ERMA GE Decision Smells of US and Political Influence

The main benefactor of the Environmental Risk Management Authority’s (ERMA) decision to allow the application by Crown Research Institute AgResearch a carte blanche application to genetically engineer (GE) cattle, sheep and goats using a huge range of E.coli bacteria, human, mouse, sheep, goats, cattle, and viruses and other material is the United States biotech company GTC Biotherapeutics (GTC), an off shoot of Genzyme Corporation, according to the Soil & Health Association.

“There has been panic on the part of AgResearch and its partner Genzyme ever since the earlier applications by AgResearch for GE animals were halted in June 2009 by the High Court through action taken by GE Free NZ,” said Soil & Health Association of NZ Spokesperson Steffan Browning.

“AgResearch should not have been presumptive in its contractual arrangements with GTC, but appeared to have had the indication from ERMA that they would get the earlier application approved. ERMA has been bending over backwards ever since to ensure AgResearch could meet its US partner’s needs. Even the US Secretary of State’s science and technology advisor Nina Federoff came calling on the government in late January.”(1)

“While ERMA  says the approval is purely for research,(2) AgResearch acknowledge it allows them to meet their contractual obligations (3), and GTC is very clear that AgResearch is to “establish appropriate transgenic founder production lines” (4), this is totally commercial and the New Zealand public are funding it to the tune of at least $8million with science funding(5). GTC’s contribution is only $200,000 but holds the US patents to any transgenic therapeutic mammalian milk proteins. (4)”

“The Chief Executive of ERMA ensuring GTC’s interests would be met, promptly ticked through AgResearch applications for indoor GE goats in December 2009 without public consultation even though ERMA acknowledged existing high public interest.”

“Highly conflicted Dr Kieran Elborough as chair of ERMA’s GM Standing Committee and who had been involved with AgResearch through his own GE work in the past, renewed the consent duration of AgResearch’s existing GE cattle on 11 March 2010 for another 2.5 years, and on 1-2 March as chair of the ERMA Decision Making Committee heard the submissions about the GE sheep, cattle and goats. Soil & Health, on March 3, had again publicly exposed the Chair’s conflict of interest but on 8 March he met with the Committee on the decision making task. On March 26 Dr Elborough joined the board of a combined CRIs joint venture, and finally acknowledged a perceived conflict of interest and 29 March stood down, leaving just one more meeting for the remaining 3 decision makers.”

GTC is highly reliant on AgResearch and has been under serious financial pressure following product development failures, contaminated medicines, and penalty costs. In its annual report GTC acknowledges its survival relies on its partners and equity programs.

Excerpts from Genzyme’s financial statements September 2009 (7)

“We also have a development agreement in place with AgResearch in New Zealand for co-funding further development of selected follow-on biologics, particularly where European patents expire prior to U.S. patents…

…We have operated at a net loss since our inception in 1993, and we used $20.3 million of net cash in our operating cash flows during the first nine months of 2009. Our recurring losses from operations and our limited funds raise substantial doubt about our ability to continue as a going concern. We are entirely dependent upon funding from equity financings, partnering programs and proceeds from short and long-term debt to finance our operations until we achieve commercial success in selling and licensing our products and positive cash flow from operations.”

Not only  is the New Zealand taxpayer spending precious taxpayers science funding money on GTC, it is at risk of being implicated in liability actions down the line as GTC’s parent Genzyme has a poor safety record in its medicines manufacture,” said Mr Browning.

“Viruses and also inert contaminants have led to massive international alerts and the most recent events had the US Food and Drug Agency (FDA) on 26 March moving into a major Genzyme plant to enforce manufacturing practice regulations.”

From Genzyme’s own media release that day, “The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.”(8)

“Once again our taxpayer owned Foundation for Research Science and Technology (FoRST) is dishing out precious research money to big US corporates trading in risky dangerous activity. Another one that has gloated about NZ taxpayers money on its annual statement is Arborgen who want to be the Monsanto of GE trees internationally and are partnered with CRI Scion. Scion also benefitted from Dr Elborough signing off without public consultation another 8 years for a previously discontinued GE pine tree field trial in full knowledge of the history of non-compliance there.”

“New Zealand government agencies are tripping over themselves to get into bed with large US corporations, and run roughshod over the New Zealand public to avoid due process and corruptly give blanket approvals to their friends GE experiments.”

“It is no wonder with such disregard for fair process, precaution and law by the agencies, that protestors consider direct action.”

Soil & Health has a vision of an Organic 2020 without risky GE or influence by US corporates over New Zealand’s science and decision making processes.

NOTES

(1)   http://www.beehive.govt.nz/release/science+meeting+highlights+strong+tie…

(2)   http://www.ermanz.govt.nz/news-events/archives/media-releases/2010/mr-20…

(3)   http://www.scoop.co.nz/stories/SC1004/S00040.htm

(4)   http://www.allbusiness.com/science-technology/experimentation-research/1…

(5)   The decision http://www.ermanz.govt.nz/find/WebResultsDetails.aspx?ID=1103

(6)   http://www.allbusiness.com/legal/contracts-law-licensing-agreements/1138…

(7)   http://google.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=687…

(8)   http://www.businesswire.com/portal/site/genzyme/index.jsp?ndmViewId=news…