Tobacco Documents Online

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~ I S'ide Fffects From Sick &nkkgs 1 g~0AlX1~ ~ `"~ I: ~ ~jtl g ~ . ate I Smokera are Mt into the atr+eets ETS AND THE EPA - BEHIND THE HEADLINES HERE IS A CONSIDERABLE ." . , and grozuing body of scient9ic opinion that there is no statisticallylsignicant increase in the potential risk of lung cancer in nonsmokers exposed'to environmental tobacco smoke (ETS). However, a draft_ - . report based on spousal smoking in the home released inj'une 1990 by the Environmental Protection Ageruy (EPA) claimed E7S o, f leri referred -to in the press as "secondhand smoke ",-or "passive smoking"--is a cause of lung cancer in nonsmokers. , Although the EPA announcement. made headlines, few members of the general public realize that the EPA , draft report,did not present new data, but was actually a review of some of the existing studies, many of which have been disputed by a large number of . highly reputable scientists who have . criticized both the studies themselves, and the methods by which the agency

arrived at its risk assessment: (See "Gti'hat the Experts Are Saying," page 8.) In,its draft report, the EPA claimed that ETS carries a relative risk for lung cancer in nonsmokets*of 1.28 (a relative risk of "1.00" means there is no statistical risk). To put this into perspective, one study has reported the relative risk of developing lung cancer THE EPA HAD TO associated with drinking WORK HARD TO BTeen tea to be 2.7, and COME UP W[TN another concluded the AKY tKCtEtsED . relative lung cancer risk RISK AT AU: reported for keeping birds as pets is~6.0! - . Epidemiologists consider relative risks of less•than 2.0 to be "weak." (S~e "A Word About Risk,"•page 7.) But even a relative i-isk of 1.28 for ETS is highly questionable when one• ~ considers how hard the EPA had to work to come up with any increased risk at all. Why has the agency worked so haj:d to come up with an increased risk? Perhaps the. answer to this question lies in the political agenda to eliminate smoking. As one example, consider the response of Mr. Michael Gough, Manager at fhe US Congress Office of'T'echnology Assessment, in a written response to a request for the EPA to consider the conclusions from the largest Afl~erican ETS study, a study which disputed the EPA's finding of an increased risk. Said Mr. Gough, "I tend to agree with the thesis and the general conclusions of your letter. On the other hand, (.:.) anything that reduces smoking has substantial health benefits, a I t I and making smokers into pariahs, for whatever reasons, does just that." In ifs rush to discourage smoking, the EPA's draft report is filled with inconsistencies, methodological errors, and bias. For example:•  Eighteen of the 23 studies consid- ered by the EPA in their draft report, show no statistically significant association between ETS and lung cancer in nonsmokers, which means that their results could be due to • ' chance. 0 The five studies that do putport to show a statistically significant increased relative risk were alliconducted on mainly Asian and Greek populations, where unaccounted for dietary and other lifestyle habits may have affected the results. -  Some of the studies that claimed to ; demonstrate increased relative risk were extremely small; one study had only six subjects. Meh, in particular, were largely underrepresented in the five foreign studies that claimed to find increased relative risk. One study had only two men.  One of the largest studies done in the world, an Asian study, was released in December 1990, and reported that nonsmokirig spouses of smokers actually had less relative risk of developing"ncer than nonsmokers I married to other nonsmokers. One of the authors of this study was a member of the Science A7ivisory Board : evaluating the EPA's draft report This. member never mentioned his own study during the entire EPA review.

 Two additional Asian studies - release¢ around the same time also . reported no statistically significant risk for lung cancer in nonsmoking women married to smokers. All three of the new Asian studies adjusted for cultural differences, and found that Asiari cooking and heating techniques posed an increased risk for the development of lung cancer among nonsmoking women, independent of reported ETS exposures. ' m The EPA originally excluded one of the largest U.S. studies ever done on ETS, conductedat Yale University by ONE OF THE LARGEST U.S. _ STUDIES EVER DONE ON ETS~' FOUND NO STATISTiCALLY . • StGNtFiCANT LtNK BETWEEN ETS AND LUNG ' CANCER IN SPOt1SES. Dr. Luis Varela. A report oq that study was published in The New Engfmui fou.rna! Qf Medicine. The stucty of 191 subjects found no statistically significant link between ETS and lung cancer in either nonsmoking spouses or coworkers. 0 Although the EPA eventually agreed to use data from The New England fournal of Medicine article, the EPA report's condusions are still being distorted by the inclusion of a much-criticized,10-year-old Japanese " study-the Hirayama study. The EPA describes Hirayama as its "flagship" ' study. Yet Dr.-Victor G. Laties, Professor of Toxicology at the - University of Rochester's Environ- mental Health Science Center and a= membeY of the Science Advisory Board review•ing the EPA draft report, said, "I would drop the Hirayama.study." 0 I i i And, referring to Hirayama's reported risk ratios, Dz Karl (Jberla, Chairman of Afedical Informatics, BiometrT, and Epidemiology at the University of Munich, said they "could be a matter of chance oi• ari artifact induced-by some of the many problems occurring in such a large study." IN ITS RUSH TO BRAND ETS A "KNOWN CARCtNOGEN,- THE EPA IGNORED MANY CRITERiA IN tTS OWN GUIDEUNES. 'A'hen asked to provide the raw data ' from his study for independent ,examination, Dr. Hirayama delayed for more than a year and ultimately said he could not produce l,iis iaw-data because they had been destroyed.  In-1986; the EPA issued internal giiidelin€s for evaluating carcinogenic risk. In its rush to brand ETS a"known carcinogen; the EPA ignored many _- , criteria in its own guidelines. •  Two studies that came out while the EPA was preparing its draft report were ignored by the agency; neither showed a statistically significant relationship between ETS and lung caricer in nonsmokers.  The EPA, which, itself, has no legal authority to regulate in the indoor environment, contracted with a private antismoking organization to write recommended workplace guidelines for dealing lv',ith ETS. EPA released these guidelines at the same time it released its draft risk assessment- before completing the process of receiving public comment, and a review by a panel of impartial scientists. The EPA was all set to issue guidelines on 0 fib

dealing with the "problem" of ETS before the EPAs own advisory board. had even had a chance to determine if a problem did indeed exist.  The EPA has treated other environmental substances differently. Does this mean the EPA is operating under a political agenda? Case in point. Recently, the agency investigated electromagnetic fields,(1.MFs) and diesel emissions as possible carcinogens: tllthough thedata against both were arguably more complete than the data on ETS, the EPA refused to dassify EMFs,`•and woidlc( only label diesel emissions a "pilobable" J ' carcinogeri. B To get the results it warited from the- data it selected, &e EPA employed a. META-ANAlYS(S ~IS Ni•"APPEFS- AND-OR/WGES" MODEI. THAT MANY SCIENTISTS FiND QI)EfiTiQNkBt.E. process called "nieta- . analysis,"- an•"apples-and- oranges" model that many _ scientist's find questionable. The resizlts. are based on small d w shQw weak samples an correlations. (See "Tennfs_and Meta- Analysis; page 10.) ~  When scientists outside the'EPA assessed the risk of developing cancer " from exposure to EMFs, a.relative risk- of 2.0 was established. Why did•the EPA..use meta-analysi;s for ETS,.but not '. for EMFs? + . v A WORD ABOUT RISK DIb YOU KNOW THAT AN epidemioiogic study has reported that the relative risk, of developing lung cancer if you are a construction worker is 1.4, which is higher than the overall relative risk for lung. cancer the , . EPA assigned ETS? Other substances and activities that have been identified as possible risk factors for lung cancer include car ' exhaust (1.5), physical'inactivity (1.6), and keeping birds as pets (6.0);•all ~ ;report h3gher•relative risks in at least some stu ' die* than.l~APA-rlairns fQr • . ETS. - Tke faCt:is; statisticaL'analysis is - , ' niakingat possible for epideniiologists to identily more and more possible risk factprs for certain diseases. Virtually ~ every activity can be'statisticaUy ~associated with disease-if only you analyze it exhaustively. An editorial writer for The New ` •En.glandjournal of Medicine YIMAttx : advocates puttirig such ~ ' £yW ACTIym, weak relative risks into `-.• Cut sE . perspective. A recent • STATtSTICIlLLY, editorial states'that while . ASSOCIATED . .there is no cLuestion that wITN DISEASE. : epiderniolagic studies are • ."of growing interest,... it is important, ,' however, to.remembe{• the pitfalls in . interpreting them and to be cautious in advising•patien'ts qn the basis of single or conflicting studies. "77jis is Particularly trut ofstudies that - jiurport to show only zueak associations between exposures crnd disease. "

. ~. - •t . A relative risk of less than ~.00-is f generally consiclered "weak" by epidemiologists and, as noted ~ previously, the EPA has assigned ETS a relative risk of only 1.28. Clearly, as the tools of,computer science become more available, and our ability to . perform statistical coxnputations increases, we must be able to identify legitiriaate significartt risks and • distinguish them from statistical :•v anomalies. ,•~. ^.- 'TENNIS D;.... ~ METQ-ANALYSIS" T HE EpA ARIEtIVED A"ITS RISK` assessment for ETS by using i roces known as "met; analysis." p3a This means that iristead of evaluating ; ' Mera-analysis would enable a tennis . a sort of weighted •average. - ' • • - '~ ~z•~ ~o4e.~`~c i 'Ofave rago NmTmjs ~ misdas$ificario c e ; s - - „ ` ~ ~ .~~LMifb TO '° :•rr ,t n' r ~ ~ t uCOO±; - ~ ' .. ; _ . • ~• . .~.. --• ; . ~ , ,,,, : ;: . ~ _ . ~ W . ,. '`~. . .. . ~; wheri • ~ • . . ;f ~- ~ .~ = ~. ~- .. ?.. ' ~..,,- ...... _ ' ' ,~ ~.: '.: :2.:' s k Y -• combined data'from all 23 of the : _. studies under review apd came up with each study individually, the EPA W.imbWon.even if he player to win at lost three out of tlie fivesgts: -If the player, won the frst two sets - f-1; 6-I, and then lost the following with inconclusive or-marginal results and manufacture a finding that,, "overall," the studies were statistically= significant It ignores the very differences that the scientificmethod is designed to control. the firsf two sets-liad won the match. By ising meta-analysis, a researcher can lump togeiher a nuinber of studies ~ .. fiiii-ee by, scores of 6-3, meta-analysis would dictatg that the pr wu~ning m ' • . _ +:.~` .'1. ~~ • , . ~ i" ~•.•' Y Without this process, the EPA would o not have been able t claim thzt the • data a ainst ETS were si nifi t g g a Dr.; Joseph F'3eiss, Head of'the Division of Biostatistics at the Columbia University School of Public Health, criticized the EPA . ' . 1 . on ETS. . - ~ ~ DtFTEMcM ' analysis in its draft*report itls vFAY for resozt9ng to meta- •~L . "Biases aue. to Soin- THAT THE of a buil'dingfs t>ccuparits: Individuals founding, Qr due. to _ t 4cluffm~>,•. ` ' ~ id everYce acros t stizdies s : , a ~ ilt lnf e tce oricx" ~°~= ' ~ ' w ~ t e ~ r r,y k f , • - t. - . . . ~ - ,t ,,, ..y In-other words, whether,iednis t~r=~ a1 : t = science, .the otitcome depernd~ ireat ;~~ deal on'who is keeping scqiG.' =~' =~ ~: ~~ ~ ~; .~ t-`»:s., , ~ , ^ SfCK BUI LD ~IG . t SYNDROME ~. NIOCUSING ALL OVT~S „ -- : . _ . . ; attention oji,ehpiroinjienfal tobaccx%-" { smoke~ the Ep1~.ignoFes.'tfie v`ery %v~` . r`eal pi•oblem o£ incl;bor Or' Yollution " ` sic~IcbutldingsXr~rom~ SBS): }. M Y.• .\'` ~ ate : S$S occius whea bad ~ , t ' . ven ilation aridindtr poli~ltants lo ~ comb}ne.td affecC'aiiverKly've hea~th • who work iv buitdings affiicted with SBS often complain•of headaches, fatigue, nausea; dizziness, and recurring flu-like sympton'Ss. Accotdirtg to indoor air quality .experts, ETS is not a major.cause of, complaints relatirigto SBS_ Studies of

us _.as.'a distraction frc~in'serio heh(. t#ri'eatA in iridustrial occupations." `- ` - ." '; OflierIriiioor air poilutarits that cari . ~ - i ~ ~oiienibnte to SBS,includc.bµilding . WOOR AM ri3ater`iai~-and ~- - offi`ce equipipent,,supplies • QU-~, ' AL1TY ~S gjtY and Clearu'hg prpducts,'" ". .". t` :' E7Y'i DOFS xo7 m old spor.~s atfergqn.'s; ~ ` ~ (:Ottt'Kte(tFE• ` and infect~ous-agents.: w,;~'• stQMFICAMM Ii•ori cally, the EIjA's own ' TO SOSofflces• ir; Washington,, , D:C., silffexed from a . -- particularl~ bad•ca'seof SBS. • _ Interestingly, the EPA originally, , presumed that th~ culprit was ETS, tesulting in a smoking ban. ~ Subsequeintly, the foc,us switched to ~ 4-PC (Phenylcyc~ohexene) frpm riew due ttSottiet factors: 31% of the" -. : . . ~. ~ sEudy, for buildings ~xair 'Zied 419h ~ ptarniple, had pibbl'8ms•sSe{naiing frocti`~ :'~~: ,- • widespread a~lergenic fi}n&i bree_ding 41 t ~ 4utr•conditio;iing; r : t ~..: si iil Io~la' ` ,p~rsit~tsk.tngfn tte wi~ng pce~` S ' ' . fdlr the `s ~utipri~othepipbiem: This ` - _„': sl~tualioFi.recentiy led~3r. Aiten `«,~ } •Crawford, fot-rqeily the Diiector Pub,lic'Health Services ofNew.South~ '~~ ~V~les; to ut~e• tthat "Just as ETS ic :' beiqg inade a scapegoat for*sick ., - . " - , large numbers of buildings conftcted ~ s ' both by.private'companies and ' ~ agencies such as the U.S. National Institute of Occupational Safety and Health report that pnly a smalI fracdon 'irsie- of complans--on 21 9!o',-coul¢ be ' ~ .` attnbut.eil tp toba,cGo nioke: A far: ', higher percentage of complain.xs were ' ` building syndrome, iir offce ~.- r= workpiaceg, so #t•is apparently servinig Aeas~ui np~ts~x~o~ not j~k'igec~ ~p scfei~iifc ffa~ .=-. ~. . ` Moiov'~ides uidi~oe~~tllx3e~ ~= ee _l, szc,`^~`~'`tc • ..y4~.'"~.. j. . °novuial Eozlii1qoY1s 1E !S is nq't rk '-='w. . . , , ~ . , ..:_ ., :. `-3'i&niScaiit facior iri-indoox aix`tq~Yality =`"; ! Nevertheless; there'are people who _~•`•: r. - are siinplq annoyed 6y cigarette smo' , ~ , atid these people deserve to b~ ••~ ; .1~t',,con1a2{~~3f~.~ -61 ! . : [lnlikz .'mar~ c1 " `w,l}icF~ au e noi toncfusiyely supp~i '_ by the avai~le , `~ s' t~2~t SOrtie pet)~1~ ~~3 i}~ WZt}K fb ... r . ' -hat cau` an sh ~ d Ould be ad~sse,d. _. 1~ ~o'~~ if is an'issot4~~ that r=u~ 5e sIvec~~d : accor9nodatiori`-9n,d' ci511-nifiIX'sense ' Proviaintig~a smoke-free public'' d' r environmeut for thase whoesire one . does not mean that all public smoking must be banne."d One-thixd of the adult public chooses fo smoke: The rights. and preferenres of 100 miilion - -European smokers are just as worthy respect as-those of honsmokers.

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