Science Policy For All

Because science policy affects everyone.

Science Policy Around the Web – March 20, 2018

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By: Leopold Kong, PhD


source: pixabay


Science Finds Once Again That Violent Video Games Don’t Turn People Into Rage Monsters

Since the recent mass shooting in Florida, the old question of whether playing violent video games can be a factor towards violent behavior has become relevant to the public again. In a recent interview with the Los Angeles Review of Books, Alfie Brown, author of The PlayStation Dreamworld, argued that video games are powerful vehicles of indoctrination and possible behavior modification: “Like a dream and unlike books and television, a video game is experienced actively, as if each player has a role in determining its events and outcomes.” Brown further elaborates in recent article published in the Guardian:

“Although affected by context, video games have long focused on the expulsion of “aliens” (Space Invaders to XCOM), fear of impure infection (Half-Life to The Last of Us), border control (Missile Commander to Plants vs Zombies), territory acquisition (Command & Conquer to Splatoon), empire building (Civilization to Tropico), princess recovery (Mario to Zelda), and restoration of natural harmony (Sonic to FarmVille) . . . video games put the user to work on an instinctual level, making the gamer feel impulsive agreement with these ideologies. Playing Resident Evil is not equivalent to watching the movie, because the controller-wielding gamer experiences the desires of the game as their own desires – not as the desires of another.”

However, a recently published study in the Nature journal Molecular Psychiatry did not find any significant behavioral changes from playing violent video games for 2 months. The study recruited three groups of volunteers (77 total, mean age= 28 years, 48 females) who were given questionnaires assessing levels of aggression, sexist attitudes, empathy, interpersonal competencies, impulsivity-related constructs such as boredom proneness, mental health and executive control functions before and after the study. The study consisted of playing a violent video game (Grand Theft Auto V), playing a non-violent video game (The Sims 3) or playing no game at all for 2 months on a daily basis. The study found no significant differences before and after playing games, and no differences between the groups. Chris Ferguson, a psychology professor at Stetson University in Florida who studies how video games affect societies commented that:

“It’s small in terms of sample size, but it’s otherwise well-done and pretty unique in that it looks at long term exposure…I think that this is an important piece of evidence that should guide us to rethink our beliefs about whether violent video games do or do not influence aggression.”

(Ed Cara, Gizmodo)

International Science Policy

Africa is the home to 15% of the world’s population, and yet produces only 3% of the global GDP and suffers 25% of the global burden of disease. Recent numbers suggest Africa accounts for only 2% of the world research output, and holds only 0.2% of the patents worldwide. In a recent study from the African Academy of Sciences, these challenges and disparities are analyzed, and possible approaches to closing these gaps through implementation of science technology and innovation (STI) policy changes are presented. The key issues and findings of the study are:

  • In 2016, fewer than half of African countries had adopted STI policies. For those countries that did, most did not focus on funding technology development, but instead on basic science.
  • Low implementation of STI policies could be attributed to low policy literacy, weak human literacy, insufficient monitoring and accountability and inadequate budget. One interviewee said: “like many previous African plans, strategies and many programs for millennium development goals did not say much if anything about research, science and technology”.
  • Information and Communication Technologies (ICT) has expanded and has driven economic growth across multiple sectors in Africa. Africa has developed an entrepreneurial class from urban incubators to remove villages, leveraging mobile-based technologies to solve logistics and infrastructure challenges unique to Africa.
  • In comparison to ICT, growth of biotechnology has been limited. Adoption of genetic modification in commercial agriculture has been inconsistent and potentially undermines potential genetic modification applications in African in the future.
  • Cooperation in international research and innovation is often short-term, based on the interests of individual scientists, and lack institutional and government support

The study made these key recommendations moving forward:

  • Ensure executive accountability for implementation of STI policy frameworks to meet national targets on gross domestic expenditure on R&D (GERD) through developing greater political and legislative oversight, establishing partnerships with international institutions such as the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the International Council for Science (ICSU) capacity building.
  • Improve policy literacy through development of educational and guidance material.
  • Collaborate with African educational institutes to develop graduate courses on innovation and technology management, as well as STIP policy.
  • Establish pan-African mechanisms to fund and coordinate research and innovation initiatives with partners such as the Bill and Melinda Gates Foundation.
  • Develop platforms to foster science-business-society dialogue.

With the global shift to knowledge-based economies, Africa may be poised for growth by leveraging a more centralized and technology-focused STI framework.

(African Academy of Sciences, Report)

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March 20, 2018 at 4:33 pm

Science Policy Around the Web – March 13, 2018

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By: Roger Mullins, Ph.D.


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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March 13, 2018 at 5:05 pm

Science Policy Around the Web – March 6, 2018

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By: Cindo O. Nicholson, Ph.D.


source: pixabay

Artificial Intelligence & Ethics

Artificial intelligence could identify gang crimes-and ignite an ethical firestorm

Today, many industries and our favorite gadgets use some form of artificial intelligence (AI) either to make better predictions on user/consumer behavior. AI is also being adopted by police departments to highlight areas where crime is likely to occur thus helping patrol officers prevent crimes before they occur (i.e. predictive policing). Recently at the Artificial Intelligence Ethics & Society (AIES) conference in New Orleans LA, researchers presented a new algorithm that could classify crimes as gang-crimes based on partial information. In particular, the new algorithm can identify gang crimes using only 4 pieces of information: the primary weapon used, the number of suspects, the neighborhood and location (street corner vs. alley for example) where the crime took place.

Many agree that the findings presented (published by the AIES) could change the way the police approach and respond to crimes by classifying the crime beforehand as gang-related. However, not all in attendance were convinced that the new algorithm would be any better than an officer’s intuition and experience. In fact, there were those who believed that there could be unintentional, negative consequences of relying on such an algorithm. A point of contention at the conference was the appearance that the research team did not give sufficient consideration to whether the training data was controlled for bias, or what would happen if individuals were misclassified as gang members.

AI is a powerful technology, and its use can be applied to solve problems in fields like ecology and conservation, public health, drug development, and others. However, like all powerful technology its development must keep pace with its regulation, and the consideration of its potential misuses and unintended consequences.

(Matthew Hutson, Science Magazine)

Science Education

Florida’s residents could soon get the power to alter science classes

The possibility that the public can make recommendations on what instructional materials are used in science classes is moving closer to reality. Two education bills are being considered by Florida’s legislature that would grant Florida’s residents the means to recommend what instructional materials are used in the classrooms of schools in their district.

The education bills being considered would add to a law enacted in June 2017 that grants Florida’s residents the right to challenge the topics educators teach students. In particular, the bills under consideration will allow Florida’s residents to review instructional materials used in class, and suggest changes to the materials. However, the final decision on whether recommendations from residents are accepted would still rest with the school board.

Among the concerns of the scientific community is that these laws would provide a mechanism for creationists, climate-change deniers, and flat-earth proponents (commonly referred to as “flat-earthers”) to insert their non-scientific viewpoints into scientific lesson plans. On the other hand, State Representatives in support of these bills contend that highlighting different viewpoints are important and would allow for debate and drawing one’s own conclusions.

While engaging the public on the content of educational curricula could have its merits, it could have negative consequences when public opinion overrides curricula that have been developed from knowledge gained and refined by rigorous, scientific interrogation over several decades. If more education bills that allow the public to challenge instructional materials are going to be approved, it will be imperative that individuals with scientific backgrounds be a voice of reason on school boards.

(Giorgia Guglielmi, Nature Magazine)

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March 7, 2018 at 11:28 am

Science Policy Around the Web – March 2, 2018

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By: Patrice J. Persad, PhD


source: pixabay

The Environment

Plastic Pollution Is Killing Coral Reefs, 4-Year Study Finds

Plastic, plastic everywhere / Disease of corals on the flare. A large-scale investigation surveying coastal regions of the Asia-Pacific, including parts of Myanmar, Thailand, Indonesia, and Australia, found that approximately 11.1 billion pieces of plastic littered coral reefs. Given that the populous China and Singapore were omitted from the analyses, the bona fide count may be higher than this published value. Supporting the hypothesis that plastic, a manmade product, may find it’s way into coral reefs proximal to regions with more humans and with less developed waste management systems, the less densely populated Australian locations had the smallest numbers of plastic items while heavily populated Indonesian sites had the largest numbers.

Although quantification of plastic occupying the seas, especially on the visible surface, were pursued by other research groups, a link between plastic and the physiological state of the corals beneath was understudied and, thus, never established. Upon viewing diseased phenotypes of coral reefs imprisoned by plastic, Joleah B. Lamb and colleagues constructed regression models to determine if coral disease presence was associated with the presence of plastic debris. The likelihood of having skeletal eroding band disease, white syndromes, or black band disease increased significantly in the onslaught of plastic debris. The team also noted differences in disease likelihood for coral anatomy/morphology categories; the massive coral morphology, the most intricate coral structure, had the highest disease likelihood when engulfed with plastic items (although this category had the lowest likelihood of plastic waste encounters).

How does plastic precisely contribute to coral disease? Researchers are not completely sure. However, there are several hypotheses. Plastic debris cloak coral reefs and bar contact with the sun’s rays. Solar interaction is vital because coral species—those involved in reef generation—have a symbiotic relationship with the photosynthetic algae, zooxanthellae. The algae nurture these corals and assist with the formation of the reef’s calcium infrastructure. Another sea of thought is that the plastic items on reefs may be gouging coral tissue and allowing pathogenic microorganisms from surrounding waters to creep in. A third explanation is that the chemical compounds constituting plastic itself may incite disease outbreak on coral reefs.

The coral reef is an ecosystem with brilliant biodiversity rivaling that of the terrestrial tropical rainforest. Like the mangrove forest and seagrass communities, the coral reef is both a nursery and asylum for various fish and invertebrate species. If these facts on the mere ecological worth of protecting coral reefs do not compel citizens, then the economic worth might. These natural underwater marvels rake in billions of dollars from tourism, aquaculture, and fishing. Coral reefs prevent beach battery in the midst of titanic tempests. The oceans and waterways are interconnected, along with the ecosystems and accompanying food webs. Even though the Asia-Pacific was the center of Lamb et al.’s study, citizens everywhere can engage in recycling plastics or diminishing use of non-biodegradable plastic items.

(Christopher Joyce, National Public Radio)

Wildlife Conservation

China’s lust for jaguar fangs imperils big cats

One fang, two fangs, three fangs, four / Of the jaguar gone in gore. Imagine you are a police officer in Bolivia. Your duty is monitoring wildlife trafficking and apprehending any individuals who are exploiting native species. Recently, you have encountered several decapitated jaguars, an endangered species, in local canals. Aside from these decapitated jaguars, other retrieved cadavers were fangless if not headless. After communicating with colleagues in neighboring Brazil and Belize, you learn that these are recurring patterns in jaguar fatalities. The next week, you discover pamphlets and posters advertising payment for a single jaguar fang: $120 – $160 USD. Your division confiscates almost 200 jaguar fangs. During a briefing with your supervisor, you gravely state, “Sergeant, I think this [wildlife trafficking] is getting bigger than we thought.”

From the above scenario, why are jaguar fangs such a popular commodity? For generations, tiger body parts, such as bone, teeth, and skin, have been important components of traditional Chinese medicine. Fortunately, authorities are successfully limiting the tiger parts trade. As a result, many in China are now directing attention, unfortunately, to another big cat, the jaguar, as a proxy. However, the jaguar is not the only big cat grievously affected by this shift. As one case in Belize features, poor species recognition by poachers ended an ocelot’s life. As the wildlife trade is highly profitable around the globe—superseded by only weapons and drugs—the conservation front in the form of law enforcement can gain little economic or corporal support. In fact, consequences for those who violate wildlife trafficking laws rarely involve incarceration. Prominent ecologist, Vincent Nijman, feels this may stem directly from the international society’s indifference to the fate of poached species, especially if the immediate reward of killing or capturing species brings in more money than saving them.

The jaguar’s plight—the species’ decimation—emerges from more than China’s hunger pangs for fangs. Urbanization has down-sized this big cat’s habitat, a range of tropical rain forests and savannas. Because of losses in sanctuary and hunting grounds, the jaguar may prey upon cattle and other agricultural animals. Consequently, irate farmers lash out by killing these feline threats. Agricultural stakeholders have several options to share the land peacefully: incorporating guard animals into herds, securing baby farm animals in complexes/shelters, granting loans on the basis of cattle/agricultural animal management history, and deterring predators with innocuous barriers, such as moats and man-made lights.

The exploitation of the jaguar, South America’s prime big cat, impacts other species’ survival and spawns from previous misdeeds against other species. Many sets of individuals are responsible for and partake in such a transgression against the jaguar. Cooperation among international conservation organizations and law enforcement agencies will be needed given the scope of wildlife trafficking and the low-key sense of emergency from society. Perhaps a beautiful friendship will cultivate between the International Criminal Police Organization’s (INTERPOL’s) environment crime division and the International Union for the Conservation of Nature (IUCN) or TRAFFIC (if such a bond has not already deepened).

(Barbara Fraser, Nature News)


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March 2, 2018 at 9:34 pm

Hold the Mayo: Supreme Court Ruling Blocks Patent Protection for Important Medical Diagnostics

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By: Jon Nye, Ph.D.


source: George Hodan, via

In President Obama’s 2015 State of the Union Address he announced the Precision Medicine Initiative. This study will follow 1 million or more volunteers over a long period of time at a cost of $215 million. The goal of this ambitious initiative is to fundamentally change the way we diagnose and treat patients by moving from a “one-size-fits-all” approach to one that tailors disease prevention and treatment based on each individual, factoring in differences such as genetic makeup, lifestyle, and environment. As we move forward into the era of precision medicine and gain a better understanding of the complex underlying mechanisms that contribute to disease, we will require the development of diagnostic tests that allow caregivers to identify the specific causes of each individual patient’s disease, leading them to select an appropriate treatment. Although the future market for diagnostic tests looks bright, recent Supreme Court rulings that will prevent companies from obtaining patent protection threatens to hamper the development of these important tools and may adversely affect patient care.

Mayo Collaborative Services v. Prometheus Laboratories

The purpose of the patent system is to encourage research and innovation by rewarding inventors with a temporary government-granted monopoly. This system has been around since the founding of our country and stems from Article I of the Constitution in which it says, “The Congress shall have power … To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries”. However, in the medical diagnostics field, recent court rulings have dramatically narrowed what is considered to be patent eligible. The most notable being the 2012 Supreme Court case Mayo Collaborative Services v. Prometheus Laboratories. This case centered on a method for determining the proper amount of a specific drug to give to patients by measuring the levels of a drug metabolite in their blood. This test provided a way to individualize dosing so that doctors could maximize the drug’s effectiveness while minimizing the side effects of receiving too much. In a unanimous decision, the Supreme Court ruled that this patent was invalid based on the fact that the test stated a “law of nature”.

“Prometheus’ patents set forth laws of nature – namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.”

In other words, any patent claim based on a test that measures compounds, metabolites, or any other marker specific to disease was now patent ineligible simply because they measure processes that occur in the human body. This extremely broad definition of what can be considered a natural law led to widespread rejection of most diagnostic tests, now referred to as a Mayo rejection.

Aftermath of the Mayo Decision

A recent study has analyzed the effect that the Mayo decision has had on the medical diagnostic patent landscape in the United States. In this study, the authors looked at 31 patents that contained either diagnostic or prognostic claims and were filed in both the US and the European Union. This revealed a huge discrepancy in the two systems. Indeed, in the EU, which has no legal equivalent to the Mayo rejection, 30 out of 31 applications had either received a patent or were still pending. On the other hand, 29 of 31 applications in the US were abandoned or were still pending after receiving a Mayo rejection. This study highlights the profound and possibly unintended consequences that the Supreme Court ruling in the Mayo case has had on medical diagnostic patent eligibility.

Surprisingly, recent federal court rulings have supported the notion that in the wake of Mayo, current guidelines are too restrictive and prevent even well-deserved new diagnostics from patent approval. Most notably was the recent case Ariosa Diagnostics, Inc. v. Sequenom, Inc. This case involved a patent on a new technique for non-invasive genetic testing of a fetus. Sequenom’s diagnostic relied on two novel findings. First, their test used fetal DNA that was found to be circulating in the mother’s blood which was previously discarded as useless. Second, they developed a method to selectively amplify DNA from the fetus apart from the mother’s by focusing on the paternal DNA contributions. Although this technique was referred to as, “a paradigm shift in non-invasive prenatal diagnosis”, by the Royal Society in the United Kingdom, multiple US courts ruled that it was patent ineligible based on Mayo. In fact, these court rulings were unanimous and all of the judges remarked that based on the Supreme Court’s guidelines their hands were tied, even though some judges believed that this novel test merited a patent. Judge Linn from the Federal Circuit Court wrote:

“This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.”

These lower court rulings had many people hopeful that the Sequenom case would make it to the Supreme Court and allow them to refine the broad language in Mayo. However, the case was declined later that year, signaling that the solution to this problem was unlikely come from the courts. Instead, congress would have to act.

A Path Forward

In the wake of the Sequenom case, it was clear to many that the only way to change the restrictive patent guidelines in the medical diagnostic field was to pass legislation that would supersede the Supreme Court ruling. In order to gain momentum and start a discussion about what a bill like this would entail, a conference was held at Berkeley. It was attended by leading industry experts, scholars, policymakers, and a retired jurist. From these discussions, it was agreed that the current patent guidelines were inhibiting research and development in the diagnostics field by undercutting incentives. Consequently, at least in the bioscience field, the current system is no longer fulfilling the original intent of the patent system which was, “To promote the Progress of Science and useful Arts”. The consensus was that future legislation should expand patent eligibility to include conventional applications of scientific discovery. This general framework for a bill is consistent with current guidelines in the EU and also consistent with the spirit and intent of the patent system outlined in the Constitution. With the continued focus on tailored individualized treatment of patients it will be important to promote research and development in this area. Therefore, changing current guidelines should be a priority before they negatively affect patient health.

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March 1, 2018 at 7:45 pm

Science Policy Around the Web – February 23, 2018

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By: Janani Prabhakar, Ph.D.


source: pixabay

Climate Change

Permafrost experiments mimic Alaska’s climate-changed future

In Denali National Park and Preserve, you will find ecologist Ted Schuur near Eight Mile Lake on an endeavor to answer some of the toughest questions in climate change research. His “laboratory” is situated in the middle of a tundra, filled with many instruments to measure changes in carbon dioxide. A gas-sensing tower can detect carbon dioxide levels a quarter mile away. Polycarbonate chambers at the top of this tower traps CO2 as it drifts through the air and measure its amount. Using a clever manipulation, he seeks to determine how rising temperatures will impact this region’s CO2 emissions.

The key to understanding the impact of rising temperature is to understand the dynamics between carbon dioxide, plants and soil. Microbes in the soil release CO2. Plants absorb more CO2 than they release, keeping it out of the atmosphere. Critically, microbes release CO2 all year while plants absorb CO2 only during growing season. For a perfect balance, there should be enough microbes in the soil that release CO2 throughout the year and enough plants in the environment to absorb it during growing season. How do rising temperatures impact this balance? Schuur measured CO2 from two different plots of land: one that was surrounded by snow fences and the other that was unfenced. Snow fences catch the cold drift and as a result, the ground they surround is 3 to 4 degrees Fahrenheit warmer than the unfenced plot. This amount of warming is significant because Alaska is projected to see an additional 4 to 5 degrees of warming by 2100. So, Schuur has created an environment within the fenced plot that mimics the projected environment of 2100.

Schuur finds that due to the warmer temperatures, slumping permafrost causes the land to lower by several feet. This, in turn, causes the depth to which the soil thaws in the summer to be deeper, allowing the permafrost layer to add more organic matter to the soil. The result is that more organic matter produces more plant growth, which means more CO2 is absorbed in these warmed fenced plots than the cooler unfenced plots. But, this only happens during the growing season. Since the deeper soil also sees more microbial growth, more CO2 is released from the soil all year around in the fenced than unfenced plot. Schuur finds that the amount of CO2 released in these warmer plots is not offset by what is absorbed by the plants in the growing season, despite the extra plant growth.

Altogether, this news is not good. Given the current rate of temperature rise, this imbalance between CO2 absorption and release may only grow. By the end of the century, the amount of carbon transferred from the thawing permafrost to the atmosphere could reach 1 billion tons, as much as present-day emissions of Germany and Japan.

(J. Madeleine Nash, Wired)


Synergy Between Nurses And Automation Could Be Key To Finding Sepsis Early

Sepsis is the body’s reaction to overwhelming infection and causes about a quarter of a million deaths in American each year. If caught early, it can be treated. But, healthcare workers struggle to identify sepsis in patients in a timely manner. Blood tests cannot specifically test for it, and there is nothing to search for under a microscope. Dr. David Carlbom, a pulmonologist at Harborview Medical Center in Seattle, devised a system to help healthcare providers identify sepsis symptoms and provide timely treatment. His system uses day to day electronic health records to detect subtle clues and send warning flags for impending sepsis. It helps to capture patterns in symptoms, including high or low temperatures, low blood pressure, fast breathing, and high white blood cell count. The system is implemented at nursing stations in the hospital. After a patient is admitted, a red box appears in the patient record, prompting the nurse to answer questions about symptoms and determine whether they point to early signs of sepsis. If the nurse determines that they do, a provider is paged and responds within a half hour. Altogether, the system is intended to ensure the patient is seen within three hours.

While this is a much more precise and efficient method than prior practice, there are circumstances that lead to false alarms. For example, faster breathing may be due to multiple factors, including simply walking down the hall. Or, symptoms such as high white blood cell count may not be due to sepsis, particularly in patients being seen for other health issues like cancer. One way to reduce false alarms is built into the system: the red box appears only every 12 hours. This ensures that providers are not paged throughout the day for false alarms. Furthermore, if nurses determine that the patient is not experiencing sepsis, they must report why and provide an explanation for the symptoms the patient is experiencing. This allows for thoroughness, accountability, and precision. It also ensures that nurses keep a close eye on their patients. The effectiveness of this system has been seen in the reduction of mortality rates since it was installed in 2011.

Despite the reduction in mortality rates, entering vital signs manually could have its shortcomings. Sepsis symptoms can arise quickly and affect the body rapidly. Nurses may miss these symptoms within the 12-hour window if they are not vigilant. Recent efforts have begun to address this issue. Dr. Matthew Churpek at the University of Chicago is partnering with a company to create a device that will go under a patient’s mattress to continuously calculate heart rate and respiratory rate. This will reduce false alarms and allow researchers to use an evidence-based approach to clinical practice. They can generate algorithms based on data to predict early onset of sepsis. Critically, this approach will allow clinicians to focus on preventative efforts rather than treatment.

(Richard Harris, NPR)

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February 23, 2018 at 10:43 pm

Clinical Trials Policy Revision: For Better or Worse

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By: Jenn L. Nguyen, Ph.D., M.P.H.


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 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