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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

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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 
a disaster?

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 
[]. 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 
the time."

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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