Does the Imprecise Definition of Overactive Bladder Serve Commercial Rather than Patient Interests?

Abstract

The tendency has always been strong to believe thatwhatever received a name must be an entity or being,having an independent existence of its own. And if noreal entity answering to the name could be found, mendid not for that reason suppose that none existed, butimagined that it was something peculiarly abstruse andmysterious. —John Stuart MillOver the last decade, physicians and the general publichave increasingly used the term overactive bladder (OAB) inreferring to the complex of urinary storage symptomspreviously known as irritable bladder or unstable bladder.The term first appeared in the literature in 1989 [1], but itspopularity increased dramatically when it was highlightedin an industry-sponsored symposium in 1997 [2]. Thepharmaceutical industry quickly adopted this simple butexhaustivesymptomterminologyanduseditsuccessfullytoexpand the indications for medications. Whereas previousdrugs had been licensed for urodynamically confirmedbladder instability, in 1998, the US Food and DrugAdministration approved tolterodine for the treatment of‘‘symptoms of overactive bladder.’’ Multimillion-dollarpromotional campaigns (including direct-to-consumeradvertising in some countries) followed.The International Continence Society introduced thecurrent standardized definition of OAB in 2002. Accordingto this definition [3], OAB syndrome refers to urinaryurgency, with or without urge incontinence, usually withincreased daytime frequency and nocturia. Althoughpatient report of symptoms is all that is required fordiagnosis,thestandardizationreportharksbacktopreviousoperational definitions, rooted in pathophysiology, propos-ing that OAB syndrome is ‘‘suggestive of urodynamicallydemonstrable detrusor overactivity,but canbedue tootherforms of urethro-vesical dysfunction’’ and that the term‘‘can beused ifthere is noproveninfection orother obviouspathology’’ [3].Despite the complex scientific terminology, the formu-lation is hampered by the lack of specificity includingterms such as ‘‘usually’’ and ‘‘with or without’’ as well asundefined ‘‘other obvious pathology.’’ The definition isproblematic in that it oversimplifies multifactorial symp-toms, implying that OAB is an independent clinicalentity with uniform treatment options. Unfortunately, thesymptoms of OAB do not constitute such a coherentconstellation [4–6]. The underlying causes of the compo-nents of OAB are not well understood [5,6], and theavailable treatments, whether for urgency, urge inconti-nence, frequency, or nocturia, are effective for only aminority of affected patients [7].For pharmaceutical companies, OAB has undeniablyprovedlucrative—theproverbial‘‘goosethatlaidthegoldenegg.’’ We continue to see the marketing of a range ofanticholinergic medications for treatment of ‘‘the symp-toms of overactive bladder.’’ As in other areas of medicine[8],buoyedupbygrowingsales,pharmaceuticalcompanieshave recruited opinion leaders to promote their treatmentsfor OAB and to align research efforts with commercialinterests. OAB publications have proliferated rapidly overthe past decade (Fig. 1). The association between commer-cial funding and positive outcomes for randomized drugtrials is well recognized [9]. A systematic review of thesources of funding for the recent literature revealed that forOAB, industry funding has extended beyond randomizedtrials: Most epidemiologic studies are indeed funded bypharmaceutical and device companies (Fig. 2) [10].A