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GE -news 9th March part 2

1) SET TO APPROVE HEART-HEALTHY LABELS FOR (GM?) SOYA
2) Scientists clash over tests on modified potatoes
3) Top Scientist Backs Calls For Gm Safety Screen
4) Arpad Pusztai, who with a few sentences last August sparked a nationwide 
alarm about genetically modified foods, told Members of Parliament 
yesterday that he had no regrets and would do the same again.
5) Diabetics not told of insulin risk
=============================

The AGRIBUSINESS EXAMINER, Issue # 24 March 9, 1999 
Monitoring Corporate Agribusiness From a Public Interest Perspective 
A.V. Krebs (avkrebs@earthlink.net) 
Editor\Publisher
FDA: 
1) SET TO APPROVE HEART-HEALTHY LABELS FOR (GM?) SOYA
While world-wide concern is being voiced not only that 
genetically-modified crops need to be properly labeled as such, but 
questioning the health risks human take in consuming such GM food, U.S. 
"life sciences" corporations and its corporate agribusiness hirelings 
are actively seeking the government's approval to advertise such 
products as health aids.
The Farm Journal's Barbara Fairchild reports that a "cumbersome" Food 
and Drug Administration (FDA) process that grants manufacturers the 
right to proclaim health benefits on food labels is winding down which 
would allow such health claims for products containing soy protein.
In 1997, 15% of the U.S. soybean crop was grown from genetically 
engineered seed. By next year, if Monsanto Corporation's timetable 
unfolds on schedule, 100% of the U.S. soybean crop (60 million acres) 
will be genetically engineered. Eighty percent of all the vegetable oils 
in American foods are derived from soy beans, so most foods that contain 
vegetable oils will contain genetically engineered components by next 
year or the year after.
Yet, Fairchild reports, after 36 months of research and petitioning, 
foods containing soy protein will be sporting heart-healthy labels by 
midyear.
The new labels can assert that using soy protein in your diet can reduce 
the risk of coronary heart disease by lowering serum cholesterol#243#a major 
cause of high blood pressure and heart disease. To lower cholesterol, 25 
g of soy protein must be consumed each day. Soy foods must contain at 
least 6.25 g of soybean protein per serving, based on four servings a 
day, to qualify for heart-healthy labeling.
The United Soybean Board (USB), the American Soybean Association (ASA) 
and some state soybean checkoff boards, she notes, played key roles in 
research and the proposal leading to revised labeling. Research money 
came from soybean checkoff dollars. Also joining with USB and ASA in the 
project were ADM, Central Soya Company Inc. (the U.S. subsidiary of the 
giant multinational Ferruzzi Finanziaria, S.p.A) and Protein 
Technologies International (PTI).
This consortium reportedly conducted clinical studies on the effect of 
soy products in the human diet. It is unreported whether GM soybeans 
were tested or not. Once evidence was compiled, PTI and ASA filed 
requests for a proposed ruling on the validity of the findings with FDA.
The agency had 190 days to review a petition and once the research 
findings were found adequate, the FDA put together a proposed rule. 
After the rule was issued, a 90-day comment period followed. After 
consideration of the comments came a final ruling#243#in this case the final 
ruling is expected by April.
Critics of the petition correctly point out that if the approval of such 
labeling (which was formally applied for by a subsidiary of the "life 
sciences" giant Du Pont) is confirmed, it may mean that GM soya in the 
U.S., far from being labeled as GM (which is not provided for by U.S. 
food regulations), would actually end up having a label specifically 
telling consumers how beneficial it would be for their health.
What that would mean in essence is that a genetically engineered food 
product which includes genetic material from a virus and a bacteria 
which has not previously been 
an integral component of the human diet (and whose long term health 
effects have been questioned within the scientific community) would get 
special market promotion on health grounds.
Yet, David Durham, USB domestic marketing chairman, and Hardin, 
Missouri, soybean grower makes the dubious assertion that "this health 
claim will help us spread the word about the healthful benefits of 
soybeans. As people adjust their diets to include soy protein, our 
soybean market will expand, putting more dollars in the farmers' 
pockets."
===========================

INDEPENDENT (London) March 9
2) Scientists clash over tests on modified potatoes
By Steve Connor, Science Editor
TWO SCIENTISTS at the centre of the controversy over genetically modified 
food clashed last night over crucial statements issued about the results 
of experiments on rats fed on GM potatoes.
Arpad Pusztai, who was suspended last year from the Rowett Research 
Institute, near Aberdeen, after suggesting GM food is unsafe, told the 
House of Commons Science and Technology Committee he had never been shown 
press releases about his work issued by the institute.
He said subsequent confusion in the press over what sort of lectin - plant 
toxins - had been used in the experiment would not have arisen if he had 
been able to see the press releases before they went out.
His institute said that Dr Pusztai had become confused about the "con A" 
lectin and another lectin from the snowdrop plant, which is why he was 
suspended.
Dr Pusztai's boss, Philip James, the director of the Rowett institute, 
told the committee Dr Pusztai had ample opportunity to correct any 
inaccuracies in the press releases. This contradicted Dr Pusztai's 
assurance to the committee that he had not seen the press releases until 
they had been issued.
Professor James said that Dr Pusztai had referred to experiments on the 
con A lectin, when these experiments had not in fact been carried out at 
the time of his interview on television.
"It's been quite astonishing how events have been misrepresented," 
Professor James said. He said that Dr Pusztai had not only seen a copy of 
the press release referring to the experiments but that he had rewritten a 
part of it.
"Dr Pusztai had actually presented information that turned out to be 
untrue, there was confusion in his group and his collaborators were 
outraged," Professor James said.
Dr Pusztai told the committee that after the television broadcast many 
people phoned him about the con A lectin experiment, whereas in fact he 
had referred only to the snowdrop lectin experiment. Dr Pusztai also said 
he had not seen a press release issued by World in Action, which 
instigated the publicity that led to his dismissal.
========================
3) Top Scientist Backs Calls For Gm Safety Screen

Guardian (London) Tuesday March 9, 1999 6:05 am
The head of the research institute which terminated the contract of a 
scientist who raised concerns over genetically modified food, has backed 
his calls for a new, tougher, safety regime for the products.
Professor Philip James, head of the Rowett Research Institute, told a 
committee of MPs "more effective and accurate screening methods" were 
needed to monitor "the unexpected consequences" of genetic modification.
Prof James' criticisms of the current system for testing so-called 
Frankenstein foods echo calls made by Dr Arpad Pusztai, whose contract 
with the institute was terminated last summer after he appeared on a World 
in Action programme which raised concerns about the safety of GM food.
In written evidence to the Science and Technology Select Committee, Prof 
James blasted American food safety standards, saying "more stringent 
testing systems are needed than those which appear to be acceptable in the 
US".
He also criticised the World Trade Organisation - which would rule on any 
British or European attempt to restrict imports of American GM foods - as 
treating public health as of "little import".
Dr Pusztai told the MPs there was a "compelling case" for an "over-arching 
body to advise on and oversee genetically modified food".
He said the current Government advisory committees on new scientific 
developments were likely to be "severely tested" in verifying the safety 
of GM foods as more and more were brought to market. They were also very 
limited in commissioning their own research, meaning their judgments were 
"mainly based on information received from the companies" developing the 
new foods.
And Dr Pusztai stood by his earlier controversial research, which 
suggested feeding genetically modified potatoes to rats could damage their 
insides.
Friends Of The Earth food campaigner Pete Riley said: "The Government has 
no alternative but to reassess the whole regulatory and safety regimes for 
GM foods." 
=======================

GUARDIAN (London)Tuesday March 9, 1999

4) Arpad Pusztai, who with a few sentences last August sparked a nationwide 
alarm about genetically modified foods, told Members of Parliament 
yesterday that he had no regrets and would do the same again.
Dr Pusztai had said, in interviews for a World In Action television 
programme, that the general public were being used as guinea pigs. 'I 
thought it was a fair comment,' he told the Parliamentary Select Committee 
on Science and Technology, 'not a wise comment, but a fair one.'
That remark, and a description of the effects experimental potatoes had on 
laboratory rats, provoked worldwide reaction and within days led to the 
ending of his contract with the Rowett Research Institute in Aberdeen.
For more than six months, Dr Pusztai said, he had kept his silence, partly 
because he understood his research contract required it, and partly 
because he did not have all his own data.
He had been testing what happened when a gene for a particular natural 
insecticide - a protein known as a lectin, made by snowdrops - was 
transferred to potatoes. He had believed this lectin to be damaging to 
insect pests, but not to mammals. 'As a matter of fact, it had a few 
beneficial properties,' he said.
And, he said, the experiments had not been designed to see if the potatoes 
would have been safe as human food. The experiments were designed to 
devise a satisfactory way of testing for safety in general.
Dr Pusztai had become troubled by preliminary data which showed that the 
transgenic potatoes affected rats in an unexpected way - and he was 
satisfied that the results were more than chance.
He had been kept on at the Rowett Institute long past the normal 
retirement age because his reputation earned extra income for the 
institute, and he took part in the programme for the same reason. He had, 
at the time, no indication that it would appear as hostile to genetically 
modified foods. The institute's director, Philip James, had supported him 
and phoned Mrs Pusztai after the broadcast 'to congratulate me on how well 
I handled the interview', he said in a memorandum to the committee.
'If the Rowett had any qualms about the content of the programme, they had 
seven weeks to stop it, but they did not, as I only talked about the 
necessity of finding new methods for testing with animals of GM foodstuffs 
before they are released.'
After that, things went wrong: the institute issued a press release which 
talked of an entirely different, incomplete set of experiments, described 
Dr Pusztai as having 'muddled' data, suspended him, and set up an inquiry 
which came to its conclusion in less than 10 hours. He was 'sent to 
Coventry', his data were confiscated, and Rowett staff were warned not to 
talk to him, he said. And he was denied any right to clarify scientific or 
other points at issue.
But, he told the committee, he still regarded the scientific evidence on 
record of possible effects of GM foodstuffs on humans - one single paper 
in a scientific journal - as inadequate. And, he warned, with the 
explosion of genetically modified crops expected in the next decade, 
scientific committees set up to advise the Government would be severely 
tested.
He also repeated something he had said on the programme: 'I believe that 
this technology can be made to work for us. And if genetically modified 
food will be shown to be safe, then we really have done a great service 
for all our fellow citizens.'
The committee also questioned Professor James on Dr Pustzai's suspension. 
Prof James repeated what he had said in August: he had withdrawn the 
scientist from what he described as a 'media circus'. There had been no 
pressure from industry, government or any other source. Dr Pusztai told 
the committee that he had no regrets. 'In one sense, what I achieved is 
that we are all sitting here and talking about it,' he said.
==================
GUARDIAN (London)Tuesday March 9, 1999
5) Diabetics not told of insulin risk
Report highlighting coma dangers to 15,000 sufferers who were switched to 
synthetic human substitute deemed alarmist, writes Paul Brown

Evidence that thousands of diabetics in Britain may have suffered a 
deterioration in their health from synthetic 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 six years ago, 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
synthetic 
human insulin.
Some of those adversely affected began, without warning, to go into comas, 
known as hypoglycaemic episodes or 'hypos'. Some 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 itdid 
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 per cent of 
insulin injectors 
preferred animal insulin and had experienced difficulties with synthetic 
insulin. 
He added that the association had published a report, The Insulin Debate, 
which dealt with the issues, continued to keep members informed of 
developments, and campaigned to keep 
animal insulin available to sufferers.
Synthetic insulin is manufactured by two major drug companies, the Danish
Novo 
Nordisk and US giant Elli Lilly. Neither company accepts that the synthetic 
version has negative 
effects.
The report was compiled following 3,000 letters of complaint over a period 
of two years about the new insulin from members of the association. The 
letters gave harrowing 
accounts of how lives had deteriorated after being switched to synthetic
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 that they were about to lapse into comas. The main 
conclusions from the letters were:
i Half the patients had no warning of passing out with hypos once on the new 
drug.
i A quarter said such episodes were more frequent, and one in five said they 
were more severe.
i Thirteen per cent said they became unconscious at night and 5 per cent 
suffered convulsions.
i Ten per cent had memory loss and another 9 per cent 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 synthetic 
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 
dramatic negative effects on his own health when he switched to the synthetic 
version. Before synthetic 
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. Synthetic 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 very real distress and dangerous symptoms had been largely 
ignored. The report was due to be 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 synthetic 
insulin were 
discussed. Mr O'Neill said the BDA continued to educate doctors and health 
professionals 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, and it is a message we are still trying to get 
out. We have campaigned to stop 
animal insulin being withdrawn. Matt Kiln and we are on the same side.'
'There was fear of going out alone or driving'
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 synthetic 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 
life, 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 on 
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:
i 'While I was on 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 on to animal insulin in July, and I have felt a different 
person since.'
i 'It was only when I went on to human insulin that I thought I was not in 
control of my diabetes, I went into hypos almost daily with no warning 
whatsoever (thanks to 
paramedics and good neighbours plus the casualty department at the local 
hospital I am still here to tell the tale).'
i 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.'
i 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.'
i 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.'
'Guinea pig' doctor became aggressive and forgot things
Matthew Kiln unwittingly used himself as a human guinea pig to test the 
effects of human insulin. At first he was delighted that modern science had 
produced a synthetic human 
version which could replace the bovine and pork varieties which had been in 
use for 50 years.
As a diabetic himself he had chosen to specialise in the illness and in his 
job as registrar at Torbay hospital ran a diabetic clinic. Diabetics, unable 
to produce insulin, keep 
their blood sugar levels at the correct level by twice daily injections, and 
can correct any problems by eating glucose tablets or other sweet foods.
If they fail to act when they begin to feel unwell or dizzy they may lapse 
into a coma known as a hypoglycaemic episode. But Dr Kiln found that, in a
few 
cases with human insulin, 
patients complained that these episodes were more frequent and occurred while 
cooking, or driving, without any of the normal signs of stress.
Dr Kiln went on to human insulin as soon as it was available. 'I kept 
passing out, I had low blood sugars. I had arguments with consultants. My 
father noticed all this and he 
urged me to change back. He just said I was more obstinate and more
difficult. 
I changed back and my condition improved.
'I tried going on to the human variety again in 1986. My wife demanded I 
change back: I had become unreliable, was forgetting things, and had become 
more aggressive.'
Dr Kiln said his experiences were mirrored by patients and their carers who 
had written to the Diabetic Association 'an extraordinary number who could 
not be ignored'. He said: 
'It needs a big scientific study to investigate the problems of synthetic 
insulin properly.'
In his south London practice he has 110 diabetics who have to inject 
themselves twice daily. He believes that about 10 per cent have had a bad 
reaction to human insulin.