Pharmaceutical Giant Accused of Human Pesticide Experiments

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> [4MOM] Pharmaceutical Giant Accused of Human Pesticide

Experiments

>

> http://www.beyondpesticides.org/main.html

>

> Pharmaceutical Giant Accused of Human Pesticide Experiments

> Thu, 12 Sep 2002 06:09:29 -0400

>

> 08 September 2002

>

> Sunday Herald -

>

> Pharmaceutical Giant Accused of Human Pesticide Experiments

>

>

> He was used to test 'highly hazardous' pesticides ... then forgotten about

> Company is using Scots test results in battle to reverse safety controls

> By Jenifer Johnston

>

> -

> 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.

>

> ----

> 2002 smg sunday newspapers ltd. no. 176088

>

>

 

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