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Articles from international sources

February 2004

• Genetically Engineered DNA Found in Traditional Seeds - Study Has Implications for Trade, Organic Agriculture, Human Health in food and environment. By Union of Concerned Scientists, USA. February 23, 2004.
• Empty promises. By Hilary Chiew, February 27, 2004
• New rules on GMOs adopted. By Koh Lay Chin and Farrah Naz Karim, Feb 27, 2004
• Is Biotechnology Losing Its Nerve? By ANDREW POLLACK, New York Times, February 29, 2004

Genetically Engineered DNA Found in Traditional Seeds - Study Has Implications for Trade, Organic Agriculture, Human Health in food and environment. By Union of Concerned Scientists, USA. February 23, 2004.

(http://www.ucsusa.org/food_and_environment/biotechnology/seed_release.html)

Washington, D.C.-The Union of Concerned Scientists today released a groundbreaking pilot study that found genetically engineered DNA is contaminating traditional seeds of three major U.S. crops. Seed contamination, if left unchecked, could disrupt agricultural trade, unfairly burden the organic industry, and allow hazardous materials into the food supply.

This study shatters the presumption that at least one portion of the seed supply-that for traditional varieties of crops-is truly free of genetically engineered elements," said Dr. Margaret Mellon, Director of the Food and Environment Program at UCS and an author of the new study, Gone to Seed: Transgenic Contaminants in the Traditional  Seed Supply. "The traditional seed supply is an agricultural treasure that must be preserved. The government should immediately follow up this study to determine the extent of contamination and the steps needed to protect this treasure."

The pilot study by UCS is the first to examine systematically whether genetically engineered (GE) crop varieties now widely adopted in the United States have contaminated the seed supply for crop varieties presumed not to contain GE elements. The seeds tested in the pilot study were for traditional varieties of corn, soybeans, and canola that have no history of genetic engineering. The tests were conducted for UCS by two commercial laboratories employing sensitive techniques capable of detecting specific sequences of DNA. The degree of concern to attach to seed contamination depends on many factors, including the nature of the genes that are contaminating the seed supply and the levels at which they occur. That information awaits the further, more comprehensive tests recommended by UCS in its report.

However, the study released today suggests that contamination is pervasive, especially in canola where one laboratory found six of the six traditional varieties tested contaminated with GE elements.

Most of the specific DNA sequences tested for in the study are found in popular GE varieties currently on the U.S. market. But there is no reason to believe that engineered DNA sequences detected in the study are the only ones moving into the traditional seed supply.

"Until we know otherwise, it is prudent to assume that engineered sequences originating in any crop, whether it was approved and planted commercially or just field tested, could potentially contaminate the seed supply," said Dr. Jane Rissler, a plant pathologist at UCS and the report's co-author. "Among the potential contaminants are genes from crops engineered to produce drugs, plastics, and vaccines."

Serious risks to human health could result if genes from pharmaceutical and industrial crops contaminate the seeds for food crops at a significant level. "Because growers and processors would not be aware of the contaminants, they would inadvertently sell them for food use-a back door to the food supply that must be closed," said Mellon.

The materials needed to detect such genes in molecular tests are not publicly available; therefore, it was not possible for UCS to test seeds for sequences from so-called "pharm crops." However, the report urges prompt action to protect seed production from these sources of contamination.

In addition, seed contamination makes it more difficult for U.S. exporters to assure Japan, South Korea, the European Union, and other export customers that grain and oilseed shipments do not contain unapproved GE crop varieties and to supply commodity products free of engineered sequences. Seed contamination also places an unfair burden on organic food production, an increasingly important sector of U.S. agriculture. Organic farmers depend on traditional seed varieties to meet organic standards and consumer demand. The contamination of traditional seeds hampers their ability to find the GE-free seed they need.

The UCS study is too limited to provide a reliable estimate of the levels of contamination across the seed supply. However, the data obtained in the study suggest a range of roughly 0.05 to 1% in the seeds tested.

Calculations done as part of Gone to Seed illustrate that even a level as low as 0.1% could translate into hundreds of tons of contaminated corn and soybean seeds inadvertently planted on U.S. farms, or the equivalent of over 55,000 50-pound bags of seed.

"We must confront the reality of seed contamination now," said Rissler. "Not only must we worry about genes in approved varieties but we must be concerned about hundreds of other genes that have been field tested but whose identities are unknown to the public in many instances. Heedlessly allowing the contamination of the seed supply to continue may cause problems which cannot be easily remedied."

"While not completely reversible, with sufficient political will it is possible to look forward to
sources of seeds that are substantially free of genetically engineered sequences," Mellon added. "But the government must act now."

UCS recommends eight steps to address seed contamination, including a government-sponsored, full-scale investigation into the extent and causes of seed contamination. The United States Department of Agriculture should also establish a reservoir of non-engineered seeds for major food and feed crops.

The new report is located here. Formed in 1969 at the Massachusetts Institute of Technology, UCS is a nonprofit partnership of scientists and citizens combining rigorous scientific analysis, innovative policy development and effective citizen advocacy to achieve practical environmental solutions. UCS advocates evaluation of the risks and benefits of and alternatives to agricultural applications of biotechnology.

(http://www.ucsusa.org/food_and_environment/biotechnology/seed_release.html)

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Empty promises. By HILARY CHIEW, February 27, 2004

HILARY CHIEW writes on the Argentine experience in which the introduction of genetically-modified soya created havoc in the nation's agricultural and dairy industries . 

KNOWN for its vast pampas with cows grazing on the pasture, Argentina has a long history as a beef and dairy producer. Indeed, that is now history.  

Gone are the pastures and happy ranchers as many farmers have converted their farmland to cultivate a new brand of crop - the Round-up Ready (RR) soya, a herbicide-tolerant plant, in 1996. 

With promises of lower cost, less maintenance and reduced use of agro-chemicals that had caused a host of environmental problems such as soil and water contamination, the farmers were, understandably, eager to try out the high tech crop. 

That was how GM crops were introduced to Argentina. Agronomist Adolfo Boy says the switch to GM crops failed to deliver the good life.  

Instead it has eroded the fundamentals of food sovereignty of Argentines - farmers have grown dependent on GM crops, fail to save their farm seeds and the environment has been further degraded. 

"We are not in a crisis. We are heading towards a catastrophe," cries Boy who has observed and documented the advent of GM crops into his country. 

According to the founding member of the Network for a GE-Free Latin America, prior to the introduction of Monsanto's RR soy, Argentina was already producing soya for the Chinese oil market since the 1970s. 

However, when Monsanto introduced its transgenic soya, the area planted with soya doubled from seven million ha to 14 million ha and production jumped from 13 million to 37 million tonnes. 

The increased production came at the expense of deforestation and the disappearance of traditional agricultural models that are increasingly being acknowledged as the foundation for a sustainable future. 

"As the area under cultivation expanded, the first effect was the abandonment of the mixed farming systems upon which sustainability was based - the rotation of crops and cattle which helps soil fertility to recover and provides security in the long run. 

"Then, fences, mills and ranching structures were gradually removed. The land entered into a process of permanent crop production, in lots comprised of several small to medium-sized farms in the range of 50 to 100ha," he recalls. 

A country that used to be able to feed its population has redirected its agriculture to export-oriented production, thus neglecting the need to take care of hunger back home. 

"Argentines do not use soya oil, we use sunflower oil. Products for local consumption were abandoned for RR soya," says Boy, noting that traditional corn, rice, lentil and dairy production were all sidelined. 

While soya production grew by 74.5% between 1996 and 2002, official figures show decreases in the area sown with the following food crops: 44.1% for rice, 26% for corn and 3.5% for wheat. 

Highlighting the irony of the short-sighted agriculture policy manifested in the dairy sector, Boy says dairy exporters were reduced from 30,141 in 1998 to 15,000 in 2002. "RR soya domination was so acute that it now reaches the point where Argentina is importing milk from Uruguay." 

Boy also points out that GM crops are a technology for large farms under the pretext of economy of scale, hence promoting the concentration of land in the hands of a few that leads to migration to the cities. 

"It has generated unemployment and the migration of more than 250,000 rural families in the last 14 years largely because their land has passed into the hands of financial institutions that prefer the 'farming pools' method and concentrate millions of hectares into soya production. 

"These contractors own bigger and faster machines, resulting in severe erosion of the fertile pampas," says an exasperated Boy. 

Reduced food production has plunged Argentina into a state of hunger and is breeding contempt for the government and social unrest. 

Disputing the seed industry's sales pitch that GM crops require less herbicide, Boy says farmers are using more than one herbicide with the introduction of RR soya. In fact, the quantity has increased and more toxic herbicides have to be used to control weeds that are getting hard to eradicate - a sign of growing resistance. 

According to the Friends of the Earth report entitled Genetically modified crops: a decade of failure (1994 - 2004), released at the COP-7 meeting in Kuala Lumpur, in 2001 alone, more than 9.1million kg of herbicide were used for GM soy in comparison with non-GM plants. The use of glyphosate herbicide doubled from 28 milliion litres between 1997-98 to 56 million litres in 1998-99 and reached 100 million litres in the 2002 planting season. 

It noted that weed resistance has prompted the use of highly toxic herbicides with RR soy, and farmers have started using herbicides that are banned in developed countries like atrazine and paraquat. 

RR soya is genetically-engineered to tolerate the spraying of herbicide, thus allowing the use of glyphosate.  

He says without patenting the RR soya in Argentina, farmers multiplied their seeds and thus flooded their fields with RR soya.  

Farmers were engaged in a well-known traditional practice called "brown-bagging" whereby they save the seeds for the next planting season to reduce their costs. 

However, the transgenic soya was patented in 2000 following complaints from American farmers who were paying US$20 (RM76) per kg of seed as opposed to US$12 (RM45.60) per kg paid by their Argentine counterparts. Hence, it is now illegal for farmers to save their seeds in the field and they face the risk of prosecution. 

Boy also challenges the apparent cost-saving advantage from the reduction in herbicide use as claimed by the seed industry. The lowered cost, he reveals, was due to the import of Chinese-produced glyphosate that was far cheaper and resulted in 50% reduction of herbicide costs for the farmers. 

Again, this savings will not be for long as Monsanto has sought legal redress against the dumping of glyphosate by Chinese producers. 

"Let Argentina be a warning to others. We are going down the path of destruction," warns Boy. 

Asia, he says, will suffer more as it has much more diverse biological resources that risk being destroyed by GMO contamination. 

His colleague, Dr Lilian Joensen, who is also a molecular biologist and researcher with the Ministry of Health of Argentina, notes that as the industry seeks to expand the cultivation of RR soya, more forests are cleared to make way for this monoculture. 

Describing the situation as total madness, she says: "My government doesn't seem to have the political will to turn back from this path. And it looks like we have to contend with more adverse consequences from GM crops." 

And there seems to be no way out as there is so much at stake for Argentina. It is the second largest exporter of GM crops after the United States. 

Despite the mayhem back home, the Argentinean government is negotiating at the first meeting of the Cartagena Biosafety Protocol in the same group of countries dubbed the Miami Plus Group that is reportedly trying to weaken the liability and redress regime that is suppose to be established by 2008. 

At the rate contamination by GM crops is raging around the world, one wonders if four years is not too long a wait to have an international liability and redress regime to address the problems created by the introduction of transgenic crops in just under a decade.

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THE 87 member countries of the Cartagena Protocol on Biosafety adopted yesterday the “newborn” international rules for documentation requirements and other procedures to promote the safety of global trade in living modified organism (LMO) or genetically modified organisms (GMO). This would pave the way for the implementation of a new operational and practical legal instrument that provides higher protection against adverse effects of GMOs, but does not impede trade.

Science, Technology and Environment Minister Datuk Seri Law Hieng Ding said this at the end of MOP1, or the first meeting of the Parties of the Cartagena Protocol on Biosafety, at the Putra World Trade Centre yesterday.

Under the new system, documentation accompanying all bulk shipments of genetically engineered crops intended for food, feed or processing are to be identified as "may contain LMOs", and should indicate the contact details of the importer, exporter or other appropriate authority.

A group of experts will meet over the next year to further elaborate the documentation and handling requirements for these bulk agricultural shipments.

Key issues still to be resolved include the percentage of modified materials these shipments may contain and still be considered GMOfree, and the inclusion of any additional detailed information. A decision will be considered at the next meeting, to be held in 2005.

Agreement has also been reached on more detailed documentation requirements for those GMOs (such as genetically engineered seeds and fish) that are meant to be introduced directly into the environment. Their shipments should be clearly identified as "destined for contained use".

The documentation should specify the common, scientific and commercial names of the modified organism, the transformation event code or unique identifier code, any handling and storage requirements, contact details in the case of emergency, and how the GMO is to be used.

Law, who is also the convention's president, said the meeting also adopted procedures and mechanisms for promoting compliance with the protocol and assisting countries in cases of non-compliance.

To make the execution of the protocol effective, a 15-member compliance committee will submit regular reports and recommendations to the governing body of the protocol.

A negotiating group of legal and technical experts on liability and redress for damages resulting from transboundary movements of GMOs was also launched, and had been asked to develop a regime by 2008. Meanwhile, protocol executive secretary Hamdallah Zedan said with a system for identifying and labeling GMO exports, countries could enjoy the benefits of biotechnology with greater confidence while avoiding the potential risks.

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Is Biotechnology Losing Its Nerve? By ANDREW POLLACK, New York Times, February 29, 2004

(http://www.nytimes.com/2004/02/29/business/yourmoney/29biotech.html?ex=1079069500&ei=1&en=daa337be15239edf)

AS a founder of four biotechnology companies, Dennis A. Carson can practically write an encyclopedia entry on risk. After all, his first start-up, a gene therapy and vaccine company called Vical, still does not have a product on the market after 16 years and more than $100 million spent.

But now Dr. Carson, who is also the director of the cancer center at the University of California at San Diego, is playing it safe, or at least safer. Rather than develop radical new technology or invent new medicines, his latest venture, Salmedix, plans to sell drugs licensed from other companies - drugs that are already on the market or that have at least gone through some clinical trials.

"We sat back and said, 'We're not going to be successful starting another company if it's going to take 15 to 18 years,' " said David S. Kabakoff, the chief executive of Salmedix. "The only way to do it in half the time is you have to start somewhere in the middle."

Many other biotechnology companies also appear to be taking fewer chances lately - to the point that the industry seems to have lost its nerve, some experts say. The worry, of course, is that their increasingly chary approach to innovation will mean fewer breakthrough drugs.

Biotechnology companies were once known for going boldly where the big pharmaceutical companies would not, developing genetically engineered medicines like Avastin, the Genentech drug, approved on Thursday, that attacks cancer by a new method and prolongs the lives of patients. Biotech ventures also plunged into experimental areas, like gene therapy and stem cell research, that have not yet paid off and perhaps never will.

But more and more start-ups now seem focused on scrounging around for existing drugs to license, often castoffs from big pharmaceutical companies. In doing so, fledgling biotech companies avoid the toil and risk of trying to discover a new cause of disease or a new compound. Some of the newer biotech companies do not even have laboratories.

"I don't know of a venture capitalist today who is willing to put significant percentages of his fund's money into de novo discovery companies," said Roger Longman, co-publisher of the medical business magazines In Vivo and Start-Up. "Instead, the real model is, 'How can I get to a product quickly, without doing all of that early biology and chemistry?'"

Most drug development companies that are planning initial public offerings fit that mold. Of the 23 companies that filed late last year to go public, for instance, 14 licensed their lead product after it had been put into clinical trials by another company, and two licensed products already on the market, said Arthur J. Klausner, a general partner at Domain Associates, a venture capital fund for health care enterprises that is based in Princeton, N.J.

What is behind the shift? Mr. Klausner and others point to a change in the investment climate. It was once possible to raise money from public investors years before products were on the market, thus providing an early return to venture capitalists. But after biotech stocks peaked in 2000 and then receded, taking such early-stage companies public has been tough.

So venture capitalists, not wanting to wait 10 or more years for a return on their investments, are backing companies that can move products to market faster. That often means developing a drug neglected by another company or finding a new use for or a new way of delivering an existing drug. The industry buzzwords are no longer "monoclonal antibodies" and "genomics" but "reformulate" and "repurpose."

"It's very hard to do a soup-to-nuts company anymore, or what we call molecule-to-market," Mr. Klausner said.

A decade ago, for instance, his firm helped finance Trimeris, the company that tapped university research to develop Fuzeon, the first of a new class of AIDS drugs. Today, a more typical start-up backed by his firm is Somaxon Pharmaceuticals, a venture based in San Diego that hopes to market a sleeping pill that contains a low dose of an existing drug that has drowsiness as a side effect.

"I hope we do something as exciting as Trimeris today," Mr. Klausner said, "but we do it on an exception basis."

NO one disputes that licensing can save time and money. Drugs that have already gone through clinical trials have at least been shown to be basically safe, so the preliminary stages of formulating a drug or testing it in animals can be skipped.

Consider Dr. Carson's company, Salmedix. Based in San Diego, it is less than three years old and has raised only $22 million, but it already has three drugs in clinical trials. One is a cancer drug, sold by a company in Germany, that must be tested before entering the United States market. Another, also a cancer drug, failed when tested by others - but Salmedix has a diagnostic test that its executives say will pinpoint which patients the drug will benefit. The third is derived from an existing anti-inflammatory drug that company scientists discovered serendipitously had an effect against cancer.

"Studies of older drugs in patients can give you information you can't get from studies in the mouse,'' Dr. Carson said.

But while retooling older drugs can result in useful products, some experts say the practice is not likely to produce home runs and could slow innovation. "We're really doing therapeutics around the edges" rather than attacking head on, said one venture capitalist, who spoke on condition he not be identified because he did not want to discourage entrepreneurs from approaching his firm.

"We're doing things like niche indications, new uses for old drugs, out-licensing of products," he said. "There's a fair question: Where's all the new stuff going on?"

Indeed, university officials say it is becoming harder to license their discoveries to young companies, or for professors to get backing to start new companies. Stanford and the University of California campuses in San Francisco and San Diego - which together gave birth to much of the state's biotechnology industry - have teamed up with SRI International, a research institute, to do early drug testing themselves, a move that would remove some risk from companies.

Mark G. Edwards, managing director of Recombinant Capital, a company that tracks drug licensing deals, said that biotech companies had licensed some 500 products from big pharmaceutical companies but that "none of the top 30 selling drugs of the biotech industry have come from that route."

The recycling trend could also hamper pharmaceutical giants. To fill their depleted product pipelines, large companies have increasingly turned to smaller ventures for drugs and research techniques. Now they often find themselves in competition with biotech companies, which are themselves looking for products to license from rivals. And the suppliers of research techniques have also shifted to developing drugs.

"All of these heretofore distinct needs can't be met anymore because everyone's chasing the same products," said Ginny E. Llobell, vice president of Defined Health, a pharmaceutical consulting company in Millburn, N.J. "The whole complex of everyone running to the same side of the boat is not sustainable."

With thousands of biotech companies out there, no one is suggesting the end of innovation. For instance, several companies were formed recently to pursue RNA interference, a promising new method of treating diseases by turning off genes.

Mr. Longman, the magazine publisher, said that many of the companies working with existing drugs were innovating, though not in the traditional sense of finding a molecule in the body that could serve as a target for a drug, or designing a drug to hit that target. "It's expanding the definition of innovation to what it should be," he said, "not limiting yourself to the belief that innovation is merely a new target, new compound, new medicine."

Consider Hypnion, whose innovation is a new way to test whether a drug is good at inducing sleep. But rather than screening new compounds, the company is testing existing drugs that it can tweak. "Take a drug that has a sleep side effect and is used for some other disease,'' said Dale M. Edgar, chief scientist and co-founder. "That's your starting point.'' Hypnion, based in Worcester, Mass., put a drug into a clinical trial in 18 months, rather than the usual three or four years.

THEN there is CombinatoRx, a start-up in Boston. The company is pursuing the possibility that existing drugs, used in combination, are effective in a way that the single drugs are not. It has set up a robotic system that systematically tests all 2,000 existing chemical drugs in combinations of two. The company, now four years old, has already started clinical trials of three combinations. It found, for instance, that a sedative and an antibiotic - both of which have been around since the end of World War II - showed, in combination, some effectiveness against cancer. "Those things have been around for two generations, but no one's ever used them together to treat cancer," said Alexis Borisy, co-founder and chief executive. "How is that not innovation?"

Specialty pharmaceutical companies, like Forest Laboratories and King Pharmaceuticals, have long licensed drugs from pharmaceutical giants that had decided not to develop them. Such companies were largely considered separate from the biotechnology industry, but now the distinction is blurring as venture capitalists who back biotech companies invest in this licensing approach.

"I see one or two business plans a week" from companies seeking to license someone else's drug, said Brian G. Atwood, a managing director at Versant Ventures in Menlo Park, Calif.

Several factors are pushing the trend. As big pharmaceutical companies have become even larger, they have concentrated on drugs with blockbuster potential rather than devote time to drugs with smaller markets. But for a small company, a crumb from a pharmaceutical giant can look like a feast.

Moreover, as big companies have merged, overlapping projects have been cut. Some companies have decided it is better to get a return on these redundant or minor drugs by letting someone else sell them in exchange for a payment or royalties.

Also fueling the recycling trend are the problems of companies involved in genomics, the technology that prompted an investor frenzy four years ago. Genomics companies were formed to find disease-related genes or to provide services and technology to drug companies.

But investors did not buy in as expected, and major pharmaceutical companies have found the payoff from genomics to be slow. "There was a clear message from Big Pharma that they did not want to buy research assets anymore," said Charles M. Hartman, general partner of CW Ventures in New York.

As a result, virtually every service and tool company is shifting to developing or licensing drugs. Millennium Pharmaceuticals, a leader in genomics, has no drugs in clinical trials resulting from its own gene hunting. Neither do big drug companies like Bayer and Abbott Laboratories, which paid hundreds of millions of dollars to tap into Millennium's expertise. A payoff may still come, but in the meantime Millennium is using the money from the deals to buy a pipeline of products. Its two drugs on the market, and all the ones in clinical trials, have come through acquisitions or licensing.

Even companies trying to discover new drugs have felt pressure to license products that are already on the market, or close to it. While those products generate revenue, the company can go about the longer process of developing novel products. For instance, Exelixis provided some of its genomics expertise to Bristol-Myers Squibb and, in return, got a cancer drug already in clinical trials. That drug has become its lead product.

Other companies have successfully licensed and then resurrected drugs that other companies passed up. Sales of Angiomax, a cardiovascular drug, are increasing at the Medicines Company, which picked up the product after it was dropped by Biogen and then passed over by many other companies.

INDEED, some drugs initially dropped by one big pharmaceutical company can end up at another after going through a smaller company. Indiplon, a sleeping pill that is now in the final stages of clinical trials, was licensed by the company now known as Wyeth to Dov Pharmaceutical, which then sublicensed it to Neurocrine Biosciences. Neurocrine in turn sold the marketing rights to Pfizer for $100 million up front, and possibly much more later.

Some analysts and executives, however, say the specialty pharmaceutical business has limits. For Big Pharma, licensing a neglected drug to a smaller company may produce only modest royalties. And biotech companies that find new uses for old drugs may have trouble protecting themselves from competition, particularly from generic versions. Moreover, the specialty pharmaceutical business is becoming mighty crowded. Some experts say that there are just not enough compounds to go around.

For that reason, some venture capitalists say investment in companies that recycle drugs will eventually wane. In a sense, it has to. Unless new drugs are invented, there won't be any to recycle.

As Drew Senyei, general partner of Enterprise Partners in San Diego, said, "At some point you are going to run out of late-stage companies, and the question is, who will fund the discovery companies?"

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