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MINISTRY OF DEFENCE
Page 1
Gulf Veterans’ Illnesses Unit
MINISTRY OF DEFENCE
Room 6/03, St Christopher House, Southwark Street,
London, SE1 OTD
Telephone
Direct dial
020 7305 4644
Helpline
0800 169 4495
Fax
020 7305 2374
Our Reference:
D/GVIU/7/1/8/2
Date:
9
th
January 2002
MINUTES OF THE SECOND DEPLETED URANIUM SCREENING PROGRAMME OVERSIGHT
BOARD ON 30
th
NOVEMBER 2001
Present
Board:
Observers:
Professor David Coggon
Surg Cdre Nick Baldock
Mr Ron Brown
Dr Chris Busby
Dr Peter van Calsteren
Mr Ivor Connolly
Mr Paul Connolly
Dr George Etherington
Miss Beverley Green
Professor Malcolm Hooper
Dr David Lewis
Dr Gordon Paterson
Professor Brian Spratt
Mrs Brigid Rodgers
Surg Cdre Peter Tolley
Mr Alan Duncan
Mr Mark Newman
INM
DRPS
LLRC
OU
NGV&FA
NGV&FA (rep S Rusling)
NRPB (rep F Fry)
RBL
GVA
INM
BRC
RS
GVIU
SGD
HJA
GVIU
Chair
Acting
Secretary
Apologies
Professor Nick Day
Dr Muir Gray
Miss Frances Fry
Mr Shaun Rusling
Dr Hilary Walker
Mrs Karen Davies
Mr Shaun Emery
IPH
NSC
NRPB
NGV&FA
DH
HSE
GVIU
Secretary
Page 2
Item Discussion
and
Decisions Actions
(Action date)
1.
Introduction
a) New attendees were welcomed and introduced.
2.
Minutes of last meeting
a) These were accepted as a true record of the meeting.
b) The Chairman reiterated that the minutes should be published in draft within
3 weeks of the meeting. GVIU stated that the OB website should be
established by the end of December.
Matters arising from last meeting
1.1 ‘Definitions
of
Terms’
appendix to be drafted and
circulated for comment
Lewis/
Calsteren
Appended to draft protocol
paper (Action 1.12). Comment
still required.
Continuing
All
(28 Jan 02)
1.2 Nominations
for
toxicologist and radiation
medicine experts to be sent
to GVIU
All OB
Members
COMPLETE
1.3
CVs and declarations of
interest to be sent to GVIU
All OB
Members
Some CVs outstanding. No
declarations of interest
received.
Continuing
Hooper,
Paterson
(short
version);
Green,
Gilmore,
Lewis
(20 Dec 01)
1.4
Secretary to establish if
payments can be made for
Board members to attend
meeting where they have
to take unpaid leave or are
self employed
Secretary
COMPLETE – Payments will
be considered on an individual
basis. Written justification
must be forwarded by Board
member to GVIU for
consideration.
1.5
Secretary to create a claim
form for expenses
Secretary
COMPLETE - Form
distributed on 23/10/01.
1.6
Secretary to distribute a
copy of the press release to
board members
Secretary
COMPLETE – Press release
distributed on 23/10/01.
3.
1.7
Board members to write to
GVIU with suggestions for
further background reading
All OB
Members
COMPLETE – Brian Spratt
asked for “Depleted Uranium:
A Problem of Perception rather
than Reality” R L Kathren to
be distributed (tabled); Chris
Busby distributed his paper
“Health Risks following
Exposure to Aerosols produced
by Depleted Uranium
weapons” Nov 01 in advance
of the meeting.
Page 3
1.8
GVIU to obtain permission
and distribute responses to
the 2
nd
consultation paper
to Board Members
Secretary
COMPLETE – distributed by
email on 13/11/01.
1.9
GVIU to distribute list of
email addresses
Secretary
COMPLETE – Distributed on
23/10/01.
1.10 Board members to suggest
suitable laboratories for
pilot study to GVIU
ALL OB
Members
COMPLETE - 14 labs
suggested and tabled.
1.11 Secretary to arrange for
invitation to express an
interest in the pilot study
to be advertised in the
relevant journals
Secretary
COMPLETE - Advert in
MOD Contracts Bulletin on
21/11 (tabled) and OJEC on
13/11.
1.12 Produce and circulate draft
protocol for pilot study
prior to next meeting
Lewis/
Calsteren
COMPLETE- GVIU
circulated David Lewis’s draft
protocol shortly before the
meeting.
4.
Terms of Reference
a) There was some discussion regarding the revised TOR. Chris Busby wanted
the TOR to allow for tests other than a urinary uranium test to take place if
the Board felt it advisable. This was agreed though the Chairman stressed that
the urine test would provide the most direct measure of exposure to DU.
b) Some of the language in the TOR was felt to be unclear. A further revised
draft of the TOR is attached to these minutes and will be sent to the Minister
for comment.
Action 2.1. GVIU to send TOR to Minister for comment
GVIU
(4 Jan 02)
5.
Additional Membership of Board
a) The list of new nominations to the Board was circulated for discussion.
Three toxicologists were considered possible candidates. Nominating
members are to arrange for CVs to be sent to Secretary who will forward
these to the Minister for a decision.
Action 2.2. CVs for toxicologist to be sent to GVIU; GVIU to forward to
Minister
b) A short list of radiation medicine experts was not agreed. Members are to
supply further names to Secretary for circulation. GVIU are to consult the
Royal College of Radiologists.
Action 2.3 Suggestions for radiation medicine experts to be sent to GVIU
Action 2.4 GVIU to consult Royal College of Radiologists
c) The Royal British Legion had nominated Miss Beverley Green, Head of
Benevolent Department, who was present, and Prof Roger Gilmore, Chief
Scientific Adviser.
d) There was a suggestion that an expert in risk communication should be
included. Risk communication was agreed to be an important role once
testing commenced but it was felt that it would be more appropriate to co-opt
a suitable expert only when required.
Coggon.
Hooper,
HSE, GVIU
(8 Jan 02)
All
(8 Jan 02)
GVIU
(8 Jan 02)
Page 4
e) Post meeting note: Ray Bristow has volunteered to be a replacement for
Shaun Rusling as a veterans’ representative on the OB.
6.
Programme Plan
a) Ivor Connolly expressed concerns about the length of the projected timescales
for the pilot study and the establishment of a testing programme. However,
Gordon Paterson, Beverley Green, David Lewis, Brian Spratt and Malcolm
Hooper agreed that it was important to ensure that rigorous tests were carried
out and that reliable data were obtained. The timescales were already
optimistic and it would be difficult to shorten them.
b) It was agreed that, if insufficient expressions of interest in the pilot study
were registered by the due date of 10 December, additional bids would be
invited. GVIU were asked to notify the Board who had applied by 10
December. George Etherington emphasised that it was important to select a
sufficiently large number of laboratories to allow for some laboratories failing
to complete the performance tests satisfactorily.
Action 2.5 GVIU to notify members of expressions of interest
c) The protocol for the pilot study of analytical methods that had been drafted by
David Lewis was reviewed. Spiked samples would be provided to the
participating laboratories. There was a discussion about whether it was
necessary to have uniformity of containers for supplying the samples. It was
agreed that the laboratories concerned must find the containers provided
acceptable but that all containers should be the same. Samples for the pilot
study should be one litre and the amount of DU within the spiked samples
should straddle the likely range which might be excreted. This could be
determined from the literature and from reports from laboratories which had
already carried out tests for uranium in the urine of veterans. It was
confirmed again that veterans’ samples would not be used in the pilot study.
Chris Busby was keen to have aqueous samples tested also. After a brief
discussion it was agreed that, if urine tests proved unsatisfactory, results from
aqueous samples might help to explain the reason.
d) Regarding collection and delivery of samples, Ivor Connolly pointed out that
the Gulf War Veterans’ Medical Assessment Programme (MAP) had a
procedure for collection of samples which could be followed.
e) Malcolm Hooper and Chris Busby were concerned that the reference samples
should not come from an area, such as Harwell, where urine might already
have a high uranium content.
f) Three suppliers were identified in the paper who might be able to prepare the
spiked samples that were needed. The Chairman said it would be an
advantage if the organisation that prepared the samples could also analyse
statistically the data from the participating laboratories. Prof Nick Day would
need to comment and advise on the statistical methodology. There was
discussion on the respective merits of the three possible suppliers. It was
agreed that the relevant experts on the OB would prepare a Statement of
Requirement for the sample preparation and statistical analysis and contact
one of the suppliers. The other suppliers would only be contacted if the first
one was unable to comply.
Action 2.6 Peter van Calsteran to draw up a Statement of Requirement for
the sample preparation by 7 December
GVIU
(12/12/01)
Van
Calsteran
(7 Dec 01)
Page 5
Action 2.7 David Lewis to contact the preferred supplier (and other suppliers
if required) to assess interest and costs
g) A subgroup of the OB (Chairman, Lewis, van Calsteran, Hooper, Secretary)
would visit the nominated supplier, preferably before Christmas, to agree
details of the sample preparation and testing. Nick Day would then need to
review the proposed experimental design and method of statistical analysis in
the same timeframe.
Action 2.8 D Lewis to arrange meeting with supplier
Action 2.9 Subgroup to visit supplier
Action 2.10 Nick Day to review protocol and proposed statistical methods
h) Other issues raised during review of the draft protocol were as follows:
• The protocol should clarify that the laboratory (ies) who produced a
successful test might not necessarily win the contract for the main
programme of urine testing
• Assurance of performance in the main programme of urine testing should be
considered at a later date, not within the protocol for the pilot study
• The source of the urine for the samples should be specified by the supplier
• Methods for measuring creatinine in urine need not be considered at this stage
– it is a standard test.
i) David Lewis was tasked to redraft the protocol, taking into account the points
that had been discussed.
Action 2.11 David Lewis to redraft protocol for pilot study of analytical
methods
[Post meeting actions:
Action 2.12 David Lewis is to draft the Statement of Requirement for the
urine testing in the pilot study, to be distributed to the OB by 21 Dec 01
Action 2.13 OB to comment to David Lewis on the SOR for the urine testing
by 1200, 10 Jan 02]
Lewis
(10 Dec 01)
Lewis
(13 Dec 01)
Coggon,
Lewis, Van
C, Hooper,
GVIU
(20 Dec 01)
Day
(28 Jan 02)
Lewis
(21 Dec 01)
Lewis
(21 Dec 01)
All
(10 Jan 02)
7.
Design of epidemiological studies
a) The Chairman said it was too early to consider this topic in detail – next
summer would be about right, when the pilot study was complete and the
testing technique was proven. However, it would be a good idea to appraise
those conducting epidemiological studies of veterans of the planned timetable
for development of the testing method so that timings could be co-ordinated.
Action 2.14 Chairman to appraise Medical Research Council of the planned
timetable for development of the testing method
b) The Chairman gave a brief résumé of the various epidemiological designs that
might be appropriate. He undertook to produce a paper for the next meeting
Coggon
(28 Jan 02)
Page 6
summarising the different types of study.
Action 2.15 Chairman to produce paper for next meeting summarising the
different types of epidemiological study that might be relevant
Gordon Paterson stressed the need to determine the distribution of uranium
excretion in the general population and suggested that it would be a good idea to
build a portfolio of potential research projects. Malcolm Hooper said that
establishing a control group might be difficult if DU was as widespread as he
believed it to be.
Coggon
(21 Jan 02)
8.
Timescales
a) Nothing further to add to item 4a.
9.
Longer term issues relating to the testing programme
a) The Chairman and others raised a number of issues which are discussed
below.
b) Custody of samples: Both MOD and veterans’ representatives agreed that it
would be important to have an auditable and tamper-proof chain of custody
for samples. Chris Busby stressed the need to have coded samples that were
analysed blind. There was also an issue over who should hold the individual
results and for how long. Gordon Paterson said it depended on whether it was
an NHS hospital or a research group; researchers would normally retain data
for 10-20 years, and they would be obliged to provide a result to the
individual concerned if requested. Results held by NHS hospitals would be
treated like other medical records. Chairman also raised the issue of the
practicality of collecting samples from across the country. Possible models
for practice regarding chain of custody included police procedures for alcohol
tests, drug testing in industry and drug testing for sports events. David Lewis
had taken a preliminary look at the procedures for sports events. GVIU were
tasked to prepare a paper for the next meeting on options for chain of custody.
Action 2.16 GVIU to prepare a paper on the options for a chain of custody of
urine samples
c) Offering the urine test to veterans: Assuming a suitable test can be
established, it will be necessary to determine a method for providing the test
to veterans. Malcolm Hooper felt that regional centres were required,
preferably under the auspices of the NHS, for example at major hospitals. He
believed the centres should be independent of MOD if possible. The
Chairman stated that good communication of the results to patients would be
crucial and that the medical staff involved should have the necessary
expertise. GPs would need to be briefed if they were involved in the process.
Gordon Paterson thought it would be better to collect urine at hospitals rather
than from GPs’ surgeries. The Chairman said that the availability of the
necessary experts would be a limiting factor; medical doctors with experience
of ionising radiation were fairly widespread but medical toxicologists were
rare and medical toxicologists with experience in heavy metal poisoning even
rarer. Clinical chemists were fairly widespread but had little involvement
with patients. The Chairman asked whether MOD would be prepared to fund
regional centres. Brigid Rodgers said she would need to seek advice within
the MOD.
Action 2.17 GVIU to identify the position on MOD funding of regional
centres
GVIU
(21 Jan 02)
GVIU
(28 Jan 02)
Page 7
d) Measurements other than in urine: Malcolm Hooper suggested that
analysis of tissue samples from autopsies of those who were suspected of
exposure to DU could be another useful approach. The Chairman said it was
procedurally difficult to get autopsies these days, but that this might be
facilitated if veterans had indicated in advance that they wished to be tested in
this way. Veterans and their families would need to be informed about the
scope for any such testing and pathologists would need information about
what tissue samples to collect, and how they should be stored. Malcolm
Hooper believed that veterans would be in favour. The Chairman suggested
that, at the appropriate time, a consent and information form would need to be
designed. First, however, it was necessary to establish whether the testing of
autopsy samples was technically feasible, and if so, what samples would be
needed. NRPB were actioned to obtain advice on this.
Action 2.18 NRPB to obtain advice on the feasibility of testing for DU in
tissue samples obtained at autopsy.
NRPB
(28/01/02)
10.
DU Background and Scientific Issues
a) The Chairman drew the attention of the Board to several issues that were
covered in the background papers that had been circulated.
• Sources of exposure to DU – there was agreement on these.
• Quantities of DU used in Kosovo– there was general agreement that some
10 – 30 tonnes had been used, although Chris Busby felt there were
uncertainties as to whether the UNEP report gave a complete picture. He also
asked whether Cruise missiles contained DU, but Ron Brown reported that
they did not.
• Percentage of particulate released into the atmosphere following impact,
and the distance travelled – there was some disagreement on this with
claims of 30% (Ron Brown) to 80% (Chris Busby) being made. Chris Busby
believed that a more contentious question was how far the particulate
travelled. Ron Brown believed this was well covered in the literature.
Gordon Paterson questioned whether these matters were critical to the
proposed testing programme. The Chairman said they could be relevant to
who was targeted for testing. Gordon Paterson felt that perhaps it would be
easier to identify who should be excluded. Ron Brown suggested that this
would be people many miles away from strike sites.
• Routes by which DU enters the body - it was agreed that inhalation of
insoluble compounds would be the main route of entry.
• Distribution and excretion of absorbed uranium – there was agreement on
the main tissues to which uranium would be distributed (lungs, lymph nodes,
kidneys, bone) and on the main route of excretion. The Chairman asked for
the relevant Annexes from the Royal Society Report to be circulated.
Action 2.19 GVIU to circulate Annexes A & D (on the current ICRP models
and Organ Doses from intakes) from the Royal Society Report
GVIU
14/01/02
11.
Dates of 3
rd
and 4
th
Meeting
a) The dates of the third and fourth meetings were set for 28 January and 28
March 2002 at 0945.
Post meeting note: The January and March meetings will be held in London in the
Marble Hall, Northumberland House and the Kensington Room, Chadwick Street
respectively. Directions will be sent to new attendees.
Page 8
12.
AOB
a) The Chairman listed a number of events which should have occurred by the
next meeting:
• Contract in place for the preparation of spiked samples for the pilot study
• Expressions of interest in undertaking the testing in the pilot study received
• Invitation to Tender (ITT) and draft protocol for the pilot study prepared.
b) The Chairman said that the draft protocol should be provided to laboratories
together with the ITT to enable them to comment on it.
Action 2.20 GVIU to provide Contracts Branch with the draft protocol in
time for ITT issue on 31 Jan 02
c) The Chairman asked for a paper to be prepared for the next meeting on the
background science to laboratory methods and their reliability, including, for
example, the issue of repeatability versus accuracy.
Action 2.21 David Lewis/Peter van Calsteran to prepare a paper on
laboratory methods
d) The Chairman asked GVIU to arrange a briefing meeting with US of S Dr
Lewis Moonie, preferably within the next few weeks.
Action 2.22 GVIU to arrange a meeting between Chairman and US of S
e) Chris Busby asked the Chairman to raise the issue of numbers of Balkans
veterans who had died from leukaemia with Dr Moonie. MEP Dr Caroline
Lucas had written to Dr Moonie on this topic. Chris Busby was advised that
the Minister would be replying to Dr Lucas shortly. Chris Busby also asked
the Chairman to ask Dr Moonie whether DU had been used in Afghanistan.
Brigid Rodgers said that this question had been addressed in a number of
recent Parliamentary Questions which could be found in Hansard; DU had not
so far been used but its use was not ruled out should the operational
requirement exist.
f) Malcolm Hooper said that it was believed that DU was in some fireworks
which could therefore be a source of exposure. The Chairman stated that
fireworks were outside the TOR of the OB.
g) Ron Brown had prepared a paper on the health effects of DU, based on the
Royal Society Report and other open literature. This was distributed after the
meeting.
h) Brian Spratt said that the Royal Society Part II paper on DU was going to
referees that day and should be published by the end of January 2002.
GVIU
(21 Jan 02)
Lewis/van
Calsteran
(21 Jan 02)
GVIU
(7 Dec 01)
Distribution:
Members
Observers
Devolved Health Authorities:
Dr Arthur Johnston, Scotland
Dr Owen Crawley, Wales
Dr Glenda Mock, Northern Ireland
Page 9
DU OVERSIGHT BOARD – TERMS OF REFERENCE – DRAFT VERSION 4
1. The purpose of the Depleted Uranium Oversight Board is to:
a. Oversee and co-ordinate the process of letting the contracts, and undertaking testing, for
uranium isotopes in urine to assess historical exposure to DU.
b. Act as a Project Board, to direct, endorse and oversee the work of the MOD Project
Manager who will:
(1) Develop a draft Statement of Requirement for a DU sampling protocol, a chain of
custody for samples and a quality control protocol for endorsement by the Board.
(2) Invite proposals for testing.
(3) Prepare an assessment of proposals received.
(4) Manage a pilot study to demonstrate the performance, precision, accuracy and
validity of the method, including the techniques for collecting, splitting, storing,
transporting and analysing samples.
c. If satisfactory methods of testing can be established, agree proposals for one or more
epidemiological studies using those methods, to determine the distribution and
determinants of excretion of uranium isotopes in urine, and to explore the relation of
historical exposure to DU to possible biological and health effects.
d. If satisfactory methods of testing can be established, agree arrangements for testing
additional individuals who are not part of the epidemiological studies. These will include the
arrangements for the involvement and briefing of GPs, and procedures for any
accompanying medical assessment.
e. Monitor progress of the testing, including auditing and quality assurance of the data.
f. Ensure that the findings of the testing and research are appropriately promulgated.
g. Report to the Under-Secretary of State for Defence and Minister for Veterans’ Affairs, on
progress issues and concerns.
2. The Oversight Board will explore and advise on other possible methods of historical
exposure assessment.
3. The Oversight Board will be invited to comment on:
a. The development of biological monitoring tests to be used by MOD for future
operations where DU is used.
b. Proposed epidemiological studies to examine possible ill-health effects of service
in the Balkans.
c. Possible arrangements for a Veterans’ Assessment Centre.