Map of life expectancy at birth from Global Education Project.

Thursday, June 07, 2007

In case you thought you'd already maxed out your outrage meter . . .

this might make it go up to 11. My friend Sheldon Krimsky and Tania Simoncelli from the ACLU have a commentary in the new JAMA that you can't read because you're just common rabble -- no fault of Shelly's, I assure you, he is probably the one person on earth who is most committed to the democratization of science. But he doesn't make the rules. Anyway, you can read the first 150 words here.

To summarize as best I can, it used to be considered unethical to test pesticides on humans. Now that seems kind of obvious, doesn't it? What I mean is just what I said: it was not considered proper to intentionally feed pesticides to humans in order to find out whether they are safe, for the obvious reason that if the answer turns out to be "no," your volunteers -- or perhaps prisoners -- are shit out of luck. This has been generally accepted since the Neuremberg trials of Nazi doctors.

So, what's the alternative? Studies on animals, obviously. But, people aren't quite the same as rats and mice, so under the Food Quality Protection Act of 1996, the EPA uses additional margins of safety: up to 10 times for the possible difference between human and animal sensitivity, up to 10 times for differences among individual humans, and up to 10 times for the extra protection of children (who are more sensitive than adults to many toxins). So, the EPA could conceivably set a human exposure limit 1,000 times lower than the dose found to be safe in animals.

Pesticide manufacturers would like to be able to get higher exposure limits, so they would like to test pesticides directly on humans in the hope they can show safety at higher levels. And they did so. Shelly and Ms. Simoncelli tell us that they submitted 16 such studies to the EPA between 1992 and 2004, which a House committee found "appear to have inflicted harm on human subjects, failed to obtain informed consent, dismissed adverse outcomes, and lacked scientific validity." Sounds to me like we're talking crimes here -- you know, reckless endangerment, assault and battery -- but as far as I know there were never any prosecutions.

Well, after various regulatory and legal permutations which I don't have room to go into here -- including a moratorium on accepting data from human studies issued by the Clinton Administration, briefly reversed by the administration of you-know-who and then finally overturned by a federal appeals court in 2003, the EPA has issued a new rule allowing the intentional dosing of humans with pesticides. As Krimsky and Simoncelli conclude:

Two statements from the Declaration of Helsinki, as amended in 1983 by the 35th World Medical Assembly, raise serious questions about the morality of intentional human dosing experiments. The first states that “biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.” Pesticides, which are often neurotoxins, endocrine disrupters, or cholinesterase inhibitors, may have acute or long-term chronic effects on those exposed. What system of moral proportionality can possibly weigh the potential of human suffering against the benefits to a company's profit margin? . . .

The presumptive moral position is that the intentional dosing of humans with nontherapeutic agents is unethical. Companies that have an interest in these experiments for minimizing their regulatory burden can, and probably will, purchase these studies and the ethics approvals to support them from private contract research organizations that typically pay members who serve on their institutional review boards. The proposed in-house ethics committee within the EPA cannot be fully insulated from political influences. Because of the complexity of health end points in human toxicology studies and the potential for long-term effects, no reasonable set of human studies will be sufficient to reveal the risks of a person's exposure to pesticides in these experiments or will be able to cover the range of health end points that can be studied using animals and cell culture. Moreover, risk-benefit analysis, 15 in which human research participants bear the risks while pesticide companies acquire the benefits, is an inappropriate criterion for deciding whether it is ethically correct to intentionally expose people to nontherapeutic neurotoxins. . . .

How many human study participants, how many experiments and replications, and how many end points must be studied to obtain the definitive answer to whether a 10-kg infant or a 65-kg adult is more or less sensitive than a 0.5-kg animal to raise pesticide residue levels in food? Is the answer to this question, for the benefit of cost-efficiency, worth the uncertain long-term risks that financially rewarded, usually economically disadvantaged, human subjects will face from intentional exposures to neurotoxins? Is dividing by 10 from mouse to men (and women) too big a burden? The answer is categorically no!

So far, the EPA intends only to permit human testing of pesticides, but it could decide to allow it for industrial chemicals as well. This is absolutely depraved. And why have we heard nothing about this in the corporate media, or from Congress? Are these the "moral values" that Mr. Bush's loyalists claim to uphold? What has become of us?

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