Science Policy For All

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Posts Tagged ‘NIH

Clinical Trials Policy Revision: For Better or Worse

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By: Jenn L. Nguyen, Ph.D., M.P.H.

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source: pixabay

As the largest public funder of biomedical research in the United States, the NIH wants to ensure that conducted trials are relevant to health priorities of the US, trials are conducted efficiently and are not duplicates of previously conducted trials, and trials contribute to scientific knowledge. In an editorial in 2016, NIH leaders noted a need for quality and efficiency improvements to clinical trials. NIH has introduced several initiatives, to enhance clinical trials stewardship by addressing accountability, transparency, efficiency, and dissemination. However, along with the widely acknowledged improvements some recent changes may hinder the pursuit of scientific knowledge.

To address accountability, all investigators and staff conducting and overseeing clinical trials must take the Good Clinical Practice (GCP) training. The training is mandatory for individuals involved with the design, conduct, oversight, or management of clinical trials. While the training may not be sufficient by itself, it does provide a standard of knowledge, a base of knowledge, standards, and guidelines for all clinical trials.

The second change requires that all grant applications for clinical trials be submitted under clinical trials specific funding opportunity announcements (FOA). Investigators interested in conducting a clinical trial can no longer submit under parent funding announcements, which made identifying clinical trials more difficult in the past. The FOAs will list specific review criteria for reviewers to consider clinical trials-related information, such as focus on the rationale, design, and operational and analysis plans. This new policy will increase NIH accountability and efficiency, as it will ensure that required information is submitted with each clinical trial application, allow staff to better track clinical trial proposals and study, and allow staff to uniformly apply appropriate review criteria.

A substantial change, however, is the limited eligibility of trainees to conduct interventional social science research, Institutional training (T) awards, which provide money to institutions for workforce training, do not allow money to be given to trainees involved in clinical trials (the exception is for D43s and K12s), Fellowship (F) awards, which support individual trainees,  do not support trainees involved in independently conducted clinical trials, but trainees can propose a research experience with a sponsor/co-sponsor.  For Career Development (K) awards, applicants may apply to either FOAs that specify “clinical trials required” or FOAs that are for “no independent clinical trials.” Scientists are concerned this may limit postdocs and students to get support for their fellowships and adequate career training.

To further address efficiency and accountability, applications must be submitted using a clinical trials protocol template that consolidates information from multiple forms, has structured data fields, and will collect information at the study level. This requirement will ensure that all investigators will submit the same information. In addition, the forms will contain fields forcing investigators to be clear and concise about their analytical and dissemination plans.

Addressing efficiency, NIH now requires use of a single Institutional Review Board (IRB) to review multisite studies. Prior, each institute involved with the study required duplicate or multiple IRB reviews, which involved the redundant assembly of experts to assure that the same proposed study was in line with the rights and protections of human and animal research subjects. Multiple reviews resulted in delays and at times, conflicting reviews. Guidance to establish a single IRB on record has been published.

Finally, there are significant changes for registration and reporting of clinical trials to address accountability, transparency, and dissemination. Investigators are now required to register their clinical trial(s) in the ClinicalTrials.gov database within 21 days of enrollment of the first participant. NIH makes the argument that this effort may help reduce the number of trials that fail, as it will require scientists to disclose their results even if the studies do not support their hypotheses urthermore, all investigators must adhere to the NIH policy on Dissemination of NIH-clinical trials. There have been longstanding concerns that investigators are not reporting all results (especially negative or non-significant results, not reporting results in a timely manner, and even sometimes, deviating from their own research protocol.

Along with these initiatives, The National Institutes of Health (NIH) broadened what was considered a clinical trial: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Adaption of this updated definition did not take effect until earlier this year and has alarmed some scientists. Clinical trials have been traditionally understood as experiments or observations for/in clinical settings to answer three questions: 1) Does the proposed treatment/intervention work? 2) Is the proposed treatment or intervention more effective than other treatments? 3) Are there side effects?

Scientists critical of the new definition first and foremost recognize and appreciate the motivation for NIH to increase transparency and replicability, specifically efforts for pre-registration, data sharing, and protocol sharing of trials. Yet, many scientists who conduct basic and behavioral research disagree agree that their work and studies should now be considered clinical trials. These scientists, and even scientific associations, remarked that the new clinical trials definition is too broad and traditional criteria to evaluate a trial might be inappropriately applied to their proposal. There is also concern that these changes will increase the administrative and bureaucratic burden for many scientists, specifically for exploratory scientists. To address and alleviate concerns, NIH released a set of case studies to help scientists identify and understand what is considered a clinical trial and must adhere to all the changes in the policy. While this effort provided clarification, many scientists are calling for NIH to hold further conversation with the extramural community.

While scientists recognize the need and laud NIH’s effort to address clinical trials stewardship, many of the same scientists are worried that these benchmarks set the wrong standards for success and rigor. Scientists are also worried about the additional administrative burden these changes will bring. As NIH enforces the policies, they have promised to monitor trouble issues and work with the community to find a solution without compromise.

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Written by sciencepolicyforall

February 20, 2018 at 3:52 pm

Science Policy Around the Web – September 8, 2017

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By: Emily Petrus, PhD

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source: pixabay

Science funding

Congress Returns and Funding Anxiety Continues for Scientists

The summer recess is over, which means congress needs to get to work and pass funding bills to keep the government running past the end of fiscal year: September 30th. The agenda is full, including funding hurricane Harvey relief, raising the debt ceiling and allocating funds for 2018. The budget fight is bound to be full of surprises, even just last night Trump sided with democrats on these three issues, throwing most conservative GOP members for a loop. It remains to be seen how the 2018 budget will impact research, but here’s what we know so far.

The 2017 budget was considered a positive one for scientists, because the large cuts demanded by the president went unheeded by congress. The president requested to cut most federal agencies, and the EPA (-31%), NOAA (-22%) and FDA (-31%) were the largest targets.  However, most research institutions did not see major cuts, and although the National Institutes of Health (NIH) budget was requested to be reduced by 22%, it received a $2 billion raise.  The upcoming 2018 fight would pit the president’s proposed agenda against senate against house, providing a 3-way fight which leaves scientists in the middle of potentially hostile waters.

Proposed budgets by the house of representatives and senate are still being formulated, but there are already discrepancies between the two proposals. For example, the house proposes increasing NASA’s budget by $94 million (+1.6%), while the senate would reduce funds by $193 million (-3.3%). The discrepancies can be found even deeper in NASA’s budget, with reversed support for planetary science (increased spending from the house) and earth science research (cuts from the house, maintained spending from the senate). These cuts could impact our ability to monitor distant planets and moons which could be sustainable for human life. For example, an unmanned mission to Jupiter’s moon, Europa, slated to launch in 2020 and land in 2024 could be stalled. In flyby missions from 1995-2003, this moon was found to have brown sediment, a warm core and probably a salty ocean under an icy surface, making it similar, albeit colder, to our planet.

Back on earth, our ability to design new ways to produce renewable, sustainable energy could also take a hit, as funding may be cut from the Department of Energy’s Advanced Research Projects Agency – Energy (ARPA-E). This department funds “high-risk, high-reward” projects and has only been in operation for 8 years, which makes it difficult to determine if the investment is worth the so far limited outputs. The senate proposes increasing this funding by 1.1%, while the house would scrap the project entirely.

Finally, the National Oceanic and Atmospheric Administration (NOAA) is on the chopping block, with the house following the president with a 22% decrease in funding, while the senate only seeks to cut the budget by 1%. Controversial projects overseen by NOAA include the Polar Follow-On programme, which monitors weather in collaboration with NASA. Cutting this program could impact our ability to predict hurricanes, something not likely to sit well with voters and representatives in states impacted by current weather catastrophes.

Although there are big discrepancies in proposed budgets between the president, the house and the senate, time will tell how much cooperation the republicans and democrats can achieve by the end of the month to avoid a government shut down. On a positive note, the NIH can hope for a boost from the house and the senate, as funding human health is an issue which usually enjoys bipartisan support.

(Rachael Lallensack, Nature News)

The science of education

School’s Back in SessionGet your learning on!

School is back in session; teachers are teaching, students are learning, and education is supposed to be breaking down socioeconomic barriers. What can science do to help educators have the greatest impact on students? There’s an intersection between teaching strategy, learning, and education policy which can be implemented for better student outcomes.

A recent report by Science News describes new strategies developed in the lab to enhance student learning. However, researchers are finding that studies performed in a lab setting with college kids do not yield the same results for optimizing student performance when applied to a bustling classroom of younger students. For example, when college students were asked to read a passage and jot down notes, their recall of the reading assignment was improved a week later. However, younger grade school students were shown to need an extra cue to help connect associations and make memories “stick”. This strategy helps teach students how to recall information, providing an extra support link until they can perform this task without a second thought. Another ongoing study is helping students improve executive function in students as young as middle school. Researchers designed a video game which requires players to shift strategies as rules change mid-game, which thus far has positively impacted the students’ performance on cognitive tests.

Being able to adapt to new situations is a cornerstone of learning, and neuroscience has long been searching for the magic that makes this task easy sometimes but challenging othertimes. The methods to study this process are becoming more sophisticated. Researchers can now view single synapses coming and going, and in some cases receptors on those synapses popping in and out. But understanding brain-wide learning requires zooming out and looking at neural network activity. It seems intuitive that to learn something new, connections must be formed between brain areas. These associations “stick” that memory or fact somewhere in the brain. Indeed, people who are learning something new display greater “brain flexibility”: the ability to not only make new connections, but let some others fall apart. Children with low math performance actually had higher connectivity during brain scans while doing math problems. It seems forgetting unimportant information to make room for new ideas is as important as making just more new connections.  In addition, a researcher scanned himself three times per week for a year, and found his brain displayed greater flexibility on days when he was in a good mood. The balance between making new connections and letting others go may be the key to better learning.

As science puts more pieces together on how learning best occurs, we can see some things coming into focus to enhance student learning. People who can make new connections and loose old ones in a dynamic fashion can be better learners. Being in a good mood, meaning a stable home and school environment with food and housing security can lead to better brain flexibility. Teachers trying new strategies to enhance brain flexibility with their students could help the students learn how to absorb and use new information. All of this information can be used to inform policy on what makes for a successful student as we proceed through the academic year.

(Susan Gaidos, Science News; Laura Sanders, Science News )

 

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Written by sciencepolicyforall

September 8, 2017 at 3:54 pm

Science For All – Effective Science Communication and Public Engagement

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By: Agila Somasundaram, PhD

Image: By Scout [CC0], via Wikimedia Commons

         In 1859, Charles Darwin published the Origin of Species, laying the foundation for the theory of evolution through natural selection. Yet more than 150 years after that discovery and despite a large volume of scientific evidence supporting it, only 33% of the American population believes that humans evolved solely through natural processes. 25% of US adults believe that a supreme being guided evolution, and 34% reject evolution completely, saying that humans and all other forms of life have co-existed forever. Similarly, only 50% of American adults believe that global climate change is mostly due to human activity, with 20% saying that there is no evidence for global warming at all. A significant fraction of the public believes that there is large disagreement among scientists on evolution and climate change (the reality being there is overwhelming scientific evidence and consensus), and questions scientists’ motivations. Public skepticism about scientific evidence and scientists extends to other areas such as vaccination and genetically-modified foods.

Public mistrust in the scientific enterprise has tremendous consequences, not only for federal science funding and the advancement of science, but also for the implementation of effective policies to improve public and global health and combat issues such as global warming. In her keynote address at the 2015 annual meeting of the American Society for Cell Biology, Dr. Jane Lubchenko described the Science-Society ParadoxScientists need society, and society needs science. How then can we build public support for science, and improve public trust in scientists and scientific evidence?

Scientists need to be more actively involved in science outreach and public engagement efforts. Communicating science in its entirety, not just as sensational news, requires public understanding of science, and familiarity with the scientific process – its incremental nature, breakthrough discoveries (that don’t necessarily mean a cure), failures, and limitations alike. Who better to explain that to the public than scientists – skilled professionals who are at the center of the action? In a recent poll, more than 80% of Americans agree that scientists need to interact more with the public and policymakers. But two major hurdles need to be overcome.

Firstly, communicating science to the public is not easy. Current scientific training develops researchers to communicate science in written and oral formats largely to peers. As scientists become more specialized in their fields, technical terms and concepts (jargon) that they use frequently may be incomprehensible to non-experts (even to scientists outside their field). The scientific community would benefit tremendously from formal training in public engagement. Such training should be incorporated into early stages of professional development, including undergraduate and graduate schools. Both students and experienced scientists should be encouraged to make use of workshops and science communication opportunities offered by organizations such as AAAS, the Alan Alda Center for Communicating Science, and iBiology, to name a few. Secondly, federal funding agencies and philanthropic organizations should provide resources, and academic institutions should create avenues and incentives, for scientists to engage with the public. Both students and scientists should be allowed time away from their regular responsibilities to participate in public outreach efforts. Instead of penalizing scientists for popularizing science, scientists’ outreach efforts should be taken into consideration during promotion, grants and tenure decisions, and exceptional communicators rewarded. Trained scientist-communicators will be able to work better with their institutions’ public relations staff and science journalists to disseminate their research findings more accurately to a wider audience, and educate the public about the behind-the-scenes world of science that is rarely ever seen outside. Engaging with the public could also benefit researchers directly by increasing their scientific impact, and influence research directions to better impact society.

While increasing science outreach programs and STEM education may seem like obvious solutions, the science of science communication tells us that it is not so simple. The goals of science communication are diverse – they range from generating or sharing scientific excitement, increasing knowledge in a particular topic, understanding public’s concerns, to actually influencing people’s attitudes towards broader science policy issues. Diverse communication goals target a diverse audience, and require an assortment of communicators and communication strategies. Research has shown that simply increasing the public’s scientific knowledge does not help accomplish these various communication goals. This is because people don’t solely rely on scientific information to make decisions; they are influenced by their personal needs, experiences, values, and cultural identity, including their political, ideological or religious affiliations. People also tend to adopt shortcuts when trying to comprehend complex scientific information, and believe more in what aligns with their pre-existing notions or with the beliefs of their social groups, and what they hear repeatedly from influential figures, even if incorrect. Effective science communication requires identifying, understanding and overcoming these and other challenges.

The National Academies of Sciences, Engineering, and Medicine convened two meetings of scientists and science communicators, one in 2012 to gauge the state of the art of research on science communication, and another in 2013 to identify gaps in our understanding of science communication. The resulting research agenda outlines important questions requiring further research. For example, what are the best strategies to engage with the public, and how to adapt those methods for multiple groups, without directly challenging their beliefs or values? What are effective ways to communicate science to policymakers? How do we help citizens navigate through misinformation in rapidly changing internet and social media? How to assess the effectiveness of different science communication strategies? And lastly, how do we build the science communication research enterprise? Researchers studying communication in different disciplines, including the social sciences, need to come together and partner with science communicators to translate that research into practice. The third colloquium in this series will be held later this year.

Quoting Dr. Dan Kahan of Yale University, “A central aim of the science of science communication is to protect the value of what is arguably our society’s greatest asset…Modern science.” As evidence-based science communication approaches are being developed further, it is critical that scientists make scientific dialogue a priority, and make use of existing resources to effectively engage with the public – meet people where they are – and bring people a step closer to science – why each person should care – so that ‘post-truth’ doesn’t go from being merely the word of the year to a scary new way of life.

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July 22, 2017 at 11:27 pm

Science Policy Around the Web – June 16, 2017

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By: Emily Petrus, PhD

Source: pixabay

Science and Politics

Politics in Science – It’s Not Just the U.S.!

Romania is a country in eastern Europe that joined the European Union (EU) in 2007. Scientists there are few and far between; research spending only accounts for 0.49% of GDP, the lowest in Europe (the US spent 2.7% in 2016). After joining the EU, Romanian researchers were encouraged to apply for European merit-based grants and sit on international review boards such as the National Research Council and the National Council of Ethics. It seemed that research was making slow but steady progress, but the new administration elected this year has shaken things up in all facets of government, including scientific research.

The new research minister, Serban Valeca, removed the international members appointed to government councils that oversee research funding, ethics, innovation and science policy, and replaced them with city council members, government-loyal union members, researchers from second tier Romanian institutes and even a surgeon being investigated for embezzlement. Grant review panels have been shuffled to remove international scientists and replace them with domestic researchers, but only if they have a certificate saying their university approves of their participation. These changes mark a departure from welcoming international input into Romanian proceedings and a movement towards scientific isolation.

To combat these changes, Romanian scientists have formed an organization, Ad Astra, which calls on researchers to boycott grant evaluations. Combined with the shuffling, the councils have been suspended for 3 months, which delays funding and puts already under-funded researchers in peril. The European University Association calls the policies deeply concerning, and although the current president may disagree with the research minister’s handling of the situation, his political ties ensure he won’t hold much sway over how this plays out. A computer scientist at the University Politehnica in Bucharest, Costin Raiciu, is concerned that the policies will affect talented researchers who have returned to Romania and says, “Without [merit-based] funding, people would either give up research altogether or move out of the country”. This is an all too familiar scenario in which it is apparent that policy and science must cooperate to produce ideal outcomes. (Alexandra Nistoroiu, ScienceInsider)

Mental Health

Clinical Trials Down, Basic Research Up at NIMH

Mental health is a notoriously tricky field. The development of the Diagnostic and Statistical Manual of Mental Disorders (DSM) in the 1950s has historically been a way to diagnose patients with mental health issues, and then give appropriate treatment. This has proved to be an imprecise treatment strategy, because within a category of diagnosis there is a broad spectrum of behaviors, and underlying this behavior there may be multiple causes. The NIH’s Precision Medicine Initiative (PMI) seeks to characterize 1,000,000 people by behavior, genetics, environment, and physiology. Researchers from the NIMH will send questionnaires evaluating behavior to detect mood and reward responses for this group of people. When this mental health evaluation is combined with information about their genetics, lifestyle and environment, scientists can characterize mental health disorders more specifically.

Many clinician researchers are upset by the steep decline in clinical trial research funded by NIMH, which has become higher profile with director Joshua Gordon’s arrival in 2016. NIMH seeks to route funding to study mental disorders using a basic research approach before spending time and money on costly clinical trials which too often lead to inconclusive or disappointing results. In 2011 NIMH launched the Research Domain Criteria (RDoC), which encourages research proposals to include a hunt for the mechanism underlying mental health studies. Since the initial call to include a RDoC perspective in grant applications, the incidence of RDoC appearing in funded applications has increased while mention of the DSM has decreased. Other buzzwords that are present in funded grants include biomarker, circuit, target and mechanism.

These data represent a shift in how funding decisions will proceed in mental health but may have broader reaching implications for other areas of research. In a blog post Dr. Gordon writes, “the idea that RDoC will facilitate rapid, robust and reproducible neurobiological explanations for psychopathology (as observed within and across DSM disorders) represents a hypothesis”. It remains to be seen if RDoC is an effective metric to evaluate successful grants. (Sara Reardon, Nature News)

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Science Policy Around the Web – June 13, 2017

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By: Nivedita Sengupta, PhD

By Mikael Häggström, used with permission. [Public domain], via Wikimedia Commons

Stem Cell Therapy

Texas on Track to Become First State to Explicitly Back Stem Cell Therapies

On 30th May, Texas passed a bill  authorizing unapproved stem cell therapies, making Texas the first state to openly recognize experimental treatments. The bill will make the use of unapproved stem cell therapies legal for patients and is currently awaiting the approval of Governor Greg Abbott, who already supports the measure. Experimental stem cell therapies for terminal and chronic conditions have struggled for years to gain support without much success. Until now, no state has provided legal validation for these kind of therapies and the current stem cell procedures are mostly done under strict regulations.

Amendments were added to the bill, which require that the treatments be delivered by doctors with the approval of an institutional review board, which deals with human research. It will also add another amendment that will allow patients to have authority to sue in case the treatments go wrong. Many scientists and advocates opposed the measure stating that unapproved stem cell therapies can be harmful rather than beneficial. They state that though the amendments add protection to the patients, there are a few aspects of the bill that make them uncomfortable. Two other bills focused on patient access to experimental therapies, also known as “right-to-try” policies, failed to pass in the Texas Senate. (Andrew Joseph, STATNews)

Research Funding

NIH Scraps Plans for Cap on Research Grants

US National Institutes of Health (NIH) decided to drop the controversial proposal of capping the number of grants that an investigator can have at a time. The initial capping attempt was suggested to gather funds for younger researchers by NIH in May. The proposal was based on studies that suggested that a lab’s productivity decreases once it holds too many grants. Younger scientists often face more difficulties in obtaining NIH RO1 grants compared to their older more experienced colleagues. As a result, many researchers applauded the NIH’s effort to provide more funding for younger scientists. Yet the capping proposal received major adverse response from the scientific community stating that the NIH’s interpretation of the productivity study data does not apply to all labs, especially to the collaborative lab groups with four or five R01s that are more productive than labs with only one. Researchers also complained that the proposed point-based scoring system will also make collaborations difficult thus hampering productivity in the long run.

NIH director Dr. Francis Collins stated that the original idea was still a work in progress and NIH is going to put a hold on it. Instead of the cap, on 8th June, NIH announced the creation of the special fund, the Next Generation Researchers Initiative (NGRI), starting with US$210 for funding young researchers. The initiative will focus on investigators with less than 10 years of experience as NIH- funded principal investigators, and on high score grant proposals that were rejected because of lack of money. The initiative will grow up to $1.1 billion over the next five years. According to NIH principal deputy director Larry Tabak, NIH will immediately start creating an inventory of investigators who meet these criteria and expects that this approach will allow more than 2,000 additional R01 grants to be funded to younger scientists compared to the cap-based plan, which would have supported only 1600 awards. Nonetheless, the current proposal is still going to generate controversy as it will affect the older researchers because of NIH’s diversion of funding. (Sara Reardon, Nature News)

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June 13, 2017 at 7:08 pm

Science Policy Around the Web – May 5, 2017

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By: Thaddeus Davenport, PhD

Healthcare Policy

House Passes Bill to Repeal and Replace the Affordable Care Act

Thomas Kaplan and Robert Pear reported for the New York Times yesterday that Republicans in the US House of Representatives voted to pass a bill that would undo a number of central elements of the Affordable Care Act. Only six weeks ago, House Republicans failed to gather enough support to even vote on the first version of this bill, which was predicted to eliminate insurance coverage for twenty-four million Americans over the next decade. Since that time, Republican lawmakers have modified the so-called American Health Care Act (AHCA) bill to appeal to the more conservative members of the House – including provisions that would limit federal support of the Medicaid program, allow states to opt out of requiring that insurance cover services like maternity and emergency care, and also enable states to apply for waivers that would let insurance companies charge higher premiums for some individuals with pre-existing conditions. Like the first version, the bill that passed the House on Thursday does away with the ‘individual mandate’, which imposes a tax on people who can afford to buy insurance but do not – an aspect of the Affordable Care Act that was relatively unpopular but critical to ensure sustainability of the insurance markets. It also replaces government-subsidized insurance plans with tax credits between $2,000 and $4,000, depending on age. Other provisions in the bill would stop federal funding to Planned Parenthood for one year as well as eliminate taxes on high-income individuals, insurance companies, and pharmaceutical companies that helped to fund the Affordable Care Act. Yesterday, 217 Republicans voted in favor of the revised AHCA bill that will certainly  not provide healthcare insurance for everyone, without waiting for a non-partisan Congressional Budget Office analysis of the bill’s impact on the federal deficit or on the American people. These representatives’ haste reveals that they care little about how the AHCA will actually affect their constituents’ lives, and Democrats are counting on voters remembering this in upcoming elections. (Thomas Kaplan and Robert Pear, The New York Times)

Science Funding

NIH Funding Changes to Support More Early Career Investigators

The NIH budget has gradually declined over the last fourteen years, from $40 billion in 2003 to about $32 billion in 2017. Given that a proposed budget from the Trump administration for fiscal year 2018 would further cut funding for NIH by $5.8 billion, it is unlikely that funding for the NIH will increase dramatically in the coming years. To address these budget limitations, and in an attempt to do more with less, Jocelyn Kaiser reported for ScienceInsider this week that the National Institutes of Health will impose a cap on the number of grants awarded to investigators. In an open letter announcing the decision, NIH director, Francis Collins, writes that 40% of NIH funding is concentrated in the hands of 10% of NIH-funded investigators. He notes that this is not inherently problematic, except that many studies indicate that there are diminishing scientific returns on each additional dollar that is granted to any individual investigator. Under the new guidelines, investigators will be limited to a maximum of three R01-equivalent grants in order to support approximately 1,600 more grants to early career and mid-level researchers, who have been particularly affected by the declining NIH budget. While it is difficult to quantify scientific impact, the NIH decision is admirable for its intent to support diversity and efficiency in funding research. (Jocelyn Kaiser, ScienceInsider)

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Science Policy Around the Web – April 4, 2017

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By: James Taylor, PhD

Photo source: pixabay.com

Research Funding

NIH Research Grants Yield Economic Windfall

Assessing the social and economic benefits of basic research – research conducted with no clear medical or financial goal in mind – has is often tricky with the former being philosophical in nature whilst the later sometimes coming years later from unexpected angles. A classic example of this process is the polymerase chain reaction (PCR), which was built on basic research on DNA replication in bacteria from hot springs published years before its invention.  Critics of publicly funded research often take studies out of context in order to ridicule them, such as Sarah Palin’s infamous “fruit flies” comment.

A recent analysis of the economic effects of the National Institutes of Health (NIH) funding has shone light on the economic benefits of basic research. Danielle Li and colleagues found that although 8.4% of NIH grants between 1980 and 2007 led directly to patents, 30.8% produced a scientific article which was later cited in a commercial patent for a drug, device or other medical technology. This demonstrates an enormous but indirect benefit of publically funded research. Furthermore, when the studies were broken down into basic or applied (research with a stated medical or commercial goal) they found no difference between the two in terms of how likely they were to be cited in a patent. This should give funding bodies pause for thought, as it calls into question their growing emphasis on applied research.

Taking into account the indirect effects of NIH funded research, the authors estimate that every $1 in NIH funding returns $1.40 in drug sales. This report is timely with proposed budget cuts for science funding looming large in the horizon, and exposes such cuts as sheer economic folly. (Elie Dolgin, Nature News)

HIV/AIDS

HIV Infections are Spiking Among Young Gay Chinese

Recent surveys of HIV infections in China have shown a worrying spike in HIV infections among young gay and bisexual men, and have sparked the implementation of a broad 5-year plan to raise awareness and boost research into new treatments by the country’s ruling State Council. In the early 2000s, HIV infections were most prevalent amongst drug users in China, but there has been a steady decrease in prevalence amongst this group. The increase in HIV infections amongst men who have sex with men (MSM) has bucked this trend, and instead has been rising at an alarming rate. The cause of this increase remains unknown, with researchers at the National Health and Family Planning Commission in Beijing and China Medical University in Shenyang rather hopelessly suggesting that it was “possibly due to several unidentified and yet unaddressed risky sexual behaviors”.

China has previously mounted an effective response to the initial HIV epidemic by providing free antiretroviral to all HIV patients. This does little good, however, if you are afraid to admit you have HIV because it may out you as gay or bisexual. Despite recent improvements in LGBT rights and growing acceptance of LGBT people among the younger generation, being LGBT in China still carries with it significant stigma. This stigma, along with that of having HIV, may be causing young men to avoid seeking help out of fear. To reach out to gay men who may be at risk, the government and concerned nongovernmental organizations are working on novel outreach programs, such as working with dating apps popular with young gay and bisexual men to spread HIV awareness. The director of the Chinese Centre for Disease Control (China CDC), Wu Zunyou, has proposed increasing the availability of HIV self-test kits and pre-exposure prophylaxis medications, both of which would help those at risk whilst lessening the pressure from social stigma. (Kathleen McLaughlin, Science)

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Written by sciencepolicyforall

April 4, 2017 at 10:00 am