January 12, 2003, The Times



Bayer CropScience, of Monheim, Germany. one of the world's biggest chemicals companies, faces an inquiry after it was found to have used students to test a "highly hazardous" pesticide linked to serious disorders.

The story says that the company paid students, mostly from Heriot-Watt University in Edinburgh, $1,100 each to consume fruit juice laced with the pesticide. The project, the fine detail of which is secret, has been condemned in the U.S. as unscientific and unethical. Lawyers point out that the Nuremberg Code, formulated after the Nazis' wartime experiments, bans the use of humans for testing poisonous substances that have no medical application.

Bayer is the daughter company of IG Farben, the manufacturer of Zyklon B, the gas used in Nazi extermination camps.

Bayer is using the results of the study, conducted between 1998 and 2000, to support an argument that restrictions on pesticide use should be eased, because no immediate adverse effects were suffered.

The story says that groups of up to 16 volunteers were housed at a privately run research centre in Edinburgh and fed azinphos-methyl (AM), an organophosphate chemical. The dosages have not been disclosed. The World Health Organization has classified AM as "highly hazardous." Exposure to it is linked to blood and nervous system problems.
The dangers are well documented. Accidental ingestion by 42 Peruvian children last year led to 24 deaths, and recent spillages of the chemical into rivers in Prince Edward Island have killed 15,000 fish.

The story adds that although Bayer has not checked on the subsequent health of its human guinea pigs, it is using the research to try to persuade the American Environmental Protection Agency to raise the levels of AM it allows farmers to use on crops. The agency is concerned about the conduct of the studies and has referred them to an expert panel of the respected National Academy of Sciences (NAS). The panel is demanding to know exactly how the unpublished trial was conducted. The agency said last week that 10 of 17 studies it is examining are in Britain and involve Inveresk, a contract research company "The NAS has until December to give an opinion on whether these human studies are ethically and scientifically valid," an agency spokesman said. Nobody from Inveresk was available for comment yesterday.

Bayer said its studies were performed "in full accordance with national and international regulations and standards."

January 12, 2003, Lois Rogers, The Times, London

Ethics of Human Pesticide Studies Questioned

WASHINGTON (Health News) - Scientists and environmental groups urged a federal advisory panel Wednesday to recommend a ban on chemical industry experiments that test the safety of pesticides and other potentially toxic chemicals in humans.

Labeling the experiments unethical and scientifically suspect, the groups asked experts on a National Academy of Sciences panel to condemn the studies and recommend that government regulators refuse to consider them when evaluating the safety of companies' chemical agents or pollutants.

But representatives of the pesticide industry defended the experiments, saying that they are ethically sound and essential to accurately determining safe exposure levels for members of the public.

Manufacturers of pesticides or other chemicals sometimes give adult volunteers a dose of the product in order to determine what levels humans can tolerate without getting sick. Determining a safe level for humans is necessary before companies can gain Environmental Protection Agency (EPA) approval to market most pesticides and other chemicals.

Scientists attacked the studies Wednesday, calling them unethical because people can only be hurt, and not helped, by receiving doses of toxic chemicals.

Most ethical standards for human medical research, including the Nuremburg Code created after the trials of Nazi doctors conducting research on World War II Holocaust prisoners, require that study participants stand a chance of gaining from research conducted on them.

"There is no benefit to the health of a subject nor to the health of anyone else," said Dr. Lynn Goldman, a professor of environmental health sciences at Johns Hopkins University and chair of the Children's Environmental Health Network.

Goldman conducted a study of a 1985 case in which up to 1,373 people were sickened after eating watermelon contaminated with the pesticide Aldicarb. Researchers uncovered probable illnesses in persons exposed to Aldicarb levels 10 times lower than those deemed safe in a 1971 study in which manufacturer Union Carbide gave it to 12 men.

The NAS panel is scheduled to meet over the next year to eventually advise the EPA on the propriety and scientific validity of human chemical tests. Citing ethical concerns, EPA in 2001 imposed a moratorium on accepting data from human chemical tests, a move that sparked a lawsuit by the pesticide industry.

Companies frequently test the effects of their chemicals in animals before applying for government marketing approval. When a chemical has not been tested in humans, the laws often require EPA to assume that a safe level for humans is many times--sometimes 100 times--lower than the level that causes sickness in animals.

Industry scientists told the panel that human chemical testing is always done with the informed consent of subjects and that the trials are key to determining exactly how humans react when exposed to dangerous compounds.

"The knowledge we gain from human volunteer studies is absolutely critical," said Dr. Monty Eberhart, director of product safety management for Bayer CropScience. The company is a major pesticide producer and one of the companies suing the EPA to lift the moratorium on human-derived data.

Eberhart told the panel that animal studies have often failed to accurately predict safe pesticide levels for humans.

"Only human data directly reflects human response," said Judith A. MacGregor, a researcher with Toxicology Consulting Services, a private research company.

But Goldman, of Johns Hopkins University, cited her study as proof that small trials testing chemicals in adult men tell little about how the compounds will effect people of different ages or sexes. One of the people hospitalized after eating the contaminated watermelon was a 66-year-old woman.

Others accused the industry of trying to use the self-financed experiments to weaken environmental standards governing its chemicals. Though many of the trials are conducted in only a few people, they could still be used to permit easier marketing if they showed that humans could tolerate a higher chemical dose than animals can.

"These tests are performed for the purposes of weakening regulatory standards," said Jennifer Sass, a senior scientist at the Natural Resources Defense Council.

Peg Cherny, vice president for government relations at Bayer CropScience, denied that the company's position or its lawsuit to force EPA to accept human studies is an attempt to weaken safety standards.

"We're trying to get appropriate standards," she said in an interview.

Lawyers for the EPA and pesticide industry are set to argue the case before the Federal Appeals Court in Washington in March.

The NAS panel is due to release its recommendations on human-based chemical testing in about one year, officials said.

By Todd Zwillich, Wednesday, January 8, 2003