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Archive for November 2015

Science Policy Around the Web – November 27, 2015

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By: Swapna Mohan, DVM, Ph.D.

Female Aedes aegypti via James Gathany/CDC

Infectious Diseases

Gene drive turns insects into malaria fighters

CRISPR does it again! Scientists at the University(ies) of California have used the revolutionary gene-editing tool to produce genetically engineered mosquitos that have anti-malarial genes. With the insertion of this 17KB stretch of DNA, the mosquito develops the ability to produce antibodies against Plasmodium, the causative agent of malaria. The antibodies prevent the parasite from advancing its life cycle within the mosquito, its primary vector. And because of integration with the germline, the gene is passed on to the next generation of vectors with 99% efficiency.

The potential of this study is that the GE mosquitos can be released to breed with mosquito populations in the wild, effectively reducing the number of carriers and limiting the spread of the disease. While this method in and of itself, cannot eradicate malaria, it can be used in conjunction with other measures such as eradication of mosquito breeding sites, prevention and treatment drugs to check the spread of malaria. According to the U.N WHO estimates there were 214 million cases of malaria in 2015 and 438,000 deaths, mostly in sub-Saharan Africa. Efficient combination of prevention strategies can help combat this disease globally. A study published in Nature showed that 15 years of malaria prevention strategies have resulted in 663 million cases of malaria being averted since 2000. Additional measures such as using GE mosquitos to control vector population may help in eradication of the disease, at least from some parts of the world.

However, as with any genetic engineering system, the CRISPR-Cas9 gene drive method is being analyzed for its potential effects on ecological stability. The National Academy of Sciences has formed a committee to understand the technique and its applications fully so as to effectively assess the environmental and ecological risks associated with the release of genetically engineered organisms in the wild. (E. Pennissi, Science and W. Dunham, Reuters)

Diagnostic Test Regulations

F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs

The Food and Drug Administration (FDA) is cracking down on unnecessary tests and medical diagnostic procedures that it says may be putting thousands of people at risk each year and raising healthcare costs. In its report, the FDA analyzed several case studies to demonstrate how inefficient and inaccurate laboratory-based testing has endangered the lives of patients either by failing to detect conditions they had or by leading to unnecessary treatments for conditions they did not have.

The 20 cases examined and discussed in this report have all used Laboratory Developed Tests (LDTs) that did not meet the minimum FDA requirements of validity and accuracy. Tests whose effectiveness has not been studied have been used and have led to unnecessary and expensive medical treatments to patients. One example discussed in the report shows that ovaries were removed from a healthy patient due to an incorrect diagnosis of ovarian cancer. The healthcare cost of unwarranted cholesterol treatment alone has been estimated to be over $2.4 billion as a result of inaccurate testing.

At a time when LDTs are expected to serve an increasingly important role in personalized medicine approaches, it is imperative to have highly reliable and accurate diagnostic tests.  Based on the results of its report, the FDA is proposing to increase the regulatory oversight of LDTs to that of commercial test kits manufactured and marketed by companies. This move is aimed at providing diagnostic services that benefit patients and healthcare providers by reducing treatment burden and minimizing harm. (R. Pear, The New York Times)

Local Climate Change Policy

Leading By Example on Climate Action

As the 21st U.N. Conference of Parties (of all countries that want to take action on climate change) draws near, three term mayor of New York City, Michael R. Bloomberg announced that he will be co-hosting an event with the Mayor of Paris, Anne Hidalgo. The event is called ‘Climate Summit for Local Leaders’ and will address the role of cities and local leadership in climate control. Since cities are the first responders to climate change-triggered catastrophes, such as floods and hurricanes, empowering the leaders of local government bodies and businesses will strengthen the effectiveness of response to such events.

The summit will discuss how to mitigate the effects of natural disasters on factories, businesses, transportation and shipping. By investing in smart risk management strategies, businesses can plan for economic risks associated with climate change.

This type of grassroots level of involvement will help cities and towns prepare for not only climate change derived disasters but also foster community support for low-carbon ventures such as cleaner transportation. This could in turn, bring about increased cost savings, energy efficiency and reduction of pollution. With this summit Mayor Bloomberg hopes to bring about a global effort from the part of local leaders, businesses and average citizens in taking action against climate change. (Michael Bloomberg, Huffington Post)

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November 27, 2015 at 9:00 am

Science Policy Around the Web – November 24, 2015

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By: Julia Shaw, Ph.D.

Photo source: CC0 Public Domain

The Environment

Deforestation May Threaten Majority of Amazon Tree Species, Study Finds

For a recent report in the journal Science Advances, over 15,000 tree species native to the Amazon were assessed for their environmental sustainability. The results of this study found that between 36–57% of Amazonian tree species should be identified as threatened. More than 150 researchers contributed to the report, many of them by directly collecting data from 1,485 approximately 2-acre plots of Amazonian forest. The data was then analyzed using two different computer models. Based on a “business as usual” model, by 2050 an estimated 40% of the forest would disappear. This was contrasted with a model of stronger governmental regulations, where they estimated a 21% destruction. Timothy J. Killeen, botanist with Agteca-Amazonica, an organization devoted to the study and preservation of South American natural resources, noted that deforestation rates in Brazil “decreased by about 75% since 2005.” By ensuring proper protection of conservation areas and parks, Hans ter Steege, lead author of the paper, said it would be possible to “protect a substantial part of the diversity in the Amazon.” Unfortunately, according to Kenneth J. Feeley, tropical ecologist at Florida International University, “It’s very easy for governments to draw a line on the map and declare an area protected. It’s much harder to make that area effectively protected.” (Nicholas St. Fleur, The New York Times)

Climate Change

Green Climate Fund faces slew of criticism

Five years ago, the Green Climate Fund (GCF) was established during United Nations (UN) talks in Mexico in order to help developing nations respond to climate change. The initial funding target was $10 billion, to be divided between mitigation and adaptation projects. However, the small administration team, based in Incheon, South Korea, only has $852 million in hand, after receiving pledges totaling $10.2 billion. The United States is one of those nations who have yet to pay-up, having pledged $3 billion with no signed agreement in place. In the world of climate finance, GCF is a minor player, yet is it the largest international public climate fund. GCF approved its first aid commitments on November 6th, to include a wetlands resilience program in Peru, and climate-resilient infrastructure in Bangladesh. However, Brandon Wu, a policy analyst for the non-governmental organization ActionAID, warns, “We are worried about the fund’s social and environmental safeguards, consultation processes, accountability mechanisms and transparency.” The GCF has no information disclosure policy and no accountability mechanism. Projects are reviewed by the board and by an independent technical advisory panel, but are not publicly released. Another concern surrounds the money flow, which is funneled through international organizations rather than directly to institutions in the applicant countries. Understaffed and underfunded, the GCF will have to prove itself over time if it hopes to attract the loyalty of wealthy contributor countries. (Sanjay Kumar, Nature)


The FDA just approved the nation’s first genetically engineered animal: A salmon that grows twice as fast

After 20 years, the Food and Drug Administration (FDA) has approved the country’s first genetically altered animal for consumption. Laura Epstein, a senior policy analyst with the FDA’s Center for Veterinary Medicine stated, “As with many products that are the first of their kind, we’re very careful to be sure we’re getting everything right.” Produced by Massachusettess-based AquaBounty, the fish, known as AquAdvantage, was found to be as safe and nutritious as conventional Atlantic salmon. AquAdvantage is an Atlantic salmon that contains a gene for a Chinook salmon growth hormone coupled with a promotor gene from an eel-like fish known as the ocean pout which can grow in near-freezing temeperatures. With these genes, the salmon continues to grow during colder months when it normally would not, ultimately resulting in a fish ready for harvesting at 18 months as opposed to 3 years. Opponents of “Frankenfish” argue that its approval sets a dangerous precedent for other genetically altered animals and suggest that it could out-compete native species, decimating their populations. However, AquAdvantage are all female, all sterile, and they will be raised in tanks in dedicated facilities in Canada and Panama. Ron Stotish, chief executive of AquaBounty, said “we’ve developed a product that mitigates many of the concerns they share and we share. I hope people take the time to consider the fact that we are an environmentally sustainable product, and that this might actually be a better way to grow salmon.” Another point of contention surrounds the labeling of genetically engineered foods. Because the FDA found no “material difference” in AquAdvantage compared to the wildtype salmon, the company is not required to label the fish as genetically modified. (Brady Dennis, The Washington Post and Nick Stockton, Wired )

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November 24, 2015 at 9:00 am

Science Policy Around the Web – November 20, 2015

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By: Eric Cheng, Ph.D.

Photo credit : chimpanzee via photopin

Animal Research

NIH to end all support for chimpanzee research

The National Institutes of Health (NIH) plans to retire the last colony of government-owned chimpanzees being held for biomedical research. In a memo leaked this week, NIH Director Francis Collins wrote to NIH administrators: “there is no further justification for the 50 chimpanzees to continue to be kept available for invasive biomedical research.” This would effectively end the federal agency’s chimpanzee research program.

In an interview with Nature, Collins said that, “this is the natural next step of what has been a very thoughtful five-year process of trying to come to terms with the benefits and risks of trying to perform research with these very special animals. We reached a point where in that five years the need for research has essentially shrunk to zero.”

Collins initially placed a temporary moratorium on new studies using chimpanzees in 2011 after an internal research panel questioned their use in medical research.  This decision led NIH to only use chimpanzees for studies of hepatitis and psychological behaviors. In 2013, NIH retired 310 chimpanzees based on recommendations from the US Institute of Medicine (now the US Academy of Medicine) while still maintaining a colony of 50 animals that could only be used in cases where the research meets a necessary criterion such as public-health emergencies.

The remaining chimpanzees owned by NIH will be relocated to a federally-funded chimpanzee sanctuary called Chimp Haven located in Keithville, Louisiana. Chimp Haven is a facility that contains over 200-acres of forest which offers an environment that stimulates behaviors similar to those in the wild. (Jocelyn Kaiser, ScienceInsider)

Food Policy

FDA Rolls Out New Food Safety Regulation

In order to combat foodborne-related illnesses that sicken millions of Americans each year, the Food and Drug Administration (FDA) has released new regulations for both produced and imported foods. These new regulations will allow the FDA to enforce food safety by making food producers and importers accountable for making certain that their products meet US safety standards.

“This is the first time the food importers have fallen directly under FDA regulation,” agency’s deputy commissioner for food and veterinary medicine Michael R. Taylor said.

The US Centers for Disease Control and Prevention estimates that 1 in 6 Americans (or 48 million) get sick, 128,000 are hospitalized, and 3,000 die from foodborne illnesses each year. These new FDA rules should help produce farmers and food importers take steps to prevent problems before they occur such as the outbreak of Salmonella Poona linked to Mexican cucumbers in October of this year which sickened 767 people with 4 reported deaths.

These new policies will cover requirements for growing, harvesting, and packing. They will even consist of standards for water quality, manure use, and employee health and hygiene. Taylor said he is confident that the new rules will improve food safety, but said success is contingent on full funding of President Barack Obama’s 2016 budget request. (Charissa Echavez, The Science Times)

Science and Society

Space mining bill passes in Congress

Introduced by Rep. Kevin McCarthy [R-CA], the bill entitled “An Act to facilitate a pro-growth environment for the developing commercial space industry by encouraging private sector investment and creating more stable and predictable regulatory conditions, and for other purposes.” This bill will allow companies to legally own and sell the resources they extract from objects from space such as asteroids. The selling of these mined resources by private companies is not explicitly denied by the Outer Space Treaty which declared that “outer space, including the Moon and other celestial bodies, is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means.“  Since these companies are regulated under US law, the law could potentially be interpreted as saying the mined celestial bodies are indeed US property.

Of course, additional language is in the bill stating that these claims are not declarations of sovereignty.

‘It is the sense of Congress that by the enactment of this Act, the United States does not thereby assert sovereignty or sovereign or exclusive rights or jurisdiction over, or the ownership of, any celestial body.’

However, not all countries will see this viewpoint in the same way. The bill also does not address how these shared resources will be allocated with other countries that may also mine the same celestial body. Although the bill is already spurring international debate, real scrutiny of this bill will not come until the UN Committee on the Peaceful Uses of Outer Space‘s annual meeting in April 2016 in Vienna.

This bill already has been passed by the Senate and will be sent to the Oval Office where President Obama is expected to sign it into law. (Sarah Fecht, Popular Science)

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November 20, 2015 at 9:00 am

Science Policy Around the Web – November 17, 2015

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By: Cheryl Jacobs Smith, Ph.D.

Public Health Policy

In Reversal, Death Rates Rise For Middle-Aged Whites

A recent study published in the Proceedings of the National Academy of Sciences (PNAS) entitled: Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century, reported an increase in mortality among middle-aged white non-Hispanic men and women of the United States. The authors of the paper, Anne Case and Angus Deaton are economics professors at Princeton University and Deaton was awarded the 2015 Nobel Prize in Economics for his work in poverty. Despite being an expert in this area of research, his most recent findings leave many questioning the veracity of his and his co-author’s findings.

Historically, minority populations in the United States have suffered disproportionately from increased mortality that many have accepted as either a result of reduced access to healthcare resulting in poor health and uncontrolled co-morbidities or poorly controlled chronic diseases leading to premature death. Rarely had white non-Hispanics been associated with poor outcomes when compared to these groups and this study is one of the first to highlight the disparity among white non-Hispanics as well as to demonstrate that it is a mortality rate that has spiked dramatically between 1999-2013.The authors state, “This change reversed decades of progress in mortality and was unique to the United States; no other rich country saw a turnaround [during this time period].”

The authors suggest that perhaps the U.S. economic downturn that occurred around that time more severely hit the white non-Hispanic population because they were not accustomed to such a decline in lifestyle. The authors further imply that perhaps this caused an increase in despair and/or depression that provoked prescription drug use that lead to drug abuse. Indeed, the number of unintentional, overdose deaths as a result of prescription pain relievers has quadrupled since 1999. This study certainly brings attention to a new population group experiencing disparity in health and warrants further investigation into this area to validate their findings and intervene to slow and/or reverse this tragic trend in mortality among white non-Hispanics. (Rob Stein, NPR)

Drug Policy

Painkiller Abusers Aren’t Completely Abandoning Prescription Opioids for Heroin, Study Shows

A study published in The New England Journal of Medicine conducted by researchers at Washington University School of Medicine, revealed that opioid abusers aren’t necessarily abandoning ship for heroin. Interestingly, after surveying 15,000 patients at drug-treatment centers in 49 states, the study found that opioid abusers are using the two drugs simultaneously as availability allows. Senior investigator, Theodore J. Cicero said, in an interview “[that] [f]luctuating between heroin and prescription opioids could potentially make it difficult for abusers to dose correctly, trying to match the high of one to the other.” This would most likely increase the adverse events associated with opioid use.

Consistent with opioid use on the rise, the authors found that 42% of patients surveyed in 2014 reported they had taken prescription opioids and heroin within a month of entering treatment. This finding is up 23.6% from 2008. The study also identified a likely drive to increase heroin use—the lower cost and availability was a driving factor among prescription opioid users switch to heroin. Understanding why people find these drugs so appealing and monitoring their prescription use will hopefully provide better avenues for drug abuse prevention and treatment. (CJ Arlotta, Forbes)

Basic Science Research

Three science ideas you’ll be hearing more about in 2016

There is important work being done in the basic sciences. If your work is judged to be a “breakthough,” you could stand to be awarded $3 million dollars—twice the dollar amount of the Nobel Price! The goal of the Breakthrough Prize award is to highlight the hard and important work being done in the basic sciences and translate these findings to the public. Three of the breakthrough ideas are highlighted below:

  1. Neutrinos are the key to understanding the unknown universe

Two of the researchers awarded the 2016 Breakthrough Prize in Fundamental Physics, Arthur B. McDonald of Queen’s University in Canada, and Takaaki Kajita of the University of Tokyo in Japan were recent recipients of the Nobel Prize in Physics for their discovery that neutrinos can oscillate. Given the ability of neutrinos to oscillate goes against dogma because it assumes neutrinos have mass—whereas the Standard Model of physics suggests neutrinos have zero mass. It is an evolving thought that neutrinos are the key to understanding the known universe.

  1. Understanding the human genome can lead to new treatments for diseases

The Breakthrough Prizes in the Life Sciences went to researchers, John Hardy of the University College London, and Helen Hobbs at the University of Texas Southwestern Medical Center and Howard Hughes Medical Institute. Their individual findings discovered inherited mutations that cause early onset Alzheimer’s disease (Dr. Hardy) or genetic variants that alter levels and distribution of cholesterol and other lipids (Dr. Hobbs) throughout the body. These findings highlight that the better we understand our genome the better we can prevent and treat disease.

  1. Exploring ancient DNA can help explain the origins of humans

Svante Pääbo of the Max Planck Institute for Evolutionary Anthropology won a Breakthrough Prize in Life Sciences for pioneering the sequencing of ancient Neanderthal DNA. The implications from his work are that we would be able to compare Neanderthal genomes to modern humans and detect specific genetic changes that resulted in the first modern humans.

“Breakthrough Prize laureates are making fundamental discoveries about the universe, life and the mind,” Breakthrough Prize co-founder Yuri Milner said. Technology is changing our view of the world advancing science at an exponential pace. Yet, the biggest questions remain to be answered. It is an exciting time to be doing science. (Dominic Basulto, Washington Post)

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November 17, 2015 at 9:00 am

Science Policy Around the Web – November 13, 2015

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By: Agila Somasundaram, Ph.D.

World Map – Temperature Trends by NASA via Wikimedia Commons

Climate Policy

Greenhouse gases hit new milestone, fueling worries about climate change

2015 is a milestone year for the Earth’s Environment. The World Meteorological Organization (WMO) recently reported that the average levels of carbon dioxide in the earth’s atmosphere has exceeded 400 parts per million (ppm) in the early months of 2015. The Met Office and Climatic Research Unit in Britain has reported that the temperature in the first nine months of 2015 exceeded historic norms by 1.02 degree C. These reports are raising serious concerns about global warming. “We are moving into uncharted territory at a frightening speed,” says WMO Secretary General Michel Jarraud. Many scientists agree that the carbon dioxide levels should remain below 400 ppm, but increasing fossil fuel usage has resulted in a steady increase in atmospheric carbon dioxide, going from 278 ppm during pre-industrial times to 397.7 ppm in 2014. “We will soon be living with globally averaged CO2 levels above 400 ppm as a permanent reality,” Jarraud said. Methane and nitrous oxide, two other important greenhouse gases, are also increasing. The long-term implications for the planet, Jarraud says, include higher global temperatures, extreme weather events, melting ice, rising sea levels, and increased acidity in oceans.  These reports on carbon dioxide levels, and the increase in the average temperature, come weeks before the start of the United Nations Climate Change Conference, where diplomats from over 190 countries will participate in discussions on reducing global greenhouse gas emissions. (Joby Warrick, The Washington Post)

Science and Decision-Making

European Commission appoints top scientists to fill policy advice gap

The European Commission has appointed seven prominent scientists to provide the Commission with policy advice. This group is part of the Scientific Advice Mechanism (SAM), and consists of four men and three women from seven different countries and fields, including Polish bioinformatician Janusz Bujnicki, Dutch sociologist Pearl Dykstra, Portuguese material scientist Elvira Fortunato, German physicist and CERN Director Rolf-Dieter Heuer, British climate researcher Julia Slingo, French mathematician and Fields medalist Cédric Villani, and Danish microbiologist Henrik Wegener. “This looks like a good group,” says Anne Glover, the first and only chief scientific adviser (former) of the Commission. “They have scientific credibility as well as a deep knowledge of the ways in which scientific evidence can be used to inform policy as well as the world of politics,” Glover adds. The seven scientists will have their first meeting in January, and the topics of discussion are likely to be dictated by current matters. The SAM also includes a €6 million grant to fund academies and societies to help provide policy advice to the Commission. James Wilsdon from the Science Policy Research Unit at the University of Sussex in the United Kingdom, though skeptical about how the new group will “safeguard its independence and navigate the political sensitivities that will inevitably arise”, is also optimistic and said that the announcement “is a serious step in the right direction for robust, independent and interdisciplinary scientific advice at the heart of European decision-making.” (Tania Rabesandratana, ScienceInsider)

Public Health Policy

U.S. Smoking Rate Declines, but Poor Remain at Higher Risk

The Centers for Disease Control and Prevention recently reported that smoking has become largely a problem of the poor in the US. Smoking has steadily declined in the last few decades – nearly half the US population smoked in the 1960s, whereas those numbers have declined to 16.8 percent in 2014. However, the differences among various sections of the population are striking. Anti-smoking campaigns have been very successful on a national scale, but the results have not been very encouraging with the poor. While only 5 percent of Americans with a graduate degree smoke, about 43 percent of people with high school equivalency diploma smoke, and the latter figures haven’t changed since 2005, compared to a 26 percent decline in smoking among people with college degrees. Nearly a third of the Americans on Medicaid smoked, in contrast to 13 percent for Americans with private insurance. Smoking among people at or above the poverty line has declined from 21 percent in 2005 to 15 percent in 2014 (a 26 percent decline), whereas it went from 30 percent to 26 percent (a 12 percent decline) for people below the poverty line. Kenneth E. Warner, a professor at the University of Michigan School of Public Health, says that disparities are the most important issue in smoking. “The people who are politically influential believe the smoking problem has been solved. It’s not in their neighborhoods. Their friends don’t smoke. Those who still smoke are the poor, the disenfranchised, the mentally ill. That’s who we need to focus on”, says Dr. Warner. A proposed federal rule that bans smoking in public housing might be a step toward changing that. (Sabrina Tavernise, The New York Times)

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November 13, 2015 at 10:06 am

Science Policy Around the Web – November 10, 2015

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By: Daniël P. Melters, PhD.

Infectious disease

Cattle trial cuts human sleeping sickness

In addition to HIV and malaria, sleeping sickness is another serious infectious disease causing major health problems in sub-Saharan Africa, resulting in many thousands of infections each year. In total over 65 million people are at risk of infection. The disease is caused by the protozoan parasite from the genus Trypanosoma, where Trypanosoma brucei gambiense accounts for more than 98% of all reported cases. The parasite is transmitted via tsetse flies. The people most affected by this parasite live in rural areas, where they are in close contact with life-stock. These life-stock hold an important step in the life-cycle of Trypanosoma. To make matters worse, diagnosis and treatment require specifically skilled staff, resulting in only about 30% of all infected individuals receiving treatment following a diagnosis.

A collaboration between the University of Edinburgh (UK), Makerere University (Uganda), and the Ugandan government has tried to tackle the problem by injecting 500,000 cows with a parasite killing agent in addition to regular fumigation with insecticide to qualm the number of tsetse flies. The number of people diagnosed with sleeping sickness went down by 90%. Following this successful trial the program will be expanded to cover the whole of Uganda, including the treatment of 2.7 million cattle. (SciDev.Net)

Precision Medicine Initiative

Privacy Risks from Genomic Data-Sharing Beacons

One of the corner stones of President Obama’s Precision Medicine Initiative is the broad sharing of medical data between many scientists, albeit in a responsible manner. In their recent report, the NIH Precision Medicine Initiative Cohort Program (PMI-CP) workgroup advised the creation of a “hub-and-spoke” model that has a Coordinating Center to provide safeguards to facilitate data access, data normalization, and participant engagement. Part of this dataset is genomic data from patients. One major concern about genomic and genetic data is that this can be used to identify the donor, even when the genomic data is made anonymous early on. A recent article by Shringarpure and Bustamante in the American Journal of Human Genetics provides evidence that it is not only possible to re-identify to whom an anonymous genetic ‘beacon’ belongs to, but also identifies their relatives with just 1000 single-nucleotide polymorphisms (SNP)s. A beacon is a web server that answer allele-presence queries in a binary manner. This might pose a serious privacy-concern for potential participants in the PMI-CP. This concern is not limited to the PMI-CP either. Recently the American Association for Cancer Research (AACR) rolled out their Project GENIE where US and European research institutes will share their cancer genomes to catalyze the development of more precise cancer treatments. Nevertheless, Shringarpure and Bustamante do make several suggestions to continue to safeguard patient privacy. (American Journal of Human Genetics)

Direct-to-Consumer Genetics

Another Genetic Testing Company in Hot Water with the FDA

In November 2013, the US Food and Drug Administration (FDA) warned the direct-to-consumers health testing company 23andMe that they needed to comply with federal regulations with respect to approval for medical devices (section 201(h) of the Federal Food Drug and Cosmetics Act). 23andMe offered a saliva-based genetics test that provided participants with an ancestry-based analysis of some of genetic markers, in addition to various health-related genetic variations (SNPs). The FDA is of the opinion that the latter one required approval by them as a medical device. Seven months after their warning, the FDA received an application from 23andMe. Recently, they obtained the federal seal of approval for a few of their health-related genetic tests.

23andMe is maybe the most well known of these direct-to-consumers genetic testing companies, but they are certainly not the only ones. On November 2nd, the Louisiana-based DNA4Life Company received a similar notification from the FDA. Just like 23andMe, DNA4Life has held the position that they do not need FDA approval to sell their genetic test kit. However, the FDA maintains that the genetic test, which predicts how patients will respond to 120 of the most common medication, meets the definition of a “medical device” and requires that the company either provide evidence of FDA approval or present why they do not need approval. DNA4Life has not yet publicly responded to the FDA notification.

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November 10, 2015 at 12:00 pm

Science Policy Around the Web – November 6, 2015

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By: Sylvina Raver, Ph.D.

Photo source:

Education and Mental Health

Sesame Street’s new brand of autism education

There’s a new Muppet on the block: her name is Julia, she’s in preschool, and she has autism. Julia’s arrival on Sesame Street is part of a coordinated effort by the Sesame Workshop – the nonprofit organization behind the long-running educational children’s program – to reduce the stigma associated with autism and to normalize the disorder among preschool children. The initiative, called Sesame Street and Autism: See Amazing in All Children, is a web-based project with resources for parents that include videos aimed at educating kids ages 2-5 about their peers with autism, a storybook featuring Julia and her friends, and free daily routine cards that parents can use to teach their autistic children basic skills like teeth brushing.

The new initiative was created based on solid academic research thanks to input from multiple universities, professional organizations, and advocacy groups. The Sesame Workshop also worked to ensure that these resources included the viewpoints of individuals with autism. One in 68 children in the US is diagnosed with autism, which ensures that young kids are almost assured to interact with an autistic peer.  Despite the prevalence of the disorder, bullying is still extremely common. One recent study by the Interactive Autism Network found that 63 percent of children with autism have been bullied. The Sesame Street initiative aims to foster tolerance and acceptance with preschool age children in the hope of decreasing bullying among older children, in part by normalizing the features of autism, rather than by exaggerating how they may be disabling to children with the disorder. There’s plenty of room for optimism concerning the effectiveness of using Sesame Street as a platform for this type of education. A 2015 report from the National Bureau of Economic Research found that the program is “the largest and least-costly [early-childhood] intervention that’s ever been implemented” in the US. (Lauren McKenna, The Atlantic; Elizabeth Blair, NPR)

Drug Policy

In heroin crisis, white families seek gentler war on drugs

The nation’s long-running war on drugs has been defined by zero tolerance and stiff prison sentences. It emerged during a crack cocaine epidemic of the mid 1980’s that was primarily concentrated in poor, predominantly black, urban areas. In contrast, the heroin epidemic of the last decade is concentrated in white communities, many of which are suburban and middle-class. This demographic shift in drug use is starting to have profound consequences on how the drug war is being waged. Families who have lost loved ones to heroin are increasingly channeling their anger and grief into efforts to change the language surrounding addiction, and to urge politicians and government to treat drug use as a disease instead of a crime. For example, the derogatory term “junkie” is falling out of favor in lieu of softer and more understanding language. President Obama visited West Virginia recently, a mostly white state with staggering numbers of heroin overdose deaths, to discuss a new proposal to expand access for drug treatment and prevention programs. Presidential hopefuls from both parties have adopted a tone of compassion, rather than punishment: Hillary Clinton has been hosting forums on the issue in New Hampshire, and Jeb Bush is openly discussing his family’s experiences with drug addiction. In a dramatic shift, the Gloucester, Massachusetts police department is employing a new approach to heroin use that at least three dozen other departments have now adopted: users will no longer be arrested if they walk into a police station for help, even if they are in possession of heroin or its associated paraphernalia.

Many people welcome this shift as a needed course correction in light of our scientific understanding of the biology of addiction. However, some black scholars express frustration that similar calls for a more empathetic approach to drug addiction were not heard when they originated from the black community.  Kimberle Williams Crenshaw, a scholar of racial issues at Columbia and UCLA law schools, notes …”had this compassion existed for African-Americans caught up in addiction and the behaviors it produces, the devastating impact of mass incarceration upon entire communities would never have happened.” (Katherine Q. Seelye, The New York Times)


Create a global microbiome effort

In last weeks’ issue of Science magazine, a group of leading scientists in the US called for the creation of a Unified Microbiome Initiative (UMI) which would assemble researchers with representatives from private and public agencies and foundations to study the activities of the Earth’s microbial ecosystems. Nearly every organism and habitat on Earth hosts a unique population of microorganisms, known as its microbiome. These microbial communities are fundamental to nearly all aspects of life on Earth. For example, soil microbes drive the production of usable forms of crucial planetary elements like carbon and nitrogen, and their manipulation shows promise for reducing agricultural use of pesticides, fertilizers, and water use. Ocean microbes produce much of earth’s oxygen, and may be able to be engineered to remove gases from the Earth’s atmosphere that contribute to global warming. Emerging research has revealed the role played by microbes that live within our own bodies in driving overall health and shaping our behavior. This human microbiome is increasingly seen as a target for new drugs, and is an essential tool for precision medicine.

Despite the crucial functions that microorgansms play, and the spectacular promise that they show for addressing challenges to environmental and human health, scientists know very little about how microbes interact with each other, their environments, and their hosts. This is in large part due to an absence of tools currently available that would “enable a mechanistic, predictive, and actionable understanding of global microbiome processes.” Addressing these technical limitations are central to the proposed UMI. The team calling for its formation describes a need for enhanced multi-disciplinary collaboration between physical, life, and biomedical sciences; engineering, and computer science in order to implement hypothesis-driven approaches that can establish causal relationships between microorganisms and their environments.

A second – and equally important – aspect of a UMI involves the need for enhanced collaboration between researchers who study different microbiome populations. Boundaries between scientists who investigate various microorganism communities are artificial and are largely due to historical divides between scientific disciplines, rather than reflecting fundamental differences between microbes that colonize a human mouth or the ocean floor. Furthermore, microbe communities are not limited to national borders but are instead part of a global microbiome. Indeed, the journal Nature contains an accompanying call for the creation of an International Microbiome Initiative to provide universal insight into the microscopic organisms all around and within us. (Alivisatos et al., Science; Dubilier, McFall-Ngai, & Zhao, Nature; Ed Yong, The Atlantic)

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Written by sciencepolicyforall

November 6, 2015 at 9:00 am