February 27

InfoMail for February 27, 2002



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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

February 27, 2002 

EPA Halts Human Pesticide Tests


The Environmental Protection Agency has announced amoratorium on ethically repugnant human pesticide tests. EPA had conceded topharmaceutical /pesticide industry pressure that sought to test pesticides inhuman beings in an effort to gain approval for more toxic pesticides.

Earlier this year the EPA had evaluated human pesticidestudies that had been conducted by Dow AgroSciences, Bayer, and Gowan in whichhuman beings were given pesticide doses–in some cases 100 to 300 times higherthan EPA considers safe for the general public.

The Washington Post reports that "One volunteer whoreceived the highest dose — four times the dose that the EPA says almostproduces adverse effects in animals — developed numbness in the upper arms,which doctors ruled was "possibly" related to the pesticide. Levels ofan enzyme in her blood fell by 28 percent — a level that company scientistsagreed was "unlikely to be due to chance."

The EPA’s retreat is a victory for the rights and dignityof human beings who should never become test subjects for poisonous chemicals.As Philip Landrigan, who heads the department of community and preventivemedicine at Mount Sinai School of Medicine in New York reminds us, "It’s ageneral principle of medical ethics that you don’t test a chemical on peopleunless there is the potential of some direct benefit to the person himself orherself."



EPA Calls for Pause in Pesticide Tests on Humans

By Shankar Vedantam

The Environmental Protection Agency yesterday announced amoratorium on considering the results of controversial trials that testpesticides on people.

The agency, which evaluated such trials for threepesticides this year, said it would ask the National Academy of Sciences torecommend whether such research is ethical and scientifically useful.

The trials have a controversial history at the EPA, withenvironmentalists and doctors generally saying they are useless and unethicaland company researchers and many toxicologists saying they could help indetermining the safety of pesticides. The Clinton administration decided not toconsider these trials, but officials at the EPA in the Bush administration saidthey would evaluate them as part of an evolving policy.

Three trials evaluated by the agency this year subjectedsome volunteers to doses of pesticides hundreds of times greater than levelsthat EPA regulators had deemed safe for the general public, according to studydocuments obtained by The Washington Post.

Many of the paid volunteers who swallowed the pesticidesdeveloped symptoms such as headaches, nausea and vomiting, but company-paidscientists concluded that the symptoms were not caused by the chemicals and thatthe pesticides were safe at the doses tested. Companies conduct the tests in thehopes of showing regulators that safety levels can be relaxed.

In response to questions about these trials, EPA AssistantAdministrator Stephen Johnson said yesterday that the tests had raisedscientific and ethical questions. He said regulators had questioned whether thestudies were large enough to provide useful information and also had concernsabout the studies’ design and the doses used. Johnson said the moral issuesencompassed "all the ethical questions."

The pesticide industry criticized the EPA’s decision as adelaying tactic that was poorly thought through, unclear and politicallymotivated. Jay Vroom, president of the American Crop Protection Agency, saidcompanies that had pesticides coming up for review might sue to force the EPA toconsider such trials. He also said that while previous studies might have hadsome flaws when seen "in the fashion of today’s modern ethicsprotocols," they should still be considered by the agency.

Others, including Erik Olson of the Natural ResourcesDefense Council, said they were optimistic the trials would no longer beconsidered.

A 1998 panel of scientists and ethicists convened by theEPA had declared such trials an unethical and scientifically unsuitable means todetermine the general safety of the chemicals.

Johnson said that the agency wanted to clarify subtletiesthat the panel had not addressed and, in a letter to the National Academy ofSciences yesterday, said the advice of the highly regarded scientificorganization would be "weighed heavily" as the EPA develops a formalpolicy.

The academy weighed in on the question of pesticides andchildren’s health in 1993, when it called for a broad strengthening of safetylevels. In an interview earlier this week, the chairman of that panel, PhilipLandrigan, said his panel had never imagined that companies would conduct humantests.

"I think it’s ethically repugnant," saidLandrigan, who heads the department of community and preventive medicine atMount Sinai School of Medicine in New York. "It’s a general principle ofmedical ethics that you don’t test a chemical on people unless there is thepotential of some direct benefit to the person himself or herself."

A 1996 law based on the findings of Landrigan’s panelreduced the amount of the chemicals that could be used on crops. Most of thehuman trials before the EPA today were conducted after the 1996 law, as thecompanies sought to show the EPA’s safety margins could be reduced.

The studies evaluated by the EPA this year tested DowAgroSciences’ chlorpyrifos, also known as Dursban, Bayer Corp.’s azinphos-methyl,which is sold as Guthion, and Gowan Co.’s phosmet, known as Imidan.

All gave volunteers doses of the chemicals close to, or insome cases higher than, levels that the EPA had said were at the brink ofproducing adverse effects in animals. Some of the doses were between 100 to 300times higher than the EPA considers safe for children and the general humanpopulation.

While the Guthion and Imidan studies were conductedoverseas, the Dursban study was conducted in Lincoln, Neb., by a Dowsubcontractor. Volunteers were paid up to $460, according to Garry Hamlin, acompany spokesman.

One volunteer who received the highest dose — four timesthe dose that the EPA says almost produces adverse effects in animals –developed numbness in the upper arms, which doctors ruled was"possibly" related to the pesticide. Levels of an enzyme in her bloodfell by 28 percent — a level that company scientists agreed was "unlikelyto be due to chance."

Other women at the same dose reported headaches, nausea,vomiting and intestinal cramps. On more than half a dozen occasions,company-paid doctors, who did not know whether the women had been given thepesticide or a placebo, ruled that the symptoms were "possibly" or"probably" related to the chemical.

But in the scientists’ final conclusion, they said thepesticide did not produce any symptoms. Hamlin and Joel Mattsson, a DowAgroSciences veterinary doctor and toxicologist, said that similar symptoms werealso seen in volunteers given a placebo and that there were no clear patternsbetween symptoms and dose. Both said the dose was far below levels that wouldcause toxicity in people.



December 15, 2001

E.P.A. Reconsiders Human Tests of Pesticides


WASHINGTON, Dec. 14 — The Bush administration is backingoff its earlier inclination to consider the results of experimental tests onpeople in regulatory decisions on toxic pesticides.

The Environmental Protection Agency turned today to theNational Academy of Sciences for a recommendation on "whether to accept,consider or rely on research involving deliberate exposure of human subjects totoxicants." It asked for an evaluation of the ethical and scientificissues.

The request means that the agency, and the Bushadministration, are re-evaluating their move to accept the results of suchstudies, which has drawn strong criticism from environmentalists. A spokesmanfor the agency said it would not accept such results until the academy hadfinished its study.

The agency’s administrator, Christie Whitman, said in astatement, "Formulating a policy that appropriately reflects our competingconcerns in this matter will not be easy, and I thank the National Academy ofSciences for agreeing to assist E.P.A. in evaluating these complex issues."

She said the agency wanted to reach a decision "in atransparent and responsible manner."

The move represents at least a temporary victory forenvironmentalists, who have said the acceptance by the government of studiesfrom the pesticide industry that involved paid volunteer human subjects wasunethical and unscientific.

The matter became an issue in the Clinton administration,when in 1998 the Environmental Working Group, a research organization here,brought to light the acceptance of such tests. The agricultural and pesticideindustries favor using human subjects because they yield more precisemeasurements of what humans can tolerate than extrapolations from animal tests.

In a letter to the academy, Stephen L. Johnson, assistantadministrator of the agency, said, "We are particularly concerned about`third party’ studies submitted by regulated entities for the agency’sconsideration."

Mr. Johnson said last month that the agency had looked athuman tests from the industry in three or four recent cases.

Richard Wiles, senior vice president of the EnvironmentalWorking Group, said of the move today: "We totally support the idea of themoratorium. It’s a big step forward, but we’ll see what the long-term policy is.We think the moratorium should be the permanent policy."

Mr. Wiles speculated that the administration had backedoff because accepting the results of human studies would be inconsistent withthe administration’s opposition to stem- cell research.

"The administration would be in an awkward positionif it was against stem-cell research but for dosing people up directly withpesticides," he said. "There is an obvious moral inconsistency thathad a lot to do with this policy."

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