There is plenty of research on how the rapid warming of the planet is going to have growing adverse impacts on global economies, health, food supplies and natural disasters.

A new study now suggests that as temperatures continue to rise — particularly with more and more 90-plus-degree days — more fetuses and infants will experience economic loss by age 30.

“There is a growing body of evidence that finds that shocks to the fetus and young child — whether nutritional, environmental, economic or stress-related — have long-term consequences on health, education and economic outcomes throughout the life cycle,” said Maya Rossin-Slater, an assistant professor of health research and policy at Stanford Medicine and a faculty fellow at the Stanford Institute for Economic Policy Research.

Rossin-Slater published her study Dec. 4 in the Proceedings of the National Academy of Sciences, indicating early-life exposure to extreme temperatures is linked to potential losses in human capital. Her co-authors are Adam Isen, an economist with the U.S. Department of Treasury, and Reed Walker, an assistant professor at University of California, Berkeley.

The researchers used data from the U.S. Census Bureau’s Longitudinal Employer Household Dynamic Files, which contain information on adult labor market outcomes linked to county and exact date of birth. They looked at weather in counties in 24 states on any given day, and then measured how many days with average temperatures above 90 degrees a child born on that day in that county would have experienced during gestation and during the first year of life. They then compared the earnings of individuals who were exposed to different numbers of such hot days, but who were of the same race and gender, and born in the same county and on the same day of the year (but in different years).

Each day a fetus or infant experiences 90-plus-degree temperatures, Rossin-Slater and her co-authors found that he made $30 less a year on average, or $430 over the course of his lifetime. While that may not seem like a huge loss of income, the authors point out that their study is best understood from a population-level perspective rather than from an individual one.

“There is a lot of research already showing that extreme heat has immediate effects on labor market productivity and GDP,” she said. “What we are saying is that there is another wrinkle to this — that there can be consequences many years later, on cohorts who are still in the womb.”

Most Americans today only experience one day a year that is 90 degrees or hotter. But the Climate Impact Lab has indicated that if countries continue to take only moderate action on climate change, by the end of this century there will be about 43 such days a year.

So, if you multiple a $30 annual loss a day by 43 days, you come up with an average $1,290 a year — and compounded in large populations of pregnant women in hot climates.

“Prior research shows that exposure to extreme heat in utero leads to lower birth weight and increases infant mortality,” said Rossin-Slater, who is also a core faculty member at Stanford Health Policy. She said poor fetal and infant health could impact adult earnings in three ways: cognitive impairment, poor health that causes people to miss school or work, and less non-cognitive skill development such as self-control.

“With regard to exposure to heat specifically, fetuses and infants are especially sensitive because their thermoregulatory systems are not fully developed and they have less capacity to self-regulate when their bodies are exposed to extreme temperatures,” Rossin-Slater said.

Hot Zones and Air Conditioners

The obvious questions that arise from such research: What happens to the babies of women who already live in very high temperatures? And why not just ensure that all pregnant women have air conditioners, at least in the developed world where it would be more affordable?

Women in warm zones such as parts of Africa and South Asia, as well as U.S. cities like Phoenix and Washington, D.C., shouldn’t worry too much. The loss of income is relatively little and people living in hot climates may actually adapt over time to exposure to extreme heat.

“Our study is not saying that individual people should be doing something differently to avoid exposure to extreme heat,” Rossin-Slater said. “Instead, we think we are providing additional evidence for the possible population-level consequences of climate change and the projected increase in the number of days with extreme temperatures.”

And what about those air conditioners? The cohorts in the study are actually born in the 1970s, during a period of rapid expansion in air conditioning across American households. The researchers found the earning losses went away in areas where most people got air conditioners installed.

“If we think that there is something biological going on as a result of the fetus being overheated, then it makes sense that AC, which prevents the overheating, can mitigate this negative effect,” Rossin-Slater said.

But it’s important to recognize, she said, that air conditioners come with costs, both financial from the perspective of individuals and households who can and can’t afford such systems, and environmental from the perspective of the country or planet as a whole.

“So this is not a `free’ solution and any cost-benefit calculations related to climate change should take into account this adaption response,” Rossin-Slater said. “But we ought to think about what these results imply at the global level — in many countries that are much hotter than the United States and still don’t have AC. So if we are trying to understand global inequality and the impacts of climate change on developing countries, our results suggest that climate change could play a role in perpetuating global inequality across generations.”

CVS Health announced it would buy Aetna, the country’s third-largest health insurance company for $69 billion, a deal that could revamp the nation’s health-care industry and impact millions of consumers who are always on the lookout for better delivery and costs.

The merger, which must still undergo an antitrust review by the government, could impact the cost of drugs and the way patients visit health-care providers.

“This combination brings together the expertise of two great companies to remake the consumer health-care experience,” CVS Health President and CEO Larry J. Merlo said in a statement on Dec. 3. “With the analytics of Aetna and CVS Health’s human touch, we will create a health-care platform built around individuals.” 

Merlo said that by using CVS’s 10,000 pharmacy locations around the country, they would make health care more affordable and accessible.

We asked Stanford Health Policy’s Laurence Baker, chair of Stanford Medicine’s Department of Health Research and Policy and an expert on health-care delivery and costs, several questions about the potential merger.

Q. Could this lead to lower drug prices for the consumer?

Baker: One of the hoped-for effects is that a combined Aetna-CVS would be better able to negotiate favorable prices for prescription drugs. It is possible I suppose, since together they would have a considerable amount of information and strengthened incentives to control costs. In a model where a pharmacy benefit manager, like CVS, did most of the negotiating with the pharmaceutical companies, and insurers like Aetna separately paid the costs, there might be less ability and incentive to negotiate for favorable prices than if the two do merge. 

At the same time, there is no guarantee that there will be savings and if there are it is not clear that they would be very large. CVS and others have been negotiating for drug prices already, and the advantages conveyed by the merger need not be that big.  I can only imagine that if there were lots of low-hanging fruit Aetna and CVS, and others, would already have had some good opportunities to pursue changes. 

One place where a combined Aetna-CVS could make a difference would be in working with doctors and patients, doing more to promote the use of better or higher-value drugs. A merged entity might be more effective at getting patients to use appropriate generics rather than expensive branded drugs, for example.  This effect could be even stronger if a merged company were to be successful in their announced plan to do more to integrate physicians and other health-care providers with CVS pharmacies.

Q: If there were savings, would consumers see them?

Baker: If a combined Aetna-CVS were to negotiate better drug prices, whether or not those are passed on to consumers or just retained by the company depends on things like the degree of competition in the insurance marketplace. If the company could benefit from lowering prices for, say, Aetna insurance policies because of the lower drug prices, at least some of the savings could be passed on to consumers. But we often worry that many insurance markets are not competitive enough, so it would remain to be seen whether consumers would see the benefits or not.

The effects of stronger efforts to move patients toward higher-value or lower-cost drugs also might or might not flow through directly to patients. Overall savings may or may not be passed on, but it is possible that some patients would see changes in their copayments that could be beneficial.

Q: Could the potential merger lead to new and improved methods of delivering care?

Baker: Leaders of CVS and Aetna talked about the potential for building new and improved methods for health care delivery, including having more care delivered through clinics associated with CVS stores. These are intriguing ideas, consistent with many discussions going on about the next generation of health-care delivery. It isn’t entirely clear why a merger is needed to develop this, nor is it clear that it would lead to widespread improvements in health care, but innovation in this area doesn’t seem likely to do harm either and would probably benefit some people.

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Q:  Would this result in reduced consumer choice of health care provider?

Baker: It does stand to reason that a merged Aetna-CVS might prefer that people with Aetna insurance use CVS rather than other competitors. They might develop restrictions or incentives that would steer their customers in this direction, and that could certainly be a concern for some people. This gets at a larger question facing the health-care system these days. It may be that the formation of more integrated care networks, with less provider choice overall, but with providers that are carefully chosen and better at working together, offers opportunities to improve care and lower costs.  This could have advantages, but would also come with tradeoffs for choice.

Q: Would a merger lead to a company that is “too big” with too much power?

Baker: One thing analysts have worried about lately is the amount of consolidation in the health-care marketplace. This would be another example of that, combining two already large players. Sometimes people argue that bigger can be better if it helps align the activities of different players in ways that could push us toward lower costs or improve quality. Often enough, however, we have seen consolidation lead to higher prices without seeing improved quality. This particular type of merger — combining a health insurer with a health care provider — is a bit less common than the consolidation we’ve most commonly seen such as hospitals merging and has some different features, so the overall effects will be something analysts will want to keep an eye on.

The high cost of prescription drugs in the United States came under scrutiny in a new report from the National Academies of Sciences, Engineering, and Medicine, “Making Medicines Affordable: A National Imperative,” co-authored by Stanford Law Professor Michelle Mello, who is also a professor of health policy and a core faculty member at Stanford Health Policy. Published on November 30, the report aims to increase both affordability and accessibility to crucial—often lifesaving—drugs for Americans, with recommendations such as better government negotiated prices, quicker turnaround for generic drugs, and increased financial transparency for biopharmaceutical companies.

In the discussion that follows, Mello explains some of the key challenges facing Americans in need of prescription drugs and key recommendations in the report.

You note in the report that Americans are paying significantly more for their healthcare but are significantly less healthy when compared to developed countries. Do we also pay more for prescription drugs?

Yes. In fact, many countries use “reference pricing” schemes, through which the price that their national health programs pay for prescription drugs is actually calculated as a percentage of what we pay!  One of the ethical issues that weighed on the Committee as we deliberated was that interventions that tamp down prices in the U.S. could have ripple effects in other, less wealthy countries if drug makers seek to recoup their losses by giving fewer price concessions elsewhere.

What is the most important factor leading to higher prescription drug costs in the U.S.? 

The old adage that “every system is perfectly designed to get the result it gets” really came to mind as we investigated why drugs cost so much.  It’s not just one factor, but a whole ecosystem in which multiple actors and factors are contributing.  At the root of it, though, is that there are distortions in the market for drugs that permit things to happen that wouldn’t occur in a truly competitive market.

Which of the 27 action points recommended in the report stand out to you as a priority—and achievable? 

We view our recommendations as a package that should be implemented together, but there are three that we think are especially promising. First, the federal government should directly negotiate drug prices on behalf of all federal programs (and any state programs that want to join in). To create leverage in these negotiations, federal programs should have the flexibility to exclude certain drugs, such as when less costly drugs provide similar clinical benefit.  Second, to improve transparency about where the money is going and where opportunities exist to recapture some of it, biopharmaceutical companies and insurance plans should make public information about the net prices they receive and pay for drugs, including discounts and rebates. Third, insurance plans—especially Medicare plans— should provide better protection against out-of-pocket drug costs. There should be limits on total out-of-pocket costs, and patients’ deductibles and coinsurance payments should be based on the net price of the drug, not the list price.

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A number of the recommendations seem quite procedural, such as eliminating misapplication of funds and inefficiencies in federal discount programs, ensuring financial incentives are not extended to widely sold drugs, and increasing information sharing about reimbursement incentives. Is part of the high cost we pay due to bureaucracy and inefficiency?  

We identified ways in which federal programs are being misused, to the detriment of consumers. One example is what is known as the “340B program,” which was intended to ensure that hospitals and other facilities that serve low-income populations receive deep discounts on drug prices, but is being used by a broad range of facilities that don’t necessarily pass those savings on to patients. Another example is the orphan drug program, which provides very valuable financial incentives for manufacturers to develop drugs for rare diseases.  Companies have obtained these rewards even when they also sell their drug for other indications for which there is a huge market, and in some cases have gotten the rewards multiple times for the same drug.  These problems aren’t about bureaucracy, they’re about gaming the system.  These programs were good ideas that have been very successful in achieving their goals, but have had unintended effects that need to be addressed.

Biopharmaceutical companies have gotten a bad rap in the press, but you note that the cost of developing drugs is very high, and success rates low, with 9 out of 10 investigational products never making it to market. So there is an acknowledgment of the high stakes, high-cost nature of the sector. The report recommends accelerating market entry and use of generic and biosimilar drugs. How can this be implemented without discouraging development of new drugs?

Ensuring affordability of drugs while not discouraging innovation is the central tension that our committee had to grapple with. It’s not easy.  The recommendations in the report strike a balance between these two important objectives.  With regard to generics, our patent system creates a workable deal with drug innovators: create a useful new product, and we’ll give you a period of market exclusivity; generics can’t enter until after that period is up. One problem that our report addresses, though, is that companies have developed ways to extend that period of exclusivity. One is to pay generic companies to delay market entry. Another is to seek follow-on patents on incremental changes to their drug. For example, one company got a new patent by demonstrating their drug could be administered by crushing it up and mixing it with applesauce. The use of this tactic, called “evergreening”, should be curbed.

One recommendation in the report is that the federal government consolidate and apply its purchasing power to directly negotiate prices with the producers and suppliers of medicine, and strengthen formulary design and management. Do government-sponsored medical plans, such as Medicaid and Medicare, already do this? 

By law, the federal agency that runs these programs isn’t allowed to negotiate directly for drug prices for Medicare patients. Instead, all the individual, private plans that provide drug coverage under Medicare Part D do the negotiating. They get discounts, but we think the discounts would be deeper if the bargaining was consolidated in one mighty purchaser.

You noted that private investment is increasingly important to drug development. How much of drug development is supported by public funding, via grants to universities, etc., that then go on to become small startups with private investment? If it is significant, does the public get a good deal on its seed investments?

American taxpayers foot the lion’s share of the bill for the basic-science research that generates information about which molecules are promising to pursue. Private companies pay most of the development costs—that is, testing the molecule in clinical trials to see if it’s safe and effective. The public has gotten a great return on investment in the sense that the industry, particularly in the last decade or so, has been turning out a lot of very innovative, useful products. The work that remains to be done is ensuring that those products are financially accessible to everyone who needs them.

One recommendation is that biopharmaceutical companies and insurance plans disclose net prices received and paid, including all discounts and rebates, at a National Drug Code level. Would this cover all international transactions too, so that we could see costs/prices in other countries? 

No, our recommendation relates to the drug supply chain in the U.S., which is highly complex and highly opaque.

Can you talk about this a bit—why this transparency is important?

One of the things that was frustrating about studying drug affordability is that the various players in our system—such as drug manufacturers, health insurance plans, and intermediary organizations called pharmacy benefit managers, or PBMs—all point fingers at one another when you ask them who is responsible for consumers’ high drug costs.  Yet, there’s very little information available by which to assess their claims. Is the problem that drug makers launch their products at excessive list prices? Or that PBMs buy them at a discounted price, which is kept confidential, and don’t pass those savings along to health plans? Or that health plans get drugs at a deep discount but make subscribers pay cost-sharing (for example, the 20% coinsurance you pay at the pharmacy) as though the drug’s cost was the list price?  Nobody will cough up the data necessary to make these judgments.  Our recommendation addresses that problem.

Are there any next steps for you and the authors of this report? Will there be subsequent research by the group—or coordination with policy makers?

We are working hard to make sure policy makers, journalists, and key stakeholders understand our recommendations and the evidence behind them.  This week, for example, our report was presented to a packed room of Senate staffers.  We have also identified some areas where additional research is needed, and hope that research sponsors will respond to that need.  There is a lot of work to be done.

Paul Wise watched as children ran around a playground attached to a health clinic at a displaced persons camp on the outskirts of Mosul — the northern city in Iraq once controlled by the Islamic State but now back in the hands of the Iraqi government.

The children had survived the Battle of Mosul, which had fallen to ISIS in 2014 but was retaken by the government forces and allied militias during a nine-month military campaign that ended in July. Many of the children suffer from physical and mental wounds and Wise wondered how they would recover with so little medical infrastructure.

Wise was part of a small delegation of physician-academics asked to evaluate a World Health Organization-led system to treat civilians injured in the Mosul fighting. Wise and his colleagues recently slipped into Mosul to visit field hospitals, review health care on the ground and determine whether there is a better way to distribute medical aid during armed conflict.

The visit left the Stanford Medicine professor of pediatrics and senior fellow at the Freeman Spogli Institute for International Studies with questions about health care, humanitarian ethics, and conduct of war: Are there better ways to deliver emergency medical care during the height of battle? How do relief workers maintain neutrality when embedded with government security forces? Has the system of financing humanitarian interventions — one that was essentially created during the Cold War — become dangerously outdated?

Answering these questions is the mission of a new health-and-security initiative at Stanford led by Wise, a core faculty member at Stanford Health Policy who has spent 40 years working to improve the health of children impacted by conflict. Much of his work has been in Guatemala through his Children in Crisis project, the first university-based program to address the needs of children in areas of unstable governance and civil war.

“In talking with the groups that are running these humanitarian efforts in Mosul, there was this uneasiness, this kind of disorientation with the way things are now,” said Wise. “It was a kind of recognition that humanitarian norms are changing, the health personnel and facilities are at greater risk; the financial gap between humanitarian need and humanitarian capability is growing; and the old way of financing humanitarian intervention is inadequate, archaic.”

An Interdisciplinary Approach

Wise believes academics are well suited to help resolve these humanitarian conundrums.

“So we are going to move ahead and try to bring all the players together to reconsider this global challenge. Here at Stanford, we have the capacity to draw upon remarkable resources,” he said.

The new biosecurity initiative led by Stanford Medicine physician and FSI senior fellow, David Relman, together with world-renowned political scientists, security specialists, computer scientists and health policy experts will “attempt to craft new strategies for the provision of critical services to populations affected by conflict and political stability.”

The initiative will collaborate with other institutions such as Johns Hopkins, UCSF, Harvard, and the American Academy of Arts and Sciences. It will also seek the engagement of partners committed to providing humanitarian services, including WHO, the U.N. High Commissioner for Refugees, Doctors Without Borders and the International Committee of the Red Cross.

“The voice of communities impacted by war should also be an essential element in this ambitious effort,” Wise said. “To break new ground, we’re going to have to do things differently; the health strategies need to take into consideration fundamental understanding of the political dynamics. But we have a special opportunity here at Stanford because we take an interdisciplinary approach.”

Children of War

Most of the children Wise saw will never be the same, he said, nor the humanitarian workers who risked their lives to treat them, their families, and fighters from all sides of the battle to oust the Islamic extremists from the city on the Tigris River.

“I look at these little kids with horrendous emotional trauma and PTSD, and I think to myself, it’s the collision of all these questions playing out within a 50-square-meter little playground,” he said. “It’s these broader, strategic and ethical questions that are really profound. And as a pediatrician who is dedicating the last phase of my career to these questions of security and the political dimensions — I have to engage on all of these levels. That’s not easy.”

Wise traveled with WHO officials, as well as Paul Spiegel, a physician who leads the Center for Humanitarian Health at Johns Hopkins Bloomberg School of Public Health; Adam Kushner, a trauma surgeon affiliated with Johns Hopkins; and Kent Garber, a surgical resident at UCLA and research associate at Johns Hopkins.

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Spiegel also believes academics are uniquely positioned to help assess the current system of responding to medical crises during conflict.

“I believe that we can bring objectivity and rigor to analyzing and evaluating important and innovative responses, such as the trauma response by WHO and others in Mosul,” Spiegel said. “Humanitarian organizations are often busy responding quickly to rapidly changing situations; they don’t always have the luxury of time to do what academic humanitarians can do.”

Making the two-hour drive from Erbil to Mosul in armored, bulletproof SUVs provided by the United Nations, they slipped into field hospitals to meet with Iraqi physicians and medical teams with the humanitarian agencies.

Wise, who was able to take a few photos and video on his smartphone, described the devastation on the ground, noting that not since the siege of Leningrad has a city of this size experienced such street-by-street fighting. In large parts of the city, virtually every building was bombed or bulleted. It will take years to clear the rubble and rebuild.

“It’s just a remarkable story of tragedy and resilience,” he said.

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Since the city was not long ago controlled by ISIS, the field hospitals are still surrounded by massive concrete barricades and tactical trucks stationed outside with mounted machine guns.

The team found that at the height of the battle for Mosul, there was tremendous pressure to treat injured civilians and discharge patients very quickly, due to the lack of medical infrastructure and personnel and the continuous wave of new injuries coming in.

“The charge for us was to evaluate the system and how well it worked, what ways could it be improved, how many lives that it saved,” Wise said. “One of the concerns, for example, was that in order to put in medical people that close to the frontline, you have to give them some kind of security. This raised issues among the humanitarians about their need for independence and neutrality, since you’re essentially embedding them with Iraqi security forces.”

Epidemiology and Ethics

“We are looking at the technical issues and the epidemiologic issues, but also dealing with the ethical issues and their implications,” he said.

They intend to write an internal report and then publish their findings in a major medical journal, to get the word out about the issue and gain support for ongoing collaborative work. They’re looking to partners like the American Academy of Arts and Sciences, which recently devoted an entire issue of its journal, Daedalus, to the factors and influences of contemporary civil war. One of the essays in that issue by Wise and his Stanford colleague, Dr. Michele Barry, who directs the Center for Innovation in Global Health, talks about the threat of a global pandemic as a potential byproduct of the 30 ongoing civil wars around the world.

“We’re trying to get the report completed quickly because the model of trauma care for civilians in Mosul is a new model and could be implemented in other combat areas, like the fighting in Syria and other places in Iraq,” Wise said.

Wise worries some see Stanford University as an insulated Silicon Valley institution in a beautiful setting and not always engaged in the real world.

“Well, this is about as engaged in the real world as you can get — this is Stanford moving and doing things out there, not just sitting around in seminar rooms. Sometimes you need to get close to the front lines to save lives,” he said.

When asked what surprised him during this trip to Mosul, Wise smiled.

“I’m sort of old and I’ve seen a lot of the world and not a lot surprises me anymore,” he said. “But it was a reminder of how desperate are the lives of millions of people — that we could do so much more. It’s a reminder of just how fragile physical security really is in this world."

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Maya Rossin-Slater uses her PhD in economics to analyze large-scale data on population health and socioeconomic outcomes to help inform policies targeting families with children, especially those who are disadvantaged or poor.

Rossin-Slater, an assistant professor at the Department of Health Research and Policy at Stanford Medicine, is the newest core faculty member at Stanford Health Policy. Prior to coming to Stanford this summer, she was an assistant professor of economics at the University of California, Santa Barbara for four years after receiving her PhD at Columbia University. Her research centers on public policies and their impacts on the health and well-being of families.She asks complex questions, often finding the answers in large administrative databases. Specializing in using “natural experiment” methods, Rossin-Slater tries to separate causation from correlation.

How do child-support mandates impact the relationship between parents and children? Does high-quality preschool compensate for early life health disadvantages? What are the long-term impacts of early childhood exposure to air pollution once they become adults?

“To me, it’s important to do this kind of research that can inform real-world policies, particularly for less advantaged families,” said Rossin-Slater, who is also a faculty fellow at the Stanford Institute for Economic and Policy Research (SIEPR) and a faculty research fellow at the National Bureau of Economic Research.

“We live in a world with limited resources and we need to understand how to best allocate them,” she said. “So I think there is value in providing rigorous causal evidence on the effectiveness of various tools and policies that impact the less advantaged so that we can get the highest return on public spending as well as the highest potential for improving the outcomes of those at the very bottom.”

In a paper published in the Journal of Public Economics, Rossin-Slater talks about the growing body of evidence that suggests in-utero conditions and health at birth make a difference in later-life well-being. She found that the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) is one of the most cost-effective and successful programs to improve health at birth for children of disadvantaged mothers.

“The estimated effects are the strongest for mothers with a high school education or less, who are most likely eligible for WIC services,” she wrote in the paper, which was cited by the White House blog under President Barack Obama.

Paid Family Leave

When Mark Zuckerberg announced he would take a two-month paternity leave when his daughter was born in 2015, the Facebook co-founder was taking advantage of his own company’s policy, which grants employees up to four months leave for all new parents.

“Studies show that when working parents take time to be with their newborns, outcomes are better for the children and families,” Zuckerberg wrote on his Facebook page.

This prompted many media outlets to turn to a co-authored study with Rossin-Slater, which found that 46 percent more men have taken time off to help take care of their newborns since California made paid family leave (PFL) law in 2004.

“The increase in paternal leave-taking may also have important implications for addressing the gender wage gap,” the authors wrote. “Our results suggest that a gender-neutral PFL policy can increase the amount of time fathers of newborns spend at home—including the time they spend at home while the mothers work—and may therefore be seen as one way to promote gender equality.”

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Here at Stanford, Rossin-Slater is using databases in the United States, Denmark and Sweden to continue her research on public policies (including paid family leave), as well as looking at how prenatal and early childhood factors impact lifelong outcomes. Does inequality and the stress of poverty in pregnancy, for example, get transmitted across generations?

In a forthcoming paper in the American Economic Review Rossin-Slater and her co-author, Stanford economist Petra Persson, found that prenatal exposure to maternal stress due to deaths in the family could have lasting consequences for the mental health of the children.

They examined nearly 300,000 births in Sweden between 1973 and 2011, in which a relative of the mother died either before her due date or in her child’s first year of life. They found that children who were in the womb when a relative died were 25 percent more likely to take medication for ADHD than those who were infants when the relative died. And those children were 13 percent more likely to take prescription drugs for anxiety once they became adults.

Take those results and one can imagine that the stress of living in poverty during pregnancy might be compounded over generations in that same disadvantaged family.

“This would imply that policies aiming to alleviate stress associated with economic disadvantage may help break the cycle of poverty,” Rossin-Slater and Persson told The Washington Post for a story on their research.

In new projects, Rossin-Slater is now studying the effects of reforms in the WIC program in California on maternal and child health, as well as the impacts of paternity leave on maternal mental health and child outcomes in Sweden. She continues using research designs that pay careful attention to establishing causality and working with large administrative databases.

“I believe in and enjoy working with data because it provides an opportunity to learn about how real-world policies actually work,” she said. “I have the privilege of being able to set my own research questions and to use my economic training and newly available data to try to find at least some answers. My hope is that these answers can be useful for creating better and more effective policies.”

There are 30 civil wars underway around the globe, where civilians are dealing with death and destruction as well as public health emergencies exacerbated by the deadly march of conflict.

Yemen is battling an unprecedented cholera outbreak which has killed more than 2,150 people this year, with another 700,000 suspected cases of the water-borne disease. The government and a rival faction have been fighting for control of the country, taking 10,000 lives since 2015.

Some 17 children in Syria have been paralyzed from a confirmed polio outbreak in northeastern districts, with 48 cases reported in a country that had not had a case of polio since 1999. The cases are concentrated in areas controlled by opponents of President Bashar al-Assad.

And in the Democratic Republic of Congo — where the civil war officially ended years ago, but thousands of people still suffer from recurrent uprisings and scant infrastructure — a yellow fever outbreak was met last year with a lack of vaccines. The WHO was forced to give inoculations containing a fifth of the normal dose, providing protection for only one year.

And yet today, of the nearly 200 countries on this planet, only six nations — three rich ones and three poor ones — have taken steps to evaluate their ability to withstand a global pandemic.

“The bottom line is that despite the profound global threat of pandemics, there remains no global health mechanism to force parties to act in accordance with global health interests,” write FSI’s Paul Wise and Michele Barry in the Fall 2017 issue of Daedalus.

“There also persists inherent disincentives for countries to report an infectious outbreak early in its course,” the authors write. “The economic impact of such a report can be profound, particularly for countries heavily dependent upon tourism or international trade.”

China, for example, hesitated to report the SARS outbreak in 2002 for fear of instability during political transition and embarrassment over early mishandling of the outbreak. Reporting cases of the 2013 Ebola outbreak in West Africa were slow and the virus killed some 11,300 people in Sierra Leone, Guinea and Liberia before the epidemic was declared over in January 2016.

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“Tragic delays in raising the alarm about the Ebola outbreak in West Africa were laid at the doorstep of the affected national authorities and the regional WHO committees, which were highly concerned about the economic and social implications of reporting an outbreak,” Wise and Barry write in the journal published by the American Academy of Arts and Sciences.

The Daedalus issue, “Civil War & Global Disorder: Threats and Opportunity,” explores the

factors and influences of contemporary civil wars. The 12 essays look at the connection of intrastate strife and transnational terrorism, the limited ambitions of intervening powers, and the many direct and indirect consequences associated with weak states and civil wars.

“Wise and Barry, both medical doctors with extensive field experience in violence-prone developing countries, analyze the relationship between epidemics and intrastate warfare,” write FSI’s Karl Eikenberry and Stephen D. Krasner in their introduction to the issue that includes eight essays by Stanford University faculty.

“Their discussion is premised on the recognition that infectious pandemics can threaten the international order, and that state collapse and civil wars may elevate the risk that pandemics will break out,” they wrote.

Eikenberry and Krasner are hosting a panel discussion about the new volume of Daedalus with FSI senior scholars, including Wise and Barry, on Oct. 23. Members of the Stanford community and the public are invited and can RSVP here. Podcasts with the authors will also be available at FSI’s World Class site over the next few weeks.

Prevention, Detection and Response

Barry and Wise believe there is significant technical capacity to ensure that local infectious outbreaks are not transformed into global pandemics. But those outbreaks require some level of organized and effective governance — and political will.

Prevention, detection, and response are the keys to controlling the risk of a pandemic. Yet it’s almost impossible for these to coincide in areas of conflict.

Prevention includes solid immunization programs and efforts to reduce the risk of animal-to-human spillover associated with exposure to rodents, monkeys and bats.

Then, early detection of an infectious outbreak with pandemic potential is crucial, through a methodical surveillance structure to collect and test samples drawn from domestic and wild animals, a capacity sorely lacking in areas of conflict and weak governance.

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“Civil wars commonly disrupt traditional means of communication,” they write. “The Ebola virus outbreak in West Africa exposed glaring weaknesses in the global strategy to control pandemic outbreaks in areas with minimal public health capacity.”

New strategies that utilize satellite or other technology to link remote or insecure areas to surveillance are urgently needed, they said.

Then there is the response in countries where civil war not only makes it difficult, but politically treacherous.

In Syria, there had not been a case of polio reported since 1999. In 2013, health workers began to see children with the kind of paralysis that is associated with a highly contagious polio outbreak.

“However, the government and regional WHO office have been intensely criticized for their slow and uneven response,” the authors note, particularly the government’s resistance to mobilizing immunization efforts in areas sympathetic to opposition forces.

Pressure from international health organizations and neighbors in the region ultimately led to the reinstatement of vaccination campaigns throughout Syria.   

“The Syrian polio outbreak is an important reminder that health interventions, though technical in nature, can be transformed into political currency when certain conditions are met,” they write. “At the most basic level, the destruction or withholding of essential health capabilities can be used to coerce adversaries into political compliance, if not complete submission.”

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Strengthening Global Oversight

The only comprehensive global framework for pandemic detection and control, the authors write, is the International Health Regulations treaty, which was signed in 2005 by 196 member-nations of the World Health Organization to work together for global health security.

The IHR imposed a deadline of 2012 for all states to have in place the necessary capacities to detect, report and respond to local infectious outbreaks. But only a few parties have reported meeting these requirements, and one-third has not even begun the process. There have also been efforts to enhance state reporting of health systems capacities through voluntary assessments of countries working through the Global Health Security Agenda consortium.

But both frameworks, Barry said in an interview, need financial and political support.

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“I see a stronger IHR with more than words — but actual money behind it in order for it to become stronger,” said Barry, noting the Global Health Security Agenda ends in 2018 and she has been asked to sit on a NAAS task force to form its next iteration. “I’m hoping we can move the needle to put money into bio-surveillance and health security, especially in conflict areas.”

Why should Americans care?

“Pathogens know no borders,” Barry said. “And with climate change, we have tremendous movement of vectors; with globalization and billions of people routinely in flight, we have tremendous health threats traveling first class and coach.”

Twenty Countries at High Risk

Meanwhile, some 20 countries are at high risk for pandemic emergence. The two Stanford professors are urgently calling for “new approaches that better integrate the technical and political challenges inherent in preventing pandemics in areas of civil war.”

Wise and Barry note that human factors, such as the expansion of populations into previously forested areas, domesticated animal production practices, food shortages, and alterations in water usage and flows, have been the primary drivers of altered ecological relationships.

So globalization with climate change brews the perfect storm.

“There is substantial evidence that climate change is reshaping ecological interactions and vector prevalence adjacent to human populations,” they said. “Enhanced trade and air transportation have increased the risk that an outbreak will spread widely. While infectious outbreaks can be due to all forms of infectious agents, including bacteria, parasites, and fungi — viruses are of the greatest pandemic concern.”

Science suggests the greatest danger of pandemic lies in tropical and subtropical regions where human and animals are most likely to interact. Most of the estimated 400 emerging infectious diseases that have been identified since 1940 have been zoonoses, or infections that have been transmitted from animals to humans. The human immunodeficiency virus (HIV), for example, is believed to have emerged from a simian host in Central Africa.

Recent analyses have suggested that the “hotspots” for emerging infectious diseases overlap substantially with areas plagued by civil conflict and political instability. 

The U.S. Agency for International Development and the Centers for Disease Control and Prevention have been working on the Emerging Pandemic Threats Program to improve local pandemic detection and response capacities by directing resources and training to countries thought to be at high risk for pandemic. However, it is not clear that this and related programs are addressing the political dynamics at the local level that will determine the essential cooperation of local communities with any imposed global health security response.

“The unpredictability of a serious infectious outbreak, the speed with which it can disseminate, and the fears of domestic political audience can together create a powerful destabilizing force,” Wise and Barry write in their conclusion. “Current discussions regarding global health governance reform have largely been preoccupied by the performance and intricate bureaucratic interaction of global health agencies. However, what may prove far more critical may be the ability of global health governance structures to recognize and engage the complex, political realities on the ground in areas plagued by civil war.”

Sometimes a straightforward explanation and an apology for what went wrong in the hospital goes a long way toward preventing medical malpractice litigation and improving patient safety.

That’s what Michelle Mello, JD, PhD, and her colleagues found in a study published Oct. 2 in Health Affairs.

Mello, a professor of health research and policy and of law at Stanford University, is the lead author of the study. The senior author is Kenneth Sands, former senior vice president at Beth Israel Deaconess Medical Center.

Medical injuries are a leading cause of death in the United States. The lawsuits they spawn are also a major concern for physicians and health-care facilities. So hospital risk managers and liability insurers are experimenting with new approaches to resolving these disputes that channel them away from litigation.

The focus is on meeting patients’ needs without requiring them to sue. Hospitals disclose accidents to patients, investigate and explain why they occurred, apologize and, in cases in which the harm was due to a medical error, offer compensation and reassurance that steps will be taken to keep it from happening again.

Positive results

The study reports on the outcome of a so-called communication-and-resolution program at two large Massachusetts hospital systems. Mello and her co-authors found that the program not only yielded positive results in terms of liability costs but also led to significant patient safety improvements.

“In these programs, hospitals scrutinize every serious harm event to answer the question, ‘What can we learn?’” Mello said. “Traditionally, a risk manager’s focus has been on the patients who complain about the care or threaten to sue. But every patient deserves to know that what happened to them is being taken seriously.”

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Despite concerns that telling patients about errors and proactively offering compensation could cause liability costs to skyrocket, of the 989 adverse events reviewed for the study from 2013 to 2015, only 5 percent led to malpractice claims or lawsuits. And when the program did lead to compensation, the median payment was $75,000. By comparison, the median payment nationwide in 2015 when plaintiffs prevailed in malpractice lawsuits was about $225,000, Mello noted.

“Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively,” the authors wrote.

Pilot program

The authors focused on a program called CARe — Communication, Apology and Resolution — at six Massachusetts hospitals: Beth Israel Deaconess Medical Center and Baystate Medical Center, and two of each center’s community hospitals.

The hospitals demonstrated good adherence to the program protocol, the authors found. Physicians were supportive of the approach but did ask for better communication about the program and what was happening with their patients.

The low percentage of events that led to litigation should reassure hospitals concerned about the risks of being honest with patients, the authors wrote. A likely explanation, according to Mello, is that explaining why adverse events occurred defused patients’ anger. About three-quarters of the time, adverse events were not actually due to error, the study said. Rather, malpractice claims frequently arise when plaintiffs perceive that the health care providers communicated poorly or attempted to cover up negligence, the authors noted.

“Given the rarity with which communication-and-resolution events resulted in settlements, it is reasonable to wonder whether the programs are worth the time they require,” the authors wrote, “but risk managers in our study thought they were. By providing explanations and expressions of sympathy for harms not arising from negligence, communication-and-resolution programs may avert lawsuits springing from misunderstanding.”

Objectives and improved safety

The CARe objectives are to improve transparency surrounding events, improve patient safety, reduce lawsuits and support clinicians in disclosing error or injury.

Medical events were bumped to a CARe evaluation if they met a severity threshold of either causing permanent or temporary harm that led to an extended hospitalization, required an invasive procedure or led to at least three outpatient visits.

Of the 989 total events studied by the authors, 60 of them entered the CARe program because the hospital received notice that the patient intended to sue. Another 929 entered the program when an adverse event was reported that allegedly exceeded the severity threshold, or that met other criteria.

The protocol called for compensation to be proactively offered whenever a violation of the standard of care caused serious harm. Only 9 percent of cases met these criteria. The largest payment made was $2 million. In 181 events, in which compensation criteria weren’t met, hospitals offered to waive medical bills or made other modest gestures, like giving the patients meal vouchers and gift cards. About three-quarters of injuries didn’t qualify for compensation because the standard of care was judged to have been met — a proportion that is consistent with prior studies of medical injuries. About a third of the injuries weren’t caused by the medical care: For example, a patient contracted an infection in the hospital but died from other causes.

“These programs are usually talked about as a way to resolve cases of medical error, but what they do more often is encourage communication with patients about non-error events — as well as systematic evaluation of each event for patient-safety lessons,” Mello said.

The authors also noted that communication-and-resolution programs “can help hospitals foster a culture of transparency by supporting clinicians in making disclosures.”

The safety interventions identified in the CARe investigations included new labeling for high-risk medications, color-coded socks for patients at risk for falls, radio frequency identification tags for surgical sponges, improved interpreter services, improvements for managing the selection of implantables after surgery, and a multidisciplinary checklist for breech deliveries.

Other authors of the study are affiliated with Harvard, Tufts, Baystate Medical Center, and Beth Israel Deaconess Medical Center.

Women now have the option of getting screened every three or five years for cervical cancer, depending on which type of test they use, according to new draft recommendations from the U.S. Preventive Services Task Force.

The group of independent medical experts is recommending that women 21 to 29 years old get a cervical cytology (PAP test) every three years, while women aged 30 to 65 should either continue to get screened with a Pap every three years, or opt to be tested for the high-risk human papillomavirus (HPV) every five years.

“Cervical cancer is highly curable when found and treated early,” task force member Carol Mangione, MD, MSPH, said in a release on Monday. “Most cases of cervical cancer occur in women who have not been regularly screened or treated. Therefore, making sure all women are adequately screened and treated is critical to reducing deaths from cervical cancer.”

Despite the dramatic reduction of cervical cancer by half since the Pap test was introduced 40 years ago, nearly 13,000 American women are expected to contract this type of cancer this year. Of those, 4,200 are likely to die, according to the American Cancer Society. African-American and Hispanic women are at even greater risk.

The task force is an independent, volunteer panel of national experts in prevention and evidence-based medicine whose recommendations are widely followed by physicians and policymakers. They assign each recommendation a letter grade based on the strength of the evidence — and this recommendation comes with an A.

“We now have two effective screening strategies for women over 30, either cervical cytology every three years or HPV testing every five years,” said Douglas K. Owens, vice-chairperson of the task force.

Owens, a physician, professor of Stanford Medicine and director of the Center for Health Policy and Center for Primary Care and Outcomes Research, said that in women ages 21 to 29, a substantial portion of HPV infections resolve on their own. Cervical cytology, or Pap tests, remains the recommended screening strategy in this age group.

The advisory panel recommended against screening in women younger than 21 and older than age 65 years who have been adequately screened and don’t have a history of high-risk lesions.

The task force emphasized that cervical cytology tests remain an effective method of screening for cervical cancer, but that evidence published since its 2012 found that both Pap tests and HPV testing alone are effective ways to screen for cervical cancer in women aged 30 to 65.

“So women should discuss with their health-care provider which testing strategy is best for them,” Owens said. “What’s most important is that women get screened regularly.”

The Food and Drug Administration in 2011 approved the first test for HPV screening, a DNA test that looks for 14 types of the HPV virus, including types 16 and 18, which cause about 70 percent of all cervical cancers. In 2014, the FDA determined that the HPV test could be used alone instead of alongside the Pap test, which looks for changes in cervical cells.

The task force’s draft recommendation and evidence review have been posted for public comment on its website. Public comments can be submitted through October 9.

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.”