September 9, 2002
Bayer Corp. is using Scots test results in battle to reverse safety controls
When Bruce Turnbull volunteered to take part in a drug trial at the Inveresk Research laboratories in East Lothian in 1998 he believed he was helping society. Three years later the company behind the tests stands accused of breaking the Nuremberg Code -- established as a response to Nazi experimentation on Jews -- and of using the results to boost profits.
Turnbull, from Edinburgh, was paid around ?700 for being one of 50 Scots to take part in study 013219. The test seemed simple enough -- the subjects were given a single dose of a substance called azinphos-methyl (AM) and then observed for seven days.
What they did not know was that the chemical, which they were given in minute doses, was a pesticide deemed 'highly hazardous' by the World Health Organisation. Nor did they know that the test had been commissioned by Bayer as part of a forceful effort to get the US Environmental Protection Agency to reverse pesticide controls introduced to protect children.
The 50 subjects have not been offered follow-up examinations to test for the long-term effects of exposure to AM. Instead, the key finding of the study -- that the pesticide test had 'no effect' on humans -- is now Bayer's key weapon in its battle to raise the safety limit on the use of the pesticide by US farmers.
Turnbull, now 51 and suffering ill-health he believes is connected to the test, says he feels bitter and cheated. 'I was under the impression I would be helping farmers, not helping a major company sell more pesticide that would end up on food. I don't think I was told who was paying for the test.' He claims he would never have volunteered for the test had he known of Bayer's intentions for it and feels badly let down by his treatment during and after the trial.
'The nurses called the substance a drug, not a pesticide. An information pack was sent to my home before the trial but I didn't understand all of it. Layman's terms jump out at you but it was heavy technical stuff,' he said.
'If you left the test early there was a financial penalty, and you would never have got on another trial again. I received no follow-ups at all -- Inveresk never contacted me to see if I was fine.' Documents given to the volunteers even predicted the outcome of the trial, stating: 'The results of this study will confirm that use of azinphos-methyl does not pose an un reasonable threat to either workers or consumers.' Turnbull is the only one of the 50 subjects so far to blow the whistle on what he now believes is a scandal. It is not known if the others even know they were tested with a pesticide.
Just as Bayer is using the Inveresk test to lobby the EPA, so its opponents are very interested in Turnbull's testimony as the only known witness to the experiment.
Erik Olson, a senior attorney at the American Natural Resources Defence Council (NRDC), an organisation of scientists, lawyers and environmental specialists dedicated to protecting public health, is fighting Bayer's attempts to reverse the pesticide controls and believes Turnbull's experience was 'shocking and unethical'.
'He wasn't told about conflicts of interest, long-term side effects, the purpose of the test or the fact that the company's profits would be boosted,'said Olson.
'If you don't look for any ill-effects then it's not surprising that you won't find any. Along with the fact he was under the impression he would suffer a financial penalty if he left the test early, there are clear violations of international codes.' The Nuremberg Code, along with other international human rights agreements put in place after the Nazis used Jewish prisoners for medical experiments, tightly govern what kind of tests can be performed on humans. Clause two of the Nuremberg Code states: 'The experiment should be such as to yield fruitful results for the good of society'.
The EPA is unequivocal in its stance on pesticides. A spokesman told the Sunday Herald: 'There is nothing for individuals to gain -- no disease will be cured because of this.' And this position extends to its attitude to human pesticide testing.
'We do not accept human data concerning pesticides. There is, however, a lot of pressure from pesticide companies who would argue that we get a fuller picture of pesticide use if we look at these tests the Inveresk trials, but there are significant moral and ethical issues.' This hasn't stopped Bayer presenting the test evidence as part of its campaign to persuade the agency that azinphos-methyl is safe. The company also denies the test breached the Nuremberg Code, insisting that the use of the pesticide benefits society.
Bayer spokesman Peter Kraus said he was satisfied that the test had been carried out to the highest standards.
'There is a need for studies like these. They are designed in-house, and then approved by an ethics committee. Inveresk also has an ethics committee. All the test subjects received full information about the test they were doing.
'We only test products with a good safety record, products we know a lot about, and which have measurable indicators that show harmful effects before they occur.' He added: 'We are doing tests like this for the good of society -- we are part of the food chain and at the end of the food chain is a healthy apple, not an apple with worms.' It is a widely disputed claim. Dr Albert Caplan, director of the Center for Bioethics at University of Pennsylvania, and a former adviser to the EPA on pesticides, told the Sunday Herald that the lack of follow-up highlights the questionable nature of testing pesticides on humans.
'Testing these substances on humans is useless because you cannot do it aggressively -- you can only use minute doses in the tests, which don't necessarily relate to what exposure people working with the substance would endure,' he said.
'The subjects are taking a risk for agriculture and business, not to find a cure for a disease or develop life-saving practices. The lack of follow-up tests on the Scottish subjects is not something that should go on in a test of this nature.' The NRDC is fearful that the Environmental Protection Agency will buckle under pressure from Bayer. 'The EPA is not strong enough to withstand the economic and lobbying onslaught of Bayer and other companies,' said Olson. 'Big companies will always come up with an excuse but this test did not help Turnbull or anyone else -- it only helped the bottom line.' The EPA has now commissioned the National Academy of Sciences to advise it on whether or not human data in pesticide testing is acceptable.
Bayer and other pesticide companies have lost patience and are suing the agency in an effort to get a decision on the increased use of azinphos-methyl.
Bayer spokesman Kraus said the EPA had to decide what kind of data it wanted. 'In recent years the EPA has said children are more susceptible to pesticides than adults -- they say that if we don't have the data to prove otherwise then they will put in further safety factors to the product. What we tried to do in this special case the Inveresk trial is show that if a human can tolerate the safe level for lab rats then it takes away a level of uncertainty for the EPA.' At the Inveresk trial in 1998 the amount given to the volunteers was 100 times smaller than the 'safe dose' for lab rats. But the pesticide was brought into the country only after the Health and Safety Executive (HSE) gave the study the green light. The dose of azinphos-methyl was set high enough to demonstrate to the EPA in the US that estimates of how much humans can withstand are too conservative.
A spokeswoman for the HSE in London said yesterday that 'the test was given a lot of thought and consideration and met all the very rigorous regulations before it could go ahead'.
Bayer is one of the world's largest producers of GM food. Azinphos-methyl is one of its most widely used pesticides, sprayed on apples in the Pacific northwest, blueberries in Maine and sugar cane in the deep South. But it is highly controversial, even in America.
In Louisiana in 1991, a flash thunder storm caused azinphos-methyl to run off sugar cane and into rivers, killing up to a million fish, along with turtles, alligators, snakes and birds.
Three years ago the EPA reported that exposure to the pesticide caused enzyme changes in the red blood cells of 127 Californian farm workers, creating fears about potential nervous system damage.
Six weeks ago Canadian officials reported that azinphos-methyl was found in high concentrations in the Wilmot River, where up to 15,000 fish had died.
By Jenifer Johnston, SUNDAY HERALD