THE $73.5 billion global biotech business may soon have to grapple with a discovery that calls into question the scientific principles on which it was founded.
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."...
Because donor genes could be associated with specific functions, with discrete properties and clear boundaries, scientists then believed that a gene from any organism could fit neatly and predictably into a larger design — one that products and companies could be built around, and that could be protected by intellectual-property laws.
This presumption, now disputed, is what one molecular biologist calls “the industrial gene.”
“The industrial gene is one that can be defined, owned, tracked, proven acceptably safe, proven to have uniform effect, sold and recalled,” said Jack Heinemann, a professor of molecular biology in the School of Biological Sciences at the University of Canterbury in New Zealand and director of its Center for Integrated Research in Biosafety. ...
While no one has yet challenged the legal basis for gene patents, the biotech industry itself has long since acknowledged the science behind the question.
“The genome is enormously complex, and the only thing we can say about it with certainty is how much more we have left to learn,” wrote Barbara A. Caulfield, executive vice president and general counsel at the biotech pioneer Affymetrix, in a 2002 article on Law.com called “Why We Hate Gene Patents.”
“We’re learning that many diseases are caused not by the action of single genes, but by the interplay among multiple genes,” Ms. Caulfield said. She noted that just before she wrote her article, “scientists announced that they had decoded the genetic structures of one of the most virulent forms of malaria and that it may involve interactions among as many as 500 genes.”
Even more important than patent laws are safety issues raised by the consortium’s findings. Evidence of a networked genome shatters the scientific basis for virtually every official risk assessment of today’s commercial biotech products, from genetically engineered crops to pharmaceuticals.
“The real worry for us has always been that the commercial agenda for biotech may be premature, based on what we have long known was an incomplete understanding of genetics,” said Professor Heinemann, who writes and teaches extensively on biosafety issues.
Yet to date, every attempt to challenge safety claims for biotech products has been categorically dismissed, or derided as unscientific. A 2004 round table on the safety of biotech food, sponsored by the Pew Initiative on Food and Biotechnology, provided a typical example:
“Both theory and experience confirm the extraordinary predictability and safety of gene-splicing technology and its products,” said Dr. Henry I. Miller, a fellow at the Hoover Institution who represented the pro-biotech position. Dr. Miller was the founding director of the Office of Biotechnology at the Food and Drug Administration, and presided over the approval of the first biotech food in 1992.
Now that the consortium’s findings have cast the validity of that theory into question, it may be time for the biotech industry to re-examine the more subtle effects of its products, and to share what it knows about them with regulators and other scientists.
This fascinating, and potentially consequential article makes reference to one of my favorite expressions (see recent postings on science and religion):
The principle that gave rise to the biotech industry promised benefits that were equally compelling. Known as the Central Dogma of molecular biology, it stated that each gene in living organisms, from humans to bacteria, carries the information needed to construct one protein.
Let me propose a central dogma from my decades in and around bioethics: We think we know more, and understand more fully, than we actually do.
My "central dogma" has this immediate corollary: That goes double when big bucks are involved.
And don't hold your breath waiting for technology companies to volunteer information on potential risks of their products.
But then, I thought Asilomar was a good idea.
Q.E.D.
No comments:
Post a Comment