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Archive for March 2015

Science Policy Around the Web – March 31, 2015

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By: Julia Shaw, Ph.D.

An Ebola treatment unit in Guinea. Photo by Samuel Hanryon/MSF

Ebola Drug and Vaccine Trials

Scientists Argue over Access to Remaining Ebola Hotspots

In contrast to previous outbreaks which were much smaller and relatively quickly contained, the current Ebola outbreak in West Africa is the worst the world has seen, causing close to 25,000 cases and 10,000 deaths. Although tragic, the scale of the outbreak should benefit the development of future vaccines and treatments for Ebola as studies advance through phase I safety studies to begin phase III efficacy testing. However, as the epidemic winds down, tensions are mounting as multiple organizations seek to complete their large-scale vaccine and drug studies.

Researchers at the National Institutes of Health (NIH) are hoping to move a vaccine study from Liberia, where new cases are few and far between, to Guinea, which reported 45 new cases last week. Yet Guinea is already host to a vaccine trial sponsored by Doctors Without Borders (MSF) and the World Health Organization (WHO) which began vaccinating last Monday. While Clifford Lane of NIH suggests “a country like Guinea is big enough to do at least two studies,” Peter Smith, an epidemiologist and chair of the board of the Norwegian Global health and Vaccination Research Program (which is co-funding the MSF/WHO vaccination trial) stated, “it would not be feasible to successfully run both trial in Guinea at the same time (unless there is a radical change in the epidemiology of the disease in Guinea and disease rates increase. . .).” The two sides have yet to meet in person to discuss the options. An assistant director-general at WHO, Marie-Paule Kieny, noted that “A compromise could be to run the two trials one after the other.” Lane contends that the ring-vaccination study approach adapted by WHO-MSF does not adequately assess longer term protection and that the NIH’s randomized controlled trial is a better approach “to get the most effective vaccine as quickly as possible to the largest number of people possible” and should not be delayed. Similarly, an NIH-led trial to test the therapeutic antibody cocktail, ZMapp, is expanding from Liberia to Sierra Leone where researchers from the University of Oxford have already begun a therapeutic trial of TKM-Ebola, another treatment which uses small interfering RNAs to limit viral replication. Lane is working with the government of Sierra Leone to provide patients with access to ZMapp which has shown better results in animal studies compared to TKM-Ebola. According to Lane, the government of Sierra Leone decides what treatment units will participate, and Port Loko, site of the TKM-Ebloa study, is currently not included in the list. However, if  ZMapp is introduced into treatment units that already have trials underway, Peter Horby, lead investigator of the TKM-Ebola study, says this would “jeopardize ongoing trials and lead to conflict.” (Kai Kupferschmidt, ScienceInsider)

Scientific Peer Review

Major Publisher Retracts 43 Scientific Papers Amid Wider Fake Peer-Review Scandal

United Kingdom-based BioMed Central, publisher of 277 peer-reviewed journals, recently retracted 43 papers due to “fabricated” peer reviews. Peer review is the process by which experts in a scientific field anonymously read and critique a submitted manuscript, judging whether it should be published based on scientific merit. Unfortunately, the process can be weakened or manipulated by poor reviewers, cronyism and outright fraud. In an investigation that began last year, BioMed Central’s associate editorial director for research integrity, Jigisha Patel, describes suspicions that surfaced due to a pattern of unusual e-mail addresses among reviewers and the discovery that the same author was reviewing different, highly specialized topics. Ultimately it was found that the scientists identified as reviewers had not actually written the reviews; someone else had simply used their names. A retraction associated with the articles states, “A systematic and detailed investigation suggests that a third party was involved in supplying fabricated details of potential peer reviewers for a large number of manuscripts submitted to different journals.” The pressure to publish may open the door for these third party agencies that offer language and publication assistance. According to Patel, “if authors are naïve and want to get their manuscripts published, they can be exploited.” The Committee on Publication Ethics, which includes over 9,000 journal editors, issued a statement calling attention to the “systemic, inappropriate attempts to manipulate the peer review processes of several journals across different publishers,” indicating this type of fraud is widespread and in no way limited to BioMed Central. (Fred Barbash, The Washington Post)

Pharmaceutical Regulation

Makers of Generic Drugs Challenge F.D.A. Plan for Updated Warnings

In 2013, the Food and Drug Administration (FDA) proposed requiring generic drug companies to update their labels if previously unknown health risks are discovered. Currently, generic drug producers cannot alter labels to reflect new health warnings unless it is ordered to do so by the FDA, while brand-name manufacturers do make changes as risks are discovered and the changes are later approved by the FDA. Public Citizen, a consumer advocacy group, supports the proposed rule, noting that the FDA lacks the resources to monitor changes for the numerous generics on the market. The drug industry counters that the proposed rule would make them vulnerable to expensive lawsuits resulting in increased costs. They further argue that they lack the full range of data available to the FDA from the brand-name producer and other sources with the end result being confusion as companies making the same drug might have different warning labels. The director of the health research group at Public Citizen, Dr. Michael Carome, admits generics are a great benefit to the public but maintains, “. . . because they dominate the market, it’s critical that they have full incentives to engage in robust monitoring of safety.” In response to the strong resistance from the generic industry including threats to sue, the FDA has reopened the period for public comment on the proposed rule until April 27th. (Sabrina Tavernise, The New York Times)

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March 31, 2015 at 9:00 am

Antibiotic Resistance: Incentivizing the Disincentive

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By: Aminul Islam, Ph.D

photo credit: danielfoster437 via photopin cc

Thanks to the serendipitous discovery of antimicrobial agents by the Scottish scientist, Sir Alexander Fleming in 1928, society at large has benefited tremendously from improved public health and advanced medical and agricultural practices. However, according to CDC (Centers for Disease Control and Prevention) reports, nearly two million people have become infected with bacteria that are resistant to antibiotics and at least 23,000 people each year die as a direct result of these infections in the U.S. This is in stark contrast to the statement supposedly made by the U.S. Surgeon General Dr. William Stewart in the 1960s that: ‘It was time to close the book on infectious diseases, and declare the war against pestilence won’. So is the golden age of antibiotics really coming to an end?

There are many issues which are thought to have contributed to the rise in antimicrobial resistance to antibiotics. They range from inappropriate prescribing by primary care physicians to reckless overuse within the agricultural industries. One major issue has been the inability of the pharmaceutical industry to continue producing new antibiotics to replace old ineffective ones. Indeed, the pipeline for developing new antibiotics has been pretty bare since 1987 as no new class of antibiotics for treating systemic infections has been developed. As a result, the marketing of a new antibiotic has become rather rare recently with a majority of the major pharmaceutical companies either closing their facilities or withdrawing from the pursuit of new antibiotic development; since it is deemed to be an unprofitable business venture. What is clear is that financial incentives are necessary to encourage research and development for novel antibiotics from within the pharmaceutical industry.

So how can we incentivize “Big Pharma” to once again see the development of new antibiotics as a profitable investment? In my opinion, this would require innovative public-private-partnerships and government policies which incentivize the development of new antibiotics without jeopardizing the preservation of current and future antibiotics. In particular, policies are needed which promote long-term antibiotic stewardship as well as sustainable business models for the private sector. This would be a tough balancing act considering that the success of nearly all pharmaceutical products are intrinsically linked to the number of units sold during the period of market exclusivity by employing aggressive marketing strategies to drive and increase sales – a practice which is all too common within the industry, but counterintuitive with regards to antibiotic preservation. Within the last year, six new antibiotics (dalbavancin, oritavancin, tedizolid, ceftobiprole, ceftazidime-avibactam and ceftolozane-tazobactam) have been approved under the FDA’s Qualified Infectious Disease Product (QIDP) framework based on the Generating Antibiotic Incentives Now (GAIN) Act, passed in July 2012, which gives these drugs an extra five years of market exclusivity. But this legislation does not either account for or guarantee long term antibiotic stewardship for these or any other antibiotics and in my opinion is not a comprehensive answer to the issue of antibiotic resistance.

I personally do not believe the golden age of antibiotics is at an end, primarily due to the attention this important issue is receiving lately (e.g. federal budget proposal for FY16) and by the governments response in setting up the President’s Council of Advisors on Science and Technology (PCAST) and executive order to combat antibiotic resistant bacteria. However, until we truly link both the incentives to developing antibiotics and the remuneration for using antibiotics directly to the conservation of current and future antibiotics, the threat of antibiotic resistance will not be fully eliminated and the market sector will remain disinterested to the needs of society for sustainable antibiotic stewardship.

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March 30, 2015 at 9:00 am

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Science Policy Around the Web – March 27, 2015

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By: Agila Somasundaram, Ph.D

Amazon Manaus forest” by Phil P Harris. – Own work. Licensed under CC BY-SA 2.5 via Wikimedia Commons.

Climate Change

Amazon Forest Becoming Less of a Climate Change Safety Net

Forests help reduce global warming by absorbing carbon from the atmosphere and releasing oxygen in return. In a recent study done by a team at the University of Leeds, Britain, researchers reported that the ability of the Amazon forests to absorb excess carbon is declining over time, a finding that does not bode well for the environment. Even though carbon emissions have been drastically increasing, the Earth’s forests and oceans have surprisingly kept up with it. But the study, done over 30 years, covering 189,000 trees across 321 plots in the Amazon basin, has reported that carbon uptake in the Amazon has fallen by half since its peak in the 1990s. Researchers postulate that the rising carbon dioxide levels may have initially sped up the growth of the trees, but the increased metabolism of trees may have led to the decline in carbon absorption. “With time, the growth stimulation feeds through the system, causing trees to live faster, and so die younger,” says Oliver L. Phillips, a tropical ecologist at the University of Leeds and one of the lead researchers of the study. Though forests are still absorbing more carbon than they are releasing, the question is if this trend will reverse. Will other forests also decrease their carbon absorption over time? “Forests are doing us a huge favor, but we can’t rely on them to solve the carbon problem,” Dr. Phillips said. “Instead, deeper cuts in (carbon) emissions will be required to stabilize our climate.” (Justin Gillis, The New York Times)


White House Science Fair celebrates student research

On March 23, 2015, the White House hosted its fifth annual White House Science Fair, where more than 100 elementary, middle and high-school students showcased their exciting and innovative research accomplishments in science, technology, engineering and mathematics (STEM) to President Obama and other government officials. “We’ve got to celebrate the winners of our science fairs as much as we celebrate the winners of football or basketball or other athletic competitions,” said President Obama. 35 student teams, the winners of STEM competitions across the country, exhibited their projects that ranged from disease diagnostics and clean energy, to enhanced information security. Sixteen-year old Sophia Sánchez-Maes has developed energy-efficient ways of extracting lipids from algae, and optimizing their use in biofuel production. Eric Koehlmoos, 18, has found that treating prairie grass with calcium hydroxide could boost ethanol production, making it a viable alternative to corn-based ethanol. Nikhil Behari, 14, created a computer protocol that measures each individual’s unique typing style to help protect online user identity. Other exhibits included carbon dioxide-powered batteries, software to identify genetic mutations that cause breast cancer, spine implants for scoliosis patients, and a Lego-based automatic page-turner. As part of the Fair, President Obama announced $240 million in funding for the ‘Educate to Innovate’ program, including a $150-million philanthropic effort to empower promising early-career scientists to become scientific leaders, a $90 million ‘Let Everyone Dream’ campaign to expand STEM opportunities to under-represented youth, and a $25 million Department of Education competition to create science- and literacy-based media to inspire students to explore. The announcements also included 120 universities and colleges to train 20,000 engineers to tackle the ‘Grand Challenges’ of the 21st century, and a coalition of CEOs called ‘Change the Equation’ to expand STEM programs to 1.5 million more students this year. The theme of this year’s science fair was ‘Diversity and Inclusion in STEM’, and the fair emphasized the importance of including minorities and women in science. “Science is for all of us,” Obama said, “and we want our classrooms and labs and workplaces and media to reflect that.” (Emily Conover, Science)

Climate Change

Arctic Ice Reaches a Low Winter Maximum

The Arctic Ocean is covered by a large amount of ice that fluctuates on a seasonal basis – the ice peaks around March, after which it melts during the warmer spring and summer climes, and reaches its minimum around September every year. This year the arctic ice reached its annual peak on Feb 25, two weeks earlier than average, and the ice cover is lower than it has been at the end of a winter, since 1978, says the National Snow and Ice Data Center in its report. The center said that this could be partly explained by recent changes in weather patterns – the North Pacific was warmer, and the south was cooler with heavier snows, because of the change in spread of the atmospheric jet stream of cold air. Walt Meier, a NASA scientist, says that the summer minimums of ice cover in the Arctic can have a greater effect on global climate than winter maximums, and that the winter ice cover is not a good predictor of how much ice will be left by the end of summer. This is because during winter, the ice near the edges of the sheet are thin, and melt, whereas the thicker ice in the center melt during summers. “When you lose summer ice you aren’t really just losing it for that year, you’re also losing some ice from many years ago,” he said. “That makes it harder for things to go back towards normal.” This long-term decline in the Arctic sea ice is mainly driven by global warming as a result of huge emissions of greenhouse gases by humans. (Derek Watkins, The New York Times)

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March 27, 2015 at 9:00 am

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Invisible No More: Making Progress on Policies for Postdoctoral Training

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By: Sylvina Raver, Ph.D.

The biomedical research enterprise in the United States is in trouble. Recent unprecedented volatility in federal research funding has prompted the biomedical workforce to grow at a faster pace than the number of available research positions. Funding booms, such as those that occurred in the late 1990’s and early 2000’s, enabled research institutions to train more young scientists, while simultaneously increasing the dependence of the entire research structure upon external federal funding. Subsequent funding cuts, as have occurred since 2003, cause the research system to contract and force young investigators into a saturated employment market after they complete their training. This workforce imbalance is a key driver of the hyper-competitive environment that now permeates the entire biomedical research endeavor and has prompted scientific leaders and professional societies, such as the Federation of American Societies for Experimental Biology (FASEB), to call the current state of US research “unsustainable,” and demand “immediate attention and action” to address its flaws.

Postdoctoral researchers, or postdocs, are vital to the research enterprise, as they perform much of the nation’s research, train junior scientists, and write grant applications and publications. Postdoctoral training conforms to an apprenticeship model in which postdocs are trained in the image of their mentor (the PI) and are expected to devote all of their effort toward conducting lab research. However, recent accounts suggest that only 15% of postdocs will go on to head a research lab. PI’s often lack knowledge about career trajectories outside of academia, and many universities and research institutions do not offer professional development for careers other than in research. The length of postdoctoral appointments has steadily increased, indicating that postdocs are struggling to find suitable positions after completing their training. Indeed, the average age at which a new investigator in the United States lands a tenure-track academic position is now 37 years old.

Despite the crucial role that postdocs play in the research community, they have long been considered an “invisible university”, as data on their numbers and career outcomes have not been well-documented. Around 30,800 to 63,400 postdocs are estimated to be currently pursuing science, health, or engineering research in the US. However, these estimates are grossly inaccurate, as these numbers do not include postdocs employed outside of academia, those training in the humanities, or postdocs with doctorates from non-US universities who may represent as much as 60% of the population. Postdocs often exist in a nebulous realm between employment categories and can thus find themselves without many benefits, such as health insurance or retirement contributions, afforded to other employees with comparable credentials and experience.

The National Postdoctoral Association’s (NPA) 2014 Institutional Policy Report revealed a typical postdoc in the US today is a scientist in their early to mid 30’s: who is likely a foreign citizen with a temporary visa, who holds their appointment for 5-6 years, is paid the minimum NIH National Research Service Award (NRSA) recommended stipend of $42,000, and who may be offered professional development only for a research career. Given the likelihood that postdocs will find a career away from the bench, training in skills relevant to an expanded sphere of employment is crucial.

The NPA is dedicated to improving the postdoc experience through education, advocacy, and community building. It convenes an annual meeting to pursue this mission in coordination with individual postdocs, Postdoctoral Associations (PDAs), Postdoctoral Offices (PDOs) and other organizations that share a stake in postdoctoral training. The 2015 meeting was held from March 13-15, during which attendees discussed pressing issues affecting the postdoc community and the biomedical research enterprise, and identified possible solutions to many of these challenges. While PDAs and PDO’s strive to enact the NPA’s recommendations at their home institutions, the NPA is actively consulting with national agencies, including the NIH, the National Science Foundation (NSF), and the National Academy of Sciences, on policy decisions that affect the entire postdoc community. Ongoing NPA advocacy efforts include proposed “increases for NIH training stipends, requirement for mentoring plans on NIH grants, more independent funding for postdocs, and increased data collection on postdocs, including tracking outcomes” (page 4 of the NPA’s 2014 Institutional Policy Report).

The NPA is not alone in its efforts, and through coordination with other groups, significant progress for postdocs has been made. A follow-up to a 2000 National Academies’ report titled, The Postdoctoral Experience Revisited, notes many major achievements. For example, the NPA’s creation in 2003 has provided a unified voice for the postdoc community, and more research institutions are participating in the NPA’s National Postdoc Appreciation Week, which recognizes postdocs’ efforts. Many universities are creating designated offices to better serve postdocs’ needs. The NSF now requires research proposals that include plans for hiring a postdoc to also include plans for mentorship. The American Association for the Advancement of Science (AAAS) has developed myIDP, an online tool that helps postdocs better understand available career options and helps them create individual development plans to better inform career decisions.

Despite these achievements, the 2014 National Academies report outlines six interconnected recommendations for improving postdoctoral training that will require concerted and coordinated efforts at all levels of the research enterprise for successful implementation:

  1. Period of Service: limit postdoc appointments to 5 years, barring extraordinary circumstances,
  2. Title and Role: reserve the title of “Postdoctoral Researcher” only for those requiring advanced research training,
  3. Career Development: expose graduate students to non-academic career paths in their first year of training, and explain that postdocs are only for those wishing to continue in research,
  4. Compensation and Benefits of Employment: raise the NIH NRSA postdoc starting salary to $50,000, annually adjust it for inflation, and provide the same benefits to postdocs that are provided to equivalent full-time employees,
  5. Mentoring: encourage host institutions and funding agencies to urge postdocs to seek advice from multiple mentors; hold institutions accountable for evaluating the quality of mentorship,
  6. Data Collection: maintain a database that tracks postdoctoral researchers, including non-academic and foreign-trained postdocs.

The venerated reputation of National Academy members lends credibility and political clout to these policy recommendations. However, some young investigators are eager to take more active roles in the future of the research enterprise. In October 2014, a team of Boston area postdocs held a symposium titled, “The Future of Research”. This event included workshops that elicited the opinions of postdoc and graduate student participants on “problems and solutions surrounding training, the structure of the research workforce, funding, and incentives and rewards in science.” A report of this event was quickly made available and distilled many ideas discussed during this symposium into three overarching recommendations:

  • Increase connectivity between junior scientists and other stakeholders
  • Increase transparency of career outcomes for postdocs and expectations for individual postdoctoral appointments
  • Increase investment in junior scientists to allow for greater independence at this stage of training

The Future of Research organization provides resources for those interested in convening similar symposia to engage their local postdoc communities.

            The challenges faced by the postdoctoral research community are complex and require coordination among all stakeholders to remedy. Although postdocs may feel as though they toil in the background of the research enterprise, it is encouraging to know that organizations such as the NPA, the National Academies, PDAs, PDOs, and grassroots assemblies of postdocs are working daily to enact meaningful change.

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March 26, 2015 at 9:00 am

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Combating Antibiotic Resistance: Are We On Our Way?

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By: Ashley Parker, Ph.D

Antibiotics have been used to treat bacterial infections for more than 70 years. Bacteria and fungi naturally produce these antimicrobial compounds to kill other microbes in their environment. The first antibiotic, penicillin, was discovered by Alexander Fleming, a professor of bacteriology at St. Mary’s Hospital in London. Most people are familiar with this antibiotic, which has saved many lives since the 1940s. Unfortunately, what was once considered to be a “miracle drug” in treating infectious diseases is no longer effective against some bacterial strains. Many classes of antibiotics have been discovered since the discovery of penicillin but unfortunately, the widespread use and abuse of those antibiotics has led to increased selection for antibiotic resistant bacteria. Microbes use various mechanisms to prevent antibiotics from killing, and thus fail to respond to antibiotic treatments. Due to the rise of antibiotic resistant bacteria, it is important to understand current strategies and developments to combat antibiotic resistance, and the various challenges.

There have been several reports of “superbug” outbreaks in the United States and across the world. Tuberculosis outbreaks in Europe are a major concern, with increasing cases of multidrug resistant tuberculosis (MDR-TB). The World Health Organization (WHO) reported in the 2014 Antimicrobial Resistance Global Report on Surveillance that 3.6% of new TB cases and 20.2% of previously treated cases were estimated to be MDR-TB with higher incidences in Eastern Europe and central Asia. Within the report on antimicrobial resistance, the WHO also reported national data on the bacterial pathogens: E. coli, K. pneumonia, and S. aureus showing that the proportion of these bacteria resistant to commonly used antibiotics was more than 50% in various settings. Recent outbreaks in the U.S. involved two California hospitals and one in Hartford, Connecticut that were associated with carbapenem-resistant Enterobacteriaceae (CRE) and drug resistant E. coli respectively.

Over the past 40 years, no new classes of antibiotics have been developed to treat gram-negative bacilli, such as E. coli and those seen in recent outbreaks. The U.S. Food and Drug Administration (FDA) has only approved two systemic antibiotics for use in humans from 2008 to 2014. According to the Centers for Disease Control and Prevention (CDC), at least 2 million people become infected with drug resistant bacteria in the United States and 23,000 deaths are reported to be directly related to these infections. As of December 2014, the Pew Charitable Trusts, published that 37 new antibiotics were in development. Of the 37 antibiotics, 10 were in Phase I clinical trials, 18 in Phase II, 8 in Phase III, and only one had been submitted for a new drug application. Most of these antibiotics are reported to be potentially effective against the current drug resistant bacteria; however, not all of the antibiotics. Considering there is only a single drug that has passed phase 3; this is clearly a major public health concern, and combating antibiotic resistance in the future will likely require national and international efforts. The U.S. has begun efforts to deal with this multifaceted problem with Congress passing the Generating Antibiotic Incentives Now (GAIN) law as part of the FDA, to extend the time of generic competition by 5 years for antibiotics that are proven to effectively treat infectious diseases.

On September 18, 2014, President Obama signed an executive order to direct federal departments and agencies to combat the rise of antibiotic resistance. In addition, with sponsorship from the National Institutes of Health and the Biomedical Advanced Research and Development Authority, the Obama administration announced a $20 million prize to rapidly implement point-of-care diagnostic tools, to identify multidrug resistant infections in healthcare facilities. In this executive order, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria was established to provide oversight for programs and policies that intend to preserve antibiotic effectiveness, along with many other efforts. To preserve the power of current antibiotics, the CDC is encouraging hospital CEOs and medical officers to appoint leaders to support program outcomes and improve prescribing practices, monitor prescribing and antibiotic resistance patterns, and offer education about antibiotic resistance to health care providers. The Departments of Health and Human Services, Defense, and Veteran Affairs will also serve a major role in improving antibiotic stewardship in compliance of the efforts outlined by the CDC.

Aside from the healthcare industry, the agricultural industry also plays a significant role in combating antibiotic resistance due to the use of antibiotics for farm animals — which may have led to reported outbreaks of antibiotic resistant strains in animal livestock. In 2007, the U.S. experienced the first reported outbreak of methicillin-resistant Staphylococcus aureus (MRSA) in farm pigs. MRSA infections can be life threatening and account for half of the more than 14 million skin and soft-tissue infections seen in the U.S each year. According to the CDC, there are approximately 100,000 cases of invasive infections each year. However, the White House has advised the U.S. FDA to continue making efforts to eliminate the use of antibiotics for the growth-promotion of animals in agricultural settings, but allow for medically important antibiotic usage that will be monitored by the National Healthcare Safety Network. In addition, the White House advisory council will provide insight and recommendations for strengthening the surveillance of antibiotic resistant infections, promote advanced research on new antibiotic treatments, seek antibiotic alternatives used for agricultural purposes, and improve global efforts to tackle antibiotic resistance.

On March 16, 2015, Gerard O’Dwyer published an article discussing a methicillin-resistant Staphylococcus aureus (MRSA) outbreak in Norway. The Norway food safety authority discovered six new pig herds infected with livestock-associated methicillin-resistant S. aureus, also known as LA-MRSA. International actions on combating antibiotic resistance, particularly for MRSA and C. difficile infections, are of political interest in England. In September 2013, the United Kingdom (UK) released its Five Year Antimicrobial Resistance Strategy, cosponsored with the Veterinary Medicines Directorate of the Department for Environment, Food and Rural Affairs, the Northern Ireland Executive, the Scottish government, the Welsh government, and the UK Public Health agencies. The antimicrobial resistance action plan covered seven core areas: addressing the efforts to improve infection prevention and control practices, optimizing prescribing practice, improving professional education, training, and public engagement; developing new drugs, treatments, and diagnostics; improving access and use of surveillance data; improving identification and prioritization of antimicrobial resistance; and strengthening international collaboration.

Overall, fighting antibiotic resistance is a major public health concern in the U.S. and abroad and must involve multiple entities, including the federal government and agencies, health care professionals, and individuals of the general public. The Obama administration and other international governments have prepared extensive guidelines and taken the necessary measures to effectively address the threat of antibiotic resistance; however the battle against antimicrobial resistance will be a continuing effort that is not expected to resolve immediately.

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March 25, 2015 at 9:00 am

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Science Policy Around the Web – March 24, 2015

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By: Courtney Pinard, Ph.D

Open Access

NSF unveils plan to make scientific papers free

The National Science Foundation (NSF) unveiled a plan last week that will require their grantees to make their peer-reviewed research papers freely available within 12 months of publication. This plan comes two years after the White House Office of Science and Technology Policy ordered U.S. federal science agencies to devise their own public-access policies. According to the plan, archives of full-text articles will be available on the publisher’s website. The push for public-access policies by some scientists and activists has been happening since the late 1990s with the National Institutes of Health (NIH) leading the effort with PubMed Central repository. Many publishers critical of repositories like PubMed Central say that public access policies infringe on their copyright and decrease their revenues. In response to these concerns, NSF has decided to work with the Department of Energy to create a system called PAGES (Public Access Gateway for Energy and Science). PAGES will contain abstracts, authors, and other metadata, but not the full-text paper. Instead, PAGES will provide a link to the full-text paper on the publisher’s website. In the future, NSF may allow open access to full-text papers through other repositories. (Jocelyn Kaiser, ScienceInsider)

Infectious Disease

Is Tuberculosis Still a Risk?

Tuberculosis is a widespread, and in many cases fatal, infectious disease caused by various strains of mycobacteria. Tuberculosis (TB) was once the top killer in the U.S. during the 19th century. With the advent of antibiotics, TB cases have steadily declined. In 2013, for example, 9,588 cases were reported in the U.S. Because of antibiotic resistant strains, there has been a surge in the number of people falling sick with TB in recent decades. Just last week, 27 people tested positive for TB at Olathe Northwest High School in Olathe, Kansas after a single case prompted testing. Due to the strength of their immune systems and access to proper antibiotics, none of these 27 people had symptoms, nor were they contagious. Without the correct treatment, however, more than 80% of people die from the infection. In fact, TB is the second leading cause of death in adults world-wide after HIV, and affects 1 million children each year. Two-thirds of the drug-resistant cases are found in the BRICS countries – Brazil, Russia, India, China and South Africa. Health policy officials in these countries started working on a TB treatment access plan more than two years ago, but little progress has been made. According to a report by the World Health Organization (WHO), three million people developing tuberculosis in BRICS countries are missed by national notification systems each year and only a fraction of cases are being treated. The WHO report emphasized the need to improve vulnerable populations’ access to quality tuberculosis care in low- to middle-income countries. Maybe, one day, TB-infected individuals in BRICS countries will have similar access to TB medical testing and treatment as those in Olathe, Kansas have. (Jacob Creswell, WHO; Dr. Salmaan Keshavjee, NPR)

Global Health and Agriculture

For the love of pork: Antibiotic use on farms skyrockets worldwide

As the developing world becomes richer, more and more people are consuming meat. Increased meat production will lead to the skyrocketing use of antibiotics, according to a study published last week in the Proceedings of the National Academy of Sciences. The study estimates that of the 228 countries who use antibiotics in livestock, total consumption will increase 67% from 63,151 tons in 2010 to 105,596 tons by 2030. The authors suggest that a huge rise in farm drug use will be especially prevalent in middle-income countries, where there is no regulation of antibiotic use on farms. That being said, although the United States Food and Drug Administration has made efforts to limit antibiotic use, critics say U.S. policies passed so far support “voluntary cooperation,” not binding regulation. (Michaeleen Doucleff, NPR)

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March 24, 2015 at 9:00 am

Science Policy Around the Web – March 20, 2015

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By: Amanda Whiting, Ph.D

Biotechnology and Bioethics

Scientists Seek Ban on Method of Editing the Human Genome

With great power comes great responsibility. The inventors of a simple and effective technique for editing and making heritable changes to human DNA have called for a worldwide ban on exactly that until the scientific and ethical consequences can be fully studied and evaluated. While the technique, known as CRISPR-Cas9, can and is used in laboratory research experiments, the authors of a recent paper are concerned about the ability of physicians and scientists to push ahead into human DNA. While clinical use of this technology is highly regulated in the United States and Europe, the paper’s authors are concerned about research in countries with fewer regulations and urge that “scientists should avoid even attempting, in lax jurisdictions, germline genome modification for clinical application in humans” until the full implications “are discussed among scientific and governmental organizations.”

The ethical considerations of such a technological ability are huge – the power to edit, repair, alter or enhance any part of the human genome in a way that can be passed on to offspring would have major implications for future generations of humans. But where do you draw the line? It’s one thing to want to correct a genetic flaw leading to a known and crippling illness, or to potentially free a family from a legacy of disease. It’s another to edit a “flaw” based on one opinion or standard to be more “beautiful” or “intelligent.” There are also concerns over potential mistakes – when the DNA is accidently changed in a way not intended – as well as with the actual consequences of making a “correct” change when the entire spectrum of effects is not known or well-understood at this time. Should any editing take place at all in humans? Is the power to direct our own genome too much?

Science in the 21st century seems to follow a trend of first developing a technique, trying to understand the consequences of using that technique, and then finally developing the necessary policy. With this ban, perhaps policy will have time to catch up to our scientific ability. (Nicholas Wade, New York Times)

Federal Research Funding

Cancer institute plans new award for staff scientists

The National Cancer Institute (NCI) is planning to try out a new “experiment” in funding science by targeting a new award at staff scientists, rather than graduate students, post-doctoral researchers or principle investigators (PI). In this way, NCI hopes to address some of the current flaws in biomedical funding, which encourage labs to over rely on (cheaper) trainees to do research (rather than longer term employees), creating an over-abundance of highly trained post-docs to very few actual PI positions at the end of the day.

The K05 “research specialist award” would be aimed at researchers with a masters, Ph.D., M.D., or other advanced degree and the applicant would need to be sponsored by a PI and the institution at which they would work. These 5 year, renewable rewards would cover 100% of the cost of the scientist’s salary (but not any supplies), and would be portable if the scientist chose to move to another lab. While mostly positively received, there are uncertainties such as creating even more competition for a shrinking pool of federal funding, and the worry that NCI would be swamped with applications. NCI plans to start with approximately 50 to 60 awards, totaling $5 million, over the next 18 months. Requests for applications can be expected later this year. (Jocelyn Kaiser, ScienceInsider)

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Written by sciencepolicyforall

March 20, 2015 at 1:06 pm