Pancreatic Enzyme Cancer Politics: Dr. Gonzalez – 2
In our little study of eleven (pancreatic cancer) patients (on nutritional-enzyme therapy), we had five that lived two years. In the Gemzar (chemotherapy) study of 126 patients, that is ten times the amount of patients, they couldn’t get one to live beyond 19 months. Dr. Nicholas Gonzalez
Although the following interview doesn’t directly pertain to osteosarcoma in dogs, I felt the need to present what many already know. That is, cancer is a business that is closely guarded by the pharmaceutical companies. And because of this, many viable solutions to cancer, human as well as canine, are buried deep, like a dog hiding a juicy bone.
This is Part 2 of a Dr. Nicholas Gonzalez interview by Dr. Joseph Mercola. There are some slight edits for easier readability.
Dr. Gonzalez. In 1993, the National Cancer Institute, as part of a legitimate effort to reach out to alternate practitioners, invited me down to present cases from my own practice (at that point, I had been in practice for about 6 years). I went down to present 25 cases.
It was a closed door, invitation only. All these hot shots from the NCI were down there. Some of them had a chip on their shoulder, but the guy that chaired the meeting Michael Friedman was very open in my opinion and seriously looking into alternative practices.
On the basis of that presentation, the NCI suggested that I do a pilot study with cases of patients who had advanced pancreatic cancer. Their thinking being that pancreatic cancer, once it’s advanced, is something that is untreatable in the conventional world. Beyond surgical repair, there’s no treatment that works, neither chemotherapy nor radiation, or immunotherapy.
They said, if you can get even three patients to live beyond one year, we’ll consider that a miracle. And they suggested a pilot study. With a pilot study, it’s not a control group getting chemotherapy, it’s just an experimental group with advanced, incurable type cancer getting experimental treatment, which was mine.
And they suggested ten patients. Later, of course, no matter what I did, I was criticized. People in the conventional world criticized me for only using 10 patients. But that’s exactly what the National Cancer group said I needed, 10 patients. With pancreatic cancer, you don’t need a whole bunch of patients. Because everyone knows within a year, year and a half, they are all dead.
Nestle, the international food company, was willing to fund the study because they got interested in my work. You know they make 50,000 food products.
Dr. Mercola. How would Nestle be behind (that sort of study)? That doesn’t make sense.
Dr. Gonzalez. It doesn’t make sense at all. I’ll tell you it’s an interesting story because Nestle and I …you know I joke with their research team. They make 16,000 products, none of which I would eat. I live by my rules. I eat organically, drink carrot juice. I don’t eat chocolate or synthetic foods…
The Chief of Research at Nestle, at that time, Pierre Bessiere, interesting guy, French born. He had been Medical Director at the Pasteur Institute, one of the preeminent research institutes of the world. And Nestle hired him away to set up a basic research division in nutrition, which is largely unknown. It was funded to the tune of 500 million dollars. Nestle is a 64 billion dollar a year company.
They have a campus in Lucerne, Switzerland that rivals the NIH (National Institute of Health). It’s on a beautiful rolling countryside near Lake Geneva with building after building. They give grants to scientists from around the world that come to do nutritional research. Their thinking is if they can add nutrition to their junkier food, they can make their junkier food healthy. So that’s the business motivation.
Bessiere was a pure scientist. He was trained as a immunologist and knew about my work. It was interesting, It was 1992, 1993, just as the NCI was inviting me down. I wasn’t that well known at the time. But he had people looking out for alternative practitioners that might provide something useful.
You know business is kind of interesting. It might be moon dust. They don’t care if it works. They want to have a patent on it and sell it. And they were very quietly looking. No one knew that they had this research group going that scoured the world looking for alternative therapies that might be useful. It was about treating anything. It wasn’t just about treating cancer. But they kept coming up with my name, even at that time.
So the chief of research Bessiere came to New York and went through my records and flew me to Switzerland a few times to lecture to their scientific staff. And they just announced that they were going to fund a study. There were no strings attached at all. They just wanted to do it for the sake of humanity. So they came up with the money and the NCI supervised the pilot study. It was supervised by eminent researchers.
We finished it about 1999. It was published in June, 1999, in peer review literature. And it showed the best results for the treatment of pancreatic cancer in the history of medicine.
To put into perspective, the latest chemo drug that’s been approved for pancreatic cancer dates actually to 1997. A major study that led to enthusiastic approval for Gemzar had 126 patients, 18% with one year survival and not a single patient out of 126 lived beyond 19 months. They were similar type patients to ours, advanced pancreatic cancer patients.
In our little study, we had 11, one of them dropped out. We had 5 that lived 2 years, 4 that lived 3 years, 2 that lived 5 years, one that quit the program and died of a heart attack, and other quit because she was just tired of living and she went off the program. She was elderly and didn’t want to keep doing the work.
In our little study of 11 patients, we had 5 that lived 2 years.
So in the Gemzar study of 126 patients, ten times the amount of patients, they couldn’t get one to live beyond 19 months.
So these were extraordinary findings. And all of these patients were approved by a really good team of cancer researchers so there really couldn’t be any doubt that they had pancreatic cancer and just had toenail fungus. There’s no question that these patients had pancreatic cancer. That was the good news.
Based on that, the NCI (National Cancer Institute) decided to fund a large scale clinical trial, again, with my work in the treatment in pancreatic cancer.
This time it was to be a Phase III study where my treatment would be used with one group of patients. Then a second group would be getting the best chemo at the time. And we’d go head to head.
The NCI said, “Are you willing to do this?”
And I said, “Yes.”
And they allocated a 1.4 million dollar study. It was to be run out of Columbia University.
Now, my friends say, “Why did you get involved with something like this? How could you trust the NCI?”
Well, my experiences with the NCI had been very fair to that point. The then director Richard Klausner, in face-to-face meetings with me down in Washington, said he really thought I was doing something interesting and needed to be properly supported.
But, unfortunately, a year after the study was approved, he left to go work for someone in a private organization. A new group came in that had a completely different attitude. My college Dr. Isaacs and I could tell from the first meetings that something had changed significantly.
All the people who had been originally assigned to the study, who were really supportive and believed that we were doing something useful were taken off of the study. One of them was told that she couldn’t talk to me, that she’d be fired if she talked to me. But she took my phone call.
I was told by another person who supported me at the NIH that I shouldn’t call him at his office because he was afraid that his line might be tapped. I should only call him at home.
That‘s how insane the politics over this clinical study got. I couldn’t believe it. I just thought this is something that you’d read about, or see on TV, or something a paranoid, alternative crazy would make up. And here I was living it.
You know, coming out of Robert Good’s group, and I don’t say that to impress people, but my background was so pure ultra-conventional, it was unbelievable to see that the profession I’d so respected and wanted to join could behave like this.
We decided not to quit, but to stick it out. Eventually, this study, in our estimation to use a kind word, was sabotaged. It turned out the principle investigator of Columbia, who was supposed to be completely neutral, had helped develop the chemo regimen that was being used against us, a conflict that was never declared.
We had to find this out. None of the geniuses at the NCI or the NIH told us. We had to find this out for ourselves.
Now, like any clinical study, there are specific requirements for entry into the study. As you know, ours is a nutritional study program. And when the first protocol was written back in 1997, 1998, we had a list of specified criteria.
First, we all had to sign a consent form that this was a clinical study. By law, any subject entered into a federally funded clinical study had to sign and file a consent form.
We had no undue expectations. We knew what we could do. We know what we can’t do. Ours is a nutritional program. Patients have to be able to eat. If they can’t eat, they can’t do our therapy. They have to be able to take care of themselves.
This is not like chemo where you show up to the doctor’s office, eat ice cream, stick your hand out and watch TV while they give you chemo, which is what happens at the doctor’s in the oncologist’s office.
This is a program the patient’s have to follow at home. They have to make their carrot juice. We have coffee enemas as part of the program. They have to do the coffee enemas and take up to 200 pills a day. They have to do it all. So, all of this is written in the protocol.
The Chief Investigator initially entered patients into the program who were able to do it, who could respond. Then there was a sudden change around 2000, 2001, where the Columbia group had total control over the interviewed patients in the study. We were excluded from that process except during the initial months.
The thinking was that if we were involved in the admission process, we enter the dreaded bias. Whereas, if conventional doctors were in control, there couldn’t possibly be a bias.
Well, of course, The Chief Investigator helped to develop the chemo regimen, so that’s virtually the definition of a potential bias.
He started sending us patients that were so sick, patients we would never even have accepted into our private practice. They were so sick that they died before they got their supplement order.
Well, there was a trick to the protocol. The Columbia team, the NCI, the NIH, insisted that we have an “intent to treat” provision in the protocol. What that means is: when there is sometimes a drug trial, the minute a patient is accepted into the trial, they are considered treated even if they never do the therapy.
So John Chabot, Chief of the Study at Columbia, would enter patients that were so sick, we had several who died before they got their supplement orders. But because of the “intent to treat” provision in the protocol, they were considered Gonzalez treatment failures.
Ultimately, 39 patients were entered to be treated by us. Maybe, at best, being kind and optimistic, six actually did it. But the great majority were so sick they couldn’t do it.In 2005, the NIH did a review of the study, and actually to their credit, in writing, came out with an official statement, saying that so many patients had been entered for treatment with us, that couldn’t, or didn’t, or shouldn’t, or wouldn’t be able to do the program that the data would have no meaning.
Basically, what they had created was an untreated control group instead of a Gonzalez treatment group. Most of the patients couldn’t, or didn’t do it. They were psychologically unsuited.
Obviously, for a program that you had to do at home, you have to have a certain amount of motivation. You have to believe in it. You have to do the work. People that are unmotivated aren’t going to do it.
And we were being told that we had to accept patients that we never would have accepted in private office. Of course, most didn’t do it. The end result is Gemzar looked better, apparently to the great exaltation to the NCI and the NIH. At least, that’s what I gather. I’ve been told that that’s what they were hoping would happen. They would do anything to make sure that Gemzar looked better.
It (the study) was actually published in the peer review journal. We filed a complaint with the Office of Human Research Protection (OHRP) at the NIH in 2006. The OHRP is an oversight group whose responsibility is to see that federally funded clinical trials are being run properly.
They took two years investigating it. You know the government takes a long time to do anything. And they found 42 out of 62 patients had been admitted inappropriately. It never made its way into the media. Chabot and the Columbia Team were able to publish the article leaving out the fact that 42 out of 62 patients had been admitted inapproapriately. It’s right on the OHRP website in the Department of Health and Human Services of the NIH.
So the study was a total boondoggle, a waste of 1.4 million dollars. Even though I won the grant, all the money went to Columbia. It’s all gone. The data, as far as I’m concerned, is worthless. And the NIH and the NCR are using it to show that my therapy doesn’t work.
So that’s how this long journey, beginning in July it will be about 30 years since I first met Kelley, has gone. Although the good news is that we’ve never been busier in our own practice.
In October, 2009, Suzanne Sommers came out with a best selling book Knockout, which is a book on alternate cancer therapies. It sold over a million copies.
I’m very grateful to her. She gave us the longest chapter. She interview nine of my patients with appropriately diagnosed disease, including two of my pancreatic patients, that lived 5, 10, 15 years since diagnosis. Interestingly enough, I never thought that any kind of recognition would come other than the usual academic channels. Of course, that was disaster. The recognition we’re getting is from a wonderful actress Suzanne Sommers.
She had a history of cancer herself. Initially, she did the conventional routine. She had breast cancer, had surgery. It’s all in her book…had radiation which really devastated her and she refused to do chemo. So, she got interested in alternatives.
She’s not my patient. But she does coffee enemas, eats organically, has her own organic garden, walks the walk, and takes a lot of supplements. She does use our enzymes. And she got so motivated that people like us weren’t getting recognition that she used her fame to write this book that’s still selling now a year and a half later.
So that book, interestingly enough, neutralized this publication about the clinical study. And the world is taking Suzanne’s book much more seriously than that published clinical study which was completely misleading.
They left out the fact that, for instance, 42 out of 62 patients had been inappropriately admitted and the fact that Chabot, Chief Investigator, had helped develop the chemo regimen, and by the NIH’s own evaluation, hadn’t done the therapy, and the data was meaningless.
So that’s the whole story. We continue to see patients and our practice has never been busier. And patients continue to respond.
We’re doing a book of a hundred cases now, our own patients with appropriate diagnosis. Now that we know that we can’t depend on the NCI and the academic community to do the right thing, we will do it on our own, put out a book of 100 cases with the medical records, written up case reports, just as I did for Kelley 24 – 25 years ago.
Because of people like you, and people interested in our work, we’ll get the word out one way or another. What you said earlier is entirely correct about the idea that alternative practitioners are these slimy people that aren’t trying to get their work out in the world.
When you do try to get the work out into the medical literature and the scientific community, they’d rather get hit by a truck. That’s the last thing they want to do. They’ll do everything they can to sabotage you.
I tell people now about this National Center for Complimentary Alternative Medicine (NCCAM). I wouldn’t send a dog to that group. They’re not there to objectively evaluate the value of alternative medicine. They’re there to undermine it. It gives the illusion that the government is interested in alternative therapies. The fact is that office is being used, as it was in my case, to undermine promising, useful, alternative therapies.
So any natural practitioner that wants to work with NCCAM, my advice is to stay away as far as you can. Take the first train out of Washington and never go back.
As you can see, the indirect results of medical and academic politics, not only affect the way cancer is presented to the public and the conventional medical community, but it indirectly impacts all conventional veterinary practices. If you are looking for solutions for your dog’s osteosarcoma, do your due diligence. There are other answers out there. Talk to your vet and also contact a holistic vet before you make any decisions. And do it quickly because decisions need to be made rapidly.
List your options and remember to “Ask your Dog” before you decide on anything. Dog bone cancer (K9 OSA) is very, very aggressive. You have no time to lose.
Filed under: Enzyme Therapy
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