The Snidely Whiplash Administration, Continued
The EPA just loves to spray poor people with pesticides!
Reversing a moratorium established by the Clinton Administration, the Environmental Protection Agency under the Bush Administration is reviewing or plans to review over 20 studies that intentionally dosed human subjects with pesticides. The pesticides administered to human subjects in these experiments include "highly hazardous" poisons, suspected carcinogens, and suspected neurotoxicants. The studies, most of which were submitted to EPA by pesticide manufacturers, appear to routinely violate ethical standards.
See also this article at the Environmental Media Services's site.
Reversing a moratorium established by the Clinton Administration, the Environmental Protection Agency under the Bush Administration is reviewing or plans to review over 20 studies that intentionally dosed human subjects with pesticides. The pesticides administered to human subjects in these experiments include "highly hazardous" poisons, suspected carcinogens, and suspected neurotoxicants. The studies, most of which were submitted to EPA by pesticide manufacturers, appear to routinely violate ethical standards.
See also this article at the Environmental Media Services's site.
posted by Management at 2:38 PM
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Waxman and Boxer Release Report on Human Pesticide Experiments
Committee on Government Reform Minority Office
Thursday 16 June 2005
Rep. Waxman and Senator Barbara Boxer released a report this morning that finds significant and widespread ethical violations in human pesticide experiments currently under review by the EPA.
The report finds that these controversial experiments, in which participants were intentionally dosed with toxic pesticides, appear to have routinely violated ethical standards by failing to obtain informed consent, dismissing adverse outcomes, and inflicting harm on human subjects.
In one experiment under EPA review, human subjects were exposed to MITC, a dangerous pesticide closely related to the chemical that killed thousands in Bhopal, India, in 1984. In another, human subjects - mostly college students and minorities paid $15 per hour - were placed in a chamber with chloropicrin, an active ingredient in tear gas, for up to one hour at a time for four consecutive days. In some experiments, subjects were instructed to swallow capsules of pesticides with orange juice or water at breakfast.
The report also finds that the adverse health effects of these studies were downplayed. In one study, headaches, abdominal pain, nausea, coughing, and rashes experienced by study participants dosed with azinphos-methyl for nearly a month were dismissed as having been caused by "viral illness," "ward conditions," or diet. Human subjects were often inadequately notified of about the health risks of participating in experiments. In one experiment in which subjects were exposed to dimethoate, a pesticide that EPA considers a neurotoxicant and suspected carcinogen, the consent form stated that the chemical is "used to protect or cure" plants and that "not a single health effect is expected."
The Bush Administration reversed a moratorium on human pesticide experiments at the urging of the pesticide industry. EPA justified the move on the grounds that such studies are "available, relevant, and appropriate." The review released today by Rep. Waxman and Sen. Boxer shows the opposite: the experiments being considered by EPA are deeply flawed.
Executive Summary
Reversing a moratorium established by the Clinton Administration, the Environmental Protection Agency under the Bush Administration is reviewing or plans to review over 20 studies that intentionally dosed human subjects with pesticides. The pesticides administered to human subjects in these experiments include "highly hazardous" poisons, suspected carcinogens, and suspected neurotoxicants. The studies, most of which were submitted to EPA by pesticide manufacturers, appear to routinely violate ethical standards.
The testing of pesticides on humans is controversial. Unlike pharmaceutical products, pesticides are designed to be toxic. And unlike pharmaceutical studies, experiments that expose human subjects to doses of pesticides offer no promise of therapeutic benefit to the subjects. For these reasons, former EPA Administrator Carol Browner implemented a moratorium in 1998 on considering or relying upon human pesticide experiments.
At the urging of pesticide manufacturers, the Bush Administration reversed this moratorium. Although the Administration's first EPA Administrator, Christie Todd Whitman, tried at one point to maintain a moratorium on agency consideration of human pesticide experiments, this effort was abandoned by the Administration after she resigned and a court ruling identified procedural defects in her actions. Under its new permissive policy, EPA has stated that "the Agency is reviewing ... or expects to review" 24 separate human pesticide experiments as part of its "hazard characterization" process. The pesticide manufacturers view EPA consideration of these experiments as central to the industry's efforts to obtain lenient regulatory standards.
At the request of Senator Barbara Boxer and Representative Henry A. Waxman, this report evaluates 22 of the 24 human pesticide experiments submitted to EPA. The report assesses whether the experiments comply with the ethical and scientific requirements for research involving human subjects, including the standards in the Nuremberg Code, the Declaration of Helsinki, the "Common Rule" that guides medical research in the United States, and a recent report on human pesticides studies by the National Academy of Sciences. The two remaining experiments submitted to EPA could not be reviewed in this report because they were not provided by the agency.
The report finds significant and widespread deficiencies in the 22 human pesticide experiments being reviewed by EPA. In violation of ethical standards, the experiments appear to have inflicted harm on human subjects, failed to obtain informed consent, dismissed adverse outcomes, and lacked scientific validity.
The Report Finds:
* Human testing of hazardous substances. The experiments deliberately exposed human subjects to dangerous pesticides, such as organophosphates, which were developed in the 1930s for use in nerve gas, and methyl isothiocyanate, which is closely related to the chemical that killed thousands in Bhopal, India. In one experiment, human subjects were placed in a chamber with vapors of chloropicrin, an active ingredient in tear gas, at levels substantially greater than the federal exposure limit, causing some subjects to experience "severe" adverse effects. An older experiment administered the pesticide carbofuran to human subjects for the explicit objective of determining "the minimum dose necessary to induce toxic effects (e.g. headache, nausea, and vomiting)." In many of the experiments, the subjects were instructed to swallow capsules of toxic pesticides with orange juice or water at breakfast.
* Serious deficiencies in informed consent. The informed consent forms used in the experiments do not appear to meet ethical standards. Some used complex jargon that participants would be unlikely to understand. Others failed to disclose the potential risks involved. One experiment exposed subjects to dimethoate, a pesticide that EPA considers a suspected carcinogen, a developmental toxicant, and a neurotoxicant. Yet the informed consent form failed to mention these or any other potential health effects, stating instead that the chemical is "used to protect or cure all kinds of plants" and that "not a single health effect is expected." The informed consent forms for other experiments repeatedly referred to the pesticide as a "drug," potentially giving the test subject the false impression that the experiment was for a pharmaceutical product. In some of the experiments, there may not even have been any attempt to obtain informed consent.
* Unethical liability waivers. The Common Rule governing medical research provides expressly that "[n]o informed consent ... may ... waive or appear to waive any of the subject's legal rights." Contrary to this requirement, the informed consent forms used in some experiments include explicit waivers of liability. For example, the consent form for the chloropicrin experiment states that the sponsor would not pay "any ... form of compensation if you are injured" other than medical costs.
* Questionable scientific validity. According to the National Academy of Sciences, "a study cannot be ethically acceptable if it is scientifically invalid." Yet in many of the experiments that exposed human subjects to harmful pesticides, the number of human subjects involved was too small to provide reliable results. Three of the experiments had just six subjects. One study had a single subject.
* Questionable interpretation of results. One experiment dosed eight subjects with the pesticide azinphos-methyl for 28 days, with all eight of the subjects reporting multiple adverse health effects, including headaches, abdominal pain, nausea, coughing, and rashes. In the written report of the experiment, the researchers discounted these events, attributing them variously to "viral illness," "ward conditions," or diet. Other studies similarly dismissed unfavorable experimental outcomes.
* Failure to conduct long-term monitoring. Exposure to many of the pesticides used in the experiments can cause long-term health effects, but the studies examined only the short-term impacts on the human subjects. In 14 of the studies, there was no medical follow up after the first 24 hours after the completion of the experiment. The Bush Administration has justified the decision to accept human pesticide experiments by arguing that such studies are "available, relevant, and appropriate." In fact, this review shows the opposite: the actual experiments being considered by EPA are deeply flawed and rife with ethical violations.
Press Release
For Immediate Release: Thursday, June 16, 2005
Contact: Chas Offutt (202) 265-7337
EPA ENCOURAGING PESTICIDE COMPANIES TO CONDUCT HUMAN STUDIES
Proposed New Rules Lack Any Ethical Protections for Study Subjects
Washington, DC — In recent Federal Register notices, the U.S. Environmental Protection Agency is proposing that pesticide companies submit human exposure experiments when seeking to market new chemicals or broaden the application of existing ones. EPA is not, however, requiring the industry to observe any ethical safeguards, such as informed consent, no undue risk to participants and exclusion of infants or other vulnerable populations, according to Public Employees for Environmental Responsibility (PEER).
These new policies hang in the balance while Congress debates whether to prohibit the agency from accepting any human pesticide dosing studies. Such a ban has already passed in the House of Representatives and consideration of a similar amendment is imminent in the Senate. Just weeks ago, EPA Administrator Stephen Johnson reluctantly cancelled a controversial study financed jointly by EPA and industry called CHEERS (Children’s Environmental Exposure Research Study) that would have paid Florida parents to apply pesticides and other chemicals in the rooms primarily occupied by their infant children in order to remove Senate objections to his confirmation.
Nonetheless, the agency is signaling a desire to propel a much broader, industry-driven human experimentation agenda. In its latest notice filed on June 8th, the agency promised that the proposed pesticide rule for toxic agents is “the first of several planned changes.”
In its new proposal, EPA would revamp nearly 20-year old data requirements for pesticides by encouraging the companies to submit human dosing studies “in addition to, or in lieu of” conventional animal studies or background environmental exposure studies, because —
· The human dosing studies may eliminate the need for pesticide companies to pay for expensive toxicological testing in cases where the human subjects evidence no detectible harm; and
· Background environmental exposure tests “usually overestimate exposure because they only provide estimates of potential exposure, not measurements of absorbed dose.”
“The issue here is not the march of science but whether standards of basic decency will be applied to experiments conducted for commercial gain,” stated PEER Executive Director Jeff Ruch, whose organization has been relaying ethical concerns raised by EPA’s own scientists. “It is beyond ironic that EPA claims these studies are required to protect human health while turning its back on the health risks posed to the troops of human guinea pigs it is creating.”
At a recent EPA office groundbreaking in Denver, Johnson decried Congressional interference in the CHEERS study. Not only has Johnson personally championed the pesticide industry drive to legitimize widespread human dosing work but he has also refused to require that industry studies conform with informed consent rules or safeguards for infants, pregnant women, fetuses and other vulnerable groups that apply to all medical experiments submitted to regulatory agencies such as FDA or research bodies, such as NIH.
The new rules will likely result in thousands of corporate sponsored human dosing studies each year, in part because EPA states that it “generally is not allowing surrogate data” using other benign chemicals. Instead, the agency “encourages applicants and registrants to generate needed exposure data using the pesticide product for which the registration is sought.” This requirement will mean separate batteries of human dosing for each new chemical or new application in order to build a meaningful database.
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