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Archive for November 2019

Science Policy Around the Web November 29th, 2019

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By Maria Disotuar, PhD

Source: Pixneo

To Drive Down Insulin Prices, W.H.O. Will Certify Generic Versions

Without insulin, a person with type 1 diabetes cannot survive, and the cost and accessibility to insulin continues to be a problem for individuals suffering from this incurable autoimmune disease. Diabetes mellitus is a chronic metabolic disease characterized by high blood glucose levels. There are two types of diabetes, Type 1 diabetes results from the loss of pancreatic β-cell function, resulting in an inability to produce insulin, a peptide-based hormone. On the other hand, Type 2 diabetes patients are resistant to insulin. Those suffering from Type 1 diabetes require daily insulin therapy to stay alive, and patients with type 2 diabetes require insulin therapy to maintain a healthy lifestyle. Currently, more than 400 million people worldwide have diabetes and this number is expected to increase in the coming years. The main problem being that there are no generic forms of insulin and the price for current insulin analogs has gone from approximately $20 per vial to $250 per vial depending on the type of insulin. This price increase over the past 20 years has made insulin unaffordable for many individuals particularly for younger generations of Americans struggling to pay student loans. For these individuals, seeing the price of insulin jump from $4.34 to $12. 92 per milliliter has meant rationing the lifesaving drug to the bare minimum – a deadly decision for some.

As a response to the growing demand for insulin and skyrocketing prices, the World Health Organization (WHO) has proposed a two year prequalification pilot project, which will allow pharmaceutical companies to produce generic insulin to be evaluated by WHO for efficacy and affordability. These types of pilot projects have been previously deployed to improve the accessibility of life saving drugs for malaria, HIV, and tuberculosis. These efforts have led to an increase in production and market competition leading to reduced costs for individuals.

Currently, the major producers of insulin, Eli Lilly, Novo Nordisk, and Sanofi have welcomed the prequalification program, vowing to be a part of the solution not the problem. According to WHO, companies in several countries, including China and India, have already expressed interest in the pilot project. This shift in insulin production would allow companies producing insulin domestically to enter the global market. As WHO-certified suppliers, these new competitors could dramatically drive down the price of insulin and improve accessibility on a global scale. Despite this positive global outlook, there are still some hurdles to cross for Americans to obtain these generic insulin products. The main one being that the pharmaceutical market is regulated by the FDA and the review process can be expensive for smaller companies. Nonetheless, Americans are fighting back to reduce the cost of insulin and other life savingdrugs, prompting lawmakers, presidential candidates, and the President to prioritize reduced drug prices for Americans. These mounting pressures will hopefully lead to a faster solution for this life or death situation.

(Donald G. McNeil Jr., The New York Times)

Will Microneedle Patches Be the Future of Birth Control?

In 2018, the The Lancet reported that between 2010 and 2014 44% of all pregnancies in the world were unplanned. Despite medical advances in sexual and reproductive health, new contraceptive methods are needed to expand accessibility and improve reliability for women. In the United States, the establishment of the Affordable Care Act (ACA) and health policies such as the Federal Contraceptive Coverage Guarantee, which requires private health plans to include coverage for contraceptives and sexual health services, has improved family planning for women of reproductive age. Despite the social and economic benefits of improved family planning and enhanced accessibility, conservatives continue to challenge these beneficial health policies. Unfavorable changes to these policies could result in major barriers for women to access some of the most effective, yet pricier forms of contraceptives such as intrauterine devices (IUDs) and implants. Studies show these long-acting forms of birth control are up to 20 times more effective in preventing unintended pregnancies than shorter-acting methods such as the pill or ring. Thus, new long-term contraceptives with reduced cost barriers would be essential in reducing unintended pregnancies and enhancing economic benefits on a global scale.

To address this issue, researchers at the Georgia Institute of Technology and University of Michigan in partnership with Family Health International (FHI) – a non profit human development organization, have developed a long-acting contraceptive administered by a patch containing biodegradable microneedles. The patch is placed on the surface of the skin and the microneedles painlessly come into contact withinterstitial fluid resulting in the formation of carbon dioxide bubbles, which allow the microneedles to detach from the patch within 1 minute of application. The needles themselves do not introduce a new contraceptive hormone, rather they provide levonorgestrel (LNG), which is regularly used in IUDs and has been deemed as safe and efficacious. After dissociation from the patch the needles slowly release LNG into the bloodstream. 

Thus far, the pharmacokinetics of the patches has been tested on rats and a placebo version has been tested in humans to test the separation process between the patch and the needles. The in vivo animal studies indicate the patch is able to maintain LNG concentrations at acceptable levels for more than one month and the placebo patch was well tolerated among study participants with only 10% reporting transient pain or redness at the site of patch application. Lastly, the researchers analyzed conceptions and acceptability of this new contraceptive method among American, Indian, and Nigerian women compared to oral contraceptives and monthly contraceptive injections administered by a physician. The results indicate women overwhelmingly preferred the microneedle patch method over the daily pill (90%) or monthly injections (100%). The researchers expect the patch to be simple to mass produce and a low-cost contraceptive option, which will reduce cost barriers and improve accessibility for women. Although the results of the study are promising, additional studies will have to be completed to address some of its limitations. Future studies will have to increase the number of animals used in the study and the number of human participants. Additionally, the release profile for LNG will likely need to be extended beyond 1-month to truly address the need for new long-acting forms of contraceptives. Finally, clinical trials will have to be completed to test the efficacy and general reliability of this method at reducing unintended pregnancies. If the microneedle patch is approved, it would be the first self-administered long-term birth control to enter the market, which could ultimately lead to enhanced accessibility for women with limited access to health care.

(Claire Bugos, Smisothian) 

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

Plastics, Problems, and Progress

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By:Jedidiah Acott, PhD

Image by Steve Buissinne from Pixabay 

Plastic is a staple of modern society, due in part to its malleable and durable properties, providing an applicability in innumerable contexts. The first plastic – known as Parkesine – was created in 1862 by heating, molding, and cooling organic cellulose; Alexander Parkes found that after processing, Parkesine could maintain a rigid shape. Less than 50 years later, the commercially manufactured synthetic plastic, Bakelite, was introduced at a chemical conference by Leo Hendrik Baekeland. Interest in the material was immediate, and soon Bakelite was widely used in the public sphere. All throughout the 20th century, new synthetic polymers were invented and brought to the industrial forefront, eventually replacing the plastic progenitors. The ubiquitous role of these synthetic plastics fills such a crucial function in modern society, that if one were to ponder the hypothetical state of the world in their absence, then it could seem like they are a cornerstone of necessity. In fact, it would appear we have become so dependent on plastics that some deem the current times as the plastic age of human history. What are the effects of our plastic addiction? This is the burning question that emerges from witnessing these extreme behaviors, and as current conditions display, where there is smoke there is fire.

It is not a stretch to say that plastics interact with almost every sphere of the global ecosystem, and similar to the inert use of mercury in a barometer compared to its’ interaction with human physiology, the consequences of using a material is determined by its context of use. The pure form of synthetic plastics appear to be non-toxic, but the inclusion of additives that leech into the environment alters the organic polymer into a mysterious and possibly dangerous material. Plastic degradation may take a thousand years or more, and as they degrade, microplastics are produced that can be readily consumed by marine organisms. On the ocean surface, microplastics smaller than 1 cm in diameter have been documented to be heavily abundant, and researchers in Honolulu have observed these microplastics to be present within the small shortbill spearfish, a population native to the area. In larger marine life, plastic bags have been found obstructing the digestive tracts of beached whales, and the stomachs of sea turtles. As a testament to the abundance of oceanic plastics, works of art entirely composed of plastic removed from the stomachs of seabirds hangs on the walls of the National Oceanic and Atmospheric Administration in Honolulu, Hawaii. Another set of researchers predicts that by the year 2050, 99% of all seabird species will have ingested plastics. It is obvious enough that mechanical obstruction can cause issues, but what of the environmental and biological consequences of plastic consumption?

It is well-known that the amazon rainforest serves as a carbon sink for atmospheric carbon dioxide, but lesser known is that sea ice serves a similar function for microplastics. One study shows that as a plastic sink, sea ice traps microplastic particulates at concentrations several orders of magnitude beyond highly contaminated waters. Even if every bit of plastic floating in the ocean were to be removed, there would remain a reservoir of plastic waiting to be re-released into the environment. On one front, increasing ocean acidity threatens the formation of calcium carbonate shells for growing organisms, while on another, plastic waste promotes the colonization of disease-associated pathogenic microbes that threaten coral reefs. In 2017, scientists studying coral reefs provided evidence that corals in contact with plastics increase their risk of disease from 4% to 89%. As one of the most diverse ecosystems on earth, coral reefs harbor plants and animals that actively contribute to drug discovery and development for human ailments. The molecules from these organisms have relevance for conditions ranging from cancer and arthritis, to bacterial and viral infections. The present circumstance does not project a promising future for the worlds’ oceans. Ecosystem imbalance, plastic reservoirs, threats to marine life, and microplastics in ocean-derived resources are immediately visible consequences, but are there tangible causes for concern toward the human species in particular?

The current literature surrounding the effects of micro- and nano-plastics on human health is sparse, but a lack of evidence is not evidence of lack. As new knowledge is created, the present paradigms are renovated, and a type of hindsight bias may emerge confounding future generations from the current apathy. A recent study published in Canada measured the contents in a cup of liquid following a normal steeping process using a manufactured plastic tea bag. The researchers found 11.6 billion microplastics, and 3.1 billion nanoplastics in the beverage, several orders of magnitude above the plastic loads reported in other foods. In accordance with this report, the Tea and Herbal Association of Canada issued a statement that no evidence shows harm to human health by microplastics, and that polyethylene terephthalate (PET) and nylon have been deemed safe for use as tea bags for hot food and beverages. Not so long ago cigarettes were claimed as being not harmful by tobacco companies and health professionals. Today though, we have ample evidence to support tobaccos’ role in cancer, heart disease, complications with blood circulation, and addiction. It would be highly irresponsible and quite the historical oversight to lay behind the thin veil of ignorance as justification for allowing plastics to continue polluting our environment and our bodies. Allowing these conditions to become precedent now, and only asking questions later, is actively participating in our own dissolution. Research has already revealed that plastic-derived BPA and DEHP are detrimental to human health, increasing risk for breast and uterine cancer, and interfering with testosterone levels and childhood development. More than enough evidence already points to the need for addressing the plastic crisis with urgency, and as we attempt damage control and eventual reparations, a multi-layered approach may now be the best option.

Equally for climate change and the plastic crisis, the current generation did not create the problem: we inherited it. But because we have also contributed to it, it is our burden to create meaningful solutions and demand institutional changes to prevent continued indifference and destruction toward the world. Several possibilities, such as government policy, institutional accountability, mechanical recycling, clean-up groups, and enzyme-based depolymerization, are already being enacted. In India, 17 states have joined together to “ban the manufacture, use, storage, distribution, sale, import, and transportation of many plastic goods and materials.” Even while making the change, industrial plastic and clothing manufacturers filed a lawsuit challenging the ban. On the basis of adverse effects to businesses, the Indian government gave the companies 3 months to dispose of banned items. A ban on imported recyclables was put into effect by the Chinese government 2017, and in relation to this ban many American counties have cancelled their recycling programs, leaving consumers to throw plastics in the trash, which may actually reduce ocean-bound plastics. Agilyx, a company in Tigard, Oregon has taken a small-scale approach toward the problem. By using chemical plastic depolymerization to break the molecular bonds between plastic polymers, the Oregon company can turn plastic into reusable raw materials. Carbios, a plastic depolymerization startup in France, is using an enzyme specific for the synthetic PET molecule, which the CEO calls a “conceptually…infinite recycling process.” Some studies have shown that chemical recycling may even reduce greenhouse gas emissions, addressing two environmental issues with one method.

Humanly-created problems require humanly-created solution, and although the plastic crisis is actively being worked on by engineers, scientists, companies, and governments around the world, international accountability may be a bottle-neck impeding authentic solutions; but with the perseverance of the human spirit, we may even yet clear the streams of pollution toward an unimpeded flow of environmental conscientiousness, and re-forge the bottle into a favorable material for future life of the planet.

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

November 23, 2019 at 1:42 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)

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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)

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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 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)

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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)

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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)

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November 5, 2019 at 4:27 pm