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5-Animals: Update on GE pharma cows in New Zealand



                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  AgResearch GE Cow Application Contravenes Law:
        Minister Must Use "Call In" Powers
SOURCE: GE Free New Zealand
        http://www.gefree.org.nz/press/21082005.htm
DATE:   21 Aug 2005

------------------- archive: http://www.genet-info.org/ -------------------


AgResearch GE Cow Application Contravenes Law: Minister Must Use "Call
In" Powers

AgResearch's recently-approved experiment to produce Lactoferrin from GE
cows has been revealed to be a full scale manufacturing business and not
a just a 'development' as previously implied in order to get ERMA's go-ahead.

According to statements from AgResearch's European business partner-"
Pharming"- the NZ Crown Research Institute will bear the full cost of
producing recombinant human lactoferrin (rhLF) as well as being
responsible for marketing across Asia.

The manufacturing plan clearly exceeds the 'development' title under
which the approval has been made by ERMA and avoids public consultation.
Worse is the intention to avoid proper testing and restrictions on use of
the GE product by persuading the US Food and Drug Administration to
approve it as "GRAS: Generally Recognised as Safe".

For these reasons the application must be called-in by the Minister under
the HSNO Act. If this project is allowed to go ahead AgResearch will make
New Zealand into a GE-nation, which will be the ultimate denial of the
public will to maintain New Zealand's GE-Free status.

The attempt to sneak approval as "GRAS" is also a threat to public health
and exposes AgResearch to liability that could run to billions of dollars
as it did with a previous GE supplement made by Showa Denko.

The biotech company's thinly veiled rhetoric saying that GE Lactoferrin
is a supplementation for neo nates sets a dangerous precedent for
regulation of such products in this country and overseas. Lactoferrin is
already a widely available iron supplement for neonates used to help with
strengthening the nerves and immune system. The very effective bovine
lactoferrin, extracted from colustrum and cows milk, has been safely and
successfully used for many years and there is no problem with supply. In
fact Fonterra have a lucrative successful export market which is now
threatened by a GE variant with much greater potential risk.

"ERMA is being disingenuous and complicit in accepting AgResearch's
rhetoric and by failing to look deeper into the scientific merit or
consulting with the public" says Claire Bleakley of GE Free NZ in food
and Environment.

"The taxpayer is heading into another million dollar loss if AgResearch
is to carry full responsibility for the cost of the production process
which is an unnecessary use of GE and which 75% of New Zealanders do not
want."

GE Free NZ demands that the Minister use her powers under HSNO to call in
the AgResearch Lactoferrin embryo application.

In May AgResearch was given an approval to import genetically modified
semen and embryo's inserted with the human gene Lactoferrin to create a
production herd. GE Free is of the understanding that this does not
constitute a development experiment under GMD 02028, as it does not fit
into the generic approval that ERMA outlined in its decision. The
original GMD 02028 approval was the subject of a previous legal challenge
made by Madge and further legal action against this latest approval is
being considered .

GE Free understands that the Lactoferrin deal is a business transaction
between a private company (Pharming) and a taxpayer-funded organisation,
but one which could potentially drive the CRI into ruin. In effect this
project is thrusting New Zealand into an overt commercial full scale
manufacturer of GE products.

"The failure by ERMA to consult with the public on this application is
shocking" says Claire Bleakley. "GE Free NZ was assured of a meeting with
all interested parties once the new ERMA CEO came to office, but this
hasn't happened."

ERMA and the Minister both have a duty to stop or call in the application
before it goes any further as it clearly contravenes the laws of this
country. This sort of application should require a full-release
authorisation under the HSNO Act legislative process.

Given initial safety studies have not been conducted, the precautionary
principle demands that the effects on ecosystems, communities, the
environment and economy should be ascertained before any approval is made.

"AgResearch is hoping that they will be able to advance the experiment by
impregnating the cows. But without full notification and consulting with
the taxpaying public on this application we believe that they will be
breaking the law," says Claire Bleakley.

"Our members are sick of the public having to bear the full cost of GE
failures and of being deliberately left in dark by the Minister and ERMA.
There is growing concern at the conflict of interesting in regulation in
New Zealand. ESR is partnered by Syngenta, AgResearch with Pharming, yet
these converging commercial interests now threaten the Public and
National Interest."

"We need a new scientific organisation that does not have links to big
business so that independent safety analysis in New Zealand is genuinely
independent and not compromised by links between vested interests."


ENDS
Claire Bleakley (06) 3089842
Jon Carapiet 0210 507 681


                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  AGResearch claims about transgenic milk are misleading
SOURCE: GE Free New Zealand
        http://www.gefree.org.nz/press/13072005.htm
DATE:   13 Jul 2005

------------------- archive: http://www.genet-info.org/ -------------------


AGResearch claims about transgenic milk are misleading

"AgResearch claims that transgenic milk is proven to be safe are
deceptive and misleading" said Claire Bleakley of GE Free (NZ) in food
and environment. "If scientists continually mislead the public little
wonder GE science is in the doldrums"

Further AgResearch is relying on a deal with Dutch biotech firm Pharming
who went into receivership in 2001 and were rivals of PPL but bought
their patent portfolio (1) The linking between Insulin and transgenic
milks is also disingenuous. Insulin is produced in bacteria in
fermentation vats in laboratories and given to a specific type of patient
who is strictly controlled. GE Lacto ferrin has not even been proven safe
for development in cows or use in humans. No transgenic milks have been
produced for any type of consumption worldwide.

To date the Myelin Basic Protein (MBP) produced in transgenic cows has
not made it to market. The clinical trials of rMBP in was withdrawn after
a worsening of the lesions in patients with multiple sclerosis. (2) The
hAAT milk in the PPL sheep for Cystic Fibrosis plunged PPL into
bankruptcy due to failure of clinical trials causing excessive wheezing. (1)

Spider thread produced in goats milk has not been successful nor was for
human consumption. In 1989 the Japanese company Showa Denko produced L-
tryptophan using bacteria which were genetically modified to dramatically
increase the yield of this amino acid supplement. The GE process resulted
not only in an over-production of the amino acid, but also an over-
production of over 60 toxic compounds normally produced in negligible
amounts by the bacteria. This resulted in the death of 36 people and
approximately 1500 more have been permanently maimed. Showa Denko has
admitted liability and has duly paid compensation to survivors. (3)

This incident highlights the fact that GE has potentially fatal
consequences and should be clinically tested at every step before such a
trial is undertaken.

"Full clinical trials should be undertaken on any organism that is
genetically modified, regardless of whether the modification is for
supplement or a food. Especially before we delve into the wholesale
production of Lactoferrin " said Claire Bleakley of GE Free (NZ) in food
and environment.

ENDS:
Claire Bleakley (06) 3089842


References:

(1) Doubts over Pharming Technology 25th March 2002
    Source: http://news.bbc.co.uk/l/hi/sci/tech/1892567.stm
    Annual Report 2001, http://www.ppl-therapeutics.com
    Goodbye Dolly again as PPL shelves drug plan, Terry Macalister, The
Guardian, Thursday, June 19, 2003.

(2) MS Clinical Trials confirm approach; demonstrate need to carefully
refine targeted peptide therapy. US Newswire Sept 28,2000
    p1008271n6955 released by the national Institute of Health: Beilekova
B., Goodwin B., et al. (2000) Encephalitogenic potential of myelin basic
protein peptide (83-99) in Multiple Sclerosis - results of a phase II
clinical trial with an altered peptide ligand, Nature Medicine, Vol 6, No
10 pp 1167 -1175
    Kaposi L., Comic G et al (2000)Induction of a non - Encephalitogenic
Th2 autoimmune response in Multiple Sclerosis after  administration of an
altered peptide ligand in placebo controlled randomized phase II trial,
Nature Medicine, Vol: 6, No 10 pp 1176-1182.

(3) Tryptophan summary (John B. Fagan, PH.D) http://www.psrast.org/jftrypt.htm
    National Eosinophilia-Myalgia Syndrome Network http://www.nemsn.org
    Does v. Showa Denko of Japan, et al. http://www.wintrials.com/CM/
Custom/TOCVerdictsSettlements.asp


                                  PART III
-------------------------------- GENET-news -------------------------------

TITLE:  Milk plan has anti-GE lobby group livid
SOURCE: New Zealand Herald, by Owen Hembry
        http://www.nzherald.co.nz/index.cfm?ObjectID=10335146
DATE:   11 Jul 2005

------------------- archive: http://www.genet-info.org/ -------------------


Milk plan has anti-GE lobby group livid

A plan by Crown research institute AgResearch to create a herd of
genetically modified cows to produce human health boosting proteins has
been criticised by lobby group GE Free New Zealand.

AgResearch is partnering Dutch therapeutic protein developer Pharming
Group with the goal of creating cows capable of producing recombinant
human lactoferrin - a naturally occurring immune system boosting protein
that may also aid bone regeneration and osteoporosis as well as fight cancer.

GE Free predicts "huge public opposition" saying the plan poses risks to
human safety, animal welfare and New Zealand's international reputation.

GE Free spokeswoman Clare Bleakely said: "It is an outrage that
AgResearch has not done due diligence by looking at safety studies on
lactoferrin construct and appears to be hoping to escape through a
loophole by putting it on the market as a supplement."

She added that factory farming of GE cows was inhumane and would damage
New Zealand's international reputation.

Jimmy Suttie, AgResearch general manager applied biotechnologies, said
Pharming was responsible for safety work, marketing and distribution.

"In terms of whether we've done due diligence the issue here is our
partners [Pharming] have done, or are in the process of doing, all of
that and they carry that risk."

Suttie said if the project was found to be unsafe it would be stopped.

He added AgResearch already operated transgenic cattle projects and held
a public hearing on these about three years ago.

"At that time there was a huge amount of publicity and AgResearch went
through the scientific, legal and public perception aspects of that and
we gained the approvals to do the work," he said.

"So what we're actually seeing here is nothing that we haven't done before."

AgResearch says commercial production of human lactoferrin will need
regulatory approval by the Environmental Risk Management Authority.

However it said testing to date had shown transgenic milk to be safe
"even taken in large quantities".

Pharming has also begun registering the product with the US Food and
Safety Administration, under the "generally recognised as safe" category.

Suttie said recombinant human insulin, injected by diabetics worldwide,
was an example of a genetically modified organism used to produce a drug
beneficial to humans.

The insertion of an extra gene will modify the genetic blueprint of cow
embryos, which when born will be raised in a small herd at a secure
containment facility.

Genetically modified bulls will mate with cows making calves that
subsequently produce normal cows milk but with the extra human protein.

AgResearch chief executive Andy West said the organisation recognised
"that genetic modification is of significant interest to the public and
that we have a responsibility to inform the public of this sort of
research and development."

He added the partnership was an important step forward for the
biotechnology industry.

"Our partnership with Pharming NV provides this country with access to
licensed transgenic technology [in animals] it would otherwise be denied."

The cow-produced human lactoferrin could be used in hospital food, infant
formulae, sports supplements, oral care products and cancer medicine.

After safety approval Pharming will test the product in a worldwide
market estimated to be worth about US$100 million ($149 million) for
initial oral applications.

Transgenic milk production is expected to begin in about three years.


What is lactoferrin?

Lactoferrin is a milk whey protein that boosts the body's natural
defences and could have wider medical benefits in treating bone
regeneration, osteoporosis and fighting cancerous tumours.

Naturally occurring within the body, lactoferrin is associated with
defensive white blood cells which fight viruses and bacterial infection.

Research unveiled by Auckland's Osteoporosis Research Group at the World
Dairy Summit, held in Melbourne last November, found the milk protein
boosted bone growth by four times the normal rate when injected directly
into bone cells.

Osteoporosis affects about 200 million people globally.

Dairy companies, including Fonterra and Waikato-based Tatua, produce
bovine lactoferrin from cows milk and sell it for about $500 a kilogram
in Japan and Korea.

About 10,000 tonnes of milk are used in the production of each tonne of
lactoferrin, with leftover milk re-used to make basic milk powder.

Fonterra head of health and nutrition Patrick Geals said last October
that lactoferrin "will be to the dairy industry what aspirin has been to
the pharmaceutical industry".

--


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