Pharmaceutical approval today suffers from a serious ethical flaw: newly FDA-approved drugs are de facto “tested” on an unknowing general public in the months and years immediately following drug approval, without either the informed consent of the consuming public or an understanding by the public of the risks that remain. This post-approval human “testing” occurs due to the inherent inability of even the largest clinical trials to detect rare adverse events, as became famously evident following the high profile withdrawal of Vioxx® (rofecoxib) almost a decade ago. Drawing inspiration from successful user-driven rating systems such as those of eBay and Amazon, this Article explores the feasibility of using a consumer-friendly online crowdsourcing platform to allow patients to evaluate the drugs they consume. Using crowdsourcing as a supplement to existing clinical trial practice holds the potential to generate large amounts of data quickly by harnessing the self-interested desire of patients to better understand the risks and benefits of the drugs they are consuming, thereby helping to remove dangerous or useless drugs from the market more quickly. In addition, public participation in drug evaluation will itself serve as an unmistakable signal to patients that drug information remains incomplete despite FDA-approval, helping to address the deficit of informed consent that is at the root of the ethical problem just mentioned. Finally, crowdsourcing has the potential to dramatically reduce the costs expended for post-approval market surveillance, which currently takes place via cumbersome programs such as Sentinel, MedWatch, and REMS.
DAN’S [F]LAW: STATUTORY FAILURE TO ENFORCE ETHICAL BEHAVIOR IN CLINICAL DRUG TRIALS Noah Lewellen* I. INTRODUCTION Paul, a sophomore at the University of Minnesota, bursts into a lecture hall, loudly claims to see monsters sitting in the seats, and offers his services in slaying them. The police are called, and Paul is restrained and delivered […]
Case Comment: Bhogaita v. Altamonte
EVERY DOG CAN HAVE HIS DAY IN COURT: THE USE OF ANIMALS AS DEMONSTRATIVE EXHIBITS Kyle R. Kroll, Volume 100, Online Managing Editor In Bhogaita v. Altamonte, the Eleventh Circuit recently decided whether to allow a dog in the courtroom as a demonstrative exhibit. Although the case presented many serious issues regarding the Fair Housing […]
Revisiting Water Bankruptcy
REVISITING WATER BANKRUPTCY IN CALIFORNIA’S FOURTH YEAR OF DROUGHT Olivia Moe, Volume 100, Managing Editor This spring, as “extreme” to “exceptional” drought stretched across most of California—indicating that a four-year streak of drought was not about to resolve itself—Governor Jerry Brown issued an unprecedented order to reduce potable urban water usage by twenty-five percent. In […]