Document text
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its~ALL II'IF|:!P5I[§!tTICl "I31-ITAIIJED
I-EPEEIIJ IS UNIX IFIEDDATE l2l52DClt- BY I':'-E32*=1 11¢ iilal-.F;"I21]~I_.-Cl
FEDERAL BUREAU OF INVESTIGATION
Date of transcription O 8 Z 19 Z 2 0 Q 5
On August 18, 2005, date of birth, social security account nu er I of
| , omeI cefiuiar telephone] il
address| wasinterviewed aE| | residence. After being advised of the identity
of the interviewing agent, and the purpose of the interview,
|voluntarily provided the following information:
Investigation on O 8 / l 8 / 2 D O 5 at J
File # 2 7 9A-WF - 2 2 2 9 3 6 -"Lig;.92@Qg~_;_;I_n Date dictated
by SA Ii
This document contains neither recommendations nor conclusions of the FBI. It is the property of the FBI and is loaned to your agency;it and its contents are not to be distributed outside your agency.
|:|
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Dd _ | l d fI i [position app Te Ior a| he I online. was s
osit | p ion of
United States Army Medical Research Institute for InfectiousDiseases USAMRIID!, Fort Detrick, Frederick, Maryland. [::::::::]
immediately accepted the position. ' as a very rare
opportunity to learn and do pure r
| Tis was a genuine research facility where you
are intended to improve our lab r or te h y ' y c niques and knowledge.On a regular basis,[::]and[:::::f:fw0uld come up new ideas and[::] would go to the lab and apply what they had discussed.| |worked with Bacillus anthracis, AMES strainJ I |
UponE::]|arrival they were completing al Ilaborato .Unli e at USAMRIID, all work here was strict;1y qm_|;;Q1;|_e_d__|r:|i
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CmmmmbndFD%Mof __{::::::::::::::::::] ,d108/18/2005 mm; 3
As previousl stated worked with B. anthracis,AMES strain, while at IID. E::]also worked withB. anthracis, Volume as eur s rains, whi e at USAMRIID. [:::]
worked with both the living organism and its DNA. The organisms
were always vegetative, never working with the resit was called theiv i is unsure 1; theB anthracis AME was already at|. fit had een acquired shortly after. Ii it was received:::::%:ff:j'[:::::::f there would be a chain of custody reflecting it had been
received, and from where it had come. At both locations, there was
a record maintained of all frozen inventories of the organisms.
There was a record of autoclaving which should show a 1:17C
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correlation of samples removed from the freezer to those
destroyed/sterilized. Every autoclave session had a control spore
strip present which would be used to make sure the autoclave cycle
was completed, The chain of custodies, frozen logs, and autoclave
logs were all handwritten in books, not computerized. Similar
records were maintained at USAMRIID. -
2| ttttt tttt ttgttttttttt $ tttttwere no enera o s maintained w lC would sh ' g g ow ow much organism
was grown from the samples, or records to reflect how much of the
grown organism was used in testing, and then subsequently
destroyed. Some reconstruction of this could be done by reviewing
the laboratory notebooks of all of the researchers who worked with
the suspect agents.
I lwhen stock samples were
removed from the freezer, they were isolated via streak plates and
grown in broth. Then for long term storage, the organism was spun
down, placed in a tube with glycerol, quick frozen in a dryiFe/<?§11t~i1.P=9l, &><?.l~1.11i.<?.111i. Eben pl,§9.<?té.ti.n. <1 .~ZQ never
lyophilized the organisms. Lyophilization would on y e necessary
if an organism was being stored for an extremely lonq time.
4
Organisms were never distributed to researchers outsideof the facilityJ:;;::::::::::::]was responsible for the or anisms,though e o eir origin, used inWhereastgijwould have been given| Iworking organisms by
at USAMRI ID .
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Upon exiting the laboratory at USAMRIID it was a one way
exit. The individual would leave the lab, discard their clothing
into a bin, then move into an anti-bacterial shower. After the
shower, the worker would exit to the locker room where he/she would
get dressed. As you moved from one area to another the "one-way"
door would close behind you preventing you from re-entering the
last area. The only way to remove and organism from this
environment would be throu h 'lacement in a body orifice. Thoughno cameras.were seen,[::::f::was told there were cameras
everywhere watching your activities.
L lorganisms were not left
out overnight. While growing they were placed always placed in the
incubators. When storing the organisms, the vials were placed in
the -70 freezer.
never attem ted, nor did work involving thedrying ofJB. anthracis. I Ialwavs worked with liggid Icultures
i Ineverisolated, rew, or dried B anthracis spores The isolationprocedure[?:]used was always used because it was easy to perform,
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had ood results, and the organism easily survived the process.[:::j%:]:never saw dry samples of organisms at| I
USAMRIID.
rTKE'USKMKITD, the organisms were examined
microscopically.
The B. anthracis AMES strain was ull ¢haracterized_bn___1
ATCQ
| lworked with IvUSAMRIID. Ivins did a lot of "spore work". Ivins andt2f:if::]were_
responsible for all of the B. anthracis spore production at
USAMRIID. Spore production of sporulating organism ewith the information available in the ' rature. [;:fi;::f:¬;TIvins make very large s ore reps. [::%ifwas very now e gea le ofspore production, but[:E:::: never saw him make the preps. 'Ivins would determine t e LD50 of pathogenic organisms with mice.
Ivins used BALBC and CBAJ mice, per the publications. Because ofhis work with spores, Ivins would do weekly spore check swipes of
the bacteriology suites, and there would occasionally be a small
contamination somewhere in the lab e.g. phone, doorknob!.
not aware of anyone lyophilizing B. anthracis
at USAMRIID.
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[:::::::]suggested that most of the individuals with l
unique knowledge of thracis spore preps could be determined bydoing a query on [::f::ij at
As previously stated, there were occasions at USAMRIID
when there were positive contamination hits for spore presence.
These were rare. This only occurred when spore preps were made at
USAMRIID for the "mice studies". '
all of work was inI I suite The main lab was in roomw1Eh Ehe autoclave in the back of the lab, and the primary
egress/ingress between[:::] and[:::::]
[:::;:::]never worked or was in USAMRIID building[:::::][::]could not escribe anything present in that building.
Cards and keypads were required at USAMRIID."Piggybacking" never occurred with, or was observed by[:::::::]
- This wasuagainst the established security*protocols.
"Piggybacking" never occurred with| l and was never observed.As at USAMRIID, this would be in V10 ation of the s;rigL_segurify
| Ibelieves that the Qnlz_may_sQmeFne could remove aselect agent froml_ labs would be by
smuggling it out via placement in a bod cavit . Because oexit protocols from the labs at! IUSAMRIIDJ i' could think of another wav to Ehe QrQanism_our I
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always paired which would make it more difficult, and a body gig
orifice would still be necessary, to get the organism out of the
lab.
E:::::::]is not aware of anyone who ever attem ted toremove a select agent from the labs in which[;:]worked.%:::]is not
aware of anyone who ever joked or suggested t at they might attempt
to remove a select agent from the lab. E::::::] was not aware of
anyone who ever suggested that the might make a select agent foruse in an improper fashion. [:::::E:]added that if someone was to
remove a select agent for the purpose of anthrax letters, they
could have used the much more virulent "New Hampshire" anthrax
strain. This New Hampshire strain has a theoretical mice LD50 of
»0.5 organisms.
[:::::;:]was not aware of anyone with the access and
ability to crea e and handle dangerous biological agents who
expressed hostile attitudes toward any political organization, the
media, or others. [:::::::]did identify that being in an educated
"liberal"henvironment people were often opinionated out politics,etc. However, no oneg:;lhas ever worked with wouldgij identify as"hostile", or remotel ggestive of doing such a t ing.,
[:::::::]is not aware of anyone ' ' e
f ' ' gs of the anthrax letters.
as a subject of the investigation. '
may have performed legitimate work somewhere withI I Il'| I rfl I w was doing legitimate workd | ould
have been inoculated, and followed up with re ular boosters. Thiswould result in a high antibody titer. If[::jwas not previously
vaccinated then the presence of any antibody titer would be
suspect.
No one who[::::::::]worked with while at USAMRIID [::]
[::::::::]were ever "lax" in the handling of the dangerous
organisms.[::]did not have, or knew of, anyone inappropriately
* interested in the pathogenic organisms.
[:::::::] was not aware of an one at USAMRIID, which waslike an academic facilityy[::::::::::fi:::]which was working for a
client with work orders that dictated the work performed, who was
rumored to be interested in gaining access to biological or
chemical agents, or the means to produce them.
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Growing the B. anthracis organism is easy. I |
In addition to the difficulty of creating a flowing
powder of the organism, the individual would have needed to grow
hundreds of liters in order to have the amount of organism used in
~;_1.1e§e, .me.i..l.in9§-.. Someone. would have noticed this happening. . If- .done outside of a level III laboratory,[:;;;;;]be1ieved that there
would have been dead animals in the area o e production of the
organism e.g. a garage or residence!. It would be difficult to
control the size of the isolation without any of it getting out,
and animals are much more susceptible to B. anthracis than are
humans. There are very few people out there who would have the
access and the ability to produce this isolation.
[:::::::]recalled that the FBI had sent out an email to
the 35,000 ASM membership asking for assistance in how it could
,have been done, or who may have done it. Some of the scientists
were offended by the request. Some of the scientists failed to see
the big picture and were resistant to the thought that one of their
own could have done this act.
[:::::::]was not aware of anyone who expressed a special
in r in getting around established forensic techniques.E::Ef:ffadded that there are, "...too many genetic markers to_get
around it."
[:::::::]does not have any personal associations with
Trenton, New Jersey, Princeton, or any Qghgr areas Qfb6
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| Ican not recall ever being in
renton, New Jersey.
I Iwas working at| L living1n| I during September and October 2001. Eifjisconfident that| I was| Jthe ant raxletter events. Due to Ehe shuting down of Ehe airlines following 'rQgL;I[::]_QQ§§_nQ;_belfeve[:1 would have been able to travel E:::::]
There were established Standard Operating Procedures
SOPs! for the decontamination of Class II and Class III biosafetycabinets while at USAMRIID [:;:;::::;;:] These SOPs were based
upon CDC guidelines for biosa e y. e procedure was as follows:
everything was removed from the hood, it was then wiped down with
70% ethanol or 10% bleach, the sash was then closed and the
germicidal lamp was left on for approximately 10 minutes.
, léee never been his? the virelesy euitensat .UEAMRIIDI did not know what decontamination procedures were
used in the virology suites, or whether it smelled of bacterial
decontamination agents. At USAMRIID, in the bacterial suite, -
paraformaldehyde decontamination was done approximately once every
month or two. There was usually a couple of days notice that this
was going to occur. The paraformaldehyde decontamina 'done at Battelle, but onlv on a '
re ularly used plastic containers a
USAMRIID plastic exclusively!. Samp ere
stored in Falcon tubes and microcenterfu e tubes. wasalso provided plastic reagent bottles. [f::::::]was un ami iar with
"sterilite", and could not say whether boxes were ever missing
while at USAMRIID. If it occurred, it was never of such a concern
that.E:]was informed, or asked about, them being missing.
While at USAMRIIDI lwas not aware of
any work being conducted in an "unofficial" or "off the record"
manner. All work in[::] laboratories was documented in lab
notebooks. At USAMRIID,[::] work product was passed through a"pass through box" with a germicidal lamp, and then entered in[:::]lab notebook. All of[:::]work was reviewed with[::;::::::] These
notebooks were maintained on the shelves in the wor area, and were
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not secured in an particular way. These notebooks remained atUSAMRIID after[:if]departure. bg
[::::::::]was shown a photocopy of a prestamped envelope.
>> . ,, .£1§Y¬%1?.P¥1.r9l1?§§§¬LQ11Y Qi Etherpxestampedcenvelopes for. eitheror for someone else. [:::::::]found them to be a short
sig te purchase with the regularly changing postage rates.
[;;:::::]was not with USAMRIID[:::::::::::]at the time ofthe Amerit rax incidents. [::::::]never came in contact with the
anthrax laced letters, and was never asked to perform analytical
work in association with this case.
I |first hea | I from [::::::::::]with this case. never worked with| lor recalledseeing| Iat USAMRIID.
[:::::::]was never asked to host a foreign visiting
scientist at either USAMRIID] I
has never heard of the Aeromedical Isolation Team
AIT!. -was not a member of_the AIT.b7».,'
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|:| stated Q could be recontacted anytimeconcernlng thls matter, an |:|offered |:|assistance as a
consultant in the Amerithrax matter. /
k ' ALL I 11'l-[ATIDIII CCINTAII-TED0 HERE LFIIII Lg.-J-JIFIEI]
[FATE l2l52DDB Bl SD32»? 1.113 haH,.">I11i;Cl5
279AWF222936-USAMRIID-@A§
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' g investigation was conducted by Special
Agent SA! of the Federal Bureau of Investigation on
September 28, 2005:
As previously reported former United States Army
Medical Research Institute of Infectious Diseases employeeE::::::::::] Social Security Account Number SSAN!:[:::::::§§§§§3
Date of Birth DOB!:[:::::::::::::]had access to the Ames strain be
of Bacillus anthracis Ba! will employed at USAMRIID. A query of h7c
available USAMRIID keycard access records for [::::::] met with
positive results. USAMRIID keycard access records indicated
keycard activitv for during the period of E::::::::::::::]
through USAMRIID keycard access records alsoindicated multiple keycard activities for[%::::::]2f USAMRIIDlocations to included, but not limited to: KeypadII IKeypad,[:::] Keypad, and[::::]keypa?. Writer opines I I
keycard activity is consistent with
personnel.
the A query F£____i______1 S I ZZEI I I database for met with positive results. b;
I L _ _ _ Iis listed as b§c ~
I a coinvestigator along with other USAMRIID personnel to include t limited to:I Qand_§£pg§ Iii on protocol] I Briefly prolocol
entails th
in USAMR ui in or Ehe coilection or positive
control specimens.I Iis urther described as
The last known address for[;;::::] was listed as:I This a ress is incorrect. A 96
internet search for indicated this was the for the Q76
I A query for on internetaddress:I Imet with positive results. [;;;;;]
- [:::::::] is further described as:LASEMNAME: EééééjE;i§I_E5ME=
MIDDKLLE NAME:
§§X$
B_A,CE: .
IiE.LG/HT:
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3 C T/NQFQRN : PM 1?:-1.5-;I:|'|n:%
FEDERAL BUREAU OF INVESTIGATION
Precedence: ROUTINE Date: 09/28/2005
To: Washington Field b6Inspection Attn: IIC[:::::::::::::::] b7:
From: Washington Field
AMX-3 bgContact: SA l b ? I 1
Approved By:
T-TJ epxafted By: | [ b6 ~_r b7CCase ID #:iQ§i 279AWF222936USAMRIIDO/ Pending!-vmq
Title: U! AMERITHRAX;
1 MAJOR CASE 184
X Synopsis: U! To document additional individuals who may have
had access to the Ames strain of Bacillus anthracis Ba! at the
United States Army Medical Research Institute of Infectious
Diseases USAMRIID!.
:>§i Der ro '
sify On:
Details: U! On 5/18/2000 at 10:40:23 a.m., Dr. Bruce Ivins
sent an email to| andl I
This email, which was identified by SSAI I was
found among archived email on 35 USAMRIID computer backup
tapes. In the aforementioned email, Ivins provided a list of
individuals who had worked on the anthrax vaccine, but were no
longer at USAMRIID. Ivins list was compared with a list of
individuals known to have had access to the Ames strain of Ba.The nmes of the following individuals were not located on the
list:
U! ACS was searched in regards to the abovementioned
individuals with the following results:
NOFORN
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Q u NOFORN '
T Washington Field From: Washington Field
D O9/28/2005O1¢U3 ~Re; :j§!i 279AWF~222936USAMRII ,
92 U I I I<U> | I
U! Interview 79A~WF222936 POI, Serial 1404! of Bruce 2:6
Ivins.
U! Ivins advised
Iwasl Iresponsible
' for the anthrax vaccine. ' Bioport with potency testlnq
members were Ivins] andH Ivins noted| |now works at
ntervlew 79AWF222936 - USAMRIID, Serial 846! of [:::::::::]
GD
AWF222936 - USAMRIID, Serial 674! 6r[::::]
n! Interview 7TA~WF222936 - USAMRIID, Serial 507! of[:::::]
' h ax U! [::::::]believes[:::::::]has worked with ant r .
rial 469! of[::::::] U! Interview 79AWF222936 USAMRIID, Se
U!g:::;;:;:]indicated that| I[:::::::]worke Wl a.
' AWF222936 - POI, Serial 766! of [:::::::] U! Interview 79
;;E§ég/NOFORN
2I <v>|
0 6 T/NOFOM Q
To: Was ington Field From: Washington FieldIT-TI Rees-:- 279A-WF-222936USAMRIID, 09/28/2005
bé U! [::::] stated[::::::::]worked and experimented with b7C
bacteria.
U! Interview 79A-WF222936 ~ USAMRIID, serial 27! ef|:|
IU I
worked with anthrax in the
I AMRIID before[::]~departure.at US
U! Interview 79AWF-222936 - 302, Serial 2660! 6r|:|
<0! I I
U! Interview 79AWF222936 - 302, serial 298! o
U! I IadvisedI H
is a specialist in anthrax.
f |_ u! Interv_iew 79AWF222936 - Serial 264! 6 |:|116I b7Iat USAMRIID studied Ba ,<U! Iand worked in room] |ln building
b7 ! Interview 79AWF222936 - 302, Serial 904! of
b6
I <9! I
| conducts research with Ba.
U! Interview 79AWF222936 - 302, Serial 134! of |:|
I:I
I <0! I I l
U! EC 79A~WF222936 USAMRIID, Serial 1131! re: Laboratory
Notebook Review Project.
T/NOFORN
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| <1 '6 T/NOFORN
[U?o: Washington Field From: Washington Field b6Re :=_>< 279AWF-222936-USAMRIID, 09/28/2005 b7c
U! Notebook revealed that on Mav 8, 2003, Amesspores were provided to I
U A f ld " o er entitled Harvesting Spores + GLP Spore
contained a copy of an email from Bruce Ivins tocipal Investigators PI!| IJ The e-mail calculated the amount of spores needed tor aeroso
challenges of 1000 rabbits and 200 monkeys.
U! EC 79AWF222936 ~ MAIN, Serial 6263! re: Laboratory
Notebook Review Project.
U! Notebook number[::::] assigned to[::::::::]
contain ' by Ivins regarding production of Ba Ames atDuqwav.i Iwas listed as the| || Ifor this project.
U! EC 79AWF222936 USAMRIID, Serial 882! re: Laboratory
Notebook Review Project.
U! An e~mail dated May 1, 1997 from Ivins to various
principal investigators's| |was found in
n ok[::::] In the e~mail Ivins discusses purifying the
spores with an ultimate viability of 4 times ten to the
we .
U! On October 9, 1997 Ivins sent another email
discussing the Dugway spores. Ivins advised the preparation
using Dugway spores would be known as RMR 1029.
| |=[_uii__1n:eriiem_lzF9A-wF-222936 - USAMRIID, Serial 1088! of[:::]
! Interview 79AWF222936 ~ USAMRIID, Serial 1024! of[:::::::]
Sfi/NOFORN
4
. S NOFORN
IU! To; Washington Field From: Washington FieldRef :}Si 279AWF222936USAMRIID, 09/28/2005
U! EC 79AWF222936 USAMRIID, Serial 1131! re: Laboratory ia
Notebook Review Project. '
U! name was mentioned in notebook number[:::] in relation to
<U> I I
U! Interview 79AWF222936 302, Serial 635! of[:::::::::::::]
U advised was no longer at
I USAMRIID an was unaware of w erea ou s.
U! EC 79AWF222936 MAIN, Serial 1115! re: Interviews
conducted at USAMRIID.
U! [::::::::::::::::]was listed as "not at USAMRIID".
U! I I
! Interview 79AWF222936 - 302, Serial 961! ef[::::::::::]
I U I '
U! Interview 79AWF222936 - 302, Serial 3489! of [:::::::::]
advised1___Ihas never worked with an animal exposed to anthrax,
as[::] conducted a necropsy of an anthrax infected animal.
did have access to the hot suites includin the hot side of. I 9
building[::::]
U! Interview 79A-wF222936 USAMRIID, Serial 483! of[:::::::]
U! Aggroximately one month after the anthraxmailings, showed] |andBruce Ivins several jars containing what] Idescribed as
simulants.| I| | Ivins stated the vial containing a substance that
oo e i e smoke in a glass" was most similar to the evidence.
:s§E§£g!NoFoRN
5b6
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-1. /NOFORN 0
To: Was ington Field From: Washington Field
LT! 27 9A~WF222936-USAMRIID, 09/28/2005
%U! Interview 79AWF222936 Lab, Serial 132! of[:::::::]
U![::::::]was asked about [;;:]and others submitting
to a polygraph, thus allowing them to e read in" to the
AMERITHRAX case.[:::::::]advised each individual would have to
agree to the polygraph voluntarily.
U! Interview 79AWF222936 USAMRIID, Serial 935! of Bruce
E. Ivins.bv
137C
U! Ivins advised |H | Ivins did notmention what type of materiall Iwas using.
! Interview 79AWF222936 - USAMRIID, Serial 1269! of|:|
! Interview 79AWF222936 - USAMRIID, Serial 508! of|:|
U!|
u! Interview 79lA-wt-222936 -|:| Serial 267! <>r|:|
<0! Interview 79AWF222936 - USAMRIID, Serial 1148! of|:|
| |
S T /NQFORN
6
|___is
1m < 5 /NOFORN 9
To: Washington Field From: Washington Fieldu? ~»Re: :§%i: 279AWF222936USAMRIID, 09/2s/2005
1 1.
U! Interview 79AWF222936 USAMRIID, Serial 499! of Bruce
Ivins.
U! Ivins advised[::::::::::::::]isolated the Ba
sample called Texas 2 from sheep liver.
U! EC 79AWF222936 USAMRIID, Serial 882! re: Laboratory
Notebook Review Project.
U! On page four of notebook[::::] Ivins detailed a
procedure in which he rew five liters of Ba strain unknown! togive tog:::;;:;;::::::f] None of the rats died after being
injecte wi is preparation and Ivins speculated he had
harvested the Ba too early. On page 18, one liter of the
Ristroph medium was a ain inoculated, and the supernatant wassaved and given t@
n! EC 79AWF22F936 1[:::] Serial 957! re:[:::::::::]0f
a lira-.u;hQr.¢ the - -
livinj BE;[::::::]
U! | }
U! Interview 79AWF222936 USAMRIID, Serial 1065! of [::::]
|:|
U! EC 79AWF222936 ~ USAMRIID, Serial 1131! re: Laboratory
Notebook Review Project.
siéii/NoFoRN
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_ .G /NOFORN a
To: Washington Field From: Washington Field beRe: >§ 279A-WF222936USAMRIID, 09/28/2005 biI F
U!| Iname was found in a folderentitled] 1 } I|andH Iassisted Ivins with a protocol involving testing guinea
pigs with strains, using Ba protectiveantigen aL-5-pratatvpe-vaccine-as;inst human anthrax.
<U> ii 1
U! EC 79AWF222936 USAMRIID, Serial 1131! re: Laboratory
Notebook Review Project.
noted there were no references to an individual
named at USAMRIID. However, a reference was made to U! JJ_E% ,
an in ividual named| } That reference follows below.
<U> |:|
U! Insert 79AWF222936 302, Serial 3745! re: ACS checks run
on variousr- Iemployees.
U! The name[:::::::::::::] was found on a list of[::::]
U! Interview 79AWF222936 - POI, Serial 1299! <>f|:|
U was listed as a coauthor with Bruce Ivinsand on a paper published inl;:::] titled [::::::::]
[lVI§_Ed[:::::]immunized Ehe animals, and lvins conducted l
aerosol challenges. E:::::]eventually developed the ca abili togeneratd[::] own protein using a procedure named.[::::fi::::iij
worked at USAMRIID|:|
S!| Ire: Request for [:::::::::]
| lanfhrax researchers.
OFORN
8
' .¢ '
To: as ington Field From: Washington Field ~~Re: ?§<T 279AWF222936USAMRIID, 09/28/2005
92 U!I i Serial 177437 re: anthrax research and
U A new anthrax vaccine was developed by[::::::::]
that is less toxic and longer lasting. The
vaccine lS rea y or commercial development and clinical trials
will begin soon. The research team created harmless mutant forms
of the three key proteins that together make anthrax fatal. A
five liter capacity fermenter can now produce approximately five
grams of protective antigen per liter.
U! EC Serial 109! IQIZI |
| Iiv! Interview 79A-WF222936 - USAMRIID, Serial 489! <>f|:|
/NOFORN
9
" l .. 4 * h /NOFORN 0
To: a hington Field From: Washington Field
Re: 279AWF222936USAMRIID, O9/28/2005
U! I
[§ddififFally4 Iworked with Bruce Ivins and| I
to
U! Interview 19AWF222936 USAMRIID, Serial 266! of
U! Interview 79AWF222936 POI, Serial 168! of source.
U! Interview 79AWF222936 302, Serial 1869! of Bruce
Ivins
U!| Iworked with vaccine strains of Ba.
U! EC 79AWF222936 USAMRIID, Serial 1309! re: Unauthorized
environmental surveys conducted by Ivins.
U! On July 7, 2002, Ivins sent an emai1 to[::::]
stating his most recent swabbing was the third time he
had found virulent anthrax outside of the hot suites. Ivins
advised in the early 80's[::::::]had injected and killed guinea
pigs with the Vollum 1B strain of anthrax. After the death of
the guinea pigs, all of the used bedding had to be removed from
the suite. Since the autoclave was not working, paraformaldehyde
was used on the bedding, and everything was sent to cagewash for
cleaning. Ivins advised prior to the bedding being shipped to
cagewash, he took and plated a sample. Ivins discovered that the
top of the bedding was sterile, but the lower layers were
contaminated with anthrax and other bacteria.
OFORN
10 U! Source described[::::::::::::]as an associate of b6
<U>| |
[Q"'¢ an .. w
EU? >é
X92 »
9 T/NOFORN *
To: Washington Field From: Washington Field
Re: 279AWF222936-USAMRIID, 09/28/2005
@n b6
,p b7CEn 912AWF777Q 6 1 Ir re: use of or studies on Ba.
[::::::::] tasked military services and select defense agencies to 23¢
review their records and identify any studies etc. using various
forms of Ba.
U! This information is being documented so that
appropriates follow-up interviews can be conducted.
QQ
SEQLNQFORN
M H 11
1
U w , ALL Inananirrnn cnnrilnfn I-IEREIIJ IQ1cL;1.ss1:-P1E1::», FD_302: Rev_10_6_95! DATE 1.5-- .»;EICIt- E11 D0524 us }:|:a1-r_:|:1]-rials
-1-
FEDERAL BUREAU OF INVESTIGATION
Date of transcription 1 O Z O3 Z 2 O O 5
On Se tember 21, 2005, Zc
born Social Seiurity Account Number '
4"l3'¢A- :? n2w "'=35'~" f3"L $,;,,g',.!~ *f;92l'-1:-1?'§§ U.S. rmy e ica Research n f§§;§mQ§fff§%?louswpisease
IID 4'2Y3' P""6'f¬'é r? s I?%.: é em_,n F1;,_ hD_w_tri ck ,,,.,1v;a-51 ';i;l:§fffd;§5';2i§7%§£ "§honenumbW¢ ~w¬§ f§§%rvf§wg a place*ofWbusines§? *@
After being a vise of the nature of the interview and the identity
of the interviewing agents,[::] provided the following information:
| I Iused to get anthrax from BRUCg;IVINSL[;::g::::] be E b Cwas s own two p otos of r
a single 1.25 mL vial labeled| |Ames Spores," and a single béphoto of the 50 mL coniiaijifjinsi e which the vial was found. [::] b
This photo was shown to by Special Agent SA Thistube and vial were seized from USAMRIIDBui1ding[£::%}:;;;;£;;E byFBI SAs dTring a consent search authorized by the Commander of Y5
I ID.land this was not the sample that] Lgot from IVINS in '
I Ibelieves this sample has already been submitted to the FBI
Baci us anthracis Ames Repository FBIR!.
b
b
[::;;2;::] thinks that the spores contained in the letters
have a morp o ogy different from Ba isolated from an infected
'anima1. Samples isolated from infected animals often have a medusa
mor hology, and samples that have been passed in culture will
|W%@won O9/21/2005 at Frederick, Maryland
File # 2 7 9AWF- 2 2 2 93 6 USAMRI II'> 92Z9292% we aimed N/A
SAby ssz-£1 |
This document contains neither recommendations nor conclusions of the FBI. It is the property of the FBI and is loaned to your agency;
it and its contents are not to be distributed outside your agency.
IF
~~
/V
O I
FD-302a Rev. 10-6-95!
27 9AWF222 93 6 USAMRI ID
Continuation of FD-302 of I , On O 9 / 2 1 / 2 O O 5 , P858 -2-
have morphologies that are somewhat asporogenic and lack the
medusahead appearance.
[:::::::]stated that IVINS uses 1% phenol as a
reservative in his spore preparationsI I
There has never been a fermentor Building 1412 and
Ba Ames as never been fermented at USAMRIID. It would have been
too dangerous to have grown Ba Ames in a fermentor.b6
7C
I Iwas inBuilding[:::] while[:::::::]was at U§AMRIID.
does not believe that I I er in
the Bacterio ogy Division at USAMRIID. S ecifi ll , doesnot believe that[:;::;;:]was ever in theI Iand containmentsuites located in ui 1ng[::::]of USAMR .
, does not know anyone referred to as [::::;:::::]or u may recognize[:::]if[::] was shown a plC ure.
The photos of the 1.25 mL vial and 50 mL conical tube
were placed in the corresponding 1A envelope. This sample is knownto the writer to correspond to FBIR sample:[::::::::]b6I b7C
6
b}C
i~ AL L IIiIFElPlit1tTI CIIII C UIiIT1'-LINEDK ' HERE In IS quits 5 IFIEID
DATE 12-15-2-0a BY 60324 ucFD-302 Rev. 10-6-95! }m"~i" -W615
_ 1 _
FEDERAL BUREAU OF INVESTIGATION
Date of transcription 10 f 13 Z 2 O O 51:6
107C
ober 12, 2005,£§Eg[:;:;:??:?f£ Sggigl Securigy Accggwtmggg er I U.S.Medica esearc Institute of Infectious Disease USAMRIID 1425
Porter Street, t. Detrick, Maryland 21702, phone numbercellular phone §bmge;£;;;;;;;;;:lwas interviewed at place 0ba§rne§at "%%er Bing'advised of the nature of the in erview and
identity of the interviewing agents,[::] provided the following
information:
Prior to the interviewJ lsent SAI la threethe
3!
page documentArmy
136
b7C
I This document was sent to SA[:::::::Tby emai1 at
Iand brought to the interview for
reference At the n. co clusion of the interview[;:::::;:Fnitialed[::::]and dated e ' ' ~~~
Investigation on l O / 12 / 2 O O 5 at Frederick , Maryland
File # 2 7 ~ - - 92 Date dictated N / A
SA
by S I
This document contains neither recommendations nor conclusions of the FBI. It is the property ot the FBI and is loaned to your agen
it and its contents are not to be distributed outside your agency.ach page of the document and it has een p aced in _ I 2:,the corresponding 1A envelope . y V I
,-be
127C
in G.
FD-302a Rev. 10-6-95!
279AWF222936USAMRIID
Continuation of FD-302 of I I , On 1 O / 1 2 / 2 O O 5 , Pageb6
b7
2
I Ff Both of these preps were produced usinga spore preparation g1ven| | by BRUCE IVINS. [:::::::]
refers to a Ba Ames spore prep given to her by IVINS in 1987 as
E:::]original Ames. when this original Ames spore prep was
examined all of the Ba colonies appeared uniform and did not
exhibit either the second layer of white growth or the
individual colonies that were raised, tan in color aasporogenic. E::::::] believes that at the same timeKi::::;]received Ba Ames from IVINS,[::::::::]received Ba V0 um s rain
from him as well.
N H D ALL UFLIIATIUN El3I92TTAII*1.'EI'J
FD-3
Rem 10,695! HE IS UIJCLASSIFIEII
' 1 DATE l2-l~5~2ClCl8 BY EJ3324 L18 1:ufi.I»I_."=;iJ<I_.>ClS
-1-
FEDERAL BUREAU OF INVESTIGATION
Date of transcription 1 O Z 2 8 Z 2 Q O 5
I l date Osecurity numbe [home address _ b7
| |home telephone numberl Iwas interviewed at| iplace of employment, the Unite a es rmy
Medical Research Institute of Infectious Diseases USAMRIID!, worktelephone number[::::::%g;:::] After being advised of the
identities of the interv wing agents and the purpose of the
interview,[:::::::]provided the following information:
I Ibegan working at USAMRIID in bg
b-1
QWhile first assigned to theg:::;:::::;::1Division untillworked in Buil ing suites ,
and in Building uring aerosol challenges. grew
cultures of Bacillus anthracis Ba! in suite and engaged instrain stufiff]with guinea pigs there. B ' ding
room during aerosol challenges.b6
b"/C
b2
b7F
Idid not work in any laboratories in
prior to and through September 2001.
Ba Ames from IVINS' collection was normally stored in
Building[::::] suite[::] Ames and other agents were stored in
cryoboxes that were not labeled on the outside. Ames was brought
to Building[::::] room[:::]only on the morning of a day on which it
was t be d f l h ll o use or an aeroso c a enge. Just after the challenge,
lates of ostchallenge material were counted.[¬:::::::::fonly brought a few supplies to building or t eir
work, including media plates, spreaders and gloves. mes was onlyin room{:::]on the day of the aerosol challenge. All left over
materia was autoclaved out at the end of the day, including post-challenge mategial and leftover Ames that was not used.
Im%@mhnm 10/19/2005 m Frederick, Maryland
File 279AWF222936USAMRlID -W15 Date dictated 10/21/2005C
C
U
FD-302a Rev. 10-6-95! Q
279AWF222936USAMRIID
b6
b7C
Continuation ofFD-302 of I , On 1 D /1 9 /2 0 Q 5 = Page 2
[::::::]did not recall Ames having been stored in any of
the following rooms or suites in Building 1412: 112, 222, 211 and
212. Room 210, the walk-in cooler, did not contain Ames from
IVIN ' boratory. id not know what room 112 was used for.Roomi::%iwas used fo work, where blood and sera were tested
for anti odies. i k in suite 211, and1iUUUdid not
work in room 212, whi wasl Ilaboratory, untilafter September 2001.i lwas ndt aware of Ames having been
stored in any of the ha ways of building 1412.
[:::::::]did not recall Ames having been stored in Building
1425, suites AA3, AA4 or AA5, or rooms AR105 and AR106. E:::]had benever heard of Ames having been stored in any hallways of Building B7:1425. To[:::]knowledge, there were no refrigerators or freezers in P2
bthe hallways of 1425 Ames was taken out of a containment 7?area, such as suites it was carried dirTfflfjto anothercontainment area, such as room[::]in Building Ames that was
not in a containment area was always in someone's possession.
When growing spores for challenges, IVINS' group used
seed stock from the original Ames slant. At one time, material
that had been grown from the original slant was sent to Dugway
Proving Ground for quick, mass production of spores. There was no
real difference between the spores made at USAMRIID and those made
at Dugway; Dugway was simply able to produce spores more quickly.
There was a lot of work involved in the preparation of spores,
including growth in a flask and the use of Renografin., IVINS'
group used the material received back from Dugway, as well as Ames
they had grown themselves, for aerosol challenges.[:::::::]knew
that the Dugway material was used for aerosol challenges, but|[::]
did not specificall remember any one challenge where the Dugwaymaterial was used.tE:::::] remembere t several rabbitchallenges were conducted with Ames.d[iij also recalled that
challenges were conducted using Vollum and possibly the Sterne
strain.b6
b7=lZ
[:::::] vaguely remembered that Building[::::] suite[::] Ec
was decontaminated and closed for renovation, and that it came back b2up sometime in 2002. E::] did not remember suite[:g ever having b7F
been closed for renovations, nor dMi[::]remember eing involved in
the inventor of items ' t th f y in sui e or e movement o samples orequipment from suite[::]to suite
[::::::] stated that other scientists were given Ames from ,IVINS group, including the Dugway material, to use in their own Eic
Q ,9
FD-30211 Rev. 10-6-95! . 0
2'79AWF-222936USA192/IRIID
Cmmmmm0®6M0f _J l ,0nlO/19/2005 ,m$ 3
experiments. Those who may have been qiven Agfs from IVINS' qroui
were anVirokog1stscouId have used bacteria such Ls Ames to challenge
animals for vaccine comparison studies. They probably would have
taken Ames back to the virology suites in which they worked, unless
it was to be used for aerosol challenges. A virologist who wanted
to obtain Ba from the Bacteriology Division would probably be
required to go through the Division Chiefs, and there would be.
paperwork involved. Virologists may have also used other bacteria
such as Plague or Staphylococcal Enterotoxin B.
When asked[:::]opinion of the case,[::::;;] stated that[::] thought the mailings were conducted and covere up by thegovernment. gggglstated that the overnment had done it before withBacillus glo in California. |g:| also stated that |:|knew
the FBI was looking at BRUCE IVINS, and that|:| did not believe he
had anything to do with the mailings.E::::]said that IVINS would
never want t h t ' ' 'o ur anyone, an ould be surprised if it turned
out that he was involved. stated[:::]did not know if the
material from the mailings came from USAMRIID.
ALL II<1'FEiF<I- EIJIJTAIIIED
M HEIFEIH IS T_ SSIFIED
if DATE 1.2-15-2303 BY E0334 1.1»: h&hT_fdJ~Z,~"ClS
* ' 279AWF222936USAMRIID ~92&1%>t I 1
The followin investigation was conducted by Special b6Agent on 11/8/2oos= bl;
On 2/22/2005, BRUCE E. IVINS sent an email from his
United States Army Medical Institute of Infectious Diseasesl USAMRIID! account to| Iatl
In the email[::::::]asks IVINS the meaning behind his
America Online AOL! screen nam Qf kin [email protected]. Thefollowing is IVINS response toi |
During the First Gulf War in 1990-1991, there was
a secret army project, called "Project Badger," in
which researchers tried to find out if they could
dilute the currently licensed human anthrax vaccine and
still have it remain efficacious. The war caught
people here off-guard, and we apparently didn't have
enough fullstrength vaccine for all the troops
00,000+! going over there. Since it was believed
that Iraq had anthrax as a biological weapon, it was
deemed of high importance to make sure that the troops
had both vaccines and antibiotics, should the agent be
used against them. Years afterward, the project was
revealed and discussed in an article in "Vanity Fair."
We had a lot of laughs about it, since we in our
division had been left in the dark about the whole
thing, especially the part about it being named
"Project Badger." I was doing a lot of anthrax vaccine
research at the time the late 1990s!, and one day our
division chief walked in and said, "I need to talk to
King Badger! The name stuck. So, when I got an AOL
account, I tried to get "KingBadger" as my handle, but
somebody else already had it. So I settled for
"Kingbadger7." If you'd like to read more about the
subject, you might check this out: http://www.vaccine-
a.com/excerDt.html.1
A review of www.vaccinea.com/excerpt revealed an
excerpt from the book VaccineA, written by Gary Matsumoto. The
excerpt discusses the potential use an oil based adjuvant known-
as squalene to boost the effectiveness of the new anthrax
vaccine. Matsumoto writes that oil adjuvants cause autoimmune
diseases. The excerp ' t USAMRIIDresearchers includingi _ IVINS and{::::::::::} There is no mention of Project Badger in the excerpt.
*4.
i -r
2'79AWF22293 6USAMRIID
2
The excerpt states that as of the early 1990s, IVINS and the
other researchers at USAMRIID had four viable prototypes of a
single shot anthrax vaccine ready for clinical trials. The last
sentence of the excerpt reads, "All Fort Detrick needed now was
the right time and place to test them." This sentence apparently
alludes to the Persian Gulf War as the time and the place to test
the prototypes.
A copy of the excerpt found at the abovementioned
website is attached to and made part of this document.
A www.google.com search using the terms "badger and
anthrax and vanity fair" revealed an article titled, "The
Pentagon's Toxic Secret" authored by GaryjMatsumoto,
The article contends that approximately 150,000 Gulf
War soldiers received a then secret vaccination known as "VaccineA", which was in actuality an anthrax vaccine. Dr. EAMEQA ASA,
Ph.D. has conducted studies on numerous Gulf War veterans and she
believes that the Gulf War Syndrome is the result of a squalene
adjuvant used in Vaccine A. The articles references "Project
Badger" as an operation that may have developed a "modified
version of its ED.A.licensed anthrax vaccine." Project Badger
was made up of 14 officers from the Army, Navy and Air Force.
According to the article, Project Badger's first meeting was on
October 9, 1990 at Fort Detrick, Maryland, the site of USAMRIID.
The purpose of the meeting was to "surge" the production of
vaccines for anthrax and botulinum toxin.
According to the article, Project Badger then
contracted with Lederle~Praxis Biologicals of Pearl River, New
York to produce the additional anthrax vaccine with the help of
the National Cancer Institutes Frederick Maryland! Cancer
Research and Development Center NCI!. Both Lederle and NCI were
not licenced to produce the vaccine. According to the article,
Lederle and NCI would produce the vaccine and ship it to the only
licensed manufacturer of the vaccine, Michigan Biologic Products
Institute MBPI! purchased later by Bioport, Inc.! who would
then bottle, label and store the vaccine. The leader of Project
Badger, Army General Ronald Blanck, denies that anybody other
than MBPI produced the vaccine.
Since the Gulf War, Project Badger has been
declassified but there have no documents found that prove that a
squalene adjuvant was used in an unapproved vaccine and the Army
has denied the claim.
92
279AWF222 93 6 USAMRI ID
1
A copy of the abovementioned article is attached to and
made part of this document.
K
T 4-
ALL IIJFURI-DLTIDN C CIIITAII-IED
HEREIN I" IIL-F15-ISIFIED0 DELTE 1.2- DUB Bit" 6-U32-2 L113 b&ttI* :.lJ1.,-"I"J.5
5
» Read the introduction <intro.html>
» Send an e-card <http://www.perseusbookspromos.com/vaccinea/index.html>
The Greatest Story Never Told
For the past 17 years, the Army has been working on a new anthrax vaccine that contains
no anthrax, and is made with an ingredient that it does not want to name. That ingredient
is called squalene. Squalene is an oil. Without it, the new vaccine will not work any better
than the old one. In fact, for all intents and pmposes, without squalene the new vaccine is
the old one. What makes squalene so important is its proven ability to stimulate a strong
response from the immune system. That is something the main ingredient of the new
vaccine, the now ultra-puried protein secreted by the anthrax microberecombinant
protective antigencannot do by itself. It is too weak.
Immunologists have a special name for substances used to boost feeble vaccines. They
are called adjuvants. Adjuvants are arguably the most extensively researched
pharmaceutical product in the last quarter century that you never heard of. I have used the
word adjuvant three times in this paragraph so far and that is probably three times more
than you have ever seen it in print before. This is partly because the most effective
adjuvants, those formulated with oils, are too dangerous for human use. That is squalene's
other proven ability, causing incurable disease, which is why it is such a touchy subject
with the Department of Defense.
The word adjuvant comes from a Latin word that means "to help." But with oil adjuvants
like squalene that term is misleading. Today, only one adjuvantan aluminum salt called
alumis licensed for human use. All the oil adjuvants are so noxious that their use is
restricted to experiments with animals, and even then, governments have written strict
regulations to govern how they are used. The classic oil adjuvant, called Freund's
Complete Adjuvant, is considered too inhumane to even inject into animals. It does a
terric job of stimulating the immune system, though. Unfortunately, Freund's Complete
Adjuvant can cause pennanent organ damage and incurable disease. As early as the
1930s, these oil additives were notorious for inducing illness. By the 195 Os, scientists
knew these illnesses were specically autoimmtme. Today that is their chief use in
researchinducing disease instead of preventing it. Scientists studying autoimmune
disease cannot wait around for its spontaneous appearance in a lab animal; they inject it
with Freund's Complete Adjuvant to reproduce autoimmtmity on demand. Oil adjuvants
made with squalene equally effective at this job, and regrettably according to Dutch
scientists, equally inhumane. , ,
Autoimmune diseases are chronic and progressively debilitating ailments; some, like
O O -2-
multiple sclerosis and lupus, can be fatal. They occur when the immune system loses its
ability to distinguish what is "self" om what is foreign. Under normal circumstances,
your immune system ignores the constituents of your own body; immunologists call this
"tolerance." But if tolerance is broken, the immune system turns relentlessly self-
destructive, attacking the body it is supposed to defend.
Adjuvants can break tolerance. In 1956, Dr. Jules Freund, the Hungarian born scientist
who gave his name to the adjuvant he created, warned that animals injected with Freunds
developed terrible conditions: allergic aspermatogenesis stoppage of sperm production!,
experimental allergic encephalomyelitis the animal version of multiple sclerosis! and
allergic neuritis inammation of nerves that can lead to paralysis!, allergic uveitis an
inammation in the eye that can cause blindness!. There was no reversing any of these
conditions.
Scientists are still unsure why oil adjuvants do this. One theory is that oils have the ability
to hyperactivate the immune system. "The cause is probably that when injecting these
molecules, you create a chaos in the immune system," says Dr. I ohnny C. Lorentzen, and
immunologist with the Karolinska Institute, which awards the annual Nobel Prize for
Medicine. He says these oils induce "an extremely powerful response," so powerful, in
fact, that the immune system goes haywire and starts attacking things it would otherwise
leave alone. Another possibility, which has not been explored very much, is that this
harmful phenomenon actually has something to do with one of the greatest distinguishing
characteristics of the irmnune systemits specicity. Over eons in time, this
extraordinarily elegant and powerful system has evolved to respond very precisely to
what it deems potentially harmful to the body. Our bodies contain all sorts of oily
molecules. It couldbe that when an oil is injected, the immune system actually responds
to it with a high degree of precision - just as it responds to everything else - but because
the adjuvant resembles too closely those oils found in the body, the immune system
begins attacking those too. In immunology this is called a "cross reaction." Neither
proposition - chaos or specicity - has been proven so far. But however oils do their
damage, it is well known that they do.
Army scientists have been as aware as anyone else of the harm that injecting oils can do.
The problem for military personnel is that these scientists learned this lesson by injecting
oils into troops in experiments that in some cases they did not agree to participate in. The
central question in this book is whether such an experiment has been done again with the
new anthrax vaccine and squalene.
Round One
Despite their dangers, oil adjuvants have come to exert an irresistible, ahnost magical
allure on researchers. If they could truly stimulate the immune system safely, oil additives
could help defend mankind from diseases like malaria and HIV. For germs such as these,
no one dared make a classic vaccine - the kind made from the germ itself - for fear of
accidentally infecting someone with an incurable, if not fatal infection. By splicing off
just little bit of such a germ not enough to make anyone sick - and combining that shard
with an adjuvant, scientists hoped to protect people from lethal microbes. If they could do
it for HIV, they reasoned, they could do it for any germ in creation. This siren song was
1 Q 0
~92' {i
so powerful iat it did more than induce researchers to indulge in cynical risk/benet
calculations; in some cases, it made them forget the risks altogether.
The rst time Army scientists succumbed to this allure was in 1951 at Fort Dix, New
Jersey in an experiment that involved 44,459 troops. More than 18,000 of them got
injected without their informed consent with a newly formulated oil additive for vaccines.
The Army thought it had something new and safe. The world's best additive that no one
dared inject into humans, Freund's Complete Adjuvant, was more than just mineral oil. It
also contained Mycobacterium tuberculosis, the germ that caused TB. The mycobacteria
were dead, but scientists thought they still might be in some way responsible for the
problems associated with this concoction. So they removed the mycobacteria in hopes
that the oil alone could do the trick; they called this new adjuvant "Freund's Incomplete
Adjuvant." The incomplete adjuvant was just mineral oil in water, and a detergent to keep
the oil evenly dispersed. Using it was a risky thing to do, but the Army considered the-
risks of not running this experiment even higher. This "incomplete" additive had been
incorporated into an experimental u vaccine. It was the u that really worried the Army.
By all accounts, the great Spanish Flu pandemic of 1918 wasn't really Spanish at all. It
was American. In fact, it was an Army flu. The rst victim, the "index patient," was an
Anny private named Albert Gitchell who worked as a cook at the Army's Camp Funston
on the vast Fort Riley military reservation in Kansas. It is believed that U.S. troops
heading to Europe brought this flu with them. Before it was over, more than 20 people
had died of inuenza around the world-the deadliest natural disaster in world history.
Army scientists wanted to prevent another global killer om emerging from an Army post
where new recruits might become an unintended hatchery for some vicious new u strain
that once again could wipe out millions of people. Trying out a new oil additive on troops
seemed like a relatively modest risk in comparison to the benets of a better u vaccine.
The Fort Dix experiment took place with the blessing of Fort Detrick. It was ftmded by
the U.S. Army Medical Research and Development Command USAMRDC!, which
would later oversee the development of the new anthrax vaccine and newer oil additives .
too. The Armed Forces Epidemiological Board AF EB!, which would be sponsor a large
number of the experiments conducted on military personnel, would later recommend the
injecting an experimental u vaccine containing oil into every man and woman in the
U.S. military without their informed consent. The risk of an outbreak of killer u seemed
too great to do otherwise. To run this experiment, the Army would contract none other
than Jonas Salk. Salk had already tested Freund's Incomplete Adjuvant on medical
students at the University of Pittsburgh under the sponsorship of the Armed Forces
Epidemiological Board, and with funding from the Army Surgeon General. Based on this
study, Salk thought it was safe.
Over the next two decades, the entire U.S. public health establishment - civilian and
military - kept watch on what happened to the troops from Fort Dix. Everyone wanted in
on the act. USAMRDC fimded this study and its follow-ups. The National Academy of
Sciences, the Walter Reed Army Institute of Research WRAIR! and the Walter Reed
Army Medical Center WRAMC! did the initial round of surveys. Then the list started to
grow. The National Academy of Sciences and the National Research Cotmcil organized
more studies at the request of the Veteran's Administration, the Army and the U.S. Public-3-
L___i__i
Health Service "in collaboration with the Armed Forces Epidemiological Board." At the
17-year mark, academia got involved too. An AF EB scientist on the faculty of the
University of Michigan School of Public Health organized yet another follow-up. No one,
it seemed, wanted to be leit out of such an important experiment.
And the experiment that seemingly had no end. Twenty-one years after Salk rst injected
unsuspecting soldiers with atheoretically new and improved u vaccine, the Fort Dix
troops were under the microscope yet again. The list of sponsors included many of .
America's most respected public health institutions: the National Academy of Sciences-
National Research Council, the American Cancer Society, the Veterans Administration,
the Department of Defense, the U.S. Public Health Service and the Commission on
Inuenza of the Armed forces Epidemiological Board. USAMRDC bankrolled this study,
just as it did the rst one. What was remarkable about this 21-year project involving the
military, civilian public health authorities and a major university - is that at no time
during its execution did any of the scientists involved publicly discuss whether it was
ethical to run a medical experiment on people without telling them. If these doctors had
any concerns, they did not publish them.
Long before the last study was completed, AF EB proposed the adoption of an
experimental u vaccine with oil for everyone in the military. In 1963 and 1964, AFEB
recommended injecting every man and woman in the armed forces with the new vaccine.
The board also recommended that Department of Defense also commence studies with oil
added to tetanus and diphtheria toxoids, and polio vaccines. , Army doctors seemed
determined to add oil to every vaccine they could.
Here is what they were not telling anybody. By 1964, the year when everyone in the
military was supposed to get immunized with an oil-boosted inuenza vaccine, the Army
already knew the risks this vaccine presented for a very specic type of ilhiess. AF EB's
Colonel Abram S. Benenson had drawn up a list of diseases that investigators should
watch out for in veterans injected with the oily u vaccine at Fort Dix. Benenson's list
read like the contents of a chapter on autoimmune disease in an immunology textbook. It
included multiple sclerosis, myelitis, Guillain-Barré syndrome, uveitis, neurodermatitis
circumscripta and disseminata, arnyloidosis, lupus erythematosus, dematomyositis,
scleroderma, chronic pericarditis, Raynaud's disease, rhetunatoid arthritis, rheumatoid
myositis and acute glomerulonephritisall of them autoimmune diseases.
The fmal study on the Fort Dix troopers had data that none of the previous ones had:
autopsy results. The soldiers had grown older and many of "them had died.
Epidemiologists, mainly working for the National Research Council and the American
Cancer Society, reported a "signicant excess of deaths" in soldiers given the oil-boosted
vaccine, which the investigators related to "ill-dened vascular lesions of the central
nervous system." They attributed this fact to the greater number of autopsies available for
the soldiers given the oil-boosted vaccine. But there were hints of a problem with
autoimmunity. Terr percent of the soldiers studied, who were injected with the oil-boosted
vaccine, developed a "collagen disease," which is a term doctors used to use
interchangeably with autoimmune disease. Still, the number of patients in this study was
too low to extrapolate any reliable conclusions om the data. That did not prevent
government and military doctors from doing just that. They concluded that the oily u-4-
1
vaccine was safe. Nevertheless, what the government then did not do was telling. The
FDA never licensed the vaccine, or the oil adjuvant, for human use.
The Fort Dix experiment was the rst time Army doctors and scientists injected an oil-
boosted vaccine into U.S. troops without informed consent; there is now clinical evidence
that it was far from the last. For more than a half century, factions in military medicine
and in the U.S. public health establishment have actively campaigned to get an oily
vaccine additive licensed, seemingly at any cost.
The Emperor's New Clothes
When scientists at Fort Detrick, following Joe Jemski's 1992 talk, reviewed the existing
literature on the Wright vaccine, it didn't look good. Even with 6 shots, the vaccine did
not protect very well. Guinea pigs vaccinated with the licensed human vaccine died when
exposed to certain strains of anthrax. In 1986 the bad news got worse. In discovering that
the licensed vaccine protected against the Army's old weapons strain, Vollum - from
which the vaccine had been derived - Stephen Little and Gregory Knudson also
discovered 8 moreanthrax strains for which the PA vaccine did not work. Among them
was the now notorious Ames strain that was mailed in 2001 anthrax letter attacks. Like
the Army's previous research, the data conrmed that a live spore vaccine provided better
protection against more strains. "The fact that the spore vaccine provided protection
against all isolates tested suggests that other antigens may play a role in active
immunity," they concluded. Which would argue for a live anthrax vaccine, but Fort
Detrick's scientists expressed an age old concern about problem with living vaccines that
could be traced all the way back to Pasteur: "Since this vaccine is a live immunogen,"
they warned, "safety factors must be considered before its use." Little and Knudson did
not rule out the possibility of resorting to alive spore vaccine, but that is not what they
then chose to pursue.
When they, along with Fort Detrick scientists Bruce Ivins and Sue Welkos, began
working on a new anthrax vaccine, they chose a design that was all the rage at the
NIHsubunit plus adjuvant. "Subunit" refers to small fragments of a germ. For safety,
NIH scientists were using subunits of lethal viruses like HIV to be the chief component of
their new generation of genetically engineered vaccines. These ultra-pure vaccines, which
reduced an immunization to mere molecules om a microbe, were safe, but at a price.
They were weak. In some cases, they afforded no detectable level of protection at all. This
is why the NIH wanted an adjuvant more robust than alum for its new vaccines.
The subunit that Little, Knudson, Ivins and Welkos chose for the Army's new anthrax
vaccine was a little surprising. It was protective antigen-the same main ingredient in the
vaccine they were trying to replace. Although all the data from both U.S. and British
military experiments from the 60's forward indicated that more components of the anthrax
microbe needed to be in any effective anthrax vaccinea fact that even Little and
Knudson acknowledge in their 1986 paper-Fort Detriclds newest generation of anthrax
investigators did just the opposite. In fact, they did one better. With recombinant DNA
technology, their new vaccine would eliminate every extra molecule of anthrax unrelated
to protective antigen. It would be purest PA formulation ever made, and would hence be
the weakest anthrax vaccine ever made. Remember, in immunology, purity equals-5-
' 6
ii ' U,
weakness.
Yet when Fort Detn'ck's scientists traveled to England in 1989 to report on their new
vaccine to the International Workshop on Anthrax, they had some startling results to
announce: Fort Detrick had found what everyone had been looking for: a single-shot
anthrax vaccine. In guinea pigs, the new anthrax vaccine produced complete protection
against the Ames strain with just one dose.
l
Ifthis was completely at odds with everything Army scientists had found over the
previous three decades, it was because the Fort Detrick team had added something new to
the formula. It was a kind of trick, though not in the sense of something fraudulent or
deceptive. The Army's scientists made no effort to conceal what they did. Quite the
contrary, they reported this trick in great detail. It was an old trick. In the 80s, scientists at
NIH had been promoting the use of oils in vaccines again. By now, there was a new crop
of oily vaccine boosters hot off the lab bench. It was the oil emulsions that helped
transform the Army's hapless protective antigen formula into a potent single-shot vaccine.
Dr. Bruce Ivins informed the workshop gathering in old cathedral city of Winchester that
he had added three different adjuvants to his one-shot Wonders. One was called "Tri-
Mix," another "DeTox," and a third was "SAF-l," which stood for Syntex Adjuvant
Formula I. They were all made with bacterial scraps from truly noxious microbes like
Salmonella typhimurium and Mycobacteria tuberculosis. The British scientists om
Porton Down tried a different tackadding a preparation to the British anthrax vaccine
made om the whooping cough germ, Bordetella pertussis. At Winchester, the Porton
contingent called their approach "microbial supplementation." All of these adjuvants
relied on bacteria, or portions of them, to stimulate the immune system.
The three additives used by Fort Detrick, however, differed from Porton Down's in one
very signicant way. The Fort Detrick additives were all emulsied in oil. The oils were
only supposed to be "vehicles" that conveyed the bits of bacteria through the bloodstream.
SAF-I, which provided less protection than the other two, contained the oil squalane. The
two adjuvants that helped provide complete protection from Ames in guinea pigs, Tri-
Mix and DeTox, were emulsied in squalene. At the time, no one at Fort Detrick or the
NIH seems to have been aware that these oils were themselves immunostimulants.
Having invested decades into rening protective antigen to a singular purity, Ivins et al.
were essentially polluting this new ultra-pure vaccine with extraneous antigens to make it
work. That is what an adjuvant wasextra antigenic material for a vaccine that hadbeen
puried to such an extent that it could no longer do the job it was designed to do. Perhaps
it was the importance of their apparent breakthrough that blinded these scientists to what
they had done. Whatever it was, it prevented them from seeing the absurdity of their new
creation, or its risks. A fully intact microbe presents dozens of different chemical binding
sites an antibody can latch onto. Each of these sites is a separate target for a multi-ont
attack by the immune system. In pursuit of purity, Army scientists had removed all of the
targets of anthrax germ but one. Now they had a dubious product that they were
determined to improve, and they did it by adding targets from germs other than B.
anthrdcis. Instead of adding more antigenic material from the anthrax microbe - as _
Lincoln had suggested in the 60s and as Turnbull and Melling had done in the 8Osthe
Fort Detrick team incorporated pieces of completely different germs.
This was Rube Goldberg immunology. The Anny's vaccine whiz kids had devised the
most convoluted, expensive and time-consuming way conceivable to make a virtually
identical productprotective antigen-and then added material that essentially diverted-7-
the immune system's attention away to antigens unrelated to anthrax. Fort Detrick's new,
souped-up single protein vaccine, like the old one, did nothing to induce an immune
response to the organism itself, which could still feed, secrete toxins and multiply inside a
vaccinated host. There was also one more aw in this design: oils are potentially toxic,
and the Fort Detrick team knew it. In Bruce Ivins frequently cited paper on the Army's
pursuit of an improved human anthrax vaccine, he noted that oil adjuvants "can provoke
toxic, allergic, ulcerative, or lethal reactions." This should have prevented him from
committing Fort Detrick to an oil-boosted anthrax vaccine in the rst place, but for
reasons that Ivins has never publicly disclosed, it did not deter him. Neither he nor
anyone else who worked on this vaccine at Fort Detrick has published an explanation for
why they did this.
Round Two
Anyone even remotely familiar with oil additives for vaccines could have told you that
they were a big problem. For reasons science has yet to fully explain, oils and other fatty
substances found in the body, like cholesterol and phosopholipids, are potent stimulants
to the immune system. Try as they might, scientists trying to harness this property have
yet to come up with an oil adjuvant safe enough to use in humans. Since the 1930's, the
gold standard has been the aforementioned Freund's Complete Adjuvantan elixir
banned from human use because of its toxicity. When Freund's Incomplete Adjuvant, a
vaccine additive made chiefly from mineral oil, proved too risky as well, scientists tried
changing the oil.
In the early 1970s, scientists at UCLA Medical Center, including one of the most
respected rhemnatologists in the country at the time, Carl M. Pearson, started looking for
a less toxic alternative to Freund's. They ran a series of experiments with a variety of
edible oils on the assumption that because they were "metabolizable" the body could
process them safely. In other words, if you could ingest them, you could inject them.
Intuitively, this premise seems somewhat dubious: your body could metabolize a
cheeseburger, for instance, but you couldn't liquefy it in a blender and inject the resulting
slurry, and then expect to feel well in the morning. Pearson's associates, Michael
Whitehouse and Frances W. Beck, injected more than dozen of these metabolizable oils
into rats, including castor oil, coconut oil, olive oil, sesame seed oil, cottonseed oil, com
oil, wheat germ oil, safflower oil, cod liver oil, oleomargarine, and the commercial
lubricating oil, silicone. When these were mixed with heat-killed Mycobacteria
tuberculosis, the UCLA group got results it didn't expect. All of the oils were toxic; they
all induced arthritis in rats with varying degrees of severity. The data changed
Whitehouse's views on the safety of metabolizable oils. "To srmnnarize very simply, I
think most oils are dangerous," he now says. Based on their ability to cause arthritis, the
researchers assigned the oils "arthritis scores," ranging from +!, which was moderately
toxic, to +Ht~!, which was guaranteed to cripple. Of all the metabolizable oils tested by
Pearson's group, two were better than all the others at causing arthritis: squalene and
squalane, the same emulsifying oils that Bruce Ivins used in his single shot anthrax
vaccines.
Squalene and squalane scored +H-! and -Hll-! respectively. Between these two oils,
squalene is the one you could denitely eat. Olive oil contains squalene; in theory, you-8-
could drizzle it onto a salad along with a little vinegar and have no worries. Your body
would metabolize it along with the arugula and endive without as much as a hiccup.
Injecting squalene, though, was another story. To make sure it was the oils that did the
damage, Beck, Whitehouse and Pearson tried injecting rats with squalene and squalane
without mycobacteria in the formula. Rats injected with either squalene or squalane all
developed experimental allergic encephalomyelitisthe same MS-like disease caused by
Freund's. The injected animals were left hobbled, dragging their paralyzed hindquarters
through the wood chips in their cages. , The UCLA team had found what it was looking
for: oils that induced autoimmune disease, but with less inammation. Between the two
of them, squalene was less desirable for UCLA's purposes. "Squalene was more
arthritogenic," Beck recalls, "but it also produced a greater inammation."
Risk v. Benet
Given these oils proven ability to induce autoimmune disease, the Army's decision to put
either of them in its second generation anthrax vaccine only makes sense when you put it
in the context of the times, and in this case, a specic location. When he cancelled
America's offensive biological warfare program, President Nixon also freed up some
building for a more popular research effort. Arriving by helicopter at Fort Detrick's Blue
and Grey Field in October 1971, President Nixon personally announced the creation of
the Frederick Cancer Research Facility of the National Cancer Institute N CI!. Nixon had
Fort Detrick allocate about 68 acres and 70 of its buildings as a new research campus for
NCI. It was a fateful decision that would have consequences that even a president as
forward-thinking as Nixon could not have foreseen. It would set in motion a series of
decisions that would lead, almost inevitably, to the use of a substance that would
endanger the health of hundreds of thousands of U.S. troops.
It is unclear how squalene first came to the attention of Army scientists at Fort Detrick,
but one possibility is through the National Cancer Institute, now on its doorstep. Eliyahu
Yarkoni and Herbert Rapp of NCI published a paper in 1979 that stirred national and
intemational interest in the alleged therapeutic benets of squalene and squalane. When
combined with fragments of a particular bacteritun, squalene and squalane had an
astonishing effect. Yarkoni and Rapp reported complete tumor regression in mice injected
with squalane, and nearly complete regression 92%! in mice injected with squalene.
When they injected these oils directly into mouse tumors, the tumors either shrank or
disappeared completely. The more oil in the mixture, the better it worked. Based on these
early experiments, oils looked like they might hold the keys to the kingdoma cure for
cancer. There was, however, a hitch.
Yarkoni and Rapp knew about the UCLA data; citing the Beck and Whitehouse paper,
Yarkoni and Rapp reported that squalene and squalane both caused autoimmune disease
in rats-a fact that you will not nd mentioned in any Army paper concerning Fort
Detrick's Work with squalene emulsions in the new anthrax vaccine. Even Yarkoni and
Rapp barely mentioned the problem with squalene and squalane; it was limited to a single
sentence at the end of their short paper. Although causing debilitating and ultimately fatal
neurological damage in animals was a big downside, their concem, aer all, was cancer.
Several more factors emerged in the 1980s that would affect the direction of the Army's-9-
l<"92l
anthrax vaccine research. The rst was HIV. After the discovery of the human
immunodeciency virus in 1984, the cause of Acquired Immune Deciency Syndrome
AIDS!, the National Institutes of Health would devote billions to develop a vaccine. That
year, the Centers for Disease Control reported 7,699 AIDS cases with 3,665 dead. By
1988, the number of diagnosed U.S. cases was 82,764 with 46,344 dead. That was a jump
of more than 1000% in just 4 years. Mortality was 100%; for someone with AIDS, drugs
could prolong life but not save it. Public health ofcials doing the math were horried.
No one dared make a whole virus vaccine, living or dead, from a germ like HIV. Vaccine
researchers embraced gene-splicing as their only altemative-inserting HIV genes into
non-lethal organisms like vaccinia. But the results were disappointing: these microbial
hybrids barely elicited an immune response. That's why a new adjuvant was essential to
NIH. Because of Yarkoni and Rapp's work, squalene and squalane emulsions had by then
established themselves as NIH's adjuvants of choice.
HIV was threatening to become the great plague of the 20th century, worse even than the
u pandemic of 1918 that claimed more than 20 million lives. It was the public health
cause célebre of the 1980s. Rock Hudson had it; so did Liberace. When an Indiana school
banned 14 year-old Ryan White from classes because he had HIV, Elton John and
Michael Jackson became his iends and offered their support. Vice-President George
Bush called for mandatory HIV testing. No other disease made as many headlines or
pushed as many political buttons. For NIH, that translated into wide open govermnent
coffers. For researchers, it offered a shot at immortality. Any scientist who found a way to
stop this new global scourge could reserve a seat in Stockholm for a Nobel Prize
ceremony. A successful recombinant HIV vaccine would be just a start. The goal was to
roll back all infectious diseases through immunization . if that were possible. But it wasn't
going to happen without a more powerful vaccine booster. The FDA, stung by criticism
from dying AIDS patients who wanted access to new drugs that could keep them alive
even a few months longer, started to "fast-track" drugs through its licensing labyrinth,
including experimental vaccines containing squalene. This was not without risks. The
problem with the fast track was knowing when someone was playing it fast and loose.
Even NATO got on this bandwagon by sponsoring a conference in Cape Sotmion,
Greece, on vaccine adjuvants in the summer of 1988. The search for a new adjuvant was
now a matter of national security. The U.S. Army sent a contingent from its Walter Reed
Anny Institute of Research led by Dr. Carl R. Alving, a proponent of vaccine boosters
emulsied in squalene, in addition to his own favorite: liposomes. Liposomes are
microscopic vesicles containing vaccine antigens. Think bath oil beads. Encapsulating
bath oil in soluble beads makes it possible to transport measured doses of oil om the
drug store where you bought them to Where you ultimately want to put themin your
bathtub. Alving's liposomes were made from cholesterol, another oily substance closely
related to squalene.
The Soviets Again
If anyone in the military had been inclined to ask questions about squalene's toxicity in
the late 1980's, something else happened around that then that might have diverted them.
In October 1989, a high-ranking Soviet biological weapons scientist defected to the
Westthe rst one to do so. This was an extraordinary intelligence coup. At the92-10-
invitation of a French pharmaceutical equipment maker, Dr. Vladimir Pasechnik of the
Leningrad Institute of Ultra-Pure Biopreparations went to Paris for a conference and
never went home. He left his family behind in Russia and wound up in Britain. One of the
scientists who debriefed Pasechnik for the British was Jack Melling. "Pasechnik chose
Britain," says Melling, "because he thought the U.S. still had an active biological warfare
program and he didn't want anything more to do with making weapons. He didn't think
the same of Britain." According to Melling, what Pasechnik told Britain's MI-6 raised
even more alarm about the U.S. and British chemical anthrax vaccines. Pasechnik said
that Moscow had created antibiotic-resistant super-strains of anthrax, plague and
tularemia. Although Pasechnik's British handlers couldn't verify this, it sounded plausible
enough to them; in part because making germs antibiotic-resistant was relatively easy to
do, and in part because the Soviets had published several papers in the 1980's disclosing
that they had developed a veterinary vaccine that immtmized against all three of these
microbes. Intelligence analysts had been asking themselves why Soviet livestock would
need to be vaccinated against plague, tularemia and anthrax-the three agents regarded by
bioweapons specialists as the most likely 'ones to be used in a biological warfare attack.
They could not come up with a good answer.
Back in Maryland, Fort Detrick now had at least four viable prototypes of a single shot
vaccine that they thought was safe. All were made from the protective antigen protein or
pieces of it. Three others were recombinant vaccines; Fort Detrick had cloned the
protective antigen gene into Bacillus subtilis, baculovirus and vaccinia. All of these
prototypes were formulated with squalene or squalane. The ones showing the most
promise were the protective antigen vaccines combined with these oils. According to
Ivins and his Fort Detrick colleagues, just one dose of these new vaccines gave protection
equivalent to three doses of the licensed U.S. vaccine . and the new vaccines were ready
for clinical trials. All Fort Detrick needed now was the right time and place to test them.-11-
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THE PENTAGON'S TOXIC SiRET-Vanity Fair Article a Page 1 of 10
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Thousands of American veterans suffer 'om debilitating GulfWar-related illnesses. But the origins have remained a
mystery.
A crusading molecular biologist and internal military documents now suggest a shocking scenario: the Pentagon's possible
use on its own soldiers of an illicit and secret anthrax vaccine.
Veterinarian Dr. Herbert Smith negotiates the nine paces across his porch to the driveway of his house as though he were on
a high wire, adjusting each deliberate step, shifting his weight from a walking cane in his left hand to another in his right.
Smith lives in Ijamsville, Maryland. a subdivision no-man's-land of two- acre lots and empty vistas where the surbs of
Washington, D.C., comingle with those of Baltimore.
He wears black leather wrist pads Velcro'd from palm to forearm and a pair of ragged government issue elbow pads to protect
himself from the falls he frequently experiences- "l'm subject to what's called nenrapraxia damage to the nerves," explains
Smith. "Like with diabetics, who then wind up with amputations. I'm trying to avoid that."
On reaching the driveway, he straightens up to shake my hand. You can still see the outlines of the elite athlete he once was.
Dr. Smith, 59 years old, is also Colonel Smith, Green Beret. His subordinates nicknamed him "Super Trooper." in deference
to his gung-ho attitude and his once Olympian physique. When he entered airbome school at Fort Benning in April 1966 he
set out to be No. 1 in a class of 687 by baiting his drill instructors to drive him harder than the others. "So, they targeted me. I
must've done a thousand push-ups a day.
<
But I knew it was all a game. I never got mad, never lost my cool- There were a couple of navy SEALs there. They were
pretty tough guys. But they weren't as tough as me." Until I991, Smith ran PT physical training! programs; the ones back in
the 80s were notoriously grueling, earning him a nickname: "Dr. Death."
He smiles at this but is unapologetic. "I wore em into the ground. In a fun way, not in a brutal way."
Today, a thick purple weltjuts from Smith's forehead an angry bulge 'om hairline to brow. Even on perfectly at ground, he
falls a lot.
The symptoms rst appeared in January 1991, the same month, Smith says, that he got his rst shot of something that does
not appear on his immunization card or in his recordsa mysterious vaccine, described to him only as "Vac A." He was then
in Saudi Arabia training Kuwaiti medical personnel in disaster relief. Sometimes the pain was so bad in his right hand he
couldn't hold a fork at meals. The next time it would be his left hand, never both hands at the same time.
By May his joints ached and his lymph nodes were swollen, and he had a fever and a red rash on his chest and legs. He was
constantly fatigued. It hurt to walk. It hurt to brush his teeth. Aer the invasion he wanted to stay on to help the Kuwaitis
rebuild, but the symptoms were getting worse, and he had no idea what was wrong. He knew he needed treatment back in the
States.
Just before he got on a transport heading home, one of his medical ofcers, who had seen similar symptoms in other soldiers,
came up to him and said, "When you get home, check out the vaccines. I think you've got a problem with them." Smith had
received vaccinations for hepatitis and tetanus, and a second shot of Vac A, which was entered into his records on February
14, 1991. - '
Back at Fort Meade, Smith was given a desk job while the military doctors investigated his condition without success. In
October I991 he le active duty, but continued to see physicians at the Waiter Reed Army Medical Center in Washington,
D.C. He didn't regard the problem as serious until the seizures started. Not grand mal, fall-on-the-oor, foam-at-the-mouth
seizures, but complex partial ones, in which he appeared to be mctioning nonnally but was actually on autopilot, without
awareness of what he was doing.
http://www.idir.net/~krogers/vantyfainhtml 1 1/8/2005i _.~" e L. 5
. THE PENTAGONS TOXIC S%ET-Vanity Fair Article . Page 2 of 10
. L Q
"I skipped periods of time," he explains. "I was in a car driving towards Baltimore on I-70, and the next thing I know, I'm
outside of Washington, D.C., on I-95, and I've got no clue how I got there."
One night, his worst, Smith became completely disoriented- "I had blacked out for an hour, hour and a half. I had to call my
wife on the phone to nd my way home. I was probably 25 miles away. Iwas an emotional mess because by then I had to
admit to myself that something was wrong with me."
By this time Smith was seeing Dr. Michael Roy, an intemist at Waiter Reed. Roy diagnosed Smith's condition as"somatization disorder," a psychosomatic illness in which a patient becomes so obsessed with an imaginary disease that he
begins to exhibit its symptoms.
Smith was not the only Gulf War veteran experiencing mysterious symptoms. In late 1991 and early 1992, some from a
reserve unit at Indiana's Fort Benjamin Harrison reported sick with a constellation of symptoms that have since been
associated with GulfWar syndrome: joint pain, headaches, fatigue, memory loss, and rashes.
Reservists in Georgia and Alabama made similar complaints. Military doctors mostly dismissed the symptoms aspsychosomatic or stress-related. As the number of people alfected began to grow, several government studies werecommissioned, including those of the Presidential Advisory Committee on Gulf War Veterans Illnesses, the Institute of
Medicine, and the Senate Committee on Veterans Affairs. By 1996 all of them had concluded that there was no single
disease that could account for all the dierent symptoms associated with Gulf War syndrome. The Department of Defense
has examined at least 20 possible health hazards, including pyridostigmine bromide PB.! pills taken by the Gulf War troops
to help protect against chemical warfare, the insect repellent DEET and various pesticides used by the soldiers, and Kuwaiti
oil-re smoke. A frequently repeated theory, still unproven, blames the syndrome on low-dose exposures to chemical-
weapons fallout. ,
About 40,000 veterans have registered with the Department of Defense's Comprehensive Clinical Evaluation Program C.C.E.P.! for Gulf War illnesses; another 70,000 or so are tallied by the VA. A C.C.E.P- spokesperson says the numbers donot overlap; i.e., the total number of 110,000 to 115,000 is accurate. Of these, 18,000 are undiagnosed, and are merely being
treated for their symptoms. To date, the federal govemment has sponsored 140 or so related research programs, exploringeverything om microwaves to biological weapons, which have been funded at a cost to the taxpayer of more than $130
million.
Colonel Smith is one of the highest-ranking ofcers on full disability for Gulf War syndrome. He believes he might have
never known the nature of his illness had it not been for the efforts of Dr. Pamela Asa, a Ph.D. molecular biologist who for
the past ve years has waged a one-woman battle with the Pentagon over the diagnosis of Gulf War syndrome and its cause.
She has conducted her own research without a penny from the government or any other benefactor. Because of Asa's work,
Colonel Smith has become more than a poster boy for a publichealth disaster. Asa believes that in Smith's blood there is
evidence that may hold the answer to why so many veterans of the Gulf War are sick.
Vanity Fair has uncovered military documents that show the Department of Defense made plans to rim a clandestine trial ofexperimental vaccines and medical products during Desert Shield and Desert Storm. Military physicians called this effort"the Manhattan Project." While many of these vaccines were never used, Vanity Fair has found evidence suggesting that the
Pentagon may have developed amodified version of its ED.A.-licensed anthrax vaccine during an operation called "ProjectBadger." IfPam Asa is right, an experimental substance that causes incurable diseases ill lab animals was mixed into an
imknown number of doses-in essence creating a new, untested anthrax vaccine. The actual administration of such a vaccine
would have violated the 10-point Nuremberg Code, which in 1947 established the conditions for experiments on human
beings - the cardinal point being informed consent. Speaking for the Pentagon, Dr. Ronald R. Blanck, a three-star general in
the army's medical command, denies that any of this took place.
"Absolutely not, he says. "I will tell you Bat out it wasn't done."
There are echoes of the antebellum South in Pam Ass's accent, in the way she can stretch three syllables out of a word like
"hey." Her speech is a genteel drawl, evoking images of hoopskirts, silk fans, and magnolia blossoms. Asa, 46 years old and
the mother of four, lives in Memphis, Tennessee. "American by birth, southern by the grace of God," she likes to say,especially in the presence of Yankees. During the Civil War, Union cavalrymen arrested her great-great-grandfather the
Reverend John Murray Robertson for rersing to pray for Abraham Lincoln, and then turned his church, Huntsville,Alabama's Episcopal Church of the Nativity, into a horse stable. But though Asa is fond of making jokes about "the War of
Northern Aggression," she is no regional chauvinist. Members of her family have fought in just about every Americanconict, from the Revolutionary War up through Vietnam. Francis Scott Key, who wrote the words to the national anthem, is
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one of her ancestors. Her father retired from the Marine Corps as a captain in the early 1960s, then worked as a quality-control director for NASA!s Redstone Arsenal in Huntsville. Asa's reverence for the military borders on idolatry. "My fathertaught me ever since I can remember to have respect for anyone who serves in the military, because they protect us. They're
willing to take bullets for us."
It was patriotism that motivated Asa to approach the Pentagon in 1994 about vaccines administered to the troops for
Operation Desert Storm. By then, the symptoms related to Gulf War syndrome had been widely publicized. They were vague
enough to point to anything from a stroke to allergies to mere tension. "But when these particular symptoms are takentogether," Asa says, "they point to autoimmune rlisease" when a person's immune system goes haywire and attacks his or
her own body.
Mostly, doctors don't know what causes autoimmune disease. Many victims develop it om unknown causes. Since 1984,
Asa had been working with her husband, Kevin an M.D. certied in both intemal medicine and rheumatology to treat a group
of women with such autoimmune diseases as rheumatoid arthritis and lupus.
Aer a series of landmark legal cases in the early 1990s which alleged a relationship between silicone breast implants andautoimmune disease the lawsuits put the main manufacturer, Dow Coming, into bankruptcy!, a large number of the Asas'patients revealed that they had received breast implants. Pam Asa became convinced that silicone had induced diseases such
as scleroderma and lupus inher patients-a conclusion that embroiled her in one of the most contentious public-health disputes
of the 90s. It is a view that has propelled her into what promises to be an even more bellicose scrap.
Asa suspected that the autoimmune illnesses showing up in Gulf War troops were also induced by a toxic substance.
For one thing, the gender breakdown of the victims was suspicious. Women develop autoimmune diseases far more oftenthan men do. With lupus the ratio of female to male suerers can be as great as 14 to 1- But among Gulf War veterans the
victims were overwhelmingly male an anomaly only partially explained by the Fact that women made up a mere 6.8 percent
of the U.S. force serving there!.
Another startling fact pointed to the vaccination program. Many of Asa's Gulf War-syndrome patients had never deployed to
the Persian Gulf. They had never been exposed to petroleum res, chemical-weapons fallout, pesticides, or the other
suspected causes of Gulf War syndrome.
But, she says, they did have one thing in common with the troops who were in theater: they had rolled up their sleeves and
gotten their shots.
For Asa, all of this pointed to an adjuvant. Adjuvants are toxic substances which make vaccines more eective by stimulatingan even stronger response om the immune system than a virus or bacterium might on its own. In the course of investigating
the possible connection between her earlier patients breast implants and their illnesses, Asa says she came across acondential Dow Coming document showing that the company had conducted research with silicone as a vaccine adjuvant in
1974. The term "adjuvant" comes from the Latin word adjuvare, "to aid." Hut the quest for a safe, etfective adjuvant has been
like the medieval chemists quest to turn lead into gold. Adjuvants work because they are toxic, generally too toxic. Eightyyears of research has produced a grand total of one that is considered safe for human use: a salt called ahmiinum hydroxide,
also known as almn.
Other adjuvants have been rejected as too dangerous; in tests on animals, adjuvants have been used over and over again to
induce autoimmtme disease.
At rst, Asa suspected sabotage. "If the vaccine manufacturers were overseas, their loyalties could lie elsewhere or be bought
for ue right price." If an enemy wanted to undermine our ghting forces undetected, she says, this would be one way to do it.
"I can't think of a more eective and insidious way to reduce the effectiveness of a military force going into combat. This
disease process aects people's minds. Patients suffer mood swings, blackouts, and cognitive disorders where a person losesthe ability to read or understand language or remember directions. This is not what you want to see happening to people who
handle guns, bullets, and bombs." Asa contends this "process" can develop into Full-blown, debilitating, and sometimes fatal
autoimmrme diseases such as lupus, rheumatoid arthritis, and multiple sclerosis.
In Itme 1994, Asa phoned Colonel John Dertzbaugh of the Pentagon's Defense Science Board with her theory. Dertzbaugh.
said it made a lot of sense, and promised to check it out. But the Science Board had just completed a report concluding thatthere was "no persuasive evidence" of Gulf War syndrome and no single cause of illness related to service in the Persian
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Gulf.
The report had gone to press, and no one wanted to reopen the investigation. Still, Dertzbaugh couldn't shake the feeling thatit was important to give Asa's theory a closer look. In December 1994, he asked her to write a report and submit it to the
Office of the Army Surgeon General. Dertzbaugh even made apersonal pitch; he told the oioe that Asa's theory appeared to
explain the patients problems, as he understood them.
Asa says she asked the once for vaccine samples to test free of charge-to no avail.
Herb Smith didn't call Pam Asa. She called him. In March 1995, 60 Minutes ran a segment on Gulf War syndrome that made
a case for chemical weapons as its cause. Promoting this view was one of the veterans whom newsman Ed Bradley
interviewed, Colonel Herbert Smith. "We were getting hammered with a lot of information about us getting affected by
chemicals. I was getting sick enough where I couldn't argue with anyone. As you noticed," Smith recalls now, "they were
talking about chemicals. [Former] senator Don Riegle [Democrat, Michigan], his team, and Jay Rockefeller [Democrat, West
Virginia] and his team they all said it was chemicals." _
Watching the program, Asa noticed that Smith's knucklejoints had a particular swelling that she had seen before. She was
convinced he had an autoimmune disease.
Asa decided to track down Colonel Smith. "60 Minutes called me and said, We got people calling and they wanna talk to
you,"' says Smith. "And I said, Fine, you know, doesn't bother me, let em call. I was getting people calling me up and
saying,'You've got Lyme disease; you've got chronic fatigue syndrome; you need to take vitamin C. They were trying tohelp, but they were nuts. When Pam called, I thought, Well, here's another one gonna tell me, you know, what I've got and
how to x it. And then she starts talking and it just makes sense to me." About one month later, Smith says, he ew to
Memphis to be treated by the Asas.
After examining Smith, Dr. Kevin Asa agreed with his wife that the diagnosis was systemic lupus erythematosus S.L.E.!.Physicians back at Waiter Reed balked. Smith recalls them protesting, "You can't have lupus! You're a white male in your
50s. People like you don't get autoimmune diseases!" They refused to run their own tests. Smith was not surprised at this
response from the people who had been telling him that his problems were all psychological. "I had a doctor there, a guy
named Michael Roy [major, U.S. Army]. ,
He accused me of bleeding myselfto fake my anemia," says Smith. "I have a degree in chemistry as well as being a doctor of
veterinary medicine. Anyway, he says I'm a pretty smart guy, so I must know how to screw up my lab results." Dr. Roy
could not be reached for comment.!
Smith wouldn't let this insult go. "I wrote a letter to the commanding general, and I told him I had an ofcer, a major, accuse
a superior ofcer, me, of conduct unbecoming an olcer, and perjury. They gave me this new doctor, and he comes in
saying,'Well, you know, Dr. Roy says you got all these psychological problems. And I said,'What about all the V.A. ndings
[which supported the conclusion that Smith was physically ill]?"The V.A..7
They're wrong. They don't know what they're doing. So I asked, If you won't beh'eve the V.A., who will you believe?
And this new doctor says,'We'll believe either N.I.I-I. [National Institutes of Health] or Johns Hopkins."
Smith sent his lab results to the N.I.I-I.'s Dr. John Klippel, who had co-edited a standard medical -school text in this eld
called Rheumatology. "He reviewed the case," says Smith, "and he said the Asas' diagnosis was correct, but he couldn't see
me, because he wasn't accepting new patients." Dr. Klippel could not be reached for comment.! Smith then sent his records
to another leading rheumatologist, Dr. Michelle Petri of Johns Hopkins University Medical School. "She called me up and
said the Asas' diagnosis was correct, but she's going to have to 1'l1Il her own tests to conrm this- I gave more blood. Did a
brain scan. And the results were pretty much the same."
When the Asas treated Smith for lupus, his pain subsided. He could get out of his wheelchair and walk again, provided he
used canes.
Word about Asa had spread on the Intemet's Gulf War-veteran grapevine, and others started to get in touch_with her. One was
Dr. Charles Jackson, a general practitioner who used to work at the V.A. hospital in Tuskegee, Alabama. Jackson told her he
had hundreds of Gulf War-syndrome patients; he didn't know what it was or how to treat it. Asa asked him to run standard
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diagnostic tests for autoimmrmity. Jackson says the lab values suggested that a full quarter of his Gulf War patients had
autoimmune problems.
But if Gulf War syndrome is adjuvant induced autoimmunity, what is the adjuvant? In 1995, Asa got the clue she sought. An
ofcial with the Senate Committee on Veterans Atfairs introduced herto a patient who had volunteered for an N.I.H.
experimental-herpes-vaccine trial. The patient complained of chronic fatigue, muscle and joint pain, headaches, andphotosensitive rashes-the same baseline symptoms as in Gulf War syndrome. She also had arthritis and other autoimmrme
disorders, diagnosed through lab tests. But this particular patient had never received the herpes vaccine. She'd been injected
with a placebo, a single shot of a compound called MF-59, which contained an adjuvant that is much stronger than alum:
squalene. This was in 1991, the same year as Desert Storm. Asa discovered from published scientic papers that squalene
was a cutting-edge adjuvant used in at least three experimental vaccines in the 1990s. These were used in tightly controlled
experiments on animals and humans, but vaccines containing squalene have never been approved by the FDA for human use.
Squalene is a lipid, or fat, that can be found in sebum, an oily substance secreted by the human sebaceous glands.
Commercial squalene is extracted from shark livers. You can buy it in health-food stores in capsules which are purported to
boost the immune system. It is also used in some cosmetics as a moisturizing oil. Squalene manufacturers say it's safe, and It
appears to be when swallowed or rubbed on the skin. But injecting it is another matter. The adverse effects of vaccines
containing squalene have been documented in papers published in such peer-reviewed scientic journals as Vaccine and the
Annals of lntemal Medicine. Since the mid- 1970s researchers studying autoimmunity have used squalene to induce
rheumatoid arthritis and a multiple-sclerosis-like disease called experimental allergic encephalomyelitis E.A.E.! in rats. Like
every other oil-based adjuvant ever concocted, squalene is apparently unsafe.
A rheumatologist who conducts research into adjuvants atthe N.I.H. disputes the idea that adjuvants can induce autoimmune
disease in humans. The researcher, who did not wish to be named, calls these allegations "junk science." He admits that
squalene can induce rhemnatoid arthritis, but alleges that it does so only in one species of rat. Published scientic studies,
however, show that squalene has been linked to the development of autoimmune disease in rats, mice, and macaque
monkeys. When asked if he thinks the FDA will ever approve squalene as an adjuvant, the N.I.l-I. researcher says no. "The
FDA has not had a track record of approving oil-based adjuvants."
Research with squalene has been done at Stockhohn's Karolinska Institute, which names the nalists for the Nobel Prize in
Medicine each year. Dr. Lars Klareskog, a rheumatologist at the afliated hospital, concurs that compormds with squalene
could be dangerous for humans. "It's true that adjuvants can, in these experimental models, tum a potential autoimmune
reaction that is otherwise not pathogenic into pathogenic immune reactions. That is true in experimental animals. Whether
that is true in humans, we do not really know. But we believe that is so. Where the event occurs in reality very much depends
on the genetic background.
In early 1995, Asa submitted to the army Surgeon general the report Dertzbaugh had asked her to write. In response, theDepartment of Defense in March 1996 published a report on the Intemet, refuting her theory without ever putting it to the
test. A letter to the commander of the U.S. Army Medical Research and Materiel Command from Dr. Waiter Brandt, who
works for the Science Applications International Corporation, a Pentagon contractor, summarized the army's critique of Asa's
theory, claiming that the only adjuvant the military used in vaccines was alum. I-Ie also criticized Asa's use of the phrase
"human adjuvant disease" H.A.D.!, a term used by Japanese doctors in the 1960s to describe autoimmune problems in
women who had received silicone injections to enlarge their breasts. Brandt's letter said, "The tenn was coined 30 years ago
and is generally not used by most informed physicians today.... There is similarity between H.A.D. and Gulf War Syndrome
in their symptomatology. However, the development of symptoms in H.A.D. requires years, not months."
Atter the Intemet report calne out, Asa's initial frustration with the army's lack of response tumed to anger. "Adjuvant disease
doesn't take years to create symptoms," Asa says. "And I wrote them about squalene and they hardly mentioned a word about
it." Recently, Dr. Brandt explained to Vanity, Fair; "The presence of squalene or squalene antibodies in blood samples would
seem to be a natural occurrence and not an indicator of adjuvant injection."
According to Dr. Robert Garry, a professor of microbiology at Tulane University School of Medicine who works with Asa,
this contradicts the fundamental denition of autoimmunity. "If that were true, we'd have antibodies to all the proteins, all the
tissues in our bodies, and the immune system wouldn't mction at all," he says.
In August 1997, Vice Admiral Harold M. Koenig, then the surgeon general of the navy, wrote that the army "has used
squalene as an adjuvant in several experimental vaccines over the past ten years... Military members who served in the
Persian Gulf received standard vaccines, licensed by the FDA, with one exception [botulinum toroid, which approximately
8,000 troops received].... Squalene was not a component of any vaccine product given."
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In June 1996, after denying for years that Iraq had ever forwarddeployed chemical weapons during Desert Storm, theDefense Department admitted that the U.S. had destroyed a large mche of chemical mlmitions at the Khamisiyah depot in
Iraq in March l99l. Using only limited data on weather and detonation patterns, in 1997 the D.O.D. and C.l.A. released
computer models of a toxic plume emanating from Khamisiyah, waiting downwind and possibly contaminating 100,000troopsby remarkable coincidence the approximate mnnber of veterans who at the time were believed to be sick. In
September 1998, aer conducting its own study, the Senate Committee on Veterans Affairs would censure both the D.O.D.
and C.LA- for aulty analysis and for sending letters to Gulf War vets suggestingwithout snfcient evidence that Gulf War
syndrome may have been due to fallout from Khamisiyah.!
The Khamisiyah computer models were suspect, but the spin was effective. The C.I.A.-produced animations were played andreplayed on television news shows. Almost overnight, chemical-weapons contamination became the conventional wisdom on
the cause of Gulf War syndrome. Saddam did it, sort of. So did the ~nd. And maybe army engineers should have taken moreprecautions. As shots in the dark go, this seemed to make sense. The appearance that the Pentagon and C.l.A. had disclosed a
possible cover-up lent the idea credibility.
But even if a toxic plume had actually existed and moved in the direction the Pentagon said it did, enveloping 100,000 troops
with minute doses of nerve agent, the theory collapses on several points with regard to autoimmune disease. First, the
symptoms don't match: the effects of chemical weapons-acute headache, nausea, shrinkage of the pupils to pinpoints, andmuscle paralysis-are well docrnnented. In more than 50 years of data on nerve gases, published since the Nazis invented the
chemical weapons sarin and soman, iere isn't a single recorded instance of a nerve agent causing autoimmune symptoms or
diseases.
Second, veterans suffering om the symptoms of Gulf War syndrome who never deployed to the Gulf could not have been
exposed to chemical-weapons fallout, or any other toxic agent in the region.
Some of the veterans never le: the United States; some went to other countries, such as Egypt; These veterans did not take
PQB. pills. Moreover, had chemical weapons caused Gulf War syndrome, one would expect to see it among those who are
native to the region. Yet according to U.S. defense intelligence documents, there are no reports of Gulf War syndrome among
the Kuwaitis or Israelis. The Egyptians, who contributed some 40,000 troops to the coalition force, don't have it; neither do
the French or the Belgians. All of them sent troops. Another cohort of people who do not signicantly report cases are thejournalists who covered the war, myself included. These groups all have at least one thing in common: they did not receive
shots for biological-warfare agents.
Retired air force master sergeant J eiey Swan, 40, says he got his shots at Fort Belvoir in Virginia sometime around March
1991. Only one of the vaccines he received was identied smallpox!, so he doesn't know which other shots he was actually
given. Because Swan speaks Arabic, French, and Greek, the air force sent him to Egypt in April 1991 to serve as a liaison
with the Egyptian military. About four months later the tremors started, which made him look as though he were suffering
from an alcoholic's D.Ts. He developed joint and muscle pain and experienced seizures similar to Smiths. In 1996, back
home in Tamworth, New Hampshire, he felt his car accelerating out of control and he slammed on the brakes. But it wasn't
moving; he was parked at a shopping center.
Swan's symptoms were the same as those of veterans who had Gulf War syndrome, but a VA. physician reised to put him
on the government registry for it. "He told me that I had Gulf War illness, but he couldn't write that in the records, because I
hadn't been deployed there, I wasn't in the right place. So he wrote 'undiagnosed illness."'
Air Force physicians have listed Swan's problem as "Major Depression with psychotic features. " For ahnost 20 years I held a
top-secret security clearance," Swan says. "On my medical chart there was a big red-and-white sticker that said,
INSENSITIVE DUTIES. I never had a doctor or dentist once note anything suspicious about my behavior. Any hint of
instability had to be reported immediately.... Anything that might affect my performance had to be reported, even a
teaspoonful of codeine. Suddenly I'm psychotic?"
Swan thinks he knows why he and other veterans have encountered this penchant to call their problems psychosomatic, if not
psychotic. "Anything I said could be dismissed. It got to a point where I didn't even believe I was having these symptoms
that I was imagining everything. If we were registered for Gulf War syndrome, then everybody would know that the sickness
couldn't be due to chemical weapons.
We're the proof." According to Asa's reading of Swan's lab tests, Swan has lupus. He says a V.A. rheumatologist also told
him that he may have atypical lupus, but that it would take more time to conrm the diagnosis. Asa has tested Swan +2
positive for squalene on a scale of 4.
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In early 1997, Asa bought 200 milliliters of squalene from Acres Organics in Gee], Belgium. She developed a scratch test to
measure sensitivity to the substance. Al 10 of her Gulf War patients were "reactive." Some suffered symptoms such as rashes
or swelling at the injection site.
She also tested a control group of healthy patients who had never taken military vaccines; none of them reacted. Still, Asa
didn't have her evidence. The scratch test indicated exposure, but didn't prove squalene had been injected. Around this time,
Asa teamed up with Robert Garry at Tulane University. Garry and the university received a US. patent in 1997 for an assay
that could detect antibodies to polymers, of which squalene is one. Asa sent Garry an initial batch of serum samples,
including one from the subject who had volunteered for the N.I.H- herpes-vaccine trial. Asa didn't tell Garry which polymer
he would be testing for, or which patients might have been exposed to it. This would be a blind study.
When the samples all came back positive for antibodies to the unknown polymer, Garry repeated the tests and got the same
results. I-Ie also tested ozen senmi samples om Gulf War veterans sent directly to him in 1993 by Department of Defense
and V.A. researchers. He had originally been asked to test the blood for evidence that the patients had been exposed to
retroviruses including I-l.I.V., for which they were virtually all negative.
Garry got these samples out of cold storage and ran the new assay on them. He had been told that some of the samples were
"om healthy control subjects; now 69 percent of the samples tested positive for antibodies to the unknown polymer.
It was at about this time, Asa says, that the phone calls started- She would answer the phone, and no one answered back.
Her phone would occasionally dial 911 by itself in the middle of the night. A year and a half earlier, just after she had
submitted her report to the D.O.D., there had been two attempted break-ins at her house.
Her husband opposed any fmther involvement with the Gulf War-syndrome patients azer the harassment began. Ifit was tied
to this work, their children could be in danger, he believed. But Asa persisted, partly, she says, for the safety of her children.
Her eldest. Chris, was in high school and would soon register for the dra.
"There not going to equate my son with a lab rat. I don't care what the vaccine is. I dont care what they claim it's supposed to
do for mankind. It's not right to experiment on people, ever."
Asa sent Garry more samples, and by the fall of 1997, Garry had the results. Ninety-ve percent of Asa's Gulf War syndrome
patients had tested positive for antibodies to the unknown polymer. Colonel Smith was positive. The subject -om the N.I.II.
vaccine trial was positive. Of those sick veterans who had never deployed to the Gulf, but who said they had received shots,
100 percent were positive.
In all, Asa and Garry tested some 350 subjects, half of them controls. "So what was that stuff?" he asked Asa. "Squalene,"
she said.
This le; one major question unanswered. Ifthe military used a squalene adjuvant, in which vaccine did they use it?
In August 1990, the month Iraqi troops invaded Kuwait, there was probable amity at the Pentagon over the prospect that
Saddam Hussein might use biological weapons to defend his newly axmexed territory. On August 8, intelligence intercepts of
Iraqi military comrnimications indicated that Baghdad had produced and probably weaponized i.e., made suitable for
warfare! many deadly biological agents, including botulinum toxin and anthrax- The U.S. Army had been purchasing small
amounts of vaccine for both, but its stocks were woefully short of what would actually be needed.
A high-ranking army source conrms that by August 1990 the United States had stockpiled between 11,000 and 12,000 doses
of anthrax vaccine. We eventually deployed 697,000 troops in the Persian Gul
According to declassied military documents, in August 1990 the army surgeon general at the time, General FrankE Ledford
Jr., ordered a team of doctors and researchers from the army, the navy, and the Air Force to form a secret TriService Task
Force on vaccinations for troops in the Gulf. On October 9, 1990, in a conference room at the army's Fort Detrick in
Frederick, Maryland, the Defense Department convened the rst meeting of the task force, which began to draft plans to
"surge" the production of vaccines for anthrax and botulinum toxin. At the next meeting, on October 12, the acting
chairperson, Colonel Garland McCarty, and a team of l3 other officers decided to give the task force and its mission the code
name Project Badger.
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Of more than 160 companies that were asked to make anthrax vaccine, all but one said no. Only Lederle-Praxis Biologicals
of Pearl River. New York, signed on. Under the suspension of General Ronald R. Blanck and Colonel Harry Dangereld,
Project Badger organized the production of additional anthrax vaccine at the National Cancer Institute's Frederick Cancer
Research and Development Center, located at Fort Detrick_ Both Lederle and N.C.I. were unlicensed and unregulated by the
FDA The plan called for subcontractors to ship vaccine to the only FDA-licensed manufacturer of anthrax vaccine, Michigan
Biologic Products Institute now BioPort!, in Lansing, Michigan, for bottling, labeling, potency testing, and storage. This
would have been another breach of federal safety regulations. As an earlier task force memo from October 10 stated "It must
be noted that any rm other than Michigan will produce a vaccine rmder an I.N.D. and not a licensed product." I.N.D. stands
for "investigational new drug," which requires special approval 'om the ED.A- for use. The army-as the executive agent for
the Defense Department's biological warfare vaccine program should have sought that approval. It did not, and N.C.I.
conrms that it never applied for an I.N.D. to produce anthrax vaccine. Weth-Ayerst Intemational, which now owns
Lederle-Praxis, could not be reached for comment.! The FDA must approve all vaccines used inthe United States and also
license the production sites, military vaccines not excepted.
General Blanck disputes this scenario unequivocally. "I have no knowledge of anybody producing any anthrax vaccine other
than Michigan," he says. "Nobody provided us or produced any vaccine, because the war ended, basically, is what
happened."
By the rst week of December 1990, Project Badger had begrm plans to test other experimental vaccines on US. troops in the
Gulf. Project scientists referred to this endeavor, rather portentously, as a "Manhattan-like project," or simply a "Manhattan
Project." They organized a crash program to manufacture, or purchase, at least fom' experimental vaccines:
Enterotoxigenic E. Coli, Hepatitis A, Centoxin, and Shigella. At least two other experimental products were ultimately used:
PB. pills and botulinum toroid vaccine, for both of which the army received from the FDA a waiver of informed consent.
As for the mysterious "Vaccine A," variously cited as Vac A, Vac A-i, or Vac A-2 in the shot records of sick veterans such as
Colonel Smith, declassied Defense Department documents identify it as anthrax vaccine. Dr. Gregory Dubay, who
commanded the 129th Medical Company, a former Alabama National Guard unit out of Mobile, gave thousands of anthrax
vaccinations to troops. He says, "Each soldier had to read a classied sheet of instructions, stating that he, or she, was
receiving a secret shot, and that this was so for reasons of operational security. You don't want to tell the enemy that you're
getting protection against one of his "weapons." Dubay-who both administered and took the vaccinati0nssays that he was
under orders not to record the inoculations in the soldiers medical records, and that the troops were not given a chance to
decline the shots. "You were just marched through, and that was it...- Then our commander told us to destroy everything
connected with itthe empty vials, the boxes, and the package inserts. We bumed them all in 55-gallon steel drums back
behind the tents."
The Pentagon says that 150,000 Gulf War troops received anthrax inoculations.
There are no documents available proving that the army used a squalene adjuvant in the imapproved vaccines, and the army
has specically denied it. But that still leaves Asa and Garry with more than 100 sick veterans who had their shots and now
test positive for antibodies to squalene. Why might the army have used squalene instead of alum, the only adjuvant approved
for human use? Probably because squalene was stronger. The licensed anthrax vaccine was relatively weak. Immunity wasn't
achieved with one shot. It took six shots, administered over a period of l8 months, then an annual booster. In l991, tens of
thousands of U.S. troops arrived in Saudi Arabia only a month before the coalition forces began the ground war. Most could
get only two shots out of the six-shot regime; some just got one. And there was, perhaps, an even more compelling reason to
enhance the vaccine. Two former members of Project Badger say the coalition suspected that Iraq had engineered a more
powerful anthrax bio-weapon. "We were corrcemed that Saddam may have made anthrax resistant to penicillin," says one,
who does not wish to be identied. "We knew he had the skills to do that people who had trained in the United States, who
had the skills to nun the bug into a resistant bug....The Brits were the ones who gave us the information, actually. We actually
knew who those people were." The anthrax vaccine licensed by the ED.A. back in 1970 was designed to protect against
anthrax germs that occasionally infect wool sorters and veterinarians. It was not known to be effective against a biowarfare
agent that Iraq had possibly made more lethal. It is plausible that the army thought an experimental antlnax vaccine was
worth the risk, especially since squalene was considered to be a superior adjuvant. However, this was a hypothesis.
Administering such a vaccine to the troops would have been tantamount to a human experiment. In order to conduct a legal
trial with squalene, one would have to le an "investigational new drug" application with the FDA and have that application
approved. This did not happen. In October 1997, the British revealed their attempts to boost the eicacy of their anthrax
vaccine during the GulfWar by using a pertussis vaccine as an adjuvant. This controversial combination had caused serious
http://WWW.idir.net/~kr0gers/vantyr"air.html 11/8/2005
MTHE PENTAGON'S TOXIC SE&ET-Vanity Fair Article Q Page 9 of 10
Q 92
side eects in animals. But Asa believes she has evidence that the British also boosted at least one of their vaccines with
squalene. In 1998, she tested ve British veterans suffering om symptoms similar to those of Gulf War syndrome. Four
were positive for antibodies to squalene. The British Ministry of Defence denies using squalene in vaccines given to Gulf
War troops.!
Among the 1991 coalition allies, the United States, Britain, Canada, and the Czech Republic have reported possible Gulf
War-related illnesses. Of these, the rst three admit to immunizing troops against biological-warfare agents.
Production of anthrax vaccine inunlicensed facilities did not end with the war. On August 29, 1991, six months aer Iraq's
surrender, re army surgeon general approved a $15.4 million contract for a company called Program Resources, Inc.
P.R.I.!, a National Cancer Institute subcontractor that managed some of N.C.I.'s labs at Fort Detrick. Contracts were dravrm
up for scal years 1992 and 1993. In a secret Pentagon log kept continuously between August 8, 1990, and February 7, 1992,
there are numerous references to the army's expanded vaccine-production program, brrt no record of any decision to halt it or
to cancel the contract with P.R.I. Chuck Dasey, a spokesman at Fort Derrick, says that no anthrax vaccine was ever produced
through the contract.
Presumably, the vaccines made during the Gulf War are part of the stockpile now being administered in the wake of the
D.O.D.'s December 1997 decision to immunize all 2.4 million people in the armed services against anthrax. When Pentagon
ofcials held a press conference about the mandatory immunizations last summer, they insisted that there had been onlyseven reported adverse reactions to the nearly 140,000 anthrax vaccinations that the military had given in the preceding six
months. But according to the FDA's Vaccine Adverse Event Reporting System, there were at least 64 reports of reactions to
the vaccine between September 2, 1998, and March 9, 1999. Activist Lori Greenleaf a day-care provider in Morrison,
Colorado, says that, based on her E-mail, there are a lot more military personnel reporting problems. Greenleaf began agrassroots campaign against mandatory anthrax immunizations because of her 23-year-old son, Erik Julius, who she says fell
ill after taking the second of three anthrax shots in March 1998. She is swamped with messagesliom fearrl enlisted men and
women. Some of them have already received their anthrax shots.
"They've got rashes, chronic fatigue, hair loss, memory loss, muscle and joint pain, numbness in their extremities." Greenleaf
says she does not know what an adjuvant is, and she has no idea what is ailing her son. "All I know is, my son and many
other people are getting sick after getting the anthrax shots, and it sounds an awrl lot like Gulf War syndrome." ,
Two servicemen who received their anthrax shots last year have tested positive for antibodies to squalene. One received
vaccine from Lot No. FAVOZO, the same lot sold to Canada and Australia. The other serviceman received vaccine rom Lot
No. FAV030. Doses from this lot were also sold to Canada, according to that country's Department of National Defence.
There is no evidence that every dose in FAVOZO and FAV030 is contaminated with squalene, but the antibodies in these
two veterans suggest that anyone immunized 'om these lots may be playing "vaccine roulette." The U.S- has shipped anthrax
vaccine from other lots to Germany, Israel, and Taiwan.
Ifthe rst casualty of war is truth, then the rule of law is a close second. As Cicero wrote, "Laws are silent in time of war." In
the fall of 1990, the Pentagon began petitioning the FDA to waive informed-consent requirements on so-calledinvestigational new drugs for the Persian Gulf This was an ethical powder keg. In 1947, rmder the authority of the U.S.
military in Nuremberg, Nazi scientists and physicians stood accused of war crimes and crimes against humanity for
performing experiments on prisoners. Seven were hanged. Following the trials, US. judges draed the l0-point Nuremberg
Code, which was intended to govem all future experiments involving human subjects. The code's rst and best-known
principle was voluntary, infonned consent. Until the Gulf War, the US. military had never argued that there should be any
exceptions. In the end, the EDA. decided to grant waivers for PB. pills and for the rarely used and as yet unlicensed vaccine
botulirrurn toxoid.
In 1994, the Senate Veterans Affairs Committee called this a violation of Nuremberg, the moral equivalent of the army's
World War H-era mustard-gas tests on troops and its LSD experiments in re 50s and 60s. "We'd like to think these kinds of
abuses are a thing of the past, but the legacy continues," said the committee chairman at the time, Senator Rockefeller.
IVDuring the Persian Gulf War, hundreds of thousands of soldiers were given experimental vaccines and drugs these
medical products could be causing many of the mysterious illnesses those veterans are now experiencing." Rockefeller could
barely contain himself: The D.O.D.'s failure to provide medical treatment or information to soldiers was unjustiable,
rmethical, sometimes illegal, and caused unnecessary suffering."
He was referring to the experimental PB. pills and botulinum-toxoid vaccine. Rockefeller and his sta made no mention of
unapproved anthrax vaccine, Project Badger, or the Persian Gulf "Manhattan Project."
http://www.idir.net/~kr0gers/vantyfairhtml 1 1/8/2005
THE PENTAGON'S TOXIC SlET-Vanity Fair Article r Page 10 of 10
. L D Q
Declassied documents show that Dr. Waiter Brandt, who helped organize the Internet report attacking Asa's theories, was
one of the original members of Project Badger. Dr. Michael Roy, the physician who diagnosed Colonel Smith's illness as
psychosomatic, also worked with members of the team in early 199 lthe same doctors who planned the "Manhattan
Project." The Pentagon says that most of the unit logs in which biological-warfare vaccinations were recorded are missing.
Vanity Fair has formd an army document showing that at least some of these records were ordered sent to the Oice of the
Surgeon General. General Ronald Blauck, who led the Project Badger Working Group on expanded vaccine production, is
the current army surgeon general.
Some might understand the decision to accelerate vaccine production by any means possible when faced with the prospect of
biological warfare. But Dr. Greg Dubay believes he should have been told if he was administering an altered version of an
existing vaccine. "If l'd known it was a vaccine that had been tampered withif it was tampered withl would have declined
the order to give it," he says. "You do not obey anunlawful order. If I knew it was done clandestinely, and had solid
evidence, I would have disobeyed the order. The rst oath of every physician is to do no hami. I don't lcnow any physician
who would purposely do something that is truly harmful, rmless you're a Mengele or something." -
A spokesman for BioPort says parts of Project Badger remain classied. Pentagon ofcials deny using a squalene adjuvant in
any Gulf War vaccines and balk at Asa's allegation that some tmdiagnoscd GulfWar illnesses are autoimmune diseases. Can
a substance that induces autoimmune disease in a rat or a mouse be dangerous to a human being? Former Marine Corps tank
commander Jeff Rawls has a solution for the naysayers. Rawls is a 31-year-old GulfWar veteran who now lives with his
parents in upstate New York. He has experienced severe shrinkage of part of his brain and can barely walk. At +3, he is
almost off the scale for antibodies to squalene.
"Inject them with the same thing and see what happens," Rawls says in a slurred and halting voice. "No one in their right
mind would volunteer for something like that."
M. _ 2 . 3 _ 1.. __,.___ in __._ ~-:11; _.
To Index
http://wvvw.idir.net/~krogers/vantyfainhtml 1 1/8/2005
»' ALL IIIFEIRI-LATIDN CUHTAIIIIED
' I-IEP,EIIIuI,HJ|3LA§-SSIFIED Rev_Q1_31_2o03! DATE 12. -.|2II1DE$ B? 60324 uc ba1;1:r.*I;IJ~:»|:ls
FEDERAL BUREAU OF INVESTIGATION
Precedence; PRIORITY Date: 12/12/2005 b6
bCTo. |:| Attn:I I
SSRA
Counterterrorism Attn: SSA
Inspection Attn: IIC
Washington Field
From: Washington Field
AMX3 §@§Contact: SA I I Q "3
Approved By:I I
Drafted By: I I
Case ID # = 2 7 9A-WF- 2,2,2_9__3_6._:LEADS_n_ Pending! ~ 92<>*9292
I2 7 9AWF 222 93 6 USAMRI ID! Pending!- 92i;;R
Title: AMERITHRAX;
MAJOR CASE 184b6
_ . . b7vSynopsis: To set lead to interv1ewI I
em lo eePY|:|
Enclosure s!: ForI IResident A enc bi RA! onl : confidentialit statement, NCIC printouts forE:::2j bVC[::::::::f::]printouts forE:::] and photographs of[::::]
Details: The AMERITHRAX Squad 3 AMX3! of the Washington Field
Office WFO! has been conducting discrete.investigations and
interviews of visiting,scientists having access to the Ames bg
strain of Bacillus anthracis Ba! while at the United States Army b7C
Medical Research Institute of Infectious Diseases USAMRIID!,
Fort Detrick, Frederick, Maryland. The Ames strain of Ba has
been determined to be the bacterium responsible for the
associated deaths and illnesses to the anthrax-laced letter
mailings of September and October 2001. One such visitinscientist to USAMRIID has been identified as[::::::::::::%:]
Social Securit Account I INumber SSAN!:I I Date of Birth DOB!:
Investigation and interviews to date have indicate an a
I _Jemployee conducted researc atUSAMRIID which utiIized the Ames strain of Ba in[::::::::] This
research was the result of a cooperative agreement between BruceI Ivins at USAMRIID andI I Irv
To: |:| Frorp Washington Field
Re: 279AWF-222936LEADS, 12/12/2005
One such location a IID known to contain the Amesstrain of Ba was known as thet:E:¬%ihot suite in USAMRIID
building[:::] Investigation an interviews have determined thatE:;:;:]had periods of unsupervised time within the[::]hot suitew 1 e working with the pathogenic Ames strain of Ba. Thus,[:::::]
would have had the potential opportunity to abscond with an
undetermined quantity of the Ames strain of Ba.
Discrete investigation and interviews pertaining tob6
b7C
be
b'7C
b2
b7F
asE:::::]has determined a number of unresolved questions. Of b7c
principal importance is determining[:::::] exact whereabouts
surrounding the two windows of opportunity associated with the
anthraxlaced letter mailings of 2001. Secondly,E:::::::]
knowledge an erience in the field of microbiology andspecificallyi:iiFbacteriolo ical interests and abilities shouldbe determined. Thirdly,[::%::] interpersonal and employer-employee relationship skills, specifically as it relates to[::::::]
conflict resolution skills should be determined.
' nthraxlaced letter
mailin personnel file indicated
Discrete investigation of[;;;;;lsurrounding theSeptember 2001 anthraxlaced letter g indicated on
J Istarted work in] |
1
To: I:I From;. Washington Field
Re: 279AWF222936LEADS, 12/12/2005
b6
b7CI Bank records durinq this period indicate I
Bank and credit card records were unremarkable for
evi ence of out of state travel during the month of September,
furthermore, there was no unusual activity or withdrawals noted.
Available telephone records indicatedI I
I I There is no activity on
b dit card, or telephone accounts that would
indicate whereabouts during the entire window of
opportunity for the September 2001 anthrax-laced letter mailing.
Investigation surroundin the October 2001 anthraxlaced letter mailing indicatedI Iwas still wtrkin?:in:fhf:::::]laboratory ofI I work schedule forLa I must be determined and any supporting
ocumentation obtained. Bank records indicated an ATM withdrawal
inl _ Iod There was no further
activity on the account untill II I I Bank records, as well as
credit card activity, were otherwise unremarkable during the
month of October 2001 Available telephone records fail to timeline[:::::] Although[::::::]2001 bank and credit card records
fail to indicate planning or evidence of out of state travel,[:;;:::]whereabouts during the entire window of opportunity for
t e October 2001 anthrax-laced letter mailing remains unknown.
Personnel indicated the employeeemployerrelationship betweenI Iandl Irapidly cooled, similar to his
previous emplovment Wltm
WFO respectfully requestsI IResident Agency RA! to discretely interview ormer
supervisorI
3
To: |:| Fromz Washington Field
Re: 279AWF222936LEADS, 12/12/2005
WFO seeks to obtain additional information pertaining
seeks to identify the following:~to| |that| |mav be knowledgeable of. It should be noted
Broadly WFOb
b»O
7C
l.
2.
3.
4
To: |:| From Washington Field ' bwRe: 279AWF222936LEADS, l2/12/2005 i
4.
WFO recognizes the above captioned outline to serve as
a guide during the interview process and WFO relies heavily upon
the interview Special Agent SA! to expand the scope and nature
of the interview as deemed appropriate.
Contact SAE;:::;;:::]for additional information and/or' ' ' prior o in erview at E:::::::::%;::] OffiC¬! Or
cellular!. Send interview resu ts as well ascurrent employment information to SA»[::::::::::] AMX 3,
WFO.
Descriptive Data:
Reference
Name
Last:
First:
Middle:Race:
Sex:
SSAN:
DOB:
Work Address es! -
Pre Direction:
Street Name:
Street Suffix:
Post Direction:
City:
State:
Postal Code:
Country:
Work Phone #:
Possible Home Addressles
Street Name:
City:
To- F .W h t F' 1.1 9 . rom. as ing on 1e
Re: 279AWF222936LEADS, 12/12/2005
State: b6
Postal Code: bl
Country: -
Possible Home Phone #:
Miscellaneous:C
NCIC query for l, and SSAN:[;:;::;;::::] b6indicated no current wan s or warran s nor any iden 1 1a e b7C
criminal history Attached!.
ACS database query for[:::::::::::::], and SSAN:[::::]
I Imet with negative results. ACS database query foraddress:| lmet with negative results.
A query ofl for telephone
number:| Ias well as met with
negative results. .
A query Qd lforil
I Iall met with
negative results.
A query of Lexis Nexis database for[::;::;:::::;;;][:::Q;::::]nmt with positive results Attached!. o eroga y
in ormation was found.
6116
137$
b"/E
b2
b7E
b6
b'}'C
b6
b7C
71?} N W? ' "~_'.. t
To: | From. Washington Field '
Re: - 222936LEADS, 12/12/2005A1.
LEAD s!:
Set Lead 1: Action!
Interview[::::::::::::] provide results to SA|:|AMx-3, wFo
Set Lead 2: Info!
COUNTERTERRORI SM
AT FBIHQ
Information Only.
Set Lead 3: Info!
INS PECT I ON
AT WASHINGTON, DC
Information Only.
O0
7b6
Io7C
ALL II-IFDFf5_.iiTIClIII C I3I*ITAII11'EI§I4 =~ . H1121-!_ti'l192.i tqnssitslizia:3. Fb°°2 R§ "$695! _ - my 92 pkg , DATE l2lE; e BY 50:24 uc hanidkfcls
_ 1 _
FEDERAL BUREAU OF INVESTIGATION
On November 23, 2005, _ date of birth
ES I I was I I social security nu er
interviewed atI |place of employment, the United States Army
Medical Research Institute of Infectious Diseases USAMRIID!, 1425
eet, Fort Detrick, Maryland, work telephone number[:::][f?iiif:§iI After being advised of the identity of the interviewingH Date of transcription 1 1 I 2 8 Z 2 O O 5
b7 C
Agent and Postal Inspector provided the followinginformation: {::::::] - 1
L:::;:::]was shown a photograph taken by the Federal Bureau
of Inves iga ion FBI! on July 23, 2004, during a search the FBI
conducted at USAMRIID. This photograph depicted a InterMed Nunc
box with what appear to be numerous tubes inside. Handwriting on
the box states, S. African Isolates Ba, Careful LyophilizinVials. [::::::::::::;:::Ldid not recognize this box. However,[;;:]advised that if the yop ilizing tubes were stoppered with cot ,
this could indicate that the tubes were not lyophilized recently,
as using cotton plugs is the old way . However, some individuals
still use cotton plugs.
s - [:::::]recalled a foreign visiting scientist,L;;;::][;::::;::] who was from the United Kingdom and who visite SAMRIIDor a proximately one year in the late 1980s. I I
I Ihad access to Ba Ames, asI Iwas developing
antibodies for the detection and purification of Ba spores.
was visiting fromII I, and had a Secret clearance level. [:;:::;:]didnot know wheEherI Ihad access to USAMRIIDs classi ie
File # 2 7 9A-WF-22 2 93 6-USAMRI I D Date dictated N /Amwmgmmtm ll/23/2005 at Ft. Detrick, Maryland
SA b
by PI
W
This document contains neither recommendations nor conclusions of the FBI. It is the property of the FBI and is loaned to your agency;
it and its contents are not to be distributed outside your agency.
FD=302a Rev. 10-6-95! I 0 0
279AWF222936USAMRIID
Continuation of FD-302 of ¬ , On 1 1 /2 3 /2 O O 5 , Page 2
b6
b7C
E::;:;;;Lcould not recall whether| Iever visite RIID or whether the two simp y met uring an
anthraxrelated meeting.
visited USAMRIID a number of times,[::::::]
worked in the sa ' ision as
when was at Porton worked with Down.
environmental samples and with Ames, although rarelyIventured into USAMRIIDs containment srites. |
' not work directly with so| I
did not kn6W WHa did while at USAMRIID. believed
|:| was involved with the| did not work wit?
The interviewing Agent and Postal Inspector accompanied|toE;:]office, whereupon 'n d out several
icrosoft xcel spreadshee g Ba strains includingsome strains procured fromTi:i22§;?::iifE]i ion, called| who was in the suites, and
axe t e in erviewing Agent and Postal Inspector four pages of
strain information from inside the suites.|
. > Fri-302a Rev. 10-6-95! -
I
92
b
279AWF222936USAMRIID NC
Continuation of FD-302 of _ , On 1 1 /23 /Z O O 5 , Page __3_
Ialso unsuccessIuI1y looked Ehroug
filing cabinets for additional information on the above-mentione
foreign visiting scientists.
[::::g:]advised s e of[:::::::::]laboratorynotebooks may e in Suite orE?::] BRUCE IVINS would know whether
[::::::::]notebooks remained therea
All INF '-ULTIDIII CDNTAIIJEDw * ' 0 HERE: LTIIIIILELEISIFIED
-92- c R§ °1414°°3 . DATE i¢- »-2005 BY 50324 us bawfdkfcls
FEDERAL BUREAU OF INVESTIGATION
Precedence: ROUTINE Date: 12/28/2005 bf
To: Washington Field Attn: A/SSA I IAMX-2 C
From: Washington Field F
AMX3 23¢Contact: I I
Approved By: I I -
I 1LCase ID_ #= 279A-WF222936LEAD Pending!- 92o<>c92 I279A-WF222936-USAMRIIDV Pending!- W3 '-
Title: AMERITHRAX;
MAJOR CASE 184
Synopsis: To set lead to review information gathered from
certain computer hard drives located at the United States Army
Medical Institute of Infectious Diseases USAMRIID!.
Reference: 279A-WF-222936USAMRIID Serial 1075
279AWF222936POI Serial 1420
279AWF~222936POI Serial 1421
Enclosure s!: Enclosed for Washington Field are copies of
documents printed from various computer hard drives located at
USAMRIID.
Details: On January 13, 2005, January 31, 2005, and February 3,
2005 electronic ' d f h d ' , copies were ma e o com uter ar drives
operated b the followin individuals: I IBruceIvins[;;:;%:g:g:::] and| I Writer reviewed documents
from a ar rives except those operated by Ivins, and found
items of potential investigative interest. These items were
electronically bookmarked and also_printed for review. Of note
for this lead are certain documents with interest of a scientific
or genealogical nature. A brief synopsis of the documents
submitted to Amerithrax-2 for review follows:
' b6
Numbered Computer Of Possible Investigative Interest b
Operated
EL1 I
émxl
II
' ATo: Washington Figd From: Washington Fiels
Re: 279AWF-222936-LEAD, 12/28/2005
LEAD S! :
Set Lead 1: Discretionary!
WASHINGTON FIELD
AT WASHINGTON, D . C .
Review copied information from com uters operated byJ a employees ofthe United States Army Med'ica Researc ns 1 u e of Infectious
Diseases USAMRIID! and take action, if appropriate.
92 90
4C
ii ALL IIIIFIJPIIATIUI-I ll EFITFAIIIEI1
p , ' I-IEREIIJ IS U11 SSIFIEDt 0 i _, DATE l2l5' .- BY 1502324 uc 1:-=1r.-.1,-"I311-:,.~*cl'_=1
FD-302 Rev. 10-6-95!
_ 1 _
FEDERAL BUREAU OF INVESTIGATION
b6
lo"/C
Date of transcription O 1 / O4 / 2 O O 6
L_United States Army
Medic Institute f Infectious Diseases USAMRIID!, date of
birth Social Secu 't Account Number home
ddress e te r
work telephone number L was interviewedatl Iplace of employment. After92being advised of the identities of b6the interviewing Agents and the purpose of the interview,[::::]provided bvc
the following information:
E;:::]believes that B INS provided the Ames strain of Ba
used in t e aer . ' ' ' osol challenge did not remember any specifics
about the specific name of the sample or history related to thestrain of Ba used other than most likely IVINS provided the Ba. Efffj
does not recall knowing if the Ames used was from was not_sure how or where the Ba used in the study was stored. i idid not
perform any Ba research outside of[:::::]
hw@@nm1 1/4/2006 M Fort Detrick, Maryland
File # - - D 924'5'5 Date dictated
W
This d nor conclusions of the FBI. It is the property of the FBI and is loaned to your agency;
g
l CO . .
FD-302a Rev. 10-6-95!
136
b7C
2'79AWF222936-USAMRIID
Continuation ofFD-302 of I I , On 1 / 4 / 2 O O 6 , Page -2-
During the interview,[::::]reviewed[:::]notes associated with
the above mentioned stud . The notes mentioned that during thechallenge, wanted[;;:%g to be stationed on the cold side of Building[;::g while was on e ot side of Building| Iwaso e in Sui e[::::::::::]be1ieves these notes were taken prior to the
challenge. These notes also stated that[:::::::::::::::]and IVINS
would provide unspecified support for the study.
[::::]<did not kee a laboratory the ' lb§abovementioned study.[::::?]believes that or IVINS could b/Cprovide additional information about when the Ba used in the study was ii?
moved from Building [:::]to Buildin | [ | | did not know if there was a lypholizer was in Suite| i
During the interview,| lprovided to[::::]
a copy of a page of IVINS laboratory notebook discussing Ames spores, b6
the Ba Ames strain dilution scheme, and the fact that eight monkeys b7Q
were to be involved in an aerosol challenge. This notebook a e wasdated 5/11/1998 two days before the aerosol challenge inlimmn studywas performed. t:::] had never seen the information detailed in thelaboratory notebook. [::;:]stated that since there were 8 monkey
challenged in his aeroso challenge, this notebook page was most likely
referring to the aerosol challenge that[:::] planned. A copy of the
laboratory notebook page is included in the accompanying 1A envelope.
[:E;;g:]jprovided photocopies of several emails discussing[:::::]
study. signed an FD-597 indicating the release of these emails
Photocopies of the emails and the original FD-597 are also included in
the accompanying 1A envelope.
inn T IPMATTHN cnuTmTwEn 1~IE1::E6:~: LTIJELASSIFIEI11
FEDERAL BUREAU OF INVESTIGATION
Precedence: ROUTINE Date: 1/11/2006
To: Washington Field
From: Washington Field
NVRA AMX-1/ 1:»:-
Contact:I 1o7C
LnApproved By:
Drafted By: IW 1
Case ID #= 279AWF222936USAMRIID Pending! -/75 ?
Title: AMERITHRAX
Major Case 184 ~
Synopsis: To summarize information obtained from collected
documentation and related interviews regarding aerosol challenges
using Bacillus anthracis Ba! Ames spores at the United States
Army Medical Research Institute of Infectious Diseases USAMRIID!
and to provide an evaluation of the availability of Ames from
aerosol challenges.
Reference: 279AWF222936USAMRIID Serial 795
Enclosures: 1! Diagram of aerosol challenge equipment, 2! Three
! pictures of flask containing RMR 1029.
Details: The USAMRIID facility located in Fort Detrick,
Frederick, Maryland, houses a service division which specializes
in exposing test animals to known pathogens and toxins for the
purpose of "challenging" the efficacy of vaccines given to the
animals prior to exposure. The vaccines are under development by
other USAMRIID divisions or other laboratories which use the
services of the Aerobiology Division for the challenges. The
pathogens and toxins used are in liquid aerosol form when sprayed
into the exposure chambers containing test animals.
In an attempt to identify potential sources of Ames
strain Ba spores which could theoretically have been used in the
preparation of anthrax1aced letters mailed in September and
October 2001, the history of Ames aerosol challenges at USAMRIID
from 1996 through 2001 was compiled.
From 12/9/1996 through 10/2001 there were 53 separate
aerosol challenges involving Ba on 35 different days. The
- is| b5
D c 17/:" Rev 01-31-2003! DATE 1-l5~2l3l3B El EH32-11 1.J.II~ 1;1&T;.T,.»"dE:_.-"1315
b6
lo"/C
To: Washington Fiegd From: Washington Field
Re: 279AWF222936USAMRIID, 1/ll/2006
aerosol h llenges were r ' rooms[:::Iand[;;:Lin Building[::::]and roomT:?:] in Building1UUiIat the United a es Army Medical
Research Institute of Infectious Diseases USAMRIID!.
Documentation collected shows that there were only 7
Primary Investigators PI! involved in the challenges. The noted
rified throu h interview, wereI Ice IvinsfI Iand There were 22 aerosol technicians
and other personnel some of the PIs were also listed in this
category! documented as being involved in the aerosol process
during this period as well. Sixteen of the 22 individuals
documented were involved in ' The
elieved to be I
I Bruce Ivins
I It shoufd be noted that of
the 53 Ba aerosol chall I I enges run, ran 37
of them. Throu h interviews, it has been suggested thatI IE::::::::::::::fran most of the challenges because of the
sensitivity of the challenges being run as part of the vaccine
efficacy studies. <
The test animals utilized in the Ames aerosol
challenges included rabbits, non-human primates NHPs!, and mice.
The Ba used in the challenges was primarily produced
and provided by Ivins. One batch of highly purified Ames spores
produced for aerosol challenges was referred to as Reference
Material Receipt RMR 10 0 It was a combined batch of sporesproduced by IvinsE:::i:::%:::] When this material began to run
out, an extensive vaccine challenge was planned which required a
very large amount of highly purified Ames spores. Ivins
contracted Dugway Proving Grounds to produce Ames spores in
fermenters and provide them to USAMRIID for use in this study.
The Dugway Ames was purified by Ivins and subsequently combined
with multiple batches of Ames spores produced by Ivins[::::]
E:::::::]at USAMRIID using a LeightonDoi broth technique. The
combined Ames spore preparation was referred to as RMR 1029. RMR
1029 and 1030 were the primary sources of challenge material
during the period for which Ba~challenge information was
compiled. However, some challenges were conducted using other
strains of Ba. The source of the Ames material used in each
challenge is provided if it was documented or could be verified
through interviews.
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In order to explain the evaluation of the availability
of Ames material used for and remaining after aerosol challenges,
a description of the process and equipment is provided.
AEROSOL CHALLENGE EQUIPMENT refer to enclosed diagrams!:
Nebulizer
A nebulizer, also known as a collison, was used to y"generate aerosolized particles of the challenge agent. A Q?collison was ' ' '
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The first documented use of the new BGI nebulizers
during a Ba Ames challenge was on July 17, 2000.
Aerosol Chamber
The size of the chamber used durinq a given aerqgpl
challenge was animaldependent. I I
| Some
types of chambers were designed to contain the whole animal
during an exposure, but other chambers were designed to expose
only the nose of the animal. These systems were referred to as
nose-only exposure chambers. Similarly, head-only chambers were
sometimes used. In these chambers, only the head of the animal
sealed around the neck at the junction! was inserted into a
sealed chamber for aerosol exposure.
All Glass Impinger AGI!
Attached to the aerosol chamber was an AGI, designed to
mimic the nasal passage of a human.|
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TRAINING OF AEROBIOLOGY PERSONNEL:
I Ibecame the defacto eaerosol system and process. Up until December 2000,E?ffEf:fE:EEj
E::::::::] ran the majority of the aerosol challenges conducted in
the Aerobiology Department at USAMRIID. When others began to
participate in the process,| ltaught the
process to their civilian and military cofleagues. Due to the
complexity of the system and process, most of the training was
process oriented rather than theoretical in nature.
USAMRIID SPACE UTILIZED FOR AEROSOL CHALLENGES:
The anthrax a ge and ostchallenge stepswere conducted in roomsEfffEEj¬E2fj, and[fi]in Building[:::]and Suite[::::]in Building|[:::]at USAMRIID. No other rooms have
been identified as having been utilized for Ames aerosol work
within Buildimg[:::]cn:[:::] at USAMRIID. Suite[:::] was only
utilized while Building[::::]was under renovation in the mid-
1990's, prior to Ivins' production of Reference Material RMR!
1029. There is no d tion to suggest that RMR 1029 was
ever taken into Suit
Room[:::]of Building[:::]*was used as a preparation and
post-challenge room for the anthrax aerosol challenges. This
space was utilized primarily by Ivins and his department,
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however, there were occasions when the room was shared with otherbé
PIs. For example, in 1998 and 1999| b7c
Iutilized room| |forBruceI1a study work
It was documented during several interviews that Ivins'
group did not keep roonQ:::]very clean and tidy. Post-challenge
agar plates were left on counters, the incubators were left full
of material, samples in the refrigerator were not disposed of in
a timely manner, and "hot" trash was allowed to build up for
weeks prio 'ng autoclaved. One former military aerobiologytechnician1:f::?frcommented that had to clean Ivins' trash
himself out o safety concerns. said that the civilians at
USAMRIID did not take safety seriously. [::::::::::]commentedthat when[:::hooked at the agar plates that had sat in the
biohazard trash bags for several days or weeks in 115, they were
covered with bacterial growth.
Room[:;:]was used to prepare the nebulizer and AGI's
for exposures. erobiology Department personnel primarily used
this room.
Rooms |:|and|:|were utilized to run the aerosolexposures. All of the aerosol challenges were run in room£:::]
until December O00 whe first anthrax aerosol chal engewas run in roomi::i. RoomW[iEikas subsequently used as anadditional Ames challenge lab. The challenges in roonJ;;:]until
December 5, 2000 used two hoodlines, titled hoods #1 & 2, for
the exposure fter December 5, 2000 only the #1 hoodline was
used in room Documentation shows that another hoodline,
hood #8, in room was utilized for subsequent anthrax
challenges.
AEROSOLIZATION PROCESS: .
The aerosol process was generally outlined in several
Standard Operating Procedures SOPs! used by the Aerobiology
Department. The SOPs include:
SOP Number Titleb2
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PREPARATION OF AMES CHALLENGE MATERIAL:
The Ba used in the challenges was maintained in suite[:1 of Building[:::]kw'Ivins. According to
prior to a challenge, Ivins transported a large flask containing
the liquid preparation of Ba to be used for the challenges. The
flask was stored in room[:::] From the flask, the investigators
prepared 15 ml conical tubes filled with 10 ml of Ba solution.
The tubes were kept in the refrigerator in room[:::]of Building
[::::]until needed for the challenge. Information provided during
other interviews contradicts the information provided by
and states that Ivins would prepare the conical tubes
in sui and trans ort only the tubes, and not the entireflask, to Building[:ii:] This portion of the investigation
remains ongoing.
No prechallenge Am kept in the walkin cooleron the first floor of BuildingTi::if but post-challenge material
was stored there. The length o ime leftover Ames was stored
remains controversial. One unresolved contradiction is that some
interviewees said that if a conical tube was missing from room
E:::] it would be noticed since they knew how many tubes they
prepared. Other interviewees said that extra tubes were prepared
in case one was dropped or damaged, so there were more tubes than
test animals. The left-over material was not carefully
inventoried or tracked. No one would notice if liquid Ames was
taken out of the tubes and replaced with water.
The spores were heatshocked prior to the challenge to
remove vegetative matter and stimulate germination. The Ba Ames
spores were suspended in a water solution. The starting
concentration of that suspension, which was transferred to the
collison nebulizer, was normally 109 colony forming units cfu!
per ml. The AGIs captured samples of the air inside the exposure
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chamber, so the amount of Ba was diluted in the AGIs compared to
the starting Ba solution in the nebulizer.
POST-CHALLENGE PROCESS:
The post-challenge process was intended to determine
the amount of pathogen or toxin actually breathed in by each
animal. This determination was made by using information
collected throughout the challenge equipment settings, gauge
readings, and animal respiration monitoring! and by determining
the concentration of Ba collected into the AGIs by growing the Ba
on agar plates and counting the colonies.
Following an aerosol challenge, approximately 7 ml of
the original Ba starting solution remained in the nebulizer.
According to Ivins, it was normal procedure to autoclave the
remaining material in the nebulizer prior to removing it from the
hood at the end of the day. The technicians who actually carried
out such tasks were not confident that this material was always
autoclaved prior to removal from the hoodlines. The exterior of
the AGIs was sprayed with a bleach solution prior to removal from
the hood so the AGI contents could be plated to determine the
concentration of Ba.
Following an aerosol challenge, Ivins conducted most of
the post-challenge work. Ivins was the PI for the majority of
the anthrax studies, and he preferred to do his own post-
challenge work [::::::] sometimes assisted Ivins with the post-
challenge work.
The post-challenge plating to determine the
concentration of Ba was conducted by creating serial dilutions of
the collected samples in the The dilution tubes were keptin the walkin cooler on the[f;if:]floor of Building because
there was not enough room in t e refrigerator in room
Several individuals stated that the 15 ml conical tubes
containing the dilutions were disposed of after the post-
challenge plating was completed, but other information suggestedthese tubes may have remained in the walkin cooler on a long- '' I
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The postcha1lenqe plating was conducted Q;img1ily____1
using]
| The plates were read
on Ehe morning toI1ow1ng Ehe cnailenge.
DISPOSAL OF POST-CHALLENGE MATERIAL b2
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Information obtained from interviews indicated that
standard protocol is and was for the postchallenge plates to be
autoclaved in the challenge labs prior to disposal in the
basement, meaning that this material should have been autoclavedtwice. Several technicians stated that this was nottflfiys the
practice. All material on the hot side of Building was
considered to be "hot", and it was the opinion of several
technicians that the PIs and their staff were not concerned if
material was autoclaved before leaving a room or lab for
disposal. The main concern was that material was autoclaved in
the basement before leaving the hot side of the building.
DOCUMENTED Ba AEROSOL CHALLENGES: '
The information below was taken from four aerosol
exposure log books obtained from the Aerobiology Division,
information furnished by Ivins regarding Ames stock distribution
within USAMRIID, interviews of USAMRIID staff, and protocol
proposals. Copies of the aerosol exposure log books are
maintained in the 1A section of the captioned file.
12/9/1996 Exposure 97~0O7H, Protocol F96-17
ech:
Room ood 4, 5 anima s exposed
12/11/1996 Exposure 97O08H -
Tech:
Room Hood 4, 23 Rabbits exposed
Exp 97-O09H[:fffEijol F96-17
PI: Tech:
Room Hood 4, 22 Rabbits exposed
Exposure 97-010 F96-17
PI: Tech:
Roo Hood 4 21 Rabbits exposed m I
Exp 97-011 1 F9616
PI: Tech:
Room Hood 4, 13 NHPs exposed12/12/1996
12/13/1996
12/17/1996
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10/27/1997
11/6/1997
11/6/1997
11/11/1997
11/12/1997
11/13/1997
11/18/1997
Note:
PROTOCOLS USING Ba:First entry on RMR Record for RMR 1030.
Documents total amount of material as 21 x 5
ml tubes. A subsequent entry in the middle
of the second page shows another 36 x 1ml
tubes.
1 x 5 ml tube of RMR 1030 was removed from
stock as per RMR Record and initialed by
Ivins.
Exp 98-001, Protocol F9708
PI: IVINS Tech:|
Ba 0
Room No animals exposedp
10 runs were completed with dilutions of
10*, 10*, 10 , 10*, and undiluted.
19 x 5 ml and 35 x 1 ml tubes of RMR 1030 was
removed from stock as per RMR Record and
initialed by Ivins 30 ml
This is the final entry on
1030. This documents that
there was 0 ml of RMR 1030
in stock.of RMR 1030!.
the RMR Record for
as of 11/11/1997
material remaining
Exposure 98-002, Protocol Egj~O8PI: [:::;] IVINS Tech |
Ba Ames tock RMR 1030Room£;;:} Hood 1 & 2, 30 Rabbits exposed
/ 2 x cfu ml
Exp 98-003,, Proto EQjQBPI:tfff:] IVINS Tech:
Ba Ames Stock RMR 1030Room[:;:;]Hood 1 & 2, 30 Rabbits exposed
2 x 10 c u/ml»
Exposure 98-004, Proto E2jQ5PI: [:::;l IVINS Tech: I
Ba Ames ock RMR 1030Room£;;:1 Hood 1 & 2, 30 Rabbits exposed
/ 2 x c u ml
The challenge on 11/18/1997 represents the
last time RMR 1030 was utilized at USAMRIID
and is the depletion of the RMR 1030 stock.
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Protocol D98-03
Title: Detection of Bacillus anthracis from Nonhuman primates
after Aerosol Exposure Using Noninvasive Methods of Sample
Collection
Objectives: The objectives of this study are to a! acquire
noninvasive samples from B. anthracis nonhuman primates exposed
to aerosolized B. anthracis spores in order to establish what
specimens and when during the first 24 hours B. anthracis
organisms can be recovered and b! to determine the applicability
of current molecular and immunological methods for detecting B.
anthracis in these types of samples.
5/13/1998 Exposure 98-035, Protocol D98-03
PI: [::::] Tech:| IDugwa Ba Ames StockRoom|_:| Hood 1, 8 NHPs exposed
=10 LD50.
This is the first aerosol challenge utilizing
the "Dugway Material" according to[:::::]
There is no entry in Ivins logs to indicate
that[::::]was given a sample of RMR 1029 or
that a sample was given out to anyone in this
time period. There is no documentation to
verify that this challenge utilized material
from RMR 1029 or from any other material
linked to Dugway. However, it is documented
that RMR 1029 was the only Ames spore
preparation containing Dugway Ames located at
USAMRIID prior to the mailings. RMR 1030 did
not contain Dugway material.Note:
' From 9/30/1998 through 8/17/1999 there were 10 anthrax
aerosol challenges completed, however, nonAmes strains wereutilized. All of these challen es listed either Ivins or[::::]asthe PI and| |or| K ?as the aerosol technician.| Mwas Ilsted as having been involved with the challenge on
98. These challenges were done as part of Protocolsnumber F9907 and B9803. The Ba strains used included| | I
Protocol D99-02
Title: Collection of Positive Control Specimens for Development,
Validation, and Fielding of Diagnostic Assays for the Detection
of Bacillus anthracis
Objective: The objectives of this study are to acquire
biological samples blood, plasma, and serum! from non-human
primates exposed to B. anthracis by aerosol route in order to:
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Experimental Design Test and compare the following diagnostic assays.
Acquire validation and check samplesb
- Develop new, more sensitive B. anthracis
detection technologies
- Search.for early pathologic, physiologic, or
clinical disease markers that may support the
results of various diagnostic assays or provide
new diagnostic indices.
Nine anthrax-naive, nonhuman primates possibly six
additional animals. see below! will be exposed tp '
9/14/1999 Exp 9-044, Proto 2PI:jiiiUU Techziimii
Ba A tOCk 1029RoomT?i;j Hood 1, 9 NHPs exposed
4.4 x cfu/ml, 10.0 x 107cfu/ml,
13.8 x 107cfu/ml, 10.8 x 107 cfu/ml,
13.8 x 107cfu/ml, 10.8 x 1O7cfu/ml
11.2 x 107cfu/ml, 13.8 x 107cfu/ml
7.4 x lO7cfu/ml, 11.2 x 107cfu/ml,
7.2 x 1O7cfu/mlI
I
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Note: This is an aerosol challenge u ' ' ' g
is no entry in the RMR Record for 1029
indicate that[::::] was given a sample
1029 or that a sample was given out to
in this time period. In an entry into
Ivins' notebooks on 9 17 1998 he indi|i|' °"Dugway Material" according to1iiifiT There
tothe
of RMR
anyone
one of
ates
that he provided GLP Ames spores
for the aerosolization of monkeys. "GLP
Ames" is another term used to reference RMR
1029.
Expo 0-0002, Protocol D9902PI: 5| Tech: |:|
Ba A ockRoomT?i:?FHood 1, 3 NHPs exposedl0/15/1999
Note: There is no entry in Ivins' logs to indicatethat[::::] was given a sample of RMR 1029 or
that a sample was given out to anyone in this
time period. There is no documentation to
veify that this challenge utilized material
derived from RMR 1029 or in any way linked to
Dugway.
Protocol B0003
Title: Selection between two recombinant PA preparations for
development of a potency assay and a correlate of immunity in
rabbits.
Objective: The first objective of this research is to determine
in the rabbit aerosol challenge model the potency of two
recombinant PA proteins when combined with Rehydragel adjuvant.
The hypothesis is that there will be no difference in the potency
of the two recombinant PA proteins. A second objective of the
research is to determine the efficacy of the rPA vaccine and to
evaluate the serological response to immunization by ELISA and
toxin neutralization assay TNA! to confirm the correlate of
immunity in the rabbit.
Experiment #1: Ib6
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Experiment #2: Potency assay and determination of an in vitro
correlate with survival in rabbits receiving only 1 immunization
of rPA. Y
Experiment #3: Confirmation of Experiment #2 for verification of
in vitro correlate measurements. Total number of rabbits: 90
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Experiment #4: Reproducibility of in vitro correlate findings.
Experiment #5: rPA vaccine efficacy study and development of an
in vitro correlate with two ! doses of rPA vaccine.
Exveriment #6: ConirmaLiQn_Qf_Exnerimen: 4511 |
4/3/2000
Note:
4/5/2000Part 1 of mu1tipart aerosol study BO0O3!
75 ml used
It is assumed that this 75 ml was used for
the 4/5/2000, 4/7/2000, and 4/10/2000
aerosol challenges.
Exposure 00-022, Protocol BO003 EicPI= lil Tecl |:|
Ba Ames Stock RMR 1029
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Re: 279AWF222936-USAMRIID, 1/11/2006
4/7/2000
4/10/2000Room[:::] Hood 1 & 2, 40 Rabbits exposed
Exposure O0-023, otoqgl Bgp-Q3PL |i| Techjl I
Ba Ames Stock RMR 1029Room[:::] Hood 1 & 2, 36 Rabbits exposed
Exposure 00-024, Protocol B00-O3PI: [:::;;:] Tech: kg lBa Ames ock RMR 10
Room[:::] Hood 1 & 2, 34 Rabbits exposed
Aerosol logs show that a total of 110 animals were exposed during
this part of study B00-O3.
7/7/2000
Note:
7/17/2000
Note:
7/18/2000Part 2 of multipart aerosol study BOO-O3!
40 ml used
It is assumed that this 40 ml was used for
the 7/17/2000 and 7/18/2000 aerosol
challenges.
Ex osur O -039 -P IPI: [::%::%] TeCh:i RBa Ames Stock RMR 1
Roon1E::] Hood 1 & 2, 28 Rabbits exposed
3 x 109cfu/ml
This was the first aerosol challenge using
the new collison nebulizers.
E 00-040 P t 1 B00-O3X OSLIIG IO OCO
Ba mes oc 029
Room[:::] Hood 1 & 2, 28 Rabbits exposed
3 x 109cfu/ml
Aerosol logs show that a total of 56 animals were exposed during
this part of study B00-03.
Protocol F0011
Title: Efficacy and immune response of two lots of AVA in the
rabbit model of inhalational anthrax.
Objectives:
1. To determine if 2 lots of AVA FAV 009 and FAV 032! made
several years ago, are still efficacious in the rabbit model of
inhalational anthrax
2. To compare the immunogenicity of the 2 lots of AVA in the
rabbit model.
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12/4/2000
Note:
12/5/2000
12/7/2000
12/11/2000
12/13/2000
Aerosol logs
study FOO-11
4/6/2001.
Note:
4/10/2001bo
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Bioport Rabbit Challenge, 100 ml used g
It has been indicated by[::;:]that F00-11
was a Bioport AVA study con ucted at
USAMRIID.
Exposure 01-012, Protocol FO011|PI:I I Techzl I IVINS, |
_Ba Ames Stock RMR 1029Room[:::} Hood 1 & 2, 33 Rabbits exposed
Exp 1-013,
PI: Tech: IVINS,
LBa Ames Stock RMR I029Room[::::::::::]Hood 8, 32 Rabbits exposed
Exposure 01-014, Protocol F0O11I PI:| I Techzl I I IVINS,
Ba A R 1029RoomT;::iiif:jMHood 1 & 8
32 Ra 1 s exposed
Exposure 01-015, Protocol F00-11
PI= Te¢h= EIIIIIIIII]
Ba ock RMR 1029
Room , Hood 8, 16 Rabbits exposed
show that a total of 113 animals were exposed during
Part 3 of mu1tipart aerosol study B00-03!
60 ml used
It is assumed that this 60 ml was used for
the 4/10/2001 and 4/12/2001 aerosol
challenges.
Exposure 01-039, toqgl BQQ-Q3
PI:| I Tech:| I
1v1Ns,| I
Ba Ames Stock RMR I029
Room[:::::::], Hood 1 & 8
28 Rabbits exposed
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4/12/2001 Exposure 01-040, rEIQLQQQl_BTO-03 haEl; I I ech: g§cIii Ivnqsi
b7F
Ba Ames Stoc RMR 1029
Room Hood 1 & 8
27 Rabbits exposed
Aerosol logs show that a total of 55 animals were exposed during
this part of study B00-O3. _
Protocol B01-07
Title: Evaluation of Antibiotic Treatments against Bacterial
Biological Warfare Agents anthrax, plague, glanders! in Mice.
Objectives:
Susceptibilities to current, and many new or experimental
antibiotics, have been established in vitro for B. anthracis and
B. mallei in our laboratory and this screening continues
attached manuscripts!. Antibiotic MICs for Y. pestis are
currently being determined. The true test of the effectiveness
of any antibiotic is the ability to contribute to a successful
treatment in an infection model. The working hypothesis is that
if B. anthracis, B. mallei or Y. pestis were used in a
biowarfare/terrorist situation these microorganisms would most
likely be resistant to the current antibiotics that are
designated for treatment. The objective of this protocol is to
identify additional antibiotics that could be used as alternate
treatments should resistance to current treatments occur.
Agents: Ames strain of B. anthracis Registry No. 2244
6/26/2001 Exposure 01-065, Protocol B0l07
PI: Tech: IB
Ba Ames Registry No. 2244
Room[:::] Hood 1, 60 Mice exposed
1 X 104, 1 X 105, 1 X 106, 1 X 107, 1 X 108,
and 1 x 10
Note: Antifoam was utilized as part of this
aerosol challenge. There is no record in b§WIvins' logs to indicate that[:::;1was b
given any of RMR 1029 prior to 10 4/2001.
7/9/2001 Part 4 of multi-part aerosol study B0OO3!
50 ml used
Note: It is assumed that this 50 ml was used for
the 7/10/2001, 7/11/2001, and 7/12/2001
aerosol challenges.
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7/10/2001 Expo ure 01-067, Protocol B0003 be
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Ba Ames Stock RMR 1029
Room[::], Hood 8, 15 Rabbits exposed
7/11/2001 Exposure O1-068, Protocoi Ei
Ba Ames Stock RMR 1029Room[:::] Hood 8, 14 Rabbits exposed
7/12/2001 Exposure 01-069, Protocol B0003- I[ZI1_[:::::::::llHlNS Ia Ames Stock RMR I029
ROOMEIIIIIIIIIJ H@@d 1 & 8
29 Rabbits exposed ,
Aerosol logs show that a total of 58 animals were exposed during
this part of study B0O03.
8/14/2001 EXp%sure:%F-079. F_2rQ;QgQ1_BQi;n1__1______1 PI: Tech:
Ba Ames Registry No. 2244
Room[:::] Hood 1, 40 Mice exposed
1 x 107cfu/ml, 1 x 108cfu/ml, 1 x 109
cfu/ml, 1 x 101°cfu/ml
Note: Antifoam was utilized as part of this ggc
aerosol challenge. There is no record in
Ivins logs to indicate that[::::]was
given any of RMR 1029 prior to 10/4/2001.
The 8/14/2001 aerosol challenge was the last aerosol challenge
utilizing Ba Ames at USAMRIID prior to the anthrax mailing on
September 17, 2001.
ANTIFOAM: 1
Antifoam was used in aerosol challenges when the
challenge material contained large amounts of protein. For this
reason, antifoam was used more often with various toxins and
viral preparations rather than with bacteria. There were rare
occasions that antifoam was added to the collison nebulizer in
the challenges. It was added to the nebulizer if the nebulizer
became foamy or gummy during a challenge. When antifoam was
20
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added to the AGI, it settled to the top of the solution. The
purpose of antifoam was to prevent bubbling inside the nebulizer
or AGI which caused poor aerosolization, or material loss when
the material stuck to the sides of the container.
The primary aerosol technicians were questioned about
the use of antifoam as part of the aerosol process. All
commented that it was not standard operating procedure SOP! to
utilize antifoam with Ba. Because the Ba aerosols used only
water in the process, there was not usually enough foam created
to require the use of antifoam.
The only documented uses of antifoam during Ba Ames
aerosol challenges were on 6/26/2001 and 8/14/2001. Both of
these challenges were conducted as part of Protocol BO107 with
E:::::]as the PI for the study. The aerosol technicians who ran
the challenges were[::::]on 6/26/2001 and[:::] on 8/14/2001.
When questioned about the instances, both technicians commentedthat antifoam wassutilized at the request of[::::::::::::]did
not recall requesting the use of antifoam. I
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On the 6/26/2001 challenge, the concentrations of the
Ba suspensions placed into the nebulizers were 1 X 104cfu/ml, 1
X 1O5cfu/ml, 1 X 106 cfu/ml, 1 X 107cfu/ml, 1 X_108 cfu/ml, and 1
X 109cfu/ml. Each run exposed 10 mice at a time. The Aerosol
Description Form noted that "AGIs contained 10 ml of PBS and 40
microliters of antifoam agent".
In the 8/14/2001 challenge, the concentrations of the
Ba suspensions placed into the nebulizers were 1 X 1O7cfu/ml, 1
X 108cfu/ml, 1 X 109cfu/ml, 1 X 1O1°cfu/ml. It was noted on the
Aerosol Exposure Sheet for run 4 "lots of foam". The AerosolDescription Form prepared byE::::]noted that "AGIs were
supplemented with 40 microliters 1:5 dilution antifoam + 10 mlPBS provided bywmmn Each of the 4 runs exposed 10
mice at a time.
All of the aerosol technicians said that they would
have noted on the challenge paperwork whether or not they had
used antifoam durin an aerosol challenge, however, they wouldnot have informed[:?::]or the PIs of the use of antifoam unlessspecifically asked. If[::::]or the PIs read the log notes, they
would have known whether or not the emulsion was used.
Difficulty was encountered during aerosol challenges
when a high concentration of the challenge agent was present in
the nebulizer, or when the challenge agent possessed a high
protein content, or when the collection material in the AGI 92
contained a high protein concentration. Bubbling of the
challenge agent in the nebulizer interfered with aerosolization,
thus diminishing the effectiveness of the challenge. During
aerosol challenges of substances with high protein
concentrations, bubbling often occurred in the AGI and material
was sucked into the vacuum tube attached to the AGI. As a
result, erroneous post~challenge concentrations were obtained. A
lipid emulsion was used to prevent the bubbling. An antifoam
emulsion was preferred; however, if antifoam was unavailable,
olive oil was used as an alternative. The aerosol technicians
preferred not to alter or add to the biological material provided
by the investigator; however, successful completion of some
aerosol challenges necessitated the addition of a lipid emulsion.
If necessary, the antifoam emulsion was added to the
nebulizer. During anthraX challenges, a clumpy, flocculent,
snow-like, milky material built up on the glass walls of the
nebulizer. [:::::::::::]attributed this occurrence to the high
concentration of the anthraX slurry placed in the nebulizer.
Occasionally antifoam emulsion was added to the nebulizer to
minimize bubbling and clumping of the anthraX. Approximately 40-
50 pL of antifoam were added to the nebulizer. The use of
22b6
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136
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To: Washington Field From: Washington Field
Re: 279AWF222936USAMRIID, l/ll/2006
antifoam emulsion did not interfere with the function of the
cipritube jets. Technicians were careful to add minimal amounts
of the antifoam emulsion, as the addition of excessive antifoam
emulsion to the nebulizer increased the viscosity of the
biological material to the oint of interfere ' 'aerosolization. [:;:::::::;?]noted that up to I
emulsion may have een use in the nebulizer during some plague
aerosol challenges.
For anthrax challenges, the AGI collection solution wasdg It was noted that antifoam Pf
emulsion was not a necessary a ition to the AGI for anthrax 3
experiments, as the water did not bubble enough to disrupt the
impingement process.
The general SOP for conducting an aerosol challenge
contained instructions for the use of antifoam emulsion; however,
the SOP did not mention the option to use olive oil.
An enlisted person ordered the antifoam through the
USAMRIID supply system. The consistency of the antifoam was very
thick and similar to that of mayonnaise. Due to the high
viscosity of the antifoam, it was difficult to pipette. As a
result, the antifoam was added to the PBS. The antifoam emulsion
was mixed by estimation and not measured exactly. Antifoam was
never used in the concentrated form during aerosol challenges.
The dilution of the antifoam with PBS was done in the
laminar flow hoods in room[:::] The diluted antifoam emulsion
was stored in an amber bottle in room[:::]of Building[::::] The
aerosol technicians sometimes made a large volume of the antifoam
emulsion, which was stable for weeks. Eventually, the antifoam
separated from the rest of the solution; however, shaking the
bottle remixed the solution.
OLIVE OIL AS AN ALTERNATIVE TO ANTIFOAM:
23b6
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1275
To: Washington Fie From: Washington Field
Re: 279A~WF-222936USAMRIID, 1/11/2006
The option of using olive oil as a substitute forantifoam was not common knowledge at USAMRIID. [::::g::%:::]
learned from[:::] thatE::]could use olive oil instea o he .
antifoam. There are several accounts of bottles of Bertolli and b7C
Pom ei olive oil being maintained on the hot side of Building b2[;:;j in one of the aerosol rooms. E:;::::;;::] stated that a b7F
o le of Bertolli olive oil was kep in e preparation rooms
used by the Aerobiology group in Building] Iused
extra virgin olive oil; however, the brand or type of olive oil
did not matter. There was not a particular reason as to why
extra virgin olive oil was used.
[:::::::::::]noted that olive oil could be used instead
of antifoam and was sometimes used in the AGIs at USAMRIID. No b5
92 documentation was found to suggest that olive oil was ever used b7@
in an Ames aerosol challenge. The amount of olive oil used in a
challenge was only a drop.
The olive oil was purchased from a local grocery store
or possibly from the commissary at Fort Detrick and was not
ordered through USAMRIID's purchasing system. [:::::::::::]stated b6
that he always used glass bottles of olive oil and could not b7@recall ever using a plastic bottle. [:;:::;:;;;:]indicated that
the bottles of olive oil were small. ne o e of olive oil waskept on the cold side of Building[;:::;in roon1E:::]and another
bottle stored on the hot side in t e g assware cabinet in room
Extra bottles of olive oil were not maintained by the;eroLiology group in Building[::::]
It has been stated that when olive oil was used in the
aerosol challenges, it was added without prior mixing with any
other solution. A 1 ml plastic pipette was used to remove olive
oil directly from the bottle. One drop of olive oil was added to
the material in the AGI. [:::::::::::]noted that one ! bottle
of olive oil lasted for years before being emptied; however,
bottles occasionally disappeared. Antifoam was taken from the
laboratory by other personnel much more often than was the olive
oil.
ICE:
Ice was used frequently in the process of handling the
material used in the aerosol challenges. Samples were typicall
maintained in ice baths prior to use. Ice machines in room
and in the hallway between rooms[:::]and[::] in Building
were the sources of the ice used. Commercially purchase ice was
never used. If the machines in Building'E:::]were not
functioning, the technicians used one of the machines in Building
|:|
Li__- 1
To: Washington Field From: Washington Field
Re: 279A~WF222936USAMRIID, 1/ll/2006
ACCESS:
In order to evaluate the access to the Ames material
used in the aerosol challenges, a review of the electronic entrylogs into Building[;:::]at USAMRIID for the period from 00:02 on
August 1, 1998 unti 11:00AM on October 9, 2001 was completed.
August 1, 1998 is the first entry in the electronic entry logs
for Building|:| at USAMRIID. 11:00AM on October 9, 2001 was
identified as the close of the window of opportunity for mailing
the anthrax laced letters to Senators Daschle and Leahy. Thisreview showed that 300 iifffiable individuals entered or
attempted to enter rooms and/or[::] the male and female
change rooms with keypads into the hot side!, or utilized the
keypads in either of those rooms during the period of review.
Another thirtyO! individuals utilized the access points but
used non-identifiable badges or non-identifiable personal
identification numbers PINs!. Below are the names of persons
who accessed the hot side of Building[:::] during this period
prior to the mailings. This list includes security guards,
computer specialists, housekeeping personnel, equipment repair
specialists, laboratory technicians and researchers. The
technicians and researchers are from various fields including
bacteriologists, virologists, and toxinologists.
It should be noted that several aspects of the timeframe RMR 1029 was stored in Building[:::] are still under
intense investigation.
252
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_»~_ __»_* DATE 12- ..-EFJU3 BY 6032!} 11¢: };|=§mr_rdJ~:,»-:12
FEDERAL BUREAU OF INVESTIGATION
Precedence: ROUTINE Date: 01/11/2006
To: Washington Field
From: Washington Field
AMX~3
Contact: SAI
Approved By: I I
b6Drafted By: b7c
Case ID #= 279AWF222936USAMRIID/ Pending!-92A<92o'?.
Title: AMERITHRAX;
MAJOR CASE 184
Synopsis: To provide a periodic update for the ongoing project
to review USAMRIID laboratory notebooks. This update summarizes
information obtained from numerous laboratory notebooks belonging
to various researchers and found in either the United States Army
Medical Research Institute of Infectious Disease USAMRIID!
library or in the individual researcher's office or space.
-
Reference: 279AWF~222936USAMRIID Serial 882
279AWF222936USAMRIID Serial 1131
279AWF222936USAMRIID Serial 1179
Enclosure s!: Enclosed is a Microsoft Excel spreadsheet listing
numerous reviewed laboratory notebooks.
.»<
Details: Numerous notebooks with entries from various USAMRIID
researchers were reviewed. Numbers were assigned by the USAMRIID
library to all laboratory notebooks issued to Principal
Investigators. These notebooks were reviewed to identify any
individuals who had access to Bacillus anthracis Ba! Ames and
were not already under investigation, previouslyunknown places
where Ba Ames was stored, people within USAMRIID or people and
places outside USAMRIID to whom Ba Ames was distributed by this
research group, and any other details of interest. Notebooks are
mentioned in this communication only,if pages of possible
investigative interest were copied; these notebooks, along
with notebooks with no pages of possible investigative interest,
are listed on the enclosed spreadsheet and located on the "S"
drive under "Notebook Compilation".
b6Notebook ' ~ was issued A ril 5, 2000 to [::::::::::] b7,
and was entitled Page 1 revealed that on
I
Notebokl I was issued April 5, 2000 to| Iand was entitled _ | On approximatelyJune 28, 2000[:::::] received Ames spores from Ivins at a
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Re: 279AWF222936, Ol/ll/2006
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7approximately June 12, 2000,[:::::]received a Bacillus subtilis bc Bs! plasmid pUB110, from Bruce Ivins for DNA wor Iwasperforming. I
concentration of 3 x 10m for two experiments to demonstrateilling with fixative and for determination of intracellularsurvival growth of anthrax within a host On July 10 2000
received more Ames spores from Ivins at the sameconcentration as above The experiment[::::] was conducting waso demonstrate complete killing of anthrax spores with EMuniversal fixative Page 24 of this notebook is a copy of theeference Material Receipt RMR! record for RMR 1029 Thisrecord shows the stora e location of RMR 1029 spores to beuilding[::::] Room[::?] The last date of RMR 1029 transfershown in this notebook is July 7 2000 Moreover, the previouslyocumented arithmetic error, in which Ivins subtracted 6milliliters from 994 milliliters and recorded the difference as
888 milliliters, is present in.[::::::]notebook
otebook[::::]was Tssued Julv 5, 2001 to| |d ntitled Page 17 dated an was e ,3/18/3 [sic], contains an entry stating "Examined A-Ames strain given to me by[:::::] [writer is unable to fully decipher]! for
PXO2 lOCi..."
Notebook was issued February 4, 1983 to[;::]and was entit e | obtained Ba mes fromBruce Ivins and perfor mmunoe ectrophoresis on March7, 1983 with the Ames. Another Rocket Immunoelectrophoresis wasperformed with Ames on March 22, 1983. It is unknown whether
Ivins provided this Ames as well.
Notebookl lwas issued October 16, 1995 to I
nd was entitled|An entry ' ' reads: A 1 ____i
An itinerary of the visit of the above TechnologicalCooperation Subcommittee followed, revealing that the event took
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' Re: 279AWF222936, O1/ll/2006
lace in 1995 and that ave a s eech entitled£::::::;:;J WI I I In addition gave a speec entit e Efp
E;::]was issued Mav 5 1992 toI I_ ok 'and[::::::f?ifEj an was entitledI I I Four pages
contained loosely within provided experiments conducted, and th' ooks £1
and
[;::;:;:] . . I . ANotebookI Iwas issued Auqust 16 1993 t [;:::::]
and was entitled age 10
is e a fermentation procedure conducted April 13 1993 using -
Sterne pPA102!CR4#2 and antifoam
NotebookI I was issued September 23, 1992 to
and was entitledl One
en ry or gel preparations listed directions for lyophilizing A-
Sterne samples in a speed vac.
Notebook[:::]vms issued August 17, 1993 toI I bi b4~/
b7Fand was entitled] _ I One
was an experiment entitled "Antifoam Compatibilitv Test
and Antifoam C."I I
Notebook wa issued November 2, 1994 to ha|:| Ii! ' 1 b7C and and was entitled
August 9, 1994 [writer is aware that this date precedes the
listed notebook issue date] reveals that fractions of RA were
lyophilized.
NotebookI Iwas issued Januarv 3, 1997 toI Iand was entit U
NotebookI Iwas i ued June 7, 2000 tosand was entitled
An experiment was conducted on Apri , O01 with
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RE: 279A-WF-222936, O1/ll/2006
two of Itai's Ames mutants", involving X-linking using gel
filtration.
NotebookI Iwas issued June 26, 2000 to
I Pnd was entitled One
entry listed a copy of Ivins' Reference Material eceip ecord
RMR! 1029, in which the spores were stored 8 degreesCelsius in 1% phenol in Building [:::] Roon1Ef:f] In addition,
Ivins' RMR 1029 spore stock was obtained for preparation of Ames
vegetative stock. The stock was then electroporated. The
experiment details have been abbreviated here, but the full
experiment was copied by writer and is available for review.
Notebtiflgggglras issued November 21, 2001 toI I[:::::g:::::] and and was entitledI I The
note ook contained experiments conducted in an attempt to
determine virulence defects in attenuated strains of Ba. It was
further determined thatI I
I I In addition several AAmes-1 samples weresent on April 8, 2002 to E::::j:::]for Mu1tilocus Variable
Number Tandem Re eat Analysis typing. All samples were received[fff?:iijher[::::fi]or [:::::::]writer believes this is [:::::]
[::::::::::§ftebookI Iwas issued July 11, 20OiUimi] and and was entitled One
page contained a small table, reproduced below:
Entitled: Sigma Materials for air pouch early germination
tebook was issued July 18, 2003 to
and and was entitled Further
information reqardln, was contained
S _ _ Ibetween
tebook was issued August 6, 2003 to
and and was entitled
experiment entitledIItis to beI I I
Notebook 4103, issued to Bruce Ivins and entitled
"Anthrax Study B9803", contained an October 27, 1998 entry in»Iwas em loyed byI |t<>T I
[writer believes
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RE: 2'79AWF222936, 01/ll/2006
which Ivins calculated the amount of Ames spores which equaled a
certain amount of Ba Zimbabwe spores.
Notebook 4306, issued to Bruce Ivins on August 28, 2000
and entitled "Anthrax", contained experiments on various topics,
including the comparison of Ba Vollum lB on MicroDiagnostics
Nutrient Agar versus Difco Nutrient Agar, the effect of
temperature on spore counts of Vollum 1B, and whether Solid Agar
medium was suitable for growing the Ba, strain V770-NPIR. An
experi onducted as a result of a conversation Ivins hadwith aqEfE:%if:j:] who advised that the United States Department
of Agriculture USDA! freezes anthrax spores at -70 Celsius in
50% glycerol. Ivins wanted to determine whether 100%, 50%, and
25% glycerol solutions in water froze at
~70 Celsius. Also contained in the notebook was an experiment to
determine loss of counts due to transfer of spores from one tubeto another. A.E:;:::::;::g::::]was mentioned in this experiment.
Another experimen invo ve spore counts on plates spread to
dryness versus counts on plates not spread to dryness.
Notebook I issued to Bruce Ivins on June 8, 2000,
with entries by| Iwas entitled
E:::::::::] This notebook included sporerelated studies on the
effects of storage conditions on spore counts in suspension on
Difco tryptic soy agar!, spore counts on different solid media
tryptic soy agar, nutrient broth agar, BHI agar, capsule agar,
sheep blood agar, and chocolate agar! percent encapsulation of
spores in preps on capsule agar!, pour plate versus spread plate
comparisons on nutrient agar; procedure written by BioPort!, and
percent of spores in preps that are refractile or nonrefractile.|Assisting with the BoPort study werelh I. It is unclear w ere these| |
individuals were employed.
Notebook[:::]vms issued January 3, 1978 toE:::::::]and was entitled "Pathogenesis of Anthrax."
lyophilized an ampule of an unknown substance on
On| |lyophilized a Ba Sterne sample.
study involving a MDPH now BioPort! antigen was condu ted, in
which the antigen was adsorbed onto alh drogel thengave samples from the above to[::::::::E] and to for
EF analysis
One page from[::::::::::::::::] Notebook wasco ied after a summary EC was written regardin the resl oflaboratory notebooks. Notebook:[:::iTwas issued July_ Notebook[:::]w ' 79 to[:::::]
[::::::::]and was entitled " A vaccine
5b6
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