What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer
An interview with Dr. Nicholas Gonzalez (July 2012)
Of all this world’s bitter mysteries, the cruelest is conventional medicine’s persecution of alternative cancer therapies. I have no more sympathy for quackery than any reasonable person, but It seems that in the United States no crime draws more relentless persecution and prosecution than that greatest of all crimes, curing cancer. That hatred calls forth unsleeping persecution, government raids, and criminal indictments.
So it happened to Dr. William Donald Kelley, who in the 1960s with a family to feed managed to cure himself of pancreatic cancer by using pancreatic enzymes, supplements, diets, and detoxification routines. People heard, and they came, and Kelley tried to help them. For his trouble, he earned lifelong persecution and vilification. It didn’t matter that in many cases, cancers were cured.
In 1981 a young medical student, Nicholas Gonzalez, investigated Kelley’s carefully kept records for five years and found astonishing success in cases conventional medicine considered hopeless. When he went into practice, he offered a similar therapy, with similar results.
In 1993 Dr. Gonzalez was invited to present 25 of his cases to a National Cancer Institute meeting in Washington. The results were so amazing that the associate director suggested he do a pilot (Stage 2) study. Those results were extraordinary enough to prompt NCI’s director at that time to suggest a Stage 3 study comparing nutritional enzyme therapy to chemotherapy.
Sounds hopeful, but over the next 8 years Dr. Gonzalez found the administrators sabotaging the study from every direction. He has written a new book, What Went Wrong: the Truth behind the Clinical Trial of the Enzyme Treatment of Cancer, about his experience. I asked him to share that with my readers through this interview, and he kindly complied on 17 July 2012.
My interest in Dr. Gonzalez’ work is not theoretical. After I first interviewed him in 1991, my sister developed breast cancer. In August she and three other women underwent surgery, and by October she was sick enough to hear my recommendation that she visit Dr. Gonzalez. She began nutritional enzyme therapy, and a year later she was the only one of those four women operated on who survived. She passed away in 2002, eleven years later, but not from breast cancer.
You can order Dr. Gonzalez’ book from New Spring Press or through his website at dr-gonzalez.com.
Gonzalez: We provide a three-part approach to cancer and other degenerative diseases: individualized diet, supplementation, and detoxification.
First, individualized diet. Many alternative doctors have one diet for everybody, Ornish and Pritikin recommend everyone be vegetarian, Atkins everyone should eat mostly meat. My mentor, Dr. Kelley, believed different people need different diets. Our ten basic diets range from largely plant-based (fruits, vegetables, grains) to an Atkins-type diet, red meat three times a day, with about 90 variations. Each patient gets a diet designed for his specific metabolic needs.
Second component is an individualized supplement program. We use vitamins, minerals, and trace elements, but very specifically and precisely. Each protocol is designed for each patient’s metabolic needs and addresses his specific health problems. For cancer patients, we add large doses of pancreatic enzymes which we believe have an anti-cancer effect.
In orthodox medicine, pancreatic enzymes have been known since 1858 as necessary for normal digestion. Beyond that, 100 years ago Dr. John Beard first suggested that pancreatic enzymes also represent the body’s main defense against cancer. Dr. Kelley used large doses of pancreatic enzymes in his cancer protocols and we continue that.
Third component is detoxification routines, controversial things such as coffee enemas. These simple procedures help the body mobilize, neutralize, and excrete toxic debris produced as the body repairs and tumors break down. We all live in a toxic environment, exposed to thousands of chemicals. There are 79,000 different synthetic chemicals in the Western environment, most never tested for safety. Even if you eat organically, you get heavy metals and pesticides in the air pollution in New York even though we’re not an agriculture area. Toxins are stored in our cells like a ticking time bomb.
On our program with all the good nutrition, every cell in the body starts dumping stored toxins, and that can overload the liver and the body’s detoxification organs. Ironically, as the body repairs toxins are released and that stresses detoxification organs like the liver and the kidney. We use simple procedures like coffee enemas and juice fasts and colon cleanses that assist the body in detoxification.
Moneychanger: Mainstream cancer therapy is pretty much cut, burn, and poison, i.e., surgery, radiation, or chemotherapy. I’m not trying to be unfair, but...
Gonzalez: No, no. You’re absolutely right. Surgery, radiation, and chemotherapy or all three.
Moneychanger: Is it correct that conventional medicine uses chemotherapy agents proven effective in less than five percent of the cases?
Gonzalez: Oh, absolutely. FDA approved Gemzar, the latest drug for treating pancreatic cancer, in 1998 based on a clinical study with 126 patients where the average survival versus the previous drug improved only about one month, from 4.5 months to 5.6 months. Out of 126 patients, not a single patient lived longer than 19 months, but it was considered such a remarkable advance that Gemzar was approved for pancreatic cancer. Today it’s a billion dollar industry based on improving survival by one month, but it doesn’t cure.
So a chemotherapeutic agent doesn’t even need to produce five percent long-term survival. Chemo drugs are approved based on minimal evidence and minimal evidence of effect.
Moneychanger: Mathematically, working five percent of the time means it fails 95% of the time.
Gonzalez: That’s correct.
Moneychanger: So we’re desperate and planning for failure when we use treatments like that.
Gonzalez: That’s correct. They claim now that up to 50% of cancer patients are cured. That may be true, but how did they arrive at that statistic? Most cancer patients today are still cured the same way they were 50 years ago, by surgery. Whatever the type, in most cases once cancer spreads chemotherapy and radiation are not effective, period. All oncologists know that.
There are over 100 different cancers, and maybe four or five respond well to chemo: Hodgkin’s disease, lymphocytic leukemia, childhood testicular cancer, choriocarcinoma, some lymphomas, really very few. Once all the solid tumors like tumors of the breast, lungs, stomach, pancreas, colon, uterus, ovaries, prostate, metastasize, chemo really does very little.
Tumors might regress. Life might be prolonged, as in pancreatic cancer, a month or two, but there’s no substantial long-term survival. Certainly quality of life doesn’t improve. Even if survival improves, quality of life is very often worse than if you did nothing.
So even today in 2012, despite the hype and $6 billion a year going to the National Cancer Institute [NCI] and $700 million a year raised for the American Cancer Society, chemo and radiation still do nothing for most cancers.
HOW EXPENSIVE IS IT?
Moneychanger: What does it cost to follow your regimen?
Gonzalez: The first year is the most expensive, running in the neighborhood of $10,000.00 to $14,000.00. After that, it’s a few thousand dollars less. Our therapy still costs only a small percentage of what chemo costs.
Moneychanger: That’s $1,000 a month. I can’t go into hospital cancer treatment for $1,000 for one day.
Gonzalez: Hospitalization can easily run $20,000-$30,000. The $14,000 a year I quoted includes things like juicers and water filters that everyone purchases at first, costs that don’t continue.
Moneychanger: Pancreatic cancer is one of the most aggressive and fast-moving cancers?
Gonzalez: It’s not necessarily the worst cancer, but certainly one of the two or three worst. Acute leukemia can be pretty aggressive, but pancreatic cancer is traditionally considered the most aggressive cancer. About 39,000 cases were diagnosed last year. Less than five percent lived five years in the conventional medical world. Even after all the years and billions of dollars spent on research, it still has a dismal prognosis. The only cases that are cured in the conventional world are those few cases that are diagnosed really early, which surgery can cure.
It’s now the fourth leading cancer killer, and it’s very deadly. Absolute survival still ranges from three to six months after diagnosis. In the Gemzar study from 1998, still considered the gold standard study, 18% percent of patients lived one year, and nobody lived longer than 19 months. It’s dreadful.
WHO IS CRAZY AND WHO’S THE QUACK?
Moneychanger: You studied Dr. Kelley’s records and found that he treated a number of people with confirmed or biopsied pancreatic cancer. Some were still alive not just five years later, but eight years or longer.
Gonzalez: True. In fact, I still follow one of those patients. Beginning in 1981 I looked into Kelley’s work. My research mentor at the time was Dr. Robert Good, President of Sloan-Kettering. He suggested that I go through Kelley’s records, looking specifically for patients with pancreatic cancer because it was so deadly. In July, 1981, 31 years ago, he told me that if I could find one patient with properly diagnosed pancreatic cancer that lived five years, that would be remarkable because no one at Sloan-Kettering had such a case.
I studied Kelley’s records from 1981 to 1986 while I was working under Dr. Good, but some patients dated back to the early 1970s. In those days, pancreatic cancer was not as common as it is today. We were able to find 22 patients who had consulted Kelley.
Ten of them never did the therapy. Relatives or family argued that Kelley was crazy and was a quack trying to steal their money, so they never did it. Their average survival was 60 days.
Another group of seven patients did it partially and incompletely for varying periods. Again, they quit the program because of family pressure and doctors criticizing Kelley. Yet even with partial compliance—some of those patients only did it for four weeks—the average survival was 300 days, which is better than what they’re getting today.
Five patients followed the therapy completely and the average survival was eight and a third years. One patient was diagnosed in August, 1982, 30 years ago next month. They opened her up for gall bladder surgery, and she had a tumor in the pancreas and in the liver. Biopsy showed the liver lesion was adenocarcinoma, the most aggressive form of pancreatic cancer, so they closed her up.
Her oncologist told her, “Chemo might give you six months.” Then she visited the Mayo Clinic in Rochester, Minnesota and met with their pancreatic cancer expert. I really respect the Mayo Clinic, because they’re very honest. It’s one of the few institutions where they tell the patient if the therapy isn’t going to work. The oncologist saved her life because he told her chemo would not help her. Had he said, “Let’s do chemo,” she would have done it and would have died. He said, “Chemo will do nothing for you. Chemo might buy a few extra months, but it will ruin your quality of life.”
So she went back home very discouraged, but that forced her to investigate alternatives. At the local health food store she found Kelley’s 1969 book, One Answer to Cancer, called him, and began the Kelley program. Thirty years later she’s alive and well. I now follow her. She hasn’t been back to any conventional doctor in 30 years, not even for CAT scans.
Here’s a woman with properly diagnosed Stage 4 pancreatic cancer, confirmed at the Mayo Clinic, one of the preeminent academic institutions in the world, who’s alive 30 years later. I know no patient in medical history—believe me, I have scoured the literature—with a properly diagnosed Stage 4 adenocarcinoma with biopsy-proven liver metastases, who’s alive 30 years later. I don’t know of any patient alive even five years later. That’s a great Kelley success story. If she were a conventional patient treated with chemo, she’d be on the front page of Time. Believe me, the National Cancer Institute would be holding press conferences and parading her before the cameras. Because she was treated by an alternative practitioner the medical media could care less.
Even though I’ve written that case up, it’s created absolutely no stir in the conventional medical world. The general response was annoyance that we were able to find such patients because it broke their preferred model: anybody who does nutrition must be a quack and fraud. That’s the kind of cases we found in Kelley’s records. They weren’t just good cases, they were extraordinary.
HOW THE NCI-NIH TRIAL STARTED: A SPEECH and A PILOT STUDY
Moneychanger: Your experience convinced you to go into practice applying nutritional enzyme therapy. What about the government-sponsored trial with the National Cancer Institute? What tempted you to do that? I’m being a smart aleck, I guess, but...
Gonzalez: No, you’re not at all. I’ve been asked that many times. I’m trained as an academician, and I actually believe real science is honorable—not science as generally practiced in academic institutions, but real science, evaluating hard facts without bias, prejudice, or emotion. I believe in that, and I conduct myself that way. I was a very conventional medical student, headed for a job at Sloan-Kettering. When I met Kelley, I said to myself, “This is different from what I’ve been taught in medical school, but Dr. Good insisted, so I’ll approach him with an open mind, even if I don’t think much of him.” Lo and behold, I found cases that were miraculous.
In 1993 after I’d been practicing six years, the NCI invited me down to Washington to present cases from my own practice. I presented 25, including patients with pancreatic cancer who were already doing well under our care. NCI’s then-associate director, who chaired that three hour closed-door meeting, suggested I do a pilot study, technically a Stage 2 study. You take a cancer for which there is no standard treatment that works, like pancreatic cancer, and then follow a small group of patients.
A pilot study doesn’t need many patients because you’re dealing with a cancer incurable by anybody’s standards. He suggested pancreatic cancer, and knowing that we were already getting patients well and that Kelley had gotten many patients well, I agreed immediately. Nestlé funded that. The NCI suggested I enroll ten patients. We eventually enrolled eleven, after family influenced one patient to quit. We got the best results in medical history.
Five patients lived longer than two years. Four lived longer than three years. Two lived up to five years, and one died with a heart attack after quitting the program in five years. This was extraordinary survival in a small group of patients, extraordinary enough that in 1998, the then-NCI director, Richard Klausner, suggested those results warranted a large-scale, fair, honest, honorable investigation—the definitive study of nutritional enzyme treatment, a Phase 3 study where my therapy would be compared to the best available chemo.
I met with Dr. Klausner in Washington for several hours, and we looked each other in the eye. I absolutely believe that he wanted a fair and honest study. Columbia University was suggested as the site for the study. Since I lived in New York, that would make it easy.
TROUBLE BEGINS: SEND IN THE B-TEAM
Trouble started about a year later when Klausner left to run a private foundation and a new team was assigned. The team initially assigned, I absolutely believe, wanted to do a fair study, but the first thing that happened was that all the supportive people—not cheerleaders, just fair objective scientists—were moved off the study.
One woman at the National Institutes of Health (NIH), an advisor to the study, supported my work and believed that I was onto something. She was told she couldn’t even speak to me or she’d be fired. I was not allowed to call her. She was removed from the study. She eventually quit and went to work for a private foundation.
What we didn’t realize at the time is the new team, whether deliberately or unconsciously, seemed motivated to make sure that my therapy didn’t see the light of day.
And it turned out that the chief investigator at Columbia, John Chabot [SHA-bo], whom I discuss at length in my book, helped develop the chemo regimen being used against us. That conflict of interest should have precluded him from serving as chief investigator. Yet after 2000 when the study had been up and running for about a year, he was given sole dictatorial control of evaluating and admitting patients into both arms of the study.
CONFLICT OF INTEREST
Moneychanger: Wait. The man they put over the study is testing his own chemo therapy against your therapy?
Gonzalez: That’s correct.
Moneychanger: Would it have been fair if they had put you in charge of the whole study?
Gonzalez: If Dr. Isaacs or I had been put in charge of the study, all hell would have broken loose, screaming from one end of the country to the other unfair, prejudice, bias. When I uncovered this and made a point of it, the NIH head seemed to shrug his shoulders like he could care less. You see a double standard in the conventional medical world.
You can never say what motivates other people, but I think the people involved with the study realized that supporting someone like me would create such controversy within the field that they would be criticized. Therefore, it was in their best career interests to make sure they found my therapy useless.
That is my opinion, but nothing else explains the study’s bad management except an ulterior motivation to undermine the therapy.
Moneychanger: Any fair-minded person can see when the cards are being stacked. You don’t have to be an academic researcher to understand that when they were qualifying people in the earlier stages of pancreatic cancer for the chemo trial, but giving you patients with later stage disease, your patients were closer to death.
Gonzalez: Absolutely. In any clinical study, the two comparison groups must be more or less equal in extent of disease and clinical status. That’s a basic, Clinical Trial Methodology 101. Yet we learned in 2004 after the study had been up and running five years that this chief investigator was entering primarily very early stage patients into the chemo arm, and predominantly Stage 4 (the worst, most advanced stage) into the nutrition arm. That creates an unheard-of bias .
The data at the time actually showed that about 75% of the nutrition patients were Stage 4 but only 25-30% in the chemo arm were at Stage 4. That immediately created a bias, yet we had to point that out. Initially, the supervisor argued that that didn’t make any difference, and I had to pull out articles from the literature to show that patients with early stage disease live longer than patients with late-stage disease, however they’re treated.
FILL THE STUDY WITH UNQUALIFIED PATIENTS
The second biggest problem was that the chief investigator repeatedly entered unqualified patients into the nutritional arm. They were either too sick to do the program or did not meet the written protocol criteria. Every clinical study has a written protocol as a roadmap. That protocol stated specific entry criteria that patients must meet to qualify. Since ours is a nutritional therapy, they had to be able to eat normally, and this is written right into the consent form as well as the official protocol. We have no illusions about what we do. It’s nutritional. If the patient can’t eat, he can’t do our therapy. We don’t use IVs. We don’t give intramuscular injections. It’s all done with oral nutrition, with diet.
Still, the chief investigator repeatedly entered patients who couldn’t eat. We had patients that were so sick, they didn’t even take a single pill, but right there was the trick. When the study was first developed, Columbia and the NCI and NIH team insisted on an “intent to treat” rule. Sounds like esoteric clinical trial methodology and academic baloney, but it’s very significant. It means that the second the patient is admitted into a trial, they’re considered as treated, even if they never do the therapy.
We argued against that. With a nutritional dietary program, we need to assess first whether they are able to do it. Under the “intent to treat” rule, patients who are entered but cannot do the therapy are counted as Gonzalez failures. They said, “Too bad. That’s the way it’s going to be.”
Then I said “At least give us a couple weeks lead-in period.” Lead-in periods are standard in clinical trials, particularly with lifestyle modification studies. If you’re studying diet’s effect on a disease you’re given up to two months’ run-in period to assess patient compliance. Why? Because drug treatment is administered in the doctor’s office so you can know whether they’re doing it or not. A lead-in period allows an assessment of whether the patient is able and willing to do it at home. If the patients can’t or won’t, they’re disqualified. That way you assure that you’re testing patients who are actually doing the therapy.
They refused to give us a lead-in period, and insisted on the intent to treat rule, so as soon as the patient was qualified at Columbia, they were counted as treated. Thirty-nine patients ultimately were entered in the nutrition arm. We estimate maybe five or six did it at all while maybe two or three did it completely. The vast majority did it a few days to a couple of weeks, and then quit. They quit because they were either too sick or not motivated.
Our program requires a certain character. You have to be committed to it. In our own practice we have an entry process to assess patients’ motivation, but all that was in Columbia’s hands, and they repeatedly entered patients that were emotionally and psychologically unsuited and too physically sick. Talk about stacking the deck. Thirty patients barely did it, did it not at all, did it briefly, and did it incompletely, and they were considered Gonzalez treatment failures
Moneychanger: It’s so hard to grasp what you’re saying, that I have to repeat it. They gave you patients who couldn’t eat, were too ill, too weak, or too poorly motivated, and then they charged those as failures.
Gonzalez: That’s correct, even though in 1998, when we wrote the first protocol version, the team allowed us to write in those entry requirements. Those rules were ignored. After 18 months into the trial we were not allowed to have any say in patient entry. Initially, we had a veto power, but that was taken away in July, 2000.
We were being forced to treat patients we would never accept into our private practice. The supervisor’s attitude was, “If you don’t like it, quit the study,” which would have pleased them just fine. Then they could say, “See the alternative guys don’t really have the guts to do real clinical studies.” But we weren’t about to quit. We kept insisting that they do it correctly, and they kept doing it incorrectly.
HIDE THE BUCK, THEN PASS THE BUCK: WITHHOLDING THE MONEY
Moneychanger: You mentioned in your book another problem: they didn’t pay you for office visits after the original consultation. Not only that, for long periods they didn’t pay for the patients’ supplements. You and Dr. Isaacs fronted the money for those out of your own pocket?
Gonzalez: When an institution like Columbia agrees to be the site for a clinical study, they get ten percent of the grant as a gift. They call it overhead. I earned the $1.4 million grant, but it went to Columbia, because that was the great academic center and I’m just this fringe guy in an office.
Clinical investigators on a government study are paid to participate. When we first wrote up the trial, we wanted to forestall any criticism that we’re trying to capitalize on patients or use the trial to our advantage. We didn’t ask for a salary—routine in clinical studies—although we spent thousands of hours on this trial. We only asked them to cover our office visits and the patients’ supplements.
Even though Dr. Isaacs and I designed most of the supplements we use, to avoid even the appearance of exploiting desperate, vulnerable cancer patients we make nothing from the supplements. We didn’t get any kickbacks directly or indirectly, but we did ask that the supplement company be reimbursed for the supplements.
Initially, they nit-picked. We should get only half what we normally charge. We agreed to that. After the first two visits, no subsequent visits were covered. We had to treat these patients for free, unheard of in any clinical trial. Doctors are always paid for doing clinical trials. In drug company studies, for example, an investigator who refers a patient to a clinical trial is often paid a bounty, up to $8,000.00 per patient.
To make things even worse, bills were not being paid timely to the supplement company. Sometimes months and months would pass before NCI or Columbia, whoever was responsible (we never quite found out) made payments. So Dr Isaacs and I were actually paying for supplements, as much as $20,000-$25,000. Eventually, a year later, we might be paid, finally, and by the study’s end, all those bills were paid.
Intentional or not, it was a source of not-too-subtle harassment. The NCI and Columbia just shrugged. Columbia blamed the NCI and the NCI blamed Columbia. I never found out who was at fault. The final attitude from the NCI spokesperson chosen to answer my complaint was, “Well, this is the way clinical studies can run.” In a letter I asked her to name another government funded clinical study where the investigator has to subsidize the study. She wrote back some cockamamie doubletalk dodging the questions. The fact is, I know of no NCI or NIH study where the investigator has to subsidize the therapy. The grant’s whole point is that the grant covers everything.
If researchers had to subsidize a government study, no one would work with the government. The fact is, researchers love working for the government because they make a lot of money off grants. Columbia got ten percent, $140,000.
Moneychanger: First, they gave you the sickest patients. Secondly, they gave you patients that couldn’t do the therapy. Third, they didn’t pay you timely. What else could they do to sabotage the study?
SOME PATIENTS ARE MORE EQUAL THAN OTHERS: DIFFERING STANDARDS OF CARE
Gonzalez: There was a different standard of care for medically managing these patients. Chemo regime patients were being treated at Columbia, famous in the academic world for acting very aggressively with pancreatic cancer. They’ll do anything—put patients in the hospital, feed them by IV, drain fluids.
One protocol requirement which we argued against required all patients be followed monthly by a local doctor. Our patients were scattered over the country, and we depended on local doctors to care for them. That created several problems. First, the Columbia team was cheerleaders for the patients on the chemo regimen and would do anything they could to keep them alive.
Our patients were under the care of oncologists spread all over the land. Only 3 of our 39 patients lived in the New York City area. The other 36 lived all over, so they had to have a local doctor, invariably an oncologist. Almost universally oncologists opposed this clinical study and my work. They described it with words like “quackery” and “fraud.” One doctor said this whole study was a scam that I set up only to make money. Ironic, since we were subsidizing the study with our own money.
That ranting had a terrible effect on patients, and with advanced pancreatic cancer patients are the most vulnerable you can imagine. Many quit the therapy after oncologists harangued them to leave the study and do chemo, and some patients who had been responding to our treatment died. When our patients had to be hospitalized, no doctor would allow them to continue our therapy. Meanwhile, chemo patients were hospitalized at Columbia and continued the chemo right in the hospital.
Pancreatic cancer patients can be very unstable. They get infections or obstructions and have to be hospitalized. As soon as they were hospitalized they had to abandon my treatment while at Columbia patients did not abandon chemotherapy.
TAKING THE FICTIONS PUBLIC
Moneychanger: Yet the published report gave the impression that you had failed.
Gonzalez: Absolutely, and there’s more. On Sunday evening, December 3, 2006 at 10:35 p.m., Boris Pasche, oncology editor of the Journal of the American Medical Association [JAMA], out of the blue called my answering service asking to speak to me. My service put the call through. He explained that he had on his desk an article written by John Chabot and the Columbia team about the clinical study maintaining that my therapy didn’t work.
I was completely unaware that they had written a paper and were trying to publish it, or that it had been submitted to JAMA. Dr. Pasche is a man of extraordinary integrity. Looking at this paper he immediately grew suspicious. The first suspicion arose because I wasn’t co-author of a study of a grant awarded to me. That didn’t make any sense to him at all.
Secondly, he said the biggest problem scientifically was that the chemo regimen in Columbia is still an experimental regimen, yet in a clinical study the new experimental treatment must be compared to the accepted standard of care treatment. But the chemo regimen at Columbia was a three- drug regimen, experimental then (and now).
This is not the way you set up a clinical study. Basically, this compares an experimental chemo regimen to an experimental nutritional regimen. The new treatment should be compared to the best standard of care, at that time the single drug, Gemzar, so that immediately undermines the whole study.
Finally, at the article’s end appeared a little addendum asserting I had refused to cooperate in writing the manuscript and had quit the study. That didn’t make any sense to him. Why would I quit a study unless there were problems?
When he called one of the investigators this person claimed that I had quit the study, and that they had tried to get me to cooperate with writing the manuscript, which was wholly untrue since I knew nothing about it. He even said I had disappeared and couldn’t be found.
That, Dr. Pasche said, was the last straw, so he decided to call me at 10:35 p.m. on a Sunday deliberately to test how difficult it was to find me. I returned his call within five minutes. [laughter]
About six months before that call, in June, 2006, I had already filed a complaint over the study’s management with the Office of Human Research Protection (OHRP). The OHRP is an NIH office set up specifically to see that federally funded clinical studies are managed appropriately. Based on my evidence OHRP had opened a formal investigation. In late June, 2006, I had written Dr. Chabot and the other investigators alerting them a federal investigation was now in progress, so please do not be so foolish as to publish any article while a federal investigation is taking place.
Dr. Pasche knew nothing about this investigation and the article never mentioned it. That investigation alone meant that no article should have even been submitted, so Dr. Pasche and the editor in chief of JAMA rejected the article, and, according to what I was told, intended to tell Columbia that they should not try to publish anywhere else.
I filed a complaint about scientific misconduct with the dean at Columbia but they never really did anything. Eventually in 2008 OHRP reported that Columbia’s Dr. Chabot had improperly admitted 42 out of 62 patients, although it didn’t mention him by name. At my insistence they eventually added that the principal investigator from Columbia acknowledged that the patients had been improperly admitted and required the Columbia staff to undergo training in research methodology.
Here’s an extraordinary story: alterative therapist trying to ensure the study is run properly while eminent academicians mismanage the study. It’s still on the OHRP website for the world to read.
As a result, the Food and Drug Administration [FDA] decided it would start its own investigation. FDA brings fear and terror into all alternative practitioners’ hearts because its long history demonstrates the agency’s opposition to making supplements available for alternative approaches. However, whatever you hear about the FDA, we had a different experience. First, because this was an NCI-NIH study, the FDA had to be involved to approve it. They approved it very quickly, within two months although sometimes FDA approval can take two years for a drug study. During the study they did absolutely nothing to harass or obstruct.
I was still a little bit nervous when I heard indirectly they were conducting an investigation, but they never even contacted me. The FDA report vindicated my allegations, and on the website acknowledged that the chief investigator—and they named him, John Chabot—didn’t follow the written protocol as required, didn’t keep accurate or complete records, didn’t properly perform informed consent.
Those are the three main clinical trial management principles: proper informed consent, following the written clinical protocol, and keeping accurate and complete records. Otherwise the study has no value. Unfortunately, there was no serious punishment. He didn’t lose his funding rights. They didn’t begin a criminal investigation or adjudicate fraud.
Yet despite two government organizations finding the study was mismanaged, in August, 2009, again without any forewarning I learned that they had managed to publish an article in the Journal of Clinical Oncology [JCO] online version with the print version due out shortly. It was basically a trumped up version of the 2006 article, with multiple inaccuracies. It never mentioned the OHRP or FDA investigations. We filed a complaint with the JCO editor. Unfortunately, they did not take the same approach as the editor at JAMA. In 2010 they published it with a large number of significant errors. Were they deliberately trying to cover things up, or were they just incompetent or inaccurate? Only God knows that.
Without ever mentioning the OHRP or FDA findings, the article implies the study was run properly, the patients completed the therapy, and they failed to respond. The Gonzalez treatment didn’t work.
My complaint to the Journal of Clinical Oncology was turned over to Columbia, and I was never contacted. So Columbia investigated itself and guess what? They found their own esteemed scientist did nothing wrong and the article was published as if it were an ideal study.
Moneychanger: Far worse than their suppressing the truth, is condemning millions to death by suppressing a therapy effective against cancer.
Gonzalez: Correct. I believe they are deliberately suppressing a useful therapy that doesn’t fit their model. This is a nutritional therapy, not what they were taught in medical school. Emotionally they can’t accept that it works. There are financial and ego motivations. After all Columbia developed a chemo regimen that was being used against me. There were all esteemed Ivy League professors, I’m this alternative fringe guy. Their colleagues would be happier if they found my therapy doesn’t work.
My new book, What Went Wrong: the Truth behind the Clinical Trial of the Enzyme Treatment of Cancer, has two prefaces. Sarah Ann Cooper, who wrote the first, was a patient that Dr. Chabot actually turned down. She was diagnosed in February, 2001 with adenocarcinoma of the pancreas and that was confirmed at the Mayo Clinic. Columbia confirmed the diagnosis. Dr. Chabot’s group initially said, “You’re eligible for the trial,” and she comes to New York, at her own expense.
She had already been told she could have surgery and then chemo and she might live 15 months. If she did nothing, she might live six months. She refused surgery because, as she said, “I won’t do that because they already told me they really can’t cure me.” During the meeting with Chabot, he suddenly announces that she should have surgery and he refuses to enter her into the study.
She was devastated because she thought she could only get her treatment through the clinical study, but that wasn’t the case. If she was rejected from the study, we could take her on as a private patient. My colleague, Dr. Linda Isaacs, took her on for free, although she had to buy her own supplements. That was spring, 2001 and 11-1/2 years later, she’s alive and well.
If she were a conventional treatment patient—chemo or radiation or surgery—she’d be on the Journal’s front page. Because we treated her, no one cares.
The second preface was written by an eminent conventional physician, Dr. Paul Rosch, who’s been president of the American Institute of Stress and was a colleague of Hans Selye who wrote over 2,000 papers on stress. He put stress on the map, and Dr. Rosch was trained under him. In his preface he notes that had this study been done right, thousands of patients could have been helped, but now because the study wasn’t done right...
Moneychanger: His own wife died of pancreatic cancer.
Gonzalez: Paul’s wife got chemo. She had localized disease. There was a reduction in the disease, and then everything was fine until it exploded into her liver and she died while getting chemo.
At that point, he had already contacted me. He had heard about the clinical study and wanted to know what really was happening. He didn’t tell me his wife was fighting pancreatic cancer until she was near death.
Two prefaces: one patient who did our therapy and 11 years later is alive, another who died 15 months after she was diagnosed. From Dr. Rosch’s very personal perspective, had this study been run properly and the results been honestly and honorably reported, he wonders if his own wife and thousands of patients could have been helped.
It’s a tragic story because people act on false information. This is not some esoteric astronomical hypothesis we’re debating, whether Saturn has 17 or 19 moons. People’s lives are at stake. Who knows how many people whom we might have helped didn’t come to see us because of this study, and instead got some useless conventional therapy that doesn’t work for pancreatic cancer and died.
Moneychanger: You’ve published this book to answer these lies, but what do you do from here? You’re not going to stop doing nutritional enzyme therapy.
Gonzalez: No. I’m not designed to stop when the truth is involved. Also, as you are, I’m a very devout Christian, so I turn it over to God. If God wants this to succeed, no matter what I do wrong, it will succeed. If God wants it to fail, no matter what I do right in the world’s eyes, it won’t succeed. I’m just a little servant doing the best job I know how to do.
I know we’re healing people every day. Had a patient in today with advanced pancreatic cancer. She’s only been with me seven months but she looked like a different person. I hadn’t seen her in three months. We see this so often, patients with terminal disease—given up with no hope—who are doing wonderfully. Do you think I give a hoot in hell what the NCI or the NIH thinks? They could go suck lemons for all I care.
Gonzalez: I challenge the NCI to match Sarah Cooper, an 11-year survivor with unresected adenocarcinoma of the pancreas. They can’t do it. On their $6 billion a year budget, they can’t produce a case like that. So why should we stop? We know we’re getting patients well.
Moneychanger: [laughs] I deeply appreciate the time you’ve given me for this interview. God bless you, and God bless your work.
Don't miss our earlier interview with Dr. Gonzalez (July 1995) — Nutritional Cancer Therapy.
It broke my heart to learn that Dr. Nicholas Gonzalez passed away suddenly on 21 July 2015. Nick was a faithful Christian man, utterly patient to teach me what he was doing, and why. He first graciously granted me an interview in August 1991, but I interviewed him several more times over the years. If I had cancer, I would use nothing but the therapy he has so successfully applied.
Nick was a national treasure that all men of good will should cherish. He was honest and fiercely valiant for the truth, heedless of any danger to himself. Nick lived and died free, utterly unintimidated by the world, ready to help everyone. It was an honour to know him. "Well done, good and faithful servant! Enter into the rest of your Lord." My God comfort his family, co-workers, and all who mourn his loss.
WARNING & DISCLAIMER: By publishing this material, neither The Moneychanger nor the author/interviewee recommends or endorses any specific treatment or therapy for any physical condition or disease. Neither The Moneychanger nor the author/interviewee guarantees or warrants any results from any treatment discussed, nor assumes any express or implied liability for any use to which the reader puts this information. By this interview, the interviewee does not prescribe any treatment whatsoever for anyone who is not his patient. All the information here is offered for information purposes only, subject to the reader’s own research, prudence, and judgment.
Originally published July 2012