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in brief
Commission calls for genomic privacy
A US bioethics panel is calling for privacy protection in a new report released in October. The Presidential Commission for the Study of Bioethical Issues (PCSBI) lays out a dozen new recommendations in its report Privacy and Progress in Whole Genome Sequencing. The overall goal is to strike a balance between encouraging genomic research to benefit human health, on the one hand, and protecting the privacy of those whose genome are being sequenced, on the other. The Commission stops short of recommending national standards, calling instead on federal and state officials to work together to assure a consistent floor to protect privacy, says PCSBI chair Amy Gutmann, who is president of the University of Pennsylvania. About half the states have laws that already provide some protection. Even if the US Congress were to set national standards, however, privacy protections are likely to remain a jumble at the international level, where genomic sequence data sharing is expected to expand. And as the cost of sequencing drops, it is not a fantasy to imagine organizations surreptitiously taking saliva or other specimens to determine DNA sequences and then using such information to exclude some individuals and perhaps also their family members from life or health insurance coverage, according to Gutmann. The commission recommends fully informed consent for all human genomic sequencing, thus excluding surreptitious sequencing and thereby protecting citizens whenever whole-genomic sequencing is Jeffrey L Fox undertaken, she says.
in their words
We have crossed some critical barriers but still need to do a lot of work to reach the final destination, Nisar Wani, head of the Reproductive Biology Laboratory at Dubais Camel Reproduction Center. Researchers in Dubai have established camel cell cultures in preparation for creating drug-producing transgenics. (SciDev.Net, 3 September 2012) This result knocked me off my chair, Scott Halstead, an adviser to the Dengue Vaccine Initiative comments on the disappointing efficacy of Sanofis dengue vaccine, which only reached half the expected 70% protection. (Reuters, 12 September 2012) These pleas are a victory for the American public, in demonstrating the FDAs commitment to investigating cases of individuals and businesses that prey on the sick and vulnerable with phony medical treatments, FDA Special Agent Patrick Holland comments on the guilty pleas entered by two fraudulent stem cell investigators, Lawrence Stowe and Frank Morales, who were outed in 2010 by the US television show 60 Minutes. (60 Minutes Overtime, 13 September 2012)
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NEWS
Media leaps on French study claiming GM maize carcinogenicity
A scandalcried French newspaper Le nouvel Observateur following publication of a paper by Gilles-Eric Sralini from the University of Caen, in France, on a long-term study of the toxicity of GM maize. The studys online publication on September 19 by Food and Chemical Toxicology prompted a media frenzy. The study made a bombshell claim, completely unprecedented in the literature: rats fed for two years on Monsantos NK603 corn expressing 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), cultivated with or without Roundup, and Roundup alone, develop a range of tumors. The authors claimed that the disruption of biosynthetic pathways that may result from overexpression of EPSPS in the GM French opposition to GMOs seems set to increase. maize can give rise to pathologies. The study, said to have cost 3 ($3.9) million, was dismissed as scientifically unsound by numerous scientists with or without ties to the agbiotech industry. Both the German Federal Institute for Risk Assessment (BfR) and the European Food Safety Authority (EFSA) lamented inadequate experimental design, poor analysis and data reporting. Writing on behalf of the European Federation of Biotechnology, biotech pioneer Marc Van Montagu comments on the study. This paper represents a dangerous case of failure of the peer-review system. Van Montagu also lambasts the communication strategy of the authors. The publication was timed to coincide with a book on the experiment and a film to be broadcast on public television and in cinemas. Most unusually, an association representing Sralini offered interested journalists a confidentiality agreement to get early access to the paper that prevented signatories from approaching third-party researchers for comment, with a penalty of several million euros to be levied if the contract were breached. As a consequence, initial media coverage was almost ubiquitously noncritical. Controversy soon followed when funding ties with several supermarket chains promoting non-GM positions were revealed; Sralinis decision not to provide EFSA with additional unpublished data also did not help. If the intention was to manage the news, it wasnt managed very well, says Jonathan Amos from the BBC, which did not sign the confidentiality agreement. Despite the papers flaws, it seems likely that the initial coverage will negatively sway public and political opinion in France, where it seems to have hardened the socialist governments already unfriendly stance toward GM organisms. Before the French Agency for Food, Environmental and Occupational Health & Safety (Anses) could deliver its opinion (expected by the end of October), the agriculture minister Stphane Le Foll stated that long-term feeding studies should become mandatory for GM food crops, even if Sralinis work is debunked. Anna Meldolesi Rome
biggest impact is expected in 2014 when GM rice and GM maize biosafety licenses expire. We are worried that the invalidity of biosafety licenses [for GM rice and maize] will dramatically postpone the commercialization process, says a scientist at Huazhong Agricultural University, who spoke to Nature Biotechnology on condition of anonymity. In India, politics have also become entangled in a radical about-face in GM crop commercialization. India was on the verge of marketing its first GM foodinsect-resistant Bt brinjal (eggplant). But a political row erupted and Bt brinjal approval was placed under an indefinite moratorium. That was 2010 (Nat. Biotechnol. 28, 296, 2010) and since then public opposition to GM foods has grown. On August 9, the Parliamentary Standing Committee on Agriculture published a report urging the government to stop all open-field GM trials and confine all research to greenhouses until the regulatory system is revamped. The report, spearheaded by nongovernmental organizations (NGOs), was written by a panel of 31 members of Parliament after examining, according to the panel, over 1,400 documents and interviewing scientists, civil society representatives and farmer organizations. Leading biochemists such as Govindarajan Padmanabhan at the Indian Institute of Science in Bangalore, who
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REUTERS/Regis Duvignau
is pro-GM, and scientists from the Department of Biotechnology, Council of Scientific and Industrial Research and Indian Council of Agricultural Research, who also support the technology, were among those interviewed. Pushpa Bhargava, a biologist and founderdirector of the Centre for Cellular and Molecular Biology in Hyderabad, who is opposed to GMwas also interviewed. India first embraced GM crops in 2002, allowing companies to produce and market cotton modified with the Bt gene using a technology owned by St. Louisbased Monsanto (Nat. Biotechnol. 20, 415, 2002). After a few years, public resistance began to rise, driven by activists and NGOs, culminating with the moratorium on Bt brinjal, despite the fact that the crop had been approved for commercialization. The latest report to the Indian government is damning. The panel unanimously declared after critically analyzing the evidence for and against that there are better options available than GM crops for increasing food production. The cultivation of Bt cotton, widely regarded as a commercial success, was also dismissed as beneficial to industry and only added to the miseries of farmers (Nature 487, 8, 2012). The report is a big setback, says Kottaram Narayanan, managing director of Metahelix Life Sciences in Bangalore and an executive
of the industry body ABLE (Association of Biotechnology-Led Enterprises). The narrow thinking of our politicians under the influence of a few NGOs is really jeopardizing the countrys progress in agriculture, adds Arvind Kapur an executive of Rasi Seeds, one of the first Indian companies to market Bt cotton. Padmanabhan fears the move will deprive the country of a powerful technology option to cater to the needs of millions of children suffering from malnutrition. If implemented, the reports recommendations could slow downand perhaps halt much transgenic work, not just in private companies, but also in the public sector. In response, on October 9, the prime ministers Scientific Advisory Council, chaired by C.N.R. Rao called for a judicious blend of traditional breeding and new technologies. Until any formal policy decisions are made, it is unclear how damaging the report will be to the dissemination of GM technology in India, says Kottaram. Even before this report came out, the requirement to obtain a no objection certificate from state governments was slowing down GM crop trials. Despite the prevailing mood, the Department of Biotechnology (DBT), which currently funds research on some 30 GM crops, will maintain its support for the technology. In fact, only recently [on August 29] we signed a deal with
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NEWS
Australias Queensland University of Technology for promoting AGM banana [for enhanced iron content], DBT secretary Maharaj Kishan Bhan told Nature Biotechnology. An indication that the government is serious about promoting GM research, if not products, also came with a cabinet announcement on August 23 to establish a Rs 2.87 billion ($54.1 million) research center dedicated to agbiotech at Ranchi. Bhan says the reports negative conclusions were likely prompted by the panels apprehension that multinational companies are taking control of Indias seed business. To allay these fears, we have to fast track our regulatory policy for products made in India, he suggests.
Killugudi Jayaraman Bangalore India and Hepeng Jia Beijing
Hundreds of individual residents provided donations to help fund the sequencing of the Puerto Rican parrot (Amazona vittata), the only surviving parrot species native to the United States.
PUERTO RICO
Leo Pharma sets up a series of long-term collaborations with clinical researchers at Berlins Charit University Hospital to discover new treatments for skin conditions including psoriasis and actinic keratosis.
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A new modular facility for the large-scale production of cell-based medicinal products launches near Paris. The 110 ($144)-million initiative aimed at developing a local cell therapy industry was set up by the C4C project, a consortium of the biotechs LFB, Celogos and CleanCells, seven public sector institutions and the state innovation agency OSEO. Companies doing applied research will benet from a substantial R&D tax credit to boost research. From September, businesses will be able to claim in-house research as well as reduce tax bills by up to 35% of the amount invested in research.
FRANCE
CHILE
A new program to boost technological innovation and capacity building receives a $200-million loan from the Inter-American Development Bank. SMEs in the agricultural, energy, health and climate-change areas will be a priority.
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