What went wrong : the truth behind the clinical trial of the enzyme treatment of cancer.

In 1998, Nicholas Gonzalez, M.D. received National Cancer Institute approval for a clinical trial to evaluate his nutritional-enzyme approach in the treatment of patients with pancreatic cancer. Though Dr. Gonzalez hoped the venture would initiate cooperation between conventional scientists and serious alternative researchers, problems plagued the study from its inception. The design discouraged patient participation; oncologists discouraged patients from joining and at times pressured those already admitted for nutritional therapy to change to conventional treatment. Then in 2000 the NCI turned over all patient selection decisions to the Principal Investigator (PI), who as it turned out helped devise the chemotherapy regimen used as the control treatment. Repeatedly, the PI approved patients for the nutritional treatment who did not meet the entry requirements, or who were too ill or uncommitted to follow the self-administered regimen. An evaluation by government scientists in early 2005 confirmed that so many patients had failed to follow the prescribed nutritional therapy that the data had little meaning. Despite such problems, without Dr. Gonzalez' knowledge the Principal Investigator published an article implying the study was properly run, patients complied fully and that the nutritional therapy had no effect. In response, Dr. Gonzalez, a former journalist, has written What Went Wrong, to bring the truth of this project to light, and show how bias, indifference, and at times incompetence undermined a promising research effort that, if properly run, might have ushered in a new direction in cancer treatment. Dr. Gonzalez graduated from Brown University (Phi Beta Kappa, magna cum laude). He worked as a journalist at Time Inc. before pursuing premedical studies at Columbia and medical school at Cornell. Dr. Gonzalez completed immunology training before opening a practice in New York in 1987. His research has been funded by Procter & Gamble and Nestle.