Healthy Skepticism Library item: 14492

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Taylor L.
Govt group calls for better ways to explain pharma risks/benefits to patients
PharmaTimes 2008 Oct 14
http://www.pharmatimes.com/uknews/article.aspx?id=14529&src=EWorldNews

Full text:

A better way of explaining to patients the risks and benefits associated with the use of medicines is necessary, as most have little understanding that an element of risk is involved and they expect the benefits to be significant, a UK government/industry forum has reported.

Media stories have contributed to the hype associated with medicines, and terms such as “benefits are marginal” do not help to communicate risk/benefit messages to patients, according to a recent Ministerial Industry Strategy Group (MISG) Forum meeting. “An examination of past failures in communication may demonstrate how we can improve the messages that we use,” the meeting’s attendees – who included medicines regulators from the UK, Europe and the USA, representatives of industry and patient groups, health economists and academics – acknowledged.

The public, health care professionals and public funding bodies all expect to be able to access and understand the risk/benefit assessments for medicines taken on their behalf, and pressure is growing on industry and regulators to be able to demonstrate how they arrive at these decisions. However, there are no agreed methodologies for describing and analysing the evidence, and decisions continue to be based on expert judgement. Delegates also queried whether decisions currently take account of patient preferences, and pointed out that what is deemed an acceptable risk/benefit balance may be different for regulators, physicians and patients when considering different diseases, and at different stages.

Communication to patients about how decisions have been taken is also essential if they are to engage in a meaningful debate about treatment options, they added.

Moreover, while patient involvement in regulatory decision-making is growing, it is still frequently “tokenistic” and takes little account of the need to present materials in a non-technical way that enables patients to contribute to the debate, the meeting heard. One improvement could be through use of Patient Reported Outcomes (PROs), which could become a powerful element of ongoing risk/benefit assessments if a way could be found to have them recorded regularly, it was suggested.

The meeting concluded that an agreement framework, with formal mechanisms and common terminology for risk/benefit analysis, is essential. A group should be set up, including representatives of the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA), to develop a pilot in risk/benefit decision analysis, which should not only draw on work already underway in the medicines field but also learn from the models used in other sectors, such as the aircraft industry and those dealing with environmental and major chemical hazards, delegates agreed.