From Dr Patricia Elliott:

I accept all your points about GM insulin not being suitable for the treatment of a significant number of diabetics. However, the point I wanted to make in my letter was that the correspondent had helped to make the case that food GMOs were not adequately safety tested or monitored. The difficulties some people had and have with GM insulin emerged because all diabetics are regularly monitored. It took some time to establish this in the minds of many doctors for the same reason that so many get brainwashed today over GM food claims made by scientists working with GM techniques. No one likes to accept that their research is open to criticism, quite apart from commercial pressures. Drug research and testing is not a guarantee of safety as many similar bad reactions have emerged with other drugs but it is infinitely better than the pathetic trials quoted in support of many GMOs.
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Original message:

Recently we carried a letter from Dr Patricia Elliott responding to a piece in the Financial Times by Greg Conko and Henry I Miller.

Dr Elliott accused Conko and Miller, who had claimed the safety of GM foods was more than proven and their benefits were 'legion', of 'bad science' - making claims unsupported by credible research - and she challenged them to identify any research regarding the effects on human health of any GM product.
http://www.lobbywatch.org/archive2.asp?arcid=1338

Alan Malcolm of the Institute of Biology subsequently replied to Dr Elliott's challenge (GM products can be the best option, Financial Times, Aug 21, 2003), using the examples of GM insulin and Factor IX.

In her reply (item 1 below) to Malcolm, Dr Elliott contrasts how such GM products are regulated in the medical field with the safety testing, or lack of it, for agricultural products.

But the excerpt (item 2 below) from a recent article by Richard Lewontin, the evolutionary geneticist and Alexander Agassiz Research Professor at Harvard University, makes clear how the approval of products like GM insulin itself raises questions about the safety of genetically engineered products.

Prof Lewontin's article is worth reading in full. He shows how DNA has been mythologised. Properties are attributed to it (principally, that of making proteins and of self-replication) that biologists know to be false. DNA, Lewontin shows, has been turned into a "magic molecule" but only by divorcing it from all the complexity of its actual context - biological, environmental, social, and economic.

Ignoring these complexities is a dangerous game - one that guarantees results other than the ones predicted. This is why, says Lewontin, we do not have a single case of a successful cure for a disease by means of gene therapy. And even if at some point in the future that is achieved, it is likely to be of very limited value. The claim that the manipulation of DNA is the path to general health is totally unfounded. It is actually irrelevant to the majority of instances of human ill health.

On the other hand, the possibility of using genetically transformed organisms for the commercial production of biologically useful molecules has been realised, notably in the case of genetically engineered human insulin. But, says Lewontin, when we begin to look at the complexity of this product's clinical, biological and economic context, we discover that it is far removed from a magic bullet. For some, in fact, it is life threatening.

Lewontin's article available in full here:
http://www.gene-watch.org/genewatch/articles/16-4lewontin.html
Worth reading in conjunction with Barry Commoner's article on DNA replication, Unraveling the Secret of Life
http://www.gene-watch.org/genewatch/articles/16-3commoner.html

1.LETTERS TO THE EDITOR: GM safety first
2.The DNA Era - Richard Lewontin
3.Coma dangers to 15,000 switched to GE human substitute
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1.LETTERS TO THE EDITOR: GM safety first
Financial Times, Aug 25, 2003
By Patricia Elliott
Sir, May I thank your correspondent Alan Malcolm, (Letters, August 21) for responding to my request for any research evidence supporting the claim that genetically modified products were safe when consumed by humans.

His reference to GM insulin and Factor IX reminds us that such products, when used for medical treatment, have had to meet stringent safety standards and are continuously monitored after approval. So far, no GM food product has met these standards. The new European Union directive has improved the requirements that have to be met and the statutory post-marketing monitoring plan, if properly enforced, would help to bridge the gap, though the practical difficulties are much greater than in the medical field.

Patricia Elliott, Saffron Walden, Essex
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2.The DNA Era
by Richard C. Lewontin [EXCERPTS]
http://www.gene-watch.org/genewatch/articles/16-4lewontin.html

The last fifty years have seen the reorganization of most of biology around DNA as the central molecule of heredity, development, cell function and evolution. Nor is this reorganization only a reorientation of experiment. It informs the entire structure of explanation of living processes and has become the center of the general narrative of life and its evolution. An entire ideology has been created in which DNA is the "Secret of Life", the "Master Molecule", the "Holy Grail" of biology, a narrative in which we are "lumbering robots created, body and mind" by our DNA. This ideology has implications, not only for our understanding of biology, but for our attempts to manipulate and control biological processes in the interests of human health and welfare, and for the situation of the rest of the living world.

The first step in building the claim for the dominance of DNA over all living processes has been the assignment of two special properties to DNA, properties that are asserted over and over again, not only in popular expositions but in textbooks. On the one hand, it is said that DNA is self-replicating; on the other, that DNA makes proteins, the molecular building blocks of cells. But both of these assertions are false - and what is so disturbing is that every biologist knows they are false.

...the possibility of using genetically transformed organisms as factories for the commercial production of biologically useful molecules, has been realized in practice. The most famous case, the mass production of human insulin by bacteria, is particularly instructive.
                  
Insulin for diabetics was originally extracted from cow and pig pancreases. This molecule, however, differed in a couple of amino acids from human insulin. Recently, the DNA coding sequence for human insulin has been inserted into bacteria, which are then grown in large fermenters; a protein with the amino acid sequence of human insulin is extracted from the liquid culture medium. But amino acid sequence does not determine the shape of a protein. The first proteins harvested through this process, though they possessed the correct amino acid sequence, were physiologically inactive. The bacterial cell had folded the protein incorrectly.

A physiologically active molecule was finally produced by unfolding the bacterially produced protein and refolding it under conditions that are a trade secret known only to the manufacturer, Eli Lilly. This success, however, has a severely negative consequence. For some diabetics this "human" insulin produces the symptoms of insulin shock, including loss of consciousness. Whether this effect is caused by a manufacturing impurity, or because the insulin is not folded in the same way as in the human pancreas, or because the molecule is simply too physiologically active to be taken in large discrete doses rather than internal, continuously released amounts calibrated by a normal metabolism, is unknown.
                  
The problem is that Eli Lilly, which holds the patent on the extraction of insulin from animal pancreases, no longer produces pig or cow insulin. Hypersensitive diabetics for whom Eli Lilly's standard treatment is dangerous no longer have an easily obtainable alternative supply.
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3.Report highlighted coma dangers to 15,000 sufferers who were switched to genetically-engineered human substitute
By Paul Brown,
The Guardian, 9 March 1999
http://www.btinternet.com/~clairejr/Insulin/insul_1.html

Evidence that thousands of diabetics in Britain may have suffered a deterioration in their health from genetically-engineered insulin has been withheld by the British Diabetics Association, whose role is to advise patients and to protect their interests.

The evidence was contained in a report, commissioned by the association and completed in 1993, which highlighted dangers faced by about 10 per cent of the 150,000 diabetics who had been switched from the traditional animal-derived insulin to genetically-engineered human insulin.

Some adversely affected began, without warning, to go into comas, known as hypoglycaemic episodes or 'hypos'. Same suffered severe injuries, a few crashed their cars, and others believed they would have died had they not been rescued as they lay unconscious. An estimated 15,000 people may still suffer because they are injecting themselves twice a day with insulin that may not suit them.

Many doctors are unaware of the problem, or have failed to put their patients back on animal insulin because they do not know it is still available. The association says it did not publish the report because it was 'too alarmist'. Simon O'Neill, head of diabetes care services, said the association agreed that up to 20% of insulin injectors preferred animal insulin and had experienced difficulties with genetically-engineered insulin. He added that the association had published a report, The Insulin Debate, which kept members informed of developments, and campaigned to keep animal insulin available to sufferers.

Genetically-engineered insulin is manufactured by the drug companies, the Danish Novo Nordisk and Elli Lilly. Neither accepts that the genetically-engineered version has negative effects.

The report was compiled following 3,000 letters of complaint over two years about the new insulin from association members. The letters told how lives had deteriorated after being switched to genetically-engineered human insulin. Eight out of 10 of a sample of the complainants examined by independent researchers said they could no longer control their symptoms and had lost warning signs of impending comas. The main conclusions from the letters were:

*Half the patients had no warning of passing out with hypos once on the new drug.

*A quarter said such episodes were more frequent, and one in five said they were more severe.

*Thirteen per cent said they became unconscious at night and 5 per cent suffered convulsions.

*Ten per cent had memory loss and another 9 percent were unable to concentrate.

Matthew Kiln a south London GP who is an expert on diabetes, was a member of the committee of inquiry set up by the association that looked into the side-effects of genetically-engineered human insulin. He told the Guardian: 'The association has failed in its duty to protect and represent the interests of diabetics by not publishing the committee's findings in full. I and other doctors who understand this issue have been quietly switching some patients back to animal Insulin to avoid the problems but thousands of people are suffering from lack of choice.'

Dr. Kiln is himself a diabetic who uses insulin and has experienced the negative effects when he switched to the genetically-engineered version. Before genetically-engineered human insulin was introduced in the early 1980s around 150,000 diabetics in Britain injected themselves twice a day with insulin extracted from pigs and cattle in slaughterhouses. Diabetes is the result of the body's inability to produce insulin which regulates blood sugar levels but it can be successfully managed by injecting animal insulin. Genetically-engineered human insulin, made from feeding nutrients to E-coli bacteria, was heralded as a breakthrough because it would avoid an occasional long term problem of antibodies being produced to combat animal insulin.

After the association received a tide of complaints, it commissioned two independent researchers, Hazel Matthews and Natasha Posner, to analyse some of the letters. Their report concluded that many patients were suffering potentially dangerous reactions. A fuller report ordered from Dr Posner concluded that doctors and specialists had failed to listen to patients and the distress and dangerous symptoms had been largely ignored. The report was due to the published in the British Medical Journal in 1993 but was withdrawn. The Diabetic Association's Journal, Balance, subsequently produced a supplement, The Insulin Debate, in which some of the problems of genetically-engineered insulin were discussed. O'Neill said the BDA continued to educate medical staff of the need to give diabetics the option of using animal insulin. He said: 'The message of the Posner report was right, it was just too alarmist, but it is a message we have disseminated. It is a message we're still trying to get out. We've campaigned to stop animal insulin being withdrawn. Matt Kiln and we are on the same side.'

The 3,000 letters of complaint written to the British Diabetic Association by patients, their relatives and doctors concerned the deterioration in their condition since being moved from animal insulin to genetically-engineered human insulin. After analysing nearly 400 of the letters, Natasha Posner, an independent researchers commissioned by the DBA, said: 'Many correspondents reported that a diabetic condition which had been stable and controlled over many years and allowed a full and normal Iife, suddenly changed and became problematic and life disrupting. For people experiencing these difficulties, the cost in terms of immediate negative effects far out-weighed any possible long term benefits of this new insulin.'

The report says that in many cases where the patient had complained, the relationship between the diabetic and doctor was breaking down and there was a potential for conflict because the patient felt his fears had been ignored.

The single most important complaint was the sudden onset of comas. A second problem was personality changes, mostly noticed by partners and colleagues. A third, and of great concern to the association, was a breakdown in relationship between the diabetics who manage their illness, and the professionals who advise them and prescribe their insulin.

There was also strong evidence that the problems were reversible. One fifth of the patients in the survey switched back to animal insulin. Of these only 1 per cent said there was no improvement when they returned to animal insulin. Many doctors refused to change them back or told them erroneously there was no longer an animal alternative.

'Correspondents reported the consequences of loss of control of the diabetes, deterioration in general health or accidents meant increased dependence an others and loss of confidence about controlling the diabetes so that there was fear of going out alone, going to bed or driving.'

Some people had lost their job, been made redundant or found that they were unable to work. A few had been refused renewal of their driving licences. There were several reports of people who had been prosecuted by police after being involved in accidents while having a 'hypo'; the report said. The report concludes: 'The letters examined constitute a source of data which amount to very much more than mere anecdotes.'

Patients' comments were directly quoted in the report: 'While I was an human insulin, my life was absolute hell. There was absolutely no warning of my blood sugar going low, and I have been in several comas because of this. My clinic put me back an to animal insulin in July, and I have felt a different person since.

'It was only when I went an to human insulin that I thought I was not in control of my diabetes, I went into hypos almost daily with no warning whatsover (thanks to paramedics and good neighbours plus the casualty department at the local hospital I am still here to tell the tale).'

One patient reported that his family noticed: 'The complete change of character. I was becoming moody critical, confused, forgetful and seemed to lack concentration. But more and more I seemed to have unnoticed hypos.'

From a wife: 'There is no doubt in my mind that had be been living alone he would now be dead, Many of the hypos occur during the night for no reason.'

From a mother 'The clinic argues that the human insulin is better for him in the long run than animal insulin - that is if he can survive.'

more items: http://www.btinternet.com/~clairejr/Insulin/insul_1.html