Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘pandemic

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!

Advertisements

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

Science Policy Around the Web – March 7, 2017

leave a comment »

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)

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

Written by sciencepolicyforall

March 7, 2017 at 9:02 am

Biosurveillance: Can We Predict And Prevent Infectious Disease Outbreaks?

leave a comment »

By: Teegan A. Dellibovi-Ragheb, PhD

The increasing frequency and scope of infectious disease outbreaks in recent years (such as SARS, MERS, Ebola and Zika) highlight the need for effective disease monitoring and response capabilities. The question is, can we implement programs to detect and prevent outbreaks before they occur, or will we always be reacting to existing outbreaks, trying to control the spread of disease and mitigate the harm to people and animals?

In some cases, the science suggests that we can predict the nature of the public health threat. For instance, scientists at the University of North Carolina at Chapel Hill identified a SARS-like virus, SHC014-CoV, that is currently circulating in Chinese horseshoe bat populations. This virus is highly pathogenic, does not respond to SARS-based therapies, and can infect human cells without the need for adaptive mutations. Furthermore, there are thought to be thousands of related coronaviruses in bat populations, some of which could emerge as human pathogens. These findings suggest that circulating SARS-like viruses have the potential to cause another global pandemic, and resources need to be dedicated to surveillance and the development of more effective therapeutics.

What is biosurveillance?

In 2012 President Obama released the first-ever National Strategy for Biosurveillance, whose purpose is to better integrate the many disparate governmental programs and non-governmental organizations that collect and monitor public health data. The Strategy defines biosurveillance as “the process of gathering, integrating, interpreting, and communicating essential information related to ‘all-hazards’ threats or disease activity affecting human, animal, or plant health to achieve early detection and warning, contribute to overall situational awareness of the health aspects of an incident, and to enable better decision making at all levels”. The “threats” described by the Strategy include emerging infectious diseases, pandemics, agricultural and food-borne illnesses, as well as the deliberate use of chemical, biological, radiological and nuclear (CBRN) weapons.

The overall goal of the Strategy is “to achieve a well-integrated national biosurveillance enterprise that saves lives by providing essential information for better decision making at all levels”. This goal is broken down into four core functions: (1) scan and discern the environment; (2) identify and integrate essential information; (3) inform and alert decision makers; and (4) forecast and advise potential impacts.

How are these programs implemented?

A number of programs were launched in response to President Obama’s Strategy. For instance, USAID’s Emerging Pandemic Threats (EPT) program created four complementary projects (Predict, Prevent, Identify, and Respond) which together aim to combat zoonotic outbreaks in 20 developing countries in Africa, Asia and Latin America that are hotspots of viral evolution and spread. Predict focuses on monitoring the wildlife-human interface to discover new and reemerging zoonotic diseases. The Prevent project aims to mitigate risk behavior associated with animal-to-human disease transmission. Identify works to strengthen laboratory diagnostic capabilities, and Respond focuses on preparing the public health workforce for an effective outbreak response.

There are many other agencies besides USAID and the State Department that participate in biosurveillance and biosecurity, including the Department of Health and Human Services (through the Biomedical Advanced Research and Development Authority). The Department of Defense and the Department of Homeland Security both have biosecurity programs as well (the Defense Threat Reduction Agency and the National Biodefense Analysis And Countermeasures Center, respectively). These focus more on protecting the health of armed forces and combatting deliberate acts of terror, however there is still a lot of overlap with emerging infectious diseases and global health. A comprehensive disaster preparedness strategy requires coordination between agencies that may not be used to working together, and who have very different structures and missions.

What are the challenges?

Global disease surveillance is a critical aspect of our biosecurity, due to accelerated population growth and migration, and worldwide movement of goods and food supplies. Political instability, cultural differences and lack of infrastructure in developing countries all present obstacles to effective global biosurveillance. These are complex issues, but are critically important to address, as rural populations in low- and middle-income countries can become hotspots of infectious disease outbreaks. This is in part due to the lack of sanitation and clean water, and the close contact with both domestic and wild animals.

Another challenge is determining the most effective metrics with which to monitor public health data. Often by the time a new pathogen has been positively identified and robust diagnostic measures implemented, a disease outbreak is well under way. In some cases, the actions of health workers can make the situation worse, such as in the tragic mishandling of the 2010 cholera outbreak in Haiti by the United Nations. One approach that has been shown to be effective for early detection is the use of syndromic surveillance systems, such as aggregating data from emergency room visits or the sale of over-the-counter medication. When combined with advanced computing techniques and adaptive machine learning methods this provides a powerful tool for the collection and integration of real-time data. This method can alert public health officials much earlier to the existence of a possible outbreak.

Scientific research on high-consequence pathogens is a key aspect of an effective biosecurity program. This is how we develop new diagnostic and therapeutic capabilities, as well as understand how pathogens spread and evolve. However, laboratories can also be the initial source of an infection, such as the laboratory-acquired tularemia outbreak, and research with the most dangerous pathogens (Select Agent Research) must be carefully monitored and regulated. It has been an ongoing challenge to balance the regulation of Select Agents with the critical need to enhance our scientific understanding of these pathogens. Of particular concern are gain-of-function studies, or Dual Use Research of Concern (DURC). From a scientific standpoint, these studies are vital to understanding pathogen evolution, which in turn helps us to predict the course of an outbreak and develop broad-spectrum therapeutics. However this also poses a security risk, since it means scientists are deliberately increasing the virulence of a given pathogen, such as the experimental adaptation of H5N1 avian influenza to mammalian transmission, which could pose a significant public health threat if deliberately misused.

How well are we doing?

The International Security Advisory Board, a committee established to provide independent analysis to the State Department on matters related to national and international security, published a report in May of 2016 on overseas disease outbreaks. They make a number of recommendations, including: (1) better integration of public health measures with foreign policy operations; (2) working with non-governmental organizations and international partners to increase preparedness planning and exercises; (3) increase financial support and reform structural issues at the World Health Organization to ensure effective communication during crises; (4) bolster lines of communication and data sharing across the federal government, in part through the establishment of interagency working groups; and (5) strengthening public health programs at the State Department and integrating public health experts into regional offices, foreign embassies and Washington for effective decision making at all levels.

The RAND Corporation, an independent think tank, conducted a review of the Department of Defense biosurveillance programs. They found that “more near-real-time analysis and better internal and external integration could enhance its performance and value”. They also found funding to be insufficient, and lacking a unified funding system. Improvements were needed in prioritizing the most critical programs, streamlining organization and governance, and increasing staff and facility resources.

RAND researchers also published an article assessing the nation’s health security research. They found that federal support is “heavily weighted toward preparing for bioterrorism and other biological threats, providing significantly less funding for challenges such as monster storms or attacks with conventional bombs”. In a study spanning seven non-defense agencies, including the National Institutes of Health (NIH) and the Centers for Disease Control (CDC), they found that fewer than 10% of federally funded projects address natural disasters. This could have broad consequences, especially considering that natural disasters such as earthquakes, hurricanes or tornadoes can create an environment for infectious diseases to take hold in a population. More work needs to be done to integrate biosurveillance and biosecurity programs across different agencies and allocate resources in a way that reflects the priorities laid out by the administration.

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

Written by sciencepolicyforall

January 13, 2017 at 10:00 am

HIV and Ebola Pandemics: It all started with one

leave a comment »

By: Aminul Islam, Ph.D.

It is amazing to think that the pandemics of HIV, and more recently Ebola, all originated with just one infected person, otherwise known as ‘Patient Zero’. It is a testament to the globalized era that we all live in that an infectious disease can originate in a single individual and span across the globe within a single decade. CDC (Centers for Disease Control and Prevention) estimates that about 40 million people in the world are currently infected with HIV with approximately 2 million new cases reported every year. Fortunately for us, Ebola has not had quite the same devastating reach as seen with HIV, but like HIV, Ebola too originated in West Africa, and this has led to some debate as to why we are seeing such viruses emerge and spread rapidly from this region across continents and what we can do to tackle them.

Both HIV and Ebola are thought to have originated in species other than humans, namely chimpanzees (HIV) and fruit bats (Ebola), therefore zoonosis playing a large part in their transmission. Whether it involves local practices of eating bushmeat, illegal exotic animal trading, development of rural areas thorough deforestation, or exploration and mining of remote regions for precious materials and resources; it is evident that humans are more frequently coming into closer contact with isolated wild animals who are judged to be the natural reservoir hosts for these viruses. This can lead to an increased likelihood for zoonotic transmissions to take place. Should we now accept the burden of dealing with these viral pandemics as a likely price we have to pay for the cost of developing low-income nations and promoting globalization? If indeed we do, then as a global community we need to prioritize certain policies and back them up with appropriate resources. The recent failure of the WHO (World Health Organization) to adequately respond to the Ebola outbreak, both in a timely fashion and with sufficient resources, reminds us that such global infrastructures are weak and lack the correct tools in the fight against viral pandemics from West Africa.

I would suggest that a more balanced approach to dealing with this situation is to spend some time developing long-term science and global health policy countermeasures which focus on setting global strategies aimed at dealing with the ecological, geopolitical and socioeconomic changes. More precisely, let us truly develop and support a respected global infrastructure charged with unrestricted and even worldwide public health surveillance; which also has the right figurehead, capability, and capacity to effectively predict, monitor and respond to global health situations and challenges of the future, such as viral pandemics. This may mean setting up a permanent global fund to provide the best catalyst of them all, money, in an efficient, fair and sustained manner to facilitate the prediction, prevention, mitigation and countermeasures for pandemics. As has been the case of late, relying just on a single global superpower to make unilateral decisions and take action may not be the most wise, stable and long-lasting way to tackle such issues going forward. In addition, U2 front man Bono will not be around forever to campaign for the plights of Africa.

Yes, it is true that these viral pandemics do start with one individual but in the end, it is up to us all to act as a global community which engages with one another and resolves the challenges we all face from viral pandemics, particularly during the fine balancing act of promoting economic development in the midst of long term public health.

 

 

 

 

 

 

 


 

 

Written by sciencepolicyforall

February 8, 2015 at 1:40 pm

Posted in Essays

Tagged with , , ,