Despite potential legal and enforcement challenges, California’s new vaccination law may set a precedent for other states, according to Stanford scholars.

The law, SB 277, ends exceptions to vaccination mandates based on religious and philosophical beliefs, leaving only medical exemptions as a path to avoid the vaccinations children are required to have before entering school.

David Studdert, a core faculty member at the Center for Health Policy/Center for Primary Care and Outcomes Research, and Michelle Mello, a core faculty member of Health Research and Policy, authored a report on the new law along with Northwestern Law School’s Wendy Parmet, which appears today in the New England Journal of Medicine. Studdert and Mello are both professors of law and medicine at Stanford.

Studdert, Mello, and Parmet discuss four factors that led to passage of the law. Strong advocacy by several members of the California legislature was one factor.  Another was the state’s efforts to publicize data showing that personal belief exemptions have doubled since 2007, enough to endanger the community. In addition, there is mounting evidence that the recent measles outbreak at Disneyland could have been prevented by better vaccination compliance. Finally, supporters of SB 277 highlighted the risks unvaccinated school children pose to vulnerable classmates. According to the report, “the bill’s proponents focused on the specific threat to schoolchildren who are too medically fragile to receive vaccinations, effectively framing vaccine refusal as a decision that endangers others rather than a purely ‘personal’ one.”

SB 277 could place pressure on other states to tighten their exemptions for school-entry vaccination requirements. At this time, only West Virginia and Mississippi have legislation that prevents personal belief exemptions for vaccination. Adding California may give such laws national attention, and Studdert said that this development may be an “indication that politics are starting to shift.”

However, opponents of the law are likely to challenge it in court. Challengers may argue that the law impinges on their First Amendment rights to free exercise of religious beliefs or that it violates unvaccinated children’s right to access public schools.  However, Studdert “would be very surprised if SB 277 ends up being struck down as a result of such challenges.”  In the past, courts have ruled in favor of public health agencies in similar cases. “For over a century, appellate courts accepted arguments that mass vaccination is crucial to the well-being of the community.”

A more difficult challenge is enforcement of the law. Unvaccinated children can still attend school as long as their parents pledge to complete the children’s required vaccinations, and schools are not penalized for failing to follow up. The authors argue that “state laws should instead task health departments with enforcement responsibility for vaccination mandates” in order to boost compliance. “Willing providers,” or doctors who sympathize with vaccination opponents, may also undermine enforcement if they choose a broad interpretation of the medical exemption criteria. Other ways around the stricter requirements include home-schooling and nannies. This would not affect school safety but could have implications for the larger community.

Rates of obesity in the United States remain extremely high. New statistics show that nearly two-thirds of adults are at an unhealthy weight and that – for the first time ever – obese Americans now outnumber those who are merely overweight.

Two Stanford public health law experts say one of biggest culprits of the obesity epidemic – on top of fast foods and our sedentary lifestyle – are sugary drinks.

And they believe the sweet spot for public health law in curbing the adverse effects of sugar-sweetened beverages (SSBs) lies in the strategic use of measures such as higher SSB taxes, limits on advertisements targeting kids, and restrictions on soft drinks and sugar-sweetened teas and sports drinks in government institutions, such as public schools.

“It’s always possible to get more and better evidence about the effectiveness of public health laws,” says David Studdert, a professor of medicine at the Stanford School of Medicine, professor at the Stanford Law School and core faculty member at the Center for Health Policy/Center for Primary Care and Outcomes Research.

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“But enough is already known about the promise of some legal interventions to curb SSB consumption – significant tax hikes and advertising restrictions are two good examples – to be fairly confident that they would make a difference.”

Studdert is the lead author of a review paper published July 7 in PLoS Medicine, entitled, “Searching for Public Health Law’s Sweet Spot: The Regulation of Sugar-Sweetened Beverages.”

Studdert and senior author Michelle Mello, professor of law and professor of health research and policy at the School of Medicine, and co-author Jordan Flanders, a former Stanford Law School student, argue that sugary drinks are a substantial, yet preventable contributor to the global burden of obesity and associated health conditions.

A new study published June 29 in the American Heart Association journal Circulation linked the consumption of sugary drinks to an estimated 184,000 adult deaths each year, with more than 25,000 of those Americans. The study, conducted by researchers from Tufts University, found that the beverages are responsible for an estimated 133,000 of those deaths from diabetes, 45,000 from cardiovascular disease and 6,450 from cancer.

While Americans’ consumption of sugary drinks has plateaued, according to the Tufts study, about three-fourths of the deaths due to SSBs are now in developing countries. Mexico leads with 24,000 total deaths. The United States still ranks fourth, however, just behind South Africa and Morocco.

The Stanford researchers say the evidence shows that sugary drinks are contributors to the global obesity epidemic, but the appropriate reach of regulation to curtail SSB consumptions remains highly contested.

The main regulatory approaches to SSBs are higher taxes, restrictions on the availability of the sugar-sweetened drinks in schools, restrictions on advertising and marketing, labeling requirements and government procurement and benefits standards.

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“Finding public health law’s sweet spot requires regulatory approaches that are capable both of achieving measurable improvements to public health and of winning victories in courts of law and public opinion,” the researchers write.

Over the last decade, many national, state, and local governments have introduced laws aimed at curbing consumption of sugar-sweetened beverages (SSBs), especially by children. The main regulatory approaches have been taxes, restrictions on the availability of SSBs in schools, calls for controls on advertising and marketing, labeling requirements, and government procurement and benefits standards.

But efforts to regulate the drinks often encounter stiff opposition, including claims that the laws are inequitable, do not achieve their goals, and have negative economic effects.

New York City’s attempt to ban the sale of jumbo-sized sugary drinks sold in city restaurants, theaters and food carts triggered international headlines and a firestorm of opposition. The soft drink industry embarked on a multimillion-dollar campaign to block the proposal championed by former Mayor Michael Bloomberg.

The proposal died last year when the New York State Court of Appeals ruled that the city’s Board of Health had “exceeded the scope of its regulatory authority.”

Taxes on SSBs, the most commonly adopted measure, vary widely, the authors write. A few countries, most notably several South Pacific island nations, where obesity rates are among the highest in the world, have introduced very high taxes on sugary drinks.

But most sugar-sweetened beverage taxes add between 5 and 9 cents per liter. This is well short of the level that experts argue is needed to significantly affect consumption and weight outcomes: a sales tax of at least 20 percent of the container’s price or a specific excise tax of 1 cent per ounce.

“In the United States, there have been many government proposals to introduce or raise taxes – most unsuccessful,” the authors write. “The beverage industry has invested heavily in public relations firms and `grassroots’ organizations to oppose the initiatives.”

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Berkeley, Calif., recently became the first U.S. city to pass an SSB tax, a penny-per-ounce excise on soda distributors, but a similar ballot measure in nearby San Francisco failed. At least 22 states have proposed SSB taxes since 2010, but only one state, Washington, passed a measure at the level recommended by economists – and it was repealed the following year in a voter referendum.

Yet U.S. childhood obesity has more than doubled in children and quadrupled in adolescents in the past 30 years, according to the Centers for Disease Control and Prevention. More than one-third of children and adolescents are overweight or obese.

“There is broad consensus in the public health community that reducing the influence of advertising is a critical step in addressing the spread of childhood obesity,” the authors say.

The United States and Canada have sought to regulate advertisers through a soft approach — mainly via voluntary guidelines and pressure to self-regulate, the authors write.

“These appear to have had only a modest impact on marketing practices,” they said. “U.S. regulators face considerable legal barriers in going further, including courts’ increasingly expansive interpretations of the scope of protected commercial speech under the First Amendment. Unless judicial currents shift, it will remain extremely difficult to impose restrictions on SSB advertising.”

Mello said low- and middle-income countries should anticipate that SSB companies will increasingly target them as promising markets, and that those developing countries should start crafting their regulatory responses now.

“Our experience with tobacco control teaches us that lower- and middle-income countries need to become wary when product regulation in the U.S. tightens,” Mello said. “Like squeezing a balloon, it pushes companies to intensify their marketing efforts overseas, and our public health problems get exported."

And, the authors note, while policy nudges have become fashionable, “there are dangers in treading too lightly.” “Strategies such as calorie labels, portion caps, and small beverage taxes preserve consumer freedom but are typically too modest to affect consumer behavior – and such modesty can be recast as arbitrariness. Industry opposition will come whether the intervention is modest or aggressive but should be easier to combat if officials can show their policy is effective,” they wrote.

“One somewhat surprising message that comes from reviewing how courts have handled challenges to SSB laws is that regulators can run greater risks of having their laws struck down if they are too timid,” Studdert said.

“Courts weigh effectiveness, and modest attempts to change behavior are often ineffective,” he said. “So one piece of advice regulators in this area should consider is to ‘go big or go home’.”

“I am the first child of my parents. I have a small brother at home. If the first child were a son, my parents might be happy ... but I am a daughter. I complete all the household tasks, go to school, again do the household activities in the evening … my parents do not give value or recognition to me.”

Stanford Assistant Professor of Medicine Marcella Alsan often refers to this comment by a 15-year-old girl from Nepal when she talks about how the division of labor among men and women starts at a young age in the developing world.

“Anecdotally, girls must sacrifice their education to help out with domestic tasks, including taking care of children, a job that becomes more onerous if their younger siblings are ill,” said, Alsan, a core faculty member at the Center for Health Policy/Center for Primary Care and Outcomes Research (CHP/PCOR) within the Freeman Spogli Institute of International Studies, and the Department of Medicine.

More than 100 million girls worldwide fail to complete secondary school, despite research that shows a mother’s literacy is the most robust predictor of child survival. So Alsan is analyzing whether medical interventions in children under 5 tend to lead their older sisters back to school.

She is one of two winners of this year’s Rosenkranz Prize for Health Care Research in Developing Countries, awarded by CHP/PCOR to promising young Stanford researchers.

Her Stanford Department of Medicine colleague, Jason Andrews, is the other recipient of the $100,000 prize given to young Stanford researchers to investigate ways to improve access to health care in developing countries.

Andrews is looking at cheap, effective diagnostic tools for infectious diseases, while Alsan is researching how older girls in poorer countries are impacted by the health of their younger siblings.

“My proposed work lays the foundation for a more comprehensive understanding of how illness in households and early child health interventions impact a critical determinant of human development: an older girl’s education,” she said.

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Alsan, the only infectious-disease trained economist in the United States, said Stanford is the ideal place to carry out her interdisciplinary global health research.

“I am humbled and honored to receive this prize, since Dr. Rosenkranz has done so much for women’s health worldwide,” she said.

Alsan – an MD with a specialty in infectious disease who has a PhD in economics from Harvard – said she intends to estimate the impact that illnesses in under-5 children have on older girls’ schooling using econometric tools.

She will compile data from more than 100 Demographic and Health Surveys (DHS) covering nearly 4 million children living in low- and middle-income countries.

The surveys ask about episodes of diarrhea, pneumonia and fever in children under 5 and record data on literacy and school enrollment for every child in the household.

Alsan also intends to collaborate with partners in sub-Saharan Africa to study the gendered effect of household illness on time use, using culturally appropriate questionnaires.

Douglas K. Owens, a Stanford professor of medicine and director of CHP/PCOR, called Alsan’s work “groundbreaking.”

“Although training is critical, more importantly, her work to date shows a degree of innovation, creativity and rigor that led us to conclude she was likely to become one of the top investigators in her field worldwide,” he said.

Low-Cost Diagnostic Tools

Andrews, also an assistant professor of medicine, has been working on ways to bring low-cost diagnostic tools to impoverished communities that bear the brunt of disability and death from infectious disease.

“I began working in rural Nepal as an undergraduate student and as a medical student founded a nonprofit organization that provides free medical services in one of the most remote and impoverished parts of the country,” Andrews said. “As I became a primary physician, and then an infectious diseases specialist, one of the consistent and critical challenges I encountered in this setting was routine diagnosis of infectious disease.”

He said those routine diagnostics were typically hindered by lack of electricity, limited laboratory infrastructure and lack of trained lab personnel.

“In my experiences working throughout rural Nepal – and in India, South Africa, Brazil, Peru and Ethiopia – I found these challenges to be common across rural resource-limited settings,” said Andrews, who founded a nonprofit Nyaya Health – recently renamed Possible Health – which provides modern, low-cost healthcare to rural Nepal.

Andrews has been collaborating with engineers to develop an electricity-free, culture-based incubation and identification system for typhoid; low-cost portable microscopes to detect parasitic worm infections; and most recently an easy-to-use molecular diagnostic tool that does not require electricity.

“The motivation for these projects was not to develop fundamentally new diagnostic approaches, but rather to find simple, low-cost means to make established laboratory techniques affordable and accessible,” he said.

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“We then perform isothermal amplification heated by a reusable, solar-heated, phase-change material,” Andrews said, adding that the entire process is completed in less than 20 minutes and can be performed by anyone with minimal training.

Andrews will enroll 250 patients with suspected cases of cholera in Nepal, using the new diagnostic tools and adapting as many local supplies as possible.

Andrews also intends to establish and curate a website to gather open-source ideas and evidence on diagnostic techniques for use in the developing world.

“Stanford is one of the world’s greatest hubs for innovation and information sharing as pertains to science and technology and is an ideal home for this venture,” he said.

In the current scientific climate, most National Institutes of Health grants go to established researchers. The Rosenkranz Prize aims to stimulate the work of Stanford’s bright young stars – researchers who have the desire to improve health care in the developing world, but lack the resources.

The award’s namesake, George Rosenkranz, first synthesized cortisone in 1951, and later progestin, the active ingredient in oral birth control pills. He went on to establish the Mexican National Institute for Genomic Medicine, and his family created the Rosenkranz Prize in 2009.

The award embodies Dr. Rosenkranz’s belief that young scientists hold the curiosity and drive necessary to find alternative solutions to longstanding health-care dilemmas.

“As in past years, the competition was extremely tough,” said Grant Miller, a senior fellow at the Freeman Spogli Institute and associate professor of medicine who chaired the prize committee this year.

“It’s exciting to see all of the truly innovative global health research being done by junior scholars at Stanford,” he said. “Both Jason and Marcella really exemplify this – and the legacy of George Rosenkranz.”

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Thought leaders from several disciplines recently gathered at the Stanford campus for the inaugural ChildX conference to discuss how to solve health problems in pregnancy, infancy and childhood. One session focused on the future of child health in an aging America and featured Stanford health policy expert and CHP/PCOR faculty Paul Wise, who discussed the evaporation of child health policy in the U.S.

In this podcast, he talks about how health policy has turned into cost-containment policy, spelling trouble for children and child health. 

Wise also addressed the conference on the future of child health policy in the United States.

As the new director of the Center for Policy, Outcomes and Prevention (CPOP), C. Jason Wang’s goal is to improve child health by bringing people together. Since Paul Wise founded the center 10 years ago, CPOP has shaped child health policy by trying to make effective healthcare not only available but easily accessible to everyone. By creating preventive strategies to decrease the risk of getting sick and to avert complications so that patients can return to their former quality of life, CPOP aims to improve quality of care and to make people healthier overall. Wang wants to further promote these goals by encouraging scholars to work together and by applying the latest consumer technology to deliver high quality care.

What are your goals for CPOP?

When I became director, I had a renewed vision for CPOP 2.0: to lead the way in child health policy through innovation and improvement in systems performance across the life course. We have three specific missions that I would like to accomplish:

1. To conduct transdisciplinary team science research between different divisions within pediatrics and different centers across Stanford.
2. To train scholars in health policy and health services research.
3. To support the Center for Health Policy and the Center for Primary Care and Outcomes Research (CHP/PCOR) in its effort in global health and in transition of child to adult health services.

We hope to build bridges. We start by connecting departments at Stanford and beyond. We also want to improve transitions between care for kids and adults and between domestic and global policy to increase health worldwide.

What are some of the big issues in child health that you would like to address?

One of the big issues that we are particularly interested in is the management of chronic disease from childhood to adulthood. We want to make sure that people are not falling through the cracks. Another area that we're particularly interested in is the impact of health insurance, particularly the Affordable Care Act, on access and utilization of health services for children with medical complexities. We want to make sure that health care reform itself is not harmful to the most medically complex children. The third area, equally important, is to help people understand how to promote good habits for children across their life course. We have done this by creating a HABIT laboratory, which stands for Health Analytics, Behavioral Interventions, and Technology. A lot of the health issues in adulthood stem from childhood behaviors. For instance, obesity leads to diabetes and heart disease, and if one could prevent diabetes by reducing obesity, then we would have a lot fewer problems when kids become adults.

How will CPOP evolve to meet your goals?

We would like to move into the area of driving health innovation. In particular, we'd like to understand what motivates patients and providers. We'd like to rethink the healthcare delivery models to strategically create cost-effective resources in the delivery process and to eliminate waste so that the system provides the highest value. To do this, we're going to try to develop more regular policy briefs and try to disseminate health information using multimedia and social networks.  We want to take advantage of the technological innovations available here in Silicon Valley.

How can working with people in Silicon Valley improve healthcare?

Everyone, even vulnerable populations, uses cell phones now, so we're going to use that to re-envision how to drive health behavioral changes, to improve communication with our patients and to improve care coordination. We are rethinking how we could drive delivery innovations using mobile devices. But technology still has its challenges. Healthcare technology requires security, and we need to make sure that we can adequately protect people's personal health information. Technology is a tool, and every time you get a new tool you have to understand its advantages and the issues that might come up. It's going to be easier for us because we work very closely with a lot of very smart people here in Silicon Valley.