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The US Environmental Protection Agency is using data from two dozen tests that deliberately exposed humans to toxic chemicals, according to a study released yesterday by congressional Democrats. 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.

At least three of the cited experiments (with Azinphos-Methyl and Guthion) were conducted by Bayer Corporation.

See full report
background on Bayer´s role

Introduction to the Report:

Waxman and Boxer Release Report on Human Pesticide Experiments

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 "no 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.

The Guardian, Friday June 17, 2005

US agency 'giving green light' to human toxin tests

Congressional Democrats accused the US government environment body yesterday of opening the door to tests of pesticides on humans that "appear to routinely violate ethical standards". The Democrats issued a report saying that, since lifting a moratorium on human testing imposed by the Clinton administration, the Environmental Protection Agency (EPA) had accepted for review more than 20 studies on the effects on human subjects of "highly hazardous" poisons and suspected carcinogens.

Critics said that by showing its willingness to look at such studies, the EPA was encouraging pesticide manufacturers to sponsor more human tests.
"We anticipate that these tests are going on now all over the world, but there's no way of knowing (because the EPA has not required notification)," said Erik Olson, a lawyer for the National Resources Defence Council. "We're calling it the wild west. The companies are doing what they will without clear legal restrictions. That's a recipe for disaster when the federal government is encouraging them to go ahead by accepting these tests."

Eleven of the studies mentioned in the report were carried out in Britain, mostly in Edinburgh, in the 1990s. It was unclear last night whether such studies were still under way.

The congressional report was sponsored by Barbara Boxer, a California senator, and Henry Waxman, a congressman from the same state. They said it had uncovered "significant and widespread deficiencies" in 22 human pesticide experiments it reviewed. "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 found. "In many of the experiments, the subjects were instructed to swallow capsules of toxic pesticides with orange juice or water at breakfast."

The "informed consent" forms were often loaded with jargon, hard to understand or deliberately misleading about potential health risks. Some studies dismissed unfavourable results. In one test, all eight subjects became sick after exposure to a pesticide, but in the report their symptoms were discounted and attributed to "viral illness".

Eryn Witcher, the EPA's press secretary issued a statement last night saying: "The agency values the importance of the scientific and ethical issues surrounding human studies, which is why the agency is expediting the process to issue its first-ever regulation on third-party studies."
Critics fear that EPA approval of the human tests could lead to a relaxation of US standards.

The EPA has yet to approve any of the human studies submitted to it, but its critics argue that simply by showing readiness to assess the tests in a formal announcement in February, the agency was giving manufacturers a green light.

Lynn Goldman, an EPA assistant administrator under the Clinton administration, said: "Once you open the door, saying we're going to look at these studies, it will encourage companies to start testing again, whether it is in the UK or wherever they can get it down.
"They could be doing it in Pakistan or Bangladesh or anywhere in the world." (by Julian Borger)

San Diego Union Tribune, June 17, 2005

Californian lawmakers want stop to human pesticide testing

By Mike Lee and Cheryl Clark

A UCSD experiment that included spraying a toxic chemical in the nostrils and eyes of young adults is one of 22 questionable research projects sparking calls for a national moratorium on human pesticide testing.
Sen. Barbara Boxer and Rep. Henry Waxman, two California Democrats, issued a 38-page report yesterday alleging that pesticide industry-sponsored studies on humans nationwide are improperly putting participants at risk.
"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 says.
At the University of California San Diego, officials said their research, which ended in 2004, met all legal and ethical standards and participants were fully informed.
"There weren't rules broken. Nothing was done in the background or in a breach of public trust. It's pretty normal science," said Dr. Daniel Masys, former director of UCSD's Human Research Protections Program.
"Clearly, someone who is writing this has an ax to grind and in doing it they trampled the careful science," said Masys, whose office oversaw the experiment's ethical guidelines. He left the campus in February for a post at Vanderbilt University in Tennessee.
The UCSD testing involved exposing 127 volunteers ages 18 to 35 to incremental doses of chloropicrin, a fumigant used in a variety of pesticides and tear gas. The experiments were aimed at showing how much chloropicrin was needed before the participants would notice the chemical.

UCSD spokeswoman Leslie Franz stressed that "no unexpected adverse events other than irritation occurred during the study."
But according to the Boxer and Waxman report, chloropicrin is "a highly hazardous poison that can be lethal in sufficient doses . . . (and) has potential DNA-damaging effects."
The lawmakers want at least a temporary ban on human chemical testing while the U.S. Environmental Protection Agency devises rules for such research.
Legislation with that goal in mind has gained wide support among environmental groups, such as the Pesticide Action Network North America.
"A moratorium is necessary . . . to see if we can begin to establish some sort of standards that are really going to keep people safe," said Tanya Brown at the group's San Francisco office.
As far back as 1998, the EPA expressed deep reservations about testing pesticides on humans, according to an agency memo from that year.
Agency spokeswoman Eryn Witcher said the EPA closely examines human studies, but a court ruling in 2003 won by chemical companies forced the agency to accept such data. She said the EPA aims to have its first regulations for human pesticide research in place next year.
Industry experts said human tests are used for less than 10 percent of chemicals, but they're needed to determine health effects not obvious in animals.
"You can't just trust the laboratory rat samples to be the reliable indicator . . . for people who would be involved in the actual use of pesticides," said Jay Vroom, president of CropLife America, a major farm chemical lobbying group in Washington, D.C.
Vroom unequivocally backed the research and is fighting the moratorium proposal.
"I have no question but that (the sponsoring companies) did everything correctly," he said.
Boxer and Waxman came to a different conclusion.
Their report covers 22 of the 24 most recent human chemical studies submitted to the EPA. While alleging widespread ethical breaches, it particularly calls into question the UCSD experiment, in which participants were paid $15 an hour to be exposed to chloropicrin.
The common farm chemical, used to kill lumber fungi and soilborne pests, also is an active ingredient in tear gas. It frequently is used with pesticides during termite fumigation because its pungent odor warns people to stay away.
During the study, some participants were exposed to chloropicrin doses of up to 150 parts per billion while they sat in a sensory chamber for up to one hour, according to the report.
In another phase of the study, the volunteers had higher doses, up to 1,200 parts per billion, shot into their nostrils and eyes, the report says.
By comparison, the Occupational Safety and Health Administration has set an exposure limit of 100 parts per billion averaged over eight hours.
The report says about 10 percent of the participants exposed to the chemical in one phase of the experiment reported "severe" adverse effects. Also, it says the "defective" consent form failed to disclose adequate information about the dangers of chloropicrin.

The report alleges that UCSD:
Improperly limited compensation for injuries participants suffered from the result of the experiments.
Failed to follow up with the participants to determine whether they suffered adverse effects more than 24 hours after exposure.
Misstated the study's intent. The experiment's stated purpose was to determine what levels of chloropicrin were needed to be sensed by young, healthy subjects as a warning agent for other potentially dangerous chemicals. Three days after the study ended, the manufacturers gave the study to EPA officials to support re-registering chloropicrin as a pesticide, not a warning agent.
UCSD student body President Christopher Sweeten found the report alarming. He said students trust that their participation in such projects won't hurt them in the long run.
"Usually, it's the case that students who participate in these things are in need of money at the time," he said. "I hope the university will contact them right away."
The lead researcher for the UCSD study was William S. Cain, an expert in chemical sensory perception. The university's $722,000 research bill was paid for by the Chloropicrin Manufacturers Task Force.
A statement from UCSD said the research provided an important social benefit. It was designed to protect the welfare of field workers who could regularly come in contact with chloropicrin and of passers-by who might be accidentally exposed to the chemical, the statement said.
"The study provides data to set accurate guidelines about the distances that should be maintained between the site of fumigation with chloropicrin from homes and businesses," the university said.
Such explanations didn't appease the Natural Resources Defense Council, which also has been reviewing chemical research projects using humans.
"The fact that somehow they persuaded some fairly well-qualified folks at UCSD to do this is baffling to me," said Erik Olson, senior attorney for the Washington, D.C.-based council.

June 16, 2005

Statement of Rep. Henry A. Waxman

Press Conference on Human Pesticide Experiments

I am pleased to join Senator Boxer today in releasing this report on human pesticide experiments.
In 1996, Congress passed the Food Quality Protection Act, which significantly reduced the amount of pesticides allowed on food. I wrote much of that law.
In many ways, the 1996 law has been a success. Thousands of tolerances that allow pesticide residues on food have been revoked. And virtually all indoor uses of hazardous organophosphate pesticides have been cancelled.
But the law has had one ironic result: it has spurred an interest among pesticide manufacturers in conducting pesticide experiments on humans. The manufacturers fear that the new standards will make it impossible for them to continue to produce older, more dangerous pesticides, such as organophosphates. They want to conduct experiments on humans in the hope that they can use the test results to argue for more lenient standards.
This experimentation is controversial. Drug companies test their products on humans. But these tests are closely regulated. And those participating in the trials can gain from the medical treatment.
But when humans are asked to swallow capsules filled with insecticide, there is no benefit to the subjects.
The Clinton Administration placed a moratorium on the use of these studies until the ethics could be carefully weighed and considered. But the Bush Administration has lifted the moratorium. Its position is that the pesticide manufacturers can be trusted to conduct ethical studies. The EPA now says that these experiments are “available, relevant, and appropriate.”
The report that Senator Boxer and I are releasing today examines these claims. It is a detailed analysis of 22 human pesticide experiments that the Bush Administration is currently reviewing or plans to review in the future. The 22 studies that we’ve examined total over 6,500 pages. The most recent one was submitted to the Environmental Protection Agency in February 2005.
What we’ve found is that the human pesticide experiments that the Bush Administration intends to use to set federal pesticide policies are rife with ethical and scientific defects.
There are four main problems. First, many of the experiments put human subjects at risk of harm without any promise of health or environmental benefits.
The pesticides used in these experiments are “highly hazardous” poisons, suspected carcinogens, and suspected neurotoxicants. Eleven of the experiments involved organophosphates, which are a class of pesticides developed in the 1930s as nerve agents for military use. One study involved chloropicrin which was used as a chemical warfare agent during World War I. Another study exposed humans to a chemical very similar to the one that killed thousands of people in Bhopal, India.
These pesticides are intentionally designed to be toxic. Their whole purpose is to kill insects and invasive plants. Yet in the experiments, test subjects swallowed insecticide tablets, sat in chambers with pesticide vapors, had pesticides applied to their skin, had pesticides shot into their eyes and noses, and were even exposed in their homes for six months at a time.
And many of the subjects suffered during and after these experiments. They coughed, vomited, had blurred vision and rashes, severe eye irritation, headaches, and full body sweating.
There is an important distinction that needs to be drawn. If pesticide manufacturers were trying to develop a safer pesticide or one that’s less damaging to the environment, it might be possible to justify exposing human subjects to some level of risk. But that’s not what’s going on here. The goal of these experiments is not to find safer alternatives. The real goal is the exact opposite: to justify keeping older and more dangerous products on the market.
And according to numerous expert bodies that have examined this issue – including the National Academy of Sciences – that’s wrong and unethical.
The second major problem we found is that the researchers conducting these experiments did not obtain the informed consent of the subjects.
The subjects were not told of the dangers of exposure to the pesticides. Sometimes, they weren’t even told the substances being tested were pesticides. They were misled into believing that they were participating in “drug” trials, not pesticide experiments.
And in clear violation of the ethical rules, they were forced to waive their rights to compensation.
Third, we also found that many studies had serious scientific and methodological flaws. In short, they violated the National Academy of Sciences rule that “a study cannot be ethically acceptable if it is scientifically invalid.”
For example, one recurring problem was the questionable manipulation of the experimental results. In one experiment, everyone who was exposed to the pesticide got sick. Yet the researchers writing up the report simply dismissed these results, saying they could be attributed to “viral illness” or “ward conditions.”
The final major problem was the failure of the researchers to conduct long-term follow-up. Even short-term exposure to pesticides can cause long-term health effects. Yet there was frequently no monitoring to detect these effects. In 14 experiments, there was no medical monitoring after the first 24 hours following completion of the experiment.
Over the last five years, the Environmental Protection Agency has undergone a sea change. The Air Office, which is supposed to prevent air pollution, allows more toxic emissions. The Water Office allows more water pollution. Information about global warming has been hidden from the public. Polluters have been protected, and the public has suffered as a result.
Today we learn that EPA’s handling of pesticides is no different. Instead of protecting us, the policies of the Bush Administration encourage pesticide companies to use the public as guinea pigs in unethical experiments.
This report clearly demonstrates that we need a new moratorium on these kinds of studies. And if the Administration won’t establish one, then Congress should do it.