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, . . ~ - . .. . ~... . . .. . .. .: ,.•....,yi:Mt'•': .Y: Xx/ .y„i.. > , Statement of Ronald E. Cape; Ph.D. -~President, Cetus Corporation, Berkeley, California at the Annual Meeting of J~; z ts. Op n '`c the American Association for the Advancement of Science "~~¢ Session on Recombinant WDNA Public Health and Biomedical Research Policy Washington, 'D C .. ~.:. ..: . '~{r . .,. ~t YTt. JD.'f~lri .! ~ L11s .~ ~ ? a i.Tt~ ~ .+rs~ M1 t r r ` t, s. ti ~. ~ T 1 .r-"C ^. ~.L$7y'~'# 1; u : February 15, 1978 ~. 91W J~IyY Ff5S,1. .E.•, T T ~}r1.i. . , . ... ......• . . . ' i'. •~ . '} . . ~ ' I want to co~rer a few points briefly. I think our differences. are blown wa out of ro t' th t o r ion k y p p a v+ , is, spea ing only for company Cet / yu f 13' •~' ~' fn`15i J~ S S1. JitJ ; »r c Corporation. I can t speak for anybody else. ~ --r- . . + .p ~ .ftsZaFa :`f~~".C [4~s ^J:`CS' ~i ~ l !a • ••ta ~ .~ ! 9 ? . t t '.3t1 o J;. :SJO As I said, our differences are wi~ldly exaggerated, and I don't like „~ ~' ;~:~`•,'•3^~ct3f3at being a parpta~i.c~xipant-~ in~, someone else's Games People Play called "Let's ~ +~cr a.i ~F :i.?..'y''.;+:..LG7AWUS'.~ :'.v,.ar>~ ~5 ^P^un • ~_.s You and Him Fight." We do have one fundamental difference, and I'll get - ~`*a°:~.?~Ap'CS'.'t.~^rr.y~,..}s_,. -to that'shortly. But I want this audience to know that, in my opinion, v>kr • u rt~:~d+all.'3!!0'3 :,.t~: a~ y:f ,-.,n0 4i there are a number of red herrings Let me briefl identif them' ~r. y y • t-•~ Red herrintgJ number 1. ; I heartlfear expressed about the hazards of large- 5::;1Y`~}C~'`:,~'/J i`, . '%t"t~`TN~ ~a r? .t .t!y `I•7 C scale industrial exploitation. The fact is that no one;'to my ;~F..'. knowledge, is undertaking or soon proposing to undertake'large= a~~.. ,"'-scale production of recombinant DNA organisms. ±-The NIH Guidelines " ~.> r t ~S.T+~ ~ .'a~`C:.c"lLta7~ ~ .J3~:1~ ~! {3 Dir> r ^r G.. `ts f¢Yi ~', :a' t.r Yr a , k~IM ~-r'A prohibit such activity. Anyone who proposes to violate this prohibi ~. tion shoti~` be a' par3aM. ` A's . I understand~it, and fiy kno wledge.a 'is s:'X #?+~i t} ~r4xC~~ IfY '~J~'4w~xfi~f'~ about the •g~xae as=•yous~s xegarding the specifics of 'e propose3 n- fi r, n *~ n. >' '~n ' ~s.. legislat..iion~, the Secretary of Health,e-Education, and Welfare i s J-,t permitted to allow exceptions to tYienlo-liter limit only^if some~9` r~ ~ compelling scientific reason persuades him that'this would be a"'"`s ~ 1C1.•~ biM .1"i:t.i.Wf..y~.. ar i...- ....t; T S rtt+ ~ .af•wr-f~;...'}. :.~_'r' ~' good idea: I hardly think that somebody's desire to'make~quick !U ~: ., ,: . - . , ... - ..:., . _ ., ... : .u. _. . t52 t-if c?r. profits will represent compelling reason to the Secretary of HEW.'" ' Y 3S This red herring, that U.S. business is hurtling forward, recklessly, N. .:.-.,~-.. and should be halted in its tracks, is almost laughable. "'I've O ~~ . ' .~1- .. ~ . . ^Y:. ~ personally been an evangelist in this field for several years,•and .. ~". if I have one' overwhelming impression,f'it's how incred.ibly conservative ` U.S business has been, how reluctaat it has been to become involved ?S3'.5 in this new technology.~ Clearly, some people here either`don't' agree with me, or don't believe me, but there it is. h. f. }r{y

+ 4. av ~ ng to a ere to the NIH Guidelines. The fact is, as far as I r=; . ...r,~.; ~u.' _ 4:,. ..,. ..: ...^ ~t. -Y^~yT . C .~ , , u .. . , . , . : . A i ' h dh Red herring'number 2 I've heard how the private sector"delights in not . legislation,. ~ And xagain, ~speaking for ourselves~ ~w,e~~a~e already controlled by local council action both in Berkeley and i'n'Emeryville ~,-.. , California. That is where we do all our work ":We don't'work in C+AV.L. ~. ...: ...: _ :-er university laboratories and w don' t k , e wor overseas. Arl ta i.- ~rt.; t ~W X ppy'i wn ?-W,~6id '9~ia_4: °r~ _~'i,.~b ' 1[i <.. - ' t?~ ~T28YJ ' w r .~:..: ~ r - Red herring number 3. People charge that secrecy-and security associated .2ec~..:: ~faas: : af :q~~ :cn ;ruo ~h;~ " 8 -,. 4,.., know, it is so_adliering, .and', more important, we are_plead'inq for . lt with industrial work will resuin less stringent administration ~ of the guidelines. -Again, speaking for Cetus, and drawing on my own observations of work habits in university and in industrialp + ` - .. r +. ...... .. ...- , .o «p.. .. •...:-: t . ~...~..;~ ~•~. labs, I reject this assertion. We are more concerned with prudence, . . ~. .. . .; .. . ~ . , ~ and less with haste than academic labs We're not after Nobel )~-4uPrizes, or even Ph D. theses We're after profits but I don't { i really believe that those profitsJwill amount.~ to much unyti'~'l~{ th~e.~}~ ~yj:.' S. S . .y . . ' ..ll.~..l.r : . ...n' ... . ~, . ..l..r...:.-. ~..'. ......f.a. i. ] '.ni. ~ /,....a.,M }~.-.'.+~},'IL af~Y"~if.r. .at'..i'. ~' 1990's, and maybe even that is'optimistic. But I am~certain that r,- ~ those profits will eventually ^come,y jand Jthat` they will,b~ery-~ i;LeiR ,., - . . 1ar. g w .~ e. That is hy we are careful to do all our work in our own a.: facilities. That is also why we are proceeding delzberately and thoughtfully. And that is also why we are so fortunate to have ._ ~ . .., ._ .. •~7i ,.~7~..: . ~iL .. r4 investors whose time frames and view of the future coincide with ' our own.YsSo;we t~,iink }t makes senseL to our s~ratrgiesJland . ..• . _ . c: : -..,-s . 5.,., °..;a7 M.'. entirely believe wkjen we_ say that we are irite~st~ rin , the ~]~ong .. v -.'~ $8*:J~J]I~..3';3 r 7 ~~C Lfi 'view, not 3.nn imirediate goals_of headlines or• money ~-we've 01ready • .. . . received more than enough of both. For t~ie 'record; 'blir• Taf" bV industrial investors are Standard Oil Company'of'Indiana'Arid-Nat_ional Distil],ers &_Chemi'cal Corporation.'`I am pleased with and proud of .-their involvemeat, and happy to say so publiclj~: Red herring number 4. This deals with federal preemptti:on• di4- loca- < _ _....._ _.._.... .._ , , .._..~ ~_ rc ~> .. :,:z.;' ' initiat,;i.ves.- As, I,4 sa~d before, we are already covered by local . "'-•--.. ~....._... . _.. _. :~.i. c =f ,action,•rso~my comments are less defensive, perlraps. I::don't think• ... ..-as ...l.L . .. -_ .1. .l. .{J'CJ ... .•.<i.~ J'_... ' r her back on the lori -standin 't d an ' t t t h w s r s o ion t' a r i ~ . ~ g g i - t yAne an a u 1_..,:: ~ ._.;_ . ~. .. ~..: . .__.: : ,...; : ...t :_~. :.'J in this country, going back to New England'towri meetings,-of citizen .. ~.JU ~..~ __... Ju. si. C10~^r :IG . . . 4l -'IG 5"13.1.7 :tilZ' ..~ts .Ti l:.tI o.'`.. . . . ' + -. . , . .. ~ _... .'ff i:....~.iTe~' .....: ] .... .. _ .. i .~<_ .. .. t , ;.V twa t 4.3{ OYTi^jF~i.~:.+ 8~' E td? i ~ M±'e-_.:~'f" 470 . .,~ Y N :t. 0 T. fs : ,

N R } 5 .e.F.. _... 1'i A `~ 1 .q,~~J.~ h41G O 1 ^j .- F 'P ~F ~ _, ~a r . ~c. ~~.~ 1 ,ar .Zf ... ~ ' ~ ~'~F'.~7e•~~~ participation in things that concern them And i further agree that if people are possibly~at risk, it is those people who should ~ ~.~y ~~ e : •w.I.e '.3.~ ... r -,..- .. ...... .. ..i. .. -... _- _ ,.._. ..J.a.~•.~il.~',~.['~~ "F-J .^ thave a key input regarding whether the r..k isk is one they are willing to t'ak`e and that what they should look at is what the benefit is d' ~~i 8 y~ -• ~: ... _ Ngoing to_ be to them. I ~! f JslaT`~ nxC r~ns~ ~ i~.~ T° ;>l ~r ~ 1r rr '~ Yi' ~i* Z« ~ i~ fl X g r 4~ L ayP ~ Sa ~ir~~~ ,t.`.7.:u3t.1 wh~~a.,~t~ really lies~behind the drive of scientists to have relatively ~~ ~~uniform~r.r rule.s~ apply across the nation is the fear that otherwise ~_~ oa'~~•-~+L .,..:......+a ..t, .. ..}, ._ . ,... .';".. ,~..''. ..-._.... ...,,_• . -. ~ . '.~ CT~ ~, ,; we' 11 ~ get a hodge-podge,y a Balkanization, _ of regulations, arid a ~ w r t Sfi'' t'. ~very undesirable pattern of migration of scientists to permissive ~ areas ~a kind o.,f/GreshaN's Law. Anyway, as I said, we already v1. >4~°Lq have local rules in our case, and I think the issue is a tempest in ry~ S ~ a teapot. ~ ~ ~; ~I a`'~'' .. f~"., y. . . . ~`. '-- ..4i ~V~ Red herring number 5.~ Leave the scientists do their thing. The pursuit {4 G..; ~ of knowledge is an absolute right. ~ This is more than, a red herring. ~- It's a debating trick~,the straw man. The opponents of DNA research ~~ ~; ~ .• talk about it €ar more than the- workers in #he field. - I think it ^Y1M is nonsense. . ... ' ' _. . . . , ~ . ~ . . ~ .. . - .. , . . . . . . . .. ~ ~ ' ~ . . . . . . ~9•~>:1TY Red herring number~6. ` This_ one ybothers me the ^most.i 4t I hear ' it, frequently {Y ~ stated, and no one argues back, that businessmen are motivated by ,:~: ` profits,; ar~d •ther~efore ~o. the logic goes, are not to be trusted, ,: :~~' ,~.,r..;y'aYG~ r4 fi '. ~ or believed ~1eA1, ~ t,hink that a healthyt slceptici= ti is appropri'ate. V t,j::'G'4 ~OfS' A r.' ~: when an e.engaqe-s, in aRolemic, but if we cari 't cu't`dawn on 'tne ~~ ~ . ~, ad hominyms and deal w}th the content of what each of tis says," r• >s ~rW ~ ~ ` a~ there'e h.t%le hqg$11Qft, , • ~ ~ I`ve lived in both worlds.- academic and indusfxial '='and•there are ` similar dollops of good'and bad in each. That "shouldn't be surprissrtg. .}•'. f~~. .. . .. . ~. .; . - ., ~. ... . .~ . .. '. . .. - . . . .. . ~ ~ )..- i Both wor,lds, ;are, oc~Wied by people. ~~. ~- `w .za _ So it is my feeiing that ,a1_though we may be far apart' on` one issue,~ which I'll get.to in:a momqnt,,we have a common purpote in=proceedinc,p_'o:, . . . Jl."., . , with prudent, ' de},iberate,, conservative caution. Buf I'thiri'k we 'cah •`arni -*:-} - .. :.: . j should proceed. '.~ . ' . N L .• ~ ~-- :.'.* ~ w. ., A

r g p y ogy ~.. try$y,'i?'.~r,r~}~:~t..~r":~~_. ..:*~~a, should do so in the case of this particular technology.'" 'I believe that~ many in this room today feel especially keenly that the private _ sector 4 ~ r. s . .~- ` -,-~ I .. ,.:.+. , ,_ ... . . ...•cu ..la ...r .,.: . ,i Now, finally ~o think many in this part i audience may c~isagree''~ = #;~ ~5 Y r : ~; with me when I~express`my conviction that the'private sector -fndustry - v,c~4 since it is specificall ~ y confi ured to harness and ap l technol ; ~ 9 t., ~~~ ~.:~"Sa ~.wt>~1<!"•,r•1~. ~~,,• ,should not have a roletin health care delivery,' and hence,'should not be"" given the task, or allowedto"take on the task, of using this~ei technology , ` ~r~S! •. ~,4+.~ to produce the medicines of tomorrow.}.5.~ I won't 'bor'e you with counter - ~~~~-- • ` . -; . ..,.. . 'i•..a>.:.,'„:_, .... . .,~ .:r..` ~+.!}., " ' r ` arguments; I suspect we haveah hdhth'anh ecear eac oers resons eoug ~ .' .... , , , times that`no new wisdom will emerge from my enunciating them now.• ;.Ari ~ ~_ ~_{d'f~'y~ . . r~ 3 , ,.. I'm sure we all know"that the steps,.•.•to exploit this technologyt industr3ally , ~~'~ . ~ ~U~{s»ie~~ f.f:: 7: .~.. . _ . _.. -....... f .:.. l d k e r are a y ta rea ing place overseas, in some cases with th deliberate an d conspicuous help of the corresponding, 9overnments 'i!`+t ~...:, f :,~ ~ .....•~'~~ %j~~T~_3•~ y~.i±. •.. . So my plea is, please don't be so apprehensive,~please don't judge tis guilty riuntil we're proven'innocent (although again,'we both need that , h t r_1T r"' healthy skepticism) , and above all, in order not to compromise the ~' important larger issues of public involvement in sc'ience'and3oth r nlalor ., ; policies please don't tilt at windmills , . , ~ , : . ~ . . .. / 5 ' , 5 ~'~ A v dt ``; t. - x~~~a~i~j~~is~~g~~~` ,74 ~ r-'JV~f :TV". _..:.-.. _ . Ts a9 , : ~ad es ~t soua~ - s.. ~t.:` '~ J ~1" a 4 +q $ r-. .~; r ~ ' . ..• ~ . .. . .. s~....{•~>u, _ . eai:J F:V ~'..a3!'~~-:a:. s"-,.i L~r-' JiZ3 D -,a f4 Gf::5 ::.i3 ~j!) ... ~ . ., _ . . . . . ~ .. t J:H7 . . q a `' ~il $!? tf~£~ ~t3 .l r ~3 !2 .a''1 :1i~.~Q7 S'7i ' c,=:6 . . ..• . .. . . ' ~ '..! : t i .. ` ~C'V'T Lastf{.year, at the National Academy of Sciences Forum herer`in Washington;°~ ~ la :~ f.tsaaef a.• !.y f:-^r• , : ~.' K. '4 S J r Ti J' someone made a wise observation I'd like to repeat Hequoted Mark~,,, i n 7? L_U~~ ~~t7P~f~Jr y ~ k:- ~l~i~.t'..aawivl.v..~•1~"'S.a.:y r ~-~ ` ~l~llYi1~~ x. C O .: Y 7A ! ~-. y