After Steve Milloy broke the news of EPA’s unethical-to-illegal human experiments in a Washington Times commentary, Milloy wrote on April 25, 2012 to Hugh Tilson, editor of the journal Environmental Health Perspectives(EHP), requesting retraction of the EHP-published case report of the experiment, asserting that the published case report was false and/or misleading:
I am requesting that EHP take corrective action concerning the study “Case Report: Supraventricular Arrhythmia after Exposure to Concentrated Ambient Air Pollution Particles,” (“Case Report”) published online September 6, 2011.
Based information obtained through a Freedom of Information Act request made to the U.S. Environmental Protection Agency, the article omits material information about circumstances relevant to the Case Report. This omission materially affects the Case Report’s discussion and conclusions.
The case study, which is presented as evidence that fine particulate matter PM2.5 is a health risk, is not simply a lone “case study.” The researchers in question, in fact, conducted 40 other experiments similar to the Case Report.
But Case Report contains no mention of these 40 other experiments — the results of which all contradict the conclusions drawn by the case study’s authors.
“Case Report” should be retracted from publication and EHP should commence an investigation of the authors’ ethical conduct with respect to the Case Report.
There is also an additional ethical concern with the Case Report — i.e., that the experiment involved exposing the study subject, who had a history of heart disease, to a potentially lethal level of PM2.5. It is EPA’s position, after all, that PM2.5 doesn’t make one sick; it simply kills.
For more on the researcher’s failure to protect a human subject and the nature of the “lethality” of PM2.5, please read this article published in the Washington Times.
I am attaching for you the FOIA response from the EPA concerning the case study.
I look forward to your timely response.
Copies of the e-mail were also sent to the members of EHP‘s editorial board, one of whom mistakenly responded to Milloy instead of of Tilson. Obviously grasping the seriousness of the central accusation, Dr. Ken Korach, chief of the Laboratory of Reproductive and Developmental Toxicology at the National Institute of Environmental Health Science, wrote:
holy cow – you didn’t need this ? what do you want us to do for you ? – have you contacted the author about this claims ?
(Click image to enlarge)
Eight days after Milloy’s April 25 letter, Tilson responded as follows [Note: Milloy's responses to Tilson's comments are in bolded brackets]:
3 May 2012
Mr. Steve Milloy
Dear Mr. Milloy:
Thank you for your email of 26 April 2012 concerning the paper by Andrew Ghio et al (Ghio AJ, Bassett N, Montilla T. Chung EI-I, Smith CB, Cascio WE. 2012. Case report: Supraventricular arrhythmia after exposure to concentrated ambient air pollution particles. Environ Health Perspect 120:275-277). We have examined our records and I am reporting our findings in this letter. [My request was submitted on April 25 and Tilson investigated the matter and responded to me in about nine days -- this must be some sort of record time for government action. Of course, based on the content of Tilson's response, I am certain that no meaningful investigation of my allegations occurred.]
The observation reported in the Ghio aet al [sic] paper was derived from a larger study conducted at the Human Studies Facility of the National Health and Environmental Research Laboratory of the US Environmental Protection Agency. [Unfortunately for Tilson's response, it is precisely this disclosure — that there were 40 other human subjects studied by Ghio et al as part of this testing — that was omitted from the Ghio et al case report.] That study was an intentional environmental exposure study (lSEE), which involves controlled exposures under rigorous experimental conditions. [Yes, Ghio et al intentionally exposed 41 humans to fine particulate matter (PM2.5) that, according to EPA, could have killed them within hours of exposure.] Informed consent was obtained from the participants prior to the onset of the study. The ISEE was approved by the University of North Carolina School of Medicine Committee on the Protection of the Rights of Human Subjects. [We have yet to see what "informed consent" means in this case. Did the study subjects actually agree to be exposed to potentially-lethal PM2.5? Regardless of whether they read, understood and signed the consent forms, is such consent valid? That is, can the EPA actually ask study subjects to risk their lives in the name of air quality experimentation?]
The purpose of the ISEE study was not to elicit supraventricular arrhythmias by exposure to concentrated ambient air pollutant particles. [The purpose of the experiment was to see what happened to humans when exposed to very high levels of fine particulate matter. The researchers may not have expected to see a supraventricular arrhythmia, but that is no defense to the accusation that they experimented on people with a potentially lethal substance to see what would happen to them. Such experimentation is per se unethical if not illegal.] The observation described in the Ghio el al paper was an unintentional side effect in a single participant enrolled in the ISEE. [This is an interesting sentence. First, Tilson admits the ISEE (i.e., all 41 human study subjects) was one experiment. This bolsters my point that reporting only the case study while omitting any mention of the other 40 results is false and/or misleading. Next, Tilson claims the supra ventricular arrhythmia was an "unintentional side effect" even though the researchers were purposefully testing for human response to the PM2.5exposures.] Reporting the effect as a case report was appropriate.[Yes, but in the context of the entire experiment, including the 40 study subjects who experienced no "unintentional side effects." As a standalone experimental result, the case report is false and misleading.] Finally, the Ghio et al paper underwent rigorous peer review before being accepted for publication.
In summary, Ghio et al observed a side effect during the course of a larger planned study and reported the side effect as a case report.[This is another admission that the 41 study subjects were all part of the same experiment.] The larger study had been approved by the university committee for the protection of the rights of human subjects and the participant described in the case report had provided informed consent prior to the onset of the study. [Did the North Carolina University School of Medicine human studies review committee know that the EPA was planning on testing potentially lethal PM2.5 on humans? I bet not.] Based on our findings, we see no reason for corrective action. [Tilson found nothing because no bona fide investigation was conducted.]
Again, thank you for raising this issue. If you would like to raise other scientific or ethics questions about the Ghio et al paper, EHP suggests that you write a letter to the editor. Note that Ghio et al will be given the opportunity to respond. As indicated in our Instructions to Authors (http://ehp03.niehs.nih.gov/static/instructions.action), a letter that is highly polemic or personal in nature will not be published. Correspondence is not peer reviewed and is published at the discretion of the EHP editors. Correspondence is limited to 750 words or less. [Tilson had his opportunity to do the right thing, but he instead opted to cover-up. While we will certainly write a follow-up letter, it won't be for publication in EHP.]
Hugh A. Tilson
Environmental Health Perspectives
Our investigation continues. Stay tuned.
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