Reviewing peer review: the NCI Clinic Alert three years later

On May 16, 1988 the National Cancer Institute fired the opening volley in what would become two major battles--one over the treatment of node-negative breast cancer and the other over the proper protocol for disseminating vital scientific information. On this date the "Clinical Alert" was mailed to thousands of physicians in the United States. It was formulated to rapidly apprise physicians of the results of three clinical trials exploring the effects of adjuvant therapy in node-negative breast cancer. These results were perceived as scientifically compelling as well as clinically relevant. The results of the trials, the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and B-14 trials and the Intergroup Study (INT) 0011, have subsequently been formally published and the results confirmed those presented in the Alert. Nevertheless, the debate over the treatment of node-negative breast cancer is far from resolved. Similarly, the debate over the vehicle employed for the dissemination of the Alert, ie, the US Mail, rages on. An unprecedented number of editorials, articles, and monographs have been published that deal with this question. At the center of this debate is the fact that the NCI elected to bypass the time honored institution of the peer reviewed journal. In effect, this debate emphasizes the need for a comprehensive review of the peer review process.