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Science Policy Around the Web November 26th, 2019

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By: Andrew H. Beaven, PhD

Source: CDC

How Best To Use The Few New Drugs To Treat Antibiotic-Resistant Germs

Bacteria have existed for 3.5–4 billion years, and their survival demonstrates remarkable environmental plasticity. One consequence of their plasticity is that bacteria are able to rapidly become resistant to antibacterial drugs (drugs meant to help humans and animals stave off infection).

Combatting antibiotic drug resistant bacteria (so-called “superbugs”) has been pinpointed as a major, modern global health concern. A new Centers for Disease Control and Prevention (CDC) report published November 14, 2019 estimates that more than 2.8 million treatment-resistant infections and 35,000 annual deaths occur in the U.S. alone. Notably, the development of new antibiotics has lagged, therefore, scientists are recommending new methods to use old drugs. These include: limiting doses for healthy people and allow the body to do its work; flooding the body with multiple drug types at once; or sequentially changing drug types every 12 to 24 hours.

Given all we know about this global health concern, why is the market not being flooded with new antibiotics? Largely, because it is not lucrative for pharmaceutical companies to chase a moving target. Additionally, antibiotics are only used for short-term ailments (as opposed to those used for chronic illness) and many antibiotics remain unused in an effort to minimize new drug resistance. To help promote new antibiotic research, U.S. Senators Bob Casey (D-PA) and Johnny Isakson (R–GA) introduced the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 (DISARM Act of 2019; S.1712) to the Senate on June 4, 2019. The goal of the act is to strengthen American antimicrobial research and improve the development pipeline. While the act was called “essential and timely” by the President of the Infectious Diseases Society of America, it has not passed the Senate at time of publication.

(Richard Harris, NPR)

As SpaceX Launches 60 Starlink Satellites, Scientists See Threat to ‘Astronomy Itself’

On November 11, 2019, the private American aerospace company SpaceX, founded by Elon Musk in 2002, launched its second Starlink satellite payload rocket into outer space. Starlink is a prodigious project that aims to provide “high speed internet access across the globe,” specifically allowing internet access to “locations where access has been unreliable, expensive, or completely unavailable.” The Starlink webpage states that they will provide near-global internet coverage by 2021 through their satellite constellation (a network in which satellites work together to provide continuous coverage).

Even with the relatively few Starlink satellites currently in place, astronomers have already noted significant impact on their work. The primary point of concern is that the satellites are very bright, and astronomers say that even if the satellites are darkened, they will have a profound effect on Earth-based astronomy. Additionally, astronomers worry that Starlink will pollute radio wavelengths used to probe deep space and permanently pollute low-orbit space with “space junk.” SpaceX says they are attempting to minimize the effects Starlink has on the scientific community and that the project is moving ahead. Indeed, Mr. Musk has requested the Federal Communications Commission to allow 30,000 more satellites than 12,000 that were already approved. If successful, SpaceX would have eight times more satellites in low-Earth orbit than currently in orbit.

Other companies, such as, Amazon, Telesat, and OneWeb, are following close behind launching similar satellite constellations. Using outer space for private gain yields an important, unanswered question – who can profit from outer space? Megan Donahue, president of the American Astronomical Society acknowledges that “international space law is pretty wide open,” and that it for now the public must trust corporate good will. Currently, a set of United Nations treaties and principles as well as resolutions have laid out guidelines on the peaceful usage of space, but few exact rules are in place.

(Shannon Hall, The New York Times

Written by sciencepolicyforall

November 26, 2019 at 3:14 pm

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 November 15th, 2019

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By Mohor Sengupta PhD

Image by David Mark from Pixabay

Rollout of Johnson & Johnson Ebola vaccine begins in Congo

To the African countries reeling with the second deadliest Ebola outbreak in history, two back-to-back launches of new vaccines may be a beacon of hope. On Tuesday this week, Merck’s vaccine Ervebo was pre-qualified by the WHO, meaning that it was declared safe for use. This occurred merely 48 hours after the European Commission granted conditional marketing authorization for the vaccine. The speed of this decision-making sheds light on the gravity of the situation at hand. 

The current outbreak in the Democratic Republic of Congo has killed more than 2,200 people. The previous Ebola outbreak, and the deadliest in living memory, rocked West Africa in 2013-16, claiming 11,300 lives. 

In addition to Ervebo, a new vaccine produced by Johnson & Johnson was approved yesterday. It passed several clinical trials, however it will now be tested for the first time in a real world setting in the village of Goma, on the Rwandan border with DRC. It will be administered to 50,000 people. 

The new vaccine by Johnson & Johnson is aimed at complementing Ervebo. While the later requires a single shot, the Johnson & Johnson vaccine will require two shots spaced at 8 weeks. Ervebo is being used as “ring-vaccination”, a strategy in which close contacts of Ebola-infected individuals will be vaccinated.  

(Reporting by Fiston Mahamba; Writing by Hereward Holland; Editing by Anna Pujol-Mazzini and Mark PotterReuters)

Written by sciencepolicyforall

November 15, 2019 at 4:35 pm

Science Policy Around the Web November 12th, 2019

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By Allison Dennis PhD

Image by Edward Lich from Pixabay 

Your DNA Profile is Private? A Florida Judge Just Said Otherwise

In a game changing decision for law enforcement, a U.S. judge approved a warrant that allowed a police detective to search the DNA records of all the users included in the GEDmatch database. This comes after GEDmatch changed its policies in May to only grant law enforcement access to the users who had chosen to opt-in to such uses. However, the warrant overruled the choice of 1.1 million users out of the 1.3 million included in the database who had not opted in. The value of these databases to law enforcement stems from their use in identifying a DNA profile through the combination of rich genealogical data with DNA profiles of distant relatives. As more potential relatives are included in the search, the likelihood a match is found increases. Theoretically there is a 60% chance that someone of European ancestry living in the U.S. will be found to have a relative in a database of 1.3 million profiles.

The U.S. Department of Justice has enacted a policy to limit the use of forensic genetic genealogy to solving violent crimes and identifying human remains. Further, under this policy, law enforcement must demonstrate that traditional crime solving methods have been exhausted before turning to DNA databases for clues. 

Many feel the recent judge’s decision may be a critical step towards law enforcement potentially gaining access to the much more valuable Ancestry.com and 23andMe databases, which each contain the profiles of 15 million and 10 million users. Both companies maintain a strict posture in resisting access to their customers data for law enforcement purposes. However, it may take either company formally challenging a warrant or a defendant claiming a violation of their fourth amendment rights to draw a clear line between genetic privacy and forensic genetic genealogy. 

(Kashmir Hill and Heather MurphyThe New York Times)

Google’s ‘Project Nightingale’ Gathers Personal Health Data on Millions of Americans

For more than a year, the second-largest health system in the U.S., Ascension, has been sharing the health records of millions of their patients in secret with Google. Known as project Nightingale, the collaboration was established to allow Google to use Ascension’s vast collection of medical records to design new software while helping Ascension improve patient care and generate revenue. This type of data sharing is allowed by the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Under HIPAA provisions, patients and doctors do not need to be informed of such arrangements if the disclosure of data to a third-party is “only to help the covered entity carry out its health care functions.”

Earlier in November, Google announced its acquisition the fitness tracking company Fitbit. Many have speculated that Google’s underlying motivation is to gain access to data that could be analyzed to provide advertisers with more educated guesses about a potential customer’s health status. However, Google has stated that “Fitbit health and wellness data will not be used for Google ads.” The sharing of Ascension patients’ data and identity with advertisers would be strictly prohibited by HIPAA. Other Google ventures including their partnership with the drugmaker Sanofi to develop a healthcare innovation lab, announced in June of 2019, reflect their interest in developing personalized approaches to medical treatment. While it is clear that the medical community sees long-term potential in capitalizing on Google’s expertise in artificial intelligence and secure storage of data in the cloud, it remains to be seen the direct benefit these partnerships will have on improving individual patient’s health.

(Rob Copeland, The Wall Street Journal)

Written by sciencepolicyforall

November 12, 2019 at 4:41 pm

Science Policy Around the Web November 8th, 2019

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By Mary Weston PhD

Image by PublicDomainPictures from Pixabay 

Scrubbing Your House Of Bacteria Could Clear The Way For Fungus

While it may seem that a ‘cleaner’ environment would mean fewer germs, a new study in Nature Microbiology suggests otherwise. Researchers comparing the diversity of microorganisms in increasingly urbanized environments found that fungal diversity was actually higher in urban homes. They examined four types of housing, ranging from thatched huts in a Peruvian rainforest community to city apartments in Manaus, the capital of the Brazilian state of Amazonas. 

One of the study’s coauthors, Dr. Laura-Isobel McCall, suggests several reasons for why this may occur. Many antibacterial cleaning products specifically target bacteria, which could free space for fungi and other microorganisms to grow. Fungi have thicker cell walls, which may make them more difficult to destroy. Also, urban homes tend to block light and trap CO2, which could be creating a favorable setting for fungi to grow. 

In general, these results indicate that urbanization has large effects on the human skin microbiota, as well as the surrounding chemical and microbial environment. This lack of bacterial diversity could be problematic, as some of them may be helpful to humans. The researchers also discovered many more synthetic chemicals in city apartments, which can originate from cleaning products, building materials, medications, and personal care products (such as shampoo and deodorant). The effects of increased exposure to synthetic chemicals are not well known.

While this study was conducted in areas of Brazil and Peru, the findings may have a broader significance. Justin Sonnenber, a microbiologist at Stanford University, asserts that “My guess is that this gradient they’ve established for these fungal communities is largely representative of what’s happening all over the world”.  

(Pien Huang, NPR)

Trump administration sues HIV prevention drug maker for patent infringement

On November 6, the Trump administration sued Gilead Sciences for patent infringement over Truvada and Descovy, drugs that are crucial in preventing the spread of HIV. The suit asserts that some of the relevant patents are owned by the government because scientists from the Centers for Disease Control and Prevention (CDC) developed the breakthrough drugs. 

The Department of Health and Human Services (HHS) argues that Gilead has repeatedly refused to obtain licenses for the use of 4 CDC patents, but are making billions of dollars from the drugs. HHS secretary Alexander Azar says that while the government recognizes Gilead’s role in selling the anti-HIV medications to patients, the company “must respect the US patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”  The lawsuit argues that “Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith.”

Gilead disagrees with these allegations, arguing that the government patents are invalid and the work performed by the CDC was “obvious and proposed by others.” Gilead asserts that “The fact remains that Gilead invented Truvada and funded the clinical trials that led to its 2004 FDA approval for use in combination with other antiretroviral agents to treat HIV.”

Truvada and Descovy are PrEP (pre-exposure prophylaxis) drugs, an HIV prevention method for people who are at a high risk of acquiring HIV. When taken daily, these medications reduce the risk of getting HIV from sex by 99% and 74% for those who inject drugs. In his 2019 state of the Union address, President Trump established a goal of ending the spread of HIV in America by 2030. Lowering the price of PrEP, which can cost around $21,000/year, would significantly advance those efforts and some hope that the Gilead lawsuit itself may result in a price reduction.

(Peter Sullivan, The Hill)

Written by sciencepolicyforall

November 8, 2019 at 10:57 am

Science Policy Around the Web November 5th, 2019

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By Silvia Preite

Source: Flickr

Natural measles infection impairs the preexisting immunity to other pathogens

Measles is one of the most contagious human infectious disease, causing over 100,000 deaths worldwide every year. Despite the availability of a safe and effective vaccine, the number of new measles cases is growing fast, with a 30% global increase between 2017 and 2018. Misguided vaccine safety concerns are leading to under-vaccination that, together with extensive international travels of people around the world, contributes to this sharp increase in measles cases. As October 2019, there are more than 1250 confirmed cases of measles in the U.S. alone – the highest number reported since 1992. 

The harmful consequences of a Measles infection go beyond the infection with the virus itself. Epidemiological studies have associated measles outbreaks with increased morbidity and mortality to secondary unrelated reasons. Two recent studies published in Science Immunology and Science shed lights on this phenomenon: the authors showed that measles suppress the body’s immune system, reducing the ability to respond to other infections. 

Scientists analyzed a cohort of children from an Orthodox Protestant community in the Netherlands that have been not vaccinated by their parents for religious reasons. A total of seventy-seven of these children partook in the study before and after a measles outbreak in 2013. The blood of children pre-measles contraction contained antibodies (proteins produced by immune cells called B cells) that protect against common pathogens. However, after a natural measles infection, between 20 and 70% of these antibodies were lost. The immune system becomes “ignorant” again to viruses that it had encountered in the past. This “amnesia” of the immune system increases the risk of infections and slows down the ability of our immune system to fight pathogens such as influenza. 

Strikingly, children receiving vaccination against measles did not display such suppression of acquired immunity. These data further support the importance of widespread vaccination strategies to protect against measles but also to maintain a proper herd immunity to other pathogens.

(Petrova et al., Science Immunology, 2019 AND Mina et al., Science, 2019)

Written by sciencepolicyforall

November 5, 2019 at 4:27 pm

Science Policy Around the Web October 29th, 2019

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By Allison Cross PhD

Image by Gerd Altmann from Pixabay 

Super-precise new CRISPR tool could tackle a plethora of genetic diseases

Since the first adaption of CRISPR-Cas9 for gene editing in eukaryotic cells in 2013, the hopes of using the technique to cure genetic diseases have been high.  Despite the ability of current CRISPR–Cas9 gene-editing tools to edit the human genome, successful edits are often accompanied by unintended and unpredictable errors elsewhere in the genome. However, a new method of editing, published this week in Nature, shows potential for greater control over genome editing.   

This new method of genome editing, referred to as prime editing, still uses Cas9 to recognize specific DNA sequencing in the genome.  However, instead of producing double stranded breaks, a modified Cas9 enzyme is utilized to cut only one strand of the DNA.  The cut strand of DNA (called nicked DNA) is then repaired utilizing a prime editing guide RNA, known as a pegRNA.  

Prime editing offers several advantages over a similar previously developed editing technique, known as base editing.  Base editing, like prime editing, does not result in double stranded DNA breaks; instead it allows researchers to make specific substitutions to the bases that make up DNA (adenine, guanine, thymine, cytosine). However, it only allows for certain subsets of single base changes to be made (C->T, G->A, A->G, and T->C).   Prime editing is more versatile, allowing for all 12 possible base-to-base changes and capable of making multi-base changes.  There is, however, a limitation to how large the changes can be using the prime editing technique.  If large insertions or deletions are desired, traditional CRISPR-Cas9 tools remain necessary.

Researchers are still evaluating how prime editing works in a variety of cells and organisms, but the initial studies published this week show promise for more versatile and precise gene editing with fewer unwanted byproducts. 

 (Heidi Ledford, Nature) 

U.S. Travel Ban Disrupts the World’s Largest Brain Science Meeting

The travel ban implemented by the Trump administration restricts U.S. travel from 7 nations; Iran, Librya, Somalia, Syria, Yemen, North Korea and Venezuela.  The ban has been a very controversial issue with wide ranging implications. After its implementation, many in the scientific community feared the ban would hurt the community by resulting in lost potential collaborators, trainees, and recruits.  

This year’s Society for Neuroscience meeting drew more than 25,000 brain scientists from around the world to Chicago this week, however, some scientists were unable to attend due to visa issues. Sepiedeh Keshavarzi, a current Australian citizen who holds an Iranian passport, was invited to give an oral presentation during the year’s meeting. Instead of attending the meeting in person, Keshavarzi instead sent a prerecorded PowerPoint presentation to the meeting after her request for a Visa to the U.S. was denied.  

With Visa problems becoming increasing common, the Society to Neuroscience created a special program aimed at helping scientists with Visa issues present their work at this year’s meeting. The program, called Science Knows No Borders, did help some scientists, like Keshavarzi, present their work; however, fewer than a dozen scientists participated in the program. 

(Jon Hamilton, NPR)

Written by sciencepolicyforall

October 29, 2019 at 2:47 pm