Most Americans don’t realize there are silent brokers helping to fix the price of their prescription drugs — or that it’s a $100 billion annual business accounting for half of Big Pharma sales.

They’re called pharmacy benefit managers (PBMs), with CVS Caremark, Express Scripts and Optum RX dominating the market. Their chief function is to develop and maintain a list called the “formulary,” a list of drugs that will be covered by health-care plans. The formulary groups drugs into tiers with different levels of patient cost sharing.

They also pool volume across health plans to negotiate with drug manufacturers and retailers on prescription drug pricing. And PBMs reap rewards from rebates and fees that drug manufacturers pay them, as well as from a ‘pharmacy spread’ where PBMs bill health plans more than they reimburse pharmacies.  

All of this comes at a cost to patients.

“Patients typically only think about what they pay out-of-pocket at the pharmacy counter,” said Alex Chan, a PhD candidate in health economics at Stanford Health Policy. He and Kevin Schulman, a professor of medicine and professor of economics, by courtesy, at the Stanford Graduate School of Business, have just published a paper in JAMA Health Forum that examines these silent and powerful intermediaries.

“As PBMs leverage the formulary design to secure more and more rebates and fees from manufacturers, these drug manufacturers raise the list price in response,” Chan said. “The patients’ out-of-pocket cost at the counter would increase but at a less noticeable rate given that they co-pay are just a percentage of the list prices.”

Unless these rebates are passed along to consumers as reduced premiums, the net effect is an increase in premiums. Furthermore, if formulary design is used to help PBMs secure better rebates, PBMs may prioritize expensive drugs over more cost-effective drugs.

Transparency

These pharmacy benefit managers have come under scrutiny as health policy experts learn more about the scale of prescription drug rebates and other questionable practices used by these intermediaries in the prescription drug market. For example, PBMs can include “gag clauses” that prohibits pharmacists from telling customers about cheaper drug options.

They ask themselves: What is the underlying value of PBMs for both payers and patients?

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“They create value by providing information on the quality and value of products and services and by providing negotiation leverage as they amass scale by aggregating smaller buyers (or sellers),” they write. “Consumers can be sure to share in this value under three conditions: when there is competition among intermediaries, when pricing is transparent, and when it is clearly defined who is negotiating on whose behalf.”

But when these conditions are not met, they add: “We can find that intermediaries can hold a powerful and self-serving position in a market.”

Chan and Schulman found that in the drug prescription market, there are significant concerns about the value of these PBMs:

1. Rather than a market where there is competition among PBMs, consolidation has resulted in a situation in which the three largest PBMs have about 80% of market share. There are significant barriers to competition among PBMs. If a health system wants to switch PBMs, it requires a significant investment in a “request-for-proposal” process.
2. Drug-specific rebates are kept confidential between PBMs and drug manufacturers, and health plans have little ability to clearly assess the cost-savings for their members or to gauge the appropriateness of the rebate passthroughs.
3. Under the rebate model, the role of the PBM has evolved to serving as an agent of both the payer and the manufacturer. The interests of payers and manufacturers are often in conflict, especially with respect to expenditures.

"One of the largest criticisms of PBMs is the lack of transparency surrounding the structure and scale of payments from manufacturers to the PBM,” the authors write. “The current PBM business is shrouded in secrecy.”

Only the PBM knows the actual scope of payments from drug manufacturers, such as rebates and service fees. They note that in 2016, for 13 pharmaceutical companies, payments to PBMs and other intermediaries (such as wholesalers) were $100 billion — or 50% of gross sales.

 “Without transparency, a PBM might develop formularies that maximize payments to the PBM rather than maximize value to patients,” Chan and Schulman write.

Suspicion over just that led health insurance company Anthem to sue Express Scripts for $15 billion in 2016 for overpayments on drug pricing. In the end, Anthem cut ties with Express Scripts to develop its own PBM.

“The PBMs have grown out of sync with what we can reasonably expect to be a value-adding intermediary,” Chan said. “It is hard to really tell how much inefficiencies have been created due to this lack of transparency.”

Legal Solutions

The authors note that Congress has taken steps to shed light on PBMs through the Patient Right to Know Drug Prices Act and the Know the Lowest Price Act, both adopted in 2018. These laws outlaw PBMs gag clauses that forbid pharmacists from telling consumers that their price through a PBM was higher than the as price for the same product.

Chan said these laws are a move toward the direction of providing patients with more transparency about their options.

“An even more promising direction would be for legislation to make a stronger push towards public disclosure of rebates, discounts, and price concessions, along with lower barriers to entry to the PBM market,” he said.

Controversies over the lack of diagnostic testing for the COVID-19 virus have dominated U.S headlines for weeks. Technical challenges with the first test developed by the Centers for Disease Control and Prevention (CDC) left the nation with minimal diagnostic capacity during the first few weeks of the epidemic, according to a new paper published today in the Journal of the American Medical Association by Michelle Mello, a professor of medicine at Stanford Health Policy and professor of law at Stanford Law School.

On February 29, the Food and Drug Administration (FDA) began allowing high-complexity labs across the country to use tests they developed in-house. On March 5, the Stanford Clinical Virology Lab deployed its own test for patients at Stanford Health Care and Stanford Children’s Health.

We asked Mello to answer some questions about the federal rollout of diagnostic testing.

You write that in the early stages, COVID-19 “spread beyond the nation’s ability to detect it.” Is there anything the U.S. government could or should have done weeks ago to get out ahead of the spread?

Adopting broader testing criteria and allowing use of a wider range of tests would have been helpful in identifying the first U.S. cases and containing the spread. Manufacturing problems like the one that arose with CDC’s test are always a risk, but the fact that CDC put all its eggs in that one basket made the manufacturing snafu highly consequential.

Also, the public messaging from Washington about the seriousness of the problem has been neither consistent nor accurate, and I worry it may have led Americans to take fewer steps to prevent community transmission than we should have. Containment was not “pretty close to airtight.” A vaccine was never going to be ready in “three to four months,” as the Trump administration claimed. The case fatality rate is not “way under 1 percent.” Part of the problem here is that as the stock market continues to plunge, the president and the task force he appointed appear to be more concerned about calming investors than stopping the virus.

We seem to be between a rock and a hard place: You write that remedying gaps in testing is imperative, yet “more testing is not always better.” How do we determine the happy middle ground?

First, the testing criteria have to be calibrated to our actual testing capacity. You can’t announce that any American who wants a coronavirus test can get one and then, within hours, announce that there aren’t enough test kits to make that possible. High priorities for testing include patients with serious, unexplained respiratory illness and contacts of known cases. From there, testing can be expanded, beginning with other high-risk groups, as capacity permits.

Second, we should consider unintended side effects of mass testing. The problem with this virus is that it doesn’t have signature symptoms. It looks like the common cold or the flu. If everyone with a cough or fever, or who has been around someone with a cough or fever, shows up in their doctor’s office demanding a test, it will quickly overwhelm care facilities that should be focusing on patients with a higher likelihood of being infected or and those who are infected and are seriously ill. It may also work against the social distancing measures that public health officials are trying to encourage, because crowded waiting rooms may spread the virus.

The CDC announced Monday it now has the testing capacity in 78 state and local public health labs across 50 states to test for the virus. There are now 75,000 lab kits cumulatively to test for COVID-19 with more coming on board by mid-March. But is there anything we could have done to roll this out earlier?

The alternative would have been to allow laboratories to deploy their own tests from the beginning, using the primers and protocols made publicly available by the World Health Organization. That’s what other countries have done. RT-PCR is a mature technology and high-complexity labs around the country are well-qualified to conduct this type of testing.

There is a public health argument for not going that route: perhaps those labs wouldn’t have done as good a job as CDC’s own lab and the state labs that it handpicked early in the outbreak. What if there were erroneous test results? We could miss cases, or we could put people into isolation, with huge social consequences, based on false-positive results. There is also a worry that some labs aren’t consistent about reporting positive test results to CDC, and underreporting could compromise disease surveillance efforts.

The counterargument is that high-complexity labs have that certification for a reason—they’re good at what they do. And of course, surveillance is also compromised when you miss cases because you don’t test.

You write in your paper that testing for COVID-19 “highlights a controversial area of public policy—the regulation of laboratory-developed tests—in which there has long been tension between the goals of access and quality.” Who should be in charge of regulating these tests?

Laboratory-developed tests are largely unregulated outside of emergencies. The FDA proposed draft guidance in 2014 that, if implemented, would have required labs to make certain showings to FDA about tests they developed in-house, with the particular evidence calibrated to the risks involved in having a wrong test result. Contrary to President Trump’s claim that an Obama-era policy constrained coronavirus testing, the guidance did not relate to emergency situations. During declared emergencies, another statute and set of regulations apply, and the FDA has broad discretion to allow or disallow use of novel diagnostics and therapies as emergency countermeasures.

As a general matter, it makes good sense to require labs to submit evidence that their in-house tests work. It’s odd that laboratory-developed tests are carved out of requirements that apply to other kinds of medical devices. It’s also sensible that our legal framework allows FDA’s regular rules to be relaxed during emergencies so we can tailor our response to the difficult and changing circumstances.

You write that diagnostic testing is critical to an effective response to the novel coronavirus. What sort of policies and guidelines should be put into place to prevent such a sluggish rollout during an emerging epidemic the next time one comes around?

The legal framework for an effective emergency response is in place. Because giving agency heads the discretion to act as potentially unforeseeable circumstances require is a linchpin of this legal framework, it only works if leaders make smart choices. Every emergency is different, and there is a danger of Monday-morning quarterbacking. But we should learn from every misstep we make, and I think the lesson here is to make better use of already developed networks of highly qualified labs to make sure we have adequate testing capacity to isolate cases and trace their contacts very early in an outbreak.

What are some innovative approaches we could be taking to speed up testing for those who really need it?

The South Koreans have set up drive-through testing stations in parking lots to avoid concentrating crowds of people indoors. Of course, that requires that you have plenty of test kits, which we don’t yet – but we should also be thinking about creative ways to address the epidemic. For example, how could video calls be used to monitor the health of people confined at home after being exposed to the virus? How can social media be used to connect neighbors to help one another when some are isolated at home? Hopefully we can find new ways for technology to bring us together when pathogens drive us apart.

More evidence-based research is needed before the U.S. Preventive Services Task Force can recommend that clinicians screen their older patients for cognitive impairment such as dementia and Alzheimer’s disease.

Cognitive impairment is a growing public health dilemma that affects millions of Americans as they age. The Global Burden of Disease study shows that Alzheimer’s rose from the 12th most burdensome disease or injury in the United States in 1990 to the 6th in 2016.

Medical experts who were commissioned to conduct an evidence report for the Task Force projected that the burden of Alzheimer’s disease is expected to grow to 13.8 million U.S. residents by 2050 — or nearly 3.3% of the projected U.S. population by that year.

Their findings, the Task Force recommendation statement and several accompanying editorials were all published Tuesday in the Journal of the American Medical Association.

The symptoms of cognitive impairment can range from problems with memory and language, to learning new things or making decisions that affect everyday life. 

“Early identification of cognitive impairment through screening would ideally allow patients and their families to receive care at an earlier stage in the disease process, potentially facilitating discussions regarding health, financial, and legal decision-making while the patient still retains decision-making capacity,” the authors of the Task Force evidence report wrote.

But after reviewing some 287 studies including more than 285,000 older adults, the Task Force determined there wasn’t sufficient evidence about the benefits or harms of screening adults 65 and older who do not have signs or symptoms. The Task Force also did not find adequate evidence that screening for cognitive impairment improves decision-making or planning by patients, caregivers or doctors.

At the same time, there is little evidence on potential harms of screening, such as depression, anxiety or lower quality of life.

“Given the burden of dementia and the intense public interest in preventing cognitive impairment, the lack of progress is disheartening,” Carol Brayne, MD, with the Department of Public Health and Primary Care at the University of Cambridge in the UK, wrote in an accompanying JAMA editorial to the Task Force evidence report.

But, she added, “Political considerations and pressure from commercial interests and patient advocacy groups notwithstanding, public policies for dementia screening should be supported by evidence.”

The Task Force — an independent panel of national experts in prevention and evidence-based medicine — encourages clinicians to remain alert for early signs of symptoms of cognitive impairment, while calling for more research on the detection of dementia.

“Research is especially needed on whether screening and early detection of cognitive impairment helps patients, caregivers, and doctors make decisions about health care or plan for the future,” said Douglas K. Owens, chair of the Task Force and the director of Stanford Health Policy.  “We share the frustration of clinicians who want to offer something that could help patients prevent cognitive impairment. We hope that additional research will enable us to know whether that’s possible.”

The most commonly used screening tests include the Mini-Mental State Examination as well as the clock-drawing test. Screening tests involve asking patients to perform a series of tasks that asses one or more aspects of cognitive functions. The USPSTF concluded that more research is needed to know whether such screening tests can lead to interventions that help prevent or improve cognitive impairment. 

Elderly patients hospitalized with congestive heart failure have a poor prognosis and high risk of death and hospital readmission. So, their post-discharge care can strongly influence their outcomes.

Yet despite data showing that transitional care interventions, such as home visits by nurses, can reduce death rates and hospital readmission by more than 30%, many health systems have not implemented such programs. Health policy experts say this is due in part to cost concerns and doubts about the effectiveness of these delivery services.

 Now, a team of Stanford Medicine and Veterans Affairs researchers has sought to assess whether transitional care interventions provide good value and better outcomes, as there are 5 million people living with congestive heart failure in the United States and 500,000 new cases diagnosed each year. CHF is the stage of chronic heart disease in which fluids build up around the heart, causing it to pump inefficiently.

The researchers updated a 2017 study on the impact of transitional care intervention with four years of additional data. They then used it to compare standard post-discharge management with three post-discharge regimes for patients 75 or older that they found to be most effective: disease management clinics, nurse home visits and nurse case management.

All three transitional care interventions delivered appreciable health benefits to the patient population, said Jeremy Goldhaber-Fiebert, PhD, associate professor of medicine at the Stanford School of Medicine and core faculty member of Stanford Health Policy.

The findings were published in the Annals of International Medicine. Goldhaber-Fiebert is the senior author. The lead authors are Manuel R. Blum, MD, MS in Epidemiology & Clinical Research at Stanford in 2019 and now at the Department of General Internal Medicine at the University Hospital of Bern; Henning Øien, PhD, Norwegian Institute of Public Health, Oslo; and Harris L. Carmichael, MD, a Stanford/Intermountain Fellow in Population Health, Delivery Science, and Primary Care

“Transitional care interventions for older individuals with congestive heart failure — particularly nurse home visits — offer a high-value care alternative that could improve the health and longevity of millions of Americans,” he said.

The researchers said these transitional care services should become the standard of care for post-discharge management of patients with heart failure.

Heart failure causes 1 in 8 deaths nationwide

The prevalence of heart failure is estimated to be 26 million people worldwide and growing. In the United states, heart 5.7 million adults have been diagnosed with HF, with an estimated annual direct cost of $39.2 billion to $60 billion. Total heart failure costs in the United States are expected to exceed $70 billion by 2030, the authors wrote. According to the Centers for Disease Control and Prevention, heart disease costs the United States about $219 billion each year from health-care services, medicines and lost productivity.

Of the 15 million Americans in their mid-70s to 80s today, about 1 million suffer heart failure.

“So population gains from more effective post-discharge care would be hundreds of thousands of life years,” Goldhaber-Fiebert said. “Likewise, tens of thousands of costly rehospitalizations could be prevented each year if these interventions were delivered successfully.”

Heart failure primarily affects older people and is the second-most common inpatient diagnosis billed to Medicare. Yet the authors cite a recent study of 18 million Medicaid charges which found that only 7% of eligible patients at risk of rehospitalization received transitional services.

The standard post-hospital care for those patients includes sending them home with some advice and scheduling follow-up visits for them with cardiologists within 14 days of discharge. The researchers found that patients who received this standard post-hospitalization care with an average age of 75 had an average life expectancy of 2.9 years and 2.9 hospitalizations during their remaining lifetime. In comparison, nurse home visits decreased the number of hospitalizations by 10 readmissions per 100 patients and increased life expectancy by approximately four months, the study found.

“If these interventions were successfully implemented at scale, they could provide important substantial benefits with very good value,” said co-author Douglas Owens, MD, the Henry J. Kaiser Jr. Professor and professor of medicine at Stanford.

Reduced hospitalizations for congestive heart failure, according to the research, produces substantial cost savings that partially offset the costs of delivering the interventions. Though nurse home visits increase lifetime health care costs by $4,622, the substantial health benefits that they deliver justify their costs: $19,570 quality adjusted life years gained, which is considered highly cost-effective.

Hospital and insurance administrators take note

“Our results have important implications for decision-makers in hospital administration as well as in insurance and policy settings,” the authors wrote. They concluded:

• Transitional care services should become the standard of care for post-discharge management of patients with heart failure;
• The increasing reimbursement restrictions and regulations affecting HF hospital readmissions, through such programs as the Centers for Medicare & Medicaid Services Hospital Readmission Reduction Program, makes this research particularly informative to decision-makers;
• Hospital administrators could use the research to determine which transitional services are most cost-effective for its rural population, overall patient base and hospital system.

The other Stanford researcher on the study was Paul Heidenreich, MD, a professor of medicine and health research and policy at the Stanford University School of Medicine and, by courtesy, professor of health research and policy at the Palo Alto Veterans Affairs Health Care System.

The toll from gun violence at schools has only escalated in the 20 years since the jolting, horrific massacre at Columbine High.

By December 2019, at least 245 primary and secondary schools in the United States had experienced a shooting, killing 146 people and injuring 310, according to The Washington Post.

At least 245 primary and secondary schools in the United States have experienced a shooting — killing 146 people and injuring 310 — since the country's first mass school shooting at Columbine High School in April 1999.

Now, new Stanford-led research sounds an alarm to what was once a silent reckoning: the mental health impact to tens of thousands of surviving students who were attending schools where gunshots rang out.

A study has found that local exposure to fatal school shootings increased antidepressant use among youths.

Specifically, the average rate of antidepressant use among youths under age 20 rose by 21 percent in the local communities where fatal school shootings occurred, according to the study. And the rate increase – based on comparisons two years before the incident and two years after – persisted even in the third year out.

“There are articles that suggest school shootings are the new norm – they’re happening so frequently that we’re getting desensitized to them – and that maybe for the people who survive, they just go back to normal life because this is just life in America. But what our study shows is that does not appear to be the case,” said Maya Rossin-Slater, a core faculty member at Stanford Health Policy and faculty fellow at the Stanford Institute for Economic Policy Research (SIEPR). “There are real consequences on an important marker of mental health.”

The study is detailed in a working paper published Monday by the National Bureau of Economic Research. It was co-authored by Rossin-Slater, an assistant professor of health policy in the Stanford School of Medicine; Molly Schnell, a former postdoctoral fellow at SIEPR now an assistant professor at Northwestern University; Hannes Schwandt, an assistant professor at Northwestern and former visiting fellow at SIEPR; Sam Trejo, a Stanford doctoral candidate in economics and education; and Lindsey Uniat, a former predoctoral research fellow at SIEPR now a PhD student at Yale University.

Their collaborative research – accelerated by their simultaneous stints at SIEPR – is the largest study to date on the effects of school shootings on youth mental health.

The study comes as the issue of gun safety continues to stoke political wrangling and public debate. And the researchers say their findings suggest policymakers should take a wide lens to their decision-making process.

“When we think about the cost of school shootings, they’re often quantified in terms of the cost to the individuals who die or are injured, and their families,” Rossin-Slater noted. “Those costs are unfathomable and undeniable. But the reality is that there are many more students exposed to school shootings who survive. And the broad implication is to think about the cost not just to the direct victims but to those who are indirectly affected.”

A Driver for Antidepressant Use

More than 240,000 students have been exposed to school shootings in America since the mass shooting in Columbine in April 1999, according to The Washington Post  data used in the study. And the number of school shootings per year has been trending up since 2015.

Yet despite this “uniquely American phenomenon” – since 2009, over 50 times more school shootings have occurred in the U.S. than in Canada, Japan, Germany, Italy, France and the United Kingdom combined – little is known about the effects of such gun violence on the mental health of the nation’s youth, the study stated.

“We know that poor mental health in childhood can have negative consequences throughout life,” Schwandt said. “At the same time, children are known to show significant levels of resilience, so it really wasn’t clear what we would find as we started this project.”

The researchers examined 44 shootings at schools across the country between January 2008 and April 2013. They used a database that covered the near universe of prescriptions filled at U.S. retail pharmacies along with information on the address of the medical provider who prescribed each drug. They compared the antidepressant prescription rates of providers practicing in areas within a 5-mile radius of a school shooting to those practicing in areas 10-to-15 miles away, looking at two years prior and two to three years after the incident.

Of those 44 school shootings, 15 of them involved at least one death. The 44 shootings occurred in 10 states: Alabama, California, Connecticut, Florida, Nebraska, North Carolina, Ohio, South Carolina, Tennessee and Texas.

Researchers found a marked increase in the rate of antidepressant prescriptions for youths nearby, but only for the shootings that were fatal. They did not see a significant effect on prescriptions for youths exposed to non-fatal school shootings.

“The immediate impact on antidepressant use that we find, and its remarkable persistence over two, and even three years, certainly constitutes a stronger effect pattern than what we would have expected,” Schwandt said.

Meanwhile, adult antidepressant use did not appear to be significantly impacted by local exposure to school shootings.

Layers of Costs, More Unknowns

The researchers also analyzed whether the concentration of child mental health providers in areas affected by fatal school shootings made a difference in the antidepressant rates, and they drilled a further comparison between the prevalence of those who can prescribe drugs, such as psychiatrists and other medical doctors, and those who cannot prescribe drugs, such as psychologists and licensed social workers.

Increases in antidepressant rates were the same across areas with both high and low concentrations of prescribing doctors, the researchers found. But in areas with higher concentrations of non-prescribing mental health providers, the increases in antidepressant use were significantly smaller – indicating perhaps a greater reliance on non-pharmacological treatments or therapy for shooting-related trauma.

The researchers also found no evidence that the rise in antidepressant usage stemmed from mental health conditions that were previously undiagnosed prior to the shootings.

In totality, the researchers say the results in the study clearly pointed to an adverse impact from a fatal shooting on the mental health of youths in the local community. Furthermore, the results capture only a portion of the mental health consequences: Non-drug related treatments could have been undertaken as well.

“Increased incidence of poor mental health is at least part of the story,” Schnell said.

Though their analysis included only 44 schools and 15 fatal school shootings, Rossin-Slater noted how the trend of school shootings is growing. She believes the mental health impact found on the local communities they studied “can be generalizable to other communities’ experiences.”

That’s all the more reason why policymakers should consider the overall negative effects of school shootings, and how further research will be needed to gauge other societal consequences, the researchers said.

“Think of it as layers of costs,” Rossin-Slater said. And when it comes to evaluating gun violence at schools, “we think our numbers say, ‘Hey, these are costly things, and it’s costlier than we previously thought.’”

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.

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.