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[Fwd: Everything on Genetic Engineering]

Lawrence F. London, Jr.

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A poll released in late January by a major biotech multinational firm
found 93% of U.S. consumers demanding mandatory labeling of G-E foods, with
a majority 54% favoring organic farming.

Splicing Away Regulations
Down on the Animal Pharm

       by Susan Wright

Twenty-five years ago, the first rather clumsy genetic engineering
techniques were immediately recognized as aimed at the molecular basis of
life. The human race had acquired the ability to wreak change on the
"interior" as well as the "exterior" of earth's ecosystems. Doors began to
open to designer bugs able to make a huge range of proteins for the
pharmaceutical and chemical industries, and, further down the road, to
genetic techniques capable of revolutionizing the slow-paced plant and
animal breeding industries and the treatment of genetic diseases.
Government, agribusiness, pharmaceutical and chemical capital has been
moving through those doors ever since.

A quarter-century on, the brave new world of genetic engineering is
populated by some remarkable and disturbing creations. The crassly
utilitarian norms that are guiding innovations have so far produced animals
to be used as factories for producing drugs; cows stuffed with bovine
growth hormone; plants constructed to grow in soil drenched with herbicides
that would normally kill them, as well as every other green thing in sight;
bacteria that chew up materials used in weapons systems; and cross-eyed,
arthritic pigs that yield more meat. What's most disturbing is that the
genetic reconstruction of life is advancing on a global scale with almost
no informed public discussion or effective oversight, and in the case of
certain military uses, without even public knowledge.

At the outset, it was noticed that gene-splicing had a downside. Grave
warnings were issued about its social misuse, about the health and
environmental hazards of modified organisms, about the ethical problems of
using our technical ingenuity on ourselves and other life-forms. In the
course of the debates that followed, millions of pages flowed forth from
committees, hearings, international bodies and the courts. And since all
this happened in the heyday of the photocopying machine and the U.S.
"sunshine" laws, both the controversy and the behind-the-scenes
calculations by leaders of science and industry  were captured in hard
copy. Genetic engineering is perhaps the best-documented technology ever to
emerge from a laboratory.

In the early 1970s leaders of biomedical research quickly moved to contain
the emerging ethical and social issues. A partial moratorium on research in
1974 was followed by the famous international conference at Asilomar,
California, where scientists addressed the hazards of genetic engineering
and agreed to impose controls on their own research. These events were
celebrated as acts of scientific responsibility. But they were also
pre-emptive strikes, demonstrating that control of genetic engineering was
best left in the hands of experts, and defining the problem as one that
only experts could address --that of "containing" possible biohazards. With
that definition, genetic engineers were soon back at work under voluntary
controls issued by the National Institutes of Health in 1976.

When intense controversy over these controls erupted shortly after their
inception, however, biomedical researchers closed ranks, launching a
sophisticated campaign against legislation designed to regulate genetic
engineering and investigate its long-term effects. New evidence unavailable
to the public at the time of these struggles shows that researchers
closeted at the N.I.H. in 1976 decided to conduct a P.R.  campaign aimed at
persuading the public that hazards were exaggerated.

Claiming that science was under attack, they agreed to direct public
attention to the inability of bacteria used for experiments to cause
epidemics -- an argument they knew was simplistic and misleading. In the
words of one scientist: "In terms of P.R., you have to hit epidemics,
because that is what people are afraid of, and if we can make a strong
argument about epidemics and make it stick, then a lot of this public thing
will go away....It's molecular politics, not molecular biology."

The same group also agreed not to pursue experiments to test worst-case
scenarios. Instead, they would do a "slick New York Times type of
experiment" -- one likely to produce negative results that would persuade
reporters that the field was harmless.

Arguments for the safety of genetic engineering created many converts, just
as commercial applications in
the field began to loom on the horizon. In 1977 scientists demonstrated
that bacteria could be persuaded to make a human protein. If this was
possible, why not insulin, growth hormone and supercows making more milk?
At this point, the president of the Pharmaceutical Manufacturers
Association weighed in against regulation: "It is quite possible that
legislation could be so restrictive, so much of a disincentive, that our
people wouldn't lose interest...they would go overseas."

Stunned by the ferocity of the scientists' lobbying effort, soothed by the
public relations campaign issuing from the N.I.H. and intimidated by the
P.M.A.'s threat to move elsewhere, Congress retreated. Concern that the
United States would lose out in the "genetic engineering race" became the
new mantra. Rapid deregulation followed.

Now we are confronting the legacy of our failure to face the issues posed
by genetic engineering. While the techniques have grown in power, precision
and range of application, even the limited regulation that was put in place
has been virtually dismantled. With one or two exceptions for genes
encoding a few o  the most dangerous toxins, pretty much any gene can be
cloned in any organism. Most experiments and industrial processes involving
genetic engineering are overseen only by local committees appointed by the
institution doing the cloning.

Furthermore, the fundamental purpose of the original controls --
containment -- has been overturned. In the Reagan years, the N.I.H.'s
prohibition on the release of genetically engineered organisms into the
environment was replaced by a patchwork of existing regulatory law with
plenty of loopholes. In theory, the Agriculture Department and the
Environmental Protection Agency regulate releases of novel plants and
microbes. In practice, these agencies have already allowed more than 2,000
experimental releases, indicating just how vigorously their "control" is

Moreover, changes in patent law are fueling aggressive efforts to
monopolize novel gene combinations and the living things in which they are
introduced. The landmark 1980 Supreme Court decision in Diamond v.
Chakrabarty established patentability for any living thing "under the sun
made by man." Over the past fifteen years, the Patent Office has taken this
decision to cover cells, microbes, plants, animals -- all living things
except, presumably, ourselves. But who knows? Lawyer George Annas argues
that there's nothing to prevent cloning enthusiasts from pursuing patents
for genetically modified human embryos.

The once-unthinkable idea that a microbe, a plant variety or an animal
breed could be owned has become accepted practice under the patent law of
many industrialized countries. During the recent GATT negotiations, the
United States pressed hard for similar practices in the Third World. All
genes are now  seen as keys to new products. Not only the gene-rich
ecosystems of Third World countries but also the cells and genes of
indigenous peoples are now envisioned as lucrative targets. In the rush to
stake claims on cell-lines and DNA samples, companies and scientists are
committing what the Rural Advancement Fund International calls "acts of
biopiracy," violating the rights of the people and countries from which the
samples are taken. RAFI has launched a campaign to take the issue to the
International Court of Justice at the Hague.

A host of transgenic creatures is emerging from genetic engineering
laboratories. Typically, these creatures are portrayed as benign additions
to the natural world, bringing "better, healthier lives to people," as
Amgen regularly tells the listeners of National Public Radio. Few of
biotechnology's critics would deny that the field will yield some useful
products; Eli Lilly's human insulin and Merck's hepatitis B vaccine already
help millions of people. Crops that can grow in the desert or resist major
pests, and vaccines for diseases like AIDS and malaria, would be
beneficial. Nevertheless, many of the applications prominent on corporate
and military agendas pose explosive social, ethical and environmental
problems. The following is a small sample:

       #164# Transgenic plants. Agrichemical and seed corporations are well on
the way to developing a wide range of transgenic crops and biopesticides.
The most visible are those that will reach supermarkets. Calgene's Flavr
Savr tomato, which can sit on store shelves for extended periods without
turning into mush, made headlines in 1994. But the most lucrative products
are emerging with much less fanfare. Over the past decade, corporations and
the government have poured millions into developing plants and trees that
tolerate the toxic effects of herbicides. According to the Union of
Concerned Scientists, the Agriculture Department has received hundreds of
applications for field trials of these crops. Two of them -- a cotton
resistant to bromoxynil and soybeans resistant to Monsanto's herbicide
glyphosate, better known as Roundup -- have already been approved. The
E.P.A. must also approve any new use of a herbicide. Last year the agency
cleared the way for full-scale commercialization by approving the sale of
bromoxynil for a quarter-million acres of bromoxynil-resistant cotton. In
the pipeline at the Agriculture Department are measures that will weaken
the agency's oversight of trials of transgenic plants and expedite
full-scale approvals.

The agrichemical industry claims that engineering herbicide tolerance will
encourage the use of a new generation of "environmentally friendly"
herbicides. The Biotechnology Working Group, a coalition of environmental,
labor and other organizations, says there's no such thing: Herbicides have
toxic effects on plants and animals; the more they are used, the greater
the likelihood of producing herbicide-resistant weeds, contamination of
water supplies and destruction of wildlife habitats. While producers claim
that their present efforts are limited to resistance to less toxic
herbicides, there is no guarantee they will accept this limitation in the
future. Indeed, many research and development efforts have focused on crop
resistance to high-toxicity herbicides such as 2,4 D and atrazine.

Environmentalists cite yet other worrisome scenarios for transgenic plants;
the truth is, no one is able to predict what might happen in the long run.
But if the past behavior of the National Institutes of Health is any guide,
the Agriculture Department's risk-assessment program is unlikely to
investigate worst-case scenarios or wait years for results before granting

       #164# Animal pharms. Meanwhile, back at the barn, bio-engineers are
turning animals into factories to make drugs in their milk or blood.
They're also making pigs and chickens with flesh that can be easily
microwaved and bovine growth hormone (BGH) to increase milk production in
dairy cows. The latter product has proved particularly controversial.
Consumer organizations in the United States an elsewhere argue that
injections of the hormone cause health problems in cattle, thereby
increasing the use of antibiotics and in turn leaving antibiotic residues
in milk. They also point to the risks of increasing the presence in milk of
insulin growth factor, which stunts growth. And it's not as if there is a
pressing need for milk. Michael Harness of the Consumers Union points out
that, because of the existing milk surplus, taxpayers have spent billions
of dollars over the past decade keeping milk off the market. One may well
ask, Who needs bovine growth hormone? The answer seems to be the four
leading corporations -- American Cyanamid, Eli Lilly, Monsanto and Upjohn
- -- that are promoting BGH worldwide.

       #164# Genetically altered humans. Applying genetic engineering to
faces major technical hurdles. "Humans are not simply large mice," a recent
scientific review states, and the introduction of novel genes to correct
for genetic diseases or cancer is no simple mechanical matter. The human
body tends to reject anything foreign, like a virus carrying a corrective
gene into a diseased cell. Nevertheless, corporations are aggressively
promoting human gene therapy even though no genetic cures are yet in sight.
Researchers are moving quickly to clinical trials, 62 percent of which are
funded by the private sector. The inserted gene, the protein it encodes and
the drugs that make the gene function are all seen as likely commercial
prospects. "Three for the price of one," was the way an editor of an
industry newsletter recently acclaimed the approach.

So far, experimental human gene treatments have been limited to treating
life-threatening diseases. They have also been confined to altering somatic
cells, as opposed to the sex, or germ-line, cells that pass on altered
genes to future generations. But expansion of these horizons is already
foreseen. In 1994, the successful replacement of sperm-forming cells of a
mouse with similar cells from another mouse at the University of
Pennsylvania was hailed as potentially capable of "shaping future
generations." Researchers already talk of treating non-life-threatening
conditions like dwarfism or infertility.

We are approaching the time, perhaps ten or twenty years away, when gene
alteration will be offered as a service. On whom should it be used? For
what purposes? Where should the lines for human genetic interventions be
drawn? No committee outside the N.I.H. has been established to address
these questions. The research-dominated N.I.H., judging from its history,
will insure that the boundaries change in tandem with researchers' shifting
goals. But with so many of those doing research directly in the pay of the
drug companies, who will insure that human needs, not profits, are foremost
in the minds of those who decide priorities for human gene alteration?

       #164# Military applications. After maintaining a low profile for use of
the biological sciences throughout the turbulent 1970s, the Defense
Department quietly initiated military applications of biotechnology in the
1980s. Citing a menacing Soviet biological warfare threat, the department
embarked on efforts to use the new biotechnology to make therapeutic
agents, detection devices and vaccines to protect against biological

Vaccines might sound like a viable form of protection, but in practice they
present huge problems. There are about thirty known biological weapons
agents, and genetic engineering may expand that number almost indefinitely.
The long latency period between vaccination and the body's immune response
and the logistical problems of manufacturing and deploying vaccines pose
further obstacles. Undaunted by the prospect of multiple injections for
U.S. soldiers in war zones and the risks such procedures carry [see Laura
Flanders, "Mal de Guerre," March 7, 1994], the Pentagon aimed vaccines
against more than forty different microbes.

More recently, the military has launched scarier schemes for biotechnology.
On the one hand, "anti-materiel" bacteria are being investigated for their
capacity to degrade militarily significant substances like rubber, engine
lubricants and other critical components of weapons systems. On the other,
novel, opiumlike substances whose minute presence induces sleep, euphoria,
anxiety, submissiveness or temporary blindness are being pursued for their
potential as incapacitants. Genetic engineering offers ways to refine both

In principle, the Biological Weapons Convention and the Chemical Weapons
Convention prohibit recourse to the use of such technologies. The
biological treaty bans development, production and stockpiling of microbes
and toxins made by living things for any weapons purpose. Pursuit of
"anti-materiel" bacteria should therefore be taken as a violation. The
Chemical Weapons Convention, however, allows development of "riot control
agents" for "law enforcement." It is apparently through this loophole that
the Pentagon is pursuing work on novel incapacitants. This year, Congress
approved $36 million for a new, largely secret "non-lethal" weapons

The cornucopia of prizes from genetic engineering projected in the
optimistic 1970s is rapidly becoming a mare's-nest of transgenic creations
that we neither need nor want. Can we reverse genetically engineered
evolution? Not easily, and not without an educated and active public. But
there are models for alternative responses. In pre-Thatcher Britain, a
broadly composed committee that advised the government on genetic
engineering policy moved much more cautiously than its U.S. counterpart,
involving unions in policy-making at the local and national levels. In
India, a well-informed public debate addressing the social impact of
monopolizing life-forms continues. Despite their weaknesses, the treaties
bannin biological and chemical weapons show that harmful technology can be
curbed when people all over the world press for restraints.

It's time for another Asilomar conference, this time led by those at the
receiving end of genetic technology, to take a long look at the genetically
reconstructed worlds being designed by corporations and the military. Or
must we wait for a genetic Chernobyl?

       Susan Wright, a historian of science, teaches at the University of
Michigan. She is the author of Molecular Politics (University of Chicago
Press) and co-author of Preventing a Biological Arms Race (M.I.T. Press). A
recent recipient of a MacArthur Foundation fellowship, her current research
focuses on North-South differences over the development and implementation
of the Biological Weapons Convention.

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