One Nation, Under Experiment
June 17, 2005
By Ken Sanders
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 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
Nothing like exploiting infants and the poor on behalf of the
The CHEERS program is not a mere anomaly. During his confirmation,
Johnson revealed that the 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 the EPA's Office of Prevention, Pesticides, and Toxic Substances
(OPPTS), the 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, the EPA didn't truly defend against the
suit - the Natural Resources Defense Council did after intervening
on the 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 the 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 a 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
In sum, embryos that might develop into people should be protected,
but not actual living 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.
Visit Ken Sanders' weblog at politicsofdissent.blogspot.com.