US Develops Lethal New Viruses

Written by Debora MacKenzie, Geneva
New Scientist
Issue: 1 November 2003

A SCIENTIST funded by the US government has deliberately created an extremely deadly form of mousepox, a relative of the smallpox virus, through genetic engineering. The new virus kills all mice even if they have been given antiviral drugs as well as a vaccine that would normally protect them.

The work has not stopped there. The cowpox virus, which infects a range of animals including humans, has been genetically altered in a similar way. The new virus, which is about to be tested on animals, should be lethal only to mice, Mark Buller of the University of St Louis told New Scientist. He says his work is necessary to explore what bioterrorists might do.

But the research brings closer the prospect of pox viruses that cause only mild infections in humans being turned into diseases lethal even to people who have been vaccinated. And vaccines are currently our main defence against smallpox and its relatives, such as the monkeypox that reached the US this year. Some researchers think the latest research is risky and unnecessary. "I have great concern about doing this in a pox virus that can cross species," said Ian Ramshaw of the Australian National University in Canberra on being told of Buller's work.

Ramshaw was a member of the team that accidentally discovered how to make mousepox more deadly (New Scientist, 13 January 2001, p 4). But the modified mousepox his team created was not as deadly as Buller's.

Since then, Ramshaw told New Scientist, his team has also created more deadly forms of mousepox, and has used the same method to engineer a more deadly rabbitpox virus. But this research revealed that the modified pox viruses are not contagious, he says. That is good news in the sense that these viruses could not cause ecological havoc by wiping out mouse or rabbit populations around the world if they escaped from a lab.

However, this discovery also means some bioterrorists might be more tempted to use the same trick to modify a pox virus that infects humans. Such a disease, like anthrax, would infect only those directly exposed to it. It would not spread around the world and rebound on the attackers. But there is no guarantee that other pox viruses modified in a similar way would also be non-contagious. Ramshaw's team made its initial discovery while developing contraceptive vaccines for sterilising mice and rabbits without killing them. The researchers modified the mousepox virus by adding a gene for a natural immunosuppressant called IL-4, expecting this would boost antibody production. Instead, the modified mousepox virus was far more lethal, killing 60 per cent of vaccinated mice. The addition of IL-4 seems to switch off a key part of the immune system called the cell-mediated response.

Now Buller has engineered a mousepox strain that kills 100 per cent of vaccinated mice, even when they were also treated with the antiviral drug cidofovir. A monoclonal antibody that mops up IL-4 did save some, however. His team "optimised" the virus by placing the IL-4 gene in a different part of the viral genome and adding a promoter sequence to maximise production of the IL-4 protein, he told a biosecurity conference in Geneva last week.

Buller has also constructed a cowpox virus containing the mouse IL-4 gene, which is about to be tested on mice at the US Army Medical Research Institute of Infectious Diseases at Fort Detrick, Maryland. Cowpox infects people, but Buller says the IL-4 protein is species-specific and would not affect the human immune system. The experiments are being done at the second-highest level of biological containment.

Ramshaw says there is no reason to do the cowpox experiments, as his group's work on rabbits has already shown the method works for other pox viruses. While viruses containing mouse IL-4 should not be lethal to humans, recombinant viruses can have unexpected effects, he says. "You'd hope the combination remains mouse-specific."

Why his group's engineered viruses are not contagious is a mystery, he says. It is not, for instance, because the host dies faster than usual, taking the virus with it. But his findings could explain why pox viruses containing IL-4 have never evolved naturally, even though the viruses frequently pick up genes that affect their host's immunity.

Despite the concerns, work on lethal new pox viruses seems likely to continue in the US. When members of the audience in Geneva questioned the need for such experiments, an American voice in the back boomed out: "Nine-eleven". There were murmurs of agreement.

Saving Seeds Subjects Farmers to Suits Over Patent

By Adam Liptak
New York Times
November 2, 2003

TUPELO, Miss., Oct. 30 - Homan McFarling has been farming here all his life, growing mostly soybeans along with a little corn. After each harvest, he puts some seed aside.

"Every farmer that ever farmed has saved some of his seed to plant again," he said.

In 1998, Mr. McFarling bought 1,000 bags of genetically altered soybean seeds, and he did what he had always done. But the seeds, called Roundup Ready, are patented. When Monsanto, which holds the patent, learned what Mr. McFarling had sown, it sued him in federal court in St. Louis for patent infringement and was awarded $780,000.

The company calls the planting of saved seed piracy, and it says it has won millions of dollars from farmers in lawsuits and settlements in such cases. Mr. McFarling's is the first to reach a federal appeals court, which will consider how the law should reconcile patented food with a practice as old as farming itself.

If the appeals court rules against him, said Mr. McFarling, 61, he will be forced into bankruptcy and early retirement.

"It doesn't look right for them to have a patent on something that you can grow yourself," he said.

Janice Armstrong, a Monsanto spokeswoman, said the company invested hundreds of millions of dollars to develop the seed. "We need to protect our intellectual property so that we can continue to develop the next wave of products," she said.

Were farmers allowed to replant the seed, the company said in its appeals court brief, "Monsanto would effectively, and rapidly, lose control of its rights."

That is because one bag of the patented seed can produce about 36 bags of seed for use in the next growing season. The number grows exponentially. By the third season, the single bag of seed could generate almost 50,000 bags.

Ms. Armstrong said that there are about 300,000 soybean farmers in the United States, and that Monsanto has disputes with only about 100 of them a year. Most disputes are resolved quickly and informally, she said.

Farmers here said the company's efforts to investigate the replanting of saved seeds have been intrusive, divisive and heavy-handed.

"They hired the whole city of Tupelo's night police force," said Mitchell Scruggs, 54, who is a defendant in another saved-seed lawsuit. "They bought a lot across the street from me for surveillance. They're spending all this money on airplanes, helicopters, detectives, lawyers."

"They told a federal judge that it wasn't a monetary issue," Mr. Scruggs said over the roar of three cotton gins at his farm here. "They wanted to make an example of me. They want to destroy me to show others what could happen to them."

In this respect, the seed lawsuits resemble the record industry's actions against people who share music files on the Internet. There, too, the goal is not primarily to recover money from particular defendants but to educate the public, and perhaps to scare other potential offenders.

Ms. Armstrong acknowledges that Monsanto must walk a fine line.

"These people are our customers," she said, "and we do value them. But we also have to protect our intellectual property rights."

Legal experts say Monsanto is likely to win its appeal, in part because Mr. McFarling signed a standard contract when he bought the seed. He said he did not read the contract at the time and it had never occurred to him, until Monsanto contacted him with a $135,000 settlement offer, that he had done anything unlawful. He had paid about $24,000 for 1,000 bags of seeds, including a "technology fee" of $6.50 per bag.

The contract, which Monsanto calls a technology agreement, said buyers could use the seed "only for a single season" and could not "save any seed produced from this crop for replanting."

One judge, dissenting in an earlier appeal that upheld an injunction against Mr. McFarling, wrote that the boilerplate contract did not give Mr. McFarling a fighting chance.

"The terms printed on the reverse of the technology agreement are not subject to negotiation and Monsanto's billions of dollars in assets far exceed McFarling's alleged net worth of $75,000," wrote Judge Raymond C. Clevenger III of the United States Court of Appeals for the Federal Circuit. The same court is hearing Mr. McFarling's second appeal.

"Even an attorney reading the technology agreement might not understand that it purports to subject one to patent liability in Missouri," where Monsanto is based, Judge Clevenger continued. Someone versed in the specialized decisions collected in law books might have understood it, he wrote, "but we may presume that few feed stores stock the Federal Reporter on their shelves."

Lawyers for the farmers here have worked hard to frame defenses that might work in court. Mr. Scruggs, for instance, promises to attack the validity of the patents themselves and to show that the company's practices amount to a violation of antitrust laws.

Mr. Scruggs said that unlike Mr. McFarling, he did not sign the technology agreement. Even without it, though, legal experts said the case against him was strong. The idea that planting saved seed amounts to patent infringement, they said, follows inexorably from two United States Supreme Court decisions allowing patents for life forms.

Monsanto's soybean seeds account for at least two-thirds of the American soybean harvest. The seeds are called Roundup Ready because they are resistant to a popular herbicide called Roundup, which is also a Monsanto product.

Mr. McFarling and Mr. Scruggs have been forbidden by court orders to use Monsanto's products. They said that conventional seed was perfectly good, but that effective herbicides had become hard to find.

Mr. Scruggs said the courts should find a way to weigh traditions almost as old as humanity against fostering high-technology innovations.

"It's a God-given right that farmers were given when they were born to save these seeds," he said. "All we are is farmers trying to scrape a living out of this dirt."

Scientists Respond to Biotech Lobby

The Editor, The Guardian
Submitted 4th November

Scientists for Global Responsibility (SGR) is an organisation of some 600 UK scientists concerned by the use and misuse of science and technology, and we would like to comment on some of the points made by the 114 biotechnology scientists in their letter to Tony Blair ("Scientists complain GM debate was mishandled", 1st November), with which we disagree.

Genetic modification of crops was introduced by multinational companies as an initiative for making potentially huge profits, leading ultimately to the control of the food chain. It has been seized upon by the Government as a significant contributor to the British economy. Unfortunately, the products were developed and then sold to American farmers and put upon the plates of the American public without making clear the nature of the technology that had been used. By the time these companies were ready to repeat their marketing operations in Europe, many of the scientists and the general public in Europe were already informed about the technology. They had also gathered information about the uncertainty, unreliability and the many failures of the modification process itself and of the performance of genetically-modified crops in the field. Europeans said 'No' to allowing such crops to be grown here. Free-marketeers might ask why a new kind of food should be inflicted on a population if some 90% does not want to buy it.

Scientists who have spent the last several years pointing out the dangers of genetic engineering, only to have their warnings dismissed by Government advisory bodies, will be surprised that the signatories to the letter feel that the Government has not been doing enough to support them. The Government has, in fact, been keen to promote genetic modification, even appointing a Science Minister who has made great contributions to the industry and who has himself a large vested interest (in a blind trust) in its success. Advisory and regulatory bodies are weighted with pro-GM members with close connections to the GM industry and, as recently seen with the GM Science Review Panel, members sympathetic to arguments against GM crops may be subjected to harassment.

It is understandable that scientists who have for several years enjoyed a bonanza of funding for research on genetic engineering should be dismayed when a threat to the continuation of their good fortune suddenly emerges. In response to public disquiet about the entire issue of GM crops and foods, the Government that was their patron and which provided enormous sums of money for their work, commissioned studies designed to allay the fears of the public and to convince them of the benefits of accepting GM technology.

Unfortunately for the pro-GM scientists, and to the surprise and embarrassment of the Government, the studies have provided evidence supporting many of the arguments made by anti-GM campaigners. The letter from the 114 scientists is a plea to the Government to save them, in spite of ever more evidence of the damage resulting from their research.

Science has reached a point where the imagination and technical capabilities of scientists are running ahead faster than society can evaluate and control the outcome of their achievements. The perception of many scientists is that all that can be done in science should be done - and if we do not do it, a competitor will. But their theoretical models of the natural world do not encompass the complexities of the real natural world. Nature works in profoundly subtle, intricately balanced and interconnected ways that the human race does not yet fully appreciate. It is for this reason that independent scientists urge caution before we release into the environment and into our own bodies, crops and foods that have been developed by crossing not only dissimilar species but even kingdoms. The long-term consequences cannot be predicted.

We have already begun to see some of the adverse effects of genetic engineering, such as the creation of several kinds of superweeds with multiple herbicide-resistance in Canada (a fact, not a 'claim'); spread of GM genes to wild plants in the United Kingdom; damage to organs and the immune system of experimental animals given GM feed; transfer of GM DNA to bacteria in the human gut. Experiments showing harm to animals and transfer of GM material in human gut have not been repeated or carried further. This is not surprising, as scientists who present evidence of harm of a controversial process have been pilloried in the past. This has been true not only in the case of GM crops but also in the crises of BSE and foot-and-mouth disease, for example.

The obligation of the Government must not be to protect the interests of the 114 (and other) scientists who have unfortunately been led up an unfruitful path but rather to look beyond and to step back from a rush to engage fully in a technology that already shows signs of threatening human health and the environment. Let the molecular biologists turn their attention to genuinely advantageous uses of their knowledge and abilities in ways that do not invade the genome. Scientists must work in partnership with nature, avoiding further stress and disruption of life and the environment on which life depends. Only under such conditions can we be confident that science will lead us to a better future.

Yours sincerely,

Dr Eva Novotny (Co-ordinator on GM issues),
Dr Stuart Parkinson (Director) Dr Philip Webber (Chair)

Scientists for Global Responsibility
PO Box 473
Folkestone
CT20 1GS
Tel: 07 771 883 696
Email: EvaN@sgr.org.uk; StuartP@sgr.org.uk; PhilW@sgr.org.uk
Web-site: http://www.sgr.org.uk/

Doubts on 'Safe' Verdict For GM Food

By Renuka Rayasam
New York
November 6, 2003

A US Food and Drug Administration report saying cloned milk and meat are safe is not conclusive, half of the 10-member Veterinary Medicine Advisory Committee has said. The committee met at an FDA public hearing to discuss the report, released last Friday, which states that such products are safe to consume.

Committee members said on Tuesday they needed more information to decide whether consuming cloned animal products was safe. "The risk assessment is characterised by a lack of hard data," said Carol Foreman, director of food policy at the Consumer Federation of America. "The information on milk is only based on one study." Because cloning is a new technology, researchers had to rely on limited data from biotechnology companies. "It's unlikely that any company would give them data that cloning isn't safe," Ms Foreman said.

Even though researchers pleaded for more companies to release their data on cloned animals, they say that available information establishes that cloned animal food products are not harmful.

The report compared cloned cows, sheep, pigs and goats to current FDA standards for their conventional counterparts. Problems with cloned animals mostly occur during pregnancy or birth. But animals with visible health problems such as deformities were not studied because they would not enter the food supply, as with all animals. The ones that outlast early problems are likely to be healthy.

"Food derived from animal clones is likely to be as safe as food we eat every day," said Dr Larisa Rudenko, senior adviser for risk analysis at the FDA's Centre for Veterinary Medicine. Even though they studied a small group of animals, about 200, the consistency of the information showed that these products were safe, she said. The research group performed medical tests on the animals, mostly cattle, but did not study the meat itself.

Because cloned animals cost about $20,000 and are valuable for research, they will not reach supermarket shelves, Dr Rudenko said. But their milk and offspring might one day.

However consumers still worry about the safety of scientifically tampering with food. Fifty-five per cent of Americans would avoid buying genetically modified food if it were labelled, an ABC News survey found in July.

top of page