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Science Policy Around the Web – November 13, 2018

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By: Mohor Sengupta, Ph.D.

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Source: Max Pixel

 

Is The Pentagon Modifying Viruses To Save Crops — Or To Wage Biological Warfare?

Defense Advanced Research Projects (DARPA), a US government agency, has recently been accused of trying to develop bio-weapons on the pretext of using plant viruses and insect vectors to edit crop genes. Dr. Blake Bextine, who is the program manager of the 2016 “Insect Allies” program of DARPA has stated that using virus infected insects to deliver genes to crops, also known as horizontal transfer in scientific jargon, is a potentially powerful and quick measure to protect crops against sudden, unforeseen environmental offenses like drought. Alternative vectors currently in use, such as insecticide sprays, and plant genetic modification strategies, including vertical gene transfer, are either not robust or take several crop generations to become fully functional, he argues. On the other hand, the Insect Allies program’s three-step technical workflow, viral manipulation, insect vector optimization, and selective gene therapy in mature plants, will ensure a quick result, effectively within a generation.

The new plan by DARPA has resulted in international concerns about the ulterior motive for developing viral carriers to infect plants. An editorial published in Science last month by Richard Guy Reeves from the Max Planck Institute for Evolutionary Biology, in Germany, explicitly states that the DARPA program could be used for potential development of biological weaponry targeting crops of enemy nations. The editorial discusses the profound environmental, biological, economic and social implications of dispersing such horizontal environmental genetic alteration agents (HEGAAs) into ecosystems. Silja Voeneky from University of Freiburg in Germany, who is an expert in international law and a co-author of the commentary, states that according to the Biological Weapons Convention (BWC), which USA ratified in 1975, use of living organisms are banned as war weapons. She doesn’t believe that the proposed Insect Allies program by DARPA will be exclusively restricted towards benefitting crops.

The most important concern raised in the commentary is the proposed use of insects to infect the crops with genetically modified viruses. The authors have questioned the use of insects, a potential bio-weapon, against simpler methods of dissemination, like sprays. The plan by DARPA to use infected insects is probably its response to similar, covert initiatives already in development by other nations towards bio-weaponry, the commentators believe. On the other hand, the authors also see the unveiling of Insect Allies program as the initiation of efforts from various nations to develop similar strategies. Effectively, it has opened the Pandora ’s Box.

Meanwhile, the program is in full swing with DARPA-funded scientists from several institutes participating in the research that will develop the HEGAA technology. One of them, Jane Polston from University of Florida, points out that the new technology can be used in many ways, including ones she can’t predict.

DARPA denied the assertions made by Reeves and his colleagues, stating that they acknowledge that the new technology can have potential dual use but they also have numerous, layered safeguards in place, to maintain biosecurity.

(Dan Charles, NPR)

 

Drug for rare disease disappoints in key trial

Niemann-Pick type C disease (NP-C) is a rare genetic disorder where lipid molecules accumulate in various tissues, like brain, liver or spleen, instead of being recycled or cleared. This inherited condition affects infants, children and adults and an estimated one in 120,000 live births has this condition. The symptoms may vary depending on the organ that has the lipid deposits. Some of the common symptoms are prolonged jaundice, enlarged liver or spleen, learning difficulties and psychiatric problems. Young patients with NP-C commonly present symptoms such as difficulty in maintaining posture and balance and difficulties in swallowing. NP-C is, however, progressive and ultimately fatal.

Mallinckrodt Pharmaceuticals, a USA based company headquartered in St. Louis, Missouri, had been carrying out a 52 week clinical trial of the efficacy of a cyclodextran  (sugar molecule) VTS-270 to limit the progression of NP-C. VTS-270 was brought into clinical trials jointly by National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH) in Bethesda, Maryland and Vtesse, an orphan drug developer based in Gaithersburg, Maryland, that funded the first clinical trial of the drug at the NIH Clinical Center. Vtesse was acquired by Sucampo Pharmaceuticals in March 2017, which, in turn, was acquired by Mallinckrodt, along with the pipeline of the pivotal VTS-270 phase 2/3 trial, earlier this year.

The trial recently came to a disappointing conclusion when no difference in clinical outcomes was found in treatment and placebo groups. The news was first circulated by investors of Mallinckrodt, through whom the families of trial participants came to know of the study results. It was a huge disappointment for these families to learn that this drug was found to be ineffective, after months of invasive treatment and some positive effects observed in several participants.

Steven Romano, the executive vice president of Mallinckrodt and its chief scientific officer told investors on a conference call on last Tuesday that although the expectation was that the treatment group would show slower disease progression than the control group, the study results surprisingly showed that the disease in both groups progressed at a similar rate during the study period, with was lower than the expected rate of progression without any treatment.  

Like most clinical trials, the VTS-270 study used traditional double-blinded and randomized control trial (RCT) statistics to arrive at their conclusions. Also, the participants were assessed only during the 52 week window of the trial, where they received spinal injections of the drug or placebo every two weeks. There are some anomalies in this research protocol, say researchers in the field. A double-blinded, RCT might not be the best method to study extremely rare diseases, where symptoms could overlap vastly with other disorders, leading to a general under-reporting. They say that the “difficulty of enrolling patients may prevent traditional trials from having enough statistical power to achieve predefined statistical significance, even when the experimental agent is actually effective”.

Dr. Mark Patterson, a child neurologist at Mayo Clinic in Rochester, Minnesota, says that the same drug was shown to be effective in studies involving mouse and cat model of the disease. He thinks that the treatment might be effective in some children, but not all of them. Moreover, observing the trial participants only during the one year trial window is not an effective assessment of the disease progression, particularly for a slow-progressing disease like NP-C, he believes. Progression should have been assessed before the commencement of the trial and followed up after the end of the trial to detect an effect of the trial medication versus placebo.

Dr. Patterson has suggested that the FDA should consider setting a different “bar” while assessing therapies for extremely rare and individually variable diseases, like NP-C.

(Meredith Wadman, Science)

 

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November 13, 2018 at 9:07 pm

Science Policy Around the Web – November 9, 2018

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By: Neetu M. Gulati, Ph.D.

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Source: Pixabay

 

 The FDA just approved the first new flu treatment in nearly 20 years

In the midst of flu season, there is a new treatment option available for the first time since 1999. On October 24, 2018, the FDA approved the use of a new antiviral drug Xofluza (baloxavir marboxil), for the treatment of influenza (flu) in patients 12 years of age and older who have been symptomatic for fewer than 48 hours. The drug is taken as a single oral dose, and is expected to shorten flu symptoms by more than a day. Now that it has been approved, Xofluza should be available within the next few weeks for purchase according to Genetech, which distributes the medication in the US.

The flu is one of the most common infectious diseases, resulting in 3 to 5 million severe cases annually worldwide. Last year the flu season was particularly deadly, resulting in nearly 80,000 deaths in the US alone according to the CDC. This could be due to a mismatch between the available flu vaccine and circulating strains of the influenza virus. However it could also be attributed to the fact that only about 4 out of every 10 Americans received the flu vaccine during the 2017 season. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Dr. Scott Gottlieb in a news release about the drug.

Xofluza, the first in a new class of antivirals for treating flu, acts differently than previously approved antiviral medications like Tamiflu. While both classes of antivirals  shorten the duration of infection and can reduce flu symptoms, they have different ways of killing the virus. Xofluza acts by inhibiting the cap-dependent endonuclease protein of the influenza virus, which is essential for viral replication, thus stopping the spread of infection.

This new medication offers a promising new treatment option for individuals with the flu. Nevertheless, Gottlieb warned that antiviral medications like Xofluza are not an alternative to getting vaccinated, saying, “seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

(Angelica LaVito, CNBC)

 

New generation of ‘flow batteries’ could eventually sustain a grid powered by the sun and wind

 

Renewable energy sources have become increasingly popular in recent years. Advancements in renewable technologies lay the groundwork towards a cleaner and more sustainable future. These renewable sources, such as wind and solar power, depend on nature to comply with the energy needs of the masses. But what happens when the sun isn’t shining? In that case, energy companies could turn to a new technology called flow batteries, large devices capable of storing enough electricity to power thousands of homes for many hours.

Flow batteries use tanks of liquid electrolyte that store electric charge. The electrolyte is pumped through electrodes to extract electrons used in electricity, and then spent electrolyte then returns to the tank. When solar panels or wind turbines provide electrons, the pumps push spent electrolyte back to the electrode, where it is recharged and returned to the holding tank. These batteries typically rely on an expensive and rare metal called vanadium for the electrolyte component. Alternatives to vanadium such as zinc-bromine and organic molecules are often short-lived or toxic, limiting their use. However, the price of vanadium has risen in recent years, and so the cost of these batteries may rise as well. The current market for flow batteries is about $230 million and is predicted to grow to nearly $1 billion by 2023.

There is a need for cheap, long-lived, safe alternatives to vanadium in flow batteries. Recently researchers reported developing an organic electrolyte that is much longer-lived than previous attempts at organic liquid electrolytes; this material loses only 3% of its charge-carrying capacity per year. This is a significant improvement over previous organic flow batteries, but still may not be good enough for commercial use. Another alternative electrolyte is iron. Iron is cheap and can grab and give up electrons. However, iron-containing flow batteries currently on the market must be operated at very acidic pH, which raises concerns about environmental damage in the case of a battery leak. Now, researchers have developed iron-containing flow batteries that can be kept at neutral pH. Furthermore, this flow battery shows no signs of degradation after the equivalent of 3 years of use. However, they are less energy-dense than vanadium flow batteries, somewhat limiting their usefulness.

These improvements in battery technology are provide hope for supporting the renewable energy moving forward. However, it remains unclear which electrolyte chemistry, if any, will win out. There is great potential for innovation and growth, but scientists are undoubtedly making progress.

 

(Robert F Service, Science)

 

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November 9, 2018 at 4:16 pm

Science Policy Around the Web – November 6, 2018

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By: Patrick Wright, Ph.D.

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Source: Pixabay

FDA

FDA says it will consider approval of first dengue vaccine, despite controversy

Dengvaxia is the world’s first licensed vaccine against dengue, and has recently entered the FDA review process. Upon starting the review process the company behind the drug, Sanofi Pastuer, received notice of priority review from the U.S. Food and Drug Administration (FDA), meaning a decision will be made regarding its status within six months. Despite the expedited review and the vaccine’s promise in the fight against dengue, there remain concerns around its safety.

There are 400 million infections of dengue a year worldwide. It is transmitted via mosquito bite and can cause high fever, severe headache, hemorrhage, and death. Although it is uncommon on the U.S. mainland, there are notable and not-insignificant levels of infection in U.S. territories, including Puerto Rico, Guam, and the U.S. Virgin Islands. In Puerto Rico, for example, 3,000-9,000 suspected cases are reported during non-outbreak years. Since 1990, there have been four large epidemics, with one as recent as 2010, in which almost 27,000 cases of suspected dengue were reported.

Dengvaxia targets all four serotypes of dengue. Infection with one is not protective against subsequent infection, and in fact the risk of having severe dengue is highest during a person’s second infection due to a phenomenon called antibody-dependent enhancement (ADE). ADE occurs when preexisting antibodies from an initial dengue infection find a viral particle from a new infection. These antibodies do not neutralize the new virus, instead allowing the new virus to infect target cells (e.g. monocytes) more efficiently. While Dengvaxia is currently licensed in 20 countries, it is only available in 10.

In November 2017, Sanofi reported that the vaccine raised the risk of severe disease in children without prior dengue infection. These data showed that children who were vaccinated after at least one dengue infection were protected by the vaccine; it lowered the risk of hospitalization for severe infection. However, in children with no history of dengue, the vaccine not only acted like a first infection, but also made any future infection of dengue more severe.

Sanofi’s findings drove the Strategic Advisory Group of Experts on Immunization of the World Health Organization (WHO) to recommend that the vaccine be given only to people who have had a previous infection. In a September 2018 position paper, the WHO stated “…countries should consider introduction of the dengue vaccine CYD-TDV [Dengvaxia] only if the vaccination of seronegative individuals can be avoided”.

Because many people infected with dengue experience mild to no symptoms, they often do not see seek formal medical care. This is especially problematic in light of the necessity for a confirmed previous infection in order to receive the vaccination. This will require people to be tested for the presence of antibodies (indicating a prior infection) before receiving vaccination, or to have a documented laboratory confirmed history of dengue infection. These concerns must be balanced against the potential widespread positive impact that dengue vaccination could have all over the world.

(Helen Branswell, StatNews)

FDA

Despite Warnings, FDA Approves Potent New Opioid Painkiller

On October 12th,  the Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to approve Dsuvia (sufentanil), a powerful opioid painkiller produced by AcelRx. The Committee assesses a drug’s safety and efficacy to guide Food and Drug Administration (FDA) decisions, and following the vote the FDA approved Dsuvia.

Notably, the committee convened in the absence of the Committee’s Chair, Dr. Raeford Brown, who had previously expressed concerns regarding opioid approval, and without the full attendance of the FDA’s Drug Safety and Risk Management Advisory Committee. Dr. Brown, an anesthesiologist at the University of Kentucky, disagrees with the approval of the drug, saying that he does not “think this [Dsuvia] is going to help us in any way”. He was unable to attend the meeting due to a scheduling conflict that he had informed the FDA about months in advance, but the meeting was held anyway. Dr. Brown stated, “I have strong feelings about the opioid crisis, as someone who lives in the Commonwealth of Kentucky. My forthright nature may have played a role in their decision about how the agency was going to manage this advisory committee.”

Before the FDA’s final decision, four U.S. senators, Claire McCaskill (D-Missouri), Ed Markey (D-Massachusetts), Joe Manchin (D-West Virginia), and Richard Blumenthal (D-Connecticut) sent a letter to the FDA’s commissioner, Scott Gottlieb, asking the FDA to deny approval to Dsuvia until the full drug safety committee and Brown were allowed to participate. The letter states: “Given the tragic arc of the opioid epidemic, it is imperative that the FDA thoroughly and completely vet any new opioids or formulations of existing opioids through a robust, transparent, and fair process. We do not believe the FDA’s process for Dsuvia has remotely met this standard.”

Dr. Pamela Palmer, an anesthesiologist and co-founder of AcelRx, argues that the risk of Dsuvia ending up with people who are not prescribed the drug (known as diversion) is low given that it will not be dispensed to patients via pharmacies; it will be only provided by health care providers directly in medical centers, such as hospitals, surgical centers, and emergency departments. AcelRx describes Dsuvia as filling a unique niche given that it is delivered sublingually (e.g. instead of injection) and is fast-acting. Dr. Palmer stated that the Department of Defense helped fund the company’s research because of Dsuvia’s potential use on the battlefield as an alternative to morphine. Sufentanil is as much as 10 times more potent than its parent drug, fentanyl, and hundreds of times more potent than morphine.

FDA Commissioner Gottlieb issued a statement on November 2nd discussing the ongoing issue of balancing the opioid crises with patients’ needs for pain management. He stated that the true underling source of discontent among critics of Dsuvia’s approval is “…the question of whether or not America needs another powerful opioid while in the throes of a massive crises of addiction. It is an important question that has surfaced in past approval decisions and will come up again in the future. We owe it to Americans who want the FDA to do our part to help end one of the biggest addiction crises of modern times, while we carefully balance these grave risks against patient needs.”

(Jake Harper, NPR)

 

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November 6, 2018 at 3:44 pm

Science Policy Around the Web – April 27, 2018

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By: Michael Tennekoon, PhD

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source: pixabay

Productivity of Science

Is Science Hitting a Wall?, Part 1

Scientific research is hitting a wall- that’s the view from a recent study published by 4 economists.  The famous metric where the density of computer chips doubles every 2 years, now takes 18 times the number of researchers to accomplish. This pattern also extends to other areas of research as well. For example in medicine, “the numbers of new drugs approved per billion U.S . dollars spent on R&D has halved every 9 years since 1950”. In general, while research teams appear to be getting bigger, the number of patents being produced per researcher has declined. Alarmingly critics argue that some fields may even be regressing- for example the over-treatment of psychiatric and cancer patients may have caused more harm than the benefits.

But why would science be hitting a wall? One major factor could be the reproducibility crisis– the problem where many peer reviewed claims cannot be replicated thus calling into question the validity of the original research findings.  Researchers suggest that intense competition for funding and jobs, has resulted in the need to conduct innovative “high risk” research, in as short of a time as possible. While this type of research can gain plenty of press, they often lack the appropriate scientific rigor that ensure the findings are reliable. However, the perceived slow-down in research productivity could also be a result of the natural advancement of science- the low hanging fruit problem. Said another way, most of the easier problems have already been solved, leaving only problems that require vast scientific resources to solve.

On the other hand, researchers in some fields can rightfully pushback and argue that scientific progression is not stalling but is in fact accelerating. For example, technologies such as CRISPR and optogenetics have been able to produce a multitude of new findings particularly in the areas of neuroscience and genetics research. However, it must be noted, that even with these new technologies, the end product for general society is still relatively disappointing.

Given these concerns how scientific research moves forward raises some tough questions for the field. Given funding limitations, how much do we, as a society, value ‘pure science’- the effort to understand rather than manipulate nature? Scientific curiosity aside, in purely economic terms, is it worth understanding the out of Africa hypothesis of human origins, or sending humans to different planets? Is it worth investing in the latest innovative technology that produces new findings with limited applicability to human health? Scientists and the general society must be open to weighing the costs and benefits of scientific enterprises and deciding the avenues of research worth pursuing.

(John Horgan,  Scientific American)

Vaccine Ethics

The vaccine dilemma: how experts weigh the benefits for many against risks for a few

Cost-benefit analysis. Sure, it’s easy to do when you’re on an amazon shopping spree. But what about when millions of lives are at stake? And what if those millions of lives are of children, unable to give informed consent? Not so easy anymore, but that is the job of the Strategic Advisory Group of Experts (SAGE) for the World Health Organization, who last week decided to scale back the use of a new vaccine to protect against dengue.

2 years ago, SAGE concluded the vaccine was safe to use in children in places with high dengue infection rates, despite theoretical concerns the vaccine may increase the risk of developing a severe form of dengue in some children. Towards the end of last year, the vaccine’s manufacturer, Sanofi Pasteur, released new data validating these theoretical concerns.   How likely was this to happen? It was estimated that in a population where 70% of individuals had dengue at least once, the vaccine would prevent 7 times as many children from needing hospital care than would be needed as a result of the vaccine. If 85% of individuals had had dengue, that figure becomes 18 to 1. Those numbers were deemed not worth the risk.

What goes into making these decisions?

One factor is the prevalence of the disease. For example, the oral polio vaccine had the ability to prevent millions of children from becoming paralyzed, but it could also cause paralysis in a rare number of cases. In the 1950s and 1960s when polio was highly prevalent, it made sense to recommend this vaccine but as polio became nearly non-existent towards the end of the 20th century, using the oral vaccine was no longer prudent.

However, dengue is still rampant in today’s world, so what is different in this case?

Public perception. The modern world is highly litigious and has access to a wide variety of information, both facts and fake. This has resulted in a very skeptical perception of science where negative press for one vaccine could cause collateral damage for many other vaccines, unlike what would have happened a few decades ago. For example, in the 1950s, it was discovered that children were given a polio vaccine that mistakenly contained live viruses. This left 51 children in the US paralyzed, and killed 5. However, polio vaccinations resumed and the company responsible (Cutter Laboratories) went on and polio was virtually eradicated. On the other hand, RotaShield, a vaccine to protect against rotavirus (a virus that causes bowel blockage), had a very different experience. Approved in 1998, it was suspended one year later after the CDC estimated that for every 10,000 children there would be an extra 1 or 2 children who would get intussusception (a type of bowel blockage) over what would normally be seen. While in developing countries, the number of lives saved would have been far more than the extra cases of intussusception, the vaccine was still suspended. A safer rotavirus vaccine only made it to market in 2006. During this time, it is estimated that 3 million children died from rotavirus infections. (Note- risk of  rotavirus infections still persist even when the vaccine is given, but at far lower rates).

Given the tremendously difficult decisions that need to be made with the implementation of vaccines and the impact that public perception can have on these decisions, society has a responsibility to become more informed about the potential benefits and drawbacks of vaccines and must actively tease apart fact from fiction.

(Helen Branswell, STAT)

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April 27, 2018 at 3:26 pm

Science Policy Around the Web – December 1, 2017

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By: Kelly Tomins, BSc

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source: pixabay

Fake Drugs

Health agency reveals scourge of fake drugs in developing world

The World Health Organization (WHO) released two concerning reports detailing the prevalence and impact of substandard and falsified medical products in low and middle income countries. Although globalization has led to the increase in e-commerce of medicine, making life-saving treatments available to a broader population, it also created a wider and more accessible market to dispense fake and harmful medicines for profit. Despite this, there was a lack of a systematic method of tracking falsified medicines on a global scale. Thus, the WHO created the Global Surveillance and Monitoring System for substandard and falsified medical products (GSMS). With this program, medicine regulatory authorities can enter information about fraudulent drug incidences into a centralized database, making it easier to understand global trends and to possibly identify the source of harmful products. The WHO also conducted an extensive literature search of nine years’ worth of medicine quality studies to assess rates of fake medicines.

Their dual analysis showed that falsified medicines are heavily prevalent, particularly in low-and -middle income countries. They estimate that an incredulous 10.5% of medicines in these countries are falsified or substandard, representing $30 billion in wasted resources. Low income countries are the most vulnerable to this type of exploitation, given their higher incidence of infectious disease and their likelihood of purchasing cheaper alternatives to more reliable and tested medicines. In addition, these countries are more likely to lack the regulatory framework and technical capabilities to ensure safe dispensing of medicines. However, reports of fake drugs were not limited to developing countries. The Americas and Europe each accounted for 21% of the reported cases, highlighting how this is a global phenomenon.

Antimalarials and antibiotics are the two products most commonly reported as substandard or falsified, with 19.6% and 16.9% of the total reports respectively. These findings are especially concerning given a recent finding that the number of malaria infections increased the past year, despite a steady global decrease from 2000-2015. In addition, the number of deaths from the disease have not decreased for the first time in 15 years. By providing an insufficient dose to eradicate the malaria parasite from the body, the use of substandard or falsified antimalarials can foster the emergence of drug-resistant strains of malaria, like those recently found in several Asian countries. Overall, the WHO estimates that falsified products may be responsible for 5% of total deaths from malaria in sub-Saharan Africa.

Despite the clear need for action to ensure drug safety around the world, there are an abundance of challenges to making this possible. The supply chain of drug manufacturing, from the chemical synthesis of the drug, to the creation of packaging and the shipping and dissemination, can span multiple countries with extremely variable regulatory procedures and oversights. The need for strengthened international framework and oversight is necessary to ensure patients receive the drugs they think they are getting and preventing hundreds of thousands of deaths each year.

(Barbara Casassus, Nature)

Biotechnology

AI-controlled brain implants for mood disorders tested in people

Mood disorders have been traditionally difficult to treat due to the often-unpredictable onset of symptoms and the high variability of drug responses in patients.  Lithium, a popular drug used to treat bipolar disorder, for example, can cause negative side effects such as fatigue and poor concentration, making it more likely for patients to elect to stop treatment. New treatments developed by the Chang lab at Massachusetts General Hospital and Omid Sani of UCSF hope to provide real-time personalized treatments for patients suffering from mood disorders, such as depression and PTSD. The treatment utilizes a brain implant that can monitor neural activity, detect abnormalities, and then provide electrical pulses to a specific region of the brain when needed. These electrical pulses, known as Deep Brain Stimulation (DSB), have already been used to treat other disorders such as Parkinson’s disease. Other groups have tried to use DSB in the past to treat depression, but patients showed no significant improvement. In those studies, however, the pulses were given constantly to a single portion of the brain. What is unique about this treatment is that the pulses are only given when necessary, or when the implant receives signals that the brain is producing abnormal neural activity. The researchers have also found ways to map various emotions and behaviors to specific locations in the brain. They hope to utilize that information in order to more finely tune a person’s behaviors. In addition, the algorithms created by the labs to detect changes in the brain can be modified for each patient, providing an alternative to the one-size-fits all pharmacological approaches currently used.

Despite the promising and appealing aspects of this personalized treatment, it also raises several ethical issues regarding privacy and autonomy. First off, with such detailed maps of neural activities, the patient’s mind is practically an open book to their doctor. They have little agency of what emotions they would want to share or, more importantly, hide. Also, the patient may feel a lack of autonomy over their treatment, as the implant itself decides when the patient is displaying an unwanted mood or behavior. The algorithms could also potentially change the patient’s personality for worse by limiting the spectrum or intensity of emotions that a patient can feel. Any type of manipulation of brain activity could be viewed as worrisome from an ethical standpoint, and although promising, this proposed treatment should undergo intense scrutiny in order to maintain autonomy for the patients.

(Sara Reardon, Nature)

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December 1, 2017 at 4:03 pm

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

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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Written by sciencepolicyforall

October 21, 2016 at 9:34 am

Posted in Essays

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