[1][3] In one non-randomized clinical trial of terminally ill people with pancreatic cancer, the Gonzalez-treated patients were found to have died much earlier than those treated with conventional chemotherapy.
[6] He graduated Phi Beta Kappa and magna cum laude from Brown University, with a degree in English literature.
[8] The Gonzalez regimen proposed as a treatment a cure-oriented change in lifestyle and nutrition, the use of oral pancreatic enzymes, large numbers of dietary supplements (up to 150 pills per day) and twice daily coffee enemas.
[14] Gonzalez's study published in Nutrition and Cancer in 1999 was criticized by an expert in integrative oncology research methods for its small sample size, selection bias, and failure to account for confounding variables.
[13][14] Gonzalez "never explicitly rejected the more orthodox precepts of his profession", insisting that he wanted his research evaluated by independent scientists.
[3] A randomized phase III clinical trial for the possible treatment of pancreatic cancer with the Gonzalez Regimen was funded by a $1.4 million grant from the National Center for Complementary and Alternative Medicine, and co-sponsored by the National Cancer Institute, awarded in 1999 to Columbia University's Rosenthal Center for Alternative Medicine.
[5] An accompanying editorial said it was troubling that expensive CAM therapies were not backed by firm evidence, and that the trial of the Gonzalez regimen was not capable of providing a definitive conclusion because of flaws in its design.
[28] Kimball Atwood said that flaws in the trial design might have led to bias in favor of the Gonzalez regimen but that it nevertheless amounted to "a slam-dunk condemnation" of the therapy.
[29] This trial had been criticized for its implausible and unsupported theoretical model of cancer development which bears no resemblance to the scientific understanding of neoplasia,[24] and because of Gonzalez's history of malpractice.