Council for Tobacco Research
[Draft of Contract for Inhalation Studies in Syrian Hamsters]
Abstract
CNF
Fields
- Depository Date
- 08 Sep 1997
- Master ID
- Ctrmn00041967-2810
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- Author
- Homburger, F., Bioresearch Consultants
- Recipient
- Lisanti, V., Ctr
- Type
- LETTER
- CONTRACT
- Box
- 267
- UCSF Legacy ID
- vmt30a00
Document Images
C.r f f"h MN 042299
BIO-BESEABCH CONSTJ'LTANTS, iNC.
tbN {U lrA(IOM
tESEAiCh - OEVElO1MENi
F. MOMSUIOER. M.D.Olraw O COMMC%CIAk AviNUi
0-SEA NFtLD.Pn.4Oir.erwdR.wrM CAMIRIDGE.MASSACHYSETiS 02,41
M171 SeA1736
December 23rd, 1969
PERSONAL AND CONFIDENTLAL
Dr. Vincent Lisanti
The Council for Tobacco Research-U. S. A.
110 East 59th Street
Ne.w York, New York 10022
Dear Vincent:
Enclosed is a draft of an Agreement between the Council for To-
bacco Research-U.S.A, and Bio-Research Consultants, Inc. for
inhalation studies in Syrian han3sters which now incorporates all
of the points we discuased. '
The quarterly payments in advance, with expenditure reports sub-
mitted within thirty days after the end of sacb auarter, is the best
method under which we are accustomed to operate. Monthly bill-
ings, as is the case with government ccntsacts, increase overhead
expenses and appear to have no advantage to CTR. Hence, we sug-
gest careful consideration of the quarterly metbod.
This type of contract, which covers a study involving considerable
expense and time before any results becomo available, requires
a clause assnring continuity to protect the client. UAder any other
arrangement, we Would be free to cancel this contract before the
study was completed. it is hoped that your lawyers will be con-
vinced of the need for such a clause, which is acceptable to us,
thoush you must realize that this contract allowe very little margin
for profit,
We hope that a final version of this Agreement c.'an be agreed upon
in time to commence work in January 1970.
Yours sincerely,
/
:P'Coz-~4 -
reddy Homburg r, M. D.
_ FH:er psesideat and Flirector
CTR CONTRACTS OOS593
11225334
c"rR NN 042300
ACAEZid1;NT betoesa The Cowetllot Tobaees Aeasateb-U,S,A,,
hextnaltar relerred to as "COi1NC13J' and sto-Reasarck Coasnltanta, Inc..
herelnafter called "Cl?NbL'LTANTS.'1
-p1MREAS Council is tnterested In the coaduct of :ernta stndies
an ei2arette smoke and its ellecta La eaperimantal s-t...ats. Lad v-mREAS
Coosoltaata poasess asparisaea in such exporimeatation and bave tAe
ateeseaq personnel and eqatpmetY to carry oat such etodies,
NOW. TNEREFORE, the parties hereia abave mmEoned agree as
follows;
Cossultar.u, is cooperat5oa With a eortract olficer appoinLed by
Council to mowitor these stodise, will p]aa and eoaduet the lollovln2 to.
vssttjatiea;
AaimaL of two (2) iabred s:raiar of Syrian ham'ters Will bs ex-
posed to vmliltsred cilarepe smoke produeed by the Waitoa--(osrtssey
reverss stnoker. The e:posars to smoke will be carrled eut at the h!jhest
tolerat.ed dose of smoke itve (f) days aweek (except lor easvea (11] holl-
days daring each year) tt Sroups of stx (6) antmals per ssposnre t~hlch
oumbe. represeats tbs eapaelty Of eaek emokta` tnachtna). The toui
number of animals to be exposed will be selected on the basis of prelimisarl-
aicparienaots whleh will measare the rate of morrslity of thess ealmale
under We eaperimeatal coaditioas at smoke axpoeure, and obe iaitial
aumber of Larnaters wed.'ill be eac0 that it raay he expected that at least
fifty (SO) aaieeala vt11 sorvive is eacL trovp aftet sixtsse (16) msatha of
esposore to aaliltersd smoke.
AddiMossl aa:oU Wll1 be aspesed to permlt atadtss oa serum CO
cmtent and on absorptton and dietrtbuioa of afcodae,as Well as tos gross
pathology and -Istopatholodical studias an ssloetad aalmaLt and at tatervals
to be dsoldad on by ooatsaet oWcer. At the time of such sacr4fiees, the
...
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CTR CONTRRCTS 005594
11225335
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CTR r I 1 / ..r I 2 LiV' W
oosirau otticer may alte reqaest ehu sarotn samples and cerain tlsattas
b.frosea and shipped to otherlaborarorias fo: varioue cooparative studies,
sa:eb ar for eratapie, detsrtolsatioa ef vlral satibody prefiLS.
The total aumber of satpnals to be IDelodsd 3n tbfs study viu be de-
aided npon Sa diseussiea with the ooncsace olfieer aad oill be adeqoate to
Allow fec periodle e;erilieas as eutllned ia the praeedtod parayraph. CILe
l3miting faotor (s the titoe requi.rad for each e:posure group of sLs (6) ham.
stars (ataehine eapaeity( ..hich.ill depend on the enaziiaal totatsted dose.
With the ameuat of manpo-rr provided for in thr ptreseoo coot:ec:. Con-
saltasu are limited to s(moltanaot;s oss of tv.o (i) machioas.
At tbe eoae(ustoa of tha study, iLL asirnaie wL11 be a:nopsiad, all
orisns evill be lesptetsd, and the lua/s wlll be removed afcer intlation vitb
neutral formaldn,byda and axa.+tiaad oader a disseetlnj microacope for laa$
raaters (Hestocte method). Histoloeical sections will be prepered from all
tissuee e6evies arnss patholory aad is s11 ani+nals lrotn Lungs. piCditaries
asd adreaals. eody aei`hts sad adreaal.eiZhts will be dtterrtiaed ta aLL
aaimals at time of autopey. A.atlable for psOwtnly eonsultadoc are
Drr. 0. K. srledsll. Worcester; L. t.turp5y, Dat Hatbor; 7. B. Cau:tlrld,
Karvard and 0. Wilgrar, ToIN.
Sinae tbs tolersoce of bamstsrr for sTose LnheLtian in the iiialtoo
snaeblae is unknowe. the ataripf+el tolerated dose will be detern%ised by
proprepeively increas(ea txposwe r2a wra of sv+oke esaeaatratioo a.d
d,uatlea) of proeps of at least Menty.feur (24) h&=rtars tn rrlve at aa
aselmattoa of the LD/SO.
Once tals dose ts haova. lts affect dnrinp preloaQcd pe:(ods of
time vtill be atndled by repeated eacposares aad measuremcot of bleed CO.
Based en thue data. the enaximal tolerated dese ~ill be Jeees in eoaeulraa eloa with the contract
offictr.
.z.
cTR CONTRRCTS 005595 °
11225336
. _ ... .- --- .. . ...~,..
C ~°t~ t1t~~ `~ 42302
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Tbs haa+st+rs to be usad will be iebred E10 hamsters purchaaed
from TELACO, Dar Hatbor, Maiaa. Ona li.e to bo ased wIll b. ta. 15. 1{
liao akeady t.stad by Dr. JoU Littlr si tha Kar.ard School of Publfe Hsa1tA
for its resistaace to incraeraeLeal lajaettoas. This llas has been found to
bs esctrseaely seasltive to asScutaaaeas DbtBA (pap.r ia prsss).
A1otAar ascosd Iiaa wLt1 ba aelacud, basad es .iral pro[i1s (as tmova
lrom sw.dLes o! ),(icroblolojisal Aassciatss)aad on other cbaraetatlstlos sl-
reidy kaasa by Coaanltaats. These charaeterlssies tacluda L.fortnatioo on
snsvlesl rlrae aad oa eirai profile. This sslacnna aill ba ntads In co3sulr+t-
tioa vith contracc offloer. The viral protlls keowa at present for TELACO's
310 bamstsrs is basad oa a stvdy by ldicrobiolodtcal Associatts ia wbich
tea (1 D) sera ssmples from eaeb strato ware tested. W411s wdy baptatars
e.re kcpt in our nems tcr holdiag rooms aad specias crose rpasaaieatioa is
extrstnely salikely, oo guaraatee can ba aivca that tpe present viral prefils
wll1 not t~hae{e du_tn= this study. Another limitatfon fee the choice of bam-
stors will be their availability from TELACO vbich dependi oa bresdlna
psS:ertttaaes of the varieue aYailabla 1ldN.
Tba refassncs cidarattas naed in this study wU be ptovided to
Coasu1mts by Couoell.
Consultuts .tll oeoduct a second study loc Coueeil W begin some- !
time duritcd thc daratioa of thia adreettunt at a tiate to be decided upoa in I
cosuultarioa .ritb coatract elficer.
This stvdy coaaeltates a rspwltlaa et ssp.rlatenes doee by U. Satllottt
(Proo. Am. Assos. Caac.r Ros. 5155, 1164) in order to aseertaia that doae od
hydtoc.asboo wblei, whea latzatr.rAaally taJected, vfll eot produce toatoss
and could be'.sed as an toltiatfas dooe Lt experiments teati.d the co-car-
ciaeraalc aflact of iatratrasJtesl cipretta .moka esadeasate aad, later oe,
+^h'-d smeka. i our (4) troups od prsaq-tiva (23) )10 18.1{ Dam+twra .!II
-3-
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CTR coNrRacTS 005596 s
11225337
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CTR 1 )p 7 YrT4! 303
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be osed aad wtll be treaeed on the acbedalm followed by safllottl (tlCteea (1S)
ooekly isjections). Tie fOllo-laj rrsimesy will be iacorporatedi
1. Hsaatite aad Dydreearbon (HC).
Z. Heetatlte and HC (at primlaK dose level) ylus ooadeasu.,
3. Hernatite and eoademaee.
The bydsooasbeo to be ueed.vitl be decided oa by conts.at afticsr.
The condensate to be a.Od wlll be provided by Co®cil.
Coueetl vill pay a lee et:73, 000. per yue to Coaeultasta. The
tlrst quarr.rly LnstalLe.at ef tAL lee (f 18, 780. ) v1LL N paM upea .i(a3ag
el this Ayeement. Tbereaflsr, payment will be made ot f 14, 750. at tbe
beZianSa/ e[ saeL subaeqseae rJaety (90) days, on the tollo.iaQ dar.st
April let, July let aud October lit, 1970. Aa accountiaj.dll be subeaitted
by Coasnltaate to CouncllwLtain rLtrty (30) days altes the sod ot e.ea luarur.
Thir A/re.cwat WSlI semala ia losce ler t6i=<y-ssc (36) rneCthe
Lzcm the date ol aiqai:.g e=.d canaat be caacelled by either puty as lonj as
Co6rultanU pe!(erm their servieef to Co.ocil berevader with due aart asd
dilijeace.
Cnnaulmts make so geuara.otte Ol a0Y sort as to the eutcome e[ tbes
e3p.rlmesu cad caasot be rerponalble lor aay Aots ct God er accldeats be
yond Cotuu:taste' eontrel ebat midbt iat.rfere vlth the conduct of taese at%.dles.
/ / .
C'Y=o 1~SL.c-/2c27-
-'
rAseaeS Coe)14atlTiac
Bwero.
Por The ooncll for Tobacea asesareh-9.3.A.
Date-
CTR CoHTRACTS CQSS97
11225338
I
C`°~' H~~ 0~~~.~~4-
