BioWorld Today Columnist

Mid-January's headline, "Biotech boasts bumper harvest amid criticism," led stories about the 252 million acres of globally engineered crops. The news undoubtedly generated much cheering in the boardrooms and labs of Monsanto and its brethren.

But on the 10th floor above the Federal Reserve in San Francisco, a very different discussion was taking place - one about transgenic crops and animals as uniquely challenging risks, able to reproduce and migrate in an uncontrolled manner, and requiring a change in how risk is assessed.

The discussion was driven by Denise Caruso, former New York Times technology columnist, founder of the intriguing Hybrid Vigor Institute and author of the newly released book "Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet" (www.hybrigvigor.org).

Caruso spends the early chapters leading the reader through a cogent explanation of why we can't know or anticipate all possible risks associated with releasing transgenic plants and animals outside the lab. She also makes a strong case for why there are real scientific risks.

I'll let you read the book, rather than try to reproduce all of the information in this short space. Suffice it to say that the chapters are based on scientific papers in peer-reviewed journals, direct conversations with researchers and reports from national agencies around the world.

My biggest surprise was finding that my sister-in-law was right about genetic information from ingested foods showing up in the gut, bloodstream and organs of animals and humans. The implications go far beyond whether the engineered food causes any direct problems, like allergies.

RNAi, the new hot technology, may be the perfect mechanism for bioterrorism - it can survive the stomach and maintain its ability to turn off its target. And it doesn't have to get to humans to cause trouble. An RNA molecule in transgenic corn that by chance changes earthworm digestion could affect their ability to regenerate soil, thus slowing food production.

Ever wonder whatever happened to Dr. Chakrabarty's oil-eating microbe, the first patented engineered life form, designed to convert contaminating oil spills into food for ocean life? The former GE scientist told an interviewer that "the bacteria by itself is nontoxic, but once in the open environment, it can combine with pathogenic elements and show undesirable results" - undesirable enough that GE never brought it to market. "There was no way I could prove its safety and non-toxicity in the open seas."

Bottom line: The potential risks fan out from the intended intervention like Bjork's stadium-covering dress at the Greek Olympics.

Diverse Perspectives Strengthen Decision Making

Caruso's unrelenting focus on showing that our assumptions of risk are probably wrong might lead you to conclude that she is adamantly opposed to innovative technology, or asking for a way to make technology risk-free.

Actually, that's not her point. Rather, she said that ignoring the reality of risk doesn't work, either. While leaving risk analysis in the hands of scientists and mathematicians generates a very precise answer, it's probably aimed at the wrong question as they focus on a subpopulation of the potential risks and benefits.

The key, Caruso said, is to broaden the discussion to include all those parties who are interested and affected, which means moving beyond the trade associations, company executives and shareholders.

We need to accept that our science, once commercialized, has political and social implications. Those groups affected must add their perceptions to the analysis.

We also need to accept that our fabulous technology gets used in the real world, where people don't take drugs as directed, perfect maintenance of equipment doesn't happen and the unexpected implications often outweigh the anticipated value.

The benefits of that inclusive approach: stronger, broader support for those technologies that emerge from the process, and a reduction in the potential long-term damage done to companies, people and economies by unanticipated consequences.

Unintended Outcomes

Our industry is full of recent examples of unintended outcomes with huge impact - think Vioxx, Phen-fen and Tysabri.

Industry analyses usually focus on market opportunity, competition, regulatory hurdles, timeframe and cost, marketing challenges and generating sufficient margins to keep investors happy. It's tougher to anticipate all potential biological, political and social implications.

What happens when you start to add in questions about how the product might be used in the real world? It's easy to miss scenarios if you don't ask folks outside your in-house team.

The recent FDA public health advisory on antidepressants and potential suicide risk in kids did not recommend avoiding those drugs, but rather scheduling more frequent follow-up visits to detect any problems. The risk was very low (4 percent versus 2 percent for placebo), and the benefit of treating depression was very clear.

What happened? Prescriptions for children and adolescents dropped 25 percent, with no improvement in follow-up care.

That contrarian response was driven, in part, by parents losing confidence in the information coming from drug companies and the FDA after reading that GlaxoSmithKline and others hid evidence of potential problems.

Censorship of technology challenges is not unique to the biopharma industry, or the business world. The U.S. government has a reputation for taking a whimsical approach to ignoring data that don't support its desired conclusions.

The net affect: People don't trust information and decisions to be objective and rational. And believe me, this is not a problem solved by increasing the number of Democrats in public office.

Denial Reduces EPS

Caruso's book really is about how denial (based on fears of lost revenue) can lead to poor business decisions and bad outcomes - far worse than the original fears.

Biopharma to date has refused to admit publicly the potential risks associated with its business, whether it's technological risk or the impact of high cost. The industry has a long history of excluding "interested and affected" parties even from our conferences.

The pressure is building, as corporate America teams up with other stakeholders to pressure Congress on health care. Our industry is in real danger of losing the chance to participate fully in the design of the future of its own business.

Society does have the right to reject even the most compelling innovation. Society may not be particularly interested in your drive to use innovation primarily to grow shareholder value. But it is very interested in the potential of that innovation to impact the environment, our food and the social fabric.

Either our industry participates fully in discussions that include the broad array of "interested and affected" folks, or it will find that non-optimal regulations are imposed upon it.

Robbins-Roth, PhD, founding partner of BioVenture Consultants, can be reached at biogodess@earthlink.net. Her opinions do not necessarily reflect those of BioWorld Today.