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[SANET-MG] Tougher Look at Biotech
A Challenge to Gene Theory, a Tougher Look at Biotech - New York Times
http://www.nytimes.com/2007/07/01/business/yourmoney/01frame.html?...
July 1, 2007
RE:FRAMING A Challenge to Gene Theory, a Tougher Look at Biotech
By 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.
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