Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘gain of function

Science Policy Around the Web – January 5, 2018

leave a comment »

By: Emily Petrus, PhD

20180105_Linkpost

source: pixabay

Reflections

Nature’s 10: Ten people who mattered this year

As we kick off a new year of discovery amidst an unpredictable social and political landscape, it helps to reflect on those who made big changes in science in 2017. Nature Magazine put together a list of the top 10 “people who mattered” this year, which runs the gamut from lawyers, patients and of course, scientists.

Academic scientists hailed from most corners of the globe and a variety of fields:

  • US geneticist David Liu (Broad Institute and Harvard University, Cambridge MA, USA) was recognized for pioneering work in gene editing. CRISPR-Cas9 is one of the hottest ways to accurately and easily edit genes. Liu’s team created new enzymes from scratch that can rewrite genetic code, swapping AT pairs to CG pairs – a team in China used this technique to cure human embryos of a blood disorder.
  • Marica Branchesi (Gran Sasso Science Institute, L’Aquila, Italy) plays a pivotal role in coordinating astronomers and physicists who study gravitational-wave research. 70 teams of scientists from all over the world shared their equipment and data on August 17, 2017 to watch two neutron stars collide in a galaxy far away. Without Branchesi’s efforts this important event would have been inadequately monitored, leaving some questions unanswered.
  • Pan Jianwei (University of Science and Technology of China, Hefei, China) is a physicist developing quantum teleportation, which can be used to create encryption keys. Jianwei’s group beamed these keys from a satellite to Beijing and Vienna, enabling groups to videochat with compete security – the photons become distorted if hackers try to intercept the signal. This technology lays the groundwork for quantum internet to be available worldwide.
  • Victor Cruz-Atienza (National Autonomous University of Mexico, Mexico City, Mexico) studies earth’s seismic activity. In 2016 he published a paper simulating how different soil structures are affected by earthquakes, using Mexico City’s ancient lake basin as an example. His calculations were validated after the 7.1 magnitude earthquake in September 2017. Cruz-Atienza’s goal is to raise awareness about upcoming earthquake threats and help countries prepare for them before they hit.

Other members on the list brought unique skills to the table to help scientists continue their work.

  • Khaled Toukan (Chairman of the Jordan Atomic Energy Commission, Acting Director of the Synchrotron-light for Experimental Science and Applications in the Middle East) paved the way for physicists to obtain and share valuable equipment in a turbulent region of the world. His skilled diplomatic interactions steered the project to completion through 20 years of funding upsets and political upheaval.
  • Lassina Zerbo (Comprehensive Nuclear-Test-Ban Treaty Organization, Vienna, Austria) is dedicated to reducing nuclear conflict. 2017 has been rife with nuclear threats, as hostile barbs are routinely traded between the US president and the North Korean leader. Zerbo coordinates a worldwide system to share information which detect data about the earth’s hydroacoustic, infrasound, seismic and radionuclide activity. This is helpful for monitoring who is doing nuclear testing, but also for tsunami detection and studying whale migration.
  • Jennifer Byrne (Children’s Hospital at Westmead, Sydney, Australia) is a cancer geneticist and flawed paper detective. Scientists must publish frequently, and the number of dubious scam journals has increased in recent years. Both factors contribute to flawed and fraudulent literature which muddy the waters in a field based on a trust that what is published is true. Byrne and a computer scientist have developed a software (Seek & Blastn) which could be used by journals to detect misconduct prior to publication.

Rounding out the list is the inspirational posterchild for novel cancer therapies, Emily Whitehead, who was recognized for her role in getting CAR-T cell therapy approved by the FDA. The dubious distinction of using creative ways to dismantle the EPA from the inside was awarded to Scott Pruitt.

(Heidi Ledford, Davide Castelvecchi, Elie Dolgin, Sara Reardon, Elizabeth Gibney, Nicky Phillips, Alexandra Witze, Nature)

Biosecurity

U.S. lifts research moratorium on enhancing germs’ danger / NIH lifts 3-year ban on funding risky virus studies

The US is a great place to do research for many scientists, and the outlook is even brighter in 2018 for a select group of viral researchers. Studying how viruses work is an important undertaking – we can prepare for pandemic outbreaks, develop vaccines, and sometimes use viruses to delivery DNA for gene therapy. However, in 2011 researchers in the Netherlands and The University of Wisconsin in Madison published a study in which they made the H5N1 bird flu easier to transmit between ferrets. This type of study is called “gain of function” and is usually a way for scientists to make viruses even more deadly or transmittable. If this sounds like the zombie apocalypse to you, it did to HHS lawmakers too; they paused funding in 2014 for this type of research. On December 19, 2017 the pause was lifted after a lengthy process of putting new policies in place.

The pause was to allow the National Science Advisory Board for Biosecurity and the HHS to craft clear new rules and regulations that all grants will have to pass before being permitted to work with research involving enhanced potential pandemic pathogens (ie deadly viruses). Grants which make it through the peer review process then experience a secondary review by a panel who will determine if the project’s benefits outweigh the risks, and make recommendations for funding and/or request modifications. In addition, such dangerous research will only be permitted in facilities which are properly equipped to handle such biosafety concerns.

Biomedical research moves at a fast pace, so most proposals that were submitted before the freeze are now obsolete, requiring researchers to submit fresh proposals, following the new guidelines. This may sound tedious and most researchers may not relish new hoops to jump through, however nobody wants a deadly pathogen released due to limited oversight. Even the CDC managed to send live anthrax, bird flu, and botulinum toxin (which causes botulism) to other labs five times over the course of a decade. The pause in funding came at the request of epidemiologists and other scientists who felt there weren’t enough regulations from a safety or ethical standpoint to support funding for gain of function types of viral research. If researchers can prove that their projects pose a limited risk and will produce valuable benefits to our knowledge of public health, their research can resume once more.

(Jocelyn Kaiser, Science) (Lenny Bernstein, The Washington Post)

 

Have an interesting science policy link?  Share it in the comments!

Advertisements

Written by sciencepolicyforall

January 12, 2018 at 1:27 pm

Science Policy Around the Web – June 27, 2017

leave a comment »

By: Sarah Hawes, PhD

Source: pixabay

Influenza

An Arms Race with Nature

H7N9, a new bird flu emerging in China, has infected roughly 1,500 people and killed 40% of them. The virus is contracted directly from infected birds but is not yet easily transmissible between humans, however researchers at The Scripps Research Institute have evidence H7N9 could potentially become transmissible between humans fairly easily. They examined a fragment of the virus that interacts with receptors on animal cells to gain entrance, and identified three minor mutations that could cause the fragment to shift from preferentially entering avian cells to preferentially entering human cells. If these mutations were to occur, it could rapidly result in a pandemic.

Tests in a viral fragment do not prove functionality in the intact virus; that would require mutating H7N9 itself. A 2014 moratorium on mutating three types of viruses (SARS, MERS, influenza) to more dangerous forms is expected to lift when the Department of Health and Human Services finishes current work drafting a new policy establishing reviews designed to assess benefit/risk ratios before funding research.

The subject is divisive, even among scientists in the field. Stanford researcher David Relman says he would support efforts to test mutations in a weakened strain of flu, but not in the H7N9 virus.  Bioterrorism expert Thomas Inglesby opposes increasing the contagious lethality of a virus, and opposes publishing such procedures due to concern that less benevolent actors would be enabled to replicate the process. NIH funded researcher, Ron Fouchier in the Netherlands, whose alteration of H5N1 to become highly contagious between ferrets (the animal model for humans) in 2011 influenced the moratorium, believes examining dangerous virus mutations in a controlled lab environment is important to identify potential pandemic viruses.

Many of these topics were discussed at the recent Immunology and Evolution of Influenza Symposium, and are sure to be a hot topic at the July 16 – 19 Centers of Excellence for Influenza Research and Surveillance meeting. With policy guidance needed on benefit/risk, potentially safer models, security, and publication limitations, the new HHS policy will be critical. (Nell Greenfieldboyce, NPR)

Conservation

Modeling with Dough – Pick your Species

The Supreme Court found the Endangered Species Act was “intended to halt and reverse the trend toward species extinction—whatever the cost.” Today, in light of the cost, conservation policy makers are being invited to triage species extinctions. Fish and Wildlife Service representatives recently met with ecologist Dr. Leah Gerber to discuss her proposed use of an algorithm guiding conservation funding.

A self-proclaimed environmentalist, Gerber says her model suggests that defunding “costly failures,” including the spotted owl, golden-cheeked warbler and gopher tortoise, could help save about 180 other species. Gerber says policy makers may opt to continue to support species that her algorithm rejects, as was done for the koala in Australia where algorithm triage has been used. In this case, a popularity contest may determine who lives and who goes extinct.

Details of the algorithm are not explicit, but Dr. Gerber’s recent publication in PNAS is a straightforward return-on-investment calculation analyzing the mathematical relationship between funds requested, spent, and species success or decline.  Gerber finds “the cost–success curve is convex; funding surpluses were common for the species least likely and most likely to recover” so it’s not simply ‘money in – species out’. Other factors – endemism, keystone status, level of species risk – are also important, though Gerber acknowledges they are not currently included.

While proponents call use of the equation “doing the best you can with what you have,” lack of data on its predictive validity make it a frightening policy tool governing something as permanent as species extinction. What if region affects costs, population growth is slower in species reaching sexual maturity later, a break-through in understanding one species’ requirements is just around the corner or we haven’t yet discovered the significance of the niche occupied by another species? What if business or political interests conflict with a species’ needs? What if the algorithm developer seeks intellectual property legal status, as is happening now with a proprietary algorithm used in parole and sentencing situations? Algorithms impacting public policy should be vetted by multiple experts in germane disciplines, validated, and kept publicly accessible for healthy scrutiny. (Sharon Bernstein, Reuters)

 

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

June 27, 2017 at 11:42 am

How Science Policy Affects Pandemic Pathogen Research

leave a comment »

By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

April 21, 2017 at 8:47 am