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Archive for January 2017

Science Policy Around the Web – January 27, 2017

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By: Nivedita Sengupta, PhD

Source: NIH Image Gallery on Flickr, under Creative Commons

Human Research Regulation

US Agency Releases Finalized ‘Common Rule’, Which Govern Human-Subjects Research

On September 8, 2015 the US Department of Health and Human Services (HHS) proposed significant revisions to the Federal Policy for the Protection of Human Subjects which is also known as the “Common Rule”. “Common Rule” is the set of federal regulations governing the conduct of clinical research involving human subjects. Among the proposed changes, an important one was regarding getting peoples’ consent before using the biological samples for subsequent studies. On 18th January 2017, the final version of the rule was released in which the proposed change was abandoned. This is a blow to the patient-privacy advocates, however the US National Academies of Sciences, Engineering and Medicine argued against that requirement and others citing that the changes would impose an undue burden on researchers and recommended that it be withdrawn.

The current version of Common Rule has generated mixed feelings among people. Researchers are happy that the government listened to scientists’ fears about increased research burdens whereas people like Twila Brase, president and co-founder of Citizens’ Council for Health Freedom in St Paul, Minnesota, are disappointed as they believe that these specific changes are ought to be made. Moreover the new version of the Common Rule requires that scientists include a description of the study, along with the risks and benefits, on the consent forms used by patients, and federally-funded trials should post patient consent forms online. However, these requirements do not extend to trials that are conducted with non-federal funds. (Sara Reardon, Nature News)

Biomedical Research

An Open-Science Effort to Replicate Dozens of Cancer-Biology Studies is Off to a Confusing Start

The Reproducibility Project on Cancer Biology was launched in 2013 to scrutinize the findings of 50 cancer papers from high-impact journals. The aim is to determine the fraction of influential cancer biology studies that are sound. In 2012, researchers at the biotechnology firm Amgen performed a similar study and announced that they had failed to replicate 47 of 53 landmark cancer papers but they did not identify the studies involved. In contrast, the reproducibility project makes all its findings open. Full results should appear by the end of the year and eLife is already publishing five fully analyzed reports in January. Out of the five, one failed to replicate and the remaining four showed replication results that are less clear.

These five results paint a muddy picture for people waiting for the outcome to determine the extent of impact of these studies. Though some researchers praised the project, others feared unfair discredit of their work and career. According to Sean Morrison, a senior editor at eLife, the reason for the “uninterpretable” results is “Things went wrong with tests to measure the growth of tumors in the replication attempts and the replication researchers were not allowed to deviate from the protocols, which was agreed at the start of the projects in consultation with the original authors”. “Doing anything else — such as changing the experimental conditions or restarting the work — would have introduced bias”, says Errington, the manager of the reproducibility project.

According to Errington, the clearest finding from this project is that the papers include very few details about their methods. The replication researchers had to spend hours to work out the detailed protocols and reagents along with the original authors. Even after following the exact protocols, the final reports include many reasons why the replication studies might have turned out differently, including variations in laboratory temperatures to tiny variations in how a drug was delivered. He thinks that the project helps to bring out such confusing details to the surface, and it will be a great service for future follow up work to develop a cure for cancer. However, scientists think that such conflicts mean that the replication efforts are not very informative and couldn’t be compared to the original and will only cause delays in advancing future clinical trials. (Monya Baker and Elie Dolgin, Nature News)

 

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Containing Emerging and Re-emerging Infections Through Vaccination Strategies

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By: Arielle Glatman Zaretsky, PhD

Source: CDC [Public Domain], via Wikimedia Commons

           Throughout history, humans have sought to understand the human body and remedy ailments. Since the realization that disease can be caused by infection and the establishment of Koch’s postulates, designed to demonstrate that a specific microbe causes a disease, humans have sought to identify and “cure” diseases. However, while we have been successful as a species at developing treatments for numerous microbes, viruses, and even parasites, pure cures that prevent future reinfection have remained elusive. Indeed, the only human disease that has been eradicated in the modern era (smallpox) was eliminated through the successful development and application of preventative vaccines, not the implementation of any treatment strategy. Furthermore, the two next most likely candidates for eradication, dracunculiasis (guinea worm disease) and poliomyelitis (polio), are approaching this status through the use of preventative measures, via water filtration and vaccination, respectively. In fact, despite the recent pushback from a scientifically unfounded anti-vaxxers movement, the use of a standardized vaccination regimen has led to clear reductions in disease incidence of numerous childhood ailments in the Americas, including measles, mumps, rubella, and many others. Thus, although the development of antibiotics and other medical interventions have dramatically improved human health, vaccines remain the gold standard of preventative treatment for the potential of disease elimination. By Centers for Disease Control and Prevention [Public domain], via Wikimedia Commons

Recently, there have been numerous outbreaks of emerging or reemerging infectious diseases. From SARS to Ebola to Zika virus, these epidemics have led to significant morbidity and mortality, and have incited global panic. In the modern era of air travel and a global economy, disease can spread quickly across continents, making containment difficult. Additionally, the low incidence of these diseases means that few efforts are exerted to the development of treatments and interventions for them, and when these are attempted, the low incidence further complicates the implementation of clinical trials. For example, though Ebola has been a public health concern since the first outbreak in 1976, no successful Ebola treatment or vaccine existed until the most recent outbreak of 2014-2016. This outbreak resulted in the deaths of more than 11,000 people, spread across more than 4 countries, and motivated the development of several treatments and 2 vaccine candidates, which have now reached human trials. However, these treatments currently remain unlicensed and are still undergoing testing, and were not available at the start or even the height of the outbreak when they were most needed. Instead, diseases that occur primarily in low income populations in developing countries are understudied, for lack of financial incentive. Thus, these pathogens can persist at low levels in populations, particularly in developing countries, creating a high likelihood of eventual outbreak and potential for future epidemics.

This stream of newly emerging diseases and the re-emergence of previously untreatable diseases brings the question of how to address these outbreaks and prevent global pandemics to the forefront for public health policy makers and agencies tasked with controlling infectious disease spread. Indeed, many regulatory bodies have integrated accelerated approval policies that can be implemented in an outbreak to hasten the bench to bedside process. Although the tools to identify new pathogens rapidly during an outbreak have advanced tremendously, the pathway from identification to treatment or prevention remains complicated. Regulatory and bureaucratic delays compound the slow and complicated research processes, and the ability to conduct clinical trials can be hindered by rare exposures to these pathogens. Thus, the World Health Organization (WHO) has compiled a blueprint for the prevention of future epidemics, meant to inspire partnerships in the development of tools, techniques, medications and approaches to reduce the frequency and severity of these disease outbreaks. Through the documentation and public declaration of disease priorities and approaches to promote research and development in these disease areas, WHO has set up a new phase of epidemic prevention through proactive research and strategy.

Recently, this inspired the establishment of the Coalition for Epidemic Preparedness Innovations (CEPI) by a mixed group of public and private funding organizations, including the Bill and Melinda Gates Foundation, inspired by the suggestion that an Ebola vaccine could have prevented the recent outbreak if not for the lack of funding slowing research and development, to begin to create a pipeline for developing solutions to control and contain outbreaks, thereby preventing epidemics. Instead of focusing on developing treatments to ongoing outbreaks, the mission at CEPI is to identify likely candidates for future outbreaks based on known epidemic threats and to lower the barriers for effective vaccine development through assisting with initial dose and safety trials, and providing support through both the research and clinical trials, and the regulatory and industry aspects. If successful, this approach could lead to a stockpile of ready-made vaccines, which could easily be deployed to sites of an outbreak and administered to aid workers to reduce their morality and improve containment. What makes this coalition both unique and exciting is the commitment to orphan vaccines, so called for their lack of financial appeal to the pharmaceutical industry that normally determines the research and development priorities, and the prioritization of vaccine development over treatment or other prophylactic approaches. The advantage of a vaccination strategy is that it prevents disease through one simple treatment, with numerous precedents for adaptation of the vaccine to a form that is permissive of the potential temperature fluctuations and shipping difficulties likely to arise in developing regions. Furthermore, it aids in containment, by preventing infection, and can be quickly administered to large at risk populations.

Thus, while the recent outbreaks have incited fear, there is reason for hope. Indeed, the realization of these vaccination approaches and improved fast tracking of planning and regulatory processes could have long reaching advantages for endemic countries, as well as global health and epidemic prevention.

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January 26, 2017 at 9:47 am

Science Policy Around the Web – January 24, 2017

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By: Leopold Kong, PhD

Landfill by Dhscommtech at GFDL, via Wikimedia Commons

Environment

New Discovery Could Lead to a Safer Solution to Plastic Pollution

Polyethylene terephthalate (PET) is a commonly used resin of the polyester family used in the fibers for clothing and liquid containers. In 2015 alone, 56 million tons of PET was produced. Although recyclable, with 1.5 billion pounds recovered annually in the United States, PET is not biodegradable and is a major presence in landfills. Screening 250 samples of contaminated soil, waste water and sludge from a bottle recycling factory for microorganisms that can grow on PET, a team of Japanese scientists has discovered a bacterium, Idoenella sakaiensis, that can break down this tough plastic. Recently spotlighted as a major breakthrough of 2016 by the American Chemical Society, research on the bacterium continues as scientists seek to unlock the mechanism behind the biodegradation pathway that was previously thought to be impossible. Professor Kenji Miyamoto, one of the study authors, said, “This is the first PET-degrading bacterium found [with potential] to develop a new and nature-friendly system”. (Research Highlights, Keio University).

Biomedical Research

Trump Asks NIH Director Francis Collins to Stay On

Last Thursday, on the eve of the inauguration, the National Institutes of Health (NIH) announced that Dr. Francis Collins has been asked to continue his role as NIH director by the Trump administration for an unspecified time. This eleventh hour development came as Collins received back the letter of resignation he had sent late last year, something all presidential appointees do. If asked to stay on through this presidential term, Collins, part of Obama’s science ‘dream team’, would be the first NIH director since the 1970s to be chosen by two presidents.

Ezekiel Emanuel, a bioethicist at the University of Pennsylvania said, “In general, I think more than eight years has not been a good idea. There’s a cycle, and eight years is hard to have new ideas and new energy.”  Nonetheless, Collins, a National Academy of Sciences member who led the human genome project and a highly vocal Christian apologist, would serve as an effective bridge between the research community and the new Republican administration to secure much needed funding for basic research. Tony Mazzashi, senior director for policy and research at the Association schools and Programs of Public Health in Washington DC said, “ I think everyone in the research community will be thrilled.” (Jocelyn Kaiser, Science)

Public Health

Novavax Starts New Clinical Trial in Bid to Prove Failed RSV Vaccine

Respiratory Syncytial Virus (RSV) is a significant public health burden, infecting almost all children by age 2, with 5 to 20 out of 1,000 requiring hospitalization and with a mortality rate of 8 to 34 out of 10,000. Unfortunately, the development of an effective vaccine has been challenging. In the late 1960s, an RSV vaccine for infants devastatingly failed clinical trials with 80% of children receiving the shot being hospitalized. Recent advances in immunology and the RSV vaccine target has led to a new generation of potentially safer and more effective vaccine candidates from industry giants Novavax, GlaxoSmithKline, Global Vaccines, AstraZeneca and MedImmune. Also being explored is vaccination of expectant mothers to protect infants.

However, the field took a hit last year when Novavax’s candidate vaccine failed its phase 3 clinical trials, resulting in a 30% layoff of its workforce. Nonetheless, last Thursday, the company announced that it has started a new phase 2 trial on older adults in the southern hemisphere.  “We expect the results from this trial to inform the next steps in our older adults program and would ensure we maintain our leadership position in this very attractive market opportunity,” said Stanley Erck, president and CEO of Novavax. (Tina Reed, Washington Business Journal)

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January 24, 2017 at 10:04 am

Science Policy Around the Web – January 20, 2017

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By: Jessica Hostetler, PhD

Climate Change

Earth Sets a Temperature Record for the Third Straight Year

The New York Times reports that scientists named 2016 the hottest year on record. This follows the record set in 2015, which followed the record set in 2014 and marks the first time in history a temperature record was set three years in a row. The data is in agreement from three governmental institutions: the USA’s NOAA and NASA and the United Kingdom’s Met Office. The findings were based on “measurements from ships, buoys and land-based weather stations” used to compute an average global temperature of the earth’s surface. The El Niño weather pattern “released a huge burst of energy and water vapor into the atmosphere” and intensified warming in 2015 and 2016, but scientists agree the upward trend over many years is caused by increasing carbon dioxide and greenhouse gasses in the atmosphere.

The warming increases were particularly pronounced in the arctic with “temperatures in the fall running 20 to 30 degrees Fahrenheit above normal across large stretches of the Arctic Ocean” potentially exacerbating sea ice melting and coastal erosion. The heating of the ocean has implications for rises in ocean levels and increased tidal flooding. The calculations from NASA showed over a half a degree Fahrenheit of warming from 2013 to 2016 which is the largest three-year increase since records were started in 1880 and of “the 17 hottest years on record, 16 have now occurred since 2000.” Both NOAA and NASA will soon report to cabinet members appointed by the Trump Administration, with concerns raised from “agencies about whether their data will now be subject to political manipulation.” (Justin Gillis, New York Times)

Human Research Policy

New Rules Ease Consent Requirements for Scientists Using Patient Specimens

STAT News reports that the outgoing Obama Administration issued new rules on Wednesday, January 18th for conducting research with human participants referred to as the “Common Rule” , which include “stepping back from proposals that would have imposed significant new regulatory requirements on scientists.” Earlier versions of the proposal would have required informed, written consent for the use of biospecimens such as “cells, blood, tumor samples, DNA” etc. that were obtained during medical procedures even if the samples had all identifying information removed. Scientists argued that such a change would stifle research; for instance if researchers wanted to use specimens from a previous study where consent was given for a new study, a new consent would be required which would require tracking down each participant.  This would prove challenging for several new White House initiatives such as the Precision Medicine Initiative or the Cancer Moonshot. The proposed change drew 2100 comments during a 90-day public comment period following release in September 2015, and the Department of Health and Human Services responded by making changes to the proposal. (Sharon Begley, STAT News)

The final rule, as posted by the HHS website, includes the following:

  • The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • Requirement that consent forms for certain federally funded clinical trials be posted on a public website.

(Sharon Begley, STAT News)

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January 20, 2017 at 10:58 am

Science Policy Around the Web – January 17, 2017

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By: Kseniya Golovnina, PhD

Source: Wikimedia Commons, by Copyright (c) 2004 Richard Ling, under Creative Commons

Biodiversity

The Mysterious World of Antarctica is More than Penguins

On December 21, 2016 the Australian Antarctic Division (AAD) released a video, which was made under the sea ice in O’Brien Bay, south of Casey research station in East Antarctica. This was the last part of the Australian Antarctic program, led by Dr. Johnny Stark, with the aim to observe the effect of climate change and ocean acidification due to increased carbon dioxide emissions on the Southern Ocean seafloor communities.

AAD biologist Dr. Glenn Johnstone and his team launched a remotely operated vehicle (ROV) through the small hole drilled in the ice and captured a rare glimpse of wonderful colorful Antarctic underwater world. They discovered a flourishing community of sea life below the massive ice sheet, at 30 meters below the surface, where the water temperature is −1.5°C year round, and the sea is covered by ice that is 1.5 meters thick for more than 10 months of the year. The video surprisingly revealed “a habitat that is productive, colorful, dynamic and full of a wide variety of biodiversity, including sponges, sea spiders, urchins, sea cucumbers and sea stars.”

About 30% of the carbon dioxide emitted into the atmosphere is absorbed by the ocean and increases its acidity. According to NASA Earth Observatory, increased acidity will increase the ocean’s ability to absorb carbon dioxide, making the carbonate shells of marine organisms such as corals thinner and more fragile. Higher water temperatures would also decrease the abundance of phytoplanktons, which play an important role in the carbon cycle absorbing excess carbon dioxide from the atmosphere. The increased carbon dioxide in the ocean might facilitate the growth of a few species of phyplanktons that take carbon dioxide directly from the water, but overall excess carbon would be detrimental to most ocean species.

Scientists are only now beginning to understand the complex underwater Antarctic ecosystem. Antarctica may be one of the first places where the detrimental effects of ocean acidification are seen, says Dr. Stark. These studies could be a good future indicator of the effects of climate change and ocean acidification on ocean ecosystems. (Australian Antarctic Division)

Food Policy

One or Two Tablespoons of Nutella?

The Food and Drug Administration (FDA) has closed collecting public comments about a regulatory change that would cut Nutella’s labeled serving size by half. More than 650 comments were collected. “One tablespoon or two tablespoons?” – The Washington Post explains the difference. The issue was about the appropriate reference amount customarily consumed (RACC) and product category. Nutella is classified as a dessert topping, with a RACC of two tablespoons. The serving size typically indicates how much Americans consume at a time and not how much they should, to make it easy for people to compare different products.

Its manufacturer, Ferrero, has asked that Nutella be reclassified as a jam or put in a different product category. This would cut the serving size that Nutella displays on its labels to one tablespoon, which would also decrease the sugar and calorie counts. It is already the second request from Nutella’s company since 2014. As they said to the Washington Post “it was simply seeking clarity as it and other companies prepare their new Nutrition Facts labels, slated for release in 2018”. However, critics of Nutella’s FDA petition including Lindsay Moyer, a senior nutritionist at the Center for Science in the Public Interest, warn people about the marketing ploy to trick people into thinking that it has less calories. If Nutella’s serving size is changed to one tablespoon, it could advertise a mere 100 calories per serving — versus roughly 188 calories for two tablespoons of peanut butter, or 196 calories for almond.

At the same time the question of one or two tablespoons seems not so relevant if one takes a look at the company’s website, where they say “you could circle the world with the amount of Nutella produced every year”. U.S. sales of Nutella are up 39% — from $161.4 million to $224.3 million — in the past five years in comparison with 5% for other nut butters. (Caitlin Dewey, The Washington Post)

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January 17, 2017 at 12:09 pm

Science Policy Around the Web – January 13, 2017

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By: James Taylor, PhD

Source: pixabay

Brexit and Science

Scientists Need To Wake Up to the Opportunities of Brexit

The decision of the United Kingdom to leave the European Union last July has raised numerous concerns about the future of science within the UK, most notably regarding access to EU funding, such as Horizon 2020, and the effect of new immigration controls on non-UK researchers and students. A recent House of Lords report has called for the UK government and scientists to come together and address these concerns.

Firstly, the government should engage scientists throughout the negotiation process and not just in regards to funding. Leaving the EU will require reworking and harmonizing numerous consumer protection, environmental and manufactory laws, for which technical advice is indispensible. The report welcomes the recent increase in science funding from the government, but states that any loss in EU funding should be compensated for. They recommend that both the Department for International Trade (DIT) and the Department for Exiting the European Union (DExEU) appoint scientific advisors immediately.

Secondly, the report calls for the scientific community’s voice to be heard alongside that of business during the negotiations. The UK’s relationship with the EU has been consistently harmonious in regards to research, providing a solid point of agreement amongst more difficult negations.

Thirdly, the UK should explore research collaborations beyond the EU. The report suggests this could be realized if the UK were to offer to host a large, international research facility comparable to the Crick Institute or the Diamond Light Source. They also highlight the potential for industrial collaboration and reform of R&D taxation which would not be possible within the EU.

Immigration remains a key concern in regards to Brexit, with many EU scientists in the UK uncertain of their futures with many now considering leaving. The report emphasizes the need to attract and retain the best international talent going as far as to suggest 10 year research grants and support for immediate family for foreign scientific leaders. They also call for the government to clearly state how immigration laws will affect researchers coming to work in the UK, and that the number of international students coming to study in the UK should not count against any immigration targets. (Graeme Reid, The Guardian)

Biomedical Research

The New Face of US Science

A recent analysis has found that the face of biomedical research has changed considerably over the last few decades. The study, which pooled data on holders of PhDs working as biological or biomedical scientists from the Survey of Doctorate Recipients and the American Community Survey, found that the doubling of NIH funding between 1998 and 2004 had a profound effect on the demographics of the scientific workforce. The authors classify scientists who entered the workforce around this time (i.e. under 40s) as a new cohort, giving them the not so snappy title of “doubling boomers”.

The 1998 to 2004 funding increase meant the number of PhD graduates increased significantly during this time, but the lack of growth in academic positions and funding cuts mean that only 1 in 5 still work in academia (as compared to 1 in two in 1990). For the aspiring academic this may seem like terrible news, but the report also found that the majority of biomedical PhDs now work in the private sector where they earn around $30,000 more a year than their academic peers and report lower pressure to publish publications.

The work force is more diverse than ever, with almost half of young biomedical scientists coming from US minority races. The largest growth has come from Asian ethnic groups, followed by a modest increase in researchers from Latino backgrounds. However the proportion of black scientists showed only a minor increase. These demographics should be borne in mind when devising recruitment and retention strategies to make the workforce more egalitarian.

Finally they found that scientists under 40 are likely to have children around the time they will be applying for their first grant. This is particularly problematic for female scientists, who the study found were less likely to have a stay-at-home spouse who can shoulder household responsibilities. The current academic career trajectory does not take in to account these important differences.

Despite many of these problems being discussed anecdotally for quite some time, the systems for tracking the fates of holder of PhDs after they graduate remain lacking, especially for those who leave academia. The authors insist that better and more transparent data is critical for designing new policies to assist young researchers. (Misty Heggeness, Kearney Gunsalus, José Pacas and Gary McDowell, Nature News)

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January 13, 2017 at 10:37 am