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Science Policy Around the Web November 19th, 2019

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By: Andrew Wright Bsc

Source: Pixabay

EPA’s ‘secret science’ plan is back, and critics say it’s worse

​The Environmental Protection Agency (EPA) has been exploring new rules on the incorporation of scientific data in its rulemaking process. The so-called “secret science” rules were originally proposed in 2018 under the EPA’s previous administrator Scott Pruitt, and have since been revised by its new administrator Andrew Wheeler in response to harsh criticism from scientific, environmental, and patient groups. Rather than addressing these criticisms to mollify the proposals detractors, the draft of the newly proposed rule, which was leaked to the New York Times, seems to drastically broaden the scope of which data cannot be used. 

According to the 2018 proposed rule, all raw data would have to be made available for studies that assessed a “dose-response” relationship, a bedrock of toxicity research. This could be difficult, if not impossible, when considering patient privacy protection laws and proprietary information requirements that would prevent the dissemination of that data. In the new draft rule, this set of constraints is imposed on all scientific studies used to guide agency procedures, instead of just dose-response studies. The draft also seeks comment on whether these restrictions should be imposed retroactively. According to the draft rule, if the underlying data were not made available, the EPA would be able to “place less weight” or “entirely disregard” those studies.  

While the draft does provide room for a tiered data-sharing approach such as those implemented at the National Institutes of Health and the Food and Drug Administration and allows for political appointees to provide exemptions, critics worry that these new requirements will effectively remove science from the EPA’s decision-making process.  Thus far, the EPA’s scientific advisory board has not been afforded the opportunity to weigh-in.

(David Malakoff, Science)

‘Insect apocalypse’ poses risk to all life on Earth, conservationists warn

A recent study looking at insect populations in the UK suggests that up to half of all insects have been lost since 1970 and that 40% of all known insect species are facing extinction. Due to the complexity of ecological systems that rely on insect biodiversity to function properly, this level of insect loss could lead to “catastrophic collapse” on a global scale. 

This study demonstrates a similar severity of insect decline as has been seen in other regions around the world. In Puerto Rico, for example, insect biomass has declined between 10 and 60 times and has led to the destruction of its rainforest’s food web. In Germany, 75% of flying insects have vanished in the past 27 years.

Solutions to address what is now considered Earth’s sixth mass extinction event are becoming increasingly complex as failing components of anthropogenic damage to the global ecosystem are beginning to interact. However, conservationists suggest that insect numbers could be rapidly recovered through a combination of pesticide reduction and land management. 

(Damian Carrington, The Guardian)

Written by sciencepolicyforall

November 19, 2019 at 11:59 am

Science Policy Around the Web October 8th, 2019

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By Mary Weston PhD

Image by Andreas Lischka from Pixabay 

A single tea bag can leak billions of pieces of microplastic into your brew

A recently published studyfrom McGill University shows that plastic teabags release billions of plastic micro- and nanoparticles into your tea. Researchers steeped plastic tea bags in 95°C (203°F) water for 5 minutes, finding that a single bag released approximately 11.6 billion microplastics and 3.1 billion nanoplastics. This concentration of plastic particles is thousands of times larger than any other reported food/drink item.

Although tea bags contain food-grade, FDA approved plastics, researchers know little about how plastics can degrade or leach toxic substances when heated above 40C (104F). Based on these new results, the study’s authors conclude that more research needs to be done to both determine how microparticles are released in our foods and the impact those substances have on human health.

To gain insight on the effect of plastic particle exposure, researchers grew water fleas, a common environmental toxicology model system, in the brewed solution, discovering they survived but had both behavioral and developmental abnormalities. While the plastic particle exposure levels these fleas experienced are far greater than what humans would be exposed to, it begs the question of what happens to humans with chronic low-dose exposure over time.

Microplastics are being detected everywhere, from the deepest parts of the ocean to regularly consumed bottled water, and their effect on human health have yet to be seen. One study suggests humans are consuming 5 grams of plastic a week, approximately the weight of a credit card.  However, In their first review of microplastics in tap and bottled water, the WHO asserts that microplastics “don’t appear to pose a health risk at current levels,” but also state that knowledge is limited and more research is needed to determine their impact on human health. 

(Rob Picheta, CNN)

Written by sciencepolicyforall

October 8, 2019 at 3:53 pm

Science Policy Around the Web September 3rd, 2019

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By Ben Wolfson PhD

Image by Dimitris Vetsikas from Pixabay 

Biohackers are pirating a cheap version of a million-dollar gene therapy

This past weekend, the 4th annual Biohack the Planet, a conference for community scientists and biohackers, was held in Las Vegas. In addition to discussions concerning the future and goals of biohacking, a group of biohackers announced their efforts to develop a pirated version of the gene therapy Glybera, called Slybera.

First approved in Europe in 2012, Glybera is a gene therapy meant to treat the rare genetic disorder lipoprotein lipase deficiency (LPLD). Glybera provided a “one-off” solution to LDLD by inducing a patients body to produce new copies of the missing protein. Approximately 1 in every million people suffer from LPLD, meaning that there existed an exceedingly small market for the drug. Moreover, upon its release it was deemed the world’s most expensive drug at approximately 1 million dollars per dose. Due to financial issues associated with this high cost, Glybera was withdrawn from market in 2017.

At Biohack the Planet, research leader Gabriel Licinia described the process of creating a prototype pirated version of Glybera, which he says cost less than $7,000 and was created in only 2 months. Licinia and his colleagues got the gene sequence used in Glybera from the original papers published describing it, and ordered the DNA from a commercial DNA synthesis company. They then inserted the DNA into a genetic construct capable of inducing mammalian cells to produce the LPL protein.

While Licinia demonstrated that this method works in cells, it would likely not have the same long lasting effects as Glybera, which uses viruses as carriers for the LDL gene, producing stable expression of the protein for a number of years.

The future of Slybera is uncertain, as there is currently no defined clinical path for products created by biohackers. However the team is taking steps to demonstrate their seriousness, including distributing their materials to fellow biohackers so they can attempt to replicate their studies.

(Alex Pearlman, MIT Technology Review

Written by sciencepolicyforall

September 3, 2019 at 3:49 pm

Science Policy Around the Web August 26th, 2019

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By Silvia Preite PhD

Image by PublicDomainPictures from Pixabay 

NIH will soon share genetic data with those who participated in precision medicine study

In 2018 the National Institutes of Health (NIH) launched the All of Us Research Program to collect multiple types of data from more than one million volunteers living in the United States. The aim of the program is to accelerate medical breakthroughs and promote human health on a large scale. All of Us is a key element of the Precision Medicine Initiative (PMI), with the long-term goal of integrating information on genetic composition, lifestyle and environment to reveal strategies for personalized prevention and treatment of a wide range of health conditions. 

Participants provide medical records along with genomic material, blood and urine samples. In addition, digital data recorded through smart phones and other electronic devices are stored to obtain extended pictures of the individual health status and life habits.

So far, about 200,000 Americans have joined the All of Us initiative. By late 2019-early 2020, 25,000 US citizens will get back their genomic information along with genetic counseling. On August 21 2019, the All of Us director Eric Dishman announced a new partnership with the California-based health technology company, Color Genomics to provide the counseling service. The genetic counseling services provided by Color Genomics will play a crucial role in communicating the genomic results to participants and their personal physicians, as well as helping them understand the implications for their health and families. These data will supply information on genetic variants that could predispose to certain diseases and influence responses to pharmacological treatments.

In particular, counseling will be given to those individuals who carry any genetic mutations that geneticists have linked to severe diseases – such as mutations in the BRCA gene associated with breast cancer.

This will be the first time that a government funded study will return genetic data to the participants on such a large scale. Another distinguished element of this study is the heterogeneity of the involved population. Up to now, half of the participants have been selected within ethnic and socio-economic groups that have been historically marginalized and under represented in research and clinical studies. Moreover, researchers could gain access to these open-source and anonymized data to investigate previously unknown genetic traits that influence human health and disease development, greatly broadening the availability and heterogeneity of data for these studies.

(Lev Facher, STAT News)

 

Written by sciencepolicyforall

August 27, 2019 at 2:38 pm

How human health depends on biodiversity

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By: Lynda Truong

Image by V Perez from Pixabay 

By many measures, the Earth is facing its sixth mass extinction. The fifth mass extinction, a result of a meteorite approximately 10 km in diameter, wiped out the dinosaurs and an estimated 40-75% of species on Earth. This time around, the natural disaster that is threatening life on Earth is us.

In May, the United Nations released a preliminary report on the drastic risk to biodiversity (not to be confused with the recent report on the drastic consequences of climate change).  The assessment, which was compiled by the Intergovernmental Science-policy Platform on Biodiversity and Ecosystem Services (IPBES), draws on information from 15,000 scientific and government sources with contributions from 145 global experts. It projects that one million species face risk of extinction. Scientists have estimated that the historical base level rate of extinction is one per million species per year, and more recent studies suggest rates as low as 0.1 per million species per year. At the established base level rates, it would take one to ten million years to see the same magnitude of extinction the planet currently faces. This accelerated rate of extinction can be linked to a variety of man-made causes, including changes in land and sea use, direct exploitation of organisms, climate change, pollution, and the introduction of invasive species. 

For some, that may not seem important. If humans are not on the endangered species list, why should it matter? As the IPBES Global Assessment indicates however, healthy ecosystems provide a variety of services, including improving air quality, purifying drinking water, and mitigating floods and erosions. The vast canopies of rainforests worldwide sequester 2.6 billion tons of carbon dioxide a year. Plants and soil microbes found in wetlands can remove toxins from water, including explosive chemicals such as nitroglycerin and trinitrotoluene (TNT). Mangrove forests serve as an important buffer against ocean storm surges for those on land. Nature is a powerful resource, and declines in biodiversity have broad implications for global development and health. 

The importance of biodiversity on global health is immediately apparent in middle- and low-income countries, which rely heavily on natural remedies and seasonal harvests for health and nutrition. The loss of entire species of plants can eliminate valuable sources of traditional medicine for indigenous communities. Genetically diverse crops are more resilient to pest and disease, ensuring a stable food supply and bolstering food security. Beyond this, ecosystem disturbances also have complex implications for infectious disease, which are often endemic to developing nations. 

However, these effects are also seen in first world countries. A well cited example for the impact of biodiversity loss on infectious disease involves Lyme disease, which is endemic to parts of the United States. The white footed mouse is a common carrier of Lyme disease, and in areas with high densities of these mice, ticks are likely to feed on the mice and subsequently transmit the disease to humans. However, the presence of other mammals that the tick can feed on dilutes the disease reservoir, lowering the likelihood of an outbreak (commonly referred to as the “dilution effect”). While biodiversity has complicated effects on the spread of infectious diseases, drastic changes to ecosystems often provide a breeding ground for disease vectors and lead to increases in transmission.

In addition to the direct effects of declines in biodiversity have on global health, an often-neglected aspect of its importance for health is as a resource for biomedical science. The IPBES assessment reports that 70% of cancer drugs are natural or inspired by natural sources such as traditional medicines. This merely scratches the surface of the influence of nature on modern biomedical research. 

Much like the communities that rely on natural products as medicine, many drug compounds produced by pharmaceutical companies are derived from nature. Morphine has been one of the most revolutionary drug compounds in history, effectively treating both acute and chronic pain. The compound was originally isolated from the opium poppy, and its chemical structure has since been modified to reduce negative effects and improve potency. While the current opioid crisis in the United States has highlighted the importance of moderate use, morphine and its analogues are some of the most useful and reliable pain relievers in modern medicine. Similarly, aspirin has been regarded as a wonder drug for its analgesic, anti-inflammatory, and cardioprotective effects. Aspirin is a chemical analogue of salicylic acid, a compound originally isolated from willow tree bark. 

Beyond general pain relief, many naturally derived drugs have also been useful for disease treatment. Quinine, the first effective antimalarial drug, was extracted from the bark of cinchona trees, and quinine and its analogues are still used to treat malaria today. Penicillin, serendipitously discovered in a fungus, has been useful for treating bacterial infections and informing modern antibiotic development. These medicines and many more have been crucial to the advancement of human health, yet could have just as easily been lost to extinction.

On a more fundamental level, scientific research has benefited from many proteins isolated from nature. Thermophilic polymerases, isolated from a bacterium residing in hot springs, are now an essential component of polymerase chain reactions (PCR) – a common laboratory technique that amplifies segments of DNA. This method is critical in molecular biology labs for basic research, and forensic labs for criminal investigations.Fluorescent proteins, which have been isolated from jelly fish and sea anemone, revolutionized the field of molecular biology by allowing scientists to visualize dynamic cellular components in real time. More recently, CRISPR/Cas systems were discovered in bacteria and have been developed as a gene editing tool capable of easily and precisely modifying genetic sequences. These basic tools have vastly improved the scope of biomedical research, and all of them would have been close to impossible to develop without their natural sources.

In addition to medicines and tools, nature has often informed biomedical research. Denning bears are commonly studied for potential solutions to osteoporosis and renal disease. Their ability to enter a reduced metabolic state where they do not eat, drink, or defecate for months at a time provides valuable insight into how these biological processes may be adapted to benefit human disease and physiology. Even more interestingly, there are a few species of frogs that become nearly frozen solid in winter, and thaw fully recovered in spring. In this frozen state, much of the water in their body turns to ice, their heart stops beating, and they stop breathing. When temperatures rise, they thaw from the inside out and continue life as per usual. Crazy cryonics and immortality aside, the freeze/thaw cycles could inform improved preservation for organ transplants.

Nature is a much better experimentalist than any human, having had billions of years to refine its experiments through the process of evolution and natural selection. Depleting these living resources, which provide invaluable benefits to human health and ecosystems, lacks foresight and is dangerously reckless. The techno-optimist approach of ceaseless development in the blind belief that whatever problem humanity encounters can be solved with research and innovation neglects to account for the dependency of research and innovation on nature. Most biomedical scientists, most physicians, and much of the general public have probably devoted a minimal amount of consideration to the importance of biodiversity. But for the one million species currently at risk, and for the hundreds of million more yet to be discovered, it’s worth a thought.

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Written by sciencepolicyforall

June 7, 2019 at 9:51 am

How are we welcoming our next generation-The first 1000 golden days?

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By: Deepika Shrestha , Ph.D.

Source: Wikimedia

The most important period for a child’s development, especially for the brain and immune system, is the first 1000 days of life. The Developmental Origins of Health and Disease (DoHAD) hypothesis suggests that the roots of many complex diseases and behavioral risks originate very early – between the time window of pre-conception to early postnatal periods. Indeed, genetic, epigenetic and environmental evidence indicate that most adulthood health and disease risk have been coded during fetal development in the intrauterine environment, lending support for the DoHAD hypothesis

The increased prevalence of an obesogenic environment and rate of chronic diseases in mothers increases the risk of childhood obesity and future cardiometabolic risk in the offspring. Moreover, increased risks can be transgenerational within families. This is also the case for Autism, Attention Deficit Hyperactive Disorder (ADHD), and other mental and psychological disorders. Given that over 50% of all mothers are overweight or obese, there is a growing cause of concern about the quality of fetal growth and development. Further, recent statistics revealed a sobering picture of increased incidence of various maternity-related illnesses such as postpartum depression (CDC Reports: as high as 1 in 5 women) and maternal mortality (CDC MMR 2019 report: 700 deaths per year- out of which relatively 3 in 5 deaths preventable, 31.3% deaths occurred during pregnancy, 16.9% on the day of delivery, and 51.8% over 1 year of post-partum days) in the US. These numbers show that many women in the US are among the most vulnerable and need sufficient support from family, society and governmental policy. There have been successful campaigns to institute policies raising awareness of issues concerning fetus growth, development and maternal/infant nutrition in developing countries, such as Golden 1000 Days. The United States needs similar programs special focusing on maternal care, especially on the nutritional, psychological, mental and financial needs of pregnant mothers and women in reproductive age groups. 

Another program has also been put in place to improve nutrition in mothers and children. The Women, Infant and Child (WIC) program provides supplemental nutritional support to roughly 8 million low-income mothers and young children under 5 years of age. With approximately 6 billion USD of funding in 2016, the current WIC program is the result of an update in 2009 after rigorous review by the Institute of Medicine (IoM) to reflect the latest nutritional science as well as public health concerns. However, recent evidence indicates that food and nutrients supplements through the WIC program might not match the nutritional need of the participants as it fails to account for women’s prepregnancy obesity status, gestational weight gain, and gestational diabetes.  For instance, concentrated fruit juice may increase the risk of gestational diabetes risk and is not a healthy food option. This important policy needs fair re-evaluation based on the updated scientific evidence for nutritional needs.

Another point of concern for expecting mothers is the lack of psychological care. Mothers-to-be undergo extensive physiological and psychological changes during pregnancy. Therefore, this 1000-day window is a sensitive time period —a time where pregnant women require support and potential intervention. Recent data highlight increasing trends of maternity related illnesses, be it postpartum depression or maternal mortality. More importantly, in the US these issues disproportionately affect women of color or low socioeconomic status.  Alarmingly, 42% of mothers  are sole or primary earners and may lack adequate financial support from their spouse and family. The Pregnancy Discrimination Act and Family and Medical Leave (FMLA) act was put in place to protect pregnant women in the job place for 12 weeks after childbirth. However, the United States is one of the few countries in the world with almost no access to paid parental leave—only 14% of civilian workers have access to any amount of paid parental leave in 2016, a slight increase from 11% in 2010

Access to paid parental leave currently serves as elite benefits and is dependent upon company policy. The most generous policies afford 16 weeks for birth mother, 8 weeks for birth father, 8–16 weeks for adoptive parents (16 for primary, 8 for secondary) according to PL+US’s report. About 23% of mothers go to work within 10 days of giving birth and are disproportionately from low-income families.In addition to maternal paid leave, recent mothers often require considerable sick leave for the first year, and providing a flexible policy could be a steppingstone towards helping the psychological as well as physiological health of a child. Furthermore, it is no secret that inspected and reputable day care facilities takes a major chunk of the family income, and are unaffordable to many families.

In addition, there is also a need for Newborn Rights. Irrespective of socioeconomic status, each baby has inborn rights and deserve equal family bonding time and breast-feeding needs. Children born to poor maternal care during pregnancy and lactating period are at increased risk of having neurological problems, poor school achievement, early school dropout, low-skilled employment, and providing poor care to their own children, thus contributing to the intergenerational transmission of poverty and malnutrition. On the contrary, children who get good nutrition and care in their first 1000 days are ten times more likely to overcome life threatening childhood disease, have higher educational retention in schools and are likely to earn more than 21% in wages as adults and also to have healthier families on their own. Therefore, there is an unmet need for a stronger policy that invests in children and their families from the very beginning and helps each child to be a healthy and contributing member of the society in their adulthood. It takes a major process and significant effort to raise a child into a healthy adult who is mentally, spiritually and physically fit to keep going in a productive society.

Paid maternity leave and insurance coverage needs support from Government/Congress to mothers or family unit regardless of the beneficiary’s work status. Investing in this policy may cost taxpayer a small percent of GDP (Gross Domestic Products) but will have a huge return in the long run when Health is valued as development index. There is ample evidence to show that countries that fail to invest in the well-being of women and children in the first 1,000 days lose billions of dollars to lower economic productivity, health issues, societal inequality and higher health costs. This is a main point of concern given that the US is lagging far behind other developed nations in this human development index (HDI). Currently, there is a huge disparity of investment in the first 1000 days based on socioeconomic status, and there is a clear and unmet need for structural and policy intervention. Issues related to the maternity period such as nutritional aspect, mental health, and paid maternity (or paternity) leave should not be considered only a women’s issue. Therefore, more than ever, there is a heightened need for research resources to understand maternity health issues and also concrete plans to address these issues.

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Written by sciencepolicyforall

May 24, 2019 at 2:21 pm

Science Policy Around the Web – April 16, 2019

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By: Mary Weston, PhD

Source: Wikimedia

Astronaut twins study spots subtle genetic changes caused by space travel

In 2015, NASA began their Twins Study, where they evaluated the biological effects of one year of spaceflight on an astronaut by comparing him to his earthbound identical twin. One year after returning to earth, the majority of observed physiological changes from space reverted back to the astronaut’s original state, with only subtle genetic changes remaining. 

Spaceflight exposes the body to ionizing radiation and near-zero gravity, and the consequences of long-term exposure to these conditions are not known. On this mission, Scott Kelly spent 340 days in space from 2015-2016 (he has a lifetime total of 520 space days). His brother Mark, a retired astronaut who had previously spent 54 days in space over four space-shuttle missions, remained on earth and acted as a near identical biological control. The study involved only two people, so not all findings may be applicable to other astronauts, but NASA hopes to use the information to direct future astronaut health studies.

Teams of researchers gathered a wide array of genomic, molecular, physiological, and other data on the men before, during, and after the mission. They reported that Scott Kelly did display signs of stress from space travel, with changes seen in most areas measured. 

However, now researchers are finding that most of the changes Scott Kelly experienced from spaceflight have reverted back to their original state after 6 months of being back on earth. NASA argues that “the Twins Study demonstrated the resilience and robustness of how a human body can adapt to a multitude of changes induced by the spaceflight environment”.

One genetic change that did persist six months after Scott’s return was to his chromosomes. Parts of them inverted (flipped), which could lead to DNA damage, and is possibly due to the large amounts of space radiation. Further, researchers hypothesized that space flight would shorten telomers, important caps at the end of chromosomes, since they decrease with age and spaceflight is expected to stress the body similar to aging. However, a majority of his telomers lengthened while Scott Kelly was in space, while only few shortened. Those that lengthened returned to their normal state after about 48hrs on earth, but the shortened ones remained. 

Given the space community’s interest in increasingly ambitious space missions and plans to explore Mars, studies exploring the long-term health impacts of spaceflight will be extremely important for the future.

(Alexandra Witze, Nature


Abnormal Levels of a Protein Linked to C.T.E. Found in N.F.L. Players’ Brains, Study Shows

Last week, the New England Journal of Medicine published a study that used experimental brain scans to compare the levels and distribution of tau, a protein linked to chronic traumatic encephalopathy (CTE), in retired NFL players and male controls who had never played football. They found that the NFL players had elevated levels of tau in areas where the protein had previously been detected postmortem. 

CTE is associated with repetitive hits to the head, like those encountered during contact/collision sports. Currently, pathologists can only posthumously diagnose CTE. This new study is the first to evaluate tau averages and overall patterns from a group of living former football players (26 men) with a control group (31 men). The project, led by Dr. Robert Stern of Boston University, used Positron Emission Tomography (PET) scans to image the brain after exposure to a radiolabeled substrate that specifically binds tau. 

Both the study’s authors and outside experts emphasize that a CTE diagnostic test is still far from ready and would likely include other markers from blood and spinal fluid as well.  However, this study represents a preliminary, first step towards developing a clinical test to detect CTE in living players, which may also ultimately assist in identifying early disease signs and those with potential risk of developing CTE. 

The relationship between CTE symptoms and the role of tau, which occurs naturally in the brain, is not clear. The study found no correlation between the amount of abnormal tau and the severity of cognitive and mood problems in the players. However, these results are preliminary and the player sample size was small. Evaluation of larger sample size of football players is needed to continue to explore the role of tau and replicate the observed elevated levels found in this paper. 

(Ken Belson and Benedict Carey, New York Times


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Written by sciencepolicyforall

April 17, 2019 at 9:34 am