DRAFT MINISTRY OF DEFENCE DRAFT

This is the html version of the file http://www.duob.org.uk/minutes3.pdf.
G o o g l e automatically generates html versions of documents as we crawl the web.
To link to or bookmark this page, use the following url: http://www.google.com/search?q=cache:upjSxKhSIc8J:www.duob.org.uk/minutes3.pdf+minutes3.pdf&hl=en&ie=UTF-8

Google is not affiliated with the authors of this page nor responsible for its content.

These terms only appear in links pointing to this page: minutes3 pdf

Page 1

DRAFT

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

DRAFT

Our Reference:

D/GVIU/7/1/8/2

Date:

February 2002

These minutes are published in draft form and are subject to confirmation at the next Board.

MINUTES OF THE THIRD DEPLETED URANIUM SCREENING PROGRAMME OVERSIGHT

BOARD ON 28

JANUARY 2002

Present:

Board:

Observers:

Professor David Coggon

Mr Ron Brown

Dr Chris Busby

Dr Peter van Calsteren

Mr Ivor Connolly

Mr Ray Bristow

Miss Frances Fry

Miss Beverley Green

Dr David Lewis

Dr Gordon Paterson

Professor Brian Spratt

Mr Shaun Emery

Surg Cdr Stuart Allison

Mr Alan Duncan

Mr Neville Higham

Mrs Brigid Rodgers

Mr Mark Newman

Mrs Janie Walker

DRPS

LLRC

NGV&FA

NRPB

RBL

INM

BRC

GVIU

SGD

HJA

HSE

GVIU

Chair

Secretary

Apologies:

Surg. Cdre Nick Baldock

Professor Nick Day

Prof Ian Gilmore

Dr Muir Gray

Dr Len Levy

Prof Malcolm Hooper

Dr Hilary Walker

INM

IPH

RBL

NSC

MRC IEH

GVA

Page 2

DRAFT

Item Discussion

and

Decisions Actions

(Action date)

Introduction

a) New attenders were welcomed and introduced.

b) The Chairman re-iterated the point that discussions and comments made

at the OB meetings are only to be communicated to persons external to the

Board through the published minutes. Individual members should be free to

speak more generally about issues relating to DU, but should make it clear

that they are acting as an individual and not representing the OB. The

Chairman also re-iterated that any individual who was not content with any

aspect of the OB would be welcome to discuss the matter with him.

c) The Chairman stated that the main aims of this meeting were to:

• Provide an update on the pilot exercise to establish if a suitable

urine test is available for retrospective assessment of exposure

to DU

• Select the pilot study laboratories

• Clarify a number of issues regarding the pilot exercise protocol

Minutes of last meeting

a) These were accepted as a true record of the meeting.

Matters arising from last meeting

a) A full list of actions arising from previous meetings and their current

status is attached at Annex A to these minutes.

b) The ‘Definitions of Terms’ attached to the draft protocol were accepted

by the OB.

c) The Secretary gave an update on progress with the DUOB website. He

stated that web pages had been produced for this site and he was currently

awaiting the registration of the domain name before the site could be

launched. The address of the site will be www.duob.org.

d) The draft Terms Of Reference for the OB have been accepted by US of

S, Dr Moonie.

e) The Chairman stated that he had been in contact with the MRC to keep

them informed of DUOB activities. He had also talked with Professor Simon

Wessley of Kings College regarding the possibility of using the established

Kings College cohorts in future research incorporating DU exposure

assessment.

f) Brigid Rodgers stated that the MOD was prepared to fund a number of

regional centres for urine collections (Action 2.17) but the details had yet to

be discussed.

g) There was some discussion regarding George Etherington’s paper on the

practicability of taking autopsy samples for DU testing. There was general

agreement that this was not easy to achieve, particularly because of the need

to obtain consent from the next-of-kin soon after death. This would be

Page 3

DRAFT

difficult unless the procedure had previously been agreed by the prospective

donor. A possible way of achieving the required consent might be to provide

veterans who wished to participate with a card or information sheet that could

be given to his/her doctors, rather like the card that was used by organ donors.

h) Annex A and D of the Royal Society report Part 1 had been distributed

with the calling notice for this meeting. It was noted that these Annexes are

very technical and that they are summarised in the main body of the RS

report. The Chairman asked about the levels of DU that might be excreted in

urine following an acute exposure many years earlier. Brian Spratt responded

that an inhaled dose of 25mg DU as insoluble oxides should be detectable

after 10 years. Ron Brown stated that he had already seen some results of DU

testing in urine and that at the Society for Radiological Protection seminar

two weeks ago Neil Stradling of the NRPB had made a presentation on

excretion profiles. GVIU undertook to make the slides of this presentation

available.

Action 3.1 GVIU to distribute NRPB Presentation

i) There was also some discussion of the results of testing that had been

carried out by Durakovic and colleagues. GVIU undertook to seek permission

to distribute the slides from a Durakovic presentation to the Royal Society in

November 2001 which contained these results.

Action 3.2 GVIU to seek permission and distribute Durakovic presentation to

j) Brian Spratt stated that part 2 of the Royal Society report is in press and

will be released on 11

March 2002. The Chairman asked if an advance copy

of the section relating to urine excretion could be made available to some

members of the OB. Brian Spratt said he would look into this.

Action 3.3 Brian Spratt to investigate if advance copies of urine excretion

section of RS report can be made available to members of the OB

Action 3.4 GVIU to distribute part 2 of RS report when available

k) The Chairman briefly described his meeting with Under Secretary of

State, Dr. Lewis Moonie, on 16 January 2002. He had explained the approach

being taken by the OB in setting up the testing programme and stressed that

the Board is aware of veterans’ concerns over the timescale. Dr Moonie was

content with the way things are proceeding.

Secretary

(15/2/02)

Secretary

(15/2/02)

Spratt

(15/2/02)

Secretary

(when

available)

OB Additional Members

a) Dr Len Levy from the MRC Institute for Environment and Health has

been appointed to the Board to fill the toxicologist role.

b) The Secretary gave an update on the additional names that have been put

forward for the Radiation Medicine role on the board. Following discussions

about the nominations it was agreed that only one candidate had the required

clinical experience. GVIU undertook to contact the proposed nomination to

see if they were interested in joining the Board.

Action 3.5 GVIU to contact proposed specialist in radiation medicine

Secretary

(15/1/02)

Page 4

DRAFT

Programme Plan

Update on pilot study laboratories

Seven expressions of interest in carrying out the pilot exercise had

been received and evaluated by a subset of the OB. Copies of these were

handed out at the meeting along with a summary document. The Chairman

stressed that these documents were Commercial-in-Confidence and should

not be removed from the meeting room and, in particular, not circulated to

non-members.

The Chairman stated that the aim of this discussion was to select from

the expressions of interest up to 6 laboratories that were judged most suitable

to carry out the pilot exercise. Ron Brown questioned the reason for this. The

Chairman replied that constraints were imposed by the amount of spiked

urine that the NEQAS laboratory could provide and by MOD funding.

Post meeting note: At the first DUOB meeting discussions indicated that 3 or 4

laboratories would be chosen for the pilot exercise. MOD funding had therefore

been sought for this number.

Peter van Calsteren led a discussion on the merits of the 7 expressions

of interest. He had evaluated them on the basis of the relevant experience of

the laboratories, accreditation, publications in journals and the equipment to

be used. This led to a prolonged discussion which is not documented in these

minutes due to the Commercial-in-Confidence nature of the expressions of

interest.

One expression of interest was considered technically much weaker

than the others, although it did propose a novel method that might be worth

investigating. After some further discussion, it was agreed to issue an

Invitation To Tender (ITT) to all 7 laboratories. If all 7 labs provided bids at

acceptable prices then, all other things being equal, the bid that had been

identified as the weakest technically would be eliminated.

Gordon Paterson expressed a concern that some of the laboratories did

not have the accreditation that would be expected by, say, the NHS. David

Lewis pointed out such accreditation would only cover the basic functions of

the laboratory and would not necessarily reflect their ability to do specific

tests for DU exposure. The Chairman said that this was not such an important

issue for the pilot exercise and that the necessary QA procedures etc. would

be built into the contract for the main testing programme.

There was some discussion regarding the size of the urine samples that

would be required. Ray Bristow said that when he went to the US for testing

by Dr Durakovic he gave a 72 hour sample which removed some of the

problems of daily variation. The Chairman pointed out that there was a

balance to be struck between accuracy and practicalities, and large volumes

of urine were difficult to obtain, store and transport. Ray Bristow stated that

anything less than 24 hour samples would not be acceptable to members of

the NGV&FA. The Chairman pointed out that one of the aims of the pilot

exercise was to establish what size of sample would be required for an

accurate test and that each lab would receive large samples (probably 1 litre)

and smaller samples (probably 100 ml) for this purpose. It was generally

agreed that it would be wise to wait for the results of the pilot exercise.

Page 5

DRAFT

Brian Spratt asked if the Canadian laboratory involved in the

Durakovic testing had been contacted about the pilot exercise. The Secretary

confirmed that they had been contacted but had not responded with an

expression of interest.

The Chairman pointed out that he was indirectly linked professionally

(although not financially) to an organisations involved in one of the

expressions of interest, and asked if the OB had any objections to his

participation in the selection process. No objections were raised.

Update on laboratory to supply spiked samples

i) At the last meeting, the National External Quality Assurance Schemes

(NEQAS) laboratory at the University Of Surrey was identified as the

preferred supplier of the spiked samples. The Chairman had visited this

laboratory along with David Lewis, Peter van Calsteren and the Secretary on

December 2001. It was agreed that NEQAS would be suitable for

carrying out the task with supervision by an appropriate Board member. Peter

van Calsteren agreed to supervise the NEQAS work.

j) The Secretary gave an update on the status of the NEQAS contract. The

quote for the work had been received and approved. The contract was

expected to be placed in the next two days.

Post meeting note: NEQAS contract placed on 30/1/02.

k) Ivor Connolly asked if NEQAS could produce the samples to fit in with

the DU pilot study timescales. The Chairman confirmed that this was the

case.

l) The Chairman asked for the Board’s thanks to David Lewis and Peter

van Calsteren to be minuted for their efforts in this area.

Pilot Study Protocol

m) There was extensive discussion regarding the spiking regime, particularly

with regard to the size of the samples and the uranium isotope ratios and

concentrations in the urine. The Chairman stated that members of the OB

should not discuss this outside the meeting in case the credibility of the pilot

exercise was compromised. It was agreed that the spiking regime should be

finalised between David Lewis, Peter van Calsteren, Malcolm Hooper and

NEQAS.

n) Ray Bristow expressed concern that the standards used to spike the

samples would not be representative of the DU contained in weapons. David

Lewis confirmed that the standards used would be ‘pure’ DU standards and

that to create, and gain accreditation for, standards that exactly represented

the DU used in weapons would add excessive time and cost to the programme

without increasing its scientific rigour. Peter van Calsteren stated that other

elements, such as Plutonium, would not affect the analyses, which would look

at the

235

238

U ratio.

o) There was some discussion regarding the supply of aqueous samples to

the pilot study laboratories. It was generally agreed that these would be useful

should there be a problem with the analyses of urine samples, to establish

whether the problem lay with the testing of urine specifically, or whether it

was a problem with the method more generally.

Page 6

DRAFT

p) David Lewis mentioned that NEQAS had contacted him to see if his

laboratory would carry out checks on the spiking agents prior to the actual

spiking of the samples and asked the members of the OB if they had any

problem with this as he was a MOD employee. Ivor Connolly expressed the

view that some veterans might be concerned about the MOD using this to

introduce delays into the programme. David Lewis clarified his position as a

board member and stressed his desire to ensure that veterans are tested

correctly. The proposed testing would not be expected to introduce any

delays. It was agreed that David Lewis’s laboratory should make the checks

required by NEQAS.

q) Gordon Paterson asked if the final details of the spiking regime could be

circulated to OB members as soon as they were finalised. He also expressed

the view that some urine samples should be held in reserve in case unforeseen

problems arose.

Chain of Custody for Urine Samples in the main testing programme

r) The Secretary introduced his Chain of Custody paper which had been

distributed prior to the meeting.

s) Ron Brown asked if tamper-evident containers were available for 24 hour

urine samples. David Lewis stated that he did not believe this would be a

problem.

t) Chris Busby asked what was known about the absorption of uranium

onto storage containers etc. Peter van Calsteren stated that this problem was

well recognised, and that appropriate plastic containers are available.

u) There was some discussion regarding the logistics of taking large

samples if they turned out to be necessary. The Chairman stated that he

envisaged the donors being given a large container and collecting the sample

at home rather than staying at a hospital for 24 hours. Gordon Paterson noted

that there are now sophisticated ways of carrying samples to a collection

point i.e. by the use of specially-designed holdalls. He also pointed out that

there are contractors who have experience in the bulk distribution/collection

of sample containers.

v) Ivor Connolly expressed concern over the splitting of samples if this

were required. It was agreed that there was little point in veterans taking their

own sample away with them as the testing could always be repeated if results

were doubted. In this respect, the situation was different from a test, say, of

blood alcohol concentration, where the timing of sample collection was

critical.

w) Chris Busby expressed concern that analyses might under-estimate the

level of DU excreted because DU particles excreted by the kidney were not

completely dissolved. Peter van Calsteren pointed out that the samples would

be acidified in nitric acid and did not see this as a problem.

x) Ron Brown asked if the Chain of Custody paper needed expanding. The

Chairman stated that the paper was a good starting point and would be refined

in the future once the results of the pilot exercise had been examined.

Timescales

a) The Secretary gave an update on the pilot exercise timescales. He stated

that the ITTs would be issued to the 7 laboratories by mid-February, once the

Statement of Requirement had been finalised. Following this, ECC

regulations require that the laboratories should have 40 days to reply. This

Page 7

DRAFT

means that the bids will come back in at the end of March. Ivor Connolly

expressed concern that the ITTs were being issued 2 weeks later than had

previously been envisaged. The Secretary stated that he believed the

programme was still on track because a month had been allowed for the

assessment of the bids and two months for the actual pilot studies to take

place, both of which were probably over-generous.

b) The Secretary asked for clarification of the purpose of the Protocol as

compared to the Statement Of Requirement. The general agreement was that

the protocol details how the entire pilot exercise is to be carried out and is

effectively an agreement between the OB and NEQAS. The SOR will be the

instructions to the pilot study laboratories stating what they actually have to

do and will, effectively, be one part of the protocol. It was agreed that the

contracted laboratories should be given a chance to comment on the protocol

before it is finalised, particularly with regard to the arrangements for

handling, storing and transporting samples. If necessary, a meeting could be

arranged for this purpose.

c) The Chairman confirmed that it was still the intention that the pilot

exercise would take place in May. In parallel with this, thought would have to

be given to the advertisement and design of the contract for the main testing

programme. The Secretary agreed to produce a paper on the requirements for

this contract.

Action 3.6 GVIU to produce paper on requirements for main testing

programme contract

Secretary

(15/3/02)

DU Background & Scientific Issues

a) Chris Busby questioned the interpretation of a recent study by the Italian

Commission of Experts into tumour cases among military personnel who had

served in the Balkans and, in particular, the response from US of S to

Caroline Lucas MEP on the subject. Ray Bristow voiced the opinion that if a

map of where DU was fired in Kosovo was examined it would be apparent

that a large number of DU attacks occurred in the Italian sector. The

Chairman said he was interested in this and would like to receive further

information, but that it was not mainstream OB business.

b) Gordon Paterson enquired about the process of setting up

epidemiological studies. The Chairman suggested that any assessment of

research should be carried out by the MRC, and that it should not be the

function of the OB to set up the research programme, although it should have

input to the assessment of proposals.

Post meeting note: GVIU have now written to the MRC for assistance in

establishing epidemiological studies to explore possible health effects of DU, if

and when a reliable method of retrospective exposure assessment becomes

available.

c) Ray Bristow expressed concern that the results of the studies might be

kept secret from veterans. The Chairman stated that the results would not be

secret from the veterans. As with any medical investigation, any veteran who

was tested as part of an epidemiological study would be told of the result if he

or she wished to know it. In addition, the results of the epidemiological study

would be published in the open scientific literature.

Page 8

DRAFT

A.O.B.

a) The Chairman asked David Lewis if he would write a short paper on

evaluating the relative performance of laboratories [This will come out of the

protocol work] and explaining some of the statistical jargon for a lay reader.

Action 3.7. David Lewis to produce paper on how laboratories can be judged

against each other.

b) There was further discussion regarding the work of Dr Durakovic. Ray

Bristow stated that Dr Durakovic should be invited to speak to the OB. Brian

Spratt pointed out the lack of controls in the Durakovic work. The Secretary

stated that MOD were very keen to talk to Dr Durakovic and that GVIU had

just written to Dr Durakovic inviting him to come over to discuss his work.

The Chairman stated that it would probably be better if we had some results

of our own before we invited Durakovic to talk to the OB. The Chairman

asked if the McDiarmid et al paper ‘Surveillance of Depleted Uranium

Exposed Gulf War Veterans: Health Effects Observed in an Enlarged

“Friendly Fire” Cohort’ could be circulated to the board.

Action 3.8. GVIU to circulate the McDiarmid paper

c) There was some discussion about whether other tests, particularly blood

tests for lymphoma, myeloma etc, should be carried out at the same time as

the urine testing. The Chairman stated that this was not appropriate and that it

was necessary to first look at the primary indicator of DU exposure i.e. the

urine test for uranium isotopes. A possible future study that could then be

carried out would be to relate the exposure to DU to early biological effects.

d) Gordon Paterson expressed the view that, whatever test was carried out,

it was very important that the method of presenting the results to veterans was

correct.

Lewis

(15/3/02)

Secretary

(15/2/02)

Date of next meeting

a) The date of the next meeting is currently set for 28

March 2002 at 09:45 and it

will be held at the Royal British Legion HQ on Pall Mall. A decision as to

whether this date needs to change will be made nearer the time, particularly as it

very close to the expected return date for the pilot exercise tenders.

Distribution:

All members

All observers

Devolved Health Administrations

Page 9

DRAFT

ANNEX A - DUOB Action List

Action Date

placed

Action

Date

Detail Owner Comments

1.1

27/9/01

16/11/01

‘Definitions of Terms’ appendix to be

drafted and circulated for comment

Lewis/

Calsteren COMPLETE – Definitions attached

to draft protocol distributed at 2

meeting

1.2

27/9/01

16/11/01

Nominations for toxicologist and radiation

medicine experts to be sent to GVIU

All OB

Members

COMPLETE – See actions 2.2, 2,3

1.3

27/9/01

26/10/01

CVs and declarations of interest to be sent

to GVIU

All OB

Members

Still awaiting Hooper (short), Levy

and Gilmore

1.4

27/9/01

12/10/01

Secretary to establish if payments can be

made for Board members to attend

meeting

Secretary COMPLETE – Payments will be

considered on an individual basis.

Written justification must be

forwarded by Board member to

GVIU for consideration.

1.5

27/9/01

12/10/01

Secretary to create a claim form for

expenses

Secretary COMPLETE - Form distributed on

23/10/01

1.6

27/9/01

26/10/01

Secretary to distribute a copy of the press

release to board members

Secretary COMPLETE – Press release

distributed on 23/10/01

1.7

27/9/01

Ongoing

Board members to write to GVIU with

suggestions for further background reading

All OB

Members

Ongoing

1.8

27/9/01

26/10/01

GVIU to obtain permission and distribute

responses to the 2

consultation paper to

Board Members

Secretary COMPLETE – distributed by email

on 13/11/01

1.9

27/9/01

26/10/01

GVIU to distribute list of email addresses

Secretary COMPLETE – Distributed on

23/10/01

1.10

27/9/01

26/10/01

Board members to suggest suitable

laboratories to GVIU

ALL OB

Members

COMPLETE – 30/11/01

1.11

27/9/01

26/10/01

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 and

OJEC on 13/11/01

1.12

27/9/01

16/11/01

Produce and circulate draft protocol prior

to next meeting

Lewis/

Calsteren

COMPLETE – 30/11/01

2.1

30/11/01

4/1/02

GVIU to send TOR to Minister for

comment

Secretary COMPLETE - Sent on 11/1/02.

Minister has approved the TOR.

2.2

30/11/01

8/1/02

CVs for toxicologist to be sent to GVIU.

GVIU to forward to Minister

Secretary COMPLETE – Sent on 15/1/02

2.3

30/11/01

8/1/02

Suggestions for radiation medicine experts

to be sent to GVIU

All

COMPLETE

2.4

30/11/01

8/1/02

GVIU to consult Royal College of

Radiologists

Secretary COMPLETE – RCR

recommendation received on 24/1/02

2.5

30/11/01

12/12/01

GVIU to notify members of expressions of

interest

Secretary COMPLETE – emailed on 13/12/01

2.6

30/11/01

7/12/01

Draw up Statement Of Requirement for the

sample preparation

Van

Calsteren

COMPLETE – 1

draft discussed at

meeting with NEQAS on 18/12/01.

Will be revised in discussion between

LEWIS, van Calsteren and NEQAS

2.7

30/11/01

10/12/01

David Lewis to contact the preferred

supplier of spiked samples (and other

suppliers if required) to assess interest and

costs

Lewis

COMPLETE

2.8

30/11/01

13/12/01

Arrange meeting with supplier of spiked

samples

Lewis

COMPLETE – see 2.9 below

Page 10

DRAFT

2.9 30/11/01

20/12/01

Subgroup

visit

supplier

Coggon/

Lewis/

van C/

GVIU

COMPLETE – lab visited on

18/12/01

2.10

30/11/01

28/1/02

Nick Day to review protocol and proposed

statistical methods

Day

Ongoing – awaiting redraft of

protocol following discussions with

NEQAS

2.11

30/11/01

21/12/01

David Lewis to redraft protocol for pilot

study of analytical methods

Lewis

Ongoing- awaiting NEQAS contract

2.12

30/11/01

21/12/01

David Lewis to draft the SOR for the urine

testing in the pilot study, to be distributed

to the OB by 21/12/01

Lewis

COMPLETE – ITT sent to NEQAS

on 14/1/02

2.13

30/11/01

10/1/02

OB to comment on the SOR for urine

testing by 12.00, 10 Jan 02

All COMPLETE

2.14

30/11/01

28/1/02

Chairman to appraise MRC of the planned

timetable for the development of the

testing method

Chair

COMPLETE – Chairman talked to

Catherine Moody of MRC

2.15

30/11/01

21/1/02

Chairman to produce paper for next

meeting summarising the different types

of epidemiological study that might be

relevant

Chair

COMPLETE – Paper circulated on

11/1/02

2.16

30/11/01

21/1/02

GVIU to produce a paper on the options

for a chain of custody of urine samples

Secretary COMPLETE – Paper circulated on

25/1/02

2.17

30/11/01

28/1/02

GVIU to identify the position of MOD

funding of regional centres

Secretary COMPLETE – MOD will fund

regional centres but the details of this

need to be decided

2.18

30/11/01

28/1/02

NRPB to obtain advice on the feasibility of

testing for DU in tissue samples obtained

at autopsy

NRPB

COMPLETE – paper distributed on

18/1/02

2.19

30/11/01

14/1/01

GVIU to circulate Annexes A and D (on

the current ICRP models and Organ Doses

from intakes) from the Royal Society

report

Secretary COMPLETE – Circulated on

11/1/02

2.20

30/11/01

21/1/02

GVIU to provide Contracts Branch with

the draft protocol in time for ITT issue on

31 Jan 02

Secretary Ongoing – awaiting NEQAS contract

2.21

30/11/01

21/1/02

David Lewis/ van Calsteren to prepare a

paper on laboratory methods

Lewis/

van

Calsteren

Not possible within this timescale –

due to DL and PvC commitments

will be re-considered in the future

2.22

30/11/01

7/12/01

GVIU to arrange a meeting between

Chairman and US of S

Secretary COMPLETE – Chairman met with

US of S on 16/1/02