Wayne Cascio, director of EPA’s Environmental Public Health Division, responds to Steve Milloy’s Washington Times commentary accusing EPA of conducting unethical human experiments or, in the alternative, exaggerating the dangers of airborne fine particulate matter.
Cascio’s letter is below. Milloy’s comments are in bolded brackets. We have been busy on this issue since the Washington Times commentary was published and will have much more to say soon.
Air-pollution studies important for health
May 1, 2012, The Washington Times
Steve Milloy’s recent Op-Ed (“Did Obama’s EPA relaunch Tuskegee experiments?” Commentary, April 25) makes allegations about critical scientific research into how air pollution might contribute to abnormal heart rhythms. [I accused EPA of either: (1) conducting unethical human experimentation or exaggerating the dangers of fine airborne particulate matter (PM2.5). It must be one or the other; it can't be neither, according to EPA's own documents.]
The Environmental Protection Agency’s (EPA) research into the health impacts of air pollution has helped to build healthier communities, provide new technology and develop new solutions to protect and manage air quality. [This is irrelevant propaganda.] In the case of research into fine-particle pollution, more than 50 clinical studies over the past decade involving human volunteers have been published by scientists from the EPA, many U.S. universities and medical centers. These describe cardiac effects in humans exposed to this harmful pollution. [So EPA admits to exposing humans to "harmful pollution." This is per se unethical human research as there is no individual or societal benefit from exposing humans to known harm (more on the "known" part, below). Also, it appears that the levels of PM2.5 that EPA exposed the study subjects to (as high as 21 times the EPA 24-hour standard of 35 micrograms/cubic meter) are the highest levels humans have ever been exposed to in an experimental setting.]
The EPA follows the Common Rule, which requires the ethical review and oversight of human research by an independent institutional review board (IRB) to ensure that any risks to study volunteers are minimized and justified. The EPA follows strict human safety protocols for all of its studies and these protocols are reviewed and approved by the IRB before any human study is conducted. Precautions are taken throughout the volunteer’s participation to ensure his safety. In the case of the EPA’s research on particle pollution, scientists studied biological changes that carry no or minimal risk while providing evidence for the reasons that particle pollution can lead to serious health problems. [The EPA clearly states in its most recent scientific document on PM2.5 that short-term exposure (i.e., hours or days) to PM2.5 can cause heart attack and/or death. As pointed out in the op-ed, Lisa Jackson's recent congressional testimony about PM2.5 is even more dire. There is no provision in either the Common Rule or EPA's other ethical requirements and guidance that permits the intentional exposure of human subjects to the risk of heart attack and/or death. In fact, the purpose of the Common Rule et al. is to prevent such experimentation. Moreover, it is not at all clear that EPA informed the study subjects that the experiments could cause heart attack or death. Finally, EPA's IRB did not review these experiments before they occurred, in violation of EPA's own rules.]
The EPA has established health-based standards for fine-particulate matter, and these protect the public from serious health problems, including aggravated asthma, increased hospital admissions, heart attacks and premature death. [More irrelevant propaganda.] Individuals particularly sensitive to fine-particle exposure include people with heart or lung disease, older adults and children. [The lone case report published by EPA scientists involved a 58-year old woman with heart problems and a family history of heart disease (her father died at age 57). Experimenting on this study subject is unethical2.]
In the United States, a heart attack occurs every 34 seconds and more than 2,200 people die of cardiovascular disease each day. It is estimated that tens of thousands of premature deaths and nonfatal heart attacks are triggered by air pollution, and this emphasizes the importance of research in this field. The health scientists and staff at the EPA are privileged to provide safe, ethical, unbiased and state-of-the-art inhalation science in support of the Clean Air Act as we work to define and understand the risks of air pollution to the American people. [Yet more irrelevant propaganda.]
WAYNE E. CASCIO
Environmental Public Health Division
Environmental Protection Agency