Environmental Health Sciences Decision Making: Risk Management, Evidence, and Ethics: Workshop Summary (2009)

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Summary The workshop on Environmental Health Sciences Decision Making was convened to inform the Roundtable on Environmental Health Sciences, Research, and Medicine on emerging issues in risk management, “weight of evidence,” and ethics that influence environmental health decision making. This is the first in a series of discussions for the roundtable to better understand the science needs in this area. The remarks in the workshop summary are the views of the individual presenters, panelists, or members and do not reflect a consensus of those attend- ing or the roundtable. This workshop focused on the strategies used to make decisions, whether they are based on the precautionary principle or cost-benefit analysis. During the initial session of the workshop (reflected in Chapter 1), the focus was on how complex decisions could incorporate new technologies and the need for a more interdisciplinary approach. The second session (Chapter 2) shifted the focus to the weights of scientific evidence and how this information is used in the ­decision- making process. The last session (Chapter 3) focused on the ethics and value of scientific information that is used for decision making. Speakers and participants discussed the issues of conflict of interest, bias, and transparency. For the field of public health, identification of a hazard is only the first step in protecting individuals and the population at risk against its harmful effects. Earlier strategies focused on one chemical at a time and often assumed that individuals are static in the environment, so that their behaviors and lifestyle choices were not taken into account. However, as understanding of toxicology and epidemiology has evolved, so has scientific understanding of the complexity of environmental hazards. Risk assessment has moved beyond the general assumption that a major cause of a problem (exposure) can easily be identified and a solution generated. Thus, according to some of the workshop participants, society is currently at a crossroads in environmental health decision making, and there is a need to look  

 ENVIRONMENTAL HEALTH SCIENCES DECISION MAKING at the paradigm very carefully and think about what science can do to improve the way those decisions are made. Holistic Approach to Environmental Health Decision Making During the workshop, Christopher Portier from the National Institute of Environmental Health Sciences stressed that complex human–environment inter- actions require a systems approach to understanding environmental health and implementing environmental health decisions. Such environmental components as basic needs, shelter factors, and endogenous factors interact with each other to determine a person’s health status. He suggested that the general assumption about risk assessment—the major cause of a problem can easily be identified and a solution generated—is an outdated approach. Furthermore, he noted that with regard to the human system and how science addresses its exposure to hazards, there is a large amount of research and testing being performed, from the population and clinical levels to the molecular level. Although all of this science contributes to understanding the impact of the environment on health, most risk assessment is based on toxicological and epidemiological evidence and not on emerging sciences, such as genetics and toxicogenomics. Scientists and policy makers therefore need to look at the emerging areas of science to find ways to incorporate this research into the environmental health decision-making process. Alternative View to Environmental Health Mary O’Brien from the Oregon Toxics Alliance furthered the discussion by noting that the presumed goal of environmental health science decision making is to produce less harm to human health and the environment. However, she stressed there is a fundamental disconnect between environmental health sci- ence and decision making for environmental health. Too often in the scientific community, among many other professions, there are many obstacles to good decision making, including a narrow power base that leads to narrow decision making and the fact that human nature is habit based and decisions are made in ways that stifle creativity and ingenuity. She noted that environmental health is fraught with examples of this disconnect in the decision-making process. An example is the substitution of one chemical for another to achieve a desired goal without careful thought and consideration given to the impact the new chemical may have on the environment. One approach to overcome these limitations is to use alternatives decision making, which has ability to take diverse perspectives to examine reasonable alternatives for producing fewer harms. By bringing to the table parties with different views and positions, the discussions can lead to the generation of more 

SUMMARY  ideas, which may offer environmentally sound solid solutions to problems not seen without those views. However, to arrive at such solutions, there must be transparency as well as a level playing field based on equal representation on all sides of an issue, concluded O’Brien. Beyond Precaution Bernard Goldstein of the University of Pittsburgh Graduate School of Public Health noted that many environmental health decisions have been made from a fragmented, narrow, reductionist approach that can often create secondary prob- lems. He echoed the call for a holistic approach for science, but at the same time cautioned about decision making under uncertainty. The precautionary principle is a moral and political principle that was developed as a result of the need for action in the face of scientific uncertainty. According to the European Commis- sion, this principle should be applied whenever the “scientific data are insuf- ficient, inconclusive, or uncertain and where a preliminary scientific evaluation shows that potentially dangerous effects for the environment and human, animal or plant health can be reasonably feared” (EU, 2008). The argument for using the precautionary principle in order to act in the face of uncertainty implies that without this principle there is an absence of action in the face of uncertainty. While attention should be paid to the premise of the principle, there is also the need to step back and examine what it means to the overall practice of public health, asserted Goldstein. If policy makers are going to rely on precaution, then they need to authorize research to ensure that a precautionary approach is needed. The research agenda should be linked to objectives of data need and data quality and involve the public. The Nature of Evidence The first step in understanding how evidence relates to scientific decision making is to look at evidence as science, noted Michael McGinnis of the Institute of Medicine. It is widely understood in the scientific community that evidence is science; however, there is another point to consider, which is the utility of evidence as science. Science may be a tool less for finding the answer than for revealing the next question to study and research; evidence may be a tool less for making the decision than for informing the context in which the decision is to be made, noted McGinnis. Evidence is not static or formulaic. Evidence is not binary in nature, but rather is a spectrum that ranges from a finding of no evidence available to one of irrefutable evidence. This view of evidence presents a chal- lenge in determining the decision rules along the path to stronger evidence—in particular, how scientists form and agree to the standards used to inform the decision-making process, with the understanding that evidence has many forms, and the context in which those decisions are made. 

 ENVIRONMENTAL HEALTH SCIENCES DECISION MAKING While the evidence spectrum is clear in clinical medicine, such a spectrum is needed for interventions in population health, noted McGinnis. These inter- ventions range from ones that originate from a purely physical or environmental process, such as fluoride in the water supply, to individual interventions, such as behavioral change interventions designed to encourage smoking cessation, increased physical activity, or change in dietary habits. In population health, effectiveness is often a function more of the nature of the intervention than the nature of the evidence; this suggests that the intervention is of such power that it carries with it an additional obligation to consider other aspects of the issues involved. Making decisions at the population level may require fewer points to consider, but their powerful impact requires understanding several factors: the potential health, economic, and social consequences of inaction; the potential health, economic, and social consequences of action; the characterization of uncertainties and mapping strategies as uncertainties resolve; and the systematic assessment and feedback factored into the approach of an intervention, concluded McGinnis. Evidence and Uncertainty Ultimately, there is a need to define variability and uncertainty distributions and to have both analysts and managers as an integral part of risk analyses, noted Dale Hattis of Clark University. Methods for estimating variability and uncertainty should ideally be based on causal mechanisms. During the workshop, Hattis outlined four implications that are important to understand as society moves forward in making risk management decisions. First, legal cases involv- ing environmental issues are increasingly calling for the recognition that some finite rates of adverse effects will remain even after implementation of reasonably feasible control measures. Second, societal reverence for life and health means making the best decision with available resources to reduce harmful effects. Third, responsible social decision making requires making estimates of how many people are likely to experience how much harm and determining with what degree of confidence. Fourth, the traditional multiple-single uncertainty factor system cannot yield estimates of health protection benefit that can be juxtaposed with the costs of health protection measures. Weighing Evidence A central tenet in scientific decision making is that any decision rendered needs to be based on the best available science, which “depends upon a disin- terested and transparent scientific process” (Steinzor and Shudtz, 2007, p. 1). In other words, scientific decisions should be made using the weight of the evidence, yet in today’s world, scientific decisions are often called into question by the legal profession, seeking to influence an outcome, noted Rena Steinzor of the Univer- 

SUMMARY  sity of Maryland School of Law. The pathway from science to science policy is often perceived by scientists and the public as a straightforward one, as the merits of the science have been vetted during peer review in the publication process (Wagner and Steinzor, 2006). However, Steinzor suggested that this is not always true. The culture of law and science are vastly different and at times clash with one another, which puts pressure on science when it is applied in the legal setting. The difference between the legal and scientific processes are most profound in the regulatory arena, where, once a scientific decision has been reached, it can then be subjected to extreme scrutiny and deconstruction by the legal profession, observed Steinzor. This deconstruction can create important data gaps and is in stark contrast to the weight of the evidence approach used by scientists (Wagner and Steinzor, 2006). Revisiting Environmental Health Decisions Drawing from his experience at the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP), Kenneth Olden of the NIEHS discussed the need for revisiting scientific decisions. The Report on Carcinogens is a congressionally mandated document “prepared by the NTP for the purpose of identifying substances, mixtures of chemicals, or expo- sure circumstances associated with technological processes that cause or might cause cancer and to which a significant number of persons in the United States are exposed. Listed in the RoC are a wide range of substances, including met- als, pesticides, drugs, and natural and synthetic chemicals” (NTP, 2005). Olden noted that the chemicals on the list go through an extensive public review and that additions are made after careful scrutiny and consideration of all available science. A decision to list a chemical in the RoC does not mean that it cannot be reconsidered. As science evolves and new information is discovered about the harmful, or not harmful, effects of a chemical, there may be circumstances for reevaluating. The case of saccharin is one example where the decision for revisit- ing the listing was based on the evolution of science. Ethics of ConflictS of Interest Conflicts of interest are ubiquitous, noted Thomas Murray of The Hastings Center. They are usually based on situations in which there is reliance on the judgment of an outside party with some very specific professional expertise. Exercise of that judgment should promote the interest of a loyal party, which can range from the individual level (e.g., the patient in a doctor–patient relationship) to a broader level (e.g., institutions). The judgment that the professional owes the client, patient, or institution may include specific recommendations, but often it includes just interpretation of information for the receiver (loyal party), who 

 ENVIRONMENTAL HEALTH SCIENCES DECISION MAKING lacks the expertise necessary to understand the information without assistance, noted Murray. To say that someone has a conflict of interest is not a moral criticism, but rather a description of a set of circumstances, observed Murray. That person has a primary interest that he or she needs to fulfill, although other interests may push or pull the person in different directions. A moral failure would be if the person neglected their primary interest and allowed these other interests to rule. The many challenges in correctly identifying conflicting interests include variation in individual interpretations of what is considered to be conflict. This can range from not recognizing an issue as a potential for conflict to assuming impartiality because the monetary outcome is the same no matter which position is decided. Having criteria to determine the nature of conflict is therefore neces- sary in any scientific organization, noted Murray. Several steps are key to detect- ing, managing, and addressing all types of conflict of interest, including those financial in nature: clarity, simplicity, fairness, and predictability. Different organizations have different techniques for addressing conflicts of interest, observed Vincent Cogliano of the International Agency for Research on Cancer (IARC). One such technique is to actually ignore the issue altogether. However, most organizations are choosing to implement some type of mecha- nism for addressing conflict, such as opting for a simple disclosure policy. Other organizations have chosen to build on a disclosure policy by adding a system of checks and balances to limit the number of experts involved if they have conflicts. In other words, the experts with conflicts are diluted by the experts who have no conflicts. While some organizations try to actively balance experts who have a conflicting interest with someone with an opposing interest, another strategy is striving to avoid conflicts of interest altogether. Using a case study, Cogliano illustrated the IARC strategy for addressing conflicts of interest that addressed the issues of best versus impartial experts, and maintain inference as they produce their monographs. Perspectives on Environmental Health Decision Making Throughout the workshop, both during the presentations and discussion peri- ods, a variety of viewpoints were expressed on how to balance issues of conflict of interest and bias and to ensure weighting of evidence for decision making. In a panel discussion, four stakeholders shared their views on how best to ensure that decision making was based on sound, credible science. Drawing from the preliminary studies of Rofecoxib (Vioxx), where there were conflicting interpretation of the same sets of data, David Michaels of George Washington University suggested the public overall may have been served better if an independent review had been conducted. He further asserted that a central tenet of the process to ensure that decisions are based on credible science would 

SUMMARY  include full disclosure and publication of conflicts, whether it was publicly or privately supported science. This disclosure would need to encompass the entire research enterprise and be applied equally to the publishing of research and the regulatory setting. Myron Harrison of ExxonMobil Corporation stated that ultimately all sci- entific findings must be judged on their merits, whatever the source of funding. He noted that in reality, the science used in public health is particularly unstable and uncertain, and therefore scientific disagreement and controversy should be expected. In the face of this uncertainty, other human factors, such as personal beliefs and values, often play a large role. He noted that in order for an agency to optimize the credibility of science used in rule making, they can strengthen the science’s credibility by using good lab practices, protecting human subjects, applying rigorous peer review, disclosing potential conflicts of interests, and implementing strong management systems. The final two speakers addressed issues related to how the science is directly used in environmental health decision making. John Balbus of the Environmental Defense Fund asserted that due to the challenges of a very high burden of proof faced by many regulatory agencies, too few environmental health decisions are actually made and the supporting (safety) data are not often required. This makes the regulatory process challenging. He further stated that peer review of data is not uniformly applied throughout the rule-making process and called for equally rigorous review of all data that may be incorporated into the rule-making process. William Farland of Colorado State University ended the panel discussion by noting that in order to move the environmental health decision-making process forward, there is a need to think strategically about how data can inform risk. Science is a moving target, and it is essential to think about what information is needed to inform decision making He noted that focusing on basic instead of applied research and on disease-based instead of topic-based research creates an inability to generate the type of data necessary for rigorous assessment of chemi- cals. One idea to move the process forward is to develop a systematic approach to working with data and weighing the evidence. Finally, the paradigm should incorporate evaluation into the decision-making process, as assessing the impact of a decision is vital to the success of future decision making.