Science and the Law

How the Communication of Science Influences Science-Based Policy Development in the Environment, Food, Health, and Transport Sectors

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This symposium set out to explore how the public communication of science influences the interaction between science and policy development in the regulation of the environment, food, health and transport. It presented a series of case studies illustrating the impact of science communication on policy development. The controversy surrounding the science behind the study of global warming and the resulting focus on the reduction of carbon dioxide emissions by international agreement and by national and international regulation is one example of such an area where science communication and policy development are inextricably intertwined. The symposium was one of a series which is seeking to identify other areas where science-based policy development is of increasing importance. The first symposium, held in Philadelphia in 2012, has recently been published as an ACS Symposium book Science and the Law: Analytical Data in Support of Regulation in Health, Food, and the Environment, Editors: William G. Town, Judith N. Currano, Volume 1167, ISBN13: 9780841229471, eISBN: 9780841229488.

Our first speaker, Fred Stoss, gave a presentation entitled “Coming out from under the cloud of “Climategate”: Are scientists effectively communicating with the public on climate change?” The strategies, resources, and tools of the groups that challenge scientific communication with the public, were discussed and various STEM-based information, communication and education resources described. Communicating with the public is not a traditional role of scientists, but is of increasing importance in today’s virtually connected world. It is incumbent that the public understands the basic scientific principles of the environments in which they live, work, learn, and play.

Climate change emerged in the 21st century as one of the most complex and controversial environmental problems. Enhanced scientific communication by scientists and their proxies was a response to the theft of emails and documents from the University of East Anglia in November 2009. These emails were strategically “leaked” days before the United Nations Framework Convention on Climate Change in Copenhagen. Climate change deniers attacked researchers, and Conservative radio talk shows dispersed allegations of fraud, withholding and manipulation of data, and suppression of publications. “Climategate” neutered the UN negotiations and, more lastingly, created public confusion and mistrust about the scientific consensus on climate change.

Scientific organizations challenged scientists to evaluate their roles as communicators and set the stage for increasing the proactive discussion of their research. In particular, they needed to explain how their research contributes to a more informed decision-making process which is necessary if we area to transform our ways of thinking: from living in a greenhouse gas-constrained world to a world not constrained by greenhouse gases.

The second speaker, Hanna Breetz, experienced logistical problems and was unable to deliver her talk on “Carbon accounting for indirect land use change (ILUC) in biofuels policy.” Fortunately, we had advanced notice of the logistical problems which were caused by Hanna’s new university position and Fred was able to fill the gap in the program without any difficulty.

Our final speaker before the intermission, Jim Solyst, described strategies for “Communicating the risk of nicotine delivery products.” The rapid increase in the use of electronic cigarettes by smokers of tobacco cigarettes has highlighted the risk perception and communication challenge facing the US Food and Drug Administration (FDA) in characterizing nicotine delivery products. Tobacco smokers believe that by switching to electronic cigarettes they are reducing their risk level. This is likely to be true, but the scientific evidence is only now being collected. FDA is a public health and science-based agency, and cannot communicate the risk reduction potential of electronic cigarettes until they have sufficient evidence, regardless of the intuitive risk reduction potential of the product.

The 2009 Tobacco Control Act provides authority to the FDA Center for Tobacco Products to regulate tobacco products, including electronic cigarettes. Section 911 of the Act, Modified Risk Tobacco Product (MRTP), provides a scientific evidence-based process by which a company can apply for and receive a MRTP order. If a product can be demonstrated to reduce harm to the individual and benefit the overall public health then it may be characterized as modified risk and FDA may communicate that information to the public.

There are products, for example, Swedish snus (a smokeless tobacco powder), for which there is a great deal of human health evidence and may at some time be granted a MRTP order; but there is no such human health evidence for electronic cigarettes due to the recent introduction of the product to the market. So what does FDA say to the tobacco smoker who is considering switching to electronic products? The best advice is not to use nicotine products at all, but does FDA have an obligation to inform smokers of the obvious benefits of switching, even if the evidence is not complete?

Our first speaker after the intermission was George Lunn from the FDA who presented “PEPFAR - a US Government program that is helping to keep millions alive around the world.” This was a good news story. PEPFAR, the President’s Emergency Plan for AIDS Relief, was announced by President George W. Bush in 2003 with the aim of preventing infections, treating infected people, and caring for infected individuals and orphans in resource-limited countries.

In a unique arrangement, low-cost manufacturers submit to the FDA New Drug Applications or Abbreviated New Drug Applications for antiretroviral drugs to treat AIDS and these applications are reviewed to the same standards as applications for products that are destined for the US market. To expedite the preparation and submission of these applications, the FDA has reached out to the manufacturers, distributors, and other interested parties. At the beginning of 2014 the FDA had taken an action on 168 applications and 6.7 million people worldwide are being treated with these antiretroviral drugs. George described the communication challenge that resulted from this outreach program.

Our next speaker was Neil Ravenhill of Weber Shandwick (who was a late substitute for Tamora Langley) and he discussed the topic “Does science or communications have greater influence in formulating policy? A UK perspective.The dynamics and principles of the scientific environment are starkly at odds with the dynamic of the political environment in which policies are made or broken. While a scientific approach is rational, evidence-based, and formed through consensus of experts, the political environment is emotional, driven by communications, and adversarial. Although decision makers aspire to evidence-based policy-making, in contested areas the side with the most effective communications often seems to “win.”

The recent economic crisis in the UK and across mainland Europe has necessitated drastic cuts in public spending, impressing on officials the need to make savings and squeeze more value out of public resources. In the UK, the government marked out the health budget as one of only two areas of public spending to be shielded from the cuts. Still, relatively flat health spending has been outstripped by rising demand for services, and so any new policies requiring additional resources remain in theory unaffordable. Where new health policies have been introduced, such as the Cancer Drugs Fund (CDF), they have been driven not by scientific developments so much as by public opinion and political decision-making. Similarly, attempted policy change driven by or expressed in terms of economic or rational imperatives (such as attempts to reconfigure health services, or attempts to change statutory regulation of dispensing medicines), have failed in the face of patient and professional campaigns. To conclude that those who shout loudest will always win is to over-simplify. Besides, in some policy debates, patient and professional advocacy groups are divided. Even if policies are pushed through by noisy campaigns, they can be reversed or stalled by the public officials who “outlive” their political masters and realize they are in practice unworkable or inefficient. The answer? Begin with the science, but recognize that the communication of science is just as critical.

David P. Richardson, described some of the pitfalls in the “Consumer communication of nutrition science and impact on public health.” Dietary interventions for vulnerable groups such as the elderly, women of childbearing age, children and adolescents can contribute beneficially to help reduce the risk of suboptimal intakes and deficiencies of micronutrients, to control costs of healthcare, and to promote the health and quality of life of people globally. Examples presented included the communication of the scientific evidence for (a) the use of folic acid/folate to reduce the risk of neural tube defects, (b) the reduction in prevalence of iron-deficiency anemia, (c) the relationship of calcium and vitamin D to bone health and reduced risk of osteoporosis, and (d) the modulation of the age-related decline in most organ functions and reduction in the development and/or progression of many chronic diseases. Richardson highlighted the need for evidence-based healthcare and communication policies, including the use of nutrition and health claims on food products to raise awareness of the role of diet in health.

The final speaker, Sarah Cooney, illustrated the problems of Communicating controversial science: The case of tobacco harm reduction and the ethics of blanket censorship” and the difficulties encountered when publishing research from the tobacco industry. It has long been accepted that cigarette smoking causes serious disease and death, and public policy has focused on reducing tobacco use. In the US, the FDA has had regulatory jurisdiction over tobacco products since 2009 and is committed to an evidence-based approach for regulatory decision-making anchored by sound science. In an effort to generate much more data about tobacco science, the FDA has established an interagency partnership with the National Institutes of Health (NIH), which is making available billions of research dollars to study priority questions about tobacco science to inform FDA regulations. This new funding should attract many new researchers, creating a larger and more diverse, transparent and results-orientated tobacco science community.

The FDA has set an example in acknowledging tobacco manufacturers both as an important stakeholder and as a potential source of valuable scientific expertise. Perhaps as a result, there is a general increase in scientific publications resulting from research undertaken by tobacco industry scientists. Additionally, most tobacco manufacturers are even more committed to developing products substantially less risky than cigarettes, and the science to evaluate the potential of such products to promote harm reduction. At the same time there is an increase in the number of scientific journals introducing blanket bans on publishing science from tobacco manufacturers, with the BMJ (British Medical Journal)being a recent example. Cooney described the ethical dilemmas surrounding scientific censorship and the role of peer review in protecting scientific integrity.

The session concluded with a panel discussion with active participation of the speakers and the audience. The layout of the room precluded the normal format of a panel discussion with all the speakers on a podium, but this worked to our advantage and may have inspired more active involvement of the audience, many of whom had followed the whole symposium.

William Town, Symposium Organizer