PESTICIDE TESTS: EPA ALTERS STANCE - C&EN Global Enterprise

Dec 3, 2001 - EPA LOOKED AT THE RESULTS of four human studies in its assessment of the pesticides azinphos methyl and phosmet this year, but those dat...
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NEtt&fifTHE WEEK EXPANSION

PFIZER COMMITS TO MICHIGAN RESEARCH State snags $800 million Pfizer boost to Life Sciences Corridor

SET TO GROW Pfizer will add 600 jobs and several new labs to its Ann Arbor research complex.

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N A DEAL THAT CAME TOGETH-

er just before Thanksgiving, Pfizer agreed to add as many as 600 jobs by 2008 and spend up to $800 million to consolidate and increase its research operations in Ann Arbor, Mich. The agreement is a big boost to the state's Life Sciences Corridor—a government-supported effort directed by the Michigan Economic Development Corp. to promote health-related businesses in concert with state research institutions (C&EN,

Oct. 1, page 31). The Pfizer deal calls for state and local authorities to forgo nearly $85 million in tax revenues over the next seven years. The tax abatement—along with the University of Michigan's agreement to sell Pfizer a 52-acre parcel of land for $27 millionsecured the deal for Michigan instead of Pfizer's alternative, a research site in New London, Conn. David Canter, director of Pfizer's Ann Arbor laboratories, the former Warner-Lambert facility where the cholesterol-lowering drug Lipitor was developed, says

ENVIRONMENT

PESTICIDE TESTS: EPA ALTERS STANCE Agency may consider results of humans tests in regulatory decisions

IN BRIEFCELEBRATION The 100th Anniversary of the Nobel Prize and this year's U.S. Nobel Laureates were honored last week by receptions at the White House hosted by President George W. Bush and at the Swedish Embassy hosted by Ambassador Jan Eliasson. Representing the chemical community were 2001 chemistry Laureate William S. Knowles (C&EN, Nov. 5, page 37) and ACS President Attila Pavlath.

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PA LOOKED AT THE RESULTS

of four human studies in its assessment of the pesticides azinphos methyl and phosmet this year, but those data had no effect on the final decisions, the agency says. However, an EPA spokesman did say the agency will be developing a proposal on incorporating data from human clinical trials in regulatory decisions on pesticides and soliciting comments on it over the next few months. This is a reversal of an informal policy established during the Clinton Administration, under which EPArefused to accept new

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data from clinical trials in which people were deliberately exposed to pesticides. According to a 1998 policy 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 purpose of human tests is to avoid the 10-fold safety factor that must be used when extrapolatingfromanimal data to human exposure. "In our opinion, human clinical trials with pesticides are un-

the existing 92-acre site is already "fully built out." Hundreds of the lab's 2,500 employees must work at satellite sites "strung out in labs like the Florida Keys," away from the main site. The university land, adjacent to Pfizer's main site, is "perfect for our needs," he says. It would make possible greater and "more productive" research in specialties such as cancer and cardiovascular, psychological, and arthritic disorders. Despite some grumbles among Ann Arbor legislators about corporate blackmail and corporate welfare, the deal adds significant heft to the Life Sciences Corridor concept. University of Michigan President Lee C. Bollinger says the school anticipates not only new collaborations with Pfizer scientists, but also "career opportunities for our graduates and technology transfer initiatives benefiting the state's economy"— MARC REISCH

ethical, immoral, and unscientific," says Elliot Negin of the Natural Resources Defense Council. They are unethical, he says, "because often the subjects are financially strapped, not very bright, and don't necessarily know what they are getting themselves into." The tests are unscientific, he explains, because the exposure groups cannot be large enough to detect responses that would occur in only a small fraction (3 to 4%) of the population. However, Jay J. Vroom, president of the American Crop Protection Association, says human test data can be collected in an ethical manner and that such data should be used to strengthen regulatory decisions. It is scientifically valid to use data from a small number of subjects—10 or 20—he says, because the goals are narrow. "You are basically testing to see whether the human response to the pesticide parallels the animal response," he says. -BETTE HILEMAN

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