Human Testing of Pesticides and Pharmaceuticals - Radical Departures in Regulation
In December 2001, EPA had asked the National Academy of Sciences to form an expert panel to advise on the subject of human testing of pesticides (see Chemically Speaking, Nov./Dec. 2001 & June 2002). One pesticide association has likened such studies to those carried out by the pharmaceutical industry and suggested they be referred to as clinical trials. A number of authorities have pointed out that such human studies are done with the highest scientific and ethical standards. Critics have compared these tests to those conducted by Germany during WWII.
Surprisingly, this mind set may be just the reverse for pharmaceuticals. On January 20, Health and Human Services Secretary Tommy Thompson announced plans to begin clinical tests this year on 12 drugs commonly prescribed for children even though their safety and effectiveness has been tested only in adults. The Secretary was quoted as saying “We need to conduct testing now to fully understand the effects of these medications in children.” However, the Association of Physicians and Surgeons questioned whether most of the drugs on the list should be tested in children because of potential risks. “Safety testing needs to be done, but adults should bear the risks.” said Dr. Jane Orient of WPS. “Once in use, it would seem that careful aftermarket surveillance of any usage in children, as medically indicated and under the supervision of a personal physician, would be greatly preferable to clinical trials.” Interestingly, congress enacted legislation last year giving drug makers financial incentives for conducting the tests. (CropLife America Spotlight, and Gainesville Sun, 1/21/03).
