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Science Policy Around the Web – February 5, 2019

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By: Neetu Gulati, Ph.D.

Source: Pixabay

Macedonia name change paves way for science cooperation with Greece

Greece and the Republic of Macedonia have been at odds for decades over the name of the latter country. After the dissolution of Yugoslavia in the early 1990s, the nation known colloquially as Macedonia was founded. However, because a region in northern Greece shares a name with the republic, Greece has disputed the country’s name, and tried to bar its entry to international organizations such as NATO and the UN. The Prespa Agreement, ratified by the Republic of Macedonia on January 11, 2019 and Greece on January 25, 2019, is set to relieve tensions by changing the disputed country name to ‘The Republic of North Macedonia,’ and the short name of ‘North Macedonia.’

The Prespa Agreement not only ends the political stand-off between the two nations, but also opens the door for strategic partnerships in many ventures, including science. While some people opposed the Agreement, scientists in both nations welcomed the change, commenting that political tensions and bureaucratic procedures will hopefully no longer hinder collaboration. “Science is done by people, and many people were affected by the mutually negative spirit among the two countries that prevailed in the past years,” commented Ioanna Chouvarda, a Greek scientist.

Many are hopeful that the name change will positively impact scientific and diplomatic ties between the two nations. A spokesperson for the Republic of Macedonia’s science ministry commented that they hope the agreement will lead to more formal scientific and technological cooperation between the two nations. Greek Alternate Minister for Research & Innovation Costas Fotakis commented, “scientific diplomacy is an effective tool that can strengthen the relations between Greece and North Macedonia, as well as the Western Balkans in general. This agreement is very timely, especially considering that several research themes are of mutual interest in both countries.” 

(Julianna Photopoulos, Nature)

The modern tragedy of fake cancer cures

The news media can sometimes sensationalize and overclaim the results of scientific advances. This is especially dangerous when results have yet to be vetted by the peer-review process, as was the case when the Dan Aridor, chairman of a small biotechnology company in Israel claimed, “we believe we will offer in a year’s time a complete cure for cancer.” The story, published by the Jerusalem Post, made bold and likely unattainable claims that the new technology would have no side-effects, be less expensive than current therapies, and be “effective from day one.” However, the new treatment has so far only been tested in a single study in mice. Furthermore, it has not yet been published and therefore has not been scrutinized or validated by other scientists in the field of cancer research. 

The claims made by Aridor may just his optimism and faith in his product, but if taken at face value they are completely unbelievable. For one thing, the original article points out that the company has not yet started clinical trials, which would take years to complete, negating the hope of a cure within a year’s time. But even those clinical trials are not likely to succeed. The odds that a cancer therapy will successfully pass clinical trials is 3-5%, according to data from MIT and the Biotechnology Industry Organization. However, even the hurdle of getting from animal studies to clinical trials is not to be overlooked, which can easily take over five years.

Cancer therapies are still worth the investment of time and money. Successful drugs like Keytruda have made a large impact on those suffering from the cancer. However, therapies do not perform the same in every patient, and ‘cancer’ is not just one disease. Often, proper dosing of cancer therapies involves a balance between the effectiveness of the treatment and the harm of the side effects. Thus, it is unlikely that a single treatment will cure all cancers without a hitch, as boldly claimed by Aridor. It is much more realistic that some treatments will work for particular types of cancers more effectively than others, with limited side effects. Speaking more conservatively about the new treatment, the CEO of the company, Ilan Morad, commented that while the company believes their therapy will cure cancer, “we still have a long way to go.”

(Matthew Herper, STAT)

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February 5, 2019 at 12:22 pm

Science Policy Around the Web – February 1, 2019

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By: Caroline Duncombe, B.S.

Source: Pixabay

How old emails hold new clues to Coca-Cola and CDC’s controversial relationship

The mission of the Centers for Diseases Control and Prevention (CDC) is to protect America from health, safety, and security threat. Yet, private emails obtained through the Freedom of Information Act reveal that a Coca-Cola Company’s influence over the federal agency refutes such a mission. Email correspondences between top CDC officials and Coca-Cola employees exposed how the soda giant tried to push the World Health Organization (WHO) to emphasize exercise over diet as the solution to the obesity epidemic via CDC’s influencing power.

            Within the 295 pages of communications from 86 emails was a request by former Coca-Cola senior vice president Alex Malaspina that WHO “should not only consider sugary foods as the only cause of obesity but consider also the lifestyle changes that have been occurring throughout the universe.” Other uncovered emails revealed that the former CDC director of Division for Heart and Disease, Barbara Bowman, gave advice to a Coca-Cola executive on potential contacts that have influence over WHO’s regional office and then director-general Dr. Margaret Chan.

            Though Coca-Cola enacted a policy in 2015 to disclose on its website its funding portfolio for scientific research and partnerships. There is little to no federal oversight over sugar and beverage industries. This is a startling fact when considering the extent of the obesity epidemic in America and the significant role that sugary drinks play in augmenting such an epidemic. After the revelation of the relationship between Coca-Cola and the CDC, discussions have increased on restricting direct contact between federal agencies and soda giants. 

(Jacqueline Howard, CNN)

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February 1, 2019 at 4:24 pm

Science Policy Around the Web – January 28, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

A Drug That Eases Miscarriages Is Difficult For Women To Get

The CDC estimates that each year in the U.S. alone, over 1 million women suffer miscarriages during the first trimester of pregnancy.  When a woman finds out that her pregnancy is not viable, she is usually given three options: wait for the miscarriage to occur on its own, take medicine to induce the miscarriage, or undergo a surgical procedure (known as a D&C) to remove the contents of the uterus.  For women who want to avoid a surgical procedure but do not want to wait for the miscarriage to occur on its own, the medically induced miscarriage is a favored option. 

Misoprostol is the medication currently prescribed in the U.S. to induce miscarriage.  Although this medication works for many, a single dose of the medicine is ineffective for about 30% of women.  When the medicine is ineffective, women end up either returning to their doctor for another dose or moving forward with surgery.  However, a recent studyin the New England Journal of Medicine found that combining the currently used medication, misoprostol, with mifepristone is more effective than misoprostol alone in inducing miscarriage.  The study followed 300 women experiencing first trimester pregnancy lose and found the combination of misoprostol and mifepristone increased the chance of successfully inducing miscarriage to 90%, a 14% increase over misoprostol alone. 

Although this new study may provide hope for women suffering an early pregnancy loss and wishing to avoid surgical intervention, most doctors in the U.S. are unable to prescribe mifepristone due to current FDA regulations.  Mifepristone was approved by the FDA in 2000 but is currently regulated under what is known as a Risk Evaluation and Mitigation Strategy (REMS).  The REMS designation means that the FDA can restrict how and where the medication is distributed.  For mifepristone, the REMS restriction prohibits its availability in commercial pharmacies; the drug can only be distributed from clinics or hospitals designated as mifepristone suppliers.  

As mifepristone is commonly used for abortions, some argue that the REMS designation for the drug is driven by political motives rather than due to concerns about drug safety.  Currently, medical societies including The American College of Obstetricians and Gynecologists, the American Academy of Family Physicians and the American Medical Association are trying to overturn the FDA REMS classification of mifepristone.  

(Mara Gordon and Sarah McCammon, NPR)

Ebola Vaccine Supplies Are Expected to Last

The Democratic Republic of Congo (DRC) is currently facing a devasting Ebola outbreak and recently reported 689 confirmed and probable infections and 422 deaths. However, the World Health Organization (WHO) recently announced that they expect to have adequate supplies of an experimental Ebola vaccine to stop the outbreak. 

The experimental vaccine, known as V920, is made by Merck and was first shown to be highly effective in a clinical trial during the West African Ebola crisis of 2014-2016. In the current outbreak, Dr. Peter Salama, WHO’s deputy director-general of emergency preparedness and response, has reported that the vaccine is “highly, highly efficacious”, showing a efficacy rate well above 90%.  

After the West African Ebola crisis of 2014-2016, Merck made an agreement with the WHO and with Gavi, the Vaccine Alliance to maintain a stockpile of 300,000 doses of the vaccine at all times while they worked to get the vaccine licensed. As most Ebola epidemics have been controlled after less than 100 cases, the 300,000-dose stockpile seemed more than sufficient. However, tens of thousands of doses of the vaccine have already been used with the recent outbreak in the DRC, raising concerns that the supply would be depleted.  

Merck’s team lead for the Ebola vaccine project, Beth-Ann Coller, confirmed that in addition to the 100,000 doses of the vaccine that the company has already sent to the WHO, they still have about 300,00 doses on hand. However, due to the uncertainly of around the outbreak, Coller said the company is also exploring options to expand the stockpile further. 

(Helen Branswell, STAT)

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January 29, 2019 at 3:18 pm

Science Policy Around the Web – November 13, 2018

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By: Mohor Sengupta, Ph.D.

Insect-Barley-Midge-Fly-Hessian-640860.jpg

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.

vaccination-2722937_1280

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 29, 2017

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By: Saurav Seshadri, PhD

digital forensics 5” by jon crel is licensed under CC BY 2.0

Forsensic Science

Now Who Will Push Ahead on Validating Forensic Science Disciplines?

The realities of forensic science remain far removed from the white-coated wizardry depicted on shows like CSI. Although forensic results often heavily influence criminal trials, there is a substantial gap between the perceived and true reliability of commonly used methods such as fingerprint and bitemark identification. The National Commission on Forensic Science (NCFS) was established in 2013 to help close this gap, by promoting rigorous, independent evaluation of forensic techniques, as well as communication between law enforcement agencies and academic scientists. The NCFS was supported jointly by the Department of Justice (DOJ) and National Institutes of Standards and Technology (NIST), and has published over forty documents reflecting the consensus of scientists, lawyers, law enforcement officers, and other stakeholders.

Recently confirmed Attorney General Jeff Sessions has decided not to renew the NCFS’ charter, which expired on April 23, 2017. Its work will ostensibly be taken over by a new entity, which will be developed by a DOJ Subcommittee on Forensics and spearheaded by an as-yet-unnamed, DOJ-appointed Senior Forensic Advisor. The DOJ is currently seeking input on how best to organize this initiative, but its actions already suggest an unwillingness to follow expert guidance, such as the original recommendations from the National Academy of Sciences that led to the creation of the NCFS. The recommendations include ‘[t]his new entity must be an independent federal agency…[i]t must not be part of a law enforcement agency’ and ‘…no existing or new division or unit within DOJ would be an appropriate location for a new entity governing the forensic science community’.

Despite this setback, some of the NCFS’ contributions, such as promoting acceptance of the need for licensing and accreditation, may have a lasting influence on the field. In the NCFS’ absence, NIST is expected to play a central role in coordinating the forensic science community. Support for these efforts will be critical to improving standards in forensic practice, and ultimately, to providing justice to the American public. (Suzanne Bell, The Conversation)

Infectious Disease

Ghana, Kenya and Malawi to Take Part in WHO Malaria Vaccine Pilot Program

While interventions such as insecticide-treated mosquito nets have dramatically reduced malaria-related deaths, almost half a million people still die annually from the disease, predominantly children in sub-Saharan Africa. Continuing the fight against malaria, the World Health Organization Regional Office for Africa (WHO/AFRO) has announced that a pilot program to test the world’s first malaria vaccine will begin in 2018. The vaccine (RTS,S or MosquirixTM) is the result of over $500 million in investment from GlaxoSmithKline and the Bill & Melinda Gates Foundation. It has shown promising results in Phase 3 trials, reducing rates of malaria by almost half in children treated at 5-17 months old. Following guidance from two independent advisory groups, the WHO will implement the vaccine in three countries that have high malarial burdens despite ongoing, large-scale anti-malaria efforts. The first stage of the program, which is being funded by several international health organizations in addition to WHO and GSK, will span 2018-2020, with final results expected in 2022.

RTS,S has followed an unconventional route to its current stage of development. It was approved by the European Medicines Agency (EMA) under Article 58, a mechanism that allows the EMA’s Committee for Medicinal Products for Human Use (CHMP) to collaborate with the WHO and international regulatory agencies to evaluate drugs intended for use in developing countries. However, in the first ten years after its inception in 2004, just seven drugs received positive opinions from CHMP through Article 58, and among these, the EMA has reported limited commercial success. This track record, combined with the emergence of more attractive incentive programs to develop drugs for tropical diseases (including a priority review voucher system launched by the FDA in 2007), has raised questions about Article 58’s effectiveness. A positive outcome for RTS,S could revitalize the program and lead to more innovative treatments for vulnerable populations worldwide. (WHO/AFRO press release)

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April 29, 2017 at 8:56 pm