Have Technological Innovations Made Unethical the Use of Human Subjects for Potency Assessments of Allergenic Extracts?

Abstract

Since the 1990s, production batch consistency and the standardization of potency units of allergenic extracts used in allergen immunotherapy has been the focus of drug regulatory reforms and much academic debate. This article seeks to expand the current debate by identifying ethical arguments in support of regulatory reforms to eliminate the use of human subjects for potency assessments of these therapeutics. Although human subject testing is the best method to assess biological potency, it also exposes subjects to significant risks, risks that ought to be avoided as much as possible. Innovation in in vitro immunoassays will soon provide feasible alternatives to biological assessments. This article argues that the allergology community must now consider eliminating human subjects in standardization and potency assessment methods as an ethical imperative in regulatory reforms. Moreover, the allergology community will soon need to reach consensus regarding when in vitro tests are “good enough” in replicating biological potency assessments so that human subject testing could be avoided without compromising the safety and efficacy of allergen immunotherapy. Overall, this discussion will provide an overview on how to structure global standardization regulations for allergenic extracts based on the principle of minimizing human subject testing, a topic that, to date, has been largely overlooked in relation to extract standardization policies.