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Comprehensive Cancer Care: Integrating Complementary & Alternative Therapies

The Dietary Treatment of Cancer (Part II)


Moderator: Susan Lord, MD

Presenters: Nicholas Gonzalez, MD; Lawrence Kushi, ScD

Commentator: Douglas Weed, MD, PhD

Session 404: June 14, 1998

 

 

Dr. Lord:    I'm very honored to be introducing our speakers. Our first speaker today is Nicholas Gonzalez. He received his MD from Cornell Medical College, and he did his post-graduate training in immunology at the University of Oklahoma. He has completed an extensive research study evaluating aggressive nutritional therapy in the treatment of advanced cancer. His present work involves treating cancer patients, often diagnosed with terminal cancer, with nutritional therapies, detoxification and enzyme therapies. He's doing some of the most exciting and controversial work in the field of cancer treatment today. He's going to tell about his work which is hopefully going to be published very soon.

Our second speaker is Lawrence Kushi. He received his doctorate in Nutrition at Harvard School of Public Health and has completed postdoctoral work in epidemiology at the University of Minnesota School of Public Health. He is now an associate professor there in the department of epidemiology. Dr. Kushi has published extensively, and his research has focused on the impact of diet and nutrition on the development and progression of cancer. He's uniquely suited to speak today on his topic, which is macrobiotics, as his father, Michio Kushi, did so much to bring this information and this philosophy to this country. He'll be speaking on both the history and the philosophy of macrobiotics and will discuss the data pertaining to cancer patients who have used this diet in their treatment.

After these two speakers have presented their material, we're going to ask Dr. Douglas Weed to comment on their work. He is Chief of the Preventive Oncology Branch of the Division of Cancer Prevention at NIH. He has a wide background in engineering, medicine, public health, and epidemiology. He received his MD from Ohio State University and an MPH and a PhD from the University of North Carolina. Dr. Weed holds academic positions at Johns Hopkins, The Uniformed Services University of Health Sciences, and at Georgetown, where he is a senior research fellow at the Kennedy Institute of Ethics. He is also a review editor of the Journal of the National Cancer Institute. His interests are in ethics and the philosophy of science. He's going to speak a little bit about how we begin to interpret data that has been presented.

The format for the morning is that we're going to take about 35 to 40 minutes for each of our speakers to present their material. Then Dr. Weed will comment for about ten minutes, and after that we're going to open the floor to questions. I ask that you line up at the microphone if you have a question. Please be brief with your questions, as we hope to be able to take as many questions as possible. Thank you. Dr. Gonzalez.

Dr. Gonzalez: Over the last 24 hours a number of people have come up to me and asked me to speak about this aspect of my work or that aspect of my work, because the actual treatment can be quite complicated. As I was thinking about it at 11:30 last night, I realized half an hour isn't a very long time. This is basically a scientific conference, where one of the main motivations is to try to bring alternative therapists and orthodox cancer researchers together to talk about new directions in cancer research for all of us, as well as ways to do clinical trials. I decided today I would stick to the research methodology that I've been involved with over the last 10 to 15 years.

Actually it takes me back to my second year of medical school in 1981. It was kind of interesting. I was just talking to Dr. Richard Rivlin, who is chief of nutrition at Memorial Sloan-Kettering. He was one of my mentors and teachers at Cornell and was very helpful to me in developing my own interest in nutrition. After the summer of second year medical school at Cornell, I was trying to decide what to do. I had gone to Cornell because I really was interested in doing cancer research. My goal in life was to be chief of medicine at Memorial. I'm not shy about admitting it. It was very orthodox. I went to Cornell because I also wanted to work under Robert Good.

Robert Good at the time was president of Memorial Sloan-Kettering, and he was a very eminent research scientist. He had published at that time over 1,300 papers and was said to have been the most published scientist in the history of the biomedical sciences. He was a controversial figure. Many of you may know in 1973 he was involved in kind of a scandal at Sloan-Kettering. One of the fellows faked data and this led to major news stories and all of that. Some people claim that that incident robbed him of the Nobel Prize, which many people think he deserved. Regardless of that, Dr. Good had one quality. Even when he was president of Sloan-Kettering, he was always open to talking to medical students. When I was a freshman medical student, I would go to his office and talk about my interest in cancer research. He was almost fatherly in his enthusiasm and taking time to talk with me and guide me.

After my second year of medical school I was thinking of some great research project I could get involved with, when a friend of mine who was a literary agent called me and said she'd had an interesting experience. She had met this very eccentric dentist by the name of Kelley, who might be brilliant, crazy, insanely brilliant or brilliantly insane. She wasn't sure which. She wanted me to meet him because she knew I had a couple of years of medical education, which in retrospect wasn't very much. She wanted me to get some idea as to whether this guy was for real and whether he warranted a book - I guess "Dr. Kelley's five-day-wonder cancer cure" type of thing.

I initially said no. Some of you have heard me talk before and tell this story. I said no several times, but she was very persistent and finally I agreed to meet with Kelley. We had a very bizarre luncheon at a chiropractor's office in Forest Hills. Believe me, in those days I really wanted to be chief of medicine at Memorial. My leanings, although I was interested in nutrition, were still very orthodox.

I met Kelley, and it was very interesting. We were talking. He was a very shy guy. He had had a very rough life. First he was a dentist. Dentists legally aren't supposed to be treating cancer. Secondly, he was using nutrition. In those days, particularly in the time when he came to fame during the 60's and 70's, it was anathema to mention nutrition and cancer in the same sentence. This has changed considerably, and gleefully it's a much different situation now.

Kelley looked like a very beaten man, and he was kind of mumbling. I couldn't quite understand why we had this luncheon. Finally I asked, "What is it, Dr. Kelley, you really want?" He looked me right in the eye. He said, "It's very simple. I may be doing something that helps cancer patients. I'm not a research scientist. I trained as a dentist. I've learned this along the way, but I really want my work tested. I really, really believe that any type of therapy, whether it's orthodox or unorthodox, needs to be tested properly."

"That's very interesting," I said. "Why did you meet with me?" He said, "Well, I heard that you knew Dr. Good, and the one research scientist in the world that I know really could do a good job on this would be Robert Good." It was very interesting that he knew about Good's work, had read many of his papers. We talked for an hour and a half. I thought that Kelley may indeed be crazy, but that he was also a very brilliant man. He seemed very determined to have his work tested.

With some courage I went up to Dr. Good's office. Ralph Moss, who knew Dr. Good and worked under him, said it was the 13th floor. I remember it as the 12th floor, but he had the president's office of Sloan-Kettering. It was a very beautiful office. He took time to talk with me. I told him the story, that I'd met this eccentric dentist who might have a nutritional therapy to treat cancer, who might be doing some good work and wanted to have his work properly evaluated.

I'll never forget what Good said, and I've told this story before. He said, "Well, it would be a great summer project. Even if Kelley turns out to be a total charlatan, you'll learn something. There's nothing wrong in science with getting involved with a project that doesn't produce success. You learn from your failures. This will teach you about cancer medicine. The way you learn about cancer medicine is to get involved with a project that's kind of offbeat, where you really have to do a lot of independent work. You should look into this guy. Spend the next couple of months looking into his work." The next day I told Kelley that I had formal approval to make this into a summer research study and the day after that I was on a plane to Dallas where Kelley had his office.

You'll hear many things about Kelley. Most of them are true, good and bad. He's a very eccentric crazy guy. He was very brilliant. Anything you hear about him is true. Acknowledging that, the only thing I cared about at that time was that he gave me total and complete access to all his records. He kept impeccable records. A lot of them were in his Dallas office, and some of them which I later reviewed were in his Washington State office. He had a home there and had seen patients there for a while. There were no secrets. He had records from every patient who had ever walked into his office, whether they were cured, whether they were not cured, whether they did the program, whether they didn't do the program. There was a wealth of information in these records.

I was a second year medical student. I was hardly a sophisticated or even unsophisticated scientist. I was really just a student. But I knew enough medicine that some of these initial cases that I was reviewing were really quite remarkable. I remember the first case was a patient with pancreatic adenocarcinoma who seemed to be alive five years after diagnosis. A case of acute myelocitic leukemia where the average survival can be measured in weeks, alive seven or eight years from diagnosis.

I spent several weeks gathering about 30 or 40 of these cases together. I put them in a suitcase, went back to New York, had a meeting with Dr. Good and reviewed these. Good was very cautious. He was particularly cautious because this was a controversial area, especially in 1981, to get involved with. Based on the records that I'd shown him, he said if this proved to be true it would make a very interesting research study. At that point he encouraged me to start doing a retrospective review of Kelley's work.

Third year medical school interfered with the project, but in the fourth year of medical school I had about four months when I had the opportunity to do an independent research study under Dr. Good. I finally had the opportunity to dive into Kelley's work. That's when we really developed our project. Dr. Good guided me, and he was a very good guide.

He said I should approach this study in two ways. First I should go through Kelley's records and put together a number of cases of appropriately diagnosed, biopsy-proven cancer, with obvious poor prognosis by anybody's standards, who are alive a significant amount of time beyond what would normally be considered the standard for that disease. We debated about the number of cases - he said to get about 50 cases such as that, and to try to find a number of cases from a variety of cancers. That would give us some interesting information.

Of course, when you do a retrospective study you can't use that to prove a therapy works. It's basically a fishing expedition. All we were looking for was to see whether there was any evidence of any kind to show that Kelley had some kind of effect in the treatment of cancer.

Good said if I put together 50 cases like that it would be interesting, but then the question is to enumerate a denominator question. Is this 50 cases out of 50, 50 out of 500, or 50 out of 50,000? He said, "If it's 50 out of 500, that's interesting. If it's 50 out of 50,000 patients, I'm not impressed." You know there's the joke in oncology, if you send 100 terminal cancer patients to cross the street, by the time they get to the other side 25 will be dead and two will be cured. Cancer can have an erratic course even in the advanced stages at times. So he said we needed to enumerate a denominator study.

He thought I should take a very bad cancer; we finally decided on pancreatic adenocarcinoma. Pancreatic adenocarcinoma is probably the most deadly cancer. It's not amenable to any therapy in the standard armamentarium, even today. The average survival for inoperable disease runs around four to five months. The two-year survival is in the range of 10% and the five year survival, depending on the study may be one or two percent. It's a very deadly disease that kills very quickly.

He said pancreatic cancer would be a good cancer to take. If you can find patients with long-term survival with this disease, regardless of the eccentricity of the therapy or the therapist, this would be very significant data. He told me I needed to take a specified time period and find every patient with pancreatic adenocarcinoma who entered Kelley's office. Find out whether they did the program, whether they didn't do the program, whether they did it partially, whether they did it completely, and find out how these patients did.

This would give us some idea in an informal, retrospective way of the success rate. It's not a formal randomized prospective trial where we're starting from day one with new patients. We knew that we were looking back at patients who had been treated in the past. We knew that this couldn't be used to prove Kelley treated cancer. But this kind of information would give us some guide as to whether there was anything in this vast collection of records that would warrant further study like a controlled trial.

Basically what we were doing was putting together a best case series. Today the NCI and the Office of Alternative Medicine use best case series as a first step in evaluating an alternative therapist. A lot of alternative therapists such as Kelley are operating out of the academic mainstream. They don't have access to funding. They can't do clinical trials in the standard way. But you can get information of some sort out of their records that can guide you as to whether this work warrants further investigation.

What I didn't expect was that the project would eventually take another three years, and I finished my fellowship under Dr. Good. One of the sad things about Dr. Good is that he was pushed out of Sloan-Kettering during my senior year of medical school. He went to the University of Oklahoma. About halfway through my internship he invited me to come to his house in Oklahoma for Christmas. I did, and then he asked me if I would be willing to join his research group there. Oklahoma was not the place I intended to spend the rest of my research career. No offense to Oklahoma, but I was born and raised in New York. I expected to spend the rest of my life at Sloan-Kettering. But I quickly agreed, because he gave me the opportunity and the funding to continue my Kelley study. I'll always be indebted to Dr. Good.

These days, I guess because of the controversial nature of my work, if you were to call Dr. Good he would say he doesn't remember me, or he sort of remembers me, or I was a student. I feel badly about that, but I owe him an enormous debt of gratitude because he allowed me to do this study. I had two full years as an immunology fellow. I had clinical requirements and responsibilities, but I also had an opportunity to really dive in and review Kelley's records.

I spent a considerable amount of time in his Dallas office, and I spent a four-month period at his home in the deep Cascade Mountains. That's a wonderful place to do epidemiological research. Kelley owned an organic farm in the Methow River valley, which is like Shangri-La, surrounded by the High Cascades. You could only get there through a two-way winding road that would go through 5,000 and 7,000 foot peaks where there'd be enormous cliffs. How patients got to his office I don't know, but even in the middle of the winter his calendar was full.

I spent years going through his records and eventually we put together our findings in a 500-page monograph. The first part of the monograph talked about his therapy. It was an aggressive nutritional therapy. Although many people have asked me to talk in detail about the therapy, I just don't have the time. Basically it involves diet and large doses of supplements. The unique aspect of Kelley's cancer therapy is he believes proteolytic pancreatic enzymes have an anticancer effect. The main anticancer element of his therapy were pancreatic enzymes. I discussed this in my brief presentation yesterday. I don't have time to go into that in depth today.

The third part, which is the most controversial, is the detoxification routine. I tell patients today, when I first met Dr. Kelley I could vaguely understand the diet. I could vaguely understand the use of supplements and enzymes. But when he started talking about detoxification, I thought he was lapsing into mysticism. I'm no different than anybody else. When I first heard about the infamous coffee enemas, I thought it was the single most bizarre thing I ever heard of.

At his insistence, when I was a second year medical student, when I had just met him, I started doing coffee enemas. I did the first one in his Dallas bathroom in his office. To my astonishment I felt better, and I've continued to do them since. But when I first heard about it I thought it was bizarre. Basically, without time to go into them in detail, these detoxification routines are just simple techniques to help the liver work more efficiently, to help the body process tumor waste products. So basically his therapy involved diet, supplements, pancreatic enzymes and detoxification.

The first third of my monograph discussed his therapy in some detail. The second part - I had 50 cases with appropriately diagnosed, biopsy-proven cancer. We got permission from the patients to actually reproduce their medical records, who are alive five and ten years after their diagnosis, well beyond what would normally be considered the average for the disease. I was thinking this morning about some of these patients who are still alive.

We had a series of six breast cancer patients, all with metastatic disease. Two of them had bone metastases and they both first came to Kelley, interestingly enough, in 1974. Both of them are still alive. One lives in Colorado. One lives in Florida. It was very interesting. They were both followed by local oncologists. The local oncologists every six months, as good oncologists will, would repeat the bone scans. You could see the tumors regressing on the subsequent bone scans, and I had all the copies of the doctors' notes. They would discuss in the records with some amazement that these patients were doing better on this silly nutritional therapy.

As the tumors gradually resolved, the doctors in total befuddlement would begin to doubt the diagnosis. It's interesting that two oncologists, one in Colorado, one in Florida, neither of whom knew each other, both came to the same conclusion. Because the patient got well, and because nutritional therapy couldn't possibly work, we have to question the diagnosis. Yet the diagnoses were very clear. These patients had metastatic disease.

All 50 patients were very fascinating. Another one had metastatic endometrial cancer. I still remember the excitement I felt when I first got that record 15 years ago. A patient with endometrial cancer, stage IV, with a huge tumor in her pelvis, came to Kelley. The initial medical note for admission to an emergency room that she presented to Kelley said terminal disease. She was on high-dose morphine. She had a readily palpable tumor in her pelvic area. It was about 1976, so 21 years later she's still alive.

We put together 50 cases such as this with full medical records. For a number of the cases we reviewed the slides ourselves. In addition to being president of Sloan-Kettering, Dr. Good was also a world-famous cancer pathologist and had been chief of pathology at the University of Minnesota before he came to Sloan-Kettering. We reviewed the slides in a number of patients just to ascertain that these patients had by a second group an acceptable diagnosis of cancer.

In addition to that we did our pancreatic study. We decided ultimately to take the years 1974 to 1982 as the years of investigation. Because Kelley kept impeccable records, I was able to track down every patient with a diagnosis of adenocarcinoma of the pancreas who appeared in his office in that time. We were able to find 22 patients. Interestingly enough it wasn't that large a population of patients. In those days pancreatic cancer was not as common as it is today. But we were able to get 22 patients with appropriate diagnosis from an outside medical center. These are patients that Kelley himself had not diagnosed.

Of that group 10 had come to Kelley, seen him once and not done the program. It's very important in this kind of retrospective study to try to track down what happened to every single patient in this enumerated denominator study. We tracked down what happened to every one of these patients. It turned out they all had died. None of them had done the program. I interviewed the family members. I interviewed the treating doctors and tried to get an assessment as to why these patients had come to Kelley and why hadn't they done the program. In every case, largely it was because of pressure from family members or physicians saying Kelley was a fraud or a quack trying to steal their money. "You're wasting your time. Take a cruise and just live out your life."

In this group of 10 patients who had come to Kelley but never did the program, the average survival was 60 days, which is about what you'd expect. All these patients, I should add, were inoperable cases of pancreatic cancer, so no one could claim they had been cured by surgery. All 22 patients had inoperable disease. This group of 10 patients presented an informal control group. This is not a controlled trial. This does not constitute a legitimate, academically acceptable control. But for an informal retrospective study, you could say it's an informal control. We got full records for 10 patients who came to Kelley once, did the program not at all, not for a single day, and had an average survival of 60 days.

We found a second group of seven patients who came to Kelley and did the program partially and incompletely for periods ranging from four weeks up to 13 months. Again I interviewed the family members, the doctors, got full records on these patients, death certificates. They all had died. These patients had quit the program not because they were too sick to do it, but largely because of family or physician pressure urging them not to do the program. In those days going to see an eccentric dentist in the high Cascades for cancer therapy was not an acceptable thing to do. These patients invariably gave up the program, and we estimated some considerable time before they actually died.

In this group of partial compliers, the average survival was 300 days. That is considerably in excess of what you'd normally expect for inoperable pancreatic cancer with a median and mean survival range in between four and five months, 150 days. We're talking about an average survival of 300 days.

The third group admittedly was a small group, only five patients with pancreatic adenocarcinoma who did the program completely and totally. The average survival at the time we stopped the study, which was 1986-87, was eight-and-a-half years. One of those patients subsequently died of Alzheimer's disease at age 82, after surviving pancreatic cancer for 12 years. When you have your pancreatic cancer patients dying of Alzheimer's, that's pretty much a success if they live that long. We got slides on these patients. There was some question about one patient who had metastases to the liver as to whether it was islet cell or not. Islet cell is one of those forms of pancreatic cancer that can be slow-growing even when untreated. We reviewed the slides and determined that all these patients had adenocarcinoma of the pancreas.

An eight-and-a-half year survival rate is rather unusual for pancreatic adenocarcinoma. These patients had inoperable disease. Several of them had metastases in the liver. One had liver metastases that were biopsy-proven at the Mayo Clinic in Rochester, Minnesota, and that woman is still alive. She lives in Wisconsin and runs a gas station with her husband, and she was diagnosed in 1982. I wrote the monograph, and I was very excited about it. Even though a retrospective study cannot be used to prove a therapy cures cancer, certainly the information was interesting enough. Certainly it warranted appropriate academically centered prospective clinical trials.

Dr. Good suggested that we had to try to publish it. A 500-page monograph doesn't lend itself to a journal article, but we thought we could select cases, or rewrite it, reduce it down to a journal form. I started sending out inquiry letters along with some information. What astonished me, and this goes back to 1986, 1987, is the universal vitriolic response that ensued. The usual response was that I wouldn't get a letter, but the editor who knew Dr. Good would write him a letter saying, "Dear Bob, have you lost your marbles? Don't you see that this guy has defrauded you, that these records can't be real, that you're involved with some kind of screaming quackery?" I had a pile of these letters.

I was devastated, because I thought if you do good science, whether the guy is using moon dust from Pluto, nutrition or chemotherapy, if the results are good, it warrants study. I was absolutely astonished. We sent it out over a two-year period to dozens of journals, dozens of medical and even lay publishers, and the universal response was it can't be true. There were some publishers who said, "If this is true it's wonderful, but it's far too controversial at this point in time." That's not an excuse or a justification for why we didn't get that published, but I did try for two years.

Kelley became very discouraged and actually went off the deep end. You'll hear in the nutritional underground, the alternative underground, that he's gone crazy. He thought I was part of a CIA plot to steal his work. He thought Dr. Good was part of a CIA plot. He sued me. He sued Dr. Good. It was a very messy situation. He retired. I understand he now lives with his 95-year-old mother in his boyhood home in Kansas. I hope he's happy.

There I was in 1987 with this data, Dr. Good dethroned from Sloan-Kettering, no funding and no opportunity to do clinical trials. Dr. Good didn't have the support base now that he might have had at Sloan-Kettering to handle something this controversial. In great dejection I returned to New York with about $200 in my pocket, trying to decide what to do with my life. I had never intended to become a clinician. I decided I had to salvage this therapy in some way, because I believed it was valuable. I believed we needed to do clinical trails with this.

I started seeing patients, which was the last thing on earth I ever thought I'd do. I started with the intention of collecting my own data to ultimately get controlled clinical trials run. I collected data and I guess I developed enough notoriety, infamy, fame, or whatever, that in 1993 the National Cancer Institute approached me as part of their effort to evaluate unconventional therapies. They suggested that I come to Washington and present what they called a best case series.

This was what we had basically already done with Kelley, and they wanted me to do a best case series of my own patients. It was July of 1993. They said I should come down and present a series of cases to the NCI. I did that. I saw Dr. Wynder just came in, who came with me then as moral support. It was very useful at that session. It was chaired by Dr. Friedman, who was then associate director of the NCI. There were about 20 people there. Wayne Jonas attended; he was at the Armed Forces at the time.

I presented a series of 25 cases from my own practice of appropriately diagnosed, biopsy-proven cancer with poor prognosis who were alive a significant time after diagnosis. I had my own series of patients. I had one patient with breast cancer with metastases to the liver who after two years had total regression of disease. Another patient with breast cancer with metastases in the lung was alive at that time three or four years after her first diagnosis. She had given six months to live, having been a chemotherapy and a radiation failure. I presented a case of pancreatic cancer. A whole series of patients with appropriately diagnosed, biopsy-proven cancer.

My hope at that time was that the next step would be randomized controlled clinical trials. Dr. Friedman suggested that's not what the NCI wanted at that point. He said I needed to do a pilot study. A pilot study is a small study without a control group, where again you follow patients from day one, as opposed to what we had done with the Kelley study where we were looking backwards. Follow patients from day one and see how they do. He said I should take the worst cancer, pancreatic cancer, and he asked me at that session if I would be willing to do that. I said I'd be willing to do it immediately.

We were able to get funding from the Nestle Foundation, and we started the study some months earlier. The NCI approved the protocol, reviewed the protocol and helped guide me in its development. Basically it was very simple. We were going to take patients with inoperable, biopsy-proven adenocarcinoma of the pancreas. We were going to use survival as the end point. We weren't particularly concerned about tumor regression, partial or complete responses. We were just interested in survival. Dr. Friedman suggested 10 patients. We began the study. Ultimately we had 11 patients. One patient dropped out of the study, but we continued to follow her and we included her in the data evaluation even though she did drop out. We have now finished that study.

We're attempting to get the study published. We had 11 patients. Of those 11, eight had stage IV disease. All of them were biopsy-proven. All of them had adenocarcinoma. I deliberately took very sick, very advanced patients, because I was beginning to learn. If I took early stage pancreatic cancer patients, maybe they would have lived anyway, or there were a subset of patients who would have done well. I deliberately took advanced cases. Eight out of the 11 had stage IV disease. Four of them had biopsies of the liver metastases confirming pancreatic cancer. Two of them had carcinomatosis, which is extensive disease in the abdomen and pelvis, all biopsy-proven. None of them had been treated with surgical intent to cure.

We ran into some problems with the study because I was not at the time involved with an academic center. We had to get patients strictly through word of mouth. Initially we were going to only enter patients who came to me within eight weeks. Very quickly we had to abandon that, which actually prejudiced the study against me. We were taking patients three or four months from diagnosis. Some of these patients were facing death. Despite that, despite that we took stage IVs, despite the fact that we didn't have a rapid accrual of patients, we were able to get the study done.

Nine out of 11 patients lived one year. To see what that means, in the recent GEMSAR studies gemcitibine is a new chemotherapy from Eli Lilly that's been approved for the treatment of pancreatic adenocarcinoma. They had 126 patients in their main study. Eighteen percent of them lived one year; none of them lived longer than 18 months. Out of 126 patients, not one lived longer than 18 months. In our little bitty study, out of 11 patients, five have lived two years, three have already lived three years, and we have a fourth coming up to three years now. It has been a success.

Yes, we had patients die. Yes, we had patients who were too sick to do the program. We didn't eliminate them from the data collection. We considered them treatment failures. Even if a patient came to me and we entered them into the trial and they couldn't do the program, or they did it for a while and then couldn't do it, we counted them as a treatment failure. We had several patients, one who lasted three-and-a-half years and died of a stent infection. She had tumors that blocked her biliary duct and had to have a stent put in to bypass that. It repeatedly got infected. Unfortunately she lived in Los Angeles, and her local doctors would not change the stent because they thought, "She has pancreatic cancer. She's going to die anyway." This was a woman who was out three-and-a-half years. She died of an infected stent because her local doctor wouldn't change it. So we had some mishaps like that.

Despite that, the data was good enough to interest a number of researchers in doing what would be the definitive study, a randomized, controlled clinical trial. In a randomized controlled clinical trial, you have a number of patients who either get a placebo or the known best therapy. The other group of patients would be given the new therapy, and then you compare the results. The Columbia oncology department has gotten interested in running the study. We've gotten full funding from Procter & Gamble.

I mention Procter & Gamble with some hesitation, because I know with Olestra they're under great criticism from the nutritional world. The division I work with is the Health Food Division. It has nothing to do with food products, and they have nothing to do with Olestra. It's a completely different bunch of people. They've gotten very interested in our work.

One things I've learned from this I offer as a message to alternative therapists. If you collect data, even if it takes you 15 years, and you collect good data, sooner or later people are going to pay attention to it. I didn't think it would take me 17 years, but we've been able to do that. We have full funding and research backing from Procter & Gamble. I don't say that boastfully. I say that very humbly. I'm so grateful that we have the opportunity finally, 17 years later, to do the controlled clinical trial I thought was needed in 1981.

Dr. Antman, who is chief of oncology at Columbia, is very anxious to do the study based on the pilot study results. Her approach is that this really has to be tested properly. The way you test something properly is to do a randomized, controlled clinical trial. At our first meeting, which was about a year ago, she said, "Are you willing to do a randomized, controlled clinical trial?" I said, "Yes. Bring it to me."

One of the things that I found a little sad last year at the POMES conference (which was a precursor to this conference, when the NIH, the NCI and the Office of Alternative Medicine got together with some alternative doctors to put on a several day conference), was that a number of the alternative physicians at that conference made it very clear that they didn't want to do research studies. They didn't want to do randomized trials. There were a number of reasons. They said, "It doesn't lend itself to that." "It's too difficult." "What if it doesn't work? I have my whole life invested."

There was a lot of criticism of Dr. Temple yesterday, because he said, "You've got to do clinical trials." I don't know Dr. Temple. I know my protocol currently sits on his desk, so far be it from me to criticize him. But I agree with what he said. I believe in clinical trials. The only way you can find out if what you're doing works, or what Kelley's doing works, or what any alternative therapist is doing works, is to do controlled clinical trials. There is nothing wrong, obscene, restrictive, oppressive or destructive about doing clinical trials.

This is the best we have. This is how you learn. This is how scientists learn. This is how I've learned. I've learned so much by doing these trials, beginning 17 years ago. We have a protocol together for this trial. We're going to have between 70 and 90 patients. The number of total patients will depend on the rate of accrual. All of them will have inoperable pancreatic cancer. All of them will be biopsy-proven. Columbia will take care of the diagnosis. I won't be involved with that. Half of them will get gemcitibine; half of them will get my therapy.

Friends in the alternative world say, "How can you be involved with something so unethical?" I say, "What do you mean, unethical?" "Well, half these patients are going to their death." First, in a clinical trial, no one is forced to get anything. If a patient gets assigned to my group and they think I'm a total jerk, they don't have to do it. They can quit the study and go get chemo. If a patient is assigned to a chemo arm, they don't have to do it.

There are patients in this world who would rather die than do a coffee enema. There are patients in this world that would rather die than do carrot juice. There are patients in this world who believe chemotherapy is the only appropriate response to cancer. And God bless them. Michael Evers was talking about freedom of choice. People should have the freedom of choice to do chemo even if we think it doesn't do anything. Patients assigned to that group have to want to do it. If they don't want to do it, they will quit. This is a good situation in the sense that this will give us data so that ultimately, hopefully we can help more patients.

My goal has always been if this therapy works, if it proves valuable, to have it accepted in the academic mainstream. This is not for any egotistical reason, because ultimately it isn't my therapy. It really came from Kelley. But I want it available to any physician who wants to administer it and any patient who wants it. If there are physicians who think coffee enemas are the most insane thing on earth, and if there are patients that think organic carrot juice is the craziest thing on earth, God bless them. Let them do chemotherapy. That's part of freedom of choice.

But if there are patients who want this therapy, if there is documentation as we are collecting now to show that it really is valuable, then it's incumbent upon me to do these trials so that we can get it accepted. Then the greatest number of patients and the greatest number of physicians who want to use or get this therapy can have it available. Having said that, the one last comment I would make is I am a strong believer, as orthodox as orthodox comes, in clinical trials. In the alternative world we have to start thinking more along those lines.

Dr. Kushi: Thanks for that interesting talk. Hopefully this will be complementary in many ways. Being an academic epidemiology researcher, I'm tied to using visuals, unlike Dr. Gonzalez. As Susan Lord mentioned, I'm the son of Michio and Aveline Kushi, who are the people who are probably most responsible for spreading macrobiotics as a social movement, and also for popularizing macrobiotics as a cancer therapy. This is from the local Brookline, Massachusetts, newspaper, where they live, where they're celebrated as New Age giants who make their home there.

This wasn't always the case. I have an excerpt from a 1966 FDA press release proclaiming that the FDA had seized food stuffs that are used in the macrobiotic diet from the George Ohsawa Macrobiotic Foundation in New York City. They were proclaiming that these foods had been used in a dietary context that has been promoted to potentially help treat various diseases. So things have changed dramatically over the years.

Macrobiotics isn't primarily a cancer therapy, although that's what I'll be talking about primarily later on. To give you some flavor, in the mid to late 60's a lot of people came to the macrobiotic movement who were interested in alternative lifestyles generally. This is a short essay on macrobiotics from John Lennon, who was a hero for a lot of us: "So I read this book, You are All Sanpaku," which some of you may have heard of. "So I was vegetarian, so I was slow. So I went to Greg's," a macrobiotic restaurant in London. Then he did ten days brown rice. "So I was fast," they were fast. "So I read this, Harmony," a magazine that was out for a while in London. "So we all need harmony," and we all need to go to Greg's macrobiotic restaurant.

What is macrobiotics? Historically, the term originates from Hippocrates. There's one phrase, "Ho bios brachys, he techre makre." Life is short, but the art is long. Macro for long, large, big and bios for life. Putting the two together we get macrobiotics, the art of prolonging life, perhaps. I like to think of it as a large perspective on what life can be.

In 1797 a German physician, Christoph Hufeland published a book on preventive medicine which he called Macrobiotik. That was one of the first times it was used in that way that I'm aware of. Joseph Needham, a British sinologist, referred to the origins of scientific thought in China as macrobiotics. But macrobiotics as we tend to think of it these days (a modern social movement and a diet with applications in cancer therapy) was introduced to the U.S. by George Osawa and my father, who was a student of his, and some of his colleagues. One, Herman Aihara, popularized macrobiotics on the West coast. A couple of the seminal books were a book called Zen Macrobiotics, and another one, as mentioned by John Lennon, called You Are All Sanpaku.

Most people tend to think of macrobiotics strictly as a dietary application. That's only one aspect of macrobiotics. It's much more a philosophical basis for looking at life. If you read any standard introductory nutrition or dietetics textbook, you'll often see a section on fad diets. The macrobiotic diet is put forth as probably the worst example of that. If you ask most dietitians, they will have the conception that macrobiotics has something to do with these different levels of diets. They think one wants to achieve diet number seven according to macrobiotic ideas, which consists 100% of whole cereal grains. That's not what macrobiotics is about. This was written about in the Zen Macrobiotics book, but it has nothing to do with the way macrobiotics was ever practiced or is currently practiced. I speak about that as someone who was raised by people who have been at the forefront of this.

That sort of thing led to the statement on zen macrobiotic diets, for example, from the AMA, published in the Journal of the American Medical Association. It is the basis for a lot of the dietetics and nutrition textbooks that talk about macrobiotics these days. "Cases of scurvy, anemia, hypoproteinemia, hypocalcemia, emaciation due to starvation and other forms of malnutrition, in addition to loss of kidney function due to restrictive fluid intake have been reported, some of which have resulted in death. When a diet has been shown irreversible damage to health and ultimately led to death it should be roundly condemned." They didn't actually cite these cases, but that's aside from the point.

What is a macrobiotic diet as generally taught these days? I pulled this off the Internet from the Kushi Institute; their web site is at www.macrobiotics.org. The standard macrobiotic diet is primarily whole cereal grains of various kinds, vegetables, beans and sea vegetables, soups of various kinds (you'll probably hear about miso soup if you start looking a macrobiotic cookbooks for example), fish and seafood, seasonal fruits, nuts, seeds and other things. No particular food is actually proscribed from macrobiotics. It is predominately vegetarian, natural foods as generally applied. But nothing is explicitly excluded per se, except maybe things like Olestra and aspartame, and other things that really aren't food.

There are some general principles on which macrobiotics are based. It's based on traditional eating patterns, as they developed over the millennia. Natural, minimally processed foods. As I mentioned, macrobiotics is not just a cancer therapy. Many of the natural food companies that help support our ability to choose good quality foods were started by people who were schooled in macrobiotics.

My parents started a company called Erewhon, which was the first natural foods wholesaler and retailer. It opened up in 1966 as a little store on Newbury Street in Boston and became the major natural foods wholesaler in the U.S. through the 70's, until they went bankrupt in the early 80's. Other companies like Eden Food (they sell the most popular soy milk, Eden Soy) were started by people who studied macrobiotics. Rice Dream, which is the most popular non-dairy beverage, was also started by people in the macrobiotic community. They were in Missouri originally, but now they're based in Palo Alto.

Food selection is based on your environment and personal needs, and going along with that is an appreciation of seasonal and climatic influences on what food choices should be. From a more philosophical perspective, it's thinking about yin and yang and energetic theories, and how that applies to food choices and lifestyle choices generally.

Here's a little bit of the more technical or scientific side of things, perhaps. This is from a study that I published about a decade ago, looking at nutrient intake profiles of people consuming macrobiotic diets. As you can see, the percent of calories from carbohydrates is about 65%. Calories from fat are about 20-23%. More polyunsaturated fatty acids than saturated fatty acids. Relatively low dietary cholesterol. The fact that there's dietary cholesterol reported means that these people were eating some animal food.

This is a comparison of that pattern with the standard American diet, which comes from the Minnesota Heart Survey that some of my colleagues are conducting. That's from early 90's data. You can see that there's considerable difference between the two. The dietary patterns that macrobiotics is an example of go along with, for example, the American Cancer Society guidelines for nutrition and cancer prevention, which are these:

Choose most of the foods you eat from plant sources. Limit your intake of high fat foods, particularly from animal sources. Those are two major components that talk directly about diets, per se. Be physically active. That's a general recommendation that comes out of macrobiotic lifestyle recommendations as well. Limit consumption of alcohol.

People eating macrobiotically have been the subject of research over the years. For example, a relatively early study published in '75 by Frank Sacks who is at the Harvard Medical School, School of Public Health, compared cholesterol levels of people eating macrobiotically, those are the vegetarian folks, with age and sex matched controls. Those people were taken from the Framingham Heart Study, which you may have heard of. You can see there are dramatic differences, overall much more preferable cardiovascular risk profiles. There have been a number of similar studies. The serum cholesterol levels (in the middle of this table) from all these surveys average between the mid 120's to 150 milligrams per deciliter. Blood pressure is also relatively low. Even when controlled for weight differences, these differences remain.

That has led to a change in perception of what macrobiotics generally is. Here's a quote, not from a peer-reviewed journal like JAMA, like the original AMA statement, but from the AMA's Family Medical Guide, where they had a section on special diets. "In the macrobiotic diet, foods fall into two main groups known as yin and yang, based on an Eastern principle of opposites, depending on where they have grown, their texture, color and composition. The general principle behind this diet is that foods biologically furthest away from us are better for us. Cereals therefore form the basis of the diet and fish is preferred to meat. Although fresh foods free of additives are preferred, no food is actually prohibited, in the belief that a craving for any food may reflect a genuine bodily need. In general, the macrobiotic diet is a healthful way of eating." This is a dramatic difference in perception.

This is the Commonwealth of Massachusetts, by His Excellency Michael S. Dukakis, a proclamation declaring August 1986 as Holistic Health and Nutrition Awareness Month. One of the things included in the second whereas is, "Whereas the Commonwealth of Massachusetts is a center for preventive health care with holistic health organizations . . . and macrobiotic centers being instrumental in alerting the public to the importance of good nutrition."

It is mainstreamed, well accepted, and also the subject of popular criticism or critique. Here's an excerpt from a Doonesbury comic strip. "Dum de dum de doo. What's for dinner, Zonker?" "Macrochaotic salad, fresh from the garden. Mmmm good, folks." "Zonker, the lettuce is dirty." "Maybe, but it's clean dirt! Ecologically pure dirt! No chemical additives! You'll love it." "Fini! Mere de la Terre Salad." "McDonald's?" "Fine with me." Macrobiotics being in the popular literature points to its broad awareness.

So, how did macrobiotics and cancer therapy come about from a general aim towards a more New Age or natural lifestyle? A book called Healing Miracles from Macrobiotics was published in 1977 or 1978. It was written by and described one person's story. He's a 56-year-old professor at Ball State University in Indiana, diagnosed with pancreatic cancer with metastases in August 21, 1973. He had an incomplete course, five days, of chemotherapy.

Someone told him about macrobiotics. He had an initial macrobiotic consultation September 23, about a month after his initial diagnosis. He did fine. In September 1980, many years later, he was hospitalized for fever and abdominal pain in Boston at Beth Israel Hospital. He was found to be hemorrhaging from a duodenal ulcer, which was thought perhaps to be related to the initial surgery that resulted in the initial diagnosis. He subsequently died during his hospital stay.

During the interim time period. people were questioning whether he actually had pancreatic cancer in the first place. An autopsy at the time of his death did confirm the fact that there was microfoci of adenocarcinoma of the pancreas. According to the surgeon who was treating him and was involved in the autopsy, his death had nothing to do with the cancer per se. He wrote the book before he died, obviously.

The book that was most responsible for spreading the idea that macrobiotics could be helpful as a cancer therapy was one called Recalled By Life. This is about an anesthesiologist at a Philadelphia hospital, who was 46 years old at diagnosis. He was diagnosed in May 1978 with stage D2 prostatic carcinoma with multiple bone metastases. He had a bilateral orchiectomy and standard estrogen therapy.

A couple of months after he was diagnosed he also adopted a macrobiotic diet. About a year after that he had follow-up bone scans which revealed that the bone metastases had completely resolved. He had another follow-up bone scan, also negative. Approximately at that time he wrote this book, Recalled By Life, which is widely available.

Subsequently he widened his diet to include foods that weren't originally recommended for this cancer therapy oriented context, including chicken (which, for example, I've never eaten, that I'm aware of). A couple of years later he had recurrence of the bone mets. He ultimately died after unsuccessful conventional therapy, including flutamide and some other things. I saw him just a few months before he died. He made an interesting comment. He said he discovered that macrobiotics works twice, first when he used macrobiotics and his cancer went away, and the second time when he drifted away from his macrobiotic recommendations and the cancer came back.

In terms of studies about macrobiotics and cancer that are in the peer-reviewed literature, as with any of these alternative therapies, there is very little. This is a study conducted by Barry Goldin, who is at the New England Medical Center at Tufts University. The study compares estrogen levels of women who are eating macrobiotic diets (these are not women who had cancer necessarily) to a group who were nonvegetarians. As you can see, the fecal excretion of estrogens was considerably higher among the vegetarians, overall more than a two-fold increase in estrogen excretion levels.

If you look at urinary excretion levels of estrogens, you see, particularly for estriol, a substantial difference, a decrease in estrogen excretion levels. The vegetarians appear to have somewhat lower urinary excretion. This translated ultimately to not significant differences in any of these things, but an overall somewhat lower plasma level of these different estrogens. The way these authors interpreted this was that perhaps lifelong exposure to somewhat lower plasma levels of estrogens would result in lower breast cancer risk. Obviously these women weren't followed long term. They didn't have cancer, but in terms of association with risk for breast cancer there was some suggestion.

Another thing that's been of interest is the role phytoestrogens possibly play in hormone-related cancers like breast cancer. This slide shows a comparison of urinary excretion of different phytoestrogen metabolites, including, for example, daidzein, which is found in soy, along with genistein. Genistein isn't explicitly analyzed here, but equol, one of its metabolites, is. Enterodiol and enterolactone are mammalian metabolites that are formed in the body if you consume lignans, which are found predominantly in whole grains and seeds. These lignans also have phytoestrogen properties.

Even though soy has gotten all the press, there are a lot of other phytoestrogens out there. These are formed if you eat a lot of whole grains. The women who are macrobiotic had the highest levels of excretion of these phytoestrogens, suggesting the highest level of exposure. The macrobiotic women are the third bar from your left. The chimpanzees had very high levels as well. Japanese are higher than the omnivores. but not quite so high as the lactovegetarians. You can see the breast cancer patients at the far end, from urine samples from Helsinki, at relatively speaking the lowest levels. This is from 1987 or 1986, Journal of Steroid Biochemistry. Herman Adlercreutz is the first author.

Here's another paper from Adlercreutz which basically shows the same thing. The young vegetarians are the macrobiotic women, although it doesn't explicitly say macrobiotics in this particular figure.

In terms of studies that have actually looked at macrobiotics and cancer outcomes, only one paper in the peer-reviewed literature looks at this. That's this one. It's the work of Gordon Saxe, who did this as part of his master's project when he was an MPH student in epidemiology at Tulane University. James Carter, the first author, was his advisor.

They talked about both pancreatic and prostate cancer. I'll show a couple of the pancreatic cancer related things from this study. They attempted to do something similar to what Dr. Gonzalez was describing regarding the Kelley regimen, but not just focusing on one practitioner. They identified 101 patients retrospectively with primary adenocarcinoma of the pancreas who had seen a macrobiotic counselor. They attempted to locate as many of these as they could. They found 28 of them.

According to criteria that they developed, 23 of those were deemed to have followed a macrobiotic diet for at least three months. They did a comparison survival with SEER data. This is one-year survival. Of those 23, 12 were alive after one year. In the SEER comparison, 142 out of 1,400 would be alive, approximately 10%. Shown graphically in survival curves, the macrobiotic group, the 23 patients, are the solid line. The SEER controls show what you would generally expect.

There are a number of methodologic issues which I complained with them about. For example, many of the people who entered their trial followed macrobiotics for at least three months. For many of them there was some time period between diagnosis and when they actually showed up in a macrobiotic counselor's office. The appropriate comparison with SEER, taking that type of information into account, would have been taking people starting at three months, or perhaps even a little later. The relative survival benefit is being exaggerated here. In any case, even if you assume that all the people they couldn't contact had died quickly, you still would see a survival proportion that would be no worse than what the SEER data would demonstrate.

We got funded by the NIH Office of Alternative Medicine to try to do a best case series. We never completed it, because those minigrants of $30,000 don't go very far. When people are paid to do other things it's hard to find appropriate study collaborators.

The macrobiotic diet is among the most common alternative therapies in terms of dietary therapies for cancer. There have been dramatic case reports, as I mentioned. But we don't really know to what extent macrobiotics and what potential harm might exist, to be balanced.

This gives you an idea of how many people come to seek advice for cancer through the Kushi Institute who we're collaborating with. Over about a 14-month period, there were about 115 different people who came through the Kushi Institute. This doesn't include records that my father may have seen outside of Massachusetts. A lot of them are breast cancer, prostate cancer, obviously reflecting common cancers. We wanted to establish procedures in which data could be collected prospectively from Kushi Institute-affiliated counselors. That's gradually been put into place, now that people at the Kushi Institute realize the value of that. But that didn't happen under the auspices of this grant.

We also wanted to document a best case series, which has been talked about. Here are the criteria for that as put forth by the Division of Cancer Treatment. People have to have cancer. There has to be documentation of that. There has to be some appropriate antitumor end point that's decided upon. At the time that the alternative therapy (in this case macrobiotics) is received, no other treatments should be received concurrently. It doesn't mean that there couldn't have been other treatments beforehand, chemotherapy or whatever, but concurrently it's not supposed to occur.

Documentation of previous cancer treatments, and the state of condition before the alternative therapy starts. Documentation of where the cancer occurred, description of the patient's general medical condition, and description of the unconventional treatment under consideration. We mailed to various macrobiotic centers and educators, to the Kushi Institute. We tried to get them on board. We mailed to people who are on the Kushi Institute mailing list. We put a few ads in some macrobiotic community newsletters to try to recruit folks who could potentially be considered as a best case.

We ultimately got 233 names. We sent those a one-page screening questionnaire corresponding to the best case series criteria. We received 126 responses. 37 of those right off the bat were found to be ineligible. They used a conventional therapy concurrently with macrobiotics, or they didn't have cancer, or they didn't have clinical follow-up after they started macrobiotics, or whatever. 89 individuals were then sent a detailed questionnaire about where they were diagnosed, how they practiced macrobiotics, and a number of other things. 74 of those folks responded. This is what the population of those who responded looked like, in terms of the types of cases of cancer they had. Obviously there are other folks out there. Most of these people have not written up their individual stories. Some of them ended up not being cancer.

Some things from our questionnaire correspond with some of the things you've heard about Barrie Cassileth's work. High income, high educational level, for example, in people who seek this out, like any alternative therapy. These are some marker items that show the extent to which people might have complied with macrobiotics. For example, rarely in the case of cancer therapy are people told to eat poultry. They're often told to eat brown rice. You can see that generally people didn't eat poultry much. They ate brown rice. Different food preparation methods- people rarely ate deep fried foods (the green bars). Raw vegetables or fruits aren't necessarily proscribed or not. As you can see there were varying intakes on that. Pressure cooked grain is often recommended as a way of cooking grains. That was adopted by many people, and that's not a common way of consuming foods in the U.S.

There are other things that may generally be recommended. We wanted to collect information on that. Examples are external applications such as body scrubs, foot baths, hip baths, ginger compress, taro plaster. I can describe what those are later if anyone is interested in knowing that. People did various other things like body work, acupuncture, moxibustion, shiatsu, do-in, other massage. Spiritual or psychological practices, prayer, meditation, chanting, and visualization explicitly for their cancer therapy were also widely practiced. Use of various supplements, vegetable juices, 43%, vitamin supplements, blue green algae specifically was mentioned by many people, homeopathy and herbal remedies as well.

We've got these cases that we've collected. We want to have these medical records reviewed by oncologists who don't have a vested interest in seeing that these look good. At least a preliminary review by some of us on the study and others indicates that there may be some cases that might look like potential best cases. There are also clearly some that don't look remarkable, even to me. Ultimately whether there's a best case series awaits completion.

I'll give you a couple of ideas of the cases that are in the series, focusing on a couple of different sites. A female born in 1954 was diagnosed in September '89 with an astrocytoma stage 1.52, with loss of vision, no medical treatment. Not quite a year later she began macrobiotics. At the end of that year the tumor was no longer detectable by MRI, and vision was normal. The neurosurgeon called this a remarkable event. At the time that we were collecting the data she was still alive, with normal activity, full time employment.

Another astrocytoma case was a woman born in 1948, diagnosed in 1985 with an astrocytoma grade III. She had some surgery and radiation therapy and chemotherapy, but at the end of that the tumor was still present. Right after that she began macrobiotics. Ultimately she did have a follow-up MRI, partly spurred by the fact that she heard the study was going on. The tumor was no longer detectable, and she was living life with normal activity last time we were in contact.

This is a male born in 1941 diagnosed with a fist-sized astrocytoma grade IV . He did have surgery and radiation therapy and chemotherapy, but the tumor was still present at the end of that by CAT scan. He began macrobiotics just four months after initial diagnosis. He didn't have any clinical follow-up, but many years later he has normal activity, is functioning well.

We had another female with astrocytoma, nonresectable, grade IV. She did have radiation therapy and chemotherapy. Just a short while after diagnosis she began macrobiotics. She also didn't have clinical follow-up but also has normal activity.

Here's another case of astrocytoma in this series, grade III. Surgery removed half the tumor. She began radiation therapy. After that there was no evidence of an effect on the tumor. She began macrobiotics a few months later. In June 1987, after about a year, the tumor was the size of a golf ball, but she hadn't had a follow-up scan. At the time that we were last in contact with her she had scheduled one, but we don't actually know if she had that. I'll skip the rest of these - a couple of malignant melanoma cases, pancreatic cancer cases, just as examples.

I went to Amherst College, where Robert Frost was on the faculty. He was before my time, but I spent many hours studying in the Robert Frost Library. I thought I'd end with a poem of his.

Why wait for science?

Sarcastic science, she would like to know

in her complacent ministry of fear

How we propose to get away from here,

When she has made things so we have to go or be wiped out.

(This is people with cancer.)

Will she be asked to show us how

by rocket we may hope to steer to some star off there,

say a half light year through temperature of absolute zero?

Why wait for science to supply the how,

When any amateur can tell it now.

The way to go away should be the same

As 50 million years ago we came,

(Basically, let's look at our traditions and what we can learn from what humankind has experienced.)

If anyone remembers how that was.

I have a theory but it hardly does.

Thanks.

Dr. Weed: I see a lot of familiar faces in the crowd from yesterday when we had another session about nutritional interventions. I see a few friendly faces as well. It really is an honor to be here at what I take to be a historic event.

Speaking of history, I was driving down here today and listened to NPR. Does anybody here not like music? I didn't think so. There's a show there, a musicology show, that Karl Haas does. I was an engineering major, so I didn't do a lot of music history, but I'm fascinated by music. Anyway, Karl Haas was talking about two composers. He was comparing Telemann to Carl Maria von Weber. He was saying that Telemann, who is a composer from several centuries ago, was extraordinarily constrained in the instrumentation that he had to do his music. On the other hand, Carl Maria von Weber had access to "the full range of tonalities," by which he meant the full range of instrumentation.

I thought. "Yes, that's real interesting. Telemann very constrained and Weber not constrained." Then I thought, "Well no, that's not quite true. Weber didn't have the electric guitar as one of his tonalities, as one of his instruments available to make his music." There are two themes that come out of this very interesting musicology history story. One is that at any given time a composer has access to a certain set of tools, and it also is true that music changes over time. There's a dynamism, there's a discovery of new tools.

Interestingly enough, exactly the same or analogous sort of situation is happening to us in science, and this conference is a good example of it. If you come to this conference and you say, "I have a claim about what is good for cancer patients," you have available to you at this time a certain set of tools. They are not musical instruments, but rather research methodologies, and measurement tools that you have access to that you can use. It's also true that as science progresses through time those measurement tools will change. We have a lot of inventing and discovery that remains to be made in science. So those are the two messages that come from that.

It's interesting that if you look over the last couple of days, at least on nutritional interventions with regard to cancer, yesterday we had Dr. Atkins here and the Gerson Clinic represented, and today we have Larry and Nick. What you can see here is a full range of the use of the contemporary methodologies of science. It ranges from claims about efficacy that have essentially no apparent measurement but rather the warrant for the claim is simply expert opinion, to in the Gerson Clinic the beginnings of collecting information, which is the absolute first step one must take if you're going to evaluate this. You've got to collect the information.

Then you see the collection of that information and the beginning of comparing that information to a control, standard, whatever you want to call it, use the SEER data. Larry had some excellent examples, but others have as well. There are a variety of databases, and as Larry pointed out, a variety of potential issues about that. Nevertheless, the key point here is that things are being measured, and comparisons are being made. There's evidence being generated to either support or not support the claims that are being made about efficacy.

Finally, and this is very important in a historic sense, if you want to call it historic, but absolutely essential, we're now moving into the realm of the randomized clinical trial. Dr. Gonzalez is talking to us about the fact that now there's going to be a randomized clinical trial of an alternative therapy. So you see across the board in nutrition complementary medicine as it has become integrated with contemporary traditional oncology - the use of a variety of techniques, a dynamic flow into the randomized clinical trial. If this conference is about integration of the two great, what were very disparate communities, I would argue, and there's evidence in these two days, that that integration is taking place.

Dr. Lord: I'd like to open up the floor to questions. If you have a question, would you please form a line at the mike.

Participant: A few questions for Dr. Gonzalez. Hello, Nick, you know I've been interested in your work for many years. I have a few questions, including a historical one. The first question is the enzymes. What exact enzymes are you using in your protocol?

Dr. Gonzalez: That's about the 30th time I've been asked that in the last two days. We use proteolytic pancreatic enzymes in our cancer therapy. The first studies go back to the turn of the century. This is not something I developed, or Kelley developed. There's a long history of the use of enzymes to treat cancer. One of the problems is, because it never got mainstream, when you go into the health food store to buy pancreatic enzymes, the quality will vary. If you're using it to treat cancer based on something you heard at a conference or from a friend who knew a friend who knew a health food store owner, you're really placing your life at risk. One of Kelley's ongoing problems was that he had great trouble finding enzymes he thought were efficacious in terms of what he wanted them to do with cancer.

Most pancreatic enzymes available both as prescription and in the health food stores are used primarily as digestive enzymes. When you're dealing with cancer you want another set of enzyme proportions, etc. Because of Kelley's total alienation from the mainstream medical world, he had great trouble getting enzymes. We've had to develop our own enzymes. They're made in New Zealand. We are deliberately not putting them into the health food stores. I get asked every day. "Gee, you could make a trillion dollars if you marketed your enzymes." Dr. Gonzalez' five day wonder health food enzyme, etc.

We're interested in doing science. First we want to prove it works. Then we'll make it available in a wide way. We're doing things backwards. We actually think we should prove it works before we start writing popular books, going on radio shows, or having the enzymes in every health food store in America. I don't mean that sarcastically. We really mean that. So they're not currently available. It's not because we're cruel or secretive, it's just that we feel we have to do it in a process. They're not available except to our patients.

Participant: Maybe you could address yourself to the question. What exact enzymes are you using? Pancreatic enzymes means lots of different things. What are the actual enzymes?

Dr. Gonzalez: I'm sorry. We use a whole range. There are at least 40 enzymes that have been identified, probably many others that haven't been identified - proteases, the amylases, lipases. We use the whole spectrum.

Participant: So you're using a mixture extracted from the pancreas of what animal?

Dr. Gonzalez: We use porcine.

Participant: Porcine pancreatic enzyme extract?

Dr. Gonzalez: Yes. I misunderstood your question earlier. I'm sorry. We use a porcine enzyme.

Participant: And it's characterized according to the actual individual enzyme, so you can tell us at the end how much chymotrypsin, how much trypsin, and so forth?

Dr. Gonzalez: It's characterized according to the amount of enzymes and the amount of activity. Enzymes are produced in the pancreas in an inactive form, and then they're activated in normal physiology in the small intestine. We have a way which we've developed of activating them without losing any of the valuable products. One of the problems with a lot of activation processes currently in commercial use is that you lose a lot of activity from associated cofactors. We've spent ten years developing a way of doing that, activating pancreatic enzymes without losing any activity associated factors.

Participant: Is it possible to find in the literature the actual ingredients of the enzymes that will be in your protocol?

Dr. Gonzalez: I'm sorry. I couldn't hear the last part.

Participant: Is it possible to find in the literature, or literature from somewhere, exactly what the enzymes are and what the activity of each one is?

Dr. Gonzalez: Of the enzymes we use or enzymes in general?

Participant: Enzymes that you will be using in the protocol with Karen Antman at Columbia.

Dr. Gonzalez: It hasn't been published yet. To be honest with you, we've just spent about a million dollars trying to characterize the pancreatic enzymes we're using. It was a very expensive proposition to get all this evaluated and get it standardized in preparation for the clinical trial.

Participant: I'll give up trying to get the specifics, but let me ask a historical question. Did you in your time with Kelley have any notion as to whether or not Kelley was involved with Max Wolf?

Dr. Gonzalez: Kelley was aware of Max Wolf but I don't think he knew him. Wolf wrote a book. I think his first books go back to 1957, and then he had in 1971 - Kelley was very much aware of Wobe Mugos and the German enzymes. So the answer is yes.

Participant: There was an example where you actually can measure them and you know exactly what you're using?

Dr. Gonzalez: That's correct. That's right.

Participant: Hello, my name is Marie Galbraith. I'm an independent researcher since 1971, was on the panel for diet and nutrition when the Office of Alternative Medicine got started, etc. I'm very familiar with the Gerson treatment, having known them since the 1970's. I'm not so familiar with yours, although much of it seems very similar. What are the exact, precise differences?

Dr. Gonzalez: Between what we do and Gerson?

Participant: Yes, because Dr. Gerson as you know started many years ago with the whole idea of diet and nutrition and the vitamins and the detoxification, the coffee enema, so many of the things which you do. I just wondered what the basic difference is, if there is one.

Dr. Gonzalez: There are very significant differences. The Gerson people basically have one diet, which is basically a vegetarian, raw foods type diet. We use ten basic diets that range from pure vegetarian to red meat three or four times a day. Horror of horrors, we have patients that we actually put on red meat. We call them our carnivores, our Eskimo patients, who genetically and metabolically need red meat to do well. We have about 90 variations of diet. They range from pure raw foods vegetarian to pure cooked food vegetarian.

Raw foods are ideal, but we have patients who are so metabolically defective they can't digest raw food. They can't even use carrot juice, so we have them use cooked food. Cooking food destroys nutrients but it does predigest food. We have patients who if we kept them on raw food would die. So we have even cooked versus raw food diets. We have diets where there are no leafy green vegetables, diets where 50% of their food is going to be leafy green vegetables. There's great variability in the dietary prescriptions.

Secondly, we use large doses of pancreatic enzymes. Patients will take 30, 40, 50 grams a day of these enzymes. The Gerson therapy uses small doses with meals.

Participant: The last quick question is once one commences on your regime, and say after four years it seems to be fine in all respects, does one have to continue the rest of one's life doing the full treatment?

Dr. Gonzalez: We say patients should only continue the therapy as long as they want to stay well.

Participant: In other words, your answer would be yes. Thank you.

Dr. Gonzalez: I follow it myself. I never had cancer. I don't do all the things a cancer patient would do.

Participant: But the maintenance.

Dr. Gonzalez: Yes, we do reduce it, to answer your question. We do reduce it as they're out longer, but only cautiously. I have patients who have been with me ten years and I'm afraid to reduce it because they had such bad cancer. My average patient will take 150 capsules a day, spread through the day. It is not a fun program. It's not an easy program, all of those things.

Participant: My question is for Dr. Gonzalez. Is your dietary approach to cancer treatment done to the exclusion of conventional therapy or can it be integrated?

Dr. Gonzalez: I don't generally recommend integration simply because first, when you're getting chemotherapy the white counts can go down. Oncologists absolutely for legitimate reasons get terrified of a patient doing coffee enemas, because they think it could stimulate infection. There are certain chemotherapy agents like methotrexate that require blocking nutrient pathways, with folic acid for example, and on my diet patients will be getting huge amounts of folic acid. Our feeling is if a patient is getting chemo they should continue doing chemo.

Also our program is very rigorous. If patients are going through chemo and suffering through the nausea and the anorexia of chemo, they can't possibly do my therapy, because we're so aggressive. It's not just a few vitamins you take to feel better. We're a very aggressive treatment regimen. If patients are getting another very aggressive treatment regimen we suggest they do that first, and if it doesn't work, see us. We don't generally encourage combining therapies.

Participant: Thank you.

Participant: Most of my questions have already been answered. I wanted to find out about the differences with the Gerson therapy. I'm an MD, and I wanted to get a few specific answers. Perhaps I can modify my question a bit to Dr. Gonzalez first of all. Have you written up your therapy so that it will be available for those who are interested, whether patients or those who would practice it? Can you give us some specifics, name of the book and so on? I'll ask Dr. Kushi as well, what book would you recommend on macrobiotics? There's a lot of literature out there that tells you to do a lot of stuff. So for both of you, which books do you recommend or have you written?

Dr. Gonzalez: I've not written a book and there really isn't a book out there. We have a very busy practice, but our main concern has been proving the efficacy of the therapy. I didn't think it would take 17 years. When that is done, then that would be the appropriate time to start training doctors and writing up the actual methodology. There are people out there trying to do what I do in a half way. I get criticized because I'm not training doctors, patients want the therapy and we can't see them all. But I really feel we have to prove it works and then we'll start training people. Then we'll start in the medical literature, as we're attempting to do right now, discussing how it works. We have to prove it works before we start the arrogance of telling doctors they should be doing it.

Participant: Have you published at all?

Dr. Gonzalez: The first article from the first study is currently out there for publication. As I said, we tried to publish for two years, unsuccessfully, during the 80's. That would have answered a lot of questions had we been able to get that monograph out. In that I discussed how the therapy theoretically worked, and it was fully referenced.

Dr. Kushi: As far as macrobiotics, I agree with the approach that Nick is taking, trying to demonstrate efficacy or effectiveness before making something widely available. Macrobiotics is a somewhat different creature, in that it wasn't primarily taught about as a cancer therapy. It has come to be known that way, and as a result people independently wrote case histories. In response to the interest and need there have been books that have been published.

Probably the best that talks about macrobiotics as cancer therapy is called The Cancer Prevention Diet, somewhat misleadingly, because it talks almost solely about macrobiotic diet as treatment for different cancers. It's written by my father, Michio Kushi, and Alex Jack. It's published by St. Martin's Press. It's widely available. As Nick described for his dietary recommendations, there are within the broad principles of macrobiotics different applications for different conditions. There are many macrobiotic counselors around the country who would be able to tell you more about that.

If you want to start with a more objective view, rather than something written by someone who promotes macrobiotics, I often recommend people read as an introduction a chapter on macrobiotics in Michael Lerner's book, Choices in Healing: Integrating the Best of Conventional and Complementary Approaches to Cancer. It was published in 1994 by MIT Press. The most recent edition of The Cancer Prevention Diet was in 1993.

Participant: Dr. Gonzalez, what dose of folic acid do you use?

Dr. Gonzalez: It varies from patient to patient. I have a variety of diets, and there a variety of vitamin and mineral doses that we'll use. It really is quite variable. We don't tend to use huge amounts at all, probably quite modest compared to what other orthomolecular type physicians might use. I rarely go above a milligram a day.

Participant: Rarely above a milligram? Also, have you given thought to the effect of the methyl xanthines in the coffee enemas in terms of inhibiting cyclic AMP?

Dr. Gonzalez: Yes. Caffeine is a member of the chemical/pharmaceutical class of drugs known as methyl xanthines. That includes theophyline, which is a smooth muscle relaxant used to treat asthma. One of the hypotheses about coffee enemas is that the caffeine as a methyl xanthine will cause relaxation of the smooth muscle in all the liver and bile ducts. That allows waste to easily and efficaciously get out of the liver and the gall bladder. We're looking into that and we've done some basic science, with funding through Procter & Gamble, to look into the biochemistry of coffee enemas. That's what I think happens. I think it's a methyl xanthine related effect.

Participant: So it relaxes the bile ducts and allows the toxins from the cancer to drain?

Dr. Gonzalez: Well, basically the liver to dump, and the metabolic wastes from dead cancer presumably are processed through the liver.

Participant: Dr. Gonzalez, it sounds like you have a very extensive evaluation process in order to individualize treatment for each patient. Would you speak to that just a moment?

Dr. Gonzalez: We do. Basically we use blood work to do that. You can look at blood chemistry and get an idea, based on our theory, whether someone should be on meat or vegetarian diets and that kind of thing. It's just our theory. Time will tell whether it's accurate or not. We'll make it available when we're sure that it works.

Participant: I don't understand the mode of action that you are hypothesizing or have documented for your enzyme preparations. We're dealing with very large molecules here, which are, it's my understanding, very poorly if at all absorbed across the gut until they get up at least to 50 kilodaltons. Are you seeing a mode of action with these systemically in the blood and in tissue levels, or are you talking about effectiveness in the gut? If so, have you got any documentation as to pathways?

Dr. Gonzalez: The orthodox teaching in physiology is that pancreatic enzymes are destroyed in the gut. The basic science research shows that a good percentage of pancreatic enzymes are actually absorbed through the small intestine through an active energy process. In 1976 the first paper in Science appeared by Charles Liebow claiming that there was an enteral pancreatic recycling of enzymes. They used radioactive labeled enzymes. The concept that enzymes are poorly absorbed has been disproven. The fact is they're very efficiently absorbed, which raises a question. Why is there such an energy-dependent process for salvaging pancreatic enzymes?

Secondly, I read a paper last week which says that the pancreas not only secretes pancreatic enzymes into the small intestine, as we all know from a hundred years ago, but that pancreatic enzymes are also secreted directly into the bloodstream as if they were a hormone, much as the pancreas will secrete insulin into the bloodstream. This is a very sophisticated process that for whatever reason had been overlooked. So there is a very elaborate secretion of pancreatic enzymes directly into the bloodstream. Secondarily there is a very elaborate process for the absorption of pancreatic enzymes from the small intestine.

The other myth is that pancreatic enzymes are very acid stable. They can't possibly survive digestion in the stomach. In 1981 a group in Russia, the Leningrad Cancer Institute, did a very basic study on pancreatic enzymes. Sometimes the most basic studies are the best. They took a mass of trypsin, put it into hydrochloric acid and boiled it. To everyone's astonishment, there was absolutely no loss of trypsin activity. Not only did they survive heat, which is contrary to what's taught in the physiology texts, but they also survive hydrochloric acid. And not only that, but if you want to boil them in acid, they'll survive that too.

Participant: So I guess we'll just tear those pages out of Guyton's physiology book.

Dr. Gonzalez: Yes, use them for kindling.

Participant: The other question is, do you have some studies showing elevations in the peripheral blood levels after oral administration of your enzyme preparations?

Dr. Gonzalez: The first studies that go back to ...

Participant: I mean your stuff.

Dr. Gonzalez: We haven't done that ourselves, although that's the next step. But there are studies going back to the 40's discussing that issue. We all know that there are pancreatic enzymes in the blood. One of the standard tests is trypsin or lipase or amylase levels. You use that to monitor pancreatitis, for example. But even in the normal patient they'll have some trypsin and some lipase and amylase in the blood. When you ingest large doses of pancreatic enzymes, the blood levels don't tend to change very much, just the way potassium or sodium levels won't change. The body seems to protect the levels.

I read a paper two weeks ago which found in animal models that when you feed animals large doses of oral pancreatic enzymes, organ levels of trypsin and chymotrypsin will increase, as if these enzymes were being stored in the liver and the spleen. There apparently is a very active process for storage of enzymes in nonpancreatic tissues. The question is why does the body have this elaborate system for sequestering pancreatic enzymes unless they serve some function other than digestion?

Participant: The enzymes themselves are not digested in the process of digestion? These are all the very significant objections that are raised every time enzymatic therapy gets brought up. I want to get it from the guru here.

Dr. Gonzalez: That's correct. The theory is if you take pancreatic enzymes, first they're destroyed in the stomach from hydrochloric acid. That's been totally disproven in 1981, although very few people read that article. Secondly, pancreatic enzymes are digestive enzymes. The proteolytic enzymes digest protein. Well, pancreatic enzymes themselves are proteins, and indeed have the capacity to digest themselves. Yes, it's true that if you leave a bunch of trypsin in an alkaline environment, which is what happens (the first part of the small intestine has an alkaline pH), they will indeed autodigest.

But it's kind of a mass effect. Pancreatic enzymes are secreted into the small intestine in an inactive precursor form, and the last five amino acids of this 256 molecule trypsin have to be cleaved off before it becomes activated. Now trypsin can produce that cleavage. Initially, because most of the enzymes are in their inactive form, most of the attack of the proteases will be against inactive precursors, and then they're activated.

As you have more and more active enzymes through mass effect, you're going to start hitting the active enzymes and reducing them. What has been found is that peptide products from trypsin autodigestion also are active and have proteolytic activity, so the actual cleavage of trypsin itself by trypsin may not produce inactive products but may produce very active peptide fragments. Those also seem to be absorbed into the bloodstream. Some of those peptide fragments may have an anticancer effect.

Participant: You have very effectively laid to rest what I thought were very serious problems with the concept of enzymatic therapy. Thank you sir.

Dr. Gonzalez: I had the same questions when I first met Kelley, and I had to go to the literature. Yes?

Participant: www.mucos.de

Dr. Gonzalez: You have all the answers. That's wonderful.

Participant: It's not mine, but the references ...

Dr. Gonzalez: Wobe Mugos is an enzyme manufactured in Germany that's very popular and used in the cancer clinics in Europe. Dr. Wolf and Dr. Ramsberger and the people who have worked with that enzyme have done very good work, both basic science and they have a very good research base. There's no question about it.

Participant: Dr. Gonzalez, I treat patients with cancer. I have followed avidly every lecture I can find that you're in. I've tried to piece the information together, and I'm only going to take one question now. I have hundreds of them, but one that's very specific that has always fascinated me that I haven't had a good explanation about I'd like you to elaborate. That has to do with the designation between hard tumors and soft tumors and how you then make recommendations for patients to either do a mental/emotional intervention that is a meditation versus one where you want to activate these, type A and type B. I've had a very hard time trying to figure that out.

Dr. Gonzalez: Yes, I understand, and I appreciate your interest in my work. Kelley's work and our work is based on autonomic physiology. It would take half an hour to get into that. You know what I'm talking about. We believe that solid tumors (the epithelial tumors, tumors of the breast, pancreas, colon and lung) occur in patients who have an overly strong sympathetic nervous system. Patients with blood based tumors (such as myeloma, leukemia and lymphoma) tend to have a very strong parasympathetic nervous system. Basically they're completely different types of people physiologically, psychologically and biochemically. The epithelial solid tumors are vegetarian types. The lymphomas, leukemias we find invariably are meat-eating types. Dr. D'Adamo has a book on blood types that touches on that, and there's a lot of accuracy in that.

Participant: The one about the lectins?

Dr. Gonzalez: The blood types, yes. We think there are ten types; he did four. We don't think blood's a good way, but his ideas are very sound in basis. We find the leukemias and lymphoma patients invariably need to be on red meat and the solid tumor patients need to be on more vegetarian type diets. Solid tumor patients do extremely well with meditation, and leukemia, lymphoma patients, who are already strongly parasympathetic, which is basically the relaxation nervous system, are already too relaxed. You want them to do the opposite.

When I say these are the patients who should watch war movies, I'm not kidding. They should not meditate. They don't do well with it. They feel worse when they do it. It makes their cancer worse. They shouldn't meditate. The classic hard tumor patient should meditate all day long if he or she can do it. Their sympathetic tone is, their fight or flight response is active even at three in the morning. These are people who need to relax.

Participant: Thank you.

Participant: Dr. Gonzalez, what are some of the parameters that you use to decide whether somebody's going to be - you actually just touched on it a little bit as far as the sympathetic nervous system, the autonomic nervous system. Give me some idea of what determines whether somebody's eating red meat three to four times a day or somebody's going to be exclusively vegetarian. You mention tumor type now, but are there blood parameters?

Dr. Gonzalez: Yes, there are, but again it's experimental. We're in the process of demonstrating that, and demonstrating a methodology for very simply testing. We don't think blood typing is that accurate. We think it's maybe 60% accurate. We're developing a methodology for doing that so it can be available to any practitioner, any patient who wants it. You want to hear the specifics. That's a long answer at the end of a long session already. It would just be too long to go through that.

Participant: Okay.

Dr. Gonzalez: There's not one simple thing that I can tell you. I'm not trying to be secretive. It's just not that simple.

Participant: I have a general question for both of you. When you recommend meat or fish or whatever, do you have a specific type? I realize it's individualized, but what I mean is organic, deep sea, etc. Do you worry about what's in the meat, what the quality of life was, whether the animal was penned up and stationary or active?

Dr. Kushi: In the context of cancer therapy, if animal food is recommended in macrobiotics it's usually fish. I have seen instances when poultry or even red meat has been recommended in certain cases. That's extremely rare in my experience. In terms of the quality of the meat, organic, naturally raised is preferred, regardless of whether it's fish, beef or whatever. That's one of the main principles of general food selection.

I'll make a little comment regarding some of the things that Nick just talked about, hard tumor and soft tumor differences. That corresponds very much with the yin yang philosophy of how macrobiotics looks at different types of tumors as well. Soft tumors, like the lymphomas, etc., generally are thought of as being more yin in quality. Therefore in order to try to bring oneself back into balance one would choose a macrobiotic diet that was somewhat more yang in quality, though perhaps not in the extreme of red meat three or four times a day. Maybe that will cure your lymphoma. But it will give you colon cancer and you'll die of a heart attack.

You would emphasize a more yang quality diet. Maybe more cooking, maybe some fish, some other things, maybe deemphasis on fruits and raw salads. In contrast, a more yin style diet would perhaps include more fresh vegetables and fruit, definitely cutting out the animal food and some other things like that.

A tumor that's more solid would be considered a more yang type tumor. Then the recommendations would be more in terms of emphasizing a more yin style diet. That goes along with the types of recommendations, perhaps not the specifics, but the general principles that were talked about.

Participant: I have two questions for Dr. Kushi. One, could you comment on vitamin B12 deficiency among those who follow the macrobiotic diet? My second question is can you think of any corollaries to the pancreatic enzymes that Dr. Gonzalez has been talking about as described in the Kelley diet?

Dr. Kushi: With respect to B-12 deficiency, if you do a MedLine search on macrobiotics you'll come up with some papers that actually do talk about B12 deficiency and macrobiotics. You won't see, for example, that paper on blood cholesterol published in 1975. You won't see that Barry Goldin paper. There's an interesting phenomenon in that when there are studies of macrobiotic people that are generally agnostic or positive, they tend to call them vegetarians. When there are studies that are definitely negative, they tend to mention macrobiotics explicitly. You will find both Adlercreutz studies, but you won't find those other ones necessarily.

There have been cases of B 12 deficiency. One of my nephews, when he was eight or nine months old, around weaning, ended up being hospitalized. If you don't eat animal food or aren't taking B12 supplements, there's no good, reliable vegetarian source of B 12. People talk about various things, but I wouldn't bet my life on it personally. Macrobiotics is not an exclusively vegetarian diet necessarily. As an adult, if you do switch to a strict vegetarian diet and don't take any supplements, B12 deficiency is not going to show up for years and years, because B12 is stored in the liver. For people adopting a strict vegetarian diet, even with no supplement recommendation, in the context of cancer therapy B12 deficiency is one of the last things they need to worry about.

The other question was about comparisons to the pancreatic enzyme. Certainly not in terms of the dosage that you were talking about. It might be looked at as a little odd from the macrobiotic perspective. I find an interesting thing, and it's reflected partly in the types of questions that have been asked in this session. Many of the alternative cancer therapies that people have been talking about may be alternative in that they're not accepted by mainstream medicine. However, they're not really alternative in terms of the paradigm - the way that people think about disease and how they're applied. A lot of the interest was in these pancreatic enzymes as a supplement or a medication or whatever used in a specific context. That's really no different from a chemotherapy agent in terms of the general principle or philosophical approach to managing cancer.

Macrobiotics is very different. Some of the other underlying aspects of the Kelley regime are also different in this way, in that it really takes a very different approach in terms of the philosophical basis and concepts (which we may or may not agree with). The proof ultimately is in the pudding. In terms of specific treatment or supplements, there really isn't a parallel per se. That doesn't mean that people in macrobiotics might not take various things. People do talk about, for example, miso having enzymes that could help digestion and a number of other things, and could help promote health generally. There are other such explanations out there that could perhaps be thought of as parallels. But in terms of the application per se, that's one of the distinctions between the two of us.

Dr. Gonzalez: Dr. Kushi is being a little bit too modest about B12. I think the chances of getting B12 deficiency on macrobiotics are very minimal. First, even though we say you can only get B12 from animal products, there's no animal on earth that makes B12. They get it from eating plant foods. B12 is only made by bacteria and molds. It's not made by animals.

Herbivores concentrate B12 in their own livers because they live on foods that contain B12 made by bacteria, legumes, for example. If you eat food such as algae, you will get B12, and there are foods in the macrobiotic diet that do contain B12. Even though we say you can only get B12 from eating animal protein, in a practical sense there's some validity to that. In a scientific sense, animals only get it from eating bacteria that produce B12, so there is B12 in that.

Secondly, we think vegetarian diets do work for hard tumor patients. When you're on a vegetarian type diet, as macrobiotics tends to be, you tend to rest your own pancreas. The proteolytic enzymes that we believe are the main anticancer element will in a high meat diet be used up digesting the meat. It's true that we have some patients who we put on meat. But for any solid tumor they have to be more vegetarian. If they eat too much protein, the pancreatic enzymes are all going to go after digesting the protein and they'll be wasted. We want all those enzymes to go after the cancer.

We believe (it's theoretical and it could be not correct) that one of the reasons macrobiotics works is because it rests the patient's own pancreas. Enzymes that would normally be wasted eating a lot of meat go into the blood stream, as we now know can happen, and will go after the cancer. You're basically resting the pancreas. That's one mechanism by which the Gerson diet and the macrobiotic diet may work. I wanted you to think about it.

Participant: I'm a little confused. I'm a relapsed, low grade non-Hodgkin's lymphoma. I've been on a macrobiotic diet for about a year and a half, and have been a vegetarian for about 13 years. I haven't had an ounce of chicken or meat. I'm confused as to why your theory is that one should have meat in a soft tumor cancer, whereas the macrobiotic diet says no meat, and fish is very rarely taken according to the book of prevention of cancer. Also one of my questions was to Dr. Kushi. In the testing done on these cancer patients, did they follow the diet in the cancer prevention book that your father wrote, where each cancer has a different diet to follow? Some of them say more grains, some say a lot of aduki beans and no chick peas, because for some reason they're more yin or yang.

Dr. Kushi: I'll answer that part first and then I can answer the former part of your question. You're talking about the best case series. Based on the questionnaires that these people filled out, they did appear to generally follow the recommendations. They didn't necessarily do it 100%, but we asked them to self evaluate approximately how much they complied. I should have mentioned we're working with David Eisenberg's center in order to wind that up. We originally had other people involved, but for various reasons they couldn't come through. The answer is yes, generally they did do what was recommended for their particular condition.

Participant: Why are there no vitamins in any of the diets?

Dr. Kushi: The general idea is that you should be able to get whatever you need from your food.

Participant: It's hard to find organic foods when you're traveling. It's real difficult.

Dr. Kushi: Right. Then you eat nonorganic foods. I agree on traveling. I ate white rice, and I'll admit it. No, I'm kidding. It is difficult. However, you look at vitamins and they're refined, processed. Many of them are based on petrochemical industry development at least, depending on which types of vitamins you get, Suppose on the one hand you're promoting organic natural food, and then on the other hand you're reaching for all these other things that are extremely refined, extremely processed. There's not necessarily a contradiction from a scientific or nutritional, biochemistry perspective. However, from a macrobiotic philosophical perspective, while they're not necessarily excluded, there's some difference between the two.

I did put up a slide showing that some other types of supplements are sometimes used and recommended. I mentioned blue green algae that 12% of these people had taken. People have done other sorts of supplements that are more holistic. They are supplements of things that are not individually isolated but concentrates of plant products or whatever. Some of those are often used and recommended in a macrobiotic context.

Dr. Gonzalez: When were you diagnosed with lymphoma?

Participant: 1993.

Dr. Gonzalez: And you were on a vegetarian diet how long?

Participant: Since 1981.

Dr. Gonzalez: I would say the reason you got lymphoma is because you're on the wrong diet for your type. I think you answered your own question. If you really were following a vegetarian diet and it was the right diet for you, you wouldn't have developed lymphoma. When I met Kelley, though, I had a similar question. I knew that Gerson had some lymphoma successes, and I don't question that. He said everybody initially will do well on a vegetarian diet. I asked why. He said that someone who's genetically a vegetarian will thrive on it because it's the right food. But if you put someone like, think of an animal model, like a lion or a tiger on a vegetarian diet, the food is so unsuited for their metabolism they'll start using their own tissues.

There is no better food for you than your own tissues. You're not allergic to it. It's already there in a predigested form. You don't have to expend any energy to digest your own tissues. It's perfectly suited for your own metabolism. It's as if your tissues were designed by God to be suitable food in times of need. A meat eater on a vegetarian diet will start using his own tissues, and initially everybody feels good on that. But we find often that leukemia and lymphoma patients who have been on a vegetarian diet for a long time start not doing so well unless they get red meat. We have many patients who have been on vegetarian diets for sometimes decades, and they develop leukemia and lymphoma. They don't understand why this would have happened. Our answer is that it's not the right diet for your type.

Participant: How do you find the type? By the blood?

Dr. Gonzalez: We do it through blood work, yes.

Dr. Kushi: Another thing on this meat and lymphoma business. We published a paper in JAMA a couple of years ago, not cancer therapy, from a study that we've been doing following 40,000 women in Iowa. Increased red meat intake was associated with increased risk of developing non-Hodgkin's lymphoma.

Also, we have looked specifically at doneness of meat, thinking that beef or red meat that had been cooked more might more often develop heterocyclic amines, increased risk or whatever. Actually we found the opposite. The women who reported preferring their red meat rare had an increased risk of lymphoma.

We're following that up working with an infectious disease epidemiologist in Minnesota and some biochemists. We're looking at the possibility that bovine leukemia virus may increase the risk of developing lymphoma. We're taking lymphoma tissue samples from the women from the study. We're going to do probes to see if we can find the viral sequence in these lymphoma tissues. I don't know if we will or not. Also there is an increased risk of lymphoma in farmers, for example.

Dr. Gonzalez: With farmers it's due to pesticides. I've read the study. In fact, a lot of my meat-eating patients immediately called me when that article came out. They said you have us on red meat and this article proves that eating red meat causes lymphoma. As Dr. Kushi or any epidemiologist knows, correlation is not proof. When I read that article I said, "Of course." My patients said, "What do you mean, of course?" People who are genetically meat eaters tend to crave red meat. People who are genetically meat eaters (for a variety of complicated biochemical reasons which I don't have time to go into now) tend to develop leukemia and lymphoma. Correlation is not proof.

People who are genetic meat eaters tend to like red meat, and they will crave it generally and eat a lot of it. People who are vegetarians tend to gag on red meat. The classic story in my office is a genetic vegetarian said, "My mother used to make me eat pot roast, and I used to gag on it," whereas the meat eaters said, "My mother used to make me eat salads and I used to gag on it. I really crave McDonald's." We believe patients who tend to develop leukemia and lymphoma have a strong parasympathetic nervous system. Patients with a strong parasympathetic nervous system, just like a lion or a tiger, will crave and tend to gravitate toward red meat.

There are certain problems with a correlation study. First, there's red meat and there's red meat. There's organic red meat, raised properly, and then there's other red meat. One of the problems with red meat is that the fat, as was mentioned yesterday in one of the lectures, is a repository for a lot of fat soluble hydrocarbons, pesticides, environmental chemicals, carcinogens, heavy metals. If you're eating nonorganic meat, you're getting a real blast of toxic chemicals. If you're eating organic red meat you may still get some, from acid rain and all that, but it will be less.

Even above and beyond that, we believe first correlation isn't proof. The fact that people with lymphoma tend to eat a lot of red meat does not prove red meat causes lymphoma. To me it proves that people who get lymphoma tend to be innately meat eaters and tend to crave and gravitate towards red meat. Dr. Kushi and I probably won't agree on that, but that's the way we look at it.

Dr. Lord: Doug, do you have something you'd like to say?

Dr. Weed: I do have a comment about this particular conversation. It is true that the epidemiological study does not prove the causation. The counter claim, however, that Dr. Gonzalez just made has no apparent evidence associated with it. We're not talking about what Nick believes or what Larry believes. We're looking at how one would compare these competing hypotheses. One is that the meat eating comes first and the risk of lymphoma is increased, versus the alternative hypothesis that meat eaters have some sort of genetic predisposition to lymphoma. Those two hypotheses are evaluable. The test of the comparison of those hypotheses is not in what I believe or Nick believes or what Larry believes but rather what is the evidence that's shown. That's the arbiter of this discussion, but certainly not at the level of expert opinion.

I want to make one more point before we get too hog wild about randomized clinical trials, even though I believe they're absolutely essential. Let's consider a randomized clinical trial which has as its treatment an intervention that is extraordinarily complex. Let's say it involves at least three different things, and those three different things include a whole slew of different things we talked about. Pancreatic enzymes are one mix of things, the detoxification scheme is another mix of things, and then we're talking about a diet and nutrition intervention which is yet another mix of things. The best that can come out of a study of that hypothesis, which is a very complex hypothesis, is either that whole thing worked, or it didn't.

It will not tell you what part of it worked. That's what you're not going to learn. That's not to say you can't learn that. A lot of the conversation has been around doing science at other levels of investigation, not the randomized clinical trial, but rather molecular studies. There's this whole realm of evidence, of understanding that needs to take place. This is not an argument against doing the randomized clinical trial. It is an argument that says even those results will have to be put into context.

Dr. Lord: Thank you Doug. We're not going to have any more time for questions, but I'd like Dr. Wynder to just make a comment.

Dr. Wynder: I am delighted. As you all know I am a great supporter of Nick Gonzalez' work. The key (and I will make that remark in my concluding remarks this afternoon), is whether a particular therapy works or doesn't. As Doug just said, I'll be happy if it works. If it works then I will separate is it the diet, is it the enzyme, or is it some other detoxification element. We are discussing here in detail mechanisms. As some of you may know I published my first paper on smoking and lung cancer in 1950. I must have published 200 papers on mechanisms. But I know if you don't smoke, you don't have to worry about mechanisms.

All the discussion in the Congress today is that we failed as a society to draw the proper conclusions from data that we published years ago. In terms of the work of Dr. Kushi and Dr. Gonzalez, the key is the randomized trial. If we had done the randomized trial two or three or four years ago, we would now be in a position, either in the laboratory, or dissecting the various elements to determine which one of these particular aspects is the active ingredient, or do they work together.

The final point is this. As part of this randomized trial we have set up an immaculate supervisory board, of which I am privileged to be the chairman, and on which Dr. Weed also serves. Every randomized trial needs that type of external review. Secondly, as part of this trial we also look at the quality of life. The quality of life is very important, because a problem with much of chemotherapy is toxicity, which clearly neither the macrobiotic diet nor the enzyme therapy carries. An important element of this conference is that we as scientists undertake these randomized trials, because if they work we all have a benefit.

We need to recognize there are some alternative ideas that may seem very crazy to some of you, but as we learn about nature we realize that nature probably has developed some internal mechanisms to deal with cancer. Pancreatic enzymes may be one of those mechanisms. I encourage all of us when we go home, and this includes Dr. Kushi and the macrobiotic diet. If you had a good randomized trial today, we would have been much further along to determine whether what you say is true indeed is so.

Dr. Gonzalez: Just one further point. First, I am very grateful that Dr. Weed has agreed to serve on the advisory panel of our randomized trial. His thoughts and comments were very much appreciated.

There is evidence from nature about humans who eat meat. These are the Eskimos. The Eskimos have been studied very heavily from the time the Harvard anthropologist Stefansson first went to live with them in 1907, I believe. He wrote a series of books in the 1910's, 1920's, discussing the fact that the Eskimos lived on an entirely meat diet. Here's an experiment in nature of a group of humans living on nothing but red meat. Interestingly enough, the Eskimo diet is high in saturated fat. The traditional Eskimo diet when it was evaluated was 80% saturated fat and 20% protein.

You have to realize that up in the Arctic Circle, where the Eskimos live, there is no growing season. All there is is tundra. There are no fruits, no vegetables, no grains, no nuts, no seeds. These people have lived there for thousands of years. In 1929, McGill University sent a research team to study the traditional Eskimos living the traditional way on an all meat, high saturated fat diet. To their astonishment their cholesterol levels ran around 130 to 135. They could find no cancer, even in the older Eskimos, and there indeed were older Eskimos. Their reports were published. There are scores of reports on the traditional Eskimos that were published between 1920 and 1940, discussing the fact that these patients were extremely healthy.

Only when they moved into the towns and cities of civilized Canada and now Alaska in the U.S., and they began to eat a low fat diet with high carbohydrates and Rice Krispies and white flour, did they become the obese, disease ridden, diabetic, cancer ridden, arthritic people we now know as Eskimos. The traditional Eskimos, first, to survive in that environment, if they weren't healthy they wouldn't have lasted. That is one of the most extreme environments on earth. They were extremely healthy. That's a ten month winter up there. Six months with no daylight. These people were not only healthy, they were extremely healthy, extremely hardy in order to survive in that environment. It was a test case. Now they no longer live the traditional life, and this is an experiment of nature which no longer exists.

Fortunately there were scientists who did go up there and did live with them. A lot of very sophisticated biochemical testing was done, even by 30's standards. In 1988 there was a study in the New England Journal which showed that Eskimos lack the enzymes to break down even simple sugars. It makes sense that in an environment where there's only red meat, nature being very conservative would get rid of the enzymes you need to use carbohydrates efficiently. Eskimos, by genetic determination, could not use carbohydrate foods or fuels well. All they can use efficiently, like a lion or a tiger, which lives on nothing but red meat, is red meat.

Lions and tigers are very healthy animals. If you doubt how healthy they can be I suggest you climb into the zoo cage with one. Lions and tigers live on nothing but red meat. They're not human beings, but there's nothing innately evil or wrong with red meat. It's a question of should that person or should that animal be eating it. No farmer would ever think of raising a cow with red meat. There isn't a lion tamer or a zoo keeper in this country who would try to raise a lion or a tiger with grain. They're different metabolisms requiring different types of food. There's nothing innately wrong with red meat, unless you're a vegetarian, human or a cow. There's nothing wrong with vegetarian food unless you're a lion or a tiger. You can die within six weeks if you're a lion or a tiger trying to live on a vegetarian diet.

Dr. Kushi: I have a comment about that. The Eskimos were living macrobiotically, exactly. They were living in harmony with their environment. There's nothing inherent in macrobiotic principles that says that red meat is bad. It's just that for most of the people who come to macrobiotic counselors or live in the U.S., a predominantly vegetarian diet is probably the most healthful way to go.

Dr. Lord: This brings up one of the major questions about nutrition today, which is that the food that is available to us has been so adulterated that it's very hard to find good food.

Participant: Especially in hospitals.

Dr. Lord: Especially in hospitals. Great. So along with all of this talk, the environmental issues are paramount to insure that we have a good food supply. Thank you all for coming. I thank all of our panelists for wonderful presentations.

 

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