Sodium-Glucose Cotransporter-2 Inhibitors: Lack of a Complete History Delays Diagnosis.

On 15 May 2015, the U.S. Food and Drug Administration (FDA) warned that administration of sodium-glucose cotransporter-2 (SGLT2) inhibitors could lead to ketoacidosis in patients with diabetes mellitus. This announcement came more than 2 years after the FDA's first approval of an SGLT2 inhibitor, although the phenomenon had been known for more than 125 years. Luminaries of diabetes research (including Josef von Mering, Frederick Allen, I. Arthur Mirsky, and George Cahill) had described ketosis and ketoacidosis induced by administration of the phytochemical phlorizin, the prototypical SGLT inhibitor, as well as in patients with familial renal glucosuria, a condition that is considered a natural model of SGLT2 inhibition. Neither government regulators nor manufacturers of SGLT2 inhibitors evinced an awareness of this extensive historical record. The absence of historical inquiry delayed notice of ketoacidosis as an adverse reaction, which could have reduced the burden of illness from these drugs.

The challenge of providing the public with actionable information during a pandemic.

Analysis of media reporting on the H1N1 vaccine during the 2009 pandemic reveals a dissonance between the nature and content of the reporting, the government's messages, and the public's perceptions of vaccine safety and desirability. Despite careful attention to history and especially the lessons offered by Richard Neustadt and Harvey Fineberg in their study of the 1976 "Epidemic that Never Was," government officials failed to escape criticism for decisions made and actions taken in the midst of the unfolding contagion threat. Moreover, public opinion polls show that substantial portions of the population failed to hear, believe, or heed the government's messages. Looking at the enduring narrative of the government's vaccine efforts through the lens of newspaper reports exposes six points of distortion. These points - the pervasive uncertainty inherent in a novel contagion; advances in information technology and electronic communications; the new news environment; the political polarization of American society; the infrastructure of the American public health system; and the oddities of public health emergency and vaccination injury compensation laws - interfered with the public's reception of the government's message and infected the public's perception of government veracity and leadership capability. They challenge us to consider whether current planning is sufficient to prepare Americans to respond effectively to a lives-threatening national crisis. If we are to ensure that the public receives and recognizes accurate and actionable information essential for the prevention or containment of a deadly contagion, we will need to understand and address the impact of these distorting forces.