Wednesday, 2 September 2009

1+1=11: The Untouchables (part 5)

In this series of articles we have looked at a number of clear-cut examples of the public being misled by false information based on shoddy data and faulty reasoning. It is not necessary to speculate on whether these scientific howlers were the result of simple incompetence or calculated dishonesty. It is enough to know that these untruths have been endorsed by major governmental and not-for-profit organisations around the world and consequently have filtered down to the public as facts.

Part of the problem is that powerful government bodies such as the Environmental Protection Agency have, over the last 25 years, become home to radicals and former activists who are instinctively antagonistic towards the private sector and any kind of perceived corporate interest.

Nearly all the big names in anti-tobacco activism in the past 40 years have managed to make careers of what was once their hobby. To name just three, James Repace - the subject of our first article - joined the EPA in 1979. Stanton Glantz - the founder of Americans for Nonsmokers Rights - currently runs the pressure groups SmokeFree Movies and TobaccoScam in addition to his work as the American Legacy Foundation's Distinguished Professor of Tobacco Control and the Director of the Center for Tobacco Control Research and Education. Simon Chapman, who founded the fanatical Australian anti-smoking outfit MOP-UP in the 1970s, is a correspondent for the British Medical Journal and editor of the international anti-smoking journal Tobacco Control.

Countless lesser names with similar extreme views hold posts in environmental and public health organisations around the world. There is no great surprise. We all aspire to having a job which combines business with pleasure and many of us prefer to work and socialise with those who share similar views and backgrounds. How often do we hear people say that they don't know anybody who disagrees with their point of view on a certain issue, even when opinion polls show that the public is deeply divided on it? But while it is attractive to work with people of the same mindset, it tends to mean that you are less likely to hear views that contradict with your own. The limits of debate become narrow and this is never a good thing for science.

One consequence of these institutions being dominated by former crusaders is that the peer-review process is often carried out by a self-selecting team of like-minded individuals with a shared agenda. If the studies examined in this series of articles are any indication, peer-reviewers are either not reading submitted papers properly or are so blinded by ideology that they will allow any rubbish to make it into print for the benefit of what they view as the greater good. Since these studies ultimately help to dictate policy, the agencies which finance and propagate research have become judge, jury and executioner on a whole range of health and environmental issues without ever being accountable to anyone but themselves. They are, in short, untouchable.

The infamous EPA report on secondhand smoke is a case in point. This wretchedly dishonest document (which James Repace's department, in his own words, "were able to convince EPA top management to initiate") will be familiar to many readers (if not, please see here.)

So biased and twisted was the EPA's conduct in fabricating the evidence for the passive smoking theory, that the tobacco industry took the agency to the District Court and won. The judge ruled that the EPA had decided from the outset that secondhand smoke was a killer and had bent the facts to fit the theory. The following extract from Judge Osteen's summing-up gives us an insight into how the EPA came to declare secondhand smoke a 'group A carcinogen':

"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." (2)

This court case graphically illustrated how the EPA had manipulated data, ignored evidence, disseminated false information and abused its power and yet the court's ruling did nothing to stem the tide of legislation against smokers that the EPA had unleashed in the 1990s.

What happened next showed that even when you win against the EPA, you lose. In 2001, the EPA appealed the decision and won on an obscure but important technicality. The EPA protested that since it did not have the power to make laws, it could not be held accountable for any legislation its 'guidelines' might have instigated. The District Court did not, therefore, have jurisdiction to overrule it. Finding in favour of the EPA, the appeal judge declared:

"The consequences complained of by plaintiffs [eg. smoking bans] stem from independent actions taken by third parties. Even if other agencies have relied on the Report in imposing tobacco related restrictions, these regulations are not direct consequences of the Report, but are the product of independent agency decision making." (3)

The appeals court did not challenge a single word Judge Osteen had said in condemning the EPA's near-criminal abuse of power but was forced to concede that, in law, the EPA existed to carry out research and that there were no direct legal or regulatory consequences from anything they reported. This was technically true, even if it was laughable in practice, and the appeals court freely admitted that "The practical consequences of the EPA Report are great and affect the livelihood of thousands" - a reference to tobacco farmers, retailers, restaurant owners etc.

Everyone knew that the EPA's report had had an unprecedented influence on government policy and had played a huge role in persuading lawmakers in the USA and beyond to pass legislation to 'protect' nonsmokers from secondhand smoke. And yet the EPA remained untouchable. It could say anything it liked on any matter without fear of being brought to book in a court of law or be held accountable for the practical consequences of what it said. It could "make findings on selective information", it could "fail to disclose important findings", it could "disregard information" and it could "leave significant holes in the administrative record." It could, in short, do and say whatever it liked, knowing full well that its judgement would be trusted by lawmakers and that its recommendations would be turned into law. But even when its dishonesty and incompetence were exposed for all to see, it would never be held accountable for anything or be prosecuted by anyone.

A glimmer of hope?

It is something of an irony that environmental and health organisations so often complain about industry being "completely unregulated" when they are subject to virtually no checks and balances themselves. There is, however, one glimmer of hope, for Americans at least.

In 2000, an obscure law tacked onto an appropriations bill - the Data Quality Act (DQA) - went some small way towards redressing the balance. Under the DQA, more than 90 Federal agencies are required to publish guidelines for basic standards to ensure the "quality, objectivity, utility, and integrity of information (including statistical information) disseminated".

Affected persons can challenge the agency and request a correction if they can show the information to be false. If the agency refuses, that person can sue. Furthermore, all raw data produced by federally funded research must be made available to the public upon request. The idea is to allow the American taxpayer - who ultimately pays for such research - to see what they are getting for their money while making it possible to have demonstrably false claims retracted.

"It's the information age," said Jim Tozzi, the main instigator of the bill, "Now in the world's most powerful government you're going to have to issue information that's accurate."(1) Who could argue with that?

As it turns out, quite a few people could argue with that. The left-wing journalist Chris Mooney called the DQA "the regulation to end all regulation" and the Washington Post's Rick Weiss dubbed it "the nemesis of regulation". These critics articulated a widely held fear amongst activists that the new emphasis on "objectivity" and "integrity" would make it difficult for environmental health laws to be passed. This says more about the standard of their evidence than it does about the DQA.

The bill was signed off in the last days of the Clinton administration but opponents depicted it as a typically Republican piece of legislation, sponsored by a former tobacco industry consultant and co-written by big business. At best, they said, it would slow the pace of regulation. At worst, it would bring it to a crunching halt. And yet, the requirements of the DQA were so modest that it was hard to see how any honest scientist could have anything to fear:

"'Utility' refers to the usefulness of the information to the intended users. 'Objectivity' focuses on whether the disseminated information is being presented in an accurate, clear, complete, and unbiased manner, and as a matter of substance, is accurate, reliable, and unbiased. 'Integrity' refers to security - the protection of information from unauthorized access or revision, to ensure that the information is not compromised through corruption or falsification. If an agency disseminates influential scientific, financial, or statistical information, that information must meet a reproducibility standard. Analytic results related to influential scientific, financial, or statistical information, must generally be sufficiently transparent about data, methods, models, assumptions, and statistical procedures that an independent reanalysis (or more practically, tests for sensitivity, uncertainty, or robustness) could be undertaken by a qualified member of the public." (4)

The fears of the likes of Chris Mooney have not been realised. Eight years after it was passed, most Americans are still unaware that the Data Quality Act even exists. Agencies have not, as some predicted, been tied up in interminable wrangling over arcane technicalities and important legislation has not been delayed. Government regulation has not slowed down and the bureaucratic machine has rolled on much as before. The DQA has been used in practice as it was intended - as a means of correcting blatantly false information. It just hasn't been used a great deal.

Predictably enough, the EPA have received the lion's share of complaints, with challenges to their data coming from everyone from the American Chemistry Council to the National Association of Home Builders. Altogether, only around 100 complaints have made under the new law in 8 years. Few are of much interest to you or me, but a few cases stand out.

Although it was predicted that the DQA would be used exclusively by right-wing industrialists, the left soon discovered that a law requiring accuracy and truthfulness could have its uses. The DQA has been used to challenge federal government's funding of family planning campaigns that emphasised abstinance-until-marriage (see here) and Public Employees for Environmental Responsibility, an environmental pressure group, has filed complaints against the Defense Department and the Fish and Wildlife Service.

Perhaps the most high profile petition has come from Americans for Safe Access, an organisation that campaigns for marijuana to be legalised for medical use. Since 2004, they have filed two complaints with the Health and Human Services (HHS) and the Food and Drug Administration (FDA), challenging its claim that "marijuana has no accepted medical value." Having got nowhere with their complaints, Americans for Safe Access filed a lawsuit and are now in the process of suing the FDA on the basis that the agency's "position on medical cannabis is incorrect, dishonest and a flagrant violation of laws requiring the government to base policy on sound science."

As this series of articles has shown, "sound science" is not always to be found in abundance in the anti-smoking movement. Most anti-smoking groups are not subject to the DQA because they are non-governmental organisations, even if they are granted very large sums of taxpayers' money. But while ASH and GASP are safe from the law, the FDA, the EPA and the Surgeon General are not.

The Data Quality Act has so far been used just twice in relation to tobacco. Philip Morris has employed it as a tool in their long-standing efforts to view the raw data of Elizabeth Fontham's secondhand smoke study of 1994. It is no surprise that the tobacco company is curious to see this data since the study remains, to this day, the only American study to have ever found a statistically significant association between secondhand smoke and lung cancer.

Fontham and her team have fought tooth and nail to suppress the data and anti-smokers have long feared that it may one day come to light. The Fontham researchers have explained their reluctance to allow the source material to be viewed by claiming that Philip Morris will manipulate it to show no risk. Commenting on Philip Morris's assumed motives, Fontham's co-author Patricia Buffler made a perceptive, if unintentional, remark about the problems of low-risk epidemiology, saying: "If you know anything about statistics, adjustments can be made to produce conflicting results." Quite so. And it is because of this - and because the Fontham finding was so unusual - that this data should be made public, available not just to Philip Morris, but to anyone who wishes to see it.*

In 2004, the National Legal and Policy Center complained about a statement in a booklet produced by the National Institute on Aging which read: "Some people think smokeless tobacco (chewing tobacco and snuff), pipes, and cigars are safer than cigarettes. They are not." This was, of course, false. Smokeless tobacco is known to be around 98% safer than cigarettes. The complaint was upheld and as a result, the US Government is no longer allowed to pretend that the health risks associated with smokeless tobacco are as great as those associated with cigarettes**.

The upshot is that the National Institute on Aging has removed one letter of one word from its statement, which now reads: "Some people think smokeless tobacco (chewing tobacco and snuff), pipes, and cigars are safe. They are not." Former Surgeon General Richard Carmona - whose 2006 report into passive smoking is one big DQA complaint waiting to happen - had to subtly change his tune from "smokeless tobacco is not a safer substitute for cigarette smoking" to "smokeless tobacco is not a safe substitute for cigarette smoking" (my italics). A slender difference indeed but an important one, because at least now these statements are not outright lies. What has replaced them may still be misleading - they do not hint at how much safer smokeless tobacco is - but, as Jacob Sullum asked sardonically in Reason magazine, "Why lie about smokeless tobacco when a misleading half-truth will do?" Demanding half-truths rather than outright lies from the anti-smoking lobby might be the most that can be hoped for in this day and age. The Data Quality Act may be the only way to get them.


* I have heard that PM have succeeded in obtaining this data but I cannot find official confirmation. If anyone has information please e-mail me. It is interesting to note, from Philip Morris's internal documents, that PM expected a 'best case' and 'worst case' outcome from obtaining the Fontham data. Either: "We get the data from the Fontham study and prove it does not show any association between ETS and disease" or "We do the reanalysis of the Fontham data and an association remains" (5). If it was PM's intention to manipulate the figures to its advantage - as Buffler suggested - the author of this piece would surely not have bothered speculating about the 'worst case' scenario.

** Anti-smoking groups, websites and charities who are not publicly owned remain be free to lie about smokeless tobacco and frequently do. For example: "The fact is, chewing tobacco is every bit as dangerous as smoking it." or "There's a widely held myth that smokeless tobacco is a safe alternative to cigarettes, when actually it's just as dangerous as smoking."

(1) The New York Times, March 21, 2002

(2) http://www.tobacco.org/Documents/980717osteen.html (p. 80-81) (p.16)

(3) http://pacer.ca4.uscourts.gov/opinion.pdf/982407.P.pdf". (p 14)[pdf]

(4) http://www.thecre.com/misc/20040606_worms.htm

(5) http://www.ajph.org/cgi/content/full/95/S1/S20#T3 (see table 3)



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