New Zealand's transgenic research centres are potentially able to cause the spread of virulent unwanted disease and must be investigated in light of the new evidence on Foot and Mouth in England.
A Foot and Mouth outbreak in Surrey England has been linked to a transgenic vaccine that was under research at the Pirbright /Merial Animal Health research farm. The discovery raises further concerns for bio-security at New Zealand and overseas research centres as a similar outbreak would have a disastrous impact on World economies.
Up to 200 animals have been killed and a ten mile quarantine zone set up to contain the outbreak in the UK. A flooded stream or human movement are the two areas suspected to have caused the spread of the virus, but research into a GE vaccine is implicated as a source (1).
Concerns have been raised at ERMA�s NGO meetings over the waste, effluent and material from research facilities that use reticulated systems for cleaning down their laboratories. The risk of GE vector mutations from the research has always been played down by ERMA and applicants.
The concerns are further strengthened in the wake of a report on the death of a subject involved in trials of a new drug for Arthritis "tg AAC94" carried out by Targeted Genetics Corporation (TGEN.O). The drug was injected into joints of the subject. The trial has been halted whilst the FDA look into it further (2) & (3). It appears that TGEN used a similar process to that used in an earlier ill-fated trial by Te Genero.
In 2006 the New England Journal of Medicine Suntharalingam et al published a full report on TeGenero�s GMO derived Arthritis drug "TGN 1412" and the life threatening reaction of six healthy volunteers, including a New Zealander. The report details adverse effects starting immediately and within hours the subjects were in a coma with severe immune system shut down and organ failure. The research participants are still ill, with one person diagnosed with a cancer related to the "vector" in the trial (3).
In 2002 a "miracle" gene therapy treatment for children suffering from the fatal "bubble boy" disease was halted in France, after one of the patients developed leukaemia linked to the "viral vector" (Mouse Leukemia Virus, MLV) as a direct consequence of the treatment.(4)
In 1999 Jesse Gelsinger died from a gene therapy trial to correct a missing enzyme that he could not produce. He died having suffered a massive immune response triggered by the use of the viral "vector" used to transport the gene into his cells. This led to multiple organ failure and brain death.(5)
The FDA is looking into the latest drug case however in the previous cases it has been found that certain rules of conduct were not complied with. Subjects were not told that the therapy was made from a GE process, nor that adverse reactions and deaths in animals had been found in previous trials.
�This is a warning for ERMA to reconsider all genetically engineered trials, whether in the laboratory, outdoor containment or in the field," says Claire Bleakley of GE Free NZ (in food and environment).
�GMO�s whether in drugs, plants or animals have the ability to interact, survive and become a severe disease risk through mutation and transformation with the billions of natural bacteria and viruses that are already in our environment�.
�ERMA is still denying the horizontal gene transfer (HGT) can occur at levels that would cause damage. These trials show that GMO�s are able to cause significant damage and stringent protocols need to be put in place when assessing the risk and disposing of laboratory and field waste material�.
Claire Bleakley (06) 3089842, Mob: 027 348 6731
(1) Britain to ease restrictions on cattle movement after foot and mouth outbreak, The Associated Press Published: August 20, 2007
(2) Targeted genetics' inflammatory arthritis phase i/ii trial placed on clinical hold. (July 2007) http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle&ID=1030172&highlight=html
(3) FDA statement of Gene Therapy Clinical Trial � July 26th 2007 http://www.fda.gov/bbs/topics/NEWS/2007/NEW01672.html
(4) Suntharalingam G., Perry M., Ward S., Brett S., Castello-Cortes A., Brunner M. and Panoskaltsis (2006), Cytokine Storm in a phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412, The New England Journal of Medicine; Vol: 355:1018-1028:10.
(5) Miracle' gene therapy trial halted; October 2002, E.Young, NewScientist.com news service http://www.newscientist.com/article.ns?id=dn2878
(6) Jesse Gelsinger 1999 http://en.wikipedia.org/wiki/Jesse_Gelsinger