This month the media have reported concerns that the drug ‘Avandia’, prescribed for type 2 diabetes patients, is still available on the NHS despite expert’s warnings of its links to increased risk of heart attacks and heart failure. These reports, including the recent BBC Panorama broadcast ‘A Risk Worth Taking?’, prompt many questions about the decision making processes that lead new medicines to our pharmacy shelves.
Analysis of the risks and benefits associated with new medicines occurs throughout the research and regulatory system. No drug is risk free, but at what point is a risk considered acceptable? And, ultimately, who should make this decision? Those balancing the associated risks against the potential benefits they may offer patients are not those living with the condition or those who will be taking the medicine. Decisions made by those organisations developing and regulating drugs are more likely to consider the benefits and risks for the population as a whole, where as a patient would base their assessment on their own personal circumstance. Exploring the differences in these two types of risk/benefit analysis would certainly be interesting.
One hypothesis is that the public and media reaction to cases or “drug scandals” such as this, have induced both an increasingly cautious approach to the approval of new products, and the prioritisation of risk avoidance over innovative research. So despite more and more information about new therapies becoming accessible to patients and families, will the increased caution in both the development and approval of new products begin unreasonably to restrict people’s access to effective therapies?
WIHSC are embarking on a new project with Genetic Alliance UK, which will help to shed some light on this complex issue, by examining how patients and families perceive the balance between risks and benefits of new biomedical therapies. Based on a Citizens’ Jury model, the project will involve up to 16 patients and family members in deliberative dialogue on this issue, and will frame recommendations that can be used as a practical tool by policy makers and regulators. For more information please contact firstname.lastname@example.org.