http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet3/brief3.gfr/tab_
h/br3h1a.txt

Excerpts, September 23, 1993 draft of VA Depleted Uranium
Follow-up Study
											
	Department of Veterans Affairs Program for the
Follow-up and Monitoring of Gulf War Veterans with Imbedded
Fragments of Depleted Uranium

Prepared by the Baltimore Veterans Affair: Medical Center
for consideration by the Department of Veteran Affairs,
Environmental Agents Service

For further Information about this draft contact 
James P. Keogh, M.D.
Director. University of Maryland Occupational Health Project
403 West Redwood Street 2nd Floor
Baltimore. Maryland 21201
410-706-7464
							
	J.  SPECIFIC AIMS

The specific aims of the project are:

1.  To provide on going clinical surveillance of Gulf War
veterans known or suspected imbedded depleted uranium (DU)
fragments, DU contaminated wounds or significant amounts of
Inhaled DU.  This clinical surveillance will provide early
detection of health effects related to the presence of DU,
and provide recommendations for treatment to participating
veterans and the physicians caring for them.  

2.  To conduct focused research into the toxicological and
radiological effects of DU in order to improve medical care
for the participating veterans.  In particular, research
will be directed to improve the scientific basis for advice
about fragment removal and other possible techniques to
remove uranium from the body.  Research will seek to improve
currently available techniques for:

(1) measuring and documenting uranium levels in affected
individuals using in vivo and in vitro measurements
techniques,
(2) modeling uranium absorption retained fragments,
distribution in tissue, and excretion to serve as a basis
for estimates of the future health risks from this exposure;
(3) comparing the clinical course of the body's response to
the DU fragments with that for other non-DU fragments to
determine whether clinically significant differences exist
due to either the chemical or radiological properties of
depleted uranium,
(4) characterizing early kidney response to DU and
elucidating the relationship between kidney does and the
biomarkets of renal toxicity,
(5) determining the risk of chronic kidney toxicity due to
the long-term chronic exposure to elevated levels of
uranium.
(6) comparing the morbidity and mortality of individuals
with retained DU fragments to other wounded and non wounded
controls.

2.	SIGNIFICANCE

In recent years, the United States Armed Forces have used
depleted uranium (DU) in the manufacture of both projectiles
and armor.   Uranium's high density makes it useful in
designing projectiles capable of penetrating armor made with
less dense metals, and conversely in armor with a high
degree of resistance to penetration.  The uranium used is
"depleted" in the sense that it is the residue of an
extraction process that selectively concentrates U235 and
leaves behind U238.  Naturally occurring uranium deposits
contain over 99 5/8 U238, with small amounts of U235 and
U234, U238 has too long a half life to be useful in making
nuclear fuel or weapons.  To create fissionable materials,
the small amount of U235 present in natural uranium must be
extracted and concentrated.  Depleted uranium is the natural
uranium left over from this process which contains even less
U235 than naturally occurring ores.  In the projectiles and
armor, depleted uranium is alloyed with small amounts of
molybdenum and titanium.

During the Persian Gulf War, 15 Bradley Fighting Vehicles
and 9 Abrams tanks were mistakenly fired on and struck by DU
munitions.  Some crew members who survived were left with
imbedded fragments of uranium.  Even depleted uranium has
some intrinsic radioactivity, and there is uncertainty about
the risk that these fragments may pose.  Uranium is known
from animal and human studies to be nephrotoxic.  the 
rate at which uranium might be absorbed from fragments is
unknown, leading to speculation about the possibility of
sufficient absorption to present a danger of renal injury.

  At present only a limited number of U.S. veterans are
known to have been wounded with DU weapon.  An initial check
by the OTSG has revealed that there are approximately 22
soldiers whose records
indicate that they have imbedded fragments that might be DU.
There are an additional 13 soldiers who were wounded and
hospitalized but were not specifically identified as having
shrapnel. Other crew
members (in addition to the 35 already discussed) were
either not wounded during (be incident or had minor wounds
that were treated in the field. The latter two sets of
soldiers might have inhaled uranium or experienced DU
contamination of wounds or minor fragmentation wound: that
were either not notIced or did not require extensive
treatment. It appears unlikely that.many other U.S.
servicemen who were wounded by DU munitions during the Gulf
War will be identified.

In addition to those individuals currently identified. there
may be large numbers of other Individuals for whom
information about the possible health effects of DU
fragments will be important In the near future.  It is
possible that some other allied personnel were wounded by DU
munitions.  An undetermined number of Iraqi soldiers may
have survived wounding by DU munitions.  U.S. forces
continue to use DU munitions, and may use them in future
conflicts. DU penetrators are now available In international
arm markets, and may become widely available to armies
around the globe.

In February 1992, OTSG requested that the Armed Forces
Radiobiology Research Institute (AFRRI) conduct a review of
the potential health hazards (radiological and
toxicological) of allowing DU shrapnel to remain imbedded
throughout the lifetime of the soldier. Specifically, OTSG
wanted to know If there was any reason to change the current
surgical practIce for fragment removal. No compelling
evidence was found in the literature review to chance
current surgical criteria for fragment removal. There were,
however, significant uncertainties about the impact of DU
fragments on the health of these patients that wanted long-
term follow-up. Concern centered principally on the
possibility that fragments could serve as a reservoir of
absorbable uranium that might cause kidney injury over time.1
{AFFRI Review Document}.

OTSG concurred with this finding and initiated action to
implement this Follow-up in the Army. The Department of
Veterans Affairs (DVA) agreed to perform the follow-up for
personnel discharged from the service.   Both the DVA and
OTSG requested AFRRI's assistance in drafting the protocol
to be used in the follow-up effort.

A group of DOD physical and scientist: met at AFRRI to draft
the protocol. At a subsequent meeting on 10 September 1992,
a panel of experts reviewed and revised the draft protocol;
representatives of the DVA and OTSG also attended this
meeting.  The protocol was once again reviewed and approved
by the panel of experts.2 {AFFRI Protocol document}.

This proposed program incorporates the protocol developed
and published as AFRRI's Technical Report 93-2 with some
additions and modifications. It benefits from the experience
and advice of the authors and reviews involved in the prior
DOD effort. Responsibility for the current proposal,
including its differences from the prior proposal, rests,
however, with the proposed program director and investigators 
from the Baltimore VA Medical Center.

Routine clinical measurements made on participants will be
compared with laboratory normals and with available clinical
measurements will underpin any clinical measurements from
prior medical records.  Initially, the stability or rate of
change in the robust clinical measurements will underpin any
clinical recommendations. Since renal toxicity is one of
greatest immediate concern, evidence of progressive changes
in blood urea nitrogen, serum creatinine and creatinine
clearance, and uric acid will be given greatest weight. 
With time, longitudinal date on these and other measures of
renal injury will be available, as well as comparisons
between exposed and control subjects.  While more
sophisticated measures of injury may reveal an ongoing
process of renal injury, caution will be used in imputing
prognostic value.  Few of these measures have been shown to
be of prognostic value in any setting and none in the
setting of uranium toxicity.  Careful follow-up of this
cohort may well reveal the prognostic value of some of these
measures.  In the meantime care will be exercised to weigh
the possible harm of any intervention to reduce uranium
burden against the likelihood of benefit to be gained.

Development of models for the rate of absorption of uranium
from fragments: Measurements of urinary excretion of uranium, 
bone concentration of uranium measured by X-rays fluorescence,
and estimate of mass and surface area of fragments will be
used to develop model for rate of absorptIon of uranium from
fragments. It is hoped that experimental animal data with
more direct tissue measurements will be available in the
near future with which, these can be compared.

Relation of estimated dose with effect:
Results of examinations on subjects will be compared with
those of controls. Subsequently, indices of dose derived
from the measures listed above will be used to assess dose
response relationships for the measures of health effects. 
Indices will be developed that rely on simple (e.g. size
measured by plain roentgenogram) as well as more
sophisticated measures (MRI dimension, body counting, bone
XRF).

4.4	Longitudinal study of health outcomes: 

Concern over the long term effects or retained DU fragments
needs to be resolved through controlled studies. The
injuries sustained by participants. the psychological
effects of participation in the conflict, the injuries
sustained and confounding effects of other exposures during
Desert Storm service may all contribute to adverse health
outcomes in participating veterans.  In order to distinguish
those effects caused by absorption of uranium from fragments
from those related to other factors, long term follow-up
must include control population which make it possible to
account for these confounders.

4.41	Methods: Longitudinal study of Death outcomes
section under development
Data management and data analysis:  Longitudinal study 
Data management: (section under development)

Analysis:
The small size of the exposed population limits the study's
ability to detect differences to only those effects where
the differences between DU and non-DU imbedded fragments are
large.  For example, it is highly unlikely that definitive
conclusions concerning cancer induction will be obtained
from the study.  However, this approach will allow a direct
comparison of differences that may exist in deterministic
effects.  Examples of such effects include differences in
the body's propensity to encapsulate a DU fragment, the
onset of local or whole-organ tissue necrosis,
thorotrastonma-like growth induction, or the
onset of chronic kidney toxicity.  In addition a non exposed
group will provide information concerning nominal values for
each metabolic value studied in protocol (e.g., normal
concentrations of uranium in the body and body fluids as
well as kidney function variations with age).

Quality assurance:
section under development

5. HUMAN SUBJECTS
Urgency and timing of the collection of clinical data
Human volunteers process at UMBAB BVAMC
Human volunteer approval for data sources to identify
control groups
How and if will consent be obtained from control populations

5.1 Distinction between clinical surveillance activities and
the research necessary to support those activities.

Participants in the clinical surveillance program will also
be asked to volunteer as research subjects.  The processes
of enrollment in the surveillance program, of obtaining
consent for clinical procedures, and of obtaining informed
consent for research participation will explicitly
distinguish what is clinical care and what is research. 
Undergoing procedures or tests that are not yet demonstrated
to be of established benefit, or providing all or part of
urine, blood, or tissue specimens for research activities
will be identified to the participants as research, and will
proceed only after explicit informed consent.

6. VERTEBRATE ANIMALS:
No research on animals planned as a direct part of this
program



Alan

http://www.veloceraptor.free-online.co.uk/enigma.html

http://veloceraptor.blogspot.com/

http://www.bushflash.com/pl_lo.html

The out come of a study to address this issue can be found at

http://www.afrri.usuhs.mil/www/outreach/pdf/tungsten_cancer.pdf

The non-radioactive tungsten alloy alternative appears far more carcinogenic 
than  DU



"Alan"  wrote in message 
news:memo.20060222120557.812B@veloceraptor.free-online.co.uk...
> http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet3/brief3.gfr/tab_
> h/br3h1a.txt
>
> Excerpts, September 23, 1993 draft of VA Depleted Uranium
> Follow-up Study
>
> Department of Veterans Affairs Program for the
> Follow-up and Monitoring of Gulf War Veterans with Imbedded
> Fragments of Depleted Uranium
>
> Prepared by the Baltimore Veterans Affair: Medical Center
> for consideration by the Department of Veteran Affairs,
> Environmental Agents Service
>
> For further Information about this draft contact
> James P. Keogh, M.D.
> Director. University of Maryland Occupational Health Project
> 403 West Redwood Street 2nd Floor
> Baltimore. Maryland 21201
> 410-706-7464
>
> J.  SPECIFIC AIMS
>
> The specific aims of the project are:
>
> 1.  To provide on going clinical surveillance of Gulf War
> veterans known or suspected imbedded depleted uranium (DU)
> fragments, DU contaminated wounds or significant amounts of
> Inhaled DU.  This clinical surveillance will provide early
> detection of health effects related to the presence of DU,
> and provide recommendations for treatment to participating
> veterans and the physicians caring for them.
>
> 2.  To conduct focused research into the toxicological and
> radiological effects of DU in order to improve medical care
> for the participating veterans.  In particular, research
> will be directed to improve the scientific basis for advice
> about fragment removal and other possible techniques to
> remove uranium from the body.  Research will seek to improve
> currently available techniques for:
>
> (1) measuring and documenting uranium levels in affected
> individuals using in vivo and in vitro measurements
> techniques,
> (2) modeling uranium absorption retained fragments,
> distribution in tissue, and excretion to serve as a basis
> for estimates of the future health risks from this exposure;
> (3) comparing the clinical course of the body's response to
> the DU fragments with that for other non-DU fragments to
> determine whether clinically significant differences exist
> due to either the chemical or radiological properties of
> depleted uranium,
> (4) characterizing early kidney response to DU and
> elucidating the relationship between kidney does and the
> biomarkets of renal toxicity,
> (5) determining the risk of chronic kidney toxicity due to
> the long-term chronic exposure to elevated levels of
> uranium.
> (6) comparing the morbidity and mortality of individuals
> with retained DU fragments to other wounded and non wounded
> controls.
>
> 2. SIGNIFICANCE
>
> In recent years, the United States Armed Forces have used
> depleted uranium (DU) in the manufacture of both projectiles
> and armor.   Uranium's high density makes it useful in
> designing projectiles capable of penetrating armor made with
> less dense metals, and conversely in armor with a high
> degree of resistance to penetration.  The uranium used is
> "depleted" in the sense that it is the residue of an
> extraction process that selectively concentrates U235 and
> leaves behind U238.  Naturally occurring uranium deposits
> contain over 99 5/8 U238, with small amounts of U235 and
> U234, U238 has too long a half life to be useful in making
> nuclear fuel or weapons.  To create fissionable materials,
> the small amount of U235 present in natural uranium must be
> extracted and concentrated.  Depleted uranium is the natural
> uranium left over from this process which contains even less
> U235 than naturally occurring ores.  In the projectiles and
> armor, depleted uranium is alloyed with small amounts of
> molybdenum and titanium.
>
> During the Persian Gulf War, 15 Bradley Fighting Vehicles
> and 9 Abrams tanks were mistakenly fired on and struck by DU
> munitions.  Some crew members who survived were left with
> imbedded fragments of uranium.  Even depleted uranium has
> some intrinsic radioactivity, and there is uncertainty about
> the risk that these fragments may pose.  Uranium is known
> from animal and human studies to be nephrotoxic.  the
> rate at which uranium might be absorbed from fragments is
> unknown, leading to speculation about the possibility of
> sufficient absorption to present a danger of renal injury.
>
>  At present only a limited number of U.S. veterans are
> known to have been wounded with DU weapon.  An initial check
> by the OTSG has revealed that there are approximately 22
> soldiers whose records
> indicate that they have imbedded fragments that might be DU.
> There are an additional 13 soldiers who were wounded and
> hospitalized but were not specifically identified as having
> shrapnel. Other crew
> members (in addition to the 35 already discussed) were
> either not wounded during (be incident or had minor wounds
> that were treated in the field. The latter two sets of
> soldiers might have inhaled uranium or experienced DU
> contamination of wounds or minor fragmentation wound: that
> were either not notIced or did not require extensive
> treatment. It appears unlikely that.many other U.S.
> servicemen who were wounded by DU munitions during the Gulf
> War will be identified.
>
> In addition to those individuals currently identified. there
> may be large numbers of other Individuals for whom
> information about the possible health effects of DU
> fragments will be important In the near future.  It is
> possible that some other allied personnel were wounded by DU
> munitions.  An undetermined number of Iraqi soldiers may
> have survived wounding by DU munitions.  U.S. forces
> continue to use DU munitions, and may use them in future
> conflicts. DU penetrators are now available In international
> arm markets, and may become widely available to armies
> around the globe.
>
> In February 1992, OTSG requested that the Armed Forces
> Radiobiology Research Institute (AFRRI) conduct a review of
> the potential health hazards (radiological and
> toxicological) of allowing DU shrapnel to remain imbedded
> throughout the lifetime of the soldier. Specifically, OTSG
> wanted to know If there was any reason to change the current
> surgical practIce for fragment removal. No compelling
> evidence was found in the literature review to chance
> current surgical criteria for fragment removal. There were,
> however, significant uncertainties about the impact of DU
> fragments on the health of these patients that wanted long-
> term follow-up. Concern centered principally on the
> possibility that fragments could serve as a reservoir of
> absorbable uranium that might cause kidney injury over time.1
> {AFFRI Review Document}.
>
> OTSG concurred with this finding and initiated action to
> implement this Follow-up in the Army. The Department of
> Veterans Affairs (DVA) agreed to perform the follow-up for
> personnel discharged from the service.   Both the DVA and
> OTSG requested AFRRI's assistance in drafting the protocol
> to be used in the follow-up effort.
>
> A group of DOD physical and scientist: met at AFRRI to draft
> the protocol. At a subsequent meeting on 10 September 1992,
> a panel of experts reviewed and revised the draft protocol;
> representatives of the DVA and OTSG also attended this
> meeting.  The protocol was once again reviewed and approved
> by the panel of experts.2 {AFFRI Protocol document}.
>
> This proposed program incorporates the protocol developed
> and published as AFRRI's Technical Report 93-2 with some
> additions and modifications. It benefits from the experience
> and advice of the authors and reviews involved in the prior
> DOD effort. Responsibility for the current proposal,
> including its differences from the prior proposal, rests,
> however, with the proposed program director and investigators
> from the Baltimore VA Medical Center.
>
> Routine clinical measurements made on participants will be
> compared with laboratory normals and with available clinical
> measurements will underpin any clinical measurements from
> prior medical records.  Initially, the stability or rate of
> change in the robust clinical measurements will underpin any
> clinical recommendations. Since renal toxicity is one of
> greatest immediate concern, evidence of progressive changes
> in blood urea nitrogen, serum creatinine and creatinine
> clearance, and uric acid will be given greatest weight.
> With time, longitudinal date on these and other measures of
> renal injury will be available, as well as comparisons
> between exposed and control subjects.  While more
> sophisticated measures of injury may reveal an ongoing
> process of renal injury, caution will be used in imputing
> prognostic value.  Few of these measures have been shown to
> be of prognostic value in any setting and none in the
> setting of uranium toxicity.  Careful follow-up of this
> cohort may well reveal the prognostic value of some of these
> measures.  In the meantime care will be exercised to weigh
> the possible harm of any intervention to reduce uranium
> burden against the likelihood of benefit to be gained.
>
> Development of models for the rate of absorption of uranium
> from fragments: Measurements of urinary excretion of uranium,
> bone concentration of uranium measured by X-rays fluorescence,
> and estimate of mass and surface area of fragments will be
> used to develop model for rate of absorptIon of uranium from
> fragments. It is hoped that experimental animal data with
> more direct tissue measurements will be available in the
> near future with which, these can be compared.
>
> Relation of estimated dose with effect:
> Results of examinations on subjects will be compared with
> those of controls. Subsequently, indices of dose derived
> from the measures listed above will be used to assess dose
> response relationships for the measures of health effects.
> Indices will be developed that rely on simple (e.g. size
> measured by plain roentgenogram) as well as more
> sophisticated measures (MRI dimension, body counting, bone
> XRF).
>
> 4.4 Longitudinal study of health outcomes:
>
> Concern over the long term effects or retained DU fragments
> needs to be resolved through controlled studies. The
> injuries sustained by participants. the psychological
> effects of participation in the conflict, the injuries
> sustained and confounding effects of other exposures during
> Desert Storm service may all contribute to adverse health
> outcomes in participating veterans.  In order to distinguish
> those effects caused by absorption of uranium from fragments
> from those related to other factors, long term follow-up
> must include control population which make it possible to
> account for these confounders.
>
> 4.41 Methods: Longitudinal study of Death outcomes
> section under development
> Data management and data analysis:  Longitudinal study
> Data management: (section under development)
>
> Analysis:
> The small size of the exposed population limits the study's
> ability to detect differences to only those effects where
> the differences between DU and non-DU imbedded fragments are
> large.  For example, it is highly unlikely that definitive
> conclusions concerning cancer induction will be obtained
> from the study.  However, this approach will allow a direct
> comparison of differences that may exist in deterministic
> effects.  Examples of such effects include differences in
> the body's propensity to encapsulate a DU fragment, the
> onset of local or whole-organ tissue necrosis,
> thorotrastonma-like growth induction, or the
> onset of chronic kidney toxicity.  In addition a non exposed
> group will provide information concerning nominal values for
> each metabolic value studied in protocol (e.g., normal
> concentrations of uranium in the body and body fluids as
> well as kidney function variations with age).
>
> Quality assurance:
> section under development
>
> 5. HUMAN SUBJECTS
> Urgency and timing of the collection of clinical data
> Human volunteers process at UMBAB BVAMC
> Human volunteer approval for data sources to identify
> control groups
> How and if will consent be obtained from control populations
>
> 5.1 Distinction between clinical surveillance activities and
> the research necessary to support those activities.
>
> Participants in the clinical surveillance program will also
> be asked to volunteer as research subjects.  The processes
> of enrollment in the surveillance program, of obtaining
> consent for clinical procedures, and of obtaining informed
> consent for research participation will explicitly
> distinguish what is clinical care and what is research.
> Undergoing procedures or tests that are not yet demonstrated
> to be of established benefit, or providing all or part of
> urine, blood, or tissue specimens for research activities
> will be identified to the participants as research, and will
> proceed only after explicit informed consent.
>
> 6. VERTEBRATE ANIMALS:
> No research on animals planned as a direct part of this
> program
>
>
>
> Alan
>
> http://www.veloceraptor.free-online.co.uk/enigma.html
>
> http://veloceraptor.blogspot.com/
>
> http://www.bushflash.com/pl_lo.html