January 11, 2014

Biosecurity

Editor’s note: This article was published under our former name, The Open Philanthropy Project. Some content may be outdated. You can see our latest writing here.

This is a writeup of a shallow investigation, a brief look at an area that we use to decide how to prioritize further research.

In a nutshell

What is the problem?

Natural pandemics, bioterrorism, biological weapons, and dual use scientific research have the potential to cause significant, and perhaps unprecedented, harm. The risks from engineered threats are likely to grow in the future.

Who is already working on it?

The U.S. federal government spent nearly $6 billion on various aspects of biosecurity in 2012. Philanthropic involvement in this area is quite limited.

What could a new philanthropist do?

Given the security aspect and large government involvement on biosecurity issues, a philanthropist would likely focus on advocacy in some form. Potential goals may be to improve disease surveillance, oversight of dual use research, or support for research and development on novel therapies, amongst others.

What is the problem?

Biosecurity covers a wide range of risks, including:^[1]“Three main risks in biosecurity are bioterrorism, pandemics, and scientific accidents. These three issues are often grouped together under the banner of biosecurity because better public health preparation would be helpful for addressing them all.” Notes from a conversation with Paula … Continue reading

Natural pandemics.
Bioterrorism and the intentional deployment of biological weapons.
Dual use research and the possibility of accidental deployment of biological agents.

We see biosecurity issues as separate from typical global health issues in that they represent relatively low-probability risks of bad outcomes with potentially global impacts, rather than ongoing health issues to be managed at the local or regional level.

We are not aware of any systematic estimates of the magnitudes of the risks discussed below. Our guess is that natural pandemics likely present the largest current threat, but that the development of novel biotechnology could lead to greater risks over the medium or long term.

Natural pandemics

Natural flu pandemics occur relatively frequently, and may be the most serious biosecurity threat, though exact probabilities are difficult to estimate.^[2]“Naturally occurring pandemics, such as influenza pandemics, are the most significant biosecurity threat that the world faces today. Definition of a pandemic An infectious disease outbreak is classified as a pandemic when: • The infection spreads internationally • The infection occurs at rate … Continue reading

The worst flu pandemic in the past century was the “Spanish” flu epidemic of 1918, which is believed to have been responsible for about 50 million deaths.^[3]“An estimated one third of the world’s population (or ≈500 million persons) were infected and had clinically apparent illnesses (1,2) during the 1918–1919 influenza pandemic. The disease was exceptionally severe. Case-fatality rates were >2.5%, compared to <0.1% in other influenza … Continue reading Due to globalization, a similar pandemic today would likely spread around the world much more quickly, though modern medical advances would also likely reduce the health impacts of such a pandemic.^[4]Notes from a conversation with Michael Osterholm on July 30, 2013: “Pandemics pose a greater international threat in modern times because of forces of globalization, such as increased international transportation speeds and greater social and economic interaction. If an outbreak similar to the … Continue reading

The H5N1 (avian flu) virus could be significantly more harmful than the 1918 flu pandemic were it to become more transmissible between humans, which could happen with relatively few genetic changes.^[5]“The H5N1 flu virus, often called avian flu, has already killed hundreds of people and is still present in birds around the world. With relatively few genetic changes, the virus could likely become more transmissible between humans (currently transmission between humans is very rare). If avian … Continue reading

Bioterrorism and biological weapons

The probability of a terrorist attack using a biological weapon is extremely difficult to estimate.^[6]“The risk of biological attack and flu pandemic should be considered to be of indeterminate rather than a specific low probability, because we have little idea how likely these events are. Both have occurred in the past and should be expected to occur again in the future.” Notes from a … Continue reading

A terrorist attack with biological weapons could take a variety of forms:

A noncontagious biological agent, such as anthrax.^[7]“The anthrax letter attacks of 2001 are an example of a noncontagious bioweapons attack on a very small scale. As may have occurred in the case of the anthrax letters, the same actor might be able to make multiple small-scale attacks. The threat of a recurring attack would be very frightening to … Continue reading
A contagious natural pathogen, such as smallpox, which has been eradicated and accordingly is no longer vaccinated against.^[8] “A pathogen such as smallpox could intentionally be released. Since vaccination against smallpox is now very rare, people would have little immunity against the disease.” Notes from a conversation with Tom Inglesby on October 2, 2013.
A contagious engineered pathogen, such as a manipulated version of H5N1 that is more transmissible between humans.^[9]“It is now possible to engineer noncontagious natural viruses to make them transmissible. In fact, in several recent experiments, researchers have engineered flu viruses that were previously not transmissible between animals similar to humans to be transmissible between those animals. Such work … Continue reading (This type of risk is discussed more fully below.)

The magnitude of harms caused by potential bioterror attacks could vary widely based on the agents employed as well as a number of other factors, but may be less significant than a major flu pandemic.^[10]“The biological agents that are most likely to be used in a bioterrorism attack would probably cause fewer catastrophic health effects than a flu pandemic. For example: • A smallpox release would be disastrous, but it could be controlled within months because the U.S. government stockpiles … Continue reading

Dual use research

“Dual use” research describes research that could be used either for positive or negative ends: scientists doing legitimate research may accidentally release a harmful agent or create tools or techniques that allow malicious actors to do so with greater ease.^[11]“Accidents during dual-use research could conceivably cause a pandemic. Whether a pandemic comes from nature or the laboratory, the potential global effects are largely the same.” Notes from a conversation with Michael Osterholm on July 30, 2013 “Scientists could accidentally create and … Continue reading For instance, there has been significant controversy recently over research aiming to alter the host range of the H5N1 flu virus to make it transmissible between ferrets, a model for humans.^[12]“Dual-use concerns in biology have gained widespread publicity in the last couple of years thanks to GOF research, which attempts to start combating potential horrors by first creating them artificially in the lab. On September 12, 2011, Ron Fouchier of the Erasmus Medical Center, in Rotterdam, … Continue reading

We have not seen any systematic assessments of the risks of dual use research or the likely impacts of an engineered pathogen. We would expect that as technology is developed further, these risks will increase and that the level of training required to use widely available technology to produce dangerous pathogens will fall, making dual use research and synthetic biology a significantly larger source of risk in the future.

While the expected harms of different kinds of biosecurity risks are extremely difficult to estimate and compare, dual use research carries at least the conceptual possibility of creating a pathogen significantly more harmful than anything that has naturally evolved.^[13]“Consider this sobering development: in 2001, Australian researchers working on mousepox, a nonlethal virus that infects mice (as chickenpox does in humans), accidentally discovered that a simple genetic modification transformed the virus.10, 11 instead of producing mild symptoms, the new virus … Continue reading

Who is already working on it?

The U.S. government plays a significant role in supporting a variety of biosecurity activities, including:^[14]“The U.S. government funds departments and agencies that work on biosecurity issues, some of which are listed below: • The Department of Homeland Security works to prevent and/or mitigate the effects of bioterrorism and pandemics. • The Environmental Protection Agency (EPA) is responsible for … Continue reading

Surveillance of emerging biosecurity threats
Intelligence efforts to prevent bioterrorism
Research and development on novel therapeutics
Stockpiling important medical supplies

Researchers at the UPMC Center for Health Security estimate that U.S. federal government funding for civilian biosecurity efforts in 2012 was about $5.6 billion, though less than 10% of that was directed to programs that exclusively focus on biosecurity (as opposed to programs that include both biosecurity and other goals, such as scientific research or general disaster preparedness).^[15] Sell and Watson 2013, Table 1, pg 197. The table reports $5,559.6 million in total U.S. government civilian biodefense funding, with $478.3 million going to programs that exclusively focus on biodefense. About $1.3 billion of that total goes to each of the Centers for Disease Control and Prevention and the National Institutes of Health, primarily for preparedness and research, respectively.^[16] Sell and Watson 2013, Table 3, pg 203. The table reports $1,329.5 million in biodefense funding for the CDC, and $1,307.8 million for the NIH.

Foundation funding for work related to biosecurity is substantially more limited. Between 2000 and 2010, the Sloan Foundation spent $44 million on a biosecurity program, which has since ended.^[17]“From 2000 to 2010, the Sloan Foundation spent approximately $44 million on its biosecurity program. The Sloan Foundation’s grant process involved studying the field, identifying and vetting potential grantees, and then inviting proposals from a small number of key people and organizations. One … Continue reading The Carnegie Foundation and the MacArthur Foundation have also supported work on biosecurity issues in the past.^[18]“The Carnegie Foundation and the MacArthur Foundation, like the Sloan Foundation, funded work on biosecurity but have exited the space. Many groups that the Sloan Foundation funded, however, are still working on issues related to biosecurity.” Notes from a conversation with Paula Olsiewski on … Continue reading

The only philanthropic funder that we know of with a program dedicated to biosecurity issues is the Skoll Global Threats Fund, though our understanding is that the Gates Foundation has also supported relevant work.^[19]“Since the Sloan Foundation exited the biosecurity space three years ago, few private funders have stepped in to work on these problems. The Skoll Global Threats Fund and the Gates Foundation fund some limited work in this area.” Notes from a conversation with Michael Osterholm on July 30, … Continue reading Based on the grants listed in their IRS Form 990, it appears that the Skoll Global Threats Fund spent about $1.5 million on biosecurity issues in 2011; we don’t have more recent figures.^[20] Skoll Global Threats Fund 990-PF 2011. pgs 22-23. The Skoll Global Threats Fund has co-funded a project led by the Nuclear Threat Initiative to improve regional disease surveillance networks with the Gates Foundation and the Rockefeller Foundation (the latter of which had a $21 million program to support disease surveillance networks from 2008 to 2011).^[21]“CORDS (Connecting Organizations for Regional Disease Surveillance) is a project co-funded by the Rockefeller Foundation, the Gates Foundation, and Skoll Global Threats Fund. CORDS connects regional surveillance networks to each other so that they can share best practices and data across the … Continue reading

What could a new philanthropist do?

We do not feel that we have a strong sense of the interventions available to a new philanthropist in this field, but we expect that most work would take the form of research and advocacy.

Some areas for philanthropic investment might include:

Advocating to policymakers to improve biosecurity initiatives
Supporting general research on the magnitude of biosecurity risks and opportunities to reduce them
Improving and connecting disease surveillance systems so that novel threats can be detected and responded to more quickly^[22]“To move towards those goals, needed improvements include: Stronger international disease surveillance systems with better interconnection and more updated technologies. Public health systems that can use electronic medical records to detect patterns in disease and to manage outbreaks.” Notes … Continue reading
Reducing the risks of dual use research by promoting stronger oversight mechanisms and cultural norms of caution amongst researchers^[23]“The Sloan Foundation’s projects in this area included: • Addressing the risks of bioterrorism. In particular, Sloan worked with building engineers to develop improved methods for air filtration in large buildings (people spend 90% of their time indoors). • Preventing people from … Continue reading
Developing novel therapies, such as broad-spectrum flu vaccines^[24]“Improving manufacturing capability for influenza vaccines is important, but existing influenza vaccines have limited effectiveness, so new and improved vaccines must be developed as soon as possible. The U.S. government and the scientific community are slowly working toward improved vaccines, … Continue reading
Improving the capacity for rapid production of vaccines in response to emerging threats^[25]“If a vaccine is not developed, manufactured, and administered within the first 6 to 8 months after a pandemic begins, it is difficult to significantly mitigate the pandemic’s effects. Unexpected influenza pandemics are particularly dangerous because it is highly unlikely that a vaccine for any … Continue reading
Creating or growing stockpiles of important medical countermeasures^[26]“Question 10: Has there been sufficient, sustained funding for the medical countermeasure enterprise? Answer: No. Initial Project BioShield funding ($5.593 billion for FY2004 to FY2013)11 was a good start, but there have been constant raids and attempted raids on the fund. BARDA is currently … Continue reading
Improving preparedness of public health and law enforcement institutions^[27]“The goal of biosecurity is to have available all the vaccines and medicines needed for any possible contingency, and to have a public health and healthcare systems in place that can respond to a serious and acute crisis. To move towards those goals, needed improvements include: Stronger … Continue reading

A 2011 report by the Bipartisan WMD Terrorism Research Center graded U.S. preparedness for a biological “Global Crisis” scenario as an “F” on five out of seven criteria, so we consider it likely that further research could identify other opportunities for philanthropic improvement, especially since we would expect the U.S. to be better-prepared than other countries.^[28] The Bipartisan WMD Terrorism Research Center 2011, pg 9.

Questions for further investigation

Our research in this area has been relatively limited, and many important questions remain unanswered by our investigation.

Amongst other topics, further research on this cause might address:

The degree to which biosecurity threats currently constitute a global catastrophic risk, and the extent to which they are likely to evolve into such a risk. More generally, we could benefit from learning more about the level of risk and the expected harms from different biosecurity threats.
The gaps in current philanthropic and government efforts to confront biosecurity issues. Some sources argue that there are large shortcomings in preparedness, but we do not feel that we have an adequate understanding of what should be done to resolve these deficits.
The opportunities for philanthropic investment in the realm of biosecurity that might carry the largest benefits. Given the large absolute level of U.S. government support, we suspect that some form of advocacy may carry the highest returns.

Our process

We initially decided to investigate biosecurity issues because they may be a global catastrophic risk (i.e. the potential devastation from biosecurity threats could be so large that investments to prevent such threats from being realized could carry large returns). Our investigation to date has been rather cursory, mainly consisting of conversations with four individuals with knowledge of the field:

In addition to these conversations, we also reviewed documents that were shared with us.

Sources

DOCUMENT	SOURCE
CORDS Launch	Source (archive)
Garrett 2013	Source
Kimball et al. 2011	Source (archive)
Myhrvold 2013	Source (archive)
Notes from a conversation with Jennifer Olsen on September 23, 2013	Source
Notes from a conversation with Michael Osterholm on July 30, 2013	Source
Notes from a conversation with Paula Olsiewski on July 19, 2013	Source
Notes from a conversation with Tom Inglesby on October 2, 2013	Source
Sell and Watson 2013	Source (archive)
Skoll Global Threats Fund 990-PF 2011	Source (archive)
Taubenberger and Morens 2006	Source (archive)
The Bipartisan WMD Terrorism Research Center 2011	Source (archive)

Footnotes[+]Footnotes[−]

Footnotes
1	“Three main risks in biosecurity are bioterrorism, pandemics, and scientific accidents. These three issues are often grouped together under the banner of biosecurity because better public health preparation would be helpful for addressing them all.” Notes from a conversation with Paula Olsiewski on July 19, 2013. “Skoll’s work on naturally occurring pandemics overlaps with approaches to combat bioterrorism and dual-use research. For example, its work on detection systems and diagnostics are applicable to outbreaks regardless of their origins.” Notes from a conversation with Jennifer Olsen on September 23, 2013
2	“Naturally occurring pandemics, such as influenza pandemics, are the most significant biosecurity threat that the world faces today. Definition of a pandemic An infectious disease outbreak is classified as a pandemic when: • The infection spreads internationally • The infection occurs at rate beyond normally expected Probability of pandemic It is difficult to estimate the likelihood that a pandemic will occur in a given time frame. However, the proper underlying conditions exist for a pandemic to occur in the near future. In particular, the H5N1 and H7N9 strains of the influenza virus and the Middle East Respiratory Syndrome (MERS), which is currently a public health problem in the Middle East and Europe, are current pandemic risks.” Notes from a conversation with Michael Osterholm on July 30, 2013. “The risk of biological attack and flu pandemic should be considered to be of indeterminate rather than a specific low probability, because we have little idea how likely these events are. Both have occurred in the past and should be expected to occur again in the future.” Notes from a conversation with Tom Inglesby on October 2, 2013.
3	“An estimated one third of the world’s population (or ≈500 million persons) were infected and had clinically apparent illnesses (1,2) during the 1918–1919 influenza pandemic. The disease was exceptionally severe. Case-fatality rates were >2.5%, compared to <0.1% in other influenza pandemics (3,4). Total deaths were estimated at ≈50 million (5–7) and were arguably as high as 100 million (7).” Taubenberger and Morens 2006 pg 15. “Some of the largest pandemics in history include: • The 1918 “Spanish flu” pandemic • The bubonic plague in the Middle Ages • Smallpox throughout the Middle Ages into the 20th century. Smallpox killed 250 million people over the course of about 40 years in the early 20th century.” Notes from a conversation with Michael Osterholm on July 30, 2013.
4	Notes from a conversation with Michael Osterholm on July 30, 2013: “Pandemics pose a greater international threat in modern times because of forces of globalization, such as increased international transportation speeds and greater social and economic interaction. If an outbreak similar to the 1918 H1N1 influenza occurred today, it would spread around the world more quickly than the H1N1 influenza did in 1918. In 2009, the H1N1 influenza virus spread from Mexico to 42 other countries within the first month of being discovered. In the event of a pandemic, governments could limit international travel to prevent spread of the disease, but it would be impossible to eliminate travel completely.” “Modern medicine and epidemiology limit some of the risks associated with pandemics. Today, there is more general health care available to save lives than existed one hundred years ago. Health care innovations such as intensive care units and extracorporeal membrane oxygenation (ECMO) machines are especially important when responding to pandemics. The progress of modern scientific knowledge was evident when, in 2003, SARS was prevented from developing into a pandemic without the use of vaccines or drugs.”
5	“The H5N1 flu virus, often called avian flu, has already killed hundreds of people and is still present in birds around the world. With relatively few genetic changes, the virus could likely become more transmissible between humans (currently transmission between humans is very rare). If avian flu became as transmissible as seasonal flu, it could circulate the world, just as other flu strains do during flu season. The difference is that while typical flu viruses have low case fatality rates, H5N1 has a 50% case fatality rate in healthy people. An H5N1 pandemic could be many times worse than the infamous Spanish flu pandemic of 1918, since that flu had a case fatality rate of only 1-2%. Besides killing many people, the virus would disrupt gatherings of people for school and commerce.” Notes from a conversation with Tom Inglesby on October 2, 2013.
6	“The risk of biological attack and flu pandemic should be considered to be of indeterminate rather than a specific low probability, because we have little idea how likely these events are. Both have occurred in the past and should be expected to occur again in the future.” Notes from a conversation with Tom Inglesby on October 2, 2013. “Dr. Olsiewski is not aware of any estimates of the likelihood of bioterrorism attacks or the estimated risk magnitude. However, one can analyze components of bioterrorism risk: • Does anyone have the intent to carry out acts of bioterrorism? Evidence about this is difficult to collect, but it seems plausible that people are trying to carry out bioterrorist attacks. • Does anyone have the capability to carry out acts of bioterrorism? There is a high number of people with science Ph.D.’s who live all over the world; it is plausible that there are people with the capability to commit acts of bioterrorism. • Could any government programs lead to bioterrorism? The former Soviet Union had about 20,000 people working in a covert bioweapons program even after it had signed the Biological Weapons Convention (BWC). Some countries still have not signed the BWC. Though the level of risk is highly uncertain, it does not appear as if the risk of a bioterrorist attack is any less likely today than it was in 2001.” Notes from a conversation with Paula Olsiewski on July 19, 2013
7	“The anthrax letter attacks of 2001 are an example of a noncontagious bioweapons attack on a very small scale. As may have occurred in the case of the anthrax letters, the same actor might be able to make multiple small-scale attacks. The threat of a recurring attack would be very frightening to the public. In the 1950s–1970s, nations developed noncontagious bioweapons designed to kill on first exposure that would have had much larger effects than the anthrax letters. The materials required for bioweapons are widely available, and assembling a bioweapon requires much less expertise than assembling a nuclear weapon. Similar techniques as were used to create the bioweapons of that era are now routinely used in the vaccine and agriculture industries, and many biomedical scientists would be capable of making bioweapons.” Notes from a conversation with Tom Inglesby on October 2, 2013.
8	“A pathogen such as smallpox could intentionally be released. Since vaccination against smallpox is now very rare, people would have little immunity against the disease.” Notes from a conversation with Tom Inglesby on October 2, 2013.
9	“It is now possible to engineer noncontagious natural viruses to make them transmissible. In fact, in several recent experiments, researchers have engineered flu viruses that were previously not transmissible between animals similar to humans to be transmissible between those animals. Such work could lead to catastrophe in two ways: 1. Further such work done to further scientific understanding could accidentally produce a dangerous virus that might escape the lab. 2. As details of such work are published, it becomes possible for a scientist to maliciously use that public knowledge to create a devastating pathogen. Currently, there are few obstacles in place to prevent this possibility.” Notes from a conversation with Tom Inglesby on October 2, 2013.
10	“The biological agents that are most likely to be used in a bioterrorism attack would probably cause fewer catastrophic health effects than a flu pandemic. For example: • A smallpox release would be disastrous, but it could be controlled within months because the U.S. government stockpiles smallpox vaccines and smallpox is a disease with a long incubation period and a limited reproductive rate. • A large-scale anthrax release would be a major problem, but it would primarily have local effects because anthrax is not contagious. Attacks such as these would have significant global implications economically, socially, and politically, but the public health effects would not be as large as the effects of a flu pandemic.” Notes from a conversation with Michael Osterholm on July 30, 2013 “The scale of the impact of bioterrorism depends on a variety of factors, including: • Whether the biological agent is contagious and how deadly it is. For example, anthrax is not contagious but it is lethal, so it poses a significant risk to a small group of people. The flu is contagious and generally kills a small portion of the people who contract it, so releasing a flu virus could have a large global impact. • Whether a vaccine exists for that agent and whether the vaccine is stockpiled. For example, the existence of a smallpox vaccine and the fact that some countries, like the U.S., have stockpiles of the vaccine, mitigate the threat from a bioterrorism attack involving smallpox. • The existence and efficacy of medical countermeasures other than vaccines. It is difficult to protect against bioterrorism because many different harmful biological agents exist and they can be released in many different ways (e.g., by infecting food and water supplies, by releasing in public areas, etc.).” Notes from a conversation with Paula Olsiewski on July 19, 2013.
11	“Accidents during dual-use research could conceivably cause a pandemic. Whether a pandemic comes from nature or the laboratory, the potential global effects are largely the same.” Notes from a conversation with Michael Osterholm on July 30, 2013 “Scientists could accidentally create and release a harmful agent from a laboratory. Such accidents can be prevented by prohibiting risky experiments, such as experiments that attempt to change the host range of a pathogen. Risky experiments have happened before. For example, the National Institutes of Health recently funded experiments that tried to change the host range of the H5N1 flu virus to include ferrets. The National Science Advisory Board of Biosecurity (NSABB) originally voted against the publication of these experiments but later the work was published. In the wake of the resulting controversy, the scientific community debated whether or not such experiments should be allowed. Few laws and agencies in the U.S. restrict risky scientific experiments. The BWC prohibits certain kinds of research. In addition, the National Institutes of Health (NIH) has guidelines that cover federally funded recombinant DNA research and it has developed some new guidance for oversight of dual-use research. There are few explicit restrictions on experiments run by private companies. Some European countries have weaker standards for safety and security in the laboratory than the U.S. does.” Notes from a conversation with Paula Olsiewski on July 19, 2013. “It is now possible to engineer noncontagious natural viruses to make them transmissible. In fact, in several recent experiments, researchers have engineered flu viruses that were previously not transmissible between animals similar to humans to be transmissible between those animals. Such work could lead to catastrophe in two ways: 1. Further such work done to further scientific understanding could accidentally produce a dangerous virus that might escape the lab. 2. As details of such work are published, it becomes possible for a scientist to maliciously use that public knowledge to create a devastating pathogen. Currently, there are few obstacles in place to prevent this possibility.” Notes from a conversation with Tom Inglesby on October 2, 2013.
12	“Dual-use concerns in biology have gained widespread publicity in the last couple of years thanks to GOF research, which attempts to start combating potential horrors by first creating them artificially in the lab. On September 12, 2011, Ron Fouchier of the Erasmus Medical Center, in Rotterdam, took the stage at a meeting in Malta of the European Scientific Working Group on Influenza. He announced that he had found a way to turn H5N1, a virus that almost exclusively infected birds, into a possible human-to-human flu. At that time, only 565 people were known to have contracted H5N1 flu, presumably from contact with birds, of which 331, or 59 percent, had died. The 1918 influenza pandemic had a lethality rate of only 2.5 percent yet led to more than 50 million deaths, so H5N1 seemed potentially catastrophic. Its saving grace was that it had not yet evolved into a strain that could readily spread directly from one human to another. Fouchier told the scientists in Malta that his Dutch group, funded by the U.S. National Institutes of Health, had “mutated the hell out of H5N1,” turning the bird flu into something that could infect ferrets (laboratory stand-ins for human beings). And then, Fouchier continued, he had done “something really, really stupid,” swabbing the noses of the infected ferrets and using the gathered viruses to infect another round of animals, repeating the process until he had a form of H5N1 that could spread through the air from one mammal to another. “This is a very dangerous virus,” Fouchier told Scientific American. Then he asked, rhetorically, “Should these experiments be done?” His answer was yes, because the experiments might help identify the most dangerous strains of flu in nature, create targets for vaccine development, and alert the world to the possibility that H5N1 could become airborne. Shortly after Fouchier’s bombshell announcement, Yoshihiro Kawaoka, a University of Wisconsin virologist, who also received funding from the National Institutes of Health, revealed that he had performed similar experiments, also producing forms of the bird flu H5N1 that could spread through the air between ferrets. Kawaoka had taken the precaution of altering his experimental H5N1 strain to make it less dangerous to human beings, and both researchers executed their experiments in very high-security facilities, designated Biosafety Level (BSL) 3+, just below the top of the scale. Despite their precautions, Fouchier and Kawaoka drew the wrath of many national security and public health experts, who demanded to know how the deliberate creation of potential pandemic flu strains could possibly be justified. A virtually unknown advisory committee to the National Institutes of Health, the National Science Advisory Board for Biosecurity, was activated, and it convened a series of contentious meetings in 2011–12. The advisory board first sought to mitigate the fallout from the H5N1 experiments by ordering, in December 2011, that the methods used to create these new mammalian forms of H5N1 never be published. Science and Nature were asked to redact the how-to sections of Fouchier’s and Kawaoka’s papers, out of a stated concern on the part of some advisory board members that the information constituted a cookbook for terrorists.” Garrett 2013.
13	“Consider this sobering development: in 2001, Australian researchers working on mousepox, a nonlethal virus that infects mice (as chickenpox does in humans), accidentally discovered that a simple genetic modification transformed the virus.10, 11 instead of producing mild symptoms, the new virus killed 60% of even those mice already immune to the naturally occurring strains of mousepox. The new virus, moreover, was unaffected by any existing vaccine or antiviral drug. a team of researchers at saint louis University led by Mark Buller picked up on that work and, by late 2003, found a way to improve on it: Buller’s variation on mousepox was 100% lethal, although his team of investigators also devised combination vaccine and antiviral therapies that were partially effective in protecting animals from the engineered strain.12, 13 another saving grace is that the genetically altered virus is no longer contagious. Of course, it is quite possible that future tinkering with the virus will change that property, too. Strong reasons exist to believe that the genetic modifications Buller made to mousepox would work for other poxviruses and possibly for other classes of viruses as well. Might the same techniques allow chickenpox or another poxvirus that infects humans to be turned into a 100% lethal bioweapon, perhaps one that is resistant to any known antiviral therapy? I’ve asked this question of experts many times, and no one has yet replied that such a manipulation couldn’t be done. This case is just one example. many more are pouring out of scientific journals and conferences every year. Just last year, the journal Nature published a controversial study done at the University of Wisconsin–madison in which virologists enumerated the changes one would need to make to a highly lethal strain of bird flu to make it easily transmitted from one mammal to another.14 Biotechnology is advancing so rapidly that it is hard to keep track of all the new potential threats. nor is it clear that anyone is even trying. in addition to lethality and drug resistance, many other parameters can be played with, given that the infectious power of an epidemic depends on many properties, including the length of the latency period during which a person is contagious but asymptomatic. delaying the onset of serious symptoms allows each new case to spread to more people and thus makes the virus harder to stop. This dynamic is perhaps best illustrated by hiv, which is very difficult to transmit compared with smallpox and many other viruses. intimate contact is needed, and even then, the infection rate is low. The balancing factor is that hiv can take years to progress to aids, which can then take many more years to kill the victim. What makes hiv so dangerous is that infected people have lots of opportunities to infect others. This property has allowed hiv to claim more than 30 million lives so far, and approximately 34 million people are now living with this virus and facing a highly uncertain future.15 A virus genetically engineered to infect its host quickly, to generate symptoms slowly—say, only after weeks or months—and to spread easily through the air or by casual contact would be vastly more devastating than hiv. it could silently penetrate the population to unleash its dead- ly effects suddenly. This type of epidemic would be almost impossible to combat because most of the infections would occur before the epidemic became obvious. A technologically sophisticated terrorist group could develop such a virus and kill a large part of humanity with it. indeed, terrorists may not have to develop it themselves: some scientist may do so first and publish the details. Given the rate at which biologists are making discover- ies about viruses and the immune system, at some point in the near future, someone may create artificial pathogens that could drive the human race to extinction. indeed, a detailed species-elimination plan of this nature was openly proposed in a scientific journal. The ostensible purpose of that particular research was to suggest a way to extirpate the malaria mosquito, but similar techniques could be directed toward humans.16 When I’ve talked to molecular biologists about this method, they are quick to point out that it is slow and easily detectable and could be fought with biotech remedies. if you challenge them to come up with improvements to the suggested attack plan, however, they have plenty of ideas. modern biotechnology will soon be capable, if it is not already, of bringing about the demise of the human race— or at least of killing a sufficient number of people to end high-tech civilization and set humanity back 1,000 years or more. That terrorist groups could achieve this level of technological sophistication may seem far-fetched, but keep in mind that it takes only a handful of individuals to accomplish these tasks. never has lethal power of this potency been accessible to so few, so easily. Even more dramatically than nuclear proliferation, modern biological science has frighteningly undermined the correlation between the lethality of a weapon and its cost, a fundamentally stabilizing mechanism throughout history. access to extremely lethal agents—lethal enough to exterminate Homo sapiens—will be available to anybody with a solid background in biology, terrorists included.” Myhrvold 2013
14	“The U.S. government funds departments and agencies that work on biosecurity issues, some of which are listed below: • The Department of Homeland Security works to prevent and/or mitigate the effects of bioterrorism and pandemics. • The Environmental Protection Agency (EPA) is responsible for decontamination after bioterrorist attacks, such as attacks involving anthrax. • The Recombinant DNA Advisory Committee (RAC), part of NIH, oversees the safety of scientific research that receives NIH funding. • The Defense Advanced Research Project Agency (DARPA) does some biosecurity work. Sequestration has decreased funding for some agencies working on biosecurity. For example, some employees at DARPA have been furloughed. In the past, the U.S. government has usually only protected against biological weapons that it has the capability to use against others, which may not be the best strategy.” Notes from a conversation with Paula Olsiewski on July 19, 2013 “The United States government prepares for pandemics in a variety of ways: • Supporting manufacturing capability for influenza vaccines • Funding research of improved influenza vaccines • Stockpiling critical medical supplies • Conducting surveillance of developing pandemics” Notes from a conversation with Michael Osterholm on July 30, 2013 “After the 9/11 attacks, the anthrax letters in September and October 2001, and elevated concern about possible future terrorist biological attacks, interest in biosecurity increased. Soon after, H5N1 (avian flu) emerged as a threat to human health, further elevating interest. The U.S. Departments of Defense, Homeland Security, and Health and Human Services all started programs in biosecurity. All have had successes, but probably none would declare they are even halfway to achieving its goals. Other countries also started programs. … Over the past decade or so, interest in biosecurity has waned. There have been no high- profile bioattacks since 2001, which has made the issue seem less urgent. It is hard for governments and foundations to manage biosecurity threats, because they tend to focus on currently pressing problems. The goal of biosecurity work is to build a robust safety system and sustain it over time, but most people do not want to focus on safety systems until something goes wrong. In addition, biosecurity can be a dark and frightening topic, which makes some want to avoid addressing it. Few legislators today are very involved in biosecurity; many more were five years ago. … Federal funding to prepare public health agencies and hospitals for disasters has declined since 2003, and this has affected the preparedness of the public health system. Positions at hospitals for disaster management specialists are mostly funded through federal grants. The amount granted is decreasing, and if the trend continues, hospitals will have to cut these positions. The budgets of federal agencies that work on biosecurity have been shrinking and are currently about half of what they were five years ago. None are immune to further budget cuts. The instability of budgets contributes to a flow of talented people out of these organizations. With the loss of foundation funding in biosecurity, researchers are losing the ability to work on independent research that might inform government work in this area. Due to the cuts in funding, many people who previously worked on biosecurity have moved out of the field.” Notes from a conversation with Tom Inglesby on October 2, 2013.
15	Sell and Watson 2013, Table 1, pg 197. The table reports $5,559.6 million in total U.S. government civilian biodefense funding, with $478.3 million going to programs that exclusively focus on biodefense.
16	Sell and Watson 2013, Table 3, pg 203. The table reports $1,329.5 million in biodefense funding for the CDC, and $1,307.8 million for the NIH.
17	“From 2000 to 2010, the Sloan Foundation spent approximately $44 million on its biosecurity program. The Sloan Foundation’s grant process involved studying the field, identifying and vetting potential grantees, and then inviting proposals from a small number of key people and organizations. One of the Sloan Foundation’s key grantees in its biosecurity program was the University of Pittsburgh Medical Center (UPMC).” Notes from a conversation with Paula Olsiewski on July 19, 2013
18	“The Carnegie Foundation and the MacArthur Foundation, like the Sloan Foundation, funded work on biosecurity but have exited the space. Many groups that the Sloan Foundation funded, however, are still working on issues related to biosecurity.” Notes from a conversation with Paula Olsiewski on July 19, 2013
19	“Since the Sloan Foundation exited the biosecurity space three years ago, few private funders have stepped in to work on these problems. The Skoll Global Threats Fund and the Gates Foundation fund some limited work in this area.” Notes from a conversation with Michael Osterholm on July 30, 2013 “Besides the Gates Foundation, the Rockefeller Foundation, and Skoll Global Threats Fund, there are few philanthropic funders in the pandemics space. Skoll has had private discussions with a few other funders potentially interested in entering this space. Olsen is optimistic that more funders will enter this space in the future. The lack of funders in this space may be due to the fact that the issue is not tied to a specific disease or a clear problem set (e.g. “eradicating polio”) and is therefore harder to place into the framework of traditional foundation philanthropy.” Notes from a conversation with Jennifer Olsen on September 23, 2013
20	Skoll Global Threats Fund 990-PF 2011. pgs 22-23.
21	“CORDS (Connecting Organizations for Regional Disease Surveillance) is a project co-funded by the Rockefeller Foundation, the Gates Foundation, and Skoll Global Threats Fund. CORDS connects regional surveillance networks to each other so that they can share best practices and data across the globe.” Notes from a conversation with Jennifer Olsen on September 23, 2013 “CORDS, an organization dedicated to improving disease surveillance worldwide, launched at the Prince Mahidol Award Conference in Bangkok. CORDS (Connecting Organizations for Regional Disease Surveillance (CORDS) is a unique, international non-governmental organization building information exchange among disease surveillance networks in different regions of the world. CORDS promotes global exchanges of best practices, tools and strategies, training courses, innovations, case studies and technical data to improve disease surveillance worldwide. … Funding of CORDS as an independent entity comes from the Rockefeller Foundation, the Skoll Global Threats Fund, and the Bill & Melinda Gates Foundation following initial project support from the Nuclear Threat Initiative, the Peter G. Peterson Foundation and the Rockefeller Foundation.” CORDS Launch. “In 2008, the Board of Trustees of the Rockefeller Foundation approved $21.3 million in support for the Disease Surveillance Networks Initiative with the aim of achieving the following objectives: 1. Improve human resources for disease surveillance in developing countries, thus bolstering national capacity to monitor, report and respond to outbreaks; 2. Support regional networks to promote collaboration in disease surveillance and response across countries; and 3. Build bridges between regional and global monitoring efforts. The intended outcomes of the Initiative are: Improved competencies (skills, capacities) in the Greater Mekong Sub-region and Eastern and Southern Africa to conduct disease surveillance and response efficiently and improve capabilities in trans-border collaboration across countries; Global collaboration and learning among regional disease surveillance networks worldwide; and Collaboration between regional disease surveillance networks and international agencies to increase the efficiency of global systems for disease surveillance and response. Of the total $21.3 million, $6.2 million in grants were awarded during the development phase of the Initiative in 2007, and another $14.5 million in grants are to be awarded during the execution phase of the Initiative (2008–2011).” Kimball et al. 2011 pg 63.
22	“To move towards those goals, needed improvements include: Stronger international disease surveillance systems with better interconnection and more updated technologies. Public health systems that can use electronic medical records to detect patterns in disease and to manage outbreaks.” Notes from a conversation with Tom Inglesby on October 2, 2013. “Improvements in detection over time A study using WHO data from 1996-2009 found significant improvements in outbtreak detection over time. In 1996, outbreak detection took about 170 days from the time of the outbreak to the time it was reported in newspapers. By 2009, the lag had been reduced to about 23 days. With technologies currently in development and deployment of best practices, lag time between outbreak and detection could conceivably shrink to one or two incubation periods (depending on the disease), helping cut off disease spread. U.S. detection rates From a global perspective, the U.S. has relatively good detection rates. However, in the U.S., institutional complexities make it hard to compile data on how fast the government detects outbreaks because information has to move through local, sub-state, and state levels before reaching national agencies. Tracking the history of this information would require gathering data on various levels.” Notes from a conversation with Jennifer Olsen on September 23, 2013
23	“The Sloan Foundation’s projects in this area included: • Addressing the risks of bioterrorism. In particular, Sloan worked with building engineers to develop improved methods for air filtration in large buildings (people spend 90% of their time indoors). • Preventing people from mail-ordering DNA of potentially harmful viruses. DNA sequences for harmful agents like smallpox are publicly available, so it is important to ensure that companies that sell DNA strands are not accidentally selling dangerous ones. • Establishing new scientific norms. It sponsored the Fink Committee report, which outlines an improved culture of responsibility for scientists and discusses what kinds of experiments are potentially dangerous.” Notes from a conversation with Paula Olsiewski on July 19, 2013
24	“Improving manufacturing capability for influenza vaccines is important, but existing influenza vaccines have limited effectiveness, so new and improved vaccines must be developed as soon as possible. The U.S. government and the scientific community are slowly working toward improved vaccines, but producing new vaccines takes time.” Notes from a conversation with Michael Osterholm on July 30, 2013 “To move towards those goals, needed improvements include… Development of medicines and vaccines for a wider range of illnesses.” Notes from a conversation with Tom Inglesby on October 2, 2013.
25	“If a vaccine is not developed, manufactured, and administered within the first 6 to 8 months after a pandemic begins, it is difficult to significantly mitigate the pandemic’s effects. Unexpected influenza pandemics are particularly dangerous because it is highly unlikely that a vaccine for any particular strain of influenza could be developed, manufactured, and distributed within 6 to 8 months.” Notes from a conversation with Michael Osterholm on July 30, 2013 “To move towards those goals, needed improvements include… A medicine and vaccine development and production process that could quickly scale up if needed. (Currently the U.S. relies on stockpiles for some specific illnesses, but it will ultimately need to be able to make medicines and vaccines for a whole range of illnesses and to be able to quickly scale up production in a crisis.)” Notes from a conversation with Tom Inglesby on October 2, 2013.
26	“Question 10: Has there been sufficient, sustained funding for the medical countermeasure enterprise? Answer: No. Initial Project BioShield funding ($5.593 billion for FY2004 to FY2013)11 was a good start, but there have been constant raids and attempted raids on the fund. BARDA is currently funded at about 10 percent of its actual requirements and FDA lacks sustained, balanced funding for work on medical countermeasures.12 Without sufficient, sustained funding there will be little chance of success. Medical countermeasures are the most important arrow in the biodefense quiver.” The Bipartisan WMD Terrorism Research Center 2011 pg 43.
27	“The goal of biosecurity is to have available all the vaccines and medicines needed for any possible contingency, and to have a public health and healthcare systems in place that can respond to a serious and acute crisis. To move towards those goals, needed improvements include: Stronger international disease surveillance systems with better interconnection and more updated technologies. Public health systems that can use electronic medical records to detect patterns in disease and to manage outbreaks. Stronger response to outbreaks of foodborne illness. (Currently it can take months to find the source of a multi-state foodborne outbreak, and sometimes the source is never found even if thousands of people are infected.) A medicine and vaccine development and production process that could quickly scale up if needed. (Currently the U.S. relies on stockpiles for some specific illnesses, but it will ultimately need to be able to make medicines and vaccines for a whole range of illnesses and to be able to quickly scale up production in a crisis.) Development of medicines and vaccines for a wider range of illnesses. A healthcare system that can respond to mass catastrophes. Specifically, hospitals need to develop plans for transferring patients, sharing medical expertise, and learning from each other.” Notes from a conversation with Tom Inglesby on October 2, 2013.
28	The Bipartisan WMD Terrorism Research Center 2011, pg 9.

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