GM giant pushes for human pesticide tests
By Leo Lewis
Bayer, the German chemicals and drugs giant, is pushing for a change in international convention to allow companies to conduct pesticide and GM tests on human beings.
The Leverkusen-based company is believed to be central to efforts to persuade the US Environmental Protection Agency (EPA) to reverse its longstanding ban on accepting data from human studies. US government sources believe a decision could be a few months away.
The ban is in place as a result of the post-Second World War Nuremburg Code and various federal laws. If the ban were undermined, the way would be clear for other companies to conduct and submit data based on such studies. Already, there are 10 other human pesticide studies awaiting EPA consideration from a variety of companies.
European environmental groups also fear that once the US authorities had caved in, similar changes would be forced on this side of the Atlantic. Although the issue under discussion centres on pesticides, Bayer's efforts are also understood to be linked to its considerable interests in genetically modified crops. Since its recent purchase of Aventis crop science, Bayer has become one of the world's largest GM producers, and currently conducts 85 per cent of UK field tests.
Bayer's role in the debate, described by the EPA as "under review as we speak", arises from data from a pesticide test conducted on humans four years ago. In 1998 eight volunteers in Scotland were exposed to small quantities of azinphos methyl, a pesticide of which Bayer is the world's largest producer.
The tests have come under heavy fire from one of America's largest lobbying groups, the Natural Resources Defense Council. A spokesman explained: "There is strong evidence that Bayer did not obtain fully informed consent because the subjects lacked knowledge and comprehension of the goals and risks."
Now that Bayer has the results of the test, it is keen that they should be used to assess the risks of its pesticides. Until now, the EPA's position has been to reject such studies as unethical and scientifically unnecessary. But statements by the EPA's administrator, Christine Whitman, strongly suggest that the position could soon change. She has now appealed to the US National Academy of Sciences to give its input on the subject.
Bayer's chief motive for pushing to end the ban is that it would loosen safety thresholds on pesticides. They are currently tested on animals, and released for sale at a 10th of the harmful strength. If the same practice were applied to human tests, stronger pesticides could be sold.
July 14th 2002
Push to overturn human test ban
JASON ALLARDYCE POLITICAL EDITOR
CONTROVERSIAL experiments on Scots volunteers who were dosed with chemicals linked to Gulf War Syndrome are being used to try to relax strict international controls on human testing.
The results of experiments in which eight students were paid to be exposed to organophosphate pesticides are being studied by the US Environmental Protection Agency, Epa.
If it accepts the merit of the research, for German drugs giant Bayer, it will allow companies to use human tests to win approval for pesticides used in the US, and place intense pressure on other countries to follow suit.
That could mean many more cash-strapped students allowing their bodies to be used for toxic tests - a practice campaigners claim is immoral.
MSPs who have become aware of the Scottish tests from 1998 are worried about the long-term health risks associated with the pesticide, which was used at Heriot-Watt University's Inveresk medical research laboratory. The experiments involved azinphos methyl, of which Bayer is the world's largest producer.
Organophosphate pesticides have been linked to long-term chronic fatigue illnesses and increased suicide rates.
Kenny MacAskill, the SNP's shadow environment minister, who received details of the tests last week, said: "I am very concerned. These people did not realise what they were getting into. People have to be protected and there must be greater supervision to ensure public safety."
Friends of the Earth Scotland wants to force Bayer to monitor the health of the students for the rest of their lives.
The association is equally concerned that an international relaxation of the rules to allow data from human experiments to be considered by environmental authorities could mean many more such tests.
Dr Richard Dixon, head of research with Friends of the Earth Scotland, fears it could lead to Scots being tested with new GM products.
Since recently completing a purchase of Aventis CropScience, Bayer has become one of the world's biggest GM producers and conducts an estimated 85% of UK field tests.
Dixon said: "It is unacceptable that a giant chemical company such as Bayer should be allowed to test potentially harmful pesticides on Scotland's students.
"Worse still they are now trying to use this research in an attempt to overturn a well-intentioned international ban on chemical tests on humans."
The tests have also been condemned by one of America's largest environmental lobbying groups, the Natural Resources Defense Council. A spokesman told Scotland on Sunday that the tests were "outrageous" and "immoral". Bayer is using the results of its Scottish research to press the US environment agency for the change which would allow firms to use data from pesticide and GM tests on human beings, to help convince authorities that these should be on the market.
The long-standing ban on using data from human studies, which may be overturned within months, is in place as a result of the post-Second World War Nuremberg Code drawn up after Nazi experiments on concentration camp inmates.
Until now, the US agency has rejected such studies as unethical and unnecessary, but recent statements from senior staff suggest a U-turn is imminent.
Campaigners say ending the ban would loosen safety thresholds on pesticides. They say if tests were conducted on humans rather than animals the chemicals could be sold at a greater strength.
A spokesman for Bayer confirmed that the company was trying to persuade Epa to relax its rules. He said the vast majority of tests would continue to take place in test tubes and with animals, but in a small number of cases this was not as effective as human testing.
He said he did not anticipate any health risk arising from the Scottish tests in 1998. He added: "The tests would have been designed to bring about a minor and completely reversible biochemical change in the blood."
No-one at the Inveresk research laboratory was available for comment yesterday but it has stressed in the past that the performance of its trials was "a very open business" with all relevant information passed to an independent ethics committee.