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Adapting NIH Research Policies During the Coronavirus Pandemic

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By Caroline Pantazis, PhD

Image by Gerd Altmann from Pixabay 

COVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, has impacted the trajectory of scientific research across the United States. Many research laboratories have reduced their workforce or completely shut down, putting research projects on temporary hold for an uncertain length of time. Throughout the scientific research community, experiments have had to be delayed or canceled, forcing scientists at every level to be flexible in their research, career, and funding timelines. While the full impact of the coronavirus pandemic on the scientific community remains unknown, it is apparent that it has already substantially impacted research productivity and output

In particular, the coronavirus pandemic has exacerbated stress over receiving and maintaining research funding. Most scientists rely on some form of external funding to support their research, which often requires data in initial applications and follow-up progress reports. Funding agencies like the NIH place deadlines on application submission, at which time all components of the grant must be submitted for review (for example). With the transition to teleworking, many scientists may have to balance family and work, making it challenging to support laboratory personnel and research remotely, care for themselves and their families, and meet grant application deadlines. The inability to perform key laboratory experiments and produce data further complicates the grant submission process, as a lack of data can highlight that scientific projects are not feasible or progressing as planned. Given these unprecedented circumstances, new research policies have been greatly needed to accommodate scientists and their work. 

NIH has adapted its policies on research funding and management to a changing research climate during the coronavirus pandemic. These newly developed policies emphasize safety and flexibility for researchers when trying to meet grant submission deadlines. Deadlines for institutional training grants were extended by several weeks beyond the application due dates. Importantly, NIH has stressed that no justification is necessary for late submissions (see PowerPoint Presentation here). In addition, the NIH Office of Extramural Research has put forth information for applicants and recipients of NIH funding that further reiterates flexibility during this time, including in project extensions and unanticipated costs, extensions to timelines for fellowship training and awards, and extensions to the early stage investigator eligibility for awards.    

With these extensions come the challenges of both how to best coordinate scientific review panels composed of large groups of scientists to discuss applications and how to incorporate late applications into established review cycle timelines. Given that travel and meetings have been restricted to only mission-critical activities, peer review meetings also cannot be held in-person as before the pandemic. NIH outlined several guidelines and considerations for peer reviewers that encouraged review criteria to adapt to the changing research landscape and restricted training opportunities. These issues include that “the environment may not be functional or accessible; …animal welfare may be affected, if institutions are closed temporarily; …travel for key personnel or trainees to attend scientific conferences, meeting of consortium leadership, etc., may be postponed temporarily”. As a result, greater flexibility has also been encouraged during the grant review process to recognize the obstacles facing both scientists’ laboratory projects and training opportunities at this time. 

Several institutes have also developed funding opportunities that are mission-specific and/or support research related to COVID-19 (see here). These funding announcements allow scientists with skills relevant to COVID-19 research to develop projects to better understand the impact of the disease. These include researching the secondary health effects (social, behavioral, and economic) of COVID-19 or the impact of the virus on pre-existing health disparities in vulnerable populations. Other awards have been put forward to focus on better understanding the immune responses elicited by SARS-CoV-2 infection, processes by which protection against the virus may be conferred, and potential barriers to serological testing. As a result, NIH research policies have sought to address the pressing need to mobilize scientific research around understanding COVID-19 pathology, prevention, and treatment. 

Finally, NIH has offered operating guidance for committees overseeing appropriate use of research animals (Institutional Animal Care and Use Committees; IACUCs) or protective measures for human studies (Institutional Review Boards; IRBs). These accredited entities are essential components of research facilities to ensure that all NIH-funded research conducted with human participants or laboratory animals is documented and approved before experiments begin. For research on laboratory animals, the NIH Office of Laboratory Animal Welfare (OLAW) has indicated that the six-month routine IACUC inspections may extend 30 days beyond this window and that IACUCs can determine the “best means for conducting the facility inspections”, which are normally conducted in-person. Also, committees can use teleconferencing for meetings or reduce the number of meetings in accordance with social distancing measures. For NIH-funded clinical research conducted with human participants, NIH encourages adopting measures to limit human-to-human contact, including reduced in-person study visits, use of virtual meetings in lieu of study visits, limited travel, and eliminating the gathering of large groups of people. As in other instances, project extensions may be possible, as will accommodations for unexpected costs that may result from adopting safety precautions.

Consequently, the tremendous impact of the coronavirus on the scientific research community has heavily influenced existing NIH research policies over the past several months and catalyzed the creation of new ones. Importantly, although some current policies are outlined here, NIH continues to update their research policies and funding announcements on the NIH Grants & Funding website. Thus far, these policies have facilitated greater flexibility in research funding and management during a particularly challenging time, but they are also rapidly evolving to address this ever-changing public health crisis.

Written by sciencepolicyforall

June 19, 2020 at 12:58 pm

The importance of science literacy and “education through science”

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By Jayasai Rajagopal, PhD

Image by Thorsten Frenzel from Pixabay 

Science plays an important part in guiding the decision making of both the citizenry and policy makers. However, science can often be misunderstood and misrepresented, and the general public has difficulty in identifying these errors. Representations of scientific findings in the media are often taken out of context or only partially reported. Further, those without expertise in a subject can easily misconstrue the meaning of scientific studies. With the rapid increase in the use of social media, such misinformation spreads more quickly than ever. One of the primary causes of scientific misunderstanding is the lack of scientific literacy amongst the general population.

Before we move on, let us precisely define what we mean by scientific literacy and how that differs from science literacy. Arizona State University professor Jane Maienschein clarifies that science literacy encompasses technical knowledge of science while scientific literacy “emphasizes scientific ways of knowing and the process of thinking critically and creatively about the natural world.” A more recent publication by PISA identifies three major requirements to be considered scientifically literate: the ability to explain phenomena scientifically, evaluate and design scientific enquiry, and interpret data and evidence scientifically. Thus, scientific literacy is essentially a way of thinking and understanding that is consistent with the scientific process.

Consider a case study where a lack of scientific literacy led to tangible negative consequences. The famous case of Andrew Wakefield’s 1998 Lancet publication tying autism to the use of an MMR vaccine has been disproven by many subsequent studies. Wakefield’s work came under further ethical questioning due to his fraudulent research practices and he was discredited. Despite its flaws, this study has been championed by anti-vaccination movements and led to a deterioration of vaccine compliance. Between 1996 and 2004, the vaccination rate in Britain fell from 92% to 80%, eventually leading to measles receiving an endemic status in 2008. While there has been some recovery in recent times, outbreaks of various diseases including measles have occurred as recently as 2019 in the US and the UK. Due to a general lack of understanding of why the study was flawed and the subsequent scientific record contradicting the finding, diseases which should be easier to manage are still a public health concern.

How do these problems perpetuate? Prominent scientific educators Scheufele and Krause identify the problem at three levels: individual, group, and social. At the individual level, a lack of scientific literacy makes it very difficult to identify scientific misinformation, which increases the spread of that misinformation as individuals repeat it and post it across social media. Additionally, individuals are limited by the extent of their experiences. Thus, they filter information through their own subjective lens which can lead to vastly different interpretations of the same data, even among those who are scientifically literate. At the level of the group, ideas which are often repeated tend to become accepted as widespread belief, especially in the age of social media. This tends to lead to a groupthink where large groups tend to follow the same logic even when contradicted by actual facts. At the social level, societal or political pressures can lead to certain beliefs becoming widely accepted based on how they are presented in media and social media.. Finally, for policymakers, scientific literacy is doubly important. Policy decisions made based on bad or inconsistent science can be extremely harmful. At minimum\, this can lead to overregulation and stifle development. At worst, policy decisions can threaten the health of many people and the planet itself. A clear example of this is the active de-regulation of environmental protections which strongly disagrees with established science.

Can this problem be fixed? Yes, but it requires a paradigmatic shift in our understanding of scientific education. Holbrook and Rannikmae outline the approach. Instead of focusing scientific education on teaching the facts of science, the focus should instead be on scientific thinking. Science is not something that is taught in a vacuum, and so must be considered within the entire enterprise of education. The goal of education is not to just provide theoretical knowledge, but produce a thoughtful and productive citizenry with useful practical knowledge. Thus, just gaining knowledge of scientific facts is insufficient as education across subjects must harmonize. Further, instead of focusing on just the “core issues” of science, focus should be placed on topics of socio-economic relevance, which may be regionally different. This allows for the building of scientific literacy on relevant topics and also focusing on the personal and social aspects of education. Thus, the goal should be to “educate through science” rather than teach “science through education.” This goal can be implemented within classrooms from the primary education to undergraduate levels by requiring classes that focus on scientific literacyimproving textbooks, and focusing instruction on relevant culture examples

By transitioning the way we think about scientific education and implementing the previously recommended practices, we can increase scientific literacy.  As the use of rigorous inquiry increases, so will the ability of people to critically and productively engage with science for both social discussion and policy making. So, scientific education should evolve to increase scientific literacy and increase public trust in science. Increased scientific literacy would enable a citizenry that is able to better understand the importance of scientific discoveries and reduce the spread of scientific misinformation. 

Written by sciencepolicyforall

June 12, 2020 at 11:01 am

Connecting the scientific community and the general public: A necessity

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By Pragya Prakash, PhD

Image by Gerd Altmann from Pixabay 

“Not only is it important to ask questions and find the answers, as a scientist I felt obligated to communicate with the world what we were learning.” – Stephen Hawking, ‘Brief Answers to the Big Questions.’

Public perception about science may “influence social acceptance of innovations as well as the progress of science”. This perception, which primarily depends on the effectiveness of scientific communication, likely impacts the “evidence-informed policymaking” to shape “the science policy-related legislation”, which, in turn, “affect the budget allocations” and funds for “scientific research and advancement”.

The effective scientific communication with the general public is challenging, but there are many initiatives adopted by the scientific community to help increase the science literacy among the general public. Press releases and newsletters represent some tools to communicate science to the world outside the research lab. However, these measures have not significantly improved the general public’s understanding about scientific information. According to a survey by Research America, there is still a “lack of scientific appreciation and literacy among the general public”, suggesting the absolute necessity of bridging “the gap between the ‘science world’ and the general, non-scientist public”. 

It is crucial for scientists to publish and present their research to the scientific world, but it is also important to communicate their scientific findings to the general public in a non-scientific, non-technical language. A scientist can nicely explain their research concepts and discoveries to the scientific community, however, communicating their scientific facts and findings to the general public is quite challenging for them, especially in this digital era. The increasingly popular practice of “infotainment” often presents scientific findings in an over-simplified or sometimes sensationalized manner to make the information more entertaining. Due to the widespread availability of social media platforms in addition to traditional media, any misunderstanding in communication is neither good for science nor for the general public. This is best represented by miscommunications about vaccine safety and climate change, which which have generated misunderstanding between the scientific community and the general public about scientific findings. To minimize such misunderstandings and misrepresentation of scientific information, scientists should be properly trained to effectively communicate with the general public. Considering the underlying importance of efficient communication, The National Academies of Sciences, Engineering, and Medicine published a report titled ‘Communicating Science Effectively: A Research Agenda’. This report “builds an evidence base useful for making decisions about how to communicate science most effectively”. The American Association for the Advancement of Science also published a ‘Communication Toolkit’ and tips for better and effective communication of science to the general public. Asking meaningful questions and providing a relevant answer is, furthermore, an imperative part of science education, which need to be incorporated early into an academic system to “help bring the true spirit of science”. 

To establish support for science for mutual scientific and societal benefit, persuasive communication, effective dissemination and easy access to scientific information are necessary among the scientific community and the general public. To better engage the scientific community with the general public, the target audience and communication objectives should be considered further to utilize different dissemination channels effectively for bi-directional communication. The scientific community must need to adapt diverse and innovative communication and outreach strategies in a co-ordinated way to expand the horizon of science to the general public. For example, a virtual ‘Science Outreach event’ for the general public in a research institute and scientific societies can promote the public participation, increasing the general public awareness, and people support in science. 

Written by sciencepolicyforall

June 5, 2020 at 11:13 am

Science Policy Around the Web April 21st, 2020

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By Ben Wolfson, PhD

Image by Bishnu Sarangi from Pixabay 

EPA can’t bar grantees from sitting on science advisory panels, judge rules

In February of this year, Judge Denise Cote for the U.S. District Court for the Southern District of New York ruled against the Environmental Protection Agency (EPA) in a suit brought by the Natural Resource Defense Council (NRDC) contesting a 2017 directive concerning the makeup of the EPA’s advisory committees.

In 2017, then EPA Administrator Scott Pruitt instituted a new policy restricting those who would be eligible to serve on EPA advisory bodies. Pruitt banned scientists who were receiving EPA grant funding, stating that the new policy was designed to prevent conflicts of interest. While politicians such as Representative Lamar Smith, the chairperson of the House science committee, lauded the policy and said it would enable “honest government, sound scientific opinions, and a more responsive EPA”, environmental groups disagree.

They believe that preventing these researchers from serving will allow industry professionals to sway the panels, and remove one of the main avenues of scientific rigor. Of note, while the new policy removes scientists who have received EPA grants, it still allows scientists and industry professionals representing the companies that are affected most by EPA regulation.

In 2018, the NRDC sued the EPA over this policy. In her opinion February, Judge Cote stated that per the Administrative Procedure Act, the EPA was required to provide an explanation for the policy change. On April 15th, Judge Cote followed this opinion with a ruling stating that the EPA cannot block recipients of EPA funding from participating on advisory boards. In light of this ruling the NRDC has stated that this is a crucial decision in support of science.

The EPA has said it will examine the ruling, and the policy change is continuing to be litigated in other cases in the U.S. Court of Appeal for the District of Columbia Circuit and 1st U.S. Circuit Court of Appeals. It remains to be seen how these courts will decide and the impact on the EPA’s policy.

(Pamela King, E&E News, Science)

Written by sciencepolicyforall

April 21, 2020 at 9:12 am

Science Policy Around the Web – June 7th, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?

Last Tuesday, the Washington Post reported that the biopharmaceutical company Pfizer had hints that their rheumatoid arthritis drug Enbrel might reduce the risk of Alzheimer’s disease, but chose not to report these findings to the public.

In 2015, after analyzing hundreds of thousands of insurance claims, a team of Pfizer researchers observed that their anti-inflammatory drug Enbrel might also decrease the risk for Alzheimer’s by 64%. They recommended that the company conduct a costly clinical trial to prove the link but, after several years of internal debate, the company decided not to pursue the lead.  The question remains: why did Pfizer not release these findings to the scientific community?

Pfizer claims they did not pursue the research due to scientific considerations – they argue that since Enbrel cannot cross the blood-brain barrier and directly reach brain tissue, it is unlikely to prevent the debilitating neurodegenerative disease. Further, Pfizer claimed that they did not to report the research because the statistical findings did meet “rigorous scientific standards” and were concerned about misleading researchers down a false path. However, Pfizer is also losing its patent protection on Enbrel soon, meaning that generics will become available and the drug will be much less profitable, reducing any financial incentive for further research or clinical trials (likely to cost around $80 million).

Some in the scientific community are questioning Pfizer’s justification. Keenan Walker, an assistant professor of medicine at Johns Hopkins, argues that the scientific community benefits when the data is available, stating that ““[w]hether it was positive data or negative data, it gives us more information to make better informed decisions.’’

Several scientists argue that Pfizer’s results should be release because they could provide clues to combating the disease and slowing cognitive decline in its earliest stages. Specifically, recent research is hinting that inflammation may promote Alzheimer’s disease. Further, neurodegenerative research is notoriously challenging and there are no major drugs that treat Alzheimer’s. Even several recent phase 3 clinical trials have been halted because the drugs were not effective. Due to a lack of progress in the field, a couple large pharmaceutical companies, including Pfizer, have just closed their neurology-related research programs.

 (Christopher Rowland, Washington Post)

Trump administration halts fetal-tissue research by government scientists

The Trump administration has announced that government scientists will stop using human fetal tissue for research and is placing new limitations on researchers in academic settings who use federal funding from the NIH.

It is not entirely known how many research projects will be affected by the new regulations. Government scientists will be allowed to continue their current work, but are prohibited from acquiring new tissue samples. Current extramural research at universities and privately funded work can continue but any new grant proposals or renewals of existing projects must be approved by an ethics advisory board that will be formed.

In addition to halting government fetal tissue research, the administration has decided to cancel an ongoing HIV research contract with the University of California San Francisco, effectively ending a 30-year partnership. The project involves using fetal tissue to develop mouse models with human-like immune systems to develop new HIV therapies.

Use of fetal tissue is essential to for studying certain human biological processes, such as kidney development. Often biomedical research uses mice as substitutes of people, but in this case, murine kidney development is too different from their human counterparts to be of use. Some researchers fear that these new restrictions will set back certain research for years to come. Important areas of research that depend on using fetal tissue including HIV, neurodegeneration, human organ growth and regeneration, Zika (determining how/why the virus affects developing fetuses so severely), and certain types of vaccine development.

POLITICO reports that this decision was made after much debate between the White and the Department of Health and Human Services (HHS), which wanted a less restrictive policy. In a statement released Wednesday, HHS said that “promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” HHS is now reviewing whether sufficient alternatives to human fetal tissue exist and will be supporting the development and validation of these models. However, good alternatives for certain fetal tissue research are elusive and many scientists say that the tissue is essential for some fields.

 (Sara Reardon, Nature)

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Written by sciencepolicyforall

June 7, 2019 at 6:11 pm

Science Policy Around the Web – March 13, 2018

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By: Roger Mullins, Ph.D.

20180313_Linkpost

source: modified from openclipart

International Science Policy

Key science agencies brace for change as leaders discuss new policies

Important changes to science policy are looming in key areas of the globe that drive a large portion of scientific publications; namely China, the European Union, and the United States of America. As international collaboration, publication, and sharing results make science a notably cosmopolitan enterprise, these developments will affect informed researchers outside of these regions as well.

China began their annual assembly of the Chinese People’s Political Consultative Conference earlier this March, during which they drafted policies to direct their development of science and technology. The latest 5-year plan that resulted placed a high priority on brain science, deep ocean exploration, conservation, stem cells, and pollution. Currently rivaling the US in terms of publications, the effect of any adjustments made within China’s centralized, top-down system of fostering science as a national priority will be of interest to the science community in general.

In the European Union, Robert-Jan Smits has handed his role over as the director-general of the European Commission’s research directorate to Jean-Eric Paquet. Smits eight-year tenure as director was marked by efforts to promote science and innovation in the EU, including the Horizon 2020 research programme and the prospective Framework Programme 9. In an interview with Nature, he outlines his ideas of what future EU research plans will include; specifically supporting research in poorer member states, potential defense research, supporting innovative companies and start-ups, and the ever-present issues of climate and health.

In the United States, Rep. Lamar Smith is expected to retire from Congress later this year. This move includes stepping down from the House of Representatives Committee on Science, Space, and Technology which he has held since 2013. While his replacement has not yet been determined, this change presents an opportunity for scientists to address lingering issues of maintaining world leadership in science via our national priorities, tackling disparities in the scientific workplace, and promoting scientific integrity and respectability.

Even so early in the year, these events signal substantial upheaval of the scientific community in several influential regions of the globe. It will be imperative for scientists in these communities to make their voices heard and set priorities for the advancement and integrity of their profession.

(David Cyranoski, Nature)

(Allison Abbot, Nature)

(Andrew A. Rosenberg, Scientific American)

Science Communication

Fake news spreads faster than true news on Twitter—thanks to people, not bots

Besides, as the vilest Writer has his Readers, so the greatest Liar has his Believers; and it often happens, that if a Lie be believ’d only for an Hour, it has done its Work, and there is no farther occasion for it. Falsehood flies, and the Truth comes limping after it; so that when Men come to be undeceiv’d, it is too late; the Jest is over, and the Tale has had its Effect…”

This observation from Jonathan Swift in 1710 is likely timeless, as shown by a new Science article about the undeniably human tendency to latch on to exciting and novel but false stories and perpetuate them. With recent news about the role of automated “Bots” in spreading false information, this study found that the lion’s share of the blame actually rests on uncritical social media users.

A key finding of this study was that Tweets containing misinformation reached other users approximately six times faster than similar-but-truthful information. For their part, the Bots themselves actually disseminated roughly equal amounts of true and false information. This is attributed to a higher degree of novelty in the false tweets and their emotional valence. False tweets that were spread more rapidly and widely were those that contained both novel and emotionally manipulative reactions, especially for those that elicited strong emotions of surprise and disgust.

How this relates to scientists whose work is written about by journalists should be apparent, as sensational misinterpretation of results is of great concern. In these times one can also expect that stories will be picked up and shared on social media as well as on the traditional web, which may only lead to faster tragic miscommunications with the public.

(Katie Langin, Science)

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Written by sciencepolicyforall

March 13, 2018 at 5:05 pm

How Science Policy Affects Pandemic Pathogen Research

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By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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Written by sciencepolicyforall

April 21, 2017 at 8:47 am

Science Policy Around the Web – February 10, 2017

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By: Saurav Seshadri, PhD

Source: pixabay

Sleep

The Purpose of Sleep? To Forget, Scientists Say

Humans spend approximately one third of their lifetime sleeping, yet the purpose of sleep is still largely unknown. A pair of recent studies in the journal Science suggest that a key function of sleep is to give the brain a chance to rewire itself, specifically by cutting down connections between neurons, which naturally scale up during wakefulness, and especially during learning.

In one paper, researchers used 3D electron microscopy to measure the sizes of these connections, called synapses, in mouse brain slices. They found that sleep produced a significant decrease in the size of synapses. Interestingly, this effect was more pronounced in smaller synapses, which were likely strengthened by general information processing while awake, than large ones (~20% of synapses), which may encode more well-established memories. In the other, researchers used two-photon imaging in live mice to observe sleep-induced changes in synapses. They found a similar decrease in synaptic strength, and went on to identify the signaling pathway that caused this effect; blocking this pathway prevented a normal reduction in the scope and magnitude of a learned behavioral response.

These findings underscore the importance of sleep, especially for memory consolidation involved with learning. Studies like these can have far-reaching effects on the public’s perception of sleep, influencing individual habits as well as policy related to education. For example, they suggest that prioritizing sleep when setting school start times (an issue currently under debate in Montgomery County schools) could improve students’ lesson retention and ultimately their test performance. They also point to important cellular and molecular processes that take place during sleep, which could help explain how existing sleep aids adversely affect brain functioning and memory (a public health concern), and ultimately lead to the development of better drugs. (Carl Zimmer, The New York Times)

Drug Policy

Massive Price Hike for Lifesaving Opioid Overdose Antidote

Increased public exposure to the epidemic of opioid abuse, which continues to intensify in the US, has made it increasingly influential in politics, possibly including the recent presidential election.  A crucial tool for communities at the forefront of this public health crisis is naloxone, which can reverse potentially fatal symptoms associated with overdose. The Evzio naloxone auto-injector, produced by Kaleo, is one of two such products approved by the FDA. Kaleo has recently come under fire for increasing the price of Evzio from $690 to $4,500.

Kaleo cites several justifications for the price hike. Firstly, they offer coupons to patients whose insurance doesn’t cover Evzio. Second, they argue that large insurance companies and government agencies (such as the Veterans Health Administration, which sees a high rate of opioid use) can negotiate prices, while other organizations are currently well funded (thanks to public concern) to absorb the increase. Thirdly, they are expanding their donation supply to allow smaller groups to apply for free devices. However, experts say that the increase is not justified by production costs, and some organizations have been forced to switch to alternative drugs.

News of the decision arrives at a time when the public is particularly sensitive to drug pricing, and have made their concern clear to lawmakers. Negotiation with drug companies over prices has been a prominent campaign issue in recent elections. Public outcry following similar moves by investor Martin Shkreli and Mylan led to hearings by a special congressional committee. Soon after the last election, a bill that would have allowed patients to import cheaper drugs from Canada became a high-profile occasion for posturing in the Senate, where it failed despite overwhelming public support. These stories highlight the often antagonistic relationships between the American public, its government, and the pharmaceutical industry, and illustrate how disruptive drug pricing can directly affect policy. (Shefali Luthra, Scientific American)

Scientists in Politics

Geneticist Launches Bid for US Senate; while Empiricists Around the Country Will March for Science

Donald Trump’s agenda of self-serving lies and denial of evidence has led to unprecedented levels of engagement and activism across the country. The scientific community has been especially impacted by Trump’s brand of broad, allegedly populist anti-intellectualism. Thus, although the empirical facts uncovered by scientific research are inherently apolitical and should be treated as such, scientists are beginning to mobilize to oppose the Trump administration in several ways.

One essential path to policy change is increased representation. With that in mind, evolutionary biologist Dr. Michael Eisen, an HHMI-funded investigator at UC Berkeley and co-founder of the People’s Library of Science (PLOS), recently announced his candidacy for the US Senate in 2018. Dr. Eisen’s platform seems to center on bringing a scientific perspective to Senate proceedings, and working towards comprehensive yet practical solutions to issues such as climate change. More of Dr. Eisen’s views can be found on his twitter feed and blog.

Protests are another way for individuals to make their voices heard by policy makers. The March for Science, which currently has over 350,000 followers on Facebook, will be an opportunity for ‘scientists and science enthusiasts’ to both call for and demonstrate support for the scientific community, and promote solidarity between science and the public. The main march will be held on April 22nd, 2017 in Washington D.C.; satellite marches are scheduled in over 100 additional cities. Organizers hope to maintain the momentum gained by January’s Women’s Marches, which saw historic attendance. (Sara Reardon, Nature News; Lindizi Wessel, ScienceInsider)

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Science Policy Around the Web – February 3, 2017

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By: Eric Cheng, PhD

Source: pixabay

Trump and Science

Scientists’ Lives Upended by Trump’s Immigration Order

New executive orders have been signed by President Trumpthat suspend immigration into the United States from “terror-prone regions.” The target countries listed are Iran, Iraq, Libya, Somalia, Syria, Sudan, and Yemen. These new immigration orders have caused chaos at U.S. airports to people from these countries, including people with a valid U.S. visa or green card who were traveling outside of the U.S. when the order was signed. It is also affecting scientists who are currently in the United States, but are visiting from the affected countries. For example:

Ehssan Nazockdast was planning to attend his sister’s wedding in Tehran in March. One hitch: The specialist on fluid dynamics at New York University in New York City is an Iranian citizen. That leaves him vulnerable under an executive order signed by U.S. President Donald Trump on Friday that calls for the rigorous vetting of applicants for U.S. visas from Iran and six other predominantly Muslim nations, and bars the entry of any citizen from those nations for 90 days while procedures for that vetting are put in place. Nazockdast has lived in the United States for nearly a decade, has a green card, and has two young daughters with a wife who is a U.S. citizen. But now that Nazockdast is branded with a scarlet letter, he dare not leave. “I’m living in a big prison called the United States of America,” he says.

A federal judge has issued an emergency stay that halts deportations of refugees with valid U.S. entry documents. Two days after executive order was signed, John Kelly, Secretary for Homeland Security, issued a statement deeming “the entry of lawful permanent residents to be in the national interest,” which was interpreted as allowing the re-entry of green card holders. from nations covered by the order, although they could receive extra scrutiny. The Council on American-Islamic Relations still intends to file a lawsuit in the U.S. District Court Western District of Virginia challenging the constitutionality of what it calls the “Muslim ban.”

Over 7000 scientists of all nationalities and religions, including 43 Nobel laureates, have signed an open letter, warning that Trump’s order “significantly damages American leadership in higher education and research” and calls it “inhumane, ineffective, and un-American.” (Richard Stone and Meredith Wadman, ScienceInsider)

Science Policy

Scientists ‘Partly to Blame’ for Skepticism of Evidence in Policymaking, says AAAS CEO

In addition to access to high-quality technical experts to handle science-related global crisis, an United States president also needs to believe that scientific evidence is useful in setting government policy says American Association for the Advancement of Science (AAAS) CEO Rush Holt. At the winter meeting of the American Physical Society in Washington, D.C., Dr. Holt remarked how scientists are partly to blame for the decreased priority of scientific evidence in U.S. policymaking.  One potential explanation for this devaluation of evidence may be due to scientists’ way of presenting evidence that is too “condescending and hierarchical. We might say, ‘Let me try to explain this to you. Maybe even you can understand this.’ And that is not very effective. So we are partly to blame,” stated Dr. Holt.

Dr. Holt believes that “reverence for evidence” has been part of the nation’s political discussion since the United States was founded, and traditionally covers both parties. The biggest challenge now will be to try and empower policymakers to think about any scientific evidence presented to them and to evaluate the validity of the conclusion based on the evidence for themselves. (Jeffery Mervis, ScienceInsider)

Public Health

Senate Finance Committee OKs Tom Price, MD, for HHS Chief

The Senate Finance Committee voted 14-0 to approve the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS). All votes were from the Republican members of the committee because 12 Democratic members boycotted the executive session to confirm Dr. Price. Although the committee normally requires at least one member from each party present to reach its quorum requirement, the rule was suspended prior to the vote. Now Dr. Price’s nomination will go before the Senate for a vote, which will only need a simple majority of 51 votes for confirmation. (Robert Lowes, Medscape)

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Written by sciencepolicyforall

February 3, 2017 at 10:01 am

Science Policy Around the Web – November 18, 2016

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By: Thaddeus Davenport, PhD

Source: pixabay

2016 Presidential Elections

How the Trump Administration Might Impact Science

Donald Trump is now the President-elect of the United States of America. Mr. Trump’s loose speaking (and tweeting) style, affinity for controversy, relative disregard for facts, and his lack of experience in domestic and foreign policy, led him to make a number of vague, and sometimes contradictory statements about his specific policy positions over the course of his campaign. In light of this, there are few people on earth – and perhaps no people on earth, including Mr. Trump – who know exactly what to expect from his presidency. In Nature News last week, Sara Reardon, Jeff Tollefson, Alexandra Witze and Lauren Morello considered how Mr. Trump’s presidency might affect science, focusing on what is known about his positions on biomedical research, climate change, the space program, and immigration. The authors’ analyses are summarized below:

Biomedical Research – Mr. Trump will be in a position to undo the executive order signed by President Obama in 2009, which eased some restrictions on work with human embryonic stem cells, a decision criticized at the time by the current vice-president elect, Mike Pence. In his characteristically brash speaking style, Mr. Trump also called the NIH ‘terrible’ in a radio interview last year, but beyond this, he has said little about his plans for biomedical research.

Climate Change – Early signs suggest that Mr. Trump will dramatically shift the direction of the Environmental Protection Agency (EPA) and undo some of its work to curb greenhouse gas emissions under the Clean Power Plan implemented by President Obama. Mr. Trump has already appointed Myron Ebell, a denier of climate change, to lead the transition at the EPA and other federal agencies involved in climate change and environmental policy. Mr. Trump has also vowed to pull out of the Paris Climate Agreement which, under the terms of the agreement, may not happen immediately, but it may influence how and whether other countries participate in the agreement in the future.

Space Program – Based on writings from Trump’s campaign advisers there may be continued support for deep space exploration, especially through public-private partnerships with companies such as Orbital and SpaceX, but not earth observation and climate monitoring programs, which account for one third of NASA’s budget.

Immigration – A central pillar of Mr. Trump’s campaign was his strong and divisive stance on immigration. He has vowed to build a wall on the US border with Mexico, deport millions of illegal immigrants, defund ‘sanctuary cities’ throughout the United States, impose “extreme vetting” of immigrants, and stop immigration from countries where “adequate screening cannot occur”, which he believes includes Syria and Libya, and set new “caps” on legal immigration into the United States. These proposals have drawn objections from human rights advocates, and scientists worry that they may discourage international students and researchers from working in, and contributing their expertise to, the United States.

It remains to be seen how Mr. Trump will shape the future of science in the United States and the world, but it is clear that he is taking office at a pivotal moment. He would do well to seriously consider how his policies and his words will impact research, discovery, and innovation within the United States, and more importantly, the long-term health of vulnerable populations, economies, and ecosystems around the globe. (Sara Reardon, Jeff Tollefson, Alexandra Witze and Lauren Morello, Nature News)

Public Health

Soda Taxes on the Ballot

Given the focus that has been placed on the outcome of the Presidential election, you may NOT have heard about the results of smaller ballot items including a decision to begin taxing sodas in four US cities – San Francisco, Oakland, and Albany, California, and Boulder, Colorado – as reported by Margot Sanger-Katz for the New York Times. These cities join Berkeley, California and Philadelphia, Pennsylvania, which passed soda taxes of their own in 2014 and June of 2016, respectively. The victory for proponents of soda taxes came after a costly campaign, with total spending in the Bay Area region campaign on the order of $50 million. Former New York City mayor, Michael Bloomberg, and Laura and John Arnold spent heavily in support of taxing sodas, but did not equal the spending by the soda industry, which opposed the taxes. During his time as mayor, Mr. Bloomberg attempted to ban the sale of sodas larger than 16 ounces in New York City in 2012, but this was struck down in the New York State Court of Appeals in 2014.

Soda tax advocates see the outcome of this year’s ballot initiatives as a sign of a sea change in public acceptance of programs intended to discourage soda consumption (and increase revenue for municipalities), but it is indisputable, especially in light of the results of the presidential election, that the set of relatively liberal cities that have adopted soda tax measures do not accurately represent the thinking of people throughout the United States. Though it is still too early to know if soda tax programs lead to improvements in public health, evidence from Berkeley and Mexico – which passed a soda tax in 2013 – indicates that these programs have the potential to decrease soda consumption. Regardless of how similar initiatives may perform in other cities on future ballots, the increasing number of cities participating in soda tax programs will provide valuable data to inform policy decisions aimed at reducing obesity and diabetes. (Margot Sanger-Katz, New York Times)

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Written by sciencepolicyforall

November 18, 2016 at 9:00 am