MINISTRY OF DEFENCE FINAL

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FINAL

Gulf Veterans’ Illnesses Unit

MINISTRY OF DEFENCE

Zone A, Floor 7, St Georges Court,

2-12 Bloomsbury Way,

London, WC1A 2SH

Telephone Direct dial

020 7305 4644

Helpline

0800 169 4495

Fax

020 7305 4166

FINAL

Our Reference:

D/GVIU/7/1/8/2

Date:

April 2003

MINUTES OF THE NINTH DEPLETED URANIUM SCREENING

PROGRAMME OVERSIGHT BOARD MEETING ON 11

MARCH 2003

Present:

Board:

Observers:

Guest:

Professor David Coggon

Surg. Cdre Nick Baldock

Mr Ron Brown

Dr Chris Busby

Mr Ivor Connolly

Dr George Etherington

representing Miss Frances Fry

Mr Jim Glennon

Dr Muir Gray

Miss Beverley Green

Professor Malcolm Hooper

Dr David Lewis

Dr Gordon Paterson

Professor Brian Spratt

Mr Shaun Emery

Air Cdre Simon Dougherty

Mr Neville Higham

Mrs Brigid Rodgers

Miss Rosie Wane

Mrs Janie Walker

Wg Cdr Charlie Wilcock

Gideon Henderson

MRC

INM

DRPS

LLRC

NGV&FA

NRPB

NGV&FA

NSC

RBL

GVA

INM

BRC

GVIU

DMSD

HSE

GVIU

DMSD

Chair

Secretary

Apologies:

Mr Alan Duncan

Miss Frances Fry

Professor Ian Gilmore

Dr Len Levy

Dr Margaret Spittle

Dr Hilary Walker

HJA

NRPB

RBL

MRC IEH

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Item

Discussion and Decisions

Actions

(Action date)

Introduction

a) The Chairman welcomed board members to the meeting.

b) George Etherington stated that Frances Fry was taking early retirement and

would no longer be attending the DUOB. Dr Etherington had represented the

NRPB on a number of occasions in Frances’s absence and NRPB were happy

for him to be their representative on the DUOB. This was agreed by Board

members.

Action 9.1. The Secretary undertook to seek approval from US of S for

George Etherington’s appointment to the DUOB.

c) The Chairman stated that Peter van Calsteren had resigned from the DUOB

due to a potential conflict of interests. Dr van Calsteren had asked for this

issue to be discussed at this meeting. The DUOB agreed that it had been

appropriate for Dr van Calsteren to resign from the Board in the

circumstances.

d) As a result of Dr. van Calsteren’s resignation, there was a need to fill a gap in

expertise on the OB. At the Chairman's suggestion, Dr. Gideon Henderson

from Oxford University had therefore been invited to attend this meeting as a

guest and possible future member of the Board. Dr Henderson introduced

himself as a lecturer in environmental earth sciences at University College,

Oxford. Dr Henderson pointed out that his department had links with

Professor Sir Keith O’Nions, the Chief Scientific Advisor (CSA) to the MOD.

Dr Henderson stated that CSA was a previous head of the Department of

Earth Sciences and still had a nominal role in the department. Dr Henderson

had worked with CSA in the past and had not bid for the main testing contract

because of this link. Jim Glennon asked if his department received any

funding from the MOD. Dr Henderson stated that he was unaware of any

MOD funding within his department and undertook to check this fact. He also

undertook to provide details of his background. A decision regarding Dr

Henderson’s membership of the DUOB would be taken outside of the

meeting.

e) Chris Busby spoke briefly about a proposal he wished to bring to the table

regarding the recent deployment of troops to the Gulf. As this was not within

the Terms of Reference of the DUOB, it was agreed to discuss it later under

A.O.B.

f) The Chairman noted that the Secretary had been drafting various documents

for the DUOB, but it was important that all members of the Board contribute

to the process by commenting on the drafts in timely fashion. At present,

comments on documents were generally received from only a core of 3 or 4

members. He asked that if a Board member had no comments on a document

then an email to this effect should be sent to the Secretary within the required

timescale.

Secretary

(28/3/03)

Minutes of Last Meeting

a) Minor changes to the minutes of the last meeting were agreed by all Board

members.

Action 9.2. Secretary to amend minutes of 8

DUOB and circulate

b) Jim Glennon queried the meaning of paragraph 8e in the last minutes. It was

agreed that this paragraph was clear in that if a veteran requested a re-test this

Secretary

(12/3/03)

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agreed that this paragraph was clear in that if a veteran requested a re-test this

would have to be considered on its individual merits. Gordon Paterson

suggested it would be wise to check the NHS situation. He stated that while

an NHS patient is entitled to a second opinion he was unsure if this extended

to a repeat of a laboratory test.

Action 9.3. Gordon Paterson to supply details on NHS re-test policy

Paterson

(4/4/03)

Matters arising from last meeting

Documents

a) The Secretary confirmed he had distributed the following documents:

• Final minutes of 7

meeting

• Malcolm Hooper’s email regarding the DU questionnaire

• Final SOR for extended pilot exercise

• Target isotope ratios for the extended pilot study (to a subset of the

DUOB)

• Schedule for putting the screening programme in place

Questionnaire to people having a test

b) Malcolm Hooper had received comments from the Chairman and Ron Brown.

The questionnaire is discussed in section 8 of these minutes.

Summary of pilot exercise

c) The Secretary stated that he had completed this action and the summary was

available on the DUOB website.

Thymol

d) Brian Spratt had received advice from two sources indicating that there was

no need to add thymol to urine other than in exceptional circumstances. It was

agreed therefore that there was no need for the DUOB SORs to specify that

thymol be added to urine samples. Contracted laboratories would be

responsible for the health and safety aspects of dealing with the samples.

SOR for Main Contract

e) The Secretary stated that he was working on the next draft of the SOR for the

main contract for laboratory testing which would be circulated soon. He

stressed that some of this work was outside his area of expertise and he

needed as much help from Board members as possible.

Plan for Analysis of Pilot Study results

f) The Chairman had produced a draft plan for examining the pilot study results.

This is discussed under section 7.

Information for GPs etc.

g) The Chairman had produced new drafts of the information. This is discussed

under section 9.

DU Research

h) With regard to section 7b of the last minutes, the Chairman stated that he had

attended a meeting of the MRC Military Health Research Advisory Group

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(MHRAG) (a committee established to advise the MOD) at the end of

January. DU had been discussed at the meeting – the general view was that

this subject was not a research priority. The Chairman said that he had

pointed out that it was a priority for some veterans. Chris Busby expressed

concern that if the MRC was saying that DU research was not a priority then

funding would not be available for related epidemiological studies. The

Secretary pointed out that the MOD had stated that it would fund

epidemiological studies once the screening programme had been set up. The

Chairman said that in relation to this research, the MRC would not be asked

to comment on the priority of proposed studies, but on their validity.

i) Ivor Connolly stated that, in his view, research tended to look at a subject in

isolation and did not study the combined effects of a number of factors. The

Chairman said that he believed that Porton Down research was looking at

interactions between vaccines and NAPS. He suggested that if members had

reasons to suspect a toxic interaction between DU and other exposures in the

Gulf or Balkans, they could present their ideas to a future meeting of the

Board.

Post meeting note: The Vaccines Interactions Research Programme will

complete in December 2003

Update on Extended Pilot Exercise

a) The laboratory responsible for producing the spiking solution for the pilot

study had written a detailed report on this. Dr. Henderson stated that from a

brief look at the report the work appeared to have been done very carefully

and along sensible lines. Dr. Henderson expressed concern over two issues.

He asked if the fact that uranium could be diet dependent had been taken into

consideration. The Chairman replied that the uranium content and isotope

ratios of the unspiked urine samples would be checked. Dr. Henderson also

expressed concern over the laboratory’s ability accurately to measure a zero

U236 reading. Dr. Henderson undertook to have a more detailed read of the

paper and report back to the DUOB.

Action 9.4. Dr Gideon Henderson to report back to DUOB on the spiking

solution paper

Post meeting note: Dr. Henderson emailed the Secretary on 13

March stating

that the U236 issue

appeared to have been dealt with satisfactorily.

b) The Chairman commented that the report indicated that the spiking samples

had been produced correctly and that the go-ahead had been given for the

laboratory to distribute the spiking solution to the other laboratories. The

Secretary stated that he expected this to happen by the end of the week.

Post meeting note: The spiking solution was delivered to the laboratories on

10/3/03.

c) Chris Busby asked about the problem of uranium absorption in the containers.

David Lewis stated he had carried out experiments in his laboratory which

indicated that this was not a problem in polyethylene bottles if the urine was

acidified.

d) It had originally been intended that, once the three laboratories had produced

the spiked samples, they would be sent to Peter van Calsteren's laboratory,

where they would be re-labelled and distributed back to the other laboratories

for measurement. It was agreed that it would not be appropriate for Dr van

Calsteren to carry out this task following his resignation, and Gideon

Henderson was asked if there was a possibility of carrying out the task at his

laboratory. Dr Henderson stated that he saw no problem with this but needed

Henderson

(21/3/03)

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laboratory. Dr Henderson stated that he saw no problem with this but needed

to check a few details before he could commit to it.

Post meeting note: Dr Henderson confirmed by email on 13/3 that it would be

possible to re-label the samples at his laboratory.

Action 9.5. Secretary to arrange the re-labelling exercise with the relevant

parties.

e) Gideon Henderson asked if all the laboratories were using the same

containers for the final spiked samples. The Secretary confirmed that this was

specified in the contract and had been brought up in discussions with the 3

laboratories. He undertook to check this. Gideon Henderson also stated that it

was necessary to check how the laboratories intended to label the containers.

The Secretary also agreed to check this.

Action 9.6. Secretary to check on sample containers

Action 9.7 Secretary to check on sample labels

Analysis of pilot study results

f) The Chairman had produced a short plan of how the pilot exercise results

could be analysed (Attached at Annex A). He talked through this paper,

stating that Item 7 (checking that discrepancies between laboratories and in

comparison to expected values are within the quoted ranges of error for each

laboratory) would p robably be the most difficult for him. The DUOB were

asked to comment on this paper within two weeks.

Action 9.8. DUOB members to comment on analysis of pilot exercise results

Secretary

(28/3/03)

Secretary

(28/3/03)

Secretary

(28/3/03)

All

(28/3/03)

Draft SOR for Normative Value Study

a) This SOR had been distributed prior to the meeting but did not include

comments received since that time. The Chairman stated that there were 4

main reasons for the normative value study:

• To establish the range of urinary uranium excretion and isotope

ratios in the general population

• To explore potential determinants of variation between individuals

such as place of residence and occupation

• To examine how uranium excretion varies throughout the day

• To establish how repeatable results are from one day to another

b) A number of issues were discussed, particularly with regard to factors that

might be associated with variation in uranium excretion. These included:

• Age

• Sex

• Residence near to the coast

• Residence near to nuclear facilities etc.

c) The Chairman undertook to produce the next draft of the Statement of

Requirement.

Action 9.9. Chairman to produce fourth draft of Statement of Requirement

for Normative Value Study.

d) The Secretary stated that this was a small contract and did not need to be

advertised. A contractor had been suggested for this study at a previous

Chairman

(21/3/03)

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meeting. The Secretary stated that he had been in preliminary discussions

with this organisation.

Draft Advertisement for Health Provider Contract

a) The Secretary stated that the activities leading up to placing the Health

Provider Contract now formed the critical path for the screening programme.

This advertisement needed to be placed as soon as possible to ensure that no

further delay occurred in the programme. [There had been no point in

advertising this previously as Invitations To Tender for the Health Provider

Contract would be issued in parallel to the main testing contract once it was

established that a suitable test was available].

b) Minor alterations to the advertisement were agreed.

Post meeting note: The revised advert was circulated by email following this

meeting and a few minor comments received. The final version was sent to MOD

Contracts Branch on 14/3/03.

Main Testing Contract

a) The Chairman sought to clarify a number of issues with regard to the main

testing contract.

Number of Laboratories for Main testing Contract

b) It was agreed that, if possible, 3 laboratories should be involved in the main

testing programme as this provided scope for interlaboratory comparison and

also provided back-up if one of the laboratories dropped out.

c) Ivor Connolly asked why the main testing contract had been advertised to

laboratories other than those taking part in the current pilot exercise as this

seemed to be delaying the programme. The Chairman explained that, because

of the uncertainty over the existence of a suitable test, the initial requirement

had been advertised for a pilot study to examine a number of techniques.

There would have been no point placing a contract for the main testing

programme at that stage. Because of the value of the main testing contract,

European Union rules required that the main testing contract be advertised in

the Official Journal of the European Community. This had elicited 7

expressions of interest in carrying out the main testing contract. However

many laboratories were asked to tender for the contract, these would all have

a set time to answer the ITT and would be considered at the same time. Hence

there would be no additional delay to the programme from inclusion of

laboratories other than those carrying out the pilot study.

Treatment of Sample

d) It was agreed that the laboratories involved in the main testing programme

would be responsible for organising the measurement of creatinine. It was

also agreed that acidification of urine samples should take place in the

laboratories rather than at the point of collection. No decision was reached on

whether the samples needed to be refrigerated. David Lewis undertook to

advise on these issues.

Post meeting note: The SOR for the Health Provider Contract will specify that the

samples must be delivered to the laboratories within 5 days of sample collection.

Consideration of creatinine measurements, acidification and refrigeration must be

made with this period in mind.

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Action 9.10. David Lewis to advise on creatinine measurements, acidification

and refrigeration of samples

Splitting of Samples

e) It was agreed that there was no need to split the samples for security

purposes. If a repeat test was required, the veteran could provide a second

sample.

f) Samples might, however, need to be split for the purpose of Quality Control,

with analysis of the same sample by two or more laboratories.

Quality Control

g) Quality Control would be achieved by analysing some of the samples in

duplicate and by providing spiked samples as in the pilot exercise.

h) It was agreed that once contracts were let for the main testing programme it

would be a good idea to get the contracted laboratories together to discuss

how a Quality Control programme could be carried out.

Assessment of Expressions of Interest in Main Testing Contract

i) The Secretary reminded the Board that the main testing programme had been

advertised last year, prior to the results from the first pilot study. Seven

organisations had expressed an interest in bidding for the main testing

contract. The Secretary stated that he now wanted expert input on which

organisations should be invited to tender. Gideon Henderson and David

Lewis were tasked with looking at the Expressions of Interest, and advising

on this.

Action 9.11. Gideon Henderson and David Lewis to review the expressions of

interest for the main testing contract

Lewis

(28/3/03)

Henderson/

Lewis

(21/3/03)

Questionnaire

a) A revised draft of the questionnaire by Malcolm Hooper had been distributed

to the DUOB prior to this meeting. There was considerable discussion about

the purpose of the questionnaire, particularly with regard to whether and how

it should be used for research purposes. Beverley Green pointed out that it

had previously been agreed by the DUOB that the questionnaire would be

used primarily for clinical purposes and not to generate data for research.

Chris Busby argued that any data obtained could be used for hypotheses

generation. The Chairman stated that data linking DU exposure to health

were likely to be biased as the scheme was voluntary. This would make

meaningful interpretation virtually impossible.

b) There was a great deal of discussion about whether a question should be

included asking if the veteran had cancer. The Chairman argued that an open

question asking about any illnesses that the veteran was worried about would

be more useful for clinical purposes. Beverley Green stated that under the

Data Protection Act it was necessary to have a reason for collecting specific

data i.e. it is not allowed to ask for information without having a specific

purpose for those data.

c) Gordon Paterson pointed out that the Factsheet supplied to the veteran would

detail the alleged health risks of DU and most likely prompt the veteran to

consider cancers etc. in answering an open question. Chris Busby argued that

an open question would not generate information on where the cancers

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appeared. Brian Spratt asked if this was something that could be picked up

when the veteran visited the Health Provider and handed in the questionnaire.

David Lewis asked if a cancer question could be considered leading and

might generate unnecessary fear.

d) Chris Busby asked for a vote on whether an explicit question about whether

the veteran had cancer should be included. Four people voted for the question

and seven voted against with one abstention. It was therefore agreed that the

cancer question would not be included in the questionnaire

e) There were further comments on the questionnaire as follows:

• The question about alcohol consumption should be removed – but

smoking left in

• Acronyms should be expressed in full

• The occupation of the veteran should be considered carefully as

many service personnel perform tasks outside of their designated

role

• The layout of the questionnaire must be further considered

• Possible inclusion of earlier residential history

f) Beverley Green expressed the view that the question relating to satisfaction

with the MOD Medical Assessment Programme was not relevant. Malcolm

Hooper explained that he was trying to collect evidence that would support or

disprove the feeling among veterans of his acquaintance that the published

figure of 95% satisfaction with the MAP was incorrect.

Post meeting note: The MAP satisfaction questionnaire is given to the veteran at

the beginning of the visit and generally filled out while the veteran is waiting for

blood tests etc. At no point does a member of the MAP staff sit with the veteran or

prompt answers. The anonymous questionnaire is placed into a box when the

veteran leaves and the forms are examined and the statistics updated

approximately every two months.

Information to Veterans/GPs

a) Muir Gray stated that he had done some work regarding the information that

should be supplied to veterans and their GPs. He distributed the papers

attached at Annex B.

b) Muir Gray recommended that the advice to veterans and GPs be combined

into a single piece of information.

c) Muir Gray also recommended that the work produced on this so far should be

passed to an organisation with experience in the preparation of resources for

clinicians and ‘patients’. His paper briefly discussed three organisations that

could carry out the task. The chosen organisation would take the information

that had already been produced, develop it using focus groups and then

supply the tested resources. The DUOB agreed with this approach and Muir

Gray undertook to prepare a report based on his discussions with the three

organisations.

Action 9.12. Muir Gray to produce report on his discussion with the three

organisations.

d) Muir Gray suggested that two members of the DUOB should be nominated to

help with the production of the information. Muir Gray and Gordon Paterson were

nominated by the Board

Gray

(28/3/03)

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10.

Timescales

a) The Secretary pointed out that the schedule for implementing the screening

programme was very tight, particularly with regard to the Health Provider

Contract. He also pointed out that if the next meeting was scheduled for May

then the SORs for the three contracts (main testing programme, Health

Provider and normative value study would need to be discussed and agreed

ex-committee. He again stressed that he would need the Board's co-operation

to achieve this.

11.

DU Background and Scientific Issues

a) David Lewis had recently visited a number of organisations in the US on

behalf of the Chairman. He provided a brief of his activities in the US,

attached at Annex C.

12.

Date of next meeting

a) The date for the next meeting was set for 12

May 2003.

13.

A.O.B.

a) Malcolm Hooper presented a proposal by Chris Busby (who had to leave the

meeting early). The main points of the proposal were that:

1) British soldiers engaged in operations in southern Iraq should be

given respirators or masks capable of stopping particles down to 0.1

microns.

2) British soldiers should be adequately and fully warned of the

dangers from DU particles

3) That British Forces should be made aware that following any

conflict they could ask for urine tests and be included in the testing

programme being carried out under the direction of the DUOB

b) The Chairman pointed out that points 1 and 2 were outside the terms of

reference of the DUOB. However, Brigid Rodgers gave a brief summary of

the instructions that have been given to British troops:

• General health and safety instructions for UK troops, which cover

encounters with DU, are incorporated in the Mounting Instructions for

the operation which have been passed to the units involved

• Safety instructions, covering all aspects of the hazard management of

DU munitions in theatre, have also been issued by the Permanent Joint

Headquarters (PJHQ) through the operational chain of command to all

units and formations deployed in the Joint Area of Operations

• Specific instructions and training packages exist for Explosive Ordnance

Disposal (EOD), Royal Armoured Corps (RAC) and support personnel,

those most likely to come into contact with DU munitions or dust.

Radiation monitoring equipment has also been provided to some EOD

units.

Brigid Rodgers stated that these safety instructions would soon be made

available to the members of the DUOB

c) With regard to point 3 of Chris Busby’s proposal Brigid Rodgers pointed out

that the MOD Biological Monitoring policy (www.mod.uk/Defence

Issues/Health and Safety/Depleted Uranium) had been discussed at the last

DUOB meeting. Under this policy post-deployment monitoring would take

place on return from the area of operations. Levels 1 and 2, according to the

definitions used by the Royal Society, would be encouraged to receive testing

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definitions used by the Royal Society, would be encouraged to receive testing

and Level 3 (which includes all personnel who have operated in a theatre

where DU has been used) would be offered a test on a voluntary basis. These

personnel would be tested with a less sensitive assay than that being explored

by the DUOB to assess exposures after an interval of up to 13 years.

d) In addition to this Brigid Rodgers provided further information about a

suggestion made at the last DUOB meeting regarding pre-deployment testing

of troops heading to the Gulf area. This would not be carried out for a number

of reasons (discussed at the last meeting). However, a normative value study

of military personnel was being planned – this would be carried out in

addition to the normative value study of the general population being planned

by the DUOB. The subjects of the study would be military personnel in the

UK and Germany and would be representative of those currently deployed to

the Gulf area.

e) Charlie Wilcock (Defence Medical Services Department) reiterated that all

those deployed to the Gulf would be eligible for a post-deployment test

should DU be used. Returning troops would be given an information card

stating that DU had been used and how to apply for a test. He also explained

that it was considered impractical to take samples from those already

deployed in the region due to the activities being carried out. Also the DU

pilot exercise had already demonstrated the ease with which contamination of

samples can occur and this would be a much worse problem in the middle of

the desert.

f) Gordon Paterson expressed the view that, from an epidemiological point of

view the normative value study appeared to be sound and that it was not

necessary for pre- and post-deployment testing to be carried out on the same

personnel. Malcolm Hooper reiterated his view that the biological half-life of

soluble uranium was 36 hours and that by the time personnel returned from

the Gulf the uranium in their bodies would be much reduced. Ron Brown

stated that he had seen no evidence of this timescale and asked Malcolm

Hooper to provide his source of information about this. Brain Spratt stated

that he was confident that DU would be easily detectable for up to a year

following exposure.

Action 9.13. Malcolm Hooper to provide information regarding biological

half-life of soluble uranium.

g) Ivor Connolly expressed the view that the DUOB should recommend to the

MOD what tests should be carried out in the Gulf and when the troops

returned home. The Chairman pointed out that this was outside the terms of

reference for the DUOB.

Post meeting note: As the subject of the terms of reference of the DUOB was

mentioned a number of time during this meeting, a copy of the TOR is attached at

Annex D

Hooper

(28/3/03)

Distribution:

All members

All observers

Devolved Health Administrations

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Annex A -Plan of Analysis for Extension to Pilot Exercise

Compare results for spiking solution – between laboratories and with expected

values.

2. Determine best estimate for uranium concentration and isotope ratios of

spiking solution.

Compare results for unspiked urines – between laboratories, and within

laboratories according to sample size.

4. Determine best estimates for uranium concentration, isotope ratios, and

“concentrations” of natural and depleted uranium in the three unspiked

samples of urine. (n.b. we do not expect to find any evidence of depleted or

enriched uranium in these samples.)

Compare results (total uranium concentration, isotope ratios, and

“concentrations” of natural and depleted uranium) for spiked urines – between

laboratories, within laboratories according to sample size, and with expected

values based on the best estimates determined previously for the spiking

solution and unspiked urines.

For each laboratory and sample size, compare the results for spiked samples

with those expected from the unspiked sample and the composition of spiking

solution as measured by that laboratory.

Check whether the discrepancies between laboratories and in comparison with

expected values are within the quoted ranges of error for each laboratory.

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ANNEX B

OUTPUTS-BASED SPECIFICATION FOR THE PREPARATION OF PUBLIC AND

PROFESSIONAL INFORMATION ABOUT TESTING FOR DEPLETED URANIUM

The National Screening Committee wishes to commission, on behalf of the Depleted

Uranium Oversight Board, the appraisal of draft information sheets for clinicians and

patients. The outputs that would be expected from the project would be:

• a general practitioner information sheet which had been tested with focus groups

of general practitioners for readability and usefulness; the general practitioners

would also be asked how much of the information being given to people being

tested they wished to see;

• a question and answer sheet for those offered the test which had been piloted and

evaluated with a focus group of veterans; it would be assumed that this would be

made available for two levels of readability using a standard process for assessing

readability;

• a report describing the process that had been undertaken in the preparation of

these resources, together with any additional recommendations the team carrying

out the development project wished to make.

Time scale

The time scale would be determined by the Ministry of Defence but testing should not

start until the Depleted Uranium Oversight Board was satisfied that they had valid and

useful resources for both clinicians and patients to accompany the testing process.

J A Muir Gray, CBE, DSc, MD, FRCP, FRCPSGlas

Programme Director – UK National Screening Committee

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DEVELOPMENT OF INFORMATION SHEETS FOR CLINICIANS AND VETERANS

Background

The National Screening Committee undertook to help the DUOB with the quality

assurance of information prepared for clinicians and veterans because of their

experience in developing resources to ensure that people offered tests made an

informed choice about whether or not they accepted the test.

A draft letter to general practitioners has been prepared with a depleted uranium fact

sheet. In addition a question and answer sheet has been prepared for those seeking a

test for depleted uranium.

The issues

In preparing material of this sort there are a number of issues that need to be

considered. Two that are of particular importance are:

1. Should there be material specifically written for clinicians and for members of the

public, or should the same material be available to all with members of the public

also having access to the same content in a simpler style? At present the proposal

is that general practitioners receive a fact sheet with those who are seeking a test

for depleted uranium being offered a question and answer sheet. Some healthcare

professionals prefer question and answer as a means of assimilating unfamiliar

knowledge and some healthcare professionals would probably prefer the question

and answer format although this does not cover all of the issues covered by the

fact sheet.

2. Similarly there are some facts on the fact sheet which are not contained in the

question and answer sheet and some people offered testing would probably like

this fact sheet linked to the question and answer sheet. It is also possible that

some veterans will want more information than healthcare professionals are

offered because exposure to depleted uranium is perceived by them as a risk of

very high significance, whereas the healthcare professional, particularly if he or

she does not understand all the issues involved, may not see it as such a serious

issue.

Testing of the draft materials

It is proposed that the services of a centre with the tools, experience and credibility in

the preparation of resources for clinicians and patients be obtained to test the

resources that have been prepared and address the two questions set out above. This

would be done by developing focus groups of veterans and clinicians and discussing

with them both the questions raised above and any questions that may be raised by the

DUOB, and then appraising the individual documents.

Document appraisal will be carried out using standardised techniques such as the

DISCERN instrument. This has been validated as a means of appraising patient

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information and covers not only the clarity of the English but also the strength of the

evidence base. Furthermore, the people who carry out this appraisal have experience

of developing patient information materials for a range of groups and could advise on

the need for one level or more than one level of resource to be made available.

The process of procurement

Three organisations have been invited to express an interest in carrying out this work.

They are widely regarded as the leaders in the field both nationally and internationally

and are independent organisations. All organisations have received grants from the

Department of Health in the past but they are charities and would certainly not see

themselves as part of government. All three have a mission to ensure that patients and

members of the public are adequately informed about the choices they face.

Using the specification attached as an appendix, one of the three organisations

described briefly below will be asked to carry out the work.

It is recommended that the DUOB nominate two people to help in the selection

process and sit on a small project board that could be consulted during the course of

the project if necessary.

[Information on individual organisations removed – Secretary]

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Annex C – David Lewis Brief on US Visit

DEPLETED URANIUM ANALYSIS CAPABILITY IN THE USA.

1. Introduction.

1.1 MOD members visited the USA between 24

and 26

February to discuss

issues surrounding depleted uranium exposure in US Gulf war veterans. This

included visits to a number of US Armed Forces establishments where

depleted uranium (DU) analysis was being performed and offered the

opportunity to discuss analytical methods and instrumentation.

1.2 The following establishments were visited.

The Armed Forces Radiobiology Research Institute

(AFRRI)

The Armed Forces Institute of Pathology (AFIP)

The US Army Centre for Health Promotion and

Preventive Medicine (CHPPM)

The Veterans Assessment Medical Centre Baltimore

(VAMC)

2. AFRRI

2.1 AFFRI is responsible for medical nuclear and radiological readiness

including; research and development, medical training and emergency

response procedures. AFFRI has been involved in the study of the health

effects of embedded uranium in animals as a model for uranium toxicity in

level 1 exposed veterans. This has involved the development of analytical

methods for the measurement of DU in urine and other biological fluids. Two

analytical methods were identified at the meeting between GVIU and AFFRI

staff.

a. ICPMS analysis. It was indicated that the AFFRI

laboratories were analysing DU in urine using a standard

Perkin Elmer Elan quadropole instrument. Samples

appeared to be pre-concentrated using an ion exchange

system before analysis. No details were obtained but the

use of ion exchange resins in this way is a standard

radiochemical procedure. An example would be the

Eichrom UTEVA resin. Unfortunately the planned

laboratory visit could not take place due to time

constraints so the performance of the method could not

be pursued, however level 1 exposure leads to excretion

of DU in µg/l quantities. A method developed for the

study of such high DU levels is unlikely to be suitable for

the ng/l levels expected in the DUOB retrospective study.

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b. Colorimetric method. AFFRI have also developed a

patented colorimetric method for analysis of uranium in

urine. The method again uses ion exchange sample

concentration followed by a colour reaction with 2-(5-

Bromo-2-pyridylazo)-5-diethylaminophenol. The test kit is

hand held and is intended as a rapid field test for uranium

in environmental samples and biological fluids. The

current detection limit is 30µg/l although it is thought this

can be lowered to 3µg/l with further development. Again

this method, although adequate for its intended purpose

cannot be considered appropriate for retrospective

analysis.

2.2 Conclusion. AFRRI methods are intended for the study of embedded

DU and field estimation of excretion immediately post exposure and are

comparable to the biological monitoring methods now to be employed by

MoD.

3. AFIP.

3.1 AFIP is the US tri-service centre of expertise in pathology with a wide

ranging remit covering all areas of advanced pathology including toxicology,

infectious disease and environmental medicine. Included in this AFIP provides

the pathology expertise in the study of Gulf War illness symptoms, including

the determination of uranium concentration and isotope ratio in urine samples

from DU exposed veterans. AFIP, like AFRRI, has a direct interest in the

study of level 1 exposures and has carried out studies on the fate of DU

shrapnel in the body.

3.2 Interlaboratory comparisons. AFIP has been involved in an

interlaboratory comparison trial to assess the performance of the laboratories

involved in the analysis of DU in urine samples from Gulf War veterans.

3.3 DU analysis at AFIP. Uranium analysis and isotope ratio methods have

been developed by a group led by Dr John Ejnik, a lieutenant in the US Navy

Medical Corps. The methods for urine analysis involve the use of a Perkin

Elmer Elan DRCII ICPMS which is a quadropole instrument with an additional

reaction cell before the main mass filter. The use of the reaction cell allows

the removal of mass interferences thus giving lower instrument backgrounds

and lower detection limits. The instrument is used in its standard

configuration using platinum cones and a quartz spray chamber.

3.4 Total uranium. Samples are collected in polythene containers that have

had minimal pre-cleaning. The samples are then ashed in nitric acid, taken to

dryness and re-dissolved in 0.2% nitric acid. U233 is added as an internal

standard and the samples are then analysed by isotope dilution mass

spectrometry using the Elan ICPMS in normal mode. Results are ratioed to

creatinine allowing spot samples to be used.

3.5 Isotope ratio. The

235

238

U ratio is measured in urine samples but other

isotopes are omitted. Samples are again collected in polythene containers and

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are acidified with 5% nitric acid prior to analysis. Analysis is direct using the

Elan ICPMS in DRC mode. Several DRC reaction gases have been used

including oxygen which forms uranium oxides in the reaction cell and allows

measurement of the uranium at masses of 267 and 270. No tracer is used

and the analysis can be performed on a 15ml urine sample.

3.6 Method performance. Data was presented demonstrating that the

method could determine accurate 235/238 isotope ratios in samples

containing 3-5ng/l total uranium. No detection limit for total uranium was

given but it is assumed that it will be at least an order of magnitude lower, ie of

the order of 0.3ng/l.

3.7. Conclusion. The data presented for the DRC ICPMS analysis confirms

that this method would potentially be suitable for assessment of current DU

excretion by Gulf War veterans.

4. CHPPM.

4.1 CHPPM is the US Army’s environmental and occupational health

organisation. Although based in Baltimore it is active worldwide. Militarily its

role is to ensure the health of US soldiers by both preventative measures and

by minimising exposure to environmental and toxicological hazards. CHPPM

has been involved in the characterisation of DU exposure pathways and the

development of awareness training for military personnel to minimise DU

exposure in future operational theatres.

4.2 DU analysis. CHPPM has investigated a wide range of analytical

methods to assess their suitability for determining DU in urine following

inhalation exposure and have concluded that ICPMS is the most appropriate.

The laboratory currently uses a Perkin Elmer 6000 quadropole ICPMS for

determination of total uranium with a detection limit of 1.8ng/l. Samples are

prepared for analysis by digestion with nitric acid and hydrogen peroxide and

diluted prior to analysis. U233 is used as a tracer and the analysis is carried

out by isotope dilution.

4.3 Sample storage. Studies are underway to fully evaluate sampling and

storage procedures but the use of polythene containers is likely with

preservation by acidification or freezing.

4.3 Isotope ratio. Current work is based around the use of preconcentration

techniques. Samples are separated using the Eichrom UTEVA resin and

analysed by ICPMS. Development work is still ongoing.

4.4 Conclusion. CHPPM is developing methods for prospective monitoring of

personnel in future operational theatres. This is focussed on the ability to

identify inhalation exposures and appears to be linked to acceptable radiation

exposure limits. As such the methods are comparable with MoD biological

monitoring methodology rather than the DUOB retrospective analysis.

5. VAMC.

5.1 The Baltimore VA Medical Center is described as the acute medical and

surgical care facility for veterans. It combines inpatient, outpatient and primary

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care services and also carries out research into medical issues, including

depleted uranium exposure studies led by Dr McDiarmid.

5.2 VAMC is involved in two separate studies which are of interest.

a. A cohort study of 39 exposed veterans most of whom are

carrying DU shrapnel. Most of these individuals are

excreting background levels of uranium.

b. A mail-in study consisting of 450 individuals who provided

24 hour urine samples by post. Data was presented

showing that the great majority of samples gave uranium

levels of less than 0.05ng/g.creatinine. Judging from the

data shown the average uranium excretion was about

10ng/l. This is especially notable as the sample

containers used are high density polythene which are

issued uncleaned. This strongly suggests contamination

was not a problem in this study. Samples for this study

are stored frozen and acidified prior to analysis by AFIP.

5.3 Normal levels. Dr McDiarmid discussed the availability or normal data for

uranium excretion and identified the following ranges and values

a. The US national study carried out by CDC – geometric

mean urine concentration, 10ng/l.

b. ICRP urine uranium dietary limit – 365ng/l

c. ICRP maximum background uranium in urine – 15ng/l.

d. DoE occupational decision level for nuclear plant workers

– 800ng/l

e. VAMC cut off level, below which isotope ratios are not

measured, 100ng/g.creatinine.

6. Overall conclusions.

6.1 The following points should be noted.

a. Of the three US methods the AFIP method using DRC

ICPMS has the lowest detection limit and can measure

isotope ratios at uranium concentrations of a few ng/l.

This is directly comparable with the levels expected in the

DUOB retrospective study.

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b. Creatinine measurements are recommended for all

samples to allow spot urine samples to be used.

c. Polythene containers are universal and only minimal pre-

cleaning is used.

Dr D Lewis

10 Mar 03

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ANNEX D

DU OVERSIGHT BOARD - FINAL TERMS OF REFERENCE

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.

Possible arrangements for a Veterans’ Assessment Centre