The Voice of Epidemiology


    Web EpiMonitor

► Home ► About ► News ► Jobs ► Events ► Resources ► Contact


Humor Quotes Wit & Wisdom EpiSource Miscellany Editor's Tips Triumphs Links Archives

Epi Wit & Wisdom Articles

Translating Epi Data Into Public Policy is Subject of Hopkins Symposium

Focus is on Lessons Learned From Experience

As the story goes, Senator Muskie was getting so frustrated with hearing testimony from scientists saying “...on the one hand...and on the other hand...” that he quipped what he needed was a one-handed scientist! The challenges and successes as well as the frustrations encountered by scientists and policy makers in translating evidence into public policy were the subjects of a one day workshop on July 29, 1998 in Washington, DC sponsored by The Johns Hopkins School of Public Health and the American College of Preventive Medicine and multiple other co-sponsors.

The day unfurled with a series of eight speakers commenting on the role and value of epidemiology in decision-making, especially regulatory decision-making, and on the clash of cultures between epidemiology, the law and politics. The day ended with a series of six presentations on the lessons learned from case studies involving dioxin exposure and cancer in workers, electromagnetic fields and cancer, folate supplementation for the prevention of birth defects, needle exchange programs for the prevention of HIV infections, particulate air pollution standards, and radiation exposure and cancer. In contrast to past discussions in which epidemiologists have debated the pros and cons of getting involved in policy matters, the speakers at this workshop seemed to take as given that epidemiologists wanted to be involved in policy matters and should be involved in policy making. Thus, the focus of the day was spent on what should be done to improve the process of translating evidence into policy, and this orientation made the workshop unique. Here is a synopsis of the workshop through the words of the speakers:

Alfred Sommer, Dean and Professor, Johns Hopkins School of Public Health

Sommer was given the honor of presenting the first talk and setting the stage for the workshop. Sommer began by stating the basic tenet that data can drive public policy, but noted the historical record is not encouraging about how often this occurs. He reminded the audience, as if anyone needed it, that other factors besides data play into decision-making. He cited two recent examples in the US related to national tobacco legislation and needle exchange programs to make his point. Sommer drew on his personal experience with investigations of vitamin A to remind epidemiologists that data do not speak for themselves, and that scientists should follow up on their leads and build a web of compelling evidence over time. He encouraged scientists to engage in the messy political arena using solid evidence, without becoming wild-eyed advocates.

Joseph Rodericks, Senior Vice President ENVIRON International Corporation


Rodericks spoke on how decisions are made about acceptable levels of risk. He traced the history of our thinking about risk and noted the evolution in earlier days from seeing risk as having a threshold with “safe limits” and when regulations could be hammered out in three days to now when no exposures are considered perfectly safe and the challenge is to determine how much risk is acceptable. Decisions are no longer made in three days and require 800 pages in the Federal Register, he said, and explained that conflicts in the area of risk management often arise because warring parties often have other agendas and the arguments are about risk in form only. The real struggles are about power and ideology. Other problems arise because the public lacks trust in public institutions and it perceives risk differently than in the quantitative terms used by experts.

Paul Portnoy, Economist, President and Senior Fellow, Resources for the Future

Portnoy spoke on the use of epidemiologic evidence in cost-benefit analyses. He reminded the audience why this is important since it is estimated that the US currently spends $150 - 160 billion a year to comply with federal environmental regulations and that not all of these regulations are beneficial. Agencies need to justify their regulations, hence the growing interest and need for cost-benefit analyses of environmental regulations. Portnoy noted that epidemiology has “an almost essential role” to play in cost-benefit analyses for a health program because it helps to determine if and how changes in exposure brought about by the regulations cause changes in health effects. “Epidemiologic analysis is not a panacea, and it is hard to control for everything when you are ‘committing’ epidemiology,” (i.e., doing epidemiologic analysis) according to Portnoy, “but from 20 years of experience, I will put my money on epidemiologic analysis every time,” he said.

Moyses Szklo, Professor, Johns Hopkins and Editor, American Journal of Epidemiology

Szklo spoke on the challenges posed in interpreting weak associations or small effects in observational studies when the weak risk may actually lead to a large population attributable risk. Szklo included, among the “threats to the assessment of small RR/large AR effects,” such issues as the imprecision of the estimates, confounding effects, bias, heterogeneity of effects and colinearity. He discussed consistency between studies and the reasons why there might be a lack of consistency, including changes in the circumstances of exposure, in the timing of the studies, and in the susceptibility to the risk factors among the populations studied. In his view, policy decisions often boil down to: How much do we stand to gain if we are right? How much to lose if we are wrong?

Lynn Goldman, Assistant Administrator, Environmental Protection Agency

Goldman gave her perspectives on the use of epidemiology in the regulatory arena. She believes there has been a “tremendous change” in the role of epidemiology in the last five years since the administrator of the Agency, Carol Browner, has made public health protection the number one goal. Goldman believes that any wall between decision makers and scientists, which exists because the former fears complexity and the latter fears loss of objectivity, is not intended to be there. She argued for more interaction between decision makers and scientists in order to produce better decisions. Goldman criticized persons who make a career out of writing op-ed pieces that point out the now well-known weaknesses in epidemiologic studies (ecologic fallacies, exposures that are estimates only, confounding, lack of known biologic mechanism, association vs. causality, and weak associations). In a theme that was to be echoed by others throughout the day, Goldman called for applying a standard to how persons criticize studies.

Arthur Bryant, Public interest lawyer

Bryant highlighted how science is very important for legal decisions and noted how it is being misused by the law at present. Sometimes courts give greater weight to scientific evidence than they should and sometimes less. For example, some courts have stated that epidemiologic studies provide the only valid proof of adverse health effects, and if there are no epidemiologic studies, experts cannot testify that a particular exposure caused an injury. Or sometimes inconclusive epidemiologic studies are allowed to trump all other studies, even good in vitro studies that may have different results. Alternatively, epidemiologic evidence is given less weight than it deserves, according to Bryant, when studies with less than twofold risk are excluded, or when only studies which have been peer-reviewed are allowed to be considered. According to Bryant, the overall result is that these actions prevent people from testifying in court and this hurts plaintiffs more than defendants because plaintiffs tend to have fewer resources to produce studies. To counter the current misuse, Bryant argued for better science education for judges, greater use of court appointed experts, and feedback to judges when they get the science wrong. “Write to judges, publish articles; call symposia; and file amicus briefs” when you are convinced that the legal system has mistakenly interpreted the best available scientific information, said Bryant. All of this so that the legal system can be “based on the truth” to the maximum extent possible.


Genevieve Matanoski, Professor, Johns Hopkins University

Matanoski discussed the conflicts that arise from the fact that epidemiologists and policy makers come from different cultures. She noted that translating scientific evidence into public policy should not be guided on the scientist’s side by a “hand-over-the-baton type of mindset” when the findings have been produced. Rather the paradigm should be one of “complete integration.” If scientists take the position that collaborating with policy makers will mean that everyone is biased, then this closes the door to cooperation. “We need communication first, and we can worry about bias later as the least of our problems,” said Matanoski. “To stop clashes, to move forward, epidemiologists need to take a different stand,” she added. The choice is clear, she said—“you can work on something with public health interest or you can stay isolated and you will not have this problem.”

Paul Gilman, Executive Director of the Commission on Life Sciences, National Research Council

Gilman spoke on “Improving Communications Between Researchers and Policy Makers.” He noted how there is now some familiarity with epidemiology at the highest levels of the Congress. As evidence for his conclusion, he searched bills and reports in Congress for the word epidemiology between 1973 and 1998. During the 1970’s and 1980’s, the term epidemiology appeared an average of 25 times in each Congress compared to 53 times in the 1990s. According to Gilman, Congress is now familiar with epidemiology and comfortable with it as a means of understanding problems and identifying culprits, but it is less comfortable with it as the support for policy initiatives and regulatory actions. He cited the recent controversy surrounding regulations for airborne particulate matter in which “everyone was acting like a bunch of kids in a food fight.” Given the rudimentary understanding of epidemiology in the Congress, Gilman offered rules of thumb for communicating credibly with Congress which include being candid about everything and disclosing all information. He warned that disclosure is the norm in Washington, and holding data confidential or not making data available would be viewed with suspicion. He also called for more norms in epidemiology. He said, “while it might be fun pointing out flaws in studies and it is okay for graduate seminars, it is not great for briefings and hearings.”

Leeka Kheifets, Electric Power Research Institute

The final session of the day was devoted to presentations of lessons learned from the case studies. Speaking about electromagnetic fields and cancer, Kheifets and her group of reviewers recommended to epidemiologists seeking to translate evidence into policy that they 1) stop promising quick answers; 2) design, analyze and present results to enhance policy; 3) be critical and keep an open mind, 4) allow for pre- and post-publication peer review;     5) evaluate and communicate uncertainty, and 6) participate in policy making and appreciate its complexities. Contrary to other speakers who sought to temper the widespread criticism in the field, she urged epidemiologists to be proud of the critical tradition in epidemiology and to urge others to do the same in their disciplines. For users of epidemiologic data, she recommended that they 1) allow sufficient time for multidisciplinary and long range examination of the issues; 2) accept that there are no yes/no answers when science is uncertain; 3) mistrust the “study of the week;” 4) value review panels as providing an ongoing monitoring process and not the definitive last word on a topic; and 5) defer regulatory decisions until the science is better understood.

Joseph Rodericks, Senior Vice President, ENVIRON International Corporation

Speaking about dioxin exposure and cancer, Rodericks and his group made recommendations about data development. They called for clear statements about the policy questions and recommended that policy makers themselves help to define questions. They also called for study designs that are relevant for policy and for appraisal of the limits of studies ahead of time. On improving how we use the results of studies, Roderick’s group recommended communication of the results in terms directly relevant to the policy question, communication about the strengths and weaknesses of the findings, and the inclusion of uncertainty analysis in the results.

Manning Feinleib, Georgetown University

Feinleib chaired the session on folate supplementation and the prevention of birth defects. He called this a “good news story” in which there was an orderly development of epidemiologic evidence over a 40 year period. His group reiterated the point made earlier by Sommer that the accumulation of epidemiologic evidence can ultimately be convincing and that a consensus can be reached about what actions to take even when uncertainty remains.

David Vlahov, Johns Hopkins University

Vlahov presented on the experience with needle exchange programs. On this topic, there has not been any question about the effectiveness of needle exchange programs. They are now widely seen as effective, yet recently President Clinton and Secretary Shalala refused to translate these findings into policy by requesting federal funds for needle exchange programs. Vlahov and colleagues noted that this research was taking place simultaneously with a war on drugs with zero tolerance, that the affected community of drug users was stigmatized and did not really serve as a constituency, and that there was vocal opposition to this particular intervention among minority communities. For the future, Vlahov and colleagues recommended that epidemiologists need to consider the ramifications of their research and its context. Along with others, they highlighted the need for epidemiologists to learn how to communicate to the public and to policy makers.

Daniel Greenbaum, Health Effects Institute

Greenbaum spoke on the controversy surrounding the setting of particulate air pollution standards. Among the lessons learned were 1) the value of emerging tools of meta and pooled data analysis (this field has more than 800 studies in the last 30 years!); 2) the Hill criteria on causality are a useful guide to the evaluation of evidence but cannot be an absolute standard; and 3) that while an expert panel can serve as a scientific referee to separate the wheat from the chaff, the political debate has no scientific referee and will be shaped by many factors. Perhaps the most contentious issue surrounding particulate air standards was the issue of data access and re-analysis. He noted that while investigators do harbor concerns about property rights, abuse of data and confidentiality, withholding data breeds suspicion. While not every study can be re-analysed he said, it may be good to do for some key studies.

Genevieve Matanoski, Professor, Johns Hopkins University

Matanoski presented the final set of recommendations stemming from the experience with radiation exposure and cancer. Her group along with many others recommended 1) teaching epidemiologists to talk with the public and with policy makers; 2) supporting interdisciplinary teams; 3) supporting forums and journals which address the scientific and policy aspects of public health problems; and 4) planning for future science and policy needs at least 10 years in advance.

While it is difficult to identify overall themes for the day, several of the points made pertain either to the limitations of epidemiology or the shortcomings of its practitioners. As for epidemiology, the speakers did not dwell on the well-recognized problems in the discipline, choosing instead to remind the audience how necessary and useful epidemiologic studies are. This generally sympathetic attitude was epitomized by Portnoy who talked about “committing epidemiology.” The most pointed remarks were directed at epidemiologists themselves for failing to engage more fully in the process of translating evidence into policy. Time and again speakers seemed to be saying that if epidemiologists really want to influence policy, they need to get serious about policy making and change their behaviors in a number of important ways to make translations of evidence into policy more frequent and more successful.

Published August/September 1998  v


      ©  2011 The Epidemiology Monitor

Privacy  Terms of Use  |  Sitemap

Digital Smart Tools, LLC