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GE Pharmageddon--How About
an AIDS Drug in Your Corn Flakes?

"Pharmageddon"

Dr. Mae-Wan Ho and Prof. Joe Cummins, 2nd December 2002

Our fields are being turned into pharmaceutical and industrial factories that
poison our food supply and entire life support system. Our governments have
been warned and should be held liable for all damages along with the
companies involved. Dr. Mae-Wan Ho reports.

The complete document with references, is available in the ISIS members
site.. Full details here http://www.i-sis.org/

We have repeatedly warned against using food crops to produce gene drugs and
industrial chemicals since 1998 [1-3]. The inevitable contamination of our
food supply has now come to light. But the more insidious pollution of our soil,
water and air has yet to be assessed [3]. Poisons can seep through the plant
roots and dissolve in ground water. Pollen carrying the offending drugs and
chemicals could be inhaled. Wild and domestic animals of all kinds are
likely to feed on the crops.

On November 11, the US government ordered the biotech company, ProdiGene, to
destroy 500,000 bushels of soybeans contaminated with GM maize, engineered
to produce a drug not approved for human consumption [4]. The US Department of
Agriculture (USDA) refused to give details on the protein involved because
it is deemed "confidentual business information".

It could be one of the following [5]: the HIV glycoprotein gp120, a blood-
clotting agent (aprotinin), a digestive enzyme (trypsin), an industrial
adhesive (a fungal enzyme, laccase), vaccines for hepatitis B, vaccine for a
pig disease, transmissible gastroenteritis.

USDA records show that ProdiGene has received 85 test permits for experimental
open-air trials of pharm crops and chemical crops in at least 96 locations.

The Oedible'AIDS vaccine with the HIV glycoprotein gp120 gene [6] has been
condemned as dangerous by a number of AIDS virologists [7-9] because the
gp120 gene and gene product can undermine our immune system and generate new
viruses and bacteria that cause diseases.

A day later, the US government disclosed that ProdiGene did the same thing
in Iowa back in September. The USDA ordered 155 acres of nearby corn to be
incinerated for fear of contamination [10,11].

This is just the tip of the iceberg. The true extent of the contamination
remains unknown owing to the secrecy surrounding more than 300 field trials
of such crops across the country since 1991. Still others sites are in Canada
[3]. The chemicals these plants produce include vaccines, growth hormones,
clotting agents, industrial enzymes, human antibodies, contraceptives, immune
suppressive cytokines and abortion-inducing drugs.

The majority of engineered biopharmaceuticals are being incorporated into
maize. ProdiGene, the company at the centre of the current scandal has the
greatest number of pharm crops and projects that 10 percent of the US maize
will be devoted to biopharm products by 2010.

Far from supporting even weak containment strategies such as buffer zones,
ProdiGene has told its shareholders it is hoping to "gain regulatory
approval to lessen or abandon these requirements altogether".

Trials in other countries have also come to light. According to a recent
report by Genetically Engineered Food Alert, a US-based coalition of environmental
and consumer advocacy groups, Puerto Rico is one of four main centres in the US
for these tests. The other three are the states of Nebraska, Wisconsin and
Hawaii.

Another report by the same group reveals that these plants are by no means
the only experimental GM crops grown in Puerto Rico. This Caribbean island has
been host to 2,296 USDA-approved GM open-air field tests as of January 2001,
making Puerto Rico host to more GM food experiments per square mile than any US
state, except Hawaii.

Puerto Rico is not a state. Its residents are US citizens but have no voice
or vote in the US Congress or in the UN.

Puerto Rico Farmers Association president Ramon Gonzalez revealed that he
plants GM crops in his farm in the town of Salinas. He said that genetically
modified crops in Puerto Rico are commercial and include a herbicide-resistant
soya made by Monsanto (Roundup-ready) and a variety of corn that produces
its own bio-pesticide, or Bt corn.

According to Gonzalez, the harvested GM crops planted there are sold as seed
to be planted elsewhere. "Puerto Rico is the preferred place to make seed
because our weather permits us to have up to four harvests a year."

Local regulatory agencies seem to be unaware of the issue. A spokeswoman for
the Puerto Rico Environmental Quality Board said that as Puerto Rico has no
laws or regulations for GM crops, it has no mandate to intervene or
investigate.

USDA spokesman Jim Rogers is reported to have said, "Nobody¹s going to know
all the possible risks", and "We mitigate these risks to what we feel is appropriate" [12].

On the contrary, we do know enough of the risks for such crops to be banned
immediately. The USDA and other government regulators have been warned, and
they should be held liable for all damages along with the companies involved..

Risks of Edible Transgenic Vaccines
Prof. Joe Cummins reviews recent developments in plant edible vaccines and
points out some additional risks that have not been considered.

The complete document with references, is available in the ISIS members

Using transgenic plants to produce vaccine cheaply has been the main area of
molecular farming. A large number of transgenic plant vaccines are being
developed and field tested [1,2].

Early tests of a hepatitis B vaccine in potato were hampered by the low
levels of antigen produced in the plant, and by the safety requirement that only
individuals previously immunized with injected vaccine should be exposed to
the plant vaccine [3]. The main safety concern is that the oral vaccine
preparations will induce "immune tolerance", thereby making the individual
susceptible to the hepatitis B virus.

Oral tolerance is a fundamental biological response to ingested antigens, so
that it is possible to eat proteins that would produce an immune response if
injected. These difficulties appear to have cooled the fervour of clinical
investigators and pharmaceutical companies. Though earlier, a vaccine for
pig gastroenteritis produced in transgenic corn was claimed to be effective and
ready for commercial release by 2003 [4].

Most transgenic plants have been produced using fertile plants, with crop
isolation to limit pollen escape. Researchers have employed chloroplast
transgene insertions to boost production levels and to limit the escape of
modified genes in pollen. But chloroplast transgene containment is known not
to be completely effective [5,6].

The two main concerns over transgenic vaccines are the contamination of food
crops through cross pollination and of the vaccine itself in plant debris
spreading as dust and as pollutants in surface and groundwater. The vaccine
antigen may affect browsing animals and humans living in the area drinking
vaccine-polluted water or breathing vaccine-polluted dust. The problem of
inducing oral tolerance has already been pointed out above.

There is another kind of immune tolerance that could be acquired during
embryogenesis. Burnet and Medawar found that the immune system established
the difference between "self" and "non-self" molecules in the developing embryo
(reviewed in reference [7]). Exposing the embryo to vaccine will cause the
newborn to be tolerant to the vaccine and thus to regard both the vaccine
and the infecting pathogen as "self". Individuals born in the vaccine-polluted
area may well not be able to produce antibodies to the vaccine antigen, and thus
to lack protection against infection by the pathogen.

A number of transgenic plant vaccines currently being developed will be
discussed. Cholera toxin gene was introduced into the chloroplast genome of
the tobacco, the construction was geared towards high levels of vaccine-antigen
production The chloroplast construction allowed 410 times higher antigen
production than nuclear gene inserts [8].

Edible cholera B vaccines were produced in transgenic tomato [9,10]. And an
antigen gene from the malaria parasite in transgenic tobacco has been
proposed as a malaria vaccine [11].

Mice fed transgenic alfalfa with a gene for an antigen to foot and mouse
virus were found to produce antibodies against the foot and mouth virus [12]. That
study bears careful scrutiny because alfalfa pollen is known to spread to
adjacent crops, and pregnant cows and sheep fed on the vaccine crop may give
birth to offspring tolerant to the virus.

Transgenic tobacco was modified to produce vaccines against hepatitis B
virus and cytomegalovirus. Virus-like particles were produced and concentrated in
the tobacco seeds. However, the modified seeds did not provoke an immune
response to hepatitis B and cytomegalovirus in mouse. Instead, a strong response to
tobacco seed proteins was observed [13]. This unexpected result ought to
serve as warning of the unpredictable risks inherent to the transgenic process.

A transgenic potato was loaded with genes for cholera, E.coli antigens and
rotavirus enterotoxin, and adult mice were found to produce antibodies to
the toxins after feeding on the transgenic potatoes. Neonate mice passively
immunized by suckling from mice fed transgenic potatoes had less diarrhea
than neonates unexposed to the vaccine [14].

The alfalfa mosaic virus was used to produce rabies vaccine in spinach and
tobacco [15]. The experiments progressed to having people eat spinach leaves
(salad) containing the vaccine. Such vaccines with recombinant viral vectors
should have been handled with very great care to prevent the viral vector
from recombining and spreading to infect crops in the field. The rabies
vaccination may be important for wild animals and humans, but problems
associated with oral tolerance or exposure of children in the womb should be
addressed before these vaccines are released to the environment, as the release
could actually increase the spread of rabies.

Transgenic crop vaccines may be useful, but the risks to human health and
the environment are real.

It is imperative that the cultivation and production of pharm crops should
be limited to controlled production facilities such as greenhouses, or better
yet, in plant tissue culture, that prevent environmental release of the
biopharmaceuticals.

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