Nicholas James Gonzalez (December 28, 1947 – July 21, 2015) was aNew York–basedphysician known for developing theGonzalez regimen (orGonzalez protocol), analternative cancer treatment.[1][2][3] Gonzalez's treatments were based on his belief thatpancreatic enzymes were the body's main defense against cancer and could be used as a cancer treatment.[4] His methods have been generally rejected by the medical community,[1] and he has been characterized as aquack and fraud by other doctors[3] andhealth fraud watchdog groups. In 1994 Gonzalez was reprimanded and placed on two years' probation by the New York State Medical Board for "departing from accepted practice".[1][3]
In one non-randomized clinical trial of terminally ill people withpancreatic cancer, the Gonzalez-treated patients were found to have died much earlier than those treated with conventionalchemotherapy. A betterquality of life was also reported by the chemotherapy arm.[5]
Gonzalez was born December 28, 1947, inFlushing, New York.[6] He graduatedPhi Beta Kappa andmagna cum laude fromBrown University, with a degree inEnglish literature. From 1970 to 1977, Gonzalez worked as a journalist forTime Inc. and as afreelance writer, covering a variety of health-related topics, including a July 1972cover story inNew York Magazine, a 1976 cover story forFamily Health Magazine, and an article forPrevention Magazine. Gonzalez became interested in medical research, and in cancer research in particular while covering these topics.[7]
Gonzalez completed postgraduate premedical work atColumbia University and received hismedical degree fromCornell University in 1983.[8] Gonzalez worked withRobert A. Good atMemorial Sloan-Kettering Cancer Center while in medical school. After receiving his medical degree, Gonzalez completed aninternship ininternal medicine atVanderbilt University. From 1984 to 1986, Gonzalez worked with Good again, completing afellowship inimmunology while atUniversity of Oklahoma andAll Children's Hospital inSt. Petersburg, Florida.[3][7]
Gonzalez died of a suspectedheart attack on July 21, 2015, at age 67.[9][10] Aconspiracy theory subsequently spread that Gonzalez was murdered as part of a systematic plot to kill "holistic" practitioners.[9]
Gonzalez's treatment methods, which he started using in 1987, were developed from previous work by the orthodontistWilliam Donald Kelley. Gonzalez believed that cancer was caused by a poor diet, a problem compounded when one does not eat a diet that corresponds with one's "metabolic type"; and that environmentalpollution and dailystress contributed to health problems.[8] The Gonzalez regimen proposed as a treatment a cure-oriented change in lifestyle and nutrition, the use of oral pancreaticenzymes, large numbers ofdietary supplements (up to 150 pills per day) and twice dailycoffee enemas.[11] A clinical trial on Gonzalez's treatments produced "limited and inconclusive" results regarding the efficacy of the Gonzalez Regimen as a treatment for cancer.[11]
In 1999 Gonzalez published an article describing prolonged life in a small, select group of patients with pancreatic cancer in the peer-reviewed journalNutrition and Cancer.[12] Subsequently, others concluded that the longer survival time reported by Gonzalez was due toselection bias and otherconfounds.[13][14]
Like his mentor, William Donald Kelley, Gonzalez's treatment method was rejected by the mainstream medical establishment.[1] Gonzalez was characterized as aquack and fraud by other doctors[3] andhealth fraud watchdog groups, and in 1994 he was reprimanded and placed on two years' probation by the New York state medical board for "departing from accepted practice".[1][3] Gonzalez was given two years of probation with a stipulation that he undergo retraining and psychological examinations,[3] and do 200 hours of community service.[15] He was fully licensed to practice in New York.[16]
Gonzalez lost twomalpractice lawsuits.[3] In 1997, a New York court found Gonzalez "negligent" for his cancer treatment;[17][18] according to news reports, Gonzalez "had to pay $2.5 million in damages to a patient he wrongly claimed to have cured" of cancer.[19][20] The former patient had been diagnosed withuterine cancer but "Gonzalez discouraged her from following through on her cancer specialist's advice, instead recommending dietary supplements and frequent coffee enemas".[21] The patient had refused both standard treatment and an experimental protocol, but after the cancer spread to herspine, she discontinued Gonzalez's treatment and received chemotherapy and external beam radiation. Sometime during this period, she began having problems with her eyesight, back and hip, and she eventually became blind.[20][22] In 2000, Gonzalez was found partly liable (49%) in the death of a patient withHodgkin's lymphoma and ordered to pay $282,000 in damages, due to his use of an unprovencancer screening method instead of standard cancer testing.[23]
TheAmerican 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.[14] The clinical efficacy ofcoffee enemas has not been proven, and they haveadverse effects.[14] Gonzalez's study published inNutrition and Cancer in 1999 was criticized by an expert inintegrative oncology research methods for its small sample size,selection bias, and failure to account forconfounding 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 IIIclinical trial for the possible treatment ofpancreatic cancer with the Gonzalez Regimen was funded by a $1.4 million grant from theNational Center for Complementary and Alternative Medicine, and co-sponsored by the National Cancer Institute, awarded in 1999 toColumbia University's Rosenthal Center for Alternative Medicine.[3][11][24] The trial was designed to compare the efficacy of pancreatic enzyme therapy plus a specialized diet withgemcitabine for stage II, stage III, or stage IV pancreatic cancer.[25] However, the study had difficulty attracting patients,[26] and most eligible patients refused random assignment, so the trial was changed in 2001 to a controlled,observational study.[27]
The trial found that patients treated with the Gonzalez regime survived on average for 4.3 months; those using standard chemotherapy survived on average for 14 months and reported a better quality of life.[5]
An accompanying editorial said it was troubling that expensiveCAM 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 ofneoplasia,[24] and because of Gonzalez's history of malpractice.[19][30][31]
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