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Dr. '''Nicholas James Gonzalez''', M.D., is a [[New York]]-based [[physician]]. Dr. Gonzalez has received significant attention for his controversial<ref name="San Diego">{{cite web |url=http://www.signonsandiego.com/news/reports/tjclinics/20020225-9999-doctor.html |title="Alternative practitioner embraces scrutiny" SignOnSanDiego.com |work= |accessdate=2008-07-29}}</ref><ref name=Frontline>{{cite news | work = [[Frontline (U.S. TV series)|Frontline]] | url = http://www.pbs.org/wgbh/pages/frontline/shows/altmed/etc/synopsis.html | title = The Alternative Fix | publisher = [[Public Broadcasting System|PBS]] }} </ref><ref name=NewYorker>{{cite news | url = http://www.michaelspecter.com/ny/2001/2001_02_05_gonzalez.html | title = The Outlaw Doctor; Cancer researchers used to call him a fraud. What's changed? | last = Specter | first = M | authorlink = Michael Specter | work = [[The New Yorker]] | date = 2001-05-02 | pages = 48}}</ref> therapies that target [[cancer]]. His practice is currently based in [[New York City]].
Dr. '''Nicholas James Gonzalez''', M.D., is a [[New York]]-based [[physician]]. Dr. Gonzalez has received significant attention for his controversial<ref name="San Diego">{{cite web |url=http://www.signonsandiego.com/news/reports/tjclinics/20020225-9999-doctor.html |title="Alternative practitioner embraces scrutiny" SignOnSanDiego.com |work= |accessdate=2008-07-29}}</ref><ref name=Frontline>{{cite news | work = [[Frontline (U.S. TV series)|Frontline]] | url = http://www.pbs.org/wgbh/pages/frontline/shows/altmed/etc/synopsis.html | title = The Alternative Fix | publisher = [[Public Broadcasting System|PBS]] }} </ref><ref name=NewYorker>{{cite news | url = http://www.michaelspecter.com/ny/2001/2001_02_05_gonzalez.html | title = The Outlaw Doctor; Cancer researchers used to call him a fraud. What's changed? | last = Specter | first = M | authorlink = Michael Specter | work = [[The New Yorker]] | date = 2001-05-02 | pages = 48}}</ref> therapies that target [[cancer]]. His practice is currently based in [[New York City]].


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]].


==Biography==
==Biography==
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===Gonzalez protocol===
===Gonzalez protocol===
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 [[enzyme]]s, large numbers of [[dietary supplement]]s (up to 150 pills per day) and twice daily [[coffee enema]]s.<ref name="Gonzalez Regimen"/>
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 [[enzyme]]s, large numbers of [[dietary supplement]]s (up to 150 pills per day) and twice daily [[coffee enema]]s.<ref name="Gonzalez Regimen"/>

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]].<ref name=trialresults/>


===Rejection by mainstream medicine===
===Rejection by mainstream medicine===
Like his mentor, William Donald Kelley, Gonzalez's treatment method has been "rejected" by the "medical establishment".<ref name="San Diego"/> Gonzalez in 1994 was reprimanded and placed on two years' probation by the New York state medical board for "departing from accepted practice".<ref name="San Diego"/><ref name=NewYorker/> Forced to submit to psychological examinations and undergo retraining,<ref name=NewYorker/> 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.<ref>[http://w3.health.state.ny.us/opmc/factions.nsf/58220a7f9eeaafab85256b180058c032/f566901672739a1a85256a4a0047d2e6?OpenDocument Professional Misconduct and Professional Discipline: Nicholas Gonzalez, MD], 24 October 1994</ref> He is currently fully licensed to practice in New York.<ref>[http://www.nysed.gov/coms/op001/opsc2a?profcd=60&plicno=171787&namechk=GON Office of the Professions: Nicholas James Gonzalez License Information], [[New York State Education Department]]</ref>
Like his mentor, William Donald Kelley, Gonzalez's treatment method has been "rejected" by the "medical establishment".<ref name="San Diego"/> Gonzalez has been characterized as a [[quack]] and fraud by other doctors<ref name=NewYorker/> 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".<ref name="San Diego"/><ref name=NewYorker/> Forced to submit to psychological examinations and undergo retraining,<ref name=NewYorker/> 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.<ref>[http://w3.health.state.ny.us/opmc/factions.nsf/58220a7f9eeaafab85256b180058c032/f566901672739a1a85256a4a0047d2e6?OpenDocument Professional Misconduct and Professional Discipline: Nicholas Gonzalez, MD], 24 October 1994</ref> He is currently fully licensed to practice in New York.<ref>[http://www.nysed.gov/coms/op001/opsc2a?profcd=60&plicno=171787&namechk=GON Office of the Professions: Nicholas James Gonzalez License Information], [[New York State Education Department]]</ref>


Gonzalez has lost two [[malpractice]] lawsuits. In 1997, a New York court found Gonzalez "negligent" for his cancer treatment;<ref>Charell v. Gonzalez, 660 N.Y.S. 2d 665 (Sup Ct., 1997).</ref><ref>"Negotiating Integrative Medicine: A Framework for Provider–Patient Conversations", ''Negotiation Journal'', Michael H. Cohen, July 2004 {{doi|10.1111/j.0748-4526.2004.00035.x}}</ref> according to news reports, Gonzalez "had to pay $2.5 million in damages to a patient he wrongly claimed to have cured" of cancer.<ref name=NewScientist>[http://www.newscientist.com/article/mg15921482.900-a-cure-for-quacks.html "A cure for quacks"], ''[[New Scientist]]'', 22 August 1998</ref><ref name="$2.5M-PLUS">[http://www.nydailynews.com/archives/news/1997/03/31/1997-03-31_cancer_doc_hit_for__2_5m-plus.html "CANCER DOC HIT FOR $2.5M-PLUS"], ''[[New York Daily News]]'', March 31st 1997</ref> 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".<ref name=VV>[http://www.villagevoice.com/2002-03-26/news/when-medicine-is-murder/ "When Medicine is Murder"] ''[[Village Voice]]''</ref> The patient had refused both standard treatment and an experimental protocol, but after the cancer spread to her [[Vertebral column|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.<ref name="$2.5M-PLUS"/><ref name="Gonzalez v. Ellenberg">[http://www.plol.org/Pages/Secure/Document.aspx?d=gKnXrE6YTy0oDSEpVFA1KQ%3D%3D&l=Cases&rp=4 Gonzalez v. Ellenberg], 2004 NY Slip Op 51518(U) (NY 10/12/2004), 2004 NY Slip Op 51518 (NY, 2004), retrieved January 1, 2009</ref> 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.<ref>[https://www.nydailynews.com/archives/news/2000/04/21/2000-04-21_doctor_liable_in_death_of_pa.html "DOCTOR LIABLE IN DEATH OF PATIENT"], ''[[New York Daily News]]'', 21 April 2000</ref>
Gonzalez has lost two [[malpractice]] lawsuits. In 1997, a New York court found Gonzalez "negligent" for his cancer treatment;<ref>Charell v. Gonzalez, 660 N.Y.S. 2d 665 (Sup Ct., 1997).</ref><ref>"Negotiating Integrative Medicine: A Framework for Provider–Patient Conversations", ''Negotiation Journal'', Michael H. Cohen, July 2004 {{doi|10.1111/j.0748-4526.2004.00035.x}}</ref> according to news reports, Gonzalez "had to pay $2.5 million in damages to a patient he wrongly claimed to have cured" of cancer.<ref name=NewScientist>[http://www.newscientist.com/article/mg15921482.900-a-cure-for-quacks.html "A cure for quacks"], ''[[New Scientist]]'', 22 August 1998</ref><ref name="$2.5M-PLUS">[http://www.nydailynews.com/archives/news/1997/03/31/1997-03-31_cancer_doc_hit_for__2_5m-plus.html "CANCER DOC HIT FOR $2.5M-PLUS"], ''[[New York Daily News]]'', March 31st 1997</ref> 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".<ref name=VV>[http://www.villagevoice.com/2002-03-26/news/when-medicine-is-murder/ "When Medicine is Murder"] ''[[Village Voice]]''</ref> The patient had refused both standard treatment and an experimental protocol, but after the cancer spread to her [[Vertebral column|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.<ref name="$2.5M-PLUS"/><ref name="Gonzalez v. Ellenberg">[http://www.plol.org/Pages/Secure/Document.aspx?d=gKnXrE6YTy0oDSEpVFA1KQ%3D%3D&l=Cases&rp=4 Gonzalez v. Ellenberg], 2004 NY Slip Op 51518(U) (NY 10/12/2004), 2004 NY Slip Op 51518 (NY, 2004), retrieved January 1, 2009</ref> 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.<ref>[https://www.nydailynews.com/archives/news/2000/04/21/2000-04-21_doctor_liable_in_death_of_pa.html "DOCTOR LIABLE IN DEATH OF PATIENT"], ''[[New York Daily News]]'', 21 April 2000</ref>
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Research supporting Gonzalez's treatment methods&mdash;performed with the help of Dr. [[Ernst Wynder]], funded by [[Nestle]], and supported by [[Procter & Gamble]]<ref name=NewYorker/>&mdash;was published in 1999 in the peer-reviewed journal ''[[Nutrition and Cancer]]''.<ref>{{cite journal |author=Gonzalez NJ, Isaacs LL |title=Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support |journal=Nutr Cancer |volume=33 |issue=2 |pages=117–24 |year=1999 |pmid=10368805 |doi= 10.1207/S15327914NC330201|url=}}</ref> 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.<ref name="San Diego"/> A 2004 study using pancreatic enzymes in a [[mouse model]] of pancreatic cancer showed positive results.<ref>{{cite journal |author=Saruc M, Standop S, Standop J et al. |title=Pancreatic enzyme extract improves survival in murine pancreatic cancer |journal=Pancreas |volume=28 |issue=4 |pages=401–12 |year=2004 |pmid=15097858 |doi= 10.1097/00006676-200405000-00009|url=}}</ref> Gonzalez claims that this treatment was the first therapy that ever yielded positive results in the model used.<ref name=interview/>
Research supporting Gonzalez's treatment methods&mdash;performed with the help of Dr. [[Ernst Wynder]], funded by [[Nestle]], and supported by [[Procter & Gamble]]<ref name=NewYorker/>&mdash;was published in 1999 in the peer-reviewed journal ''[[Nutrition and Cancer]]''.<ref>{{cite journal |author=Gonzalez NJ, Isaacs LL |title=Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support |journal=Nutr Cancer |volume=33 |issue=2 |pages=117–24 |year=1999 |pmid=10368805 |doi= 10.1207/S15327914NC330201|url=}}</ref> 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.<ref name="San Diego"/> A 2004 study using pancreatic enzymes in a [[mouse model]] of pancreatic cancer showed positive results.<ref>{{cite journal |author=Saruc M, Standop S, Standop J et al. |title=Pancreatic enzyme extract improves survival in murine pancreatic cancer |journal=Pancreas |volume=28 |issue=4 |pages=401–12 |year=2004 |pmid=15097858 |doi= 10.1097/00006676-200405000-00009|url=}}</ref> Gonzalez claims that this treatment was the first therapy that ever yielded positive results in the model used.<ref name=interview/>


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.<ref name=NewYorker/><ref name="Gonzalez Regimen">{{cite web |url=http://www.cancer.gov/cancertopics/pdq/cam/gonzalez/healthprofessional/allpages |title=Gonzalez Regimen |format= |work= | publisher = [[National Cancer Institute]] | accessdate=2008-07-29}}</ref><ref name=pmid10986163>{{cite journal |author=Josefson D |title=US cancer institute funds trial of complementary therapy |journal=West. J. Med. |volume=173 |issue=3 |pages=153–4 |year=2000 |month=September |pmid=10986163 |pmc=1071044 |doi= 10.1136/ewjm.173.3.153|url=}}</ref> 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.<ref name=trialinfo>{{cite web | url = http://clinicaltrials.gov/ct2/show/NCT00003851?term=NCT00003851&rank=1 | title = Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III, or Stage IV Pancreatic Cancer | | publisher = clinicaltrials.gov}}</ref> However, the study had difficulty attracting patients,<ref>[http://www.wired.com/science/discoveries/news/2002/10/56072 "Cancer's Enema No. 1? Make That 2"], ''[[Wired (magazine)|Wired]]'', 30 October 2002</ref> and most eligible patients refused random assignment, so the trial was changed in 2001 to a controlled, observational study.<ref name=trialresults/> The study closed early to new enrollment in October 2005.<ref name="NCCAM: Q&A">{{cite web | url = http://nccam.nih.gov/news/19972000/121599.htm | title = Questions & Answers: The Phase III Gonzalez Protocol Trial | publisher = [[National Center for Complementary and Alternative Medicine|NCCAM]] }}</ref> While the published 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" <ref name=trialresults>{{cite journal |author=Chabot JA, Tsai WY, Fine RL, ''et al.'' |title=Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer |journal=J. Clin. Oncol. |volume= 28|issue= 12|pages= 2058–63|year=2010 |month=April |pmid=19687327 |doi=10.1200/JCO.2009.22.8429 |url= |pmc=2774251}}</ref> Dr. Chabot had worked very closely with his Columbia colleague Dr. Robert Fine developing the very “GTX” chemotherapy regimen being used against the Gonzalez treatment in the clinical study. This was a gross conflict of interest as Dr. Chabot was responsible for assigning the patients to each arm of the study. It was obviously in his best interest to make his own protocol appear more successful. 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."<ref name=trialcritique>{{cite journal |author=Levine MN. |title=Conventional and Complementary Therapies: A Tale of Two Research Standards? |journal=J. Clin. Oncol. |volume= 28|issue= 12|pages= 1979–81|year=2010 |month=April |pmid=20308650 |doi=10.1200/JCO.2010.28.5320}}</ref>
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.<ref name=NewYorker/><ref name="Gonzalez Regimen">{{cite web |url=http://www.cancer.gov/cancertopics/pdq/cam/gonzalez/healthprofessional/allpages |title=Gonzalez Regimen |format= |work= | publisher = [[National Cancer Institute]] | accessdate=2008-07-29}}</ref><ref name=pmid10986163>{{cite journal |author=Josefson D |title=US cancer institute funds trial of complementary therapy |journal=West. J. Med. |volume=173 |issue=3 |pages=153–4 |year=2000 |month=September |pmid=10986163 |pmc=1071044 |doi= 10.1136/ewjm.173.3.153|url=}}</ref> 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.<ref name=trialinfo>{{cite web | url = http://clinicaltrials.gov/ct2/show/NCT00003851?term=NCT00003851&rank=1 | title = Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III, or Stage IV Pancreatic Cancer | | publisher = clinicaltrials.gov}}</ref> However, the study had difficulty attracting patients,<ref>[http://www.wired.com/science/discoveries/news/2002/10/56072 "Cancer's Enema No. 1? Make That 2"], ''[[Wired (magazine)|Wired]]'', 30 October 2002</ref> and most eligible patients refused random assignment, so the trial was changed in 2001 to a controlled, observational study.<ref name=trialresults/> The study closed early to new enrollment in October 2005.<ref name="NCCAM: Q&A">{{cite web | url = http://nccam.nih.gov/news/19972000/121599.htm | title = Questions & Answers: The Phase III Gonzalez Protocol Trial | publisher = [[National Center for Complementary and Alternative Medicine|NCCAM]] }}</ref> 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.<ref name=trialresults>{{cite journal |author=Chabot JA, Tsai WY, Fine RL, ''et al.'' |title=Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer |journal=J. Clin. Oncol. |volume= 28|issue= 12|pages= 2058–63|year=2010 |month=April |pmid=19687327 |doi=10.1200/JCO.2009.22.8429 |url= |pmc=2774251}}</ref> 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."<ref name=trialcritique>{{cite journal |author=Levine MN. |title=Conventional and Complementary Therapies: A Tale of Two Research Standards? |journal=J. Clin. Oncol. |volume= 28|issue= 12|pages= 1979–81|year=2010 |month=April |pmid=20308650 |doi=10.1200/JCO.2010.28.5320}}</ref>


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]],<ref name=pmid10986163/> and because of Dr. Gonzalez's history of malpractice.<ref name=NewScientist/><ref>{{cite news | url = http://query.nytimes.com/gst/fullpage.html?res=9800EEDA113FF930A35757C0A9679C8B63 | title = A Conversation with Stephen Straus; Separating remedies from snake oil | last = Dreifus | first = C | work = [[The New York Times]] | date = 2001-04-03 }}</ref><ref name="Review for NCCAM Is Overdue">{{cite journal | url = http://www.sciencemag.org/cgi/reprint/313/5785/301.pdf | title = Science and Government: Review for NCCAM Is Overdue | journal = [[Science (journal)|Science]] | date = 2006-07-21 | volume = 313 | issue = 5785 | pages = 301–302 | pmid = 16857923 | doi = 10.1126/science.1126978 | last1 = Marcus | first1 = DM | last2 = Grollman | first2 = AP }}</ref>
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]],<ref name=pmid10986163/> and because of Dr. Gonzalez's history of malpractice.<ref name=NewScientist/><ref>{{cite news | url = http://query.nytimes.com/gst/fullpage.html?res=9800EEDA113FF930A35757C0A9679C8B63 | title = A Conversation with Stephen Straus; Separating remedies from snake oil | last = Dreifus | first = C | work = [[The New York Times]] | date = 2001-04-03 }}</ref><ref name="Review for NCCAM Is Overdue">{{cite journal | url = http://www.sciencemag.org/cgi/reprint/313/5785/301.pdf | title = Science and Government: Review for NCCAM Is Overdue | journal = [[Science (journal)|Science]] | date = 2006-07-21 | volume = 313 | issue = 5785 | pages = 301–302 | pmid = 16857923 | doi = 10.1126/science.1126978 | last1 = Marcus | first1 = DM | last2 = Grollman | first2 = AP }}</ref>

Revision as of 06:13, 11 November 2010

Nicholas James Gonzalez
NationalityAmerican
Alma materCornell University Medical School
Scientific career
Fieldscancer, nutrition

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.

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.

Biography

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.[4]

Gonzalez completed postgraduate premedical work at Columbia University and received his medical degree from Cornell University in 1983.[5] 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][4]

Cancer treatment and research

Gonzalez's treatment methods, which he's been using since 1987, are developed from previous work by William Donald Kelley, DDS, MS. 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.[5] 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, current clinical data are "limited and inconclusive" regarding the efficacy of the Gonzalez Regimen as a treatment for cancer.[6]

Gonzalez protocol

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.[6]

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]

Rejection by mainstream medicine

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.[8] He is currently fully licensed to practice in New York.[9]

Gonzalez has lost two malpractice lawsuits. In 1997, a New York court found Gonzalez "negligent" for his cancer treatment;[10][11] according to news reports, Gonzalez "had to pay $2.5 million in damages to a patient he wrongly claimed to have cured" of cancer.[12][13] 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".[14] 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.[13][15] 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.[16]

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 confounders.[17]

While Gonzalez's treatment regimen has found little support in the medical research community, his treatments have received support from some alternative outlets. Gonzalez was featured in Suzanne Somers' book Knockout.[18]

Support for research efforts

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.[19] 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.[20] Gonzalez claims that this treatment was the first therapy that ever yielded positive results in the model used.[5]

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][6][21] 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.[22] However, the study had difficulty attracting patients,[23] 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.[24] 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."[25]

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,[21] and because of Dr. Gonzalez's history of malpractice.[12][26][27]

References

  1. ^ a b c d ""Alternative practitioner embraces scrutiny" SignOnSanDiego.com". Retrieved 2008-07-29.
  2. ^ "The Alternative Fix". Frontline. PBS.
  3. ^ a b c d e f g h Specter, M (2001-05-02). "The Outlaw Doctor; Cancer researchers used to call him a fraud. What's changed?". The New Yorker. p. 48.
  4. ^ a b Nicholas James Gonzalez, M.D., curriculum vitae
  5. ^ a b c Interview: Nicholas J Gonzalez, MD: Seeking the Truth in the Fight Against Cancer, Alternative Therapies, Jan./Feb. 2007, vol. 13, no. 1. PMID 17283743
  6. ^ a b c "Gonzalez Regimen". National Cancer Institute. Retrieved 2008-07-29.
  7. ^ a b c Chabot JA, Tsai WY, Fine RL; et al. (2010). "Pancreatic Proteolytic Enzyme Therapy Compared With Gemcitabine-Based Chemotherapy for the Treatment of Pancreatic Cancer". J. Clin. Oncol. 28 (12): 2058–63. doi:10.1200/JCO.2009.22.8429. PMC 2774251. PMID 19687327. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)CS1 maint: multiple names: authors list (link)
  8. ^ Professional Misconduct and Professional Discipline: Nicholas Gonzalez, MD, 24 October 1994
  9. ^ Office of the Professions: Nicholas James Gonzalez License Information, New York State Education Department
  10. ^ Charell v. Gonzalez, 660 N.Y.S. 2d 665 (Sup Ct., 1997).
  11. ^ "Negotiating Integrative Medicine: A Framework for Provider–Patient Conversations", Negotiation Journal, Michael H. Cohen, July 2004 doi:10.1111/j.0748-4526.2004.00035.x
  12. ^ a b "A cure for quacks", New Scientist, 22 August 1998
  13. ^ a b "CANCER DOC HIT FOR $2.5M-PLUS", New York Daily News, March 31st 1997
  14. ^ "When Medicine is Murder" Village Voice
  15. ^ Gonzalez v. Ellenberg, 2004 NY Slip Op 51518(U) (NY 10/12/2004), 2004 NY Slip Op 51518 (NY, 2004), retrieved January 1, 2009
  16. ^ "DOCTOR LIABLE IN DEATH OF PATIENT", New York Daily News, 21 April 2000
  17. ^ "Making Treatment Decisions: Metabolic Therapy". American Cancer Society. Retrieved 2009-03-25.
  18. ^ Knockout: Interviews with Doctors Who Are Curing Cancer--And How to Prevent Getting It in the First Place ISBN 0307587460
  19. ^ Gonzalez NJ, Isaacs LL (1999). "Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support". Nutr Cancer. 33 (2): 117–24. doi:10.1207/S15327914NC330201. PMID 10368805.
  20. ^ Saruc M, Standop S, Standop J; et al. (2004). "Pancreatic enzyme extract improves survival in murine pancreatic cancer". Pancreas. 28 (4): 401–12. doi:10.1097/00006676-200405000-00009. PMID 15097858. {{cite journal}}: Explicit use of et al. in: |author= (help)CS1 maint: multiple names: authors list (link)
  21. ^ a b Josefson D (2000). "US cancer institute funds trial of complementary therapy". West. J. Med. 173 (3): 153–4. doi:10.1136/ewjm.173.3.153. PMC 1071044. PMID 10986163. {{cite journal}}: Unknown parameter |month= ignored (help)
  22. ^ "Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III, or Stage IV Pancreatic Cancer". clinicaltrials.gov. {{cite web}}: Cite has empty unknown parameter: |1= (help)
  23. ^ "Cancer's Enema No. 1? Make That 2", Wired, 30 October 2002
  24. ^ "Questions & Answers: The Phase III Gonzalez Protocol Trial". NCCAM.
  25. ^ Levine MN. (2010). "Conventional and Complementary Therapies: A Tale of Two Research Standards?". J. Clin. Oncol. 28 (12): 1979–81. doi:10.1200/JCO.2010.28.5320. PMID 20308650. {{cite journal}}: Unknown parameter |month= ignored (help)
  26. ^ Dreifus, C (2001-04-03). "A Conversation with Stephen Straus; Separating remedies from snake oil". The New York Times.
  27. ^ Marcus, DM; Grollman, AP (2006-07-21). "Science and Government: Review for NCCAM Is Overdue" (PDF). Science. 313 (5785): 301–302. doi:10.1126/science.1126978. PMID 16857923.

Publications

  • One Man Alone: An Investigation of Nutrition, Cancer, and William Donald Kelley (2010, New Spring Press; ISBN 978-0-9821965-1-9)
  • Foreword to: Beard, J. The Enzyme Treatment of Cancer and Its Scientific Basis. (2010, New Spring Press; ISBN 978-0-9821965-2-0)
  • Gonzalez NJ, Isaacs LL. The Trophoblast and the Origins of Cancer: One solution to the medical enigma of our time. (2009, New Spring Press; ISBN 978-0-9821965-0-2)
  • Fuhrman MP, Payne C, Eiden K, Steinle N, Gonzalez NJ. Nutrition and the Pancreas. In: Marian MJ, Williams PA, Bowers JM, eds. Integrating Therapeutic and Complementary Nutrition. (2007, CRC Press; ISBN 978-0-8493-1612-8)

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