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Science Policy Around the Web – March 7, 2017

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By: Allison Dennis, BS

Synthetic opiates

Opioid Crisis

Keeping up With the Synthetic Opioids

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

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

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

Influenza

Keeping up with the Neuraminidases

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

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

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

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March 7, 2017 at 9:02 am

Science Policy Around the Web – August 28, 2015

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By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Drug Policy

FDA approves drug for female libido amid controversy and lingering questions

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

Health Policy

A universal flu vaccine may soon be a reality

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

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

Public Health and Drug Control Policy

Illicit Version of Painkiller Fentanyl Makes Heroin Deadlier

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

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August 28, 2015 at 9:00 am

Dual Use Research of Concern (DURC) Funding Pause: A Risky Response

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By: Kaitlyn Morabito

photo credit: AJC1 via photopin cc

On October 17th, the Obama administration announced a funding pause on new gain of function (GOF) research and a voluntary moratorium of current research on Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), and both highly pathogenic and low pathogenic influenza viruses. The re-evaluation of the potential risks and benefits of federally funded GOF research will be pioneered by the National Science Advisory Board for Biosecurity (NSABB) and National Research Council (NRC) of the National Academies. These organizations will consult with the biomedical community and are responsible for developing a new policy on “dual use of research of concern” (DURC), which includes GOF research, using a deliberate process that is expected to be decided in 2015. Formation of the new policy will determine what DURC research can be done and whether the funding pause will be lifted. Although this funding pause is limited to MERS, SARS, and influenza, this policy will have implications for many other areas of research. While a discussion on the future of DURC is merited, the funding pause has broader implications that may affect our ability to prepare for potential pandemics.

When life science research has the potential to be used for malicious as well as beneficial intentions, it may fall into the category of DURC. Although a lot of the recent debate has surrounded GOF studies involving avian flu virus transmission, the definition of DURC is wide reaching. Infectious pathogen research is a major component of DURC, with a particular focus on agents and toxins which fall into the Federal Select Agent Program, including Ebola and anthrax among others. There are seven kinds of experiments that may be considered DURC and are generally referred to as GOF research. These involve creating mutations within the pathogen, allowing it to gain a function such as increased host range or tropism, transmissibility, or ability to be disseminated. Additionally, changes to pathogens that lead to resistance to prophylactic or therapeutic agents, or make a vaccine or natural immunity less effective, are considered DURC experiments. The final categories involve enhancing vulnerability of a host population and generation of new pathogens or regeneration of previously eradicated or extinct Select Agents. These experiments are considered to be biosecurity threats since modified agents can be used for bioterrorism or accidently released. There has been a lack of open discussion between researchers and policy makers regarding DURC research and there are four major issues that need to be addressed. What dual-use research should be allowed to be done? Should the public fund this research? Who should determine which research can and cannot be done? Should the details and results of these studies be published and available to the public? While these issues are important and need to be discussed and a DURC policy developed, the moratorium on GOF research is not the solution.

The major problem with the GOF moratorium is the overall vagueness of it. There is no end date to the moratorium in which a new policy has to be decided. The initial controversy regarding avian flu transmission studies appeared over two years ago; however, prior to the funding pause, NSABB has failed to hold any scientific meetings to work on DURC policy. Although they have already organized a meeting of scientists in December, without a deadline for the funding pause, there is no motivation to determine the policy. Additionally, the definition of the types of research that fall into this category is vague; the funding pause applies to any work by which researchers could “reasonably anticipate” an increase in pathogenicity or transmission. This definition could apply to nearly any research involving passaging or mutating these viruses.

The timing of this moratorium may hinder work on pandemic preparedness particularly in the case of the recently emerged MERS coronavirus. There is currently no small animal model for the pathogenesis of MERS. Animal models that recapitulate human disease are often developed by passaging a virus through a small animal such as a mouse. However, this type of research is not allowed under the funding pause because the virus may be gaining host range or pathogenicity in the animal. Animal models allow researchers to better understand the virus as well as test treatments and vaccines. Without these models, there is a real hindrance in the development of new prophylactics and treatments, which may prevent epidemics from becoming pandemics.

Another important aspect of pandemic preparedness is surveillance of naturally occurring genetic mutations in viruses. By collecting samples from sick patients or animals and then sequencing the viruses, a researcher can monitor the spread and mutation of different viruses throughout the world. This surveillance is a powerful tool in predicting outbreaks, drug susceptibility, and determining the contents of the influenza vaccine. However, monitoring genetic changes without understanding the level of functional changes is not very informative. This surveillance needs to be used in conjunction with reverse genetics in the laboratory to determine the effects of these changes on pathogenicity, transmission, drug susceptibility, treatment, and immunization. Using laboratory data to supplement surveillance is one aspect of the relationship between surveillance and GOF research. It is also very important to have the reverse relationship with laboratory research informing surveillance. Genetic mutation in viruses is fairly noisy, with many changes having little or no effect on the virus or a detrimental effect. Determining potential mutations in the laboratory that may increase pathogenicity can help determine signals above the noise. Without the ability to supplement knowledge gained by surveillance in the laboratory, the data obtained through surveillance is insufficient to understand the potential outcomes of genetic mutation in viruses.

When talking about DURC, it is impossible for one to avoid the debate swirling around two avian flu studies (1, 2), which involved increased transmission among ferrets. In these studies, an important aspect is often overlooked. Increased transmission among ferrets decreased the pathogenicity of these viruses, with fewer ferrets dying from the transmitted virus. So while this study increased one aspect of GOF, transmission, there was a compensatory loss of function since lethality decreased. This is an important aspect of DURC. By doing these GOF experiments, researchers can also discover loss of function (LOF) mutations, which can be exploited for drug development and also better understand the potential costs of these mutations to the pathogen.

The risk of dual-use research or accidental release of these altered pathogens is real.   This moratorium comes on the heals of a number of highly publicized laboratory incidents including the discovery of a vial of smallpox in an FDA laboratory and the CDC’s distribution of anthrax that had not properly been inactivated. However, the pausing of new research and cessation of current research involving these viruses, which have the potential to cause pandemics, is a bigger threat. A new policy and guidelines for DURC and oversight of research is needed, but until that has been established, researchers should be trusted to determine which DURC should be done.

 

Resources:

1) Science – Avian Flu Transmission in Ferrets Paper

2) Nature – Avian Flu Transmission in Ferrets Paper

3) Office of Science and Technology Policy – Doing Diligence to assess Risk and Benefits of GOF

4) mBio – Influenza-Gain of-Function Experiments

6) mBio – Moratorium on Research intended to create Novel Potential Pandemic Pathogens

7) mBio – Vagueness and Cost of GOF Funding Pause

 

 

 

 


 

 

Written by sciencepolicyforall

January 21, 2015 at 9:00 am

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Science Policy Around the Web – December 9, 2014

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By: Jennifer E. Seedorff, Ph.D.

Flu Season – Public Health

Potential for a deadlier flu season

This flu season has the potential to be an especially bad season. This year the predominant circulating flu strain is a H3N2 virus, and historically the H3 strains have been associated with more severe flu seasons, including increases in hospitalizations and deaths. This season may be especially bad because some of the circulating H3 viruses have mutated since the strains for the vaccine were chosen, and these mutations may mean that the vaccine may be less effective against the mutated strain. Despite the mismatch between the flu strains and the vaccine, vaccination is still highly recommended. The vaccine will still provide protection against other strains of flu, including the unmutated H3N2 strain that is also in circulation, and may still provide a “weak defense” against the mutated strain, according to the CDC.   Additionally, this year CDC recommends that anti-viral drugs like Tamiflu (oseltamivir) be given to vulnerable patients with flu symptoms without waiting for a positive flu test, since these drugs work better when given earlier in the infection. Dr. Thomas Frieden, director of the CDC, said that, “Flu is unpredictable, but what we’ve seen thus far is concerning.” (Donald McNeil, Jr. New York Times)

 

NASA

Successful test flight of the Orion spaceship

NASA’s Orion spaceship successfully completed its first unmanned test flight on December 5th. Orion is intended to replace the retired shuttle for manned spaceflight, including missions to the Moon and eventually Mars. Mark Geyer, NASA’s Orion program manager, commented on the successful flight and splashdown in the Pacific, “It’s hard to have a better day than today.” This 4.5 hour unmanned spaceflight was intended to test the performance of critical re-entry systems, including its thermal shielding. The Orion spaceship is being developed in parallel with a new launch rocket that will likely be ready around 2017-2018. Amos reports that commentators are “worried that the policy as laid out cannot continue in its current guise.” John Logsdon, a historian, commented that, “the first Orion launch with a crew aboard is 2020/21, and then nothing very firmly is defined after that, although of course NASA has plans. That’s too slow-paced to keep the launch teams sharp, to keep everyone engaged. It’s driven by the lack of money, not technical barriers.” Ellen Stofan, NASA’s chief scientists said that, “We have all these technologies mapped out and we’re asking, ‘what is the most sustainable path we can get on (to acquire them)?’” Despite concerns about the pace of development and future missions, Friday’s launch was a reason for celebration. As mission control commentator Rob Navias said, “There’s your new spacecraft, America.” (Jonathan Amos, BBC News)

 

Regulatory Policy – FDA

New drug labels to include more information on risks of medications during pregnancy

In June 2015, the Food and Drug Administration (FDA) will begin to require labels on prescription drugs and biologics to include more information on risks to pregnant and breastfeeding women, and on the reproductive risks to both men and women. Prior to this rule change, drugs were given a letter grade based on known or unknown risks of the medication during pregnancy and breastfeeding. “The ABC system was useless. Every thing was C, and all it said was there was no known data during pregnancy but that wasn’t necessarily the case,” said Jacques Moritz, director of gynecology at Mount Sinai St. Luke’s and Mount Sinai Roosevelt in New York. Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research, FDA, wrote, “Our new method provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, the breastfeeding children, and women and men of reproductive age.” The new rule will require that the information packets included with medications approved since 2001 include subsections on “Pregnancy,” “Lactation,” and “Females and Males of Reproductive potential” and include a summary of risks and the data to support the conclusions.  The rule will not require companies to do studies on the risks during pregnancy and lactation, but will require them to provide the information, if it exists. “Oftentimes the research is out there in the medical literature,” Kweder said and that, “oftentimes companies know about it,” but may not include it. (Brady Dennis, Washington Post and Sabrina Tavernise, New York Times)

 

GMOs – EU

Compromise in debate over genetically modified plants in the European Union

Recently, a compromise was reached in the approval process of genetically modified (GM) plants for cultivated in the European Union (EU). Approval of genetically modified crops has been particularly controversial in Europe where resistance and support for GM crops varied greatly amongst the member states. Prior to this compromise, approval by the EU Commission would have allowed GM crops to be grown in all member states, some of which have laws that ban cultivation of GM plants. This compromise agreement will allow individual member states to overrule EU approval of GM crops in their state. This agreement should help to speed up the approval process, but still needs to be approved to come into force. The compromise of letting individual member independently decide on whether to allow GM crops to be grown has met with resistance from both supporters and defenders of GM crops. Still the EU commissioner of Health and Food Safety Vytenis Andriukaitis called the deal “a significant step forward, after 4 years of intense debates . . . (The agreement will) give the democratically elected governments at least the same weight as scientific advice when it comes to important decisions concerning food and environment.” (Daniel Cressey, Nature News)

 

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December 9, 2014 at 2:16 pm

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Science Policy Around the Web – February 7, 2014

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By: Tara Burke

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Guidelines urge women to monitor stroke risks more closely than men – The American Heart Association (AHA) and American Stroke Association (ASA) released guidelines yesterday aimed at preventing strokes in women. While women share many of the same risk factors as men, they also have unique risks that stem from pregnancy complications and hormone use. These additional guidelines emphasize maintenance of safe blood pressure levels, especially in young women, and suggest that women be screened for high blood pressure before taking birth-control pills. The AHA and ASA also advocates that women who experienced preeclampsia and eclampsia during pregnancy consider these conditions a risk factor for stroke well after their pregnancy.  (Lena H. Sun)

New Avian Flu Virus Ravages Poultry in Korea – A new strain of avian flu identified in South Korea on 17 January has spread nationwide and 2.8 million domestic chickens and ducks have been culled since the outbreak was discovered. Additionally, the strain has killed dozens of Baikal teal and other migratory birds. Previously this strain, H5N8, had not been seen in such a highly pathogenic form. Scientists are arguing over the origin of this strain and, to date, there are no reports of human infections. However, there is a serious worry that this strain may affect over 15,000 hens and ducks used in animal husbandry and breed improvement research. Destroying all of these animals would severely disrupt the center’s genetic resources and ongoing research projects. (Dennis Normile)

An Unusual Partnership to Tackle Stubborn Diseases – On Tuesday, the NIH along with seven nonprofit organizations and 10 large companies announced a partnership aimed at speeding up the development of drugs to treat Alzheimer’s disease, Type 2 diabetes, rheumatoid arthritis and lupus. The partnership involves a 5-year, $230 million effort in which the participants will share data in meetings and conference calls. This partnership will also make their findings publicly available. This joint effort benefits both academic research and industry with the ultimate goal of benefiting those suffering from these diseases. Drug companies have been strained by the enormous amount of money they have put into developing drugs but have the medications failed in clinical trials. Scientists are dealing with a flood of data from gene sequencing and other technologies, making it difficult to conclude what has been discovered. The partnership should speed up analysis and streamline communications amongst all different facets of research required to effectively create drug treatments. (Gina Kolata)

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February 7, 2014 at 2:15 pm

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Science Policy Around the Web – January 17, 2014

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By: Kaitlyn Morabito

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

 

photo credit: Greencolander via photopin cc

photo credit: Greencolander via photopin cc

U.S. Science Agencies get Some Relief in 2014 Budget – The 2014 budget agreement was released Monday, and includes increases for US Science Agencies. However, not all fields received equal increases.  Agencies geared towards physical science, such as NOAA, NIST, Agricultural Research Services, and DOE’s Office of Science and Advanced Research Projects Agency-Energy, received budget expansions ranging from ~10%-23.8%. The biomedical science agency, the NIH, however, received only a 3.5% budget increase, beating only one agency, the U.S. Geological Survey.  Agencies such as NASA, NSF and the Census bureau fell between these groups.  (Jeffery Mervis)

 This Week’s Forecast: What Flu Season May Look Like – Scientists at Columbia University have developed computer models to predict how the flu season will unfold in the US in real time.  They have been testing these models since last year and continue to make improvements.  They hope the flu forecast will eventually be part of the local weather report similar to pollution reports and pollen counts which already accompany this news.  The group at Columbia University, lead by Dr. Jeffery Shaman, use Google search engine data, as well as other factors such as humidity, to predict the peak of flu in many US Cities.  These predictions can help hospital staff and healthcare workers prepare for a potential influx of flu patients. (Carl Zimmer)

 FDA: Acetaminophen doses over 325mg might lead to liver damage – In addition to containing opioid drugs, combination drugs such as Percocet, Vicodin and Tylenol with codeine, contain acetaminophen.  Many people are unaware that acetaminophen is an ingredient in these drugs, and may take an additional dose of acetaminophen to help with pain management.  This can lead to acetaminophen doses that exceed the 4,000mg daily maximum recommended by the FDA.  Excessive doses of acetaminophen can lead to liver damage, serious skin conditions and even death.  To help combat this problem, in 2011, the FDA set a limit on 325mg per capsule for combination drugs with a deadline of January 2014.  Any manufacturers who have not followed these guidelines risk losing approval of their prescription drug.  (Holly Yan)

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January 17, 2014 at 4:00 pm

Science Policy Around the Web – January 24, 2013

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photo credit: patries71 via photopin cc

photo credit: patries71 via photopin cc

By: Jennifer Plank

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Agency Moves to Retire Most Research Chimps – An NIH council unanimously recommended that most of the 451 chimpanzees used for biomedical research should be retired and moved to sanctuaries.  The recommendations will be open for public commentary for 60 days. Following this time period, the NIH director Francis Collins will decide whether to implement the recommendations. The council recommends that a small colony of approximately 50 chimps be maintained for future research. (James Gorman)

Supreme Court rejects challenge to Obama stem cell policy – The US Supreme Court has refused to hear a case challenging the president’s policy to expand government funded stem cell research. The case began in 2010 when a federal judge required the NIH to halt funding of human embryonic stem cell research. Last year, an appeals court overturned the ruling. The plaintiffs in lawsuit, Dr. James Sherley and Dr. Theresa Deisher, then appealed to the Supreme Court in fall 2012. The Supreme Court justices denied the case without comment. (David G. Savage)

Work results on lethal flu strains – A year ago, scientists agreed to halt research producing deadly strains of the H1N5 avian flu virus. The conflict began over whether it was safe to publish 2 papers in which several mutations were introduced in the H1N5 genome to allow the virus to spread among ferrets. In a letter published in Nature, the 40 scientists involved in the research claimed the moratorium has served its purpose and allowed the proper authorities to review the conditions under which the research will be conducted. (Declan Butler)

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January 24, 2013 at 11:57 am