Tobacco Documents Online

Investor's Business D • i • Clrculation 155,000 r,,.,„,„,.w„„aw,T NATtONAL 1SSU E IS EPA BLOWING ITS OWN SMOKE? How Much Science Is Behind Its Tobacco Finding? By Michael Fumeato !n Los Angeles "Taken together, the total weight of evidence is conclusive that environmental tobacco smoke increases the risk of lung cancer in nonsmokers." So declared Environmental Protec- tion Agency Administmtor William Reilly at a news conference earlier thu month, announcing the impending re- lease of an EPA report attributing approximately 3,000 deaths a year to passive smoking, or environmental tobacco smoke. Yet many in the scientific and mcdi- caI community say the data the EPA cites does not bear out its conclusion. While virtually all scsentists agree that smoking is unhcalthful - both for smokers and those around them - it's the degree to which smoking is an- healthful, and the way the government musters its scientific case, that raises questions. Some scientists and policy analysts who say they couldn't care less about tobacco company profits or even the rights of smokers are worrying aloud that the EPA report is paving the way forjusuifying new health-based govern- ment regulations and programs without any real science behind them. Said Banner Cohen, editor of EPA Smoking Gun? Relative rlsk of lung cartcer 100 General population 2,200 WhHa male F; - , smakers I+ .~ 1,200 Whitelemale i smokers '~ Colorado miners -i exposedto radon gas 119 Passive smokers 6aaM: EPA nKa~ nwrN CaM, rm.,amc.caes.q Watch based in Chantilly, Va., "It's now open season on whatever contami- nant the EPA chooses to label the killer contaminant of the week, with the etTect that once again, Americans are going to be stampeded into fearing a substance for reasons which upon close inspection are scientifically indefensible," Yale University epidemiologist Alvan Feinstein, writing in thejoumal Tosico- logical Pathology, said he recently heard a prominent leader in epidemio- logy admit of the EPA's work on passive smoking: "Yes. it's rotten sci- ence, but it's in a worthy cause, It will help us to get rid of cigarettes and to become a smoke-free society." "TBe Newspaper For lrnportanr Decision Makers" Thureday, January 28, 1993 Another critic, Alfred P. Wehner, president of Biomedical and Environ- mental Consultants Inc, in Richland. Wash., said: "1 did work for the EPA in the past and thought of them rea- sonably w'ell, but when I saw that report. I was reall_v embarrassed, It was a bad document." One thing both sides ngree on is that the direct policy ramifications of the EPA report could be tremendous. "You can bet your next paycheck that OSHA nhe Occupational Safety and Health Administrationl will ban alI smoking in the workplace," said John Shanahan, the enviroomental policy analyst at the Heritage Foundation. Although. in unveiling the report. Reilly expressly referred to cancer in children and in the workplace, the statistical analysis in the EPA report actually ignored the studies that looked for such links. Rather, the EPA survey is based on 1I American studies of spouses of smokers. The report discussed, bur did not put into its statistical analysis. the results of 19 other studies done outside the U.S. In its analysis of those I I studies, the EPA found that there was z"statisti- ca(ly significani' difference in the num- ber of lung cancers suffered by non- moking spouses of smokers. equal to 119 such cancers in nonsmoking spouses of smokers compared to 100 lung cancers in nonsmoking spouses of non- smokers. This finding of statistical significance allowed it to rank passive smoking as a Class A carcinogen, the highest risk ranking possible. Statistkal slgni6cance, while saund- ing like arcane academic talk, is actually quite important. It Is used to account for the possibility that something happened - in this case the 19 additional lung cancers-bychance. But critics say that, using its own previous statistical standards, the EPA report shows no such signif~cance. "Frankly, I was embarrassed as a scientlst with what they came up with, The main problem was the statistical handling of the data;" said Wehner, who headed a panel of scientists and doctors that analyzed rhe draft version of the EPA report for the tobacco industry. '.Yteta-Analysu' One aspect of this problem, say crltlcs. Involves the combmation of the II studies into one big group - what the EPA called a "meta-anxlvsis," The EPA has never before done this. Critics say such combinations may be valid. but if the studies weren't done in the same way, the results will be like comparing apples and oranges and pears, Not everyone agrees. "Metaanalysis is totally fair; ' said Stanton Glantz of the Institutc of Health Policy Studies at the University of California, San Francisco, "I review reports like that for the State of Califor- nia, and the work the EPA did is absolutely first rate, onc of the bcat pieces of science I've seen about any- thing." But W'ehner said the study was faulty. "To get scientifically valid data, there are very strict rules and requirements on how and when you can apply meta- analysis, and virtually all of them were violated in the EPA analysis." he said. 'Confidence Intervals' The II studies together actually reflected 10 studies that showed no statistically significant increases in can- cer and only one that did. When the EPA says that the weight of II studies showed harm from passive smoking, it really meant one positive combined with 10 neutrals, More important than the use of the meta-analysis, say critics, is the EPA's use, also for the first time, of a less rigorous statistical analysis. Epidemiologists - those who study disease and accident patterns to estab- lish why they oa;ur-calculate "confi- dence intervals" to express the likelihood that a result could have happened strictly by chance. A 95% confidence interval means that A re is a 95% possibility that the result n't happen from chance. or a 5% possibility that it did. Until the passive smoking report, the EPA has always used a 95% confidence interval. as have most researchers doing epidemiological studtes. Indeed, all of the individual ETS studies were pub- lished with 95:'a confidence Ntervals. Yet, in its averaging of those ETS studies, the EPA decided to go with a 90°Po confidence interval. "That doubles the chance of being wrang;" explained James Enstrom, a professor of epidemiology at the Uni- versity of California, Los Angeles. Reilly said simply: "With repect to the confidence interval, we have here a 90% confidence level, And that was- in fact, what was recommended to us by the scientific community as appropriate to this data." Repeated calls to the EPA to find out who in the scienti6c commu- nity had done so went unanswered. 'Hairsplitting' Factor Glamz said the criticism of the change in the confidence level is a kind of "hatrsplitting that only professors care about." Many epidemiologists. however, dis- agrtt. "In most cases, a scientist would never do this sort of thing;" Enstrom said. "IYs surprising that they would try to get away with it." The bottom line is that such "hairs- plitting" allowed the EPA to come to a totally different conclusion than it would have using its normal method. It could now de- ctare that the m- sults of the American studies, when lumped to- gether. we 'sta- listicaIIy significant," a term of great impor- tance to the medi- cal community. At a 95 % confidence William N.Illy ]5e

interval, the result would not have been statistically significant and the EPA could not have labeled passive smoking a type A carcinogen. only one major newspaper or tele- vision news show covering the EPA announcement made any reference to this sudden change of policy. Critics say this statistical maneuver- ing amounts to little other than moving the goal posts to ensure that a football that landed on the two-yard line would countasatouchdown. "They're using it so they can get an effect," Enstrom said.'"They're going all out to get something they an call signitiant" Glantx responds, "There is nothing magical about (the 959.). I know that scientifically it's widely used, but there is a strong body of thought that people are too slavishly tied to 95°G." But critics say that noting that the original selection of 95% was arbitrary misses the point. It was arbitrary to make a football field 100 yerda long, but once that's the standard, you an't change the length in the middle of a game. "You cannot nm scieva with the government changing the rules all the time," said Michael Gough, program manager for biological applications for the congressional Offta of Technology Assessment. 'Oue-TaBei' AndyW Glantx said that anather statistical reporting change, using what is known as e"one-miled" analysis as opposed to a two-tailed one, compematee for lower- ing the statistical confrdance. In fact, it actually reduoes the conft- dence level even further, providing a greater chance of labeling something carcinogenic when it uv 't. Said loe] Hay, a health economist at the University of Southern California who teaches statistics, "In essence, that's more like going to an 85%" level, which would triple the chance of n mistake due tochance. "If they've done both, then they're obviously reaching for results," he said. Thetobaccoindustrycharyedthatthe EPA left out of its analysis a recent major study, released in the November American 7ournal of Public Health, which, if combined with the other I I American studies, would have resulted in no statistically significant fmdings even using the moved goalposra. Reilly responded to the charge by saying that the EPA report was too far along to include these latest Bndings. But, "When one new study an throw it from nonsignificant to significant and another can throw it back again, you're not demonstrating a clear trend," said Alan Gross, a professor of biostatistics At the Medical University of South Carolina in Charleston. Enstrom notes that substances prc- viously labeled carcinogens normally have been found to have a much greater difference between levels of cancer in those exposed and in those nct exposed. With lung cancer caused by direct or active cigarette smoking, for example, there may be 1,000 cancers compared to 100 for nonsmokers, as compared to the I19 per passive smoker the EPA found per 100 for nonsmokers. Enstrom said, "For a heavy smoker exposed to asbestos, you an get up in the range of a relative risk of a hundred or more,' meaning that for every (00 unexposed persons with lung cancer you find 10,000 exposed ones. "With a disease like lung cancer and finding excess risk of only two or less, you really have to think about what you'rc doing with the data," he said. "To me, ie's frightening that they could make such a case out of such a small risk factor when you've got so many varia- bles " Inexnct9clence One problem with slicing the data so thinly as the EPA passive smoke study does is that epidemiology is not an exact science. A single variable unaccounted foran destroy a whole study According to Gary Huber, a doctor with the University of Texas Health Center in Tyler- "At least 20 confound- ing factors have been identified as important to the development of lung cancer. These include nutrition and dietary prevention, exposure to occupa- fional arcinogens, exposure to various air pollution contaminants, genetic pre- dispostion and family prevalence," amongotherfactors. "You're going to see huge lifestyle differences lxtween tfamilies with smok- ers and families with no smokers) generally," said Gross. One of the 19 non-U.S. epidemiologi- cnl studies that the EPA did not put into its data base, conducted by American and Chinese researchers in China, actu- ally found a statistically significant deureasetnrisk. "When you change just one of the assumptions EPA madc." said Wehner. "just one parameler, you can prove ETS saves lives -- and, of course, thai s just nonsense. But it demonstrates how easily results can vary when assump- tions arc changed only slightly." EPA Watch's Cohen and other EPA critics think that the passive smoking report isjust the latest in a litany of EPA abvses of science to achieve political ends - most promtnently that of enlarging its own authority, especially to gain more control over indoor air regulation. Cohen notes that while the EPA has attributed 5.000 lung cancer deaths a year lo radioactive radon gas seeping up from the earth into houses, the epide- miologicai studies on household radon tend to show that houses with higher levels of the gas have lower levels of lung cancer. Outside EPA Repnrt's W+ming "The science of which EPA avails itself is that which happens to Gt the political agenda of the moment," Cohen said. "Epidemiology didn't support its position on radon, so they ignored it:' Cohen notes that an outside report commissioned by the EPA released last year found that there was a wide perception that the agency's science was "adjusted to fit policy." He says that clearly, the EPA did not heed the report's warning. "The EPA was not unaware of the fact that the tobacco industry is an extremely appeahng target with few allies in the public arena:" Cohen said. "Furtheq the tobacco industry has cried wolf so many times that it doesn't have any credibility anymore." But Enstrom says that "politically correct" science isn't science at all, and that regardless of how one feets about smoking and passive smoking, the EPA's tack is simply wrong. '9 don't think it bodes we11 For the field," Enstrom said. It's going to make it hard to distinguish a real (problem) from a manufactured one using statisti- cal manipulation:' • . Reprinfed oourfesy oF Irtveslor's Bnsiness DaiH.