RUTHFULLY YOURS

The iconic academic journal of American medicine, the New England Journal of Medicine (NEJM), published since 1812, has committed itself to a Noble Lie[1], that ambient (natural) air quality in America kills hundreds of thousands annually.

Jeffrey Drazen, MD, lung specialist, Editor in Chief of the NEJM since 2000, Distinguished Parker B. Francis Professor of Medicine at the  Harvard School of Medicine, professor  in the Department of Environmental health at the Harvard T. H. Chan School of Public Health, is in his 17th year of tenure as editor of the NEJM and in that time he has approved publication of false claims about air quality lethality, resulting in the NEJM become a partisan news outlet that promotes the US EPA political agenda and onerous burdensome air regulations that chase a phantom air quality scare.  Air quality in America isn’t killing anyone.

The bias and partisanship of the NEJM and Dr. Drazen and his editorial board is displayed in the publication of an article in June of 2017, authored by Di, Dominici, Schwartz, and others titled “Air Quality and Mortality in the Medicare Population” that claimed to show deaths from exposure to American air quality in a very large study of elderly Americans.   They claimed thousands of elderly Americans were dying every year from bad air quality, but their study showed a very insignificant increase of 8% in deaths, in the range of what scientists call “noise” (natural variance) as opposed to good evidence, called “signal.” In spite of that unreliability, as described in the Federal Judicial Center’s Reference Manual on Scientific Evidence (Chapter on Epidemiology, pages 597-606), Dr. Drazen approved publication in the NEJM and joined in writing an editorial applauding the article ”Air Pollution Still Kills.”

Earlier in 2017, two published studies on air quality effects said just the opposite of the Di study, that ambient air quality wasn’t killing anybody.  The first research report by James E. Enstrom was a reanalysis of old studies relied on by the EPA in the 1990’s to justify air regulations.  The second study was by Young, Smith and Lopiano, a comprehensive decade long study of all the heavily populated air basins in California that showed no death effect from small particle or ozone air quality. These two studies refuted the premise and claims of the Di NEJM study of June 2017 and all the EPA funded and sponsored studies used to justify aggressive air quality regulations.

In legitimate science activity, researchers are expected to comment on studies that conflict or contradict their assertions, but the Di, Dominici, Schwartz article did not comment on or discuss the Enstrom and Young studies, or other studies that showed no death effect.  The editors of the NEJM would be expected to demand that authors display a proper scientific temperament and cite contradictory studies and attempt to explain or refute the contradictions.  Instead the Di authors and the editors of NEJM ignored the conflicts in results, and asserted their position. That’s how the Noble Lie is perpetrated; establishment researchers repeat themselves and assert the matter is settled.

Dr. Enstrom wrote an eloquent letter objecting to the Di article.  Enstrom’s letter and the response of the Di authors showed that the Di authors didn’t think Enstrom’s objections deserved their time.

Then Steve Milloy wrote a protest demanding NEJM correction, followed by a second letter by Dr. John Dunn (with cosigners).  The arguments by Milloy and Dunn condemning the study and article as well as the letter of defense made by the authors to Dr. Enstrom’s critique were:

1. The Di article authors were dishonest to claim they ignored contradictory studies because there are “hundreds” of supportive studies, since in science studies that disprove a hypothesis are more important in assessment of its veracity and reliability. The test of a scientific theory is to fail to refute or disprove it.
2. The Di article and letter authors didn’t cite any null studies or allude to possibility that null studies exist, ignoring the record.  That is dishonest scientific misconduct.
3. The editors of NEJM were complicit in the misconduct because they knew of contradictory studies and allowed the article and the editorial to leave readers with the impression the science was settled.
4. Di authors claim they didn’t control for smoking because a “sensitivity analysis” showed it would be “unlikely” to confound the association, but such a claim is nonsense in an air quality study.  Cigarette smoke is heavily contaminated with small particles.
5. The scientific misstatement of most moment is the Di authors is that the claim that their study had “strong” evidence when a Hazard Ratio of 1.08 is not strong at all but very weak, a negative not positive result.

After Editor Drazen dismissed Milloy’s and Dunn’s requests to take remedial action, describing their complaints as a “disagreement” when it was an accusation of flagrant scientific misconduct.  Milloy wrote to the Department of Health and Human Services Office on Research Integrity, complaining of the conduct of the Di authors and the NEJM in the matter, misconduct that violated the law in a federally funded research project, Milloy wrote in pertinent part:

[Since] the NEJM study authors carefully, if not cynically, used the term “associated with” rather than “causes,” there can be no doubt as to their intent to convey a false certainty that PM2.5 (2.5 micron size particles, compared to the 10 micron diameter of a human hair) causes death….

The researchers have committed misconduct by knowingly misrepresenting the research record….  [S]tudies, in particular, were well known to those involved with the NEJM study. NEJM study funder HEI, NEJM study author Dominici and the NEJM study editor-in-chief Drazen all knew of these contradictory findings….  This can only have occurred by design….

Misrepresenting research so it is not accurately represented in the research record is misconduct….  [G]overned by the standards established in 42 CFR Part 93  —  Public Health Service Policies on Research Misconduct. Thereunder, “research misconduct” means… knowingly misrepresenting the research record.

No mention made of contradictory research….

The NEJM study authors omitted mentioning the limitations of epidemiology, including that there is no biological plausibility for the notion that PM2.5 kills.

….National Academy of Sciences and National Cancer Institute… stated in a media release on October 26, 1994:  In epidemiologic research, relative risks of less than 2 are considered small and usually difficult to interpret. Such increases may be due to chance, statistical bias or effects of confounding factors that are sometimes not evident.

In his highly-valued 1965 essay in the Proceedings of the Royal Society of Medicine, entitled “The Environment and Disease: Association or Causation,” Sir Austin Bradford Hill described the criteria for evaluating epidemiologic studies and discounted hazard ratios below 2.0:

First upon my list I would put the strength of the association….

The reason hazard ratios below 2.0 are unreliable is because much epidemiologic data are incomplete, guesstimated and/or otherwise of dubious validity.

The unreliable data problem is writ large in the NEJM study:

The NEJM Di study data lacks information on the cause of death for any individual in the Medicare population ⎯ so deaths not possibly caused by PM2.5 (e.g., those resulting from accidents, homicide/suicide, cancer, etc.) are included in the study population….

In essence, the NEJM study assumes all “excess” deaths are PM2.5-related….

Also, the NEJM study authors repeatedly present their hazard ratio estimates as “risk” estimates. It is “Epidemiology 101” that, despite terminology like “relative risk,” hazard ratios are not estimates of risk…. But hazard ratio estimates have nothing to do with risk per se. Communicating hazard ratios as risk is deceptive….

Given the current political situation ⎯ a new administration reportedly looking to cut EPA’s budget (including for university-conducted research into PM2.5) and cut EPA’s regulatory overreach  —  the political nature and timing of the HSPH/NEJM study and editorial cannot be overlooked…..

The editorial drives home a wild political attack on President Trump, concluding with the irresponsible implication that President Trump’s administration is going to cause U.S. air to be polluted to lethal levels  —  i.e., “Do we really want to breathe air that kills us?”

It is worth noting that while air quality did kill people on several occasions during the 20th century, these deaths were not caused by particulate matter but by temperature inversions that trapped and concentrated emissions of caustic gases….

In an interview about the NEJM study, NEJM study author Francesca Dominici told the media:

We are now providing bullet-proof evidence that we are breathing harmful air.

So the intent of the NEJM study authors is clear ⎯ to present their study as incontrovertible evidence that PM2.5 kills….Theirs is a deliberate attempt to misrepresent the research record. This is a fraud on the government and taxpayers who have funded this “research.” These researchers and the NEJM editor Dr. Drazen, as sponsors of the article should be appropriately reprimanded and sanctioned for promoting and supporting scientific misconduct.

In addition to basic income as Editor of the NEJM, 650 thousand dollars annually, Dr. Drazen receives a salary from Harvard, as well as honoraria and consulting income for his wide-ranging activities.  Dr. Drazen’s research interests include his partnership with a researcher at the Mayo Clinic School of Medicine, Dan Tshumperlin MD, who has received, according the NIH Research Portfolio Online Reporting Tools (RePORT), federal funding dating from 2013 through 2017 of more than 3.1 million dollars  from the National Heart, Lung and Blood Institute (NHLBI), a federally government funded and organized entity.   Dr. Drazen is not named as the principle in the Tshumperlin grant information, but the Harvard School of Public Health information on line indicates that Dr. Drazen has a research relationship to Dr. Tshumperlin, and would, no doubt, receive remuneration for his collaboration.

Editor Drazen, in spite of or possibly because of his position as a the most important medical journal editor in America, and a remarkable tenure of 17 years, has received $1.9 million in federal grants for research since 2014, according to RePort, and his grants are also from NHLBI.  It is difficult to assess the amount of money awarded to the Harvard School of Public Health from federal agencies due to Dr. Drazen’s position and influence, but it is naïve to think it would not be multiples of the amounts above, and the grants related to environmental health research would tend to prove up agency policy positions and regulatory actions as beneficial. Research that creates a “crisis” or “threat” is essential to agency hegemony.

Dr. Drazen is uniquely positioned to promote the environmental scares and regulatory agenda of the US EPA, so he is well armed to be a scientist zealot for the agenda of the US EPA and not shy about attacking anyone who would question the science sponsored by the US EPA and affiliated federal agencies like the National Institutes of Health and other federal medical science funding agencies.  Drazen is, therefore, one part of the “expert” army that promotes the Noble Lies necessary for promoting policy.

The granting agencies and their paid researchers have a dog in the fight to tell the public that the EPA is doing the right thing on air quality regulations going back more than 2 decades.

The Di article authors and NEJM editorial staff shill for the EPA regulatory regime and promote the Noble Lie that air quality kills with another government funded data dredge, another federal agency public relations release, a well-timed effort to promote the EPA claims of killer air quality and the need for new and stricter air standards that will save hundreds of thousands of lives.  Send lawyers, guns and money.  Taxpayer money.

We object.   It is a scam, a very expensive scam that harms the public and the economy.  The strategy is scaremongering, the Noble Lie perpetrated to allow for regulatory tyranny imposed on the public by the US EPA.

John Dale Dunn MD JD is an emergency physician and attorney, Steve Milloy, MS  Biostatistics), JD, LLM, is proprietor of JunkScience.com, a web site devoted to debunking fraudulent science and public policy making.