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Science Policy Around the Web December 6th, 2019

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By Hannah King, PhD

Image by Steve Buissinne from Pixabay 

200,000 Uninsured Americans to Get Free H.I.V.-Prevention Drugs

World AIDS Day, held annually on December 1st, has led to a flurry of AIDS-related announcements this week.

The Trump administration has released an announcement outlining how it plans to distribute HIV prevention drugs donated by the pharmaceutical company Gilead, which manufactures the drugs. These drugs will be available to 200,000 uninsured Americans who have a prescription and recent evidence of their HIV-negative status.

While other programs exist in the US to provide these drugs free of charge (including those run by cities in high-incidence areas and a program from Gilead itself) this announcement marks the first time the government has provided such HIV-prevention medicine free to individuals not enrolled in a federal health program. With 37,500 new HIV infections per year in the US, and 1.2 million Americans estimated as being at high risk for HIV-acquisition, widespread distribution of this preventative treatment is an important public health initiative. 

Access to HIV prevention and treatment medication is also a worldwide issue. In further encouraging news, an Indian drug manufacturer has announced that it will make a pediatric formulation of HIV medication, that is strawberry flavored and the size of sugar granules! The current medication is either formulated as hard tablets, or requires refrigeration, reducing either the tolerability to children or accessibility of the product. As 160,000 children are born with HIV each year, but only approximately half receive treatment, this new formulation will hopefully reduce the AIDS-related morbidity and mortality in this vulnerable population.   

(Donald G. McNeil Jr., New York Times

China’s CRISPR babies: Read exclusive excerpts from the unseen original research

Further details of the research purporting to use CRISPR to create gene-edited babies have emerged, reinforcing the “serious, unresolved safety concerns” associated with this human research. 

MIT Technology Review has released excerpts from an unpublished manuscript outlining a study by the Chinese researcher He Jiankui which describes the creation of the first gene-edited human babies. The mutation introduced into the embryos is a deletion in the gene expressing a protein called CCR5. A deletion in this CCR5 protein occurs naturally in some individuals and renders them resistant to infection with HIV – the stated rationale for this experiment. However, the manuscript shows the deletion that was introduced into the genomes of these babies is similar, but not identical to the naturally occurring deletion, and no attempt is made by the authors to validate its ability to confer HIV resistance.

Furthermore, despite the manuscript describing the experiments a “success”, the data shows the CCR5 deletion is absent in one chromosome on one of the babies, meaning she carries one copy of the functional CCR5 gene, and is still susceptible to HIV infection. Data in the manuscript, showing DNA sequencing of cells from the babies following their birth also indicates that not all cells in these babies share the same genetic code, suggesting that not all cells carry the CCR5 deletion, or that other “off-target” effects with unknown health implications may be present.

This newly available data, in addition to the many ethical concerns previously raised, further demonstrate this experiment is not the “success” nor the path forward to “control the HIV epidemic” that He Jiankui claims it to be.

(Antonio Regalado, MIT Technology Review)

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December 6, 2019 at 1:51 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 August 6th, 2019

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By Allison Dennis B.S.

Image by rawpixel from Pixabay 

Researchers weigh in on Trump’s $500 million plan to share childhood cancer data

Researchers are contemplating developing what they call The Childhood Cancer Data Initiative (CCDI). This approach comes in response to the 10-year $500 million research budget for childhood cancer proposed by President Donald Trump during his January State of the Union Address. Federal officials implementing the proposal have seized on an ongoing effort to transform “big data” into new medical discoveries by looking to expand the sharing of patients’ data to develop new approaches to treat childhood cancers. Currently, patient data can be found spread across state registries, tumor DNA databases, and clinical trial records, obscuring potential insights. 

A symposium held by the National Cancer Institute (NCI) in August 2019, gathered members of the research community to brainstorm the future of the CCDI. Experts made clear the need to first inventory what data already exists, including making efforts to digitally join the five largest existing pediatric cancer databases. Close attention and broad changes will be needed to unify the individual observations being made as children battling cancer make their way through the medical system. Yet despite these big ideas, it is not yet clear that Congress will follow through to appropriate the $50 million down payment needed to kick start CCDI. 

(Jocelyn Kaiser, Science)

 

‘Mosaic’ HIV vaccine to be tested in thousands of people across the world

The ‘mosaic” vaccine is the latest innovation in HIV prevention scheduled to start late-stage clinical trials in September. The experimental vaccine is designed to elicit an immune response to protect against more strains of HIV than any developed so far. The phase III trial (termed “Mosaico”) will be conducted in Europe and the Americas to follow its effectiveness at preventing the transmission of HIV in 3,800 participants, divided evenly into groups receiving four injections of vaccine or placebo. The innovative approach taken by researchers started with engineering a disabled common cold virus to carry pieces of DNA encoding synthetic copies of three HIV genes. The synthetic genes help the body to recognize several different global HIV strains. In addition to the DNA sequences, the vaccine is delivered with two synthetic proteins designed to match HIV strains common in Africa, the Americas, Europe, and Australasia.

Only four HIV vaccines have ever been tested for efficacy in humans. One which initially showed promise but whose efficacy waned over time resulted in a modest 31% difference in rates of infection between groups who received the vaccine compared with placebo. By combining DNA sequences and proteins reflecting a broad diversity of globally circulating HIV strains, the Mosaico team is hoping to give the body an immunological snapshot to prepare it to defend against any strain it might be exposed to. 

(Emiliano Rodriguez Mega, Nature)

 

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August 6, 2019 at 4:47 pm

Science Policy Around the Web – June 25th, 2019

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By Ben Wolfson, Ph.D.

Image by Darwin Laganzon from Pixabay 

North Korea claimed to be free of HIV. But infections appear to be surging

Since its first diagnosis 1981, HIV/AIDS (Human immunodeficiency virus infection and acquired immune deficiency syndrome) has infected more than 70 million individuals worldwide and resulted in 35 million deaths.

HIV/AIDS is classified as a pandemic, with infected individuals found throughout the world. However, as of a December, 2018 World AIDS Day event, North Korea reported no known cases, crediting this to widespread testing and prevention methods.

A new paper has reported that these data were false, and that in fact following a North Korean “patient zero” in 1999, HIV/AIDS infections have slowly ballooned. These findings come from a collaboration between North Korean scientists and DoDaum, a nonprofit in North America that runs health and education projects in North Korea. While officials originally asked DoDaum not to discuss the increasing prevalence of HIV/AIDS in North Korea, the North Korean Ministry of Public Health felt they had to overcome traditional reticence in order to seek help in targeting HIV/AIDS.

While both a cure and vaccine remain elusive, widening usage of Pre-Exposure Prophylaxis (PrEP), also called Truvada, has the potential to significantly reduce new HIV infection. PrEP has been shown to be more than 90% effective at preventing new HIV infections, and remains underutilized in most countries, including the USA. This is in part due to cost, a factor which is the subject of a new bill introduced in the Senate that would make PrEP free to most patients.

(Richard Stone, Science)

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June 25, 2019 at 5:37 pm

Science Policy Around the Web – December 6, 2018

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By: Neetu M. Gulati, Ph.D.

man-2125123_960_720

Source:Pixabay

 

The CRISPR Baby Scandal Gets Worse by the Day

Ethical concerns and controversy came to the forefront last week when news broke that Chinese scientist He Jiankui had supposedly created genetically edited babies using CRISPR technology: a first in the world. CRISPR/Cas9 technology, or CRISPR as it is more commonly known, is a scientific tool that allows researchers to edit (add, subtract, or change) the expression of genes quickly and precisely. This technology could be used to fix mutations that cause human disease. However, there are also risks, using CRISPR for gene editing may have disastrous side effects such as potentially leading to cancer.

He Jiankui claimed that he used the technology to alter a gene called CCR5 to reduce the risk of of HIV infection in embryos before implanting them in a woman, who then gave birth to twin girls. He claimed another CRISPR baby may be on the way from another pregnant woman. It is unclear if He has actually done what he claimed, and he has not yet published his results in a peer-reviewed journal. Nevertheless, the response to He’s claims have been strongly negative. Many people are concerned that He violated ethical norms by editing human embryos, especially because the overall consensus among scientistsin the field of gene-editing was that “there is a need for caution” and to only use the technology after “much more research to meet appropriate risk/benefit standards.”

Since the public has learned about He’s experiments, numerous scientists, including pioneers in the CRISPR field, have spoken out against He’s actions and have called for a temporary moratorium on similar experiments. Southern University of Science and Technology in China, where He has been on unpaid leave since February, has opened an investigation into He after finding out about his research. China’s National Health Commission is also investigating He.

Amid the backlash, He defended himself and his actions at the Human Genome Editing Summit in Hong Kong, claiming to be “proud” of his work. Dr. He has not been seen since the summit, however, and there are now concerns that he may be missing.

(Ed Yong, the Atlantic)

 

Trump emphasizes workforce training in new vision for STEM education

The White House released a new five-year strategic plan for science, technology, engineering, and mathematics (STEM) education this week, with a vision that “all Americans will have lifelong access to high-quality STEM education and the United States will be the global leader in STEM literacy, innovation and employment.” The report emphasizes workforce training in STEM, focusing primarily on opportunities outside of traditional classroom settings, such as apprenticeships. The plan also highlights the need for more diversity in STEM, such as minorities and women.

Overall the strategic plan focuses on four pathways to success: developing and enriching partnerships between educators, employers, and the community; engaging students in trans-disciplinary learning, including advancing innovation and entrepreneurship education; building computational literacy; and operating with transparency and accountability. The plan put forth by the Trump administration diverges from some of the key priorities of the former administration, including efforts focused on traditional academic environments such as training more teachers, and improving STEM instruction in colleges and universities. Instead, this plan appears more focused on how STEM education prepares students for the years after schooling is completed. “STEM education is absolutely critical to supporting the American worker, and this plan brings together a number of programs that are part of our emphasis on the American worker,” said Michael Kratsios, deputy assistant to the president at OSTP.

(Jeffrey Mervis, Science)

 

NASA’s InSight Mars explorer lands safely on the Red Planet

For only the eighth time in human history, a spacecraft has been landed on Mars. The InSight lander touched down on Martian soil on November 26, 2018 after over six months of space travel.

NASA’s InSight mission aims to gather information about Mars, and is part of the NASA Discovery program for focused solar science missions. InSight will study the crust, mantle, and core of Mars, to allow scientists to learn more about the formation of rocky planets in the solar system.

InSight has already begun taking photos of the surface of Mars, which have been posted on social media accounts such as Twitter. The lander has also set up solar panels, which allows InSight to power its cutting edge instruments. In doing so, the lander set an ‘off-world record,’ generating more electrical power than any previous vehicle on the planet’s surface. InSight project manager Tom Hoffman spoke on the importance of this achievement, “The 4,588 watt-hours we produced during sol 1 means we currently have more than enough juice to perform these tasks and move forward with our science mission.” This almost doubles the energy produced in a Martian day produced by NASA’s Curiosity rover, which previously held the record.

InSight will continue taking pictures of the surface of Mars to study its new surroundings and use its robotic arm to set up instruments to place them on the surface of Mars for the next few weeks. It will take two to three months before the lander begins conducting science on the Red Planet.

 

(Sarah Kaplan, Washington Post)

 

 

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December 6, 2018 at 5:23 pm

Science Policy Around the Web – November 27, 2018

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By: Allison Dennis, B.S.

forest-1161868_1280

Source: Pixabay

 

California’s Wildfires Could Mean A Generation Of Lung Problems

The acute dangers of uncontrolled wildfires are undeniable, yet chronic dangers remain poorly understood. Changes in air quality due to wildfire smoke may have long-term and widespread health effects that researchers are only beginning to decipher. In 2017, nature provided the near perfect conditions for a much needed experiment. As the Mendocino Complex Fire raged, its smoke drifted over 200 miles to blanket the living space of an outdoor colony of primates bred for research for 10 days. 500 infant rhesus macaques, a commonly used model of human disease, were exposed, allowing respiratory immunologist Lisa Miller to begin an experiment looking for long-term respiratory damage in a pediatric population. Her previous studies of a smaller group of monkeys exposed in 2008 revealed monkeys born in wildfire conditions grew up to have a reduced lung capacity and compromised immune system . Ten years after the fire, monkeys who were infants at the time of the fire have a high incidence of idiopathic pulmonary fibrosis, a fatal human disease associated with environmental pollutants and cigarette smoking. By carefully recreating her impromptu 2008 experiment, Miller is hoping to gain deeper insights into what damage can occur in the developing lung tissue that will lead to possible interventions.

Miller’s research already suggests that a brief exposure to smoke early in life can have a lifetime of consequences. Smoke inhalation is much more widespread than the immediate dangers of fire, and will need to be incorporated into disaster preparedness plans. Financial assistance may be needed to help families temporarily relocate following fires not only due to burned homes, but also to homes blanketed in smoke. Currently, websites like airnow.gov provide up to date measures of air quality and can be used to decide when to limit children’s time outdoors. Parents with other options may need to weigh the potential risks of raising a family in places where wildfires are an annual occurrence.

(Maggie Koerth-Baker, FiveThirtyEight)

 

Genome-edited baby claim provokes international outcry

 

The announcement of the first genome-edited babies is shocking ethicists, scientists, and spectators around the world. He Jiankui of the Southern University of Science and Technology of China in Shenzhen claims to have altered the embryonic DNA of two twin girls born in November 2018 by using CRISPR-cas9 to disable the protein CCR5, known to provide HIV access to human cells. The study has not yet been submitted for publication and will likely undergo extensive peer review for verification. He recruited couples looking to conceive, where the male partner had HIV. The risk of transmission of HIV between father and offspring is very low, and removing semen from sperm before fertilization is commonly used to further mitigate the small risk. However, He thought these would-be parents would especially value the benefits of conferring their child with a lifetime protection against HIV through altered genetics.

Since its first demonstration as a gene-editing technique nearly ten years ago, ethicists have debated the potential application of CRISPR-cas9 to alter human DNA. Because reproductive tissues develop from the edited zygotic cells, it is likely that the twins will pass these changes on to their offspring along with any other possible off-target changes to the genome. While lacking the CCR5 gene has been shown to confer protection against HIV infection, it may subsequently increase the risk of other viral infections. Many still feel that not enough is known about the long-term and generational effects of altering a person’s germ-line using these proteins to justify the risks they could pose over an unborn person’s lifespan. To what extent the institutions that facilitated the experiment were consulted or informed of the true nature of the search remains unclear. The trial was only registered on November 8th, well after the work had begun. However in the race to be first, He appears to understand that any harm to the children arising from the experiment stating these risks are “going to be my own responsibility.”

 

(David Cyranoski, Nature News)

 

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November 27, 2018 at 10:24 am

Science Policy Around the Web – April 4, 2017

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By: James Taylor, PhD

Photo source: pixabay.com

Research Funding

NIH Research Grants Yield Economic Windfall

Assessing the social and economic benefits of basic research – research conducted with no clear medical or financial goal in mind – has is often tricky with the former being philosophical in nature whilst the later sometimes coming years later from unexpected angles. A classic example of this process is the polymerase chain reaction (PCR), which was built on basic research on DNA replication in bacteria from hot springs published years before its invention.  Critics of publicly funded research often take studies out of context in order to ridicule them, such as Sarah Palin’s infamous “fruit flies” comment.

A recent analysis of the economic effects of the National Institutes of Health (NIH) funding has shone light on the economic benefits of basic research. Danielle Li and colleagues found that although 8.4% of NIH grants between 1980 and 2007 led directly to patents, 30.8% produced a scientific article which was later cited in a commercial patent for a drug, device or other medical technology. This demonstrates an enormous but indirect benefit of publically funded research. Furthermore, when the studies were broken down into basic or applied (research with a stated medical or commercial goal) they found no difference between the two in terms of how likely they were to be cited in a patent. This should give funding bodies pause for thought, as it calls into question their growing emphasis on applied research.

Taking into account the indirect effects of NIH funded research, the authors estimate that every $1 in NIH funding returns $1.40 in drug sales. This report is timely with proposed budget cuts for science funding looming large in the horizon, and exposes such cuts as sheer economic folly. (Elie Dolgin, Nature News)

HIV/AIDS

HIV Infections are Spiking Among Young Gay Chinese

Recent surveys of HIV infections in China have shown a worrying spike in HIV infections among young gay and bisexual men, and have sparked the implementation of a broad 5-year plan to raise awareness and boost research into new treatments by the country’s ruling State Council. In the early 2000s, HIV infections were most prevalent amongst drug users in China, but there has been a steady decrease in prevalence amongst this group. The increase in HIV infections amongst men who have sex with men (MSM) has bucked this trend, and instead has been rising at an alarming rate. The cause of this increase remains unknown, with researchers at the National Health and Family Planning Commission in Beijing and China Medical University in Shenyang rather hopelessly suggesting that it was “possibly due to several unidentified and yet unaddressed risky sexual behaviors”.

China has previously mounted an effective response to the initial HIV epidemic by providing free antiretroviral to all HIV patients. This does little good, however, if you are afraid to admit you have HIV because it may out you as gay or bisexual. Despite recent improvements in LGBT rights and growing acceptance of LGBT people among the younger generation, being LGBT in China still carries with it significant stigma. This stigma, along with that of having HIV, may be causing young men to avoid seeking help out of fear. To reach out to gay men who may be at risk, the government and concerned nongovernmental organizations are working on novel outreach programs, such as working with dating apps popular with young gay and bisexual men to spread HIV awareness. The director of the Chinese Centre for Disease Control (China CDC), Wu Zunyou, has proposed increasing the availability of HIV self-test kits and pre-exposure prophylaxis medications, both of which would help those at risk whilst lessening the pressure from social stigma. (Kathleen McLaughlin, Science)

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April 4, 2017 at 10:00 am