Emerging Leaders in Biosecurity Initiative

The Center for Biosecurity of UPMC has launched the Emerging Leaders in Biosecurity Initiative, a competitive program that will develop and maintain a network of promising early career professionals from multiple disciplines who are considering future careers in biosecurity.
 
In this first year of the program, the Initiative will select up to 25 highly talented new professionals as Fellows from academia, government, defense, private industry, science, public health, medicine, and the social sciences. Fellows selected will be sponsored during the year to attend two biosecurity meetings, engage in networking opportunities with established leaders in the field, participate in a writing competition that can lead to publication and public presentation opportunities, and participate in educational webinars. Involvement in the Initiative will enable Fellows to develop leadership skills and connections that can propel them into a career in biosecurity.
 
Program description and application details available at:  (www.emergingbioleaders.org).
 
Applications must be submitted NLT March 15, 2012.
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The Risk of Engineering a Highly Transmissible H5N1 Virus

Editorial by Thomas V. Inglesby, Anita Cicero,
and D. A. Henderson

   
Thomas V. Inglesby, MD, is the Chief Executive Officer and Director; Anita Cicero, JD, is Chief Operating Officer and Deputy Director; and D. A. Henderson, MD, MPH, is a Distinguished Scholar, all at the Center for Biosecurity of UPMC, Baltimore, Maryland. Drs. Inglesby and Henderson are Coeditors-in-Chief of
 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.

   
Over the past 8 years, H5N1 avian influenza has sickened 571 people, killing 59% of them. To give some perspective, the fatality rate of the virus that caused the 1918 Great Pandemic was 2%, and that pandemic killed on the order of 50 million people. Like all influenza strains, H5N1 is constantly evolving in nature. But thankfully, this deadly virus does not now spread readily through the air from person to person. If it evolves to become as transmissible as normal flu and results in a pandemic, it could cause billions of illnesses and deaths around the world—the proportion of the global population affected by past pandemics.

Scientists recently have announced that they genetically modified H5N1 in the laboratory and that this mutated strain spread through the air between ferrets that were physically separated from each other. This is ominous news. Since ferret influenza virus infection closely mirrors human infection and is similarly transmissible, these scientists appear to have created a bird flu strain with characteristics that indicate it would be readily transmissible by air between humans. In fact, the lead scientist on one of the experiments explicitly stated this.

The question is this: Should we purposefully engineer avian flu strains to become highly transmissible in humans? In our view, no. We believe the benefits of this work do not outweigh the risks. Here’s why. 

There are no guarantees that such a deadly strain of avian flu would not escape accidentally from the laboratory. This particular experiment was performed by internationally respected scientists in biosafety conditions considered top of the line. They seem to have taken the expected and necessary precautions. The risk of a person accidentally becoming infected and starting an outbreak with this new strain is low. But it is not zero.

The safety record of most labs working at high biocontainment levels is outstanding, and the historic number of accidents is very low. In almost all situations, even if a laboratory worker comes in contact with a dangerous pathogen and becomes sick, the risk of extensive wide community spread is negligible. This is because very few dangerous pathogens are as highly transmissible as influenza is. An accidental escape of an influenza strain from a lab in 1977 proves the possibility: That accident led to widespread flu epidemics. Given the potential global consequences of an accident with the newly modified strain of avian flu, we are playing with fire.

We are not opposed to research in high-containment labs using dangerous pathogens, including H5N1. Over the past decade, the Center for Biosecurity has publicly argued for the importance of such research to develop diagnostics, medicines, and vaccines for the most threatening infectious diseases. But research and development for those purposes does not require engineering lethal viruses to make them more transmissible between humans. There is no virus disease today other than influenza that has exhibited the potential attributes of global transmission such as has been documented with flu over the past 2 centuries and more. Thus, it occupies a unique position in the pantheon of microbes.

Some who defend the value of this recent experiment have argued that it is important to determine whether the present H5N1 strain could acquire genetic characteristics of a pandemic strain and, if so, what the particular characteristics might be. The thinking is that currently circulating strains of the H5N1 virus could then be screened for these characteristics, which, if found, might serve as an early warning. It is a speculative hope but not worth the potential risk.

Others have argued that the benefit of this experiment and its findings will be to motivate more work on H5N1 flu vaccines. Scientists have already developed bird flu vaccines, and research and development work continues. Should there be more money and effort devoted to improving our vaccine and medical defenses against H5N1 and other flu strains? Absolutely. But should we undertake experiments that engineer a transmissible strain of deadly flu in hopes that the frightening results invigorate R&D for vaccine development?

Still others have argued that this experiment may help directly in the vaccine development process. That argument is that now that we have this new transmissible strain, we should use it to test whether our current vaccines are effective against it. But it is unclear that vaccine protection against this engineered strain would correlate with vaccine protection against an H5N1 pandemic strain that evolves naturally in the world. Again, we would argue that the risk of accidental release outweighs the potential and uncertain benefits of engineering a pandemic strain.

An eminent scientific journal is considering whether to publish this work. A critical tenet of the advancement of science is the publication of new research in a form that allows other scientists to reproduce the work. This principle should be followed in almost all conceivable circumstances. But in this circumstance, it shouldn’t.

Publishing the methods for transforming the H5N1 virus into a highly transmissible strain would show other scientists around the world how to do it in their own labs. One concern is the possibility that the strain would be recreated for malevolent purposes. Even disregarding this risk (which we shouldn’t), scientific publication would encourage others that this is a research initiative worthy of additional exploration.

There are already checks in the research review process that include scientists’ consideration of these issues at project conception, deliberation at the time of funding decisions, institutional biosafety committee approvals, and the scientific publication review process. In principle, these elements should provide the necessary checks and balances. In this case, it will be important to understand the reasoning and decision making that led to the execution of this work. In the future, when an experimental plan calls for engineering a lethal virus into a highly transmissible one, then the rationale for funding and approval should be made explicit publicly.

Whether this experiment is published or not, it is a reminder of the power of biology and its potential. We need new approaches for the rapid development of large quantities of medicines or vaccines to protect us against new emerging viruses. But engineering highly transmissible strains of avian flu is not the way to get us there. 

 

http://www.upmc-biosecurity.org/website/resources/publications/2011/2011-12-15-editorial-engineering-H5N1

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Response to Dr. Salzberg’s Commentary in Forbes

A few comments on Dr. Steven Salzberg’s  posting in Forbes on October 30:    Link

Testing the Anthrax Vaccine on Children:
Getting the Facts Right

I cannot comment on the wide range of opinions within the biodefense, public health, and medical communities regarding the testing of the anthrax vaccine on children, but I will comment on my recent conversations with senior FDA personnel regarding this subject.

My understanding is that FDA wants to ensure a program would be in place to collect data on children if there was a national emergency and parents were offered the opportunity for children to receive the vaccine. This is a far different issue than what Dr. Salzberg discussed.

Furthermore, Dr. Salzberg states, “…anthrax is not infectious.”  Unfortunately it is.  Anthrax is not contagious, it does not pass from human to human, but that fact does not mean that a vaccine is therefore not required.  Tetanus is not contagious, yet the vaccine is critically important to public health.  That is because the bacterium, Clostridium tetani.  Is ubiquitous in nature.  That is why CDC recommends a tetanus shot every ten years, or more often after a potential exposure.

Bacillus anthrasis (the causative agent of anthrax) exists in nature, which is why Ted Turner lost nearly 300 buffaloes on his Montana ranch in the summer of 2008. The good news is that currently we are not experiencing a public health emergency from anthrax exposure. That could, however, change quickly since anthrax remains the top bioterrorism threat.  An act of bioterrorism in major city would put millions at risk—a certain number from the initial release, and a far larger number from the potential of secondary aerosolization.

This secondary risk was demonstrated on the island of Gruinard off the coast of Scotland where the British tested anthrax weapons during World War II.  Anthrax is the one potential bioweapon that is persistent. It took the British four decades to adequately “clean” the environment on Gruinard. (Virtually all other pathogens would be rendered harmless by environmental conditions within hours/days.)

The recent WMD Center’s Bio-Response Report Card (www.wmdcenter.org) gave failing grades for America‘s capability to properly cleanup after an aerosol release of anthrax.  This means there would only be two courses of action following a large-scale outdoor release in an urban area:  evacuate for months, possibly years, or vaccinate the population.

I commend FDA for considering the implications and taking actions in preparation for what the bipartisan Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism stated was the top WMD threat—an anthrax attack.

Whether or not we do studies on children prior to a national emergency is highly controversial issue. However, if an attack occurred, I would want the vaccine to be an option for all parents, and I would expect FDA to have a plan for collecting information.

This is an important debate, and even more important that the debaters get the facts right.

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New York Times Magazine October 30

How Ready Are We for Bioterrorism?

By WIL S. HYLTON

 

 

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WMD Center’s Bio-Response Report Card

Senators Bob Graham and Jim Talent release a report card on America’s bio-response capabilities.  Report Card

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Senators Bob Graham & Jim Talent to Release Report Card

The Bipartisan WMD Terrorism Research Center’s

Bio-Response Report Card

October 12, 2011
11:00 AM

Army-Navy Club
901 17th St NW
Washington DC

Light Lunch Provided

RSVP:  sara.rubin@wmdcenter.org

http://www.wmdcenter.org/

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op-ed: The Lesson of 9/11

The Free Lance-Star

Fredericksburg VA
September 11, 2011 12:15 am

As we pause to reflect upon the unspeakable horrors we witnessed 10 years ago today–and the incredible courage of the first responders at the World Trade Center and the Pentagon, and of the passengers and crew of United Flight 93–I cannot help but think back to 1994, when I first began to study homeland security.

The Air Force had selected me for a one-year national security fellowship. I was to spend the year thinking and writing about national security in the 21st century. When I arrived at the Matthew B. Ridgway Center at the University of Pittsburgh, I had a vague notion for a topic–asymmetric warfare–but nothing specific.

I did know that one of the most important lessons current and future adversaries have learned from Desert Storm is that anyone who chooses to fight the United States head-on will lose. However, this doesn’t mean adversaries can’t challenge the U.S.; they just have to do so with unconventional methods. My research into these unconventional methods led me to examine how small nations and even some non-state actors could threaten our homeland using asymmetric warfare–in particular biological and nuclear terrorism.

By 1999, I was teaching a graduate course in homeland security at the National War College in Washington. This was a challenge: We didn’t know if any students would sign up for such a course, and there were no textbooks, virtually no journal articles, and little interest in the subject within the military, law-enforcement, intelligence, and public-health communities.

My first class of the fall semester in 2001 was scheduled for the afternoon of Sept. 11. I never made it to class that day.

For years afterward, people would ask if I was surprised by the attacks. My answer: No. I was shocked, but not surprised. I was shocked that people would deliberately kill large numbers of innocent civilians, but I was not surprised that there are people in the world who hate America and have the means to bring war to our homeland.

Several years later, Lee Hamilton and Tom Kean, co-chairmen of the 9/11 Commission, told us that our greatest mistake had been “a failure of imagination.” I was as guilty as all the rest. I had never imagined a scenario where people would hijack airplanes and turn them into powerful weapons.

I haven’t forgotten Hamilton and Kean’s warning, and I worry about it on this 10th anniversary of 9/11. America is once again falling victim to a failure of imagination. That failure is directly linked to another warning of the 9/11 commissioners: “What if the worst people in the world obtain the worst weapons in the world?”

Congress created a bipartisan commission to investigate the likelihood of such an event and to offer recommendations on how to prevent it. In 2009, I was director of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, chaired by former U.S. Sens. Bob Graham (D-Fla.) and Jim Talent (R-Mo.). The commission’s unanimous conclusion: It is possible to prevent nuclear terrorism if the nations of the world took “urgent and decisive actions.”

Preventing nuclear terrorism is not easy, but it is simple. All we have to do is “locate, lock down, and eliminate weapons-grade nuclear material.” Terrorists do not have the capability to enrich uranium or make plutonium; they can only buy it or steal it. If we successfully “lock it up,” there will be no mushroom cloud over an American city.

On the other hand, the biotechnical revolution has advanced at such a rapid pace that we cannot prevent acts of bioterrorism. That was the unanimous conclusion of the nine bipartisan WMD commissioners. Deadly pathogens, such as anthrax, plague, and tularemia, are readily available in nature. A small team of individuals with graduate-level training in several key disciplines, using equipment readily available for purchase on the Internet, could take naturally occurring pathogens and produce sophisticated bioweapons capable of killing hundreds of thousands of our citizens.

The clock is ticking. It is only a matter of time before America experiences a large-scale bio-event. It could be an act of bioterrorism, or it could be a natural pandemic. Will we be prepared to respond, or will we once again be guilty of a failure of imagination?

When the WMD Commission disbanded in February 2010, Sens. Graham and Talent and I created a research organization (WMD Center) to continue our work. Our goal is to help our leaders understand the threat of bioterrorism, and explain what can be done to prevent it from becoming a WMD.

On Oct. 13, the WMD Center will release its report card on America’s bio- response capabilities. Sens. Graham and Talent and I hope that this grade will be better than the “F” assigned by the WMD Commission in January 2010.

A nation that is properly prepared for response can remove bioterrorism from the category of “weapon of mass destruction.” Bioterrorism will always be a threat, but with diligence, we can mitigate its potential. Think “truck bomb,” rather than a catastrophic event that would change the course of history.

A new movie has been released: “Contagion.” Yes, it’s Hollywood, but the science depicted in the movie is very real. The story, albeit fictional, clearly demonstrates why America needs to improve its bio-response capabilities. Whether the pandemic comes from terrorists or Mother Nature,

America must improve its capabilities to rapidly diagnosis disease and quickly produce vaccines and therapeutics that are safe and effective. America must also increase the surge capacity of our medical-delivery system. Doing so will be neither cheap nor easy, but achieving these capabilities is what we call “no-regret investments.” Whether or not we experience an act of bioterrorism, these improvements will be of great benefit to our children and grandchildren.

The question that is foremost in my mind today: Will America learn the lesson of 9/11 before it’s too late?

_______________________

Colonel Randall Larsen, USAF (ret) is the CEO of the WMD Center (wmdcenter.org), a Senior Fellow at the Homeland Security Policy Institute at George Washington University, and the author of “Our Own Worst Enemy” (Grand Central, 2007).

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