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Posts Tagged ‘CRISPR-Cas9

Science Policy Around the Web – February 17, 2017

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By: Thaddeus Davenport, PhD

Source: pixabay

CRISPR

Decision in the CRISPR-Cas9 Patent Dispute

This week, Heidi Wedford from Nature News reported that the United States Patent and Trademark Office (USPTO) made a decision on the disputed patents for the gene editing technology known as CRISPR-Cas9 in favor of the Broad Institute of MIT and Harvard. The CRISPR-Cas9 system has been widely publicized, and this publicity is arguably not out of proportion with the potential of this technology to simplify and accelerate the manipulation of DNA of both microbial (prokaryotic) and higher order (eukaryotic) cells for research and therapy. A simplified, programmable version of CRISPR-Cas9 for use in gene editing was initially described by Charpentier and Doudna, and it was rapidly translated for use in eukaryotic cells by Zhang and colleagues at the Broad Institute in parallel with Doudna, Charpentier, and others.

The USPTO decision follows a dramatic and ongoing dispute over whether the patent application submitted by the University of California on behalf of Doudna and Charpentier – which was submitted before that of the Broad Institute, and described the technology in broad terms as a method of cutting desired DNA sequences – was sufficient to protect the CRISPR-Cas9 intellectual property when the Broad Institute later filed a fast-tracked patent application describing the use of CRISPR-Cas9 for use in eukaryotic cells. Because the Broad Institute’s application was expedited, it was approved before the University of California’s application. In January of 2016, the University of California filed for an ‘interference’ proceeding, with the goal of demonstrating to the USPTO that Doudna and colleagues were the first to invent CRISPR-Cas9, and that the patent application from the Broad Institute was an ‘ordinary’ extension of the technology described in the University of California application.

On February 15th of this year, the USPTO ruled that the technology described in the Broad Institute’s application was distinct from that of the University of California’s. The importance of this decision is that the patents granted to the Broad Institute for the use of CRISPR-Cas9 in mammalian cells will be upheld for now. It also creates some complexity for companies seeking to license CRISPR-Cas9 technology. Because of the overlapping content of the CRISPR-Cas9 patents held by the University of California and the Broad Institute, it is possible that companies may need to license the technology from both institutions. The University of California may still appeal the USPTO’s decision, but this is a significant victory for the Broad Institute for the time being. For many scientists, this dispute is a dramatic introduction to the inner workings of the patent application process. We would do well to familiarize ourselves with this system and ensure that it works effectively to accurately reward the discoveries of our fellow scientists and to facilitate the transfer of technology to those who need it most, without imposing undue economic burden on companies and consumers. (Heidi Wedford, Nature News)

Scientific Publishing

Open Access to Gates Foundation Funded Research

Also this week, Dalmeet Singh Chawla reported for ScienceInsider that the Bill and Melinda Gates Foundation had reached an agreement with the American Association for the Advancement of Science (AAAS) that will allow researchers funded by the Gates Foundation to publish their research in the AAAS journals Science, Science Translational Medicine, Science Signaling, Science Immunology, and Science Robotics. This agreement follows an announcement in January in which the Gates Foundation decided that research funded by the foundation would no longer be allowed to be published in subscription journals including Nature, Science, and New England Journal of Medicine, among others, because these journals do not meet the open access requirements stipulated by the new Gates open-access policies. The new Gates Foundation policy requires its grant recipients to publish in free, open-access journals and to make data freely available immediately after publication for both commercial and non-commercial uses. A similar policy is being considered by the nascent Chan Zuckerberg Initiative.

In the agreement with AAAS, the Gates Foundation will pay the association $100,000 in order to make Gates-funded published content immediately freely available online. Convincing a journal as prominent as Science to make some of its content open-access is a step in the right direction, but it is perhaps more important as a symbol of a changing attitude toward publishing companies. Michael Eisen, co-founder of the Public Library of Science (PLoS) open-access journals, was interviewed for the ScienceInsider article and noted, “[t]he future is with immediate publication and post-publication peer review, and the sooner we get there the better.” This sentiment seems to be increasingly shared by researchers frustrated with the hegemony of the top-tier journals, their power over researchers’ careers, and the constraints that subscription-based journals impose on the spread of new information. Funding agencies including the Gates Foundation, Howard Hughes Medical Institute, and the National Institutes of Health are in a unique position to be able to dictate where the research they fund may be published. A collective decision by these agencies to push the publishing market towards an improved distribution of knowledge – through open-access publishing and post-publication peer review – and away from the historical and totally imagined importance of validation through high-tier journal publication would enrich the scientific ecosystem and accelerate innovation. In this regard, the efforts by the Gates Foundation are laudable and should be extended further. (Dalmeet Singh Chawla, ScienceInsider)

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February 17, 2017 at 12:44 pm

Science Policy Around the Web – August 9, 2016

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By: Thaddeus Davenport, Ph.D.

Infectious Diseases

Local Transmission of Zika Virus in Miami

Most of the world became aware of Zika virus earlier this year when doctors in Brazil noticed a correlation between Zika virus infection in pregnant women and microcephaly in their newborn children. Recent articles in the New York Times on July 29th and August 1st report a notable shift in the course of the Zika virus epidemic – local transmission of the virus within the United States. In the last year, there have been over 1600 cases of Zika virus detected in the United States, but nearly all of these were imported infections, in which individuals became infected while traveling in Zika-endemic regions or through sexual transmission of the virus from people traveling outside of the United States. Because the Zika-carrying mosquito species, Aedes Aegypti is resident in parts of the continental United States, many people expected that it was only a matter of time before Zika virus would be transmitted locally within the United States. On July 29th, the Centers for Disease Control and Prevention and the Florida State Department of Health reported that Zika virus was transmitted to at least four individuals in the Wynwood neighborhood of Miami. By August 1st, the number of individuals infected in the neighborhood had risen to fourteen, and the CDC issued a travel advisory discouraging pregnant women from traveling to the affected area. Though Congress went to recess last month without passing a bill to provide funding for the fight against Zika virus, perhaps, and hopefully, the news of local Zika transmission will motivate bipartisan action in Congress to fund mosquito control efforts and basic research on this still poorly understood virus. (Pam Belluck, New York Times)

Clinical Research

First CRISPR-based clinical trial set to begin this month

The gene-editing technique commonly referred to as CRISPR-Cas9 has received significant attention over the last year because of its impressive potential to target, cut, and modify nearly any sequence of interest within a genome. David Cyranoski reported for Nature News that scientists in China are poised to be the first to use CRISPR-Cas9 technology in a human clinical trial. The trial will enroll individuals with metastatic, non-small cell lung cancer, for whom other treatment options have failed. T cells, immune cells capable of killing infected, cancerous, or otherwise afflicted cells, will be removed from these individuals and modified using CRISPR-Cas9 to delete the gene for a protein called PD-1, which plays a role in downregulating the immune response. It is hoped that removing PD-1 will make the participants’ T cells better able to mount an immune response against cancer cells. As an additional measure of safety, the genome of modified cells will be sequenced in order to confirm that there are no off-target modifications outside of the PD-1 gene that might impact the safety or validity of the study. Initially the trial will test the safety of introducing CRISPR-Cas9-modified cells into ten individuals at three different dosages, while also monitoring the effect of the treatment on cancer progression. A similar trial is set to begin in the United States later this year. These will be important proof-of-concept studies to show that CRISPR-Cas9 can be applied safely and effectively in the treatment of disease. (David Cyranoski, Nature News)

Drug Development – Antibiotic Resistance

New Funding for Antibiotics Development

Bacterial resistance to antibiotics is a significant and emerging threat to public health. Methicillin resistant Staphylococcus aureus (MRSA) – a commonly reported and widely feared strain of S. aureus – is one example of a bacterium that was once readily treatable with penicillin and related antibiotics, but which became difficult to treat after acquiring resistance genes. As current antibiotics become less effective against pathogenic bacteria, doctors are running out of tools to treat infections. An important hurdle to addressing the problem of antibiotic resistance is obtaining the funding necessary to support basic research. Unlike drugs to treat chronic health problems, effective antibiotics designed to cure infections of limited duration, are not necessarily a good investment for pharmaceutical companies. Asher Mullard reported for Nature News that CARB-X – Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator- a public-private partnership supported primarily by the US government, Wellcome Trust, and the UK-based Centre for Antimicrobial Resistance hopes to provide US $350 million to motivate and accelerate the development of new antibiotics over the next five years. While many biotechnology companies support the initiative, some researchers, including Kim Lewis a researcher at Northeastern University, worry that CARB-X is too heavily focused on drug development instead of the discovery of novel antibacterial compounds. Despite their limitations CARB-X and other similar programs will likely provide valuable incentives for biotechnology and academic researchers to work towards better antibiotics for the common good. (Asher Mullard, Nature News)

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August 9, 2016 at 9:00 am

Science Policy Around the Web – June 28, 2016

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By: Sterling Payne, B.Sc.

Licensed via Creative Commons

Bioengineering and Human Trials

First CRISPR clinical trial gets green light from US panel

Since its discovery, CRISPR-Cas9 has become one of the hottest and most sought-after techniques and area of research in science. Whether owing to its ease of use, wide accessibility, or myriad modifications, the research and public health worlds are captivated by CRISPR. Almost one week ago, on June 21st, the National Institutes of Health (NIH) opened the door for the first use of CRISPR in humans as a potential therapeutic in a clinical trial. The trial in question focuses on the use of T-cells to fight cancer by introducing exogenous genetic material via CRISPR-Cas9, followed by the infusion of the cells into cancer patients.

This is not the first time that a gene-editing technique has been used to edit human cells. In 2014, Carl June, an immunologist at the University of Pennsylvania and scientific adviser on the current trial, led a trial that used zinc finger nucleases to edit T-cells in hopes of preventing viral infection. However, the recent approval of this single CRISPR proposal will most likely pave the way for many more, and in a short amount of time. The advancement of CRISPR-Cas9 in the past few years and its potential use in humans is staggering. However, an influx of clinical trials involving this technique will pose more policy discussions and questions to assure scientists and the public that the technique is being used humanely and ethically. It will be interesting to see how the definitions of what is humane and ethical in the eyes of policy-holders potentially changes in the coming years thanks to CRISPR. (Sara Reardon, Nature News)

Brexit and Research

Researchers deplore U.K. decision to leave the European Union 

On June 23rd, 2016, the electorate of Britain voted in a referendum to leave the European Union, creatively named the “Brexit”. Fast forward several days, and the consequences of the vote on multiple levels – such as global markets, immigration, employment, timelines and next steps – are still being determined. At it’s core, the U.K.’s decision to leave was not largely based on research science. However, multiple British science authorities are flabbergasted by the decision, a majority of whom believe was a mistake.

With Britain’s decision to leave the EU, it will be interesting to see how policymakers deal with the inevitable battles in terms of funding, personnel, and travel. One particular talking point is the fate of the U.K.’s standing in the Horizon 2020 program, a massively financed research initiative with 9 billion British pounds of funding over seven years (2014-2020). The initiative provides a means of support for collaboration across different European countries, and if the U.K. would like to continue as a player in the initiative, they will have to make a decision now and start preparing the necessary documents necessary to become an “associate”, for example. Policymakers have a long, winding road ahead of them in order to ensure the survival of the myriad collaborations and research projects headed by Britain. (Daniel Clery, Science News)

Patent Law

The Supreme Court decision that’s shaking up biotech 

The Supreme Court recently rejected the request to hear an appeal from Sequenom (San Diego, CA), a biotech. company specializing in prenatal testing. Sequenom’s test, MaterniT21, relies on the presence of fetal DNA in the plasma of the mother, allowing for a non-invasive method of analyzing the fetus for certain conditions such as Down’s syndrome (trisomy 21). The patent for the test remained intact until 2013, where in a case against Ariosa Diagnostics, a lower court ruled the patent as invalid. The Supreme Court’s failure to hear Sequenom’s appeal means that the previous ruling stands, and that poses a problem with implications far beyond a single biotech company.

Sequenom turned to the Supreme Court for thorough consideration and a final decision on whether or not their patent remains valid, although it does rely on the naturally occurring process of fetal DNA showing up in plasma. The highest justice’s silence in this situation creates an ambiguity around all patents in the biosciences. At what point does novelty evanesce into nature? Should patents, the protectors of intellectual property, really be granted in a case where natural processes are required to retain their validity? These are the types of questions that are being asked as a result of the Court’s silence, and that could plague future investments in biotechnology, a field that is highly represented by startups. (Douglas C. Pizac, AP/STATnews)

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June 28, 2016 at 2:30 pm

Science Policy Around the Web – January 15, 2016

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By: Amanda Whiting, Ph.D.

photo credit: Microbe World via photopin cc

West Africa Ebola epidemic

WHO declares Ebola outbreak over

On Thursday, January 14, 2016, the World Health Organization (WHO) marked the end of the Ebola epidemic in West Africa at a press conference in Geneva, Switzerland, by declaring Liberia free of Ebola. This declaration means that at least 42 days (two 21-day incubation cycles of the virus) have passed since the last confirmed case of Ebola in Liberia tested negative for the virus twice. The other two countries most affected by the outbreak, Sierra Leone and Guinea, were declared Ebola-free in early November and late December 2015, respectively. This announcement marks the first time that all known chains of viral transmission in these three countries have been stopped. “Detecting and breaking every chain of transmission has been a monumental achievement,” said WHO director-general Margaret Chan in a news release. The final cost of this epidemic has been estimated at 11 300 people killed out of 28 500 infected, making it one of the worst international health disasters in history.

While Rick Brennan, directed of emergency risk management and humanitarian action at WHO stated that “today is a good day,” the risk of virus reemerging is a very real threat, and he stressed the need for continued vigilance. Liberia was first declared Ebola-free in May 2015 but has twice encountered new flare-ups of the virus, with the latest in November 2015. The risk of Ebola causing new flare-ups comes from the fact that Ebola can persist in some tissues and bodily fluids of survivors for months, such as in the eyeball fluid of one survivor, and in the semen of some survivors up to a year after infection.

With the outbreak now officially over, scientists and public health officials are looking at what lessons can and should be learned from it. The most important lesson, according to Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) and public face of the small US-based outbreak, is the need to strengthen health care systems in low- and middle-income countries. “If there was a system to have recognized and stopped the outbreak that began with the child in Guinea in December, 2013, we might have avoided the explosive outbreaks in Sierra Leone and Liberia.”(Kai Kupferschmidt, ScienceMag.org, Erika Check Hayden, NatureNews)

Embryonic Research

U.K. researcher details proposal for CRISPR editing of human embryos

A researcher in the United Kingdom, Kathy Niakan, of the Francis Crick Institute in London, has proposed using CRISPR genetic editing on embryos to study genes involved in early human development. Dr. Niakan previously applied to the U.K.’s Human Fertilization and Embryology Authority (HFEA) in September 2015 to renew her existing license to use human embryos in research, and to extend that license to include CRISPR editing. This proposal has just come up for review by HFEA, and Niakan met with journalists from the Science Media Centre on January 13th to talk about her research and proposal in advance of any decision. Her research currently uses human embryos that are left over from in vitro fertilization attempts and donated for research. After their use, these embryos are destroyed when they are 7 days old. Niakan hopes to use CRISPR to knock out genes known to play a role in human development when the embryos are single cells at only 1 day old, and study how that affects their development into blastocytes, a 5-day old embryonic structure. While Niakan speculated that research of this type might one day lead to improved treatments for infertility, for the near future her research involves one narrow goal – to determine what specific genes do in blastocytes. Whether or not she will be able to pursue these studies still depends on the near-future decision of the HFEA. (Erik Stokstad, ScienceInsider)

Public Heath Recommendations

Eggs are okay again

The final version of the 2015-2020 Dietary Guidelines for Americans was announced on January 7, 2016 in a joint press release from the Department of Health and Human Services (HHS) and the US Department of Agriculture (USDA). One of the more interesting points that many have jumped on was the fact that the 2015 guideline does not include a limit to cholesterol intake, and instead just states that “individuals should eat as little dietary cholesterol as possible.” Previous guidelines had recommended that Americans restrict their daily cholesterol intake to no more than 300 mg. This new governmental stance on cholesterol is more in line with current research and the findings of other nations. This does not mean that high blood levels of cholesterol are no longer bad – high levels of low-density lipoprotein (LDL) cholesterol have been clearly linked to heart disease. However, the contribution of foods high in cholesterol (such as eggs) to overall blood cholesterol levels may be overshadowed by the amount of cholesterol produced by a person’s own liver. As such, the amount of cholesterol one consumes becomes an individual’s personal decision based on their own medical history and situation. As with many aspects of health care, personalized nutrition may become the future of nutrition science. (Ariana Eunjung Cha, The Washington Post)

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January 15, 2016 at 9:00 am

Science Policy Around the Web – December 29, 2015

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By: Emily Petrus, Ph.D.

photo credit: DSC03602.JPG via photopin (license)

Biotechnology

And Science’s Breakthrough of the Year is …

Designer babies used to be the stuff of science fiction, however now they are potentially within reach. As such, Science’s 2015 “Breakthrough of the Year” is ….. CRISPR. CRISPR is a method originally discovered in bacteria which has launched us into a new era of gene editing. Although other methods of inserting, deleting, and switching genes on and off have been around for some time, CRISPR is more efficient, less expensive and easy to reproduce in a variety of species, including human embryos. This new technology means that being able to edit out harmful genes or splice in beneficial genes into human babies is technologically possible; however, this raises serious ethical implications in the policy realm.

A summit earlier this month in Washington, DC (December 2015) organized by the National Academy of Science and others from China and the UK confronted the issues surrounding the ethics and legality of editing human genomes. Conclusions from the summit included a call for extensive basic/preclinical research into the effects of editing human embryos and germline cells, but these experiments should not be used to establish a pregnancy. In addition, gene editing used in humans to target diseases – such as modifying red blood cells in Sickle Cell Anemia or deleting the Huntington’s Disease gene from reproductive cells also should be carefully studied before implementation. Germline editing is especially fraught with ethical issues, as altering human DNA for offspring equates to evolution on the generational scale. The deletion of “undesirable” traits could enhance social inequality. Overall the summit concluded that gene editing may have potential benefits, but a yearly summit designed to address the sure to come legal and ethical issues is imperative to carefully implement this new technology. Finally although we are able to edit our genes, in the end, do we want to? (John Travis, Science)

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December 29, 2015 at 9:00 am

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Science Policy Around the Web – December 8, 2015

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By: Ian McWilliams, Ph.D.

Drug Policy and Public Heath

Applying Public Health Principles to the HIV Epidemic — How Are We Doing?

December 1st marked World AIDS Day and a time to raise awareness about the fight against HIV and AIDS. With approximately 1.2 million people in the United States alone affected by the disease, much focus is given to the prevention and control of HIV. Significant progress has been made over the last two decades towards controlling the epidemic. More sensitive diagnostic tests that can detect the virus earlier and better treatments has improved the health of HIV patients and allowed them to live longer. Although US public health departments, community organizations, and other groups have made concerted efforts to provide access to treatment and eliminate transmission of this disease (as evidenced by a 36.5% decrease in deaths related to AIDS), many hurdles still remain. There are currently 45,000 new HIV infections every year and 65 percent of all Americans diagnosed with HIV are not currently on treatment.

To further combat the HIV epidemic, Thomas R. Frieden, director of the Centers for Disease Control and Prevention (CDC),  and other public health leaders recommend applying public health principles of communicable diseases such as prompt diagnosis, systematic partner notification, and accountability for treatment for all patients. In the same issue of the New England Journal of Medicine, renowned HIV/AIDS expert Anthony Fauci emphasized the importance of antiretroviral therapy (ART) in the treatment and prevention of transmission of HIV. By calling for patient empowerment, community engagement, clinical excellence, and focus on outcomes these leaders hope to unite groups with a common cause against HIV and AIDS. (Thomas R. Frieden, Kathryn E. Foti, and Jonathan Mermin, New England Journal of Medicine)

Bioethics in Research

Scientists Debate How Far To Go In Editing Human Gene

The CRISPR-Cas9 gene editing system has garnered attention for the unprecedented ease by which DNA manipulation can occur. This powerful technique has possibly opened the door to treating hereditary diseases such as Huntington’s disease, cystic fibrosis, and Tay-Sachs disease. Although this could be a potent treatment modality, germline editing of sperm, eggs, and embryos raises many ethical and safety concerns. Further compounding these concerns are reports that CRISPR can have off-target effects that could result in unintended deleterious consequences. Geneticist George Church weighed in on this matter to suggest these effects are manageable and not as dangerous as we think. Adding to the complexity of this issue are fears that the ease by which this technology can alter DNA will allow for “designer babies” and “eugenics,” where individuals will try to manipulate germline DNA to create super humans.

In an effort to address these dilemmas, the International Summit on Human Gene Editing recently convened “to discuss the scientific, ethical, and governance issues associated with human gene-editing research.” The consensus of the committee, chaired by David Baltimore, call for more “intensive basic and preclinical research” and “the creation of a ongoing forum to continue to assess the state of the research and society’s readiness.” Of note, the committee cautioned “there is a need to understand the risks” and “it would be irresponsible to proceed” in reference to somatic and germline gene editing respectively. This certainly wasn’t a ringing endorsement for human gene editing, but does allow the scientific community to further develop these gene-editing tools while actively engaging with the communities to assuage fears and define care. (Rob Stein, NPR)

Health IT and EHRs

“Unsexy Plumbing,” Integrated Data And The Future Of The Healthcare System

Electronic health records (EHR) will be an important component of a modernized health care system. Improved connectivity within health organizations will provide better access to more useful data and can support larger public health programs, such as the Precision Medicine Initiative. However, the implementation of these systems has faced many hurdles such as outdated technology that is time-consuming and incompatible with newer systems and privacy-related regulations. Many initiatives have been made to share health data in order to reduce costs, increase efficiency, and improve quality of care, but currently, less than half of doctors surveyed think that EHRs have improved patient outcomes.

To address these shortfalls, efforts from government and the private sector are attempting to ease integration of EHRs. Because the Affordable Care Act limits the amount insurance companies can spend on administrative costs, and EHRs would reduce administrative burden, many insurance providers are introducing payment incentives to healthcare providers that use EHRs. Additionally, the private sector could further drive the transition to EHRs with cloud-based solutions and improved wearable devices for data gathering. These changes will lead to better payment solutions, data analytic tools, and even better insurance plan selection. (Jason T. Andrew, techcrunch.com)

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December 8, 2015 at 9:00 am

Science Policy Around the Web – October 20, 2015

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By: Patricia Kiesler, Ph.D.

Photo source: pixabay.com

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 (clinicaltrials.gov). “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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October 20, 2015 at 9:00 am