The U.S. government's global hunger and food security initiative, Feed the Future, has prevented 2.2 million children from experiencing malnutrition in sub-Saharan Africa, according to new research led by Stanford Health Policy's PhD candidate Tess Ryckman.

The researchers compared children’s health in 33 low- and middle-income countries in sub-Saharan Africa. In 12 of those countries, Feed the Future provided services such as agricultural assistance and financial services for farmers, as well as direct nutrition support, such as nutrient supplementation. 

The study, published online Dec. 11 in The BMJ, found a 3.9 percentage point decrease in chronic malnutrition among children served by Feed the Future, leading to 2.2 million fewer children whose development has been harmed by malnourishment.

“What we see with stunting rates is striking,” Ryckman said. “I would argue that 2 million fewer children stunted over seven years is major progress and puts a substantial dent in total stunting levels. And that’s 2 million children who will now have the levels of physical and cognitive development to allow them to reach their full potential.”

Stunting, or having a low height for a particular age, is a key indicator of child malnutrition. Children who aren’t properly nourished in their first 1,000 days are more likely to get sick more often, to perform poorly in school, grow up to be economically disadvantaged and suffer from chronic diseases, according to the World Health Organization.

A Controlled Study

Feed the Future is thought to be the world’s largest agricultural and nutrition program, with around $6 billion in funding from USAID (plus more from other federal agencies) between 2010 and 2015. Despite its size, much remains unknown about the effectiveness of the program.

The researchers analyzed survey data on almost 900,000 children younger than 5 in sub-Saharan Africa from 2000 to 2017. They compared children from the Feed the Future countries with those in countries that are not participants in the program, both before and after the program’s implementation in 2011.

The researchers found the results were even more pronounced — a 4.6 percentage point decline in stunting — when they restricted their sample to populations most likely to have been reached by program. These included children who were younger when the program began, rural areas where Feed the Future operated more intensively, and in countries where the program had greater geographic coverage.

“Our findings are certainly encouraging because it has been difficult for other programs and interventions to demonstrate impact on stunting, and this program has received a lot of funding, so it’s good to see that it’s having an impact,” Ryckman said.

Multifaceted Approach to Nutrition

Experts are divided about the best way to help the world’s 149 million malnourished children: Is assistance that directly targets nutrition, such as breastfeeding promotion or nutrient supplementation, more effective? Or is it also beneficial to tackle the problem at its root by supporting agriculture and confronting household poverty?

The authors, including Stanford Health Policy’s Eran Bendavid, MD, associate professor of medicine, and Jay Bhattacharya, MD, PhD, professor of medicine, a senior fellow (by courtesy) at the Freeman Spogli Institute of International Studies and a senior fellow senior fellow at the Stanford Institute for Economic Policy Research, said their analysis supports the value of a multifaceted approach to combating malnutrition among children, namely leveraging agriculture and food security interventions.

“Independent evaluations of large health policy programs such as Feed the Future help build the evidence base needed to tackle persistent patterns of undernutrition,” said Bendavid, an epidemiologist. “The widespread prevalence of stunting and chronic undernutrition is among the most common and yet most stubborn cause of underdevelopment in the world, and learning what works in this space is sorely needed.”

The researchers, including Stanford medical students Margot Robinson and Courtney Pederson, speculated that possible drivers of the program’s effectiveness include three features of Feed the Future’s design: its country-tailored approach; its focus on underlying drivers of nutrition, such as empowering female farmers; and its large scale and adequate funding.

The authors hope their independent evaluation of the program might lead to more funding and support for it. At the very least, they said, it should demonstrate to people working on Feed the Future and the broader global nutrition program community that programs focused mostly on agriculture and food security — indirect contributors to malnutrition — can lead to success.

Value Unknown

Feed the Future has been scaled back in recent years — it once served 19 countries and now reaches only 12. The program’s budget also remains somewhat murky.

“While there isn’t much data on the program’s funding under the Trump administration, the program appears to have been scaled back, at least in terms of the countries where it operates,” Ryckman said. “It’s possible that some of these gains could be lost, absent longer-term intervention from Feed the Future.”

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The researchers also did not look at whether the program provided high value for the money spent.

“While we find that it has been effective, it hasn’t led to drastic declines in stunting and it is unclear whether it is good value for money,” she said.

Ryckman also noted that USAID’s own evaluation of its program is tenuous because it looked only at before-and-after stunting levels in Feed the Future countries without comparing the results to a control group or adjusting for other sources of bias, which is problematic because stunting is slowly declining in most countries.

“These types of evaluations are misleading,” Ryckman said. “The U.S. government really needs to prioritize having their programs independently evaluated using more robust methods. That was part of our motivation for doing this study.”

Support for the study was provided by the National Institutes of Health (grant P20-AG17253), the National Science Foundation and the Doris Duke Charitable Foundation.

Stanford Health Policy researchers, led by Josh Salomon, have been awarded a five-year grant from the Centers for Disease Control and Prevention (CDC) to conduct health and economic modeling to guide national and local policies and programs focusing on some of the most important infectious diseases in the United States.

The CDC grant establishes the Prevention Policy Modeling Lab at Stanford, continuing a multi-institution collaboration that began when Salomon was a professor at Harvard prior to joining Stanford in 2017.

“The overall mission of the Prevention Policy Modeling Lab is to leverage the best available evidence to inform strategic decision-making about major public health problems,” Salomon said. “We do this by combining techniques from decision science, simulation modeling and health economics to estimate and project major patterns and trends in these diseases and to evaluate different clinical and public health strategies to address them.”

The initiative will focus on policy and practice in the areas of tuberculosis, HIV, hepatitis, sexually transmitted infections and adolescent health. The grant from the Centers for Disease Control and Prevention supports a wide range of modeling activities, including those that assess: 

• Projections of future morbidity and mortality
• Burden and costs of diseases
• Costs and cost-effectiveness of interventions
• Population-level program impact
• Optimized resource allocation

Stanford researchers who are involved in the Modeling Lab include Douglas K. Owens, Margaret Brandeau, Eran Bendavid, Jeremy Goldhaber-Fiebert, Jason Andrews, Samuel So and Mehlika Toy. The consortium also includes partners at Harvard, Yale, Michigan, Boston University, Boston Medical Center and the MA Department of Public Health.

“As a multi-institution consortium, on any given problem we’re able to assemble a team that includes both subject matter experts and collaborators who specialize in statistics, epidemiology, data science, economics and decision analysis,” Salomon said. “The policy models that we develop allow us to synthesize a wide array of different types and sources of evidence to shed light on the essence of the problem and to weigh the likely benefits and costs of responding in different ways.”

Prior work from the consortium on the potential impact and cost-effectiveness of expanding testing for hepatitis C virus was cited in the recent decision by the U.S. Preventive Services Task Force to revise their screening recommendations to cover all adults. The Modeling Lab has also examined prospects and strategies for eliminaitng tuberculosis in the United States and policies relevant to the rising threat of antimicrobial-resistant gonococcal infection among other topics.

A team of Stanford experts has produced a series of videos aimed at benefiting children detained at the U.S. border. Intended for lawyers who work with detained migrants, the videos describe how to interview young people using techniques informed by scientific knowledge on trauma. 

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To ask such questions in a sensitive way, the videos recommend giving children and teens as much control as possible: For example, attorneys are encouraged to explain that they want to help; familiarize themselves beforehand with what they need to say so that they can speak warmly instead of reading from a list; praise interviewees for their effort rather than the content of their answers; and tell kids they can take breaks or end the interview at any time, or skip answering questions if they wish.

When it comes to rooting out wasteful spending in federal entitlement programs, attention has long focused on preventing beneficiaries from gaming the system.

A new Stanford study identifies a fresh cause for concern: the for-profit companies that the U.S. government increasingly tasks with providing benefits to Americans who are often poor, elderly or both.

In a new working paper, Maria Polyakova, an assistant professor of medicine, finds that outsourcing public assistance services to third parties can lead to unanticipated effects on prices as well as on which beneficiaries gain the most from public dollars.

That’s because companies are in the business of making money. And when they know which of their consumers are likely to get certain levels of public support, they will try to use this information to maximize their profits, according to the research published this week by the National Bureau of Economic Research.

Polyakova shows that when companies act in their self-interest, unforeseen inequities and inefficiencies can arise that may hurt some consumers while helping others. At a time when governments in the United States and around the world are increasingly turning to the private sector to provide public benefits — namely in health care and in education — Polyakova says policymakers need to better understand how these intermediaries are affecting welfare programs.

“Policymakers have to be more careful about introducing intermediaries into public services,” says Polyakova, who is a faculty fellow at the Stanford Institute for Economic Policy Research (SIEPR), and teaches at the Stanford School of Medicine. She is also a core faculty member of Stanford Health Policy. “They may want to revisit how they think about outsourcing when research is showing that there are unintended consequences that may be positive or negative.”

Health Insurance Pricing under the Microscope

Intermediaries are central to a number of public services where the U.S. government provides subsidies to consumers, often based on income, age or employment status. Prominent examples include privately-managed Medicare Advantage Plans, drug benefits under Medicare Plan D, and charter schools in secondary education.

According to Polyakova, most research into wasteful spending within government subsidies has focused on consumers and how they try to trick the system by, for example, hiding income to qualify for a tax credit or cash assistance. Governments, though imperfect, have long been seen as benign players.

The increasing involvement of for-profit companies, she says, shows there’s a need to closely examine what’s happening on the supply side of public welfare.

To do that, Polyakova found an ideal setting: the federal health insurance marketplace created by the Affordable Care Act of 2010. Most consumers who shop for coverage through www.healthcare.gov receive a subsidy in the form of a tax credit that covers all or part of their insurance premium. The amount of their tax credit is tied to their household income.

The dollars at stake are significant. The Congressional Budget Office estimates that in 2019 the federal government will pay $560 billion in subsidies for privately-provided health insurance, including the spending on the Affordable Care Act marketplaces as well as other similarly designed programs. That figure is expected to hit $1.2 trillion over the next decade.

The Neighborhood Effect

Polyakova and her co-author — Stephen Ryan of Washington University’s Olin Business School — analyzed data from 2017 covering more than 9 million enrollees across some 2,570 counties around the country. They find that the presence of an intermediary significantly impacts insurance prices and key measures economists use to calculate the effects of a policy beyond a given benefit’s face value.

Specifically, they show that health insurance companies will have an incentive to raise premiums in markets where more consumers receive the higher tax credit because their incomes are low and the government is required to subsidize them.

On the flip side, insurers will charge lower prices in places where such subsidized consumers are less willing to buy coverage if they think it costs too much.

To illustrate the unintended consequences of the insurers’ actions, the researchers point out that, in the first instance where prices increase, consumers with incomes that are slightly higher than other community members will end up paying more for the same coverage. Under the second scenario, consumers who don’t qualify for the tax credit because their incomes are too high benefit from the lower premiums aimed at nearby residents.

“The price you pay for insurance will depend on who your neighbors are,” says Polyakova. “If you live near people who are poorer than you, you will be affected differently than if you live near people who are richer than you.”

Change the subsidy, change the calculation

Like with financial aid, tax credits for insurance coverage are calculated based on consumer income. But there is another type of subsidy that policymakers could use — flat vouchers, in which all members of a market receive the same benefit regardless of income, age or some other characteristic. For their research, Polyakova and Ryan also analyze how flat vouchers that only vary by age, but not by income, would hypothetically alter private health insurance prices in the federal Affordable Care Act marketplace.

Here, too, the scholars find different impacts on different types of consumers whether the subsidy is based on income or delivered as a flat voucher.

The analyses, says Polyakova, drive home the point that policymakers need to understand that there are trade-offs to relying on for-profit companies to provide government services and that the type of subsidy offered can alter how they calculate prices in disparate ways.

“There’s nothing wrong with companies trying to maximize their profits,” says Polyakova. “But sophisticated policymakers need to understand what happens when private markets get involved.”

Global warming and more days of extreme heat are exacerbating the health risks of pregnancy, particularly among African-American women, according to new Stanford-led research.

The maternal mortality rate among all women in the United States is already the worst of any industrialized nation. And black women are three to four times more likely to die from pregnancy-related problems than white women.

“It is truly a crisis that in America, one of the wealthiest countries in the world, more women are dying from pregnancy or childbirth complications than in any other developed country,” said Maya Rossin-Slater, a core faculty member at Stanford Health Policy and a faculty fellow at the Stanford Institute for Economic Policy Research.

In a new working paper published by the National Bureau of Economic Research, Rossin-Slater and two other health economists underscore how little research is out there about the impact of rising temperatures on the health of mothers and their newborns.

Pregnant women, for example, are not able to regulate body temperature as efficiently as non-pregnant individuals due to the physiological changes they undergo during gestation. Heat exposure can alter blood flow in the placenta, which can weaken the placenta and lead to complications. And high heat can lead to other pregnancy complications, such as hypertension, preeclampsia and prolonged premature rupture of membranes.

“All of these issues can translate into women needing to be hospitalized during pregnancy and experiencing complications during childbirth,” wrote Rossin-Slater, an assistant professor of health research and policy at Stanford Medicine. Her co-authors are Jiyoon Kim, assistant professor of economics at Elon University, and Ajin Lee, an assistant professor of economics at Michigan State University.

The researchers said most of the discussion about maternal health focuses on the health-care system, but that other determinants of poor maternal health and racial disparities are much less understood, particularly when it comes to how the environment is impacting pregnancy.

So they launched what they believe is the first study to identify the causal effects of prenatal exposures to extreme temperatures on the health of the mothers themselves.

As the Earth Warms, So Does Exposure to Extreme Heat

Their paper focuses on an environmental factor that is becoming increasingly relevant due to the growing consensus that climate change is contributing to a gradual warming of the earth: exposure to extreme heat.

The researchers studied the effects of exposure to extreme temperatures during pregnancy on maternal and child hospitalizations, using inpatient discharge records from three U.S. states with different climates: Arizona, New York and Washington. Their data comes from the State Inpatient Databases from the Healthcare Cost and Utilization Project, including 2.7 million inpatient records of 2.7 million infants and 2.2 million mothers in those three states.

And to measure temperature exposure, the researchers obtained data from the National Oceanic and Atmospheric Administration (NOAA).

For every county in their data, the researchers calculated the average temperature for every month. Then for every given day in a specific month in that county, they looked at the historic average for how high or low that day’s temperature was relative to the overall temperature in that month in that county.

For example, a 90-degree day in Arizona in September would not be classified as extreme heat since it’s relatively common. But a 90-degree day in New York would be, since temperatures that high are much less common. They classified “extreme heat” as a given day when the temperature is more than three standard deviations (3SD) above that historic county mean.

Then, they compared the outcomes of women who are of the same race giving birth in the same county and calendar month, but in different years. These women are likely similar in terms of their demographics and socioeconomic status, but may be exposed to different temperatures during pregnancy. For example, consider a black woman giving birth in November 2011 in Queens County, New York, and a black woman giving birth in November 2012 in the same county. If there were a heat wave in Queens in the August 2012, then the latter woman is exposed to more extreme heat during pregnancy than the former. 

The economists found that each additional day with heat that is at least 3SDs — or substantially higher than the historic county-month average — during the second trimester of pregnancy increases the likelihood that a newborn is diagnosed with dehydration by .008 percentage points.

“Our results provide new estimates of the health costs of climate change and identify environmental drivers of the black-white maternal health gap,” they wrote. “Understanding the health consequences of this increase in extreme heat is critical information for discussions about the costs of climate change and the possible benefits of mitigating policies.”

The researchers found that each additional day of extreme heat exposure during pregnancy increases black women’s likelihood of hospitalization during pregnancy. Since black women on average are exposed to more extreme heat than white women — due to different residence patterns and access to mitigating technologies like air conditioning — extreme heat may contribute to exacerbating the already large gap in maternal health between black and white women.

Detrimental Consequences of Rising Temperatures

Scientists predict global average temperatures will continue to rise over the next 50 to 100 years as greenhouse gases continue to trap more heat in the Earth’s atmosphere. The U.N. Intergovernmental Panel on Climate Change last year warned that nations worldwide must quickly reduce fossil fuel use to keep the rise in global temperatures below 1.5°C by 2050. 

The panel also said the number of days with mean temperatures above 32°C in the average American county is forecasted to increase from about 1 to 43 days per year by 2070-2099.

That could have detrimental consequences for babies and mothers alike.

“Overall, our findings on infant health suggest that exposure to extreme heat during the second trimester increases the likelihood of the baby being dehydrated at the time of birth,” the researchers wrote. “This, in turn, appears to increase the likelihood of subsequent readmission to the hospital many months later for causes linked to dehydration.”

And these impacts are typically missed when researchers only measure infant health using more standard variables, such as birth weight.

The authors note dehydration is one of the leading causes of morbidity and mortality in children. Studies show that children under 5 years old who have an average of two episodes of gastroenteritis associated with dehydration per year leads to 2 to 3 million pediatric office visits and accounts for 10% of all pediatric hospital admissions in the United States. 

Experts believe black women are three- to four-times more likely to die from pregnancy-related causes due to lack of access to and the poor quality of health care, as well as clinicians not monitoring black women as closely — or actually dismissing their symptoms altogether.

“The fact that the adverse impacts on health during pregnancy are larger for black than for white mothers suggests that climate change may exacerbate the already large racial gap in maternal health,” the researchers said.

I always find it hard to believe so many people are living in poverty: some 39.7 million Americans, or 12.3% of the population. It’s such a wealthy country, yet so many are poor.

In a twist that could be interpreted as good news — it doesn’t seem fair to say there is anything positive about living in poverty — I recently learned that older, low-income Americans tend to be healthier if they live in more affluent areas of the country.

Not only are they healthier, but their physical well-being is better across the board with a lower prevalence of dozens of chronic conditions, particularly if they live in rural communities. This, despite their income having less purchasing power in those better-resourced neighborhoods.

This was the key finding in new research published by Stanford Health Policy’s Maria Polyakova in the Annals of Internal Medicine.

While recent studies have reported that low-income adults living in more affluent areas of the United States have longer life expectancies, less has been known about the relationship between the affluence of a geographic area and morbidity of the low-income population.

“I was interested in figuring out whether the same relationship holds for morbidity: Are poorer people less sick in richer areas?” Polyakova told me. “And if so, are there any specific conditions that drive these differences that could be the target for policy-making?”

So Polyakova, a faculty fellow at the Stanford Institute for Economic Policy Research, and her co-author, Lynn M. Hua at the University of Pennsylvania, set out to evaluate the association between chronic conditions among low-income, older adults and the economic affluence of a local area. 

They focused on nearly 6.4 million Medicare beneficiaries in 2015 aged 66 to 100 years old who received low-income support under Medicare Part D, a prescription drug program for Medicare enrollees. They investigated the prevalence of 48 chronic conditions among these patients, including common chronic conditions such as hypertension, depression, diabetes and Alzheimer’s disease. They found the presence of all conditions is highly correlated: places, where the poor tend to have a high prevalence of one disease, are likely to have a high prevalence of all 48 conditions.

“While we cannot ascertain a causal relationship, our results clearly point towards the importance of further understanding why the socioeconomic environment of low-income, older adults is so tightly linked to such a broad measure of health,” the researchers wrote. 

The results, they said, were broadly consistent with the extensive literature on the social determinants of health. But their work takes that literature even further.

“Our study extends this research by providing measures of the prevalence of chronic conditions among low-income, older adults for a large national sample of the U.S. population,” Polyakova said. 

The researchers used clinical, rather than self-reported measures of diagnoses and reported this group’s variation in morbidity across local areas of the country, rather than nationally. 

“Our results raise the bar for researchers who are trying to find out what factors drive health disparities in the U.S.; these factors would have to be able to explain the differences in nearly 50 condition,” Polyakova said.

The study supported by the National Institute on Aging came to three key conclusions:

1. The health of low-income, older adults in the United States varies substantially across local geographic regions, and this variation cannot be attributed to one specific disease or a narrow set of conditions. 
2. Consistent with their original hypothesis, they found that more affluent local areas of the country have a lower prevalence of chronic conditions in the low-income, older adult population.
3. The researchers found that low-income, older adults have better health in rural areas of the country.

I wondered why these poor, older adults do particularly well in rural communities, as those regions often lack easy access to high-quality health care and state-of-the-art hospitals.

“We don’t know the exact answer, but there is a general sense that differences in the social fabric and lifestyle in rural areas — could contribute to this pattern,” Polyakova told me. “It appears that better health in these areas persists, despite challenges of accessing formal care.”

On August 26, Judge Thad Balkman delivered a $572 million judgment against pharmaceutical giant Johnson & Johnson for the company’s role in fueling the opioid epidemic in Oklahoma. In the discussion that follows, Stanford Law Professors Michelle Mello and Nora Freeman Engstrom discuss the decision and how other cases tied to the national opioid crisis are developing.

The Oklahoma decision took many onlookers by surprise. How did the case unfold? And what did Judge Balkman find? On Monday, Cleveland County District Judge Thad Balkman of Oklahoma issued a judgment that capped off a long and closely-scrutinized trial wherein the Oklahoma Attorney General faced off against Johnson & Johnson (J&J), claiming that J&J contributed to the opioid epidemic that has devastated the state of Oklahoma.

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Stanford Law Professors Michelle Mello and Nora Freeman Engstrom

To understand the verdict, a bit of background is helpful. When Oklahoma initially sued, it cast the net broadly, asserting claims against several defendants under several causes of action.  Certain defendants (namely, Purdue and Teva) chose to settle rather than roll the dice at trial. (Purdue, the maker of OxyContin, agreed to pay Oklahoma $270 million and Teva, one of the world’s leading providers of generic drugs, $85 million; neither admitted wrongdoing.)  Further, over time, Oklahoma’s various causes of action got winnowed down to the singular claim that J&J had created a public nuisance by aggressively and deceptively marketing opioid products to Oklahoma’s doctors and patients.  This posture meant that Oklahoma’s victory at trial was far from a foregone conclusion, as public nuisance claims can be very hard to prove, particularly in cases that relate to dangerous products.

With that table set, the trial began on May 28, 2019.  In a crowded courtroom in Cleveland County, it stretched on for nearly seven weeks and featured dozens of witnesses and more than 800 exhibits. The trial was a bench trial, meaning there was no jury, but there was a written opinion explaining the judge’s decision.  Judge Balkman’s 42-page opinion offers a cogent summary of the evidence and governing law and, broadly, vindicates Oklahoma’s litigation strategy. The opinion finds that J&J engaged in a deceptive marketing campaign designed to convince Oklahoma doctors and the public that opioids were safe and effective for the long-term treatment of chronic, non-malignant pain. Further, this “false, misleading, and dangerous marketing” caused “exponentially increasing rates of addiction [and] overdose death,” which ravaged the Sooner State. The picture Judge Balkman draws is stark and, for J&J, devastating.

Are individuals suing drug companies too? Are there class action cases that are relevant?

There are some suits by individuals, but we don’t believe that’s where the big money damages—and the real social impact of the litigation—will be.  More important is the pending federal multi-district litigation (MDL), which consolidates nearly 2,000 individual federal lawsuits brought by cities, counties, municipalities, and tribal governments in a single action before Judge Dan Polster in Cleveland, Ohio. Additionally, 48 states have initiated separate litigation, with a lineup of claims and defendants similar to the MDL.

Does this win for Oklahoma mean these other plaintiffs have an easy road ahead?

Not easy, but potentially easier. The Oklahoma case is what we call a bellwether. Like the ram that leads the other sheep this way or that, the bellwether trial doesn’t control the path of future litigation. But it does go first, and it helps to indicate trends.

As a bellwether, the big verdict here is very reassuring to the many states, counties, municipalities, and tribes suing opioid makers, distributors, and retailers, and it is, correspondingly, very disturbing for those who made and sold opioids to the American public.  The verdict suggests that this litigation has legs, and that judges and juries may be willing to pin blame not just on Purdue, the maker of OxyContin, but on others who played an arguably less central role in fueling this public health crisis.

What is striking is how damning Judge Balkman’s factual conclusions about J&J’s conduct are, and how similar they are to the allegations made against other opioid manufacturers in other cases.  All the things he objected to regarding J&J’s marketing practices are things that others, too, allegedly have done. Some of them are things that multiple companies banded together to do. Plaintiffs’ attorneys should be feeling pretty confident about their chances of persuading other courts that those practices are problematic.

Is Oklahoma free to use the award as it wishes? Will the state share some of the award with the people who died or suffered in the opioid crisis (if the decision is upheld on appeal)?

The damages, in this case, are intended to fund Oklahoma’s “nuisance abatement plan.”  That’s the remedy in a public nuisance case: The defendant has to pay to clean up the mess it made. In this case, Oklahoma provided a detailed plan laying out what would be needed to abate the opioid problem in the state. The costs added up to $572 million for the first year, and that’s what the judge awarded—not the $17 billion Oklahoma sought for a multi-year abatement effort.

The plan specifies that the money will be used for opioid use disorder screening, prevention and treatment ($292 million), housing and other services for those in recovery ($32 million), continuing medical education programs ($108 million), a pain management benefit program ($103 million), treatment of neonatal abstinence syndrome ($21 million), and other services.  Individuals won’t be direct recipients of the funds, though they may receive the services funded.

Legally, what happens next?

J&J has vowed to appeal the “flawed” Oklahoma judgment, and we expect that the judgment will be appealed, first to Oklahoma’s intermediate, and then, likely, to its supreme, court.  More immediately, though, attention will turn from Oklahoma to Ohio.  The first bellwether trial in the MDL, involving claims from Ohio’s Cuyahoga and Summit counties, is scheduled to begin on October 21.

Even as they prepare for trial, however, lawyers for both plaintiffs and defendants are also, no doubt, continuing to work toward reaching a broad and encompassing settlement.  When Judge Polster was first assigned the MDL back in January 2018, he made no bones about his desire to do “something meaningful to abate this crisis”—and to do it quickly.  It hasn’t been easy to execute on that, which isn’t surprising given the unprecedented magnitude and complexity of the litigation.

Still, we expect that, sooner or later, the opioid litigation will settle.  Indeed, even as we write, news is breaking that Purdue and the Sacklers may be in the midst of a negotiation whereby Purdue would declare bankruptcy and the Sacklers would contribute a cash payment of roughly $4.5 billion-plus relinquish ownership of the company, in return for peace with plaintiffs.

But even forging a settlement involving just those two entities is tricky—and forging a broader settlement will be exponentially harder for a number of reasons.  One is that any truly global agreement needs to pass muster with a range of defendants, some of whom have comparatively shallow pockets, and all of whom sold (or made or distributed) different products, at different times, in different quantities, in different states.  And, on the other side of the table, any settlement agreement needs to get buy-in from both those plaintiffs in the MDL and also state attorneys’ general, who have their own distinct set of priorities and interests relating to their separate lawsuits.  Further, because only a small proportion of eligible cities and counties have joined the MDL to date, any global settlement needs to somehow—equitably but firmly—close the courthouse door on those potential future plaintiffs.  None of this will be easy to accomplish.  But whenever new information reduces uncertainty about how courts would resolve a legal dispute, settlement becomes more likely—and, here, the Oklahoma verdict makes a significant contribution.

 

Nora Freeman Engstrom, Professor of Law and Deane F. Johnson Faculty Scholar, is a nationally-recognized expert in tort law, legal ethics, and complex litigation. Her work explores the day-to-day operation of the tort system—particularly its interaction with alternative compensation mechanisms. Michelle Mello, Professor of Law and Professor of Health Research and Policy (School of Medicine), is a leading empirical health scholar and the author of more than 150 book chapters and articles, including “Drug Companies’ Liability for the Opioid Epidemic,” recently published in the New England Journal of Medicine.  

A task force of national health experts has released a draft recommendation to screen all adults 18 to 79 years for the hepatitis C virus (HCV), noting the opioid epidemic has fueled what has become the most common chronic bloodborne pathogen in the United States.

Cases of acute HCV have increased 3.5-fold over the last decade, particularly among young, white, injection drug users who live in rural areas. Women aged 15 to 44 have also been hit hard by the virus that is spread through contaminated blood.

The U.S. Preventive Services Task Force, which makes recommendations followed by primary care clinicians nationwide, has until now recommended that people who are at high risk be tested for hepatitis C, as well as “baby boomers” born between 1945 and 1965.

“Unfortunately, HCV now affects a broader age range than previously with three times as many new infections per year,” said Stanford Health Policy’s Douglas K. Owens, chair of the independent, voluntary panel of national experts in prevention and evidence-based medicine.

The Task Force now recommends that clinicians encourage all their adult patients, even those with no symptoms or known liver disease, get a blood test for the virus. Pregnant women should also be screened; from 2009 to 2014, the prevalence of HCV infection among women giving birth has nearly doubled.

“The explosive growth in HCV has been fueled by the opioid epidemic, with the spread of HCV into younger populations,” said Owens, director of the Center for Health Policy and the Center for Primary Care and Outcomes Research. “HCV now kills more Americans than all other reportable infectious diseases combined, including HIV.”

An estimated 4.1 million people in the United States are carrying HCV antibodies; about 2.4 million are living with the virus, according to the Task Force. The HCV infection becomes chronic in 75% to 85% of cases and some of those people develop symptoms such as chronic fatigue and depression, and liver diseases that can range from cirrhosis to liver cancer.

Approximately one-third of people ages 18 to 30 who inject drugs are infected with the virus; 70% to 90% of older injection-drug users are infected.

There currently is no vaccine for hepatitis C although research in the development of a vaccine is underway. But there are effective oral direct-acting antiviral (DAA) medications that can clear the virus from the body, particularly if caught early.

“The good news is that treatment for HCV is far better, and far better tolerated than in the past, offering a cure to most people,” Owens said. “Early identification of HCV is important to prevent long-term complications of HCV including liver failure, liver cancer, and death.”

The Task Force said in a release that there are several key research gaps that could inform the benefit of screening for HCV infection:

1. ·     Research is needed on the yield of repeat vs. one-time screening for HCV.
2. ·     Research is needed to identify labor management practices and treatment of HCV infection prior to pregnancy to reduce the risk of mother-to-child transmission.
3. ·     Trials and cohort studies that measure effects on quality of life, function, and extrahepatic effects of HCV infection (such as renal function, cardiovascular effects or diabetes) would be helpful for evaluating the impact of DAA regimens on short-term health outcomes.
4. ·     Additional studies are needed to examine the epidemiology of HCV infection and the effectiveness of DAA regimens in adolescents.