Involving patients in drug licensing decisionsBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4329 (Published 16 July 2013) Cite this as: BMJ 2013;347:f4329
- Nicky Britten, professor of applied health care research1,
- Sarah Denford, associate research fellow1,
- Ken Stein, director of peninsula technology assessment group (PenTAG)1
Gale’s editorial about the adverse consequences of incretins concludes that: “The problem lies in a system that subordinates the public interest to commercial secrecy.”1 Another problem is that the system does not regard patients, or the public, as legitimate stakeholders whose judgments could or should contribute to licensing decisions.
The National Institute for Health Research Collaboration for Leadership in Applied Health Care Research for the south west peninsula conducted a small feasibility exercise to explore the possibility of patients taking part in licensing decisions. Working with members of the Peninsula Patient Involvement Group, we used data from the Food and Drug Administration website available at the time of licensing of liraglutide to run a mock licensing panel.
On the basis of an agreed protocol, a panel of five members of the public (four of whom had type 1 or type 2 diabetes) was provided with the FDA summary document and a summary of data on benefits and harms of liraglutide.2 A public health doctor experienced in health technology assessment also presented a summary of the FDA material and answered questions. The panel’s ensuing discussion focused on the side effects, balance between harms and benefits, comparative value of experiential knowledge and scientific knowledge, expertise of experts, difficulty of reading and interpreting scientific data, and the FDA’s processes. The panel decided not to license liraglutide by three votes to two—not dissimilar to voting in the licensing decision taken by the FDA in 2010, when the chair cast the deciding vote in favour of licensing.2
Patients could therefore be involved in licensing decisions if scientific data were presented in an accessible format. Patients are the ones who directly experience the benefits and harms of drugs, so involving them in decision making would improve the current system. We believe it is morally indefensible not to do so.
Cite this as: BMJ 2013;347:f4329
Competing interests: None declared.