If Any PI or IRB Approved This Protocol, They Would Be in Jail

I’m guessing I wouldn’t be able to get away with this–nor would I want to (boldface mine):

Over the past decade, the EPA has apparently been paying hundreds of people $12 an hour for the privilege of exposing them to high levels of air pollutants like diesel exhaust and PM2.5 particulate matter in an operation run at the University of North Carolina’s School of Medicine.

A lawsuit has been filed in the federal court, charging the EPA with conducting illegal and potentially lethal experiments of hundreds of financially vulnerable people.

According to an EPA testimony before Congress in 2011, particulate matter—a key component of diesel exhaust fumes–causes premature death. “It doesn’t make you sick. It’s directly causal to dying sooner than you should.”

In addition: “If we could reduce particulate matter to levels that are healthy we would have an identical impact to finding a cure for cancer.”

Apparently, however, test subjects were not apprised of the exact risk involved. While the EPA has dramatized the dangers of PM2.5 exposure before Congress, with its test subjects, the message has been toned down to warn of the potential of airway irritation, coughing or shortness of breath. The courts will have to determine whether test subjects were sufficiently briefed on the risks.

This is how the EPA gathers the research it needs to support the implementation of strict regulations. Two major new regulations that have actually been rejected by the D.C. District Circuit Appeals court are the Cross-State Air Pollution Rule and the Mercury Air Toxics Standard—both based on the dangers of PM2.5.

Two things to note. First, the person pushing this story is Steven Milloy, who has made a career out of using junk science for odious purposes (e.g., defending the lung cancer/smoking lobby). Second, I can’t imagine a single academic IRB that would allow exposure to these agents without full disclosure of potential effects, if for no other reason to avoid lawsuits. By behaving unethically, the EPA has exposed itself (pun intended) to having regulations overturned.

Unacceptable.

This entry was posted in Ethics, Public Health. Bookmark the permalink.

3 Responses to If Any PI or IRB Approved This Protocol, They Would Be in Jail

  1. Bayesian Bouffant, FCD says:

    “It doesn’t make you sick…”
    This may be semantics, but I consider ‘dead’ to be a particularly severe form of ‘sick.’

  2. Zachary Smith says:

    I know government-funded researchers have in the past pulled some stupid boners, and have also perpetrated some actual horrors. That said, I’m reserving judgement about whether or not this story falls into either category.

    The involvement of Steven Milloy make this one smell to high heaven. And I’m afraid I won’t necessarily trust the Obama folks either, not after they threw Shirley Sherrod under the bus. In many cases they operate on the level of scumbags like Milloy.

    BTW, here is a link to what is probably the offending paper.

    http://www.smw.ch/content/smw-2012-13597/

  3. onkelbob says:

    Thank you Zachary for the link. The subjects were only in the chamber for 2 hours, and a “weakness” of the study is only short term outcomes are observed. It does not appear that the EPA engaged in some heinous human testing, while it does seem that much sound and fury is being raised over nothing. The test design wanted to mimic real world conditions, in other words, what your local bike messenger experiences on a daily basis. So the assertion that this 2 hour session (even if conducted over multiple days) somehow inflicts undue harm is a stretch. What is left unacknowledged is that bike messenger analogy – namely these conditions already exist, they exist in the broader world, and people are being subjected to them without their informed consent. For obvious reasons I do not believe Milloy is going to bring that up.

Comments are closed.