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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 20, 2018

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By: Jennifer Patterson-West, Ph.D.


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source: USEPA via flickr

Food waste

Grocery Stores Get Mostly Mediocre Scores On Their Food Waste Efforts

Food waste is often thought of as unavoidable. Everyone creates food waste. However, steps can be taken to minimize or eliminate waste.

The Environmental Protection Agency (EPA) has issued simple guidelines to reduce food waste. These ‘guidelines’ have been outlined into a hierarchical ranking based on their effectiveness at preventing food waste. The most effective tier is ‘Source Reduction’, which entails reducing the total volume of food generated. Source reduction reduces pollution and cost associated with the growth, preparation, transport, and disposal of excess food.   Producers can save money by reducing the cost of labor and other resources (such as water and pesticides) associated with unused food.

The second tier is focused at ‘Feeding the Hungry’ by donating extra food. In 2016, it was estimated that ~15.6 million American households faced low or very low food-security at some point. Low food security is defined as households that obtained enough food by participating in food assistance programs, such as community food pantries, whereas very low food security applies to those that experienced a disruption in normal eating patterns due to insufficient money or other resource for food. Taken into account, that over 38 million tons of food was wasted in 2016 alone, the donation of excess food could significantly reduce food-insecurity in America. Food donation programs have already been implemented by the 10 largest U.S. supermarkets. To promote donations by corporations, potential tax deduction for food donation are available to companies and they are protect from liability by the Bill Emerson Good Samaritan Food Donation Act.

The third tier promotes diverting food scraps to ‘Animal Feed’. Converting food scraps to animal feed is often cheaper then transporting it to a landfill. Although this practice has been implemented by farmers for centuries, corporations can also participate by donating extra food to producers of animal feed or zoos. The fourth and fifth tiers are ‘Industrial Uses’ and ‘Composting’, respectively. For industrial purposes, food can be converted into biofuel or other bio-products. Composting, which creates nutrient-rich soil amendments, is a great option for inedible parts of food waste that remains after all other actions are taken.

These guidelines were recently used by the Center of Biological Diversity and The Ugly Fruit and Veg Campaign to score the 10 largest U.S. supermarkets for their handing of food waste. A report of their findings was recently released. They found that the surveyed companies focused on donating and recycling food waste instead of preventing it with none of them achieving an A scoring. A limitation to this survey is incomplete tracking and reporting of the amount of food waste throughout an entire company. Some practices that were specifically noted as reducing food waste include Whole Food’s use of produce that is pulled from shelves to make prepared meals, Walmart’s replacement of eggs within partially damaged packages to reduce waste, and Walmart’s standardization of expiration labels.

(Menaka Wilhelm, NPR)

The opioid crisis

Nursing homes routinely refuse people on addiction treatment – which some experts say is illegal

Opioids account for more than 50% of all drug overdoses, however, total deaths are likely underestimated due to under coding in mortality data The opioid epidemic which was largely isolated to Appalachian communities and minority populations in the 1990s has rapidly spread across the United Stated into more affluent suburban communities. The surge in opioid use correlates with an acceleration in the prescription of legal opioid pain relievers, such as OxyCotin. For this reason, many individuals with opioid use disorder (OUD) became addicted due to long-term use of prescription pain medication. This link between prescription drugs and addiction are likely why evidence-based medication-assisted treatments (MAT) are treated skeptically by the public.

MAT has been shown to reduce symptoms of withdrawal, thereby significantly reducing the risk of relapse and overdose. These drugs, such as methadone or buprenorphine, reduce cravings associate with withdrawal by activating the same receptors in the brain without providing the euphoria associated with other opioid use. Contrary to evidence, many patients are directed away from medications and toward treatment programs that have no scientific or medical evidence supporting their efficacy. In fact, only 1 out of 5 OUD patients receive MAT of any kind.

Two major barriers to MAT, including prescribing restrictions and issues finding extended care facilities. Currently, authorized physicians can use buprenorphine to treat a maximum of 275 patients for opioid dependency. In order to get authorization to prescribe buprenorphine, physicians must apply for a waiver from the Substance Abuse and Mental Health Services Administration. However, the physician must have already been authorized under the Drug Addiction Treatment Act of 2000 to prescribe buprenorphine to up to 30 patient for one year prior to applying. These restrictions are thought to be essential to limit over use of these drugs; however, they increase the administrational burden on physicians and decrease assess to MAT. In an effort to expand access to treatment, the declaration of public health emergency under the Trump administration in 2017 gave doctors the ability to prescribe medications for addiction remotely through telemedicine services.

In addition to limited access to MAT treatment, patients also face the possibility that if they receive MAT they may be refused for admittance into nursing home facilities. For instance, a trade group in Ohio released a written statement that none of its more than 900 member facilities will accept patient receiving either methadone or buprenorphine for addiction. Experts exert that refusal of OUD patients receiving MAT is illegal under the Americans with Disabilities Act (ADA) for nursing facilities. Despite an unknown prevalence of such restrictions, Massachusetts Department of Public Heal release a circular letter in 2016 providing guidance for nursing facilities caring for patient on medications for addiction. Similar efforts can be expanded by other states to educate nursing facilities of their legal obligations and to provide guidance for proper care.

(Allison Bond, STAT news)

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April 20, 2018 at 9:29 pm

Science Policy Around the Web – February 6, 2018

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By: Liuya Tang, PhD

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source: pixabay

Cancer treatment

Breast cancer treatments can raise risk of heart disease, American Heart Association warns

Common cancer treatments include surgery, chemotherapy and radiation therapy. Chemotherapy and radiation therapy are always applied before or after surgical removal of a tumor, or applied to cancer patients when surgery cannot be performed. Not only will they attack tumor cells, chemotherapy or radiation therapy will also damage normal cells at the same time, which increases risks for other diseases. A recent report in the journal Circulation said that breast cancer treatments can raise risk of heart disease. It has been noticed that “breast cancer survivors who are 65 and older and were treated for their cancer are more likely to die of cardiovascular problems than breast cancer.” The possible cardiovascular consequences of breast cancer treatments may not be new to oncologists, but new cancer treatments have complex side effects which may not fully understood as they work differently from conventional cancer treatments. For example, the newly-developed cancer treatment, immunotherapy, stimulates the patient’s immune system to attack tumors, but sometimes the surging immune response can overshoot its target and attack healthy tissues and organs.

It is not a good idea to stop cancer treatment due to side effects, as saving ones life from a dangerous cancer is critical. But for this double-edged sword, how to make one edge blunt while keeping the other edge sharp? This requires surgeons and oncologists to work together to make a personalized treatment plan. As suggested by Dr. Deanna Attai, a breast surgeon at the University of California at Los Angeles, the patients with less-aggressive tumor may skip chemotherapy based on the test results on the cancer’s risk of recurrence. In addition, adopting different ways to deliver chemo drugs and developing more-targeted radiation can reduce the risks of cardiac damage for breast cancer patients.

It is not solely a doctor’s responsibility to monitor the side effects of cancer treatments, patients also need to be aware of what types of treatments and what the possible side effects are. Wrong treatments of side effects can aggravate symptoms, which may lead to severe problems. The new emerging immunotherapy presents a big challenge to the health care system as the side effects are not thoroughly understood. Doctors’ organizations and nonprofit groups are joining information campaigns to narrow the knowledge gap on immunotherapy, which will help patients better understand procedures of cancer treatment and manage any side effect if it occurs.

(Laurie McGinley, The Washington Post)

 

Drug development

Racing to replace opioids, biopharma is betting on pain drugs with a checkered past

The opioid epidemic has become a significant problem in the US, as 116 people died every day from opioid-related drug overdoses in 2016. To resolve this issue, biopharma continues to develop pain drugs. The class of drugs are called NGF inhibitors, which were halted by FDA in 2010 due to their severe side effects. NGF is short for nerve growth factor, which is a neuropeptide. When an injury occurs, the production of NGF is increased, which helps the brain perceive the pain. Theoretically antibodies that specifically bind NGF before it reaches cell receptors could be a good choice to inhibit NGF function, therefore treating people with chronic pain. But it was found that NGF antibodies are not suitable for a subset of patients with osteoarthritis, for whom treatment lead to dramatic joint deterioration. To obtain FDA’s approval of entering further clinical trials, drug companies showed that NGF drugs will probably be safe for patients not at risk of joint deterioration and shouldn’t be taken with nonsteroidal anti-inflammatory drugs such as Advil. So the clinical study was resumed in 2015. Will it become a replacement drug of opioids? Will the benefits outweigh its risks? The results will be put on table this year after drug companies finish their Phase 3 studies.

 

The severity of the opioid epidemic and the high need of non-addictive painkillers have kept drug companies optimistic about developing NGF drugs despite the side effects. However, there are opposite voices. The watchdog group Public Citizen criticized that the side effects are obvious and “further pursuit of testing in humans was an unreasonable course of action”. Criticisms also come from the business side. Leerink analyst Geoffrey Porges has warned Regeneron’s NGF drug would carry “all of the liabilities” of the past and scolded their continuing to pour money into the project. The failure has already been seen in the development of fulranumab, which is one type of NGF antibody. Even if NGF antibodies were approved by FDA, doctors would have concerns for prescribing a medication with potentially dangerous outcomes for patients with certain conditions.

(Damian Garde, STAT News)

 

 

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February 6, 2018 at 10:53 pm

Science Policy Around the Web – June 20, 2017

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By: Eric Cheng, PhD

Source: Flickr, via Creative Commons (CC BY 2.0)

Research Funding

America is Still First in Science, but China Rose Fast as Funding Stalled in U. S. and Other Countries

American scientific groups continue to publish more biomedical research discoveries than groups from any other country, and the United States still leads the world in research and development expenditures. However, American dominance is slowly diminishing as China’s increase in funding on science over the last twenty years are starting to pay off. Chinese biomedical research now ranks fourth in the world for total number of discoveries published in six top-tier journals. This is with China spending three-fourths of the amount of money that the U.S. spent on research and development in 2015. In addition, new discoveries and advances in science are becoming more of a collaborative effort, which include researchers from around the world.

These findings come from research published in The Journal of Clinical Investigation by a group of University of Michigan researchers. The analysis comes at an important time for Congress to think about whether the annual uncertainty of the National Institutes of Health’s(NIH) budget and proposed cuts are in the nation’s best interest over the long-term. Bishr Omary, the senior author of the article commented, “If we continue on the path we’re on, it will be harder to maintain our lead and, even more importantly, we could be disenchanting the next generation of bright and passionate biomedical scientists who see a limited future in pursuing a scientist or physician-investigator career.”

The research was based on data up to 2015. During the current fiscal year of 2017, funding for NIH was proposed to be increased by 2 billion dollars, which is the second year in a row where funding was increased after 12 years of flat budgets. With this increase in funding, Omary hopes that, “our current and future investment in NIH and other federal research support agencies will rise above any branch of government to help our next generation reach their potential and dreams.” (University of Michigan, ScienceDaily)

Opioid Crisis

The Role of Science in Addressing the Opioid Crisis

Opioid addiction is an ongoing public health crisis. Millions of individuals all over the United States suffer from opioid use disorder with millions more suffering from chronic pain. Due to the urgency and scale of this crisis, innovative scientific solutions need to be developed. As part of a government-wide effort to address this crisis, the National Institutes of Health (NIH) is supplementing current research efforts with a public-private collaborative research initiative on pain and opioid abuse.

The Director of NIH, Dr. Francis Collins met with research and development leaders from biopharmaceutical companies in April 2017 to discuss new ways in which  government and industry can work together to address the opioid crisis. Dr. Collins stated how some advances such as improved formulations, opioids with abuse-deterrent properties, longer-acting overdose-reversal drugs, and repurposing of treatments approved for other conditions may be quick. Other advances such as mu-opioid receptor-based agonists, opioid vaccines, and novel overdose-reversal medications may be slower to develop. Overall, the goal for this partnership is to reduce the time typically required to develop new, safe, and effective therapeutics to half the average time. (Nora D. Volkow and Francis S. Collins, New England Journal of Medicine)

Climate Change

France is Offering US Scientists 4-year Grants to Move to the Country and do Research

Following President Donald Trump’s decision to withdraw the United States from the Paris climate agreement, France created an initiative that will allow researchers, teachers, and students to apply for a fully financed four-year grant to combat climate change. The website for the initiativesays,

“You will be able to stay in France at least for the duration of the grant, and longer if you are granted a permanent position. There is no restriction on your husband / wife working in France. If you have children, note that French public schools are free, and the tuition fees of universities and ‘grandes écoles’ are very low compared to the American system.”

Since Emmanuel Macron won the French presidential election in May, he has addressed American scientists who feel alienated by the Trump administration. Macron has promised strong funding for climate initiatives. However, some U.S. scientists like David Blockstein of the National Council for Science and the Environment see Macron’s invitation as “both a publicity stunt and a real opportunity.” Although it is not very likely that many U.S. researchers will take up the offer, it does provide a “sharp contrast to an increasingly hostile U.S. political environment for science.” (Chris Weller, Business Insider)

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June 20, 2017 at 1:10 pm

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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Written by sciencepolicyforall

March 7, 2017 at 9:02 am