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Science Policy Around the Web – August 28, 2015

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By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Drug Policy

FDA approves drug for female libido amid controversy and lingering questions

On August 18, the FDA approved the drug flibanserin to treat female sexual dysfunction. Flibanserin, which will be sold under the brand name Addyi, has been billed as “female Viagra” and as a remedy for Female Sexual Interest/Arousal Disorder. With its recent approval, flibanserin becomes the first drug approved to specifically address female sexual problems, compared to the 26 pharmaceuticals approved for this purpose in men. Indeed, highlighting this stark gender inequality in treatment options was instrumental in the drug’s FDA approval. Sprout Pharmaceuticals, Addyi’s manufacturer, joined with non-profit and health care organizations in 2013 to form Even The Score, an advocacy organization that waged a hugely successful lobbing campaign to seek FDA approval of flibanserin by framing its approval as one “women’s sexual health equality.” Critics say that an accusation that the FDA is biased against women, championed by Even The Score, had greater influence on the drug’s approval than did data on the compound’s efficacy and safety. Addyi was found to have an effectiveness rate of between 8 and 13 percent, and led to side effects ranging from dizziness to sudden drops in blood pressure that were exacerbated by alcohol or hormonal contraception. Flibanserin will carry a warning that it can not be taken with alcohol, despite the odd fact that the alcohol safety study submitted to the FDA by Sprout Pharmaceuticals listed 23 of the 25 participants as men. This has led to lingering questions about how women – the intended users of the drug – would react to a flibanserin alcohol interaction, particularly because, unlike Viagra, Addyi is taken daily rather than just before a sexual encounter. The mild effectiveness of flibanserin, combined with concerns about its safety, resulted in two prior rejections of FDA approval prior to the third successful attempt. Addyi comes to market in October 2015. (Cari Romm, The Atlantic; Editorial, Nature)

Health Policy

A universal flu vaccine may soon be a reality

Every fall, millions of people are vaccinated against the flu with vaccines that are developed by scientists who predict which influenza strains are most likely to be problematic that particular year. New shots are required every year because there are thousands of influenza strains that constantly mutate, and one shot cannot protect against them all. Sometimes, the predictions are correct; sometimes, like in 2014, they miss the mark and tens of thousands of US citizens die from influenza. Furthermore, because flu vaccines are currently based on portions of the influenza virus that evolve throughout the flu season, protection is not guaranteed. Two independent groups of scientists have recently reported considerable progress towards a universal flu vaccine by using a novel approach. Both labs targeted hemagglutin, a protein found on the surface of the H1N1 influenza virus, that is composed of a head region that mutates and varies between different flu strains, and a stem region that is constant between different strains and does not mutate.

The two reports – published in Nature Medicine and Science on Wednesday, August 26 – employed different molecular engineering techniques to stabilize the stem portion of hemagglutin when it is isolated from the head region, thus producing a stable structure for the vaccine that is common between different strains. This new method resulted in almost 100% immunity in mice against the lethal H5N1 flu strain, which is distantly related to the H1N1 strain, and partial protection in ferrets and non-human primates. More research is needed to determine whether immunity extends to other strains of the influenza virus, as well as to determine the degree of protection in humans using a vaccine derived with these new approaches. (Hanae Armitage, Science; The Economist)

Public Health and Drug Control Policy

Illicit Version of Painkiller Fentanyl Makes Heroin Deadlier

An extremely potent opioid analgesic called fentanyl, often administered prior to surgical procedures or prescribed for severe cancer-related pain, is increasingly being added to heroin and causing deadly consequences for heroin users across the United States and Canada. Fentanyl is 30-50 times more potent than heroin, and nearly 80-100 times more potent than morphine, and results in a drug combination that is much stronger than what heroin users expect to be administering. The flood of fentanyl-laced heroin is exacerbating the ongoing epidemic of heroin-related overdose deaths, as authorities in some states report a more than 600% increase in fentanyl-related deaths from 2013 to 2014, and see no sign of a slowdown. Drug dealers are increasingly adding fentanyl to heroin in order to restore the potency of the drug that’s been previously diluted by those higher in the distribution chain. Law enforcement officials and policymakers are scrambling to keep pace with the problem. In the past two years, Mexican drug cartels have increased production of a synthetic form of the compound, acetyl fentanyl, that is not yet included in many screens for toxic drugs in the US, and is currently classified as a banned substance in only a few states. Last year the US DEA added acetyl fentanyl to its list of federally banned substances, and in March 2015 the agency issued a warning that fentanyl poses a “threat to health and public safety.” Drug enforcement and public health authorities are attempting to boost public awareness of the dangers of fentanyl-laced heroin, and are alerting local communities when a compound drug batch is detected. (Fred Bever, NPR; Nadia Whitehead, NPR)

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August 28, 2015 at 9:00 am

Science Policy Around the Web – August 25, 2015

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Climate Change

New U.S. climate rules target methane leaks

The U.S. Environmental Protection Agency (EPA) proposed new measures to cut methane emissions from the oil and gas sector by 40 to 45 percent from 2012 levels by 2025. These new measures will mainly target industrial sources which will include the capturing of natural gas from hydraulically fractured oil wells, as well as limiting emissions from new and modified pneumatic pumps and other equipment used at natural gas transmission compression stations.

Methane, the main component of natural gas, has been found to be 80 times more powerful as a greenhouse gas than carbon dioxide when measured over a 20-year period. Preventing the escape of methane from gas fields and pipelines is predicted to have a measurable affect on reducing gases which contribute to global warming by reducing the equivalent of 7.7 to 9 million metric tons of carbon dioxide. In addition, reduction in carbon dioxide released into the atmosphere is estimated to have a net climate benefit of $120 to $150 million in 2025.

Critics of the new proposals argue that there is already a “strong economic incentive to capture and utilize methane” and “that producers have already made deep cuts in methane emissions through voluntary measures and best practices.” U.S. Senator Jim Inhofe (R–OK), chair of the U.S. Senate Environment and Public Works Committee, in a statement believes that these new measures are “not only unnecessary, but another example of the [Obama] administration’s punitive expansion of their war on fossil fuels.” The EPA will take comments on the proposals for 60 days after they are published in the Federal Register. (Eli Kintisch, ScienceInsider)

Infectious Diseases

Tackle Nepal’s typhoid problem now

Nepal continues to struggle to rebuild their infrastructure stemming from the two earthquakes in April and May of 2015. This damage to the country’s infrastructure has disrupted the water resources of up to 1.3 million people as well as sanitation support for up to 1.7 million. In addition to the disruption to water and sewage systems, thousands still live in temporary shelters and camps. All these issues along with the current monsoon season has lead to an increase in typhoid outbreaks which can easily lead to an epidemic in the hardest hit areas such as the Sindhupalchowk and Gorkha districts of Nepal.

Typhoid fever, a potentially fatal multisystemic illness caused by Salmonella enterica, can be treated with antibiotics. However, Salmonella enterica strains resistant to antibiotics such as fluoroquinolones and azithromycin are emerging. Currently, prevention of infection is key to tackling the typhoid problem. Clean water and sanitation is still the best way to prevent typhoid, but it will take decades for Nepal to repair and build the necessary infrastructure to pre-earthquake levels. Typhoid can also be prevented through vaccination. However, the Nepalese government does not have sufficient funds to vaccinate millions of people using the vaccine recommended by the WHO.

There are cheaper vaccines that Nepali health officials can deploy that are not pre-qualified by the WHO, and it is unclear why they have not yet done so. What is known is that buying and delivering enough doses will almost certainty require outside financial support for Nepal. This support could come from institutions such as Gavi, the Vaccine Alliance, based in Geneva, Switzerland, which is committed to increasing access to vaccination in poor countries, or support could come from the profits of pharmaceutical companies. (Buddha Basnyat, Nature: News & Comment)

Ethics in Research

Apparent ‘pay to cite’ offer sparks Internet outrage

This past June Cyagen, a contract research organization and cell culture product manufacturer, sent out an email entitled: “Cite us in your publication and earn $100 or more based on your journal’s impact factor!” Based on Cyagen’s formula: Voucher Value = (impact factor) * $100, a citation in Science magazine (impact factor = 30) could entitle the author to $3,000. It is only in recent days that this email promotion was picked up by Twitter and bloggers about the possible conflict of interest involved with participating in this promotion.

Upon more careful reading of the promotion, the deal is not what it appears at first glance. The reward is not cash, but store credit for a future purchase from the company. In addition, the citation Cyagen requires for the store credit is nothing more than a notation in the materials and methods section of the journal that a Cyagen product or service was used in that particular paper. This notation is something that is already required by most scientific journals in order assist in other researchers to be able to faithfully replicate a particular experiment. Some believe this promotion is akin to receiving “undisclosed funds in exchange for a citation.” While others such as a developmental biologist from the University of Amsterdam do not believe that this promotion would generate any conflict of interest because it does not appear any different “from any other discount you often get when buying lab equipment, antibodies, transgenic services.” (John Bohannon, ScienceInsider)

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August 25, 2015 at 9:00 am

Science Policy Around the Web – August 21, 2015

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By: Amy Kullas, Ph.D.

Photo source: pixabay.com

Genetically Modified Organisms

Scotland says ‘no’ to GMOs        

In March 2015, the European Union (EU) agreed on an amendment to its genetically modified organism (GMO) regulation. The amendment allows individual member countries and devolved authorities to restrict or prohibit GMOs (including reasons ‘other than science’) in food or feed once the EU has approved a GMO. Previously, GM crops were approved at the European level.

This amendment allows Scotland to ban GMO crops. As Richard Lochhead, Scotland Rural Affairs Secretary, confirmed that the Scottish government will submit a request that Scotland be excluded from any European consent for allowing GM crops. Thus, the growth of crops containing genetically modified organisms (GMOs) will not be allowed in Scotland. To justify this decision, Mr. Lochhead stated: “Scotland is known around the world for our beautiful natural environment – and banning genetically modified crops will protect and further enhance our clean, green status.” Latvia and Greece have already submitted their requests to the EU to ban GM crop cultivation in those countries.

This decision by Scotland has troubled many scientists because Lochhead made his decision without public consultation. Almost 30 scientific societies and organizations are urging the Scottish government to reconsider this ban. Further, the Royal Society of Edinburgh and the British Society of Plant Breeders have requested a meeting with Lochhead to discuss the “scientific evidence on GM crops”. Lochhead responded “I will be happy to meet representatives of the science community and reassure them that these changes will not affect research as it is currently carried out in Scotland. (Ned Stafford and Chemistry World, Scientific American and Erik Stokstad, ScienceInsider)

Animal Rights and Biomedical Research

Has U.S. biomedical research on chimpanzees come to an end?  Follow-up from post on June 26, 2015: ZERO labs have applied for a permit!

Earlier this summer, the US Fish and Wildlife Service (USFWS) revealed its plan to change its classification of captive chimpanzees, including those used in research laboratories, to endangered under the Endangered Species Act (ESA). Additionally, the USFWS also announced that it was going require a permit for doing scientific research on captive chimps.

However, with the implementation deadline of September 14 looming less than a month away, no labs have applied for an ESA permit to conduct research on chimpanzees in the United States. At this point, it is unclear if the biomedical research on chimps has stopped or will stop; however, once stopped it will be significantly more difficult to start that line of research again. The USFWS requires at least 90 days for review of the permit request; therefore no labs will have a permit before upcoming deadline meaning any ongoing projects must stop on September 14. Dr. Robert Lanford, the current director of the Southwest National Primate Research Center (SNPRC), said no research is currently being done on any of the chimpanzees in the Center and that recent research ended early to avoid the upcoming deadline. He further stated “public opinion is currently heavily influencing this process…nobody wants to be the first test case.” (David Grimm, ScienceInsider)

Global Policy

Incentives for vaccination and beyond

In an attempt to increase the immunization rates of poor children, 70 local health clinics, in the Indian state of Haryan, have begun offering parents a free kilogram of sugar if their child(ren) begins the standard vaccination series. Additionally, if the child(ren) finishes the series of vaccines, then the parent will get a free liter of cooking oil. This concept of giving incentives mirrors the model currently used in randomized controlled trials to test the efficacy of new medicines or treatments.

Based on a pilot study, scientists, epidemiologists, and economists gained insight into why the immunization rates are low. In contrast to regions of the United States, the issue is not that people are opposed to immunization. Ester Duflo, an economist at the Massachusetts Institute of Technology, reveals that instead “it is certain obstacles, such as lack of time or money, are making it difficult for them to attend the clinics.” Further, this ideology is translating to other social programs, such as educational programs. This philosophy is generally welcomed in the global development arena as a mechanism to enable governments to: “promote development, relieve poverty and focus money on things that work.” (Jeff Tollefson, Nature)

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August 21, 2015 at 9:00 am

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Science Policy Around the Web – August 18, 2015

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By: Rebecca A. Meseroll, Ph.D.

Photo source via pixabay

Climate change and food supply policy

Global food supply imperiled by severe weather

In recent years, droughts and other severe weather conditions have contributed to crop failure and subsequent spikes in the global food price index measured by the Food and Agricultural Organization of the United Nations (FAO). Last week, the Global Food Security (GFS) program, released an in-depth report highlighting the potential risks to the worldwide food supply due to increasing extreme weather events brought on by climate change, as well as potential social, political, and economic consequences of a stressed global food supply. The report lays out a theoretical “plausible” worst-case scenario of a significant global production decrease of four major crops (rice, wheat, corn, and soybeans) simultaneously, based on actual data from years when these crops were affected by drought. Under the conditions of this worst-case scenario model, the GFS program report expects that developing nations would suffer the most, as people in those nations would likely go hungry, while other import-dependent nations could experience social and political upheaval as a result of rapidly increasing food prices. Meanwhile, consumers in richer, industrialized nations would be not be especially affected. The report makes several recommendations to prevent a future food supply catastrophe, including a call for increased research to understand the actual risk of the theoretical scenarios laid out in the report, improving governmental policies to buffer against spikes in the food supply market, and innovating agricultural techniques to improve productivity and production resilience in the face of extreme weather. (Erik Stokstad, ScienceInsider)

Clinical trials

Positive results for cardiovascular clinical trials in decline

A study published in PLoS One earlier this month found that there has been a steep decrease in positive results in a subset of clinical trials published since 2000, as compared to those published between 1970 to 2000. Specifically, the study examined the outcomes of all large randomized clinical trials supported by the National Heart, Lung, and Blood Institute (NHLBI) between 1970 and 2012 to evaluate drugs or dietary supplements that aimed to treat or prevent cardiovascular disease. A total of 55 trials met the researchers’ criteria, and were scored for whether they reported a positive, negative, or null result for the main outcome tested. In the trials conducted prior to 2000, 57% reported a positive result, in stark contrast to the mere 8% after 2000. The authors of the study conclude that the difference in outcomes is associated with the inception of preregistration of trials with clinicaltrials.gov, which was created by the Food and Drug Administration Modernization Act of 1997 and requires trials to disclose their study design and expected outcomes before data collection begins. This suggests that an increase in transparency resulted in more stringent science, and also calls into question the results from the pre-2000 trials. Although the authors of this study note that the association of trial registration and the upward trend of null trial outcomes cannot be determined to be causal based on the limited dataset they present, the scientific ideal of impartiality is certainly encouraged by increased transparency and a priori identification of expected outcomes. (Chris Woolston, Nature)

Celebrity drug endorsements

Kardashian drug endorsement prompts FDA admonition

Prompted by an Instagram post in which Kim Kardashian extolled the virtues of the morning sickness drug Diclegis, the drug’s manufacturer, Duchesnay Inc., was issued a warning letter from the FDA’s Office of Prescription Drug Promotion. Although Kardashian publicized her partnership with Duchesnay Inc., included links in her post to Diclegis’ safety information website, and encouraged women considering the drug to talk to their doctor about it, the FDA concluded that complete omission of any drug risk and limitation information was inconsistent with the FDA guidelines for celebrity drug endorsements and testimonials. One major limitation of Diclegis noted by Robert Dean, who penned the FDA’s warning letter, is that it has not been studied in women who suffer from hyperemesis gravidarum, a condition marked by severe and persistent nausea during pregnancy. Kardashian’s post has since been removed, but this episode raises the issue of how celebrity medical endorsements in general should be regulated, especially on social media platforms where advertisements can intermingle with other content more readily than it can in a clearly delineated commercial break on television or radio. (Christine Hauser, The New York Times)

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August 18, 2015 at 9:00 am

Science Policy Around the Web – August 14, 2015

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By: Patricia Kiesler, Ph.D.

Photo credit: via pixabay.com

Laboratory Animal Rights

Animal advocacy group targets cat and dog research using novel crowdsourcing campaign

The Los Angeles–based Beagle Freedom Project (BFP) animal advocacy group filed a complaint on Monday with Ohio State University (OSU) and the National Institutes of Health (NIH) alleging that a NIH-funded OSU laboratory has violated NIH rules concerning the use of dogs in biomedical research. In the past, U.S. research facilities would procure dogs from Class B dealers, who would sell animals that they obtained from pounds, breeders and “random sources”. The latter are associated with stolen and abused pets. In 2013, the NIH announced that researchers using the agency’s funds could not procure dogs from Class B dealers, as of October 1, 2014, and could not use such dogs in projects funded in 2015 and beyond. According to BFP, OSU has violated both guidelines. In their complaint, BFP provided records suggesting that the university obtained four class B dogs on October 6, 2014, and that one of the class B dogs was still alive as late as July of 2015. OSU has disputed both accusations and provided evidence to ScienceInsider indicating that the dogs were purchased before the NIH rule went into effect, on September 11, 2014, and said that no class B dogs are currently involved in laboratory research.

BFP has gathered this evidence against OSU through a unique crowdsourcing technique. Public supporters browse the BFP’s website and its list of more than 1200 cats and dogs kept at 17 public research universities in the U.S. and “adopt” one of these animals. BFP then sends supporters a Freedom of Information Act request form, which they fill out and send to the university housing the animal. Any information collected (health records, protocols, necropsy reports, etc.) is forwarded to BFP. Through this strategy, the animal advocacy group has generated hundreds of public records requests to engage the public and pressure universities to release animals and/or end their research. (David Grimm, ScienceInsider)

Scientific publishing policy

Courts refuse scientists’ bids to prevent retractions

Two scientists have sought to prevent journals from retracting or expressing concern about their papers this year. But U.S courts have dismissed their legal bids. Guangwen Tang from Tufts University in Boston, MA had hoped to stop the American Journal of Clinical Nutrition from retracting her 2012 paper on the value of providing Golden Rice to children. This rice is a genetically engineered form of rice that is rich in b-carotene for use as a source of vitamin A. Following Tufts University ‘s discovery that parents had not been informed that the rice provided to their children was genetically modified, the journal decided to retract her paper and did so after the court’s ruling. Mario Saad from the University of Campinas in Sao Paulo, Brazil had also hoped to prevent the journal of Diabetes from publishing expressions of concern about four of his papers. The journal said online that it had been alerted to potentially manipulated images in his studies and that was concerned about the reliability of some of his data. The first investigation launched by the University of Campinas found mistakes, but no dishonesty, in Saad’s work and the conclusions of a second investigation have yet to be released. The court, however, swiftly denied his injunction bid and a request to reconsider thereafter. As a result, Diabetes published print concerns regarding all four of his papers.

“In both cases, the courts decided that the scientists’ requests would deny journals their right to free speech. The decisions do not prevent the scientists from suing for damages from defamation, however, and legal action is ongoing in both instances”. But a scientist suing a journal to stop retractions is unheard of and researchers may find it difficult to win defamation cases against publishers in the U.S. as defamation charges have a high burden of proof in this country; “plaintiffs [would] have to show that publishers acted with malice or reckless disregard”. (Monya Baker, Nature News)

International – Children’s health

Mexico bans giveaways of baby formula at hospitals in an effort to encourage breastfeeding

Mexico has one of the lowest breastfeeding rates in Latin America with only one in seven mothers breastfeeding exclusively during their babies’ first six months. This poor record is amplified in a country where millions live in extreme poverty and drinking water is often unhealthy. In an effort to increase breastfeeding rates, the Mexican government has banned free baby formula at hospitals. But Mexican health authorities said that baby formula could still be supplied at a doctor’s request and would be available for purchase. Mexico’s measure follows the World Health Organization’s recommendations that exclusive breastfeeding for the first six months of life and continued breastfeeding for up to two years or beyond supplemented with complementary foods provide health benefits to babies that translate into adulthood. These recommendations have recently been supported by a long-term study in Brazil that involved nearly 3,500 babies who were followed up 30 years later. The research, published in The Lancet Global Health last April, found that those who had been breastfed the longer scored higher on intelligence tests as adults. They were also more likely to reach higher educational attainment and to earn greater incomes. Although breastfeeding was evenly distributed across social class and the researchers tried to rule out main confounders including mother’s education, family income and birth weight, experts agreed that further research was needed to explore any possible link between breastfeeding and intelligence. The large sample size and number of factors monitored, however, made this a powerful study. (BBC News)

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August 14, 2015 at 10:00 am

Science Policy Around the Web – August 11, 2015

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By: Danielle Friend, Ph.D.

Photo credit: via pixabay.com

International Policy

A deal with Iran leads to new hope for science

On July 14th, six countries and Iran agreed on a nuclear deal, or Joint Comprehensive Action Plan, that would increase the amount of time necessary for Iran to produce enough fissile material to produce a nuclear bomb. Should the Iran nuclear deal pass scrutiny by the United States Congress, in addition to loosening sanctions on Iran, the deal may also give Iran the opportunity to expand scientific programs and develop scientific collaborations with Western countries. In agreement for dismantling the nuclear program, Iranian scientists could have the opportunity to work with scientists across the globe on issues relate to nuclear fusion, astrophysics, and the development of radioisotopes for the treatment of cancer. Additionally, the deal includes converting one of Iran’s uranium enrichment sites, known as Fordow, into an international nuclear, physics, and technology center. Fordow is located beneath a mountain and its location is concerning because it would be difficult to destroy. Re-purposing the location into a science center could be a positive alternative. While the exact research that will be conducted at Fordow has yet to be determined, Iran plans to invite proposals for projects and will host an international workshop to review and determine which projects will be chosen. Russia has also agreed to help Iran convert the existing uranium centrifuges at Fordow into centrifuges that have the ability to produce isotopes for medical imaging. An additional part of this agreement would include strengthening Iran in other areas of science such as neutrino astronomy and fusion research, and allowing Iran to participate in the International Thermonuclear Experimental Reactor. Of course, Iranian scientists will be restricted in their ability to participate in some types of nuclear research such as studying metallic uranium and plutonium but overall these terms provide Iranian scientists with hope for the future of science in Iran. (Richard Stone, ScienceInsider and Declan Butle, Nature News)

Science and Ethics

APA overhauling policies and leadership after torture report

For the last five years, the American Psychological Association (APA) has denied involvement in United States government’s use of torture to interrogate detainees. However a recent external investigation commissioned by the APA reports that APA psychologists and association officials were in fact involved in the interrogations lead by the Central Intelligence Agency (CIA) during the George W. Bush administration. The report from Former inspector general, David Hoffman reports that the APA assisted the United States government in allowing torture of detained individuals. The APA has since released statements indicating that they will change their policies including the prohibition of psychologists from participating in national security interrogations. In addition to announcing these new policies, much of the APA leadership has resigned their positions. Although president Obama since banned interrogation techniques used during the Bush administration, interviews conducted by psychologists are still widely used by the United States. Should these new policies be adopted by the APA, interrogation techniques would need to change. (, ScienceInsider and James Risen, NY Times)

Military Fitness

The Unites States Army takes a scientific view at preparedness for combat

What fitness and combat tests best predict whether a service member is prepared for combat? And more specifically, what tests best judge a female service member’s ability to carry out certain tasks? As the United States government begins to allow female service members to participate more in combat operations, questions such as these become important given that women physically have smaller hearts, skeletons, smaller muscle mass, and a greater percentage of body fat relative to their male counterparts. In order to answer these questions and help identify the best predictors of those who will most successfully be involved in combat, the US Air Force has designed a study to be led by exercise physiologist, Neal Buamgartner. Buamgartner has already recruited 63 female and 109 male airmen to participate in the study. The subjects will complete fitness tests as well as combat and rescue simulations and Baumgartner plans to examine the data for correlations between measures of physical fitness. Such correlations might be “does the ability to do crunches predict how fast an airman can climb a rope ladder, or do push-ups correlate better?” From this data, he will also develop standards to to judge whether an airman is physically fit for combat. Although Baumgartner’s work is geared at setting standards for all airmen these data may specifically inform standards for women in combat. Additional concerns regarding women serving in combat positions include their increased risk for musculoskeletal injuries. More research examining the differences between men and women in combat training may provide greater insight into how these injuries can be better prevented. (Kelly Servick, Science News)

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August 11, 2015 at 9:00 am

Science Policy Around the Web – August 7, 2015

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By: Cheryl Jacobs Smith, Ph.D.

Drug Policy

First 3D-printed drug approved by FDA

In an unprecedented move, the Food and Drug Administration (FDA) approved a prescription pill formulated using 3-D printing. The drug, Spritam levetiracetam, will be used to treat seizures that arise in people suffering from epilepsy. The drug’s manufacturer, Aprecia Pharmaceuticals, says it creates the pill using a 3-D printing process which adds layers upon layer to the pill until the right dosage is reached. Using 3-D printing technology, the manufacturer claims that the pill is more readily dissolved after oral administration thereby delivering a higher dosage of medicine to the patient efficiently and quickly. “As a result, Spritam enhances the patient experience – administration of even the largest strengths of levetiracetam with just a sip of liquid,” Aprecia said in a statement on Monday. “In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go.” Be prepared to see more medical manufacturers using this approach to not only produce new drugs but to also use this technique for tissue regeneration, bone replacements, and even prosthetics. (Hope King, CNN Money)

Climate Policy

What you need to know about Obama’s biggest global warming move yet — the Clean Power Plan

On Monday, President Obama unveiled a major climate change plan called the Clean Power Plan. What is the Clean Power Plan? This is a ‘plan’ of regulation advanced by the Environmental Protection Agency (EPA) under the Clean Air Act that strives to cut carbon dioxide emissions from U.S. power plants 32 percent below their 2005 levels by the year 2030. Although federally mandated, this regulation allows states to make their own cuts due to the diversity in energy needs across the U.S. This legislation is stricter than the existing Clean Air Act and the finalized plan can be found on the White House fact sheet. Here, it outlines that although the Clean Power Plan is stricter than the Clean Air Act, the new legislation adds two extra years to get started on cutting emissions. A clear difference is that the Clean Power Plan does not rely upon natural gas as a source for electricity generation. Rather, the Clean Power Plan incentivizes “early deployment of renewable energy and energy efficiency.” Many see this as a push back from the Administration to slow down the switch to natural gas and promote other renewable resources for energy. The U.S., along with other nations, has promised, as part of the United Nations climate negotiations, to reduce total emissions by 2025 to 26-28 percent below 2005 levels. The newly released Clean Power Plan will be a key component of getting there. (Chris Mooney, The Washington Post)

Government Science and Public Access

Reporters See Barriers to Science Information at Federal Agencies

The Union of Concerned Scientists (UCS) released a new report on August 4, “Mediated Access,” that found that journalists find it hard to keep the public informed about government science due to barriers put in place by federal agencies. The journalists identified difficulty in conducting interviews with scientists because agency public information officers would frequently sit in on the interviews making open conversation more difficult. Additionally, pre-approval rules put in place by government agencies often required science writers/journalists to submit questions beforehand. In some cases the interviews were denied or interview questions evaded. “Federal agency scientists set policies that affect the air we breathe, the water we drink, the food we eat and the products we buy,” said Dr. Andrew Rosenberg, director of the Center for Science and Democracy. “When agencies limit access to those scientists, the public loses. We need better media policies and better practices to make sure scientists can share the work they’re doing in a clear, straightforward way.” Perhaps not only government agencies should increase their transparency regarding scientific and medical issues. This rhetoric is even more applicable amidst the Planned Parenthood controversy over aborted fetal tissue. Many argue that increased Planned Parenthood visibility would allow the public to have input regarding fetal tissue distribution and research. Agencies should strive to increase transparency to the public maintaining the integrity and safety of the working place. (Union of Concerned Scientists)

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August 7, 2015 at 11:00 am

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