Human testing procedures questioned

UPDATE: A representative from EPA provided the statement below.

“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.”

The U.S. Environmental Protection Agency is being sued for performing unethical human testing on UNC’s campus for several years.

The EPA has been accused of exposing human subjects to lethal air pollutants at the its Human Studies Facility, located on Mason Farm Road.

The motion hearing will be held today in Virginia. The American Tradition Institute, an environmental think tank, is the plaintiff, suing the EPA for failure to protect the human participants by informing them of harmful risks.

The institute also aims to force the agency to cease current experiments. Steve Milloy, publisher of junkscience.com and a member of the institute, said he found reports of these experiments occurring on UNC’s campus from as early as 2004.

Jennifer James, spokeswoman for UNC Health Care, said in an email that no University researchers took part in the experiments.

“While this facility is physically located on the campus of UNC-Chapel Hill, it is leased and controlled by the federal government, and is not ‘part of the University,’” she said.

But because the EPA’s facilities were technically on UNC’s campus, the studies had to be reviewed and approved by UNC’s Biomedical Institutional Review Board, said David Schnare, director of the institute’s Environmental Law Center.

Schnare, who is acting as the institute’s lawyer in the case, said the EPA excluded information about health risks in its application, but added that it was the board’s responsibility to ensure that participants’ health was not put in jeopardy.

“Someone didn’t ask the questions, and the EPA didn’t provide the answers,” he said.

Schnare said the EPA has a responsibility to set standards for clean air, but it’s not the agency’s responsibility to determine how air pollutants cause disease.

“The problem is you’re not allowed to experiment on human beings unless it helps them,” Schnare said.

During the contested experiments, Schnare said, participants entered a glass chamber and inhaled a pollutant called PM2.5 that was pumped inside.

He added that the experiments were performed on unhealthy people — including obese and asthmatic participants — because they are more susceptible to the effects.

Milloy said he was first alerted to the EPA’s testing after reading a case study about a participant who had been hospitalized because of exposure to the pollutants.

“Scientific reports and testimony (from the EPA) to Congress basically describe PM2.5 as the most toxic substance on earth,” he said.

“The only way they don’t have liability is if it is not as dangerous as they had previously said — in which case the EPA is lying to everyone.”

He said he attempted to settle the dispute outside of court by contacting the EPA before filing the lawsuit.

A representative from the EPA declined to comment.

Landon Huffman, a UNC alumnus, participated in the studies in 2006-07 during his freshman year after responding to an advertisement in The Daily Tar Heel looking for volunteers with asthma.

He said he was looking to make a little extra money, and the study seemed fairly safe.

Huffman was required to sign consent forms, but he said wheezing and coughing were the only negative side effects mentioned, and they were only expected to last a few hours.

“I had no idea what was on the other end of that pipe,” he said.

Schnare said UNC is not named as a defendant in the lawsuit, but the institute aims to cease funds to the University from the EPA.

Milloy said he sent a letter to Dr. Bill Roper, dean of UNC’s School of Medicine, in June asking him to look into the experiments performed on campus and received a response saying that Roper would review the study and investigate further if necessary.

Roper could not be reached for a comment. James said his initial response was merely an acknowledgement of the inquiry and did not reflect UNC’s involvement.

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