Facilitating Regulation: The Dance of Statistical Significance and Clinical Meaningfulness in Standardizing Technologies for Dementia

Abstract

Regulatory activities are intended to safeguard the health of citizens by ensuring that new drug therapies meet the highest standards of safety, efficacy and quality. Recent initiatives emphasize streamlining and speeding up approval, and are intent on harmonizing standards for international competitive advantage. In Canada and the United Kingdom, a second order of evaluation is necessary in order to have the costs of a federally licensed drug covered under provincial or state health insurance programmes resulting in wider patient access to potentially cost-prohibitive products. While new therapies can get approved by federal regulatory scientists based upon acceptable evidence from data meeting the standards of safety, quality and efficacy, the determination of the formulary committees, such as the UK National Institute for Health and Clinical Excellence (NICE), or the Canadian Common Drug Review (CDR), take into consideration the economic costs and benefits of the therapeutic agent. This analysis considers the technical-political-social-moral positions taken by various actors involved in legitimizing and contesting the effectiveness of cholinesterase inhibitors (ChEIs) for treating people with Alzheimer's disease. It examines ambiguities in the ‘norms of appropriateness and legitimacy’ of clinician researchers, and the construction and legitimization of what is appropriate in clinical research and regulatory practices.