A new book explains how the system trashed the groundbreaking NIH/National Cancer Institute clinical trial on this extremely promising therapy.
Integrative medicine pioneer Nicholas J. Gonzalez, MD, has been researching nutritional approaches to cancer since 1991. With his colleague, Dr. Linda Isaacs, they offer a profoundly individualized treatment program for patients with all kinds of cancer, as well as patients with a variety of other problems. All of their treatment protocols include diet, supplements, and detoxification.
In 1998 the National Cancer Institute approved funding for a large-scale clinical study in which this nutritional enzyme therapy for the treatment of patients diagnosed with inoperable pancreatic cancer—a treatment initially proposed in 1906—would be compared to the best available chemotherapy. Drs. Gonzalez and Isaacs’ initial enthusiasm turned to disappointment as they discovered that conventional medicine is still overwhelmingly biased against any treatment methods developed outside the mainstream, and that scientists and physicians at the highest levels of academia would do anything—even change the truth—to prove that an unconventional therapy has no value:
Eventually, under the direction of the supervisors from Columbia (the site for the project), from the National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM), the study degenerated into a morass of mismanagement, meaningless and manipulated data, the welfare of patients put at risk, and sadly, cover-up of the mismanagement right into the office of Dr. Elias Zerhouni, former NIH director. Repeatedly now we’ve seen the meaningless data of a mismanaged study used in the effort to “prove” my treatment worthless, and undermine my twenty-eight years of hard, determined research.
As Dr. Gonzalez reveals in his book What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer, poor trial design, poor implementation at the highest levels of the research, and improper supervision in the trial itself completely derailed the study.
The book also calls into question the validity of double-blind placebo studies as the gold standard of mainstream medicine. Dr. Gonzalez delves into biases of scientific health community that make the fair testing of unconventional treatments so difficult.
Gonzales graduated from Brown University, Phi Beta Kappa, magna cum laude, then pursued pre-med studies at Columbia before getting his medical degree from Cornell. During a postgraduate immunology fellowship under Dr. Robert A. Good, considered the father of modern immunology, he completed a research study evaluating an aggressive nutritional intervention in the treatment of advanced cancers, eventually focusing mainly on pancreatic enzymes.
During the NCI/NCCAM clinical trial at Columbia, Drs. Gonzalez and Isaacs repeatedly pointed out flaws in the study design, but their objections were ignored. Some of the problems in the clinical trial:
- The question of randomization. Conventional medicine believes that randomization is essential when selecting study participants. However, this doesn’t work for alternative medicine—“such a design most likely would create rather than prevent bias,” says Dr. Gonzalez in his book. With a strict nutritional regimen, compliance on the part of the patient is essential. It requires discipline and usually a preexisting interest in alternative medicine. Therefore selecting study participants requires some sort of screening—the opposite of randomization. In general, patients with an interest in following a strict nutritional regimen to treat their cancer are likely to quit the study once they realize that they have a 50% chance of being in the chemotherapy group rather than the alternative treatment group. By the same token, patients who prefer chemo are likely to quit when they realize that there is a 50% likelihood that they will be placed in the nutritional treatment group instead.
- The lack of a “lead-in.” A two-week lead-in (at minimum) is necessary to fully vet the patients in the nutritional regimen study group to make sure they follow the program. The chief investigators refused to allow for a lead-in period.
- Improper screening of study candidates. Contrary to the initial agreement, Drs. Gonzales and Isaacs were excluded from participating in the selection of study subjects. As a result, as many as 39 patients followed the nutritional regimen only for brief periods or did so inconsistently—with some not following the protocols at all—making the data meaningless.
- Sabotage attempts. Because of the controversial nature of nutritional therapy for cancer, many members of the oncology community were vocal in their opposition to the project and deliberately tried to undermine it.
- Delays. “Over the years, since my fellowship days…I have observed that when the NCI want to get a study done, it gets done….Our study proceeded along a completely different pathway….In our case, the [process] hardly ran expeditiously….Not a single delay involved some deficiency or non-compliance on our part.”
Without Dr. Gonzalez’s knowledge, a misleading article was published about the findings from the clinical trial. Despite his best efforts in dealing with NCI, NCAAM, the Office for Human Research Protections (OHRP), and the Office of Research Integrity, none of the parties responsible for mismanaging the clinical trail or disseminating the misleading information were held accountable. Even an FDA investigation and pressure from Congress was not enough to correct the situation.
Dr. Gonzalez’s experience is a testament to the failure of mainstream medicine. As noted in the foreword of his book, the “war on cancer” has been a failure due to a combination of politics, money, greed, and corruption—largely the result of an unholy alliance between the American Cancer Society, NCI, Sloan-Kettering, and the drug companies.
With such a powerful—and powerfully biased—medical system, all clinical trials of unconventional treatments are destined to fail. “This particular model of medicine—and it is just that, a model—lauds synthetic and high-tech creations as it relegates diet, food and nutrition to a very minor rule in any consideration of human health and disease,” says Dr. Gonzalez. “This cosmology dominates academic medical thinking, and certainly dominates all teaching in medical schools.”
Dr. Gonzalez’s book, What Went Wrong: The Truth Behind the Clinical Trial of the Enzyme Treatment of Cancer, is available from New Spring Press.
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I am so fed up with the medical industry milking our diseases.
How do you contact Dr. Gonzalez?
Just go on google and tipe dr.gonzalez, it has all the info you need.
More and more MDs these days are understanding the CAM (Complementary and Alternative Medicine) approach as being the basis of not only treating the whole person but ways that traditional Western medicine and complementary modalities can work together for the high level wellness of human beings. Dr. Gonzalez, you obviously did everything you could to make this a valuable and worthwhile study with the prospect of providing true nutritional support for such a hopeless prognosis of treating pancreatic cancer by most of the medical community. It sounds like we need real changes in the randomization study guidelines along with most things in our political world. I am entering into research and will look forward to reading your book.
big drug companies can’t make any money on herbs or alternative treatments….so of course all these are derailed. sad…but true.
the same thing happened with the vitamin B17 — Laetrile –Amygaline.. banded..
Believe me, I have been working with people with cancer for a long time and pancreatic cancer is not difficult if you do all the things necessary and stay with it.
I wrote a book, HEAL THYSELF, OPTIMUM HEALTH FOREVER by Dr. Gary Steven Gautier.
It’s not promising, it is about doing the things that God intended us to do and that is it. It works fine for all cancers too!
Sincerely, Dr. G
I’d love to know how the cancers are treated, that is, more specifically re the diet and what enzymes.
Go to the website mentioned above. http://www.dr-gonzalez.com
Please take a look at this is you are interested in where The War on Cancer has gone(or hasn’t!)… What a shame that money, greed, profits are more important than ever finding a cure! Read 2030 by Albert Brooks to read about how and when the Cure will come about – even in fiction form as this book is; there is hope one day it will happen if the AMA and Big Pharma get out of the way!
There are big bucks in not expeditiously curing cancer.
After seeing what chemo does to people I’d try anything but that to treat any cancer. The telling thing is that when you go to the oncologist for your first meeting after being diagnosed they tell you not to take any other medications of any kind without their approval. Not even a vitamin tablet. Now that tells me something.
Dear Dr. Gonzales,
I feel so sad and so much hopeless about any possibility of the main-stream-medicine multi-billion industry to give up their revenues ever on behalf of saving million of peoples lives by their having their freedom in exercising any treatment they choose.
First, the food-medicine-agro-pharma one-“family” conglomerate produces and sells the “stuff” labeled as “food” that is quite instrumental in developing cancer not only in their own citizens, but also around the globe.
Then, they make 100% sure that no human would be allowed for any freedom to choose his/her own health treatment.
So making money on producing toxic synthetic artificial carcinogenic foods is not enough for them. They go then for the second round of brainwashing the poor sick-people’s minds by selling them their expensive highly-toxic not-working deadly drugs coupled with their invasive treatments that finish up the sure job of killing the naive uneducated souls, or if not killing them, then continue pulling their money to the rest of their lives.
Why do they do that? Why Dr. Gonzales is persona non grata for the medical establishment?
Because… again, too huge money, astronomically-high numbers of profits the food-pharma industry gains to allow people EVER to exercise their constitutional rights to choose their health treatment.
Doctors you are light in the darkness.
The powers that be are not in the light so can not see
or understand. Please hold fast to your knowledge
keep it us and the world
Thank you for all of your work to save lives.
None of this surprises me, the coverups will continue. It will be up to us as individuals to shun conventional methods daily, as well as if & when we are faced with a devastating illness, effectively carrying out our own study. It is unfortunate but greed & power will continue to trump until each of us “votes” with our $$$ to send a message.
Natural cures didn’t help Steve Jobs.
Which ones did he try?
Jobs had a liver transplant… the drugs he had to take greatly impaired his immune system…. thus he can’t be used as a good example of anything…
and… remember, everyone’s survival-ability of life is zero…. something will kill all of us at some point…. we just need to retain the right to treat our ailments and dis-ease as we want
Steve Jobs rejected Dr. Gonzalez’s treatment!
Those with a healthy immune system do not get cancer. Stress can make an immune system unhealthy. Stress includes not being fed essential nutrients. For example, RounUp Ready crops are missing essential metal nutrients needed for a healthy immune system. Stress includes consumption of toxins. For example, corn, soy, etc. have been genetically engineered by insertion of the Bt-gene to manufacture the Bt-toxin that degrades the immune system. Other toxins include mercury, fluorine, arsenic and aspartame that are added to our food and water that also degrade our immune system. I believe most of the cancer in the United States is caused by the lack of essential metal nutrients and the consumption of toxins. Unfortunately, these foods are not labeled. Yes on CA Proposition 37. http://opinion.fartoomuch.info/Cancer.htm
Obviously much needs to be done to get the corruption out of the FDA which obviously as you have shown, is rampant! It has not always been that way…A corrupt Senate and House trickles down to other government agencies of course..Doesn’t have to be this way if there are measures in place to make the FDA and all government agencies accountable…But the congress will not allow this…Therefore, we need to get rid of what has been called the worst congress in the history of this country since they have been an obstructionist congress that has really acted on less than any other Congress in our history…. or so those who are truly in the historical know have been reporting. Then gradually, once the corruption has ceased, than the corruption will stop in the government agencies as well…
.I am a retired teacher and so have first hand knowledge as to how leadership can effect the school system…When administrators do not know how to administrate, than things go wrong..The Education system is just a small microcosm but ultimately a fine example of what bad leaderhip can do for a country.
Right now our Democracy is at an ebb…and therefore our freedom as well …Until we can elect those who will have the country and the people at heart, which must include the middle class and the poor as well,we will not be able to make any changes for the better in government…Presently with the suppression of our right to vote to influence who is elected President of our country, ,.. our Congress and Supreme Court as well, is certainly not up to our past standards; that is a fact.
This country will remain in trouble if we don’t vote for the right people to fill the seats up there…and now that the suppression of the vote is rampant across the country and many of us will be unable to vote, we may still not be able to elect the Senators, Representatives and even the President that we wish to have;.so hard to say whats coming in our our future now that the corrupt run our Congress and some of those appointed to the various government agencies long ago..such as in the justice department…As a result, we the people are in BIG trouble and I don’t like to think it but it could be decades before we get this country all straightened out….until the rich are paying their fair share of taxes and the military cuts are put in place in this country..The military is the strongest and most extensive and capable military in place on this earth and if anything, will be…
Well then don’t vote Republican because they are what got us right here, and now.
Well then you will have to just not post it..I have told the truth and I see nothing abusive in these comments….I have shown cause and effect here and if you don’t like it than don’t post it…Del Dutrow
He is the doc I would want to go to if G-d forbid, I had cancer.
Dr Gonzalez treated my husband for pancreatic cancer. The regimen was rigorous and eventually my husband could not do it any more, which supports what Dr Gonzalez says about the need to ‘vet’ any potential study subjects so you get people who can follow the regimen exactly. While my husband did follow it, he did well and very likely lived a longer time and a better quality of life than he would have either with chemo or without treatment. The squashing of Dr Gonzalez and Issac is indeed a sad statement about our medical-industrial’s hold on our health. Take it into your own hands, that is my advice!
It is extremely discouraging to forge a brilliant new pathway based on good science, good imagination and good ethics, contrary to so much of what’s out there today (and yesterday), to have it end like this. Kudos to Dr. Gonzales for maintaining a higher standard and striving for better; I hope he perseveres.
We the public must not continue to allow the NCI, AMA and FDA and other such institutions and especially drug companies to continue denying promising treatments and the study of such treatments simply because these institutions cannot find a way to control and profit immensely from these treatments. It is an outrage!
The medical and drug companies just don’t seem to care about any body but themselves. It’s a tragedy to see and to know that they are the ones who are given he green light to do almost everything, while the true health care professionals (naturopaths, herbalists, hydro-therapists …) are side lined and persecuted even in this present modern days. It will seem that the more things change the more they stay the same. I still have Hope, I still believe… Some day, some day soon.
My Father and Grandfather both died of pancreatic cancer so genetically I am a candidate for the same. I am very concerned that main stream medicine is not interested in my well being by blocking Dr. Gonzales’ work and is only working to promote synthetic approaches.
What’s the mission of the agency? Protecting profits for the cancer industry? It’s time to start a separate agency with the sole purpose of evaluating the FDA, comparing them to similar foreign agencies, and bringing the FDA out of the Dark Ages with a few new ideas!!
Makes me sick to my stomach! How in “modern times” can the “experts” and those in power be so backwards as to ignore the healing power of essential nutrients? Are the arrogant, greedy people destroying healthcare in this country really so ignorant as to think that they hover above it all unaffected?
When my husband, age 54, got diagnosed with stage 4 Pancreatic Cancer ten mths ago, he immediately started chemo and juicing and transitioned into a vegetarian diet. We read books by Dr Andrew Weil, Dr Gonzales, Charlotte Gerson, Beating Cancer With Nutrition, and The China Study by Dr Campbell.
Today, August 2012, ten mths later, his tumors have shrunken 85% and his CA19-9 blood test is 10. Normal! It was 5025 in Oct. 2011 and it is now 10! He is strong and energetic with full quality of life. He is only fatigued for about five days after his chemo treatment, then he springs back. He has a full appetite, he maintains his weight of 163, he rides his motorcycle. He avoids all stress, including work, sleeps well, and exercises. His oncologist has actually done a good job of reducing the chemo based on the positive results. We owe our success to the combined regiment and promote the vegetarian diet to everyone we know.
My husband died of mid-esophageal cancer within 10 days of a diagnosis in 2008. Six months later, his brother (his only sibling) was diagnosed with pancreatic cancer and died within 11 months of my husband. There was no explanation for the cause of his cancer, except he’d been a Viet Nam Vet and exposed to Agent Orange, had shrapnel in his head, etc. Two months ago, my eldest brother was suddenly diagnosed with renal cancer (following a heart catherization and stent procedure) … suddenly the HMO says there’s cancer (after they did the other procedure). Sad thing is, he was an engineer who actually DESIGNED a piece of equipment for the treatment of cancer that is currently being used today. He was really jerked around and it was a terrible, terrible thing how he suffered and his family those few weeks before he passed. If only more natural treatments were available and not being suppressed by the medical community, so many of our loved ones would still be here. Most of these cancers are so aggressive and fast moving, there isn’t even time to react, even using natural methods. It definitely makes one believe corporations, the medical industry, drug companies and our environment are to blame, along with the things that are in our foods, etc.
WhAt kind of chemo did he have…
I wish I could say I am surprized but I am not. My history of being a visiting RN, et al, and now as an FOH (Fed. Occup. Health) RN with a background in behavioral science has already taught me that the good old human traits of pride, arrogance, and greed, etc. are alive and well in the medical community. My interactions with various physicians have taught me that those who should be at the top rung of levels of integrity, honesty, and thorougness in society–those who affect the health and well-being of our nation most profoundly-are often mediocre at best, with some at the bottom.
The tragic result is too many cases of needless suffering and/or death by unsuspecting patients.
My condolences to Dr.Gonzalez and those working with him. God help us all!!
There is a lot of Big money and interest behind that money involved in Cancer/Oncology Treatment. So given the way we’ve seen this world go this article gives credence to what I’ve though. Thank you Dr. Gonzalez, you are very brave to put this information into the public forum.
THere is some indication that constituents found in cannabis sative have been used effectively on many different cancer forms.
Drs. Gonzalez’ and Dr. Isaacs’ experience with the medical establishment mirrors Dr. Burzynski’s inquisition and punishment at the hands of the FDA and the government. There are many other examples of effective alternative therapies being trashed, hidden, prosecuted, and persecuted by the “cut-burn-poison” brigade. Cancer treatment is big business and Big Pharma is going to make sure that their stooges at the FDA (Federal Dollar Administration) get rid of any treatment modalities that can’t be patented and make big bucks. The AMA and the FDA exist primarily to ensure a large flow of capital to a few people and only secondarily to safeguard consumers. The only trouble with some of the alternative treatments is that they are expensive and are not covered by insurance, Medicaid, or Medicare. Thus they are not available to many of us. Of course the researchers and therapists are entitled to recoup their expenses and make a living; we can’t expect pro bono treatment. It’s a shame the establishment doesn’t really serve us.
It is my honest belief that they did the same thing with Dr. Wakefield regarding his findings on the connection between vaccines, mercury and the epidemic of Autism, which I recently noted was said to be 1 in 85 children now. My granddaughter and my brother’s grandson, on opposite sides of the country, BOTH born in 2001, have Autism. Vaccines with the mercury were still on the shelves being used at that time. In every single Pediatricians office you will find taped to the desks, the walls, etc. in prominent places … the DEBUNKING and smearing of Dr. Wakefield’s studies. Yet, I have since heard that the people who “debunked” his findings have since been debunked themselves, and still, you don’t see it in the media.
which is exactly why Obamacare is absurd….making us pay for insurance that supports a health system that does not work
As a post breast cancer patient, and registered nurse, I would like to know what this breakthrough treatment is that the FDA and NCI removed from public view without having to buy another book. It seems to me that if there is a cure available for people who are suffering, and is available now – it should be freely published as we all could use a break from the endless onslaught of cancer related marketing for treatment and cure dollars. Please, if you don’t mind Sir!
And how much did you spend on treatments for your cancer? I don’t recall traditional medical drs giving their treatments away.
You can go to the website mentioned above http://www.dr-gonzalez.com and read the basics of the history of the treatment and the protocols. But this is not a Do-It Yourself project as treatment is individualized to a person’s biochemistry and detox consequences can require professional assistance. As the article points out, one must be persistent and diligent to follow the diet and protocols. I pursued this treatment in the late 70’s, before Dr Gonzalez began practicing. It was developed by William Donald Kelly, DDS. I believe I had a return of my 1969 cancer but can’t say for sure because I never went to a doctor. All I know is it took over 2 years to feel well and did require real commitment. I still follow the principles upon which the treatment is based.
Good luck!
“The “war on cancer” has been a failure due to a combination of politics, money, greed, and corruption— …”
Please don’t leave out Depopulation, the deliberate indirect murder of perhaps billions, cumulatively since Doctor Warburg solved cancer in 1924. DEPOPULATION is IMO the overriding political factor driving “Cancer Prevention/Treatment”.
Hi. Thank you for the opportunity to express my dismay with the methods of the current medical profession. My experience with the medical profession in the past twenty years reveals a very bad attitude for true healing. One female OBGYN told me when I approached her with a personal serious issue, to “just get used to it.” It was a serious issue and I was depressed for three days. Then, I went to my health food store and got a natural product which fixed my problem in one week! My most recent experience was 2 skin issues that I was suffering from simultaneously. I went to one Dr. and he walked into the room, diagnosed on his feet without eye contact, walked out of the room, and I never saw him again. He prescribed a medication, that I surveyed my friends about, because the side-effects were severe. Several told me of the dangers they experienced and I didn’t take the drug. I went to another Dr. in our health group. The Dr. was young and healthy and I was heartened to believe she would be open and available to alternative medicine. Her last words to me, after I asked her, “When will this go away,” she said, “Never.” I couldn’t believe she said that to me! I went home, researched my books, and the web, and within 2 months I cured myself! My family physician, who I almost never see, gets a blank look and stops writing, when I tell him how my natural methods have ended a cold in 24 hours, healed a problem, fixed my knees and other issues with Yoga postures and breathing, etc. Sad isn’t it. There is so much true healing available and so little consciousness or openness to how to really help people without toxic, dangerous side effects from dangerous drugs, which don’t even always work. I am sincerely hoping change will take place. We are all biased on certain things. It is the institutional bias which is dangerous for us all. Sincerely, Lu DiGrazia
All of us have to die one way or another, and dying from cancer is one of them. While we are told that we can be cured of cancer if we do and follow such and such a treatment, we are kidding ourselves. What is happening is that we are just prolonging the dying process, and along the way, money goes from from one hand to another until none is left to go around or death takes over. All the attempts to find a cancer cure , whether successful or not, is just one great human economic activity to keep certain section of the human race busy on earth, while others are fighting, bombing, and killing each other.
Thank you Dr.Gonzales for everything you do. I was lucky to hear your lecture in Toronto not long ago and bought your book. Unfortunately last year I’ve got adenocarcinoma that now spread to my bones. No oncologist in Toronto want to hear about any natural treatment last year and because I had aggressive cancer under my brain it was making me eysite and pain worse every week. I was told that my prognosis was no good! The first oncologist gave me high dose of radiation that I could not take. I saw him right after but he refused to reduce the dose or to give me anything to help. I could hardly walk to taxi outside to go home. He refused to allow me stay in the hospital during treatment. I had to phone him that I can no take that kind of treatment. I live alone and after first radiation may hands were so shaky that I could not carry a glass of water from kitchen counter to the table.After searching friends and family from Japan to Germany I used my life savings and flew overseas. Now, after one year I am still alive but only thing that oncologists offer here is chemo or radiation.
They refuse to talk or even hear anything else. I will have to go back overseas to get human treatment and use the rest of my savings over there. I have pain in my spine and as soon as it gets better I have no choice but to fly overseas. This is what Ontario OHIP system is doing to its citizens.
A friend of mine has been a patient of Dr. Gonzales for more than 15 years. His therapy has helped her live with her several cancers. I read his book that explains how he was trained and developed his treatment protocols. It makes perfect sense! Give the body the nutrition, sleep, exercise and de-stressors it needs to be healthy, and it can be.
Dear Gail,
I read your letter and it is very encouraging. My brother has been diagnosed with pancreatic cancer two years ago. He has several bout of chemo at MD Anderson and was doing good until about three months ago. He has lost more that 30 lbs in just two months. He does not have any appetite. He can not eat any thing. He vomits whatever he eats.
I have been trying to convince him to try Alternative treatment but he is very reluctant. Is there any way you can provide a contact of your friend.? I will at least try to convince my brother to talk to her directly to know how the alternative treatment has benefited her.
Thank you and I will appreciate your help in this matter.
Best Regards,
WS
Hi WS,
Thank you for your comment! For more information on this treatment for pancreatic cancer, please visit: http://www.dr-gonzalez.com/index.htm.
I hope this information is helpful!
Best,
Liz
I don’t know if this would be helpful to anyone, but in 2008 a former co-worker and friend came down with pancreatic cancer when we were working together. He was so ill he had to quit his job, but he kept in touch with me. I spoke with him after he had taken a couple of rounds of chemo and he sounded like he was at death’s door. He said he wasn’t going to take any more chemo and was looking for a holistic approach. About two months later he called me and he sounded fantastic. I asked him what was going on and he said he had been taking Graviola, enzymes, and was juicing organic vegetables. He said he was feeling so much better. He was able to eat two small meals a day and went back to walking 1/2 mile a day. A couple of months after that conversation, he called me again and told me he was in remission. He told me his doctors were mystified at his condition (and that was because he would not reveal what he was doing on the holistic thing because he knew they would make him stop). I saw him at Christmas two years ago and he was doing great. He was still in remission and he attributed that to staying on the Graviola, enzymes, and juicing. This man is over 70 years old, so I don’t think this is a fluke.
I can’t wait to read Dr. Gonzalez’s book…
The more I read about what is going on in USA when it comes to the FDA and NCI the more I really believe now that there is a conspiracy against Americans. It proves how the medical and pharmaceutical complex does not care about your health. They prefer costly and murderous and useless treatments. It is more lucrative for them to ruin you and kill you quicly. Pure Evil exists. And Dr. Gonzalez is not the only one. Dr. Burzynski was also persecuted and imposed a fraudulent clinical study.