Sick people used like laboratory rats in GM trials (4/3/2007)

1.Sick people used like laboratory rats in GM trials

EXTRACT: "This was an irresponsible trial to carry out and totally unethical, especially when already ill subjects were enrolled. These people truly were guinea-pigs." - Dr Michael Antoniou, medical biotechnologist

1.Sick people used like laboratory rats in GM trials
By Geoffrey Lean, Environment Editor The Independent on Sunday, 4 March 2007

Genetically modified potatoes developed by Monsanto, the multinational biotech company, have been fed to sick patients in an experiment. Rats that ate similar potatoes in the research suffered reductions in the weight of their hearts and prostate glands.

Dr Michael Antoniou, reader in molecular genetics at Guy's, King's and St Thomas' School of Medicine, said use of humans was "irresponsible and totally unethical, especially when already ill subjects were enrolled. These people truly were guinea pigs." Other scientists said the trials were too short, on too few people, to give meaningful results of long-term effects.

Monsanto said the vegetables were safe, and the researchers conducting the experiment said effects on the rats were within "permissible" limits.

The experiment is described in a hitherto unpublished report by the Nutrition Institute of the Russian Academy of Medical Science, done "by agreement with Monsanto Company" in 1998.

The report says "10 patients suffering from hypertensive disease and ischemic heart disease" were fed a pound of the Russet Burbank potatoes - modified to resist Colorado beetles - every day for three weeks, and monitored.

It goes on: "A certain risk of GM food products for human health does exist, as there can be by-effects of inserted genes besides the designed ones." The report describes the patients as "volunteers" and says they liked the GM potato so much they all "expressed their intention to consume it at home".

After comparing them with 10 other patients fed conventional potatoes, the report concludes: "The genetically modified potato provided by Monsanto did not reveal toxic, mutagenic, immune modulating and allergic effects within the examined parameters of the present experiment".

It recommended the GM potatoes "can be used for human nutrition purposes in further epidemiological research". The report says the rats, tested over six months, suffered "increases of kidneys' absolute weight" when compared to ones fed conventional potatoes but that all changes were "within permissible physiological fluctuation".

But Dr Irina Ermakova, of the Russian Academy of Science, calls the GM potatoes "dangerous" for rats, adding: "On this evidence, they cannot be used in the nourishment of people".

Tony Coombs from Monsanto UK said in a statement: "Potatoes genetically improved to prevent Colorado beetle destroying the crop have already been consumed, as safely as conventional or organic ones, in North America for years."

Press Release 4th March 2007 from GM Free Cymru

Monsanto GM potatoes which are classified as pesticides in America were fed to Russian hospital patients in 1998 in a bizarre feeding trial.

The information is contained in comprehensive Report from the Institute of Nutrition of the Russian Academy of Medical Sciences, suppressed by Monsanto and the Russian authorities for 8 years but now available thanks to the determination of Greenpeace Russia. The Report (1) is now translated into English. In 1998 the Institute, with the full cooperation of Monsanto, conducted a trial in which Bt potatoes were fed to patients with different diseases in a Moscow clinic (2). The feeding continued for 3 weeks, and according to the Institute no negative effects were found. In other words, nobody got even more ill, or died, as far as the research team was aware.

On the basis of the human feeding study, and other studies involving mice and rats (3), the Institute of Nutrition concluded that "the studied types of potatoes can be used in human nourishment for the conduct of further epidemiological studies", i.e. during the study of the clinical picture of diseases and their distribution among the human population. These conclusions have been heavily criticized by three independent reviewers on the basis that they do not accord with the data in the Report (3).

The potatoes used in the study were Monsanto GM NewLeaf potatoes bred in 1988 -1995 from the Russet Burbank variety to be resistant to the Colorado Beetle. The GM event was registered as 082, and the potatoes are included in the Bt group of GM crops. It is probable that the variety code is NL10-RBK. The potatoes also contain an antibiotic resistance marker gene (4), and they are male sterile. The potatoes were deregulated in the USA in 1998/1999, without any feeding studies being required. Even earlier, in 1996, Monsanto started to introduce the potatoes into Russia and Georgia, and probably into many other countries with lax approval regimes as well. Partly on the basis of the 1998 feeding trials, consent was duly given in 2000 by the Russian regulators for the GM potatoes to be grown and marketed for human consumption. However, the NewLeaf GM potato was a failure. It was nutritionally inferior to traditional Russian potato varieties; and it proved to give poor yields and to be susceptible to disease in European environments. Monsanto also knew (on the basis of this study and others) that it was dangerous. The company pulled out of GM potato development in the USA and Europe in 2002 (5), but nonetheless cynically continued to work with the Russian authorities to develop a further GM (Bt) potato variety called Elizabeth (6). This variety is now approved for human consumption in Russia.

GM plants that are engineered to be resistant to the Colorado Beetle and other insects through the insertion of the Cry3A and NPTII genes are referred to as Bt varieties, and they act as powerful insecticides. All parts of the GM plant are toxic, and that is why the plants are classified as pesticides which come under the control of the Environmental Protection Agency in the United States (7). Many GM-Bt varieties, including cotton, maize and potatoes, have been found to be more dangerous than other GM varieties (8). In 2004 twelve cattle in Hesse, Germany, died after being fed on Syngenta's Bt176 maize; thousands of sheep and goats have died in India after feeding on the foliage of Bt cotton plants; and many non-target organisms are killed on the leaves, in the leaf litter and among the roots of Bt plants in field conditions (9). In addition, ther

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