The Misguided Regulation of Cardiac Emergencies: The Rise of the IRB-Industrial Complex and the Increasing Risk to Cardiovascular Research and Our Patients.

Abstract

> Good judgment seeks balance and progress; lack of it eventually finds imbalance and frustration. > > —President Dwight D. Eisenhower, January 1961 speech on the growing military-industrial complex. The increasing regulatory burden and cost of doing clinical trials in cardiac emergencies has greatly impacted the development of novel therapies resulting in increased morbidity and mortality of patients. A new regulatory framework is required. Over the past 2 decades, great progress has been made in the treatment of ST-segment–elevation myocardial infarction (STEMI). The development of regional systems of care for delivery of primary percutaneous coronary intervention,1 advances in pharmacotherapy and public education have significantly reduced the time to reperfusion. Although the rapid restoration of coronary blood flow is the most effective means of reducing infarct size and preserving left ventricular function, it is not without consequence as reperfusion may also be associated with further injury to the myocardium and vasculature. Reperfusion injury may increase infarct size to a degree that is similar to the initial ischemic insult2 by increasing myocyte cell death, activating apoptosis, and promoting endothelial dysfunction. Improvements in reducing ischemia–reperfusion (I/R) injury are urgently needed as this represent the largest remaining target available to reduce infarct size. This achievement could significantly improve patient’s quality of life and reduce the great expenditures associated with the development of congestive heart failure. Unfortunately, efforts at reducing I/R injury by methods successful in animal models have largely been unsuccessful in clinical trials.3 To date, clinical trials to limit reperfusion injury have targeted many areas including reactive oxygen species, reductions in calcium overload, inflammation, mitochondrial permeability transition pore to name just a few. The reasons for disappointing results in the majority of trials may include the frequently longer duration of ischemia and comorbidities in humans with STEMI compared with animals, the frequent inability …