We will see how much of the U.S. scientific establishment is willing to have its reputation dragged into the gutter inhabited by the air pollution fraudsters.
July 5, 2017
Dr. Jeffrey M. Drazen
The New England Journal of Medicine
10 Shattuck Street
Boston, MA 02115-6094
Re: Request for Retraction of NEJM Articles “Air Pollution and Mortality in the Medicare Population” and “Air Pollution Still Kills“
Dear Dr. Drazen,
I am writing to request that the New England Journal of Medicine retract the study entitled, “Air Pollution and Mortality in the Medicare Population” (NEJM Study) and the accompanying editorial “Air Pollution Still Kills” (NEJM Editorial), both of which appear in the June 29, 2017 issue. The basis for this request is scientific misconduct on the part of the study authors and editors.
I. The NEJM Study Authors Omitted Significant/Material Contradictory Information.
The NEJM Study omits material information and data that contradict the its conclusions. The NEJM editorial is, then, the fruit of this poisonous tree.
Specifically, there is no mention of the existence of the contradictory findings of other high quality PM2.5/mortality epidemiologic studies despite knowledge by the authors/editors of their existence. Just some examples of recent significant contradictory findings include the following (Citation/Excerpt from Abstract/Comment):
- Young S et al. Air Quality and Acute Deaths in California. Regul Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2017.06.003. (In press, online June 13, 2017). “Neither PM2.5 nor ozone added appreciably to the prediction of daily deaths. These results call into question the widespread belief that association between air quality and acute deaths is causal/near-universal.” Although this study became available at Regulatory Toxicology and Pharmacology in June 2017, it was first made available on Cornell University’s arXiv.org web site on February 10, 2015 (https://arxiv.org/abs/1502.03062) and was presented at a poster session at the 2016 annual meeting of the Health Effects Institute (HEI). As you know, HEI is one of the funders of the NEJM study.
- Enstrom J. Fine Particulate Matter and Total Mortality in Cancer Prevention Study Cohort Reanalysis. Dose-Response. http://journals.sagepub.com/doi/10.1177/1559325817693345. (Published March 28, 2017). “No significant relationship between PM2.5 and total mortality in the CPS II cohort was found when the best available PM2.5 data were used.” Not only was this study published three months ahead of the NEJM study but you personally rejected the study for publication in the NEJM on June 28, 2016.
- Greven S et al. An Approach to the Estimation of Chronic Air Pollution Effects Using Spatio-Temporal Information. Journal of the American Statistical Association. http://amstat.tandfonline.com/doi/abs/10.1198/jasa.2011.ap09392 (Published January 12, 2012). “[W]e are not able to demonstrate any change in life expectancy for a reduction in PM2.5.” One of the co-authors of this study, Francesca Dominici, is also a co-author on the NEJM study.
Please note that NEJM Study funder HEI, NEJM Study author Dominici and yourself as NEJM editor-in-chief are aware of these contradictory findings, yet there is no mention or allusion to them in the NEJM Study or NEJM Editorial.
II. Omission of Material Information Is Scientific Misconduct.
According to the standards for scientific misconduct applicable to studies funded by the Department of Health and Human Services established in 42 CFR Part 93 ⎯ Public Health Service Policies On Research Misconduct, “research misconduct” means:
…fabrication, falsification, or plagiarism in proposing, performing or reviewing research or in reporting research results.
(a) Fabrication is making up data or results and recording or reporting them.
(b) Falsification is manipulation research materials, equipment or processes or changing or omitting data or results such that the research is not accurately represented in the research record. [Emphasis added]
(c) Plagiarism is the appropriation of another person’s ideas, processes, results or words without giving appropriate credit.
III. The NEJM Study Omitted Key Information In Violation of Federal Rules.
Albert Einstein is credited with the observation that:
No amount of experimentation can ever prove me right; a single experiment can prove me wrong.
Regardless of the source of the quote, the thrust of the comment is axiomatic to science. It applies to the NEJM Study as follows: If PM2.5 kills, then it kills everywhere, in the same way, and all the time, and every study result should either be consistent with that hypothesis or be explained away as flawed or faulty.
There are many studies that fail to associate PM2.5 with death ⎯ e.g., the three studies cited above. But the NEJM Study and NEJM Editorial fail to mention or even allude to the existence of this contradictory evidence, let alone explain it away.
Omitting to even mention the existence of contradictory results is a clear misrepresentation of the research record. Worse, this misrepresentation can only be viewed as intentional as the existence of contradictory results are provably known to the NEJM Study funder, authors and you, co-author of the NEJM Editorial. Most likely, the existence of these contradictory studies is known by the NEJM Study reviewers. There is no reasonable excuse for the omissions.
Although omission of the aforementioned significant contradictory evidence constitutes scientific misconduct on its own, there were other material omissions as well.
As every epidemiologist knows, epidemiology is merely statistical in nature and statistics cannot establish causation by themselves. As the U.S. Environmental Protection Agency, which is responsible for regulating PM2.5 in outdoor air, acknowledged to a federal court in litigation involving PM2.5:
[E]pidemiological studies do not generally provide direct evidence of causation; instead they indicate the existence or absence of a statistical relationship. Large population studies cannot assess the biological mechanisms that could explain how inhaling [PM2.5] can cause illness or death in susceptible individuals.
To assess the “biological mechanisms” that could explain how inhaling PM2.5 could cause death or illness, animal toxicology or human clinical research is necessary. But none of the extant PM2.5 animal toxicology, human medical research or human clinical research studies supports the hypothesis that PM2.5 kills. In short, there is absolutely no physical evidence that supports the claim that PM2.5 kills.
In addition to the absence of biological, medical, or other physical evidence supporting the notion that PM2.5 in outdoor air kills, there is a host of real-world evidence ranging from the smoking epidemiology to the epidemiology workers with high exposure to PM2.5 (e.g., coal miners) to other high, real-world PM2.5 exposures that plainly contradict the PM2.5-kills hypothesis. In short, if PM2.5 kills hundreds of thousands of Americans per year and millions around the world, as some claim, no physical evidence of this phenomenon has ever been produced.
The NEJM study (and NEJM editorial) also rely on a statistical precision that simply doesn’t exist in epidemiology because of unavoidable uncertainty surrounding the data. This is the “garbage-in, garbage-out” phenomenon.
While the NEJM Study pretends to condemn PM2.5 based on a hazard ratio on the order of 1.08, every professional epidemiologist knows that hazard ratios below the level of 2.0 are unreliable. This is has been a long-held view maintained by bodies such as the National Academy of Sciences, National Cancer Institute, World Health Organization and U.S. Food and Drug Administration. This principle was also embraced by Sir Austin Bradford Hill in his famed criteria for interpreting epidemiologic results.
The unreliable data problem is writ large in the NEJM Study as it, for example, lacks information on the cause of death for any individual in the Medicare population, relies entirely on guesstimated exposure data, and fails to consider confounding factors such as smoking, socioeconomic status and any of the other myriad potential competing risk factors for death.
All this key information is also omitted from the NEJM Study and NEJM Editorial.
There can be little doubt that the NEJM Study and NEJM editorial omit key information that would otherwise place the reported results in accurate context. Given that the NEJM Study was federally funded, these omissions constitute scientific misconduct under federal regulations. I am requesting that the NEJM Study and NEJM Editorial be immediately retracted.The politicized nature of the NEJM Editorial, which attacks President Trump by name concerning the unrelated issued of U.S. withdrawal from the Paris climate agreement, only underscores the “political science” nature of this sordid incident.
None of this is rocket science. It is a plain question of basic scientific integrity. You have placed your publication’s reputation in peril by publishing the NEJM Study and NEJM Editorial. I look forward to your prompt response. Please let me know if you require any more information.
Committee on Publications of the Massachusetts Medical Society
NEJM Editorial Board