July 05, 2007

On Tuesday, the Science Times section of the New York Times published a column (op-ed?) by Denise Caruso, who argues that a recent finding by the National Genome Research Institute should cause us to rethink how we regulate products produced through biotechnology.

It is a thoughtful piece and worth reading in full:

"Last month, a consortium of scientists published findings that challenge the traditional view of how genes function. The exhaustive four-year effort was organized by the United States National Human Genome Research Institute and carried out by 35 groups from 80 organizations around the world. To their surprise, researchers found that the human genome might not be a 'tidy collection of independent genes' after all, with each sequence of DNA linked to a single function, such as a predisposition to diabetes or heart disease.

Instead, genes appear to operate in a complex network, and interact and overlap with one another and with other components in ways not yet fully understood. According to the institute, these findings will challenge scientists 'to rethink some long-held views about what genes are and what they do.'

Biologists have recorded these network effects for many years in other organisms. But in the world of science, discoveries often do not become part of mainstream thought until they are linked to humans.

With that link now in place, the report is likely to have repercussions far beyond the laboratory. The presumption that genes operate independently has been institutionalized since 1976, when the first biotech company was founded. In fact, it is the economic and regulatory foundation on which the entire biotechnology industry is built."

Caruso also goes on to say that "evidence of a network genome shatters the scientific basis for virtually every official risk assessment of today's commercial biotech products, from genetically engineered crops to pharmaceuticals."

I must disagree. Until recently, scientists did not understand in depth (and may still not) how many commonly available drugs - from aspirin to oral contraceptives to antidepressants, affect every function of the human metabolism.

And we continue to make additional findings regarding the efficacy and safety of many old and new medicines that were not predicted in advance by scientists or manufacturers. And yet no one would seriously advocate that we do away with these interventions until our knowledge of them was perfect and complete.

While the reductionist view of gene action may be simplistic, it does not follow that we should abandon the intellectual property rights regime that spurs research into gene function, or embrace a precautionary principle - as Ms. Caruso seems to - that we shouldn't market any of these medicines until we have a complete understanding of their effects on the entire human genome.

(Her example of unintended consequences is that of antiobiotics, which have been widely overused, leading to drug resistant organisms -but that development is a social failing of our health care system, not of the medicines themselves or the regulations under which they were approved. Arguably, the shortage of new antibiotics is actually a product of perverse regulatory incentives.)

Caruso's argument is tantamount to saying that we ought not to approve the internal combustion engine, or voting rights for women, until we have a full and complete understanding of their effects on human society and the environment, their net risks and benefits.

The FDA has approved medicines for decades without recourse to sophisticated genome scans, using science that was, by today's standards, relatively primitive. We do not ask for complete safety for our medical products or, for that matter, for any products. We only ask that the risk be reasonable given the use of the product. In this sense, our regulatory system has been remarkably effective.

Of course, the law of unintended consequences remains in effect - as much for biotechnology as for politics or for government regulation. But we shouldn't inhibit innovation out of an excess of caution, like sailors who refuse to voyage into new terriotory because of the monsters that lurk there.

Posted by Paul Howard at July 5, 2007 10:10 AM