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Science Policy Around the Web – March 7, 2017

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By: Allison Dennis, BS

Synthetic opiates

Opioid Crisis

Keeping up With the Synthetic Opioids

At the center of the opioid crisis is an ever-expanding class of would-be-regulated drugs, exploited for their ability to produce morphine-like effects. Opioids, including morphine, heroin, and oxycodone interact with the opioid receptors found on the surface of our nerve cells to trigger feelings of euphoria, and block pain. Unfortunately, these substances can adversely affect the respiratory rhythm generating area of the central nervous system, resulting in respiratory depression, effectively disrupting the body’s instincts to breathe.

In 2013, the U.S. Drug Enforcement Agency began to detect in confiscated supplies of heroin the synthetic compound, Fentanyl, which is 50 to 100 times more potent and carries a much higher risk of respiratory depression. The supply was traced to illicit online pharmacies in China, prompting Chinese officials to implement an export ban on fentanyl. Just as medical drug makers audition new compounds through structure-based drug design, illicit drug makers quickly modified the structure of fentanyl to produce furanyl fentanyl, temporarily circumventing the ban. This was followed by the production of the elephant tranquilizer, carfentanil. As of March 1, 2017, China has placed a ban on the sale and manufacture of these compounds along with acrylfentanyl and valeryl fentanyl.

However the dynamic that has emerged is a global game of whack-a-mole. Cutting off the global supply of fentanyl-derived compounds will require negotiations with individual governments to cooperate in their ban. Willing chemists in Mexico may already be setting up to fill the gap left by the ban in China. As each substance is entering the U.S. Drug Enforcement Agency’s radar, the list of designer fentanyls is expanding. The rotating portfolio of synthetic opioids has left local law-enforcement and coroners stumped as to how to test for drugs not-yet-known to their screens, leaving a critical lag in identifying local suppliers. (Eric Niler, Wired Magazine)

Influenza

Keeping up with the Neuraminidases

The H7N9 strain of bird flu may be gaining ground as a global threat to human health. On Monday, the U.S. Department of Agriculture confirmed the presence of a highly pathogenic H7 avian influenza strain in a flock of chickens in Lincoln County, Tennessee. The agency is hurrying to establish the neuraminidase protein type, or “n-type” of the virus. In combination with the H7 hemagglutinin type, an N9 would consign this virus to the class of influenza the WHO has described as “definitely one of the most lethal influenza viruses we have seen so far.”

First detected in China in 2013, the H7N9 strain has been the source of yearly epidemics of human infections. These infections are characterized by severe respiratory illness, which has lead to death in 40% of cases. Over 5 flu seasons, 1222 human cases of H7N9 flu have been confirmed. Most infections have been tied to direct exposure to poultry where the avian strain circulates, indicating that the virus is not currently suited for sustained person-to-person spread. However, the ability of these viruses to recombine, gaining new specificities, keeps public health officials watchful.

Following the first reports of H7N9 infections in humans in 2013, the U.S. Department of Health and Human Services amassed a 12 million-dose stockpile of H7N9 specific vaccines. However, the strains selected as the seeds for these vaccines may not adequately protect against the particular H7N9 virus circulating now.  The U.S. CDC is currently evaluating the need to update its vaccine stockpiles in addition to recommending inclusion of H7N9 in next year’s seasonal flu vaccine. Many researchers are hoping to circumvent these concerns with the development of a universal vaccine, protective against all known flu strains. (Helen Branswell, STATnews)

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March 7, 2017 at 9:02 am

Containing Emerging and Re-emerging Infections Through Vaccination Strategies

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By: Arielle Glatman Zaretsky, PhD

Source: CDC [Public Domain], via Wikimedia Commons

           Throughout history, humans have sought to understand the human body and remedy ailments. Since the realization that disease can be caused by infection and the establishment of Koch’s postulates, designed to demonstrate that a specific microbe causes a disease, humans have sought to identify and “cure” diseases. However, while we have been successful as a species at developing treatments for numerous microbes, viruses, and even parasites, pure cures that prevent future reinfection have remained elusive. Indeed, the only human disease that has been eradicated in the modern era (smallpox) was eliminated through the successful development and application of preventative vaccines, not the implementation of any treatment strategy. Furthermore, the two next most likely candidates for eradication, dracunculiasis (guinea worm disease) and poliomyelitis (polio), are approaching this status through the use of preventative measures, via water filtration and vaccination, respectively. In fact, despite the recent pushback from a scientifically unfounded anti-vaxxers movement, the use of a standardized vaccination regimen has led to clear reductions in disease incidence of numerous childhood ailments in the Americas, including measles, mumps, rubella, and many others. Thus, although the development of antibiotics and other medical interventions have dramatically improved human health, vaccines remain the gold standard of preventative treatment for the potential of disease elimination. By Centers for Disease Control and Prevention [Public domain], via Wikimedia Commons

Recently, there have been numerous outbreaks of emerging or reemerging infectious diseases. From SARS to Ebola to Zika virus, these epidemics have led to significant morbidity and mortality, and have incited global panic. In the modern era of air travel and a global economy, disease can spread quickly across continents, making containment difficult. Additionally, the low incidence of these diseases means that few efforts are exerted to the development of treatments and interventions for them, and when these are attempted, the low incidence further complicates the implementation of clinical trials. For example, though Ebola has been a public health concern since the first outbreak in 1976, no successful Ebola treatment or vaccine existed until the most recent outbreak of 2014-2016. This outbreak resulted in the deaths of more than 11,000 people, spread across more than 4 countries, and motivated the development of several treatments and 2 vaccine candidates, which have now reached human trials. However, these treatments currently remain unlicensed and are still undergoing testing, and were not available at the start or even the height of the outbreak when they were most needed. Instead, diseases that occur primarily in low income populations in developing countries are understudied, for lack of financial incentive. Thus, these pathogens can persist at low levels in populations, particularly in developing countries, creating a high likelihood of eventual outbreak and potential for future epidemics.

This stream of newly emerging diseases and the re-emergence of previously untreatable diseases brings the question of how to address these outbreaks and prevent global pandemics to the forefront for public health policy makers and agencies tasked with controlling infectious disease spread. Indeed, many regulatory bodies have integrated accelerated approval policies that can be implemented in an outbreak to hasten the bench to bedside process. Although the tools to identify new pathogens rapidly during an outbreak have advanced tremendously, the pathway from identification to treatment or prevention remains complicated. Regulatory and bureaucratic delays compound the slow and complicated research processes, and the ability to conduct clinical trials can be hindered by rare exposures to these pathogens. Thus, the World Health Organization (WHO) has compiled a blueprint for the prevention of future epidemics, meant to inspire partnerships in the development of tools, techniques, medications and approaches to reduce the frequency and severity of these disease outbreaks. Through the documentation and public declaration of disease priorities and approaches to promote research and development in these disease areas, WHO has set up a new phase of epidemic prevention through proactive research and strategy.

Recently, this inspired the establishment of the Coalition for Epidemic Preparedness Innovations (CEPI) by a mixed group of public and private funding organizations, including the Bill and Melinda Gates Foundation, inspired by the suggestion that an Ebola vaccine could have prevented the recent outbreak if not for the lack of funding slowing research and development, to begin to create a pipeline for developing solutions to control and contain outbreaks, thereby preventing epidemics. Instead of focusing on developing treatments to ongoing outbreaks, the mission at CEPI is to identify likely candidates for future outbreaks based on known epidemic threats and to lower the barriers for effective vaccine development through assisting with initial dose and safety trials, and providing support through both the research and clinical trials, and the regulatory and industry aspects. If successful, this approach could lead to a stockpile of ready-made vaccines, which could easily be deployed to sites of an outbreak and administered to aid workers to reduce their morality and improve containment. What makes this coalition both unique and exciting is the commitment to orphan vaccines, so called for their lack of financial appeal to the pharmaceutical industry that normally determines the research and development priorities, and the prioritization of vaccine development over treatment or other prophylactic approaches. The advantage of a vaccination strategy is that it prevents disease through one simple treatment, with numerous precedents for adaptation of the vaccine to a form that is permissive of the potential temperature fluctuations and shipping difficulties likely to arise in developing regions. Furthermore, it aids in containment, by preventing infection, and can be quickly administered to large at risk populations.

Thus, while the recent outbreaks have incited fear, there is reason for hope. Indeed, the realization of these vaccination approaches and improved fast tracking of planning and regulatory processes could have long reaching advantages for endemic countries, as well as global health and epidemic prevention.

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January 26, 2017 at 9:47 am

Science Policy Around the Web – December 9, 2016

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By: Amy Kullas, PhD

Infectious Diseases

Current Mumps Outbreak is the Worst in Recent History

2016 has been the worst in recent history for mumps outbreaks. According to a report released by the Center for Disease Control (CDC), almost 4,000 cases of mumps have been reported. This number is almost triple the number of cases reported in 2015. Mumps symptoms include: puffy cheeks and a swollen jaw (due to swollen salivary glands), fever, headache, tiredness, and loss of appetite.

In prevention of mumps, the measles, mumps, and rubella (MMR) vaccine is ~88% effective when a person gets both of the recommended doses and ~78% effective when a person received a single dose. The mumps vaccination program began in 1967. Prior to this, mumps was considered a ‘classical’ childhood disease in the United States. Some clinicians say, “the efficacy of the vaccine wanes after 10 to 15 years.”

Though mumps outbreaks can still occur in vaccinated communities (particularly in close-contact settings like colleges), high vaccination rates aids to limit the size, length, and spread of the outbreak. This ongoing outbreak is hard-hitting college campuses. In fact, some universities have scaled back dining hall hours in addition to asking students to “cancel nonmandatory social gatherings” in an attempt to thwart the infectious disease. Other universities have begun to recommend and offer a third dose of the mumps vaccine to students. (Melissa Korn, The Wall Street Journal)

Vaccination

Antivaxers Meet with Trump

Andrew Wakefield, the orchestrator of the “anti-vaccine movement”, met with Donald Trump this past summer. This misguided movement began with a paper published in 1998 by the now discredited Wakefield in The Lancet. The authors claimed that 2/3 of children developed autism soon after receiving the measles, mumps, and rubella (MMR) vaccine. Though this study has been disproven numerous times and has been retracted, the impact still flows not only through the scientific community, but also into the general public. This is why the scientific community cringed when Trump appeared to be sympathetic towards their cause.

When parents refuse to vaccinate their children, they cite the belief that vaccines cause autism or state that vaccines are “unnecessary”. Vaccination is an extremely effective strategy for preventing infectious diseases. However, this strategy is only successful when the vast majority of individuals are immunized against a particular pathogen in order to offer some protection to individuals who are not medically able to receive the vaccine.

Wakefield stated, “For the first time in a long time, I feel very positive about this, because Donald Trump is not beholden to the pharmaceutical industry. He didn’t rely upon [drug makers] to get him elected. And he’s a man who seems to speak his mind and act accordingly.” While Trump has appeared to be interested and open-minded on vaccines, there are limits to what he can do to undercut vaccination policies. But the antivaxers remain hopeful that Trump will be a powerful ally who would trigger more of a cultural impact as opposed to passing laws. (Rebecca Robbins, STAT news)

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December 9, 2016 at 9:40 am

Eradicating global infectious disease: Two steps forward and one step back?

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By: Jessica Hostetler, PhD

Source: CDC

The world made some good progress recently toward controlling or eliminating several diseases. Such gains are often long and hard fought. Vaccines are often a primary tool for eliminating diseases, which makes the rise in vaccine scepticism in many developed nations all the more troubling and fears of disease resurgences and outbreaks all too real.

The good news for disease control started in July with the commendation from the World Health Organization (WHO) to India for its work in eliminating yaws earlier in May of 2016. Yaws, often described as a “forgotten disease,” is a chronic skin disease caused by the bacterium Treponema pallidum, which is closely related to the organism that causes syphilis. It affects primarily children in poverty-stricken, crowded communities in about 13 countries with limited access to clean water, sanitation, and healthcare and can lead to severe disfigurement if not treated. Yaws is treated by a single dose of oral (Azithromycin) or injected (Benzathine penicillin) antibiotic. India tackled yaws through a campaign spanning years. “Highly targeted awareness and early treatment campaigns in vulnerable communities enabled treatment of yaws cases and interruption of disease transmission,” said Dr. Khetrapal Singh, the WHO Regional Director for South-East Asia in a WHO July press release. The success in India as the first country to eliminate yaws under the 2012 WHO neglected tropical diseases (NTD) roadmap gives renewed momentum toward global eradication in the remaining yaws-endemic countries by 2020.

More good news followed on September 5th with the announcement from WHO that Sri Lanka is now free of malaria. It is a large turnaround from the historical burden of the disease which was as high as 5 million cases per year in the 1930’s followed by a highly successful elimination program resulting in only 17 recorded cases in 1963. However, due to multiple factors, potentially including “human migrations, asymptomatic parasite-carriers, vector-reintroduction, behavioural changes in the vector and the emergence of drug and insecticide resistance,” cases soared again to half a million or more cases per year in the 1970s and 1980s. With a renewed focus on global malaria elimination in the 2000s, Sri Lanka has become a remarkable success story. As laid out in the WHO September press release, Sri Lanka’s strategy for elimination included targeting the parasites and the mosquitoes transmitting them through “mobile malaria clinics in high transmission areas” to give “prompt and effective treatment,” which reduced disease transmission and the parasite reservoir. Work such as this requires large teams of people for “effective surveillance, community engagement and health education.” But given Sri Lanka’s proximity to India, where malaria is still endemic, active surveillance for newly introduced cases will be essential to keep the disease at bay.

On September 27th, 2016, the Pan American Health Organization (PAHO) certified that the region of the Americas is free from endemic measles. This news isn’t strictly “new” as the last locally transmitted case of measles in the Americas occurred in Venezuela in 2002. Certification as being disease-free is a long process, however, and the Americas continued to experience over 5000 imported measles cases between 2003 and 2014, necessitating careful documentation to ensure local transmission had ended. Measles is a highly contagious virus and causes fever and a characteristic rash. It can lead to severe symptoms including “pneumonia, brain swelling and even death.” This is a historical success, but the WHO reports that measles still caused over 100,000 deaths globally, mostly children, in 2014. Continued vigilance and worldwide vaccination compliance are needed to maintain gains and reduce the disease where it still spreads endemically.

Such good news represents decades of hard work from international organizations, national governments and NGOs and many field workers on the ground. These efforts represent the best of humanity in working to alleviate suffering and eradicate disease. One of the primary tools in the fight against infectious diseases remains the development and mass administration of vaccines. In the US, vaccination skepticism has been growing for years on the heels of a now-retracted study in The Lancet in 1998 that proposed a link between the Measles-Mumps-Rubella (MMR) vaccine and the development of autism. While there is no evidence that vaccinations or vaccine ingredients cause autism in any way, the paper caused lasting damage to the public perception of vaccinations. A recent study examining American Academy of Pediatrics Periodic Surveys from 2006 and 2013 reports that while most parents no longer cite autism as a reason for avoiding vaccines for their children, many are now avoiding vaccinations because they are “unnecessary.” An increasing number of pediatricians (up from 6% in 2006 to 11% in 2013) report always dismissing patients for “continued vaccine refusal” citing both a lack of trust in the physician-patient relationship and concern for other patients as primary reasons. Non-compliance with vaccinations is largely viewed as the driver behind an outbreak of measles in and around the Disneyland resort in California in 2014-2015 as 67% of those with infections (who were vaccine eligible) “were intentionally unvaccinated because of personal beliefs.” Vaccination rates in some California communities had fallen below the level required for protection of the population; this spurred a controversial tightening of regulations requiring vaccinations for all public-school educated children with no exemption for religious or personal beliefs.

The international news is even more concerning with a recent global survey (with a commentary in Science) looking at attitudes toward vaccination showing that 41% of respondents from France and 31% of respondents from Japan disagreed with the statement that vaccines are safe. Russia had the highest scepticism about the importance of vaccines at 17%. The survey notes that “Countries with high levels of schooling and good access to health services are associated with lower rates of positive sentiment, pointing to an emerging inverse relationship between vaccine sentiments and socio-economic status.” The WHO reports that vaccines prevent 2-3 million deaths per year from diphtheria, tetanus, pertussis (whooping cough), and measles, but that as many as 1.5 million children under the age of 5 died from vaccine-preventable diseases in 2008. Vaccine-scepticism and outbreaks from vaccine non-compliance represent an alarming and avoidable threat as we aim to eliminate vaccine-preventable diseases from the world. As a perspective by Dr. Douglas S. Diekema in the New England Journal of Medicine notes, we must set a high goal in the US and globally to improve childhood vaccination rates through increased and free access to vaccines, but also swift rebuttals of unbalanced or incorrect reporting on vaccinations. The physician-patient relationship may offer the best opportunity to educate and “influence the vaccine-hesitant.”

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October 21, 2016 at 9:34 am

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Science Policy Around the Web – June 17, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Biomedical Research Funding

NIH gets $2 billion boost in Senate spending bill

The Senate approved a $2 billion dollar boost to the National Institutes of Health (NIH) budget for the 2017 fiscal year. This will increase the agency’s overall budget to $34 billion which represents a 6.2% increase from the previous year. This boost in funding represents an increase to NIH’s funding for the second year in a row after more than a decade of stagnate funding. NIH received an additional $2 billion last year.

The increase to NIH’s funding is the result of bipartisan negotiations between Senate Labor, Health and Human Services, and Education Appropriations Subcommittee Chairman Roy Blunt (R.-Mo.) and Ranking Member Senator Patty Murray (D-Wash.)

“Last year, for the first time in 12 years, we were able to have an increase in [funding to support] NIH research,” Blunt said at a subcommittee meeting to unveil the budget proposal. “We have worked hard to repeat that this year.” Adding that he hopes to establish a pattern of increases for health research funding, he further noted that “if you are going to have an annual pattern, year two is critical. So we’re proposing for the second year in a row we make a substantial commitment to NIH research.”

The bill will include $1.39 billion for Alzheimer’s disease research, a $100 million increase for Obama’s Precision Medicine Initiative, an additional $100 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) brain-mapping project, and $50 million in new spending for a federal initiative to combat antimicrobial resistance. Not mentioned is the $670 million proposal for Vice President Joe Biden’s proposed moonshot to double progress against cancer. (Jocelyn Kaiser, ScienceInsider)

Federal Accountability

House sharpens oversight of new NSF facilities

The U.S. House of Representatives approved bill H.R. 5049 by a vote of 412 to nine which would direct the National Science Foundation (NSF) to audit its major multi-user research facilities. This bill was passed in response to the problems that have plagued NSF’s National Ecological Observatory Network (NEON) under construction at dozens of sites across the country. Last December NSF fired the contractor, NEON Inc., citing a potential $80 million cost overrun and continued delays in completing the project.

The passage of the NSF Major Research Facility Reform Act of 2016 would direct the NSF to audit its major multi-user research facilities in order to prevent such cost overrun problems in the future. The Congressional Budget Office estimates that conducting these audits required by the legislation would cost about $2 million annually and $10 million over the 2017-2021 period. Specifically, the bill would require NSF to analyze how much every large research project would cost by the first year of the start of construction.

NSF officials remain concerned on how these changes in legislation would affect how audits are conducted and the use of management fees for a contractor. Such additional restrictions on management fees could potentially scare off some highly qualified would-be bidders for future projects. In addition, they believe that the proposed audits would not have caught the problems that NEON faced. (Jeffrey Mervis, ScienceInsider)

Infectious Diseases

Zika virus added to the FDA Priority Review Voucher Program Act

U.S. Senators Amy Klobuchar (D-Minn.) and Al Franken (D-Minn.) supported emergency funding to help stem the spread of the Zika virus in the United States. Over $1 billion in emergency funds passed the Senate today on a bipartisan basis to help mitigate the spread of Zika and respond to outbreaks of the virus.

“The Zika virus is a real threat, and we need action to curtail its spread and encourage the development of treatments and a vaccine,” said Franken. “This emergency support will help fight back against the disease, and now, we need to work with the House of Representatives and with President Obama to make sure that the funding measure becomes law. This is far too important of an issue to ignore.”

The Centers for Disease Control has reported that over 150 pregnant women in the U.S. have been diagnosed with Zika virus, which can cause a range of birth defects including devastating neurological defects. There are currently no known treatments or vaccines for the disease. The funds will be used to control mosquitos that carry the Zika virus, raise awareness of Zika virus disease, provide education on how to reduce risk of becoming infected, and accelerate development of a vaccine. (Congressional Research Service)

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June 17, 2016 at 9:00 am

Science Policy Around the Web – August 28, 2015

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By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Drug Policy

FDA approves drug for female libido amid controversy and lingering questions

On August 18, the FDA approved the drug flibanserin to treat female sexual dysfunction. Flibanserin, which will be sold under the brand name Addyi, has been billed as “female Viagra” and as a remedy for Female Sexual Interest/Arousal Disorder. With its recent approval, flibanserin becomes the first drug approved to specifically address female sexual problems, compared to the 26 pharmaceuticals approved for this purpose in men. Indeed, highlighting this stark gender inequality in treatment options was instrumental in the drug’s FDA approval. Sprout Pharmaceuticals, Addyi’s manufacturer, joined with non-profit and health care organizations in 2013 to form Even The Score, an advocacy organization that waged a hugely successful lobbing campaign to seek FDA approval of flibanserin by framing its approval as one “women’s sexual health equality.” Critics say that an accusation that the FDA is biased against women, championed by Even The Score, had greater influence on the drug’s approval than did data on the compound’s efficacy and safety. Addyi was found to have an effectiveness rate of between 8 and 13 percent, and led to side effects ranging from dizziness to sudden drops in blood pressure that were exacerbated by alcohol or hormonal contraception. Flibanserin will carry a warning that it can not be taken with alcohol, despite the odd fact that the alcohol safety study submitted to the FDA by Sprout Pharmaceuticals listed 23 of the 25 participants as men. This has led to lingering questions about how women – the intended users of the drug – would react to a flibanserin alcohol interaction, particularly because, unlike Viagra, Addyi is taken daily rather than just before a sexual encounter. The mild effectiveness of flibanserin, combined with concerns about its safety, resulted in two prior rejections of FDA approval prior to the third successful attempt. Addyi comes to market in October 2015. (Cari Romm, The Atlantic; Editorial, Nature)

Health Policy

A universal flu vaccine may soon be a reality

Every fall, millions of people are vaccinated against the flu with vaccines that are developed by scientists who predict which influenza strains are most likely to be problematic that particular year. New shots are required every year because there are thousands of influenza strains that constantly mutate, and one shot cannot protect against them all. Sometimes, the predictions are correct; sometimes, like in 2014, they miss the mark and tens of thousands of US citizens die from influenza. Furthermore, because flu vaccines are currently based on portions of the influenza virus that evolve throughout the flu season, protection is not guaranteed. Two independent groups of scientists have recently reported considerable progress towards a universal flu vaccine by using a novel approach. Both labs targeted hemagglutin, a protein found on the surface of the H1N1 influenza virus, that is composed of a head region that mutates and varies between different flu strains, and a stem region that is constant between different strains and does not mutate.

The two reports – published in Nature Medicine and Science on Wednesday, August 26 – employed different molecular engineering techniques to stabilize the stem portion of hemagglutin when it is isolated from the head region, thus producing a stable structure for the vaccine that is common between different strains. This new method resulted in almost 100% immunity in mice against the lethal H5N1 flu strain, which is distantly related to the H1N1 strain, and partial protection in ferrets and non-human primates. More research is needed to determine whether immunity extends to other strains of the influenza virus, as well as to determine the degree of protection in humans using a vaccine derived with these new approaches. (Hanae Armitage, Science; The Economist)

Public Health and Drug Control Policy

Illicit Version of Painkiller Fentanyl Makes Heroin Deadlier

An extremely potent opioid analgesic called fentanyl, often administered prior to surgical procedures or prescribed for severe cancer-related pain, is increasingly being added to heroin and causing deadly consequences for heroin users across the United States and Canada. Fentanyl is 30-50 times more potent than heroin, and nearly 80-100 times more potent than morphine, and results in a drug combination that is much stronger than what heroin users expect to be administering. The flood of fentanyl-laced heroin is exacerbating the ongoing epidemic of heroin-related overdose deaths, as authorities in some states report a more than 600% increase in fentanyl-related deaths from 2013 to 2014, and see no sign of a slowdown. Drug dealers are increasingly adding fentanyl to heroin in order to restore the potency of the drug that’s been previously diluted by those higher in the distribution chain. Law enforcement officials and policymakers are scrambling to keep pace with the problem. In the past two years, Mexican drug cartels have increased production of a synthetic form of the compound, acetyl fentanyl, that is not yet included in many screens for toxic drugs in the US, and is currently classified as a banned substance in only a few states. Last year the US DEA added acetyl fentanyl to its list of federally banned substances, and in March 2015 the agency issued a warning that fentanyl poses a “threat to health and public safety.” Drug enforcement and public health authorities are attempting to boost public awareness of the dangers of fentanyl-laced heroin, and are alerting local communities when a compound drug batch is detected. (Fred Bever, NPR; Nadia Whitehead, NPR)

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August 28, 2015 at 9:00 am

Science Policy Around the Web – February 10, 2015

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By: Agila Somasundaram, Ph.D.

photo credit: ynse via photopin cc

Precision Medicine

The Problem with Precision Medicine

President Obama unveiled the Precision Medicine Initiative last week. Precision medicine, i.e. personalized, genetics-based medical treatments, would deliver “the right treatments at the right time, every time, to the right person.” But is the science ready for it? DNA testing is increasingly used to detect and treat various diseases, including cancer and birth defects, and the cost of genetic analyses has dropped significantly. But many doctors are not qualified enough to correctly interpret the data, make the right connections between DNA and disease, and successfully communicate it to their patients. Incorrect diagnoses based on genetic data are common. Children have been mistakenly diagnosed with serious syndromes. Sometimes mistakes can cause greater harm than just increasing anxiety of patients or their loved ones. In 2012, The Cancer Journal described the case of a woman who underwent major surgery because her genetic-test results were not interpreted correctly. There is a paucity of genetic expertise among physicians, partly because most of the currently practicing physicians went to medical school before the human genome was sequenced, when only a handful of genes had been identified/associated with diseases. “It’s very complicated, especially for generalists, who have a million other things on their minds besides genetics,” says Mary Norton, a clinical geneticist at the University of California, San Francisco. Doctors could seek help from specialists, but there is a dearth of trained medical geneticists, so doctors end up receiving instructions from companies that are pushing their products without adequate proof of their efficacy. A survey published in the journal Genetics in Medicine reported that a majority of the participants do not fully understand genetic test results or devote sufficient time to discuss outcomes with patients. MedSeq, launched by Robert Green, a medical geneticist at Brigham and Women’s Hospital and Harvard Medical School, is an example of an initiative that educates physicians about genetic testing. Martin Solomon, a MedSeq participant and a physician at Brigham and Women’s, says genetics is simply a new tool with a learning curve, like the electrocardiogram. But Mary Norton does not think that it is that simple. Given the pace of genetics research, the variability of test methods and results, and the companies’ marketing strategies, she says that though “over time everyone will come to have a better understanding of genetics… It will probably be a bit worse before it gets better.” (Cynthia Graber, The New Yorker)

 

Vaccines

Psychological Biases Play A Part In Vaccination Decisions

Why do some people choose not to vaccinate their children? The recent outbreak of measles in the US has triggered discussions around this topic. Misinformation is one reason – people’s belief that there is a link between vaccines and autism. But what might be the psychological biases that contribute to parents not willing to ‘intervene’ on their kids? Omission bias might be playing a role here, where parents judge vaccination (an action) as more harmful to their kids than failing to vaccinate (an omission) even if the risks associated with vaccination are lower than that from not vaccinating their children. People also exhibit this omission bias to varying degrees. A study published in the journal Medical Decision Making in 1994 showed that parents who objected to vaccinating their kids were more likely to think that vaccinating was more dangerous than not vaccinating their kids. Participants were asked if they would vaccinate their child under 3, in a hypothetical situation, if 10 out of 10,000 kids not vaccinated will die from the flu, while vaccination could have a fatal side effect on 5 out of 10,000 children. If a straight assessment of risk is done, parents should have opted to vaccinate their kids. But the study showed that parents who did not believe in vaccination had a lower mean ‘tolerable risk’ than parents who did not object to the vaccine. In other words, they would vaccinate their children only if the hypothetical vaccine had a risk of 2.4 deaths per 10,000 (even though the risk from the flu itself is 10 in 10,000), while the parents who were not opposed to vaccinating their kids had a mean tolerable risk of 5.4 deaths per 10,000. To vaccinate their children, both sets of parents needed a higher risk from the disease than from the vaccine itself, but the gap was greater for the non-vaccinators. One reason could be that the non-vaccinators did not wish to ‘intervene with nature.’ Another reason could be causal responsibility for a death resulting from an action (vaccination) versus an omission (failure to vaccinate). And lastly, a related reason could be anticipated regret – parents who feel they would be causally responsible for negative consequences of vaccination also anticipate feeling greater regret about having vaccinated their children if something went wrong. But how do we define ‘act’ and ‘omission’? The author concludes that merely educating people about the benefits of vaccinations maybe insufficient to change peoples’ attitudes. However, in a society where vaccination is the norm, and not vaccinating the exemption, interpreting failure to vaccinate as the deliberate ‘act’ could have some positive effects. (Tania Lombrozo, Psychology professor at the University of California, Berkeley, NPR)

 

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February 10, 2015 at 11:12 am

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