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Posts Tagged ‘biomedical research

Is Novelty Killing Research Science?

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By: Aaron Rising, PhD

20180419_Essay

source: Sean MacEntee via flickr

Within the past decade or so, researchers have become aware of the prevalence of scientific studies whose results cannot be replicated, which has been dubbed the ‘reproducibility crisis.’ While the phrase may be a slight hyperbole, there is a real concern about how many published scientific studies are valid and reproducible. One of the most eye-opening studies into this issue was in the field of psychology in 2015 where 100 different experimental and correlation studies were redone in order to reproduce the conclusions of the original experiments. Overall, this study found that only 36% of the replicate experiments had significant results, despite 97% of the original set reporting significant results. Combining the two sets of studies (the original and the replicate experiments) resulted in nearly 70% significance of the two experimental sets, essentially meaning that ~25% of the original results were potentially a false positive. While the specific reproducibility percentages are debated (1, 2)  and being talked about in the media (3,4), it is worrying that a sizeable amount of published research, through no fault of the original researchers involved in the study, may turn out to be inaccurate. In a poll by Nature, 70% of researchers reported that they have failed to replicate another groups work. What’s even more troubling? More than half could not replicate their own findings.

There are multiple reasons why reproducibility of a single study can be called into question. Different labs use different mouse strains or cell lines, reagents from different companies or lot numbers can vary, or even two people can inherently perform the same experiment differently. All of these are examples could result in the exact same study ending up on either side of the significance threshold (usually set at p<0.05). And it shouldn’t be ignored that there are laboratories who use more nefarious methods to get positive results such as p-hacking, excessive removal of outliers, or just plain making up or editing data. But a more fundamental issue maybe driving this ‘crisis’, and it is one of ‘novelty.’  As humans, we love novelty. We are attracted to things that are innovative, new or never been done or seen before. It is ‘boring’ to rehash the same topic constantly. This desire or need for novelty flows into how we fund ideas and how we publish scientific results.

To get funding to do research, scientists must apply for and receive grants. In the United States roughly 40 to 50% of the science R&D funding comes from either the federal or local and state governments (5,6,7). Requirements for federally funded grants mostly rely on building on previous work and coming up with new and innovative ideas that have not been done previously. For instance, the U.S. National Institutes of Health (NIH) requires proposed projects to be unique and cannot, by law, use taxpayer money to pay for research that is already done. While not bound by law, other funding sources outside of the government such as Alzheimer’s Association, The Heart Foundation and the Leukemia and Lymphoma Society all emphasize that the research funded by their grants be ‘novel’  in concept, approach, and or strategy. Everything proposed in these grant applications, for the most part, is new, innovative and assumes all prior work is correct and can be reliably built upon.

On the other end of the research pipeline is the publication of results. Like when a researcher is trying to get funding for their work, they must show novelty and innovation to get published. As examples, two top tier journals, Cell and Nature require that the research being submitted for publication is ‘novel.’ Cell states that they are looking for papers ‘that report results that prompt new thinking about a biological problem or therapeutic challenge—work that will inspire others to want to build on it.’ Nature has two criteria points that state the work must be ‘of extreme importance to scientists in the specific field’ and ’ideally, interesting to researchers in other related disciplines.’ These criteria obviously promote and result in good, high quality papers, but such policies also box out research publications that might be important but only conformational.

There are journals such as PLOS One that just look at the quality and rigor of the science itself as criteria for publication, but these types of journals are not nearly as common. PLOS One states: ‘Judgments about the importance of any particular paper are then made after publication by the readership, who are the most qualified to determine what is of interest to them’ and that the journal accepts studies with negative results. However, when ranking journals, using the standard Impact Factor rankings as of 2017, Nature and Cell come in at 10th and 22th respectively and PLOS Medicine (a sub journal of PLOS One and highest ranked PLOS One journal) is ranked 167th. It’s easy to see where a scientist would rather publish to advance their career considering most jobs and tenure track promotions look not just at the number, but the quality (impact factor) of scientific publications.

A few groups have been attempting to solve both the funding and the publishing issues described here. The Dutch Organization for Scientific Research, an organization in the Netherlands similar to the NIH in the U.S., has begun to fund grants for replication research (8,9). Grants can either be for reanalysis of the data already collected or can be a complete repeat of the study to confirm its results. This initiative by the Dutch helps on the front end of the science pipeline by specifically allocating grant money for repeating a set of experiments already done by other groups rather than doing the proposed conformational experiments with ‘extra’ money that was intended for innovative and new work. On the publication end of the scientific pipeline, there are foundations and groups of concerned scientists that are working on publishing replication studies (10,11). In addition, the PLOS One Biology journal has recently announced that it will take ‘scooped’ work as long as it is submitted within 6 months of the original article. As a well-articulated article in The Atlantic points out, this will help the first group that publishes by allowing the ‘second place’ group to confirm their results and thus add to the reproducibility of that original study. The “second place” group still receives recognition through publication of the work they likely spent months if not years doing and does not waste the money and resources on that work that would normally not see the light of day.

While the over emphasis of novelty by the scientific community is not the only reason for the ‘reproducibility crisis,’ it is part of the underlining culture that might be contributing to it. Other factors eluded to above such as the pressure to publish in high impact journals, variable cell and mouse lines, and lab personnel differences also contribute to the problem. The Dutch initiative, PLOS One Biology and Open Science Collaborations are all examples of ongoing projects and attempts to help solve part of this ‘crisis.’ Other ideas to further this effort to increase science reproducibility in the United States would be for a policy change at the NIH funding level. With a slight tweak to current policy, the NIH could allow for one of the specific aims of a grant to specifically verify something that is pivotal or groundbreaking in the field. This explicit allowance would start to make replication studies more acceptable and perhaps make researchers more apt to perform and publicly verify or dispute previous studies. Another idea would be for other journals to take PLOS One Biology’s lead and allow for ‘scooped’ research to be published. Depending on the prestige (impact factor) of the journal, the time frame of said ‘scooped’ research could be shortened from the 6 months of PLOS One and have more stringent review requirements. An additional policy that all journals could adopt that would greatly strengthen scientific confidence in pivotal papers is to attach short communications/addendums that show peer reviewed replication attempts of that work. These addendums would add to the strength of the original paper if conformational, or suggest there is more nuance and the need for further study if they do not confirm the original paper. All found in one place to boot!

Implementation of further replication policies would take a real push by the scientific community, but would beneficial to the ongoing efforts in trying to solve the ‘reproducibility crisis.’  While it may take time before we see any tangible or measurable results from the current endeavors, we should look to other ideas and concepts that enhance science reproducibility. We can’t afford to squander the public’s great faith in the scientific community due to highly touted papers that turn out to be a false positives or simply wrong.

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Written by sciencepolicyforall

April 25, 2018 at 9:32 pm

Old Wounds and Shifting Tides: Potential Consequences of and Remedies for Health Disparities and Inequity in the United States

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By: Calais S. Prince, Ph.D.

20180416_Essay

By Jsonin [CC-BY-4.0], via Wikimedia Commons

By the year 2060, the percentage of racial and ethnic minorities is expected to increase by 49% in the United States. As the country becomes more diverse, it will become imperative to understand the genetic/epigenetic, molecular, cellular, and environmental differences associated with increased risk for disease onset. Currently, it is still clear that certain minority groups have a greater propensity for several diseases including diabetes, stroke, heart disease, and cancer. Health disparities are preventable differences in disease manifestation that can be attributed to social, political, and environmental factors. These factors can include, but are not limited to: discrimination, poverty, access to education, and exposure to hazardous chemicals.

Segregation in health care and the potential influence on participation in biomedical research

Although commonly perceived as a relic of the past, health care segregation in the United States persists and can be attributed to the Jim Crow laws that were designed and implemented following the Civil War through the 1960s. For example, “[m]any hospitals, clinics, and doctor’s offices were totally segregated by race, and many more maintained separate wings or staff that could never intermingle under threat of law” contributing to “subpar health care standards.” A glaring, present day example is that of Boston City Hospitals and Mass. General, which is both a reflection of the “the referral system that dates back five decades” and the type of care that will be covered by insurance. Another powerful, and personally relevant, example that demonstrates the importance of understanding how environment influences the risk for disease was discussed in a recent article. In African American/Black women, the consequences of racism had a significant impact on intrauterine stress as there are higher incidences of complicated pregnancies, miscarriages, premature births, and infant deaths which correlate with self-reported experiences with racism and discrimination. Conversely, African women were reported to have similar birth rates as Caucasian/White women. However, maternal health, pregnancy, and neonatal health of the grandchildren of African immigrant women born in the United States trend towards the patterns described in African American/Black women. These disparities are believed to contribute to the low percentages of minorities that participate in clinical and biomedical research as some of the barriers to participation are “distrust, provider perceptions, and access to care.” The cyclical nature of disparities: disparate living environments, disproportionate access to education and health care, postnatal complications, wealth inequalities, accelerated aging and morbidity, warrants a multifaceted solution to a pervasive, generational problem.

Mechanism that can potentially facilitate health care integration and improve participation in research

In 2010, the redesigned National Institute on Minority Health and Health Disparities (NIMHD) was established with a vision in which “all populations will have an equal opportunity to live long, healthy, and productive lives.” To accomplish this, NIMHD raises national awareness about the prevalence and impact of health disparities and disseminates effective “individual-, community-, and population-level interventions to reduce and encourage elimination of health disparities.” This vision recognizes the need to study health disparities within a variety of different modalities ranging from biomedical to social sciences as the majority of clinical and translational studies have been conducted in Caucasians/Whites. Specifically, there are four major NIMHD sponsored programs that provide funding to address the components of health disparities, inequity, and inequality at the levels of academe (Research Endowment Program), community (Community Based Participatory Research Program, Small Business Innovation Research/Small Business Technology Transfer Program), and internationally (Minority Health and Health Disparities International Research Training Program). It is also essential to facilitate mentoring of up-and-coming scientists and clinicians from underrepresented groups. The National Research Mentoring Network is a consortium composed of biomedical and clinical professionals that provide “evidence based mentorship professional development” for undergraduates through professionals; this serves as an important way to make inroads to increasing diversity in biomedical sciences. Earlier exposure to the sciences for underprivileged youth, as well as parental and community support, could serve as valuable avenues to combat health inequity.

Concluding thoughts: Demographic changes in the United States and the impact on biomedical research

The conversations surrounding disparities can be difficult, however, they are necessary. A concerted effort to improve the lives of those that are at risk/underserved have the potential to improve the lives of the individual as well as strengthen the scientific community. The projected increase of minorities in the United States warrants improved access to life saving treatment and encouragement of participation in biomedical research, as there is mounting evidence that environmental factors can influences the cellular and physiological response to stress. We also need to examine methodologies that will build trust in the scientific community which starts by: continuing to dismantle the remnants systematic discrimination, introducing science to underrepresented minorities earlier in their didactic training, providing community support, and train future researchers and clinicians to be more sensitive and responsive to the needs of the community in which they serve.

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April 16, 2018 at 9:57 pm

Science Policy Around the Web – April 6, 2018

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By: Sarah L. Hawes, PhD

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source: pixabay

Biomedical Research

Mitochondrial Replacement moratorium – are we over-regulating cures?

You may recall learning in grade-school science about the ‘mighty’ mitochondria which function as cellular power-plants, translating energy from your food into ATP to fuel subcellular processes. Failure in this fundamental process results in devastating mitochondrial diseases. Power-hungry tissues of the body – brain, heart, lungs, muscles – are hard hit by mitochondrial dysfunction, leading to degradation of heart, liver, kidney, gastrointestinal, respiratory and brain function. Perhaps you also recall learning that your mitochondrial DNA is a very small fraction of your total DNA, and is inherited solely from your mother? This feature has made it possible for researchers to develop mitochondrial replacement (MR) therapy which can be targeted to the egg prior to fertilization. In this procedure, donated mitochondria replace mutation-bearing mitochondria within unfertilized eggs, allowing women who carry aberrant mitochondrial DNA to give birth to genetically related, healthy children.

Unfortunately, a 2016 moratorium on U.S.-based research in which a human embryo is intentionally created or modified currently prohibits clinical MR therapy despite modification taking place prior to fertilization. Nonetheless, replacing mutation-bearing mitochondria with donated genetic material falls under a broad category of genetic modification prohibited by the moratorium – which has no named authors, and was passed without major congressional or public discussion.

A recent commentary in Obstetrics & Gynecology calling for this moratorium lift was authored by Professors Eli Adashi at Brown University’s Warren Alpert Medical School, and Glenn Cohen at Harvard Law School. Adashi points out the high number of children born in the U.S. annually with mitochondrial disease, and states “…this issue is not about the sanctity of life. There is an inherent hypocrisy in holding this procedure hostage at the expense of 1,000 children each year who are doomed to die a painful death.”

Adashi and Cohen detail a comprehensive process to move forward with reevaluating the moratorium, and laying the groundwork for policy enabling MR therapy in the U.S. These processes would engage the public, medical professionals, patient advocacy groups, the U.S. Food and Drug Administration and Congress. Authors describe a careful 15-year process of policy development in the U.K. ending in 2015 with Parliament approving MR under stringent regulatory oversight and within a single licensed clinic. They also note that, without FDA oversight and approval at home, American families seeking to safeguard their children against mitochondrial disease will seek care abroad given that successful MR therapy has now taken place in both the U.K. and Mexico.

(Gillian Kiley, News from Brown)

The Opioid Crisis

Provisions for legal medical cannabis are associated with reduced opioid use

Last year, the U.S. Department of Health and Human Services declared a public health emergency due to the more than 42,000 deaths from opioid overdose in 2016, with more than 40% of these deaths resulting from prescription medications. Two studies published this week in the Journal of the American Medical Association, Internal Medicine examined the number of opioid prescriptions filled in a recent five-year period, and related this number to coincident medical marijuana laws.

Co-author Bradford from one study explains that “Some of the states we analyzed had medical cannabis laws throughout the five-year study period, some never had medical cannabis, and some enacted medical cannabis laws during those five years,” enabling researchers to ascertain “what happens to physician behavior in terms of their opiate prescribing if and when medical cannabis becomes available.”

Bradfords’s team found that availability of legal medical marijuana via dispensaries was associated with a significant decrease in opiate use, amounting to about 14% fewer annual opiate prescriptions relative to states without legal access. Clearly these findings are correlative, however researchers included a useful control:  the examination of prescription rates for non-opioid drugs such as flu medicine and blood thinners – none of which might be replaced by medical marijuana. The study found no relationship between these prescriptions and marijuana laws. These results suggest that availability of marijuana as an alternative pain treatment alleviates public use of prescription painkillers.

A separate but similar study reports a more modest 6% reduction in the rate of opioid prescription writing coincident with medical marijuana laws. This figure includes states with a broader range of legal access to marijuana, regardless of whether dispensaries exist. Researchers in this group investigated fiscal impact as well:  medical and adult-use laws were associated with a 9.78% reduction in Medicaid spending on opiates, and 8.36% reduction in Medicaid spending on non-opiate pain medications.

There are clear caveats to medical marijuana usage. Effects of cannabis are inadequately understood and require further study. Proper dosage has yet to be clearly defined for this drug.

“Regardless, our findings suggest quite clearly that medical cannabis could be one useful tool in the policy arsenal that can be used to diminish the harm of prescription opioids, and that’s worthy of serious consideration,” said Bradford. Such policy may find broad public backing. In fact, a recent poll by University of Michigan Medical school indicates roughly 80% of persons aged 50-80 (a prime demographic for pain medication) support allowing medical marijuana if recommended by a physician. Given the opioid crisis and public reliance on physician actions (recommendations, prescription-writing), it would be prudent to focus on developing basic and clinical research and policy geared at defining and permitting safe use of opioid alternatives – including marijuana.

(Kate Sheridan, Stat News)

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April 9, 2018 at 11:31 am

Science Policy Around the Web – July 7, 2017

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By: Liu-Ya Tang, PhD

Source: pixabay

Autism

Is There Such a Thing as an Autism Gene?

Autism has become a global burden of disease. In 2015, it was estimated to affect 24.8 million people globally. Significant research efforts are underway to investigate the causes of autism. Autism is highly heritable – there is an 80 percent chance that a child would be autistic if an identical twin has autism. The corresponding rate is about 40 percent for fraternal twins.

However, is there such a thing as a single autism gene? Researchers haven’t found one specific gene that is consistently mutated in every person with autism. Conversely, 65 genes are strongly linked to autism and more than 200 others have weaker ties, many of which are related to important neuronal functions. Mutations in a variety of these genes can collectively lead to autism. The mutations could be from single DNA base pair, or copy number variations, which are deletions or duplications of long stretches of DNA that may involve many genes. Most mutations are inherited, but some mutations could also happen in an egg or sperm, or even after conception.

Besides genetic factors, maternal lifestyle and environmental factors can also contribute to autism. Exposure to air pollution during pregnancy or a maternal immune response in the womb may increase the risk of autism. While there is speculation on the link between vaccines and autism, it is not backed by scientific evidence.

Since both genetic and non-genetic factors play a role in the development of autism, establishing the underlying mechanism is complicated. There is no single specific test that can be used for screening autism. However, some tests are available to detect large chromosomal abnormalities or fragile X syndrome, which is associated with autism. (Nicholette Zeliadt, Washington Post)

STEM Education

New Florida Law Lets any Resident Challenge What’s Taught in Science Classes

A new law was signed by Florida Gov. Rick Scott (R) last week, and has taken effect starting July 1. The law requires school boards to hire an “unbiased hearing officer” to handle complaints about teaching materials that are used in local schools. Any county resident can file a complaint, and the material in question will be removed from the curriculum if the hearing officer thinks that the material is “pornographic,” or “is not suited to student needs and their ability to comprehend the material presented, or is inappropriate for the grade level and age group.”

There are different voices in the new legislation, which affects 2.7 million public school students in Florida. Proponents argue that it gives residents more right in participating in their children’s education. A sponsor, state Rep. Byron Donalds (R-Naples), said that his intent wasn’t to target any particular subject. However, Glenn Branch, deputy director of the National Council for Science Education, is worried that science instruction will be challenged since evolution and climate change have been disputed subjects. A group called Florida Citizens for Science asked people to pay close attention to classroom materials and “be willing to stand up for sound science education.”

Like the new law in Florida, the legislature in Idaho rejected several sections of the state’s new public school science standards related to climate change and requested a resubmission for approval this fall. Since the Trump administration began, there has been “a new wave of bills” targeting science in the classroom. To protect teacher’s “academic freedom,” Alabama and Indiana adopted non-binding resolutions that encourage teachers to discuss the controversy around subjects such as climate change. A supporter of the resolution, state Sen. Jeff Raatz (R-Centerville), told Frontline, “Whether it be evolution or the argument about global warming, we don’t want teachers to be afraid to converse about such things”. (Sarah Kaplan, Washington Post)

 

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July 7, 2017 at 1:32 pm

Science Policy Around the Web – June 20, 2017

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By: Eric Cheng, PhD

Source: Flickr, via Creative Commons (CC BY 2.0)

Research Funding

America is Still First in Science, but China Rose Fast as Funding Stalled in U. S. and Other Countries

American scientific groups continue to publish more biomedical research discoveries than groups from any other country, and the United States still leads the world in research and development expenditures. However, American dominance is slowly diminishing as China’s increase in funding on science over the last twenty years are starting to pay off. Chinese biomedical research now ranks fourth in the world for total number of discoveries published in six top-tier journals. This is with China spending three-fourths of the amount of money that the U.S. spent on research and development in 2015. In addition, new discoveries and advances in science are becoming more of a collaborative effort, which include researchers from around the world.

These findings come from research published in The Journal of Clinical Investigation by a group of University of Michigan researchers. The analysis comes at an important time for Congress to think about whether the annual uncertainty of the National Institutes of Health’s(NIH) budget and proposed cuts are in the nation’s best interest over the long-term. Bishr Omary, the senior author of the article commented, “If we continue on the path we’re on, it will be harder to maintain our lead and, even more importantly, we could be disenchanting the next generation of bright and passionate biomedical scientists who see a limited future in pursuing a scientist or physician-investigator career.”

The research was based on data up to 2015. During the current fiscal year of 2017, funding for NIH was proposed to be increased by 2 billion dollars, which is the second year in a row where funding was increased after 12 years of flat budgets. With this increase in funding, Omary hopes that, “our current and future investment in NIH and other federal research support agencies will rise above any branch of government to help our next generation reach their potential and dreams.” (University of Michigan, ScienceDaily)

Opioid Crisis

The Role of Science in Addressing the Opioid Crisis

Opioid addiction is an ongoing public health crisis. Millions of individuals all over the United States suffer from opioid use disorder with millions more suffering from chronic pain. Due to the urgency and scale of this crisis, innovative scientific solutions need to be developed. As part of a government-wide effort to address this crisis, the National Institutes of Health (NIH) is supplementing current research efforts with a public-private collaborative research initiative on pain and opioid abuse.

The Director of NIH, Dr. Francis Collins met with research and development leaders from biopharmaceutical companies in April 2017 to discuss new ways in which  government and industry can work together to address the opioid crisis. Dr. Collins stated how some advances such as improved formulations, opioids with abuse-deterrent properties, longer-acting overdose-reversal drugs, and repurposing of treatments approved for other conditions may be quick. Other advances such as mu-opioid receptor-based agonists, opioid vaccines, and novel overdose-reversal medications may be slower to develop. Overall, the goal for this partnership is to reduce the time typically required to develop new, safe, and effective therapeutics to half the average time. (Nora D. Volkow and Francis S. Collins, New England Journal of Medicine)

Climate Change

France is Offering US Scientists 4-year Grants to Move to the Country and do Research

Following President Donald Trump’s decision to withdraw the United States from the Paris climate agreement, France created an initiative that will allow researchers, teachers, and students to apply for a fully financed four-year grant to combat climate change. The website for the initiativesays,

“You will be able to stay in France at least for the duration of the grant, and longer if you are granted a permanent position. There is no restriction on your husband / wife working in France. If you have children, note that French public schools are free, and the tuition fees of universities and ‘grandes écoles’ are very low compared to the American system.”

Since Emmanuel Macron won the French presidential election in May, he has addressed American scientists who feel alienated by the Trump administration. Macron has promised strong funding for climate initiatives. However, some U.S. scientists like David Blockstein of the National Council for Science and the Environment see Macron’s invitation as “both a publicity stunt and a real opportunity.” Although it is not very likely that many U.S. researchers will take up the offer, it does provide a “sharp contrast to an increasingly hostile U.S. political environment for science.” (Chris Weller, Business Insider)

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June 20, 2017 at 1:10 pm

Science Policy Around the Web – June 16, 2017

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By: Emily Petrus, PhD

Source: pixabay

Science and Politics

Politics in Science – It’s Not Just the U.S.!

Romania is a country in eastern Europe that joined the European Union (EU) in 2007. Scientists there are few and far between; research spending only accounts for 0.49% of GDP, the lowest in Europe (the US spent 2.7% in 2016). After joining the EU, Romanian researchers were encouraged to apply for European merit-based grants and sit on international review boards such as the National Research Council and the National Council of Ethics. It seemed that research was making slow but steady progress, but the new administration elected this year has shaken things up in all facets of government, including scientific research.

The new research minister, Serban Valeca, removed the international members appointed to government councils that oversee research funding, ethics, innovation and science policy, and replaced them with city council members, government-loyal union members, researchers from second tier Romanian institutes and even a surgeon being investigated for embezzlement. Grant review panels have been shuffled to remove international scientists and replace them with domestic researchers, but only if they have a certificate saying their university approves of their participation. These changes mark a departure from welcoming international input into Romanian proceedings and a movement towards scientific isolation.

To combat these changes, Romanian scientists have formed an organization, Ad Astra, which calls on researchers to boycott grant evaluations. Combined with the shuffling, the councils have been suspended for 3 months, which delays funding and puts already under-funded researchers in peril. The European University Association calls the policies deeply concerning, and although the current president may disagree with the research minister’s handling of the situation, his political ties ensure he won’t hold much sway over how this plays out. A computer scientist at the University Politehnica in Bucharest, Costin Raiciu, is concerned that the policies will affect talented researchers who have returned to Romania and says, “Without [merit-based] funding, people would either give up research altogether or move out of the country”. This is an all too familiar scenario in which it is apparent that policy and science must cooperate to produce ideal outcomes. (Alexandra Nistoroiu, ScienceInsider)

Mental Health

Clinical Trials Down, Basic Research Up at NIMH

Mental health is a notoriously tricky field. The development of the Diagnostic and Statistical Manual of Mental Disorders (DSM) in the 1950s has historically been a way to diagnose patients with mental health issues, and then give appropriate treatment. This has proved to be an imprecise treatment strategy, because within a category of diagnosis there is a broad spectrum of behaviors, and underlying this behavior there may be multiple causes. The NIH’s Precision Medicine Initiative (PMI) seeks to characterize 1,000,000 people by behavior, genetics, environment, and physiology. Researchers from the NIMH will send questionnaires evaluating behavior to detect mood and reward responses for this group of people. When this mental health evaluation is combined with information about their genetics, lifestyle and environment, scientists can characterize mental health disorders more specifically.

Many clinician researchers are upset by the steep decline in clinical trial research funded by NIMH, which has become higher profile with director Joshua Gordon’s arrival in 2016. NIMH seeks to route funding to study mental disorders using a basic research approach before spending time and money on costly clinical trials which too often lead to inconclusive or disappointing results. In 2011 NIMH launched the Research Domain Criteria (RDoC), which encourages research proposals to include a hunt for the mechanism underlying mental health studies. Since the initial call to include a RDoC perspective in grant applications, the incidence of RDoC appearing in funded applications has increased while mention of the DSM has decreased. Other buzzwords that are present in funded grants include biomarker, circuit, target and mechanism.

These data represent a shift in how funding decisions will proceed in mental health but may have broader reaching implications for other areas of research. In a blog post Dr. Gordon writes, “the idea that RDoC will facilitate rapid, robust and reproducible neurobiological explanations for psychopathology (as observed within and across DSM disorders) represents a hypothesis”. It remains to be seen if RDoC is an effective metric to evaluate successful grants. (Sara Reardon, Nature News)

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Science Policy Around the Web – June 13, 2017

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By: Nivedita Sengupta, PhD

By Mikael Häggström, used with permission. [Public domain], via Wikimedia Commons

Stem Cell Therapy

Texas on Track to Become First State to Explicitly Back Stem Cell Therapies

On 30th May, Texas passed a bill  authorizing unapproved stem cell therapies, making Texas the first state to openly recognize experimental treatments. The bill will make the use of unapproved stem cell therapies legal for patients and is currently awaiting the approval of Governor Greg Abbott, who already supports the measure. Experimental stem cell therapies for terminal and chronic conditions have struggled for years to gain support without much success. Until now, no state has provided legal validation for these kind of therapies and the current stem cell procedures are mostly done under strict regulations.

Amendments were added to the bill, which require that the treatments be delivered by doctors with the approval of an institutional review board, which deals with human research. It will also add another amendment that will allow patients to have authority to sue in case the treatments go wrong. Many scientists and advocates opposed the measure stating that unapproved stem cell therapies can be harmful rather than beneficial. They state that though the amendments add protection to the patients, there are a few aspects of the bill that make them uncomfortable. Two other bills focused on patient access to experimental therapies, also known as “right-to-try” policies, failed to pass in the Texas Senate. (Andrew Joseph, STATNews)

Research Funding

NIH Scraps Plans for Cap on Research Grants

US National Institutes of Health (NIH) decided to drop the controversial proposal of capping the number of grants that an investigator can have at a time. The initial capping attempt was suggested to gather funds for younger researchers by NIH in May. The proposal was based on studies that suggested that a lab’s productivity decreases once it holds too many grants. Younger scientists often face more difficulties in obtaining NIH RO1 grants compared to their older more experienced colleagues. As a result, many researchers applauded the NIH’s effort to provide more funding for younger scientists. Yet the capping proposal received major adverse response from the scientific community stating that the NIH’s interpretation of the productivity study data does not apply to all labs, especially to the collaborative lab groups with four or five R01s that are more productive than labs with only one. Researchers also complained that the proposed point-based scoring system will also make collaborations difficult thus hampering productivity in the long run.

NIH director Dr. Francis Collins stated that the original idea was still a work in progress and NIH is going to put a hold on it. Instead of the cap, on 8th June, NIH announced the creation of the special fund, the Next Generation Researchers Initiative (NGRI), starting with US$210 for funding young researchers. The initiative will focus on investigators with less than 10 years of experience as NIH- funded principal investigators, and on high score grant proposals that were rejected because of lack of money. The initiative will grow up to $1.1 billion over the next five years. According to NIH principal deputy director Larry Tabak, NIH will immediately start creating an inventory of investigators who meet these criteria and expects that this approach will allow more than 2,000 additional R01 grants to be funded to younger scientists compared to the cap-based plan, which would have supported only 1600 awards. Nonetheless, the current proposal is still going to generate controversy as it will affect the older researchers because of NIH’s diversion of funding. (Sara Reardon, Nature News)

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June 13, 2017 at 7:08 pm