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Posts Tagged ‘research funding

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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April 4, 2017 at 10:00 am

Science Policy Around the Web – February 21, 2017

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By: Rachel Smallwood, PhD

Obesity

Should We Treat Obesity Like a Contagious Disease?

Researchers are modeling obesity from a public health perspective as a contagious disease. There are many factors associated with obesity, including genetics, low levels of physical activity, and high caloric intake. An earlier study examined the effects of different social factors on an individual’s risk of being obese; it found that people with obese friends and family were at an increased risk for obesity, and this trend was influenced by how close the relationships were.

In this model of the prevalence of obesity, the researchers included a factor to represent obesity as a “social contagion”, reflecting those previous findings and indicating a potential increased risk and increased prevalence due to transmission from one person to another. This mechanism is assumed to be related to people adopting the behaviors of those close to them; notably, activity levels and type and quantity of food consumed. The model predicts obesity rates in populations with terms associated with the genetic contribution to obesity, the mother’s non-genetic contribution to her offspring, and the prevalence of obesity. Essentially, the more obese individuals there are in a society, the more likely it is for someone to know and interact with an obese person.

The models indicate that obesity prevalence plateaus around 35-40% without an intervention. The model is still fairly primitive, but the researchers hope that in future it could provide insight into the effects of potential interventions. For example, is it better to target an intervention to individuals who are already obese, or should the reach of the intervention be more broad and target the population as a whole? When the models reach a level of complexity comparable to the existing factors for obesity, they can be a powerful tool in preventing and addressing the epidemic. (Kelly Servick, Science Magazine)

Autism

Brain Scans Spot Early Signs of Autism in High-Risk Babies

A study recently published in Nature showed that alterations in brain development in children who go on to be diagnosed with autism precede behavioral symptoms. High-risk infants’ brains were scanned with MRI at 6, 12, and 24 months. It was determined that the infants who were subsequently diagnosed with autism had a faster rate of brain volume growth between 12 and 24 months. Additionally, between 6 and 12 months, these infants had a faster rate of growth in the surface area of folds on the brain, called the cortical surface.

Taking these findings, the research team used a machine learning approach called a deep-learning neural network to make a model to predict whether an infant would be diagnosed with autism based on their MRIs from 6 and 12 months. This model was tested in a larger set of infants, and the model correctly predicted 30 out of 37 infants who went on to be diagnosed (true positives), and it incorrectly predicted that 4 infants would be diagnosed with autism out of the 142 who were not later diagnosed (false positives). These results are much more robust than behavior-based predictions from this same age range.

More work needs to be done to replicate the results in a larger sample. Additionally, all of the participants were high-risk infants, meaning they had a sibling who was diagnosed with autism, so the results are not necessarily generalizable to the rest of the population. Further studies need to be done in the general population to determine if these same patterns are observable, but that would require an even larger sample due to the lower risk. However, the early detection of symptoms and prediction of diagnosis are potentially valuable tools, especially considering another recent publication showed that early intervention in children with autism affects the severity of symptoms years down the road. (Ewen Callaway, Nature News)

Science Funding

Ebola Funding Surge Hides Falling Investment in Other Neglected Diseases

Funding totals from 2015 reveal a trending decrease in funding for neglected diseases, excluding Ebola and other viral hemorrhagic fevers. Neglected diseases are diseases that primarily affect developing companies, thus providing little incentive for private research and development by commercial entities; the other diseases include malaria, tuberculosis, and HIV/AIDS. Given the recent surge of funding for Ebola research, the analysis firm, Policy Cures Research, decided to separate it from the other neglected diseases in its analysis to observe funding patterns independent from the epidemic that dominated the news and international concerns. Funding was tracked from private, public, and philanthropic sources.

The funding for Ebola research has primarily gone to development of a vaccine, and over a third of the funds were provided by industry. For the other diseases, the decline in overall funding is mostly represented by a decline in funding from public entities, primarily comprised of the governments of large, developed countries. Those countries accounted for 97% of the research funding for neglected diseases in 2015, so any significant change in that funding category would affect the overall funding amounts. However, there was also a slight decline in philanthropic funding. When including Ebola with the others, funding of neglected diseases was actually at its highest in the past ten years. It is not known whether money was funneled from the other diseases to Ebola research, or if this decline is indicative of less research spending in general. (Erin Ross, Nature News)

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February 21, 2017 at 10:03 am

Science Policy Around the Web – October 7, 2016

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By: Eric Cheng, PhD

Source: pixabay

Antibiotic Resistance

World health leaders agree on action to combat antimicrobial resistance, warning of nearly 10 million deaths annually if left unchecked

World leaders committed to take action on antimicrobial resistance during their September 21, 2016 high-level meeting on Antimicrobial Resistance in New York. This is the first time Heads of State made a commitment to address the root cause of antimicrobial resistance in human health, animal health, and agriculture. Dr. Margaret Chan, Director-General of the World Health Organization emphasized that “antimicrobial resistance poses a fundamental threat to human health, development, and security. The commitments made today must now be translated into swift, effective, lifesaving actions across the human, animal and environmental health sectors. We are running out of time.”

The committed countries pledged to strengthen regulation of antimicrobials, improve knowledge and awareness, and promote best practices. World leaders also agreed to foster innovative approaches using alternatives to antimicrobials and new technologies for diagnosis and vaccines. The committed countries will base their national action plans on the Global Action Plan on Microbial Resistance, a blueprint developed in 2015 by the World Health Organization along with Food and Agriculture Organization of the United Nations and the World Organization for Animal Health. (United Nations Meetings Coverage and Press Releases)

Zika

Documents reveal intense battle over CDC Zika tests

In addition to battling the spread of Zika infections, the Center for Disease and Prevention (CDC) is currently in an internal battle with determining which test will be best in diagnosing someone with the disease. Robert Lanciotti is the Chief of the Diagnostics and Reference Activity in the Division of Vector-Borne Infectious Diseases in Fort Collins, CO. At the center of the debate is the agency’s prioritization of the Trioplex real-time PCR-based assay that tests for Zika, dengue, and chikungunya over the Singleplex assay which only detects Zika, which Lanciotti’s research found to be 39% more effective than the Trioplex assay.

Lanciotti claimed that the CDC “created a substantial and specific danger to public health” when it did not disclose lower sensitivity of the test it used. Lanciotti was subsequently reassigned to a non-supervisory position in his laboratory who then filed a whistleblower retaliation claim with the US Office of Special Counsel. Lanciotti alleged that the demotion was because of his concerns with the Zika test. Lanciotti has since been reinstated as director of his lab. In addition, the Office of Special Counsel requested that the CDC investigate Lanciotti’s concerns with the sensitivity of the Trioplex test.

The CDC’s own investigation found that Dr. Lanciotti’s allegations “are not substantiated by the available evidence.” The CDC ruled that “[t]here is insufficient, statistically robust, definitive data to reach an evidence-based conclusion that use of the Trioplex assay over the Singleplex in clinical practice will result in 39 percent of Zika virus infections being missed.” The CDC also noted that it is continuing to improve on the Trioplex assay such as enabling testing laboratories to use larger sample volumes in order to increase the assay’s limit of detection. The Trioplex assay is still approved for use as a method of detecting Zika virus, dengue, and chikungunya. (Jon Cohen, Science Magazine)

Research Funding

HHMI Launches New Program for Early-Career Scientists

The Howard Hughes Medical Institute (HHMI) recently launched a new program to recruit and retain early-career scientists that are underrepresented in the life sciences. These individuals include those coming from a disadvantaged background. The selected HHMI scientists will become Hanna H. Gray fellows, named after Hanna H. Gray, former chair of the HHMI Trustees and former president of the University of Chicago.

The purpose of the Gray Fellows Program is to find and encourage talented students and early scientists that are committed to continuing their scientific training in the nation’s top laboratories. The Hanna H. Gray Fellows grant competition is open to all eligible applicants and no nomination is required.  Selected fellows are required to devote at least 75 percent of their total effort to research during both the postdoctoral training and faculty phases of the award. In addition, part of the goal for the program is to position Gray fellows to be competitive for NIH grants and other awards when they transition to the faculty phase of their careers. (Howard Hughes Medical Institute)

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October 7, 2016 at 11:12 am

Science Policy Around the Web – August 9, 2016

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By: Thaddeus Davenport, Ph.D.

Infectious Diseases

Local Transmission of Zika Virus in Miami

Most of the world became aware of Zika virus earlier this year when doctors in Brazil noticed a correlation between Zika virus infection in pregnant women and microcephaly in their newborn children. Recent articles in the New York Times on July 29th and August 1st report a notable shift in the course of the Zika virus epidemic – local transmission of the virus within the United States. In the last year, there have been over 1600 cases of Zika virus detected in the United States, but nearly all of these were imported infections, in which individuals became infected while traveling in Zika-endemic regions or through sexual transmission of the virus from people traveling outside of the United States. Because the Zika-carrying mosquito species, Aedes Aegypti is resident in parts of the continental United States, many people expected that it was only a matter of time before Zika virus would be transmitted locally within the United States. On July 29th, the Centers for Disease Control and Prevention and the Florida State Department of Health reported that Zika virus was transmitted to at least four individuals in the Wynwood neighborhood of Miami. By August 1st, the number of individuals infected in the neighborhood had risen to fourteen, and the CDC issued a travel advisory discouraging pregnant women from traveling to the affected area. Though Congress went to recess last month without passing a bill to provide funding for the fight against Zika virus, perhaps, and hopefully, the news of local Zika transmission will motivate bipartisan action in Congress to fund mosquito control efforts and basic research on this still poorly understood virus. (Pam Belluck, New York Times)

Clinical Research

First CRISPR-based clinical trial set to begin this month

The gene-editing technique commonly referred to as CRISPR-Cas9 has received significant attention over the last year because of its impressive potential to target, cut, and modify nearly any sequence of interest within a genome. David Cyranoski reported for Nature News that scientists in China are poised to be the first to use CRISPR-Cas9 technology in a human clinical trial. The trial will enroll individuals with metastatic, non-small cell lung cancer, for whom other treatment options have failed. T cells, immune cells capable of killing infected, cancerous, or otherwise afflicted cells, will be removed from these individuals and modified using CRISPR-Cas9 to delete the gene for a protein called PD-1, which plays a role in downregulating the immune response. It is hoped that removing PD-1 will make the participants’ T cells better able to mount an immune response against cancer cells. As an additional measure of safety, the genome of modified cells will be sequenced in order to confirm that there are no off-target modifications outside of the PD-1 gene that might impact the safety or validity of the study. Initially the trial will test the safety of introducing CRISPR-Cas9-modified cells into ten individuals at three different dosages, while also monitoring the effect of the treatment on cancer progression. A similar trial is set to begin in the United States later this year. These will be important proof-of-concept studies to show that CRISPR-Cas9 can be applied safely and effectively in the treatment of disease. (David Cyranoski, Nature News)

Drug Development – Antibiotic Resistance

New Funding for Antibiotics Development

Bacterial resistance to antibiotics is a significant and emerging threat to public health. Methicillin resistant Staphylococcus aureus (MRSA) – a commonly reported and widely feared strain of S. aureus – is one example of a bacterium that was once readily treatable with penicillin and related antibiotics, but which became difficult to treat after acquiring resistance genes. As current antibiotics become less effective against pathogenic bacteria, doctors are running out of tools to treat infections. An important hurdle to addressing the problem of antibiotic resistance is obtaining the funding necessary to support basic research. Unlike drugs to treat chronic health problems, effective antibiotics designed to cure infections of limited duration, are not necessarily a good investment for pharmaceutical companies. Asher Mullard reported for Nature News that CARB-X – Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator- a public-private partnership supported primarily by the US government, Wellcome Trust, and the UK-based Centre for Antimicrobial Resistance hopes to provide US $350 million to motivate and accelerate the development of new antibiotics over the next five years. While many biotechnology companies support the initiative, some researchers, including Kim Lewis a researcher at Northeastern University, worry that CARB-X is too heavily focused on drug development instead of the discovery of novel antibacterial compounds. Despite their limitations CARB-X and other similar programs will likely provide valuable incentives for biotechnology and academic researchers to work towards better antibiotics for the common good. (Asher Mullard, Nature News)

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August 9, 2016 at 9:00 am

Science Policy Around the Web – July 19, 2016

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By: Emily Petrus, Ph.D.

Photo source: digitaltrends.com

Data Mining

Big Data Fighting Terror

How do we stop terrorist attacks before they happen? The US Department of Defense (DOD) has projects dedicated to maintaining our military prowess; however, a new branch of science may be our best bet in fighting this increasingly sinister opponent. Managing huge sets of data from multiple sources presents a challenge for our intelligence and military organizations as we scramble to thwart acts of terror. This involves identifying target locations, suspects and reacting quickly and/or proactively.

After the terror attacks of 9/11, the Patriot Act was passed to allow the government unprecedented access to data from Americans, including bulk phone metadata – famously leaked by Edward Snowden after working for the National Security Agency. Although this type of data is no longer accessible since the bill expired in 2015, the government now has more data than it knows how to handle from social media platforms such as Twitter and Facebook. The National Science Foundation and the DOD are seeking interdisciplinary approaches to efficiently analyze huge data sets and enhance predictive abilities to spot potential terror suspects or events.

It is estimated that ISIS members make up to 90,000 posts on social media per day, so sifting through these posts is a challenge being tackled by researchers and data miners. A 2015 paper looked at 3.1 million Arabic tweets related to ISIS from 250,000 different users over the span of a few years. Using big data analytics they were able to use present tweets to determine if users were pro or anti-ISIS. After identifying users’ present status, they used an algorithm to look at past tweets and predicted which users became ISIS supporters with 87% accuracy.

Our country must weigh the benefits of using big data to foil terror plots before they happen against the loss of privacy. Just this month the House of Representatives voted to block expansion of the Patriot Act, which would have allowed banks to share information with federal authorities of those suspected of funding terrorism. America may be the land of the free, but like France, this leaves us vulnerable to opportunistic terrorists.

GMOs

House gives thumbs-up to GMO label law; bill goes to Obama

Food labels are about to get more complicated: a law proposed by the Senate was passed by the House of Representatives on July 14th will require foods containing genetically modified organisms (GMOs) to be labeled. The labels will be designed with United States Department of Agriculture (USDA) oversight, and can include text, a logo, or a Quick Response (QR) smartphone code. The federal government was pushed to action by the recent legislation in Vermont, which required GMO labeling for foods in grocery stores. This caused many food products to be removed from sale in Vermont such as Coca-Cola, Sabra Hummus, and Heinz Ketchup because companies did not have the motivation or time to prepare labels for Vermont’s new law.

The benefits of passing a law reduces the patchwork of laws bound to spring up in other states, which decreases the burden of individual state labeling for food makers. However there is no consensus on what qualifies as a GMO, as some genetic modifications are simply via selective breeding, while others are “in the lab” like recombinant DNA techniques. Other problems with the bill are exceptions; including foods made with a GMO no longer have the genetic material after processing, which is the case with many sweeteners and cooking oils.

Although the “right to know” movement stimulated by public interest has good intentions, unfortunately the anti-GMO movement is not backed by scientific research. Recently, more than 100 Nobelaureates penned a letter to Greenpeace requesting they stop their anti-GMO campaign. They point to examples of GMO products being better for public health and the environment, as they increase food’s nutritional value and often reduce the amount of chemicals required.

Overall, the mandatory GMO labeling is a compromise bill which will increase the amount of information available about the foods we purchase. Unfortunately the variety of methods used and the complexity of genetic modification of food makes it difficult to make into a simple label for the general population’s benefit. (Jim Spencer, Star Tribune)

Brexit

Science’s status shifts in new Brexit government

The weeks following the Brexit yielded an atmosphere of chaos for British politicians, citizens and scientists as the world came to grips with what an EU exit would do for the economy and everyday lives of those in the UK. Scientists in the UK are especially anxious following the Brexit, as researchers have much at stake with a split from the EU. These include limited access to EU research dollars, less mobility for scientists seeking training opportunities and collaborations between the UK and EU, and an uncertainty for the level of support they will receive from the new UK government.

Now the UK has selected a new prime minister, Theresa May, who has been busy re-organizing government offices. A new department responsible for research funding and oversight will now be headed by Greg Clark, a previous science minister, which is positive news for the scientific community. The department of Business, Energy and Industrial Strategy (BEIS) replaces the Department for Business, Innovation and Skills which had research budget of $6.3 billion. The Department for Energy and Climate Change (DECC) also seems to be rolled into the BEIS, although some worry that without a specific department for environmental concerns, funding and priority for this research and combating climate change will fall by the wayside.

With a swift ascension to the prime minister spot and no actual campaign, scientists have very little idea if May values scientific research. In the past she has pushed to restrict visas (hampering scientist movement and training opportunities), and supported a bill to ban “designer drugs”. However scientists remain hopeful as “[s]he has been an example of good practice in gathering evidence, and also of explaining her decisions when they have not gone with the scientific advice” said Sarah Main of the Campaign for Science and Engineering in London. For the future, scientists will have to wait and see if May views science as a funding priority. (Davide Castelvecchi, Nature News)

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July 19, 2016 at 9:00 am

Science Policy Around the Web – July 1, 2016

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By: Daniël P. Melters, Ph.D.

Image source: Scientia Salon blog

Research Participant Protection

National Academy of Sciences advises White House to rewrite Common Rule

In order to protect participants of clinical studies from being harmed by the very same studies, a set of regulations was set-up for this purpose. These regulations are called the Common Rule and most researchers will encounter the Common Rule when they submit their proposal for ethical review with their local Institutional Review Board (IRB). The rules (45 CFR 46) that apply today were drafted back in 1991 and have not been updated since. Thus last year the U.S. Department of Human and Health Services (HHS) proposed a major revision. The proposal was greeted with criticism and on June 29th, 2016 the National Academy of Sciences, Medicine, and Engineering (NAS) joined the critics. According to the NAS, the HHS proposal is “marred by omissions, the absence of essential elements, and a lack of clarity.” Therefore, NAS made bold suggestions to the Obama administration withdraw the proposed revision to the Common Rule and create a independent national committee modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to essentially rewrite the Common Rule from scratch. (Rob Stein, NPR News)

Science Funding

Interdisciplinary research proposal are less frequently funded

Although interdisciplinary research is frequently praised and encouraged, funding such projects has proven to be difficult. The latest report by an Australian group is similar to those conclusions drawn by the U.S. National Institutes of Health (NIH) before it launched the Roadmap for Medical Research in 2004 to stimulate interdisciplinary research. What makes the most recent Australian study stand out is the metric they developed to determine how interdisciplinary a proposal was. This metric is called “interdisciplinary distance”. The measure assigns a value between 0 and 1 on the basis of the information included in the proposal. A value of 0 represents a proposal that only covered one discipline, whereas all other proposals would receive a value up to 1 depending on how distant and abundant the disciplines were. The method is similar to a biodiversity metric that takes into account the distance between species on an evolutionary tree and their relative abundance in an ecosystem. The group then analyzed over 18,000 proposals submitted to the Australian Research Council Discovery Programme between 2010 and 2014. Betsy Wilder from the NIH Office of Strategic Coordination wants to use the new metric to see if the Roadmap has made progress in funding interdisciplinary research over the last 10 years. (Elena Bozhkova, Nature News)

Cancer MoonShot

Vice-President Biden threatens to cut funding to non-compliant medical research institutes

During the 2016 State of the Union, President Obama revealed his latest biomedical initiative: the moonshot to cure cancer. This initiative is led by Vice-President Joe Biden. The goal of this initiative is to stimulate collaborative research to accelerate the potential of combination immunotherapy as the next generation standard for cancer treatments. The goal is to initiate randomized Phase II clinical trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the moonshot to develop an effective vaccine-based immunotherapy to combat cancer by 2020. On June 29th, 2016, Biden attended the National Cancer Summit at Howard University. Here he made comments following a STAT investigation revealing frequent lapses in reporting clinical trials. If this is found to be true, Biden promises to cut funding. This falls in line with new rules imposed by the National Institutes of Health that will help crack down on institutions that lapse, not just individual investigators. In addition, the Food and Drug Administration (FDA) will soon be able to impose a $10,000/day fine to non-compliant companies. All together, this is a push to make clinical trials funded with public money be part of the public record and thereby facilitate collaborations and accountability. (David Nather and Charles Piller, STAT news)

Natural Resources

Large helium reserves found in Tanzania

Everyone knows helium for one of two things: 1) keeping balloons afloat and 2) making people sound funny. Nevertheless, helium is a remarkably important gas, especially in medicine and science. To keep the magnets of an MRI machine cool, it requires helium. To keep the Large Hadron Collider at CERN running, it needs helium. Helium is also used in other industries that require superconductivity. It is a naturally occurring gas that is formed from decaying uranium and thorium, but this is a slow process. Furthermore, helium does not react with anything (ergo its important role in cooling) and is very light. As a result, helium escapes to the atmosphere quickly and cannot be retrieved. The great demand on helium has led to several moments of shortages. It has been vital to discover a new deposit on helium.

To date, helium was only extracted as a by-product of oil and gas drilling, but these deposits only contain a small amount of helium. By understanding how helium is released from rocks, a team of researchers have devised a method to explore for helium in a new and specific way. Just like other gasses, released helium has to be trapped by underground formations. Using the same kind of seismic studies in oil and gas exploration, helium can be recovered. An area in the Tanzanian part of the East African Rift was proposed to be a prime candidate region to find helium. Indeed, a large amount of helium was discovered there. As much as 1.5 billion cubic meter of helium is thought to be trapped. This is more than twice the amount that is currently stocked at the Federal Helium Reserve near Amarillo, TX. This reserve supplies 40% of the helium used in the U.S. (Henry Fountain, NY Times)

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July 1, 2016 at 2:00 pm

When Industries Attempt to Drive the Scientific Narrative: The NFL and Concussion Research

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By: Valerie Miller, Ph.D.

Photo credit: DSC5623.jpg via photopin (license)

Earlier this spring, before a congressional panel, the vice president for health and safety of the National Football League (NFL) admitted for the first time that there is a connection between head injuries sustained playing football and chronic traumatic encephalopathy (CTE), which causes devastating memory and psychological problems. Despite the NFL’s longstanding denial of the connection between head injuries sustained playing football and CTE, these comments were made based on the work of Dr. Ann McKee, professor of neurology and pathology at Boston University (BU). Dr. McKee leads the famed “Brain Bank,” which has been collecting and examining the brains of former NFL players, finding that nearly 100 former players brains’ exhibited the degenerative disease. However, the science behind CTE is still in its infancy, and many questions remain unanswered. For example, it is unknown how much risk of developing CTE each player faces, what percentage of players develop CTE or why some players may be more susceptible than others. Additionally, the link between psychological problems that some former players exhibit and changes in (their) brain pathology remains tenuous. Adding to the confusion, CTE can only be diagnosed after a person has died and their brain can be examined. Clearly, a number of larger studies are needed to begin addressing these important questions. Although it would seem that the NFL would be most interested in answering these questions in order reduce player injury and risk while protecting their industry and product, the NFL has been less than forthcoming regarding the risks of concussions and traumatic brain injury, and has attempted to control the science produced regarding concussions.

Flawed Concussion Research

In 1994, amid growing concerns regarding player safety and concussions, the NFL formed a “concussion committee” to investigate the rate of concussions and the long-term harm they may cause players. The committee, comprised mostly of physicians associated with NFL teams, began a study that tracked all concussions diagnosed by team physicians on all teams from 1996-2001, and published a series of 13 peer-reviewed articles in the journal Neurosurgery based on this data. The league has used these articles as evidence that there is no connection between concussions sustained playing football and long-term effects in players. However, a recent New York Times investigation showed that the NFL studies omitted over 100 diagnosed concussions that were reported to the league, more than 10% of the total number. The NFL’s studies, based on this incomplete data, gave the appearance of a reduced rate of concussion among its players. The NFL has long stood by its research, claiming the legitimacy of the published papers because they underwent rigorous scientific peer-review. However, the New York Times received pages of comments and questions between peer reviewers and the committee, showing that reviewers wanted to stop the publication of the papers, with one reviewer stating “many of the management of concussion suggestions are inappropriate and not founded on facts.” The committee rebuffed the criticism and the articles were published.

NFL Tries to Influence Independent Concussion Research

In 2012, the NFL donated $30 million to the Foundation for the National Institutes of Health to study the effects of traumatic brain injury (TBI), including concussions. The research would be overseen by the NIH, and the NFL stated at the time that they would have no influence on how the money was used. Five studies were to be funded, including a seven-year, $16 million grant that would be awarded to study the progression of CTE, with the goal of determining how to detect CTE in living patients. After a rigorous scientific review process and additional review by an NIH advisory council, the National Institute of Neurological Disorders and Stroke (NINDS) awarded the grant to a team of 50 researchers at 17 institutions, led by Dr. Robert Stern, the director of clinical research at BU’s CTE Center. However, as first reported by ESPN’s Outside the Lines, the NFL reneged on its deal to fund the study, and instead tried to lobby the NIH to fund a proposal submitted by the NFL’s own researchers. In response to these allegations, members of the House Committee on Energy and Commerce launched an investigation, and issued a 91-page report detailing the ways in which the NFL publically claimed to fund impartial studies, only to privately attempt to influence the direction of concussion research. BU researcher Dr. Stern has long been critical of the NFL and their denial of the relationship between head injury and brain degeneration. Claiming that Dr. Stern would be unable to perform unbiased research, the NFL instead suggested funneling the $16 million grant to a different project lead by members of the NFL’s brain injury committee, avoiding the peer-review process by the NIH. This plan was subsequently rejected by NIH Director Francis Collins. According to Dr. Walter Koroshetz, Director of NINDS, the actions by the NFL are unprecedented, and that he “was aware of no other instance” in which private donors lobbied the NIH or attempted to direct the grant funding process. Ultimately, the NIH determined that the NFL’s allegations against Dr. Stern were unfounded. The study, which launches this June, is still funded by the NIH, but is being paid for by US tax dollars.

Where Do We Go from Here?

At this point, the general public has been made aware of the potential risks that concussions pose. The issues regarding repeated TBIs were brought to the forefront with the release of the 2015 movie Concussion, detailing the work of Dr. Bennet Omalu, who first discovered CTE. An increasing number of NFL players have been speaking out about player safety and are retiring early due to injury. Also, players have expressed interest in donating their brains to CTE research after death. In addition, rules are changing at all levels of play to reduce the incidence of concussions, and, as parents are becoming more wary of the risks of injury, participation in youth football is declining, although a great deal of questions surrounding concussion and CTE remain unanswered. Most importantly, the public is also now aware that the NFL has been less than forthcoming regarding the risks to player health. It can only be speculated what changes to the sport of football we will see in the upcoming months, years and decades, but for now, the NFL has been put on notice.

Written by sciencepolicyforall

June 22, 2016 at 10:00 am