Many people who do not like smokers like to use some of the same arguments: "Your smoking will give me cancer!" is the rally call of choice. These people are referencing the EPA study that "proved" that lung cancer in non-smokers is the direct result of breathing in SHS. It has become a rally cry for anti-smoking lobbyists in recent years to get local, and state governments to pass anti-smoking laws.
Some of these laws are very radical, and in a few cases directly oppose people's rights to privacy within their own homes. Some such statewide laws and city ordinance are in effect within many states in the United States. For example: In Massachusetts it is illegal for a police officer to smoke, even while off duty, as per Chapter 41, Section 101A, of the Massachusetts General Laws; Montgomery County Md. had tried to get an ordinance passed making it illegal to smoke in your own home if it offends/bothers your neighbors (as reported by ABC News 20/20), some towns in other states have similar ordinances in place, and enacted; California passed a law making it illegal to smoke in bars/restaurants, and Delaware has recently passed the same law (other states are also considering it); New York city has made a law requiring that smoking sections in restaurants must be completely sealed off from non-smoking sections and must use separate ventilation (servers and customers must pass through what is essentially an air-lock, to ensure that no air intermingles between smoking and non-smoking sections); etc.
Each of these local, or statewide laws can trace their beginings to the EPA's well publicized findings in 1993 that labeled SHS as a Class A Carcinogenic, which can be directly responsible for lung cancer within non-smokers.
The EPA Report
In 1993, the EPA released the findings of a Meta Analysis of various other studies in regards to the threat of SHS on non-smokers. This Meta Analysis is the combining of the results of various other studies already being worked on, or completed.
The EPA found 33 such studies happening at the time they began their Meta Analysis. They dropped 2 of those studies from their analysis, and then later dropped a third that they didn't agree with. From these 30 studies they began to form their conclusions. In the end, however, the EPA only used the findings of 11 of the 30 studies.
One such conclusion was that non-smokers subjected to SHS received the "equivalent of about one-fifth of a cigarette per day." In other words, every 5 days would give the non-smoker the effective nicotine levels of a single cigarette within their blood, according to the EPA's report. However, other studies have since come forth do dispute this. These studies, which actually monitor nicotine levels within the blood of non-smokers who work in smoky environments, say that the non-smoker gets the equivalent of 6 cigarettes per year, instead of 6 cigarettes every 30 days like the EPA suggested.
Because of how they found their findings, the EPA gave SHS a Relative Risk (RR) rating of 1.19.
Relative Risk is measured in percentiles. In order to understand what this means, the average relative risk for something is considered 1.0. Any rise in the RR means there is that much of a percentage of whatever you are comparing will happen, while any lowering will mean the risk is reduced.
By giving SHS a RR of 1.19, the EPA states there is a 19% increase in the chance of getting lung cancer from second hand smoke. So if 100 non-smokers who never got exposed to SHS got lung cancer, of those who were exposed to SHS, there should be 119 cases of lung cancer. This, however, goes of their assertion that non-smokers around smokers gain the equivalent of one-fifth a cigarette per day.
Normally, any RR of below 2.0 is thrown out as being inconsequential. RR's of less than 2.0 are considered the result of bias or human error. In the EPA's case, however, they decided that the findings of a RR of 1.19 was indeed significant, and needed to be addressed.
Through their method, they discerned that up to 3000 cases of lung cancer per year, in non-smokers, were the direct result of SHS. It should be noted, however, that in order to get their numbers to be this high, the EPA doubled their margin of error for the findings while the studies were already taking place. In other words, the results were below expectations, and they changed the odds to get the results they wanted.
Thus, with a RR of 1.19, the EPA determined that SHS was a Class A Carcinogen. One-thing readers should take note, however, is that the EPA has given other substances a rating of 2.6 or higher (exposure is 160%, or higher, more likely to harm someone exposed to them vs. those not exposed to them) and not labeled them as Class A Carcinogens.
After The Report
After the EPA released their findings, the media and anti-smoking lobbyists, took it as a call to arms about banning smoking in certain areas. The rally cries of being around smokers was as good as signing a non-smoker's death warrant became commonly heard, and are still heard today.
However, the Congressional Research Service issued their review of the EPA's findings in 1995. They were, in fact, highly critical of the findings, and found things within them that could bring the findings into question. Problems arose in the validity of the findings. Among those problems include, but are not limited to:
According to the CRS "The studies relied primarily on questionnaires to the case and control members, or their surrogates, to determine EST exposure and other information pertinent to the studies."
The CRS pointed out that "from a group of 30 studies. . six found a statistically significant (but small) effect, 24 found no statistically significant effect and six of the 24 found a passive smoking effect opposite to the expected relationship."
Three other large US studies were in progress during the EPA's study. The EPA used data from one [i]ncompleted study, the Fontham study, and ignored the other two, Brownson and Kabat.
The Fontham study showed a small increase in risk. The CRS report referred to it as "a positive risk that was barely statistically significant."
The CRS report said the Brownson study, which the EPA ignored, showed "no risk at all."
The above quotes taken from Davehitt.com.
By using findings from an uncompleted study along with their own, and ignoring the results of studies that disagreed with the studies chosen, it became questionable to members of the CRS as to whether the EPA's study was free of bias.
Because of the CRS' doubts, the tobacco industry sued the EPA over the study, claiming that the EPA had pre-conceived notions and results before the study was even begun; that the EPA's doubling of the margin of error in their findings was for the sole purpose of providing the numbers the EPA wanted (EPA had already ignored nearly half the data found in the studies, and still hadn't come up with the numbers they wanted); that the EPA released the findings before all the research was completed; and other reasons.
On July 17, 1998, Judge William Osteen finally passed judgment on the case. In a 92 page judgment, he found partially for the plaintiffs (the tobacco industry) in the case, and passed a summary judgment in their favor.
While this judgment did not totally destroy the EPA's report, he did order that the first six chapters of the findings be removed, or vacated as the term goes, from the public record as being biased and unsound. As a result, the EPA is no longer allowed to use these vacated parts of the study to try and show the effects of SHS on non-smokers.
Some choice quotes from the judgment are as follows (any emphasis is mine):
--"First, there is evidence in the record supporting the accusation that EPA "cherry picked" its data. Without criteria for pooling studies into a meta- analysis, the court cannot determine whether the exclusion of studies likely to disprove EPA's a priori hypothesis was coincidence or intentional. Second, EPA's excluding nearly half of the available studies directly conflicts with EPA's purported purpose for analyzing the epidemiological studies and conflicts with EPA's Risk Assessment Guidelines."--
Most of the media, however, ignored the ruling, and the findings. Because most of the media has ignored this ruling, the anti-smoking lobby is still able to sway public opinion their way.
--"In summary, Plaintiffs raise legitimate questions not addressed in the record regarding EPA's bioplausibility theory. If confronted by a representative committee that voiced industry concerns, EPA would likely have had to resolve these issues in the record. It is not clear whether EPA could have or can do so. These issues are more than periphery. If EPA's a priori hypothesis fails, EPA has no justification for manipulating the Agency's standard scientific methodology."--
--"Plaintiffs contest that EPA excluded studies and data on workplace and childhood exposure to ETS, as well as the "two largest and most recent" U.S. spousal smoking studies, because inclusion would have undermined EPA's claim of a causal association between ETS exposure and lung cancer. 35 (Conformed Mem. Supp. >Pls.' Mot. Summ. J. at 66.) In its memorandum before this court, EPA offers four reasons for excluding the workplace and childhood data.
"First, such data are less extensive and therefore less reliable." (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at 88.) EPA's three citations to the record do not support this
All three citations state there is less information in the disputed studies. One of Dr. Brown's draft responses also calls the disputed studies inadequate, without reason or explanation. IAQC also recognized the disputed studies contained less information, however, IAQC concluded "the report should review and comment on the data that do exist . . . ." SAB 1991
Review at 5 (JA 9,470). The court has also found no record support or reason for the assertion that smaller studies are less reliable for purposes of meta-analysis. The purpose of meta-analysis is utilization of smaller studies."--
--"The record and EPA's explanations to the court make it clear that using standard methodology, EPA could not produce statistically significant results with its selected studies. Analysis conducted with a .05 significance level and 95% confidence level included relative risks of 1. Accordingly, these results did not confirm EPA's controversial a priori hypothesis. In order to confirm its hypothesis, EPA maintained its standard significance level but lowered the confidence interval to 90%. This allowed EPA to confirm its hypothesis by finding a relative risk of 1.19, albeit a very weak association. EPA's conduct raises several concerns besides whether a relative risk of 1.19 is credible evidence supporting a Group A classification. First, with such a weak showing, if even a fraction of Plaintiffs' allegations regarding study selection or methodology is true, EPA cannot show a statistically significant association between ETS and lung cancer."--
--"In this case, EPA publicly committed to a conclusion before research had begun; excluded industry by violating the Act's procedural requirements; adjusted established procedure and scientific norms to validate the Agency's public conclusion, and aggressively utilized the Act's authority to disseminate findings to establish a de facto regulatory scheme intended to restrict Plaintiffs, products and to influence public opinion. In conducting the ETS Risk Assessment, disregarded information and made findings on selective information; did not disseminate significant epidemiologic information; deviated from its Risk Assessment Guidelines; failed to disclose important findings and reasoning; and left significant questions without answers. EPA's conduct left substantial holes in the administrative record. While so doing, produced limited evidence, then claimed the weight of the Agency's research evidence demonstrated ETS causes cancer. Gathering all relevant information, researching, and disseminating findings were subordinate to EPA's demonstrating ETS a Group A carcinogen."--
Because of this, the cry of "second hand smoke causes cancer in non-smokers" is still heard today. Even with studies like these, that find that the risk of getting lung cancer, or other diseases, from SHS is not non-existant but it is much lower than earlier beleived and hyped.