Sweta Chakraborty

The changing nature of communication and regulation of risk in Europe

The regulation and communication of risk have changed significantly over the past 20 years or so, partially as a result of a number of regulatory scandals in Europe and elsewhere, which have led to greater public distrust of regulators and policy‐makers. This increase in public distrust has resulted in a phasing‐out of consensual‐style regulation, and the emergence of a newer model of regulation based on variables including public participation, transparency and increasingly powerful non‐governmental organisations (NGOs). This paper discusses some of the consequences of adopting this new model of regulation through a series of case studies.

Transparency Initiative by the FDA’s Center for Drug Evaluation and Research (CDER): Two qualitative studies of Public Perceptions

Recent calls for transparency targeted towards regulatory bodies such as the US Food and Drug Administration has prompted investigation into the indubitable adoption of such measures. Specifically, the FDAs quarterly postings of AERS (Adverse Event Reporting System) signals on its CDER (Center for Drug Evaluation and Research) website, stemming from FDAAA legislation introduced in September 2007, is analysed from a risk perception and communication perspective. This paper consists of two qualitative studies examining public perceptions and subsequent reported behaviour related to increased transparency. Interviews were conducted on two separate samples of seventy respondents in both Pittsburgh and New York City. The results found that signals postings may prove counter productive in terms of increased public alarm and early or inappropriate termination of a drug appearing on the list. We also found communication from the FDA perceived as inaccessible or confusing, particularly that the AERS signals are posted strictly on the web, while the majority of our respondents cited their primary and secondary media sources as broadcast television. We recommend that the FDA reconsider its communication strategy of AERS to the public as it may prove to be a ‘transparency step too far.’

Transparency and the Food and Drug Administration-A Quantitative Study

In Europe and North America, there is increasing political pressure being put on health regulatory agencies to become more transparent. To date, however, there has been little academic evaluation—let alone analysis—of these transparency initiatives from a risk communication perspective. This review examines whether the U.S. Food and Drug Administrations Adverse Event Reporting System quarterly signal postings, put in place after the passage of the Food and Drug Administration Amendments Act 2007, will assist patients and doctors in their decision-making processes, on the basis of results of a quantitative Internet survey of 433 physicians and 1,000 American adults. The results indicate that there is significant disagreement between physicians and the public about when medical safety issues should be communicated in the first place, with physicians opposed to early signal postings while the public in general is in favor. In addition the findings show that if the public were to find their drugs listed on the Adverse Event Reporting System signals web postings, more than a quarter would stop taking their medicine. Going forward, the Food and Drug Administration needs to work to a greater degree with social scientists in developing scientific-based communication strategies, rather than developing transparency initiatives on the basis of stakeholder consultations.

Risk Communication and the Pharmaceutical Industry

Risk communication is central to the risk management strategy of a pharmaceutical company. Pharmaceutical companies primarily communicate risk through labelling tools such as the Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) and the carton, which are currently regulated based on templates such as those of the EU. Recent research raises concern about how effective the SmPC is alone in communicating risk. There is some evidence that carton design can influence risk comprehension. Processes to check new trade names cannot be confused with existing names is a simple measure to mitigate one form of risk. Given the central role and the vast amount of resource that is consumed, it is surprising there has not been extensive original research to see whether product information such as the SmPC is a good tool for communicating risk. Recently, EU agencies have assessed the communication value of the PIL and revised the template and guidelines. However, no evaluation of user testing has been conducted at European level since the introduction of these new requirements. As regards ‘Dear Healthcare Professional Communications’, there is inconsistent evidence about their ability to change patient and physician behaviour. There is a dearth of evidence about what sort of communications materials are the most effective under which circumstances.The use of templates restricts the flexibility of companies to adapt their risk messages to their targets. Effective communication requires understanding how different audiences perceive the message and what the funda-mental drivers are for altering patient and prescriber behaviour to be safer. This requires careful consideration of the relationship between risk communication, perception and management. However, the focus of a company’s risk communication plan is normally on the International Conference on Harmonisation (ICH) regions and their regulations. Although the same regulatory tools are used globally, we are not aware of any research into their effectiveness outside the ICH regions.What listed companies can communicate about benefits and risks is strongly influenced by the obligations of companies to the market and investors. There needs to be internal coordination for simultaneous release. Internal communications about significant issues should be restricted to those who know how to manage the risk of insider dealing from internal communications that may later be made public.Unfortunately, there is evidence that some companies do not have a cohesive strategy for communicating risk which should take into account all forms of promotional material and company-sponsored information sources on the Internet.A pharmaceutical company is not the only stakeholder responsible for communicating risks on their products. However, the relative roles and responsibilities of all relevant stakeholders are not defined and are often un-clear. This means it is difficult to evaluate whether a company’s actions might be duplicative or inefficient. We recommend that companies have a dedicated communications group whose role is to coordinate the company’s communications strategy mapped to objectives that have been agreed with key stakeholders apart from just regulatory agencies. This same group can assess effectiveness of the communications, monitor audience reaction and adjust the communication strategy accordingly.

Part II: the role of trust in patient noncompliance: a quantitative case study of users of statins for the chronic treatment of high cholesterol in New York City

It is widely known that increased perceived risk associated with a drug, even if in a completely different class of medicines, may influence patient compliance to their treatment regimes. Media reports of alleged scandals and controversies associated with certain prescription drugs, such as Vioxx, are easily accessible in public recollections and may influence attitudes towards other drugs. Reports of increased noncompliance following such media reports contribute to the existing 50–70% of the US adult population of chronic prescription users who do not take medications in accordance with physicians’ instructions. This can have impacts ranging from faster onset of disease for the noncompliant individual to wider impacts for society as a whole, such as increased federal spending on social health funds. The rates of noncompliance described, and their alleged relationship with increased public suspicions, suggest a role for trust in shaping compliance behavior in patients. This study applied the mental models approach for the purpose of understanding lay perceptions in relation to existing scientific information on the risk of noncompliance. In accordance with the approach, 30 participants were interviewed, and 200 questionnaires were administered in New York City to eligible users of statins for the chronic treatment of high cholesterol. This original research reports the primary findings from the 200 confirmatory questionnaires in relation to the qualitative interview findings from the previous article. The themes of distrust in various actors in the health care system identified during the interviews were supported statistically through the questionnaires, and a statistically significant correlation between distrust and noncompliance was established. The results of this research should be taken into consideration for any future efforts at addressing risks associated with patient noncompliance.

Risk Communication ∙ Pink Slime versus Garbage Chic: A Consideration of the Impact of Framing on Consumer Behavior Towards Food Waste

With the global population growing from seven to nine billion people by 2050, avoiding food waste would appear to be an easy way of feedingmore people using resources already at hand. The relentless pursuit of efficiency by food manufacturers, which havegreatly reduced foodwaste fromall stepsof food processing, has not always been appreciated by consumers and, in some cases, has been stigmatized by them. By reframing the conversation on food waste from one of quality or health to the frame of sustainability, public attitudes towards food scraps can be modified. This paper examines two case studies in which the public frame for the conversation determined public attitudes towards the effort to reduce food waste. These studies are discussed within the context of risk perception literature to better comprehend public perceptions, and how such perceptionsmight be successfully reframed to address food waste and sustainability.

Implications of the Risk Communication Guidelines for the European Union

Communicating risks related to public health and safety issues requires careful consideration before widespread dissemination. Communications must first be tested before being released to the public in order to ensure that they are received as intended.1 Designing and dispensing risk communications is a careful process that has evolved over time resulting in current guidelines that are widely accepted among academics. These guidelines are being increasingly acknowledged as an effective regulatory tool in the United States if properly utilized by health and safety regulatory bodies, such as the US Food and Drug Administration. This perspective examines the risk communication best practice guidelines and discusses their potential as an effective health and safety regulatory tool for the European Union.