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When he filed his complaint last June, Milloy pointed out that the two EPA doctors who published a case study of the experiment in the Journal Environmental Health Perspectives mentioned only the 58-year-old woman who suffered the cardiac incident. The 40 other test subjects, who experienced “no clinical effects requiring follow-up,” were omitted from the report. Since properly conducted research requires results both “for” and “against” the hypothesis on which the research is based, the study is scientifically worthless.
Yet a quote from that study is quite revealing. “Although epidemiologic data strongly support a relationship between exposure to air pollutants and cardiovascular disease, this methodology does not permit a description of the clinical presentation in an individual case. To our knowledge, this is the first case report of cardiovascular disease after exposure to elevated concentrations of any air pollutant,” it said.
Milloy concluded that the way the doctors framed their study meant one of two things: either the EPA believes fine particulate matter is as deadly as they claim–and thus, these doctors are guilty of misconduct–or their claims that thousands of lives have been lost from inhaling fine particulate matter are utter nonsense. “If PM2.5 does not kill then (the EPA’s) utility Mercury Air Toxics Standard and Clean State Air Pollution Rule benefits claims are entirely bogus,” Milloy wrote an email. “Must be one or the other; can’t be neither.”
If PM2.5 is indeed toxic, then the EPA violated its own requirements, aka its “Common Rule,” which states that researchers must minimize risk to subjects, and that those risks must be reasonable compared to anticipated benefits. Furthermore, subjects are supposed to be fully informed of the risks involved, and studies with “risk of substantial injury to a human subject” are not to be approved, except in extremely rare cases that must be given the OK by higher agency authorities. Milloy, who obtained 3,500 pages of documents as a result of his FOIA filing, noted that since the EPA already considers PM2.5 lethal, no benefits could possibly accrue from subjecting people to it. He further alleges that none of the patients were told that breathing in such toxic fumes were life- or health-threatening.
Among the demands outlined in the lawsuit are the ideas that the EPA should be barred from conducting illegal life-and health-threatening experiments; a formal investigation of the experiments the EPA has already conducted should be initiated; and the regulations based on the illegal experiments should be suspended, pending an investigation.
The EPA sent a statement responding to Milloy’s lawsuit to the Washington Times’ Kerry Picket. “EPA is one of 15 federal departments and agencies that conduct or support research with human subjects under the governance of the Common Rule,” it said. “All human exposure studies conducted by EPA scientists are independently evaluated for safety and ethics, and the results are peer-reviewed. The complaint has been referred to the Department of Justice and further inquiry regarding litigation should be directed to them.”
That would be arguably the most politically compromised DOJ in recent history, one already enmeshed in a major scandal of its own, courtesy of the Fast and Furious debacle. Nonetheless, Americans owe a debt of gratitude to Steven Milloy and the National Legal and Policy Center for their tireless efforts to expose one of two disturbing realities: either the EPA has needlessly endangered the lives of uninformed participants in a worthless experiment or they have knowingly lied for years about the dangers of airborne particulate matter. In either case, the American people deserve answers and accountability.
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