Conflicts of Interests Affect Fibromyalgia Drug Development

Conflicts of Interests Affect Fibromyalgia Drug Development

Over the last few decades there has been a dramatic rise in pharmaceutical industry funding and support of biomedical research. This has led to financial conflicts of interest (FCOIs) between scientific investigators and industry, raising concerns over the possibility of inappropriate influence of industry on biomedical research. Moreover, most studies so far have demonstrated that industry-funded research is linked to an increased probability of pro-industry results.

In a study entitled “Financial conflicts of interest and their association with outcome and quality of fibromyalgia drug therapy randomized controlled trials“, published in International Journal of Rheumatic Diseases, a team of researchers led by Winnie K. Pang, MD, from the University of Southern California-Los Angeles County Medical Center, analyzed the process of drug development and investigation in the field of fibromyalgia research.

The authors concluded that “the majority of FM-RCTs [fibromyalgia drug therapy randomized controlled trials] were industry-sponsored, and had at least one author with an FCOI [financial conflicts of interest]. Reporting of key methodological measures was suboptimal. After adjusting for study sample size, no association of industry funding or author’s FCOI with study outcome was seen.”

This cross-sectional study analyzed data of original, parallel-group, fibromyalgia drug therapy randomized controlled trials, published from 1997 to 2011 in Medline and Cochrane Central Register of Controlled Trials. The main purpose of the analysis was to assess the existence of financial conflicts of interests as well as its relation to the characteristics, results and methodological quality of the trials.

Two independent reviewers evaluated data from 47 RCTs, from which 55,3% were funded by the industry, 17% by non-profit sources, 10,6% had mixed funding, and 17% had unspecified funding. According to the investigators, there is a higher probability for industry funded RCTs to be multicenter and include a larger amount of patients.

The study results also demonstrated that key methodological measures were suboptimal and that both industry and non-profit funded RCTs are similar in their reporting, while 63.8% of the trials had at least one author with disclosed conflicts of interests, including research grants, being an industry sponsor employee, consultancy fee or honorarium and stock ownership.

Despite the current situation of pharmaceutical-sponsored trials and the existence of financial conflicts of interest, the authors believe that “continued surveillance of the potential influence of FCOIs on clinical trial outcomes, and policies to encourage transparent and adequate reporting of clinical trials will help to lessen concerns of industry bias in the study of drug therapies involving FM and other conditions.”