US regulators need patient-centric approach to obesity drug reviews
This article was originally published in SRA
Obesity-focused stakeholders in the US are calling on regulators to take a more patient-centric approach when evaluating the benefits and risks of obesity drugs1,2.
The George Washington University's (GWU) School of Public Health and Health Services has published Obesity drug outcome measures, a report detailing the consensus of findings from a stakeholder dialogue group, convened by the university, outlining a series of new approaches that should be considered by regulators when looking at obesity drugs.
"The current FDA [Food And Drug Administration] framework does not adequately categorize which types of patients with obesity could achieve benefits in feeling, function and health risk. Nor does it adequately capture the many potential benefits of weight loss (short-term symptomatic, longer-term comorbidities, or effects on QoL [quality of life]) that may be improved through modest weight loss, aided by pharmacologic treatment," note the authors.
Synthesising the thoughts of the dialogue group, the GWU team has identified critical points which it says redefine how drugs to treat obesity should be viewed, developed, approved and used.
"At a time when so many Americans suffer with obesity and are faced with limited treatment options, there has been a rising call to review the emerging science on obesity to update the framework used when evaluating obesity drugs. The FDA is likely to take a wider, more comprehensive, look at how drugs developed to treat obesity affect how individuals with obesity feel and function. This report may help update the risk-benefit framework," added GWU's Professor Christine Ferguson.
The GWU team believes a more comprehensive patient-centred approach in making risk-benefit determinations could help the FDA ensure that safe and effective obesity drugs are available to both adult and paediatric patient groups for whom the benefits of improved physical and mental health and QoL outweigh the risks associated with a particular drug.
References
1. George Washington University press release, 14 August 2012, http://sphhs.gwu.edu/releases/index.html
2. Obesity drug outcome measures, 12 August 2012, http://sphhs.gwu.edu/releases/obesitydrugmeasures.pdf