Food and Drug Quality and Safety

Nutrition and food science contributes evidence relating to food quality and safety policies. These have long been a priority for policymakers, as illustrated in the United States by the Food Drug and Cosmetic Act of 1938 that established several categories of food standards, including quality standards. Transfusion scientists, including hematologists, immunologists, and biochemists, contribute evidence to support the safety of transfused blood, which constitutes a priority in policymaking decisions, with a broad range of standards existing worldwide despite evidence regarding best practices (Faber, 2004).

While food quality constitutes a priority in policy decision-making, it also demonstrates the challenges related to evidence that may be complex or nonexistent, and bureaucracy associated with systems of policymaking. In the early 20th century in the United States, for example, states adopted their own laws in the absence of a national food quality policy, with contradictions contributing to manufacturing nightmares as individual companies had to meet the standards of each state. Upon publication of Upton Sinclair’s novel The Jungle in 1906, describing conditions in Chicago’s packing plants, meat sales plummeted in response, and the decades of debate surrounding a food safety bill came to a head, illustrating the significance of agricultural economic interests together with the public’s health. Theodore Roosevelt was president at the time, and his efforts shepherded a meat inspection bill through Congress. That 1906 law made it illegal for interstate and foreign commerce to deal in adulterated and misbranded food and drugs. In the 21st century, public health debates about the safety and efficacy of vitamins and supplements compete with product manufacturers’ claims (Bent, 2008).

Licensing

The process of making blood safety a priority illustrates the broad arena of licensing associated with policy decisions (American Red Cross) based on health and risk sciences. The licensing of tests to screen for hepatitis B and syphillis, for example, have allowed testing to be conducted in the United States on each unit of donated blood since the 1980s. This policy implicitly conveys evidence indicating that these diseases were sufficiently prevalent to pose risk to individuals receiving transfusions and to warrant commercial efforts to devise testing. Moreover, the science assessing the tests to identify their presence progressed sufficiently to achieve sensitivity–true positive rates, and specificity–true negative rates, leading to policy in the United States. Tests for the human immunodeficiency virus (HIV-1 and HIV-2), hepatitis C virus (Zou et al., 2010), and the human T-lymphotropic virus (HTLV-I and HTLV-II) are conducted on the U.S. donated blood supply as well. These diseases, too, are regarded as transfusion-transmitted diseases with sufficient risk to individuals based on scientific evidence to warrant testing for them, a policy adopted to achieve the priority associated with a safe blood supply. The limitations of health and risk evidence and screening emerge in consideration of policy for the blood supply when considering parasitic infections such as malaria or babesiosis, a parasitic infection that may be transmitted by tick bites, posing potential transfusion risk (Lobo, Cursino-Santos, Alhassan, & Rodrigues, 2013). In these cases, U.S. blood centers rely on donors to report exposure risk FDA; Centers for Disease Control and Prevention (CDC).

Air and Water Quality

Similarly contentious debates worldwide exist relating to air and water quality. Policymakers charged with the public’s health acknowledge their responsibility in these realms, owing to the realities that individuals cannot draw lines in the air or demarcate public water sources, though they may try to do so. In the United States, the Clean Water Act, originally passed in 1948 but revised continually and amended almost annually, give the Public Health Service the authority to develop programs to reduce or eliminate pollution of interstate waters, as well as improve sanitary conditions of surface and underground waters. A long-standing challenge for policymakers focuses on lead in drinking water. This risk particularly threatens children, for whom lead exposure can delay physical and mental development (Lidsky & Schneider, 2003). Combined with other major sources of lead exposure, including contaminated soil and lead-based paint, the world’s poorest children may be at greatest risk, a reality demonstrated in the United States with children in low-income neighborhoods in Flint, Michigan (Hanna-Attisha, LaChance, Sadler, & Schnepp, 2016). Government officials may hesitate to assess the extent of poisoning, lacking policies and resources to address the issue. The U.S. Clean Air Act first passed in 1963, with ongoing debate also contributing to policies being revised toward this priority. At the international level, inconsistent water quality policies threaten health, posing risks both in terms of having access to water and the unsanitary conditions of much drinking water (IOM, 2009; National Center for Biotechnology Information (NCBI)). Air quality polices also challenge international policymakers who deem this aim a key priority (Lode, Schonberger, & Toussaint, 2016).

Laboratory Testing

Health and risk sciences evidence associated with laboratory testing (Plebani, 2006), screening, and quality prompts policymakers at government levels to adopt programs aimed at improving and assuring laboratory quality as well. In the United States, for example, the CDC’s Newborn Screening Quality Assurance Program utilizes evidence to guide screening laboratories in practices aimed at accuracy and timeliness in diagnosis (Jesus, Mei, Bell, & Hannon, 2010). Important interactions between health policy and health behavior that may find their way into health and risk messages are notable as well. Advice about ways to avoid health hazards associated with the environment, including staying indoors when the air quality is poor and installing radon gas systems in our homes, represents the personal end of the communication spectrum associated with the physical environment. It also illustrates the interaction between health policies and personal practices in communicating about health.

Epidemiology

Policymaking incorporates health and risk sciences evidence associated with epidemiology, including disease causation and transmission, such as how the flu (Patrozou & Mermel, 2009) or Ebola virus (Chowell & Nishiura, 2014) are transmitted; incidence, such as the number of new cases of influenza among outpatients during peak flu season (Fowlkes et al., 2013); prevalence, relating, for example, the percentage of population diagnosed with flu in the past year; morbidity and comorbidities, considering whether those with CVD may be at greater risk for flu; and mortality rates, such as the number of deaths from influenza or CVD. These many lines of evidence guide decisions about how best to mitigate an influenza pandemic (Oshitani, 2006).

In order to facilitate the availability of valid health and risk sciences evidence to guide policies, policymakers make decisions about how to obtain valid databases. The availability of data corresponds to eras of policy initiatives aimed at supporting the role of knowledge transfer. Strategies to generate surveillance data, for example, may be passive based on reports from institutions, including vital statistics for births and deaths, programs such as the CDC’s Measles Surveillance System in the United States or the FDA’s Adverse Events Reporting System in the United States. Research that examines the health consequences associated with allowing exemptions from the requirement for children to be vaccinated against measles examined data from 1985 through 1992 was collected by the Measles Surveillance System of the CDC (Salmon, Haber, Gangarosa, Phillips, Smith, & Chen, 1999). The researchers combined that data with annual state immunization program reports for youth aged 5 to 19 years, leading to the finding that exemptors were 35 times more likely to contract measles than were vaccinated persons; exemptions are granted for religious and philosophical reasons, and have been found to cluster in certain geographic regions (Salmon et al., 1999).

Active surveillance activities base data on a system with a protocol to guide regular contact with reporting systems. Disease registries, for example, may systematically collect information about specific conditions, promoting calculations of incidence and prevalence, while treatment registries follow individuals who receive a particular treatment, granting access to data about treatment efficacy. The data promote understanding about a disease and treatment outcomes in a broader real-world context beyond a clinical trial, but may suffer from bias related to inclusion, as patients may attend providers not participating in a registry (IOM, 2011). In cancer research, for example, policies enable and perpetuate data collection to facilitate applications aimed at cancer control policies. The ability to filter data in search of disease patterns and variances contributes to the passage of future policies and research to support better health. In the United States, Congress established the National Program of Cancer Registries (NPCR) in 1992, enacting the Cancer Registries Amendment Act. This act authorizes funds for states and territories to improve existing registries, plan and implement registries where none existed, develop model legislation and regulations for states to enhance registry operations, set standards for data, train registry personnel, and establish a computerized reporting and processing system.

Dilemmas

A number of dilemmas face policymakers considering health and risk sciences evidence to develop policies, including conflicting evidence and gaps in evidence. For example, CVD has been correlated with sedentary behavior, but the evidence largely rests on self-reported surveys on the amount of time spent watching television, perhaps neglecting industry evidence associated with worker sedentary tasks, or feasibility studies in workplace and transit settings that break up the periods of time spent sitting (Owen, Healy, Matthews, & Dunstan, 2010). Also, some policies based on health and risk science evidence leave enforcement to local authorities with no funding support, a practice described as an “unfunded mandate.” Sewer and water systems, for example, illustrate a patchwork of policies with variances from community to community. Moreover, health and risk policy decisions may expand, intensify, and coordinate research activities related to a topic or limit these undertakings. While expanded research increases the likelihood of new treatments and even cures being developed, expansion of data collection surrounding disease and risk also increases the likelihood that personal information will be collected in databases that have some risks associated with them in terms of privacy and informed consent issues (Volkman, Parrott, Hopfer, & Lengerich, 2010). The policy debates surrounding individual rights and health information increase as the science and technology surrounding human health expands. While the individual incidence of disease and the economic good of our country do not tie directly to these issues, our willingness to support policy decisions associated with health and healthcare are often tightly coupled with such matters.

A Historical Context

If you saw the movie Titanic, you may remember the use of quarantine to isolate passengers that might spread “pests” among the other travelers. Prevention science evidence deems isolation to be effective in limiting the spread of disease, with quarantine found to be more controversial and likely to add little to disease control beyond isolation, assuming that infected individuals can and will remain isolated (Day, Park, Madras, Gumel, & Wu, 2006). Historically, one of the most consistent prevention effort policies focuses on childhood immunization (Wonodi et al., 2012). The U.S. president, Thomas Jefferson, and Benjamin Franklin, whose son died from smallpox, supported the smallpox vaccination—the only available vaccination in the United States at that time. The use of immunization requirements that are often referred to as “school laws” require a child to be vaccinated for specific conditions before entering school. These often include diphtheria, pertussis (whooping cough), measles, mumps, polio, and rubella. Many higher-education institutions also require students to have particular immunizations, with such policies based on prevention science evidence. These policies are adopted in the wake of much discussion and debate regarding the efficacy of vaccines and the rights of individuals, including religious freedom, once a disease has been named as serious and preventable by vaccine.

Efficacy

Prevention scientists utilize expertise from biological, cognitive, behavioral, and social sciences. Systematic prevention science reviews can guide policymaker decisions. One such review asserts the efficacy, based on prevention science evidence, of tuberculin skin testing and related preventive therapy, screening for sickle cell disease among high-prevalence populations, pneumococcal and influenza vaccines for the elderly, folic acid supplementation for women of childbearing age, prenatal care to prevent low birthweight, removing lead-based paints from homes, and childhood vaccines, as well as bicycle safety helmets to prevent head injuries (Messonnier, Corso, Teutsch, Haddix, & Harris, 1999). Another found strong evidence to support smoke-free indoor policies, and taxes and pricing as strategies that decrease tobacco use, as well as supportive evidence for cutting cessation costs to decrease morbidity and mortality linked to tobacco use; increased access to physical activity facilities has strong evidence related to increased exercise; urban planning and policies that include sidewalk continuity and street lighting has sufficient evidence to support health and reduce risk (Brownson et al., 2006). Despite evidence to support the efficacy of these interventions, health and risk policies associated with them have not been widely adopted, conveying the competing priorities and value-laden landscape within which policymaking occurs, which are often part of broader social policies related to the economy.

Children’s Health

A group of prevention scientists in the United States developed a model to be applied in efforts to bridge gaps in children’s health, outlining the distal and proximal influences associated with children’s cognitive development, social and emotional competence, absence of psychological and behavioral problems, and physical health (Komro, Flay, & Biglan, 2011). According to an in-depth summary of extant systematic reviews associated with policy-relevant strategies applied to children’s health interventions around the world, such as bicycle helmet use, 46 effective actions based on at least two high-quality trials emerged:

access to places for physical activity, alcoholic beverage excise tax, alcohol outlet density, bicycle helmet use, graduated driver licensing, prenatal micronutrient supplementation, quality preschool/early childhood education, sexual health education and contraceptive interventions, street lighting, and water fluoridation.

(Komro, Tobler, Delisle, O’Mara, & Wagenaar, 2013, p. 175)

Komro et al. (2013) provides a summary of the 46 policy-related strategies identified, with each relating to at least a 30% change and some more than 70%; the figure highlights the outcomes and notes the domain of intervention (e.g., physical environment).

Communication

Health and risk communicators contribute to prevention science evidence partly via research that promotes greater understanding of individual uptake of practices linked to policies based on prevention science. For example, belief in vaccine efficacy has been found to relate directly to actual vaccination behavior, with social media, schools, or employers prompting individuals to be vaccinated ranking as the most predictive information sources; in addition, pharmacy or grocery store signs enhanced behavioral intentions (Avery & Lariscy, 2014). Efforts to eradicate polio through immunization in Pakistan and India have demonstrated increases in awareness and the intent to immunize children following exposure to television and radio spots in which movie and sports figures promote vaccination and dispel myths about it (Obregon et al., 2009). Prevention science evidence associated with diffusion strategies linked to health and risk policies has been summarized in a review considering the effectiveness of mass media when used to disseminate content about child survival, specifically in low- and middle-income countries (Naugle & Hornik, 2014). Building media interventions as a prevention strategy revealed significant positive outcomes for child survival across several topics, including nutrition, HIV, respiratory disease, reproductive health, diarrhea, and malaria (Naugle & Hornik, 2014). Such reviews promote policymakers’ confidence that policy and practice drawn from the evidence will demonstrate positive outcomes.

A review of smoking cessation media campaigns worldwide concludes that these interventions, often part of public tobacco control policy initiatives, reduce adult smoking prevalence; television was found to be the most effective source to reach and influence adult smokers; negative health effect messages increased knowledge and quitting behavior, while other messages had mixed results across interventions (Durkin, Brennan, & Wakefield, 2012). Prevention science evidence also demonstrates positive health outcomes for the use of community health workers, assuring policymakers in low- and middle-income countries that the resources devoted to this intervention approach for malaria prevention, newborn care, health education, and breastfeeding promotion will likely result in benefits (Gilmore & McAuliffe, 2013). A total of 11% of the interventions in the Naugle and Hornik (2014) review included community health workers, likely acting to increase exposure and reinforce media messages.

Work Sites

Work site safety and injury prevention policies have focused on evidence that guides regulations, monitoring, and enforcement to address worker protection through safety and health programs, exposure assessment, medical surveillance, and recordkeeping. The Occupational Safety and Health Administration (OSHA) is the federal policy oversight agency for workers in the United States that sets minimum standard policies to be followed by all states; individual states may propose their own additional plans to cover some issues not addressed by OSHA and found to be relevant in their own areas (OSHA State Plans). OSHA was created in 1971; in the first three decades of the agency’s efforts, fatalities in the workplace were reduced 50% while injuries were cut 40%. Still, much remains to be done worldwide to prevent occupational injuries (Smith, 2001). Prevention science evidence relating to occupational safety and health has expanded the focus to psychological realms, including an emphasis on burnout (Melamed, Shirom, Toker, Berliner, & Shapira, 2006). One meta-analysis concludes that higher job demands, lower resources, and rigid organizational expectations create this organizational stress and related psychological and physical health problems (Alarcon, 2011). While policies to address this prevention science evidence have been difficult to innovate, one Korean intervention found that a program of two 30-minute circuit training with dynamic stretching twice daily for all workdays prevented metabolic syndrome, and improved physical function among office workers, contributing to overall well-being (Yoon et al., 2016).

Dilemmas

A growing body of prevention science evidence contributes to policymaking that aligns with “do-knowing that it’s been done” and effectiveness, but issues relating to healthcare and public health quality associated with equity pose dilemmas for decision-makers. For example, in strategic efforts to apply health and risk science related to our diets and well-being across the spectrum, policymakers acknowledge that food environments directly relate to what we eat. Access to healthy foods predicts a greater likelihood of eating healthy, but low-income communities are more likely to have less access (Sallis & Glanz, 2009). Policymakers faced with their inability to address socioeconomic barriers to eating healthy also may limit efforts to promote behaviors that they know the environment will not support. Policymakers may leverage their influence to get fast food eateries to add salads to their menus, but when the dollar menu items include only the high-calorie, high-fat choices, individuals with limited incomes still have limited choices. Health and risk communicators trying to design strategic messages that promote nutritious eating should be aware of individual and community barriers to action, striving to adapt broad guidelines.

Policy Interventions

An exception to the absence of economic analysis was a study conducted by the CDC of the costs associated with 19 policy interventions, including wearing bicycle helmets, screening for breast and cervical cancer, lead abatement in homes, and childhood vaccines (Messonnier et al., 1999). The analysis conveyed in concise fashion the cost, for example, of preventing head injury based on a law requiring cyclists to wear a helmet, which includes costs for the start-up and maintenance of the program balanced against the cost for emergency room visits and hospitalization for head injuries (Messonnier et al., 1999). The analysis revealed that injuries—of which there were 140,000, with 247 deaths—cost more than $3 billion (in 1991 dollars), while increasing helmet use from 4% to 47% was projected to cost $36,643 per head injury prevented (Messonnier et al., 1999). The analysis and tables, which provide important information with much utility for health and risk policymakers, have not been updated, thus making the content unreliable; this example demonstrates the challenge of seeking economic science data to guide policymaking.

The costs associated with prevention interventions related to children’s health by Komro et al. (2013) have not been projected, leaving policymakers to look elsewhere for such evidence or to give lower priority to strategies that lack such evidence. Decreasing budgets for health systems and agencies leads policymakers to rate financing and cost-effectiveness as extremely important far more often than the strength of scientific evidence to support the priority or even disparities in healthcare and public health quality among different groups (Leider et al., 2013). In essence, the theory of expected utility based on maximizing expected utility based on estimated costs and benefits of various options guides these decision-makers (Goncalves, 2013).

Employment Issues

Health and risk policymakers seek information about a broad landscape of economic issues when deliberating. How regulations could affect employers’ hiring practices, for example, becomes important in considering the evidence, in addition to evidence related to how a regulation may reduce risk of injury on the job or long-term health status. Satisfying a nation’s economic and strategic aims requires a healthy workforce, which supports the economy by working. Thus, within an economic science model, the evidence may legitimate a policy role relating to health and risk without necessarily referencing the science associated with health and risk, or prevention. It became unrealistic in the first two decades of the 20th century to link a human being’s material fortune to character traits and morality. Middle-class progressives began to consider social insurance as they dealt with the realization that the American industrial society’s working-class citizens suffered injury through no fault of their own. Workplaces were often unsafe, and workers were injured performing their jobs.

In 1905, a number of economists formed the American Association for Labor Legislation (AALL) for the purpose of studying labor conditions and labor legislation. The very fact that it was a group of economists taking on this task is noteworthy. Their initial efforts to argue the merits of such legislation focused on workers’ compensation. They achieved passage of workmen’s compensation laws as the first successful social insurance in the United States, with this policy linked to greater vigilance to make workplaces safe, as well as conveying the cost-effectiveness of doing so.

Comparative Analyses

Making comparisons among varied approaches to address health or risk illustrates policymakers’ efforts to employ comparative effectiveness analysis (Zusman, 2012). For example, in 17 high-burden countries associated with childhood undernutrition, including Indonesia and Bangladesh, the cost benefits of intervening, including averting illness and improving cognitive outcomes, have been demonstrated but failed to influence policy, likely owing to such comparative analyses (Hoddinott et al., 2013). Metrics used in economics that provide useful content to policymakers include economies of scale, with health policymakers aiming to achieve such savings for most products associated with policies and practices (Bernet & Singh, 2014). Demonstrating cost-effectiveness often proves difficult, with policymakers sometimes using cases of disease avoided or life-years gained to project benefits, and also asserting the need to report strong positive gains in terms of return on investment (Neumann et al., 2008). Sometimes policymakers consider health-related quality of life to evaluate the efficiency of health systems (Romero, Vivas-Consuelo, & Alvis-Guzman, 2013).

Econometric-Epidemiological Studies

Policymakers may also examine econometric-epidemiological studies. For example, taxation data may be correlated with a measurable outcome such as food expenditure data, and deaths owing to disease related to diet would be estimated (Mhurchu et al., 2015). Econometric-epidemiological evidence may be used to support taxation’s revenue-generating potential and its ability to help offset health and risk costs associated with consumer consumption (Sassi & Belloni, 2014). For example, modeling data from New Zealand projected that a 20% tax on saturated fat sources could contribute to 1,500 deaths prevented or postponed (DPP), while a 20% subsidy for fruit and vegetables projected to 560 DPP (Mhurchu et al., 2015). The Global Burden of Disease study proposed the use of fiscal policies, including taxation and subsidies, as a strategy to address poor diet as a cause of death and disability based on evidence that these policies influence food choices (Niebylski, Redburn, Duhaney, & Campbell, 2015). Media have disseminated stories about farm subsidies contributing to the obesity epidemic by making high-fat foods affordable, but systematic economic analyses conducted worldwide do not support these claims (Alston, Sumner, & Vosti, 2008). Analysis in several nations has related taxation to alcohol consumption, with Finland demonstrating that lowering alcohol taxes correlated with increased alcohol-related hospitalization for men (Herttua, Makela, & Martikainen, 2011).

Quality-Adjusted Life-Year (QALY) Analysis

A review of policy intervention data in the United States for 1976–2003 summarized the cost (in 2003 dollars) associated with each quality-adjusted life-year (QALY) gained via the activity, noting instances where the cost of intervening generated savings; cost savings emerged for seatbelt laws and hip protectors for women to prevent motor vehicle injuries, but a $24,000 cost for QALY for air bags in cars; in the regulatory environment, no cost savings were observed, while $75,000 cost aligned with QALY for restrictions on use of cell phones while driving, and $270,000 cost aligned with QALY for changing to use of emission-controlled urban transit buses (Neumann et al., 2008). Cost-effectiveness evaluations do not consider equity, with evidence suggesting that having more material, social, and physical resources increases the likelihood of being influenced. Smoking cessation attempts and sustained abstinence, for example, have been found to be greater among smokers in higher socioeconomic status facing increased cigarette prices and state-level antismoking media campaigns (Levy, Romano, & Mumford, 2005). Even when sometimes costly, evidence for effectiveness and long-term efficiency sways decision-makers. An analysis of the costs associated with mass media campaigns in tobacco control, for example, used data from 10 studies that included economic evaluations and concluded that, despite substantial investment to undertake them, these programs demonstrate cost benefits (Atusingwize, Lewis, & Langley, 2014).

Dilemmas

Social justice issues should be considered when evaluating the value of public health systems as well, but measuring these poses unique challenges to policymakers (Neumann et al., 2008). For example, lead-abatement programs associated with dangerous levels of lead in paint in homes face obstacles on several fronts, despite the reality that the poorest children are often at highest risk. There may be little money to address the problem, which may be compounded by affected homes being located near major highways that link to high-industry areas where lead and other metals occur. Since the location issue cannot be resolved, no monies will be allocated to determine the extent of lead poisoning, knowing that the issue will still remain a low priority linked to cost and efficiency. Moreover, the political economy is often not supportive of taxation to support health and reduce risk, as has been the case for tobacco tax policy in many instances, as selling tobacco generates money (van Walbeck, Blecher, Gilmore, & Ross, 2013). In such cases, decision-makers may consider evidence of economic harm for society with a narrow or wider lens.

Examples

The desire to take precautions has guided some environmental and food and drug legislation, at times giving regulators authority to act even though harm has not been proven. For example, as a precautionary measure, the FDA requires all new drugs to be tested before they are put on the market, placing the burden of proof on drug manufacturers to demonstrate their safety. The challenge of identifying who should be required to exercise precautions and be monitored for compliance finds broad domains emerging. Pesticides illustrate the reality associated with a product and practice aimed to promote agricultural production through pest control that also poses a hazard to humans (Damalas & Eleftherohorinos, 2011). Many countries establish maximum residue levels (MRLs) but differ in their policies (Bryant Christie, Inc., 2016). The differences convey the uncertainty related to the science of pesticide exposure as a hazard (Global MRL Database) balanced with the benefits of food production.

In the United States, the National Environmental Policy Act (NEPA), which was signed into law at the beginning of 1970, requires that environmental impact statements, including air and water effects, must accompany proposals for major federal undertakings, such as interstate highways, pipelines, and airports (Alm, 1988). In the United States, California enacted policy that mandates choosing environmentally preferable purchasing (CalRecycle), demonstrating the influence of positive economics in taking action. In this case, the purchasing power associated with custodial products and other government contracts motivated a movement toward reducing toxic product use, recycling, and conserving resources. In many other cases, policies reflect efforts to create accountability via engaging an educated public, illustrated by both right-to-know laws aimed at providing information about toxic substance release and management and labeling requirements that require companies to warn about hazardous exposures. To strengthen policy, the FDA continues to work toward educating the public, in part through the use of advisory groups, including one in 2009 that provided suggestions about ways to improve risk communication related to foods, drugs, and medical devices and updated it in 2012.

The European Union formed a policy based on the PP that requires chemicals to be tested for effects on health and the environment, putting the burden on chemical manufacturers to demonstrate product safety and granting regulatory authority to governments when products appear problematic (Welker-Hood, Condon, & Wilburn, 2007). Numerous efforts worldwide fit within the scope of a precautionary approach, including the Cartagena Biosafety Protocol aimed at governing genetically modified organisms (Klinke & Renn, 2012). In the United States, strategic approaches to address issues considered as possible threats include screening the blood of randomly selected individuals, including infants and children, for a broad selection of toxic substances to develop an evidence base, finding pesticides, endocrine disruptors, and polychlorinated biphenyl (PCB), in addition to lead and mercury (Myers & Raffensperger, 2005). Precaution guides these actions as a preliminary step to assert risk based on scientific evidence that these substances are toxic.

Dilemmas

Dilemmas associated with using the PP to sort through existing and nonexistent evidence across multiple realms form around the claim that the PP functions as a barrier to progress (Adler, 2011). A frequent example of such claims appears with regard to new drugs coming to market, but also emerges in discussions about innovations in business (Kazman, 1990). These tensions emerge particularly prominently for developing countries struggling to promote agriculture industry while protecting the public and the environment (Harari, Morales, & Harari, 2004). However, economic interests in all nations pose barriers to applying uncertain science in policymaking. In short, history demonstrates that protecting the public’s health via protecting the environment requires economic resources, and thus such protection constitutes a good, in the language of economic science and must be purchased. The most developed countries thus illustrate that financing environmental safeguards, be they drinking water purification, raw sewage containment, or low-emission transportation, is costly. While low- and middle-income countries may wish to exercise caution, they mostly lack the means (and thus the motivation) to do so. Economic growth fuels technological advances and generates the resources necessary to deploy new methods for meeting human needs efficiently and effectively. Public support for environmental measures, both public and private, is correlated with changes in personal income.

Advocacy Activities

Advocates may frame the evidence that gains the attention of policymakers by working to gather both information and money as resources to respond to local environmental issues such as encouraging designs for active living (Zusman et al., 2014) and population group issues such as visual impairment (Harrison & Lazard, 2015). As a form of strategic communication, the process of policy advocacy involves gathering and formulating information into arguments, thus using evidence in efforts to influence policymakers’ decisions. In one case related to Uganda’s increasing levels of stunting associated with malnutrition, for example, an advocacy group successfully worked to gain food and nutrition legislation but abandoned efforts to institutionalize the presence of nutrition experts within government due to unfavorable government reaction (Pelletier et al., 2013). The Ugandan advocates developed brochures and other messages about malnutrition for policymakers, together with workshops, newspaper articles, a television documentary, and radio discussions with call-ins; this led to a place for nutrition as a key issue in a Ugandan National Development Plan, in political party platforms, and in the Ugandan president’s Nutrition Action Plan with support from the prime minister (Pelletier et al., 2013). Advocacy efforts related to malnutrition in Vietnam are credited with extending paid maternity leave from four to six months, bolstered by messaging similar to Ugandan activities together with the nation’s social security’s office financial analysis demonstrating capacity to do so—thus leveraging economic evidence (Pelletier et al., 2013).

Policy advocates may utilize or develop policy and research briefs related to their issue (e.g., Datta & Pellini, 2011, http://research.apc.org/images/c/ce/Communicating_research.pdf), contextualizing the evidence with local experiences and practices, and tailoring content to address multiple audiences (Fox, 2001). In efforts to advocate for child nutrition, for example, audiences include nutrition scientists specifically, health scientists more broadly, agriculture decision-makers, employers, finance sectors, and elected officials; advocates identify competing priorities for each group and the evidence supporting these interests in order to derive their messages. For example, for employers, protecting private-sector interests and limiting regulation is key, with evidence suggesting that this promotes efficiency and competitiveness; advocates must thus demonstrate that worker productivity and economic growth aligns with initiatives that support maternal and child health (Pelletier et al., 2013).

The approaches used by advocates include public education, capacity building, relationship building, network formation, leadership development, and even lobbying and litigation. Advocates’ use of public education, for example, has achieved significant improvement in public engagement with policy and efforts to improve community conditions, which in turn increases social capacity (Mandarano, 2015). Advocates’ analysis of United States’ litigation, on the other hand, has prompted consideration of laws related to the public’s health and use of a wide range of products, including guns, vaccines, and motor vehicles. Contentious debate between health advocates and manufacturers regarding the outcomes related to some laws reveals that active manufacturer lobbying accompanies various policies. The Protection of Lawful Commerce in Arms Act regarding guns, passed in the United States in 2005, illustrates this reality. Opposing views from some members of the public health community, health advocates, and gun manufacturers focused on the Act’s prevention of suits against gun manufacturers and dealers, which gun safety advocates allege erodes the incentive to make guns safer (Vernick, Rutkow, & Salmon, 2007).

Advocate Backgrounds

Policy advocates may be members of professional organizations working to bring attention to issues important to them. For example, the American Nurses Association (ANA) includes policy experts hired as part of the ANA’s Department of Nursing Practice and Policy to derive issue briefs of significance to nurses, including nursing licensure portability, and to provide position statements on matters such as mercury in vaccines (ANA, 2016). In the United States, the California Food Policy Advocates group has 501(c) nonprofit organization status to focus on food policy, specifically aimed at improving the health of low-income Californians through working for access to nutritious and affordable food. The European Union has an Association of Accredited Public Policy Advocates. Policy advocates may focus on community economic development, addressing the economic science associated with improved health and reduced risk and working to create jobs, for example (Sherraden, Slosar, & Sherraden, 2002).

Scientists, some of whom strive to be policy-neutral, may become advocates for particular policies in areas associated with health and risk as they translate their research into understandable briefs, and the evidence leads policymakers in a particular direction (Lackey, 2007). Other advocates may organize into nonprofit organizations or nongovernmental organizations (NGOs), organizations that are not government or private firms, with the former term used in the United States consistent with the tax code while the latter is used more often internationally; large NGOs include CARE International and the WHO. Their role in advocacy activities forms a core mission. A survey of national executive directors of U.S. nonprofit advocacy organizations serving disadvantaged groups dependent on public funding shows that such groups are limited by laws regarding nonprofit lobbying and advocacy activities, making it difficult to carry out advocacy consistent with funding received from donors (Silverman & Patterson, 2011). In the United States, tax codes further subdivide nonprofits into public charities and private foundations, with charities often being the recipient of public funds and private foundations having few sources of funds. Foundations are frequently bequeathed by an individual or family (e.g., the Bill and Melinda Gates Foundation, the Ford Foundation, the W. K. Kellogg Foundation) or corporations (e.g., AstraZeneca Foundation, Lily Endowment Inc., Bank of America Charitable Foundation). Foundations worldwide offer health grants totaling billions of dollars (Schang & Czabanowska, 2012).

The Pew Charitable Trusts, the W. K. Kellogg Foundation, and the Robert Wood Johnson Foundation have been lauded for generating change through funding of both health and risk research, emphasizing collaboration with institutions generating research and care, as well as providing loans and technical assistance to researchers and providers, as well as institutions (Lipson & Lamphere, 1995). U.S. foundations, however, have resisted appeals to fund consumer advocacy to improve health owing to the concern that lobbying would be used, a violation of federal tax rules in the United States; one exception, a Robert Wood Johnson Foundation grant that funded consumer health advocacy networks, demonstrates increased consumer involvement with health policy through representation in health reform debates (Strong, Lipson, Honeycutt, & Kim, 2011).

Pakistan and India have demonstrated increases in awareness and intention to immunize children following exposure to television and radio spots in which movie and sports figures promote vaccination and dispel myths (Obregon et al., 2009). Advocacy efforts, including pediatricians communicating with harder-to-reach groups, enhanced the goal to increase immunization awareness and intentions (Obregon et al., 2009). Proponents of health advocacy in policymaking note the need to ensure that advocates go beyond elites, such as pediatricians advocating for child nutrition, to speak to the public more broadly. Mothers may effectively act as advocates by telling their stories to other mothers about successful attempts to provide nutritious meals, or by eating healthy themselves, supporting their pregnancies and breastfeeding (Pelletier et al., 2013).

Dilemmas

Dilemmas associated with policymakers utilizing advocates as sources of evidence include the reality that those without resources often also lack advocates. Also, profit motives of some organizations lead them to develop nonprofits that fraudulently front for advocacy, using communication to deceive the public and stop legitimate advocacy efforts and success. These front groups may be difficult to identify, as their names often sound like they are groups formed in the public interest. For example, a front group called Citizens for Fire Safety was exposed in the United States as a front group associated with defeating efforts to ban toxic fire retardant chemicals (PR Watch). A top-down approach to advocacy has been noted and criticized as well, with some working in nonprofits asserting that the focus on building resilience among poor communities may actually perpetuate poverty among resource-poor groups who have survived despite their situations and whose highest priorities are seeking jobs and safe places to live (e.g., Diprose, 2014).

Scientific Research Paradigm

Beyond the volume of published research, broadly speaking, there are structural and contingent barriers to use, with structural barriers likely to pose impediments that are more resistant to change. In efforts to use the voluminous bodies of health and risk sciences evidence in policymaking decisions, structural barriers appear that relate to (a) the scientific research paradigm and (b) the organization of health systems worldwide. With regard to the first, the traditional method for reporting research limits its dissemination and application (Hyder et al., 2011). Some characterize this as ‘too little and too late’ (Oliver, Innvar, Lorenc, Woodman, & Thomas, 2014). A primary barrier in this regard relates to the method of disseminating results via peer-reviewed scientific journals, including the time that it takes for research papers submitted to prestigious journals to undergo peer review and be published; the process may take months, or even longer. While this may be addressed with online access or making data available, both of these paths pose risks for the scientists. Some journals will not be amenable to reviewing articles already made available online, and data accessibility may lead other scientists to use the data in innovative analyses, reducing the original investigator’s cache. As more online journals with open access appear, time to publication may be reduced, but the evaluation of the journal quality creates confusion for scientists and their supervisors (Ray, 2016).

Another scientific paradigm barrier exists in terms of the issues that are studied and the evidence gap associated with these choices. While a theme persists over several decades related to the importance of collaborations between researchers and policymakers, the emphasis has been on disseminating research and/or setting the agenda regarding issues of importance, but not on the reality that policymakers have needs for specific research that could guide priorities (Hanney & Gonzales-Block, 2011). Thus, while in some cases, the number of studies overwhelms intention to translate the content, in other cases, there is little or no research to consider. This is particularly true when considering intervention efficacy and/or economic analyses, as discussed in the sections related to use of prevention science evidence and economic science evidence in policymaking decisions. Even when some economic analyses are included, research often fails to report data that the policymakers seek. In light of the significant role that cost-benefit analyses play in health and risk policymaking, research that demonstrates an economic rationale in support of specific policies forms a crucible of critical importance to these deliberations. Yet such research is scarce, and what exists too often fails to reach policymakers, even when high-burden areas associated with an issue have been identified (Stone, Braccia, & Larson, 2005). In other cases, the barrier relates to information policies that set standards and regulations regarding the collection and dissemination of health information, limiting access (Braman, 2006).

Health Systems

In addition to structural barriers posed by the scientific paradigm from which evidence is derived, health system barriers to evidence use limit policymakers’ application. These include the policy context in terms of the political landscape. For many nations, such matters as where a nation is in the electoral cycle will affect policymaking decisions (Hyder et al., 2011). Moreover, in many cases, legislative and institutional arrangements affect policy, as well as the flexibility with which decision-making may include new research. Health systems are notably less dynamic than the economy and decision-making, with structures and approaches to making decisions becoming outdated (Hyder et al., 2011), and organizational and health system fragmentation and bureaucracy inhibiting interaction (Imani-Nasab, Seyedin, Majdzadeh, Yazdizadeh, & Salehi, 2014). A hierarchy often exists within which one level of government adopts policies that other levels are responsible for implementing, thus acting as helpmates to regulators. Some systems are complex networks whose functions include funding, division of authority and supervision, programmatic guidance, and service provision. For example, in the United States, New Jersey adopted a policy mandating the collection of a surcharge associated with motor vehicular violation fines to support spinal cord research administered by the department of health and overseen by a commission on spinal cord injury (see p. 9, https://www.nj.gov/health/spinalcord/documents/2015_annual_report.pdf). In other cases, policy affects accessibility to cancer screening and education programs, reimbursement for screening, accreditation of facilities, alternative therapies, and more.

Evidence and Policymaker Characteristics

Beyond structural barriers, contingent barriers form in relation to content associated with evidence and policymaker characteristics. A study of policymakers at the national level in Argentina, Egypt, Iran, Malawi, Oman, and Singapore identified their perception that communication about research findings was of poor quality (Hyder et al., 2011). The term quality has been further specified to relate to uncertainty related to evidence posing a barrier to use. While some may adopt a precautionary approach, as previously discussed, when resources are limited, looking for policies that represent sure things relating to positive outcomes takes priority in decision-making. Quality has been further specified in terms of content traits that include new knowledge and innovative approaches, contextualized information, itemization of resources needed and cost, and best practices for particular settings or groups (Imani-Nasab et al., 2014).

Policymakers’ own lack of skills regarding the meaning of economic analyses, measures of disease burden and distribution, and lack of confidence about how to use such evidence in making policy decisions inhibits evidence use as well (Hyder et al., 2011). This is not a barrier limited to low- and middle-income countries. Policymakers in the United States and United Kingdom also have been found to have major misunderstandings of methodology and study design, as well as misinterpretations of evidence (Neumann et al., 2008). A review of more than 2,000 articles focused on interviews with policymakers from all levels of government in several countries found that the most common barrier to using research evidence in decisions, besides the volume of information, was technical presentation (Innvaer, Vist, Trommald, & Oxman, 2002). Another characteristic of policymakers that impedes the use of evidence is mistrust of policymakers and researchers. This arises partly because policymakers view scientists as having a lack of understanding about the complexity of the health systems within which policymakers function (Innvaer et al., 2002). In addition, mistrust aligns with perceived conflicts in values, leading decision-makers to enact practices such as abstinence-only sex education programs (Santelli et al., 2006) and “Just Say ‘No’” drug-resistance education programs, despite evidence that such programs do not work. Mistrust also occurs due projects such as the “Merchants of Doubt” (Oreskes & Conway, 2010) that provides examples of scientists and industry acting in a duplicitous fashion to create evidence that contradicts the accepted knowledge regarding risks. These activities may create uncertainty about issues ranging from climate change to cigarette smoking, discrediting valid scientific evidence via use of poor-quality science to support the authority of the doubt merchants.