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Safety Regulations For GE Under Threat

GE Free NZ has just received information under the OIA on the EPA-approved GE clinical trial of a vaccine for liver cancer.

Pexa Vec (Pexastimogene Devacirepvec) a live genetically engineered small pox (vaccinia) virus failed to reach its clinical endpoints and was closed down eighteen months early. The phase III clinical trial enrolled 600 subjects in 142 international locations, two were in New Zealand (Auckland and Christchurch). [1]

The Pexa Vec phase II clinical data on 86 patients recorded serious reactions; worsening liver function, disease progression, fever and 17 deaths, one considered treatment related. Deaths occured earlier in patients who received Pexa Vec. [2]

“We extend our condolences to those who lost their loved ones,” said Claire Bleakley, president of GE Free New Zealand.

“However, this result shows that there are still many uncertainties about how GE technologies impact human health. All gene edited and genetically engineered (GM/GE) products - including food, should undergo stringent trials to gauge any adverse effects, overseen by health professionals and Regulatory Agencies.”

The scientific community remains deeply divided over the safety of genetic modification and gene editing but the National Party and The Opportunities Party (TOP) have policies to deregulate powerful and potentially dangerous gene editing techniques. [3] [4]

"Policies to deregulate Gene Editing represent a huge risk to people, the environment and our exports," said Jon Carapiet, spokesman for GE-Free NZ and advocate for Brand New Zealand

"They would be throwing away our reputation for safe, clean food and destroying New Zealand's marketing point of difference against low-end US commodities, and other contaminated food products on the world market."

Gene Editing is only 8 years old and a growing body of published research is showing serious unanticipated off-target effects on the organisms being genetically engineered. The silencing of genes has caused damage to the organism's functions in unrelated parts of the organism’s genome.

Just published research by Drs. Van Eenenaam and Owen (2020) [5] used CRISPR, one of the main GE technologies, to engineer and implant 200 embryos into surrogate cows. Only one calf survived, and analysis showed the genome had been littered with deletions and random insertions in the wrong places, even upside down. Bacterial genes from the plasmid were also found. It is unknown how this will affect the calf’s life but AgResearch’s other GM Animal trials have failed due to the suffering of the sentient animals. [6]

"Never before have so many scientists been so polarized or compromised. Science is about seeking knowledge, but some research organisations are exposing themselves to being disastrously compromised in the chase for patent profit through monopoly control of seeds, and license fees,” said Claire Bleakley.

“We need only to look at the sad, cruel failed GE experiments on animals in New Zealand to understand why Government has an ethical and moral obligation to ensure that Gene Editing is regulated.”

Scientific research and development funding is also compromised by its dependence on quickly commercialising products to make a return on investment, regardless of the longer term risks.

"Regulation is necessary to moderate risk-taking and in order to benefit from the independent research highlighting the dangers that GE techniques pose," said Jon Carapiet.

"Safety evaluation must be independent of the scientists and corporations developing and marketing GE products. Trust in New Zealand’s regulation of experimental gene technologies is vital for the future."

References:

[1] https://clinicaltrials.gov/ct2/show/NCT02562755?term=PHOCUS&rank=1

[2]Vaccinia-based oncolytic immunotherapy…a randomized multicenter Phase IIb trial https://www.tandfonline.com/doi/full/10.1080/2162402X.2019.1615817

[3] https://www.newshub.co.nz/home/shows/2019/05/nz-embracing-gene-editing-is-a-no-brainer-geoff-simmons.html

[4] National would overhaul law governing gene editing https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=12274640

[5] A Crispr Cow Is Born. It’s Definitely a Boy https://www.wired.com/story/a-crispr-calf-is-born-its-definitely-a-boy/

[6 ] GE Animals in New Zealand: The first 15 Years. https://www.gefree.org.nz/assets/pdf/GE-Animals-in-New-Zealand.pdf

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