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The EPA, Human Studies, and Getting the Science Right

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A few months ago, the House Committee on Science, Space, and Technology took interest in a small piece of the tremendous amount of research—and funding of research—that EPA does on air pollution and its health effects. What were the lawmakers concerned about? They were purportedly worried about the adverse health impacts for people who participate in air pollution studies. The committee (whose direction and focus seem to have shifted in the past few years) requested that the EPA Inspector General (IG) investigate. That IG report was released yesterday and its conclusion is as follows:

“The EPA followed applicable regulations when it exposed 81 human study subjects to concentrated airborne particles or diesel exhaust emissions in five EPA studies conducted during 2010 and 2011. However, we identified improvements that could be made to the EPA’s policies and guidance to enhance its protection of study subjects.”

Our national air pollution laws rely on scientific studies of how air pollution affects our health--from biological and toxicology studies to large-scale population studies.

Our national air pollution laws rely on scientific studies of how air pollution affects our health–from biological and toxicology studies to large-scale population studies.

Despite this conclusion, the headline on the press release from the House science committee suggests something more sinister, in what can only be understood as the third installment in the committee’s efforts to attack the science that informs air pollution standards. (You can read about the prior attacks here and here). What the report actually found was some areas in which EPA could update its existing policies in order to better inform study participants of risks.

Why Do We Experiment on Humans?

But let’s bring it back to what these studies actually are. Since the nation’s air quality standards are based on science, it is essential that we have a solid and continually advancing understanding of how air pollution affects our health. To address this, EPA does research in areas ranging from toxicology studies to large-scale studies of populations in multiple cities.  All these studies contribute a different puzzle piece to our overall comprehension of air pollution’s health impacts. We need population studies to show us what is happening in real world conditions, we need laboratory studies to understand the biological mechanisms through which air pollution harms us, and we need people who participate in studies to understand how pollutants affect the human body.

Importantly, many scientific areas must work with people to move forward. Ever seen an advertisement for a clinical trial before? For drug development, scientists do a ton of research in laboratories to determine if drugs are safe and effective. But before that drug hits the market, it ultimately needs to be tested with people, not just on animals or on cells in a petri dish. So scientists conduct clinical trials with volunteers.

The Power of People

Clinic trials and other studies with volunteers help  researchers advance scientific understanding and enable new medical advances and better public health protections. Photo: NIH

Clinic trials and other studies with volunteers help researchers advance scientific understanding and enable new medical advances and better public health protections. Photo: NIH

Before a university, a federal agency, or an individual does any sort of research using human subjects, it needs to get approved by an Institutional Review Board (IRB). IRBs have been around for decades. They uphold consistent and strict ethics standards for experiments that involve people. They were first developed in response to the notoriously unethical experiments in World War II and in Tuskegee. That’s why it is so offensive that that the former American Tradition Institute (now the Energy and Environment Legal Institute)  and Steve Milloy–who runs JunkScience.com and has a history of interfering with science–have made such extreme comparisons between these EPA studies and experiments conducted against people’s will and without their consent. This comparison is not only inaccurate, but insulting to the men and women who perform air pollution and health studies as well as the people who choose to participate in them.

Today, for drug trials, air pollution exposure studies, and anything else that involves people, participants first volunteer for such studies, and second, must sign informed consent documents. This means participants are provided with information about the risks posed. In the case of EPA, this procedure was followed. What the IG report did say about this was that the procedure should be improved by being applied more consistently across studies and that some additional risks should be noted, even if their probability is very small.

This is an important point. Volunteers deserve to know about any risks posed by their participation. In fact, this is their right. The EPA should take these recommendations from the IG report seriously and I hope they are implemented. But suggesting a policy improvement is very different than accusing a federal agency of conducting unethical experiments

Using Science, Saving Lives

The irony here is what actually saves lives when it comes to air pollution.  Let’s look at the numbers, shall we? The IG report concerned 81 study subjects, six of whom experienced “adverse effects” of any kind. The studies were done over a two-year period. In one year, air pollution causes some 200,000 premature deaths per year in the United States (and 35 times that number globally).  EPA air pollution standards save tens of thousands of lives every year compared to the air quality we would otherwise experience. But at what cost, you ask? Actually, economic analyses have shown that the existence of the Clean Air Act programs have had a net benefit of $22 trillion.

In other words, the same lawmakers who claim to be concerned with the wellbeing of 81 volunteers have opposed standards that prevent death and sickness of thousands of Americans. So is this really about public health? Or is it about attacking the EPA on any possible grounds? The latter seems more likely. If lawmakers are truly concerned about the health of the American people, I would recommend they do a simple scale analysis and focus their efforts on where they’re most needed.

Posted in: Science and Democracy, Scientific Integrity Tags: , , , , , ,

About the author: Gretchen Goldman is a lead analyst in the Center for Science and Democracy at UCS. She holds a PhD and MS in environmental engineering from the Georgia Institute of Technology and a BS in atmospheric science from Cornell University. See Gretchen's full bio. Follow her on Twitter at @GretchenTG.

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