- - Thursday, October 18, 2012

The U.S. Environmental Protection Agency (EPA) has been sued in federal court for allegedly conducting illegal experiments on human beings. The case tests whether a government agency can violate the law and the most sacrosanct ethics of scientific research — and get away scot-free.

Based on thousands of pages of documents obtained through the Freedom of Information Act, since 2004 and continuing through the Obama administration, the EPA intentionally has been exposing dozens, if not hundreds, of human subjects to extraordinarily high levels of air pollutants such as diesel exhaust and fine particulate matter, known as PM2.5. The experiments occurred at an EPA facility located on the campus of the University of North Carolina School of Medicine.

Many of the study subjects were health-impaired — suffering from asthma, metabolic syndrome, old age (up to 75 years) or, worse, combinations of those factors. They were all financially needy, since they enrolled in the experiments for compensation of $12 per hour.

Since 1997, the EPA has regulated PM2.5, which is also a major component of diesel exhaust, on the basis that it kills people. In 2004, the EPA determined that PM2.5 could kill on a short-term basis — i.e., within hours or days of exposure. The EPA also determined in 2004 that there is no safe level of exposure to PM2.5. That is, any inhalation of PM2.5 can kill. EPA says health-impaired people and the elderly are most vulnerable to the effects of PM2.5. EPA also says the evidence is strong that PM2.5 and diesel exhaust cause cancer.

The chairman of EPA’s Clean Air Scientific Advisory Council, Dr. Jonathan M. Samet, wrote in a 2011 commentary in the New England Journal of Medicine that there is no safe exposure to PM2.5, a view reiterated to House Energy and Commerce Chairman Fred Upton, Michigan Republican, in a February 2012 letter by EPA’s air chief, Gina McCarthy.

EPA Administrator Lisa P. Jackson testified in Congress in September 2011, “Particulate matter causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you should.” She also testified, “If we could reduce particulate matter to levels that are healthy, we would have an identical impact to finding a cure for cancer.” Cancer kills about 570,000 people in the U.S. annually, according to the American Cancer Society.

EPA does more than just say bad things about PM2.5 and diesel exhaust. It has issued stringent multibillion-dollar regulations that limit emissions. In addition to setting national air quality standards, which EPA is in the process of tightening, the agency has issued many rules during the Obama administration, the two biggest being the Cross-State Air Pollution Rule and the Mercury and Air Toxics Standards. EPA’s cost-benefit justification for both rules depends entirely on its condemnation of PM2.5 as a killer.

In addition to testing the lethal and cancer-causing PM2.5 and diesel exhaust on frail and needy people, the EPA failed to inform the study subjects that it had determined that those substances were so deadly and toxic.

While EPA repeatedly over many years has told the public and Congress that PM2.5 can kill within hours of exposure, the agency only told the study subjects, for example, “You may experience some minor degree of airway irritation, cough or shortness of breath or wheezing. These symptoms typically disappear two to four hours after exposure, but may last longer for particularly sensitive people.”

One obese woman with a personal and family history of heart disease developed a cardiac arrhythmia during her experiment. She was rushed to the hospital for an overnight stay. The EPA, in a published report, attributed her heart problem to PM2.5, but it then failed to warn subsequent human subjects of the risks of cardiac arrhythmia.

In its lawsuit against the EPA, the nonprofit American Tradition Institute asserts that all this conduct runs afoul of virtually every rule and ethical standard established since World War II and the Tuskegee syphilis experiments to protect human study subjects from rogue and abusive scientific research.

In answer to the lawsuit, EPA included a declaration in which the clinical studies coordinator claims to verbally warn study subjects right before experimentation, “There is the possibility you may die from this.” In addition to the shocking nature of this “warning,” even if it were acceptable to risk the lives of human study subjects for the sake of science, such a warning would need to be in writing, according to the Common Rule.

EPA also has potential civil liability to the study subjects and criminal liability for fraud and assault and battery. While the mere testing of such toxic substances clearly is prohibited, EPA has compounded wrongdoing with its failure to obtain informed consent.

So if PM2.5 and diesel exhaust are, in fact, as dangerous as EPA says, the agency could face serious legal liabilities. The only way the agency wouldn’t face those liabilities would be if it has been grossly misleading the public, and Congress and PM2.5 and diesel exhaust aren’t really so toxic after all.

At least three of the EPA researchers involved in these experiments are North Carolina-licensed physicians. The North Carolina Medical Board has opened an investigation. The University of North Carolina School of Medicine, which provided EPA with the required institutional review board for approving the experiments, has commenced its own inquiry. In contrast, the Obama-appointed Presidential Commission for the Study of Bioethical Issues has refused so far to get involved, despite multiple requests, claiming it already has a full agenda.

Because EPA so far has resisted efforts, including those of Congress, to respond substantively to these allegations, it will now have the opportunity to do so before a federal judge and, possibly, North Carolina state courts.

Steve Milloy publishes JunkScience.com and is the author of “Green Hell: How Environmentalists Plan to Control Your Life and What You Can Do to Stop Them” (Regnery, 2009).

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