A must read on biogenetic modifications

[Guest guest]

" Last month, a consortium of scientists published findings that

challenge the traditional view of the way 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,

like a predisposition to diabetes or heart disease.... 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 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. "

 

INTERNATIONAL HERALD TRIBUNE, 3 JULY 2007

The only 'surprise' here is that the scientific community is 'surprised'

by this.

(For more context see *'Quantum bio-physics in living organisms'* - Dec

2001- www.btinternet.com/~nlpwessex/Documents/quantumbiology.htm

<http://www.btinternet.com/%7Enlpwessex/Documents/quantumbiology.htm>).

------

http://www.iht.com/articles/2007/07/03/business/biotech.php

<http://www.iht.com/articles/2007/07/03/business/biotech.php>

*INTERNATIONAL HERALD TRIBUNE*

* *

*Change to gene theory raises new challenges for biotech*

 

By Denise Caruso

Published: July 3, 2007

 

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 the way 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,

like 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

that it will deliver. But when it comes to innovations in food and

medicine, belief can be a dangerous thing. 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.

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

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, " 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 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

Miller, a fellow at the Hoover Institution who represented the

pro-biotech position.

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 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. That means that 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, " 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.

 

*Denise Caruso is executive director of the Hybrid Vigor Institute,

which studies collaborative problem-solving.*

[Guest guest]

Very interesting. This should rattle a few cages.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

May

 

The Best Years in Life (under construction).......

/

http://thecorner4women.com

"Empowering Women Throughout the World"

http://dipetanesoutheast.com

 

 

"robert-blau" <robert-blau ; SymphonicHealth ; oleander soup Sent: Monday, August 20, 2007 12:25:57 PM Fwd: A must read on biogenetic modifications

 

"Last month, a consortium of scientists published findings thatchallenge the traditional view of the way genes function. Theexhaustive, four-year effort was organized by the United States NationalHuman Genome Research Institute and carried out by 35 groups from 80organizations around the world. To their surprise, researchers foundthat the human genome might not be a 'tidy collection of independentgenes' after all, with each sequence of DNA linked to a single function,like a predisposition to diabetes or heart disease.... Even moreimportant than patent laws are safety issues raised by the consortium'sfindings. Evidence of a networked genome shatters the scientific basisfor virtually every official risk assessment of today's commercialbiotech products, from genetically engineered crops to pharmaceuticals.'The real worry for us has always been that the commercial agenda forbiotech may be premature,

based on what we have long known was anincomplete understanding of genetics,' said Heinemann, who writes andteaches extensively on biosafety issues. 'Because gene patents and thegenetic engineering process itself are both defined in terms of genesacting independently, ' he said, 'regulators may be unaware of thepotential impacts arising from these network effects.' Yet to date,every attempt to challenge safety claims for biotech products has beencategorically dismissed, or derided as unscientific. "INTERNATIONAL HERALD TRIBUNE, 3 JULY 2007The only 'surprise' here is that the scientific community is 'surprised'by this.(For more context see *'Quantum bio-physics in living organisms'* - Dec2001- www.btinternet. com/~nlpwessex/ Documents/ quantumbiology. htm<http://www.btintern et.com/%7Enlpwes

sex/Documents/ quantumbiology. htm>).------------ --------- --------- --------- --------- --------- -http://www.iht. com/articles/ 2007/07/03/ business/ biotech.php<http://www.iht. com/articles/ 2007/07/03/ business/ biotech.php>*INTERNATIONAL HERALD TRIBUNE** **Change to gene theory raises new challenges for biotech*By Denise CarusoPublished: July 3, 2007The $73.5 billion global biotech business may soon have to grapple witha discovery that calls into question the scientific principles on whichit was founded.Last month, a consortium of scientists published findings that challengethe traditional view of the way genes function. The exhaustive,four-year effort was organized by the

United States National HumanGenome Research Institute and carried out by 35 groups from 80organizations around the world. To their surprise, researchers foundthat the human genome might not be a "tidy collection of independentgenes" after all, with each sequence of DNA linked to a single function,like a predisposition to diabetes or heart disease.Instead, genes appear to operate in a complex network, and interact andoverlap with one another and with other components in ways not yet fullyunderstood. According to the institute, these findings will challengescientists "to rethink some long-held views about what genes are andwhat they do."Biologists have recorded these network effects for many years in otherorganisms. But in the world of science, discoveries often do not becomepart of mainstream thought until they are linked to humans.With that link now in place, the report is likely to have

repercussionsfar beyond the laboratory. The presumption that genes operateindependently has been institutionalized since 1976, when the firstbiotech company was founded. In fact, it is the economic and regulatoryfoundation on which the entire biotechnology industry is built.Innovation begets risk, almost by definition. When something is trulynew, only so much can be predicted about how it will play out.Proponents of a discovery often see and believe only in the benefitsthat it will deliver. But when it comes to innovations in food andmedicine, belief can be a dangerous thing. Often, new information isdiscovered that invalidates the principles - thus the claims of benefitand, sometimes, safety - on which proponents have built their products.For example, antibiotics were once considered miracle drugs that, forthe first time in history, greatly reduced the probability that peoplewould die from common

bacterial infections. But doctors did not yet knowthat the genetic material responsible for conferring antibioticresistance moves easily between different species of bacteria.Overprescribing antibiotics for virtually every ailment has given riseto "superbugs" that are now virtually unkillable.The principle that gave rise to the biotech industry promised benefitsthat were equally compelling. Known as the Central Dogma of molecularbiology, it stated that each gene in living organisms, from humans tobacteria, carries the information needed to construct one protein.The scientists who invented recombinant DNA in 1973 built theirinnovation on this mechanistic, "one gene, one protein" principle.Because donor genes could be associated with specific functions, withdiscrete properties and clear boundaries, scientists then believed thata gene from any organism could fit neatly and predictably into a

largerdesign - one that products and companies could be built around, and thatcould 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, provenacceptably safe, proven to have uniform effect, sold and recalled," saidJack Heinemann, a professor of molecular biology in the School ofBiological Sciences at the University of Canterbury in New Zealand anddirector of its Center for Integrated Research in Biosafety.In the United States, the Patent and Trademark Office allows genes to bepatented on the basis of this uniform effect or function. In fact, itdefines a gene in these terms, as an ordered sequence of DNA "thatencodes a specific functional product."In 2005, a study showed that more than 4,000 human genes had alreadybeen patented in the United States

alone. And this is but a smallfraction of the total number of patented plant, animal and microbialgenes.In the context of the consortium's findings, this definition now raisessome 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 crucialcomponent of the network is claimed by someone else?Might owners of gene patents also find themselves liable for unintendedcollateral damage caused by the network effects of the genes they own?And, just as important, will these not-yet-understood components of genefunction tarnish the appeal of the market for biotech investors, whoprefer their intellectual property claims to be unambiguous andindisputable?While no one has yet challenged the legal basis for gene patents, thebiotech industry itself has long since

acknowledged the science behindthe question."The genome is enormously complex, and the only thing we can say aboutit with certainty is how much more we have left to learn," wrote BarbaraCaulfield, executive vice president and general counsel at the biotechpioneer Affymetrix, in a 2002 article on Law.com called "Why We HateGene Patents.""We're learning that many diseases are caused not by the action ofsingle genes, but by the interplay among multiple genes," Caulfieldsaid. She noted that just before she wrote her article, "scientistsannounced that they had decoded the genetic structures of one of themost virulent forms of malaria and that it may involve interactionsamong as many as 500 genes."Even more important than patent laws are safety issues raised by theconsortium's findings. Evidence of a networked genome shatters thescientific basis for virtually every official risk assessment of

today'scommercial biotech products, from genetically engineered crops topharmaceuticals."The real worry for us has always been that the commercial agenda forbiotech may be premature, based on what we have long known was anincomplete understanding of genetics," said Heinemann, who writes andteaches extensively on biosafety issues."Because gene patents and the genetic engineering process itself areboth defined in terms of genes acting independently, " he said,"regulators may be unaware of the potential impacts arising from thesenetwork effects."Yet to date, every attempt to challenge safety claims for biotechproducts has been categorically dismissed, or derided as unscientific.A 2004 round table on the safety of biotech food, sponsored by the PewInitiative on Food and Biotechnology, provided a typical example:"Both theory and experience confirm the extraordinary predictability andsafety of

gene-splicing technology and its products," said Dr. HenryMiller, a fellow at the Hoover Institution who represented thepro-biotech position.Miller was the founding director of the Office of Biotechnology at theFood and Drug Administration, and presided over the approval of thefirst biotech food in 1992.Now that the consortium's findings have cast the validity of that theoryinto question, it may be time for the biotech industry to re-examine themore subtle effects of its products, and to share what it knows aboutthem with regulators and other scientists.This is not the first time it has been asked to do so. A 2004 editorialin the journal Nature Genetics beseeched academic and corporateresearchers to start releasing their proprietary data to reviewers, soit might receive the kind of scrutiny required of credible science.According to Heinemann, many biotech companies already conduct

detailedgenetic studies of their products that profile the expression ofproteins and other elements. But they are not required to report most ofthis data to regulators, so they do not. That means that vast stores ofimportant research information sit idle."Something that is front and center in the biosafety community in NewZealand now is whether companies should be required to submit theirgene-profiling data for hazard identification, " Heinemann said. With nosuch reporting requirements, companies and regulators alike willcontinue to "blind themselves to network effects," he said.The Nature Genetics editorial, titled "Good Citizenship, or GoodBusiness?," presented its argument as a choice for the industry to make.Given the significance of these new findings, it is a distinctionwithout a difference.*Denise Caruso is executive director of the Hybrid Vigor Institute,which studies collaborative

problem-solving. *