Connecting Public Health Law with Science

Beverly Gard

Today I will discuss with you some of the considerations and factors that influence legislators as they seek to address public health issues and to apply scientific information in that process. I am speaking as a member of the Indiana State Senate and also from my own professional

It is important to recognize that legislators are very diverse individually and that legislative bodies differ considerably from state to state in their organization, resources, timetables, and in other ways. Every legislator is an individual and has his or her distinctive personality, background, constituencies, priorities, and interests. We come from many professional and occupational backgrounds and, in general, tend to know a little about a lot of things rather than having a great deal of depth in the many issue areas we deal with. Some legislators are full-time and some parttime. Legislators' compensation varies widely as does our access to professional and technical staff.

Now, let me just give you a profile of some of the major factors that legislators tend to take into consideration as they weigh policy options. It is important for public health professionals and advocates to understand that virtually every legislator has multiple big-picture and smaller-picture concerns in mind at any given time. Budget constraints rank very high because most states are dealing with strained budgets. We care about cost-benefit ratios and try to weigh what is the best investment of scarce funds-because there always are many competing priorities. We care about the economic impact of a new program or expenditure: Will they help create jobs in our communities or bring other benefits? We look at the scope of the given problem and try to conduct a risk assessment. Many legislators may not be used to risk assessments but the idea is very similar to program evaluation and we need to improve our ability in this area. We look for sources of scientific data and take that very seriously. Some legislatures have in-house agencies to conduct independent, scientific and technical research into issues. We certainly take quality-of-life concerns and public opinion into account when considering new public health policies and programs. We want to know what is important to our immediate constituents and, more broadly, to our entire state. In this context, legislators are very concerned with individual rights and apply that concern to policy proposals. Many legislators search for non-regulatory solutions and for ways they can set broad policy goals and leave it to administrative agencies to implement them rather than put too much prescriptive detail in the statute. Also, legislators have special-interest constituencies and often have their own interest in being reelected. This can lead to an emphasis on quick results even though some programs take a long time to bear fruit.

Now that I've painted this contextual picture, let me outline some of the major public health issues we are dealing with in Indiana and in other states as well. What these all have in common is the interweaving of science and the other types of considerations I just outlined.

* Childhood Immunization: In spite of the high success rate of most recommended vaccinations, there are constituencies that fight every proposal to require a new immunization and we in Indiana have responded, in part, by authorizing religious exemptions so that issue doesn't keep us from our larger goals.

* HIV Testing: We have made HIV testing mandatory for pregnant women in Indiana but do allow exemptions if requested for the mother. We do not allow exemptions for the infant.

* Combined Sewer Overflows: This is a serious problem during wet weather events and has caused documented public health problems in Indiana municipalities. Federal and state laws have set standards but the cost of compliance is extremely high at a time when the states are struggling with very weak budgets.

* Failing Septic Systems: We have allowed counties to create on-site waste management districts to monitor septic system function and we want the health department to be more aggressive in approving new technologies for on-site solutions. Serious public health problems can arise from failing septic systems and they need to be addressed. Scientific evidence is badly needed on the contribution that septic systems make to nitrate contamination of groundwater versus other sources of nitrates in groundwater. We are reluctant to embed numerical standards in the law until we have those data.

* Optional Medicaid Services: Medicaid services can be expensive, but if we have good evaluation data we can show that providing such optional services as prenatal care, dental care, and mental health medications actually can be cost-saving.

* Birth Defects and Cancer Registries: These registries can be invaluable sources of empirical data on public health problems and we in Indiana have expanded reporting requirements over considerable provider opposition. We also have addressed privacy and HIPAA issues.

* Obesity: Legislators are looking carefully for evidence of what works. School meals and physical education programs are being reviewed, as are school vending machines. We are reluctant, however, to pass anti-obesity legislation on a piece-by-piece basis and really want the science that will tell us what works. A lot of attention also is being given to using land-use planning to fight obesity, for example, by encouraging mixed-use development, multimodal transportation and safe routes to schools.

* Lead Poisoning: Weighing the science and the risk, Indiana legislators have concluded that it is more realistic to aspire to "lead-safe" goals than to "lead-free" goals. The cost of total abatement is prohibitive and as a result this can discourage the problem being addressed. We are focusing on affordable cleanup, education, and coordination of programs for greatest effect.

* Tobacco: A key issue here is the tension between science and individual rights. We are working hard on this in Indiana and have made some good progress. We have strengthened penalties for selling to minors, restricted cigarette vending machines to areas minors do not frequent, and prohibited Internet cigarette sales to anyone who does not produce an adult ID. We have been less successful with indoor smoking bans thanks to considerable resistance from the tobacco industry and the hospitality industry.

* Vehicle Passenger Restraints: Here is another area where individual rights and scientific information collide. State laws vary a good deal. In Indiana we recently mandated booster seats for children under eight, which is one of the most strict booster seat laws in the country but opponents have been quite effective in other areas. As a result Indiana does not require seatbelts in SUVs or trucks.

In conclusion, let me say that the public health issues legislators wrestle with are numerous and very complex. We want and need more scientific information to work with. With my own scientific background, I find that many of my colleagues do value my perspective and that kind of reliance on colleagues with special skills can be very helpful.

Legislators do have access to some extremely valuable sources of independent, scientific information. In some states, but not all, we have skilled legislative staff and staff in the state health department and other agencies, as well as interns and fellows. When a special issue comes up that needs a concentrated effort, we can form special task forces that may have access to scientific data and resources. Outside of our state governments, we can rely to some extent on legislative support organizations like the National Conference of State Legislatures and the Council of State Governments, on federal agencies, on consultants and academics, as well as on private and non-profit experts. These sources can be very beneficial in helping legislators evaluate scientific information, conduct risk assessments, shape legislation for maximum effectiveness, and conduct program evaluations.

Stephanie Zaza

The term "evidence-based medicine" has largely become synonymous with evidence provided by systematic reviews of scientific literature. This misnomer has crept into our public health language as well, where "evidence-based public health" is implied to require a systematic review of the scientific literature in order to make a decision. While scientific evidence is an essential part of public health decision-making, it is not the only type of evidence available. In fact, many daily decisions in public health do not require scientific evidence, and must be made based on other types of information or "evidence."

Scientific evidence consists of individual studies, reviews that synthesize those studies, and practice guidelines that make recommendations, often, but not always, based on science. Reviews that synthesize the scientific literature can be done in a variety of ways. An expert review is much like a chapter in a textbook. These reviews are carried out by an expert in the field who gathers information based on his or her own experience and knowledge. In contrast, systematic reviews are conducted based on a set of a priori rules that lay out the study question, a search strategy, inclusion and exclusion criteria, quality parameters that will be applied to each study, and data analysis methods. A subset of systematic reviews is the meta-analysis. This type of systematic review calculates an overall effect size for the group of studies included in the review according to specific statistical methods. Practice guidelines are often developed based on the various types of scientific evidence. Such guidelines assist clinical or public health providers in deciding which preventive services, treatments, or other interventions should be offered or implemented.

A specific example of systematic reviews and practice guidelines for public health is the "Guide to Community Preventive Services." The Community Guide provides recommendations based on literature reviews about a variety of types of public health interventions. The Community Guide is available in serial format in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, the American Journal of Preventive Medicine, as well as at <http://www.thecommunityguide.org>. It will also be available in book format in early 2005.

Systematic reviews and practice guidelines are important tools for decision-making, but clearly these are not the only tools we need to make good decisions in public health. It's a little like thinking that since we have a hammer, all of our jobs should be about pounding nails. Instead, we are confronted daily by complex public health problems that require a series of decisions each of which needs a different tool or type of evidence. For example, here is one set of common public health decisions that might arise around a given issue:

1. Should something be done?

2. What should be done?

3. How should it be done?

4. Is what we are doing working?

Each of these questions has a series of important subquestions:

Should something be done? What is the burden of the disease or risk factor? What is the urgency of the problem? Is it a priority for my community? What is the perceived need? These questions cannot be answered by systematic literature reviews. Rather, surveillance data, special studies, basic medical data, trend analyses, community surveys, and consensus opinion are all important types of evidence that should be collected, analyzed and used in determining whether a particular issue needs to be addressed.

What should be done? What is the essential nature of the problem? What works? What is acceptable to the community? What can our community afford? What is feasible given our resources and capacity?

Once a decision is reached that something should be done to address a particular problem, it is important to get at the essential nature of the problem to make sure that it is addressed appropriately. For example, a mass media campaign to improve vaccine coverage is unlikely to increase immunization rates if the real problem is that people don't have access to clinics where the vaccine is offered. Again, systematic reviews and practice guidelines are of little help in answering this question; a detailed analysis of the local situation is required to understand how the problem should be addressed.

Answering the question, "what works?" is where systematic reviews and practice guidelines are the most appropriate type of evidence. Once an effective solution is identified, though, additional questions about acceptability, affordability, and feasibility are determined by the community through focus groups, key informant interviews, economic analysis, and systems analysis.

How should it be done? Or, what steps do we need to take to implement this intervention? Practice guidelines sometimes take this important next step and provide information about how to implement the intervention or treatment. In addition, experience, anecdote and documentation from previous implementations can be useful sources of evidence to answer this question.

Is what we are doing working? Program evaluation is essential to make sure that any action taken has the desired effect. Is it being implemented well? What does the community think of the intervention? Is it improving health risks or outcomes? If it isn't working, why isn't it? These questions are best answered using evaluative strategies such as checklists, interviews, focus groups, surveillance data, and specifie scientific studies.

There is a new CDC-funded program called, "Steps to a Healthier US." This program was implemented in order to provide sufficient funds to communities to go through the type of decision-making framework just described and implement selected evidence-based interventions to address several chronic diseases and risk factors. The Steps Program focuses on diabetes, asthma, obesity, physical activity, nutrition, and tobacco. Activities are implemented in communities, schools, worksites, and other settings where people live, work, and play. Twenty-four communities were funded in 2003 and an additional sixteen communities were funded in 2004. Each community had to go through many of the types of questions posed earlier and use a variety of types of evidence to provide sufficient justification for funding. They continue to use these questions and evidence sources to evaluate, modify and improve their programs. They use the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Survey, community coalition input, the Guide to Community Preventive Services, focus groups, deep knowledge of local assets, existing surveillance systems, and other sources of evidence to make decisions on a daily basis.

In summary, this presentation has described a framework for evidence-based decision-making that is a continuous and cyclical process. As new information is gathered, published and summarized, it becomes part of the evidence base that we can use to make future decisions.