EPA Didn't Disclose Health Risks To Human Subjects In Tests Offering No Potential Benefits To Participants — And That's Illegal
An internal watchdog stated in a report on Monday that the Environmental Protection Agency (EPA) did not consistently disclose health risks to its human experimental subjects and neglected to include information about cancer risk. The EPA’s Office of Inspector General conducted an independent review and issued its report in response to a congressional request, which may have been inspired in part by a 2012 lawsuit filed by nonprofit Energy and Environment Legal Institute. The case was later dismissed by the judge.
“We brought the case just to try to stop the studies that were ongoing,” Dr. David Schnare, General Counsel of E&E Legal, told Medical Daily.
In November 2012, E&E Legal (formerly the American Tradition Institute) charged the EPA with conducting illegal and possibly lethal experiments since 2004 without informing subjects of the health risks. The lawsuit, which was based on documents obtained through the Freedom of Information Act, identified research studies that exposed human participants to high levels of toxic air pollutants at the University of North Carolina’s School of Medicine. The financially needy and in some cases elderly or health-impaired participants were paid $12/hour, according to Forbes.
“I worked at the EPA for 33 years,” Schnare said. “I learned in 1979, 1980 that the Office of Research and Development was an entity unto itself.” He believes that office operates with no controls.
In Monday’s report, the Office of Inspector General (OIG) alludes to “six adverse events” reported during or following EPA studies. To complete its review, OIG interviewed three people involved in adverse events in addition to reviewing the 88 signed consent forms from 81 subjects who were exposed to pollutants during 2010 and 2011 in five studies. The OIG found evidence that the EPA exposed one human subject to pollutant concentrations that exceeded the Institutional Review Board-approved concentration target. Yet the OIG concluded the EPA had obtained informed consent that met the requirements of 40 Code of Federal Regulations Part 26 — the regulation that establishes minimum standards for protection of human experimental subjects. However, the OIG noted, “we found that exposure risks were not always consistently represented. Further, the EPA did not include information on long-term cancer risks in its diesel exhaust studies’ consent forms.”
In March 2013, Matthew Cipparone, a non-smoker with no history of asthma, brought a complaint against the EPA seeking more than $2 million in damages. Since his involvement in experiments conducted by the agency, Cipparone experienced a severe and persistent cough and symptoms consistent with asthma. Quoting from his complaint, WNCN reported, “On at least five occasions since EPA exposed him to diesel exhaust ozone and other harmful substances, Cipparone has experienced coughing spells so severe that he has vomited.” According to the NBC affilliate news station, Cipparone described a truck pulling up beside the building where the experiment took place while participants inhaled the pumped in fumes.
“Forget all the mistakes of not telling people they could die,” Schnare said. “Human testing is done only when there is a benefit to the volunteer.” Yet, Schnare said, the EPA conducts human experiments that potentially endanger participants’ health without any possibility of benefit. Included in the blame, he believes, are the universities where these research studies are conducted. They, too, have to approve these studies and the faculty members on the Institutional Review Boards are, according to Schnare, “just as complicit. They never said, 'What’s the benefit to the human subjects?'”
The OIG also noted in its report that “the EPA’s policies, guidance and consent forms do not establish the EPA’s clinical follow-up responsibilities.” Medical Daily contacted OIG, but that office was unable to respond to questions in time for this article.