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Science Policy Around the Web – July 31, 2015

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By: Kaitlyn Morabito, Ph.D.

GMOs

US House moves to block labeling of GM foods

The debate about genetically modified organisms (GMOs) labeling has made it to the federal level. On July 23rd, the US House of Representatives approved H.R. 1599, the Safe and Affordable Food Labeling Act. This bill prevents states and localities from being able to require the labeling of GMOs on food products and sets up a voluntary US Department of Agriculture (USDA) program for foods to be certified as non-GMO. Additionally, it expands the ability of the FDA to regulate and prevent the sale of food based on safety data or a lack of safety data. States such as Vermont, Connecticut, and Maine already have laws related to the labeling of GMO foods. If this bill becomes law, the laws in these states will be negated. Proponents of this bill, including the food industry, Republicans and some Democrats, argue that the scientific community has reached the consensus that GMOs are not harmful and that this bill makes a uniform national policy on the labeling of food. Opponents of the bill, argue that consumers have a right to know what is in their food. The fate of this bill in the Senate and White House approval is unknown. (Puneet Kollipara, Science Insider)

2016 Budget

Budget showdown leave US science agencies in limbo

With the fiscal year nearing a close, it is once again time for the annual panic over whether Congress will pass a 2016 budget or if the government will shutdown. Congress will be back in session beginning in early September and will have 3 weeks to hammer out a budget deal for 2016 before the 2016 fiscal year officially begins on October 1st. Experts do not expect a 2016 budget to pass by this deadline, but do anticipate that a temporary deal will prevent a government shutdown. During these negotiations, the budgets of the US science agencies hang in the balance. The Senate and House of Representatives have both passed 2016 budgets, but these bills need to be reconciled between the two chambers and approved by the White House.   While funding for the government’s largest science agency, National Institutes of Health (NIH), is expected to rise by about $1 billion with either budget, other science agencies may not fair as well. The largest discrepancies in funding are among the agencies that fund climate change research and the social sciences including NASA, National Oceanic and Atmospheric Administration (NOAA) and National Science Foundation (NSF). The Republican-controlled House Budget included many stipulations on how these agencies can use their funds. A final budget may not be passed until months into the 2016 fiscal year. (Chris Cesare, Nature News)

Vaccines and Global Health

First malaria vaccine takes a key step forward

The first efficacious malaria vaccine (RTS,S) has health organizations and the manufacturer, GlaxoSmithKline (GSK), puzzled about how best to use it, if at all. An ideal vaccine would achieve 95% efficacy, but this malaria vaccine only showed 30% efficacy in a phase III clinical trial in young children in sub-Saharan Africa. Although experts only expected 50% efficacy at the start of that trial, the vaccine only protected 39% of toddlers and 27% of infants against malaria. Although a huge achievement, the market for RTS,S is not clear and there are many other aspects that need to be considered including “cost-effectiveness, feasibility and the public-health value of the vaccine compared with other interventions” such a mosquito control. Use of vaccines and other interventions are often based on recommendations from organizations such as the World Health Organization (WHO) and European Medicines Agency (EMA). So far, the EMA has released a “positive scientific opinion” of the vaccine in Africa for children between 6 weeks and 17 months old based on the fact that vaccine does more good than harm. The WHO has yet to release a recommendation, but is expected to do so by the end of the year. Recommendations from these health organizations do effect funding for vaccinations, but does not directly determine their use, which is decided by the countries themselves. (Leslie Roberts, Science Insider)

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July 31, 2015 at 9:00 am

Science Policy Around the Web – July 28, 2015

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By: Sara Cassidy, M.S., Ph. D.

Legislative policy

House and Senate pass legislation to assist ALS sufferers

Both chambers passed the Steve Gleason Act of 2015 in a verbal vote on July 15th, sending the bill to the President’s desk for signing. The bill modifies Medicare provisions for people with amyotropic lateral sclerosis (ALS, A.K.A. Lou Gehrig’s Disease) to allow for the purchase of medical equipment that aids in speech generation (speech-generating devices, SGDs). ALS is a neurodegenerative disease that affects motor neurons and sufferers progressively lose the ability to move limbs and facial muscles necessary for speaking. However, cognitive abilities remain intact. SGDs are electronic systems that allow for verbal communication for individuals with severe speech impairments. The famous physicist Steven Hawking relies on an SGD for communication, for example. These devices often use gaze or eye-tracking to relay information to a computer to generate sound or written messages. The bill is named after a former New Orleans Saints football player diagnosed with ALS and was championed by legislators from Louisiana, Sen. David Vitter (R) and House Majority Whip Steve Scalise (R). Steve Gleason played with the Saints for 8 years (from 2000-2008) and famously blocked a punt in 2006 in the first game played in the Superdome after the devastation caused by Hurricane Katrina. Gleason wrote an op-ed for the Washington Post about the value his SGD gives to the remaining years of his life, and the importance of Medicare coverage of these devices for other ALS sufferers in 2014. (Cristina Marcos, The Hill)

Legislative policy

Congressman Upton urges momentum for medical innovation legislation

Fred Upton (R-MI), chairman of the House Energy and Commerce Committee, is asking the Senate to move forward with a bill that they have been crafting in the Health, Education, Labor, and Pensions (HELP) committee that aligns with the recently passed 21st Century Cures Bill in the House. The goal is to potentially combine the bills in conference negotiations so the final product can be enacted by the end of the year. “We all know what happens in presidential years, right? Things really just sort of get gummed up,” Upton explained to an audience at the Alzheimer’s Association International Conference in Washington, D.C. “We don’t want it to be put into next year.”

The 21st Century Cures Act (H.R. 6), co-authored by Diana DeGette (D-CO), passed the House in a 344-77 vote July 10th. Upton plans to meet the Senate HELP committee chairman Lamar Alexander (R-TN) and ranking Democrat Patty Murray (D-WA) to explain the House legislation by the end of this week. “We want to just walk them through what we went through so that they don’t feel like we jammed them,” Upton said. “Do interoperability [of electronic medical records], do some FDA reform, do something that’s relevant to what we’ve done and we’ll go to conference and we’ll accept it,” he said.

The HELP committee is expected to have a medical innovations bill in September, but recent efforts have been focused on education. On July 16th, Alexander and Murray advanced their committee’s bipartisan elementary and secondary education bill (S. 1177) through the Senate by an 81-17 vote.

Upton said the goal of the Cures Bill was to get more than 300 votes on the House floor to get the attention of the Senate and prod the chamber to act. “Our goal was always 300 votes,” he mentioned in a previous interview, “344 was icing on the cake. We’ll continue to work with all of our colleagues.” However, while the bill did garner bipartisan support, 70 of the 77 unsupportive votes came from Upton’s own party. One of the dissenters, Budget Chairman Tom Price (R-GA) took issue with the $8.75 billion slated for the NIH, because it is categorized as mandatory funding and therefore not subject to budget caps. Price believes this issue could hold up the Senate’s acceptance of the bill. Notably, Sen. Richard Burr (R-NC), who authored a white paper on medical innovation with Sen. Alexander, said he supports keeping the NIH budget discretionary. “This is a discretionary program today; it should stay there,” he noted. And importantly, an amendment to the 21st Century Cures Bill, presented to the House by Dave Brat (R-VA), that would have made the NIH funds discretionary, failed in a 281-141 vote.

Funding authorized by the bill could begin as early as Oct 1st, Upton noted, if the Senate can enact legislation by then.

(Melissa Attias, CQ Roll Call; Caitlin Owens, The National Journal)

Publishing policy

Scientists fed up with sexist overtones at Science Magazine

Science is one of the oldest and most prestigious journals in the academy. In recent years, it has branched out beyond primary scientific research to cover topics like science policy (Science Insider) and career advice for scientists (Science Careers), among others. However, some recent Science publications have proponents of diversity up in arms; so much so that Aradhna Tripati, Jennifer Glass, and Lenny Teytelman authored an open letter to Science (signed by more than 300 scientists) urging its editors to use their influence in the scientific community for the promotion of diversity in science, instead of elevating outdated gender stereotypes typified by the offending posts.

The first offense listed by the letter’s authors was in June 2014. That month, one cover of the weekly Science Magazine was a photo of transgender sex workers in Jakarta whose heads were cropped out of the image. According to Retraction Watch, which was given permission to publish excerpts of the letter, “The cover photo of headless transgender sex workers of color with the caption ‘Staying a step ahead of HIV/AIDS’ fed into stereotypes associating prostitution and HIV/AIDS with three underrepresented communities – women, people of color and the transgender community – along with its general harmful representation of disembodied female bodies”, the authors note. In July of that month Science editor Marcia McNutt did add an addendum to the webpage displaying that cover apologizing for the offense. Congresswomen Jackie Speier (D-CA) also weighed in on the photo, “The use of headless, sexualized women of color on the cover of the most prestigious science publication in the United States sends the message that women and minorities still do not fully belong in the ‘boy’s club’ of science.”

On June 1st, 2015, a post-doc wrote to a Science Careers advice column penned by virologist Alice Huang (Senior Faculty Associate, CalTech) complaining that her new male advisor constantly stares down her blouse. Dr. Huang effectively told her to grin and bear it. To their credit, Science Careers retracted the article within hours, however her advice drew immediate attention from the Internet and was cited by the Washington Post, among others.

The final straw came earlier this month, when Science Careers published an article by Dr. Eleftherios Diamandis, wherein his advice on how to “make it” in academic science involved passing off all domestic responsibilities to your wife in favor of working excessively long hours. “I worked 16 to 17 hours a day, not just to make progress on the technology but also to publish our results in high-impact journals. How did I manage it? My wife—also a Ph.D. scientist—worked far less than I did; she took on the bulk of the domestic responsibilities. Our children spent many Saturdays and some Sundays playing in the company lobby. We made lunch in the break room microwave,” he wrote. And while some commenters at Inside Higher Ed were unfazed by this advice, others are fed up. Janet Stemwedel (associate professor at San Jose State University) told Retraction Watch, “My big issue with the Science Careers career advice/exemplars of people succeeding that are clearly meant to convey something advice-like is how mired they are in a status quo that many of us have been trying to dismantle for (what feels like) forever. Advisor who views you as a pair of boobs rather than a fully human future colleague? Grin and bear it! Need to make an impression to get noticed in your field? Work an unhealthy number of hours and foist the (unpaid/undervalued) domestic and emotional work on your wife! Tips on how to make it assume that nothing’s going to get better — and indeed, they give people following them no reason to work to change the system to make it any better.”

Science Careers published an apology penned by Marcia McNutt, July 16th, acknowledging some mistakes but also asserting their commitment to promoting diversity in science. (Retraction Watch, Rachel Feltmen, Washington Post)

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July 28, 2015 at 11:00 am

Science Policy Around the Web – July 24, 2015

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By: Julia Shaw, Ph.D.

Photo credit: reynaldodallin via pixabay.

Environment and climate change policy

At Vatican, Mayors Pledge Climate Change Fight

On Tuesday, approximately 60 mayors from around the globe gathered for a two-day conference convened in Vatican City. The Vatican organized the conference in order to encourage grass-roots action in support of Pope Francis’ recent encyclical, “Laudato Si,” which calls on everyone to recognize the dangers of environmental degradation and climate change and to take action politically, economically, and culturally to protect the earth and those most-afflicted by development. With a view to the upcoming global summit on climate change planned for this December, the mayors declared they would pressure world leaders to accept a “bold climate agreement that confines global warming to a limit safe for humanity, while protecting the poor and vulnerable from ongoing climate change that gravely endangers their lives.” The mayors themselves recognized their own power as well. Bill de Blasio, mayor of New York stated, “We, the local leaders of the world, have many tools, more than we may have in fact realized, and we must use them boldly even as our national governments hesitate.” Mayors can often pass regulations to make buildings more energy efficient, encourage mass transit, recycling, and “green” thinking. Governor Jerry Brown of California called-out denialists, saying they were attempting to “falsify the scientific record” and stressed that “political and business leaders are not taking climate change seriously enough.” In their concluding declaration on Tuesday, the group recognized human-induced climate change as a “scientific reality” and declared ameliorating climate change a “moral imperative for humanity.” In order to more effectively deal with climate change, Gov. Brown acknowledged, “We need a moral dimension . . . and Pope Francis is providing that.” Pope Francis addressed the attendants saying, “We can’t separate man from all else. There is a mutual impact.” In closing, the pope expressed optimism for the future and subtly challenged the local leaders to continue to pressure for change saying, “I have great hopes for the Paris summit in December.” (Gaia Pianigiani, The New York Times)

Biomedical research training

Society asks NIH to act now to lessen biomed scientist glut

The American Society for Biochemistry and Molecular Biology (ASBMB) recently published eight suggestions to deal with the excess of young biomedical scientists being groomed for a prohibitively small pool of academic research positions. Published in the Proceedings of the National Academy of Sciences (PNAS), the study is the result of the analysis of nine previous reports containing over 200 recommendations issued by a variety of scientific groups. Not surprisingly, they call for a larger and more stable budget for the NIH and fewer administrative regulations for researchers. They go on to recommend an increase in postdoc salaries; limited financial support for graduate students and postdocs (restricted to 5 years each); a reliance on fewer temporary trainees in favor of more permanent staff scientists; and urge a reversal of the trend to support more graduate students and postdocs on research grants instead of fellowships and training grants. However, Sally Rockey, NIH Deputy Director for Extramural Research, warned about the effect an increase in postdoc wages could have on the overall research grant budget. In terms of the length of graduate and post-graduate training, she noted that NIH training grants and fellowships are capped at five years and that most graduate students earn their Ph.D. in fewer than 7 years anyway. Additionally, the NIH restricts eligibility for their K99/R00 awards, grants designed to transition from postdoc training into an independent research career, to applicants with less than 4 years of postdoc training. Rockey further cautions that shifting graduate students and postdocs currently on research grants to training grants would “ not be practical or feasible, at least in the short term” and that non-U.S. citizens or those who are not permanent residents (which equates to nearly 25% of graduate students and 50% of postdocs) are not currently eligible for training awards. However ASMB representative Chris Pickett and others suggest coordinated actions like simultaneously creating incentives to hire staff scientists while increasing postdoc salaries or supporting training grants for small as well as large institutions to ensure smaller schools are not disadvantaged in a shift away from research grant to training grant support. ASBMB hopes to follow-up by gathering authors of some of the reports, industry and advocacy leaders to “hammer out a defined advocacy plan” and consensus that will “give NIH the OK to move forward.” (Jocelyn Kaiser, Science Insider)

Health policy and education

Standing desks at schools: The solution to the childhood obesity epidemic?

An increasing number of schools are testing the use of standing desks in the classroom. Technically most are “stand-biased desks” that include stools at standing height. The goal is to get kids, who may spend 65-70% of their day sitting, moving more throughout the day. This could be a simple way to combat the growing obesity epidemic in the United States, improve cardiovascular health, reduce risk of type 2 diabetes, and help transform classrooms into “activity-permissive environments.” Studies in Britain and Australia found that students with standing desks had about a 10% decrease in sitting time that carried over to time outside of the school day. A study in the American Journal of Public Health found that 1st graders with standing desks burned 17% more calories than those at sitting desks, and effect that was even more significant for overweight children who burned 32% more calories. Furthermore, surveys indicate standing desks are well liked by parents, teachers, and students alike. Mark Benden, a professor at Texan A&M University and published author on the topic, wrote a commentary for The Conversation noting that sufficient physical activity directly impacts one’s ability to focus on challenging cognitive tasks. According to Benden, “Children become more restless and distracted with prolonged sitting. Active workstations reduce behavior problems and increase students’ attention by providing them with a different method for completing academic tasks and breaking up the monotony of seated work.” Thus standing desks could theoretically benefit children both physically and mentally. (Ariana Eunjung Cha, The Washington Post)

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July 24, 2015 at 9:00 am

Science Policy Around the Web – July 21, 2015

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By: Amanda Whiting, Ph.D.

photo credit: timtom.ch via photopin cc

Funding policy

Congress pushes NIH to spur breakthroughs through prizes

A provision in the new 21st Century Cures bill, which passed through Congress last week, would create a new program from which to launch biomedical prize competitions at the National Institutes of Health (NIH). Prize competitions have been used by other federal agencies, such as the Defense Advanced Research Projects Agency (DARPA), to offer challenges in robotics and engineering tasks as way to speed up innovation and research. Though offering prizes for success can garner applications from sources outside of the traditional academic mainstream, “there only a few places where prizes really work in health,” said Christopher Frangione, vice president of prize development at XPRIZE, a private organization dedicated to facilitating global changes and innovation through competition. For example, long term studies involving basic, fundamental research might be poor candidates for a “grand challenge” competition, whereas benefits might be seen in areas that require an engineering feat, or would be helped by encouraging interdisciplinary research. Other opponents of the bill fear that prizes would reduce grant funding through other, more traditional means, and worry that having politically appointed advisers “threatens to undermine the independent peer-review process that is the bedrock of NIH funding,” said Rep. Frank Pallone (D–NJ). Still, any new avenue to pursue ground-breaking medical research is worthy of exploration! It will be interesting to see if NIH ends up following up with the potential Innovation Prizes Program. (Kelly Servick, ScienceInsider)

Scientific rigor and reproducibility

Collaborate and listen to reproduce research

A new report from the American Society for Cell Biology (ASCB) suggests that suggests that researchers in particularly hard to reproduce fields like cell biology, could better their results in replicating published data if they reached out to the original authors for assistance or method clarification. ASCB surveyed its membership and found that 60% of those who reported problems with reproducibility said that they were able to fix the issue by checking with the lab that conducted the experiment in question to resolve issues about the methods. While this may seem like an obvious solution, some researchers may be reluctant due to competition within the field or other reasons. One solution to this issue would be to have each field adopt their own consistent standards of proof, said Mark Winey, one of the report’s authors and a molecular biologist at the University of Colorado in Boulder and chair of the ASCB’s Data Reproducibility Task Force. In addition, a majority of respondents to the survey said that the quest to publish in high-profile journals hampered reproducibility, an opinion shared by Arturo Casadevall, a microbiologist and immunologist at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. “Science is messy, and high-impact journals often demand clean stories with a clear punchline,” he says. “That creates perverse incentives for cherry-picking data.” (Chris Woolston, Nature | Research Highlights: Social Selection)

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July 21, 2015 at 9:00 am

Science Policy Around the Web – July 18, 2015

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By: Courtney Pinard, Ph.D.

Mental illness

Long-Term Adverse Effects of Childhood Mental Illness

According to the National Institute of Mental Health and the Centers for Disease Control and Prevention, 13% of children in the U.S. have a diagnosable mental illness resulting from changes in brain circuits, behavior, and cognition. A child with a mental illness is more likely to function poorly as an adult than a child without a mental illness. This was the conclusion from a population-based study published this week in the Journal of the American Medical Association (JAMA) Psychiatry. The study examined survey results of 1420 male and female participants from 11 rural counties in North Carolina, to assess if a psychiatric illness in childhood was more likely to predict negative outcomes later in life such as criminal activity, inability to keep a job, divorce, multiple addictions, multiple psychiatric problems or suicidality. Survey responses were taken over two periods, between 9 and 16 years of age and between 19 and 26 years of age. Out of the 1420 participants, 466 (30%) met criteria for subthreshold psychiatric problems only, 527 (26.2%) displayed behavioral or emotional disorders during childhood, and 427 (42.7%) never met these criteria. Participant survey responses taken between 19 and 26 years of age indicated adverse long-term outcomes for adults in the subthreshold psychiatric and behavioral/emotional disorder groups. Participants with a childhood psychiatric disorder were six times as likely to have one adverse adult outcome compared to those with no history of psychiatric problems. Those with milder symptoms were three times as likely to have problems as adults. Interestingly, many of the adult outcomes studied were related to symptoms of antisocial personality disorder. Mild cases of mental illness including emotional or behavioral disorders may remain outside of diagnosable cases, especially during childhood. While it may not be surprising that children with a mental illness often display continued impairment into adulthood, the novel findings here are that the long-term adverse effects were evident even after controlling for sex, race, childhood family hardship variables, and adult psychiatric status. (Ina Yang, NPR)

Stem Cell Research

Using Stem Cells in Research Shows Promise for Autism Models

Federal policies allowing for responsible scientific research involving human stem cells were put in place in 2009 to help scientists better understand the human body, discover new drugs, and replace tissue damaged by disease, aging, or injury. Neuroscientists can use stem cells to study disorders of brain development, such as autism spectrum disorder (ASD). Autism spectrum disorder affects 1 in 68 children in the U.S. Most cases lack a clear genetic basis, and the difficulty of re-enacting human brain development has prevented a full understanding of ASD. A new study published in the journal Cell, by the laboratory of Dr. Flora Vaccarino, the Harris Professor of Child Psychiatry and Professor of Neurobiology at Yale School of Medicine, used a three-dimensional neuron network derived from stem cells derived from the skin of four autistic patients to investigate developmental changes in individuals with severe ASD. While no known underlying genomic mutation could be identified, the researchers did find an upregulation of genes involved in cell division and synapse formation. The number of inhibitory neurons in the neuron network had also increased. A specific gene, FOXG1, was found to be responsible for the overproduction of these inhibitory neurons and correlated with patient symptom severity. Through the use of stem cells, this study may have found one biomarker of ASD that could be a potential drug target. (Melissa Healy, Los Angeles Times – Science Now)

Global Health

Crowdsourcing Simple Solutions to Save Millions of Lives

Every two minutes, a woman dies in childbirth. One in ten newborns needs help breathing and many die without proper care. Clean drinking water is rare in some parts of the world. These global health problems may be eradicated with new cost-effective innovations. The Innovation Countdown 2030 is a list of 30 innovations set up by the international nonprofit, PATH, with the goal of identifying, evaluating, and showcasing health technologies with great promise to save lives. The top 30 were chosen by independent health experts and include a uterine balloon tamponade developed by Massachusetts General Hospital used to stop bleeding in hemorrhaging women, a Zimba Batch Chlorinator to chlorinate water, and a Laerdal Upright Resuscitator to help babies breathe. Most of the innovations on the list are currently in use or undergoing trials in developing countries. With projects like The Innovation Countdown, PATH aims to help make the Sustainable Development Goals, as defined by the United Nations, into reality. (Ina Yang, NPR)

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July 18, 2015 at 9:00 am

Science Policy Around the Web – July 14, 2015

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By: Agila Somasundaram, Ph.D.

Climate Change

Climate Change Is Shrinking Where Bumblebees Range, Research Finds

Climate change has caused the geographical range of bumblebees in North America and Europe to shrink, according to a recent study published in Science. Increasing temperatures have caused the southern limits of bumblebee travels to shrink by 170 miles since the 1970s, but there is no corresponding increase in the northern limits of their travels, likely because the northern areas may be less habitable to the bees. The researchers, led by Jeremy T. Kerr, conversation biologist at University of Ottawa, Canada, studied 67 species of bumblebee in North America and Europe. They compared populations from 1974-2010, when temperatures started increasing, to 1901-1974, when climate change was less of a concern. They found that the southernmost geographical limits of the bumblebee retreated north at about 3 miles per year, and that the trends were quite similar for Europe and North America. Dave Goulson, a bee biologist at the University of Sussex in England, says that he is not surprised by the findings given that bees thrive in cooler climes and would be affected by temperature changes. Many entomologists who disagree with the findings say that the study provides a correlation between climate change and decreasing bumblebee habitat, but not direct evidence that warming climates are the major cause. Entomologists Sydney Cameron and James Strange warn that there are other factors that could affect bumblebee habitat, such as pesticide use, parasites and habitat destruction, and it is too early to say that climate change is the main reason for bumblebees’ shrinking habitat. (Nicholas St. Fleur, The New York Times)

Biomedical research funding

21st Century Cures bill sails through House

The U. S. House of Representatives recently approved the 21st Century Cures Act, a bill to speed the discovery and development of new health cures. The bill supports new funding for the National Institutes of Health (NIH) – $8.75 billion over 5 years, $500 million per year to fund research within NIH’s 27 institutes, including research on precision medicine, while the remaining money would fund high-risk, high-reward research, intramural research and others. The bill also authorizes $550 million to the Food and Drug Administration (FDA) to handle new responsibilities including priority review process for certain antibiotics, speedy approval for certain medical devices, and creation of new guidance documents for drug developers. New provisions include ones that would allow the FDA to approve cures for rare, life-threatening diseases based on smaller clinical trials, given the difficulty in recruiting large number of patients for these studies. Though the bill has the support of many industries, research and patient organizations, it has raised concerns about whether speeding cures might compromise patient safety. There are concerns about “…the misperception that you might be able to speed innovation by lowering standards for safety and efficacy, and we think that would be a terrible mistake,” said former FDA commissioner Margaret Hamburg. Safety concerns include risks of using fast track antibiotics on patients who may not fit the profile of people the drugs were originally tested on, and the risk of increased antibiotic resistance that might result from increased use of newer antibiotics by hospitals, encouraged by higher Medicare reimbursements. An amendment passed with the bill directs the Center for Disease Control and Prevention to study whether increased incentives for the use of new antibiotics would lead to increased antibiotic resistance. The bill is now headed to the Senate. (Kelly Servick, ScienceInsider)

Drug safety

Should you take painkillers? FDA bolsters safety labels, warns of heart attack, stroke risk.

The FDA recently strengthened its safety warnings on over-the-counter and prescription painkillers. Painkillers can increase the risk of heart attack and stroke, and these new labels will be added on non-steroidal anti-inflammatory drugs (NSAIDs), a commonly used class of painkillers for temporary and chronic pain, including ibuprofen (Advil and Motrin) and naproxen (Aleve). A safety label has already been on NSAIDs since 2005, but now the wording would be changed from “may cause” problems, such as heart attack and strokes, to “cause.” A number of research studies have shown that long-term use of high doses of NSAIDs can increase the risk of cardiovascular diseases and death. But recent studies show that the risk of heart attack and stroke are associated with even short-term use of these drugs. Though the risk is higher for people with a history of cardiovascular diseases, everyone may be at risk, says Judy Racoosin, deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products. The FDA says that consumers can still take NSAIDs, given that they are effective in treating pain, but people should avoid taking more than one NSAID containing drug at the same time. Also, people should watch for symptoms of a heart attack and stroke, and seek medical help. (Ariana Eunjung Cha, The Washington Post)

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July 14, 2015 at 9:00 am

Science Policy Around the Web – July 10, 2015

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By: Daniël P. Melters, Ph.D.

Picture source: Pictures of Big Data

Big, big data

Big Data: Astronomical or Genomical?

Computing power increases according to Moore’s law, which states that the number of transistors in central processing units (CPUs) double every two years or so. However, this exponential increase in computing power has been humbled by rapid growth in the amount data being generated by DNA sequencing, and was observed back in 2012. As a consequence, more and more computing resources are needed to handle and store genome data. A recent report in PLoS Biology has argued that genomic data production will exceed the storage resources of that needed to handle both Twitter and Youtube combined. They estimate that in 10 years time between 100,000 and 2 billion human genomes will be sequenced. To store all this data would require about 2-40 exabytes (or 2-40 million terabytes), including storing all sequencing errors and preliminary analysis.

The need to be able to store large quantities of genomic data is a realistic challenge, and a number of groups around the globe are working towards that goal. The authors of the PLoS Biology paper did not consider any major improvements in data compression technologies in their analysis but various groups (here, here and here) are in the process of developing such technologies. One group claims to be able to compress genomic data by ~9,500 fold, compared to the current National Center for Biotechnology Information (NCBI) standard used to store genomic data (.sra) 46.9 fold. Europe has set sight on a continent-wide computing cloud to facilitate data sharing between research groups in various scientific disciplines. As well, stemming from the January 20th announcement of the Precision Medicine Initiative (PMI), the National Institutes of Health (NIH) has started to draft how it will approach the vast amount of genomic data that PMI will require. Many angles are being worked on to handle the ever growing volume of genomic data and a coordinated effort might be beneficial to streamline the efforts towards this. (PLoS Biology Perspective)

Chemical regulations

New U.S. rules on helium sales said to stifle competition

Two years ago, Congress passed the Helium Stewardship Act designed to establish a competitive market for federal helium by switching from having the U.S. Bureau of Land Management (BLM) sell off helium at a fixed price to instead selling it at auction. A recent congressional panel showed the opposite effect of this new law. The number of companies buying from the reserve fell by 50% (from 8 to 4). Helium is a indispensable noble gas for many types of technology and scientific research, including cooling MRI scanners, industrial leak detection systems, and telescope lenses. As a byproduct of natural gas drilling, the U.S. accrued a vast reserve of helium from the 1960s onward. In a natural geological formation near Amarillo, Texax about 1 trillion liters of helium gas is stored. In 1996, U.S. Congress passed the Helium Privatization Act ordering BLM to sell the helium reserve. This law forced BLM to sell helium at a price that would recoup the amount the government had spent in accumulating the gas. This selling strategy led to wasteful use of helium, as a 2010 report from the National Academies’ National Research Council pointed out. Furthermore, BLM had a mandate that lasted up to the point when all the $1.3 billion was recouped. That would have happened in September 2013, leaving about 370 billion liters of helium stored away. This led Congress to pass the Helium Stewardship Act. Of the 12 companies that sell refined helium, only four refine the helium themselves and these four companies used the auction to limit their competitors access to federal reserves of helium by being willing to pay premium (+52% compared to non-auction prices) for the gas. At the end of the day, the various companies and researchers are the ones that suffer most as some people pay as much as $40 per liter of liquid helium. The helium reserve is expected to last another six years. The next BLM auction is scheduled for August 18th. (Adrian Cho, ScienceInsider)

Antibiotic resistance

Bacteria-Eating Viruses Could Be New Ally Against Superbugs In A ‘Post-Antibiotic Era’

Bacteriophages are viruses that are capable of infecting and killing bacteria in a host-specific manner. While it is dangerous for humans when a virus jumps the species-barrier – as was the case with the swine flu (H1N1 pandemic) and SARS (whose origin is thought be to be the masked palm civet) – it is extremely rare for viruses cross kingdom-barriers, as would be required for bacteriophages to infect humans. In light of the increasing reports of antibiotic resistant bacteria, the World Health Organization has classified this threat as a growing global health problem. An alternative approach to tackling antibiotic resistance would be combat bacteria with its natural enemies: bacteriophages. After all, they are been extensively used and studied in biomedical science. A few European countries already use bacteriophages to combat bacterial infections, but they are not authorized as a medicinal product. Physicians would like to see regulatory agencies allow them to use phages on a single-patient basis, whereas pharmaceutical companies’ ultimate aim is to achieve marketing authorization in the European Union. The European Medicines Agency (EMA) held a workshop on the therapeutic use of bacteriophages on June 8th. The EMA emphasized that the efficacy and safety of phages in a clinical setting need to be shown first before any further recommendations for approval can be given, similar to established treatment methods. This is not the case for bacteriophage therapy at the moment for which very few randomized controlled clinical trials have been conducted to date. Nevertheless, the EMA is looking forward to gathering more robust evidence on the value of bacteriophage treatments and to further discussing the scientific and regulatory aspects relating to the biological characterization of the phages. Pharmaceutical companies are encouraged to engage in early dialogue with EMA by applying for scientific advice through which they can receive further guidance on how to develop their products. (Ben Hirschler, Huffington Post)

Quick note!

Marcia McNutt, editor-in-chief of the Science family of journals, has been nominated to become the first female president of the U.S. National Academy of Sciences.

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Written by sciencepolicyforall

July 10, 2015 at 10:31 am

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