Incretin therapy: should adverse consequences have been anticipated?BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3617 (Published 10 June 2013) Cite this as: BMJ 2013;346:f3617
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Gale’s editorial about the adverse consequences of incretin therapy concludes that ‘The problem lies in a system that subordinates the public interest to commercial secrecy…’ (Gale 2013). Another problem is that the system does not regard patients, or the public, as legitimate stakeholders whose judgements could or should contribute to licensing decisions.
At the NIHR Collaboration for Leadership in Applied Health Care Research (CLAHRC) for the south west Peninsula, we have been conducting a small feasibility exercise to explore the possibility of patients taking part in licensing decisions. Working with members of the Peninsula Patient Involvement Group (PenPIG), we used data from the FDA website available at the time of licensing of liraglutide to run a mock licensing panel. On the basis of a collectively agreed protocol, a panel of five members of the public (four of whom have either type 1 or type 2 diabetes) was provided with the FDA summary document (FDA, 2010) and a brief document summarising the data on benefits and harms of liraglutide. A public health physician with extensive experience of HTA gave a presentation to the panel in which he summarised the FDA material, and answered the panel’s questions. The panel’s ensuing discussion focused on side effects, the balance between harms and benefits, the comparative value of experiential knowledge and scientific knowledge, the expertise of experts, the difficulty of reading and interpreting the scientific data, and the FDA’s processes. In a vote, the panel decided not to license liraglutide by 3 votes to 2. This was not dissimilar to the close voting for the licensing decision taken by the FDA in 2010, when the chair cast the deciding vote in favour of licensing the drug (FDA, 2010).
We conclude that it would be feasible to involve patients in licensing decisions, provided that scientific data are presented in an accessible format. One way of improving the current system of drug licensing and regulation would be to involve patients in decision making, on the grounds that it is patients who directly experience the benefits and harms of medicines. We believe it is morally indefensible not to do so.
Nicky Britten, Sarah Denford, Ken Stein
Gale E. Incretin therapy: should adverse consequences have been anticipated? BMJ 2013; 3456:f3617 (10 June 2013)
FDA Summary Review. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000sumr.pdf. Accessed June, 2013.
Competing interests: No competing interests