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Science Policy Around the Web – February 10, 2017

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By: Saurav Seshadri, PhD

Source: pixabay

Sleep

The Purpose of Sleep? To Forget, Scientists Say

Humans spend approximately one third of their lifetime sleeping, yet the purpose of sleep is still largely unknown. A pair of recent studies in the journal Science suggest that a key function of sleep is to give the brain a chance to rewire itself, specifically by cutting down connections between neurons, which naturally scale up during wakefulness, and especially during learning.

In one paper, researchers used 3D electron microscopy to measure the sizes of these connections, called synapses, in mouse brain slices. They found that sleep produced a significant decrease in the size of synapses. Interestingly, this effect was more pronounced in smaller synapses, which were likely strengthened by general information processing while awake, than large ones (~20% of synapses), which may encode more well-established memories. In the other, researchers used two-photon imaging in live mice to observe sleep-induced changes in synapses. They found a similar decrease in synaptic strength, and went on to identify the signaling pathway that caused this effect; blocking this pathway prevented a normal reduction in the scope and magnitude of a learned behavioral response.

These findings underscore the importance of sleep, especially for memory consolidation involved with learning. Studies like these can have far-reaching effects on the public’s perception of sleep, influencing individual habits as well as policy related to education. For example, they suggest that prioritizing sleep when setting school start times (an issue currently under debate in Montgomery County schools) could improve students’ lesson retention and ultimately their test performance. They also point to important cellular and molecular processes that take place during sleep, which could help explain how existing sleep aids adversely affect brain functioning and memory (a public health concern), and ultimately lead to the development of better drugs. (Carl Zimmer, The New York Times)

Drug Policy

Massive Price Hike for Lifesaving Opioid Overdose Antidote

Increased public exposure to the epidemic of opioid abuse, which continues to intensify in the US, has made it increasingly influential in politics, possibly including the recent presidential election.  A crucial tool for communities at the forefront of this public health crisis is naloxone, which can reverse potentially fatal symptoms associated with overdose. The Evzio naloxone auto-injector, produced by Kaleo, is one of two such products approved by the FDA. Kaleo has recently come under fire for increasing the price of Evzio from $690 to $4,500.

Kaleo cites several justifications for the price hike. Firstly, they offer coupons to patients whose insurance doesn’t cover Evzio. Second, they argue that large insurance companies and government agencies (such as the Veterans Health Administration, which sees a high rate of opioid use) can negotiate prices, while other organizations are currently well funded (thanks to public concern) to absorb the increase. Thirdly, they are expanding their donation supply to allow smaller groups to apply for free devices. However, experts say that the increase is not justified by production costs, and some organizations have been forced to switch to alternative drugs.

News of the decision arrives at a time when the public is particularly sensitive to drug pricing, and have made their concern clear to lawmakers. Negotiation with drug companies over prices has been a prominent campaign issue in recent elections. Public outcry following similar moves by investor Martin Shkreli and Mylan led to hearings by a special congressional committee. Soon after the last election, a bill that would have allowed patients to import cheaper drugs from Canada became a high-profile occasion for posturing in the Senate, where it failed despite overwhelming public support. These stories highlight the often antagonistic relationships between the American public, its government, and the pharmaceutical industry, and illustrate how disruptive drug pricing can directly affect policy. (Shefali Luthra, Scientific American)

Scientists in Politics

Geneticist Launches Bid for US Senate; while Empiricists Around the Country Will March for Science

Donald Trump’s agenda of self-serving lies and denial of evidence has led to unprecedented levels of engagement and activism across the country. The scientific community has been especially impacted by Trump’s brand of broad, allegedly populist anti-intellectualism. Thus, although the empirical facts uncovered by scientific research are inherently apolitical and should be treated as such, scientists are beginning to mobilize to oppose the Trump administration in several ways.

One essential path to policy change is increased representation. With that in mind, evolutionary biologist Dr. Michael Eisen, an HHMI-funded investigator at UC Berkeley and co-founder of the People’s Library of Science (PLOS), recently announced his candidacy for the US Senate in 2018. Dr. Eisen’s platform seems to center on bringing a scientific perspective to Senate proceedings, and working towards comprehensive yet practical solutions to issues such as climate change. More of Dr. Eisen’s views can be found on his twitter feed and blog.

Protests are another way for individuals to make their voices heard by policy makers. The March for Science, which currently has over 350,000 followers on Facebook, will be an opportunity for ‘scientists and science enthusiasts’ to both call for and demonstrate support for the scientific community, and promote solidarity between science and the public. The main march will be held on April 22nd, 2017 in Washington D.C.; satellite marches are scheduled in over 100 additional cities. Organizers hope to maintain the momentum gained by January’s Women’s Marches, which saw historic attendance. (Sara Reardon, Nature News; Lindizi Wessel, ScienceInsider)

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Science Policy Around the Web – December 23, 2016

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By: Joel Adu-Brimpong, BS

Source: Flickr, by Ben Gordon, under Creative Commons

Public Health

Looking Beyond Flint

All eyes turned to the city of Flint, Michigan as it burst onto the national scene after reports revealed that children were being exposed to dangerously high levels of lead in their drinking waters. Although shocking, a recent study shows that the Flint narrative is no abnormality. “In fact, it doesn’t even rank among the most dangerous lead hotspots in America,” states Reuters, an international news agency and investigative body that conducted the study.

In this Reuters report, it was discovered that almost 3000 areas in the country had at least twice the lead poisoning rates of the infamous Michigan city, with much less press coverage. In some areas, such as Baltimore, Cleveland and Philadelphia, areas with multigenerational lead poisoning, about 40 to 50 percent of children had elevated levels of lead. Nationwide estimates by the Centers for Disease Control and Prevention (CDC) purport that approximately 2.5 percent of small children, children between ages one and five, present highest levels.

For this study, Reuters obtained lead poisoning data from state health departments and the CDC. But rather than peruse and detail state or county-level data, Reuters pursued more granular results; testing for lead poisoning at the neighborhood-level. Altogether, Reuters observed 2,606 census tracts, or small county subdivisions, and 278 zip codes across the country with at least twice the prevalence rate of lead poisoning as Flint. It was noted that while poverty remains an integral predictor of lead poisoning, victims span the American tapestry of rich and poor, urban and rural and black and white.

Federal aid to assist states in lead poisoning management is quite limited. After the Flint debacle, Congress delivered $170 million in aid to Flint. However, the budget allocated to the CDC to assist states in lead poisoning control is only a fraction of the Flint package. With the 21st Century Cures Act set to withdraw approximately 3.5 billion from the Prevention and Public Health Fund, a fund established under Obamacare, and a pervasive political rhetoric regarding the repeal of Obamacare, lead poisoning may return to its obscure position in the public sphere. (M.B. Pell and Joshua Schneyer, Reuters)

Drug Policy

When Drug Prices Rise, Americans Turn Outward?

A recent study revealed that 70 percent of Americans take at least one prescription drug a day. And if you are among this group, or care for someone on medication, you are most likely aware that drug prices have been rising. In fact, a 2015 poll by the Kaiser Family Foundation (KFF) found that roughly 80 percent of Americans deemed costs of prescription drugs ‘unreasonable.’ A report by the IMS Institute for Healthcare Informatics earlier this year indicated that, after accounting for estimated reimbursements, net medication spending for the 2015 year was roughly $310 billion. So what happens when drug prices exceed affordability in the U.S.?

A poll by KFF last month found eight percent of survey respondents, or roughly 19 million adults in the U.S., had or knew someone in their household who had imported a drug at some point. Drug prices when obtained outside the country (i.e., Canada, Mexico, etc.) may be half the sticker price in the U.S., or even cheaper. This finding comes on the heels of recent spikes in prescription drug prices such as that of Daraprim, a life-saving drug often prescribed for AIDS patients, Cycloserine, a drug used to treat tuberculosis, Epipen, an injection device for patients with severe allergies, and others which have caused national outrage.

Although illegal for Americans, in most instances, to import drugs into the U.S. for personal use due to safety and effectiveness concerns, experts contend that eight percent is a conservative number. Some respondents may be reluctant to report violations of the law or are uncomfortable with talking about daily struggles with drug affordability. Demographics of individuals who imported prescription drugs ranged from young adults in college to elderly retirees, with prescription drugs imported spanning treatments for chronic and acute conditions.

Earlier this week, Senate Democrats sent a letter to Donald Trump urging the President-elect to effect bipartisan support to curb rising drug prices. But with no assurances in sight to curtail the epidemic of rising drug costs, will even more Americans turn outward in order to meet their prescription needs? If so, how might this affect the quality of circulating drugs and medication adherence practices? (Rachel Bluth, Kaiser Health News)

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December 23, 2016 at 9:00 am

Science Policy Around the Web – November 22, 2016

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By: Rachel Smallwood, PhD

Photo source: pixabay

Federal Research Funding

US R&D Spending at All-Time High, Federal Share Reaches Record Low

Recently released data from the National Science Foundation (NSF) showed trending increases in scientific research funding in the US across the past several years. Estimates of the total funding for 2015 put the value at an all-time high for research and development (R&D) funding for any country in a single year. In 2009, President Obama stated a goal to devote 3% of the USA’s gross domestic product (GDP) to research, and we have been making slow progress to that point; in 2015, 2.78% of the GDP went to research. Businesses accounted for the largest portion of overall scientific funding, contributing 69% of the funds. The second largest contributor was the federal government; however, it had the lowest percentage share of the total since the NSF started tracking funding in 1953, and the actual dollar amount contributed has been declining since 2011. Therefore, although the overall percentage of GDP going to research is increasing, that increase is driven by businesses, whereas the GDP percentage contributed by the federal government has dropped to almost 0.6%.

When taking a closer look at types of research, the federal government is the largest funding source for basic science research, covering 45% of the total. However, businesses make up the majority of the funding for applied research (52% in 2014) and experimental development (82% in 2014). This disproportionality in funding types combined with the decreases in federal research spending are concerning for the basic science field. There is more competition for less money, and this concern is compounded by uncertainty and questions about President-Elect Trump’s position on and plans for scientific funding. Aside from a couple of issues, primarily concerning climate change and the environment, he has said very little about science and research. Many scientists, institutions, and concerned citizens will be watching closely to see how science policy develops under Trump’s administration and its effects on federal spending and beyond. (Mike Henry, American Institute of Physics)

Biomedical Research

‘Minibrains’ Could Help Drug Discovery for Zika and for Alzheimer’s

A group of researchers at Johns Hopkins University (JHU) is working on a promising tool for evaluating disease and drug effects in humans without actually using humans for the tests. ‘Minibrains’ are clusters of human cells that originated as skin cells, reprogrammed to an earlier stage of development, and then forced to differentiate into human neural cells. They mimic the human brain as far as cell types and connections, but will never be anywhere near as large as a human brain and can never learn or become conscious.

A presentation earlier this year at the American Association for the Advancement of Science conference showcased the potential utility for minibrains. A large majority of drugs that are tested in animals fail when introduced in humans. Minibrains provide a way to test these drugs in human tissue at a much earlier stage – saving time, money, and animal testing – without risking harm to humans. Minibrains to test for biocompatibility can be made from skin cells of healthy humans, but skin cells from people with diseases or genetic traits can also be used to study disease effects.

A presentation at the Society for Neuroscience conference this month demonstrated one such disease – Zika. The minibrains’ growth is similar to fetal brain growth during early pregnancy. Using the minibrains, Dr. Hongjun Song’s team at JHU was able to see how the Zika virus affected the cells; the affected minibrains were much smaller than normal, a result that appears analogous to the microcephaly observed in infants whose mothers were infected with Zika during the first trimester.

Other presentations at the meeting showcased work from several research groups that are already using minibrains to study diseases and disorders including brain cancer, Down syndrome, and Rett syndrome, and plans are underway to utilize it in autism, schizophrenia, and Alzheimer’s disease. Though there might be a bit of an acceptance curve with the general public, minibrains potentially offer an avenue of testing that is a better representation of actual human cell behavior and response, is safer and more affordable, and reduces the need for animal testing. (Jon Hamilton, NPR)

Health Policy

A Twist on ‘Involuntary Commitment’: Some Heroin Users Request It

The opioid addiction epidemic has become a significant healthcare crisis in the United States. Just last week the US Surgeon General announced plans to target addiction and substance abuse. He also stated the desire for a change in perception of addiction – it is a medical condition rather than a moral or character flaw. Earlier this year, the Centers for Disease Control published guidelines that address opioid prescribing practices for chronic pain, strongly urging physicians to exhaust non-pharmacologic options before utilizing opioids. In response to the rising concern over prescription opioid abuse, steps have been taken to reduce prescriptions and access. This has resulted in many turning to heroin – which is usually a cheaper alternative anyway – to get their opioid fix.

One of the first steps in treatment and recovery for addiction and dependence is detoxing. However, opioids are highly addictive and many people struggle with the temptation to relapse. Additionally, many of the programs designed to help with the initial detox have long wait lists, are expensive, and may not be covered by insurance, further deterring those with addiction and dependence from getting the help they need. These factors have caused many to start turning to their states, asking to be voluntarily committed to a program on the basis that they are a danger to themselves or others because of their substance abuse. This is currently an option in 38 states. These programs can be held in either privately-run institutions or in state prisons. However, this practice is controversial because if the person’s insurance does not cover their stay, it falls to tax payers to foot the bill. While this is unpopular with some, advocates say the civil commitment laws are important options while there may be no other immediate ways for an individual to get help. (Karen Brown, NPR)

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November 22, 2016 at 9:00 am

Drug policy changes: Marijuana legalization and its therapeutic potential

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By: Kseniya Golovnina, PhD

Source: Flickr, under Creative Commons

On November 8th 2016, nine states voted on legalizing recreational and medical marijuana (Cannabis L.). All US presidential candidates supported relaxing current restrictions on marijuana use. Since 2011, more than 50% of Americans consistently show positive attitudes towards legalizing marijuana. It is estimated that marijuana industry tax revenues for federal, state and local governments could total up to $28 billion. In addition to tax revenues, the non-profit advocacy group the Drug Policy Alliance highlights that marijuana legalization will reduce harm to young people and people of color, create new jobs, save money on law enforcement, and promote development of tests for drug impairment.

One of the challenges in marijuana regulation is how it is generally perceived—either as a drug or as a harmless recreation. On the one hand, it is a central component of the long standing ‘war on drugs’ that is a primary part of US law enforcement. According to the legal system, marijuana remains classified as a Schedule I substance under the Comprehensive Drug Abuse Prevention and Control Act of 1970, along with heroin. On the other, prominent thinkers argue that it is a drug of choice, without a known lethal case, which helps produce serenity and insight, and should be regulated as alcohol and tobacco. Recent policy shifts will strike a new balance between these views.

While prohibited at the Federal level, marijuana decriminalization laws have been passed in several states by lawmakers, and often through public ballot measures. In 25 states, Cannabis is legal for medical use and in 5 states, for recreational use. Out of the 9 states that voted on Nov 8, only Arizona hasn’t supported marijuana initiatives. In 2013, the Obama administration clarified Federal marijuana enforcement to deemphasize some criminal behavior, and remain in harmony with new and evolving state laws. The US Congress is acting as well, with a petition introduced (the CARERS Act) intended to remove conflicts between state and federal laws.

Marijuana in science

Shown clearly by these recent political trends, the public attitude has been shifting rapidly, and legalization appears to be only an issue of time. From a scientific point of view, legalization of Cannabis will open the door for robust federally approved research on marijuana’s therapeutic value. The reasonable scientific question now is whether and to what degree Cannabis can be a real new frontier of therapeutics?

Marijuana chemical science started from the identification of THC (delta-9-tetrahydrocannabinol) as the main active ingredient. Today, more than 460 chemicals are known to be Cannabis ingredients, more than 60 of which are grouped under the name cannabinoids. In the early 1990s, cannabinoid (CB) receptors were discovered and cloned. Cannabinoids, along with their receptors, make up the endocannabinoid (EC) system, which participates in the regulation of neurotransmission. Surprisingly, a number of chocolate-derived chemicals can activate the human cannabinoid system, both directly and indirectly, suggesting that chocolate and marijuana can have overlapping effects. The identification of natural agonists anandamide and 2-arachidonylglycerol, which also act on CB receptors, has stimulated interest in the medical uses of Cannabis. On PubMed the number of publications with the term “cannabis” has increased from 71 in 1990 to 1195 in 2016, revealing both the unexpected Cannabis therapeutic horizons and warnings about its effect on adolescent brain.

A 2003 review on cannabinoids as potential anticancer agents reported, “cannabinoids have favorable drug-safety profiles and do not produce the generalized toxic effects of conventional chemotherapies.” Thirteen years later in 2016, cancer therapy using cannabinoids is still paradoxical but evident. In 2006, based on the analysis of 72 controlled studies evaluating the therapeutic effects of cannabinoids, it was shown that “cannabinoids present an interesting therapeutic potential as antiemetics, appetite stimulants in debilitating diseases (cancer and AIDS), analgesics, and in the treatment of multiple sclerosis, spinal cord injuries, Tourette’s syndrome, epilepsy and glaucoma”. A potential antipsychotic effect of cannabidiol was also reported in 2012. At the 2015 AAAS Annual Meeting, researcher Mark Ware from McGill University Health Centre in Montreal, Canada, reported, “it’s clear that the weight of evidence now is such that cannabinoids are analgesic drugs,” while also emphasized that more studies are needed to understand the best dosing and delivery methods for medical use.

A search on the website ClinicalTrials.gov, maintained by the National Institutes of Health shows 557 clinical trials with ‘known status’ for the term “cannabis” as of October 26, 2016. More than one hundred of them are open now. Topics for these studies relate to Cannabis abuse as well as new treatments for a variety of medical conditions such as schizophrenia, cancer, autoimmune diseases, epilepsy, musculoskeletal diseases, and others. For example, GW Pharmaceuticals Ltd. was conducting clinical trials with Nabiximols (trade name Sativex) to investigate its safety in treating cancer pain. However, out of ten cannabis-related drugs on the world market, only three (including Sativex) are approved for medical use in the US.

Legalization, public interest and scientific research on Cannabis has promoted regulatory agencies such as the Food and Drug Administration (FDA) to develop new policies and guidance. It is stated on the official FDA website that “the FDA supports researchers who conduct adequate and well-controlled clinical trials which may lead to the development of safe and effective marijuana products to treat medical conditions.” Non-profit US Pharmacopeial Convention (USP), a known leader in developing and controlling drug standards, has organized a Cannabis expert committee to develop USP Standards for medical Cannabis. Their aim is to control quality specifications for the Cannabis used in clinical studies.

While the frontier of science appears to be opening for Cannabis in the US, the regulatory regime will need to keep pace. As medical use legalization proliferates, there will be a strong, even urgent need to revamp regulation to accommodate and emphasize research and best uses. Until the regulations are properly developed there will be some uncomfortable unknowns from a public health perspective, leading to greater risks and missed benefits.

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November 14, 2016 at 9:00 am

Posted in Essays

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Science Policy Around the Web – November 6, 2015

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By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Education and Mental Health

Sesame Street’s new brand of autism education

There’s a new Muppet on the block: her name is Julia, she’s in preschool, and she has autism. Julia’s arrival on Sesame Street is part of a coordinated effort by the Sesame Workshop – the nonprofit organization behind the long-running educational children’s program – to reduce the stigma associated with autism and to normalize the disorder among preschool children. The initiative, called Sesame Street and Autism: See Amazing in All Children, is a web-based project with resources for parents that include videos aimed at educating kids ages 2-5 about their peers with autism, a storybook featuring Julia and her friends, and free daily routine cards that parents can use to teach their autistic children basic skills like teeth brushing.

The new initiative was created based on solid academic research thanks to input from multiple universities, professional organizations, and advocacy groups. The Sesame Workshop also worked to ensure that these resources included the viewpoints of individuals with autism. One in 68 children in the US is diagnosed with autism, which ensures that young kids are almost assured to interact with an autistic peer.  Despite the prevalence of the disorder, bullying is still extremely common. One recent study by the Interactive Autism Network found that 63 percent of children with autism have been bullied. The Sesame Street initiative aims to foster tolerance and acceptance with preschool age children in the hope of decreasing bullying among older children, in part by normalizing the features of autism, rather than by exaggerating how they may be disabling to children with the disorder. There’s plenty of room for optimism concerning the effectiveness of using Sesame Street as a platform for this type of education. A 2015 report from the National Bureau of Economic Research found that the program is “the largest and least-costly [early-childhood] intervention that’s ever been implemented” in the US. (Lauren McKenna, The Atlantic; Elizabeth Blair, NPR)

Drug Policy

In heroin crisis, white families seek gentler war on drugs

The nation’s long-running war on drugs has been defined by zero tolerance and stiff prison sentences. It emerged during a crack cocaine epidemic of the mid 1980’s that was primarily concentrated in poor, predominantly black, urban areas. In contrast, the heroin epidemic of the last decade is concentrated in white communities, many of which are suburban and middle-class. This demographic shift in drug use is starting to have profound consequences on how the drug war is being waged. Families who have lost loved ones to heroin are increasingly channeling their anger and grief into efforts to change the language surrounding addiction, and to urge politicians and government to treat drug use as a disease instead of a crime. For example, the derogatory term “junkie” is falling out of favor in lieu of softer and more understanding language. President Obama visited West Virginia recently, a mostly white state with staggering numbers of heroin overdose deaths, to discuss a new proposal to expand access for drug treatment and prevention programs. Presidential hopefuls from both parties have adopted a tone of compassion, rather than punishment: Hillary Clinton has been hosting forums on the issue in New Hampshire, and Jeb Bush is openly discussing his family’s experiences with drug addiction. In a dramatic shift, the Gloucester, Massachusetts police department is employing a new approach to heroin use that at least three dozen other departments have now adopted: users will no longer be arrested if they walk into a police station for help, even if they are in possession of heroin or its associated paraphernalia.

Many people welcome this shift as a needed course correction in light of our scientific understanding of the biology of addiction. However, some black scholars express frustration that similar calls for a more empathetic approach to drug addiction were not heard when they originated from the black community.  Kimberle Williams Crenshaw, a scholar of racial issues at Columbia and UCLA law schools, notes …”had this compassion existed for African-Americans caught up in addiction and the behaviors it produces, the devastating impact of mass incarceration upon entire communities would never have happened.” (Katherine Q. Seelye, The New York Times)

Microbiology

Create a global microbiome effort

In last weeks’ issue of Science magazine, a group of leading scientists in the US called for the creation of a Unified Microbiome Initiative (UMI) which would assemble researchers with representatives from private and public agencies and foundations to study the activities of the Earth’s microbial ecosystems. Nearly every organism and habitat on Earth hosts a unique population of microorganisms, known as its microbiome. These microbial communities are fundamental to nearly all aspects of life on Earth. For example, soil microbes drive the production of usable forms of crucial planetary elements like carbon and nitrogen, and their manipulation shows promise for reducing agricultural use of pesticides, fertilizers, and water use. Ocean microbes produce much of earth’s oxygen, and may be able to be engineered to remove gases from the Earth’s atmosphere that contribute to global warming. Emerging research has revealed the role played by microbes that live within our own bodies in driving overall health and shaping our behavior. This human microbiome is increasingly seen as a target for new drugs, and is an essential tool for precision medicine.

Despite the crucial functions that microorgansms play, and the spectacular promise that they show for addressing challenges to environmental and human health, scientists know very little about how microbes interact with each other, their environments, and their hosts. This is in large part due to an absence of tools currently available that would “enable a mechanistic, predictive, and actionable understanding of global microbiome processes.” Addressing these technical limitations are central to the proposed UMI. The team calling for its formation describes a need for enhanced multi-disciplinary collaboration between physical, life, and biomedical sciences; engineering, and computer science in order to implement hypothesis-driven approaches that can establish causal relationships between microorganisms and their environments.

A second – and equally important – aspect of a UMI involves the need for enhanced collaboration between researchers who study different microbiome populations. Boundaries between scientists who investigate various microorganism communities are artificial and are largely due to historical divides between scientific disciplines, rather than reflecting fundamental differences between microbes that colonize a human mouth or the ocean floor. Furthermore, microbe communities are not limited to national borders but are instead part of a global microbiome. Indeed, the journal Nature contains an accompanying call for the creation of an International Microbiome Initiative to provide universal insight into the microscopic organisms all around and within us. (Alivisatos et al., Science; Dubilier, McFall-Ngai, & Zhao, Nature; Ed Yong, The Atlantic)

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November 6, 2015 at 9:00 am

Science Policy Around the Web – October 27, 2015

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By: Amy Kullas, Ph.D.

Drug pricing

After the price gouging by Turing, competitor announces it will offer $1 pill

Martin Shrkeli became infamous after he became CEO of Turing Pharmaceuticals and skyrocketed the price of a Daraprim pill, used to treat toxoplasmosis, from$13.50 to $750, a price hike of over 5000%! At that price, the Infectious Diseases Society of America had estimated that it would cost $336,000/year to treat a patient with toxoplasmosis. Turing acquired marketing rights for Daraprim from Impax Laboratories in August for $55 million; though it had initially been made and sold by GlaxoSmithKline for $1 a pill. The United States has no price control on medicines even though in they are common in Europe.

This move by Shrkeli and the news that other drug makers have bought the rights to old, cheap medicines that are the last resort for serious diseases subsequently raising prices has not only angered patients and physicians. It has triggered government investigations, heavy scrutiny by the media and a plunge in biotech stock prices, as well as becoming a political talk point in the upcoming election to fight “price gouging”.

However, there is a new player in the field. Imprimis Pharmaceuticals announced that it can make a ‘close, customized version’ of Daraprim for about $1 per pill. A current caveat is Imprimis’ formulation itself is not FDA approved, and can only be used when prescribed by a doctor for a particular patient. Imprimis CEO, Mark Baum, released the following statement that “Imprimis is forming a new program called Imprimis Cares which is aligned to our corporate mission of making novel and customizable medicines available to physicians and patients today at accessible prices.” (Maggie Fox, NBC news)

Infectious Diseases

Yersinia pestis has been plaguing humans for over 3000 years

In a recent article published in Cell, Rasmussen et al. published that the plague-causing bacteria Yersinia pestis (Y. pestis) DNA was found in human teeth from Asia and Europe dating from the Bronze Age or ~2500-5000 years ago. This is well before any record of plague. These scientists examined over 100 human skeletons and found that the teeth in seven tested positive Y. pestis DNA. The oldest skeleton was 5783 years old! The authors suggest, “plague may have shaped early human populations.” Their data implies that Y. pestis did not become the flea-borne mammalian pathogen it is today (by acquiring the ymt gene), until sometime in the first millennium BC, well before the historically recorded plagues. (Simon Rasmussen, et al, Cell and James Gallager, BBC News website)

Global Health/Infectious Diseases

Interview with Margaret Chan, director general the World Health Organization

On October 14, 2015, Kai Kupferschmidt, a contributing correspondent for Science, had the opportunity to interview the director general of the World Health Organization, Margaret Chan.  The previous week was the first week that there was not a single new case of Ebola reported. This Ebola outbreak has killed over 11,000 people in almost two years.

During the course of the interview, two discussed many aspects of the current outbreak, including the lack of an initial response and how critical it is to get proper resources to those who need most. She stressed that countries impacted by an outbreak should report the disease while countries not affected by the outbreak should not impose their own trade or travel restrictions other than those recommended by the WHO. Chan has said to the WHO’s member states, “If you want WHO to be strong and fit for purpose, keep your promises. Put your money where your mouth is.”

Unfortunately, the WHO reported two new cases of Ebola in Guinea only two days after the interview on October 16, ending a two-week period in which no new cases had been detected across West Africa. The WHO does not consider a region Ebola-free until 42 days, or double the potential incubation time, have passed without a new case. The other two countries, Liberia and Sierra Leone, which were also heavily impacted by this outbreak, are further out from their last reported cases: Liberia is has met the deadline and is considered Ebola-free, while Sierra Leone is over halfway through the 42 day time period. The 42-day guideline may in fact be just that ‘a guideline’ as the Ebola virus has been isolated from seminal fluid 82 days after symptom onset. (Kai Kupferschmidt, Science)

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October 27, 2015 at 9:00 am

Science Policy Around the Web – September 25, 2015

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By: Elisavet Serti, Ph.D.

Image courtesy of NIH Image Bank

Drug Policy

The new hepatitis C virus bottleneck: Can delaying therapy be justified?

Chronic Hepatitis C infection affects more than 3.2 million people in the United States, resulting in severe liver disease, cirrhosis, hepatocellular carcinoma and death. The FDA approval of the new anti-Hepatitis C direct acting antivirals marked a revolution in HCV therapeutics; it is now possible to offer patients safe and highly effective (more than 90%) alternatives to pegylated interferon and ribavirin. However, the high cost of these new treatment regimens has proven to be a major obstacle to their delivery. Twelve weeks of anti-Hepatitis C oral treatment costs between $80,000 and $95,000, and it has been estimated that total health care costs related to Hepatitis C therapy could soon reach $27 billion per year. As a consequence, many state-funded and private insurance programs have restricted access to direct acting antiviral-based therapy to patients with advanced fibrosis and extra-hepatic manifestations. In Texas, Medicaid has elected not to cover this type of therapy at all.

In a recent Hepatology editorial, the editors wondered about the potential burdens of this Hepatitis C therapy bottleneck that leads to exclusion of the majority of chronic patients due to high costs. The editors argue that “while persons with advanced fibrosis are clearly at higher risk for short-term complications, it is not clear that persons with lesser degrees of fibrosis are not at risk for harm.” A recent meta-analysis has demonstrated that rates of fibrosis progression may be far more accelerated than previously thought. This means that the option of delaying therapy runs the risk of progression to cirrhosis and development of hepatocellular carcinoma. The editors argue that delaying therapy could introduce the added burden of implementation of hepatocellular carcinoma or portal hypertension screening. Also, chronic Hepatitis C has been associated with a variety of extra-hepatic manifestations like diabetes, cardiovascular disease, psychiatric disorders, depression, renal dysfunction and rheumatologic conditions. This means that we should factor these extra-hepatic complications when calculating the cost effectiveness of the new Hepatitis C therapies. For these and several other reasons, the American Association for the Study of Liver Diseases (AASLD) – Infectious Diseases Society of America (IDSA) HCV guidance recommends that all infected persons should be treated.  (Tracy G. Simon and Raymond T. Chung, Hepatology)

Biomedical Research

Is the Alzheimer’s protein contagious?

A study recently published in Nature concluded that human transmission of amyloid-b pathology and cerebral amyloid angiopathy is possible. In simpler terms, they concluded that Alzheimer’s disease can be transmissible person-to-person, under special iatrogenic (or medical treatment) routes. The researchers examined the brains of eight people that had died of iatrogenic Creutzfeldt-Jakob disease (CJD) as a result of treatment with human cadaveric pituitary-derived growth hormone contaminated with prions. Prions are misfolded proteins with incubation periods that can exceed five decades. Human transmission of prions has occurred via medical and surgical procedures worldwide as well as via cannibalism in Papua New Guinea. Although treatment with cadaveric-derived growth hormone stopped in 1985, iatrogenic CJD continues to be found.

The researchers showed evidences of amyloid-β spread in the brains of these subjects, which is responsible for the development of Alzheimer’s disease, supporting the theory that the contaminated growth hormone injections could have contributed to the development of iatrogenic Alzheimer’s disease as well. It has never been reported in the past that amyloid-β protein can be transmittable through other medical procedures, such as brain surgery or blood transfusion. These results and their interpretation spurred criticism from several neuro-specialists and researchers who noted that the prions causing CJD can also trigger the formation of amyloid deposits in these brains. Still, there is no epidemiological connection between the contaminated growth hormone injections and the development of Alzheimer’s disease (Emily Underwood, Science Latest News).

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Written by sciencepolicyforall

September 25, 2015 at 9:00 am

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