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SOU'FHAM~ ENGLAND BRITISH- AMERICAN TOBACCO COMPANY LIMITED llll| m C.J-~ This confidential ~ is the pn~erty of British-American Tobacco Comoat~' LIT/Tiled ar:d m11~1 1101 t?e C(qlif?~ OI ,~'~n~,%'71 |CI UI~,IIITIfl " "'~ r~.~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION

DR .)f.A.L IUTSSELL'S "SAFER CZ~" STUDY REPORT HO. ]U). 1652 l~S'l~trc'rY~ 1.3.1979 o. AUTHOR: D.E. Cru£gh~on PROG. I~F. : 13.01.12 pIS'I"ILT.]K~;ON: Dr. S.J. Grelm Dr. T..W. Bu4r,~s I)1:. LA. hu~ord LN.. GLbb, Zsq. L S. Wade, F~lq. I.G. Bicholla, Esq. ie=~ E. R.:Lt:tershams Ih:. F. Seeho£er ~. J-J. ~a~mski ~. C.J'.P. de S:LquIJ.TI Dr. D.G. 7e1:o,, LLbwaz'j, Copy No. 1-7 tt 8| 8 " " 9, 10 " "* 12, 13, It, " " 15, 16 " " 17 " " 18 " " 19 n " 20 . n 21 " " 22, 2.3 xo.- BAT Co LTD - MINNESOTA TOBACCO LITIGATION

OECI~I46L Croup Research & Development Centre, British-Amer£can Tobacco Co. Ltd., SOUTHAMPTON. 1st Karch 1979. OK M~A.H. RUSSELL'S "SAFER CIGARETTE" STUDY (Report No. RD.1652 Res¢=icted) An ezperiment, car=ied out in conjunction vlth Dr. M.A.H. Russell of the Aadiction Research Unit, London, has been completed. A panel of 25 smokers, recru£tod from smokers An S.E. London, smoked their o~ b=a~d, • control ciKarette and one of ~ao exper£mental ciKarettes. One o£ the • xperimencal cIKaretcas was a con,-antlonal low dellvery des£sn (0.7 m8 nicotine, 11 m4;~WNF, 13.6 ms TPH) and the other a clEar•tee w£th a Low tar to nicotine ratio (l.2 mg nicotlne, 10.2 mS PHIJNF, 12.4 m8 TPH). Blood samples were taken from the smokers by Dr. Russell. The smokers who chanKed Co the conventiorual low delivery ciKarette had blood plasma nicotine levels 28Z lowar and blood carboxyhaemoglob£n levels $Z lower tl~n whqm they smoked their own brands. The smokers of the Low tar to nlcotine =at£o clEar•tee had blood plasma nicotine levels 2OZ hiiher and carboxyhaemoslob£n levels &2X lower than when they smoked their o~m brands. These de~a a:e broadly consistent wlth :•sults obtained by pu£f dupltcation of some of the records obtained Ln thls test. These show that the subjects who chinked to the convent£onal low del£ver~ c£satette BAT Co LTD - MINNESOTA TOBACCO LITIGATION O'-, r',o

-2- took 2SZ less n£cot£ue, 24Z less TPM, 16Z less carbon monox£de and 7Z more smoke (by volume) when compared ~£ch chelr uau81 brands. The mmDkers o~ the Zoo car co nicotine rac£o cijarecce cook the same.veiKhc Of nlcoclne, 49Z less ~ ~nd 72Z less carbon monoxide as they cook from tbe£r usual brands, but cook 66Z more smoke (by volume). The results oboe/ned for the low car to n~cotine ratio c£garectes, ms smoked by Chls panel con£orm co Dr. Eussel's criteria £or a "safer" c/@arecce (e.g. Zow delLvery of car and reduced carboxyhaemoglobln Zevels). lto~ever, further development o£ ChLs parc£cular low tar co n~coc~ue rac£o c£aacecce would be necessary to make lc more senerally acceptable co smokers. Thls cLKarette appears co have de£1clencles £n taste and flavour, possibly asaoc£mced ~ch the very high level o£ v~cilec£on used. We have a number o~ critic£sms to make of Dr. Russell's experimental dmsign and procedures and recommendaCloas are made thaC would Lap.rove the precis£oo ~th which the results from 8 simLla~ test could be obta£ned and £ncerpreted. • BAT Co LTD - MINNESOTA TOBACCO LITIGATION O",

-3- .INTRDDUCT Z0N H£tharto, smoking behaviour studies in Southampton have used panels of subjects recruited from within Group R. & D. Centre. These panels may noC be typical of ohm smokins public and tend Co be over-uc£1£sed. There are constraints on the sore of experiments which we would ~rfsh co inflict on B.A.T employees when used as subjects. For example, the Caking of blood samples for plasma nLcotine and carboxyhaamoglobin measurements on a resular basis, which is necessary for certain experiments, is noc likely" co encourase recruitment and maintain panel loyalty. We have, chere£ore considered various ways in vhich an external panel could be used for smoking behavlour studies. If blood samples are required as part of such a study, a medically qualified person needs to be involved in aC least a supervisory capacity. Dr. N.A.~. lussell, of the InsCicuta of Psychiatry, London University, has cazried out a number of studies into aspects of smoking behaviour, and, after discussions, ic yes asreed thac a poolinS of resources in an ms~pcr4menc could be advantaeeous. Dr. ~ssell. an influential =~aber of the medical profession, has oaken an interest in smokins and has extensively published his thoughts and results in medical and scientific journals over a number of years. Zt was, chmre£ora, considered thac there could be additional advancaees in openlnS a dlalosue with him, particularly as some of has viers on smolclng, a.S. ss a £orm of add£cclon, have not been accepted universally (I). On cha other hand., Dr. ~sell has advocated the introducc4on of c£8aratces • r~ch reduced tar co nicoClne ratios, am a poslt£ve approach to safer ~ k.~.~, (Z), BAT Co LTD - MINNESOTA TOBACCO LITIGATION c.J'l

-4- Dr. ~ssell and h~s colleasues have developed analyses of blood plasma £or the nlcoclne content and blood £or its carboryh&emoglob£n and chlocyanmCe concur (3, A). Thlocyanaces are mecabollc pwoduccso£ the cyanide dellvered in smoke; knowing the dellvery of hydrosen cyanide ic ? mishc be possible Co use chiocyanace levels as an indicator of smoke ow taw ~Caka. It vas agreed chaC the company would supply Dr. Russell w£ch two cilarecCe types; one of which was a low tar cilareCce with convencionaI consCrucclon and car co nicotine zac£o and another rich similar car level but higher nlcoc£ne delivery and hence lover caw co nicoclne ratio. The mod~ied cisarecCe design would also o££ew a lower carbon monoxide o delivawy chart the convenclonal des£sn, when smoked by machLne under standard condlclons. We also o~[erad Co loan Dr. Kussell the portable pu££ recorder (5) developed in Group R. & D. Cencre in association ~r~Ch Projects CCC Led., since D=. Russell does not have the equipment or the techniques available co measure, record or duplicate human smok£n8 paccerns. Xt was also aSreed Chat the design and execution of the experiment vould be the sole responsibility o£ Dr. ~ussell, buc ve would make available co him all the dace chmt we processed. ~rlch Dr. Russell £ree Co publlsh as much of the d&ca as he wished. As yec no £ormal publicaclon from Dr. Russell has appeared £n the llceraCure alChoush Dr. ~ussell has made eva£1able co us the blood analysis data. Dr. Russell called Chls scud7 "The Safer C£sarecte Study" and hls objectivm was co compare the intake o£ car, nlcotlne and carbon monoxlde and the,Chlocyanmt~ levels, for smokers of the two designs of cigarette. The tes~ cigarettes yore Co be compared v~ch smokers' o~n brands and a BAT Co LTD - MINNESOTA TOBACCO LITIGATION c c.,r" k.,r"

-5- v klJ2g s£zad coumercially ava£1able control ciearette. The objectives fitted in wall ~Zh our c~n thinking and ef£orts to examLna cigarettes of toy tar to u~cot£ne ratio. 1. The CiKareCCes The epec£f£eatlons of the ~iK&rettes chosen £or ~LLS study and the Piccadilly EinK SiRe vhich yes chosen as the control brand are shorn in T&ble 1. TABLE 1 DELIVERIES AND D I~fENSIONS OF CIGARETTES USED IN DR. RUSSELL'S SAFER CZGA~ITE STUDy (sam) (m) (m) (am) (c-/mJ.n. char) (cc/ml.n. char) (~/=£s) (ms/cig) (~/cig) (Z) (=s/cLs) Overall LenKth Tobacco ib=d Length Filter Length Filter Construction TippinK Paper I~ngtb CLrcumterence TLppInK Paper Paper PeL3seab ~ llCy Tol~c co Type PNt4NF l~ivecy • ~a Delivez7 Water Carbon Hc~oxide Carbon Honoxide Puff H~bar Co ~ Kac£o "TPH Co Carbon Honox£de ltac£o 39485 84 64 20 C.A. 23 25.0 Not Porous 1,20 PC Bland 10.9 0.70 2.C~ 2.9 12.9 10.1 ].9.4 1.1 Code 8548Y 84 64 20 16 mm Hyria 6 mm C.A. 23 25.0 Porous 9OO 2OO FC Blend 10.2 1.20 0.92 1.3 6.8 12.0 10.3 1.8 . | | , . , m, ,.|. *Dmcm abscracced from PDL Produce Data Report 1977. Piccadilly Kink S£z=~ 84 64 20 C.A. 2& 24.6 Not: Porous 52 FC Bland 18.9 1.20 2.60 4.3 17.2 10.0 18.9 1.3 -...4 (,..-.j BAT Co LTD - MINNESOTA TOBACCO LITIGATION

-6- 2. The Panel The panel was recruited from smokers who replied co an advercisrmenC pZaced in a London evening paper and from smokers who had reported Co the Addiction Research Unit as needing help to reduce or stop smoklng. As sucht it is of course possible chac this particular panel was even less typical of smokers in 8eneral than is a panel recruited ~rom smokers e~1oyed by B.A.T in Southampton. The subjects a11 live in the South London area. Sixty-six subjects (thirty-nine female and twenty-seven male) were recruited and completed ec least one smoking test. Only twenty-six subjects completed the whole series, eighteen females and eight males. + The results of one subject who held the cigarette in her mouth conC£nualLy were disregarded as unreliable. 3. ExperlmentaI Des £~u Dr. Russell used hLs own experimental desi&n, even though advice Irma o££ered to him on more precise des£Sns which ~ould have reduced the work load and made scacietLcal analys£s more effect£ve. We have deduced the desiKn o£ the exper~Jnent From the decoding of the tropes l~eturned to us. 1st V£s£c 2rid Visit 3rd Visit 4th to lOeb Visits 8ubjecc's own brand. Piccadilly I~uK Size (Control). Subject's ovn brand (noc uecessar~17 the same as first v£sLc) Part of the panel smoked 8548Y and parr smoked 394B5. Due to drop outs. sickness and 1 death. 15 subjects (11 £emala and 4 male) smokqd 39485 and ZO subjects (6 £emale and 4 male) smoked 8548¥. BAT Co LTD - MINNESOTA TOBACCO LITIGATION O",

-7- llth Visit example of 85&8Y and the l0 subjects who smoked 8548Y crossed over to smoke one example of 394B5. • T'nrouKbout the e~per/~nent the subjects bought ciKarectes. Own brand cigarettes and Piccadilly Kfng Size control were bouKhc from theft normal supplier8 and the experinuencal brands were bought from Dr" Russell at the reduced race of ~Op per packet (usual price for similar size ciKarettes 50-55p). The subjects were asked to smoke their assianed experimental brands exclusively throughout the designated period. When chanaes were ~ada from one brand or cilarecce type to another, the first c£$arette of the changed type was smoked in the laboratory and recorded. Filter ~£p AnalTs£s During the different phases of this experiment the smokers were Kivan metal c£garatCe boxes into which they were asked to place all the ciKazette stubs from a day's 8mok£nK. The *.ins containing the stubs were collected from Dr. Euesell so that the filter tips could be analysed for nicotiue content (as Total Nicotine Alkaloids) in Southampton. The stubs from the cigarettes smoked in the laboratory were also retained, stored in ~II 8an~le tubes and collected for analysis of filter tip nicotine content. 5. Smok~n'g Pattern B4cordLnz Dr. Russell and h~8 colleague l.lr. $.K. Sutton vis£tad the Croup K. & D. Centre laboratories where we demonstrated our apparatus co chem. We showed them the laboratory p~f analyaer and data logger (6) and the puff duplicator (7). ~ portable puff recorder and its decoder (5) ware both fully explained and demonstrated. The format of the data to The 15 subjects who smoked 39AB5 crossed over to smoke one m Cr~ BAT Co LTD - MINNESOTA TOBACCO LITIGATION

-8- be made available to Dr. Russell was •greed, •s follows: A full set of analogue flow profile traces from • chart recorder, a full set of reduced format teletype printouts and s magnetic tape of the reduced former dace in standard IBM compatible code (DUP-2) and the appropriate systems demOLition. The portable puff recorder was delivered co Dr. Russell cog•Chef with cigarette holders, mouthpieces, blank cassette tapes etc. and an Ol~trating check-list for the equipment. Both Dr. Russell and Hr. Sutton recorded smoking pattern data in our presence, and an operational protocol for recording was •greed so that we would have the necessary information to identify subject, cigarette etc. and the necessary spaclng to decode the cassette tapes. The record~ of smoking pattern data started in early November 1977 and was completed in May 1978. All recordings mere made in the afternoon or •vening (15.30-19.00 ho~r8). Th• subjects ware not gmailiarised ~r~th the equipment or techniques before the test, nor mere we present during the recording o£ any og the data £n this test. A total of 36~ smoking patterns war• recorded of which all but 26 were • uncessfully dacod•d (i.e. 93Z successful). 6. Experlment•l Procedure All subjecr~ recruited for this test were required to fill in a number of questionna£r•s both before and during the study. We have not yet seen any analyses of thee• dates nor have we seen examples o£ all the questionnaires used. One o£ these questionnaires attempts to assess the acceptability or satisfaction of the experimental brands vhen compared • rlth o~ns brand. A copy o£ this questionnaire £s shown in Appendix Z. .mmmab enmmm~ CT~ CT% BAT Co LTD - MINNESOTA TOBACCO LITIGATION