Bio-pharming begs closer scrutiny

Original Article: http://www.roanoke.com/editorials/commentary/15313.html

Benjamin K. Sovacool
Sovacool is a graduate research assistant at the Center for Science &
Technology Studies at Virginia Tech.

A recent symposium on the legal and social implications of genetic
engineering held at Virginia Tech underscores the need for more public
debate about transgenic animal research and bio-pharming.

A common misconception is that most genetic engineering in the world
involves large Western corporations and their use of genetically
modified organisms, or GMO, in the production of big agriculture. Such
a belief obscures two important trends in the biotechnology industry
concerning the genetic manipulation of organisms.

First, a majority of the GMO in development are being designed for
industrial, rather than agricultural, purposes. Most biotechnology
research focuses on the creation of enzymes for industrial processes.
Many companies have started to genetically enhance trees to produce
better paper, modify oilseed rape to construct better detergents and
lubricants, and use maize and sugar to make bio-fuel and bio-plastics.

Second, a significant number of biotechnology firms are not
traditionally "Western." China already produces 7.2 million hectares
of genetically modified cotton, and almost a quarter of manufacturing
in India involves the use of GMO.

Moreover, the Australian government has begun using genetically
modified grass to make better golf courses, and New Zealand, Chile and
Japan recently used carrot genes to help produce pest-resistant pine
trees that can flourish in acidic soil.

One type of industrial biotechnology frequently overlooked in
discussions about the dangers of genetic engineering is bio-pharming,
or the genetic altering of plants and animals to produce
pharmaceuticals. For example, early in 2004 regulators at the European
Medicines Agency agreed to consider a new drug, ATryn, to treat
hereditary antithrombin deficiency, a condition that causes deep-vein
thrombosis.

ATryn, manufactured by inserting a human gene for protein into a
goat's egg alongside a beta-caseine promoter, uses a therapeutic
protein derived from the milk of a transgenic goat. When extracted
from the milk, the transgenic protein is indistinguishable from the
antithrombin produced in healthy humans. This is not the only
transgenic pharmaceutical under development. Biotheraptuetics, the
Framingham, Mass., firm responsible for producing ATryn, has 65 other
transgenic drugs in research and development.

The act of using transgenic animals to produce human proteins,
antibodies and hormones is rapidly becoming the new trend in
industrial biotechnology. Nexia, in Montreal, breeds transgenic goats
to provide vaccines against chemical weapons. TransOva, in Iowa, uses
transgenic cows to produce proteins capable of treating anthrax, the
plague and smallpox. Pharming, a company based in the Netherlands,
uses rabbits to create therapeutic proteins to fight Alzheimer's.
Minos Biosystems, in Greece, is researching the drug-making potential
of fruit flies.

Yet such projects may be extremely irresponsible and dangerous.
Ethically, the use of transgenic animal research, by attempting to
create a cheap, easy and quick production line for needed
pharmaceuticals, functionally turns animals into "biofactories." Like
slaughterhouses and chicken farms that use massive industrial
complexes to produce products, bio-pharming facilities raise serious
questions about animal welfare.

Medically, many types of transgenic research are commercially untested
for safety. Combining human and nonhuman proteins is believed to be
responsible for the creation of mad cow disease, which spreads through
prions. One researcher recently admitted to the Economist, "With goat
and cow milk, especially, I worry about the risk of animal viruses and
prions being transferred in some minute way." The chance of
inadvertently creating new strains of diseases is exceptionally high.

Environmentally, both Greenpeace and the Union of Concerned Scientists
are concerned that transgenic animals could substantially alter the
genetic composition of many other species. A transgenic animal could
easily escape into the wild, mate with an indigenous animal and
contaminate the gene pool, triggering all types of unintended
consequences.

In reverse, an animal from the wild could find its way into one of the
pens where transgenic animals are located, make contact and then
escape to expose other animals in the wild.

Despite these concerns, the United States Food and Drug Administration
has issued more than 40 permits this year for bio-pharming field
trials involving the use of tomatoes, potatoes, alfalfa, maize, rice,
lupin, rats, goats and flies. The list of potential products is vast
and includes human albumin and hemoglobin, interferon and vaccines for
hepatitis-B, anthrax, cholera and dysentery.

The rapid rise of transgenic animal research suggests there is a
growing need for more balanced discussions about genetic research.
Because many people believe that human cloning and GMO agriculture
represent significant threats to human health and the welfare of the
environment, other pressing issues connected to genetic engineering
are frequently disregarded. Bio-pharming should be added as one of the
important concerns being raised by the advancement of GMO research,
and should not proceed without intense scrutiny, debate and
regulation.