Biopharm Roulette

November 20, 2002
From <>

Biopharm Roulette

by Brandon Keim

When people think of genetically modified crops, they usually think of
plants that are meant to be eaten. However, to industry insiders, food is
just the beginning. The real money is supposed to be biopharming: the
engineering of plants to produce pharmaceutical and industrial substances.

It might sound futuristic, but a lot is being spent to stake a claim in
what investors hope will be a multibillion dollar industry by the decade's
end, and the people involved aren't about to bother with pesky details like
regulations or public safety. Hundreds of fields of experimental
drug-producing crops have already been planted throughout the nation.
Because these plants contain "confidential business information," they are
planted secretly -- and because the best-kept secrets are hidden in plain
sight, they are planted in the open, unidentified and unsecured.

This mass experiment has been conducted with the cooperation of the U.S.
Department of Agriculture. The USDA rarely visits trial sites more than
once, and sometimes not at all. So far, they've relied primarily on the
"voluntary compliance" of biopharm companies. Voluntary compliance, we all
know, is a business term for virtually unregulated.

Luckily, perhaps, the biopharm industry's veil of secrecy was ripped
spectacularly off last week when newspapers across the U.S. reported that
the Food and Drug Administration had ordered the destruction of half a
million bushels of Nebraska soybeans. The crop had been contaminated by
biopharmaceutical corn which was planted last year in the same field and
unexpectedly sprouted again.

Ever the masters of "the dog ate my press release" school of public
service, the USDA announced the next day that they had burned 155 acres of
similarly contaminated Iowa soybean fields back in September, only they
hadn't told anyone. It was, technically, a surprising admission. Just weeks
ago, USDA officials informed activist groups concerned about the open
planting of biopharmaceuticals that contamination testing hadn't even

Clearly, the USDA decided to reveal what happened in Iowa only after it
became obvious that it could no longer be hidden. As it happens, the rogue
corn in both states was developed by ProdiGene, a Texas-based corporation
whose cavalier attitude towards their technology has long drawn the ire of
environmentalists. Joe Jilka, ProdiGene's vice president of product
development, once the planting methods used in their 85 USDA-approved crop
trials as this:

"The best way to secure it is to grow it just like any other corn. In other
words, the anonymity of it just completely hides it. You know, our TGEV
[pig vaccine] corn was up here by Story City right by the interstate, and
no one could have ever seen it."

Both ProdiGene and the government refuse to identify what drugs or
chemicals so very nearly ended up on dinner tables across the nation.
However, based on ProdiGene's history, it was likely one of four things: an
AIDS vaccine which some researchers think may actually suppress immune
response, a blood clotting agent which causes pancreatic disease in lab
animals, an asthma-inducing digestive enzyme used in pharmaceutical
processing, or an industrial adhesive.

Of course, it could have been something else entirely. All we know is that,
according to the FDA's own press release, the "genetically modified
material" is being studied under an Investigational New Drug application.
In other words, they're still don't know whether it's safe to test on

The USDA's response was insultingly tepid. "The department may consider
revising its rules to lessen the chance of similar problems in the future,"
said Cindy Smith, a senior administrator. "May consider"? "Lessen the
chance"? Exactly what would make the USDA take seriously the fact that
millions of people were nearly fed experimental drugs and chemicals? A few
spectacular deaths, perhaps, or a steady increase in debilitating disorders
that is only noticed decades later, when it is too late? Or, in starkly
economic terms, the loss of even more export markets?

The USDA needs to publicly document every single secret trial crop in the
nation, and demonstrate a genuine commitment to regulating the
biopharmaceutical industry. Until then, there should be an immediate
moratorium on all open-field trials. No commercial gain is worth the risk
that is now being taken, without our permission, with us.

Brandon Keim is the Director of Communications of the
<>Council for Responsible Genetics
Email: <>


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