Interviewed By Richard A. Passwater Ph.D.
History Sharkliveroil l What is squalene? l The Role of Squalene in Health l Dr. Carl A. Luer
Dr. William Lane interview by dr. Passwater l Dr. William Lane l Dr. Bikul Das l G.S. Kelly Clinical uses
Wetenschappelijke research & LiteratuurShark Cartilage and Cancer: The Exciting Possibility of a Cancer-free State with a Natural Product
Interview With Dr. I. William Lane
Interviewed By Richard A. Passwater Ph.D.
I. William Lane, Ph.D. received both his B.A. and M.A. in the field of Nutritional Science from Cornell University. He received his Ph.D. in Agricultural Biochemistry and Nutrition from Rutgers University. As a researcher, he studied and worked under two Nobel prize winners, Dr. James B. Sumner (1946) and Dr. Selman A. Waksmann (1952).
Dr. Lane applied his research in poultry nutrition in association with Perdue Farms and Tyson ...... Although his research in poultry-feed formulation brought him to my "neck of the woods, we did not meet at that time. Later he became a vice president for Grace and Company heading its Marine Resources Division. This experience in biochemistry and marine science provided Dr. Lane with a special background to pursue his research with shark cartilage.
Introduction: I am excited about your recent clinical studies showing that Shark cartilage is eliminating tumors in Stage III and IV terminal cancer patients. If additional and larger human clinical trials are confirmed by others, it truly will be the most important health news that I have ever heard.
We have chatted before about the theoretical mechanisms and the various University studies showing effectiveness in the laboratory, but at that time, you had no human clinical studies completed. When I saw that your book, "Sharks don't get cancer," was being introduced at the Nashville NNFA convention, I was hoping to get a chance to get updated.  But, alas, our schedules were too hectic.
I have been studying the cancer process for twenty years. Cancer is a multi-step process in which cells accumulate multiple genetic alterations as they progress to a more malignant mutation. Although there are many steps, they can be grouped into three distinct phases. My research has concentrated on preventing the first step, while your research has concentrated on preventing the third step, and more importantly, eliminating cancer tumors in advanced cancer patients.
The first step in the process is the damage caused by agents known as carcinogens. carcinogens can damage critical parts of genes called proto-oncogenes directly or by generating free radicals. Carcinogens may be chemicals, radiation or a viruses. Antioxidant nutrients protect against damage that can be caused by carcinogens.
The initiating the development process does not necessarily lead to cancer. This process alone will only produce a series of independent precancerous cells. In order for cancer to develop, the process must be propagated to the point where these precancerous cells will reproduce, associate and develop their own blood supply and defense system. If there is no propagation or if the immune system is activated and destroys these precancerous cells, then there will be no cancer developed.
The second step in cancer development, called "promotion," allows the precancerous cell to reproduce rapidly and change their membrane surface properties to those characteristic of malignant cells. Anything that promotes cell reproduction decreases the chance that repair enzymes will repair (deactivate) the activated oncogene.
Even with promotion, the proliferating cells will not necessarily develop into cancer. The cell mass must grow large enough to affect body metabolism and start their own blood supply and defense system. This is the third step called "progression." Progression leads to cancer, including the malignant tumors of carcinoma (consisting largely of epithelial cells) and adenocarcinoma (cancer of a gland), and eventually metastasis (the invasive spreading to other areas).
Conventional therapies try to cure cancer by killing more cancer cells than healthy cells. You have found in your search why sharks don't get cancer, that the process that stops the third step in cancer development also can be used to eliminate existing cancers. You were the right man with the right background at the right place at the right time. Let's start near the beginning.
Passwater: Your book is entitled, "Sharks don't get cancer." I've never worked with a laboratory room full of sharks -- at least not the finned kind. Is your title an exaggeration to make a point and is it relevant whether or not sharks get cancer?
Lane: "Never" is a slight exaggeration to make an important point. Actually, as stated in the book, some cancer has been reported in sharks, but fewer than one in a million sharks show cancer -- less than one percent of the incidence of tumors reported for all other species of fish. What is relevant is that sharks rarely get cancer and that this fact has been tied specifically to their cartilage skeleton and the strong anti-tumor activity of shark cartilage.
Passwater: I have also been following the research of Dr. Robert Langer of the Massachusetts Institute of Technology and the preliminary research of Dr. John Prudden, a Harvard-trained physician, showing a factor in cartilage that inhibited tumors. [2-4] What is different about cartilage that would explain why this factor is present in cartilage?
Lane: In 1976, Dr. Robert Langer showed that shark cartilage contained an inhibitor of new blood vessels in tumors. When the body makes new blood vessels, the process is called "neovascularization" or "angiogenesis." Angiogenesis is the term most often used, and it is derived from "angio" meaning "pertaining to blood vessels" and "genesis" meaning "formation of," thus angiogenesis merely means the origin and development of blood vessels.
Earlier, Dr. Judah Folkman of Harvard had put forth the theory that one could prevent a tumor from exceeding one-to-two square millimeters (the size of a pencil point) if a blood network could be prevented from forming.  A blood network is needed to feed the tumor and remove waste products. This concept opened up a whole new strategy for controlling cancer and is the approach with which I have been working.
In 1983, Drs. Anna Lee and Robert Langer pinpointed the mechanism to this approach which I had been following. They reported that an extract of shark cartilage inhibited both new blood vessel growth and tumor development.  They also showed the inhibitor to be 1,000 times more concentrated in the shark cartilage than in the cartilage of other animals. Bovine cartilage, when processed to remove the fat as Dr. John Prudden did, is very low in blood vessel inhibiting activity. Rather, bovine cartilage relies primarily on its ability to stimulate the immune system with mucopolysaccharides (glycosaminoglycans, a class of complex carbohydrates) which is a positive, but weak, development, nowhere near the magnitude of importance or effectiveness of antiangiogenesis (preventing blood vessel development).
It was postulated that the logical place to look for such natural inhibitors of angiogenesis would be in tissue not having blood vessels (avascular). The most common avascular tissue is cartilage. The theory being that cartilage is avascular because it contains inhibitors of new vascularization, and that shark cartilage, pound for pound, is by far the most actively antiangiogenic.
Passwater: When we last spoke, you mentioned that several antiangiogenic factors have been discovered in cartilage, and that this is a distinct advantage of your whole cartilage food over a purified drug which is a single compound. What type of compounds are these antiangiogenic factors, and how sensitive are they to environmental factors such as processing?.
Lane: It is believed that all of the antiangiogenic factors in shark cartilage are proteins. In late 1992, two separate proteins, both with major antiogenic properties have been identified, one, by Dr. Robert Langer, and a second, by Japanese researchers. [7,8] It is postulated that as many as five separate active antiangiogenic proteins are in shark cartilage. With the whole shark cartilage properly prepared, all would work synergistically. Proteins are easily denatured (inactivated) by heat, acids, alcohols, acetones, and many other chemicals. Thus, proper processing to prevent denaturization is most important.
The mucopolysaccharides and their ability to stimulate the immune system, as found in shark and other cartilage, are important, but I believe that most, if not all, of the activity I am showing comes from the antiangiogenic proteins.
Passwater: Can you verify and quantify your claim that shark cartilage has more antiangiogenic activity than bovine or other cartilage?
Lane: Yes, the scientific literature documents this fact. Dr. Robert Langer of the Massachusetts Institute of Technology has studied various cartilages and reports in the highly respected peer-reviewed scientific journal Science that shark cartilage is 1,000 times more potent in antiangiogenic factor, all of which is in the protein fraction, than bovine or other mammalian cartilage. Based on this, I find it hard to understand how most "copy-cat" products stress their mucopolysaccharide content, and are very low on active protein and antiangiogenic activity.
These "copy-cat" products -- which based on assay and their own correspondence -- usually are not whole shark cartilage, and are often diluted with dextrins (hydrolysis products of starch) or sugars. When life or death is at stake, those offering them unproven and questionable "copy-cat" products should be run out of the industry, in my opinion. I have identified them most of them, including some well-known names. One has to wonder if they would offer a "copy-cat" and ineffective product in something this important -- how good can some of their other products be?
Passwater: How can we be sure that significant amounts of antiangiogenic factor are in shark cartilage products?
Lane: An standard assay method developed by Dr. Judah Folkman of the Harvard Medical School, Dr. Robert Langer of Massachusetts Institute of Technology, and others, called the CAM (short for chick Chorioallantoic Membrane) assay allows one to measure the angiogenesis inhibiting capability of a product. This assay involves adding the material to be tested to a fertilized chicken egg yolk sac and measuring the amount of new blood vessel development under standardized conditions.
Using the CAM assay, one can, and should control production lots. I know of only one commercial product in which this is done with all batches, and that is Cartilade(tm). I used the CAM assay early on in my research to improve production methods. I was able to materially increase inhibition activity using the CAM assay as a guide, and I continue to seek better processing methods constantly.
Passwater: Has commercial processed shark cartilage been effective against human cancers?
Lane: By all means -- all tests and clinical trials, except for the first one, have been on a commercially available product called Cartilade(tm). The first test was a more concentrated experimental product which is not yet produced commercially because of high cost.
All of these studies with only advanced cases -- usually stage III and stage IV terminal patients -- with shark cartilage as the only therapy have shown results which are most significant. In eight breast tumor cases where the tumors were all larger than golf balls in size, all eight women were tumor-free or approaching a tumor-free state in eleven weeks. In three other studies on breast cancer, the results have been the same. With seventy-six cancer cases in the United States, a New Jersey physician has shown all seventy-six patients responding to the shark cartilage therapy. The shark cartilage therapy works on all solid tumors, but appears to be most effective with breast, liver, brain and esophageal tumors, where major changes within four-to-six weeks are noticeable. Lung and prostate cancers seem to respond more slowly, and we have seen good responses with pancreatic tumors at very high dosage levels.
Passwater: How have these studies demonstrated that it was the shark cartilage and not some residual effect of other treatments that was effective?
Lane: Residual effect is always a possibility, however, in a clinical trial in Cuba on 27 advanced cancer victims, no patient was selected that had not been off other therapies for at least weeks, and in the three Mexican studies, all patients had been off all other therapies for extended periods. In practice, many patients not in clinical trials do take the shark cartilage along with other therapies like chemotherapy or radiation therapy. No one wants to suggest countermanding a physician's suggestions, but patients want the shark cartilage because they doubt the positive effects of much conventional therapy and have had good reports on the effect of shark cartilage.
Passwater: How do we know that the tumors are actually being destroyed?
Lane: In all clinical trials and with all patients of Dr. Martinez in New Jersey, a starting-point, mid-point and end-point scans by either MRI (magnetic resonance image) or CAT (computer-assisted tomography) are done to follow the progress of tumor tissue death (necrosis). These scans often show the development of air spaces in the tumors as the malignant tissue dies away due to lack of a blood supply as the therapy progresses. Many radiologists who are not used to seeing tumor necrosis in advanced cancer often are puzzled about the appearance of air spaces, and they often suspect abscesses. I refer to the appearance of air spaces -- especially in large breast tumors as "the Swiss cheese effect."
Passwater: What clinical trials are now underway?
Lane: The clinical trial led by Dr. Martinez is ongoing, as is a twenty-seven patient study in Cuba. I expect another clinical trial to get underway in Cuba that will include breast, uterine/cervical, brain, and esophageal cancer patients, with thirty patients included in each cancer category. In Germany, four patients are being treated with shark cartilage by Dr. Helmut Keller, and in Austria, four patients each with Drs. Steinheller and Werkmann are just starting treatment.
In all of these studies, MRI scans, blood chemistries and photographs will be taken so that publications can be forthcoming. My problem has been the lack of funding for extensive clinical trials, especially in the United States.
Passwater: Have all of the completed human studies been done with, and will the new studies be done with the same material?
Lane: Yes! With the exception of the first study with Dr. Contreras, all studies have used a whole shark cartilage product called Cartilade(tm).
Passwater: Shark cartilage has been available since 1989; who produced the first shark cartilage in capsules and why?
Lane: I was responsible for the first shark cartilage capsules. In fact, early on, I encapsulated much of it in my kitchen for early arthritis research. In early studies on dogs and humans, I was working primarily with the mucopolysaccharide immune stimulation effect. My major cancer work only started in 1991, and was at high dosage use involving powder rather than capsules, although the active material is the same.
Passwater: Just how much shark cartilage is required to treat human cancers?
Lane: My first study in Mexico was based on the equivalent of 60 grams of whole shark cartilage per day based on body weight of under 140 pound patients. At this time in trials, we have gone as high as 120 grams daily with advanced cancer cases. An average of 60 to 80 grams daily is generally used, and the success rate with solid tumors has been higher than 80 percent. The shark cartilage is administered orally in juice or buttermilk at the rate of 15 to 20 grams each time, spread throughout the day and taken between meals. In some advanced cases, and in the Cuban study, all is administered rectally at the rate of 15 to 20 grams in four ounces of body-temperature water. These enemas are given four times daily as retention enemas.
After one becomes tumor-free (metastases and all), a preventative dose of ten to fifteen grams daily probably should be used for an extended time, but to date, I have no specific data on this.
Passwater: What other angiogenic diseases might be helped at that treatment level?
Lane: We have seen in clinical trials that not only are the original and metastasized tumors affected, but since the mechanism is systemic, other diseases such as psoriasis, fibroid tumors, diabetic retinopathy, Kaposi's sarcoma, and arthritic pain all seem to disappear -- often before the cancerous tumors are all gone.
Since there are so many hysterectomies performed each year -- and many are needless -- I will be looking into doing a fibroid tumor study.
Passwater: What do we know about the safety of Shark cartilage?
Lane: Shark cartilage -- like all active materials -- must be used properly. Since it inhibits new vascularization, those having suffered a recent coronary occlusion (heart attack), pregnant women and those wanting to conceive, and people recovering from recent surgery should all refrain from use for a logical time period.
We have experienced some stomach upsets -- primarily with those on a macrobiotic or vegetarian diet who also respond more slowly. We see some very limited allergic responses, but in general, most people can use shark cartilage with no problems at all.
The cost of the high-dosage therapy will generally be between $2,000 to $3,000 to reach a tumor-free state based on clinical experience covering a period under sixteen weeks. This is only a small fraction of the cost of conventional therapy, and based on the clinical studies conducted so far, the success rate is far superior.
Passwater: I remember what happened to the Pacific yews in Oregon when it was found that taxol (tamoxifen), the experimental drug being studied to treat breast cancer, could be extracted from their bark. Will Sharks be endangered by our need to cure human cancer?
Lane: About 10 million sharks are caught each year based on statistics of shark fin usage for the shark-fin soup market. If the heads and backbones, representing most of the cartilage were kept and used, there would be enough shark cartilage to treat 625,000 cancer patients a year without catching a single additional shark than are caught now. It would just be greater utilization of material now thrown away unused. Hopefully, synthesis of the active components will follow shortly as well.
Passwater: My research was presented to the National Cancer Institute in 1978, but it has only been recently that they became interested in it. Didn't you present your research to them also?
Lane: Yes! I did present my research to the National Cancer Institute in 1991. I gave a seminar for Dr. Robert Gallo and thirty of his top research scientists, and they gave me a standing ovation and an immediate offer to collaborate. However, within three months, the offer to work with me was withdrawn and no acceptable excuse was given. I assume it was because there was a resistance to work with a natural product. They have followed my research, however, and it has even been written up in the July 1992 Journal of the National Cancer Institute. However, no offer to renew collaboration was ever made to my knowledge, even though I am told that patients phoning the NAtional Cancer Institute and asking about shark cartilage are given encouraging comments in general.
Passwater: Did your research lead to any patents?
Lane: On Christmas Eve (December 24, 1991), I was granted Untied States Patent # 5,075,112 covering the use of shark cartilage to inhibit angiogenesis. This patent was fully supported by CAM assay and showing the inhibition of angiogenesis by shark cartilage. A second patent covering the processing techniques used in manufacture has been applied for.
Passwater: Dr. Lane, I don't know what to say. This is the most exciting development that I have ever experienced. I will be looking for the results from your next round of studies.
Shark Cartilage and Cancer, Revisited:A follow-up interview
Every day I can count on calls and letters on three subjects -- one of them is shark cartilage. Ever since William Lane, Ph.D. discussed shark cartilage and cancer with us in the March 1993 issue and the "60 Minutes" TV show that followed in three-to-four weeks, I have been getting requests for more information such as how much to use shark cartilage, which doctors are using it, are the results from the clinical trials known yet, and what is the latest that is known about shark cartilage. Dr. Lane was kind enough to address these questions in a follow-up discussion.
To refresh your memory, the first interview discussed how cancer grows, how shark cartilage destroys tumors and how shark cartilage can be tested for effectiveness. Basically, cancers that have solid tumors require a blood supply to feed the tumors. Cartilage is tissue that contains no blood vessels due to special proteins that inhibit blood vessel formation. These proteins are called "antiangiogenesis" factors. This term is derived from "anti" meaning here that it will inhibit, "angio" meaning "pertaining to blood vessels," and "genesis" meaning "formation of." Without blood vessels to feed the tumor, it will die.
The blood network of a tumor is fragile. Tumor capillaries are different from those of normal tissues and may be considered to be "immature." Their walls are thinner and decidedly more fragile. Tumor blood vessels are constantly broken down and replaced by new blood vessels. When an existing blood vessel is broken down in the presence of antiangiogenesis factors, it is not replaced by a new vessel and the section of the tumor fed by that blood vessel dies (necrosis).
Dr. Lane has been lecturing on shark cartilage all over the world, but we had a chance to chat again during the first week of November at the American College for Advancement in Medicine (ACAM) where I was speaking on the latest in antioxidant research.
Passwater: Dr. Lane, in mid-February 1993, the "60 Minutes" TV show reported on your research with shark cartilage and 29 Stage III and Stage IV terminal cancer patients in Cuba from late 1992 through early 1993. The story was rebroadcast in July of 1993. Did the "60 Minutes" show aid or hinder your research efforts?
Lane: The "60 Minutes" show didn't aid my research efforts but it seems to have added credibility to shark cartilage therapy. It also opened the doors for an Investigative New Drug (IND) application with the Food and Drug Administration (FDA). The "60 Minutes" show was better than a peer-reviewed journal article because they did their homework to prove that it worked. In fact, they spent $350,000 on doing that 12 minute segment including relatively large expenses to ensure that they weren't getting caught in a fraud -- especially with the CBS Network's leading program and its star, Mike Wallace. So, they studied everything including where I went to school and if I actually graduated. They went to Cuba with me four times to see the patients and that is what convinced them. At the beginning, they saw that the patients were not able to get out of bed. After six weeks they saw the patients starting to stir. After eleven weeks, they saw the patients with major tumor reductions On the fourth visit, after sixteen weeks they were taping Mike Wallace running around the track with this prostrate cancer patient who couldn't get out of bed 16 weeks earlier.
Now remember, these patients were diagnosed as being terminal by two physicians. They were "stage four" patients who were not expected to live six months. The remarkable thing is that as we speak, it has been two- and-a-half years after that study started. To get one to live eight months is almost impossible. It has been 2-l/2 years now and half of those patients are completely normal people today-- running, walking, bathing, swimming. All the brain cancer patients responded; only nine of the 29 patients died of cancer. Of those 9 that died of cancer, they all died in the first 17 weeks. Since that time 6 others died but not of cancer; two in accidents, two had heart attacks; pneumonia, but not cancer -- and 14 of them are normal.
I returned to Cuba last Spring as part of the filming of a documentary now on my research called "The Politics of Cancer; A study in chaos." . While I was there the movie team and I visited with seven of the patients. One of them -- a woman who had a 24-pound tumor -- had me to her home. She broke down and cried and said, "Dr. Lane, without you, I would have been long gone. I never would have seen my home or my children again. Here I am again back with my family. It was heartwarming.
The" 60 Minutes" show did my research a lot of good, but it had a bad side as well. Bad because it suddenly brought in about 30 new competitors. Some of them are good products but some of them are not. It seems odd that something that took me years of research to develop took others less than two weeks. You can't even run tests in two weeks! Yet, there were 30 new products on the market in about two weeks. Half of these "overnight" products were half sugar. There seem to be more sharks on the land than there are in the ocean.
Passwater: Does "60 Minutes" plan to do a follow up on your research?
Lane: To my knowledge, "60 Minutes" has never in their history done a follow-up. They did the story on my research twice, which is itself is remarkable, and when they did it, it was the promo piece each time, They are following the work. I talk to Mike Wallace periodically. Whether they ever do a follow-up is hard to say. It's not their style but in the same token they are still very much interested.
Passwater: What has been the National Cancer Institute's (NCI) response?
Lane: NCI is still saying "we still don't know about it," " it's no good," " the Cuban study was worthless," "come to us with a $2 million study, fully documented, and we may look at it." NCI is still very negative. The support that I have gotten is from the FDA. The FDA, especially the New Drug Application Department, has bent over backwards to cooperate with me. There is an Phase II Investigative New Drug (IND) study underway for Cartilade(tm) led by Dr. Michael Rothkopf. Now the FDA is telling me that they will give the "fast track" to a new product that I am researching called BeneFin(tm). We plan to have the submission stage underway before the end of 1994. We will be submitting for IND approval for Kaposi's Sarcoma which is a tumor-like situation common in AIDS patients, as well as for prostate cancer.
Passwater: You mentioned following up with the Cuban patients. Do you have much follow-up with patients taking shark cartilage?
Lane: I am involved with some patients first hand as part of clinical trials conducted by various physicians. I also refer a lot of patients to doctors who use shark cartilage in their treatments. I have to rely on these patients or their doctors calling me to let me know what is happening. This is second hand and is never very accurate. Each week I get receive an average of 20 to 30 "God Bless You, Dr. Lane, for keeping me (or their loved ones) alive letters. I have kept a file. In fact in my new book called "Sharks Still Don't Get Cancer," I discuss several cases that are complete with the proper documentation from the medical community. We're finding tremendous effect on brain cancer; in fact, I'd say we're getting almost 100 percent response on various types of brain cancer.
Passwater: How about ovarian and breast cancers?
Lane: We don't see that many ovarian or uterine/cervical cancer cases any more. Years ago there seemed to be more. It's breast cancer that is increasing alarmingly in the U.S. Now you will find the uterine and ovarian cancers in the underdeveloped countries presumably because the men don't wash as much so women have more infections which are believed to increase the risk of uterine and ovarian cancers. In our society we get less cancer percentage-wise in that part of the human body. I am a consultant for many physicians who use shark cartilage in their therapy for breast, prostate, brain, and lung cancers and most other solid tumors.
What breaks my heart is that my office also gets a lot of calls from multiple myeloma, Hodgkin's and lymphomas which I can't help. I tell you it makes you cry. I try to insulate myself not to talk to the patients because I'm not a medical doctor. Sometimes my assistant who takes many of the calls tells me that I have to take a certain call because it is so pathetic and I try to help them by referring them to one of the doctors on my list. I have set up a network of doctors in different areas of the world to which I refer patients. In fact here at the American College for Advancement in Medicine (ACAM) meeting where we are talking, I have added 20 more doctors to my network.
Passwater: The word about shark cartilage eliminating tumors in stage III and stage IV terminal cancer patients is getting around among holistic physicians. Are orthodox physicians using shark cartilage therapy to any great extent?
Lane: I estimate that twenty - to- twenty-five thousand people are using shark cartilage therapeutically around the world. Japan and the entire Far East have become a gigantic market for shark cartilage. As big as the United States is, it can't hold a candle on a per capita basis to some of these other markets. It's because the conventional doctors are slow to try it. If they get sick or their wives gets sick or their children get sick, I get a phone call. But most physicians don't use it for their patients. Since no large drug company is involved, their is no sales person or "Detail man" calling on the doctors.
Some of the physicians that do know about the benefit of shark cartilage are still afraid to use it on their patients. I can understand this in a way, and it bothers me in another way, because they take an oath to help their patients but they seem more concerned about possibly being sued. There are ways they can get around that. They can suggest to the patient --"Look, we can't help you but there is something else and I'll be happy to monitor you." In that manner, the doctor isn't at risk of a suit, but most of the doctors aren't even willing to go that far.
We are talking here in California at the ACAM meeting. I have spoken in California, the Los Angeles area maybe twenty times in the last three years. Telly Savalas died of advanced prostrate cancer. No excuse, as we get 90 percent response on prostrate cancer; did his doctors try it? No! They just let him die. Dr. Linus Pauling and I had an hour talk two months before he died . He heard about my research and he wrote to me. At the end of our talk he said, "Dr. Lane, you've got something that is good; I know it, but I have devoted my life to vitamin C and I would find it very hard not to follow along with it." What's the answer? I don't know. People are humans and every human has to make his or her own decision.
Passwater: Can patients call you to help locate a doctor near them that is trained in using shark cartilage therapy?
Lane: I have set up an information service with an 800 number (800-742-7534) People who call will be sent a list of the 15 most asked questions and their answers about shark cartilage. Then if they want to follow up we will check the list of doctors in the network for doctors in their area or nearest their area. The problem is there is always someone who will call from a town where there is no one trained in shark cartilage therapy. It's a matter of life and death so even if there isn't a local doctor trained, I recommend that the patient travels to where there is a doctor trained in shark cartilage therapy. There just isn't one in every town or in every city.
Passwater: Not yet. How do you train doctors in shark cartilage therapy?
Lane: It's hard. Most of them are so locked up in orthodox medicine, but I can tell you it is changing. My research was just written up in "Oncology Times" which goes strictly to oncologists. The article was only lukewarm, so I wrote a letter to the editor. They printed it on Page 2 in the October 1994 issue and they printed it in its entirety. So we are getting through. It takes time but alternative medicine has made more strides in the last two years than it has made in the ten previous years.
Passwater: You have researched shark cartilage for many years and developed the product. It has been more than a year since our first Whole Foods discussion. What have you learned about shark cartilage since then?
Lane: Well, I developed that original product five years ago and I think it was a great breakthrough in that we helped a lot of people. That the product worked but like anything else, further research leads to improvements. When helping physicians treat cancer patients using shark cartilage therapy, the big problem was that we might start 10 patients on it, but only one or two would stay on it because the of the taste and odor. In Australia I discovered a new technology when I was there presenting my research to a major big health conference.
This new technology uses a "good" bacterium to clean shark cartilage of flesh including the blood vessels and the nerves in the channel in the backbone. In addition, this new technology is even able to clean the cartilage without having to cut off the fins that stick out of the backbone. When cartilage is cleaned by hand, these fins have to be cut off. But, these fins contain a lot of the antiangiogenic activity. The good bacterium used in the new technology only removes the shark meat and not the cartilage, so those fins stay on. As a result, a product has now been developed, called BeneFin(tm) , which is about 35-40 percent more effective antiangiogenically
as an inhibitor of angiogenesis. Just as important, it has a major reduction in smell and odor and has no aftertaste at all. The aftertaste of shark cartilage made by the old method caused nausea in many patients and was the major reason why patients discontinued its use. In addition, the new process is around 30-35 percent less costly because there is little manual labor involved as the bacterium does the work.
Passwater: Since you use a bacterium to clean the product, some readers may be concerned that the product may be contaminated with bacteria. Would you please comment on that?
Lane: There are good bacteria and there are bad bacteria. The lactobacillus strains are good bacteria and this a variation of those strains. Still, the product is almost sterile and this is achieved without heat or chemicals -- not even ethylene oxide, and without irradiation as these processes could harm the fragile antiangiogenesis (angiogenesis inhibiting) factors in the shark cartilage. As I said, the problem has been the taste and odor. The bad taste and odor are partly caused by the blood vessels and nerves of the backbone that can't be removed by mechanical cleaning, and partly by the high bacteria load which has been on the product. The bacteria count can be in the trillions which are killed in the end, but all the time they have been alive they have been making toxins. These toxins are not removed and those toxins and plus all these dead bacteria bodies result in a distinctive taste. It's fine to kill the bacteria at the end, but it's a lot better to keep the product basically sterile throughout and not have the toxins and dead bacteria accumulate.
Passwater: In our March 1993 discussion, you educated our readers on the Chick Chorioallantoic Membrane (CAM) assay. Now you are relying on the Quantitative Endothelial Cell (QEC) assay. Please tell our readers about this test and why you use it?
Lane: I stopped using the CAM assay about a year ago because there was such inconsistency with results. Fertile eggs must be used and there is great variability in the length of time that the eggs have been fertile. Another factor that causes variability is the egg of the hen. Whether or not the hen has just started to lay eggs or is at the end of her productive cycle makes a difference in the CAM assay. I found too much variation and poor correlation.
In the QEC assay, which has been developed and is being used in California by one of the top universities and a professor who has worked on shark cartilage almost as long as I have worked on it. Shark cartilage works by stopping endothelial cell development. Endothelia cells are needed to make the walls of the blood vessel. If you stop the formation of the walls of the blood vessel, you stop the formation of the blood vessel and you stop the feeding mechanism which brings about the necrosis. Basically, the QEC assay uses known amounts of cultured endothelial cells divided into aliquots to which known amounts of test materials and standards are added. These aliquots are incubated for three days. After three days, you go back and weigh the endothelial cell cultures and compare the results to the standards and controls.
You then determine if the growth of endothelial cells in the control culture was good. If it is normal, then we proceed with the test and assign the control a relative value of 100%. Next we measure the test cell cultures. Let's say that the product we are testing produced very modest growth, which means the inhibitor worked pretty darn well. You give that sample a gradation based on the its comparative weight. So the QEC assay is a very accurate evaluation.
We have done this measurements on only two products so far, but we will do it on all of the major shark cartilage products being sold. We did it on the new product BeneFin(tm) and we did it on the product that was the standard before, a product called Cartilade(tm). We have shown that the BeneFin(tm) is about 35 percent more effective based on the QEC test, and we have it now on two evaluations. I will evaluate another seven or eight products when I return from this meeting. I am particularly interested in seeing if any inhibition results from a product from Canada that is being marketed that is about 99-l/2 percent water. The manufacturer claims that if you take seven milliliters of their liquid, it produces the same results as 100 grams of shark cartilage powder. It sounds preposterous and I have found the patients are dying on that one and so I'm going to be sure to evaluate that one. I'm going to evaluate all of the major shark cartilage products by this comparison. This test is an expensive test but it's a very meaningful test and I take the position that before a product is sold to someone in a life and death situation, the patient that is putting out the money deserves to have the person who is selling it to him or her do some research. Concrete evidence is needed, not just saying it's good. I want to provide meaningful evidence for comparison to the people who spend the money.
Also, I am hoping to get some human studies going pretty quickly, in China, possibly in Russia, possibly in Malaysia and then hopefully in the US we will have FDA approval we'll have the U.S. studies with the FDA's approval. In the meantime, I will have QEC assays and bacteria evaluations which are the only evaluations provided on shark cartilage products. Additionally, human clinical trials have now been arranged for breast and uterine/cervical cancers in Mexico to start in January 1995 at the Contreras Clinic.
Passwater: Are you still seeing good results with shark cartilage on rheumatoid arthritis and psoriasis?
Lane: Yes, it's amazing. When you are treating cancer, you often find improvement in other diseases the patient has as well. Many of the patients in the Cuba study had either psoriasis or rheumatoid arthritis. While these patients were being treated for cancer, all of sudden after four weeks, the psoriasis and rheumatoid arthritis just disappeared at that high dosage rate. Patients of those diseases who do not also have cancer will be helped at a lower dose, but it will take longer. So, I am now suggesting about 30 grams a day for psoriasis patients and I am finding people are responding beautifully. I mean that within four to five weeks it's a different person. With rheumatoid arthritis, you can't reverse the knurled knuckles, but you can ease the pain. If there is a pinched nerve, the shark cartilage doesn't help, but if it is angiogenesis as you find in a lot of rheumatoid arthritis patients, shark cartilage has a good affect.
Passwater: While we are discussing the amount to take, let's review your recommendations for cancer patients.
Lane: In all of my previous research with shark cartilage, and the clinical trials on non-responsive advanced breast and prostate cancers, including the FDA IND now underway, a dosage level of one gram of shark cartilage for each kilogram of the patients body weight (about one gram per each 2.2 pounds of body weight) has been used. Routinely, this level has shown promising results with many desperate cases. This dosage level is significantly higher than the dietary dosage recommended on shark cartilage labels which are intended for nutritional dietary supplement purposes. For patients with extremely advanced cancer, some doctors have nearly doubled the dosage to almost one gram of shark cartilage for each pound of body weight with good results and no observed toxicity or side effects. As I said, some patients don't like the taste and don't like to take that much, so perhaps the new product can be used in lesser quantity because it is more effective. Hopefully, the Mexican study about to begin will give more information tying the QEC assay to human clinical trial results.
Passwater: Are there any tricks to help the patient tolerate the taste?
Lane: The new product tastes much better, but generally when shark cartilage is taken orally, it is mixed with a pulpy juice such as pineapple, tomato or apricot nectar. Up to 20 grams (4 level teaspoons) of shark cartilage powder is blended in a mechanical blender with 6-8 ounces of juice to make a frothy and aerated "shake." This is taken three or four times daily, usually before meals.
If taken rectally via a retention enema, use 20 grams in 3-4 ounces of body temperature water. It is introduced into the lower rectal area as a free-flowing slurry using a 3-4 foot hose from an enema bag or a kit is available from Real Life Products at 800-547-6649 (* check last digit could be a 7). Often a few drops of aloe vera added to the slurry produces a smoother mix. Load 3-4 large (60-80 cc) plastic syringes with the slurry, insert one end of the hose into the rectum, and squeeze the loaded syringes through the hose. Laying on one side for 25 minutes allows absorption. Remember, this is a retentive, not evacuative, enema.
Passwater: When can a patient expect to see results?
Lane: Many patients, learning of remarkable results for cancer patients being treated with shark cartilage, anticipate immediate, dramatic improvement in their own condition. After a week or two of treatment, they often become disappointed when expected improvements are not noted; immediately they cease continuing with shark cartilage and miss an opportunity that may save their lives.
Similar to every other cancer treatment, shark therapy does not produce immediate improvement in a patient's condition. Occasionally patients will experience an improved quality of life as early as the fourth week. However, with advanced cancer, results are rarely noted in less than six-to-eight weeks. I cannot stress enough the need for patience. Remember, it took years to develop the cancer and this is a biologic response which takes time.
As the quality of life continues to improve other results follow -- continued reduction of pain, tumor size reduction and tumor morbidity (tumor death). As I mentioned in our first discussion, this tumor encapsulation has been confirmed by examination and the "Swiss-cheese" effect can be observed by Magnetic Resonance Image (MRI) and Computer-assisted Tomography (CAT scan).
Passwater: Dr. Lane, your research is an amazing story, one of the most important advances in alternative medicine as well as in the nutrition and health food arena. We will all be awaiting the FDA IND and Mexican clinical trial results. Thank you for keeping us up to date.
1. Sharks don't get cancer Lane, I. William and Comac, Linda Avery, Garden City Park, NY (1992)
2. Isolation of a cartilage factor that inhibits tumorneovascularizationLanger, Robert; Brem, H.; Falterman, K.; Klein, M. andFolkman, J.Science 193:70-2 (1976)
3. Shark cartilage contains inhibitors of tumor angiogenesis.Lee, Anne and Langer, RobertScience 221:1185-7 (1983)
4. The treatment of human cancer with agents prepared from bovinecartilage.Prudden, John F.J. Biolog. Response Modifiers 4:551-84 (1985)
5. Tumor angiogenesis: Therapeutic implications.Folkman, JudahNew Engl. J. Med. 285:1182-6 (1971)
6. Shark cartilage contains inhibitors of tumor angiogenesis.Lee, Anne and Langer, RobertScience 221:1185-7 (1983)
7. Identification of an inhibitor of neovascularization fromcartilage.Moses, Marsha A.; Sudhalter, Judith and Langer, RobertScience 248:1408-10 (1990)
8. A novel angiogenic inhibitor derived from Japanese sharkcartilage.Oihawa, H.; Ashino-Fuse, H.; Shimamura, M.; Koide, U. andIwaguchi, T.Cancer Letters 51:181-6 (1990)
All rights, including electronic and print media, to this article are copyrighted by © Richard A. Passwater, Ph.D. and Whole Foods magazine (WFC Inc.).
WILLIAM LANE, Ph.D. holds his B.S. and M.S. Degrees in Nutrition from Cornell University and his Ph.D. in Biochemistry and Nutrition from Rutgers University where he worked under two Nobel Prize winners. He recently was awarded the honorary degree of Doctor of Integrated Medicine from The Florida College of Integrative Medicine in Orlando, Florida where a new School of Naturapathic Medicine is being organized which will be named after Dr. Lane. In August of this year Dr. Lane was invited down to the South American nation of Peru to assist them in utilizing the plants and flora which were widely used by the Incas as effective medicines before the advent of Western Chemical Medicine.
Dr. Laneís research is behind the interest in Shark Cartilage which is now the subject of a 600 patient, phase 3, seven million dollar study largely funded by the NIH and being run by the Mayo Clinic on advanced breast and colon cancer patients. Dr. Lane directed a human study which was successfully run in Cuba on 29 advanced cancer patients who had failed all conventional treatments and were receiving shark cartilage as the only medication. This was positively featured on CBSís 60 Minutes with Mike Wallace in February and July 1993.
Dr. Lane has co-authored 4 books: Sharks Donít Get Cancer (1993), Sharks Still Donít Get Cancer (1996), The Skin Cancer Answer (1998) and Immune Power (1999). His work in Alternative Therapies and Anti-Aging has helped to increase the acceptance of natural treatments in complimenting mainstream medicine.
Dr. Lane will be talking about a new, highly effective test for cancer to measure the effectiveness of therapies as well as a screening test for the presence of cancer. The commonly used tumor markers and their reliability compared to this new test, called the CARE TEST will be discussed.
He will speak on The New Innovative Cancer CARE Test.
Some sources you can seea summary in PDF-files. You need Adobe Acrobat Reader.
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