there were limitations with the quality of the
comprised SMSE. The use of different outcome
measures such as increased symptom reporting of Gulf
War illness, which was defined differently by different
authors, made it difficult to assess the research in
relation to the symptoms seen in definition of chronic
multisymptom illness as set out in SoPs. In particular
the papers were limited in quality by possible
exposures to multiple agents, the lack of exposure
information including concentrations or cumulative
exposures levels, the possibility of confounding (from
other exposures), and recall bias from self-reported
health symptoms.
4
26
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Smoke from oil well
Conclusion:
In its review of the SMSE, the Council identified a number of
It is pertinent to note that
Review section, revise,
fires
Insufficient SMSE
studies, two studies examined exposure to oil well smoke
the neurological symptoms
and refine conclusions.
and chronic multisymptom illness (CDC defined),(27, 28) two
of chronic multi-symptom
Grade: 4
other studies compared two definitions of Gulf War illness
illness have not been
(CDC and Kansas defined)(37) and Gulf War unexplained
associated with
illness (CDC and PEHRC defined),(6) and two studies used
firefighting.(40-42).
different definitions of Gulf War illness (Gray defined)(29)
and (Lucas defined).(38) One study examined association
with burn pit emissions and chronic multisymptom illness
(CDC defined).(36) Others examined exposure to smoke
from oil well fires and respiratory disease,(22-24, 35, 44)
post-war morbidity from exposure to oil well fire smoke,(30,
39) and one study examined the biological uptake of oil-fire
associated volatile organic compounds concentrations in
whole blood of US military Army personnel and firefighters
and medical and para-medical personnel working at the
burning oil wells.(43)
Insights into smoke-related morbidity and mortality may be
gained by examining occupational studies of firefighters.
Three studies of firefighters were reviewed.(40-42) Overall,
in assessing a potential causal relationship between chronic
multisymptom illness and exposure to oil well fire smoke, it
is pertinent to note that the neurological symptoms of
chronic multisymptom illness have not been associated with
firefighting.(40-42).
5
27
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Chemical warfare
Tests –
The quality of the available evidence concerning exposure to
Three papers
Review section, revise,
counter measures
Reasonable
pyridostigmine bromide and the development of chronic
and refine conclusions.
(Pyridostigmine
Hypothesis
multisymptom illness is limited. The Council noted that of
Lack of plausible biological
bromide) – for
Balance of
the three papers (6, 27, 28) which used the CDC definition
mechanism
for chronic multisymptom illness to examine the association
chem/biological
Probabilities
between exposure to pyridostigmine bromide. Unwin et
warfare agents see
al(27) and Wolfe et al(28) each demonstrated a mild
below.
Conclusion:
significant association of pyridostigmine bromide and
Insufficient SMSE
chronic multisymptom illness. While Spencer et al(6) did not
demonstrate a significant association. However, there were
Grade: 4 or 5a?
major limitations with the overall quality of the evidence. All
of the studies relied on self-reporting and the Spencer et
al(6) study was the only study which combined self-reporting
with clinical evaluation.
In all studies, exposure assessment of pyridostigmine
bromide in military personnel have been based on
individuals’ recall of the measures they received or took,
frequently under stressful situations, and have seldom been
verified by records. This potential for recall bias also
contributes to the difficulty in identifying specific causes of
the veterans’ health problems. It is unclear whether the
actual exposure or the belief in exposure is the most
important aetiological factor.
6
28
Factor/definition Conclusion/Grade Comments from Summaries
CMI Symptoms
Actions:
Key Papers
(please list)
Vaccinations
Tests –
Although the quality of the available SMSE was limited, the
Only one positive study
Review section, revise,
Reasonable
Council considered the most informative studies on
and refine conclusions.
Hypothesis
exposure to vaccinations and the development of chronic ill
Balance of
health in Gulf War veterans were those studies where
vaccination books, electronic documentation of vaccinations
Probabilities
and medical chart reviews were used to support data
analysis.(27, 109, 120, 121, 123) Of these studies, four found
Conclusion:
no association between vaccinations and the development
Insufficient SMSE
of chronic ill health in Gulf War veterans,(27, 120, 121, 123)
and the only positive study(109) produced conflicting results
Grade 4.
when the data were re-analysed using a different
paradigm.(122)
Overall, there seems to be insufficient evidence to
incriminate a definite pathophysiological link between
exposure to vaccines and the development of chronic
multisymptom illness. The available studies are of
insufficient quality, consistency or statistical power to permit
a conclusion regarding the presence or absence of a causal
association between vaccinations and chronic multisymptom
illness.
7
29
30
s 47F(1)
s 47F(1)
s 47F(1)
s 47F(1)
s 47F(1)
s 47F(1)
31
