A superb new paper by Dr. Gigi Kwik Gronvall.

Mitigating the Risks of Synthetic Biology

A brilliant idea from Ken Bernard and Ken Coleman from the op-ed page in yesterday’s WSJ.

OPINION

Tracking Down Smallpox Before It Kills Anew

Do more samples of the virus lie hidden in labs? Pay scientists who find them.

Ebola is now the infectious disease of international concern, but many have forgotten what a massive killer smallpox once was. Before it was declared eradicated in 1977, smallpox killed as many as 300 million people in the 20th century alone—far more than all the wars of that century combined. The danger is that it could become a killer again.

In early July, the Centers for Disease Control and Prevention announced that six previously unknown vials of freeze-dried variola, the smallpox virus, had been found in a cold-storage room at a research facility in Bethesda, Md. No one at the lab, which is used by the Food and Drug Administration, was exposed or fell ill. But the virus in the sealed vials, which likely had been sitting there for more than 50 years, was still viable and potentially infectious.

We believe other vials exist in other labs, and propose a market-based solution to help ensure that something worse—either accidental or as a form of terror—doesn’t happen next time.

The recent lab discovery raises two immediate questions. One is why the smallpox vials weren’t found years ago. Even more important is the question of how many other laboratories world-wide may still have samples of this deadly virus sitting in their storage freezers. Experienced microbiologists are often compulsive collectors and many are recipients of long-neglected and uncataloged collections of samples. Passed down from an earlier generation of researchers, the samples lie disregarded like so many old textbooks sitting in a dusty library basement. Unlike books, these old sample collections can be lethal. Fortunately, their current guardians may also provide the solution to this problem.

In 1980, three years after the disease had been eradicated, the World Health Organization urged all countries to either destroy their existing smallpox lab samples or send them to two high-security labs, one at the CDC in Atlanta, and one in Moscow. But the WHO did not have the ability or authority to independently verify that every country and laboratory complied with its request. Such was the concern that in 2011 the U.S. urged the WHO to ask every country to examine its laboratories and recertify that they retained no unauthorized samples of smallpox. Many governments objected, noting that there was no reason to repeat a certification done more than 30 years ago. The latest find—in a U.S. lab, no less—argues otherwise.

While the WHO has taken a government-based approach to eliminating the samples, a way is needed to reach out directly to laboratory directors and staff scientists who could ferret out those last remaining samples. We propose that an incentive program be created to buy back any smallpox samples that may have been inadvertently overlooked. It could be set up at an international institution with WHO oversight and with government or private foundation funding.

Because a mistake resulting in a virus release could cost many lives and potentially billions of dollars, we suggest buying back all samples of variola, of any vintage or source in the world, for between, say, $25,000 or $50,000 or even $100,000 for each confirmed sample.

Whether such a program is privately or publicly funded, this would not be the first pay-for-performance scheme to spur the removal of unwanted and potentially dangerous stockpiles from around the world. Gun buyback programs are the most well known, but outdated electronics, exotic fish and reptile pets have also been targeted for what is in effect surrender by their owners for a reward. These programs are generally successful when they are well funded and focused. Ours would be both.

There is little downside to this proposal. The cost could be low, as one hopes relatively few vials will be found. The details, including funding levels, oversight, and protection from people trying to game the system could be relatively easy to work out, with the CDC, for example, having responsibility for confirming and destroying any submitted samples. It would be a win-win-win for society, the public health community and the individual or laboratory that submits a found sample.

The risk of a global pandemic resulting from an inadvertent smallpox release—or the virus’s acquisition by terrorists—is low. But recent events show that it also is not a risk to be dismissed as negligible. Let’s find the lost and forgotten smallpox samples before they find us.

Dr. Bernard, a retired Public Health Service rear admiral, was a senior director for global health security in the Clinton administration and special assistant for biodefense policy to President George W. Bush. Dr. Coleman is a microbiologist and entrepreneur.

http://online.wsj.com/articles/kenneth-bernard-and-ken-coleman-tracking-down-smallpox-before-it-kills-anew-1409828692

I seriously doubt if anyone who reads this blog takes medical advice from former Playboy bunnies, but I must admit that I have family members who do. Since I know they are not likely to read lengthy reports from IOM or CDC, I am going to send them this Penn and Teller video.

If you are offended by an occasional “F” word, DO NOT WATCH, but for me, the anti-vaccine movement is far more offensive.

Recently, an article appeared in the LA Times mischaracterizing one of the leaders of the efforts against bioterrorism as self-interested and inappropriately masking a conflict of interest. The following two letters, which appeared Sunday in the LA Times, better describe the situation.

The second letter was signed by all the people shown, but the LA Times publication policies permitted only three signatures (mine was one of them) to be shown.

_____________________________________

Letter from Richard Danzig:

Your article alleging that I didn’t adequately reveal a conflict of interest doesn’t mention that the “About the Author” page of my 2003 bioterrorism report explicitly stated that I was “a director of the Human Genome Sciences Corporation.”

Moreover, readers who pursue your article to its 58th paragraph will find that it acknowledges that in the 2003 report, far from obscuring any conflict, I wrote: “As a member of the Board of Directors of Human Genome Sciences, a NASDAQ listed company, I have encouraged the company in its efforts to develop an anthrax antitoxin. I do not believe that my views on this point are distorted by any financial interest, but readers will want to make their own determination.”

The article notes that I wrote six other reports on bioterrorism without flagging my director status, but the only one cited as relevant and posted on The Times’ website referred just tangentially to antibiotic-resistant anthrax, and actually argued against the strategy of buying specific drugs for specific pathogens for anthrax. The report criticized this approach, saying, “This is like strengthening forts along the Maginot Line.”

Finally, the article deprecates the risk of antibiotic-resistant anthrax. Yet in 2006, the secretary of Homeland Security determined that this was a material threat. And last year, the Institute of Medicine of the National Academy of Sciences concluded: “The level of microbiologic knowledge needed to create [multi-drug resistant] anthrax is not high, and descriptive methodology is available in the open literature.”

Richard Danzig

Washington

The writer, a former secretary of the Navy, is a biowarfare consultant to the Pentagon and the Department of Homeland Security.

_____________________________________

Group letter from 30 colleagues in the biosecurity community:

The article describes Danzig in ways completely contrary to our experience. For more than a decade we — along with dozens of other experts in the private, not-for-profit and academic sectors who have read and agree with this letter — have worked with him in a broad effort to reduce the risks of bioterrorism. We do not all share the same perspective of the threats or the solutions, but we do value the openness with which the dialogue takes place.

The article implies that Danzig inflated the risk of antibiotic-resistant anthrax without adequately disclosing that he was associated with a company that could profit from attention to the risk. Our experiences don’t bear this out.

The article neglects to say there is a consensus of scientific thought that the risks of antibiotic-resistant anthrax are real; that dissent about the plausibility of this and other propositions was encouraged by Danzig himself; and that he neither originated the issue nor was he particularly associated with it but instead drove discussion about many aspects of protecting civilian populations from the threat of deliberately released biological agents.

Danzig’s fostering of discussion and honest debate on topics central to national security has become a role model for many of us. As active participants in the discussions on bioterrorism, none of us has ever found him to be misleading or self-serving.

Michael Goldblatt, PhD, JD
Michael Hopmeier, MSME
Randall Larsen
D. A. Henderson, MD, MPH
The Honorable R. David Paulison
Noreen A Hynes, MD, MPH, FIDSA, FASTMH
Kenneth Bernard, MD, DTM&H
Paula Olsiewski, PhD
David Franz, DVM, PhD
John Vitko, PhD
Elin Gursky, MSc, ScD
Donna Barbisch, PhD
Michael Callahan MD, DTM&H (U.K.), MSPH
Jeffrey Runge, MD, FACEP
Kaveh Zamani, PhD
Tom Inglesby, MD
Roger Breeze, DVM, PhD
Steve Morse, PhD
Lynne Kidder
Margaret Jo Velardo, PhD
Ed McCallum
Klaus Schafer, MD
Ed Bailor
Lawrence Wein, PhD
Eric Eisenstadt, PhD
Shaun Jones, MD
Robert Kadlec, MD
Jim Thomas;
Terry Leighton, PhD
Bob Ross
Stewart Simonson, JD

May 19 article: http://www.latimes.com/news/nationworld/nation/la-na-anthrax-resistant-20130519-dto%2C0%2C3192936.htmlstory

June 2 Letters to the Editor: http://www.latimes.com/news/opinion/letters/la-le-0602-sunday-bioterrorism-20130602,0,6333955.story

When I served as the chairman of the Department of Military Strategy and Operations at the National War College, we used short segments from movies such as Crimson Tide and Dr. Strangelove to stimulate discussions with our students.  Later, the Errol Morris classic, Fog of War was added to the list. Today, all students in military colleges and universities, perhaps all military officers, and without question, all 535 members of Congress and senior leaders in the Obama Administration should watch The Gatekeepers.  It is the best documentary on national security I have ever seen.

This Oscar-nominated documentary features interviews with all surviving former heads of Shin Bet, the Israeli security agency, accounting for every year from 1980-2011 except 1987.  Were it not based on the interviews with these top Israeli counterterrorism officials, the film would be have been panned as anti-Semitic, revisionist claptrap.  Instead, the New York Times film critic A. O. Scott said it was “the best documentary of 2012”, and the Wall Street Journal film critic Joe Morgenstern declared it “one of the best 10 films of 2012”.  The National Society of Film Critics selected it as the Best Documentary of 2012.

The Gatekeepers not only provides a superb analysis of the Israeli-Palestinian issue, but also brings current US counterterrorism policy into focus.  If you plan on thinking, talking or writing about either issue in 2012, you must see The Gatekeepers.

Update – 2PM EST: Watch the hearing webcast here.

Statement of Colonel Randall J. Larsen, USAF (Ret)

Founding Director Bipartisan WMD Terrorism Research Center

House of Representatives Committee on Homeland Security

Subcommittee on Counterterrorism and Intelligence

November 15, 2012

Mr. Chairman … I would like to thank you for convening this hearing, and to express my appreciation to the Aspen Institute, in particular, Mr. Clark Kent Ervin, for leading the research and analysis for the report submitted to the Subcommittee.

As one of the founding directors of the Bipartisan WMD Terrorism Research Center, my opening statement and responses to your questions will reflect my own opinions and not necessarily those of the entire research team convened by the Aspen Institute.

Mr. Chairman … in a recent press conference, Governor Chris Christie described the destruction of the New Jersey shore as “unthinkable.”  I like the governor, but I will nevertheless point out his error.  He could have stated the destruction was catastrophic or calamitous, but it was most certainly not “unthinkable.”

Since 2005, the Department of Homeland Security has provided Federal, state and local government officials with descriptions of 15 disaster scenarios. The hurricane scenario describes a Category IV hitting a major metropolitan area, killing 1,000 and hospitalizing 5,000. It portends major portions of the metropolitan area would be flooded, with structural collapse in many buildings and homes, and significant infrastructure damage.

Thankfully, Sandy was only a Category I storm, and evacuations significantly limited the number of deaths and serious injuries.  In other words, the effects of Sandy were far from “unthinkable.” They were far less severe than our National Planning Scenario described.

My concern, Mr. Chairman, is that we have once again fallen into a mindset best described by the 9/11 Commission as “a failure of imagination.”  Most of our homeland security, public health and disaster response personnel at the federal, state and local levels understand what is “thinkable”, including the members of this committee.  I cannot, however, say the same for many other appointed and elected officials.  I base this assessment on the actions–or should I say, lack of action–of these officials.

In December 2008 the WMD Commission concluded that an act of bioterrorism was more likely than an act of nuclear terrorism.  Additionally, the national planning scenarios list only one weather-related disaster, but four biological disaster scenarios.  Nevertheless, our preparedness to respond to a major biological event is far less today than for a major hurricane.

In October 2011, former Senators Bob Graham and Jim Talent released the WMD Center’s report card on the nation’s bio-response preparedness.

Mr. Chairman, the WMD Center assembled an extraordinary team of more than two-dozen advisors to guide this assessment. It included a former deputy commissioner of the Food and Drug Administration, the director of disaster medicine at the American Medical Association, and a former special assistant for biodefense to both Presidents Clinton and Bush. We identified a wide spectrum of possible attacks—ranging from small-scale, such as the anthrax letters of 2001, to a global event of near Biblical proportions.

In its recommendations, the WMD Center’s report suggested the Congress and Administration should focus on improving response capabilities to the type of attack described in both the 2008 WMD Commission report and the National Planning Scenarios: aerosolized anthrax.

The grades were merely a snapshot of a point in time, but the most valuable aspect of the report card is the fundamental expectations developed by our team of experts that served as metrics for the assessment.  Additionally, the report provided a series of questions to assess capabilities in achieving these expectations.

This committee and other Congressional committees should be using these metrics and questions in 2013 to determine if we are making progress in strengthening bio-preparedness and response capabilities.

With respect to the Aspen Institute WMD Working Group paper submitted to your committee, the WMD Center fully supports all nine recommendations, and in particular, reauthorization of the Pandemic and All-Hazards Preparedness Act.

Mr. Chairman I will close by thanking the other members of the Aspen Institute’s WMD Working Group, and in particular Dr. Lenny Cole.  It was a pleasure working with the group and a great learning experience.

Aspen Institute WMD Working Group Report

Michael G. Kurilla, MD, PhD

Director Office of BioDefense Research Affairs, National Institute of Allergy and Infectious Diseases (NIAID)

Description

Dr. Kurilla describes the key contributions of the National Institute of Allergy and Infectious Diseases to US biosecurity, including early stage research and development of drugs and vaccines, and transitioning candidate products to the most appropriate federal or industry partners for further development. Dr. Kurilla offers insight on how development timelines could be shortened, and he suggests that one way to increase the nation’s medical preparedness to biological threats could be to explore methods to enhance the host immune response, as opposed to focusing on a “one-bug-one-drug” approach.

Video Produced by the Center for Biosecurity of UPMC