www.checkbiotech.org ; www.raupp.info ; www.czu.cz

Fruits and flowers are not the only things blooming in the tropics. At the
invitation of the U.S. State Department, I presented a series of lectures
and briefings in the Philippines about an exciting advance in agricultural
biotechnology: biopharming - the programming of plants to produce
pharmaceuticals that can be purified or that might even be delivered by
eating the plant material itself, November 2006 by Henry I. Miller.

The early-stage R&D I saw during my travels was astonishing. University of
the Philippines, Manila, Professor Nina Barzaga?The Illustrious Nina, as she
is known locally?has introduced into banana plants the genes that express
potential vaccine proteins for typhoid fever, rabies, and HIV. Dr. Barzaga
and her collaborators intend to process the bananas sufficiently to be able
to standardize the dose, by converting them to dried banana chips, for
example, and then to carry out clinical testing.

As I met with scientists, regulators, agency heads, and senior politicians,
I found that while much of the science is stunning, as in much of the rest
of the world over-regulation is a significant obstruction to progress.

The concept of biopharming is not new. Many common medicines, such as
codeine, morphine, bulk laxatives, and the anticancer drugs taxol and
vincristine have long been purified from plants. But biopharming?s great
promise lies in using gene-splicing or genetic modification, techniques to
make old plants do radical new things. Gene-splicing has been applied to
plants for decades in order to improve their nutritional value and agronomic
traits (yield, pest- and drought-resistance, etc.). The production of high
value-added substances is a logical, straightforward extension.

Biopharming offers tremendous advantages over traditional methods for
producing pharmaceuticals. There is great potential for reducing the costs
of production. The energy for product synthesis comes from the sun, and the
primary raw materials are water and carbon dioxide. And if it becomes
necessary to expand production, it is much easier to plant a few additional
hectares than to build a new bricks-and-mortar manufacturing facility.
(Think Tamiflu, the anti-influenza drug, which is in short supply.)

Finally, vaccines produced in this way will be designed to be heat-stable so
that no refrigeration chain from manufacturer to patient will be required?a
major advance for use in developing countries, especially in the tropics and
throughout Africa.

Biopharmed Products

Approximately two dozen companies worldwide are involved in biopharming,
about half have products in clinical trials, and at least one biopharmed
medical diagnostic is being sold. The spectrum of products is broad, ranging
from the prevention of tooth decay and the common cold to treatments for
cancer and cystic fibrosis. In April, California-based Ventria Bioscience
(www.ventria.com) reported favorable clinical results with two human
proteins biopharmed in rice and used to treat pediatric diarrhea.

There are major, interrelated obstacles to moving these projects through to
commercialization, however. Excessive, unscientific regulation, the bleating
of anti-biotech nongovernmental organizations (NGOs), and shortfalls in
funding all conspire against the projects; worse still, these negative
factors reinforce one another.

Over-regulation makes field trials difficult and hugely expensive to do,
which makes it hard to attract big pharma collaborators or funders. In
addition, the NGOs endlessly wring their hands about risks and point
skeptically (and cynically) to the absence of medical breakthroughs.

Critics of the new technology have made dire predictions of contamination of
the food supply, warning of ?drugs in your corn flakes.? However, the
sophistication of modern agriculture enables us to sequester different crop
varieties when necessary and to cultivate safely the same species of crops
for food and for new pharmaceuticals. Having said that, one must admit that
human error is inevitable, so it is reasonable to ask, What is the
likelihood of consumers? sustaining injury if a few biopharmed plants find
their way into the food supply?

In order for unwanted health effects to occur, several highly improbable
events would have to occur. First, the active drug substance would have to
be present in the final food product?say, corn chips or oil, if the drug
were made in corn, for example ?at sufficient levels to exert an adverse
effect from either direct toxicity or allergy. But there is generally a huge
dilutional effect, as small amounts of biopharmed material are pooled into a
much larger harvest. With few exceptions (e.g., peanuts), even an allergic
reaction requires the presence of more than a minuscule exposure. Second,
the active agent would need to survive milling and other processing and
cooking. Third, it would need to be orally active (usually, proteins are not
because they are degraded in the gut).

The probability that all of these events would occur is extremely low.

To be sure, biopharming, conducted unwisely, could present valid safety
concerns. It would be irresponsible, for example, to produce the antiwrinkle
drug Botox in an edible plant, except under very high conditions of
containment, probably in a greenhouse or screenhouse. The active ingredient
in the drug is, after, all, the highly lethal botulinum toxin (which is safe
when injected under the skin in tiny doses).

One constant around the world is the over-regulation of agricultural
biotechnology, especially biopharming. For example, the regulations of the
U.S. Department of Agriculture impose highly prescriptive standards that
fail to take into account the actual risks of a given situation, but
mindlessly dictate one-size-fits-all, draconian requirements. These include
large buffer zones between biopharmed and other crops; restrictions on
subsequent use of land used to grow biopharmed plants; and the setting aside
of planting, storage, and harvesting equipment exclusively for biopharmed
crops.

Moreover, the USDA has imposed a zero-tolerance for any biopharmed crop in
food - which is unscientific, unrealistic, and unnecessary. (Regulators seem
to have forgotten about the long-established tolerance levels in grains for
unwanted substances such as insect parts, rodent droppings, and harmful
fungal toxins.)

Countries such as the Philippines that lack large, sophisticated regulatory
apparatuses often follow the lead of the U.S. or the United Nations, whose
regulations are lethal to innovation in poorer countries. If you are running
a small-scale but high-quality R&D operation that can?t test its biopharmed
plants in the field because of regulatory obstacles, it is hard to convince
potential commercial collaborators that you are for real.

Biopharming can bring us safe, affordable, innovative solutions to some of
the world?s most vexing health problems, but to harvest its benefits we will
need to inject science and common sense into public policy. If we fail to do
so, biopharming?s development costs will continue to be hugely inflated,
only very high-value-added products will become development candidates, and
consumers worldwide ultimately will see few biopharmed drugs in the
pharmacy. And in the process, the impressive work of people like The
Illustrious Nina will be for naught.

[www.genengnews.com]

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