A new biosecurity initiative at the Freeman Spogli Institute for International Studies (FSI) aims to identify and mitigate biological risks, both natural and man-made, and safeguard the future of the life sciences and associated technologies.

The initiative will be led by David A. Relman, a senior fellow at the Center for International Security and Cooperation and FSI. Relman, the Thomas C. and Joan M. Merigan Professor in the Departments of Medicine, and Microbiology & Immunology, has served as the science co-director at CISAC for the past four years. He will leave this position on Aug. 31 to lead the new initiative.

Michael McFaul, director and senior fellow at FSI, said, “With exceptional leadership skills, valuable experience and abundant energy, David Relman is ideally positioned to work with scholars from across campus who offer critical expertise in biosecurity. This is an exciting, challenging and important new initiative for FSI that is designed to protect public health from the many new risks now accelerating.”

Relman said the biosecurity initiative will seek to advance the beneficial applications of the life sciences while reducing the risks of misuse by promoting research, education and policy outreach in biological security. His CISAC leadership gives him the know-how to lead such a wide-ranging effort across diverse disciplines and communities.

Relman said, “The opportunity to serve as co-director at CISAC has been a wonderful experience, one that has afforded me the chance to get to know outstanding faculty and staff, their scholarship, and critical policy-relevant work, all of which I had not fully appreciated sitting across campus. This experience has made clear the unusual qualities of Stanford University, and the great people that work here. I am now greatly looking forward to this new opportunity at FSI.”

Biosecurity collaborations

During Relman’s term as CISAC’s science co-director from 2013-2017, he led an expansion of the transdisciplinary work in science and security to include biology, biological and other areas of engineering, medicine, and earth and environmental sciences.

The foundations for work in biological science, technology and security were established at CISAC, especially in the hiring of Megan Palmer, a senior research scholar at CISAC and FSI. Both Relman and Palmer worked together on engagements and discussions with a growing network of more than 20 faculty involved in biosecurity across Stanford.

Palmer said, “Stanford has an opportunity and imperative to advance security strategies for biological science and technology in a global age. Our faculty bring together expertise in areas including technology, policy, and ethics, and are deeply engaged in shaping future of biotechnology policy and practices.”

New insights, new risks

In his new post, Relman said he intends to build on this foundation by creating an initiative that consolidates and focuses activity in biosecurity, develops research and educational programs, attracts new resources, and looks outward at opportunities for policy impact and changing practices across the globe.

Relman said that “new capabilities and insights are reshaping important aspects of the life sciences and associated technologies, and are accompanied by a host of new risks.” If misused, whether by malice or accident, “they pose the potential for large-scale harm,” he noted.

Relman added that the initiative will bring together interest and expertise across the centers and programs of FSI in partnership with Schools and Departments across the university.

At FSI, CISAC will co-sponsor the biological security initiative, which will leverage Stanford expertise in the life sciences, engineering, law and policy.  Key partners will include Tim Stearns (biology), Drew Endy (bioengineering), Mildred Cho (bioethics), and Hank Greely (law), according to Relman. The biosecurity group will also partner with another new program at FSI in global health and conflict, which is led by Paul Wise, Frank Fukuyama, Steve Stedman, Steve Krasner, and others, he added.

Stanford’s School of Medicine and Department of Medicine will also co-sponsor the initiative, thanks to leadership from Lloyd Minor, Michele Barry and Robert Harrington. Relman looks forward to establishing similar relationships with other schools and departments, he said.

 “These partnerships are critical. I’m excited to work with a growing community both within and beyond Stanford towards the goal of a peaceful and prosperous world in the century of biology,” he said.

MEDIA CONTACTS:

David Relman, Center for International Security and Cooperation: relman@stanford.edu

Megan Palmer, Center for International Security and Cooperation:  mjpalmer@stanford.edu

Clifton B. Parker, Center for International Security and Cooperation: (650) 725-6488, cbparker@stanford.edu

Design learning and journey maps are all the rage here at Stanford University and in Silicon Valley. So why not apply it to health systems to reduce diagnostic errors?

That’s what Stanford Health Policy’s Kathryn M. McDonald is trying to do: Map the journey of worrisome scenarios that keep clinicians up at night, and then plant design seeds that might just help those clinicians get back to sleep.

One of those real-world scenarios involves a preventable diagnostic error made as a high-risk condition unfolds across multiple visits to the doctor. Missed cancer diagnoses, for example, are the leading cause for paid medical malpractice claims in the ambulatory setting, with one in 20 patients experiencing potentially preventable diagnostic errors each year.

“For example, a patient who has a positive fecal blood test, but no follow-up colonoscopy within a reasonable period may experience a missed opportunity to detect and successfully treat colon cancer,” McDonald said.

McDonald and her team worked with San Francisco public health clinics that cater to low-income patients to investigate this key problem — missed diagnosis and prevention activities during outpatient care — then came up with design seeds to plant possible solutions.

She and her co-authors published their research in the journal Implementation Science. The project was conducted at the Ambulatory Safety Center for Innovation (ASCENT), a patient safety learning laboratory led by Dr. Urmimala Sarkar at University of California San Francisco, and funded by the federal Agency for Healthcare Research and Quality.

The team used a research design approach called “journey mapping,” a tool that tells the story of a customer’s experience through his own viewpoint. They constructed maps for each pathway used by doctors to monitor patients with sinister findings, starting with the initial diagnostic assessment during an initial clinic visit and continuing through ongoing follow-up visits.

“Whenever participants in the study verbalized elements of the pathway that were particularly vulnerable to error or poor monitoring, we marked the activity with a bullseye target, also referred to by clinicians as a ‘pain point,’” the authors wrote. “To our knowledge, this technique has seldom been applied to the ambulatory setting, and has not been targeted to clinic workflow efficiency or patient safety intervention development.”

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“A design seed gives the specs for what a solution needs to do,” said McDonald, who is the executive director of Stanford Health Policy’s Center for Health Policy and Center for Primary Care and Outcomes Research. “Once you know the vulnerabilities through journey mapping, you create all the design seeds that are tied to the problem, then the implementation stage becomes much more straightforward and more likely to assure that all the key goals are met.”

To test out this theory, McDonald’s team spent the last two years working with doctors, residents, nurse practitioners and registered nurses with the San Francisco Health Network. The publicly funded integrated health network operates under the auspices of the San Francisco Department of Public Health and includes 14 primary care clinics, as well as urgent and specialty care at Zuckerberg San Francisco General hospital.

“The health system serves many of the most medically and socially vulnerable patients in San Francisco,” the authors wrote in their research paper. “Like many safety-net systems and ambulatory practices, the health system does not have a comprehensive electronic health record system and struggles with information transfer as well as fragmentation of health information across over 50 electronic platforms.”

The health system had more than half a million outpatient visits last year by people who could not afford care. Patients at the network’s main clinics and hospital are diverse: 35 percent are Latino, 21 percent are white, another 21 percent are Asians, and 17 percent are African-American.

Only 1 percent of the network population has commercial insurance; 10 percent were uninsured; 57 percent were on Medi-Cal — California’s Medicaid program — 21 percent were on Medicare and the remaining 11 percent were covered by other, mostly public sources.

This type of ambulatory health care is complex, requiring constant tracking and reconciliation of individual patient activities, patient data, and the unique evolution of each clinical case.

"Human factors and industrial design methodologies have tremendous potential to help unravel these complexities and provide fundamental insights that can drive the development of novel solutions," said co-author George Su of the University of California San Francisco School of Medicine.

McDonald said that journey mapping helped frontline clinic members see their workflow for a specific task, which in this case was monitoring this diverse population for follow-up visits after a potentially sinister finding. The system challenge is population management of an ill-defined problem.

“Lots of ambulatory care work is done one patient interaction at a time, but robust monitoring requires a view from a higher plane,” she said in an interview. “Journey mapping makes the aerial view more tangible and realistic for clinic team input.”

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McDonald’s team selected high-risk cancer situations: incidentally discovered pulmonary nodules; monitoring for breast, colorectal and prostate cancers; and ear, nose and throat cancers. These high-risk cancers require recurring and timely follow-up care to assure intervention whenever the disease takes hold.

The team interviewed clinicians from each of five specialty clinics responsible for these high-risk patients in pulmonary medicine, breast cancer, gastroenterology, urology, and otolaryngology. They asked the frontline clinicians: “What keeps you up and night? And what are your clinical hunches about who might fall through the cracks?”

While the providers talked about the types of patients who become lost to follow-up visits, the researchers found, none of the clinics had a standardized and efficient method of quantifying how many patients were lost to follow-up care and, perhaps more importantly, why.

“Many other health networks share similar struggles with incomplete documentation and measuring the real-time scope of patient safety problems,” wrote McDonald and co-authors Sarkar, Su and Sarah Lisker of the University of California San Francisco School of Medicine; and Emily S. Patterson of Ohio State University College of Medicine.

“When a patient has a warning signal for a serious condition that has yet to materialize but may in the future, the ability of a clinical team to watch the patient closely over time hinges on incredible vigilance on the part of individual clinicians — hardly an ideal solution,” McDonald said.

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This is the crux of the problem, she said, and where so-called “design seeds” are planted.

“The design seeds lay the groundwork in a very specific fashion. Journey mapping and process tracing figure out the problem, in our case, vulnerabilities, and then the design seeds are the first-stage of the solution,” McDonald said. “It’s very user-focused, learning directly from those who are on the frontlines of the work, and making sure that the problem is specified in a way that allows for the developments of solutions that can scale more flexibly during implementation.”

The team identified 45 vulnerabilities within San Francisco’s publicly funded health clinics.

“Repeatedly, we heard that clinicians worry about properly tracking these patients, and are troubled by the significant personnel time required in carrying out patient-level monitoring activities without tools and organization approaches for population-level monitoring,” they wrote.

But even then, the team did not jump straight to solutions. That’s the next step.

The team will launch a pilot project to test possible solutions that will grow from the design seeds, such as whether new digital technology, workflow arrangements, and structured data collection could help find those patients lost in the cracks of an overloaded system.

“Such focused and potentially scalable work is particularly needed for patients who may be lost to follow-up in systems that are stretched for dollars and time,” the authors concluded. “Providers will often create informal workarounds in response to the lack of comprehensive and coordinated record-keeping systems, which can result in errors as well as redundant efforts.”

The ASCENT team is already implementing a monitoring solution informed by the journey mapping activities, in subspecialty care clinics at Zuckerberg San Francisco General, by testing technical and workflow models.

“We determined the need for a registry for high-risk patients in the otolaryngology clinic to help us monitor the entire process,” said Sarkar, a primary care physician and head of the ASCENT lab at UCSF. “This means the final diagnosis, workup and treatment planning, the actual treatment itself and then surveillance and follow-up.”

Siegfried S. Hecker wrote the following essay for Politico Magazine on the subject of the Trump administration's approach to North Korea:

Now that the nuclear crisis on the Korean Peninsula has been at least temporarily defused thanks to Kim Jong Un’s announcement that he would wait and see before launching missiles toward Guam—despite ominous North Korean propaganda as the U.S. and South Korea launch their latest joint military exercises—it’s time to step back and ask ourselves the big questions about just how useful our approach to North Korea’s nuclear program has been so far. 

My answer: Not very useful at all. During the past 15 years, North Korea first built the bomb and then expanded it to a nuclear arsenal that threatens the region, while Washington has continued to deny reality with its call for complete denuclearization. Which is why it’s time to take a long and serious look at the next option: talking with North Korea.

Although a Wall Street Journal op-ed by Secretaries Jim Mattis and Rex Tillerson earlier this month served to lower tensions by stating that the United States was still pursuing peaceful denuclearization, it does not introduce any new elements that could bring the two sides closer to ending the nuclear crisis. The op-ed, which reassured Kim that “the U.S. has no interest in regime change or accelerated reunification of Korea,” is a welcome relief from Mr. Trump’s “fire and fury” warning to Kim. But this approach is likely to fare no better in compelling Pyongyang give up its nuclear weapons than the Obama administration’s “strategic patience.”

So—how can we make real progress?

Washington should drop its preoccupation with North Korea’s intercontinental ballistic missile (ICBM) threat. It is misplaced and dangerous. Instead, Trump administration officials should talk with Pyongyang, face to face, without any preconditions, to avert what I consider the greatest North Korean nuclear threat—that of stumbling into an inadvertent nuclear war on the Korean Peninsula, which may lead to hundreds of thousands deaths including thousands of American citizens.

It’s important to understand why Kim is so obsessed with these weapons: to deter the United States from attacking North Korea and what Pyongyang calls “hostile policies.” Striking the U.S. with a nuclear-tipped missile would be suicide, and there’s no evidence that Kim is suicidal.

What’s more, there’s a lot to indicate that North Korea isn’t close enough to developing ICBM-capable missiles to strike the United States even if it wanted to. The panic over North Korea’s missiles was elevated recently when leaked classified U.S. intelligence estimates were reported to indicate that Pyongyang has already achieved such capabilities, in addition to possessing as many as 60 nuclear weapons in its arsenal. But I don’t concur with those estimates.

Based on my 50 years of experience with nuclear technologies and nuclear weapons, combined with what I saw and learned during my seven visits to North Korea beginning in 2004, I don’t believe Pyongyang has yet mastered the key elements of delivering a nuclear-tipped ICBM to the continental United States. Although North Korea demonstrated significant progress in the missile field with two launches in July, experts have raised serious questions about whether it has demonstrated all the missile and re-entry vehicle technologies that will protect the nuclear warheads during the fiery plunge into the Earth’s atmosphere.

Moreover, the nuclear warhead that must be mounted on the missile is the least developed and least tested part of North Korea’s nuclear ICBM ambitions. It must survive the extreme temperatures and mechanical stresses involved during launch, flight and re-entry into the atmosphere. It must detonate above the target by design, not accidentally explode on launch or burn up during reentry. More missile tests are needed that mirror real ICBM conditions to permit measurements that more accurately define the extreme conditions that the delicate materials such as plutonium, highly enriched uranium and chemical high explosives experience inside the warheads. It is much simpler to detonate a nuclear device in an underground tunnel under controlled conditions than to simulate all of the conditions a warhead experiences on the way to its target. 

What makes matters even more challenging for Pyongyang is that it has very little plutonium and highly enriched uranium. I have estimated that North Korea has 20 to 40 kilograms plutonium and 200 to 450 kilograms highly enriched uranium. My analysis is based on what I saw during my visits to the Yongbyon nuclear complex and on extensive discussions with their nuclear experts. These stocks have to serve multiple uses: They must be shared between experiments required to understand the world’s most complex elements, nuclear tests to certify the design of the weapons and stock for the arsenal. My best estimate, albeit with considerable uncertainty, is that the North’s combined inventories of plutonium and highly enriched uranium suffice for perhaps 20 to 25 nuclear weapons, not the 60 reported in the leaked intelligence estimate.

North Korea will need a few more nuclear tests because its experience with either material, plutonium or highly enriched uranium, for warheads is too limited for ICBM use. Nuclear test site preparations appear complete, but Pyongyang is most likely weighing the technical benefits against the political risks of conducting such tests. Whereas I believe North Korea has insufficient test data for ICBM warheads, we must assume it has already learned enough to mount a warhead on its shorter-range missiles that can reach all of South Korea and Japan because these missiles are able to accommodate bigger nuclear warheads and these would experience less stringent operational conditions.

In other words, the North still has a ways to go to pose a serious ICBM threat, but it is clearly working in that direction. The danger is that in his drive to achieve a greater balance with the United States by perfecting a missile capable of delivering a nuclear weapon to the continental U.S., Kim could miscalculate where Trump’s red line actually is, triggering a retaliatory action by Trump that could escalate to a nuclear war on the Korean Peninsula. Our problem is that we know nothing about Kim and the military leaders who control his nuclear arsenal and drive the missile and nuclear development programs. It’s time to talk and find out.

And we have to talk now, without demanding that North Korea agree to any preconditions, such as those suggested by Mattis and Tillerson – namely, an immediate cessation of its provocative threats, nuclear tests, missile launches and other weapons tests. Pyongyang is not about to make unilateral concessions before talks. One should read Kim’s announcement that he will wait with the missile launches as a positive signal, although he added that the U.S. must stop its “arrogant provocations.”

The diplomatic opening created last week on both sides makes such talks possible. President Trump should send a small team of senior military and diplomatic leaders to talk to Pyongyang. These talks would not be negotiations—not yet. Importantly, these talks would not be a reward or a concession to Pyongyang and should not be construed as signaling acceptance of a nuclear-armed North Korea. Talking would, however, be a necessary step toward re-establishing critical links of communication to avoid a nuclear catastrophe. The dialogue should stress the need for mechanisms to avoid misunderstanding, miscalculation or misinterpretation of actions that could quickly bring us over the cliff into a nuclear war.

The talks would provide an opportunity to convey Secretary Tillerson’s message that Washington does not seek regime change face to face in Pyongyang. In simplest terms, the team could underline the message that Washington is deterred from attacking the North, but not from defending the United States and its allies. It should reiterate that any attack on South Korea or Japan, be it with conventional, chemical or nuclear weapons, would bring a devastating retaliatory response upon North Korea.

The team can also impress upon Pyongyang that ensuring the safety and security of nuclear weapons is an awesome responsibility. These two issues are becoming more challenging as North Korea strives to make its nuclear arsenal more combat-ready. A nuclear-weapon accident in the North would be disastrous, as would a struggle to control the North’s nuclear weapons in the case of attempted regime change from within or without. All indications are that such talks would be strongly supported by the North’s two most important neighbors, South Korea and China, particularly if Washington consults them before.

For too long, America’s policy toward North Korea has been based on impractical goals. Complete, verifiable and irreversible denuclearization was a hallmark of the George W. Bush administration’s approach to North Korea and was also pursued by the Obama administration. Whereas complete and verifiable denuclearization might be realistic long-term goals, irreversible is impossible short of the total loss of human memory. The U.S. Manhattan Project produced the bomb in 27 months more than 70 years ago, and that was without knowing with certainty at the outset that it was even possible.

It was under Bush that North Korea first built the bomb and under Obama that it expanded to a threatening nuclear arsenal. Both presidents failed to address the root cause of Pyongyang’s determined effort to build a nuclear weapons arsenal—assuring the Kim regime’s security. Now, Trump faces a North Korea with the ability to inflict unacceptable damage to U.S. allies and U.S. assets in the region, while it also continues its drive to threaten the continental U.S. Perhaps, much as Dwight Eisenhower talked to Nikita Khrushchev, Richard Nixon to China’s Mao Zedong, and Ronald Reagan to Mikhail Gorbachev, Trump can take the next step with North Korea, and talk now to avert a nuclear catastrophe.

Rod Ewing will serve as co-director of the sciences for Stanford’s Center for International Security and Cooperation.

Ewing, a mineralogist and materials scientist, is the Frank Stanton Professor in Nuclear Security at CISAC and senior fellow at the Freeman Spogli Institute for International Studies. He begins his new position on Sept. 1, following David Relman, the previous co-director for the sciences. Amy Zegart is the CISAC co-director for the social sciences.

Ewing, whose research is focused on the properties of nuclear materials, leads the Reset Nuclear Waste Policy program at CISAC. He describes the center as a unique organization that “explicitly acknowledges” the role of science and the social sciences in formulating policy. 

“CISAC is a rare opportunity for political and social scientists, historians and scientists and engineers to work together on solving pressing problems. The fact that we have two co-directors reflects a serious intent to integrate knowledge from the widest range of perspectives in order to find policy solutions to important problems,” he said.

Scholarship, research

Ewing is the author or co-author of more than 750 research publications and the editor or co-editor of 18 monographs, proceedings volumes or special issues of journals. He has published widely in mineralogy, geochemistry, materials science, nuclear materials, physics and chemistry in more than 100 different journals. Ewing was granted a patent for the development of a highly durable material for the immobilization of excess weapons plutonium. He is also a founding editor of the magazine, Elements. In 2015, he won the Roebling Medal, the highest award of the Mineralogical Society of America for scientific eminence.

“My work on nuclear waste started out with a focus on technical issues, but over several decades, I realized that technical solutions were not enough.  I now focus on trying to understand why institutions – universities, national laboratories and federal agencies – fail to arrive at the technical solutions. I have been surprised to learn how little science has been applied to the nuclear waste problem – and how social issues have dominated the outcome,” Ewing said.

Expertise, policy

In particular, Ewing seeks to understand why so little information from experts rise through an organization and change accepted ‘truths.’

“I first saw this when I was a soldier in Vietnam and continue to see the same problem in many other areas, that a disconnect exists between the on-the-ground reality and policy,” said Ewing who served in the U.S. Army as an interpreter of Vietnamese attached to the 25th Infantry Division from 1969 to 1970.

“At the very highest levels, policies seem to be based on a hunch or a bias rather than an analysis of the problem. I have always wondered why this is so common – as it often leads a country or organization down a wrong and often dangerous path,” he added.

Born in Abilene, Texas, Ewing attended Texas Christian University (B.S., 1968, summa cum laude) and graduate school at Stanford University (M.S., 1972; Ph.D., 1974). He began his academic career as an assistant professor at the University of New Mexico (1974) rising to the rank of Regents’ Professor of Earth & Planetary Sciences in 1993.

From 1997 to 2013, Ewing was a professor at the University of Michigan, and in 2014, he joined Stanford.

MEDIA CONTACTS:

Rod Ewing, Center for International Security and Cooperation: (650) 725-8641, rewing1@stanford.edu

Clifton B. Parker, Center for International Security and Cooperation: (650) 725-6488, cbparker@stanford.edu