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Archive for March 2019

Science Policy Around the Web – March 26, 2019

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By: Neetu M. Gulati Ph.D.

Image by Dimitris Vetsikas from Pixabay

Sunscreen ban aimed at protecting coral reefs spark debate – among scientists

Corals around the world have begun “bleaching,” turning white and expelling the algae that live within them. After a 2015 study found that oxybenzone can harm corals, environmentalists have worked to bar the sale of sunscreens containing the chemical. Last year, Hawaii was the first US state to ban sale of sunscreens containing oxybenzone, as well as another harmful chemical octinoxate, which are found in up to 75% of sunscreens on the US market. The ban will go into effect in 2021. Florida and California are considering similar laws. However, while some are fighting to limit the use of these toxic chemicals, others say the major issue is not sunscreen – it’s climate change.

Evidence indicates that harmful chemicals and warming oceans due to climate change are both damaging corals and leading to bleaching. Scientists agree that the major contributing factor is climate change and the chemicals play a lesser role. Nevertheless, they disagree about what should be done. C. Mark Eakin, an oceanographer and the coordinator for NOAA’s Coral Reef Watch program, commented “if we don’t deal with climate change, it won’t matter what we do about sunscreens.” Furthermore, some people believe there is not enough clear evidence explaining how damaging these chemicals can be. While many scientists share this viewpoint, others think that every step towards saving the corals matters. Some lawmakers agree with this philosophy; Teri Johnston, the mayor of Key West, Florida, said of banning the harmful chemicals, “if it’s something we can do to minimize damage to reefs, it’s one small step we’re going to take.” The city of Key West banned the sale of sunscreens containing oxybenzone and octinoxate last month, an act that will go into effect in 2021.

Damage to coral reefs is a complicated issue, with multiple stressors likely to be involved: not only climate change and sunscreens, but also pollution and other harmful chemicals. While many are worried about protecting the reefs, there is also concern as to how these bans will affect human health. In response to the Hawaii ban, the Skin Cancer Foundation put out a statement which said, “by removing access to a significant number of products, this ban will give people another excuse to skip sun protection, putting them at greater risk for skin cancer.” 

One possible solution is to expand the number of ingredients permitted in sunscreen, to allow for other protective chemicals that are less harmful to the environment. The FDA has not expanded its list of approved ingredients in approximately 20 years. Comparatively, Europe allows for more chemicals, hopeful that any one single chemical will have a less harmful environmental impact when more diversity of ingredients is allowed. Towards this end, the FDA recently proposed new regulationsto improve American sunscreens.

(Rebecca Beitsch, Washington Post

In a first, U.S. private sector employs nearly as many Ph.D.s as schools do 

The career landscape for burgeoning PhDs has changed drastically in the last 20 years; while the number of PhDs awarded has increased, especially in the fields of life and health sciences, the proportion of PhDs employed in tenured and tenure-track positions has declined. This is in contrast to what some current faculty members, who may assume that tenure track positions are the standard path for PhDs, and other career paths are “alternative.” According to the Survey of Doctorate Recipients from the US National Science Foundation (NSF), in 2017, for the first time, private sector employment of PhDs (42%) is nearly equivalent to employment by educational institutions (43%). This is in stark contrast to 1997, when educational institutions employed 11% more PhDs than the private sector. While the survey takes into consideration all PhDs under the age of 76 who are employed full-time in the US, it is expected that newer PhDs are less likely to secure tenure-track positions. 

As career trajectories change, some universities are using new information about PhD outcomes to improve programming for current graduate and prospective students. According to the Coalition for Next Generation Life Science, ten academic institutions have released data onlineabout the career outcomes of their PhD graduates, with more institutions planning to release similar data by the end of next year. The data indicates the traditional model of training, which treats graduate school like an apprenticeship to becoming faculty, is outdated. Other skills that transfer beyond educational institutions, may be necessary to successfully train the next generation of PhDs. 

(Katie Langin, Science)

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March 26, 2019 at 5:00 pm

Science Policy Around the Web – March 22, 2019

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By: Caroline Duncombe.

Image by 1388843 from Pixabay

FDA Approves First Drug for Postpartum Depression

In the USA, about 400,000 women develop post-partum depression (PPD) each year. Up until Tuesday, there was no FDA approved pharmaceutical treatment designed specifically for PPD. In attempts to alleviate PPD episodes, doctors previously prescribed drugs designed for general depression, such as selective serotonin-reuptake inhibitors (SSRIs). Such drugs were not specifically designed for PPD which involves distinct mechanisms of action that are directly related to pregnancy and childbirth. SSRIs often take months to achieve remission or adequate response, if ever. Such deficiencies are supposedly addressed by the new drug, brexanolone, marketed at Zulresso, which was designed specifically to address post-partum depression and acheives rapid onset of response alleviation.

Although brexanolone is the first FDA approved treatment for PPD, the long infusion period, the high cost of the treatment, and lacking evidence on the effectiveness of this treatment demonstrate the long road ahead before PPD treatment is ubiquitous and operational. The Brexanolone treatment is not simple: it involves a continuous intravenous (IV) infusion over the course of 60 hours. Due to the risk of the treatment, patients will be required to stay within an in-patient unit of a hospital for those 2.5 days. Considering that the treatment alone cost $34,000 for a full course, the additional cost of in-patient care would make this treatment inaccessible for many who demonstrate severe PPD. Some insurance providers may decide to cover the treatment cost, but for those who do not have insurance or are denied coverage this treatment will be inaccessible.

Additionally, the FDA approval application was largely informed by a flawed phase III clinical trial funded by Sage Pharmaceuticals, the producer of Zulresso. The trial only included 246 participants, which is a relatively small sample size for a phase III trial. A large sample size is important to providing a conclusive clinical trial result on drug side-effects. This is crucial because if a severe side effect is found within 1 in every 1000 participants (or 1 in 10,000, etc) that level of risk would most likely not be detected within a trial only enrolling 246 participants. Additionally, this specific trial compared participants to a placebo, and not existing treatment standards of anti-depressants like SSRIs. The trail also only assessed the women volunteers over a 30-day follow-up period post infusion, which means that the lasting effects beyond the first month of Brexanolone are still unknown.

Further research on Brexanolone will be necessary to definitively assess its impact of reducing PPD. At this moment Sage Therapeutics is also implementing a phase III trialon a PPD treatment drug that is structurally similar to Bexanolone but is capable of being administered via a pill. If successful, such a drug could make treatment for post-partum depression more accessible to all. 

(Pam Belluck, New York Times)

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March 22, 2019 at 5:24 pm

Science Policy Around the Web – March 18, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

Scientists track damage from controversial deep-sea mining method

The extraction of rare and valuable metals and minerals from the deep sea is highly attractive to mining companies.  Scientists, however, have long raised concerns about potential harmful effects of these activities on marine ecosystems.  Next month, the mining company Global Sea Mineral Resources is scheduled to harvest precious metals and minerals on the seafloor in the remote Pacific Ocean for eight days with a team of scientists working alongside them.  The scientists will be using deep-sea cameras and sensors to monitor sediment plumes created by the mining activity.  

Scientists are concerned that sediment plumes created during deep sea mining could extend tens or hundreds of meters above the seafloor and “bury, smother and toxify” the marine communities in these regions.  The research exhibition scheduled for next month is intended to help scientists understand the potential impact of deep-sea mining and inform the development of an international code of conduct for deep-sea commercial mining.  

The code of conduct for deep sea commercial mining will be created by the International Seabed Authority (ISA), an organization founded in 1994 to organize, regulate and control all mining activity in international waters.  The ISA is planning to finalize the code by 2020, allowing companies that have been granted licenses to extract minerals from the deep sea to begin full scale mining in the Pacific Ocean.  

Though the experiment scheduled for next month will provide key insight into how long it takes for sediment plumes to resettle, and how far they can travel, the experiment is just too short to gauge potential long-term effects of mining activities.  Craig Smith, an oceanographer at the University of Hawaii at Manoa in Honolulu cautions “We will not really understand the actual scale of mining impacts until the effects of sediment plumes from full-scale mining are studied for years”.

(Olive Heffernan, Nature Briefing)

U.S. blocks U.N. Resolution on Geoengineering

Last week, during the fourth session of the UN Environment Assembly (UNEA) in Nairobi, the United States, Saudi Arabia, and Brazil joined together to block a resolution aimed at studying the potential risks of geoengineering.  “Geoengineering”, also referred to as climate engineering or climate intervention, aims to mitigate effects of global warming using techniques like solar radiation management and carbon dioxide removal.

Geoengineering technologies are not yet operational and while proponents believe these techniques could help curb the impact of climate change, opponents worry about the potential risks of these techniques on both people and nature. Notably, one proposed method of solar radiation managementinvolves using aerosols to reflect a portion of inbound sunlight back out to space. Research in this area is still in its infancy and some worry that infusing the atmosphere with aerosols could lead to undesired side effects, like severe weather.  

The proposal raised at the UNEA meeting last week, backed by Switzerland and nine other nations, aimed to direct the U.N. Environment Programme to study the implications of geoengineering and compile a report by next year on current scientific research in this area. 

While there is some consensus that issuesof geoengineering technologies need to be explored, countries disagree on who should be overseeing these efforts. It has been reported that the United States prefers questions about geoengineering to be dealt with by the Intergovernmental Panel on Climate Change (IPCC), rather than by UNEA. The IPCC is reported to be assessing geoengineering as a part of its next report set to be published in 2021 or 2022. 

(Jean Chemnick, Scientific America)

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March 19, 2019 at 7:45 pm

Science Policy Around the Web – March 15, 2019

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By: Allison Dennis. B.S.

Image by Gabriela Sanda from Pixabay 

A Genetic Mutation Might Explain Why Birth Control Can Fail

Hormonal contraceptives have been increasingly embraced as an effective tool for family planning since their approval for contraceptive use by the FDA in 1960Fewer than 1 in 100women will get pregnant in a year when using the contraceptive pill correctly, but the cause of the few unintended pregnancies remaines a mystery. 

To ask if there was a genetic reason why hormonal contraceptives might be ineffective at preventing pregnancy for some women, researchers measured the amount of etonogestrel in the blood of women using the etonogestrel contraceptive implant (Nexplanon). While the findings of this small study were not significant, the researchers did observe that women carrying a mutation in their CYP3A7gene had lower concentrations of etonogestrel in their blood. Of the women with mutation, 28% had etonogestrel levels lower than what is needed to suppress ovulation. Only 9% of women without the mutation had critically low levels. The CYP3A7 gene produces a fetal enzyme, responsible for breaking down excessive steroid hormones in the developing fetus. Usually the gene is turned off in adulthood, but genetic mutations can result in it staying active throughout one’s life, possibly leading women with these mutations to break down the etonogestrel being supplied by the Nexplanon implant. 

To begin capturing the ability of particular genetic variants to predict which patients will or will not respond to particular medication, experience adverse events, or need a particular dose, the FDA maintains a list of drugs whose use may be complicated by particular Pharmacogenomic Biomarkers. Only one of the 232 on the list is a hormonal contraceptive, listed because women carrying a particular mutation may respond negatively to one of its inactive ingredients, not because it is less effective for these women. The etonogestrel study is the first to associate particular genetic variants with birth control performance. As researchers delve into the complicated intersection between genetic differences and drug responses their discoveries promise to lead to better outcomes for all those seeking effective family planning options. 

(Megan Molteni, Wired Magazine)

New call to ban gene-edited babies divides biologists

The birth of genetically modified children is now possible thanks to technologies like the genome-editing CRISPR-Cas9which can introduce heritable changes in germline cells, including human sperm, eggs, and embryos. In November 2018, He Jiankui’s demonstrated the technique by orchestrating the birth of two babies whose genomes were altered between in vitro fertilization and implantation. He Jiankui’s experiment may have shown editing the human germline was possible, but it did not address the safety or efficacy of the genetic changes for his two inaugural patients. While many view He Jiankui’s experiment as prematureand possibly illegal, it has undeniably brought discussions of the appropriate use of the technology to a forefront. 

On March 13th, a group of prominent scientists and international specialists published a call for a global moratorium on clinically making genetically modified children. The first step, as they see it should be setting a deadline before which all clinical use of germline editing will be put on hold. They suggest five years from now. During this time, they propose that nations engage in “discussions about the technical, scientific, medical, societal, ethical, and moral issues that must be considered.” Technical issues arise from the need to demonstrate germline editing as safe and efficacious. Scientifically, the long-term effects of specific genetic enhancements or corrections must be understood. Many potential changes imagined to be possible may not be medically necessary. As for societal, ethical and moral considerations, the authors stress the importance of carefully weighing “the appropriateness of altering a fundamental aspect of humanity.” The commentary acknowledges that not all nations will be ready to proceed at the same rate but suggests that any nation that does decide to proceed only do so after consulting broadly with other countries and allowing their public to reach societal consensus that the next step is appropriate. 

The motivation of the authors’ is clear. “We’re trying to force the spotlight on what comes next,” said co-author Eric Lander, President of the Broad Institute. To what extent international consensus can be built surrounding what the National Institutes of Health calls“a crucial moment in the history of science: a new technology offers the potential to rewrite the script of human life”  remains to be seen.

(Jon Cohen, Science Magazine)

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March 15, 2019 at 4:00 pm

Taming the “Natural” – Regulating Dietary Supplements and Botanicals in the US

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By: Katelyn Lavrich, Ph.D.

Image by Seksak Kerdkanno from Pixabay

Taking supplements is a part of the American culture, as three out of four Americans use a dietary supplement. An estimated 50,000-80,000 unique supplements are on the market, with over 20,000 botanical supplements in the U.S. marketplace. Dietary supplements are defined as a product intended for ingestion but not representing a complete or conventional food source.  They are marketed in many different forms, including powders, capsules, gummies, and teas. Botanical and herbal supplements are a subset of dietary supplements containing whole plants, parts of plants, powdered plant material or plant extracts. Dietary supplements are usually marketed as beneficial for health and often recommended by physicians, especially as we age. 

In February 2019, the FDA announced“one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” Though plants and herbal remedies have been used in therapeutics since the beginning of civilization, companies are now capitalizing on our obsession with health using ‘natural’ products. The dietary supplement industry is estimated to be over $40 billion a yearand rapidly growing, with some estimates that it could hit over $278 billion by 2024. Of that market, an estimated $7.5 billionwas spent on botanical supplements in 2016. 

As part of the FDA’s announcement, 17 warning letters were sent to companies for illegally marketing products to prevent, treat, or cure Alzheimer’s disease, diabetes, and cancer. This highlights a key distinction between dietary supplements and pharmaceutical drugs. Dietary supplements are substances that are used to add nutrients to the diet or lower the risk of health problems but have not been rigorously tested to help specific diseases. Pharmaceutical drugs go through years of testing for safety and efficacy before ever making it to market. Dietary supplements are regulated in the U.S. under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This law establishes the FDA’s role in regulating safety of botanical supplements once the product is on the market. The FDA can only take action against a misbranded or adulterated supplement after the product is already on the market. The agency tracks side effects reported by consumers and supplement companies, and can take legal action against a manufacturer or distributor if a product is found unsafe. They can also issue a warning or require that the product be removed from the marketplace. DHSEA places the liability on the company to have evidence of safety prior to introducing a drug on the market. No organization must prove efficacy of the product, and the FDA strictly prohibits health claims. This leaves thousands of supplements on the market with little idea of their safety before people consume them.

Dietary supplement safety is not straightforward, especially when evaluating botanical supplements. Botanicals are complex mixtures of chemical constituents and these mixtures can be highly variable based on the plant background and how the plant is processed. In contrast to pharmaceutical drugs that usually only have one active chemical in them, botanical supplements may have several active chemicals in them that can interfere with multiple biological functions all at once to different degrees. Manufacturing processes add a high degree of variability to safety testing of botanical supplements as many are proprietary, and often differ between companies. 

Contaminants can be introduced into botanical products during the manufacturing process. Intentional adulteration of botanical products is a serious concern worldwide. There have been documented cases of botanicals being spiked with pharmaceutical additives to enhance the marketed effect. For examples, stimulants, antidepressants, appetite suppressants, and laxatives have all been found in weight-loss supplements. And phosphodiesterase-5 inhibitors, such as Viagra, have been found in botanical supplements marketed for sexual performance. While intentional adulteration is a concern for the botanical industry, more common are likely non-pharmaceutical contaminants introduced unintentionally during the manufacturing process. 

The FDA is taking steps to improve how they regulate dietary supplements. They’re developing a tool to rapidly alert the public of when products have been shown to contain unlawful or potentially dangerous ingredients. The tool would also alert manufacturers to avoid making or selling these ingredients. The FDA is establishing guidelines requiring the submission of new dietary ingredient (NDI) notifications, giving the agency an opportunity to evaluate the safety of a new ingredient before it comes on market. While these are positives steps to improve safety knowledge to all stakeholders for single ingredients, these actions fail to take into account the potential synergistic effects ofthe mixture of ingredients together in dietary supplements.

Standardization is needed to measure and adjust the ratio of key components to help control batch-to-batch variability. Plant identification is complicated, because many features are lost during the manufacturing process. Several standards have been released including the United States Pharmacopeia (USP), the European Pharmacopoeia and the Pharmacopoeia of the P eople’s Republic of China. While these resources set out guidelines for specifications and tests in Good Manufacturing Practice settings, they are not mandatory for dietary supplements in the U.S.

Because of the high variability between products, reproducibility in research studies using botanical supplements is a major issue. NIH’s National Center for Complementary and Integrative Health released a natural product integrity policy in 2007 to require that all NIH grants address composition of research materials. Any clinical research that is evaluating the efficacy of a botanical product in “curing, treating, or mitigating a disease” shifts the research to the pharmaceutical approval track. Researches must submit an Investigational New Drug (IND) application, forcing exhaustive analysis of the product. However, the IND process makes the composition of botanicals proprietary. Better reporting and more transparency is needed in preclinical research using botanicals. The National Institute of Neurological Disorders and Stroke released a 2012 report recommending better reporting of samples size, randomization methods, and data analysis details. Of the studies they reviewed ,only 15% of clinical trials on popular botanicals (e.g. Echinacea, Ginkgo Biloba, St. John’s Wort) reported that they tested the content of the botanical, and only 4% provided enough information to compare the measure content to the expected content. 

Manufacturers of botanicals are under numerous legal obligations to ensure their products are not adulterated. Some manufacturers pursue external certification from U.S. Pharmacopeia (USP) or NSF international, though USP has only verified 139 productsto date. There is a zero-tolerance policy for all foods imported from outside the US, including botanicals. If any level of pesticide residue is detected, even if it is extremely low, it will be rejected at US ports of entry, even if the botanical is of the highest quality standards and would be allowed on the European market. Manufacturers are urging the EPA to set tolerances for pesticides on imported botanicals, as the zero-tolerance standard is nearly impossible to obtain, especially with new technology enabling extremely low limits of quantitation. 

The rapid growth of the dietary supplement industry is from the increased demand for health and wellness products. Often touted as a “healthy” alternative to pharmaceutical drugs, dietary supplements are plagued by a lack of safety regulations and manufacturing standards. Due to their complexity, toxicologists and risk assessors are alike still working out best practices to measure and interpret findings from mixtures. Collaboration between manufacturing, production, and research agencies is essential to learn how to best provide safe supplements and more information to consumers.

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March 15, 2019 at 10:46 am

Science Policy Around the Web – March 12, 2019

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By Andrew Wright, BSc

Source: Pixabay

The war on ‘prediabetes’ could be a boon for pharma—but is it good medicine?

Diabetes is highly prevalent in the United States, affectingnearly 10% of the US populationand accounting for approximately 80,000 deaths every year. While the pursuit to reduce or mollify the societal and economic impact of this disease is undoubtedly necessary in a country where fully 39.8% of adults are obese, there are some who wonder if such efforts have slipped into problematic territory. 

            Similar to how the introduction of pain as a fifth vital signhelped to unintentionally spur on the devastating opioid crisis, there is fear that the expanding diagnostic criterion of prediabetes could lead to the familiar territory of unnecessary treatment. For one, the risk of prediabetic patients developing diabetes from year to year is low: just under 2% according to the Centers for Disease Control (CDC).  At the same time the methods of treatment for prediabetes, designed to prevent progression to the full disease, are not particularly effective in achieving that goal. While a 2009 study demonstrated that exercise intervention or metformin, a common drug used to treat diabetes, did prevent some prediabetic patients from transitioning to full diabetes, methodological concerns have been raised with the authors’ results. One of the major issues is that the study used high risk patients at the upper end of the prediabetic spectrum, which is significant given that the American Diabetes Association (ADA) reduced the lower threshold of what counts as prediabetes around the same time. Of these “less” prediabetic patients, many never transition to the full disease. This suggests at the very least that treating these patients, especially pharmacologically, is not necessary or beneficial.

            Despite these issues being raised, there is a worrying trend of medical professionals doing just that. While no drug has been approved to treat prediabetes, doctors are continuing to treat prediabetic patients with diabetes drugs by prescribing them off-label at the recommendation of the ADA. Not only does this include metformin, which has its own difficult side-effects, but also several medications with “black box” labels that denote severe risks. Particularly when one considers that those who progress to full diabetes will be treated with these same drugs as their condition worsens, using them prophylactically is likely overzealous.

            Finally, there have been concerns raised about financial conflicts of interest, to which the medical and pharmaceutical industry are certainly not strangers. The companies behind the most prominent diabetes drugs have gifted millions of dollars to those in positions of influence at the ADA and other medical institutions. Perhaps as a result, while international groups such as the World Health Organization (WHO) have rejected prediabetes as a condition outright, the American medical community seems to be falling in line with the diagnosis. When top-down societal changes to reduce obesity may a be more effective means to reduce diabetes according to the WHO, the over-medicalization of prediabetes could ultimately do more harm than good.

(Charles Piller, Science)

Microplastic pollution revealed ‘absolutely everywhere’ by new research

With estimates that the ocean will have more plastic than fishby weight by 2050, it should come as no surprise that global plastic pollution is becoming rapidly untenable.  It is well understood that plastic does not biodegrade, but rather breaks down into increasingly smaller pieces know as microplastics. These pieces of plastic can become so small that they can be ingested by zooplankton, one of the fundamental building blocks of the marine food chain, which means they eventually make their way to the human digestive system.  

            While the problem was previously thought to be relegated to the worst polluted waterways and places like pacific vortexes (colloquially known as the “Great Pacific Garbage Patch”), recent studies have shown that microplastic pollution is so pervasive that pieces are found in every area tested. This includes freshwater bodies in the United Kingdom, groundwater supplies in the United States, the Yangtze river, off the coast of Spain, and in tap water around the world.

            The problem is not relegated to shallow water bodies either, with microplastics being found at the bottom of the Mariana Trench at levels of up to 2,200 pieces per liter of sediment. While these levels of contamination are undoubtedly perilous to wildlife, the affect they might have on humans is unclear. However, research from the National University of Singapore has demonstrated that microplastics harbor both bacteria that cause coral bleaching and those that cause gastroenteritis.  Further,  the possibility remains for chemicals contained in microplastics such as polychlorinated biphenyls (PCBs), which are carcinogenic, to cause deleterious health effects as chronic exposure leads to cumulative effects. What is clear is that without some method of reducing plastic pollution or monumental cleanup efforts, microplastics will become a troubling global burden in the years to come.

(Damian Carrington, The Guardian)

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March 12, 2019 at 4:53 pm

Science Policy Around the Web – March 6, 2019

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By Patrick Wright, Ph.D.

Source: Pixabay

High-Profile Subscription Journals Critique Plan S

Plan S, a new European-led initiative that mandates free access to results published starting in 2020, is receiving pushback from some scientific journals. The Plan’s primary mission states: “After 1 January 2020 scientific publications on the results from research funded by public grants provided by national and European research councils and funding bodies, must be published in compliant Open Access Journals or on compliant Open Access Platforms”. The national funders and charitable foundations include the Luxembourg National Research Fund, UK Research and Innovation, National Science Centre Poland, and the Bill and Melinda Gates Foundation However, this requirement that researchers supported by the funders must publish their results either in open-access (OA) journals or make a near-final copy of the manuscript immediately available in an approved repository has elicited a range of opinions and criticisms from journals and publishers; a recent open comment period to solicit feedback and consultation on Plan S received about 600 responses.

Some highly selective journals have argued that high internal costs likely could not be recouped in a fully open-access model and subsequent cost cutting could potentially compromise journal quality. The American Association for the Advancement of Science (AAAS), which publishes the Science family of journals, and Springer Nature, publisher of Nature journals, argue that high costs come from the highly selective nature of their selection processes: both employ many in in-house editors who evaluate and reject many more papers than they publish. Springer Nature estimates that it costs approximately €10,000-30,000 to publish an article in one of its Nature-branded journals, which is says is much higher than at more specialized or less selective journals. 

Another selective journal, Proceedings of the National Academy of Sciences(PNAS), published by the National Academy of Sciences (NAS), estimated in its response to the consultation solicitation that it would need to charge approximately $6,000 to publish an article open access, on top of the millions of dollars needed to switch infrastructure to a full open access model. Of this cost, NAS president Marcia McNutt stated: “I do not know of many scientific societies, including the NAS, that have financial reserves of that magnitude to transition their journals to full OA”. In a recent editorialon Plan S, McNutt has said: “I am also concerned that the architects of Plan S have not consulted broadly with researchers, editors, and leaders of scientific societies to obtain their views of how devastating this plan might be for the very organizations that support researchers and their disciplines”. 

Going forward, the International Association of Scientific, Technical and Medical (STM) Publishers which include Elsevier, the world’s largest scientific publisher, said that there is no one-size-fits-all approach to open access. Some groups, including Springer Nature, suggest that Plan S coalition engage in individual, confidential talks with publishers to explore “bilateral solutions”, whereas others prefer the formation of working groups consisting of representatives of publishers and coalition funders.  

(Holly Else, Nature)

University of California Boycotts Publishing Giant Elsevier Over Journal Costs and Open Access

The University of California (UC) system, a collection of 10 campuses with a total of over 238,000 students and 190,000 faculty and staff, recently announced it will stop paying to subscribe to Elsevier journals after a deal to reduce subscription fees and make all articles published by UC authors open access could not be reached following 8 months of negotiations. According to the head of UC Berkeley’s library and co-chair of the negotiation task force, Jeff MacKie-Mason, the offer from Elsevier did not move far enough to UC’s position; it was closer to the goals regarding open access but included price increases. 

The UC system accounts for roughly 10% of all publishing output in the United States, publishing about 50,000 articles in 2018, approximately 10,000 of which appeared in Elsevier journals. UC wished to pay one fee that covered both the article processing costs (APCs) and subscription costs. APCs allow individual papers to become available on an open-access basis. Thus far, Elsevier has been charging for both the subscription fee and APCs, which could be considered a form of “double-dipping” according to Ivy Anderson, associate executive director of UC’s California Digital Library and co-char of the negotiation task force.  

UC will still provide access to Elsevier publications, which include Celland The Lancet, at no cost for new articles through various methodsincluding interlibrary loan. Also, UC students and scholars will still be able to use ScienceDirect to access most articles published prior to January 1, 2019 because the UC system retains permanent access rights. 

Elsevier, the world’s largest scientific publisher, aims to keep the negotiations ongoing. Vice president for communications Tom Reller stated that the company’s offer “provides a clear path allowing every researcher to choose to publish for free or open access and provides a scaled path to reduce the costs for each campus library. We hope we can bridge this divide with them soon.” 

(Alex Fox & Jeffrey Brainard, Science)

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March 6, 2019 at 4:47 pm

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