October 26

Human Pesticide Experiments

Human Pesticide Experiments

“Allowing human experiments, such as those conducted recently in the United Kingdom, to serve as the basis for registering pesticides, is ethically indefensible.” Ken Cook, President Environmental Working Group

January 8, 2003 "Should the EPA Accept Human Pesticide Experiments?", testimony by Vera Hassner Sharav before the Committee on the Use of Third Party Toxicity Research with Human Research Participants; Science, Technology, and Law Program; The National Academies of Science

Sept. 9, 2002: Infomail – Human Pesticide Experiment: The Slippery Slope

Jan. 19, 2002: British Medical Journal. Bayer faces Swiss criminal probe over cerivastatin, by Fiona Fleck.

August 15,1998: BMJ. Organophosphate pesticides are being tested on students, by Richard Harling.

The American Public as Lab Rats for Monsanto: An Uncontrolled Experiment Karen Hudson. http://www.factoryfarm.org/docs/rBGH-Hudson.doc

1998: Environmental Working Group. The English Patients: Human Experiments and Pesticide Policy. http://www.ewg.org/reports/english/English.pdf

"Neither the EPA nor pesticide regulators in the United Kingdom require human experiments as part of pesticide assessments. But the EPA has accepted a number of them from chemical companies and used them for regulatory purposes, particularly studies that measure effects that are short-term and reversible. In fact, EPA has developed no formal policy on the use of humans in scientific experiments, including pesticide feeding studies on humans."

But absent a government policy that prohibits accepting any data obtained from unethical human experiments—among them, pesticide tests—has given pesticide manufacturers a powerful economic incentive to conduct human studies and submit their biased findings to the EPA when seeking regulatory approval for their noxious products.

Dec. 14, 2001: EPA Halts Consideration of Human Pesticide Tests http://www.policyalmanac.org/environment/news/pesticides-2001-01.shtml

The Environmental Protection Agency issued a moratorium on December 14, 2001, precluding the consideration of pesticide tests on human beings. The agency asked the National Academy of Sciences to review the ethics and usefulness of testing on human volunteers.Some pesticide companies, hoping to establish a basis for raising regulatory restrictions they deem overly strict, have paid volunteers to ingest limited quantities of certain pesticides to determine the health consequences, such as nausea and vomiting. Some test doses are 100 to 300 times levels currently deemed safe by the EPA. Environmental regulators and environmentalists have questioned the ethics of such studies and whether they are useful, given the relatively small number of subjects studies.”It’s a general principle of medical ethics that you don’t test a chemical on people unless there is the potential of some direct benefit to the person himself or herself,” said Philip Landrigan in an interview with the Washington Post. Landrigan chaired a 1993 Academy panel that looked into the matter, told the Washington Post.-12/14/01

July 27, 1998: EPA Statement

EPA is deeply concerned that some pesticide manufacturers seem to be engaging in health-effects studies on human subjects as a way to avoid more protective results from animal tests under the new Food Quality Protection Act. The government has in place very stringent standards that apply to federally funded research to ensure the protection of human subjects. EPA will be asking its independent Science Advisory Board to apply these same standards to pesticide data submitted to EPA by companies for review. No human test data has been used by EPA for any final decisions about acceptable levels of pesticide under the new food safety law. The protection of public health from adverse effects of pesticides can be achieved through reliance on animal testing and use of the highest ethical standards.


June 7, 2000: Washington Post. US Rejects Pesticide Tests on Humans. By Joby Warrick. Page A02

The Clinton administration has decided to sidestep a major political and ethical quagmire by rejecting the use of human experiments in setting regulatory limits for pesticides.

Worried about a resurgence in human experiments by pesticide companies – some of which have been testing products on students and other volunteers for decades – the Environmental Protection Agency will adopt a policy officially ignoring such studies in establishing legal limits for pesticides in food and water, agency officials said yesterday.

The decision essentially preempts a long-awaited report by an EPA scientific panel that had been deadlocked for months over the morality of administering pesticides to people to test their safety. A draft of the report released to panel members this week concluded that certain kinds of human experiments may be acceptable, and even desirable.

The prospect of even a limited EPA endorsement of human experiments had deeply troubled several scientists on the panel and outraged environmentalists and some medical ethicists.

“Studies that dose people intentionally with pesticides are scientifically and morally bankrupt,” said David Wallinga, a physician and senior scientist with the Natural Resources Defense Council, which has been lobbying against the use of humans in pesticide tests. “This is a rerun of government tests in the 1950s, when we lined up soldiers in front of nuclear blasts to see what would happen.”

The EPA panel’s draft report, obtained by The Washington Post, supports limited, carefully controlled experiments to determine how pesticide a reprocessed by the human body. But both the panel and top agency officials rejected the use of human subjects merely to establish a pesticide’s toxic threshold-the legally crucial level where harmful effects are first observed.

“There is nothing in the report that will change our policy,” said Steven Galson, director of science and policy in EPA’s pesticides division. While the EPA does not directly regulate scientific research by private companies, it is traditionally relies on industry studies in establishing safe limits for pesticides. In most cases the regulations are derived from experiments on laboratory animals or on people inadvertently exposed to chemicals, such as farm workers. Several industry groups have advocated more human studies, arguing that regulations based on animal research are often excessively strict.

“The lab animal data could overstate human risk or it might understate it,” said Roger McClellan, president emeritus of the Chemical Industry Institute of Toxicology. “It all speaks to using data from human if at all possible – but only under ethical circumstances.

Since the 1960s, chemical companies have quietly submitted to the EPA scores of studies in which humans were knowingly exposed to pesticides. In one typically experiment in 1973, volunteers at a New York state prison were fed small amounts of the potent insecticide chlorpyrifos and monitored for weeks. In a more extreme example, pregnant women and newborns were exposed to the compound DDVP in fly strips at a hospital in Italy.

Questions over the ethics of such tests returned to the spotlight two years ago when the Environmental Working Group, a Washington-based advocacy organization, reported a surge in humans experiments in Britains in the 1990s. The researchers, working mainly fort U.S. companies, paid youthful volunteers about $600 each to ingest small amounts of pesticides over several weeks, according to documents obtained by the environmental group. Last April, a similar study was conducted on student volunteers in Lincoln, Neb., by pesticide manufacturer Dow Agrosciences Ltd.

Public outcry over such experiments led to the creation on the special EPA advisory committee on human experiments in July 1998. But instead of offering ethical guidance on the issue, the panel quickly bogged down into bitter and sometimes public disagreement over whether human tests could ever be ethically acceptable.

The draft released this week by the panel’s leaders was described as a compromise, though several members continued to disagree sharply yesterday over its central conclusions. The report states that the use of humans in pesticide experiments “is acceptable, subject to limitations ranging from ‘rigorous’ to ‘severe’.”

While volunteers in such experiments are not likely to see direct benefits, the knowledge gleaned from human studies benefits society as a whole, the draft concludes. Ideally, administering very small amounts of pesticides to humans could yield important medical insights- for example, by helping scientsist understand how the chemicals are processed and stored within in the human body.

But the draft urges “active and aggressive scrutiny” of all humans tests by the EPA, and it cautions against giving pesticides to young children under any circumstances. Human tests should never substitute for animal experiments in answering basic questions about a pesticide’s toxicity, it said.

Arthur Kaplan, a panel member and one of the nation’s most prominent medical ethicists, described the debate as “one of the toughest ethical dimellams I’ve ever haced.” Unlike most drug trials, human experiments with pesticides offer no direct benefit to the partucupant, and typically attract subjects only through coercion or cash.

“It seems from the publics point of view that testing is absolutely essential; from the point of view of protecting the individual it looks absolutely abhorrent,” said Kaplan, director of the Center for Bioethics at the University of Pennsylvania.

But another panel member said the report dialed to reflect the views of several members who are disturbed by both structural flaws and moral issued raised by previous human tests. “The questions were: Should these tests be done, are they scientifically defendable and are they ethical,” said the scientist, who asked not to be identified. “The answer to all three is no.”

A9 200 The Washington Post Company

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