Lawsuit claims human subjects in EPA trial at UNC inhaled danger - WNCT

Lawsuit claims human subjects in EPA trial at UNC inhaled dangerous fumes

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By Charlotte Huffman

A Virginia-based public policy foundation claims that the EPA knowingly piped diesel exhaust into the lungs of dozens of people at UNC-Chapel Hill.

The American Tradition Institute Environmental Law Center is suing the Environmental Protection Agency for on-going experiments at the EPA's Human Studies facility at UNC-Chapel Hill. The lawsuit alleges an EPA trial took diesel exhaust and piped it into the lungs of 41 people to see what would happen.

The institute says the EPA has exposed unhealthy patients to high levels of PM2.5, a toxic substance found in diesel exhaust, in experiments that began roughly six years ago.

The institute says the EPA parked a diesel truck next to a UNC building and pumped the diesel exhaust into a glass chamber, where patients unknowingly inhaled the lethal fumes for up to two hours.

In 2006, Landon Huffman was a UNC-Chapel Hill undergraduate trying to pay for college when he saw an advertisement in the university’s campus newspaper.

“I was 18 years old and just interested in making a little extra money. It seemed like a relatively easy and safe thing to do,” said Huffman, who signed up for the trials and earned $3,000 dollars over the course of a year for his participation.

Huffman does not recall any mention of PM2.5 and says the EPA never informed him the air he was breathing was dangerous.

“They convinced me that what I was doing was harmless. That I was breathing air from outside... Why would they lie to me, why would they mislead me like that?”

While Huffman has unanswered questions for the EPA and UNC, he spoke to NBC-17 because he wanted to make other students aware.

Steve Milloy, a public health advocate, filed the lawsuit and says the EPA made guinea pigs out of the patients.

"The experiments never should have been conducted in the first place because PM2.5, according to the EPA, is just about the most toxic substance on the planet," Milloy said. "So it's bad enough that they were conducted. But then to not inform the patients or the study subjects that they were being exposed to this most toxic substance which EPA thinks could kill them within hours -- that borders on the criminal."

The EPA program told NBC-17 that all of its studies are evaluated for safety and ethics and did not answer specific quesitons but e-mailed NBC-17 the following statement:

EPA is one of many federal departments and agencies, in addition to other research institutions, that conduct or support research with human subjects under the governance of the Common Rule. All human exposure studies conducted by EPA scientists are independently evaluated for safety and ethics, and the results are peer-reviewed. The Department of Justice is representing the United States in the litigation and further inquiry regarding the case should be directed to them.

While Milloy is suing the EPA, he said UNC's Institutional Review Board has a responsibility as well because the IRB is the last line of defense between patients and medical trials.

“UNC completely let these people down… they jeopardized the health and welfare of their human subjects that they are charged to protect.”

UNC refused to talk on camera about the trial.

NBC-17 emailed the UNC Dean of the School of Medicine Dr. William Roper asking if the IRB was aware of the dangers. And if not, NBC-17 asked, did the IRB do the due diligence of researching the known dangers of PM2.5 before approving the trials?

The university did not answer the specific questions, but UNC spokeswoman Stephanie Crayton responded with a statement that read in part, "We are investigating the circumstances surrounding the exposure studies in question to ensure that these ethical and regulatory obligations were met."

The American Tradition Institute Environmental Law Center has filed a temporary restraining order to have the on-going trials at UNC stopped and has called for an investigation into the EPA.

EPA requirements for trials say researchers must minimize risk to subjects, and the risk to humans must be reasonable compared to the anticipated benefits.

Milloy said that because the EPA already has determined that PM2.5 is lethal and can cause death within hours of breathing it, Milloy’s view is that no apparent benefit could have been gained from the research.

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