Most of the stillbirths that occur around the world are among women who live in low- and middle-income countries. Some 2.5 million women suffer the heartbreaking loss each year.

Yet determining the causes and prevention of stillbirths has largely been ignored as a global health priority — the incidence not even included in the WHO Millennium Development Goals.

Stanford Health Policy’s Rosenkranz Prize Winner, Ashley Styczynski, MD, MPH, discovered the alarmingly high level of stillbirths while working in Bangladesh as a 2019-2020 Fogarty Fellow, studying antimicrobial resistance in newborns in the hospitals there.

The $100,000 Rosenkranz Prize is awarded to a Stanford researcher who is doing innovative work to improve health in the developing world.

“I was surprised to learn that the rates of stillbirths were comparable to sub-Saharan Africa and that in many cases they had no idea of the cause,” Styczynski said in a Skype call from Dhaka, where she has been living for eight months while conducting her antimicrobial resistance research.

Rosenkranz Prize Winner Ashley Styczynski takes specimen samples with women in Dhaka, Bangladesh, for her research on antimicrobial resistance in newborns. This research led to her prize-winning proposal to investigate the alarmingly high rate of stillbirths in the South Asian nation.

The South Asian nation is among the top 10 countries with the highest number of stillbirths, with an average of 25.4 stillbirths per 1,000 births. Studies have implicated maternal infections as the cause; one ongoing study in Bangladesh has recovered bacteria from blood samples in stillborn babies in whom no prior maternal infection was suspected.

Styczynski believes intrauterine infections may be an underrecognized factor contributing to the excess stillbirths in Bangladesh. She intends to perform metagenomic sequencing on placental tissues of stillborn babies, a process that will allow her to examine the genes in the organisms of those tissues and evaluate the bacterial diversity.

“The alternative hypothesis would be that stillbirths are caused by non-infectious etiologies, which I will be assessing through interviews,” Styczynski wrote in her Rosenkranz application.

Those interviews will be with mothers to evaluate for frequency of infectious symptoms during pregnancy, including fever, rash, cough, dysuria and diarrhea, as well as possible toxin exposures. She will compare the findings with the metagenomic sequencing results to determine how frequently potential pathogens may be presenting as subclinical infections.

“By applying advanced technologies and software platforms, this research will not only enhance our understanding of causes of stillbirths in Bangladesh, but it may also provide insights into causes of early neonatal deaths," Styczynski said.

Bangladesh, one of the poorest and most densely populated nations in the world, offers a rich variety of emerging and known diseases that go undetected.

“The panoply of infections that could contribute to stillbirths is really unknown,” Styczynski said. “That’s why metagenomics is a great tool here. It just hasn’t been accessible here because of the expense. Now this tool will begin to unpack what’s causing these stillbirths.”

The Rosenkranz Prize was started and endowed by the family of the late Dr. George Rosenkranz, who devoted his career to improving health-care access across the world and helped synthesize the active ingredient for the first oral birth control pill.

“No one is more deserving of the Rosenkranz Prize than Dr. Ashley Styczynski”, said Dr. Ricardo Rosenkranz. “Because of her tenacity, originality and focus, Dr. Styczynski exemplifies the ideal Rosenkranz Prize recipient. She has chosen an often overlooked adverse outcome that may prove to be mitigated by her findings. As a neonatologist interested in health disparities, I fully realize the potential relevance and urgency of her work and am excited to see it come to fruition. As the son of George Rosenkranz, for whom this prize is lovingly named, I know that my father would appreciate Dr. Styczynski’s pioneering spirit as well as her desire to affect global positive change by improving medical outcomes in vulnerable communities. We can’t wait to celebrate her work back at Stanford in the near future."

Sheltering in Place

Styczynski spoke from her flat in Dhaka, where she has been confined for three weeks as the world’s third-most populated city prepares for the onslaught of the coronavirus. The country is on lockdown; no international flights in or out.

As of Thursday, there were 1,572 cases in Bangladesh and 60 deaths, according to the widely used Johns Hopkins Coronavirus Map.

But Styczynski believes that’s about 1% of the actual disease activity in the country because testing was so slow to start. She said there is great stigma in the country over testing — red flags are put on the homes of those who have been diagnosed with COVID-19 — because it breaks up the unity of families and the surrounding community. Health-care workers are being kicked out of apartments by frightened landlords and people are afraid to use the health-care system for fear of infection.

“So, the hospitals are quite empty — more so than they’ve ever been,” she said.

Styczynski likened it to waiting for the tsunami that you know is coming.

“That’s why I wanted to jump in to stave off the morbidity and mortality that will be inundating one of the most populated countries in the world,” she said. Some 165 million people are packed into 50,250 square miles — a land mass about the same size as New York State, which has some 19.5 million people.

Ashley Styczynski goes through a thermoscanner was when I was testing out the triage system at an upazila health complex.

The Centers for Disease Control and Prevention (CDC) has a small team of four people working in Bangladesh. Having spent two years as an Epidemic Intelligence Service Officer at the CDC, Styczynski has now joined its Bangladesh team and is also working with the infection prevention and control team of the International Centre for Diarrhoeal Disease Research, Bangladesh.

“Many people here in Dhaka live in high-density apartments with six to 12 people living in the same room,” she said. “How do you isolate when you have a one-room home?”

Ninety percent of the population are daily wage earners, Styczynski noted, who say they’d rather take their chances with coronavirus than die of starvation.

They take those chances at great risk. There is one ventilator for every 100,000 people in Bangladesh and the district hospitals have maybe one to two days of oxygen supply, Styczynski said.

They started out training military hospitals on medical triage, quarantine and isolation, and infection prevention strategies.

“We’ve also been going to some district hospitals to assess some of the challenges they are facing and to identify some of the gaps in preparedness so that we can communicate back to the Ministry of Health how they can better support these district hospitals,” she said.

Her pandemic travels to the district hospitals and preparedness work has allowed her to gather contextual data for her colleagues back at Stanford who are working to address the lack of personal protective equipment (PPE) in low-resourced countries.

“We hope we can generate some evidence very quickly so that we can share some of this information to better protect health-care workers in other low-resource countries,” she said.

Despite her research being temporarily sidelined, Styczynski is upbeat.

“This is what I signed up for as a Fogarty fellow, to help build local capacity,” she said. “But I am also an infectious disease specialist, and these are the types of situations we run towards rather than away from. We build our career for moments like these.”

Stanford Health Policy's Eran Bendavid and Jay Bhattacharya write in this Wall Street Journal editorial that current estimates about the COVID-19 fatality rate may be too high by orders of magnitude.

"If it’s true that the novel coronavirus would kill millions without shelter-in-place orders and quarantines, then the extraordinary measures being carried out in cities and states around the country are surely justified. But there’s little evidence to confirm that premise—and projections of the death toll could plausibly be orders of magnitude too high.

"Fear of Covid-19 is based on its high estimated case fatality rate — 2% to 4% of people with confirmed Covid-19 have died, according to the World Health Organization and others. So if 100 million Americans ultimately get the disease, 2 million to 4 million could die. We believe that estimate is deeply flawed. The true fatality rate is the portion of those infected who die, not the deaths from identified positive cases."

"The latter rate is misleading because of selection bias in testing. The degree of bias is uncertainbecause available data are limited. But it could make the difference between an epidemic that kills 20,000 and one that kills 2 million. If the number of actual infections is much larger than the number of cases—orders of magnitude larger—then the true fatality rate is much lower as well. That’s not only plausible but likely based on what we know so far."

Read the Editorial 

As the deaths and detected cases from the COVID-19 epidemic continue to rise globally, government planners and policymakers require projections of its future course and impacts. They also need to understand how potential interventions might “flatten the curve.”

“It’s important to understand these overall effects by geographic area, demographic group, and for special populations like health-care workers,” says Stanford Health Policy’s Jeremy Goldhaber-Fiebert, who will be teaching a new class in the spring on infectious disease modeling with Stanford Medicine’s Jason Andrews. “Doing this requires mathematical models that incorporate the best available clinical, epidemiological, and policy data along with their associated uncertainties — the state-of-the-art of infectious disease modeling.”

Goldhaber-Fiebert and Andrews will debut the new course, Models for Understanding and Controlling Global Infectious Diseases (HUMBIO 154D for undergrads and HRP204 for graduate students) in the upcoming spring quarter. Stanford Provost Persis Drell announced last week that all spring courses at the university will now be taught online and pushed the start of the new quarter April 6.

Andrews is an infectious disease physician and assistant professor of medicine and Goldhaber-Fiebert, an associate professor of medicine, is a decision scientist.

The class will enable students to become critical consumers of studies using infectious disease modeling and to learn the building blocks for constructing infectious disease models themselves.

Despite the course being new and listed in the middle of winter quarter, they have seen enrollment rise from eight — prior to the rise of COVID-19 in the U.S. and its direct impacts on Stanford’s operations — to nearly 30 students as of March 22.

“Together Jason and I are leading one of several efforts on COVID-19 modeling here in Stanford,” said Goldhaber-Fiebert. “And we anticipate that the course will increase the number of Stanford students with the necessary skills to contribute to Stanford’s leadership in this area.”

Updated January 24
Millions of residents in China are under lockdown measures as the number of reported deaths from the coronavirus outbreak rises to 26. In the United States, dozens of people are being monitored for the virus. The World Health Organization on January 23 said at a press conference the outbreak did not yet constitute a global public health emergency.

The outbreak of a novel coronavirus that began in December 2019 in Wuhan, China “is evolving and complex,” said the head of the World Health Organization (WHO) after its emergency committee convened on Wednesday, January 22, and decided that more information was needed before the WHO declares whether or not the outbreak is a public health emergency of international concern. The new virus, known as 2019-nCoV, causes respiratory illness and continues to spread across China. Chinese health authorities, reports the Washington Post, announced that at least 17 people have now died as a result of infection and confirmed cases have been reported in Japan, Thailand, South Korea, Hong Kong, and Macao, with one travel-related case detected in the United States, in the State of Washington. The WHO decision was made as the city of Wuhan shut down all air and train traffic to try to contain the spread of the virus.

With concern over and coverage of the situation rapidly developing, Karen Eggleston, APARC Deputy Director and the Asia Health Policy Program Director at the Shorenstein Asia-Pacific Research Center, offered her insights on the outbreak and its impact on both Asian and international healthcare systems.

Q: Why has this outbreak raised so much concern in China and internationally, and how worried should people be about it?

Infectious disease outbreaks can challenge any health system. Events such as SARS, Ebola, and MERS outbreaks, and even the devastating flu pandemic a century ago, remind us of the frightening power that infectious diseases with high-case fatality can have. The global burden of mortality and morbidity is mostly from non-communicable chronic diseases, but no country or society is immune to old, newly emerging, and re-emerging infectious diseases. And although health systems are generally stronger now and have more technologies to trace and contain outbreaks, there are also deep and complicated challenges that make swift, coordinated disease response difficult even in the modern era.

Any government leadership or healthcare responders who have tried to manage an outbreak situation before are hyper-aware of the need to prepare for and manage future incidents, but we are living in a moment of very complicated social dynamics surrounding public health and healthcare. Distrust in drug companies and government agencies, controversies over vaccines, and increasing skepticism in science, even if only from vocal minorities, all make it more difficult to manage a cohesive international response to an outbreak situation and protect vulnerable people.

Q: As you’ve mentioned, many people looking at this situation with the memory of outbreaks such as SARS or H1N1 in mind. How is the Chinese government addressing this crisis and how does its reaction compare with China’s history of emergency health responses?

China’s health system is much more prepared now, compared to the SARS crisis 17 years ago. More training and investment in primary health care, disease surveillance and technology systems for tracking and monitoring outbreaks, and the achievement of universal health coverage with improving catastrophic coverage even for the rural population, all suggest a health system that is much better prepared to handle a situation like this. Top-level leadership in China had already begun to publicly address the situation within days of the outbreak to assure the public that strict prevention measures will be taken and to urge local officials to take responsibility and share full information. Until more information is gained and more is understood about the nature of this virus, it’s been categorized as a “Grade B infectious disease” but will be managed as if it is a "Grade A infectious disease," which requires the strictest prevention and control measures, including mandatory quarantine of patients and medical observation for those who have had close contact with patients, according to the commission. China currently only classifies two other diseases as Grade A infection diseases—bubonic plague and cholera—and so that tells you something about how seriously this is being treated by those in leadership positions.

Q: And what about the response from the international health communities?

As with any major healthcare crisis, health systems around the globe must also respond with alacrity and integrity, including effective surveillance, monitoring, and infection control. Individuals also play a crucial role in supporting the instructions and recommendations made by established healthcare professionals. For example, the individual with the confirmed case in Washington State proactively told medical personnel about his recent visit to the Wuhan area. His medical providers then exercised appropriate levels of caution, given the unknown nature of the virus, and isolated him while his symptoms developed. He is currently combatting an infection similar in severity to that of mild pneumonia, and so far no other cases have been reported in the United States, though some may arise in the coming days and weeks.

There is always a fine balance between safeguarding public health while still respecting individual rights, civil liberties, and undertaking a prudent, scientific response. The aim is to remain clear and transparent in communications and actions without reverting to disproportionate or overly aggressive responses which lead to panic, distortion, and misinformation about the situation. Some countries, like the Democratic People’s Republic of Korea, may choose to seal their international borders until more is understood about the nature of this virus, but most nations will use tried-and-tested methods of monitoring travelers and alerting population health systems so that information about cases is widely available to health authorities and medical researchers trying to understand the cause and develop a potential cure.

Q: As this situation continues to develop, and with inevitable future disease outbreaks around the globe, what would you hope people keep in mind about the role we all play in healthcare crises and in public health?

One issue this outbreak reminds us of in a visceral and intimate way is how closely people are linked together across the world. Globalization and air travel almost instantaneously link continents, countries, and regions. The timing of this outbreak is particularly fraught, because it’s the beginning of the Lunar New Year, when there is a vast migration of people both within China, throughout greater Asia, and across the globe as massive populations go home to celebrate the holidays with family. The potential for a contagious disease to spread easily through crowds and across borders in circumstances like this is very high, and highlights the need for the international communities to share information, scientific expertise, and understanding.

We need to remember that this is not just a problem in a remote part of the world that has no impact on those of us who live in relative comfort in high-income countries. Rather, this is something that could easily impact anyone. Perhaps this latest outbreak and response will showcase how vital additional, ongoing investments in both domestic and international healthcare systems, technologies, and people are.

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 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.

Most studies that look at whether democracy improves global health rely on measurements of life expectancy at birth and infant mortality rates. Yet those measures disproportionately reflect progress on infectious diseases — such as malaria, diarrheal illnesses and pneumonia — which relies heavily on foreign aid.

A new study led by Stanford Health Policy's Tara Templin and the Council on Foreign Relations suggests that a better way to measure the role of democracy in public health is to examine the causes of adult mortality, such as noncommunicable diseases, HIV, cardiovascular disease and transportation injuries. Little international assistance targets these noncommunicable diseases. 

When the researchers measured improvements in those particular areas of public health, the results proved dramatic.

“The results of this study suggest that elections and the health of the people are increasingly inseparable,” the authors wrote.

A paper describing the findings was published today in The Lancet. Templin, a graduate student in the Department of Health Research and Policy, shares lead authorship with Thomas Bollyky, JD, director of the Global Health Program at the Council on Foreign Relations.

“Democratic institutions and processes, and particularly free and fair elections, can be an important catalyst for improving population health, with the largest health gains possible for cardiovascular and other noncommunicable diseases,” the authors wrote.

Templin said the study brings new data to the question of how governance and health inform global health policy debates, particularly as global health funding stagnates.

“As more cases of cardiovascular diseases, diabetes and cancers occur in low- and middle-income countries, there will be a need for greater health-care infrastructure and resources to provide chronic care that weren’t as critical in providing childhood vaccines or acute care,” Templin said.

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Free and fair elections for better health

In 2016, the four mortality causes most ameliorated by democracy — cardiovascular disease, tuberculosis, transportation injuries and other noncommunicable diseases — were responsible for 25 percent of total death and disability in people younger than 70 in low- and middle-income countries. That same year, cardiovascular diseases accounted for 14 million deaths in those countries, 42 percent of which occurred in individuals younger than 70.

Over the past 20 years, the increase in democratic experience reduced mortality in these countries from cardiovascular disease, other noncommunicable diseases and tuberculosis between 8-10 percent, the authors wrote.

“Free and fair elections appear important for improving adult health and noncommunicable disease outcomes, most likely by increasing government accountability and responsiveness,” the study said.

The researchers used data from the Global Burden of Diseases, Injuries, and Risk Factors Study; V-Dem; and Financing Global Health databases. The data cover 170 countries from 1970 to 2015.

What Templin and her co-authors found was democracy was associated with better noncommunicable disease outcomes. They hypothesize that democracies may give higher priority to health-care investments.

HIV-free life expectancy at age 15, for example, improved significantly — on average by 3 percent every 10 years during the study period — after countries transitioned to democracy. Democratic experience also explains significant improvements in mortality from cardiovascular disease, tuberculosis, transportation injuries, cancers, cirrhosis and other noncommunicable diseases, the study said.

Watch: Some of the authors of the study discuss the significant their findings: 

What Templin and her co-authors found was democracy was associated with better noncommunicable disease outcomes. They hypothesize that democracies may give higher priority to health-care investments.

HIV-free life expectancy at age 15, for example, improved significantly — on average by 3 percent every 10 years during the study period — after countries transitioned to democracy. Democratic experience also explains significant improvements in mortality from cardiovascular disease, tuberculosis, transportation injuries, cancers, cirrhosis and other noncommunicable diseases, the study said.

Foreign aid often misdirected

And yet, this connection between fair elections and global health is little understood.

“Democratic government has not been a driving force in global health,” the researchers wrote.  “Many of the countries that have had the greatest improvements in life expectancy and child mortality over the past 15 years are electoral autocracies that achieved their health successes with the heavy contribution of foreign aid.”

They note that Ethiopia, Myanmar, Rwanda and Uganda all extended their life expectancy by 10 years or more between 1996 and 2016. The governments of these countries were elected, however, in multiparty elections designed so the opposition could only lose, making them among the least democratic nations in the world.

Yet these nations were among the top two-dozen recipients of foreign assistance for health.

Only 2 percent of the total development assistance for health in 2016 was devoted to noncommunicable diseases, which was the cause of 58 percent of the death and disability in low-income and middle-income countries that same year, the researchers found.

“Although many bilateral aid agencies emphasize the importance of democratic governance in their policy statements,” the authors wrote, “most studies of development assistance have found no correlation between foreign aid and democratic governance and, in some instance, a negative correlation.”

Autocracies such as Cuba and China, known for providing good health care at low cost, have not always been as successful when their populations’ health needs shifted to treating and preventing noncommunicable diseases. A 2017 assessment, for example, found that true life expectancy in China was lower than its expected life expectancy at birth from 1980 to 2000 and has only improved over the past decade with increased government health spending. In Cuba, the degree to which its observed life expectancy has exceeded expectations has decreased, from four-to-seven years higher than expected in 1970 to three-to-five years higher than expected in 2016.

“There is good reason to believe that the role that democracy plays in child health and infectious diseases may not be generalizable to the diseases that disproportionately affect adults,” Bollyky said. Cardiovascular diseases, cancers and other noncommunicable diseases, according to Bollyky, are largely chronic, costlier to treat than most infectious diseases, and require more health care infrastructure and skilled medical personnel.  

The researchers hypothesize that democracy improves population health because:

1. When enforced through regular, free and fair elections, democracies should have a greater incentive than autocracies to provide health-promoting resources and services to a larger proportion of the population;
2. Democracies are more open to feedback from a broader range of interest groups, more protective of media freedom and might be more willing to use that feedback to improve their public health programs;
3. Autocracies reduce political competition and access to information, which might deter constituent feedback and responsive governance.

Various studies have concluded that democratic rule is better for population health, but almost all of them have focused on infant and child mortality or life expectancy at birth.

Over the past 20 years, the average country’s increase in democracy reduced mortality from cardiovascular disease by roughly 10 percent, the authors wrote. They estimate that more than 16 million cardiovascular deaths may have been averted due to an increase in democracy globally from 1995 to 2015. They also found improvements in other health burdens in the countries where democracy has taken hold: an 8.9 percent reduction in deaths from tuberculosis, a 9.5 percent drop in deaths from transportation injuries and a 9.1 percent mortality reduction in other noncommunicable disease, such as congenital heart disease and congenital birth defects.

“This study suggests that democratic governance and its promotion, along with other government accountability measures, might further enhance efforts to improve population health,” the study said. “Pretending otherwise is akin to believing that the solution to a nation’s crumbling roads and infrastructure is just a technical schematic and cheaper materials.”

The other researchers who contributed to the study are Matthew Cohen, Diana Schoder, Joseph Dieleman and Simon Wigley, from CFR, the University of Washington-Seattle and Bilkent University in Turkey, respectively.

Funding for the research came from Bloomberg Philanthropies and the Bill & Melinda Gates Foundation. Stanford’s Department of Health Research and Policy also supported the work.

The Trump administration has proposed a new rule that would require direct-to-consumer TV advertisements for prescription drugs to disclose the price of their products.

The Centers for Medicare & Medicaid Services (CMS) said the disclosures would help consumers “make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid, both of which are significant problems.”

The idea enjoys broad public support, since medical care and drug costs continue to skyrocket.  A U.S. Senate report earlier this year revealed that the cost of the 20 most commonly prescribed brand-name drugs have risen tenfold in the past five years.

In a June 2018 poll, 76 percent of Americans favored required drug advertisements to include a statement about how much the drugs cost.

But Michelle Mello, a Stanford Law School professor and Stanford Medicine professor of health research and policy, writes in this New England Journal of Medicine perspective that the proposed rule raises substantial public health and legal concerns.

A potential unintended consequence of price disclosure may be to dissuade patients from seeking care, writes Mello and her co-author, Stacie B. Dusetzina of Vanderbilt University School of Medicine, because of the perception that they cannot afford treatment. For example, Trulicity, a widely advertised drug for type 2 diabetes has a list price of $730 a month.

“Patients who could benefit from diabetes treatment may assume that they cannot afford it, when in fact insured patients’ costs for Trulicity may be much lower, and cheaper treatment options available,” they write. Metformin, for instance, costs $4 per month for patients who pay cash.

CMS would demand drug makers use the list prices from the Wholesale Acquisition Cost (WAC) in their television ads, including that costs “may be different” for those who are insured.

“This wording doesn’t communicate that costs to patients are probably much lower than the WAC,” writes Mello, a core faculty member at Stanford Health Policy.

This could have important legal implications as well, as compelled disclosures in advertising impinge on commercial speech protected by the First Amendment. Furthermore, they write, “disagreement about whether the WAC accurately represents a drug’s price could affect how courts assess the rule when constitutional challenges are inevitably filed.”

The researchers say three aspects of the proposed rule undercut the government’s ability to argue that it would improve patient decision-making and reduce drug spending: 

1. Price information does little to inform consumer decisions if it inaccurately represents actual cost.
2. Consumers can already obtain information on cash prices online and their own cost from their insurer.
3. The rule contains no meaningful enforcement mechanism; CMS plans only to list violators on its website, calling into question whether companies will comply.

“We think that a better alternative would be making patient-specific cost information accessible at the point of prescribing, “ the authors write. 

The cost of prescription drugs should become a routine part of clinician-patient discussions, although they acknowledge that this would put more time constraints on medical practices.

“Providing salient cost information at the right time could help reduce drug spending while preserving patient choice, but we believe that direct-to-consumer advertising is the wrong vehicle,” they write.