Tag: gain-of-function

Pandora Report 1.13.2017

by spopescu, posted in Pandora Report

Make sure to get the CRISPR a cappella song stuck in your head for not only a catchy tune, but one that educates you on the genome editing tool! In light of the recent sanctions, GMU Biodefense Director, Gregory Koblentz is discussing why holding the Assad regime accountable for its use of chemical weapons is likely a lost cause.

Recommended Policy Guidance for Potential Pandemic Pathogen Care & Oversight
On Monday, the White House Office of Science and Technology Policy (OSTP) released their report “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).” It would seem that P3CO is the new term for GoF research of concern (or GoFROC). Although, as Megan Palmer of Stanford noted, it’s going to be a challenge not calling it the C3PO policy. Adoption of these recommendations will satisfy the requirements for lifting the current moratorium on certain life sciences research that could enhance a pathogen’s virulence and transmissibility to produce a potential pandemic pathogen (an enhanced PPP). This policy follows the 2016 NSABB Gain of Function (GoF) research oversight recommendations, which emphasizes the importance of domestic and international stakeholder input, tracking of lab incidents, etc. One of the suggestions was to refer to the GoF research (meeting the specific criteria) as GoFROC as to avoid lumping all GoF research within the same category of concern. Per the press release, “First, HHS will ask the NSABB to continue to provide advice on the oversight of the creation, transport, or use of enhanced PPP.  After HHS has reviewed its paused projects and made decisions about whether and how those projects will proceed, NSABB will review the process employed by HHS and provide advice, if necessary. Continued NSABB input will be essential to ensuring robust oversight of these projects. Further, discussing the department-level review process with NSABB will promote transparency and provide valuable forums for continued public dialogue. Second, given that studies involving enhanced PPP are often described as ‘dual use’ research, HHS is currently conducting a review of the implementation of policies for the oversight of dual use research of concern (DURC). HHS has asked NSABB to host a series of regional stakeholder meetings to gather information about the implementation of the DURC policies, and it will also solicit feedback more broadly related to their implementation.” Some of the proposed suggestions include risk mitigation and project oversight comments like “modifying the design or conduct of the project” or “if the risks posed by the project cannot be adequately mitigated with these measures, agencies should determine whether it is appropriate to: request voluntary redaction of publications or communications resulting from the project.” The plan will help U.S. agencies decide if they want to fund projects that will enhance the virulence and transmission capacity of dangerous organisms, which will hopefully end a two-year moratorium on GoF work regarding MERS, SARS, and H5N1.

Thinking About Bioterrorism with Schelling’s ‘Thinking About Nuclear Terrorism” 
GMU Biodefense MS student, Greg Mercer is looking at bioweapons through the lens of Thomas Schelling. Professor Schelling, who passed away in December, was an economist and Nobel laureate famous for his work on nuclear strategy and coercive diplomacy. Mercer uses Schelling’s 1982 article, Thinking About Nuclear Terrorism, to consider how he might have addressed the threat of biological weapons in the hands of terrorists. “As with nuclear weapons, it is immensely difficult to acquire and weaponize pathogens. Using them to coerce might be even harder. There are a very few distinct examples of bioterrorism. The Aum Shinrikyo cult, in addition to their sarin gas attacks on the Tokyo subway, pursued biological weapons. This was never viable, thanks to a number of mistakes, including using the wrong strain of anthrax.”

Whole Genome Sequencing in Developing Countries
The WHO/Pan-American Health Organization are working towards utilizing Whole Genome Sequencing (WGS) as a surveillance tool in developing countries. Experts will be meeting this week in DC to discuss the applications and practical advice needed by the recipient countries of such mechanisms. “WGS has the potential to change the way we detect, assess, investigate, manage, and monitor microbiological hazards and to improve the treatment of people suffering from infectious diseases. It allows for the identification and characterization of microorganisms with a level of specificity not previously possible. The technology provides significant cross-sector potential, enabling uniform typing systems across animal, food and human sectors.” This will be a new roadmap for WGS in developing countries, as its history has been primarily research based. While many agree that there are several roadblocks ahead, the potential for application is promising however, it needs the correct leadership to maintain efficacy.

Pandemics, Bioterrorism, and Global Health Security on LinkedIn
Looking for a LinkedIn group that is dedicated to analyzing the challenges facing the world at the nexus of health, science, and security? We’ve got just the one – Pandemics, Bioterrorism, and Global Health Security. The group’s purpose is to serve as a unique forum for discussions and debate on the critical issues on global health security. Nearing 3,000 members, you’ll find a diverse and engaged group of people who are looking to tackle the challenges that are posed by biological threats, regardless of source. This group is devoted to bridging the gaps between science and policy and between health and security to develop new strategies for reducing the risks posed by transnational threats to global health security. It is hoped that this group can serve as a means of keeping scientists informed about the latest policy developments in the global health security domain as well as to educate practitioners about the policy implications of emerging infectious diseases and advances in the life sciences and biotechnology.

America’s Growing AMR Problem  

Courtesy of Reuters
Courtesy of Reuters

Let’s start with a bit of a good news – for the first time, federal injury reports will include healthcare-associated antibiotic resistance bacteria infections in attempts to set penalties for healthcare facilities. The fourth installment in Reuter’s investigational series regarding antimicrobial resistance is out and it brings the issue full circle. Focusing on the costs of AMR, the lack of new antibiotics, and personal accounts, this series is everything we need to paint the full picture of the antibiotic abyss. The fourth installment, Deadly Silence, is particularly fascinating as it looks at the problem from a healthcare reporting perspective. Coming from this infection preventionist, it isn’t surprising to see the lack of required AMR reporting across the U.S. however, it is shocking to see the general indifference towards changing it. Focusing on long-term care facilities (like nursing homes or rehab centers), it becomes increasingly apparent that they’re uniquely vulnerable to outbreaks and have little incentive or responsibility to report cases or events. “As Reuters reported in September, the Centers for Disease Control and Prevention, the national public health monitor, lacks regulatory power to track superbug deaths. It also lacks the authority to enforce outbreak reporting. Instead, it sometimes assists states with their outbreak investigations, a spokesman said, but each state decides which diseases must be reported.” The reporting issues are especially important because it’s not just that we have a problem with lack of new antibiotics or a growing number of antimicrobial resistance, or even a growing usage of antibiotics among humans and animals, but also that we lack the oversight and enforcement to ensure healthcare facilities monitor the problem and do something about it. This gap means that we have little true understanding for not only the depth of the issue, but also the breadth of it. Simply put, we need a new game plan for combating the growing threat of antibiotic resistance.

PHEMCE Strategy & Implementation Plan
HHS recently released their 2016 Public Health Emergency Medical Countermeasures (PHEMCE) Strategy and Implementation Plan (SIP). The report provides updates and a blueprint regarding their plans to enhance national health security via medical countermeasures (MCM). Within the PHEMCE SIP, you can find a summary of their major accomplishments, activities currently being pursued, recap of the advanced research and development and procurement awards, and more. “In FY 2015, BARDA continued to work closely with NIH and DoD to monitor the progress of programs supported under research and development and transition promising candidates. In FY 2015, BARDA re-issued the three BAAs to support advanced development of CBRN and Influenza MCMs and the BAA for Innovations. They were modified to align with the 2015 PHEMCE SIP and to address remaining gaps in preparedness as well as address new initiatives such as CARB and EID.”

Zika Outbreak Updates
As Angola reports cases, a new Moderna Therapeutics mRNA vaccine enters clinical trials. “A $54.2 million grant in 2016 from BARDA has supported the development of the vaccine through the scale-up for larger phase 2/3 efficacy trials. Based on the vaccine’s performance and availability of more funding, BARDA may provide up to $125.5 million to further advance the development of Moderna’s vaccine.” On January 11th, the CDC reported a total of 4,866 cases of Zika within the U.S. Physicians have released a photo showing symptoms of the first person to experience local Zika transmission in the U.S.

Stories You May Have Missed:

  • FDA Drops Plan to Release GMO Mosquitoes – Initial FDA plans to drop millions of genetically engineered mosquitoes in Key Haven, Florida, were halted after local residents voted against it.  The plan “was designed to help fight the Zika virus with mosquitoes that had been genetically altered. It would have been the first such initiative executed in the United States. However, attorneys for Key Haven and concerned citizens noted that the FDA did not complete adequate testing on the potential impact the release would have on people, the local environment, nor area species concerned threatened and endangered. Local residents were presented with the issue via voting ballot in November 2016, in which voters unanimously shot down the release. The Florida Keys Mosquito Control Division met after the Nov. 8, 2016, public referendum and voted against the trial run in Monroe County in Florida, according to http://www.flkeysnews.com.”
  • The Woes of Camel Vaccination Plans – In efforts to test an experimental vaccine against MERS, researchers are trying to slow the spread via camel vaccination. We often forget the battles that make up public health and vaccine development, but camel vaccination is definitely a new one. “Camels are not a very, let’s say, cooperative kind of animal from this point of view,’’ Segalés told STAT. “To get them out from the truck was not that easy. To get them into the facility was not that easy. And to get them into the box (holding pen) was not that easy. Trying to push them in was quite difficult sometimes. And the worst-case scenario was trying to take them out.”
  • Trump Picks Vaccine-Skeptic to Lead Vaccine Safety Commission– “Robert F. Kennedy Jr., a proponent of a widely discredited theory that vaccines cause autism, said Tuesday that President-elect Donald Trump asked him to chair a new commission on vaccines. Hours later, however, a spokeswoman for Trump’s transition said that while Trump would like to create a commission on autism, no final decision had been made.”

Pandora Report 1.6.2017

by spopescu, posted in Pandora Report

Welcome to 2017 and a whole new year of biodefense news! While you’re heading back to work, make sure to wash your hands and stay safe – the CDC has reported increasing flu activity.

The Best of Bio and Chem Weapons Coverage in 2016
The Bulletin of the Atomic Scientists has put together their “five best articles” for bio-chem weapons in 2016 and we were happy to see two familiar faces – GMU PhD alum Daniel M. Gerstein and GMU Biodefense professor, Sonia Ben Ouagrham-Gormley. Daniel Gerstein’s article, How genetic editing became a national security threat, discusses the threatening components of gene drive, like low cost and growing availability. “Armed with the proper genetic sequences, states or bioterrorists could employ genome editing to create highly virulent pathogens for use in such attacks. They could, for example, change a less dangerous, non-pathogenic strain of anthrax into a highly virulent form by altering the genome, or recreate pathogens such as the deadly smallpox virus, which was eradicated in the wild in 1980.” Sonia Ben Ouagrham-Gormley teamed up with Kathleen Vogel to discuss the good, bad, and the hype of gene drive. They emphasize the importance of understanding gene drive to really discern the benefits and risks of the technological process. Looking at all angles, their article gives a wholistic approach to better appreciate the complexities of gene drive for biodefense. “Without a clear and detailed understanding of the range of social and technical factors that cause scientists to succeed or fail in their gene-drive endeavors, threat estimates can only rely on speculation and fantasy rather than fact.”

GMU Biodefense Students – Win Registration for 2017 ASM Biothreats Conference!
Calling all GMU Biodefense students – the program will be offering free registration to four lucky students to attend this premier biodefense event at the Marriott Wardman Park in Washington, DC on February 6-8th. This year, the meeting incorporates three major tracks, “Research, Response, and Policy” to cover relevant topics in basic and applied research; public health, emergency response and preparedness; and biosecurity, government, and policy responses. The exchange between these multidisciplinary communities will shape the future of this very important field. The keynote session on February 6 will be given by Thomas M. Countryman, Acting Under Secretary for Arms Control and International Security and Assistant Secretary to the Bureau of International Security and Nonproliferation at the Department of State.  Anthony S. Fauci, M.D., Director of NIAID Director at the National Institutes of Health, will be presenting at a special session on February 7. You can find the rest of the agenda here. As an attendant for the 2016 conference, I can tell you that it’s a great experience for not only learning, but also networking. Please check your GMU email for the information Dr. Koblentz sent out. To apply: students are required to submit a 250-word essay about how attending the conference will benefit your education/professional aspirations by 5pm today (Friday, January 6th) to Dr. Koblentz. Winners will be announced the following Monday and those selected will be asked to write up summaries of at least two panels for publication in the Pandora Report.

USGS Disease Maps
screen-shot-2017-01-03-at-6-04-01-amLove maps and diseases? Or do you simply like knowing what kinds of vectored diseases are transmitted around you? Check out the USGS disease maps that also allow you to interact with them. Utilizing data from CDC’s ArboNET, you can look at transmission among humans, mosquitoes, birds, sentinel animals, and veterinary transmission. The observable diseases include West Nile Virus, St. Louis Encephalitis, Eastern Equine Encephalitis, Western Equine Encephalitis,  La Crosse Encephalitis, Powassan Virus, Dengue fever (locally acquired and imported), and Chikungunya (locally acquired and imported). The USGS disease maps allow us to not only have a better understanding of vectored disease transmission, but also landscape epidemiology.

CRISPR Off-Switch
CRISPR is going to be a hot story in 2017 and here are the seven things to look for. The burgeoning concerns regarding CRISPR technology involve the rapid pace of development and lagging DURC policies, not to mention the inability to predict future outcomes. The interest and unease over this new form of genome editing has left many searching for an “off button”, but thankfully, researchers are believed to have found one.  While the new “off switch” isn’t capable of reversing changes that were already made, it can stop the system from making additional edits. “The switch is a series of ‘anti-CRISPR’ proteins that were discovered inside viruses that attack bacteria, where they’re used to disable the gene editing tool and sneak into the bacterial DNA. ‘Just as CRISPR technology was developed from the natural anti-viral defence systems in bacteria, we can also take advantage of the anti-CRISPR proteins that viruses have sculpted to get around those bacterial defences,’ said lead researcher Benjamin Rauch. The team isolated these anti-CRISPR proteins from Listeria bacteria that had been infected by viruses. The team isolated the proteins that appeared to be involved and tested whether any of them could stop CRISPR editing from taking place in human cells. They found that two of these proteins, AcrIIA2 and AcrIIA4, worked together to inhibit the CRISPR systems commonly used by scientists.”

CDC Concludes CDP Ricin Exposure Inspection
The CDC just finished their inspection of the lab that sold the ricin toxin that was used by the Centers for Domestic Preparedness (CDP) training facility. The ongoing debate between the CDP and lab regarding the mishandling or misunderstanding points to bigger, systemic issues in regards to select agents. CDP states that the lab is to blame, noting that they ordered a less toxic version of ricin, while the lab rebutted by pointing out that the ricin was always properly labeled as the toxic version and they, in fact, never offered the less toxic version. The site visit and inspection findings are under review as the CDC determines if the lab is responsible and violated federal regulations. The conclusion of the inspection also comes at a challenging time for the CDC as the agency is taking heat for blacking out many details in reports recently released via the Freedom of Information Act. The released laboratory reports were requested by USA TODAY and only fuel the attention to lab incidents and poor biosafety practices.

NAS DURC Committee Meeting 
This week the National Academies held the Committee on Dual Use Research of Concern (DURC): Option For Future Management. You can get not only the webcast recording (check out 2:42:00 in and you’ll see GMU Biodefense director and professor, Gregory Koblentz, talk about the zero sum game in terms of regulating DURC research – to regulate or not to regulate, that is the question!), but also the full presentations. Since the 2011 H5N1 controversies, “it remains unclear as to whether there are practical mechanisms or approaches for managing such dual use research of concern (DURC) and, specifically, how to deal with situations where there is a pressing need, for public health reasons, to publish research findings while limiting, due to national security concerns, the dissemination of certain details that ordinarily would be published. This is especially true in cases where an initial assessment of proposed research does not anticipate results that would warrant such consideration.”

Zika Outbreak Updates
Scientists are currently unveiling the key proteins in the virus that made it so deadly. The first comprehensive description of the Zika genome has identified seven key proteins that are helping researchers understand the devastation the virus does to the human body. “To test the virus, Dr. Zhao used fission yeast, a species that in recent years has become a relatively common way to test how pathogens affect cells. Fission yeast was originally used to make beer, particularly in Africa, where it originated. (Its species name is Schizosaccharomyces pombe; pombe means beer in Swahili.) Over decades, fission yeast has been used by many scientists to find out mechanisms and behavior of cells. For the experiment, Dr. Zhao and his colleagues separated each of the virus’s 14 proteins and small peptides from the overall virus. He then exposed yeast cells to each of the 14 proteins, to see how the cells responded. Seven of the 14 proteins harmed or damaged the yeast cells in some way, inhibiting their growth, damaging them or killing them.” The Entomological Society of America has noted that socioeconomic factors provide protection against a large scale Zika outbreak in the U.S., but that small outbreaks are an ongoing concern. As of January 4th, the CDC reported 4,618 cases of Zika in the U.S., of which 216 were locally-acquired.

Does the CDC’s New Quarantine Rule Violate Civil Liberties?
With a new vaccine and hopeful approach to emerging infectious diseases, have we buried Ebola? Back in August, the CDC proposed a new rule regarding its powers to respond to potential outbreaks via screening, testing, and quarantining people traveling into or within the U.S. You can read the new rule here, but it focuses on “non-invasive public health prevention measures” and reporting requirements for commercial passenger flights of death or illness to CDC, etc. While this may seem pretty reasonable given health emergencies like Ebola and SARS, many ” epidemiologists, lawyers, and health organizations say that the rule, in its current form poses a serious threat to civil liberties, allowing authorities to detain and examine people with little heed to due process and informed consent.” Attempted in 2005, this rule was initially met with criticism, however the recent Ebola outbreak has changed the way we approach travel during times of infectious disease outbreaks. Public health emergencies are defined as ‘communicable disease events’ that the director believes could be high risk for death or serious illness. “It is already authorized to detain people suspected of carrying diseases like plague, Ebola, and (somewhat improbably) smallpox. But the new rule does away with a formal list. It extends the same powers to any “quarantinable communicable disease,” and uses wider range of symptoms (from a list that federal agents can update as the need arises) for defining ‘ill’ people.” While the CDC can detain travelers prior to decision to quarantine, it notes that this shouldn’t last longer than 72 hours and fails to make provisions for a lawyer if the person can’t afford one. “The rule also gives the CDC ultimate authority to carry out medical tests and treatments, stating that ‘the individual’s consent shall not be considered as a prerequisite to the exercise of any authority’.” What are your thoughts? We’d love to hear from our readership – please email or tweet @PandoraReport to give us your thoughts!

USDA ARS 4th International Biosafety & Biocontainment Symposium Registration Deadline
Don’t miss the January 13th registration deadline for this event in Baltimore, Maryland! From February 6-9, the focus of the symposium will be Global Biorisk Challenges-Agriculture and Beyond. Seven presymposium courses will address topics including unique biocontainment challenges, decontamination and inactivation, and institutional governance. Topics include biorisk management challenges in a One Health World, arthropods, HPAI, risk assessments, and more!

Stories You May Have Missed:

  • 85 People Suspected to Have Contracted Rabies– Like something out of a zombie movie, 85 people are suspected of having contracted wild rabies after being bitten by bats in Peru. “Regional director of Health of Cusco, Julio César Espinosa La Torre said that among the group of victims with a bat bite are the 15 soldiers transferred to Lima, of this group, two cases were confirmed, of which one is deceased. Espinoza la Torre said that to date, more than 912 civilians and 680 soldiers have been vaccinated in Alto and Bajo Urubamba, in the district of Megantoni, who must receive up to four doses, every 7 and 14 days.”
  • Anticipating Epidemics Using Computational Models – the White House recently released a report to strengthen the capacity for outbreak prediction. Spearheaded by the National Science and Technology Council, Toward Epidemic Prediction: Federal Efforts and Opportunities in Outbreak Modeling, looks to predictive modeling and data utilization to better understand the “processes that drive disease emergence and transmission could help to predict and prevent large-scale outbreaks. These programs range from foundational research into disease emergence and spillover, to predictive modeling contests, to the development of decision-support technologies for public health responders.”
  • Pandemic Chats – Struggling to chat to a younger generation about diseases? Check out how the Bill & Melinda Gates Foundation is talking to the next generation about the next pandemic.

Pandora Report 11.9.14

by juliadhomstad, posted in Pandora Report

We’ve got some timely stories this week: just in time for Veteran’s Day, we look at military exposure to chemical agents in Iraq, and at the beginning of flu season we look at the newest suspension of Yoshihiro Kawaoka’s H5N1 research. We’ve also got an Ebola update.

Have a great week!

More Than 600 Reported Chemical Exposure in Iraq, Pentagon Acknowledges

With Veteran’s Day on Tuesday, The New York Times uncovered an unfortunate military oversight that could affect over 600 service members. Originally, NYT found 17 soldiers who had been exposed to abandoned, damaged, or degraded chemical weapons in Iraq. Later 25 more came forward, and after a review of Pentagon records, Defense Secretary Chuck Hagel has said that hundreds of troops told the military they were exposed. The Pentagon says it will now expand outreach to veterans who believe they may have been exposed.

The New York Times—“Phillip Carter, who leads veterans programs at the Center for a New American Security, called the Pentagon’s failure to organize and follow up on the information “a stunning oversight.” Paul Rieckhoff, founder and executive director of Iraq and Afghanistan Veterans of America, said the military must restore trust by sharing information.”

Kawaoka’s Controversial Flu Research at UW-Madison On Hold Again

Once again, Yoshihiro Kawaoka has halted his research of H5N1 at the University of Wisconsin-Madison. Kawaoka created an altered version of the H5N1 flu virus to look at transmissibility between mammals. On October 17, the Obama administration said they would postpone federal funding for gain-of-function studies, including those involving flu, SARS and MERS. Roughly 50% of Kawaoka’s work involves gain of function, and he paused all experiments that “might enhance pathogenicity or transmissibility.”

Wisconsin State Journal—“The White House announcement comes in response to incidents this year involving anthrax, flu and smallpox at the Centers for Disease Control and Prevention and the Food and Drug Administration. “The incidents occurring at federal facilities this summer have underscored the importance of laboratory safety, and they also prompted calls for a reassessment of the risks and benefits that are associated with research involving dangerous pathogens,” Samuel Stanley, chairman of the National Science Advisory Board for Biosecurity, said during a meeting of the group Oct. 22.”

This Week in Ebola

The Ebola ‘outbreak’ in Texas is over and MSF has confirmed the decline of cases in Liberia, however, Ebola cases have risen ‘sharply’ in Sierra Leone. While Kari Hickox remained in the news explaining the reasons she fought against quarantine, it appears, as feared, that mandatory quarantine for volunteers returning from West Africa is causing some to re-consider their commitments. Meanwhile the U.S. Army has identified five possible bases for returning troop quarantine and the Pentagon has awarded a $9.5 million contract Profectus BioSciences, Inc. for development of an Ebola vaccine. President Obama asked Congress for $6 billion to fight Ebola in the U.S. and West Africa. NBC News reported that “The U.S. is keen to be seen as leading the international response to Ebola” but there is another country in the Americas contributing to the fight—Cuba. Also in the Americas, Canada’s policy of denying visas for people coming from West Africa is called into question, and five American airports are learning a lot about infection control. Back in West Africa, Nigeria’s success in fighting Ebola has been attributed to their fight against polio. Lastly, on the heels of Mark Zuckerberg’s $25 million donation to fight Ebola, he launched a button at the top the newsfeed that links users to places where they can donate, too.

Stories You May Have Missed

 

Image Credit: NBC News

C. botulinium’s Deadliest Toxin: To Share or Not To Share?

by juliadhomstad, posted in News

By Alena M. James

Two years ago, Dr. Stephen Arnon and Dr. Jason Barash discovered a new strain of Clostridium botulinum. Typical C. botulinum strains are known to express any of the seven different botulinum neuron toxins, Botulinum Toxin Types A-G.  The new strain discovered by Arnon and Barash, after studying infant botulism at the California Department of Public Health in Sacramento, was found to express neurological toxins, Botulinium Toxin Type B and a new Botulinum Toxin Type H.   Dr. Arnon and Dr. Barash published their findings of the new toxin in the Journal of Infectious Diseases in 2013, but elected to withhold from the public and the rest of the scientific community any genetic sequencing information regarding the new strain. The withholding of this information has remained a point of contention between the researchers and individuals representing various organizations wishing to study the bacteria.

After publishing a story on the case last Monday, NPR revealed that Dr. Arnon had not been engaging in scientific information sharing practices regarding the new toxin with other professionals also studying botulinum toxins. According to NPR’s coverage, Dr. Arnon remained reluctant to disseminate information on the newly discovered neurotoxin, Type H, with other scientists or with federal officials. In an article published by New Scientist, the editors of the Journal of Infectious Diseases announced that Arnon and Barash held consultations with several representatives from different federal agencies before deciding against publishing genetic sequencing information on the new stain in their scientific article.

From NPR’s coverage of this case, federal officials claim they were not responsible for the researcher’s decision to not make the genetic sequences available and never said not to publish the information. Given the lack of an antitoxin antidote available to stop the dangerous effects of the Type H toxin, many individuals desire to perform research on the strain of C. botulinum that can produce the Type H toxin. Several scientists and federal institutions have tried to request the sequences and/or live strains of Arnon’s new strain of C. botulinum. However, Arnon remains steadfast in not sharing the bacteria.

The case raises an unresolved issue that persists in the sciences. That issue is defining the parameter by which we are able to distinguish dual use research.  Dual use research in the biological sciences is research that can be performed to benefit humans, but can also be performed to harm humans. In this particular case, the Type H Toxin has been declared the most deadly toxin and has great potential to be deployed as a biological weapon.  The absence of an available antitoxin that can be administered to infected patients raises great cause for concern that the bacteria producing the toxin could be mass-produced to harm innocent people. From NPR’s story, it seems that this sentiment is shared with Type H’s discover Arnon.

Upon Arnon’s discovery of Type H, the CDC, US Army Laboratories, and DHS all expressed interest in acquiring the strain that produces this new neurotoxin. These federal institutions’ interest in studying the toxin in order to develop a cure is the same goal as numerous other scientists who want to perform research on the strain. So how does one build biodefense against a pathogen one cannot gain access?  Maybe from Dr. Arnon’s perspective, keeping Pandora’s Box closed maybe the best weapon of defense for the US against the botulinum Type H neurotoxin.

 

You can listen to NPR’s initial report of this story here.

Image Credit

Airborne Bird Flu Transmission: Balancing Scientific Recourse and National Security

by juliadhomstad, posted in News

By Chris Healey

Articles recently published in the scientific journal Cell mark the end of a long battle for one researcher in his endeavor to publish research that raises security concerns.

Ron Fouchier, a virologist with Erasmus University Medical Center in the Netherlands, published an article in Cell explaining how H5N1, the causative agent of bird flu, can be genetically modified for airborne transmission between mammals. Dr. Fouchier says his research can help prevent bird flu pandemics. However, others in the scientific community believe Dr. Fouchier will cause what he seeks to prevent.

David Relman, a researcher at Stanford University, says Dr. Fouchier is essentially giving would-be terrorists instructions on how create a deadly contagion.

The controversy began in December 2011 when the  National Science Advisory Board for Biosecurity (NSABB), a federal advisory committee composed of twenty-five members who provide expertise in areas such as molecular biology and infectious diseases, advised all scientific journals to refrain from publishing Dr. Fouchier’s H5N1 airborne transmission research.

In February of 2012, the World Health Organization released its own evaluation of the research. The WHO stated Dr. Fochier’s work had scientific value and should be shared in its entirety. Shortly after the WHO’s report, the NSABB reevaluated the research findings. In March 2012, it retracted its recommendation to refrain from publishing. The complete study, along with all its findings, was finally published in Cell on April 10, 2014.

By its nature, science is a cumulative process. Communication among professionals is essential to promote progress and mutual understanding. Experts agree scientific advancement progresses best when least inhibited by authority. Government intervention generally pushes great minds away from heavily-scrutinized areas into those less regulated.

However, national security remains a priority and precedent exists for controlling scientific literature. The Atomic Energy Act of 1946 was passed to control and restrict nuclear weapons research conducted in the United States during WWII. No similar legislation exists to prevent communication of biological findings. However, the government can take steps to restrict research with dual use findings.

Government information classification, colloquially known as identifying information as top secret, secret, or confidential, is useful for keeping government-owned information away from the public. However, research the government had no part in creating, either through federal funding or conducted by government employees cannot be given a sensitivity label.

A common practice in government funding of scientific research is the requirement of funding to be contingent upon acceptance of sensitive but unclassified contract provisions. Those provisions allow the government to have authority on whether research findings can be published.

Dr. Fouchier’s research was precarious because it was conducted in a foreign university but supported by U.S federal funds. Outside the United States, the federal government has less control over research conducted under its auspices. It is unclear if Dr. Fouchier’s research was subject to a sensitive but unclassified contract provision.

With the power of the purse, the federal government can influence research and publication decisions through threat of funding withdrawal. While federal money funds much scientific research, simply pulling funding is not a fool-proof censorship method. Private benefactors can step in for lack of government support. The government can wield no financial influence on those sources receiving no government funding, including research funded by foreign governments.

Outside of financial influence, the government can best stop publication of sensitive material through NSABB recommendation. The committee has many ties to scholarly publications and is generally well respected. Initial recommendations not to publish Dr. Fouchier’s research were very influential; it was not published until well after committee approval.

There is no straight-forward answer to questions concerning science and security dissidence. Benefits of sharing scientific research must be weighed with harm that could arise from that research.

 

Image Credit: James Jin/Flickr

The Pandora Report 1.3.13

by Siddha Hover, posted in Pandora Report

The first Pandora Report of the new year, and it’s (unsurprisingly) flu heavy. Highlights include H1N1 attacking the young, new MERS-CoV cases, H7N9 in Taiwan, H5N1 in China, and the gain-of-function debate (so more H5N1). Happy Friday!

Notice to Clinicians: Early Reports of pH1N1-Associated Illnesses for the 2013-14 Influenza Season
The CDC has a health alert out, detailing the tendency of this season’s predominant flu strain (which, as we’ve said before, looks like its going to be H1N1) to disproportionately affect the young. This is possibly because the elder amongst us are more resilient, due to cross-reactive immunity – they’ve been around longer, which means there’s a greater chance they have been exposed to similar viruses. The upshot is if you’re young and healthy, get a flu shot.

CDC – “From November through December 2013, CDC has received a number of reports of severe respiratory illness among young and middle-aged adults, many of whom were infected with influenza A (H1N1) pdm09 (pH1N1) virus. Multiple pH1N1-associated hospitalizations, including many requiring intensive care unit (ICU) admission, and some fatalities have been reported. The pH1N1 virus that emerged in 2009 caused more illness in children and young adults, compared to older adults, although severe illness was seen in all age groups. While it is not possible to predict which influenza viruses will predominate during the entire 2013-14 influenza season, pH1N1 has been the predominant circulating virus so far. For the 2013-14 season, if pH1N1 virus continues to circulate widely, illness that disproportionately affects young and middle-aged adults may occur.”

Six new cases of MERS virus hit Saudi Arabia, UAE
The WHO has reported six new cases of MERS-CoV. Of the six, five are Saudi nationals, with one case in the United Arab Emirates. Three of the cases, including one involving a wife tending to an ill husband, are reportedly asymptomatic. Ages of the new patients range from 59 to 73 years old, with the latter succumbing to the virus. The new cases bring the global total to 176, with 74 deaths. There is still no substantive information on the virus’ source, transmission, or vector. Sadly, “it might be camels” remains our most conclusive evidence to date – which is not to impugn the work of the scientists involved, which has been fastidious, but rather to bemoan the complexity of the virus itself.

Reuters – “MERS emerged in the Middle East in 2012 and is from the same family as the SARS virus. It can cause coughing, fever and pneumonia. Although the worldwide number of MERS infections is fairly small, the more than 40 percent death rate among confirmed cases and the spread of the virus beyond the Middle East is keeping scientists and public health officials on alert. Cases have been reported in Saudi Arabia, Qatar, Kuwait, Jordan, United Arab Emirates, Oman and Tunisia as well as in several countries in Europe, and scientists are increasingly focused on a link between the human infections and camels as a possible ‘animal reservoir’ of the virus.”

Hundreds monitored in Taiwan after H7N9 strain of bird flu after infected tourist discovered
A tourist infected with H7N9 spent over a week travelling through Taiwan from mainland China before being hospitalized. Health authorities in Taiwan are scrambling to reach all people he potentially came in contact with during his tour. Three medical personal who had dealings with the infected patient have subsequently developed symptoms of upper respiratory infections themselves. However, it should be emphasized that there remains no conclusive evidence of sustained person-to-person transmission of the virus.

Channel Asia – ”  As many as 500 people may have had contact with him, all of whom are being asked to report to doctors should they develop possible symptoms, the statement added. The 149 people who may have had close contact include two family members accompanying him on the tour, the tour guide, bus driver, medical personnel and patients sharing the same hospital ward, it said.”

China confirms H5N1 bird flu outbreak in Guizhou
Following the death of approximately 8,500 birds on a farm in Southwest China,  health authorities have confirmed an outbreak of H5N1 amongst poultry in the area. The area has subsequently been sealed off, with a further 23,000 birds culled for safety. As of yet, no human cases have been reported in the area.

Xinhua – “The southwest China province of Guizhou has reported an outbreak of H5N1 in poultry, the Ministry of Agriculture (MOA) announced Thursday. Some chickens at a farm in a village of Libo County in the prefecture of Qiannan in Guizhou showed symptoms of suspected avian flu and 8,500 chickens died on Dec. 27, 2013. The National Avian Influenza Reference Laboratory confirmed the epidemic was H5N1 bird flu after testing samples collected at the farm, according to the MOA.”

European Researchers Urge H5N1 Caution
The debate over gain-of-function (GOF) research continues to rage in the scientific community – in the most recent move, fifty scientists have drafted an open letter to the head of the European Commission, urging him to hold a press conference to discuss the merits of GOF research. For those of you not interested in macropolitics within the scientific community, gain-of-function research involves experiments in which viruses are carefully but deliberately mutated to increase pathogenicity in some way – in this case, by increasing transmissiblility between mammals. The research which launched the current maelstrom was Ron Fouchier’s  mutation of H5N1 to make it more transmissible between ferrets (and therefore, also, humans). We’ll leave the polemic arguments to those who are better informed, but in the meantime, the  letter is available here.

Science – “Fouchier’s struggles, which included the Dutch government using export regulations to bar him from publishing his results, compelled the European Society for Virology (ESV) to write its own letter to the EC in October. That letter expressed concern that the Dutch government’s tactics were inappropriate and threatened to set a precedent that could stymie the dissemination of research findings elsewhere. On the scientific side of the debate, some have argued that gain-of-function research, especially those studies that engineer deadly strains of the bird flu virus, can potentially result in inadvertent escapes from the lab and widespread infection. Proponents of the work argue that studying how mutations confer the ability to infect new individuals via novel routes can yield key insights into how the pathogens spread.”

(image of H1N1 via CDC/ Doug Jordan, M.A.)

New developments in legal battle over H5N1 research

by Siddha Hover, posted in News

Ron Fouchier, the virologist at the center of the last year’s controversial gain-of-function H5N1 research, is back in the media following the ruling on his research in Dutch courts this week. The ruling surrounded the legality of the Dutch government’s decision to request Fouchier to first obtain an export licenses before sending his H5N1 research out to the magazine Science. The government did so after classifying Fouchier’s work as dual-use research of concern, the dissemination of which could be perceived as potential proliferation. This week’s ruling not only supported the government’s requirement of an export license, but extended the requirement to all future work on H5N1 transmission. Needless to say, Fouchier is not pleased. He’s accused the Dutch government of disadvantaging Dutch scientists and mitigating their academic freedom.

Read more at Science.

(Image: Selbe B./Flickr)

Researchers mutating H7N9, increasing virulence and P2P transmission

by Siddha Hover, posted in News

Twenty-two researchers from labs across the world submitted a letter to Nature and Science yesterday detailing their proposed “gain-of-function” research on the avian influenza virus H7N9. Their work would genetically engineer H7N9 to make it both more virulent and more readily transmissible person-to-person. The research sounds controversial, not the least because one of the scientists involved is Dr. Ron Fouchier, whose on gain-of-function work on H5N1 ingnited furious debate over what should research should and shouldn’t be published. However, there is a very real possibility that H7N9 will naturally mutate to transmit effectively between people. We already know that the virus is just a single amino acid mutation away from becoming easily transmissible between people. Indeed, news of the first confirmed case of such transmission was published in the British Medical Journal this week. With a 60% fatality rate and a completely naive global population, the results would be catastrophic. The proposed research would give us an idea of potential pandemic scenarios, giving us a head start on potential vaccine and antiviral development.  It may be controversial, but it’s absolutely necessary.

For the full letter, see here.

(image credit: Yoshihiro Kawaoka University of Winsconsin, Madison)