Fascinating. Thanks for sharing. Joel
At 10:27 AM 7/19/07 -0400, you wrote: >BIO-IPR docserver | http://www.grain.org/bio-ipr >________________________________________________________ > >TITLE: A challenge to gene theory, a tougher look at biotech >AUTHOR: Denise Caruso >PUBLICATION: The New York Times >DATE: 1 July 2007 >URL: http://www.genetics-and-society.org/newsdisp.asp?id=1226 >________________________________________________________ > >New York Times | July 1, 2007 > >A CHALLENGE TO GENE THEORY, A TOUGHER LOOK AT BIOTECH > >Denise Caruso > >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." > >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. > >Innovation begets risk, almost by definition. When something is truly >new, only so much can be predicted about how it will play out. >Proponents of a discovery often see and believe only in the benefits it >will deliver. But when it comes to innovations in food and medicine, >belief can be dangerous. Often, new information is discovered that >invalidates the principles -- thus the claims of benefit and, sometimes, >safety -- on which proponents have built their products. > >For example, antibiotics were once considered miracle drugs that, for >the first time in history, greatly reduced the probability that people >would die from common bacterial infections. But doctors did not yet know >that the genetic material responsible for conferring antibiotic >resistance moves easily between different species of bacteria. >Overprescribing antibiotics for virtually every ailment has given rise >to "superbugs" that are now virtually unkillable. > >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. > >Proteins are the cogs and the motors that drive the function of cells >and, ultimately, organisms. In the 1960s, scientists discovered that a >gene that produces one type of protein in one organism would produce a >remarkably similar protein in another. The similarity between the >insulin produced by humans and by pigs is what once made pig insulin a >life-saving treatment for diabetics. > >The scientists who invented recombinant DNA in 1973 built their >innovation on this mechanistic, "one gene, one protein" principle. > >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. > >In the United States, the Patent and Trademark Office allows genes to be >patented on the basis of this uniform effect or function. In fact, it >defines a gene in these terms, as an ordered sequence of DNA "that >encodes a specific functional product." > >In 2005, a study showed that more than 4,000 human genes had already >been patented in the United States alone. And this is but a small >fraction of the total number of patented plant, animal and microbial genes. > >In the context of the consortium's findings, this definition now raises >some fundamental questions about the defensibility of those patents. > >If genes are only one component of how a genome functions, for example, >will infringement claims be subject to dispute when another crucial >component of the network is claimed by someone else? Might owners of >gene patents also find themselves liable for unintended collateral >damage caused by the network effects of the genes they own? > >And, just as important, will these not-yet-understood components of gene >function tarnish the appeal of the market for biotech investors, who >prefer their intellectual property claims to be unambiguous and >indisputable? > >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. > >"Because gene patents and the genetic engineering process itself are >both defined in terms of genes acting independently," he said, >"regulators may be unaware of the potential impacts arising from these >network effects." > >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 is not the first time it has been asked to do so. A 2004 editorial >in the journal Nature Genetics beseeched academic and corporate >researchers to start releasing their proprietary data to reviewers, so >it might receive the kind of scrutiny required of credible science. > >According to Professor Heinemann, many biotech companies already conduct >detailed genetic studies of their products that profile the expression >of proteins and other elements. But they are not required to report most >of this data to regulators, so they do not. Thus vast stores of >important research information sit idle. > >"Something that is front and center in the biosafety community in New >Zealand now is whether companies should be required to submit their >gene-profiling data for hazard identification," Professor Heinemann >said. With no such reporting requirements, companies and regulators >alike will continue to "blind themselves to network effects," he said. > >The Nature Genetics editorial, titled "Good Citizenship, or Good >Business?," presented its argument as a choice for the industry to make. >Given the significance of these new findings, it is a distinction >without a difference. > >________________________________________________________ > >GOING FURTHER (compiled by GRAIN) > >National Human Genome Research Institute, "New findings challenge >established views on human genome - ENCODE research consortium uncovers >surprises related to organization and function of human genetic >blueprint", National Institutes of Health, Bethesda MD, 13 June 2007. >http://www.genome.gov/25521554 > >GRAIN, "Blinded by the gene", Seedling, Barcelona, July 2003. >http://www.grain.org/seedling/?id=239 > >Barbara A. Caulfield, "Why we hate gene patents", IP Worldwide, 30 >December 2002. >http://www.law.com/jsp/article.jsp?id=1039054490790 > >________________________________________________________ >ABOUT BIO-IPR -- BIO-IPR is an irregular listserver produced by GRAIN. >Its purpose is to circulate news and information about recent >developments in the field of intellectual property rights related to >biodiversity and associated knowledge. BIO-IPR is a strictly >non-commercial and educational service for nonprofit organisations and >individuals active in the struggle against IPRs on life. The views >expressed in each post are those of the indicated author(s). >ARCHIVES -- The full archives are online at http://www.grain.org/bio-ipr. >SUBSCRIPTIONS -- To subscribe or modify your subscription details, >please go to http://www.grain.org/subscribe/bioipr.cfm and either join >or login. 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