| Nicholas James Gonzalez | |
|---|---|
| Nationality | American |
| Fields | cancer, nutrition |
| Alma mater | Cornell University Medical School |
| Influences | William Donald Kelley |
Dr. Nicholas James Gonzalez, M.D., is a New York-based physician. Dr. Gonzalez has received significant attention for his controversial[1][2][3] therapies that target cancer. His practice is currently based in New York City. He developed the Gonzalez protocol, a treatment of cancer based on the belief that cancer is caused by toxins and physiological imbalances. Gonzalez's treatment methods have been rejected by the medical community,[1] and Gonzalez has been characterized as a quack and fraud by other doctors[3] and health fraud watchdog groups. In 1994 he was reprimanded and placed on two years' probation by the New York state medical board for "departing from accepted practice," although he never explicitly rejected more orthodox treatments and practices.[1][3] In 1999 Dr. Gonzalez published an article describing prolonged life in a small group of patients with pancreatic cancer in the peer-reviewed journal Nutrition and Cancer;[4] subsequently others concluded that the longer survival time reported by Gonzalez was due to selection bias and other confounds.[5][6]
A test of his protocol, published in 2009, found that Gonzalez's patients died faster than those treated with conventional chemotherapy, and had significantly worse quality of life.[7]
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Gonzalez graduated Phi Beta Kappa & magna cum laude from Brown University, with a degree in English literature. From 1970-1977, Gonzalez worked as a journalist for Time Inc. and as a freelance writer, covering a variety of health-related topics, including a July 1972 cover story in New York Magazine, a 1976 cover story for Family Health Magazine, and an article for Prevention Magazine. Gonzalez became interested in medical research, cancer research in particular, while covering these topics.[8]
Gonzalez completed postgraduate premedical work at Columbia University and received his medical degree from Cornell University in 1983.[9] Gonzalez worked with Dr. Robert A. Good at Memorial Sloan-Kettering Cancer Center while in medical school. After receiving his medical degree, Gonzalez completed an internship in internal medicine at Vanderbilt University. From 1984-1986, Gonzalez worked with Good again, completing a fellowship in immunology while at University of Oklahoma and All Children's Hospital in St. Petersburg, Florida.[3][8]
Gonzalez's treatment methods, which he's been using since 1987, are developed from previous work by the orthodontist William Donald Kelley. Gonzalez believes that cancer is caused by poor diet, a problem compounded when one does not eat a diet that corresponds with one's metabolic type; environmental pollution and daily stress contribute to health problems.[9] According to the National Cancer Institute, which co-sponsored with the National Center for Complementary and Alternative Medicine a clinical trial on Gonzalez's treatments produced "limited and inconclusive" results regarding the efficacy of the Gonzalez Regimen as a treatment for cancer.[10]
The Gonzalez protocol is based on the belief that cancer is caused by toxins and physiological imbalances, and proposes as a treatment the use of oral pancreatic enzymes, large numbers of dietary supplements (up to 150 pills per day) and twice daily coffee enemas.[10]
In August 2009 the regimen was reported to be ineffective compared to chemotherapy; in fact, patients receiving the Gonzalez protocol did worse than patients on conventional chemotherapy, dying three times faster than those receiving conventional chemotherapy and reporting significantly worse quality of life.[7]
Like his mentor, William Donald Kelley, Gonzalez's treatment method has been "rejected" by the "medical establishment".[1] Gonzalez has been characterized as a quack and fraud by other doctors[3] and health fraud watchdog groups, and in 1994 was reprimanded and placed on two years' probation by the New York state medical board for "departing from accepted practice".[1][3] Forced to submit to psychological examinations and undergo retraining,[3] Gonzalez was given two years of probation with a stipulation that he undergo retraining and do 200 hours of community service, which he completed satisfactorily.[11] He is currently fully licensed to practice in New York.[12]
Gonzalez has lost two malpractice lawsuits. In 1997, a New York court found Gonzalez "negligent" for his cancer treatment;[13][14] according to news reports, Gonzalez "had to pay $2.5 million in damages to a patient he wrongly claimed to have cured" of cancer.[15][16] The former patient had been diagnosed with uterine cancer but "Gonzalez discouraged her from following through on her cancer specialist's advice, instead recommending dietary supplements and frequent coffee enemas".[17] The patient had refused both standard treatment and an experimental protocol, but after the cancer spread to her spine, she discontinued Gonzalez's treatment and received chemotherapy and external beam radiation. Sometime in this period, she began having problems with her eyesight, back and hip, and she eventually became blind.[16][18] In 2000, Gonzalez was found partly liable (49%) in the death of a patient with Hodgkin's disease and ordered to pay $282,000 in damages, due to his use of an unproven cancer screening method instead of standard cancer testing.[19]
The American Cancer Society notes that there is "no convincing scientific evidence that [the Gonzalez treatment] is effective in treating cancer" and that some portions of the treatment may be harmful. A review article from the Journal of Clinical Gastroenterology is cited that notes the clinical efficacy of coffee enemas has not been proven and the therapy is associated with severe adverse effects previously described in a few case reports. 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.[5][6]
Gonzalez was featured in Suzanne Somers' book Knockout.[20]
Gonzalez "has never explicitly rejected the more orthodox precepts of his profession", insisting that he wants his research evaluated by independent scientists.[3]
Research supporting Gonzalez's treatment methods—performed with the help of Dr. Ernst Wynder, funded by Nestle, and supported by Procter & Gamble[3]—was published in 1999 in the peer-reviewed journal Nutrition and Cancer.[4] The study measured survival rates for 11 patients with pancreatic cancer. In the study, patients on the Gonzalez's regimen lived an average of 17.5 months, approximately three times longer than patients treated with chemotherapy. The study was too small for definitive conclusions to be drawn, but was of enough interest to the National Cancer Institute that they provided funds for a larger study.[1] A 2004 study using pancreatic enzymes in a mouse model of pancreatic cancer showed positive results.[21] Gonzalez claims that this treatment was the first therapy that ever yielded positive results in the model used.[9]
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.[3][10][22] The trial was designed to compare the efficacy of pancreatic enzyme therapy plus specialized diet with gemcitabine for stage II, stage III, or stage IV pancreatic cancer.[23] However, the study had difficulty attracting patients,[24] and most eligible patients refused random assignment, so the trial was changed in 2001 to a controlled, observational study.[7] The study closed early to new enrollment in October 2005.[25] The results of the study showed that patients undergoing conventional gemcitabine-based chemotherapy lived three times longer and had better quality of life scores and lower pain scores than those undergoing the Gonzalez Regimen and those receiving the pancreatic enzyme therapy had a shorter median survival than patients with similarly staged pancreatic cancer. The results demonstrated that the Gonzalez Regimen was significantly worse for cancer patients than conventional treatment.[7] An accompanying editorial criticizes the trial design, stating: "Can it be concluded that their study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow's ear. Given the scarcity of resources for cancer research, there are many more important questions to address."[26]
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,[22] and because of Dr. Gonzalez's history of malpractice.[15][27][28]