GE Free New Zealand in Food & Environment, 19th March 2006

GE recombinant drugs result in life threatening reactions

It is time that full stock is taken over the hazards and horrors that surround GE recombinant drugs that have genes from multiple animal species. (A recombinant product is created by sourcing DNA from two or more organisms, often from different animal or plant species (foreign genes) into a single recombinant molecule using bacterial or viral vectors).

The latest disaster of the recombinant cloned bio pharmaceutical human phase 1 clinical trial of TGN1412, has ended in a life threatening severe allergic (anaphylactic) reaction that many scientists have been warning about for years.

“The irresponsible panicked rush to put a GE drug on the market has caused many blunders and failures but none as big as this. The revolving door politics by big pharma-companies has allowed short cuts and safety parameters to be whittled down, ending up treating humans as guinea pigs”. said Claire Bleakley of GE Free (NZ) in food and environment.

“There is still little known about the mixing of genes across species barriers and the virulent immune system reactions that might occur”.

TGN1412 has been created by Te Genero and had reached the Phase 1 stage of human clinical trials after being given Orphan status the year before. The human recombinant pharmaceutical had shown that, in test tube experiments, the potential for the immune system to be fully stimulated by activating T lymphocytes, had therapeutic potential for a number of autoimmune/ inflammatory as well as cancer diseases.

However there have been deaths from GE trials going wrong over the years. Jesse Gelsinger died after severe immune reaction following gene therapy, three children developed mouse leukemia after the gene vector mutated. The failure of the PPL cystic fibrosis and the Multiple Sclerosis recombinant trials were due to severe immune reactions causing breathing and wheezing distress.

In 1989 a GE L-Tryptophan supplement, manufactured by Showa Denko in E-coli, caused Eosinophilia Myalgia Syndrome and ended in 100 deaths 1500 people to become permanently disabled.

This incident calls into doubt whether ERMA and AgResearch have taken into account the full risks associated with the creation of the GE human Lactoferrin Cows. ERMA approved the importing of embryos containing the Human lactoferrin for a supplement in neonates and immune compromised people.

As supplements do not have to be clinically trialed there is danger that we might have a similar devastating outcome of TGN1412 bio pharmaceutical sourced from a human/mouse clone.
We hope that ERMA considers these unforeseen, un- predictable and devastating outcome of meddling with nature and crossing all species barriers and moves demand that full clinical trials are conducted on the GE milk before the trials goes any further.

It is a sad outcome and our thoughts go out to the families whose loved ones are in intensive care”.

Claire Bleakley (06) 3089842



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