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Science Policy Around the Web September 13th, 2019

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By Neetu M. Gulati PhD

Image by mika mamy from Pixabay 

Genetically modified mosquitoes breed in Brazil

An experiment to curb the population of tropical disease-carrying mosquitoes in Brazil may have failed. In 2013 and 2015, mosquitoes with a modification called OX513A, which prevents these mosquitoes from reaching adulthood and being able to reproduce, were released into a region of Brazil. This experiment was meant to limit the spread of mosquito-borne infectious diseases that plague the area, including zika, dengue, and yellow fever. 

Initially, the goal of the genetic modification experiment was to reduce the mosquito population by 90%, which was successful during the field trial. Only about 4% of genetically modified mosquitoes were expected to be able to reach adulthood, and it was hypothesized that these mosquitoes would be too weak to reproduce. However, about 18 months after the experimental trial period ended, the mosquito population has returned to pre-trial levels. A recent study has revealed that the gene modification has been passed on in 10-60% of the mosquitoes in the area, suggesting they were able to reproduce. Furthermore, modified mosquitoes are as able to carry infectious diseases as non-modified mosquitoes. Critics of the experiment warn that not enough was known about these mosquitoes and there may be unintended consequences to the genetic modification, including a possibility of making the species more robust. The authors of the new study posited “These results demonstrate the importance of having in place a genetic monitoring program during releases of transgenic organisms to detect unanticipated consequences.”

(Fabian Schmidt, Deutsche Welle

America is in danger of losing its “measles-free” status

In 2000 the United States was declared measles-free, 37 years after the introduction of the measles vaccine in the US and Canada. Now, almost two decades later, the US is at risk of losing an official designation of “measles-elimination” status in October. This status is only given to countries without continuous measles transmission for at least one year, where cases of the disease can be linked back to a traveler who brought the virus from another place where it has been circulating. An outbreak of measles in New York state now jeopardizes this. The CDC reported over 1,200 measles cases in the US, with over 75% of the cases occurring in the state of New York. 

This is occurring because it is common in some groups to opt out of the measles vaccine. And it is not just the US; measles cases have increased around the world, and some other countries have also lost measles-free status in the last year.

The outbreak in New York can be traced back to Ukraine, which has had tens of thousands of measles cases in the last year. It then spread throughout a tight-knit community of people who chose not to vaccinate for perceived safety concerns. So while this outbreak can be linked to a traveler, many are concerned that if vaccine coverage rates continue to decline, the virus could spread enough, especially in under-vaccinated communities, that the outbreaks will begin to be “homegrown.”

(Julia Belluz, Vox)

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Written by sciencepolicyforall

September 13, 2019 at 10:53 am

Science Policy Around the Web September 9th, 2019

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By Ben Wolfson PhD

India Is Trying To Make Contact With Its Vikram Lander After Finding It On The Moon

During an attempt to become the fourth country to land on the moon (after the U.S., former Soviet Union and China), India lost communication with its lunar lander Vikram early last Friday. Contact was lost during the “15 minutes of terror”, the autonomous final descent to the lunar surface.

The Vikram lander was being carried by the Chandrayaan-2 orbiter, which was launched in July. It was attempting to land near the South Pole of the moon, currently a region which is completely unexplored. After landing Vikram would have deployed Pragyaan, a rover that would have collected data for 2 weeks.

Over the weekend the Indian Space Research Organization (ISRO) announced that they had located Vikram using the Chandrayaan-2 orbiter, and that they were attempting to reestablish communication.

Despite the landing failure, Indian scientists remain optimistic about the future of the Indian space program. Even with the loss of the lander, they will still be able to do research using the Chandrayaan-2 orbiter. The orbiter has eight instruments and will map the moon from orbit for at least one and potentially up to seven years. In light of this success, the ISRO stated that 90-95% of the mission objectives were successful.

(Jonathan O’Callaghan, Forbes)

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September 10, 2019 at 3:42 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

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September 3, 2019 at 3:49 pm

Science Policy Around the Web August 30th, 2019

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By Andrew Wright, BSc

Image by Steve Buissinne from Pixabay

EPA’s controversial ‘secret science’ plan still lacks key details, advisers say

In early 2018 under its previous administrator Scott Pruitt, the U.S. Environmental Protection Agency (EPA) first proposed rules to restrict the use of scientific findings whose data and methodologies are not public or cannot be replicated. Following the removal of all sitting Science Advisory Board (SAB) members who receive EPA grants in late 2017 (roughly half of its members) there was concern that environmental experts were being sidelined from EPA decision-making, which the proposed rule seemed to support. While making data public and replicable has merits, the SAB has raised concerns that the proposed rule would make it impossible to use the most accurate information as many environmental studies are long-term ones that assess human exposure to toxins and cannot be ethically or efficiently replicated. Now, under administrator Andrew Wheeler, how this proposed rule will be implemented is still unclear. 

A central concern is how to maintain privacy over personally identifiable information (PII) to comply with existing privacy laws and concerns (such as the Health Insurance Portability and Accountability Act or HIPAA). One proffered strategy is to try a tiered approach based of the model currently used by the National Institutes of Health, whereby the more sensitive the PII is, the more restricted its access will be. 

As the SAB has decided to engage in a consultation of the proposed rule, individual members will have their comments written up in a report to be sent to Wheeler but will not have to come to a consensus for the proposed rule to move forward.  

(Sean Reilly, Science (Reprinted from E&E News

 Brazilian Amazon deforestation surges to break August records 

While the recent spate of fires in the Amazon rainforest have been capturing international attention, regular deforestation via cutting and clearing techniques have also been rapidly increasing. In August alone, 430 square miles, or a region the size of Hong Kong, has been cut down. This comes after the July’s loss of 870 square miles, a 275% jump from the previous year.  At the current rate of deforestation Brazil is on track to lose more than 3,800 square miles of rainforest, or an area roughly one and a half times the size of Delaware, this year.

“The August data from Deter is hardly surprising,” said Claudio Angelo of Climate Observatory, referencing the Deter-B satellite that was put into place in 2015 to monitor Brazil’s rainforests. According to him and other representatives from non-governmental organizations, the Bolsonaro government is delivering on its promises to support local industries such as mining, ranching, farming, and logging rather than enforcing environmental protections. 

While this deforestation data is separate from data on forest fires, felled trees are often left to sit and dry before they are lit aflame, leading forest engineers to portend that the fires are going to get worse in the coming months.

Since the Amazon rainforest generates its own weather patterns, studies have demonstrates the possibility that after 40% deforestation has occurred, the biome may irreversibly convert to savannah. This could impact global weather patterns, affected Brazilian weather most severely. However, recent estimates place that tipping point closer to 20-25% due to the synergistic effects of climate change. According to the World Wildlife Fund, approximately 17% of the rainforest has been lost in the past 50 years, putting uncontrollable forest conversion much closer than previously assumed.

(Jonathan Watts, The Guardian

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August 30, 2019 at 11:08 am

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)

 

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August 27, 2019 at 2:38 pm

Science Policy Around the Web August 23rd, 2019

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By Allison Cross PhD

Source: Flickr

A Once Common Gecko Is Vanishing from Parts of Asia

The tokay gecko, once commonly found across Southeast Asia, southern China and India, is now becoming a lot less common. Recently studies assessing gecko population trends suggest that populations have declined as much as 50 percent in China, Vietnam, Thailand, Myanmar, Indonesia, the Philippines and Bangladesh.  This recent decline has scientists and conservationists concerned about major population collapse and even extinction.

The vanishing gecko population is believed to be, at least in large part, due to the large, currently unrestricted, trade of these animals. Though the exact number of tokay geckos captured for trade each year is unknown, the figure is estimated to be at least one million.  Most of these animals are sold to China, where the gecko is used as an ingredient in traditional Chinese medicine. 

Currently, there are no international rules regulating the trade of geckos, but this may soon change.  The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), an international treaty aimed at protecting endangered plants and animals, is set to vote at the end of August on whether geckos should be added to the treaty.  If the vote goes through, countries will be required to monitor and report all trade and prove that it is not harming the gecko population.  While members from Australia, the European Union, India, the Philippines and the U.S. support the addition of the tokay gecko to the treaty, China and Indonesia remain in opposition. 

(Rachel Nuwer, Scientific America)

Treatment for Extreme Drug-Resistant Tuberculosis Wins U.S. Government Approval

The World Health Organization (WHO) estimates about half a million people worldwide are diagnosed every year with multi-drug-resistant tuberculosis (TB), and around 8.5% of cases are characterized as extensively drug-resistant (XDR) TB.  Common TB treatments are ineffective for those suffering from XDR TB and, up to this point, the treatment offered to these patients involved an eight-drug combination taken for more than a year.  This eight-drug combination comes with serious side-effects and is largely ineffective, with as many as two-thirds of patients succumbing to the disease despite treatment. 

For decades, research into development of new TB treatments was rare, but donations from governments and philanthropist in the early 2000s sparked more research in the area. This research has resulted in a new and promising therapy developed by the TB Alliance, a non-profit research group in New York City. The new therapy is a three-drug regimen; pretomanid, bedaquiline, and delaminid.  Clinical trials of the new regimen were extremely promising; 90% of XDR TB patients recovered following 6 months of treatment. This success rate far exceeds the 34% success rate obtained with the current treatment options.

The new XDR TB regimen was approved by the U.S. Food and Drug Administration on August 14th and it has the potential to quickly reach the patients who need it the most.  As TB mostly effects the world’s poorest people, the key to success is to keep the price low. Currently, the TB Alliance is negotiating a price for the latest treatment with the two pharmaceutical companies.

 

(Amy Maxmen, Scientific America) 

 

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August 23, 2019 at 3:18 pm

Science Policy Around the Web August 20th, 2019

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By Mohor Sengupta PhD

Image by Ryan McGuire from Pixabay 

FDA makes new push for graphic warning labels on cigarettes

According to government records, the percentage of smokers in the U.S. has reduced from 40% of the population in the 1960’s to 14%. Despite this dramatic decrease, approximately 480,000 people in the U.S. die each year from diseases directly related to smoking. In an attempt to educate smokers about the dangerous medical consequences of smoking, in 2009 the FDA proposed 9 graphic labels to be printed on cigarette packets. However the FDA’s plan didn’t see the light of day when five tobacco companies challenged the FDA’s decision in court and in 2012 won on grounds of free speech. The judges who ruled in favor of the tobacco companies said that “[the images were] crafted to evoke a strong emotional response,” rather than educating consumers. 

The FDA then backed out saying that it will work on introducing new images and it was soon to announce new proposed labels. In 2016, a lawsuit was filed by health groups against the FDA for not proposing a new plan soon enough. Last Thursday, the FDA announced 13 new graphic labels to be displayed on cigarette packets that would show cancerous tumors, diseased lungs, and feet with amputated toes. The FDA’s tobacco director Mitch Zeller said that these new labels had been designed while keeping in mind the limited public awareness of lesser-known diseases caused by smoking. 

For 35 years, everything that the USA’s cigarette packets have told consumers about the harmfulness of smoking has been contained in a warning statement so tiny that it is missed by most consumers. Research has shown that graphic label inclusion on cigarette packets discourages smokers, and Canada was the first country to adopt this measure in 2000. 

Since then, more data have come to light identifying graphic images as an effect anti-smoking measure. A 2013 study showed that participants tended to respond to graphic labels rather than warning statements on cigarette packets. Another 2013 study estimated that if the FDA had adopted graphic labels in 2012, 5.3 to 8.6 million adults would have quit smoking in a year. They based their results on similar data from Canada where graphic labels are in use. 

It is anticipated that Big Tobacco will challenge the FDA’s move once again. Some of them are already citing the First Amendment as their defense. It is now time to see what is decided if the matter is taken to the courts once again. While thousands of people continue to die because of smoking habits in the USA, and graphic label inclusion on cigarette packets are repeatedly challenged by the tobacco industry, nearly 120 countries across the world have already adopted this measure and are reaping its benefits. 

(Matthew Perrone, STAT)

Experimental Ebola Drugs Saved Lives In Congo Outbreak

Ebola is raging in the Democratic Republic of Congo (DRC). However, a climate of distrust around Ebola clinics compounded with political upheavals in DRC has discouraged patients in the early stages of infection from leaving their community and seeking help in designated Ebola clinics. In this way, the virus has rapidly spread across communities and now threatens people outside of DRC as well. 

Despite these issues, efforts are underway to combat Ebola and develop more effective treatment strategies. A NIAID-funded study that compared four drugs against the Ebola virus recently concluded that two of them showed better results in combating the disease. The study, called ‘Pamoja Tulinde Maisha’ (PALM), is a randomized controlled trial of the four drugs and started on November 2018 as part of the emergency response in DRC.

The four investigational agents were Remdesivir, a commonly used antiviral drug, ZMapp, which showed effectiveness in previous Ebola outbreaks, REGN-EB3, developed by Regeneron and mAb114, a monoclonal antibody jointly developed by NIAID and INRB (in the DRC). 

Having reached a definite conclusion about the effectiveness of the four drugs, the PALM trial stopped earlier than originally scheduled. Preliminary results released on August 9, 2019 show only 30% of Ebola Virus Disease (EVD) patients treated with REGN-EB3 or mAb114 succumbed to the infection, compared to half of those treated with ZMapp or Remdesivir. When analysis was restricted to the relatively healthier patients receiving the more potent treatments, 6% and 11% died on REGN-EB3 and mAb114 treatment regimes respectively. 

With these preliminary results, patients on Remdesivir and ZMapp will now be switched to one of the more effective drugs based on their physician’s discretion. The study will continue to measure the effects of the two drugs from now on. The final analysis of the study data is likely to be made available later this year. 

(Richard Harris, NPR)

 

Written by sciencepolicyforall

August 20, 2019 at 4:56 pm