Feds Playing Biopharm Roulette

by Brandon Keim

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 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 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 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? 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.