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l"of ~he I~CCOY~I Decombor ~2, 196~ Acting Director, N~t~om~l Cancer Institute Diseussiol with Di'. Dean Bu.ri~ on H~s Activities in M~ttel.s of "Lacti'ile" and Cig~'r~tt.e S~ol(e Modiflc~tioa Di'. or. ~. ~ I met from 2:30 p.m, untJl ~:15 p.m. in the a~crnoon of Dec~:d~cr ~ in ~ office. Dr. Durk c~me ~o the meeting at my request. ! e~pl~in~:d tha~ ~ wa~ receiving l~.rge numbers of inquiries about his activlt~,~:s ~nd had i,ccelved ~ zi~b~r of concerns about statcme~its ~bbi'~bU~reL to h~i. These derived from state government offlci~in, Cons~'cc~;aen, ahd others, i wi~h~d, thei•cfore, to hc~r directly from i'~i~:; abou~ thc~e activities and ,,~ .,ested th~ the dlscus~ion cover "v~o i~:~.:[~ ~:~rt~: i) "I~%c~ri3~" activlt~cs and 2) cigarette smohe ~c~iv:P~,~.~, an& %h~% e~ch aT thos~ be £u~the~ divided into th~ ~c~cntl/'ic a~p~cts and non-seien~ifi¢ a~l~CtS. |4oreover, within th~ ca~c[~ory of ~cici~tifie a~mct~ I ~i'~be~ to 6isc~s~ ~:w ;'~tr_ ~ ~nd in F irma s~u~ic~ a~d, ]~ost i~l~ortantly, the il~terpret~tion~ Of th~ dat~ in ".'cfcvo~cc t~ u,~a%. ~le In~ilcat~d h~ w~ 61ad t~ h~ve the opp~rt~mity to 4iscua~ these activities and im-@lled that he had not had, he felt, ~uffic~' .,nt opportunity lu th~ past t~ di~u~ ~ome ~%ters ~ith ~eni~ "L~:e~r ~ ie" Aetivi_. tie__~ss Oleo of the co~,fusinS Issues which we agreed upon ~as the lack of ]n'cc~ioh of ~Ae te~m "L~cti'il.e." Dr. B~k ~t~ted theft this ~I~.~ class tera~ for Syoups of compot~Id8 that could under certain ~ond~tions i,='cGucc iiC '. 1[¢ ~t&tc~ th&t tl',el'e ~e 16 eem~o~i%(l~ ibex% h~vo been 2of erred to at cite t~me or another ao "L~etrile" by different groups. ~iost of tile ~<vt~.dalin used ks extracted from bitter &]itond ~eats. with h~m~ ir.activ~tlou ~f ~uz~ ~hleh ~h~ s~llt the eompc~d. A ~U~the~ ¢o:aplin~tion in the d2r;cussions of "Laetrile" has originated from the be siren concui-l.ently with the ar~v~d~lln and/or other eot~pounds. Yet, it :~ak~:s cousi~l'abla difference xdlether amy64ali~ i~ ~.iveu aloha or • in combln~tion with these e~zyr~e prepar~tion~ since ~-glucosldase Sl~llts the ~<y~dalln i~to benzaldehyde~ }ICi~ an& ~lucoao~ while ~i~'6(bili~. almue i

-2- p,_"ob~A,ly is not ~plit to any appreciable desl, ee. FYOm the data ~,vail~:~ie it nppc~r~ theft ~.j~(~lin alone ic a compound of io~ CJven ~th no :~e~i;l[w~tle ~:]'jn~ of toxicity b!f several p~maeter~-- corL,~.i:~:L~' at levcl:~ of about 500 mlLligx'~l/kilo~r~n). On th:~ other hdl~d, ",:hen it i~ g~[w:u ill col1~not~on ~tlth ~-~,l~eo:~d~t~e enz~.~c )u, cp:,:'~.tio;~, the ~(,xicity can b~ a))Drcci~ble ~t co~'tain do~o ~-~n&,es. ~'he tD~.c ~'ela~ionI~i:~pl, h~'twecn the a6ministrmtion of the enzymes s- -v~ ~ e ~ ) ~, ~lin a:'~ also ~po~tol~t in tea-ms of toxicity D~'. L'~?. h~s p~.zson~:lly conducted many oypcrlment~ lu v~t),o utilizing ~zcibc~ and other cc~l culture~ ~li~ ~,".~d(~li~ ~nd rel~ted compox~l~s. ~.'ith ~nd ~ritho~b addition of ~-glueo~ida~e preparations. He ~as~cs k"~o;~icity" h~ ScverI~l ~o~'~lo~osic~l ~nd hioch~lic~l p~..r&meters differ,'n~ t~es. lie h~z ~I~o do~e ~ fc~" exper~en~s ~'I! v~vo in tumor- bca~in:~ ;,~ice ~nd l'~ts ~ thou~h by his o~n ~d~.d[.Dio~. il~ufficicnt llu:~,.b~r:; to d~'a~ ~t~int~.~aliy valid conclusions in the:'-e ~fnole aural expe1'iments. (~ stated th,%t he believes these experiments tended to be con~,~tcu-~ with the dat& reported in the SCIi~ report, K.V.) II~ ~l]. of the~e experi;~ents, no indic~tlo~ of toxlolty nor ant~t~mo~- : cffec~;~ ~:ye noted ~len a~I~(ii~:L~1~ alc~ %'as civ0~. (Dr. ~u'k indicated ~h~Lt pr~l~min~ry ~;tud~e~ ~ug~est~d sol~o hinds of ~ot~'ity ~'h.~n the do~c :LCW~:LS of ~=!~,Zdalln ~cx'e pushed %o ¢~xtr~:~ly h~h leve~ thoiL~h i~e did no~ :;pccify ~:hi~ kln~i of ~c~ivity, ) On the ot!~or hand, ~thcn ~.-~iuco~i~i~;e ~rci,:~a~ions (~'u~.lly derived f~'o~ plant i;ourcc~) %'ere LL<h~il~.ste~ed~ si~v~l biolo~icz~l r~spo;1.~es %~oFe di!tocb~le, ~l[d~ ~t h~h~" luvols, toxicit~ W~rS evldelr~. ~t i0 f~rthe~, e].a~lued %h~t those prc~,:.~.t~on~ ~ %¢~h the ~-~Inoo~ida~e givc~ IP so~Ioti~o bofor~ the cd~ini::trmtion of the ~ygdalin, produce anti-tu~lor effects (studiec reported in the SCII,D report indicate increased life span and/or reduction in t~or size in both mice ~nd rat %priors--Dr. Burk's studies performed in his laboratory arc consistent with thc~o findlz~ ~ithough s~%all nt~ibers of au~als have bcun studied). I asked Dr. Bark if h~ knew of a~ soundly conducted clinical tyials ~.ork vith any of the substances eall~d "Laotrile". ~-nd he. said he did not ~ow Of an~. tho~ several thou~Id pstiol)ts h~vo been treated vith the sub~tancc. ~e ~ppa-~ently ~c' ~r,~ressed %h~t soverzl patients , h~vo shol:n improvc~nt follo~in~ treatment0 I indicated that it ~a~ ~ell hnO~ in clinical work tha~ thi~ kind of inform~tion (i.e., reports of ~oue p~%ticnt~ .~howing improvements in uncontro31cd o~udie~) %~s¸ totally unreliable in indic~tlng ~h~ther ~ sub~tance ~as of eliniea~ value. I also t~'ied to conv£n¢o him.that the ~6~ents to be made in evaluating m~teri~l~ of cl~r the~apo~ti~ benefit in m~n form ~ ccmlplex ......... : ................... :7-~-7 ...............

- 3 - A~ rc$;:~rd~J i~; r~,por~, on the rcquc~ for an ~fi~ on ~vgdalir~ ~iTb~e" .~, ~, ~u, lulpi~cJ:~el}ly to co co!z~uctcd at the Unlvor.':i~y of ' ~'~ ~.[cdlcal Sc,~ool Y.otpitcl~ C:~n i"~'aI~cisco, i said I wondered why. in vicar of %he co:~plc~csy Dc~:ative f!lld~u~ with r.d~¢inistratlon of ~.y~;d~lin a-~onc it. ~uiu~l~, a nyoz'.c ~:o~Id ~I,~!it to acbainister the mcot¢:yi~l to v, all. I n~:vcr ~,ot ~ cl,~l" mmv~:i, to this question, lie responded to the qucsbion by not~tij, th:~% f~everr~l ~:bients ~npl:ov~d %~ith ~&~linistratlon of amygdI~lin or '~Lc~ct:'i!e:' (a,lp~rently often these patients h~ve rcccive~ othc~ forms o2 trcat::~cut), i ~old his, I ald not thinh th~%t that ~as a s~itisfactory reason for ~,~:~'t'~.~i~ in y~;:,lle o;' in his ~oLt~.~rs, ~uch a~ %be one to :.h'. F~rxcr ~,~ch ~:~ ~'.a~i:, public. ~ ~a~ clinical tri,~ls ~tith "Laetrlle" should be alio'~'~d, particularly since some activities in the "Laetrile" ar~a ara illc~ul and a l~lll;iba~, of individuals ~:ith less than adequate z,edical stand~n'd~ have been a~ainlsterlng this ~cteylal to ~atlents, shirti~z the la~,'s" ~d receivizg iucolue therefrom. Spcclflcally i ~nqulyed abo~t the ~ctlvitics of Dr. l~'ebs ~nd his son. |{e allo~ed tho.t their , r_cbivlt±c~ ~ere not entirely responsible o~es ~md eSalmed no association ~, ~t ~ ~t~.. ,~ I pc.~n~cd out. ho~eve~, that many people ~erc sssoe~atln~ not onl~" z,i,~, hub be¢~u:~ of his title, the ~;atlonal Cancer Iustlt~rbe -' ~' "' ~ nativities ~rh.!ch are clearly a,,;~lus~ the policy of }I!:4 and the i~Cl.,.~- responded th~ he cmLld not be re~Imnsihle for what kind of associations ~oplo would m~he. "' '~' i did not f'c~l that I convinced hi~ t~%t activities such as ~?pcarlng ~: on the pro~r,~ ~'~ the ~cctin~ of Lhe Ir.ternational Assoeiatio~ for ' C~,~ car Victims and Fric~,Js, Inc., ~hich included chiropractors and '. ~, o~i~ezs of inadequate z~edical capabilities, ~¢erc inappropriate aud not co;~.con~nt vl'~h the policies of the Institute and Eh~. Dr. Ik~v]c felt t~:~t it ~;~: his decision on ~;h~t~vcr 6roo.ps he ~i~hed to talk befor~ oi~ a~y ~ub~ects he tho~<ht were important. I did not feel also that . I ~uccccdcd ~n convincin~ hi~:, that the probla~ ~s more co'replicated .... ~h~ ~cl th.%t his actions affected many othe~" people besides hiauclf .~id the ic~.ediate au~Icl%cc. }~<o:~ples provided bM me included ~,.::onG o'5hcr~ the l?robl¢~%s ¢rc~ted for the heelth officer's of the ~, ~e of Co, lifornla who ~•re att¢~phlnz to sSop quackery In the State of California. Considerable co~ccz"ns ea'o belnS ex|)rosscd by these offiolal~ ~nld thely ~ledical consul%ants that Dr. Burk,%'ho is listed a~: a nt~ff z~enber of th(! *;~tio*lal C~ncer InstitKt~ has been t~ll,~ &,;;d '~ritir<q f¢~vorably ~bo%It "Laetrile" ~nd that this was m~]~in~: the job ~,~ore difficult fo~ the health officials to o~%tla~ quacked-/. I s~o.tcd t~, a/i?e~ont %,ith theD~ colleerno ~i~ rolter~ted ~y vi~ that ~uch t, ctions on his I~rt al.e inappropriate ~o long as he it ~ staff uc~:bcr of the ~C~ a/%d in the D}I~ but ~i~*. X 61~ *%st feel 7 had sueces holy made the point with Dr. Beth. I think he feel~ that data obtained in the laboratory should be communleatod Irros~eotlve

of ~uch octlvlt~es. Tllou[~h he cl~iIaod th~Lt h¢ %~S only co:~4~nunlerltillC fL~S~ i 6i~,qroed ~.~:~I ~ti~tc(~ th;~t )~is ~nt~rprcti~tlonE,~ such as u~v~ir,~ that ol~i~c:.l tri~!s be ),erfor,~cd In the face of insufficient evidence %0 ~l~%~?t this ~671~i~io%~ (U~ I ~aW ~t), could h~'dly ~ consldol'cd . ]:cr<~l~ n discussion of the f~c~c. I also exprensed s~rpl,i~ that as a ~c~iof f, cien%ict of lone ~tandln6; ~*d pa~ic~p:rtIDZ Ove~' the years il~ "~he :,~ore cu~tehaiD' Sot~ie%y mectln~s~ such &s the F¢,der~tlo~ ~icetin/~,s pco21e--~%d~ dn I$" vic~ ~n~ompete*it %,~ the usual s~elltlf~0 st~uldards-- c~, :~ev¢l'ed of thole o~: the ~o<~r~z of the r~cotln~, of the [nterootlonal A~:~,oei~t:;o~i of Ccr, cer ~ict~l~lo &nd F1,1end~, ~ne. ~ to~ohed o~ the ~htO ~J,'~n~ ew~l~ation of effects ~ ~Aa~)~ ~id in'tc~l~re~io[~ of e]i~llcGl d~tc~9 ko felt he had l'~ad ~uffl~icn~ly in thos~, s~b~ecZs to b~ well il~fo1~;',~. I said I d~d not thlnh this ~zas suff~ci~Dt ~Incc it co'ald Y~o~ ~;,;~%~;h %h~ ~cti~ItdoB of thOSe %~hO Ira/St ~et~nlly ~e ~oh ~coision~ ~:~ develop f~/rly elahol'ato a~ste~,s for d~811~ ~i~h %he~e co~,~lex subjec~. i dSnc~a~,~, d,~$~ f~'om %hu CaTloor Chemotherapy ~ntioi~l ~e1"~Ice Ce2*tcr i~ ~ic-~c~i~[~ toxlelty and iucffectu~] a~vSi-t~o%' ~ffect~ }le nc~i he ~:0~,~ :~ou~d i:* view of the GC~/;~]) report vh~ch h0 felt rugorto~ r~o%%:idly co;,d%i~:~e~ %;o~,~:. lie ~oell~ves that the illfor~atJ.o]~ W~s ]%Ot eonclusiv~ ~'~'e:'l the %;ozk Of %h~ C~n~e~ In~tit~t~ ~ndlc~%ti~ ei~h~ toxicity 01" ~.tl,.t~or il~c/foctivenesS. ~ told him It wa~ ;,~y impressio~ El'ore gl:u~clni~ at so~o data thief there w~u~ more info~;~atlon ava~l~ble tha~ ol~ 2~- m'.il;~ais, hut I wo~ld look ipto this l%~rther. }~c ~sked if he l,~i~ht h~ve ~l~Ition~l d~%~ if it is ~nil~le. m%~ I indicated I would oupi~ly him ~ith thlo if it proved to be th~ case. Here krlofly, b~c~use of the ~teness of the hour, ~ re/sed a i~u~,bor of q'~cstions ~S to in %,itro and _iD v~vo data on stuai~s c01~¢erned ~'ith the effects of cigarette ~moke O~ biological systeI~Is, l[c In6ie~t~d hc l~d doric ~ n~nbor of studies %~It}l different filters, eo~))a~dng tOXiCity effects Of poOlfle~ ~u~d %u%modlfied smoke on c~lls ~ yli'ro. SO~;o filtcr~ ~ore effective in reducing toxicity ~s meast~'ed by %hls D~'. Kenslcr fro~ the Tobacco Working Croup had vimited D~~, ~r~. r~cen~ly ~.d concluded that much'of the work r~p~osentod dat~ from indivi '~l ~yo~ocol~ an~ ~h~% i~f~icien% ~Iz~%ion Of %h~ d~%a

-5- b,~d ~¢en do~30 tO ~e,'~,Lit ~l~tAly$~is of DAd eo~elusi~zJm f1"o~, the l'osu]t~. • ~ur,~ ir~d~c~tcd thc~ ~; the Dt%Ldles pl'ogrosl~od he intended to })col the info~utlon to~c~h~r into nu I~ro~rlat~ L~2~r~zatlo ~it~le for ~ublioa'~ion ~;i i~ p~.ler. To llJy hl~owledce he has go~c ~o i~ wive ~mrk, aud "~e had ex~e*;slve di~eu~zions again or: th~ l!etbo~ Of-rolat~i~l~'~, the ~j~ vitro data to mcu. I indlcated it wa~ ~;~i~oadir~g to talk about ~'3}.~.t~j3'r ci2arcti¢~, in p~a't, because Ics.~ h~::~rdous sc~:mcd to co.w~'y l~or< ,~D~ro)~r~tc]y that ~d~atev~r'~--dih",~sl~c" hazar~ ~ould wry likely i'r p~'~'~ent, aud hcJ]thicl, di(l not con,~uro ~Ip thIG concept. ~ut v.orc ±~).orti,~t3y, ~mp][c~.tion th,~.~ the i_n.v:i_tr_o data could Imply + ~ + .. ~.ac, clc~-~ uufouz+ao(i. Moreovcr~ I ~tatcd th~.t dc~(:r,~i~,~t~o:~ of cffc, cts of l.~odifie~tion on cigarette sI~okc as regards r~n c*~n be d~tcrmincd o.-.ly from data collected in human pol~lations. ]):-. Luz~k fools that ]ooclfleatlon of biochemical pathways, ~lhich n~.e co; nou to :2a~,y types of org~lisms. ~ncludi~, man, c~l serve as an" indication of the offsets in r.cn. I t,!~reed tbo.t it might he rcoaonable ~..~c~ that re6uction in uy~nide levels might be bencfl¢~l to l::a~ eonp~rcd to the ]limber levels (if~ }}icy_ a}'.e h~5~~ fn_o~vlh). 7 told 'i~ I ~,'6s concerned cites ~b~t his personally ngreelug to test filters ~.,~G.r~erLaps other Imterial ~la' cerises" ~ , i)~cludi)~g those from profit -~ ,~ ~.,,.x ~,~ organization~, on two coquets: (i) ~','e have establi~bed ih conjunclio:l ~r~th the Tobacco Worhing Group a critic~l set of er]turie for t¢.~tini~ g~evlccs sad modifications propo:,ed by indivi(hlal i~vel~tors t~d orc~u~i~mt~on~. ~lov~ver, ~re }lave told all of ~hel~ tbat ~.~o ~:ill not acccp~ their devices or ~odIflc~tlo.~8 for t~sti:~g until after we haw obtai~cd baseline data I~~, the selected assay systems and are reag~v to cater all th~ (rcasol~able) d(:'¢icc:~ or i:~vcntions for ~vf.l~atloll at ti~c z~,y~e time to sssure equity. This equitable treatment now is ~ ~c, ca ~o be upset by Dr. ~urh since he, a~ a :~lember of the i':CI, J~ tcllind a f(~. individuals that be vill s~s~o their dcviec~. I a~ked hLc whether he had develoFcd any means for equitable treatment of ~3~ those who might w~sh to have their r~aterlals tested. (2) I stated th&'~ I was particularly eoncen~cd about this since it also appe~.red t at he w s psri'on~dns what might be considered devel-. op~ie~t~Ll yeso&rch for • • ~ " - -* " 1 lof~t m~glng or~,a~i~%1o~ ~;itb the ta×p,Ivers' ~'~o:~cy c~d even in some cr~es selectively ~rov~ding an endorsement of (~ ~?roduct by a Oover~ent empl(~,co, }iis answer was that he ~as obtain~zg certain information and i~cterials from these individuals which helped him in his own research~ therefore, he did *~o~ see that ~bis was (~ ~ ,oblam. Again, ~ felt I had not quite communicated the main points. /

AD~C=" ~,o:~a d~cu~on of the dlffere~c~ bot~cen ~n~Iv~dual bollc£s ~i~d i~u]iclcs of or~i~.l z~tlou~, ~rin~ ~ich ho cl~il~cd ho va$ c~rt~i~ly o~fi~c ~i~ ~o~i~ of all corF~.~pO1~den~ ~o ~n~ from h~ on L'Laet~le" ~-ot ~po~ ~o ~c eonL:ornc6 ~hon I ~id %hat ~ nccdcd to keop tr~¢k ~f ~c~ ~ctiviti~,~ ~;~d f~4o~ ti~c to tlmc %hat it ~ould D~ob~.bly b~ not bc i.n ~rc¢;~% ~ith h~ v~¢w~. '~Ic d~d ~ot ~eem %o be dlct~d Carl G. Ba~:er, M.D.