Who'll protect kids from the EPA?

Via my better half, an article from the Baltimore Sun reporting that new EPA rules allow testing of pesticides on children.

Now, the thing is, these are new rules that were prompted by criticisms of earlier problems -- including pesticide studies whose human subjects didn't know what they had been exposed to, nor even the purposes of the studies in which they were subjects! So, the idea was that the new rules would address these problems. Right?

Quoting from the article:

In unveiling the new rules last week, the EPA promised full protection for those most at risk of unethical testing.

"We regard as unethical and would never conduct, support, require or approve any study involving intentional exposure of pregnant women, infants or children to a pesticide," the rule states.

But within the 30 pages of rules are clear-cut exceptions that permit:

• Testing of "abused or neglected" children without permission from parents or guardians.
  
• "Ethically deficient" human research if it is considered crucial to "protect public health."
  
• More than minimal health risk to a subject if there is a "direct benefit" to the child being tested, and the parents or guardians agree.
  
• EPA acceptance of overseas industry studies, which are often performed in countries that have minimal or no ethical standards for testing, as long as the tests are not done directly for the EPA.
  

Shall we take these point by point?

1. It is not on the face of it outrageous to think that there might be certain instances in which participating in a scientific study could have a potential benefit for a human subject. If that human is a competent adult, the idea is to explain the potential benefit, as well as the potential harms, and let that competent adult make her own decision. If the human is a child, generally we look to the parent or guardian to make the decision that is in the best interests of the child. (And, there may be an argument here that the adult rendering consent for a child needs to be extra careful, not only about the immediate costs and benefits to the child, but also about how this decision may affect the child's later range of choices in certain, sometimes irreversible ways.)

An abused or neglected child, arguably, does not have access to parents or guardians who can make decisions in the best interests of the child. (Set aside, for the moment, concerns about who gets labeled as abused or neglected; I think there are really worries to raise here, but even if there weren't, we've still got stuff to worry about.) So, the abused or neglected child can't get proper consent from a parent or guardian to participate in a scientific study. But, they get to participate in a study without their parent's permission.

Why is the default position here getting to be a subject in a pesticide study? We're not talking about testing a new, promising drug (late in the drug-approval process, past the stage of figuring out how much of the compound a body can take without getting sick) when no other treatment is available for an illness that is doing you serious harm. We're talking about being exposed to pesticides. What is the potential benefit for the child?

2. I would love to see a succinct explanation of the "ethically deficient" research that is being allowed. Are we talking sloppy notebooks? Lying to the IRB? Being mean to the human subjects? Help me out here.

Also, what are the guidelines for what is crucial to protect public health? How precisely are we defining public health, and what are the boundaries on what is permissible in its protection? (Surely having nourishing food, safe water, and proper sanitation is essential to public health, and sometimes the government ... eh, just doesn't get around to it right away.)

Are unethical scientific experiments suddenly going to lead to big improvements in public health?

3. If we're going to allow kids to undertake more than a minimal health risk, someone needs to spell out what the "direct benefit" to the child being tested could be. Again, we're talking about exposing kids to pesticides. Is this expected to make them healthier? Smarter? What is the likely payoff that justifies the risk they are being asked to undertake? (And c'mon, if the parents are the ones rendering consent here, or if the kids are infants, they aren't even being asked, so it's even more important not to screw up.)

Or are we counting as the "direct benefit" something along the lines of warm meals and a ride to the clinic in an air-conditioned car? Because honestly, that hasn't worked out so well in the past. (Ask the Public Health Service.)

4. Oversees industry studies, performed in places where human subjects are not afforded the protections they are here ... because if you need to have the science to sell your products, you might as well be able to do the studies somewhere life is cheap. It's just good economic sense.

While I suppose it is possible to get scientifically valid data from studies where one treats human subjects unethically, it isn't something scientists like to do. Medical journals tend to have policies against publishing such results. Studies that treat human subjects badly could make it harder for other scientists, no matter how ethical, to find human subjects to participate in future studies -- especially if it makes the news. (In the aftermath of the Tuskegee syphilis experiment, how much harder was it to find willing participants in AIDS research than it might have been otherwise?)

Possibly there is some scientific knowledge that it would be hard to get except by asking human subjects to undertake significant risks. Depending on the nature of those risks, and the age of the subjects, it might even be that the clearest ways to get that knowledge would be, by accepted definitions, unethical.

Is this a good reason to relax the definition of what is ethical?

First, there may be other good ways to answer the scientific question that are not unethical, Sometimes ethical constraints make scientists more clever in how they approach problems. (On the other hand, it would seem that an overabundance of humans on whom to experiment made some of the medical researchers in Nazi Germany absolute morons, scientifically speaking.)

Second, it seems like we shouldn't even get to the let's-lighten-up-on-the-ethics stage unless the scientific knowledge in question is absolutely essential. The harm of not finding a workable answer to the scientific question has to be big, and it has to harm more than just the R&D team trying to bring a new product to market, or the shareholders, or the CEO.

If testing pesticides on children is so essential, and promises so much benefit to the children, then maybe we should go right to the children of the pesticide industry. No, not the kids of the parents working the line in the pesticide factory -- the kids of the CEOs, the stockholders, the lobbyists, etc.

The EPA will make sure it's OK.


Technorati tags: EPA, pesticide, ethics