Never Never Never Neglect News values if any - Critics must be Reporters First. Deadly Medicine describes in American investigative journalese the events which led up to the registration, marketing and consequent disaster with Class 1 anti-arrhythmic drugs, particularly encainide, flecainide and mexiletine. This was a 'proxy' for preventing sudden cardiac death presumed to be due to dysrhythmia. When, after drug registration and marketing, a trial was mounted to study the real outcome, mortality, there were significantly more deaths in the treated group than in the placebo group. The thought-provoking parts of the diatribe are the uneasy triangular relationship between academic medicine, the pharmaceutical industry and the drug regulation authorities, and the issue of using proxy outcome measures.
Conflict of interest becomes the understatement of the decade.
The drugs did suppress PVCs. This was relatively easy to answer. To answer the more fundamental question, did the drugs reduce the incidence of sudden cardiac death, would have cost a great deal more and taken longer to do. If such trials had been done the drugs would not have been registered. The fact that more patients died on the drugs than on placebo would have been apparent earlier.