At least 91 Americans die every day from an opioid overdose. The epidemic has claimed more than 300,000 lives since 2000 and is expected kill another half million over the next decade.

So perhaps it’s time to step up lawsuits against the drug manufacturers that sell the opioids to the tune of $13 billion per year, Stanford Health Policy’s Michelle Mello argues in a commentary in the current issue of The New England Journal of Medicine.

Mello, a professor of law and of health research and policy, and co-author Rebecca L. Haffajee, an assistant professor of health management and policy at University of Michigan School of Public Health, note that although heroin and illicitly manufactured fentanyl account for an increasing proportion of opioid overdoses, the majority of people who are addicted to opioids get hooked on prescribed painkillers.

While clinicians and health-care providers are trying to prescribe fewer opioids, Mello and Haffajee believe litigation is another crucial method to fight the crisis.

“The search for solutions has spread in many directions, and one tentacle is probing the legal accountability of companies that supply opioids to the prescription market,” the authors write.

The final report of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis details decades of aggressive marketing of oxycodone from 1997-2002 that led to a tenfold rise in prescriptions to treat moderate to severe pain. “To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis,” the report said, noting the industry had sponsored some 20,000 conferences for physicians on managing pain with opioids while claiming their potential for addiction was low.

Mello and Haffajee argue that similar to the early cigarette promotions by Big Tobacco, opioid manufacturers have failed to adequately warn patients about addition risks on drug packaging and in their marketing campaigns.

“Some recent claims allege that opioid manufacturers deliberately withheld information about their products’ dangers, misrepresenting them as safer than alternatives,” they write.

Early attempts to bring class-action suits against opioid manufacturers have encountered procedural barriers. Judges typically find that proposed class members lack sufficiently common claims because of different circumstances surrounding opioid use and clinical conditions.

But the tide may be turning. There has been an uptick in litigation against Big Pharma since Purdue Pharma, the maker of the blockbuster painkiller, OxyContin, agreed in 2007 to pay $600 million to settle charges that it misled federal regulators, doctors, and patients about the drug’s risk of addiction and its potential to be abused.

“As the population harmed by opioids grows and more information about the population is documented, it becomes easier to identify subgroups with similar factual circumstances and legal claims — for example, newborns with neonatal abstinence syndrome,” they said.

Perhaps most promising, the authors write, is the “advent of suits brought against drug makers and distributors by the federal government and dozens of states, counties, cities, and Native American tribes.

“Because the government itself is claiming injury and seeking restitution so that it can repair social systems debilitated by opioid addiction, these suits avoid defenses that blame opioid consumers or prescribers,” they said. “They also garner substantial publicity.”

The government is borrowing from the playbooks used to sue tobacco and firearms companies, relying on four strategies:

• Focus on the “public scourge” created by the opioid manufacturers due to their oversaturation of the market, arguing that opioids constitutes a public nuisance;
• Paint the opioid companies’ business practices as deceptive;
• Call out the manufacturers’ lax monitoring of suspicious opioid orders; and
• Ask courts to make companies disgorge the “unjust enrichment” they have reaped at the government’s expense through their unfair business practices.

Two large settlements have occurred in state cases that included unjust enrichment claims, the authors note, although the pharmaceutical companies avoided admitting fault. The Commonwealth of Kentucky settled with Purdue Pharma for $24 million in 2015 over allegations that it had profited while Kentucky was left paying associated medical and drug costs of those who became addicted.

Earlier this year, drug wholesaler Cardinal Health Inc. agreed to pay $20 million to settle a lawsuit brought by West Virginia’s attorney general over accusations that it flooded the market with opioids in a state that now has the highest opioid overdose rate in the nation.

Such lawsuits have garnered a lot of media attention and contributed to pressure on the U.S. government to take action against the abusive practices of drug manufacturers and distributors.

“Win or lose, lawsuits that very publicly paint the opioid industry as contributing to the worst drug crisis in American history put wind in the sails of agencies and legislatures seeking stronger oversight,” Mello and Haffajee write. “Together, litigation and its spillover effects hold real hope for arresting the opioid epidemic.”

Listen to a podcast with Haffajee talking about the opioid crisis.

Family planning programs in developing countries that offer contraceptives and reproductive health advice apparently do more than prevent pregnancies — they can keep girls in primary school for up to a year longer, even before the youngsters start to think about marriage and babies.

New research by Stanford Health Policy’s Grant Miller and Kim Singer Babiarz indicates that the availability of modern contraceptives alone can keep young girls in the classroom longer, likely because their parents develop greater expectations for their daughters’ long-term health outcomes and economic opportunities.

“What we find is that family planning exposure at a young age is linked to greater opportunities later in life – including economic empowerment,” said Babiarz, an SHP research scholar with a PhD in agricultural economics who focuses on women and children in development. “The fertility effects were modest; the most striking findings were the incentives created to keep girls in school and improvements in the types of jobs women have later in life.”

Babiarz and Miller, a senior fellow at the Freeman Spogli Institute for International Studies and director of the Stanford Center on Global Poverty and Development, unveiled their study at the annual meeting of the Center for Global Development in Washington, D.C. on Dec. 7.

They conducted research with Christine Valente, an associate professor in the department of economics at the University of Bristol and Tey Nai Peng, the principal investigator for the Malaysia Family Life Survey. The Southeast Asia nation was one of the first low-income countries to provide modern contraceptives on a large scale, first in 1954 and then establishing a National Family Planning Board in 1966.

The government then scaled up its national program between 1966 and 1974 and conducted robust surveys with retrospective life histories and detailed community-level information about the timing of family planning availability. The use of contraceptives such as the pill, condoms and IUDs, went from 3 percent in 1961 to 39 percent in 1975. The country also experienced a decrease in the fertility rate of 6.2 children to 4.3 during the same period.

The researchers were able to compare what happened to Malaysian girls who were very young when contraceptives became available in their communities to those who were adolescents when they first gained access to modern contraception. They were not surprised by the effects on fertility; that has generally been the case in countries that adopt large-scale family planning programs.

But they also found unintended incentives: that girls in communities with family planning clinics stayed in school six months longer, increasing to more than an additional year for the girls who were born after the family planning programs began. And it didn’t matter if the girls had fewer younger siblings at home.

Other benefits later in life included better jobs when they became adults. When the Malaysian girls were grown, they were more likely to take in their own elderly parents (relative to their husbands’ parents), a signal of increased status in their households. In fact, they found that the incentives for investing in girls created by family planning may actually outweigh its direct effects, which work through reductions in fertility and changes in birth timing.

“The existence of family planning and contraceptives may lead parents to believe their daughters can participate in the labor force and that more schooling will therefore benefit them,” Miller said. “In other words, it can change their expectations about the world their daughter will live in one day.”

Few studies explicitly distinguish the incentive effects of family planning on women’s education from its direct effects on fertility. Miller said he hoped the new findings might lead policymakers to consider the broader beneficial consequences of family planning beyond those that work directly through changes in pregnancy and fertility.

“A central contribution of this working paper is that it studies the possible incentive effects of family planning programs for human capital investment in girls,” the authors wrote,” which could then translate into improvements in women’s economic status throughout their lives.”

There is no denying the Affordable Care Act has significantly increased the number of Americans with health insurance. Yet many policymakers and consumers question the value of Marketplace plan coverage under the ACA because cost-sharing can get pretty high.

A survey by the Kaiser Family Foundation and The New York Times last year found that 22 percent of people who purchased health insurance through an ACA Marketplace plan had trouble paying their medical bills due to copayments, high deductibles, and co-insurance payments.

Out-of-pocket costs under a typical silver plan, for example, can be twice as high as they are in the average plan provided by employers.

So Stanford health policy researchers conducted a study, published online in Health Affairs, in which they simulated out-of-pocket spending for bronze, silver and gold Marketplace plans — those having actuarial values of 60 percent, 70 percent and 80 percent, respectively.

They found that while Marketplace plans significantly reduce exposure to the financial risk of a catastrophic illness, the use of actuarial values can be misleading. For the vast majority of consumers, the proportion of covered spending is likely to be far less than their actuarial values.

“Many Americans may find themselves not using their health insurance plan in a given year because they didn't get sick,” said Maria Polyakova, an assistant professor of health research and policy at Stanford Medicine and lead author of the paper.

In fact, only when annual health-care spending exceeds $16,500 for bronze plans, $19,500 for silver plans, and $21,500 for gold plans do plans in these metal tiers cover the proportion of costs matching their actuarial values. These metal levels are intended to provide standardized information on coverage generosity to help consumers choose among plans.

Marketplace plans provide relatively comprehensive coverage for the small proportion of people who experience extremely high health-care spending, the authors wrote. But the vast majority of enrollees experience relatively little direct benefit from their coverage in any given year because most of their services out of pocket because their expenses fall below the deductible limits.

But Polyakova, who is also a faculty research fellow at the National Bureau of Economic Research, said it’s important not to conclude that purchasing health insurance is a waste of money for the young and healthy.

“Indeed, most working-age adults do not use much health care,” she said. “The idea of health insurance, however, is to protect household finances in those cases when someone does get sick and needs expensive care. In this paper, we find that for many consumers, Marketplace plans are likely to provide valuable risk protection.”

The mismatch between expected and experienced coverage for the majority of people who have low health-care expenditures is one factor that may have inhibited enrollment in Marketplace plans among relatively healthy people, the authors wrote, a phenomenon that could have contributed to Marketplace instability.

“More generally, a weakness of using actuarial value is that doing so distracts consumers from the key purpose of insurance, which is financial risk protection,” said Polyakova and co-author Kate Bundorf, an associate professor of health research and policy and chief of the Division of Health Services Research at the Stanford School of Medicine.

“Policymakers should consider alternative ways of communicating plan generosity that more accurately convey to consumers their likely out-of-pocket spending in a plan and how much risk protection plans provide,” they wrote. “Moreover, it may be important and valuable to emphasize the risk protection value of plans in the public debate.”

One fairly easy fix, Polyakova said, would be for healthcare.gov to show consumers their expected spending under different “sick” and “healthy” scenarios. Currently, the health site asks consumers whether they expect to be sick or healthy and then shows which out-of-pocket costs would result. But it doesn't show people who expect to be healthy what would happen to their spending if they did get sick.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Prevention, Detection and Response

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

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

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

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

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

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

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

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

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

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

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

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Strengthening Global Oversight

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

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

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

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

Why should Americans care?

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

Twenty Countries at High Risk

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

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

So globalization with climate change brews the perfect storm.

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

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

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

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

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