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The GM Injection (11/5/2005)

Many thanks to Colin Holden <C.J.Holden@hw.ac.uk> for this very useful article and collection of links. [at end]

EXCERPTS: "Tony Blair, for one, has hailed human insulin as a shining example of the benefits of GM technology."

"Since its introduction 20 years ago this summer, genetically engineered insulin has been linked not only to an increasing number of unexplained deaths but to a range of side-effects that some patients say have destroyed their lives. These range from unexpected hypos to massive weight gain, violent mood swings, memory loss, joint pains, mental confusion and crippling exhaustion."
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THE GM INJECTION
Daily Mail, August 29, 2002

Tainted crops in our fields. Superweeds that can't be killed. Fears over mutant cattle, fish and pigs. Recent weeks have brought alarming revelations over GM technology. But does this special Mail dossier reveal the biggest scandal of all? By Jo-Ann Goodwin

Jonathon was 19 years old when he died. Tall and strongly built, he was a keen all-round sportsman with a particular passion for football. He had chosen to study law after leaving school, and quickly settled in at Southampton University. On the last night of his life, Jonathon shared a curry with his flatmate, Ben. Exams were looming, and the two students spent a while revising before going to bed. Next morning Jonathon failed to turn up for football practice. His body was discovered later that day. He had died in bed some time in the early hours of April 23, 1995.

To this day, his mother Cheryl is haunted by memories of the police arriving at the door of her Midlands home to break the news. But what haunts her even more is the terrible possibility that Jonathon was killed by the very medication he was taking to keep himself alive.

He had been diagnosed as diabetic just before his 17th birthday. And like almost all sufferers in recent years, he had been prescribed genetically engineered 'human' insulin, commonly - and rather misleadingly - referred to as 'human' insulin.

Diabetics need insulin to prevent their blood sugar levels spiralling out of control. But in Jonathon's case, something went catastrophically wrong. The cause of his death was officially recorded as hypoglycaemia -meaning that the level of glucose in his blood had plunged so low that his body effectively ran out of fuel.

'Hypos' of varying severity are a constant hazard for diabetics, but in the months before his death Jonathon had suffered them with increasing frequency. They would strike without warning, leaving him disoriented and on the brink of collapse.

His mother now believes that there was a simple and deeply disturbing explanation: Jonathan's body was unable to cope with genetically engineered insulin. 'He was put straight on it as soon as he was diagnosed, , she says. 'No one told us there was any alternative. It was only afterwards - when it was too late - that I found out that things could be different.'

Indeed, as Jonathon's mother has discovered, his death is part of a far wider story.

Since its introduction 20 years ago this summer, genetically engineered insulin has been linked not only to an increasing number of unexplained deaths but to a range of side-effects that some patients say have destroyed their lives. These range from unexpected hypos to massive weight gain, violent mood swings, memory loss, joint pains, mental confusion and crippling exhaustion.

Complaints have been voiced by thousands of diabetics around the world. But they have failed to stop human insulin almost completely replacing insulin derived from pigs and cattle - although the animal insulin doesn't seem to have the same effects. In a striking echo of the MMR controversy, those who dare to question official policy have been vilified as alarmists. Tony Blair, for one, has hailed human insulin as a shining example of the benefits of GM technology.

Now, according to campaigners against human insulin, the need to challenge such complacency has never been greater. They fear that recent developments in the pharmaceutical industry could soon choke off all remaining supplies of alternative medication. They speak of feeling 'the noose tightening around our necks', and warn that more tragedies like Jonathon's are inevitable unless urgent action is taken. Now their campaign has received a major boost with the publication of a damning report on research into the new insulin. It challenges the reliability of trials that supposedly gave the product a clean bill of health.

Concerns over GM technology tend to concentrate on the crops in our fields and food on our plates. But insulin is a substance that thousands of diabetics inject directly into their bodies every day. For the drug companies involved, millions of pounds in profits are at stake. And as the unsettling saga shows, profits can sometimes seem to be more important that the interests of patients.

At the beginning of the 1980s, two corporate giants were engaged in a breakneck race. Eli Lilly and Novo - later to become Novo Nordisk - were vying for control of the lucrative worldwide insulin market.

Previously, all diabetics had relied on animal insulin extracted from the pancreases of pigs and cattle. But the bright new dawn of biotechnology had arrived, and Eli Lilly had succeeded in cloning a synthetic form of the insulin molecules found in the human body. It was an astonishing breakthrough - but Novo already held 40 per cent of the UK insulin market and had no intention of losing it to Eli Lilly. Concentrating resources, it quickly caught up with its rival.

By 1981, Novo had its own genetically modified product. Although described as 'human' insulin - a public relations masterstroke, that helped ensure its acceptance by diabetics - it was, in fact, synthetic. Today it is manufactured from yeast cells or E coli bacteria.

The insulin was put before the Medicines Control Agency, a government body which checks the safety of drugs before licensing them for sale. Novo was desperate to get its product on the market before Lilly's, and found the MCA officials extremely co-operative. 'It was cutting-edge science and very glamorous,' says Dr Laurence Gerlis, who was then Novo's director of medical research but is now an outspoken critic. 'The MCA were keen to be seen encouraging biotechnology.'

Opponents of human insulin now suggest that the MCA failed to demand sufficiently rigorous clinical trials for what was the first genetically produced drug to be licensed in Britain.

The first research using human insulin had been carried out in 1980 using just 17 people - none of them diabetic, and all of them men - and it seems that the pre-licensing trials were carried out on a group of only 300. Nowadays, trials generally involve groups of 1,000 to 1,500. But back in the 1980s, according to Dr Gerlis, standards were not so demanding. 'We just had to prove that this really was insulin,' he says.

To market the new drug, Novo's intention was to employ a 'substitution strategy'. If the company could persuade its existing animal-insulin users to switch over to the human version, it could effectively clean up before Eli Lilly's launch in September 1982. The medical justification for this strategy depended on the new product having an identical effect on the human body to insulin from pigs. But when Novo's medical advisory committee met in Copenhagen in April 1982, Dr Gerlis told the marketing men the bad news: animal and human insulin were not the same.

Pork insulin is less soluble than human insulin and has different amino acids. Crucially, says Dr Gerlis, human insulin is faster and more aggressive in its effect on blood sugar levels. As far as Dr Gerlis was concerned: 'We were asking for a licence to market human insulin, not for permission

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