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(DV) Sanders: One Nation, Under Experiment







One Nation, Under Experiment
by Ken Sanders
June 16, 2005

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Ostensibly, the Food and Drug Administration ("FDA"), as well as the Environmental Protection Agency ("EPA"), are regulatory agencies entrusted to protect the health and safety of the public. However, as starkly revealed by recent events, neither the FDA nor the EPA is particularly concerned about the public. Rather, they see us as test subjects, lab rats, to be exploited for experimentation by or on behalf of the chemical and pharmaceutical industries.

Take, for instance, the April threat by Senators Bill Nelson and Barbara Boxer to block Bush's nomination of Stephen Johnson to head the EPA. The Senators took exception to the EPA's CHEERS (Children's Environmental Exposure Research Study) program, in which low-income, minority families were promised up to $970.00 if they allowed the application of pesticides and other chemicals in rooms primarily occupied by their infant children. The study was partially funded by the American Chemistry Council, a lobbying arm of pesticide manufacturers, to the tune of $2 million. Johnson promised to terminate the CHEERS program in exchange for his confirmation.

Nothing like exploiting infants and the poor on behalf of the pesticide industry.

The CHEERS program is not a mere anomaly. During his confirmation, Johnson revealed that EPA is conducting more than 250 other experiments on human subjects. Several of those experiments involve testing chemicals on children, including: exposing children to a pesticide (chlorpyrifos) that was banned for residential use in 2000; paying children to inhale methanol vapors at levels described as "a worst case scenario"; and having asthmatic children inhale harmful ultra fine carbon particles.

In fact, after Johnson became Acting Assistant Administrator in 2001 of EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS), EPA institutionalized chemical testing on human subjects. In 2003, the EPA reversed its policy of refusing to accept research involving the testing of pesticides on human subjects. The reversal came after what can only be described as a "friendly" lawsuit by the pesticide industry to force the EPA to reverse its policy. Like when a husband sues his wife to recover under her insurance policy following a car wreck, there was nothing legitimately adversarial about the lawsuit. Indeed, EPA didn't truly defend against the suit - the Natural Resources Defense Council did after intervening on EPA's behalf.

Currently, the EPA considers results of industry tests of pesticides upon human subjects on a "case-by-case basis." The EPA has no safeguards in place to protect infants, neonates, pregnant women, and prisoners, although it promises to adopt such protections sometime in the future. Additionally, EPA's "case-by-case" analysis does not require industry to abide by such ethical principles as obtaining the informed consent of its subjects and avoiding inappropriate inducements.

The only condition placed by EPA on industry's ability to test pesticides on human subjects is that there not be "clear evidence" that the test was "fundamentally unethical." Of course, neither "clear evidence" nor "fundamentally unethical" are defined by EPA. Shouldn't be difficult for industry to satisfy that standard.

Similarly, under Bush's FDA, concern for the health and well-being of walking and talking people is all but nonexistent. Take, for instance, the recent revelations regarding the fatal side-effects of the COX-2 inhibitors Vioxx, Celebrex, and Bextra. Despite the mountain of evidence that the drugs unduly increased the risk of heart attacks and strokes, the FDA's advisory committee voted in February to allow the continued marketing of the drugs.

As it turns out, 10 of the 32 members of that advisory committee were affiliated with the manufacturers of COX-2 inhibitors. Another 17 members of the committee were affiliated to other drug manufacturers. According to the New York Times' analysis of the advisory committee's vote, the committee would not have approved further marketing of the drugs had the conflicted scientists not been allowed to vote.

Following the COX-2 debacle, resulting in the drugs' removal from the market, the FDA announced the formation of its new Drug Safety Oversight Board (DSB). The DSB, however, has no real authority, like the authority to order a harmful drug be pulled from the market. What's more, while touted as an independent body within the FDA, a majority of the DSB members are also senior managers of the department responsible for approving the drugs in the first place. Finally, unlike those of FDA advisory committees, the DSB's deliberations will be closed to the public.

The FDA's disregard for the public's safety is not a new phenomenon. Since Bush took office, the FDA has become increasingly lax in ensuring the public's safety. FDA enforcement against false and misleading advertisements by pharmaceutical companies has declined 70 percent since 2001. The FDA's decreased enforcement is commensurate with the pharmaceutical industry's 61 percent increase in prescription drug advertising.

In sum, embryos that might develop into people should be protected but not actual people.

That seems to be the way of the Bush administration, conservative Republicans, and radical Christians. When it comes to fetuses and embryos, they will fight like hell to protect the rights of the unborn. Once those fetuses and embryos exit the womb, however, as far as Bush and like-minded conservatives and fundamentalists are concerned, all of their maudlin sympathy goes out the window.

Ken Sanders is a writer based in Tucson, Arizona. Visit his weblog at:

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