(00:00:00) The United States Food and Drug Administration has outlawed the manufacture of laetrile in this country citing numerous tests that have found it neither prevents nor cures cancer. However, 11 states have legalized it and a growing Pro laetrile movement including some Physicians hail the drug as a cancer deterrent the medical establishment charges proponents with quackery and using this extract from apricot seeds as a get rich scheme at the expense of suffering cancer victims several clinics in Mexico are prospering and more and more Americans are purchasing laetrile via a sophisticated Underground Market the Senate Health subcommittee chaired by Edward Kennedy of Massachusetts yesterday resolved that further tests on the drug should be run cooperatively by opponents and supporters of laetrile to resolve the controversy. However, no date testing site or type of tests were decided upon but FDA commissioner Donald Kennedy agreed to set something up despite his belief that the Drug is a fraud that may actually be harmful to users the first person to testify before the committee was commissioner Kennedy. (00:01:07) I know that there are people who believe in their hearts that laetrile will cure them and I have deep sympathy for those people but there are 200 million people whose health and safety depend on in some measure on the Integrity of the FDA the commissioner of Food and Drugs has neither the moral nor the legal right to disregard the laws of Congress and the evidence of science. We cannot and will not permit the introduction of laetrile into interstate commerce his German that statement was actually made by then FDA Commissioner James Goddard 12 years ago and in reading it to you, I have only substituted the name laetrile for the name Kiribati has in the cancer fraud of that time before krebiozen was proved worthless by FDA it gave false hopes to thousands of American Cancer victims and built them of Ian's of dollars before that. Dr. Hoxie's medicine the cock treatment and even something called. Dr. Johnson's mild cancer cure did the same it is important to view the laetrile question in this historical perspective because in (00:02:16) its pattern of (00:02:17) promotion in its (00:02:18) Reliance on people's frustration (00:02:20) with the medical establishment and its use of testimonials laetrile is retracing precisely the course of these earlier remedies, mr. Chairman FDA has been asked to provide a district court in Oklahoma with an administrative record on which that Court can review the basis for fda's contention that laetrile is a new drug under the food drug and cosmetic act thus requiring pre-market approval by the agency before it can be lawfully distributed in compiling that record FDA has received written submissions from proponents of laetrile and from the scientific and medical community. In addition, we held two days of public hearings in Kansas City on May 2nd and 3rd 1977. We've now prepared our analysis of that record and it will be published in the Federal Register later this month and delivered to the court in Oklahoma City. I now want to summarize for the subcommittee members are Central finding from this extensive record. They indicate Beyond serious question first that laetrile is not generally recognized by qualified experts as a safe and effective cancer drug and second that laetrile is not exempt from the pre-market approval requirements for new drugs by virtue of the grandfather provisions of the food drug and cosmetic act to the contrary all of the evidence shows that both now and in the past laetrile has been regarded by the overwhelming majority of qualified experts as being of unproven safety and of no Effectiveness, whatever the the evidence regarding efficacy brought To Us by the proponents consists entirely of hearsay, or Humans and patients testimonials. The subcommittee is familiar with the long experience. We have had with such testimonials Time After Time persons or corporations wishing to introduce new drugs onto the market have tried to persuade us that General clinical experience or the subjective Judgment of Physicians or the conviction of patients should substitute for controlled experiments in the approval process Time After Time. My agency is insisted on the scientific data that result from controlled experiments and Time After Time. The courts have upheld that position by confirming that the intent of the Congress in the 1962 drug efficacy amendments was to insist that proof of efficacy requires more than personal belief. I know you share my view that Congress was wise. So to insist it is not uncommon for the course of cancer or other diseases to fluctuate patients experience complete remission for causes that are unknown almost 20 percent of all patients with breast cancer Will Survive for five years without any treatment if they had taken laetrile, they would attribute I suppose the cure to that. I think that is often the case. Mr. (00:05:17) Chairman (00:05:19) many patients also are receiving several different therapies at the same time under which conditions both patient and physician may be under serious temptation to believe that a cure which may only be a remission is attributable to a particular therapy. That is why we insist on controlled trials. That's why we cannot trust testimonials no matter how poignant they are and no matter how deeply we may sympathize with those who provide them. We did not find any evidence that laetrile is exempt from the pre-market approval requirements for new drugs by virtue of being grandfathered. No evidence was presented to us that experts in 1962 recognize laetrile to be safe and effective in the treatment and management of cancer. None of the experts who submitted testimony knows of scientific reports on which such recognition could have been predicated or knows of medical textbooks or medical schools where the use of the substances are recommended or taught or nose of medical experts who were then or are now of the view that laetrile has any useful effect in treating cancer. I think the most important outcome of our analysis of this lengthy administrative record is one that emerges entirely from the assertions of laetrile is proponents. It is simply this those who wish us to legalize laetrile cannot give us a consistent picture of what it is or what it does. It is either amygdalin or a substance called el Mandela Nitro beta glucan a sign from which laetrile was originally named or it is a mixture of these and other compounds or it is these plus some enzymes depending on who and when you ask like this is important you mean it's a variety of different substances and compounds. It has just one subject matter. It is an extraction procedure. Mr. Chairman that as far as we can tell is subject to a great deal of variation from place to place its identity has been claimed in very different terms by proponents at different times in its history and it is even now not easy for us to dredge out of our administrative record a Assistant pattern of agreement as to its identity. You mean people in different parts of the country are taking different compounds that is very clear from the examinations using chemical analytical techniques and all of the names. They're all under the general name of (00:07:43) laetrile. (00:07:45) Not entirely. Mr. Chairman. Some are called laetrile with a capital l some are called laetrile or laetrile is with a small L. The most common designation now is laetrile, but under that name different compounds that we have seized in analyzed have different chemical composition. Well, it's spelt the same a b. Is that correct? Yes, it is spelt the same but it's different in terms. It can be different in terms of its substance in the makeup of the substance. Is that correct? It is either of you seen is me just while we're on this point. Is there any scientific information that has been submitted to (00:08:26) you or that you know (00:08:28) about that indicates the efficacy of any of these (00:08:33) compounds that are (00:08:35) that you've just mentioned here that go under the name of laetrile. Have you tested the mall or have you got any scientific information that we have not discussed this with any? Yeah, we have not tested them all ourselves or indeed have not tested any of them ourselves. Mr. Chairman. We have subjected them to chemical analysis which allows us to say that they are often different one from another the tests that have been performed on on Animals by the National Cancer Institute by dr. Thomas has Sloan-Kettering Institute by others have shown that it is without effect on animal tumors. It has not been subjected to anything that one would call a scientific test in human. Kings I might just mention mr. Chairman that also depending on who you talk to. It is either a drug or a vitamin in the latter case it would be unique because I know of no deficiency disease nor does anyone else that's associated with it. It is either to be taken by injection or orally depending on who you talk to and if it is taken orally we have very serious doubts about its safety and you will hear more from other members of the panel on that subject later. Well, I think that's an important point because of there are those that say well perhaps there isn't the the effectiveness in terms of curing but since it's a safe the why not let people take it. Your testimony is that you have reason to believe that taken orally that it may not be safe. I think there are very good reasons for believing that senator. In summary, then this is a substance that has no fixed identity and in the literature of its own proponents, it also has no fixed identity in the hands of our analytical chemists who find that the amount of amygdalin and the ratio of its isomeric forms varies widely in samples of the material. We have seized. I don't know of any honest therapy that lacks an identity to this degree indeed in sifting the strange mixture of nomenclature alleged chemical identity and proposed mechanism of action that comprises laetrile is record of the past 25 years one becomes gradually convinced that these uncertainties are not entirely accidental. Are you suggesting intentional deceit? I think that the fact that laetrile is such a moving Target makes it extraordinary effective as a cover for the promoters because failure to achieve a result can always be attributed to having used the wrong material and arguments against one hypothesis of action can always be met by taking refuge in another As you will hear later this morning, there is a substantial incentive to cover one's tracks well in such a business because laetrile pays and pays well. Mr. Chairman, I'd like to conclude by testimony with a few words about the freedom of choice argument. I think the importance of that freedom was underscored in 1962 by President Kennedy and his consumer messages that year and it's important to remember that in his list of four basic consumer rights the right to choose directly followed another right the right to be informed President Kennedy knew and we should all be reminded that the only free choices are informed ones to say that the laetrile promoters are offering cancer patients free choices is to debase the concept of Freedom beyond all recognition. Mr. Chairman if I sound a little angry it's because I am I hope however that I am not seen as unsympathetic because in fact my anger derives from the sympathy I feel for those cancer patients who turn to laetrile. They are being victimized twice once by their disease and once by the prophet ears The conviction of cancer patients who believe firmly that they are being helped by laetrile is real and a present powerful and moving appeals one can understand why they do cancer the disease Americans fear more than they fear War has for decades resisted the best efforts of science to provide a cure. We now think we know why it is not a single disease but a whole set of diseases many of them have complex largely environmental origin cancer probably does not even have a single cure yet a single cure is exactly what The Afflicted person hopes for most desperately the convincing sales person who offers one for a price is likely to make a sale not only with the patient but with family and loved ones when I hear testimonials from such patients, it is hard for me to avoid anger at their exploiters. And I think it is a deplorable suggestion that this government should on the falsely applied issue of freedom of choice. And aside and allow vulnerable people to be exploited by a therapy that is unproven in Merritt false in its promise and even uncertain in its identity. If I understand the the sense of your testimony is that laetrile cannot be generally recognized as safe and it's certainly not effective in treating cancer. And that it promoted stand to make a lot of money. And that they take advantage of the fears and hopes and feelings of helplessness of cancer victims and their families. And that in many cases they prevent these victims from seeking legitimate therapy. (00:14:15) I would you say that that's a fair summary of your your (00:14:18) position. Yes. Mr. Chairman. I've provided a more extended set of views for the record to you. The statement I read is is necessarily brief. I would emphasize that no evidence was presented to us that suggests that it could be regarded as a grandfather drug. It is a new drug under the definition of the federal Food Drug and cosmetic act no evidence has been offered as to its efficacy. It is never been generally recognized as safe and indeed the shift in view that now that now says miraculously that it's a vitamin is dangerous and Troublesome because vitamins are characteristically taken orally and taken orally most of the stuff that's offered for sale as laetrile is dangerous. (00:15:07) Well now why don't why don't you do a test and resolve this this issue once and for all. (00:15:16) Well, mr. Chairman, I think my colleagues on the panel will probably be responding to that. I would only say that from my personal perspective a test a clinical test on the efficacy of laetrile would have to be done in such a way that the material was of proven authenticity and and analyzed prior to the test. And then of course a whole set of ethical problems involving the access of human subjects to other modes of therapy would have to be solved. I'm not suggesting that these are impossible and doctors Frederick's and Newell and Thomas no more than I about those kinds of problems. I would I think concentrate in my own in communicating my own concerns to you on the question of identity because I think I can predict that if this is done with one kind of laetrile, if as we all expect it would fail in a rigorous. To demonstrate its efficacy then there would be quick resort to the explanation that well. We didn't have the best kind of material to work with and the (00:16:25) test Donald Kennedy commissioner of the Food and Drug Administration the committee then heard from dr. Guy Newell director of the National Cancer Institute who charge that laetrile be it called vitamin B17 or amygdalin is no preventative Miracle rather a cruel hoax. The NCI has performed some tests on laetrile. Although their validity is challenged by laetrile supporters. (00:16:50) The results of these tests conclusively show that laetrile has no significant anti-cancer activity based on these tests. We feel that laetrile is likely to be inactive against cancer in a clinical trial if we do conduct one. In spite of this is you've heard we estimate that approximately 50,000 patients in the United States are taking this drug each year and at Great personal cost to themselves and their families and as you know, 11 states now have enacted legislation to legalize the use of the substance within those States. We firmly believe mr. Chairman that the average citizen in this country does not have the resources nor the technical skills necessary to select develop and test materials for the treatment of his disease. Neither. Does he have the background that will enable him to make enlightened decisions concerning the selection of individual therapeutic agents, we believe that the administration and the profession are uniquely qualified to make these judgments in the interest of the public. In the course of establishing new drugs we go through seven. Well defined steps and I'll just list them rather than go into any detail. We have a very elaborate mechanism for acquiring new materials and we actually put on test about 15,000 synthetic compounds a year. We have continually updating a screening process where we use various animal systems animal systems that carry both animal tumors and human tumors as a pre-screen for these compounds once a compound passes the screen we have to go through an elaborate drug development procedure and we have to learn its toxicity the toxicology about that drug, these are done and then larger animals dogs and monkeys and it's at this stage that we apply for an investigational new drug application or an i and D with the FDA just as any other it just as any drug. Company would apply for this and we have to get the FDA approval before we can proceed having gotten the approval. We enter phase 1 clinical trials, which is designed really to determine the major toxicity of the compound the drug. Although we do expect it to have some clinical activity and then we enter phase two which is where the anti-cancer activity of the drug is evaluated in this phase II clinical top trial is what we would propose what we are considering with compound laetrile following Phase 2 if the comp you (00:19:42) can I think run through I think generally with our we followed this process within the agency and the testing so if you want to summarize this aspect of it and then get into the We'll make it a part of the record all the statements in their entirety this morning would be made part of the (00:19:59) record. Well, let me just conclude. Mr. Chairman. I think what is most of what their has is to say has probably been said the ethical moral and the legal implications of clinical trial is a very very important and controversial problem. There are several Alternatives that are available to us ranging from doing nothing. To the initiation of the trial (00:20:28) immediately. Dr. Newell director of the National Cancer Institute. The next witness was dr. Lewis Thomas director of the Memorial Sloan-Kettering Cancer Institute. It's a been asserted (00:20:40) that since laetrile is not a particularly toxic substance. It ought to be made available to patients who want to use it as a matter of free choice. There is however a very real danger here. If for example children with early leukemia or sarcoma or women with cancer of the breast or young men with Hodgkin's Disease are persuaded to give laetrile a trial before anything else the outcome will almost certainly be death in circumstances where appropriate therapy could be life-saving. There are already instances where this is known to have happened in various parts of the country and they will very likely increase if the material becomes more widely used and in this sense laetrile can fairly be regarded as a lethal drug. Now in normal circumstances one would not Advocate clinical studies in human beings for any drugs, unless scientific research and experimental animals or in cell cultures gave some reason for expecting benefit. This is not the case with literal but these are not normal circumstances. The material is already in wide use and its use appears to be spreading further each week. It has received official sanction from several state governments and increasing segment of the public has been persuaded that it may be beneficial and is therefore worth a try all this has happened in the absence of any real data there exists. No solid information about its effects on humans beyond the likelihood that it is not in itself very toxic for these reasons. It is now essential that the public be provided with solid information about laetrile based on some scientific facts and their art seems to be two possible courses that could be taken rather. Quickly, the first is an epidemiologic study of a statistically significant sample of the patients who have already been treated with lateral should be launched many such patients are now known to their own private physicians and information is probably available for some of them concerning the microscopic nature and extent of the tumor the stage of the disease and the details of other treatments, if any including radiation surgery and chemotherapy, if a sufficient sample of cases with this level of information can be located. It should be possible to determine whether the course of the illness was or was not significantly altered by laetrile. This kind of retrospective study could not in itself be conclusive because of the absence of controls within the same study nevertheless. It might be capable of revealing whether or not there is any basis in Truth for the most strident of claims made by the Layers of laetrile, for example The Disappearance of tumors the prolongation of active life the relief of intractable pain and the restoration of a feeling of good health. And second a clinical trial of laetrile in cancer patients should be planned and only under sponsorship and supervision by the National Cancer Institute this ought to involve at least three major major Cancer Center, isn't it ought to be a double-blind study in which neither the patient's know the Physicians will know whether laetrile or some other substance are being administered and it should be aimed at answering the central questions about laetrile. Does it relieve pain does it prolong life and does it cure cancer on ethical grounds? It would not be possible to treat any patient with lateral alone. If there are other forms of therapy conceivably beneficial for that patient and therefore for most of the patients to be studied any clinical trial would have to involve laetrile as an add-on to other treatment. This is a serious but unavoidable limitation even so the keep questions about pain relief and well-being could undoubtedly be answered and such answers would tell us at least whether this Substance provides any clinical benefits at all, but there is one overriding problem referred to by dr. Kennedy which will have to be settled before any sort of clinical testing can be undertaken by anyone what example what exactly is it that is to be tested under the name of laetrile. There are by some accounts any number of quite different preparations carrying this label out in the marketplace and they differ from each other chemically in fundamental respects. They cannot all be tested unless The Advocates of the treatment can provide a single standardized preparation on which they will agree to base their claims of benefit to cancer patients the prospects for scientific evaluation of laetrile are so remote and the results would be so inconclusive that the undertaking is hardly worth the considerable effort that would be involved. If there is to be a clinical trial of lived through the data should eventually be reviewed and evaluated by a special committee. I would suggest composed both of clinicians with General experience in clinical science and lay persons with some sagacity and good common sense. It is of importance that this committee be recognized as fair-minded and without vested interest one way or the other for if the results are negative, there will surely be a quick accusations of bias from the marketers of laetrile. It has to be remembered that an enormous amount of money is being made from laetrile and the stakes for those who now control this Market are very high indeed. (00:26:09) Dr. Thomas of the Sloan-Kettering Institute the committee then heard from a group of us attorneys who have prosecuted laetrile traffickers. They charge that in hundreds of cases cancer patients were lured away from conventional treatment and misled about Leia Trails purported affects. The economics of laetrile are phenomenal. They said with vendors potterpaul. Getting millions of dollars those charges were refuted by the drug supporters who we will hear from now this witness is dr. Ernest Krebs of California the author of a book about laetrile. He said laetrile vitamin B17 must be reintroduced into our diets to prevent cancer the questioners our Senators Kennedy schweiker of Pennsylvania, and now Pell of Rhode (00:26:53) Island. I'd like to have a go to the question of the Axiom for a moment. (00:26:58) And as I understood it you said what was that word any metabolic (00:27:01) disease any metabolic or chronic disease and I believe Senator. This is where the what was the word again metabolic metabolic metabolic disease, what would be another (00:27:11) example of metabolic disease besides cancer? Oh (00:27:16) pernicious anemia, which now is found a resolution. Alright scurvy very very pellagra. And you see after these diseases have found their resolution then retrospectively we say, oh (00:27:29) well that Was just a (00:27:30) chronic nutritional deficiency disease, but (00:27:34) there is no chronic metabolic (00:27:38) disease that has ever been prevented and Orchard except by non-toxic factors normal to the (00:27:44) diet. I heard that I wish you would respond specifically the question then trying to get into my mind is it cancer is primarily a natural disease? It does not come from bacteria or from germs. That's correct Senator what you're saying is that any natural disease where the cells grow it untoward speed? (00:28:07) Yes, or you (00:28:08) have anemia which is perhaps a mild form of cancer that those are curable by natural means is that which (00:28:15) is yes pernicious. Anemia is found total resolution in prevention by vitamin B12 and folic acid, for example, and besides beat before that. It was at a higher death rate than cancer. You see this The laetrile the science the lid frail represents a breakthrough into an area that is very tested credibility is just it is so foreign to what is believed (00:28:47) it what you're saying that be 17 or whatever it is. It does not cure (00:28:51) cancer. But if you take enough of it every day, you don't catch it take enough of it. You do not develop now. Let me emphasize this. I don't mean taking it and tablets or capsules. But if we ate the (00:29:03) seeds of all the common (00:29:04) fruits that along with the fruit if we ate milord if we ate buckwheat if we ate bamboo shoots that we ate lima beans if we turn consciously to increasing the concentration of vitamin B17 in our American diet up to level of 50 milligrams a day. I am in convinced that cancer would be resolved in the same way. That scurvy was by supplementing. Taste with lime juice to give me (00:29:32) a short answer. If one took sufficient B-17, you would eliminate cancers that correct govt. (00:29:40) I believe Senator Pell that if we ate the food that contain vitamin B17 is the Hunts of cuts do we would have the same incidence of cancers a hunch that cuts which is zero incidents (00:29:53) to be specific. If you took the adequate number of B-17 pills each day as a general course without eliminate (00:30:01) cancer. I do not want to leave myself in the position of recommending pills or tablets. But the thrust of my effort is to bring the bring the people to the Nutritional practices that will supply them while still in health with inadequacy of vitamin B17 by pointing to the foods that are rich in it buckwheat Millet bamboo shoots lima beans and also point to the effect of plant hybridization in blindly eliminating this essential Factor, (00:30:43) but what is wrong with taking the B-17 in pill form like we take vitamins in the morning, right? (00:30:49) You can do that, but that that is a partial or atomistic solution. We have deviated in our diet from that which is evolutionarily appropriate. Remember we belong to a primate stem about Three million years of age today we are doing we have deviated from mend ously from biological experience and we're in a disaster pattern and just taking vitamin B17 tablets (00:31:18) or capsules is not going to solve that overall (00:31:22) pattern Our Food and Drug Administration is by doing some good work there, but it must move more rapidly and more deeply into the elimination of additives from Foods the improper additives. We must move over to a high concentration of vitamin B17 in the diet time doesn't permit my going into detail on the occupational carcinogens. They are real that they are overrated Senator Kennedy. May I clarify what laetrile is the laetrile is a term used for a miglin the chemical term for a migdal in his label mandello nitrile beta-d-glucose site. Kennedy is completely in the air when He suggests that there are a number of formula for it nitrile aside amygdalin vitamin B17 and laetrile are all (00:32:15) synonymous. Well, I (00:32:19) mean his analysis of that the description is not correct. Is that what you're saying up? That's correct, Senator Kennedy. What is the correct one the correct analysis of laetrile as it is available now is a refined form of amygdalin to wit the label isomer label Mondello nitriles beta-d-glucose side and it may be very quickly checked out in any any competent chemical laboratorium about 10 or 15 minutes by putting it into a polarimeter and checking its specific Optical rotation. Now, do you understand that? Dr. (00:32:57) Kennedy keep having this problem that this lot of (00:33:04) D, isomer in there that the amount of amygdalin varies but if these folks will give us for Ella miglin is that we'll get our clinical colleagues at least off to some kind of stardom at a Texas has Day, because it's the first day we heard some people agree with this stuff miss you provide that substance would mr. Kennedy is correct. There are dextro isomers is dr. Kennedy your mr. Krabs. I think I'll say yes will be in order. Maybe an order order please order order will be in order, please. Yes, Senator Kennedy that is a part of the character assassination. I feel time is so limited. We haven't gone into personalities but character assassination is a major instrument in this movement. I happen to be a graduate of the University of Illinois. I've had three years of medical school. I've had two years to graduate work at the University of California and the Christian College in Tulsa. Oklahoma gave me an honorary doctor of science. I don't considered honorary because I considered more than fully earned but in the political miasma that sound that surrounds this issue as denied access to a higher degree on this subject and that if I don't propose to stand still for a further his characters hell, I don't think anyone's attempting. I think what we're there is a standards yet in terms of being called doctors for practicing doctors there. Just in the in the state they've been respected by the states within the military casualty on it. And I think that it so happens that your to dr. Dr. Rick Kennedy has a Ph.D. And he is not qualified in the area of cancer. He is totally unqualified and I would be delighted to put him under cross-examination on the subject. Yeah. Well he is now will be annoyed spent 25 years in this area and I know precisely what I am doing and what we are doing in this Movement. We have a tremendous power against laetrile. We have 400,000 Americans a year dying from cancer and each one who dies depends on an average of twenty thousand dollars a year before he dies and this represents eight billion dollars a year spent by these dying people. This is a tremendous economic and political force. The man who should be here is neither. I nor dr. Richardson, but it's Your heart and be Jones the University of California (00:35:46) school of medicine Department of (00:35:47) biophysics rules said in a very scholarly manner reported before the New York Academy of Sciences in a magnificent monograph entitled The demography of the cancer population. He reached this conclusion. He said my studies indicate that that population of cancer patients left entirely untreated live longer and suffer less than those who are treated. Dr. Jones should be here should be under cross-examination by the experts of H. Ew, so should prize Nobel Prize winner. Dr. Watson who is characterized as cancer Scandal is a nasty bill of goods being sold. The American people the laetrile movement is not fun. Are you suggesting? Dr. Watson believes in laetrile? No, I do not need their does. Dr. Jones, but they baited the basic Point here. Is that the base? The point here is to make it clear whether or not the present methods of therapy are not actually as dr. Jones suggests counterproductive. And dr. Watson should be asked to explain why he describes this isn't a no stranger to this committee. Mr. Krabs. He's appeared before our committee and always welcome. Let me ask you what we are attempting to deal with is to find out with the commissioner of FDA here is whether given all of the other problems in terms of dr. Frederickson the ethical questions about how these tests could be established whether there could be The the the kind of scientific analysis that you believe that you've been denied and we've got at least the person in this room that can be enormously helpful with dr. Kennedy and we're trying in an open Forum. It's not about meetings (00:37:33) and public calls (00:37:34) not in rallies not in closets not in rooms to try and find out exactly what that substance is that you want to test. And what I am prepared (00:37:46) is with the establishment of that test (00:37:48) to say that getting the best and the fairest kind of test to be willing to abide by it. And and dr. Richardson is indicated the same. I think we're making some progress here this morning in terms of trying to to recognize that in a Civilized Nation and in a country that we do have to have some basic kinds of standards on it. We have definite parameters that they Theon and efficacy now if we can agree on that, we will this this will be Extremely let for (00:38:20) tonight. Well, I would like to hear from you and just appreciate (00:38:26) that. Now we agree on what that substance is so that dr. Kennedy we can go back to him and say alright, we've got the substance that should be tested and now see if we can't work out the the ethical. I don't believe that these are easy question. We agree on what the substance (00:38:43) is testimony from Ernest Krebs a laetrile Advocate. The next witness was Robert Bradford and electrical engineer and chairman of the freedom of choice committee for cancer therapy a laetrile support group during Bradford's testimony. You will hear the voice of dr. John Richardson of California physician who was stripped of his license for dispensing laetrile Richardson was also charged with pocketing thousands of dollars as a result of his illicit practice. He has sued the California medical board now Robert Bradford of the freedom of choice (00:39:15) committee. I would like to offer into evidence a letter to Benson devotee MD director division of cancer treatment National Cancer Institute, Bethesda, Maryland As a major proponent of laetrile research and decriminalization efforts in this country the committee for freedom of choice in cancer therapy cannot help but cheered by the news that the National Cancer Institute will at long last undertake clinical trials of this greatly misunderstood compound. We are however somewhat distressed that we see a decisive Fair trial. Not which we are not completely confident that the NCI has in mind. No genuine human trials will be resolved will resolve the controversy unless laetrile is administered as part of an overall metabolic program. The program is provided exclusively in the metabolic program that it is not in adjunctive or to chemotherapy and/or radiation and or surgery and see it is administered by or at least supervised by a qualified metabolic physician with experience in training in this admittedly new field. Now I charge Senator that Orthodox medicine is not qualified to evaluate laetrile either by experience or education. It has been demonstrated right here today that Mouse studies for instance transplanting human tumors in mice and then attempting to control those tumors with laetrile was ineffective. We could have saved the government thousands upon thousands of dollars if they had just collaborated with the pro laetrile people before they started the test because that isn't the way it works. Now if they are going to use any more of the taxpayers money, the only thing that we're asking them to do is collaborate with the people who've had 20 years of experience on how to use this compound. I don't think that's too much to ask. We are openly offering our services in this area to anybody this committee or any government agency who wants it up to our financial capabilities. And I'd like to have Senator I'd like to stress at this point that the freedom of choice committee had a budget last year of slightly over a hundred thousand dollars compared to just the ACs alone, which had a budget of nearly a million dollars. So if one asked why some of this data is not available now it's because you're looking at this table at the people who have to do it all we can't hire secretaries or computers and we don't have large Banks of people to do the work for us. We need your help. And that's one of the reasons why we're here not to cause additional fractions between the various groups were asking for your cooperation and where your were offering hours. (00:42:25) Well, it's the the information You're talking about you say it's just a small group and yet you're talking about the treatment of various of people thousands of people in this country. And all we're asking is that we get the independent study we've agreed now in terms that would be the Merc definition will get an independent review and the scientific evaluation and that's the way that it should be done. We don't permit when they drug company wants to know what Avail with a particular drug that they are going to be the ones that are going to decide how a particular drug is going to be evaluated you use the test and the procedures which are established to do it and I would hope if we can get the questions of the ethical consideration which are very significant that that would publish in the Federal Register how that to particular model was going to be as established and that we did invite the scientific Community to make comments and we'd invite your people to make comments. I think that's the only way they can be discarded. That's the only way to end. The only thing that's that we can agree on it. Of course what I think as well is that we ought to suspend it until we get a final definition. I mean, that's the way they do in terms of other drugs. You don't continue to use it till you prove it one way or the other but it seems to me if we can and and I think that is really the appropriate way to proceed on it, but we can get we're on record now in terms of following that that that that the profile of that model or that test. They will make a lot of make a lot of progress. I'd like to ask (00:44:06) I would like to also stress Senator and I do not want to leave the impression with the with this committee or on the Senate record that this information has not been available and we have not tried to cooperate in the past as you may or may not know at the Kansas City hearings we offered. Clinical data to doctor young who is head of the new drug section of NCI and he made a statement before that committee to at the end that he found this data and information extremely interesting and that he would visit our Seidel Clinic we have there was 14 cases as last week. We presented another 30 cases from aside L Clinic to NCI. So we are doing everything within our limited power. I'd like to also put everything in proper perspective and when we talk about dr. Richardson who I'm not only dr. Richardson, but the some other 1200 positions in this country who brought this whole issue to the American people. I'm really proud to be associated with them. Now. These doctors are not on grants. They have practices and not only that they have been harassed in this country for four years. It hasn't been easy for these positions to generate the type of statistical information that is required to show the efficacy of this drug in this country. That's why this ideal Clinic exists because we put up a clinic outside of this country utilizing all Orthodox modalities as well as the metabolic approaches to cancer patients utilizing computer patient workups. Use analyzing all the facilities including nuclear scanning diagnostic x-rays complete laboratory facilities. And this is the information that is now being presented to NCI and to the FDA so we are doing everything in our power. To comply and to bring this to a head now, I would like to yes, sir. Only on the side of the mice experiments and they were waste of money because this isn't the way it works now in a nutshell in layman's language. How does it work? Dr. Griffin would just respond to that very briefly. Yes, when there's no sense in having a whole new series of (00:46:40) experiments if they're going to be correct verse you before we start and that's why I do support the concept we ought to are the (00:46:47) procedures and the way we're going to go or we're obviously back in the same kettle of fish. (00:46:52) Yes, Senator schweiker, the one area of honest difference and of contention between the literal clinicians on the one hand in the standard on the other is this matter of gross to me faction the Lumpur the bump we contend that the lump or bump the tumor is but a symptom of an underlying systemic dietary deficiency State disk metabolic state. And this is the state that is corrected by the administration of laetrile or vitamin B17. The lumps are bumps do not magically disappear and all over the country these people who are indeed the victim The Architects of the liat real Victory these patients who have been on their Trail for four or five years are still carrying these lumps and bumps and very many of these patients have examined to date by an honest competent surgeon would be told my God, if you don't get into surgery and have this cut off within the next month, you're not going to continue. You're not going to live. You're not going to make it you see we are faced with a science scientific revolution here just as profound as a germ theory of disease. It's just as profound as the difference between the copernican theory and the their tables of Ptolemy. This is we do not necessarily speak the same language though. In the laetrile movement and those out of it. This is not difficult to understand in view of the fact that 400,000 Americans are dying every year. This is mute test is testimony to the total futility of what we're doing and is I've earned to Senator Kennedy and I would repeat much more important at this juncture. Then the lift will program itself is to bring in men like Professor hardened be Jones put them under oath bring in experts and let them decide sect this contention that the cancer population when considered as a population live for a shorter period of time and suffer more when treated then if left entirely alone. (00:49:08) Yes, I think I think we've got off to the question of whether or not Orthodox therapy is is effective or not and just to summarize The state that we are in the protocols that exist for orthodox therapy are not applicable for the most part to metabolic therapy and laetrile. I don't know whether you caught that or not senators and this is one of the reasons why we're having problems the protocols in screening techniques as they exist today are not applicable to lay a trail and metabolic therapy. And this is one of the reasons why collaboration is going to be absolutely necessary. If we are going to receive any or we're going to get in meaningful data anything that both sides is going are going to accept. So this is the basic problem. I have another (00:50:03) problem where you're not a reneging on our agreement (00:50:06) absolutely not alls I'm saying is it's going to be difficult Sloan-Kettering a couple of weeks ago said, they didn't know how to set up protocols for metabolic therapy and alls I'm saying is it has to be done. It hasn't been done for 20 years and we're willing to work on it. I'm trying to find out how I am doing. That's the senator I could give (00:50:22) another little bit of an insight into the way I (00:50:25) think of this that (00:50:28) that normally you have a cancer cell that has a job to do in the normal (00:50:36) body and it is Sir under a survey and factor, which is a vitamin vitamin B17. And if you're taking this vitamin, then you keep this population under control. If you're if you become deficient in that vitamin than that cell that potential cancer cell begins to spread and metastasize at some particular Point than the body is going to have an immune reaction. It's going to attempt to surround a collection of these malignant cells and then you're going to have your tumor. So the cancer itself started way way back. I mean the metabolic deficiency disease started (00:51:18) without giving Will giving a control (00:51:20) group that was (00:51:21) terminally ill with cancer or laetrile and a (00:51:24) control group. Not laetrile. Is that is that what you're talking about? No, I'm just talking about in the normal person. We have a normal cell that you know what my question was. How do we have a fair test? All right. I'm getting to the point. It's going to be difficult unless you would say now everyone in the country can take vitamin B17 and the sooner you did that. The sooner the price would plummet drop to know what's wrong with the test of a (00:51:50) group is taking it one. That doesn't (00:51:52) okay as long as you as long as you include we're talking about like program. They wouldn't be anything wrong with we're talking about a preventative. That's the True Value now when we get over the bridge into that Final Phase that terminal phase then we're dealing with the tumor which laetrile isn't going to get rid of sometimes it does and that's But the whole thing is that they will notice this immediately and they did in the 53 1953. It wasn't a 53 California report when it was used for cancer, then which (00:52:24) shows that the FDA has been grandfathered incidentally, (00:52:28) but at that point they noticed that did you catch that. Yeah, they noticed at that point that the person was relieved of pain. They didn't have any pain. This is one of the things we noticed in our Clinic. Okay, second thing their appetite increases their weight gains and they have a feeling of well-being. This is what they will notice in that terminal patient. It can be given with all other things but the other things might be making them sick and you know nauseated and there might be other side effects. So it wouldn't be a consistent testing of laetrile by itself. You see what I'm they will notice this but they're not going to notice tumors go. Away, they might sometimes they do. I think we're getting into the actual protocols. Now John (00:53:17) good to just a minute or two left. (00:53:19) Let me let me finish then if I may and there's the boat and the rather get or period of time that we have and I'd like to just sum up by saying that I'm very proud of the progress that the committee has made and some 1,200 doctors that using laetrile of made but I'm here among other things to warn this Committee of my concerns the longer the FDA continues to treat laetrile as an illegal substance. The sooner is the time before authentic organized crime gets into the ACT. You cannot have a market as vast as the laetrile market is now with adeb and so great for a compound so harrassed without driving it into the hands of organized crime Senator and gentlemen, if there are already abuses in laetrile pricing and distribution and if organized crime does surface and Trail you can place the blame squarely in exorbitantly at the door of the federal government. Rest assured gentlemen that the people demand laetrile you saw that in your recent Harris poll and they are going to get it whether big brother wants it or not. Those are the realities of life. Our organization has offered its good offices to work with the establishment in using and testing laetrile. We repeat that offer now, but we cannot expect that thousands of American Cancer sufferers are going to wait for more long years while the federal government fiddle-faddle through animal tests and more red tape Senator gentlemen, the Hot Potato really is in your hands. (00:54:58) Well, the Hot Potato has been in our hands here this morning would indicate quite clearly that according to the best scientific information from the Food and Drug Administration from researches and every important scientific institution of this country. Find contrary to what your own findings are in terms of scientific fact that there isn't a scintilla of evidence that it provides any sense of Hope in terms of curing or preventing cancer. That's the record to date that in the instances that they've been Wholesale profiteering in terms of this this this substance that there have been gross malpractices and a number of the individuals who have both appeared a here today in terms of the distribution of it and the lesson from this hearing or to go on out very clearly that it's it's unwise certainly for any American who will be willing to experiment or accept this particular drug and believe that they're going to be dealing with the disease of cancer. That's that's the Hot Potato. The one thing that we have indicated on this is that if there is new information that we would not be responsible if we didn't provide some opportunity or some vehicle for those to present that information the same way that any drug company presents its information to be subject to the same kind of scientific review the best in terms of that this country can provide. And that too will certainly work as members of the committee to ensure and insist that we try given the ethical considerations that that test be done. And my commitment is that that test is done and it does show that it is Meaningful in terms of it. You're going to find you're going to have no finer champion in terms of legitimate legitimate sizing this but if it doesn't your commitment is to stop halt cease raising false hopes among the American people that there is some Panacea and that the some people whose families have been struck by cancer in the most vulnerable times their lives are not going to listen to was slick salesman or for a false sense of hope and that is what the what the conclusions of this hearing is is morning and we ought to understand what that what that conclusion is at least in terms of my (00:57:24) own my own position other members things your your insinuation Senator are not acceptable but your plan is acceptable and we will cooperate (00:57:34) and that was Senator Kennedy concluding yesterday's laetrile hearings before the Senate Health subcommittee Kennedy. Forged a compromise between opposing groups to collaborate on clinical tests of the controversial drug. However, the FDA has yet to establish ground rules for a test. And it's expected action is at least several months off. You have been listening to taped highlights of these Senate Health subcommittee hearings on laetrile. I'm Nils and Anthony.