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Potential for molecular farming slowing down

In 1999, the road ahead for molecular farming, one of the more promising fields
of study in biotechnology, appeared to be boundless. Promising because unlike
glyphosate tolerant soybeans or Bt corn, molecular farming was the branch of
genetic enhancements that would bring medicinal compounds from farmers' fields.

In 2005, that same road has developed some cracks, yet maintains the hope of
'getting back on the road' and realizing some of the potential it held just
six years ago. While six years may not seem like much, it can appear to be an
eternity in the ever-changing world of technology and the shifts in practices
and mind-sets that result. In that relatively brief time span, the scientific
community has recognized certain expectations of the past will go unfulfilled.

To start, molecular farming came to particular prominence in 1999 when London,
Ontario, and its array of medical and research facilities played host to an
international conference. Attendees included researchers, venture capitalists
and biotech company representatives. It was suggested then that corn seeds,
potato tubers and tobacco leaves represented the greatest potential for growing
everything from Interleuken 10 to proteins and antibodies that could pave the
way for interspecies organ transplants.

One step forward…
Since then, however, science has pared the list of prospective plants to just
tobacco as the better growth medium, while various interests, particularly in
Canada, have voiced opposition to interspecies organ transplants, no matter
how critical the need.

Dr. Gordon Surgeoner, president of Ontario Agri-Food Technologies in Guelph,
Ontario, is an avid proponent of molecular farming and greatly supported the
1999 conference in London. He also acknowledges the lost potential that has
resulted from some unfortunate setbacks, particularly by one US company, and
by a public quest for 'no risk' living in the face of many new scientific applications.
From his perspective, the real risks and regulatory costs are endangering progress,
in Ontario or Canada, to the extent that some companies have moved their operations
to countries like China and South Korea.

"The vast majority of people involved in molecular farming are saying,
'we will not put this in a food crop' because of the concerns and the massive
new increase in regulatory oversight," says Surgeoner. The oversight issue
is one that is far-reaching in Canada's agri-food and scientific communities.
"Regulatory oversight has increased so dramatically, people are re-evaluating
how they move their products to market."

Surgeoner points to Texas-based ProdiGene and its troubles with a field of
genetically enhanced corn. The field was planted in 2001 and harvested without
incident. But in 2002, during an inspection by authorities with the US Department
of Agriculture-Animal and Plant Health Inspection Service (USDA-APHIS), volunteer
corn was found growing among soybeans. They ordered the removal of the corn
plants despite not finding any viable seed. The grower, however, failed to remove
all of the plants before the soybean crop was harvested, and APHIS inspectors
ordered the Nebraska storage facility where the harvested crop was found to
hold the shipment. Another field in Iowa suffered a similar fate, with the surrounding
155 acres of crop incinerated, as well.

Regaining lost ground a big step
In the end, ProdiGene was fined US$250,000 and it is these events that Surgeoner
maintains have hurt further development. "ProdiGene didn't properly control
their material and that set the regulatory scene back dramatically. For the
human pharmaceutical side, I believe progress will be seen coming from large
greenhouses, in a tobacco-type plant, but it's not going to be in the big commodity
crops like corn and soybeans," he says, again citing the regulatory costs
as the biggest hurdle. "If I can make money growing tomatoes, surely I
can make money growing human pharmaceuticals and monoclonal antibodies in greenhouses."

Surgeoner acknowledges there are other applications that could benefit from
molecular farming. Industrial uses like refining canola oil into automotive
lubricants by Vancouver, British Columbia-based Linnaeus Plant Science may be
possible in the future. But on the human health side, Surgeoner says too many
people are intent on reducing risk to zero, which is impossible. The other stumbling
block he mentions is the 2005 settlement by US pharmaceutical giant Merck to
pay what could be billions of dollars to patients adversely affected by VIOXX.
The cost for companies to defend themselves against potential legal action will
encourage many to go elsewhere with their research. The ultimate loss though,
will be felt by people wanting those products and willing to take that small
risk. "I think the day will come when I go to get a prescription, I'm just
going to sign a waiver because I'll want that drug!" says Surgeoner, adding
it is his right to make that choice for himself, not have it made by others.

Despite these setbacks, Dr. Jim Brandle, with Agriculture and Agri-Food Canada,
is optimistic about science's progress since 1999. "Research continues
as usual," says Brandle, a plant geneticist and molecular biologist with
AAFC's Southern Crop Protection and Food Research Centre in London, Ontario.
He points to SemBioSys in Calgary, Alberta; Plantigen in London, Ontario; and
Medicago in Quebec City, Quebec; as the three major players in Canada. As for
whether the science or the market for products have advanced, Brandle is unapologetic.
"Of course it hasn't moved as fast we thought it would, but that's typical."

Field crops not an option, but…
Although he agrees that field crops like corn, soybeans or potatoes are not
an option for advancing molecular farming, Brandle says he still believes there
are opportunities for rural communities. "If you think of the way drugs
are manufactured, it's a very controlled situation, and if you're going to do
the same thing with plants, you're going to need the same kind of controls,"
states Brandle, adding that rural areas will still play a part, since that is
where the crops will be grown.

"The relationship with the rural community might be different, it may
be with people who live there and have jobs in these high-tech facilities where
the production, extraction and purification happens. There's still an opportunity,
it just doesn't take the shape that we thought it would."

Brandle agrees with Surgeoner's reasoning about the potential for industrial
uses as well. With industrial applications, there is less need for containment,
controls are fewer and larger acreages are required. "You think about things
like food ingredients or industrial feedstocks like polymers or material you're
making in plants, in those cases, you're going to need major acreage,"
says Brandle.

But on the approach to human health and acceptance issues, he is a little more
optimistic in the long-term, at least where research and development is concerned.
He believes public acceptance of the technology has improved concerning its
use in the manufacture of medicines to help the sick. "Things are moving
forward, of course, the technical hurdles, the regulatory hurdles, they've all
been significant and perhaps underestimated in those early heady days,"
concedes Brandle, adding that it can be a very lengthy process.

"People are learning what the technical limitations of their systems are:
Can you produce enough protein in that system? Is that system going to be safe?
And this is where the food and non-food debate comes in." -30-