6-Regulation: How it happened that the US doesn't regulate biotech
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TITLE: How it happened that we don't regulate biotech
SOURCE: Tidepool, USA, by Donella Meadows
DATE: August 18, 2000
-------------------- archive: http://www.gene.ch/ --------------------
How it happened that we don't regulate biotech
Back in the 1970s the awesome news that scientists had learned how to
redesign genes started a regulatory flurry. Distinguished panels met
to ask imponderable questions. Could some human-created form of life
carry self-multiplying havoc into the world? How can we prevent such
Back then genetic escapes were considered so likely that gene-
splicing research was carried out in sealed labs. The citizens of
Cambridge, Massachusetts, home of Harvard and MIT, forbade such labs
within their city limits. Congress debated dozens of bills to
regulate genetic engineering.
Then, suddenly, the concern disappeared. Genetic engineering became
routine in academia and a hot field of competition in business.
Nowadays scientists and corporations create gene-spliced organisms
and release them into nature with astounding little oversight.
I always wondered how that happened. It's not as if the serious
questions about "genetic pollution" were ever answered. Our ignorance
of the health and ecological and evolutionary impacts of gene-spliced
crops and other products is still enormous. But somehow the biotech
enterprise got a social and regulatory green light. No questions
asked. Full speed ahead.
Why? How? When?
A partial answer to that question has appeared in the July issue of
"Gene Watch," the bulletin of the Council for Responsible Genetics
[http://www.gene-watch.org]. Susan Wright, a science historian at the
University of Michigan, writes about an MIT archive in which she
found the transcript of a fateful meeting that took place in 1976 at
the National Institutes of Health.
Then, as now, the greatest area of concern was microbes. Higher
organisms carry their DNA around in discrete packages inside cell
nuclei. They release genes into the world only under relatively
controlled acts of reproduction. Bacteria and viruses, on the other
hand, slosh genes around in a shockingly messy way.
They pick them up and drop them off, shuffle them, trade them, insert
them into the supposedly organized genomes of higher forms of life.
That's how viruses infect us. It's also one of the ways geneticists
paste genes from one kind of critter into another. First they insert
a snipped-out gene, from a flounder, say, into a virus or bacterium.
Then they use the microbe to smuggle the flounder gene into, say, a
salmon or a tomato.
The problem is that once the gene has been loosened from the
organized flounder into the disorganized microbial world, there's no
telling where it might end up. One single-celled creature could pass
it to another. For all we know, it could end up in a minnow or a
whale or in our own guts.
In 1976 an august committee of NIH virologists was asked to test this
danger. They were to snip out from a virus a gene that causes tumors
when the virus infects mice. They were to paste that gene into
bacteria and then see whether the bacteria could cause tumors in
other animals. If so, it would not only be evidence that some kinds
of gene-splicing might turn cancer into a communicable disease, it
would also be evidence that genes unleashed into microbes could
spread beyond anyone's recall.
The committee debated what kind of bacteria to use in the test.
Scientifically the answer was obvious; you seek out the worst case.
You use bacteria likely to thrive and infect the test animals. But
the virologists had more than science in mind. They worried about
politics, about public controversy, about their own work being
regulated. So they chose to use weakened bacteria that were unlikely
to do harm.
In short, they fudged the test. Here are some of the things they
said, recorded in the transcript of the meeting. "By using known
pathogens, it seems to me we go politically in the wrong direction
even though scientifically it does make more sense." "If we want to
get these experiments done so we can go about our work quickly, maybe
one shouldn't introduce problems of this level." "It's molecular
politics, not molecular biology, and I think we have to consider
both, because a lot of science is at stake."
They wanted "a slick New York Times kind of experiment." But even the
weakened bacteria they ended up using did infect some test animals
with tumors. That result, says Wright, "had the NIH campus buzzing at
So they fudged again. The disturbing results were never published in
a major journal. To the contrary, a 1979 NIH press conference
announced that "this form of research is perfectly safe." The New
York Times reported that "the risks are considerably less than had
been feared." All through the 1980s and 90s, this study was cited as
evidence that bioengineering poses no threats. Only in 1988, at a
meeting of federal regulators, did one of them honestly articulate
our government's actual policy: "If the American public wants
progress, they will have to be guinea pigs."
Next time you hear a scientist asserting that gene splicing is safe,
remind yourself that there is no scientific evidence for that
statement. We are profoundly ignorant about what we are doing to the
code that generates all life. And unfortunately some scientists,
including those entrusted with public safety, are willing to lie.
Donella H. Meadows is an adjunct professor of environmental studies
at Dartmouth College. Her column appears each Friday in Tidepool.
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