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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 – July 10, 2018

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By: Liu-Ya Tang, PhD

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source: pixabay

Public health

Chronic pain patients, overlooked in opioid crisis, getting new attention from top at FDA

The opioid crisis has become a big problem in the United States, with more than 40,000 deaths from opioid overdoses a year. To resolve this issue, opioid production was reduced by 25 percent in 2016 and by an additional 20 percent in 2017 aiming to prevent the over-prescription of opioids. However, cancer patients who need it for pain control may suffer due to the shortage of this medication. Moreover, cancer patients face stigma for using opioids as a pain reliever from both health care providers and society in general.

Sara Ray and Kathleen Hoffman, who work for a health-oriented social network called Inspire, reviewed 140 public posts, written by cancer patients and their caregivers. These people expressed problems with getting the medications they need. One prominent issue is that some doctors are reluctant to prescribe opioids due to the possibility of addiction, which has made cancer patients feel like drug seekers. There is also an overwhelming amount of information about addiction and drug dependence from the media, the government, and even health care providers, which can cause confusion and misunderstanding among cancer patients and their caregivers. As a result, some patients would rather tolerate the pain than risk addiction. Some patients commented that not all oncologists are knowledgeable about treating cancer-related pain, and that cancer patients should seek help from health care providers who specialize in pain management.

Ensuring that every cancer patient has equal access to such health care, pain management awareness, as well as increased availability of pain medication are important. Both health care providers and patients need better education on pain management, which could help counteract the current stigma and remove the barriers on legitimate use of opioids for cancer patients.

(Jayne O’Donnell and Josephine Chu, USA Today)

Research progress

There’s no limit to longevity, says study that revives human lifespan debate

The average human life span has increased steadily over the past 100 years. Life expectancy has more than doubled, from about 25 years to about 65 for men and 70 for women. This sparks the question: is there a limit to the length of human life? A recent study, published in Science, reported that there may be no limit to how long humans can live.

A research team, led by Sapienza University demographer Elisabetta Barbi, and University of Roma Tre statistician Francesco Lagona, did a statistical analysis on the survival probabilities of nearly 4,000 ‘super-elderly’ people in Italy, all aged 105 and older. They found that the risk of death seems to increase as people age before reaching age 105, while they found that the death risk flattens out after age 105, which might suggest that there is no limit to human longevity. The concept of a mortality plateau is not new, as it has been mentioned in previous studies. However, compared to previous claims, this study has a more rigid data collection process and better statistical methods.

Despite this, there are many different voices regarding this finding. Since this statistical analysis was only done in the Italian population, Jean-Marie Robine, a demographer at the French Institute of Health and Medical Research in Montpellier, suggested doing a global analysis. He notes that unpublished data from France, Japan, and Canada suggests that evidence for a mortality plateau is “not as clear cut”. Some experts question the conclusion based on biological facts of human body. Jay Olshansky, a bio-demographer at the University of Illinois at Chicago, said that some types of cells, such as neurons, cannot replicate and have their “length of life”, and irreversible cell death that comes with aging places “upper boundaries on humans”.

Though there are differing opinions on whether there is a limit to the human life span, many researchers hope to better understand the mechanisms of the mortality plateau and the process of aging, to facilitate developing interventions that slow aging.

(Elie Dolgin, Nature news)

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July 17, 2018 at 4:54 pm

Science Policy Around the Web – December 12, 2017

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By: Mike McKenna, BA

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source: SalFalko via flickr

The Scientific Workforce

House G.O.P. Tax Writers Take Aim at College Tuition Benefits

If House Republicans get their way with tax reform, graduate students could be hit where it hurts the most – their pockets. Without a single hearing or vote of support from the Democrats, on Nov 16, the House passed the most extensive tax reform bill in the past three decades. Included in the bill is a provision to treat tuition waivers as taxable income. According to figures cited in the New York Times, over 145,000 graduate students receive free education, often through tuition waivers. NPR reports that of those 145,000 graduate students, 60 percent of them are in STEM related fields. These waivers, which often come along with a stipend, are typically tied to positions graduate students fill, such as teaching assistants or research assistants, and cover the cost of a student’s graduate training. Currently, graduate students only pay taxes on money from university stipends, which is treated like normal income.

How hard will the tax hike hit grad students? If the House bill becomes law, the hike could take away up to a third of their income. For example, the New York Times reports that for a student at the Carnegie Mellon College of Science, which give students a $43,000 tuition waiver and a $29,400 stipend, they may pay close to an extra $10,000 in taxes a year. Instead of only having to use 10 percent of their stipend to pay taxes, graduate students would be committing around 40 percent of their stipend to Uncle Sam.

However, some individuals blame universities for creating this issue by charging high tuition prices and then providing a waiver instead of making tuition $0 for graduate students. Critics of this practice  partly attribute it to institutions wanting to collect additional funding from government grants since many grants pay a portion of graduate students tuition.  Others note that universities could reclassify tuition waivers as scholarships, which would still be not taxable. Under this plan universities could waive the requirement for graduate students to work as teaching or research assistants to receive financial assistance, but could still tie stipends to these positions.

Barring a university response, graduate students are not without hope though, as the passed Senate version of the tax reform bill does not include a provision to classify tuition waivers as taxable income. The two separate bills are currently being reviewed by a conference committee who will create a final piece of legislation. This new piece of legislation would have to pass both the House and the Senate before being signed into law by President Trump.

(Erica L. Green, The New York Times)

The Opioid Crisis

Court-mandated Opioid Rehab Rarely Meets Medical Standards

According to a recent study published in Health Affairs, the top ranked health policy journal, only five percent of individuals court ordered into rehab programs for opioid use disorder are getting the best treatment available- methadone and buprenorphine therapy. Opioids are a class of drug known for their pain relief properties. However, use of these types of drugs can also produce euphoria, contributing to why individuals misuse opioids. Opioids include prescription medications such as OxyContin, Vicodin, codeine and morphine and the illegal drug heroin. Methadone and buprenorphine, both medications classified as opioid agonist therapies, help reduce cravings and withdrawal from long-term opioid use.

Despite being the gold standard for the treatment of opioid use disorder, not even a majority of individuals outside the criminal justice system are referred to specialty treatment programs that utilize agonist therapies. The study’s authors found that only 41 percent of individuals referred by non-criminal justice sources received methadone or buprenorphine as part of their treatment. However, this is still four times higher than those in the criminal justice system, who often have little say over the type of treatment they will receive.

According to the study’s author, individuals in the criminal justice system often receive less effective treatments. The programs focus on abstinence while providing peer counseling and psychotherapy, which does not adequately address the biological maladaptation caused by opioid use.

Limitations of the study include that the analysis only examined first time clients, so perhaps repeat patients are more likely to receive medication assistance. But with such a drastic difference between methadone and buprenorphine treatment rates in individuals within and outside the criminal system, the authors note that the criminal justice system must provide more options for patients.

Driving this issue is the stigma against methadone and buprenorphine treatment by both individuals in need of treatment and by those providing treatment, who see it as replacing one drug dependency with another. But experts contest this claim, saying that medications like methadone and buprenorphine stabilize individuals by preventing the onset of withdrawal symptoms while not providing a high.

(Lisa Rapaport, Reuters)

 

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December 12, 2017 at 4:04 pm

Science Policy Around the Web – October 31, 2017

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By: Michael S. Tennekoon, PhD

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source: pixabay

Forensic DNA testing

Using DNA to Sketch What Victims Look Like; Some Call it Science Fiction

CSI on Steroids”. That is how the latest forensic tool used by law enforcement agencies has been described. It is called phenotyping. But is it all that it promises to be?

Phenotyping is a technique that uses human DNA, from materials such as skin or blood, to predict an individual’s appearance. By analyzing the genetic sequence, scientists can look for genes that code for physical characteristics such as skin color, eye color, geographic ancestry, and many others. This information is then plugged into a computer algorithm to predict an individual’s appearance. Today, dozens of law enforcement agencies from New York to Louisiana use phenotyping for cases where traditional forensics has resulted in no leads.

However, critics argue that this technique is reaching far beyond its means, especially as there is a lack of peer-reviewed research to back up its claims. Indeed, Parabon Nanolabs, one of the pioneering companies that offers phenotyping to law enforcement agencies, has yet to publish the methods underlying its techniques. Furthermore, Dr. Yaniv Erlich, a computer scientist that studies genetics at Columbia University, states that apart from basic predictions like human ancestry, phenotyping of faces is “on the verge of science fiction.”

In addition to concerns about the reliability of phenotyping, there are other ethical and legislative concerns. For example, the New York Civil Liberties Union points out that using ancestry to identify potential suspects in a criminal case will place many innocent people without any connection to the incident under suspicion. Theoretically, this could be used in a similar way to ‘stop and frisk’. These concerns are in addition to the already well-documented susceptibility of DNA testing to human error and bias.

States are still in the process of establishing laws and guidelines to regulate DNA testing, including phenotyping, for use in criminal cases. For example, in New York, one must have authorization from state officials before DNA testing is done.

Ethical issues not withholding, supporters such as Deputy Chief Katranakis, who is the commander of the New York Forensics Investigation Division believe that phenotyping offers more benefits than drawbacks, especially for cases where there are no other alternatives. However, as the use of phenotyping becomes more prevalent, caution must still be urged when weighing the contribution of phenotyping to criminal cases.

(Ashley Southall, The New York Times)

 

 

Research Misconduct

The Cookie Crumbles: A Retracted Study Points to a Larger Truth

Generously, the chances for a PhD student to get a job in academia are less than 15%. Therefore, the pressure to publish has never been higher. Some would argue that, because of this pressure to publish, there is an increased quantity of lower quality research. Perhaps unsurprisingly then, there is a big problem of researchers failing to replicate studies in the social sciences, and there has been a sharp increase in the number of the papers that have been retracted over the past decade.

On Friday, October 20th, another study which appeared to offer a cheap and simple tool for the fight against national obesity has just been retracted as well. The study suggested that simply placing cartoon Elmo stickers on apples could nudge more children to pick an apple over cookies when offered the choice. However, other researchers noted discrepancies with the numbers in the paper, which led to the submission of a replacement article by the original authors. However, the problems continued when it became known that the study was actually performed on children much younger than originally reported (3-5 years old rather than 8-11 years old, as reported). This situation is exacerbated by the fact that these concerns may also have impacted other published reports from the same lab.

Studying ways to change complex eating behaviors in children is no easy task. Children are considered a vulnerable population and there are several additional regulatory requirements for doing work specifically with children. Examples include parental permission, working on school premises, and getting additional approval from Institution Review Boards to name but a few. However, these hurdles are no excuse to bypass scientific rigor. Given the ease by which scientific findings can reach the masses through social media and the press, scientists must take on the responsibility to be extra vigilant to ensure their findings are accurate, or risk losing the public’s trust and ultimately public funding for the wider scientific community.

(Aaron E. Carroll, The New York Times)

 

Climate Change

Fighting Poverty Might Make it Harder to Fight Climate Change

At first glance, the goal of tackling poverty appears noble and completely unrelated to tackling climate change. However, new research shows that eradicating poverty may indeed make it harder to tackle climate change. Why? If extreme poverty is eradicated, people may travel more and increase their energy consumption, thus creating a larger carbon footprint.

Given this potential conflict, researchers from the University of Maryland in College Park modeled what the impact of eradicating poverty would be on climate change. The authors found that eradicating extreme poverty (i.e. increasing income from less than $1.90 a day to between $1.90 and $2.97 a day) would not jeopardize current targets for tackling climate change. However, lifting everyone to the next income level (the global middle-income level defined as living on $2.97-8.44 per day) would have a significant impact (an extra 0.6°C of warming) on climate change.

This leaves the global society in the precarious moral position of deciding what level of poverty is acceptable to ensure the sustainability of the planet. If we not only want to eradicate poverty, but also wish to bring everyone to the middle class, we would need to dedicate almost 7 times more resources than we are currently towards tackling climate change.

However, all hope is not lost. Clean energy, if it becomes cheaper than fossil fuels, would be a viable option for developing nations to use to fuel economic growth and hence would reduce future carbon emissions. There are some encouraging signs that this may be a possibility. In recent years, while the global economy has grown, carbon-dioxide emissions have not followed suit. Amazingly, emissions in the United States, Europe and China have actually fallen—though the amount of carbon-dioxide accumulated in the atmosphere has increased. In the meantime, however, the authors of the current study call for lifestyle changes, such as taking public transportation, living in smaller houses, and eating less meat.

(Allie Wilkinson, Science Magazine)

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October 31, 2017 at 8:43 pm

Science Policy Around the Web – October 27, 2017

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By: Cindo O. Nicholson, Ph.D.

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source: pixabay

The Opioid Crisis

Engulfed in opioid deaths, Ohio turns to science

The state of Ohio has been the most plagued by the opioid scourge in the United States. It suffered the most opioid-related overdoses in 2014, and the number of opioid overdoses have since increased by 32% according to the state’s health officials. The increase in opioid-related overdoses is not due to a lack of effort on Ohio’s part. In fact, the state spent nearly $1 billion on measures like prevention, law enforcement, and treatment, but all to no avail.

In May of this year, the state of Ohio has embraced a new strategy to curb its opioid crisis – technology. The state has passed a request for $20 million to boost the development of new technologies that will stem the tide. While the three-phase, prize-base Ohio initiative is still accepting applications, technologies vying for funding can be broadly grouped into two categories, non-opioid compounds or devices for treating pain and chemical compounds that effectively reduce the withdrawal symptoms of those already gripped by addiction. Non-opioid technologies for pain treatment that are seeking funding include, an implantable mesh of a special polymer, loaded with sufficient doses of non-opioid pain relievers, allowing the controlled delivery of pain medication and a wearable device that uses electric pulses to calm nerves that are sending pain feedback to the brain.

A compound that has already been FDA approved for use in helping recovering addicts manage withdrawal symptoms that could be immediately put to use in Ohio is Probuphine. Probuphine is an implant that consists of a partial opioid receptor agonist buprenorphine linked to a polymer. When worn, the Probuphine implant provides a low dose of the chemical over a six-month period.

These measures are not a “cure-all” as their success will be dependent on patients’ adherence to strict drug regimens. Also, patients will need to resist the urge to discontinue their follow-ups with doctors upon having early success with these interventions. Nevertheless, there is hope that more research and development of effective non-opioid pain therapies and therapies that can minimize the withdrawal symptoms will significantly reduce opioid overdoses in Ohio. The success of this approach in Ohio will serve as model for other states and countries, and show how policies in support of scientific research can benefit communities.

(Alfonso Serrano, Scientific American)

Genomics Policy

The Navajo Nation is considering a new policy to allow genetic research

Tribal leaders of the Navajo Nation are considering put in an end to a fifteen-year moratorium on studying the DNA of its people. The Navajo Nation is an independent Native American territory occupying 71,000 square kilometers (27,413 square miles) of land on portions of Arizona, Utah, and New Mexico. Like many Native American Nations, the Navajo were concerned about the potential for misuse and privacy infringements of genetic research performed by scientists from outside the community. Additionally, in the early 2000s the Navajo Nation’s department of health did not feel they had enough expertise to pursue genetic research and wished to develop their own research policies.

Now, the Navajo Nation will open its first oncology center in Tuba City, Arizona. This will be a major help to Navajo people living on the reservation who currently have to drive hundreds of kilometers to get specialized care. It also has also elicited a reconsideration of the moratorium on genetic research. If the moratorium on genetic research is lifted, it would allow the collection of blood and other tissue samples for further study. The Navajo Nation’s department of health is collaborating with traditional leaders, tribal officials and other delegates to draft a policy that would allow approval of genetic research, and maintain control of DNA samples.

Being able to collect genetic material and maintain them on the reservation would allow research to be conducted on the reservation which now has tribe members that are geneticists, bio-ethicists and other types of medical experts. Lifting the moratorium would allow Navajo scientists and medical experts to research genetic and environmental factors underlying other diseases exhibited by members of the Navajo population.

Ultimately the success of whatever new policy adopted by the Navajo Nation should increase the availability of specialized and personalized care for its people. It would lay the groundwork for regulating the use of genetic material requested from Navajo repositories by scientists outside of the territory. In addition, the success of a new policy for genetic research would serve as a model for other Native American territories seeking to establish their own policies on genetic research.

(Sara Reardon, Nature)

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October 27, 2017 at 5:05 pm

Science Policy Around the Web – August 11, 2017

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By: Saurav Seshadri, PhD

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source: FDA

Health information privacy

Finding the legal line between voluntary disclosure and doctor-patient confidentiality

The American Civil Liberties Union (ACLU) has suffered a setback in its efforts to protect private health information from what they see as unjust and unauthorized access by the government. Last week, a court in Utah ruled that federal agents are free to collect sensitive prescription records without a warrant. The concept of ‘third party doctrine’, which states that individuals lose their expectation of privacy when information is disclosed voluntarily (in this case, to a physician or pharmacist), played a key role in the court’s reasoning. This position contradicts common-sense expectations of doctor-patient confidentiality, as well as the spirit of the Health Information Privacy and Accountability Act of 1996 (HIPAA), which pledges that ‘your health information cannot be used for purposes not directly related to your care without your permission’.

The details of the case are as follows. Like almost every state, Utah monitors the prescription and distribution of controlled substances, ostensibly to prevent drug abuse and overdose, and archives this information in a database. Utah began requiring a probable cause warrant to access the database after an incident of police misconduct in 2015, but since then, DEA agents have been circumventing this rule by using administrative subpoenas to pull any record they feel is relevant to an investigation, without judicial oversight. When Utah stopped complying on the grounds that this practice violates state law and the Fourth Amendment, the DEA challenged the state in court and won.

The decision is disappointing, considering the ACLU won a similar suit in Oregon in 2014. However, there is hope that it may be revisited soon: United States vs. Carpenter will use the context of cell phone data to question the validity of the third party doctrine, which, if successful, would have clear implications for this case. Carpenter will be argued by the ACLU before the Supreme Court this fall.

(Brett Max Kaufman, ACLU)

 

International science policy

Indian scientists get their day to speak out

Though hundreds of international sites participated in the March for Science earlier this year, major cities in India were conspicuous by their absence. On Wednesday, a series of public demonstrations finally gave the Indian scientific community an opportunity to add their voices to this global movement. The marches, organized by the Breakthrough Science Society, saw modest but encouraging turnout, despite reports of scientists being instructed not to attend.

India is the largest source of immigrant scientists and engineers in the US, but it lags behind its regional peers in numbers of top-tier scientific publications. Part of the reason for this discrepancy is a lack of government support for scientific institutions and funding agencies. While the Indian Department of Science and Technology has received substantial boosts in funding in recent years, budgets are still far short what scientific department heads say they need. One of the march’s core demands was for the government to increase investment in R&D from ~0.8% to 3% of GDP, in line with other developed Asian countries.

The other main goal of the march was to counteract rising levels of pseudoscience and religious intolerance of science in Indian culture. Organizers point out that violent incidents motivated by superstition still occur regularly, and cite ‘confrontational chauvinism’ regarding science by high-ranking officials. While this toxic blend of anti-science sentiment and nationalism is not unique to India, the country is unusual in that its constitution explicitly includes developing a scientific temperament as a ‘Fundamental Duty’ of its citizens. Ultimately, as in the US, the extent to which such events will truly promote rational discourse and evidence-based policy remains to be seen.

(Sanjay Kumar, Science)

 

Marijuana legalization/Opioid crisis

Hands-off/Hands-on approaches to the war on drugs

Initial recommendations from two separate commissions on drug policy set up by the Trump administration have yielded unexpected results. First, the Task Force on Crime Reduction and Public Safety has urged officials to continue the Obama administration’s hands-off stance on enforcing federal anti-marijuana laws. This is a surprising outcome, considering the Task Force was created by Attorney General Jeff Sessions, and was expected to support a crackdown on state-level legalization: Sessions has blamed marijuana for increased violent crime, and recently notified several pot-tolerant states that they will face increased scrutiny from his Justice Department. Though the report’s suggestions are not binding and several methods to discourage legalization still exist (such as raiding dispensaries or suing state governments), given the overwhelming public support for legal marijuana and Sessions’ increasingly tenuous political position, it appears unlikely that any significant changes in enforcement policy are on the way.

The second report comes from the President’s Commission on Combating Drug Addiction and the Opioid Crisis. The death toll and burden to society of opioid addiction have increased dramatically in recent years, and the commission offers several constructive, bipartisan solutions that echo those advocated by public health and drug policy experts. However, Trump has already signaled his disinterest in these suggestions, ignoring the commission’s ‘urgent’ request to ‘declare a national emergency under either the Public Health Service Act or the Stafford Act‘ in order to divert more resources into fighting opioid abuse. Trump routinely exploited the opioid epidemic for political points while on the campaign trail, often using it to justify ‘tough-on-crime’ proposals such as a Mexican border wall, mandatory minimum sentencing, and property seizure. The report does not recommend any of these measures, instead encouraging expanded drug treatment under Medicaid, which would have been gutted by the GOP’s attempted repeal of the Affordable Care Act. Failure to effect change in opioid-afflicted communities, which strongly supported Trump in 2016, could be politically costly for him in 2020; but steadily climbing rates of addiction mean that this timeline would be too late for many.

(Daniel Politi, Slate, and Christopher Ingraham, The Washington Post)

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Written by sciencepolicyforall

August 11, 2017 at 5:54 pm