In the background of corporate scandals over recent years, it was quite disconcerting last week to learn of the details of a new drug being developed to prevent heart attacks in patients with cholesterol buildup in their coronary arteries. Virtually every faux pas of clinical trials was committed. The company, AtheroGenics (nasdaq: AGIX - news - people ), is developing a drug for patients with coronary artery disease. The trial, which randomized patients to receive either the drug or a matching placebo, was initially intended to see whether the drug would limit the extent of scarring at the site of a stent placement--a process known in the medical community as restenosis. However, in the middle of the trial, the company decided to change the focus to see if accumulation of cholesterol blockages could be affected--atherosclerosis. This mid-stream change in the primary purpose of doing a clinical trial is exceptionally rare, and virtually unprecedented in this domain of coronary artery disease research. This can be considered “strike one.”
