Biopharm Roulette




W

hen
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 is a business term for virtually unregulated.


Luckily,
perhaps, the biopharm industry’s veil of secrecy was ripped
spectacularly when newspapers across the U.S., reported on November
12, 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 happened.


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 Prodi- Gene, 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, described the planting methods
used in their 85 USDA-approved crop trials: “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 Prodi- Gene’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 that 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 press release, the “genetically
modified material” is being studied under an Investigational
New Drug application. In other words, they still don’t know
whether it’s safe to test on people.


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?


The
USDA needs to publicly document every single secret trial crop in
the nation, develop a system to guarantee the containment of genetically
modified crops, and work with the FDA to create a strong, enforceable
regulatory framework. Until then, there should be an immediate moratorium
on all open-field trials. Furthermore, the open-field testing of
plants that produce unapproved substances should be permanently
banned.












Brandon
Keim is director of Communications at the Council for Responsible
Genetics.