Pesticide firms want to test chemical toxicity on humans instead of rats
Sat, 4 Jan 2003
Count the reasons why not human pesticide experiments:
1) quantum increase in commodification of subjects,
2) presumptive utter absence of benefit to subjects,
3) end term purpose of inquiry is forensic (e.g. the San Bernardino cases where testing with perchlorate was sponsored by defendant in litigation) or regulatory (to determine “safe” levels of exposure to chemicals or toxins where “safety” is only relative and ultimately destined for an economic cost/benefit decision),
4) likely subjects will be vulnerable (e.g. VA patients, as in San Bernardino),
5)intent is to provide protective cover against liability by manufacturers seeking to immunize themselves against litigation (e.g. they can demonstrate that government approved testing shows exposure levels to be “safe”).
There is very little difference between this horrible proposal and
a) 3rd Reich high altitude testing, or
b) an imagined scenario in which Ford Motor Company might have conducted frequency testing on Pinto gas tanks installed on subjects’ vehicles to see if the $11 dollar gizmo it proposed to use to secure the tank could indeed withstand rear end collisions without resulting in an explosion.
Tom Dalglish, J.D., Ph.D.
Director of Research Integrity
University of Louisville, Ky
A Public Forum will be held about this surreal issue:
Date: Wednesday, Jan 8, 2003.
Address: National Academy of Science in Washington DC
Address: NAS 2100 C Street NW Washington DC
The Forum is to provide input to the Committee on Use of Third Party Toxicity Research with Human Participants (i.e., pesticide experiments on human subjects).
Also, on Thurs. Jan 9, 2003: Second Meeting of the Committee Science, Technology, and Law Program will meet The National Academies Washington, D.C. Jan 9 Address: 2100 Constitution Ave NW
The Alliance for Human Research Protection (AHRP) will be among the invited non-industry organizations presenting: Environmental Working Group, Natural Resources Defense Corp Children’s Environmental Health Network, Farm Worker Justice Fund Physicians for Social Responsibility
Humans as lab rats — experts will weigh in Pesticide firms want to measure toxicity by paying volunteers
Saturday, January 4, 2003
By JOAN LOWY SCRIPPS HOWARD NEWS SERVICE
Should chemical and pesticide companies be allowed to replace lab rats with humans to test the safety of toxic chemicals?
That’s the volatile question a special panel of the National Academy of Sciences is scheduled to take up next week.
A year ago, the Environmental Protection Agency asked the academy to examine the ethics and scientific value of paying people to eat or drink small amounts of pesticides, rocket fuel and other toxic substances to gauge the level at which they affect human health.
Pesticide companies have taken the EPA to court to force the government to consider the results of human studies performed by private contractors in regulatory decision-making. Industry officials say the human tests are a more precise gauge of the potential health impacts of some toxic substances than laboratory tests on animals.
Critics, however, claim the industry is trying to get around the EPA’s formula for establishing a safe pesticide exposure level for humans, which is 10 times stricter than the toxicity threshold in animal tests. For children and other sensitive groups, the parameters are 10 times stricter than for the general public.
“The best information we can obtain about the possible health effects of pesticides on humans is through the studies that have been performed directly on volunteers,” said Ray McAllister, vice president of CropLife America, a pesticide trade association. “We need confirmation that the animal studies are in the right ballpark.”
Environmental and public health activists, however, say it’s unethical to lure people with offers of easy money into taking actions that cannot benefit them and may harm their health. Study volunteers have included welfare recipients, the homeless and college students.
“It’s unbelievable to us that we’re even discussing this in this day and age,” said Mike Casey, a spokesman for the Environmental Working Group, a non-profit environmental research group. The Environmental Working Group brought the issue to public attention in 1998 in a report about studies submitted by industry to the EPA that paid people in England to eat a bug killer, dichlorvos, that is common in pet collars. In another study in Scotland, subjects drank doses of the extremely toxic insecticide, aldicarb.
Most of the studies have been conducted outside the United States. However, Dow Agrosciences underwrote a 1999 study in Lincoln, Neb., in which 60 volunteers were given either doses of chlorpyrifos, a leading pesticide, or a placebo. The volunteers were paid $460.
According to results from the study, volunteers who swallowed the pesticide capsules reported developing one incident each of nausea, vomiting, abdominal pain, shortness of breath, impairment of sensation and chest pain.
That same year the EPA banned most industrial and home uses of chlorpyrifos (marketed under the name Dursban) because it can disrupt the nervous system. The pesticide is still permitted for some agricultural uses.
In another study underwritten by Lockheed Martin and the U.S. Air Force two years ago in San Bernardino, Calif., 100 people were paid $1,000 each to eat a dose of perchlorate every day for six months. Perchlorate is a toxic component of rocket fuel that damages thyroid function, preventing healthy development of fetuses and children and causing cancer.
Perchlorate contamination has been found in drinking water supplies in dozens of communities around the nation, especially in Southern California. The EPA is in the process of deciding what level of exposure to perchlorate is safe for humans. That decision could greatly affect how much money it will cost defense contractors to clean up contamination in water supplies relied upon by millions of Americans.
The EPA imposed an informal moratorium on the consideration of human dosing studies in regulatory decisions in 1998. A scientific panel assembled by the agency also recommended human dosing studies be used only in rare cases, if ever.
After President Bush took office in January 2001, EPA officials quietly dropped the moratorium and began considering human testing data in re-registering some pesticides. However, the EPA formally reimposed the moratorium in December 2001 after a flurry of negative publicity.
Dr. Lynn Goldman, who was responsible for the EPA’s pesticide and toxic chemicals regulatory programs during the Clinton administration, said the human dosing studies are often skewed because they are usually comprised of young, healthy adult males and are not representative of the general population.
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