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Posts Tagged ‘scientific publishing

Science Policy Around the Web – February 17, 2017

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By: Thaddeus Davenport, PhD

Source: pixabay

CRISPR

Decision in the CRISPR-Cas9 Patent Dispute

This week, Heidi Wedford from Nature News reported that the United States Patent and Trademark Office (USPTO) made a decision on the disputed patents for the gene editing technology known as CRISPR-Cas9 in favor of the Broad Institute of MIT and Harvard. The CRISPR-Cas9 system has been widely publicized, and this publicity is arguably not out of proportion with the potential of this technology to simplify and accelerate the manipulation of DNA of both microbial (prokaryotic) and higher order (eukaryotic) cells for research and therapy. A simplified, programmable version of CRISPR-Cas9 for use in gene editing was initially described by Charpentier and Doudna, and it was rapidly translated for use in eukaryotic cells by Zhang and colleagues at the Broad Institute in parallel with Doudna, Charpentier, and others.

The USPTO decision follows a dramatic and ongoing dispute over whether the patent application submitted by the University of California on behalf of Doudna and Charpentier – which was submitted before that of the Broad Institute, and described the technology in broad terms as a method of cutting desired DNA sequences – was sufficient to protect the CRISPR-Cas9 intellectual property when the Broad Institute later filed a fast-tracked patent application describing the use of CRISPR-Cas9 for use in eukaryotic cells. Because the Broad Institute’s application was expedited, it was approved before the University of California’s application. In January of 2016, the University of California filed for an ‘interference’ proceeding, with the goal of demonstrating to the USPTO that Doudna and colleagues were the first to invent CRISPR-Cas9, and that the patent application from the Broad Institute was an ‘ordinary’ extension of the technology described in the University of California application.

On February 15th of this year, the USPTO ruled that the technology described in the Broad Institute’s application was distinct from that of the University of California’s. The importance of this decision is that the patents granted to the Broad Institute for the use of CRISPR-Cas9 in mammalian cells will be upheld for now. It also creates some complexity for companies seeking to license CRISPR-Cas9 technology. Because of the overlapping content of the CRISPR-Cas9 patents held by the University of California and the Broad Institute, it is possible that companies may need to license the technology from both institutions. The University of California may still appeal the USPTO’s decision, but this is a significant victory for the Broad Institute for the time being. For many scientists, this dispute is a dramatic introduction to the inner workings of the patent application process. We would do well to familiarize ourselves with this system and ensure that it works effectively to accurately reward the discoveries of our fellow scientists and to facilitate the transfer of technology to those who need it most, without imposing undue economic burden on companies and consumers. (Heidi Wedford, Nature News)

Scientific Publishing

Open Access to Gates Foundation Funded Research

Also this week, Dalmeet Singh Chawla reported for ScienceInsider that the Bill and Melinda Gates Foundation had reached an agreement with the American Association for the Advancement of Science (AAAS) that will allow researchers funded by the Gates Foundation to publish their research in the AAAS journals Science, Science Translational Medicine, Science Signaling, Science Immunology, and Science Robotics. This agreement follows an announcement in January in which the Gates Foundation decided that research funded by the foundation would no longer be allowed to be published in subscription journals including Nature, Science, and New England Journal of Medicine, among others, because these journals do not meet the open access requirements stipulated by the new Gates open-access policies. The new Gates Foundation policy requires its grant recipients to publish in free, open-access journals and to make data freely available immediately after publication for both commercial and non-commercial uses. A similar policy is being considered by the nascent Chan Zuckerberg Initiative.

In the agreement with AAAS, the Gates Foundation will pay the association $100,000 in order to make Gates-funded published content immediately freely available online. Convincing a journal as prominent as Science to make some of its content open-access is a step in the right direction, but it is perhaps more important as a symbol of a changing attitude toward publishing companies. Michael Eisen, co-founder of the Public Library of Science (PLoS) open-access journals, was interviewed for the ScienceInsider article and noted, “[t]he future is with immediate publication and post-publication peer review, and the sooner we get there the better.” This sentiment seems to be increasingly shared by researchers frustrated with the hegemony of the top-tier journals, their power over researchers’ careers, and the constraints that subscription-based journals impose on the spread of new information. Funding agencies including the Gates Foundation, Howard Hughes Medical Institute, and the National Institutes of Health are in a unique position to be able to dictate where the research they fund may be published. A collective decision by these agencies to push the publishing market towards an improved distribution of knowledge – through open-access publishing and post-publication peer review – and away from the historical and totally imagined importance of validation through high-tier journal publication would enrich the scientific ecosystem and accelerate innovation. In this regard, the efforts by the Gates Foundation are laudable and should be extended further. (Dalmeet Singh Chawla, ScienceInsider)

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February 17, 2017 at 12:44 pm

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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Science Policy Around the Web – July 22, 2016

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By: Nivedita Sengupta, Ph.D.

photo credit: Alex E. Proimos via photo pin cc

The Common Rule and human testing

Science academies blast US government’s planned research-ethics reforms

The ultimate advancement in human health and welfare depend on research with human subjects. To achieve this, properly controlled studies with human subjects is imperative for eliminating abuse of human subjects and proper protection of the data. To address these concerns the “Common Rule” was established in 1991 influenced by the Belmont Report, a 1978 document which laid out principles for ethical research with humans, such as minimizing patient harm and maximizing the benefit to society. The ‘Common Rule’ is the current human subject regulation policies which addresses ethical issues such as informed consent, storage of study participants’ biological specimens and many others. However with technological advances over time, achieving these goals has become more complicated and thus imposes difficulties in maintaining patient privacy. Hence in September, 2015 the US government proposed revisions for regulations governing studies of human subjects.

Recently however, an independent advisory panel proposed that the US government’s proposed overhaul of  the Common Rule is flawed and should be withdrawn. On June 29th the US National Academies of Sciences, Engineering and Medicine said that the government’s proposed changes are “marred by omissions and a lack of clarity”. They indicated that it would slow down research and will do little to improve protections of patients enrolled in studies. The panel recommended that the government should appoint an independent commission to craft new rules for such research.

The changes proposed by the US Department of Health and Human Services (HHS) attempted to address concerns that have arisen since the ‘Common Rule’ was established. For instance, the HHS reforms suggests a requirement for participants’ consent to use stored samples, such as blood or tissue, for future research. But the US academies’ panel pointed that the new consent requirements would slow research unnecessarily because little harm is likely to come to a person as a result of the use of stored samples. Moreover the extra consent forms can link the samples to the person’s name and thus increasing risk of identification.

Currently HHS is reviewing more than 2,100 public comments to its proposal and many of these comments were critical. However, the US academies’ panel says that the proposal should be scrapped and HHS should start fresh by appointing an independent commission to recommend reforms for the Common Rule. Meanwhile an HHS spokesperson said that the government is still pondering over the public’s comments and the report. She adds that the proposal comes after “many years of work,” and “that starting over would require many more.” (Sara Reardon, Nature News)

Scientific Publishing

Beat it, impact factor! Publishing elite turns against controversial metric

Journal Impact factor (JIF) – one of the most promoted and controversial metric system in the field of science is currently facing negative reviews from the scientific community. Impact factor is a measure of the average number of citations that articles published by a journal in the previous two years have received in the current year which is calculated by various companies. It is solely aimed to indicate the quality of journals said Heidi Siegel, a spokesperson for Thomson Reuters, the major publisher of JIFs. However, the irony is researchers often use the JIF to judge individual papers instead and in some cases even the authors.

On July 5th, several leading science publishers posted a paper to the preprint server bioRxiv asking all journals to consider a different metric which will capture the range of citations that a journal’s articles acquire. Also the American Society for Microbiology in Washington DC announced its plans to discard impact factor from its journals and website, and also from marketing and advertising.

Stephen Curry, a structural biologist at Imperial College London and also the lead author on the bioRxiv preprint paper said that sadly many researchers evaluate papers by the impact factor of the journals and this can also influence decisions made by hiring committees and funding agencies. Curry’s team highlighted some limitations by plotting the distribution of citations (used to calculate the 2015 impact factors) for articles published in 2013–14 in 11 journals, including ScienceNatureeLife. They showed that most of the papers gathered fewer citations than the impact factor for the journal: 74.8% of Nature articles were cited below its impact factor of 38.1, and 75.5% of Science papers were cited fewer than 35 times with its impact factor of 34.7. Highly cited papers are the cause of this disconnect as Nature’s most cited paper in the analysis was referenced 905 times and Science’s 694 times. Curry and his team highly recommends the use of citation distribution curves instead of JIF as it provides a more informative snapshot of a journal’s standing.

However, Ludo Waltman, a bibliometrics researcher at Leiden University in the Netherlands, thinks that citation distributions are more relevant than impact factors for making decisions in hiring and promotion. But he feels that impact factors can be useful for researchers in some cases. Nonetheless anti-impact-factor campaigners believes that it will take time and pressure from various directions to diminish the influence of impact factor as it has become a cultural thing in the scientific field. (Ewen Callaway, Nature News)

Brain research advancements

Human brain mapped in unprecedented detail

Neuroscientists have long sought to divide the brain into smaller pieces to better appreciate how it works as a whole. On July 20th,  Nature published the new unprecedented map of the brain’s outermost layer — the cerebral cortex — subdividing each hemisphere and valley-like folds into 180 separate areas. Ninety-seven of these areas have never been previously described despite showing clear differences in structure, function and connectivity from the neighboring areas.

“Until now, most brain maps were based on a single type of measurement which provides an incomplete view of the brain’s inner workings” says Thomas Yeo, a computational neuroscientist at the National University of Singapore. This new map is based on multiple MRI measurements which measures the flow of blood in response to different mental tasks, which Yeo says “greatly increases confidence that they are producing the best in vivo estimates of cortical areas.”

The map was constructed by a team of people led by neuroscientist Mathew Glasser at Washington University Medical School. They collected imaging data from 210 healthy young adults participating in the Human Connectome Project, an National Institutes of Health-funded initiative to map the brain’s structural and functional connections. They collected information of cortical thickness; brain function; connectivity between regions; topographic organization of cells in brain tissue; and levels of myelin — fatty substance that speeds up neural signaling. The borders on the map was delineated by areas which showed significant changes in two or more of these properties. Analysis of all the data confirmed the existence of 83 previously reported brain areas while identifying 97 new ones. Scientists further tested the map generated by Glasser and his team, and found it accurate by looking for these regions in the brains of additional 210 people. But the size of the areas varied from person to person and these differences may reveal new insights into individual variability in cognitive ability and opens up the possibility to explore further the unique intersection of individual talents with intellectual and creative abilities.

But the map is limited in some important ways as it reveals little about the biochemical basis of the brain and about the activity of single neurons or small groups. However, Glasser says that “We’re thinking of this as version 1.0, that doesn’t mean it’s the final version, but it’s a far better map than the ones we’ve had before.” (Linda Geddes, Nature News)

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July 22, 2016 at 9:00 am

Science Policy Around the Web – May 10, 2016

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By: David Pagliaccio, Ph.D.

Source: Ashley Fisher / Flickr

Scientific Publishing

Who’s downloading pirated papers? Everyone

Sci-Hub is an online repository for millions of scientific and academic articles, which has sparked major controversy among the scientific and publishing communities. The site, launched in 2011 by Alexandra Elbakyan, a graduate student in Kazakhstan, provides free access to ‘pirated’ articles. These articles would otherwise only be accessible through personal or institution journal subscriptions or by purchasing individual articles, which often can cost ~$30 each. Recent analysis of Sci-Hub’s 28+ million download requests from September-February 2015 found that requests were coming from over 3 million different IP addresses (potentially many more individual users as those sharing university internet network will often share an IP address). These download requests came from all over the world and across all types of scientific fields. Download rates reached more than 200,000 per day. An opinion survey regarding Sci-Hub found that at least half of users download articles from Sci-Hub because they do not otherwise have access to the articles at all. Interestingly, many others use Sci-Hub purely out of convenience when they would still have access through their institution. Many respondents also use Sci-Hub in objection to the profits made by publishers off of academics and feel that efforts like Sci-Hub have the power to disrupt the status-quo of science publication. That said, Elsevier, of the largest publishers affected by Sci-Hub, launched a lawsuit against Elbakyan last year for infringing on their legal rights as copyright holders. Despite having their domain seized during the lawsuit, Sci-Hub is largely beyond the reach of the U.S. legal system by being based in Russia. This is an still evolving situation and debate, which may have large effects on the state of scientific publishing today particularly given the major support from much of scientific community. (John Bohannon, Science News)

Mental Health

New Study Shows Mental Health Diagnoses and Treatment Vary Significantly by Race and Ethnicity

The Department of Research and Evaluation at Kaiser Permanente published result of a large study in the journal Psychiatric Services regarding the diagnosis and treatment of mental health conditions. The study included data from electronic health records of 7.5 million adult patients. The patients were part of 11 private, not-for-profit health care systems participating in the Mental Health Research Network. The results indicated that 15.6% (1.17 million) of these patients received a mental health diagnosis in 2011. This varied by race and ethnicity from 7.5% among Asians to 20.6% among Native American/Alaskan Native patients. Most groups had generally lower diagnosis rates than non-Hispanic white patients. Importantly, regardless of race and ethnicity, all patients with a diagnosed mental health condition were much more likely to receive psychiatric mediations (73%) than they were to receive formal psychotherapy treatment (34%). While the study does not point to any specific causative factors, they do indicate a need for evaluation of the causes and effects of racial and ethnic differences in diagnosis and treatment of mental health conditions as well as those relating to the vast discrepancy in treatment by medication vs. therapy. (PR Newswire)

Child Development Policies

Bringing Brain Science to Early Childhood

Researchers at Harvard’s Center on the Developing Child are pushing better use of developmental psychology and neuroscience research in the creation and implementation of policy regarding early-childhood programs. Particularly, they critique incentives in the current policy system and call for research and development on the most effective early-childhood programs for stemming intergenerational poverty. Programs for child development should all be based on the rapidly evolving knowledge base in the scientific field and should be allowed to develop as we learn and understand more. Work in this area has shown lifelong consequences of early childhood stress as well as lifelong benefits of early positive parenting both on mental and physical health. The Center has already been to pilot programs in Washington state aimed at improving executive function and self-control among parents and children and hopefully to improve parental engagement. This work allows for testing and refining of new interventions based on data collected from the pilot testing. On the other hand, many interventions have previously been enacted at large-scale without adequate follow-up testing or methods for improvement based on outcomes. For example, they cite that the Head Start program, which aims to help young disadvantaged infants and children, has but has not utilized the infrastructure to evaluate the effectiveness of their various programs and to identify which programs benefit which types of individuals most. As research suggests, intervening early in development can be incredibly impactful, and thus we should be capitalizing on our scientific understanding to implement the most evidence-based programs and utilizing outcomes data to constantly improve our programs. (Emily Deruy, The Atlantic)

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May 10, 2016 at 9:00 am

Science Policy Around the Web – January 19, 2016

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By: Amy Kullas, Ph.D.

Water Contamination

Michigan attorney general to investigate into Flint, Michigan water crisis

Michigan’s attorney general, Bill Schuette, announced on January 15, 2016 that he will be conducting an investigation into the ongoing water crisis in Flint, Michigan to assess whether any laws have been violated. “The situation in Flint is a human tragedy in which families are struggling with even the most basic parts of daily life,” Schuette said in a statement. “While everyone acknowledges that mistakes were made, my duty as attorney general requires that I conduct this investigation.”

The water crisis stems from a decision two years ago by the state of Michigan, which had taken over the city’s budget amid a financial emergency, to save money by switching Flint’s water supply from Lake Huron to the Flint River. This decision was billed as a temporary cost-saving measure until a new supply line to Lake Huron was ready. However shortly after the switch, residents began to complain the water looked, smelled and tasted funny. Later, researchers revealed that the river water was highly corrosive (almost 20 times more corrosive than the water in Lake Huron) and that there were elevated levels of lead in the drinking water. Sadly, a Flint pediatrician, Dr. Mona Hanna-Attisha, announced that records showed blood lead levels in local toddlers doubled or even tripled in some cases since the water switch.

Governor Rick Snyder has already declared a state of emergency and requested that President Obama declare a state of emergency at a federal level. The extra assistance would provide much needed assistance like grants for temporary housing and home repairs as the city deals with damage done to its water system. On Saturday, the President authorized the Federal Emergency Management Agency and the Department of Homeland Security to lead the national disaster relief efforts. Additionally, singer Cher is trying to help. She and Icelandic Glacial are combining to donate 181,440 bottles of water to Flint residents. (Jason Hanna, Sara Ganim and Eliott C. McLaughlin, CNN)

Women in Science

Female engineers receive fewer citations even though they publish in better journals

While gender disparity is not a novel phenomenon in science, certain specialties are worse than others. A recent study that analyzed almost 1 million engineering-related publications showed that while female engineers are published in slightly higher impact journals on average than their male counterparts, their work receives fewer citations. This study used bibliometrics, which is the statistical analysis of written publication patterns. The authors filtered for engineering journals published between 2008 and 2013, resulting in 679,338 articles with nearly 1 million co-authors. In order to assign gender to the researchers, the authors utilized databases of male and female first names originating to the country of the researcher’s affiliation. The results showed that women made up only about 30% across all scientific disciplines and a dismal 20% of the authors on the engineering papers. However, the study also showed that when the main author was a female, that research was generally published in a more prestigious journal (demonstrated by a 2% higher impact factor score). Further, the authors of the study correlated that these papers were cited 3% less frequently than publications from male-led studies. The authors suggest that women scientists could close this gap if they were to collaborate with each other as often as they do with male researchers. (John Bohannon, ScienceInsider and Ghiasi, et. al, PLOSone)

Clinical Trials

Clinical trial goes tragically wrong

Biotrial acknowledged on January 15, 2016 that their phase I clinical trial in France was going terribly wrong. The compound that they were testing is an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme that breaks down endocannabinoids in the brain. The drug was aimed to treat multiple disorders, such as neurodegenerative diseases, anxiety, and chronic pain. At the time of the initial announcement, there were six male patients in the hospital: one who was brain-dead (and later died), at least three patients may suffer irreversible brain damage if they survive, one other has neurological symptoms and the last was under observation with no noticeable symptoms. MRI imaging has shown “deep, necrotic and hemorrhagic lesions in the brain” of the effected patients.

This trial was authorized this previous summer after successful completion of animal studies, including those conducted in chimpanzees. This phase I trial consisted of 128 previously healthy male and female volunteers ranging from 18-55 years of age. Phase I studies are designed to test safety and tolerability of a drug, as well as how, and how fast, the chemical is processed by the human body. Participants of this particular study group were to receive €1900, which included travel expenses; in return, they agreed to stay at Biotrial’s facility in Rennes for 2 weeks, swallow either drug or placebo for 10 consecutive days, undergo extensive medical tests, and provide at least 40 blood samples.

Ninety individuals were given the drug in varying doses while the others were given placebo. The first of the volunteers began taking the drug on January 7th and the symptoms began surfacing three days later. “The 84 other volunteers exposed to the drug have been contacted,” announced the hospital. Ten of them came in to be examined and did not have the ‘anomalies’ seen in the hospitalized patients. (Martin Enserink, ScienceInsider)

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January 19, 2016 at 9:00 am

Science Policy Around the Web – September 4, 2015

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By: Amanda Whiting, Ph.D.

Scientific Publishing

Fake Peer Review Scandal Shines Spotlight on China

On August 18th, Springer, one of the world’s largest academic publishers, announced that it was retracting 64 articles from 10 of its journals after the discovery that those papers were associated with fake email addresses and that “subsequent internal investigations uncovered fabricated peer review reports”. The fake addresses led back to study authors writing their own peer reviews and to peer review “services” which sold names and contact information for fake experts with positive reviews. The latest aspect of this controversy is that nearly all of the retracted papers were authored by Chinese academics, based on a search for retracted papers on Springer’s site. While William Curtis, executive vice-president for publishing, medicine and biomedicine at Springer said that the retractions “do not offer a representative picture of the quality and ground-breaking research being published by researchers in China”, other researchers recognize the pressure many academics are under to publish at all costs. “We don’t think that Chinese researchers are any worse than anybody else. But what we know is that the pressure to publish — for example in Western journals — is enormous in China,” said Dr. Charlotte Haug, vice-chair of the U.K.-registered Committee on Publication Ethics (COPE). Publishers are starting to implement polices to help prevent this type of abuse of the peer review system, such as no longer allowing authors to suggest reviewers for their own papers and mandating that peer reviewers communicate through institution-based email addresses only. (Felicia Sonmez, Wall Street Journal)

Biomedical Research and PMI

Giant study poses DNA data-sharing dilemma

Next month, a working group run by the National Institutes of Health (NIH) for the Precision Medicine Initiative (PMI) is set to release a project plan and observers are keen to find out the answers to one really big question – how much information about disease risk (including genetic data) will the project share with the people who participate? PMI aims to collect health data including genomic information, health records and physiological measurements from up to 1 million people in order to have a large cohort to study how genetics, environment and lifestyle influence disease risk and the effectiveness of treatments. Within this large amount of data could be trends that influence disease treatments for public health as a whole, but it could also include more specific information about individual participants and diseases/conditions they never even knew they had. Proponents of data-sharing believe that participants should at least be given the option of seeing their own data, truly making them “active partners in the process” of research, as it would allow them to further investigate findings related to their own health. Opponents believe that it would be irresponsible to just dump data onto people since the raw information can be challenging to interpret and of uncertain significance. If data sharing does go ahead, it raises new challenges such as how to actually share the data, what level of quality the data must be at to be shared (for clinical decision making vs. research), and whether data on deceased patients could be released to their families. Given the size and profile of the PMI, the decisions of this working group could have a significant effect on how biomedical research on human cohorts is conducted in the future. (Sara Reardon, Nature News)

Drug Policy

F.D.A. Warns 5 Producers of Powdered Caffeine

The Food and Drug Administration (FDA) stated that it has sent warning letters to five producers of pure powdered caffeine over concerns of public safety and overdose risks. While caffeine is legal substance that can be found naturally in coffee and tea and is added in small amounts to gum and energy drinks, a teaspoon of pure caffeine is equivalent to approximately 28 cups of coffee and a tablespoon’s worth can be lethal. According to the FDA’s statement from September 1st, “the difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small.” The statement goes on to say that “safe quantities of these products can be nearly impossible to measure accurately with common kitchen measuring tools.” Bulk powdered caffeine has been linked to the deaths of two young men in otherwise good health in 2014. Laura MacCleery, regulatory affairs director of the Center for Science in the Public Interest consumer advocacy group, celebrated the move by the FDA and hoped that this was merely the first step towards a product ban. In explaining the dangers of bulk purified caffeine she said that “[p]eople assume something this dangerous would not be sold to consumers in this form. They are used to seeing warning labels and childproof caps on aspirin. And this is just a zip-lock bag.” (Sabrina Tavernise, New York Times)

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September 4, 2015 at 9:00 am

Science Policy Around the Web – August 14, 2015

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By: Patricia Kiesler, Ph.D.

Photo credit: via pixabay.com

Laboratory Animal Rights

Animal advocacy group targets cat and dog research using novel crowdsourcing campaign

The Los Angeles–based Beagle Freedom Project (BFP) animal advocacy group filed a complaint on Monday with Ohio State University (OSU) and the National Institutes of Health (NIH) alleging that a NIH-funded OSU laboratory has violated NIH rules concerning the use of dogs in biomedical research. In the past, U.S. research facilities would procure dogs from Class B dealers, who would sell animals that they obtained from pounds, breeders and “random sources”. The latter are associated with stolen and abused pets. In 2013, the NIH announced that researchers using the agency’s funds could not procure dogs from Class B dealers, as of October 1, 2014, and could not use such dogs in projects funded in 2015 and beyond. According to BFP, OSU has violated both guidelines. In their complaint, BFP provided records suggesting that the university obtained four class B dogs on October 6, 2014, and that one of the class B dogs was still alive as late as July of 2015. OSU has disputed both accusations and provided evidence to ScienceInsider indicating that the dogs were purchased before the NIH rule went into effect, on September 11, 2014, and said that no class B dogs are currently involved in laboratory research.

BFP has gathered this evidence against OSU through a unique crowdsourcing technique. Public supporters browse the BFP’s website and its list of more than 1200 cats and dogs kept at 17 public research universities in the U.S. and “adopt” one of these animals. BFP then sends supporters a Freedom of Information Act request form, which they fill out and send to the university housing the animal. Any information collected (health records, protocols, necropsy reports, etc.) is forwarded to BFP. Through this strategy, the animal advocacy group has generated hundreds of public records requests to engage the public and pressure universities to release animals and/or end their research. (David Grimm, ScienceInsider)

Scientific publishing policy

Courts refuse scientists’ bids to prevent retractions

Two scientists have sought to prevent journals from retracting or expressing concern about their papers this year. But U.S courts have dismissed their legal bids. Guangwen Tang from Tufts University in Boston, MA had hoped to stop the American Journal of Clinical Nutrition from retracting her 2012 paper on the value of providing Golden Rice to children. This rice is a genetically engineered form of rice that is rich in b-carotene for use as a source of vitamin A. Following Tufts University ‘s discovery that parents had not been informed that the rice provided to their children was genetically modified, the journal decided to retract her paper and did so after the court’s ruling. Mario Saad from the University of Campinas in Sao Paulo, Brazil had also hoped to prevent the journal of Diabetes from publishing expressions of concern about four of his papers. The journal said online that it had been alerted to potentially manipulated images in his studies and that was concerned about the reliability of some of his data. The first investigation launched by the University of Campinas found mistakes, but no dishonesty, in Saad’s work and the conclusions of a second investigation have yet to be released. The court, however, swiftly denied his injunction bid and a request to reconsider thereafter. As a result, Diabetes published print concerns regarding all four of his papers.

“In both cases, the courts decided that the scientists’ requests would deny journals their right to free speech. The decisions do not prevent the scientists from suing for damages from defamation, however, and legal action is ongoing in both instances”. But a scientist suing a journal to stop retractions is unheard of and researchers may find it difficult to win defamation cases against publishers in the U.S. as defamation charges have a high burden of proof in this country; “plaintiffs [would] have to show that publishers acted with malice or reckless disregard”. (Monya Baker, Nature News)

International – Children’s health

Mexico bans giveaways of baby formula at hospitals in an effort to encourage breastfeeding

Mexico has one of the lowest breastfeeding rates in Latin America with only one in seven mothers breastfeeding exclusively during their babies’ first six months. This poor record is amplified in a country where millions live in extreme poverty and drinking water is often unhealthy. In an effort to increase breastfeeding rates, the Mexican government has banned free baby formula at hospitals. But Mexican health authorities said that baby formula could still be supplied at a doctor’s request and would be available for purchase. Mexico’s measure follows the World Health Organization’s recommendations that exclusive breastfeeding for the first six months of life and continued breastfeeding for up to two years or beyond supplemented with complementary foods provide health benefits to babies that translate into adulthood. These recommendations have recently been supported by a long-term study in Brazil that involved nearly 3,500 babies who were followed up 30 years later. The research, published in The Lancet Global Health last April, found that those who had been breastfed the longer scored higher on intelligence tests as adults. They were also more likely to reach higher educational attainment and to earn greater incomes. Although breastfeeding was evenly distributed across social class and the researchers tried to rule out main confounders including mother’s education, family income and birth weight, experts agreed that further research was needed to explore any possible link between breastfeeding and intelligence. The large sample size and number of factors monitored, however, made this a powerful study. (BBC News)

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Written by sciencepolicyforall

August 14, 2015 at 10:00 am