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European Biopharmaceutical Review

Product Commercialisation in an Era of Public Risk Aversion

 

The public is sceptical about the value of the global pharmaceutical industry. They question its ability to provide treatments against a background of increased concern about drug safety. New legislation in Europe, the US and other countries has made the demonstration of drug safety a key priority for drug approval and continued marketing. The pharmaceutical industry needs to incorporate new strategies and tactics to understand and address this new era of public risk aversion.

THE NEW ERA

Public scepticism about the motivations of pharmaceutical companies has been driven by the media attention given to the withdrawal of medications with lifethreatening side effects, such as Vioxx. Vioxx was a Cox-2 pain relief medication which had similar benefits to ibuprofen, but without the more serious side effects of life-threatening intestinal ulcers. It was withdrawn by its manufacturer, Merck (US), in 2004 following evidence that the drug increased the risk of heart attack and stroke with long-term use (1). Although the FDA subsequently determined that there was insufficient evidence to conclude that Vioxx had a different cardiovascular and cerebrovascular risk profile relative to other Cox-2 inhibitors and non-steroidal anti-inflammatory medications (2), this did not receive the same media attention and public perceptions were shaped by the initial negative coverage.

To build a pharmaceutical industry which can thrive in this new era, we need to understand why pharmaceutical companies are generally poor at using information about public risk perception and developing risk communication strategies to provide a more balanced picture regarding their products. The traditional recipient of pharmaceutical company communication efforts is the prescribing physician. The physician uses company information, but is ultimately responsible for treatment. Physicians serve as the safeguard to weigh the relative individual benefits and risks of a product against patients’ desire to access therapies for their illness. This protects the pharmaceutical company from direct liability as long as it maintains accurate product labelling and product descriptions in medical communication. This model is reinforced by regulations which limit direct-to-consumer advertising in most countries.

The limitation of this model is that it allows pharmaceutical companies to ignore the concerns and perceptions of non-patients. These non-patients are the large majority of people with no direct experience of disease, and who are therefore more likely to be negative about the value of a medicine when confronted with information about its side effects. These negative perceptions of nonpatients may promote both activism for change and receptivity to political messages about the need for more restriction on pharmaceutical company business practices.

THE PSYCHOLOGY OF RISK PERCEPTION

Pharmaceutical companies can improve their understanding of the concerns of all people interacting with their company products by learning from risk perception research. People use a number of shortcuts to evaluate information which allows us to make quick decisions at times of threat. However, this shortcut thinking tends to focus on those elements which can be more easily understood to drive decision making. The result is that people will often fear the occurrence and consequences of events which they can more readily imagine. For example, most people can more easily imagine cancer or malformation of foetuses than they can aplastic anaemia or agranulocytosis. As a result, they will be more likely to underestimate the occurrence and consequences of the difficult to understand conditions (3).

Risk perception is also shaped by the way people feel about an object. People’s judgments of the risk and benefit of an object are usually negatively correlated. Objects judged as high risk are generally seen as low benefit, and vice versa. In research investigating how perceptions are shaped by previously held opinions, Solvic measured individual responses to the benefits and risks of nuclear power (4). They demonstrated that people with a negative feeling about nuclear power concluded that it contained low benefits, while those who were positive about nuclear power concluded that the risks were low.

Risk perception research has also identified several factors which can amplify risk perception. Dramatic accidents or highly publicised risk events increase the ability of people to remember and imagine an event, which increases the perception of associated risk (5,6). Public attitudes are also negatively affected by disputes among the various stakeholders (such as companies, physicians and regulators) about the nature of risk related to a hazard (7).

These factors combine following the presentation of a new potential hazard to drive public policy. In general, the perception of the size and threat associated with a new risk will be driven by these cognitive biases, which may result in over-estimation of the threat associated with a given hazard. This, in turn, can lead to an over-reaction in the development of public policy to counter these perceptions.


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Dr William C Maier, is Vice President of Epidemiology, Risk Management and Drug Safety at REGISTRAT-MAPI, an international CRO and consulting group specialising in Late Phase Research, Epidemiology and Risk Management.. Will has over 20 years of experience in drug development and commercialisation at pharmaceutical companies in Europe and the US and academic appointments in the UK and the US. In July 2007, he presented the Tysabri Risk Management Plan at an FDA advisory committee meeting.
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