Gonzalez Regimen
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Nicholas James Gonzalez (December 28, 1947 – July 21, 2015) was a
New York New York most commonly refers to: * New York City, the most populous city in the United States, located in the state of New York * New York (state), a state in the northeastern United States New York may also refer to: Film and television * '' ...
-based
physician A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...
known for developing the Gonzalez regimen (or Gonzalez protocol), an
alternative cancer treatment Alternative cancer treatment describes any cancer treatment or practice that is not part of the conventional standard of cancer care. These include special diets and exercises, chemicals, herbs, devices, and manual procedures. Most alternative ...
. Gonzalez's treatments are based on the belief that pancreatic enzymes are the body's main defense against cancer and can be used as a cancer treatment. His methods have been generally rejected by the medical community. and he has been characterized as a
quack Quack, The Quack or Quacks may refer to: People * Quack Davis, American baseball player * Hendrick Peter Godfried Quack (1834–1917), Dutch economist and historian * Joachim Friedrich Quack (born 1966), German Egyptologist * Johannes Quack (b ...
and fraud by other doctors and
health fraud Quackery, often synonymous with health fraud, is the promotion of fraudulent or ignorant medical practices. A quack is a "fraudulent or ignorant pretender to medical skill" or "a person who pretends, professionally or publicly, to have skill, k ...
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". In one non-randomized clinical trial of terminally ill patients with pancreatic cancer, the Gonzalez-treated patients were found to have died much earlier than those treated with conventional
chemotherapy Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemotherap ...
. A better
quality of life Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards ...
was reported by the chemotherapy arm.


Biography

Gonzalez was born December 28, 1947, in
Flushing Flushing may refer to: Places * Flushing, Cornwall, a village in the United Kingdom * Flushing, Queens, New York City ** Flushing Bay, a bay off the north shore of Queens ** Flushing Chinatown (法拉盛華埠), a community in Queens ** Flushing ...
, New York. He graduated
Phi Beta Kappa The Phi Beta Kappa Society () is the oldest academic honor society in the United States, and the most prestigious, due in part to its long history and academic selectivity. Phi Beta Kappa aims to promote and advocate excellence in the liberal a ...
and ''
magna cum laude Latin honors are a system of Latin phrases used in some colleges and universities to indicate the level of distinction with which an academic degree has been earned. The system is primarily used in the United States. It is also used in some So ...
'' from
Brown University Brown University is a private research university in Providence, Rhode Island. Brown is the seventh-oldest institution of higher education in the United States, founded in 1764 as the College in the English Colony of Rhode Island and Providenc ...
, with a degree in
English literature English literature is literature written in the English language from United Kingdom, its crown dependencies, the Republic of Ireland, the United States, and the countries of the former British Empire. ''The Encyclopaedia Britannica'' defines E ...
. From 1970–1977, Gonzalez worked as a journalist for
Time Inc. Time Inc. was an American worldwide mass media corporation founded on November 28, 1922, by Henry Luce and Briton Hadden and based in New York City. It owned and published over 100 magazine brands, including its namesake ''Time'', ''Sports Illu ...
and as a
freelance writer ''Freelance'' (sometimes spelled ''free-lance'' or ''free lance''), ''freelancer'', or ''freelance worker'', are terms commonly used for a person who is self-employed and not necessarily committed to a particular employer long-term. Freelance w ...
, covering a variety of health-related topics, including a July 1972
cover story Cover story or Cover Story may refer to: * A magazine or newspaper article whose subject appears on that issue's front cover, and may be profiled in depth. * A fictitious explanation intended to hide one's real motive; see disinformation, cover-u ...
in ''
New York Magazine ''New York'' is an American biweekly magazine concerned with life, culture, politics, and style generally, and with a particular emphasis on New York City. Founded by Milton Glaser and Clay Felker in 1968 as a competitor to ''The New Yorker'', ...
'', a 1976 cover story for '' Family Health Magazine'', and an article for ''
Prevention Magazine ''Prevention'' is an American healthy-lifestyle magazine published by Hearst Corporation featuring articles about health conditions, wellness, food and nutrition, weight loss, fitness, and beauty. Founded in 1950 by J. I. Rodale and published i ...
''. Gonzalez became interested in medical research, cancer research in particular, while covering these topics. Gonzalez completed postgraduate premedical work at
Columbia University Columbia University (also known as Columbia, and officially as Columbia University in the City of New York) is a private research university in New York City. Established in 1754 as King's College on the grounds of Trinity Church in Manhatt ...
and received his
medical degree A medical degree is a professional degree admitted to those who have passed coursework in the fields of medicine and/or surgery from an accredited medical school. Obtaining a degree in medicine allows for the recipient to continue on into special ...
from
Cornell University Cornell University is a private statutory land-grant research university based in Ithaca, New York. It is a member of the Ivy League. Founded in 1865 by Ezra Cornell and Andrew Dickson White, Cornell was founded with the intention to teach an ...
in 1983. Gonzalez worked with Robert A. Good at
Memorial Sloan-Kettering Cancer Center Memorial Sloan Kettering Cancer Center (MSK or MSKCC) is a cancer treatment and research institution in the borough of Manhattan in New York City, founded in 1884 as the New York Cancer Hospital. MSKCC is one of 52 National Cancer Institute– ...
while in medical school. After receiving his medical degree, Gonzalez completed an
internship An internship is a period of work experience offered by an organization for a limited period of time. Once confined to medical graduates, internship is used practice for a wide range of placements in businesses, non-profit organizations and gover ...
in internal medicine at
Vanderbilt University Vanderbilt University (informally Vandy or VU) is a private research university in Nashville, Tennessee. Founded in 1873, it was named in honor of shipping and rail magnate Cornelius Vanderbilt, who provided the school its initial $1-million ...
. From 1984-1986, Gonzalez worked with Good again, completing a
fellowship A fellow is a concept whose exact meaning depends on context. In learned or professional societies, it refers to a privileged member who is specially elected in recognition of their work and achievements. Within the context of higher education ...
in
immunology Immunology is a branch of medicineImmunology for Medical Students, Roderick Nairn, Matthew Helbert, Mosby, 2007 and biology that covers the medical study of immune systems in humans, animals, plants and sapient species. In such we can see there ...
while at
University of Oklahoma The University of Oklahoma (OU) is a Public university, public research university in Norman, Oklahoma. Founded in 1890, it had existed in Oklahoma Territory near Indian Territory for 17 years before the two Territories became the state of Oklahom ...
and
All Children's Hospital Johns Hopkins All Children's Hospital, formerly All Children's Hospital, is a pediatric acute care children's hospital located in St. Petersburg, Florida. The hospital has 259 beds and is affiliated with the USF Morsani College of Medicine and ...
in
St. Petersburg, Florida St. Petersburg is a city in Pinellas County, Florida, United States. As of the 2020 census, the population was 258,308, making it the fifth-most populous city in Florida and the second-largest city in the Tampa Bay Area, after Tampa. It is the ...
. Gonzalez died of a suspected
heart attack A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may tr ...
on July 21, 2015, at age 67. A
conspiracy theory A conspiracy theory is an explanation for an event or situation that invokes a conspiracy by sinister and powerful groups, often political in motivation, when other explanations are more probable.Additional sources: * * * * The term has a nega ...
has subsequently spread that Gonzalez was murdered as part of a systematic plot to kill "holistic" practitioners.


Cancer treatment and its effectiveness

Gonzalez's treatment methods, which he's been using since 1987, are developed from previous work by the orthodontist
William Donald Kelley William Donald Kelley (November 1, 1925 – January 30, 2005) was an American orthodontist who developed "non-specific metabolic therapy," an alternative cancer treatment, now known to be ineffective, which he based on his personal belief that " ...
. Gonzalez believed that cancer is caused by a poor diet, a problem compounded when one does not eat a diet that corresponds with one's "metabolic type"; and environmental
pollution Pollution is the introduction of contaminants into the natural environment that cause adverse change. Pollution can take the form of any substance (solid, liquid, or gas) or energy (such as radioactivity, heat, sound, or light). Pollutants, the ...
and daily
stress Stress may refer to: Science and medicine * Stress (biology), an organism's response to a stressor such as an environmental condition * Stress (linguistics), relative emphasis or prominence given to a syllable in a word, or to a word in a phrase ...
only contribute to health problems. The Gonzalez regimen proposes as a treatment a cure-oriented change in life style and nutrition, the use of oral pancreatic
enzyme Enzymes () are proteins that act as biological catalysts by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrates into different molecules known as products. A ...
s, large numbers of
dietary supplement A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order ...
s (up to 150 pills per day) and twice daily
coffee enema A coffee enema is the injection of coffee into the rectum and colon via the anus, i.e., as an enema. There is no scientific evidence to support any positive health claim for this practice, and medical authorities advise that the procedure may be ...
s. According to the
National Cancer Institute The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
, which co-sponsored with the
National Center for Complementary and Alternative Medicine The National Center for Complementary and Integrative Health (NCCIH) is a United States government agency which explores complementary and alternative medicine (CAM). It was initially created in 1991 as the Office of Alternative Medicine (OAM), ...
a clinical trial on Gonzalez's treatments produced "limited and inconclusive" results regarding the efficacy of the Gonzalez Regimen as a treatment for cancer. In 1999 Gonzalez published an article describing prolonged life in a small group of patients with pancreatic cancer in the peer-reviewed journal ''
Nutrition and Cancer ''Nutrition and Cancer'' is a peer-reviewed medical journal covering research on the role of nutritional factors in causing or preventing cancer. It is published eight times a year by Routledge. According to the ''Journal Citation Reports'', the j ...
''. Subsequently, others concluded that the longer survival time reported by Gonzalez was due to
selection bias Selection bias is the bias introduced by the selection of individuals, groups, or data for analysis in such a way that proper randomization is not achieved, thereby failing to ensure that the sample obtained is representative of the population int ...
and other confounds.


Rejection by mainstream medicine

Like his mentor, William Donald Kelley, Gonzalez's treatment method has been "rejected" by the "medical establishment". Gonzalez has been characterized as a
quack Quack, The Quack or Quacks may refer to: People * Quack Davis, American baseball player * Hendrick Peter Godfried Quack (1834–1917), Dutch economist and historian * Joachim Friedrich Quack (born 1966), German Egyptologist * Johannes Quack (b ...
and fraud by other doctors and
health fraud Quackery, often synonymous with health fraud, is the promotion of fraudulent or ignorant medical practices. A quack is a "fraudulent or ignorant pretender to medical skill" or "a person who pretends, professionally or publicly, to have skill, k ...
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". Forced to submit to psychological examinations and undergo retraining, 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. He was fully licensed to practice in New York. Gonzalez lost two
malpractice In the law of torts, malpractice, also known as professional negligence, is an "instance of negligence or incompetence on the part of a professional".Malpractice definition, Professionals who may become the subject of malpractice actions inc ...
lawsuits. In 1997, a New York court found Gonzalez "negligent" for his cancer treatment; according to news reports, Gonzalez "had to pay $2.5 million in damages to a patient he wrongly claimed to have cured" of cancer. The former patient had been diagnosed with
uterine cancer Uterine cancer, also known as womb cancer, includes two types of cancer that develop from the tissues of the uterus. Endometrial cancer forms from the lining of the uterus, and uterine sarcoma forms from the muscles or support tissue of the uteru ...
but "Gonzalez discouraged her from following through on her cancer specialist's advice, instead recommending dietary supplements and frequent coffee enemas". The patient had refused both standard treatment and an experimental protocol, but after the cancer spread to her
spine Spine or spinal may refer to: Science Biology * Vertebral column, also known as the backbone * Dendritic spine, a small membranous protrusion from a neuron's dendrite * Thorns, spines, and prickles, needle-like structures in plants * Spine (zoolog ...
, 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.Gonzalez v. Ellenberg
2004 NY Slip Op 51518(U) (NY 10/12/2004), 2004 NY Slip Op 51518 (NY, 2004), retrieved January 1, 2009
In 2000, Gonzalez was found partly liable (49%) in the death of a patient with
Hodgkin's lymphoma Hodgkin lymphoma (HL) is a type of lymphoma, in which cancer originates from a specific type of white blood cell called lymphocytes, where multinucleated Reed–Sternberg cells (RS cells) are present in the patient's lymph nodes. The condition wa ...
and ordered to pay $282,000 in damages, due to his use of an unproven cancer screening method instead of standard cancer testing. The
American Cancer Society The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into six geographical regions of both medical and lay volunteers operating in more than ...
notes that there is "no convincing scientific evidence that he Gonzalez treatmentis effective in treating cancer" and that some portions of the treatment may be harmful. A review article from the ''
Journal of Clinical Gastroenterology ''Journal of Clinical Gastroenterology'' is a peer reviewed medical journal covering gastroenterology and hepatology, published by Lippincott Williams & Wilkins. It was established in 1979 and the current editor-in-chief is Ronnie Fass, MD (Case We ...
'' is cited that notes the clinical efficacy of
coffee enema A coffee enema is the injection of coffee into the rectum and colon via the anus, i.e., as an enema. There is no scientific evidence to support any positive health claim for this practice, and medical authorities advise that the procedure may be ...
s has not been proven and the therapy is associated with adverse effects previously described in a few case reports. Gonzalez's study published in ''
Nutrition and Cancer ''Nutrition and Cancer'' is a peer-reviewed medical journal covering research on the role of nutritional factors in causing or preventing cancer. It is published eight times a year by Routledge. According to the ''Journal Citation Reports'', the j ...
'' in 1999 was criticized by an expert in integrative oncology research methods for its small sample size,
selection bias Selection bias is the bias introduced by the selection of individuals, groups, or data for analysis in such a way that proper randomization is not achieved, thereby failing to ensure that the sample obtained is representative of the population int ...
, and failure to account for
confounding variables In statistics, a confounder (also confounding variable, confounding factor, extraneous determinant or lurking variable) is a variable that influences both the dependent variable and independent variable, causing a spurious association. Con ...
. Gonzalez "never explicitly rejected the more orthodox precepts of his profession", insisting that he wanted his research evaluated by independent scientists.


Clinical trial

A randomized phase III
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
for the possible treatment of
pancreatic cancer Pancreatic cancer arises when cell (biology), cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a Neoplasm, mass. These cancerous cells have the malignant, ability to invade other parts of t ...
with the Gonzalez Regimen was funded by a $1.4 million grant from the
National Center for Complementary and Alternative Medicine The National Center for Complementary and Integrative Health (NCCIH) is a United States government agency which explores complementary and alternative medicine (CAM). It was initially created in 1991 as the Office of Alternative Medicine (OAM), ...
, and co-sponsored by the National Cancer Institute, awarded in 1999 to
Columbia University Columbia University (also known as Columbia, and officially as Columbia University in the City of New York) is a private research university in New York City. Established in 1754 as King's College on the grounds of Trinity Church in Manhatt ...
's Rosenthal Center for Alternative Medicine. The trial was designed to compare the efficacy of pancreatic enzyme therapy plus specialized diet with
gemcitabine Gemcitabine, with brand names including Gemzar, is a chemotherapy medication. It treats cancers including testicular cancer, breast cancer, ovarian cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer. It is administered by i ...
for stage II, stage III, or stage IV pancreatic cancer. However, the study had difficulty attracting patients, and most eligible patients refused random assignment, so the trial was changed in 2001 to a controlled, observational study. 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. 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.
Kimball Atwood Kimball C. Atwood IV is an American medical doctor and researcher from Newton, Massachusetts. He is retired as an assistant clinical professor at Tufts University School of Medicine and anesthesiologist at Newton-Wellesley Hospital. Atwood is ...
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. 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 A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists ...
, and because of Gonzalez's history of malpractice.


See also

*
List of ineffective cancer treatments This is a non-exhaustive list of alternative treatments that have been promoted to treat or prevent cancer in humans but which lack scientific and medical evidence of effectiveness. In many cases, there is scientific evidence that the alleged tr ...


References


Publications

*What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer (2012, New Spring Press; ) *One Man Alone: An Investigation of Nutrition, Cancer, and William Donald Kelley (2010, New Spring Press; ) *Gonzalez NJ, Isaacs LL. The Trophoblast and the Origins of Cancer: One solution to the medical enigma of our time. (2009, New Spring Press; ) *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; )


External links


Personal website
{{DEFAULTSORT:Gonzalez, Nicholas 1947 births 2015 deaths Alternative cancer treatment advocates American oncologists Brown University alumni Columbia University alumni Pseudoscientific diet advocates Weill Cornell Medical College alumni