A Physician’s Perspective on the EPA’s “Data Derangement Syndrome”

Guest essay by Charles Battig M.D.

Derived from Heartland Climate Conference, June 11-12, 2015 Presentation by Charles G. Battig, MD: Panel 8 “Human Health and Welfare” June 11, 2015

In the latest iteration of propaganda tactics employed by eco-environmental activists and the EPA, emotion has become the chosen media tool. Mothers and children pose on the capitol steps and wave signs proclaiming their fight for clean air and the children’s health. Images of these “lovable lobbyists” for the EPA’s Clean Power Plan are heart tugging. It is maternal instinct vs. scientific debate; if it sounds bad, that is all that such moms need to hear, and in fact, it is hard to overcome such pleadings with cold facts alone. Such “do something” demonstrations find politicians and agencies all-to-ready to craft new legislation and regulations. I view this much like physicians who succumb to patients’ “do something” demands by prescribing antibiotics for the common cold…a useless, if not dangerous practice.

A general fear by the public for anything labeled a chemical or requiring some comfort with numbers is a powerful psychological tool for the alarmists. In-the-street TV interviews showing fearful reactions to the chemical name di-hydrogen oxide, which we recognize as ordinary water, is but one example. If the air is hazy it automatically assumed to be injurious to one’s health, but what about invisible toxins? The linear-no-threshold mind-set governs the government’s toxicology proclamations. One is to assume that any and all substances in any amount may be injurious to health, until proved otherwise. Forgone possible health or economic benefits of the demonized substances are not considered. Economist Julian Simon coined the term “false bad news” to describe the innocuous made to sound harmful by the media, when they target a concept and set-out to destroy it. Impartial and convincing scientific rebuttals are mostly ignored by the media since they specialize in publicizing bad news and perpetuating their own prejudiced agendas. Hollywood celebrities and politicians have become authoritative founts of scientific knowledge for the media-obsessed public.

The EPA reports that the six major EPA Clean Air Act pollutants are down some 62 per cent. Also according to the EPA, reported asthma incidence has gone up from 8.9 per cent in 2005 to 9.4 per cent in 2010. Why? Some possible factors are: increased public awareness; expanding its definition to include all reactive airway disease; and blunted development of natural immunity as the childhood environment is made perhaps too clean to challenge developing immune systems.

“Never let a hypothetical disease go to waste” and “look for those data that prove the assumption” seem to have been the bases for the “designer disease syndrome” the EPA has labeled PM2.5 (particulate matter 2.5 microns or smaller in diameter). PM2.5 is a most peculiar disease-causing agent when compared to traditional disease concepts such as Koch’s postulates. Its pathophysiologic mechanism is undefined, even by the EPA.

PM2.5 represents a mixed bag of substances united solely by being really tiny…they must pose a substantial health threat because the EPA says it believes it to be so. The particles have no unique chemical composition, and are known to arise from both natural and made-made activities. They vary in composition from one geographic location to another, and over periods of time.

The EPA claims that any inhalation of PM2.5 can cause death, including sudden death, as well as long-term deaths, labeled as “premature deaths.” Thus this substance is said to cause death from short term, long term, and in any dose exposure…really scary stuff. What level is the healthy level or safe level, and by whose and what criteria? EPA’s Lisa Jackson seemed to know as she testified before Congress in 2011 that: “If we could reduce particulate matter to healthy levels, it would have the same impact as finding a cure for cancer in our country.”

The EPA faces a science credibility dilemma. One the one hand it claims PM2.5 to cause death, but it is a postulated disease of statistical etiology. Epidemiological studies do not provide direct evidence of definitive causation, nor do they provide validated hypotheses for the biological mechanisms to do so. Thus the EPA needs to test humans, just to be sure. Volunteer applicants are supposed to be given informed consent. On the one hand PM2.5 is associated with death, but on the other hand it isn’t as they are told (page 21) that the “EPA has conducted 297 controlled human exposures to PM with only one clinically significant event, in which the study participant experienced no harm or injury.”

EPA testing has included both animal and human laboratory testing. Experimental designs must define what animal strains, what human test subjects, and what test dose size? Were all possible confounding factors identified and accounted for? Are these valid, random population samples, or biased selections? Computers can be programmed to find the sought-for correlations. Weak statistical correlations are presented as claims of proof of cause-and-effect. Data banks are trolled looking for that needle-in-the-haystack clinical correlation which can then be used to project concern to the general public.

The EPA has been conducting controlled human exposure studies to air pollutants on the University of North Carolina campus for more than thirty years. During that time more than six-thousand volunteers have been studied without a single serious adverse event being observed…so is there a health problem to investigate or not? How much more testing looking to define a disease? It looks more like a disease concept in search of a susceptible victim.

The Harvard Six Cities Study (Laden et al 2006) forms the scientific basis for much of the EPA claims regarding PM toxicology. Yet examination of the data shows that the statistical relative risk (RR) for total mortality claims range from below one to barely above one and a fraction. They do not meet the minimum legal standard of a RR of 2 to identify a significant population risk. In addition, these Harvard studies have walled-off their raw clinical data from independent investigators by claiming patient confidentiality, thereby preventing duplication of results by others. Independent reproducibility and verification of test results are the traditional hallmarks of scientific research. Invoking patient confidentiality to block access to raw data casts doubt on the entire process since providing such patient protection is not particularly difficult.

Representative Lamar Smith (R-TX-21) has led the effort to make governmental agencies provide open disclosure of the data and analyses used to formulate policy. H.R. 1030 is the Secret Science Reform Act of 2015, and was designed to ensure such ethical behavior. Public funds support most such research, and the public has the right to expect that its funds are used in an open and ethical manner.

The EPA claims that “epidemiological studies…have found consistent, precise positive associations between short-term exposure to PM2.5 and cardiovascular mortality…at short lags (0-1 days).” Zero to one day lag? Are near-instant deaths being predicted? So-called precise positive associations are not proof of cause-and-effect relationships.

In view of EPA PM2.5 mortality claims at 35µg/m3, why are airport smokers and the Shanghai population not dropping dead on the spot? Airport smoker lounges have ambient levels of 600µg to 10,000µg PM2.5. A single draw on a cigarette floods a smoker’s lungs with 10,000µg to 40,000µg. The Shanghai press reports PM outdoor levels of 600µg/m3. It also reports that the average life expectancy there is 82.5 years…a life expectancy greater than any major U.S. city. Where are the overflowing emergency rooms and mortuaries?

Carbon pollution has become the universal rallying cry of clean air advocates, including the EPA. On rational examination, the phrase is a scientific oxymoron. It is an open-ended, political propaganda term…a non-scientific sound bite pejorative of EPA origin. The EPA seems to have forgotten that humans are carbon-based life forms enmeshed in the Carbon and Krebs Cycles of life. Here is an orchestrated propaganda effort linking an essential component of life(carbon) in the Earth’s atmosphere with an emotionally laden, negative-connotation word…a sort of Saul Alinsky wordsmithing effort to create a new fearful sounding label with which to demonize fossil fuels…a psychological media campaign working to shape public opinion to fear the normal by invoking guilt-by-association. For example, the Federal government claims that “Greenhouse gas pollution threatens the American public’s health and welfare by contributing to long-lasting changes in our climate that can have a range of negative effects on human health and the environment.” Neglected is any quantification of “contributing,” nor validation of “range of negative effects.”

In June 2014, the EPA proposed the Clean Power Plan. Carbon dioxide (labeled carbon pollution) is to be “cut 30 per cent from the power sector by 2030, while maintaining an affordable, reliable energy system.” What about the negative public health impacts from more expensive, less available, and less reliable electric energy? Affordable by whom? What about loss of jobs and incomes to support good health and nutrition?

As we are all carbon-based life forms, such demonizing of carbon dioxide becomes an endeavor of self-denial and intellectual corruption in the service of justifying another encroachment upon our constitutional rights. The media and governmental agencies have labeled carbon dioxide as an unbounded scape-goat for any real or imagined societal or health ill. Yet, our lungs operate in an environment of 40,000 ppm even as environmental zealots fume over atmospheric carbon dioxide levels of 400ppm. Human-generated carbon dioxide is an essential plant food. In turn, plants produce oxygen essential for our life.

Global warming is decried as an environmental disaster in slow motion, yet winter vacations are preferentially spent by many in warm climes. Death rates climb in winter; asthma attacks climb in winter.

Atmospheric CO2 has not lived up to its panic-inducing billing. Over the past eighteen plus years, the average global atmospheric temperature as measured by satellites has remained unchanged. Over the same time period, atmospheric carbon dioxide has risen about 10 per cent. This failure has spawned a variety of new labeling terminologies such as climate change, climate disruption, and climate weirding; the only real disruption has been to expose the falsity of the CO2 scare story, and the attempt define manmade CO2 as the prime driver of global climate change.

In 2014 the EPA issued a reasonable sounding standard which stated that: “EPA’s task is to set standards that are ‘requisite’ neither more nor less stringent than necessary…The law does not require EPA to set primary standards at a zero-risk level.” What happened to the Precautionary Principle that so defines much of the EPA’s regulatory enthusiasim?

Don’t worry, it is here, on steroids…EPA-set standards are ratcheted ever lower by EPA director Gina McCarthy who is dedicated to her 2012 policy: “The best scientific evidence…is that there is no threshold level of fine particle pollution below which health risk reductions are not achieved by reduced exposure.” Zero dust outdoors even in the Great Smoky Mountains and in the pristine desert….a zero tolerance policy guaranteeing perpetual employment for regulatory agencies, and ever increasing electric power bills for all.

Continual ratcheting down of ambient ozone levels by the EPA is one example of the EPA’s ever-receding goal posts of what it defines as clean air. Once 75 ppb was enshrined into law, the EPA declared 60ppb to 70ppb as next goal. Neglected is the fact that ozone levels have been and continue to decrease in the US with measures already in place.

A 2014 EPA report titled “Regulatory Impact Analysis of the Proposed Revisions to the National Ambient Air Quality Standards for Ground-Level Ozone” claimed short-term exposure premature death savings ranging from sixty-five to three-hundred-and-fifty…out of a 350,000,000 population. These numbers are so small as to be statistical noise inseparable from daily random events. What is a premature death anyway? How does a physician diagnose a “premature death”? Premature compared to what other deaths that might have occurred that same day? Real doctors don’t see premature deaths; only computers sifting dodgy data, and using wobbly confidence brackets experience premature, statistical-deaths.

EPA-funded researchers reliably produce studies supporting EPA air quality objectives. Are such studies free of EPA influence and vice versa? The public reads headlines confirming EPA policy, even as the media ignore contradictory scientific studies. Borrowing from the fashion world, I term this “bespoke science” or made-to-order science. In 1961, President Eisenhower warned: “The prospect of domination of the nation’s scholars by Federal employment, project allocations, and the power of money is ever present – and is gravely to be regarded”…to which I say, how sadly true fifty years later.

Asthma has been adopted as the emotional picture-child for promoting EPA’s definitions of clean air by both the EPA and by President Obama. April this year, the president claimed that his daughter Malia’s childhood asthma was an example of the harmful effects of climate change. In the medical literature, asthma is recognized to be primarily a genetically based disease. Children 18 years of age and younger have experienced no changes in global temperatures or statistically valid measures of climate change during their entire lifespans. Yet, papers are published which cite correlations of childhood asthma with carbon dioxide as “due to” climate related factors. Observational data-combing is not statistically validated proof. Claims of linkage fail the test of validation and reproducibility. Asthma is triggered primarily by plant allergens, although susceptible individuals will react to a variety of physical allergens, including cold.

Steve Milloy’s Sacramento California hospital asthma admission study found no increased asthma admissions or deaths related to PM2.5; Stan Young and James Enstrom have already refuted these EPA claims with hard data, and more such studies are in progress. The EPA refuses to acknowledge these studies.

My anesthesia patients responded most keenly to my self-introduction as the doctor who was there to make sure they would wake up, not as the would-be guardian of the climate. Yet a Yale researcher would have anesthetic agent selection influenced by the recent finding of a few molecules of some popular agents in the Antarctic atmosphere. Exploitation of the public’s chemophobia and a loss of perspective by grant-funded researchers desperate to produce in a publish-or-perish academic environment add to the tidal wave of pseudo-science publications.

In conclusion, how might we counter this deluge of “false bad news”? As a physician, my guiding principle must be “First, do no harm.” Money and politics serve their own ends by preying upon the public’s health fears. This is a process abetted by a non-inquiring or biased media and activist groups. Those within the political process should recognize the pitfalls of catering to “just do something” provocations by enacting legislation based on fear and ideology, or financial gain rather than on sound science. Quite simply, the very real ills of unintended consequences follow from the wrong diagnosis of the wrong disease, and the wrong therapy.

Charles G. Battig, MS, MD, Piedmont Chapter president, VA-Scientists and Engineers for Energy and Environment (VA-SEEE). He is an “expert” advisor to the Heartland Institute. His website is www.climateis.com