GENET archive


DRUGS & PHARMACROPS: Down on the pharm

                                 PART I
------------------------------- GENET-news -------------------------------
TITLE:  Down on the pharm
SOURCE: The Guardian, UK
AUTHOR: David Adam
DATE:   30.04.2007

Down on the pharm

A new breed of genetically modified crops could provide cheap drugs and
vaccines for the developing world. Only one problem: what if they get
into the food chain? Environment correspondent David Adam reports on
'pharming', the new GM front line

In a windowless room on the roof of a hospital in south London, the air
is being slowly sucked away. It's not enough to notice, but it keeps the
sealed laboratory at a slightly lower pressure than the air outside.
It's a security measure. The contents of this laboratory are highly
controversial, and if anything escaped it would be a public relations
disaster for the scientists who work here. The lab holds some of the
most controversial plants in the UK, which nearby residents would be
less than happy to find drifting on the breeze through their back
gardens. Open the door, and air rushes in, not out.

The plants are tobacco, but they are not intended to be smoked. Instead,
the scientists who work on them believe they could save lives. Each has
been genetically engineered to carry a gene that is usually found in
common algae. Inside its cells, the foreign DNA forces the tobacco plant
to churn out a protein that is useless to it, but that happens to be a
potent drug against HIV. The scientists say the drug, and others like
it, could save millions of lives across the developing world. The
technique has been dubbed pharmaceutical farming, or pharming, and it is
emerging as the latest battleground in the war over genetic modification.

Britain has rejected GM plants once already - a media and consumer
backlash persuaded most companies there was little market in the UK for
crops that have had their genes tweaked to be resistant to pests or
herbicides. But with pharming the battle lines are less clearly defined,
as protesters who trashed experimental GM corn plants in France
discovered. The crops were making a protein that could be used to treat
cystic fibrosis, and when patient groups angrily denounced the action,
mainstream green campaigners were forced to deny involvement.

To the scientists developing this new generation of GM plants, the
benefits are clear. Conventional ways to make modern medicines are
expensive, which means pharmaceutical companies generally target those
diseases that affect lots of people who can pay. Plants can be grown,
harvested, and the useful medicine purified from them at a fraction of
the price, so using them as leafy drug factories saves a fortune, and
opens the doors to treating people in poorer countries. Advocates say
just 250 acres of GM potato crop could churn out enough hepatitis B
vaccine to protect the entire population of south-east Asia from the
disease for a year.

But there are concerns too. As with GM food crops, there are fears about
whether pharmed plants could breed with wild relatives and disturb the
natural gene pool. They could find their way into the food chain -
potentially exposing people to uncontrolled doses of potent drugs. And
then there is the yuk factor, because the experiments often mingle plant
and human genes. The Daily Mail says there are "serious ethical concerns
about such a fundamental interference with the building blocks of life".

Professor Julian Ma leads the GM tobacco project at the Centre for
Infection at St George's Hospital, in south London, and is responsible
for the plants on its roof. He is passionate about the benefits of
pharming; he insists they could give hope to millions: "The advantages
they offer simply cannot be equalled by any other system. They provide
the most promising opportunity open to us to supply low-cost drugs and
vaccines to the developing world." Other scientists across the world are
growing plants that have been given the genetic instructions to make
antibodies, vaccines against disease such as rabies and hepatitis B, and
dietary supplements.

The HIV drug produced by the London tobacco plants is called cyanovirin-
N, which can help stop the virus entering human cells. Experiments with
rhesus macaques, which have a similar reproductive physiology to humans,
have suggested that the drug could dramatically cut transmission of the
virus during sex, and the St George's team wants to turn it into a cream
that could be applied by women in countries where men are resistant to
using condoms. "If you're a woman in sub-Saharan Africa, you're not
going to pay even a dollar or two a week for this. It has to be pennies,
and that means it has to be produced in plants," Ma says. He reckons
five tonnes of cyanovirin-N would be needed for 10 million women to have
two doses a week - a production scale way beyond the economics and
capabilities of conventional drug manufacturing.

He is frustrated by the attitudes to genetic modification in the UK and
has little time for the "ethical" arguments against placing human genes
into plants because, he says, medicines from GM organisms are nothing
new. Growth hormones and insulin, routinely taken by a million diabetes
sufferers in Britain, are made by adding the relevant human genes to
bacteria and growing the GM bugs in vats to produce the human proteins -
a fundamental interference with the building blocks of life that has
been widely accepted since the 1980s. (Although a minority of diabetes
sufferers do object to GM insulin and request older-style drugs made
from animals.)

"From a scientific point of view there really isn't anything special
about plants with drugs in them," Ma says. "We can't divorce the science
from public attitudes, but life is all about risk assessment and it just
isn't feasible to make enough of these medicines in any other way."

Neither is it feasible to make enough from a few plants on a hospital
roof, which is why the team is also growing the GM tobacco on a Kent
farm, in ultra-secure greenhouses with twin-skin plastic walls strong
enough to resist a hurled brick. Ma says these are the botanic
equivalent of the containment facilities used by microbiologists to work
on biological weapons - a level of security he calls "ridiculous".

Conventional drug manufacturers have shown little interest in pharming
technology. With a few exceptions, the big companies do not smell big
profits in the vulnerable people or regions of the world that would
benefit most. Monsanto, the agrochemical giant behind many GM food
crops, closed down its pharming efforts in 2003. The field is now
largely the domain of university scientists and small biotechnology
companies, several of which have found the financial going too tough and
folded. As a result, progress has been slower than expected and no drug
produced in a genetically modified plant has yet cleared clinical trials
and been given a licence.

When such a medicine comes, it is likely to be in North America, where
opposition to GM technology is milder and transgenic crops such as maize
and cotton are already grown on a massive scale. The California-based
company Ventria Bioscience is developing rice that produces anti-
bacterial proteins found in human breast milk and saliva, and recently
got permission to grow it across 200 acres of farmland in Kansas.
Eventually, the company wants to plant closer to 3,000 acres, which
would give it enough drug to conduct the large-scale human trials needed
before approval for such a medicine would be granted. It says the
proteins in its rice, lactoferrin and lysozyme, could treat children
with diarrhoea, a major killer in the developing world.

To some, this rice-growing on open farmland is a step too far. As Helen
Wallace of Genewatch, a British campaign group, points out: "If they put
these genes into food crops then it is only a matter of time until there
is a mix-up and they get into the food chain." And the US agricultural
system does have a patchy record on keeping GM and conventional produce
separate. Starlink, a variety of GM corn meant only for animal feed,
turned up in taco shells sold as snacks across the US in 2000, and
Prodigene, a Texas biotech company, was fined $250,000 in 2002 for
contaminating a soybean crop with corn engineered to produce an
experimental pig vaccine.

In a statement, the USA Rice Federation, an industry body, said: "If
Ventria's pharmaceutical rice were to escape into the commercial rice
supply, the financial devastation to the US rice industry would likely
be absolute. There is no tolerance, either regulatory or in public
perception, for a human gene-based pharmaceutical to end up in the
world's food supply."

But to the companies developing drugs in plants, food crops such as rice
offer a quicker and cheaper route than alternatives such as tobacco.
They tend to produce more protein and it stays stable for longer - which
means the sensitive medicines do not have to be harvested and processed
immediately. Because of this, corn, soybean and wheat have also emerged
as popular choices for commercial pharming - to the distress of even
previously ardent supporters of GM technology. In an editorial in 2004,
Nature Biotechnology, the traditionally pro-industry science journal,
said: "It seems an industry in which the PhD is the intellectual norm is
either incapable of learning a simple lesson from the past or cannot
bring itself to act appropriately, despite what it has learned
previously ... This position is not anti GM - we should be concerned
about the presence of a potentially toxic substance in food plants.
After all, is this really so different from a conventional [drugs]
manufacturer packaging its pills in candy wrappers?"

New Scientist magazine has repeatedly pleaded with scientists not to
grow drugs in modified food crops, a move it calls "daft". A 2005
editorial said: "Some ideas, no matter how good they look on paper,
should never be tried in practice. One of these is producing drugs or
vaccines in genetically engineered food crops. The risk of these potent
chemicals finding their way into the human food chain is just too high."

To some campaigners, even these statements do not go far enough. They
want a ban on any pharmaceutical plant grown outdoors. "It's important
not to use food crops and it's important not to grow any GM plant out of
containment," Wallace says. "The benefits are still unproven and with
any product designed to have an effect on human health, there could also
be unforeseen side effects."

Ma argues that such a hardline approach means the main benefit of
pharming - scale - will never be fully realised. He says also that
different standards are being applied, purely because the technology is
labelled as GM. While some farmers in Britain grow rape seed for food,
others produce a variety high in a natural chemical called erucic acid,
an additive for the plastics industry. "That is much more toxic that
anything I grow," he says. Of lysozyme, the saliva protein engineered
into Ventria's rice, he says: "If you want to stop that getting into the
environment, you need to stop people spitting in the street."

GM scientists now come armed with a battery of new technologies to stop
cross-contamination from their plants, he adds. These include growing
sterile varieties of the plants, fluorescent markers to identify stray
seeds, and genetic tricks to stop the foreign genes appearing in pollen.
And, unlike GM food producers, the scientists have a strong interest in
keeping their plants isolated. Also, since the aim is to produce
medicine, each step of the pharming process is subject to strict
regulations. "You have to make sure that people don't walk into your
field and have a picnic and mistakenly eat your crop," he says. "But I'm
equally concerned that I don't contaminate my plants with food."

Other companies are soon expected to follow Ventria's lead and request
permission to plant large amounts of pharmaceutical plants outdoors, and
will probably face similar opposition. One enterprising company,
Controlled Pharming Ventures, thinks it has a solution: it has converted
an old limestone mine in Indiana into an underground drug farm. Experts
at nearby Purdue University have already succeeded in producing corn
down there, inside a giant illuminated room.

Others think they can find places sufficiently remote to manage the risk
of cross-contamination to wild plants - in irrigated plots in arid
regions across southern Spain or Africa, for example. The Icelandic
company ORF Genetics is producing antibodies and vaccines inside the
only barley cultivated anywhere on Iceland (the theory being that
whatever it puts in the barley can't jump ship without any other barley
to jump to). But to critics of GM technology, even those safeguards are
unlikely to be enough, because contamination of food supplies could
still occur after the pharma crops have been harvested and processed.
(For example, seeds might get mixed up in a factory.)

So Ma and his pharming colleagues around the world are pinning their
hopes on an unlikely ally: public opinion. Ma says people opposed to GM
crops for food would be much more likely to accept them for medicines
because the benefits to society are so much clearer. "The most important
thing is to get that first product out there, then people will realise
what we can do," he says. Until then, his tobacco plants will remain
locked securely away, swaying only in an artificial, heavily filtered breeze.

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                                 PART II
------------------------------- GENET-news -------------------------------
TITLE:  Plan to plant gene-modified rice alarms interest groups
SOURCE: The New Standard, USA
AUTHOR: Megan Tady
DATE:   27.04.2007

Plan to plant gene-modified rice alarms interest groups

Apr. 27 - A government agency is currently weighing a controversial
proposal to allow a biotechnology company to plant up to 3,200 acres of
rice genetically modified to treat diarrhea.In February, the US
Department of Agriculture (USDA) released an Environmental Assessment on
the company Ventria Bioscience's petition to field test the rice in
Kansas this spring, finding the proposal did not pose threats to the
environment. The public comment period on the Assessment closed last
month, and advocates expect the decision to come soon.

Environmental and food-safety advocates, citing concerns over potential
public health and environmental impacts, urged the USDA to reject the
field-test permitand to impose a moratorium against Ventria conducting
further human experimentation.

The company has introduced modified human genes into the rice in order
to produce the milk proteins lactoferrin and lysozyme under the trade
names Lactiva and Lysomin. Ventria, which has already tested the
genetically engineered (GE) rice on children in Peru, wants to use the
proteins produced by the rice to treat infants suffering from diarrhea.
The company has also proposed to use the protein as supplements in
yogurts, meal-replacement bars and beverages, granola bars and sports
drinks for the general population.

Dr. William Greenough, professor of medicine at Johns Hopkins
University, called the GE rice a "Holy Grail" in a press release put out
by Ventria. "We'd like to have something that both hydrated people and
could shorten the illness [of diarrhea]," he said. "That is what every
mother would want for their child."

The Center for Food Safety (CFS), which released a report this week
about Ventria's GE rice, is concerned that the products could have
adverse health effects. Neither Lysomin or Lactiva have been approved as
safe for human consumption by the Food and Drug Administration. Ventria
is not required to get approval from the FDA, however, which only
monitors genetically engineered plants when manufacturers voluntarily
submit to an approval process.

CFS also worries that pollen from the GE crops, or the plants
themselves, will contaminate surrounding soil and other crops, including
food grown for humans. As reported by The NewStandard last August, a
different strain of GE rice unapproved for human consumption
contaminated US commercial long-grain rice supplies. In March, the USDA
announced another occurrence of commercial rice contamination with GE rice.

"This Ventria trial is particularly a great concern because of these
episodes of widespread contamination of rice with unapproved [GE] rice
variety," Bill Freese, science policy analyst for CFS, told TNS. "What
it shows is that USDA regulation is not nearly adequate or strong enough
to prevent unapproved [GE] crops from getting into the food supply."

The non-profit Union of Concerned Scientists joined CFS in opposing
Ventria's permit request, and called into question the validity of the
USDA's environmental assessment (EA).The EA is used to determine whether
a more in-depth environmental-impact statement is needed, or whether a
permit should be issued.

The Union of Concerned Scientists blasted the EA report, saying the USDA
never considered how weather would impact the potential to disseminate
the GE seeds,failed to consider contamination during seed production and
transport, and did not reveal the acreage of the planting to the public.

In its comments to the USDA in March, the group urged the agency to "ban
the outdoor production of all pharma food crops."

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