Nature Biotechnology24, 233 - 234 (2006)
Published online: 8 March 2006; | doi:10.1038/nbt0306-233
News In Brief
South African GM label confusion Most maize and soy products sold in South African food stores contain detectable amounts of genetically modified organisms (GMOs), including products that are labeled 'non-GMO,' 'GMO-free,' or 'organic,' reveals a study by the University of the Free State in Bloemfontein in South Africa. Of 20 products carrying one of these labels, randomly selected in major supermarkets and health-food stores, 14 tested positive for genetically modified (GM) organisms. "It appears that the vacuum in [South African] regulations ... in terms of non-GM food has also left a vacuum in the use of such labels," lead researcher Chris Viljoen and coauthors write in the African Journal of Biotechnology (
5, 73–82, 2006). South Africa currently has no laws defining negative GM labels. Viljoen, who heads a GMO-testing facility affiliated with international company Genescan of Freiburg, Germany, did no quantitative tests, so some or all cases may concern trace amounts. Nonetheless, Julian Kinderlerer, a bioethicist and a professor at the department of law and ethics at the University of Sheffield, UK, says he finds it of concern "that the [research] finds little truth in [the] assertions [on labels]." He adds: "we need to ask what the purpose of labeling is, and then assure that the label meets that purpose." South Africa is currently the only country in Africa that allows the growing of GM crops, including corn, soybeans and cotton. PV
Bush fans bioethanol flames US President George W. Bush on January 31, in his State of the Union address to Congress, created a buzz around biofuels by announcing a fresh policy push to replace much of gasoline oil imports by bioethanol produced from agricultural waste. His new 'Advanced Energy Initiative' should help make it possible to cut American oil imports from the Middle East by 75% in 2025, in part by making fuel from biorefineries "practical and competitive within six years." Apart from funding research into hybrid, electric and hydrogen-fueled cars, the president asked Congress to increase its budget for biorefineries that turn cellulosic materials into bioethanol from $90 million this year to $150 million in 2007. Jim Greenwood, president and CEO of the Biotechnology Industry Organization, in a statement, applauded Bush's words, saying the US "could produce 25% of [its] transportation fuel need by 2015 if we dramatically ramp up biorefinery development." Jeff Passmore, executive vice president at enzyme and ethanol production company Iogen in Ottawa, Ontario, says the additional money would be best spent on speeding up the commercialization of technology rather than on additional research. "We're ready to go," Passmore says, calling lenders' unease with investing in unproven technologies the most important bottleneck in trying to get the company's first $350-million biorefinery near Idaho Falls off the ground. PV
ImClone up for sale
Bolton Archive/ZUMA Press/NewsCom
If ImClone meant to show the world that they had meaningful buyout or merger opportunities by hiring investment banking shop Lazards to explore 'strategic alternatives' for the company, they likely failed. New York City-based Bristol-Myers Squibb, a large ImClone shareholder and widely anticipated to be the leading suitor for the biotech research company, took the unusual step of notifying Wall Street on February 1, 2006, through an SEC filing, that the company would take a wait-and-see approach towards the ImClone sale. One likely stumbling block for any suitor would be the agreement that gives Bristol-Myers Squibb effective control over Erbitux (cetuximab), ImClone's cancer-fighting drug and lone revenue generator. Indeed some analysts are pointing to the agreement with Bristol-Myers Squibb as one of the prime reasons a deal with another suitor is unlikely. In a research note dated February 2, 2006, UBS Securities analyst David Molowa says that any prospective buyer would find ImClone more attractive without the Bristol-Meyers Squibb agreement in place. "This is not a company that was built to compete over the long haul," says Eric Schmidt, an analyst with SG Cowen in New York City. "They have had a lot of turnover. They don't have a strong corporate culture and things are going to get worse for them." The New York-based oncology biopharmaceutical gained popular notoriety when then-CEO Sam Waskal, together with an executive at OmniVision media organization and celebrity Martha Stewart, got mixed up in stock trading scandal in the spring of 2002. JR
USDA approves the first plant-based vaccine In what could be a milestone for veterinary as well as human vaccine research, the US Department of Agriculture (USDA) on January 31, 2006, announced it had issued the first market license ever issued to a veterinary vaccine produced in plant cells. The vaccine, made by Dow AgroSciences of Indianapolis, Indiana, a wholly owned subsidiary of the Dow Chemical Company, has proven safe and effective in protecting chickens from illness caused by the Newcastle disease virus, according to the USDA's Center for Veterinary Biologics. The subunit vaccine was produced using modified tobacco plant cells in an indoor, biocontained production system, eliminating environmental or consumer concerns about pharmaceuticals produced in food crops or open fields. Although Dow may decide not to sell the now-approved chicken vaccine because of market concerns, the company called the license a "regulatory milestone," allowing it to develop a range of other veterinary vaccines. Using the same production system for human vaccines is "a real possibility," the company said. Charles Arntzen, a biotech researcher at Arizona State University in Phoenix, who has been pushing plant-based vaccines for many years, welcomes the approval. "It shows that large companies are investing product-development resources in plant-derived pharmaceuticals, [and] that the [USDA] is receptive to the new strategy," Arntzen says. PV
Revlimid approval Revlimid (lenalidomide), approved by the US Food and Drug Administration to treat a subtype of the blood disease myelodysplastic syndrome (MDS) last December, may already be expanding its indications. The drug's manufacturer, Celgene of Summit, New Jersey, has already filed an application for using the new oral immunomodulatory agent to treat multiple myeloma, a form of blood cancer. Meanwhile, the company's recent trials have suggested that the drug may also be effective in treating chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Revlimid is a second-generation version of the company's drug Thalomid (thalidomide), which gained notoriety in the 1950s and 1960s because of the severe birth defects it caused in the fetuses of pregnant women who took it as a sleeping aid. Lei Zhong, senior research analyst at Banc of America Securities in New York, notes that Revlimid combines unprecedented effectiveness with oral availability. "It's shaping up to be an oral Avastin for liquid tumors," Zhong says. So far, no other phase 2 candidate drugs for multiple myeloma or leukemia have appeared on the horizon, he says, leaving Revlimid without a competitor in sight, which means it could become at least a $2-billion drug in the US alone. AK
WTO finds 'undue delay' for GM import in Europe In often delayed, still secret, but not unexpected preliminary findings, a three-person expert panel at the World Trade Organization (WTO) in Geneva, on February 7 was said to have ruled that many European bans on genetically modified (GM) crops and food products breached trade agreements. Such agreements declare that market approval procedures of food products should be science-based and without 'undue delay.' Press reports based on leaked copies of the ruling said the WTO panel found country-wide bans by Austria, France, Germany, Greece, Italy and Luxembourg of EU-approved crops violated agreements. The panel also found that a pause in EU product approvals between 1999 and 2003 amounted to an illegal moratorium. Of the 27 cases the panel weighed it said 24 had met undue delays. In response, on February 8, European Commission trade spokesman Peter Power said WTO rulings "will not alter the system or framework within which the EU takes decisions on GM [organisms]". The EU had argued that lengthy procedures merely reflect rigorous review. The dispute was brought before the WTO in May 2003 by the United States, Canada and Argentina. After the WTO report is published, rules then allow for an appeal. If the EU defies a final ruling, the US and its allies could get permission to impose tariffs on imported European goods. PV
