A More Systematic Approach to Biological Risk
Management of emerging risks in life science and technology requires new leadership and a sober assessment of the legacy of Asilomar.
Center on Democracy, Development and the Rule of Law is housed in the Freeman Spogli Institute for International Studies
Management of emerging risks in life science and technology requires new leadership and a sober assessment of the legacy of Asilomar.
The United States needs to build a better governance regime for oversight of risky biological research to reduce the likelihood of a bioengineered super virus escaping from the lab or being deliberately unleashed, according to an article from three Stanford scholars published in the journal Science today.
"We've got an increasing number of unusually risky experiments, and we need to be more thoughtful and deliberate in how we oversee this work," said co-author David Relman, a professor of infectious diseases and co-director of Stanford's Center for International Security and Cooperation (CISAC).
Relman said that cutting-edge bioscience and technology research has yielded tremendous benefits, such as cheap and effective ways of developing new drugs, vaccines, fuels and food. But he said he was concerned about the growing number of labs that are developing novel pathogens with pandemic potential.
For instance, researchers at the Memorial Sloan Kettering Cancer Center, in their quest to create a better model for studying human disease, recently deployed a gene editing technique known as CRISPR-Cas9 on a respiratory virus so that it was able to edit the mouse genome and cause cancer in infected mice.
"They ended up creating, in my mind, a very dangerous virus and showed others how they too could make similar kinds of dangerous viruses," Relman said.
Scientists in the United States and the Netherlands, conducting so-called "gain-of-function" experiments, have also created much more contagious versions of the deadly H5N1 bird flu in the lab.
Publicly available information from published experiments like these, such as genomic sequence data, could allow scientists to reverse engineer a virus that would be difficult to contain and highly harmful were it to spread.
And a recent spate of high-profile accidents at U.S. government labs – including the mishandling of anthrax, bird flu, smallpox and Ebola samples – has raised the specter of a dangerous pathogen escaping from the lab and causing an outbreak or even a global pandemic.
"These kinds of accidents can have severe consequences," said Megan Palmer, CISAC senior research scholar and a co-author on the paper. "But we lack adequate processes and public information to assess the significance of the benefits and risks. Unless we address this fundamental issue, then we're going to continue to be reactive and make ourselves more vulnerable to mistakes and accidents in the long term."
Leadership on risk management in biotechnology has not evolved much since the mid-1970s, when pioneering scientists gathered at the Asilomar Conference on Recombinant DNA and established guidelines that are still in use today.
Palmer said that although scientific self-governance is an essential element of oversight, left unchecked, it could lead to a "culture of invincibility over time."
"There's reliance on really a narrow set of technical experts to assess risks, and we need to broaden that leadership to be able to account for the new types of opportunities and challenges that emerging science and technology bring," she said.
Relman described the current system as "piecemeal, ad hoc and uncoordinated," and said that a more "holistic" approach that included academia, industry and all levels of government was needed to tackle the problem.
"It's time for us as a set of communities to step back and think more strategically," Relman said.
The governance of "dual use" technologies, which can be used for both peaceful and offensive purposes, poses significant challenges in the life sciences, said Stanford political scientist Francis Fukuyama, who also contributed to the paper.
"Unlike nuclear weapons, it doesn't take large-scale labs," Fukuyama said. "It doesn't take a lot of capacity to do dangerous research on biology."
The co-authors recommend appointing a top-ranking government official, such as a special assistant to the president, and a supporting committee, to oversee safety and security in the life sciences and associated technologies. They would coordinate the management of risk, including regulatory authorities needed to ensure accountability and information sharing.
"Although many agencies right now are tasked with worrying about safety, they have got conflicting interests that make them not ideal for being the single point of vigilance in this area," Fukuyama said.
"The National Institutes of Health is trying to promote research but also stop dangerous research. Sometimes those two aims run at cross-purposes.
"It's a big step to call for a new regulator, because in general we have too much regulation, but we felt there were a lot of dangers that were not being responded to in an appropriate way."
Strong cooperative international mechanisms are also needed to encourage other countries to support responsible research, Fukuyama said.
"What we want to avoid is a kind of arms race phenomenon, where countries are trying to compete with each other doing risky research in this area, and not wanting to mitigate risks because of fears that other countries are going to get ahead of them," he said.
The co-authors also recommended investing in research centers as a strategic way to build critical perspective and analysis of oversight challenges as biotechnology becomes increasing accessible.
The Ebola epidemic, which could affect hundreds of thousands of West Africans, can only be contained by rebuilding public trust and local health systems decimated by years of neglect, according to a panel convened by the Freeman Spogli Institute for International Studies and Stanford Medicine. FSI Senior Fellows David Relman, Paul Wise, Stephen Stedman, Michele Barry and Douglas Owens were among the panelists.
The World Health Organization estimates 2,811 people have died of the virus since the outbreak began earlier this year and that 5,864 people currently are infected in Sierra Leone, Liberia, Guinea, Senegal and Nigeria.
In this Stanford Medicine news story, Owens, a professor of medicine and director of the Center for Health Policy at FSI, cites a new report by the Centers for Disease Control and Prevention that estimates that even with "very aggressive" intervention, there would be at least 25,000 cases by late December. If intervention is delayed by just one month, the CDC estimates there would be 3,000 new cases every day; if it's delayed by two months, there will be 10,000 new cases daily. "It gives you a sense of the extraordinary urgency in terms of time," Owens told the audience.
Relman and CISAC biosecurity fellow Megan Palmer have also done a Q&A about the virus.
And you can listen to a KQED Public Radio talk show about Ebola that included Relman.
Dr. Luby comes to us from the International Center for Diarrheal Diseases and Research, Bangladesh (ICDDR, B) after serving as the research director there for the past eight years in a shared position with CDC. Prior to this position, he taught at the Aga Khan University in Pakistan. He will be leading our research efforts within CIGH and we are looking forward to his start in September 2012.
CISAC Conference Room
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Prof. Stephen Luby studied philosophy and earned a Bachelor of Arts summa cum laude from Creighton University. He then earned his medical degree from the University of Texas Southwestern Medical School at Dallas and completed his residency in internal medicine at the University of Rochester-Strong Memorial Hospital. He studied epidemiology and preventive medicine at the Centers for Disease Control and Prevention.
Prof. Luby's former positions include leading the Epidemiology Unit of the Community Health Sciences Department at the Aga Khan University in Karachi, Pakistan, for five years and working as a Medical Epidemiologist in the Foodborne and Diarrheal Diseases Branch of the U.S. Centers for Disease Control and Prevention (CDC) exploring causes and prevention of diarrheal disease in settings where diarrhea is a leading cause of childhood death. Immediately prior to joining the Stanford faculty, Prof. Luby served for eight years at the International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b), where he directed the Centre for Communicable Diseases. He was also the Country Director for CDC in Bangladesh.
During his over 25 years of public health work in low-income countries, Prof. Luby frequently encountered political and governance difficulties undermining efforts to improve public health. His work within the Center on Democracy, Development, and the Rule of Law (CDDRL) connects him with a community of scholars who provide ideas and approaches to understand and address these critical barriers.
President Obama and Mitt Romney meet for their third debate to discuss foreign policy on Monday, when moderator Bob Schieffer is sure to ask them about last month's terrorist attack in Libya and the nuclear capabilities of Iran.
In anticipation of the final match between the presidential candidates, researchers from five centers at Stanford’s Freeman Spogli Institute for International Studies ask the additional questions they want answered and explain what voters should keep in mind.
What can we learn from the Arab Spring about how to balance our values and our interests when people in authoritarian regimes rise up to demand freedom?
What to listen for: First, the candidates should address whether they believe the U.S. has a moral obligation to support other peoples’ aspirations for freedom and democracy. Second, they need to say how we should respond when longtime allies like Egypt’s Hosni Mubarak confront movements for democratic change.
And that leads to more specific questions pertaining to Arab states that the candidates need to answer: What price have we paid in terms of our moral standing in the region by tacitly accepting the savage repression by the monarchy in Bahrain of that country's movement for democracy and human rights? How much would they risk in terms of our strategic relationship with Bahrain and Saudi Arabia by denouncing and seeking to restrain this repression? What human rights and humanitarian obligations do we have in the Syrian crisis? And do we have a national interest in taking more concrete steps to assist the Syrian resistance? On the other hand, how can we assist the resistance in a way that does not empower Islamist extremists or draw us into another regional war?
Look for how the candidates will wrestle with difficult trade-offs, and whether either will rise above the partisan debate to recognize the enduring bipartisan commitment in the Congress to supporting democratic development abroad. And watch for some sign of where they stand on the spectrum between “idealism” and “realism” in American foreign policy. Will they see that pressing Arab states to move in the direction of democracy, and supporting other efforts around the world to build and sustain democracy, is positioning the United States on “the right side of history”?
~Larry Diamond, director of the Center on Democracy, Development, and the Rule of Law
What do you consider to be the greatest threats our country faces, and how would you address them in an environment of profound partisan divisions and tightly constrained budgets?
What to listen for: History teaches that some of the most effective presidential administrations understand America's external challenges but also recognize the interdependence between America's place in the world and its domestic situation.
Accordingly, Americans should expect their president to be deeply knowledgeable about the United States and its larger global context, but also possessed of the vision and determination to build the country's domestic strength.
The president should understand the threats posed by nuclear proliferation and terrorist organizations. The president should be ready to lead in managing the complex risks Americans face from potential pandemics, global warming, possible cyber attacks on a vulnerable infrastructure, and failing states.
Just as important, the president needs to be capable of leading an often-polarized legislative process and effectively addressing fiscal challenges such as the looming sequestration of budgets for the Department of Defense and other key agencies. The president needs to recognize that America's place in the world is at risk when the vast bulk of middle class students are performing at levels comparable to students in Estonia, Latvia and Bulgaria, and needs to be capable of engaging American citizens fully in addressing these shared domestic and international challenges.
~Mariano-Florentino Cuéllar, co-director of the Center for International Security and Cooperation
Should our government help American farmers cope with climate impacts on food production, and should this assistance be extended to other countries – particularly poor countries – whose food production is also threatened by climate variability and climate change?
What to listen for: Most representatives in Congress would like to eliminate government handouts, and many would also like to turn away from any discussion of climate change. Yet this year, U.S. taxpayers are set to pay up to $20 billion to farmers for crop insurance after extreme drought and heat conditions damaged yields in the Midwest.
With the 2012 farm bill stalled in Congress, the candidates need to be clear about whether they support government subsidized crop insurance for American farmers. They should also articulate their views on climate threats to food production in the U.S. and abroad.
Without a substantial crop insurance program, American farmers will face serious risks of income losses and loan defaults. And without foreign assistance for climate adaptation, the number of people going hungry could well exceed 15 percent of the world's population.
~Rosamond L. Naylor, director of the Center on Food Security and the Environment
What is your vision for the United States’ future relationship with Europe?
What to listen for: Between the end of World War II and the end of the Cold War, it was the United States and Europe that ensured world peace. But in recent years, it seems that “Europe” and “European” have become pejoratives in American political discourse. There’s been an uneasiness over whether we’re still friends and whether we still need each other. But of course we do.
Europe and the European Union share with the United States of America the most fundamental values, such as individual freedom, freedom of speech, freedom to live and work where you choose. There’s a shared respect of basic human rights. There are big differences with the Chinese, and big differences with the Russians. When you look around, it’s really the U.S. and Europe together with robust democracies such as Canada and Australia that have the strongest sense of shared values.
So the candidates should talk about what they would do as president to make sure those values are preserved and protected and how they would make the cooperation between the U.S. and Europe more effective and substantive as the world is confronting so many challenges like international terrorism, cyber security threats, human rights abuses, underdevelopment and bad governance.
~Amir Eshel, director of The Europe Center
Historical and territorial issues are bedeviling relations in East Asia, particularly among Japan, China, South Korea, and Southeast Asian countries. What should the United States do to try to reduce tensions and resolve these issues?
What to listen for: Far from easing as time passes, unresolved historical, territorial, and maritime issues in East Asia have worsened over the past few years. There have been naval clashes, major demonstrations, assaults on individuals, economic boycotts, and harsh diplomatic exchanges. If the present trend continues, military clashes – possibly involving American allies – are possible.
All of the issues are rooted in history. Many stem from Imperial Japan’s aggression a century ago, and some derive from China’s more assertive behavior toward its neighbors as it continues its dramatic economic and military growth. But almost all of problems are related in some way or another to decisions that the United States took—or did not take—in its leadership of the postwar settlement with Japan.
The United States’ response to the worsening situation so far has been to declare a strategic “rebalancing” toward East Asia, aimed largely at maintaining its military presence in the region during a time of increasing fiscal constraint at home. Meanwhile, the historic roots of the controversies go unaddressed.
The United States should no longer assume that the regional tensions will ease by themselves and rely on its military presence to manage the situation. It should conduct a major policy review, aimed at using its influence creatively and to the maximum to resolve the historical issues that threaten peace in the present day.
~David Straub, associate director of the Korea Studies Program at the Walter H. Shorentein Asia-Pacific Research Center
Compiled by Adam Gorlick.
Megan Smith, Vice President, New Business Development and General Manager, Google.org., argued that greater interconnectedness achieved by information technology is a major liberating force in the world. Whether it is aiding the coordination of protests or increasing transparency of governments, the exchange of information has huge benefits. This is not a new phenomenon. In places where people have been able to exchange information easily, social progress has followed. Megan cited the example of Seneca Falls, New York where the canal system allowed for extensive communication; it became significant in both the women's rights and abolition movements.
While a large proportion of the world is benefiting from greater interconnectedness, Africa still lacks the infrastructure to take full advantage. Submarine fiber optic cables are necessary for quick and cheap internet cables and many African countries, particularly in the east, are not connected to these, relying instead on satellites. This is likely to change over the next few years, bringing great potential for further development.
The mission of Google.org is to use technology to drive solutions to global challenges such as climate change, pandemic disease and poverty. The organization was set up as part of a commitment to devote approximately one percent of Google's equity plus one percent of annual profits to philanthropy, along with employee time. Google.org now places its strategic focus on those projects that can leverage the resources of Google staff, particularly its engineers.
Current projects that harness the power of information include:
Abstract
One of the biggest themes of the 21st century is interconnection -- specifically, the interconnection of people and data. These interconnections can change everything about how we see the world, how the world sees us, and how we work together. Where some people might see "big brother," I see empowerment -- empowerment of groups and individuals to improve quality of life and reduce our impact on the planet.
Megan Smith oversees teams that manage early-stage partnerships, explorations and technology licensing. She also leads the Google.org team, guiding strategy and developing new partnerships and internal projects with Google's engineering and product teams. She joined Google in 2003 and has led several of the company's acquisitions, including Keyhole (Google Earth), Where2Tech (Google Maps), and Picasa. She also co-led the company's early work with publishers for Google Book Search. Previously, Megan was the CEO and, earlier, COO of PlanetOut, the leading gay, lesbian, bisexual and transgender online community. Under her leadership, PlanetOut grew tenfold in reach and revenue. Prior to that, Megan was at General Magic for six years working on handheld communications products and partnerships. She also worked in multimedia at Apple Japan in Tokyo.
Over the years, Megan has contributed to a wide range of engineering projects, such as designing an award-winning bicycle lock; working on a space station construction research project that eventually flew on the U.S. space shuttle; and running a field-research study on solar cookstoves in South America. She was also a member of the MIT-Solectria student team that designed, built, and raced a solar car in the first cross-continental solar car race, covering 2000 miles of the Australian outback. She was selected as one of the 100 World Economic Forum technology pioneers for 2001 and 2002.
Megan holds a bachelor's degree and a master's degree in mechanical engineering from MIT, where she now serves on the board. She completed her master's thesis work at the MIT Media Lab.
Summary of the Seminar
Megan Smith, Vice President, New Business Development and General Manager, Google.org., argued that greater interconnectedness achieved by information technology is a major liberating force in the world. Whether it is aiding the coordination of protests or increasing transparency of governments, the exchange of information has huge benefits. This is not a new phenomenon. In places where people have been able to exchange information easily, social progress has followed. Megan cited the example of Seneca Falls, New York where the canal system allowed for extensive communication; it became significant in both the women's rights and abolition movements.
While a large proportion of the world is benefiting from greater interconnectedness, Africa still lacks the infrastructure to take full advantage. Submarine fiber optic cables are necessary for quick and cheap internet cables and many African countries, particularly in the east, are not connected to these, relying instead on satellites. This is likely to change over the next few years, bringing great potential for further development.
The mission of Google.org is to use technology to drive solutions to global challenges such as climate change, pandemic disease and poverty. The organization was set up as part of a commitment to devote approximately one percent of Google's equity plus one percent of annual profits to philanthropy, along with employee time. Google.org now places its strategic focus on those projects that can leverage the resources of Google staff, particularly its engineers.
Current projects that harness the power of information include:
Wallenberg Theater
This paper tests the claim that a small number of distinct „welfare regimes,
combining institutional patterns and social welfare outcomes, can be identified
across the developing world. It develops a methodology for clustering a large
number of developing countries, identifying and ranking their welfare regimes,
assessing their stability over the decade 1990-2000, and relating these to important
structural variables. It identifies three meta-welfare regimes: proto-welfare state
regimes, informal security regimes and insecurity regimes (distinguishing illiterateinsecurity
and morbidity-insecurity regimes). Membership of these is „sticky over
time, but has been modified by two global trends: the HIV-AIDS pandemic in Africa
and the growing role of remittances in some countries.