A Challenge to Gene Theory, a Tougher Look at Biotech


Richard Moore

Original source URL:

July 1, 2007
A Challenge to Gene Theory, a Tougher Look at Biotech

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 

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 ³tidy 
collection of independent genes² 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 ³to rethink
some long-held views about what genes are and what they do.²

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 ³superbugs² 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, ³one gene, one protein² 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 ³the 
industrial gene.²

³The industrial gene is one that can be defined, owned, tracked, proven 
acceptably safe, proven to have uniform effect, sold and recalled,² 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 ³that encodes a specific 
functional product.²

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 consortium¹s 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.

³The genome is enormously complex, and the only thing we can say about it with 
certainty is how much more we have left to learn,² wrote Barbara A. Caulfield, 
executive vice president and general counsel at the biotech pioneer Affymetrix, 
in a 2002 article on Law.com called ³Why We Hate Gene Patents.²

³We¹re learning that many diseases are caused not by the action of single genes,
but by the interplay among multiple genes,² Ms. Caulfield said. She noted that 
just before she wrote her article, ³scientists 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.²

Even more important than patent laws are safety issues raised by the 
consortium¹s findings. Evidence of a networked genome shatters the scientific 
basis for virtually every official risk assessment of today¹s commercial biotech
products, from genetically engineered crops to pharmaceuticals.

³The 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,² said Professor Heinemann, who writes and teaches 
extensively on biosafety issues.

³Because gene patents and the genetic engineering process itself are both 
defined in terms of genes acting independently,² he said, ³regulators may be 
unaware of the potential impacts arising from these network effects.²

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:

³Both theory and experience confirm the extraordinary predictability and safety 
of gene-splicing technology and its products,² 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

Now that the consortium¹s 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.

³Something 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,² Professor Heinemann said. With no such reporting 
requirements, companies and regulators alike will continue to ³blind themselves 
to network effects,² he said.

The Nature Genetics editorial, titled ³Good Citizenship, or Good Business?,² 
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.

Denise Caruso is executive director of the Hybrid Vigor Institute, which studies
collaborative problem-solving. E-mail: •••@••.•••.

Copyright 2007 The New York Times Company

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