Science Policy For All

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Science Policy Around the Web – October 20, 2015

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By: Patricia Kiesler, Ph.D.

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Biomedical funding

A new, life-or-death approach to funding heart research

The National Institutes of Health (NIH) is changing the way it finances heart research. The federal agency that funds the majority of heart research in the U.S. will “focus resources on efforts with real-world impact and life-or-death implications.” This new practice is the result of the realization that many studies are never published. Although this is an issue becoming apparent in several fields of medicine, it is now well documented in the area of heart disease. In 2013, Dr. Michael Lauer, a cardiologist and the newly appointed deputy director for extramural research at the NIH, and his colleagues at the National Heart, Lung and Blood Institute (NHLBI) reported in The New England Journal of Medicine that NHLBI spent 2 billion dollars funding 244 clinical trials between 2000 and 2011. But only three out of five of these studies were ever published. The others were either not published or published after unacceptable delays. Other reports have also discovered high rates of non-publication. Starting next year, NHLBI will require that the results of all its funded research, even those not published, be reported in a federal database ( “If the government is going to pay for these studies,” said Dr. Francis S. Collins, director of the NIH, “the public should be able to see the data.” In addition, there will be a change in the design of large clinical trials with a new emphasis “on so-called pragmatic trials that look for outcomes that matter, like reductions in heart attacks or deaths.” The institute is turning down smaller studies and insisting the costs of large studies go down. For example, to reduce costs, researchers will be required to make use of available clinical data on their patients collected during routine care. This new plan will reduce the cost of a typical clinical trial to less than 10 million dollars, an amount well under the 50 million or much more that the institute has paid for a trial. (Gina Kolata, New York Times)

International environment and energy policy

Australia approves controversial Carmichael coal mine

Last Wednesday, the Australian government approved the construction of what is going to be one of the world’s largest coal mines. The Carmichael mine project owned by Adani, an Indian group, and worth about 12 billion dollars will expand an area in the Galilee Basin in Queensland comparable to seven times the size of Sydney Harbor. It will produce 60 million tonnes of coal per year for export, mainly to India, and will include rail infrastructure. The project was first proposed in 2010 and approved in 2014. In August of this year, a Federal Court temporarily blocked the project based on concerns raised by critics that the habitat of two Australian reptile species would be threatened. The animal species under concern were the Yakka Skink lizard and the Ornamental Snake. The approval now granted to Adani by the Australian government is subject to 36 strict conditions the group must meet in order to proceed with mining. For example, they must commit to protecting and improving 31,000 hectares of special wildlife habitat and must commit funds (0.75 million dollars) for research on conservation of threatened species in the area over the next ten years. But the Australian Conservation Foundation (ACF) did not agree with the approval of the mine and railway project. “To approve a massive coal mine that would make species extinct, deplete 297 billion liters of precious groundwater and produce 128.4 million tonnes of carbon dioxide a year is grossly irresponsible,” said ACF president Geoff Cousins. (BBC News)

Biosafety regulations

CRISPR tweak may help gene-edited crops bypass biosafety regulation

A new DNA-free genome editing technique in plants was published this week in Nature Biotechnology. Geneticist Jin-Soo Kim of Seoul National University and his team modified the popular CRISPR/Cas9 technique so that it can edit plant genomes without introducing foreign DNA into cells. Traditionally, researchers use Agrobacterium tumefaciens, a bacterium that has the ability to introduce genetic material into a plant cell, to shuttle the Cas9 enzyme and its guide RNA sequences (the components necessary to delete genes) into plants. Instead of using this gene-shuttling approach, Kim and his team used solvents and reported the successful deletion of selected genes in tobacco plants, rice, lettuce, and thale cress. “In terms of science, our approach is just another improvement in the field of genome editing. However, in terms of regulations and public acceptance our method could be path-breaking, “ said Kim. He believes the resulting plants may be exempt from current regulations affecting genetically modified organisms (GMOs). Other researchers have also achieved similar results with different genome editing techniques introducing protein complexes called TALENs directly into plants or using nanoparticles to aid protein delivery. But it is unclear what regulatory authorities will do; plants that lack foreign DNA might still be classified as GMOs. The European Commission is currently debating regulations to incorporate the latest biotechniques. In the U.S., the Animal and Plant Health Inspection Service currently regulates plants edited with Agrobacterium while plants edited in other ways have bypassed regulations. But this may change. Last July, the White House initiated a multiyear review of federal regulations on agricultural biotechnology. (David Cyranoski, Nature News)

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Written by sciencepolicyforall

October 20, 2015 at 9:00 am

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