JUMP START: ACCELERATING GOVERNMENT RESPONSE TO A NATIONAL BIOLOGICAL CRISIS

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July 2015

A large-scale biological attack, or campaign of attacks, against one or more US cities could lead to catastrophe, both in terms of lives lost and in economic and societal disruption. However, it is within the power of the US government to mitigate the consequences of a biological crisis through effective leadership, policy, research, and emergency response.

The anthrax attacks in 2001 galvanized government action to advance national programs in biodefense research, drug and vaccine development, medical countermeasure (MCM) stockpiling, hospital preparedness, and a range of other biosecurity and biodefense initiatives. As a result, the United States currently has a much higher level of biopreparedness than it did prior to 2001. Yet, despite the progress made since 2001, a large-scale biological attack (or the immediate threat of such an attack) against one or more American cities would require additional and extraordinary national action in short order.

This report examines a scenario in which the United States is suddenly faced with a newly emerged intentional biological threat (biothreat) that could produce catastrophic public health consequences and threaten our economy, government, and social structure. This scenario was presented to 71 biodefense, medical, public health, life science, and homeland security thought leaders who were then asked what near-term and long-term policies and programs they would recommend in response to such an emerging crisis.

Based on our analysis of expert responses, this report condenses the best ideas into an organized set of proposals for leadership in the areas of:

  • Governance and Strategy
  • Public Health Response
  • Medical Countermeasures
  • Healthcare System Response
  • Decontamination and Remediation
  • Environmental Detection

In other words, this report is intended to provide a Jump Start for an effective response in a time of national crisis. If the recommendations in this report are fully implemented, the effects of a biological attack on this country could be significantly reduced.

See full report

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The Reemergent 1977 H1N1 Strain and the Gain-of-Function Debate

The Reemergent 1977 H1N1 Strain and the Gain-of-Function Debate

Michelle Rozo and Gigi Kwik Gronvall

Editor Mark R. Denison, Vanderbilt University Medical Center

ABSTRACT

The 1977-1978 influenza epidemic was probably not a natural event, as the genetic sequence of the virus was nearly identical to the sequences of decades-old strains. While there are several hypotheses that could explain its origin, the possibility that the 1977 epidemic resulted from a laboratory accident has recently gained popularity in discussions about the biosafety risks of gain-of-function (GOF) influenza virus research, as an argument for why this research should not be performed. There is now a moratorium in the United States on funding GOF research while the benefits and risks, including the potential for accident, are analyzed. Given the importance of this historical epidemic to ongoing policy debates, we revisit the evidence that the 1977 epidemic was not natural and examine three potential origins: a laboratory accident, a live-vaccine trial escape, or deliberate release as a biological weapon. Based on available evidence, the 1977 strain was indeed too closely matched to decades-old strains to likely be a natural occurrence. While the origin of the outbreak cannot be conclusively determined without additional evidence, there are very plausible alternatives to the laboratory accident hypothesis, diminishing the relevance of the 1977 experience to the modern GOF debate.

For full article see:   http://mbio.asm.org/content/6/4/e01013-15

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Ebola 2014: Pandemic Preparedness Lessons Learned

In late July and early August many Americans were first learning about the Ebola threat to our nation and families—and we had a lot to learn. For those of us who had read Richard Preston’s Hot Zone (Anchor, 1995), the word Ebola produced frightening images of a deadly and contagious disease that caused organs to dissolve while patients were still alive, and ended in death for more than 90 percent of those infected.

As the first patient arrived in America for treatment, these “facts” were being hyped by cable news outlets as helicopter camera crews followed an ambulance down Atlanta freeways to Emory University Hospital. (I must admit, I was one of the news junkies watching.) However, we should have all realized we had much to learn when Dr. Kent Brantly walked from the ambulance into the hospital under his own power.

We quickly learned that high-quality supportive care can significantly reduce Ebola mortality, and that certain aspects of America’s bio-response capabilities have significant deficiencies. Here is a partial list of the lessons learned from Ebola 2014. They are in no particular order, but the final one may be the most important.

  • Ebola is a horrifying disease that is causing major public health, social, economic, political and security problems in West African nations. It is also an international public health threat that requires a unified international response, but as predicted in August by Dr. Tom Frieden, the Director of CDC, Ebola is not a serious public health threat to the United States.
  • The best strategy for protecting American families from Ebola is to focus efforts (spending) on West Africa, including the use of the U.S. military for what it does best: logistics, communications, transportation and organizing international relief efforts.
  • The Food and Drug Administration has demonstrated remarkable flexibility in rapidly responding to requirements for Ebola medical countermeasures (diagnostic tools, vaccines, and therapeutics). This was partially due to the fact that a lot of basic science and advance development research has been underway for a decade with funding for defense against bioterrorism. This is the dual-benefit aspect of spending on biodefense—improvements in rapid diagnostics, the ability to produce vaccines and therapeutics faster and less expensively, improved capacity for surge medical care are good for defense against bioterrorists, but also for defense against naturally-occurring diseases.
  • However, erratic funding for research and development of medical countermeasures (basic science, advance development and regulatory science) has caused serious delays in many programs critical to biodefense. Investments in medical countermeasures (MCMs) must be made years before the pandemic, not during it. MCMs are similar to sophisticated military weapon systems, they have very long lead times for development and deployment.
  • America does not have the capability to rapidly produce medical countermeasures in a crisis. Even if one of the Ebola candidates currently in testing proves to be a “silver bullet” as a vaccine or therapeutic, America does not the capacity to rapidly produce significant quantities. We need to understand that in the 21st century, America’s pharmaceutical and biotech industries are part of our defense industrial base. Today, more than 80 percent of the active pharmaceutical ingredients in prescription drugs sold in America are made in Asia. (Would we allow China to make our next-generation fighter jet?)
  • The federal government needs a single leader with authority, responsibility, and accountability for pandemic preparedness and response. Today, these three leadership issues are spread out among more than two dozen presidentially-appointed, Senate-confirmed individuals in more than dozen departments and agencies. Not one of these leaders has pandemic preparedness and response as a full time job. It is like an NFL team with 24 assistant coaches, but no head coach. Do you think this team would make it to the Super Bowl?
  • America needs significant improvements in the ability of federal, state and local governments to work in unison during any major disaster, including public health. There were many stumbles during the early response (or as they say in DC, mistakes were made). This lack of coordination could be catastrophic during a major pandemic.
  • State and local public health departments will always be the frontline of our pandemic response capabilities. Since 2008, reduced federal funding has driven a 20 percent reduction in public health personnel at the state and local level.
  • We must improve messaging. Leaders need to be open and honest with the American public. One sentence from President Obama on September 16th caused many problems with public confidence.
    • “First and foremost, I want the American people to know that our experts, here at the CDC and across our government, agree that the chances of an Ebola outbreak here in the United States are extremely low.”
    • I am sure that the people who wrote this sentence for the President knew what they meant by the word “outbreak”, but the American public did not, particularly when two weeks later Ebola came to Dallas.
    • It would have been far better for the President to say that in the 21st century, disease can come to America from the most remote corners of the world within hours; however, Ebola is not the type of disease that could rapidly spread in America.
    • It would have also been helpful for political and public health leaders in federal, state and local governments to say that there will be a learning curve as we deal with this new threat—as we saw during the SARS epidemic of 2003—a deadly contagious disease that was contained. There will likely be some mistakes, but we will admit them and take immediate action to correct them and make sure that all public health and medical personnel are informed.
    • Ron Heflin, Program Manager NASA Space Shuttle, set the example for senior government leaders to follow on February 1, 2003. During the first press conference after the breakup of the space shuttle Columbia, he said: “We wanted to meet with you and be as fair and open with you given the facts as we understand them today. We will certainly be learning more in the coming hours, days and weeks. We will tell you as much as we know, and we will be as honest we can with you and will certainly try to fill in blanks in the coming days and weeks.”

Bottom line: During the past 30 years, we have seen at least a dozen newly-emerging diseases come to America each decade. As the world becomes more crowded and jet travel makes it smaller, this trend is likely to increase. We should learn the lessons from Ebola 2014 and consider it a wake-up call for pandemic preparedness.

_________________________________________

Colonel Randall Larsen, USAF (Ret) is the national security advisor at the UPMC Center for Health Security and the former executive director of the bipartisan Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism.

 

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Mitigating the Risks of Synthetic Biology

A superb new paper by Dr. Gigi Kwik Gronvall.

Mitigating the Risks of Synthetic Biology

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Tracking Down Smallpox Before It Kills Anew

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.

Sept. 4, 2014 7:04 a.m. ET

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

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Penn and Teller on the Anti-Vaccine Idiots

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.

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Interview about WMD Center’s Report Card on Bio-Response

Randall Larsen and Lynne Kidder talk about the WMD Center’s Bio-Response Report card with Luke Muehlhauser for MIRI

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