Gerson Research Organization

UNCONVENTIONAL CANCER TREATMENTS U.S. Congressional Office of Technology Assessment March 9, 1990 Advisory Panel Meeting 600 Pennsylvania Ave. SE Washington, D.C. ROSEMARY STEVENS (Advisory Panel Chair): The purpose of today's meeting is to review the content of the review draft. As an advisory panel this is our last chance, and our task is to listen to and discuss with each other a broad view of this report. We both have been asked by OTA to listen to some strong criticisms of the report from outside reviewers and we are very happy to have their published statements available. In the morning, this morning, we will only hear from 16 outside reviewers. That is the 16 who responded to OTA's invitation to present their criticisms of the report. I'd like to keep concentrated on the major issues. This is a very rich report and I want everybody to have a fair share of time so that we might define the more important stuff to take each comment from the advisors. So I'd like you to keep concentrated on the major issues, including the findings of options, rather than on the many details of the report which can be handled through written recommendations from individuals as written responses. Detailed written comments should be sent to the OTA staff directly along with any supporting material, and I know that many of you have already done this. Thank you. We're happy to have all the other observers, as well, who are not scheduled to speak. We're happy to have you here, listening. Unfortunately, we cannot invite you to speak, and we will not take questions or comments from observers who've not called. The OTA staff would be very happy to hear from you, too, in writing or by telephone. We are all anxious to have appropriate comments. Those introductory remarks having been said, can you now hear me? No? Is it on? SOUND TECHNICIAN: Yes. STEVENS: We'll do with it. This morning, in a sense, it's more important that the speakers have adequate mics. Can you keep working? We'll need to keep going as fast as we can. I would like to hand over now to Dr. Gibbons. JOHN GIBBONS (OTA Director): Thank you madam Chairman. I personally want to thank you and the advisory panel for your long service, extensive guidance, and critique of this assessment, and also, although most of them aren't here, to the many additional reviewers that have, as usual, supplemented and complemented the kind of review that the panel was able to give us. Our work -- and you know that, while its ultimately OTA's job to do the final writing and delivery of the information to the Congress -- in other words we excuse the panel from any blame or credit -- we depend extremely heavily on our advisory panel and our review process to make certain that our small band is able to capture effectively and accurately the national wisdom on the issue. We very much appreciate the extraordinary amount of time and effort you've put into this. I also note that we have a little unusual number of visitors with us. The last time this number joined us, I think, was about a month ago when we were doing a final review of the financial markets of the U.S., and we had a lot of people from stock exchanges in other parts of the country and it was an interesting and busy day. So, we do welcome you with us, and because many of you are not as familiar with OTA and its work for Congress as the rest, I thought I'd take just a moment to remind you of what we are. We're the smallest of the four support agencies to Congress. The General Accounting Office is the largest by a factor of about 35 times larger than we are. Their job is to audit the operations of Government and make sure the agencies are doing what the law says they should be doing. The Congressional Research Service, which is a part of the Library of Congress, is a common resource for all Members and Committees for whatever subjects they need to be given a quick review, in terms of what the literature has to say. They handle thousands of requests for information each year. The Congressional Budget Office and OTA are the smallest of the agencies. The Budget Office is the Congressional counterpart to the Office of Management and Budget, and they look at issues of finance and financial implications of proposed legislation. OTA, on the other hand, is charged with looking at the impact or implications of changing technology on the issues before the Congress. We work only for the Committees of Jurisdiction of the Congress and, again unique in the four agencies, we are governed by the Technology Assessment Board which is a twelve member group, a working board of directors, that meets about every six weeks to enable the agency to use its limited resources in a way that's most effective for the whole of the Congress. Typically, a study at OTA is requested by a group of Committees, all of which have some jurisdiction in the matter, and our job is to act as a shared resource to these Committees in doing the analysis of the uncertainties of the implications of changing technologies on society. Our mission is not to tell the Congress what they should do. Our mission, rather, is to try to help narrow breadth of the debate about social/technical issues to a point that it's more manageable by these, our elected representatives. Our job, in other words, is to help focus debate by narrowing the argument as best we can, leaving those things that must be adjudicated to the Members. Having done as much narrowing as we can, we then try to provide, not recommendations about what Congress should do, but rather options and alternatives of what Congress has at its hands that can be derived from a careful analysis about what sort of a road map Congress has. We don't try to tell them which road to take, we simply try to provide them with information about what the roads look like. Our Board of Directors approves the undertaking of each major study, and we always have about two dozen studies going on at any time. Once that approval for undertaking is given by the board, it's up to OTA and its advisory panel to pace the work and complete the study, usually in as brief a time as possible. Typically our work will take eighteen to 24 months, or so. This work has taken twice that time, and that indicates the fact that, sometimes, a study is so complicated, or other issues of priority pushed aside our resources for a while, that more time is required to complete the work. It was about a year ago that we had a major meeting on this. We realized, as a consequence of that meeting, we still had some more work to do, and that's why we are yet another year down the road. But I think Congress, and we, and all concerned people are interested in seeing how this issue can close, and we hope, and believe that this will be the last meeting of the advisory panel. Our process after today will be to carefully review the happenings of the day, the information that has come in from reviews, and from the dialogue. We will then prepare a draft that will go to our board who will have two weeks to consider it. This will probably happen in the late spring, and if the Board considers -- authorizes -- its release we will then undertake a final review and edit before we publish at sometime, I would presume, around near the midsummer; June or July. Again, I want to thank the panel for its perseverance and help, and also for our reviewers, our supporters, our critics, because we are, we are a little bit of what I call the Archemedes principle of analysis. We manage to stay upright and on target only if we have appropriate pressure from all sides, and it's this gathering of national wisdom that's occurring here aging today that enables OTA to much more accurately reflect the collective national wisdom to try to focus the arguments for Congress and then provide them with some options for their careful consideration. So, I want to thank you again. There are some materials about OTA in the outer hall, and I will stop because my job today, as usual, is to listen and learn, and we have a busy day before us. Thank you. STEVENS: Thank you. We will now have an introduction by the project director Hellen Gelband just for those of you who haven't seen the agenda. We will then have brief sets of remarks by the panel members, and then we will go directly on to the statements which will all be given this morning. So it's a full morning, and, I think, a very important one. And without ado I will turn to project director Hellen Gelband. HELLEN GELBAND (OTA "Unconventional Cancer Treatments" Project Director): Thank you. I'd like to add my welcome to Rosemary and Dr. Gibbons'. I also want to mention that there are a number, several advisory panel members who couldn't make it to the meeting today, but I've heard from most of them and I've talked with them and had correspondence with them, so I also have a sense of their reading of the report, and if it's appropriate I'll mention their comments. Actually all I'm going to do is go through a few administrative details before we get right into the meeting. I think Dr. Gibbons covered the central things that are necessary. For the press, since there are a number of press here, there's a press room on your way in, it's conference room H. You're welcome to use that room for interviewing speakers or panel members or to make phone calls. We ask that no filming or videotaping be done while the meeting is in session, or flash pictures while the meeting is in session. Audio taping is fine. There are bathrooms the back of the lounge area over here to my right and down the hall to the left. When we break for lunch the advisory panel will meet down the hall in the room on the left, and for all the visitors there are many places outside on Pennsylvania Avenue. There's no smoking anywhere in the building except in the lobby. The meeting materials, I hope everyone found, for visitors and speakers are in the room, in the back of the room where there's visitor seating. There's coffee back there and coat racks and reading material which include the statements provided by specific speakers. We don't have them all yet and some of them are still being copied, so as we get them and they are copied we'll have them available there. Otherwise, thank you very much. STEVENS: Yes. MICHAEL LERNER (Special Consultant): Yes, may I? Just a point of information for Hellen. Hellen, you spoke of press interviewing panel members. I thought that our rule was panel members are not supposed to comment on the thing in public. I just wondered if that's incorrect. GELBAND: Well, I would hope that we'll be treating the contents of the report still as a draft, but people are free to express opinions. ROGER HERDMAN (OTA Deputy Director of Health): Hopefully the draft process relies on the material being considered changeable in the draft because our preference is that the press not be told options and conclusions in such a way that they think that this is OTA saying it. But a panel member or anybody else who decides they would like to talk to press is on their own. We have no control over that. Obviously that's the type of organization we are. We prefer a draft be considered a draft. STEVENS: Let's move ahead then and go around the room giving the advisory members a chance to introduce yourselves and make a brief -- very, very brief, please -- general statement, if you have one, about the draft. We've got to move on to the outside reviewers, and I feel like a time cop here. Please help me out because the advisory panel clearly has the opportunity for a great deal of input later as well. So, perhaps we could go around this way and start with Jeanne Achterberg. JEANNE ACHTERBERG (Advisor): I'm Jeanne Achterberg and I'm director of research now at the Institute of Transpersonal Psychology in Menlo Park. I'm pleased to say that I never thought I would see this document in my lifetime. With all the criticism we may subsequently make of it, it is a first, almost clear picture of what we're dealing with in federal problems we face in terms of managing cancer. I would like to be able to see us, if not today at least in the near future, come up with a clear set of recommendations so that the document itself doesn't die on the vine. It isn't worthy of that. It needs to go forth. I would like to see us come up with a clear understanding that curing is not the only endpoint in the treatment of disease, and if we come to that then a lot of focus in the document starts to shift in terms of the way we look at the data. I would like to see us pull out the middle ground of those things that are not intended to cure but are intended to care. That's a lot of work for today and I don't have any illusions that that's going to take place at a set point (unintelligible). GIBBONS: You mean by middle ground to pull out... ACHTERBERG: Pull out those that don't pretend to be curative treatments, and there are many, many things in there that don't project that. GIBBONS: To emphasize the, not remove them? ACHTERBERG: Yes. KIETH BLOCK (Advisor): My name is Keith Block and I'm a physician in Illinois. I'm a private physician, although I teach at the university of Illinois, and I believe the right approach is a clinical program which combines the best of both worlds. I'm somewhat embarrassed as a physician that it took really a response to political pressure instead of scientific zeal to get to this point, and I really believe, while this has been a wonderfully mammoth project in its undertaking, and that there's some extraordinarily good points within this, that there's also some significant details which I'll deal with in writing, omissions as well as some structure here and there, very significant and very substantial. Read me a little bit concerned about as it is in its present state. I think its been echoed by some of us in conversation that if this were a first draft we'd all be very, very comfortable with it. Seeing that this is our last real opportunity to give interactive communication over this face to face, it's a little bit concerning to me. I have one last opinion. I'll give you a number of points this afternoon in terms of my feelings about the middle ground as Jeanne has said in what specific omissions I see and specific structural problems I see with the piece as it stands now, but I really don't believe that anyone yet has earned the public credibility, has really earned the right yet, for any kind of exclusive on cancer care. And I think that that's one of the things that this piece has to ask us is "Where do we go from here?" If this is a jumping off point, that's great, but if this is the final statement as to where the industry as it exists in both worlds right now is at, I think we have some problems. JONATHON COLLINS (Advisor): I'm Jonathon Collins, practitioner in Washington State, and I employ conventional and unconventional therapies. I also edit the Townsend Letter which is a publication for all the alternative community. From a report that I had feared being a complete wash out, I think that this report has some balance that I'm pleased with, although a great deal of the writing had some significant negative implications on most of the proponents of unconventional cancer treatments. I feel that, unlike most of the writing that appears in the New England Journal , and other journals, this report presents the position of unconventional practitioners in a way that offers some fairness, at least from their position of what these treatments are. I also think that one of the respective ways of approaching unconventional cancer therapies that is coming out of this report is the description of best case reports, and I don't think that that idea has ever been something that has been accepted in the study of conventional treatments. I think that this a means of recording data in the future which the conventional oncology community will need to take seriously and will have to confront, because there is a very serious interest in unconventional cancer treatments. MICHAEL LERNER (Special Consultant): My name is Michael Lerner, and I'm the president of Commonweal, a health and environmental research institute in Marin County, and for the past ten years I've devoted essentially half my time to the analysis of alternative and adjunctive cancer therapies. I want to associate myself with all of the remarks that the preceding three panelists have made. I think that this report will be a source document in the national debate over unconventional cancer therapies. I want to associate myself with the specific comment that if this had been the first draft, we would all be very pleased, because this would be a starting point for refinement that I believe should take place if this report is to reach the level of quality that OTA is well known for. So I think that, although light years of progress have been made from the first draft to this draft, there are still some very, very important corrections. Specifically, I'd like to associate myself with the comment that what I think is missing most of all is that the middle ground, that does come forward in the section on psychological approaches, is absent in the sections on nutritional and spiritual approaches, just to take the most obvious ones. And that if the nutritional middle ground were there, there would be a placing of many of the alternative nutritional therapies in a scientific context in which they would make much more sense. As it is, the negatives that are applied to the specific nutritional therapies take place in an absence of the context of the premises that do scientifically substantially suggest that some of these approaches have grounds. I think that that is very important, and I, personally, have such respect for the OTA process, that I would like to see what I believe would be a historic document really fulfill its promise and to see OTA take the time and the effort that will be needed to take that next step. Finally, I would like to say that I think that what Mr. Gibbons mentioned, basically the narrowing to key options, I'd really like to see the key options section strengthened, and I think that one of the most constructive things that could happen that would unify us all in this area is that I know that many of the people who brought this request into being wanted to see funding and a regular mechanism for the evaluation of unconventional therapies. And I think that would serve everyone. And so I think that a strengthened section on a regular and fair and objective system for the evaluation of unconventional therapies, including funding earmarked for that, and a decision process that represented all constituencies, that would go a long way toward overcoming the present absence of scientific information which leads and organization like OTA to the many specific negatives that we see in this report. GAR HILDENBRAND (Advisor): I'm Gar Hildenbrand. I'm the executive director of the Gerson Institute. I am also, possibly, one of the more outspoken critics of OTA's process and of the report as it stands right now. Without going into detail, but just simply from an overview, I think that my greatest concern is that, while the science issues have been addressed, the purely policy issues, socioeconomic issues which could possibly be legislated by Congress -- because Congress can't legislate science -- are not, to me, seem not to be clearly articulated. And I do not see, in the options in this draft, solutions to those socioeconomic issues which are meaningful, and I'll submit detailed comments in writing regarding that. It has to do with legal decisions as well. Overall, I am able to say that I think there's enough structure here to hammer nails into, and I think that I would like to echo Michael's sentiment that this is a good first draft. Would that we were eighteen months away from a full draft and an outside review, because the possibility does exist to get from this, as a starting point, to an adequate description of the socioeconomic problems in the trades. That's my comment at least at this point. ROBERT C. EYERLY (Advisor): I'm Bob Eyerly and I represent the American Cancer Society, and we have decided to make a general statement right now and then sometime within the next two weeks we will have a more detailed written statement that we shall offer Miss Gelband and her staff. At this time the Society commends, as many others have thus far, the Office of Technology Assessment, for the thorough research and painstaking review of unconventional therapies presented. We are well aware of the difficulties in gathering information and data on unconventional therapies. The staff has done a tremendous job. Our major concern is the evaluation data of the efficacy of unconventional therapies. We believe in order to prove a therapy is effective in treating cancer the promoter should be able to demonstrate the three following basic questions in the affirmative: 1. Has the method been objectively demonstrated in the peer reviewed scientific literature to be more effective than nothing? 2. Has the method been objectively demonstrated in the peer reviewed scientific literature to be as safe as doing nothing, or has it shown potential for benefit which clearly exceeds the potential for risk? 3. Have objective studies been conducted under appropriate peer review and approved by reasonable human studies committees to answer these questions? It is clear from the evidence in this document that these unconventional therapies do not answer these questions in the affirmative. The Society also cautions that even the best case review has historically failed to produce valid conclusions. It must be understood that it is impossible to demonstrate efficacy by best case review. The report is punctuated by editorial comments throughout that appear to be logically invalid. For example, there is frequent citation throughout the report that the lack of evidence regarding the safety and efficacy of unconventional therapies constitutes evidence. This appears to rationalize their use. The constant use of the word "alternative" to describe unconventional methods is inappropriate. And, as I said previously, these are our opening comments and we will be having a written document within the next two weeks to the project director. Thank you. C. NORMAN SHEALY (Advisor): I'm Norm Shealy of the Shealy Institute for Comprehensive Health Care of Springfield, Missouri. I believe that the improvement that has been made in this draft is so great that I trust that the final refinements will further complete that, and I think that the document is really, as it stands, an excellent overview of the tough opposition that exists in unconventional therapies. The major difficulty is funding. Pharmaceutical houses routinely spend up to a hundred million dollars getting a new drug to the market place, and I think you've done a really elegant job of emphasizing the lack of great scientific validity for some of the current conventional therapy of cancer. What I would like to recommend is a policy that Congress fund a national research policy or fund for unconventional therapies to be managed outside NIH, NCI, or universities; that a committee of fifteen people be chosen, one third of them being neutral conventional scientists, one third being unconventional proponents, and one third being neutral laypersons to choose grants for such unconventional research. JOHN FINK (Advisor): I'm John Fink, president of the Santa Barbara chapter of Cancer Victors and Friends. I'm well aware of all of the tremendous amount of work that's gone into this report; also aware of much of the work that may be ahead. In the order of brevity I'd like to say that I agree with most of the sentiments -- most of the sentiments -- that have been expressed previously, and I would like to withhold my comments for this afternoon when we go down and specifically address each chapter. RICHARD RIEGELMAN (Advisor): I'm Dick Riegelman, an internist and epidemiologist, and I'm very impressed with this document as a very thorough expression of the current state of the art. My focus, however, is really on the process and the methodology used to evaluate future therapies as well as these therapies. As the day proceeds I would like to make some comments on the options that are available for methodologies. I do think it's important that this report express the full spectrum of options here. But as a report that frames the issues needed to be (unintelligible). BARRIE R. CASSILETH (Advisor): I'm Barrie Cassileth of the University of Pennsylvania Cancer Center and like everyone else I appreciate the work that went into this draft and, more than that, I appreciate difficulty of writing the document that required somehow communicating with, at this point, two polar opposites. Hopefully in the future that won't be so, but I think that it is right now. A number of the panelists have mentioned the importance of methodology and evaluation and that's my feeling as well. I think we can regard 95% of the document as a review of what is happening now. And I would like to focus it on where do we go from here and how do we do it. And I'd like to see a much earlier emphasis on that last little part. I'd like to expand it considerably. I think that we need to talk about options; the value, the relative value of given options; what appropriate methodology is. I think the one thing that we can do as a panel, more important than anything else, is to agree on a (unintelligible) of evaluation -- that's not upon methodology -- but agree on a quality, a standard of what we would like to see in order to go forth with a particular regimen or treatment. Thank you. STEVENS: We're having a little technological difficulty up here with the microphone. (Unintelligible) I think I've covered all panel members. Perhaps we could get those OTA members who haven't introduced themselves. Perhaps you would like to introduce yourselves so everybody knows who everybody is. ROGER HERDMAN (Assistant Director OTA Health and Life Sciences Division): I'm Roger Herdman, assistant director of OTA for health and life sciences. CLYDE BEHNEY (OTA Health Program Manager): Clyde Behney, Health Program Manager. JULIA T. OSTROWSKY (OTA "Unconventional Cancer Treatments" Principal Analyst): I'm Julie Ostrowsky, OTA. I've been primarily involved in the assessment of unproven treatments and I'll be continuing with the revision. GWEN SOLAN (OTA Analyst): My name is Gwen Solan and I'm a physician practicing in Massachusetts. I've had some experience, clinical experience, with families and patients going through cancer treatments. I'm here today because, for two out of three years of the project, I worked as an analyst on the staff on a lot of key sections, and I join the staff in looking forward to (unintelligible). SARAH DRY (OTA Research Analyst): I'm Sarah Dry, OTA Staff. STEVENS: Thank you very much, everybody. Have all of you been gotten around the table? Everybody's spoken? I'm Rosemary Stevens of the University of Pennsylvania. I'm a historian. I feel this report, again, I'm impressed by the way the report has evolved over time. The purpose of writing this draft has been a dialogue, a process. I think it's been rather clear from the comments of people around this table, we're dealing with, largely, a panel which was drawn from a variety of different perspectives. (unintelligible) At the moment, it may be impossible to produce a report which will reflect everybody's views adequately. It's important to get different views out for discussion, across disciplines and areas which traditionally have not done very much about that sort of (unintelligible). I very much look forward to the views of the other panel members and those who have made some criticisms of the report at this stage, and also those who were thorough enough to make a deliberation going chapter by chapter which is going to take place later today. I'm glad everybody's here to start to participate in what I think is an occasion which it would have been very beautiful to see even ten years ago. That's my historian's perspective, speaking so delicately. And we will come back to some of these, some mentioned criticisms of the report, particularly in terms of the way we see these recommendations and the substance of the evaluations as we go on later today. You will be amazed to note that we are actually ahead of time. So I congratulate the advisory panel in doing this, so that we can now go on directly to invited scheduled speakers in the room. And I would reiterate, the major invitation, the invitations were given to individuals to whom the report was sent who have particularly critical views. The range, the speakers do not reflect the entire range of responses to the report. But Hellen as invited people who have particularly strong beliefs so that at least we would be sure that these would be available to members of the advisory panel and to observers as well. We told the speakers in advance that each person would be given five minutes. Each of you will have five minutes for a statement and five minutes for questions of the advisory panel. And we will be keeping time by that little light panel. This advisory panel has not done that before. I am informed that this is the common practice in other public spheres. The green light will stay on for five minutes, and then the red light will come on. Don't be alarmed. I'm supposed to give a rap on the gavel when it turns red. Just finish your statement. Try to wrap it up then. As soon as it turns red the light will be reset to green for the second five minutes. If you run into the second five minutes, what you will be doing is you will be cutting into the discussion time. And I guess I do a particularly hearty rap when the light goes off, so we'll just have to play it as it goes. If any of you, at the beginning of this, were not yet here you will obviously be given the chance to reorganize, to reorder as we go. Does anybody on the advisory panel have any comments or questions before we move ahead? STEVENS: All right, the first statement is by Seymour M. Brenner. Is Seymour Brenner here? SEYMOUR M. BRENNER: Yes. STEVENS: Thank you. BRENNER: Where do I go? STEVENS: There by this ominous looking battery of mics, and if you need any visual aids, let us know. BRENNER: My time starts now? STEVENS: Yes. BRENNER: Essentially, I am a physician who treats cancer in New York. I'm basically a radiation oncologist. I've been doing it for thirty-nine years. I have a rather successful practice, in that I see, probably, a hundred to a hundred and fifty patients a day. My great frustration is that, in thirty-nine years of practicing medicine and treatment of cancer, I say that we have seen no significant progress. Because of my frustration, I have, for the past five years, on my own, been investigating alternative methods of treating cancer. In the latter part of 1988, I went before the NCI and the FDA with the support of Congressman Molinari (R-NY) to try to get approval to do a research program into the treatment -- into the investigation of alternative methods. I was told by the chairman of the FDA that new preparations have to be evaluated in a certain fashion. I said, "What is that fashion?". He said, "Well, they have to be tested in the laboratory first, then on animals before we go to humans". I said, "How long would that take?". He said, "An average of three to seven years -- a range of three to seven years with an average of five years". I said, "I see millions of people dying in five years; I see hundreds of billions of dollars being spent in five years: why do we have to wait that long?". No constructive answer. What I would like to recommend is that an independent panel of competent physicians -- and I would say that I have spoken to five oncologists at various major medical centers who've agreed to go on an independent panel -- would send word out to the medical community: "If you have a patient who is considered hopeless with an established diagnosis of cancer, refer them to this panel". This panel will either approve or disapprove the hopelessness of the situation. If, in fact, they are hopeless on standard methods, I would then like to invite the directors of alternative method clinics to send us protocols that we use to test on dying patients. We have nothing to loose; they're dying. We have everything to gain, because we could save lives. So far, nothing constructive has happened. Now, how do I know that these alternative methods work? -- because I heard, I think, and I've read that alternative methods do not work. One of the men I've investigated is Dr. Revici in New York, who is ninety-four years old, and has been the target of much criticism and many attacks. I would just like to tell you about ten patients who I have investigated who he has cured, who I would not cure, who would die under my supervision. And I challenge any doctor to question what I'm saying about these patients. Incidentally, for each one of these patients, I went back to the primary institution. I did not take the records from Dr. Revici. I confirmed the diagnosis of the primary institution. I had an independent panel of pathologists who agreed to work with me, who confirmed the histological diagnosis, so there's no question about the diagnosis or stage of their disease. I don't know how many of you are physicians. Just listen briefly. A forty-three year old male. Memorial Hospital, Sloan-Kettering. Cancer of the bladder diagnosed at Memorial Hospital. They said to him, "The only way you can be treated is if we take your bladder out and make a bag on the side". He said no. He went to Dr. Revici in 1980, September -- I'm sorry -- he went to Dr. Revici in October, 1980. In 1987, the patient went back to Memorial Hospital for a cystoscopy. Cystoscopy negative. Seven years later, bladder in position, no cancer, cured. Second patient: Twenty-nine year old female also from Sloan-Kettering. Operated on at Memorial Hospital in 1983. Had a chordoma, a brain tumor. The tumor was incompletely resected, followed by a course of radiation. The patient's condition progressively worsened between the time of surgery, and for the next twelve months. The patient was seen by Dr. Revici in 1984. At that time, the patient was wheelchair confined with limited function. She now, in 1990, has had two babies, functions perfectly well. Her only problem is she walks with a cane. A true miracle as far as I'm concerned. Thirty year old woman operated on at NYU. Had an ovarian carcinoma. Bilateral salpingo-oophorectomy and hysterectomy was performed. All gross tumor was removed. Patient was placed on chemotherapy, which she continued for six months; accepted standard therapy. In November of 1985, second surgery was performed. She had a pelvic tumor with omental metastases. Biopsy only performed to establish the diagnosis. Patient was seen in Dr. Revici's office in January of 1986. January 1st of 1990 she is in good health. Next patient, patient four. A fifty year old individual. Adenocarcinoma of the left lung. Tumor unresectable. Put on radiation therapy which is an alternative, an accepted alternative to surgery, and unfortunately the patient's condition worsened. He went to see Dr. Revici in October of 1981. It's now 1990, and as any doctor in this room knows, unresectable carcinoma of the lung does not live nine years on no treatment, so something must have converted that patient from death to a nine year survivor. Thirty-four year old man underwent a knee amputation of the left leg for a giant cell tumor of the femur. In 1979 he had a right thoracotomy for removal of two nodules. In 1980, chest x- ray showed a new 1.5 centimeter nodule and several small nodules in the right lung. An IVP (intravenous pyelogram) showed a ten by thirteen centimeter renal mass. In October, 1980, the patient went to Dr. Revici. Obviously, he's well or I wouldn't talk about it. I have five more cases like that, but I don't want to use all the time. Essentially, what I am saying to these people here and I've have said before, and -- a woman came into my office last week. Twenty-seven year old girl with a three year old child and her husband. Her problem was she had carcinoma of the breast with brain metastases, and she said to me, "Will you, please, don't let me die." Now, I can't cure that lady. What do I do with her? I don't know if Dr. Revici, or Dr. Burzynski, or Dr. Burton, or any of them can cure her, but I am tired of watching people come to my office and plead for their lives and I have nothing to offer them. So, what I am saying to this committee is, let's not turn our back on alternative methods. I'm not saying they are all good. In fact, I've seen patients treated by these clinics that should not have been treated by them, so I can tell you bad things about them. So, what I think we should do, is set up a committee to investigate them in a scientific, approved manner, and tell them, "If you don't open your doors to our investigation, we'll use that to close you down. But, if you do open the doors, and we find out that your method works, that will give you the identity you're entitled to." And again, I telling, to the authorities, if we find that their methods don't work in a scientific fashion, we can use that information against them. But, I think that here, the statement that alternative methods do not work is a mistake. If anybody on this committee would like to see a hundred and fifty patients that I can confirm the diagnosis, the stage of the illness, the hopelessness of the case, and I can show you the data with the slides and everything, that are now alive and well from three to ten years, that would have died if I, an approved physician -- and I'm pretty approved. I worked with CALGB, acute leukemia B group. I did the first study in America, I was a senior investigator, in using chemotherapy and radiation combined in the treatment of ovarian carcinoma. I'm inot a bad doctor, but I'm frustrated and I'm angry and I'm depressed when I see a twenty-seven year old girl who says, "Don't let me die," and I have to let her die. So what I'm saying to the authorities that be is let's set up a committee working in an honest, objective, scientific fashion, and once and for all, see if these alternative methods work. Thank you. LERNER: I just want to say, I particularly appreciate Dr. Brenner's comments because what he has done is what OTA is recommending which is a best case analysis of some of Dr. Revici's patients. I just want to point out that what you speak to we'll find when we go over the chapters. In the first chapters, in the first chapter, in the introduction, the reasons why U.S. patients seek out these therapies, and they talk about various things, but they don't talk about the fact that people seek alternative therapies because of the existence of real recoveries. My real comment is that, with the amount of work and effort that has gone into this, that I would like to see your material on Dr. Revici included in the Revici section. And I just think that's tremendously important, because what we have now, aside from occasional anecdotal cases, there is no scientific evidence. And I think, for a report that is calling for best case analysis, to not include the existence of best case analyses on the important therapies is a critical problem. BRENNER: I have, and I could give you this if you... STEVENS: One very quick remark. BRENNER: OK, what I have, I have twenty-five cases from Dr. Burzynski, twenty-five cases from Gerson clinic, twenty-five cases from Dr. Revici, twenty-five cases from Nick Gonzales, that I have established independently, that are alive and well with incurable cancer. The only thing I didn't say, and I would like to stress, that we should also tell alternative clinic directors, don't see a patient, for example, I saw patient at one of these clinics that had a stage I breast cancer, a young girl thirty-two years old. A stage I breast cancer treated in a standard fashion today has a 96.5% cure rate. Therefore, they should be told, and somehow we should find a way to implement this, that they should not treat patients who are curable on standard methods. That thirty-two year old girl, incidentally, is being treated and is not doing well when she could have been cured on standard. So I'm not without criticism of alternatives, but I think we have to have a legal force, once and for all, to establish the route to go. HILDENBRAND: Rosemary, a comment. A comment. STEVENS: Gar. HILDENBRAND: I think Dr. Brenner's point is well worth taking seriously, regarding the exclusive use of any management, conventional or unconventional, which has no curative intent, when other options are available and can be used in a complementary sense. I think "complementary" is a focus that can, perhaps, extend from Dr. Brenner's comments. STEVENS: Thank you. And, again, we might come back to looking at the decisions in the report. Peter Chowka. PETER BARRY CHOWKA: Thank you for this five minutes, during which five Americans will die of cancer. The daily toll exceeds fourteen hundred; over half a million this year. Most will die despite receiving the benefits of conventional therapies. Paralleling the incessant rise in cancer incidence and mortality is the increase in spending. Around one trillion dollars has been spent on conventional cancer research and treatment since the cancer war began in 1971. Objectively speaking, the only victory now in sight is one of public relations over the reality that has become a medical Vietnam. According to independent national public opinion polls, the majority of adult Americans are dissatisfied with conventional medical care and support freer access to unconventional therapies. The OTA report does not adequately address the urgency of this context. Also underaddressed, the persistent, pervasive, cumulative legacy of decades of unfair condemnation and neglect of unconventional therapies without regard to their promise or demonstrated efficacy. This context is absolutely vital to understanding many of the current institutional and other roadblocks that marginalize alternative therapies. There's an axiom that conventional, status quo science seldom willingly admits or submits to challenges by unorthodoxy, especially in the case of cancer therapy, where many of the alternatives are simply incompatible, scientifically and economically, with an interlocked system that admits only expensive, toxic approaches. For decades now, unconventional medicine has been locked out by official science. Not surprisingly, the OTA draft therefore finds official evidence of efficacy lacking. That should have been the starting point for the OTA's analysis. But for each therapy under review here we get a section entitled, pejoratively, "claims", followed by another sections entitled "adverse effects". The last words we're left with shall always be negative. Two very different therapies, vitamin C and Hoxsey, are dealt with similarly: no attempts by OTA to contact the Linus Pauling Institute or the Biomedical Hoxsey Center; instead, an emergency room physician is dispatched to do a literature search hatchet job on vitamin C while a largely positive contract report on Hoxsey by a noted independent academic is covered up. OTA was stymied in a search for adverse reports on the Hoxsey therapy, so the authors resort, instead, to citing toxicity resulting from high doses of individual herbs that are ingredients of the Hoxsey medicines. And arsenic, we are told, can be fatal when ingested, but arsenic is used only topically, and never internally, in the Hoxsey therapy. I wish the authors of this report had ventured into the real world of unconventional cancer treatment, like Benedict Fitzgerald, a respected Justice Department attorney who led a similar government investigation in 1953. His method, however, was on site, thorough, and probing. The OTA draft cites Fitzgerald a couple times, but ignores his important conclusions. It also twists his assertion one hundred and eighty degrees and says that Harry Hoxsey was bold and combative and therefore attracted the notice of that godfather of the quackbusters, Morris Fishbein. In reality, as Fitzgerald confirmed for me last week, Hoxsey became combative only after he was harrassed by the likes of Fishbein. This is hardly a minor point, and really gets to the issue we're talking about here. Did the OTA ever try to contact Fitzgerald? Did it even care to? This draft is not neutral and comprehensive. Rather, in the sections that count, it is an uncritical, selective review of biased, uninformed, official science. Curiously, parts of the report seem relatively fair, like the section on macrobiotics. But, parts of the report also strike one as the latest chapter in a long campaign of official denial, disinformation, and suppression of unconventional therapies. The draft's recommendations are inadequate. They're minor tinkering will only help to perpetuate the medical twilight zone that alternative therapies are automatically relegated to. OTA has faced a major challenge during the last three and one half years of this report. Perhaps it's beyond the present capabilities of OTA, judging by this draft. Yet it's an important mission. The Congress and the American people demand clear information, reasoned insight and possible solutions regarding this life and death situation. Instead, we get an obsolete, inadequate road map of a challenging, rough terrain. For the sake of the millions of people with cancer who will die in the years ahead and for the future of free scientific inquiry and progress, I suggest that this draft needs major, if not complete, revision, or else it should be scrapped. STEVENS: Questions, comments, from the panel members? ACHTERBERG: Could the speaker please tell the panelists who he is? STEVENS: Could you please identify yourself? CHOWKA: Yes. My name is Peter Chowka. I'm an independent investigative journalist. In the past sixteen years I've published numerous magazine articles, book chapters, photographs and worked in several documentary films on controversies in medicine, particularly in cancer, and now AIDS as well. LERNER: I'd like, Peter, since you are particularly expert on the Hoxsey treatment, I'd like to ask whether you feel that there is available for Hoxsey, through your work and that of others, such as Ken Ausabel, a well documented set of best case analyses on Hoxsey that could be made available to OTA just to give them the kind of list that Dr. Brenner has on some of the other therapies. CHOWKA: Well, I'm not sure how well documented it is or how one would even find that, but certainly there are a number of best cases available. The files at the Hoxsey Biomedical Center are open to serious investigators, including the OTA. As I mentioned in my comments, OTA apparently never phoned or wrote to the Hoxsey clinic to request such information. It simply went to the medical literature. But my understanding is that, yes, there are best cases available and I think Mildred Nelson would be willing to cooperate in any serious inquiry to look into them. STEVENS: Thank you very much. Michael Culbert. MICHAEL L. CULBERT: I appreciate being invited to speak. I'm Michael Culbert, chairman of the board, Committee for Freedom of Choice in Medicine, a California Corporation. I also represent the Bradford Research Institute of California and Mexico, and American Biologics-Mexico, S.A. Medical Center in Tijuana, which some people think of as a center of high-tech quackery. We hope that's not the case. I also am the author or co-author of eleven books in the politics and economics of medicine, and metabolic therapy. Our review of the second draft of the OTA study on unconventional cancer treatments has led us to several conclusions. The first is that we do believe, outside all the hooplah, that, probably, a good faith effort has been made in general to assess treatments and devices developed outside the standard medical models currently in vogue in the United States. Second, we are cheered that the draft notes that provision should be made for ways to evaluate "best-case" scenarios and subjective response. Our Committee and our affiliated AB-Mexico hospital would be interested in possible collaboration along those lines, and, indeed, we did send a little review of our first five thousand cases to OTA. Third, the draft, of course, raises far more questions than it answers simply because of the sweep and depth of the cancer problem. Therefore it turns out in many ways, essentially, to be an irrelevant document; irrelevant because as we sit here, literally twiddling our thumbs all day, and we will be doing a lot of twiddling, more than one American per minute -- it literally works down to about 1.3 Americans per minute -- will be dying of cancer, five hundred fifty thousand this year alone. At least two other Americans per minute will be diagnosed with cancer while we're studying the problem. The extent of cancer and mortality from it are greater in our history than ever before, mollifying comments by this nation's cancer establishment attempting to put a gloss on this notwithstanding. The document refers several times to the interesting phrase, "scientific medicine", and therein lies not only the fallacy of the document, but indeed, of the entire thought system of the American medical establishment. We just wonder when medicine stopped being an art and became a science. Orthodoxy cannot escape its blind allopathic paradigm; one based on, essentially, discarded Newtonian mechanistic principles. It cannot any more grasp the concept of individualized, integrated total metabolic protocols in the management of cancer than it can abandon its obsession with animal tumor systems, cell lines, tumor types, and its central, key conceptual error: concerning cancer to be tumors. The document refers to the difficulty of attempting to evaluate outside-the-pale cancer approaches within the existing framework. Indeed, there a difficulty. It is positioning square pegs into round holes. Therefore, it can't really work. The same mind-set which undergirds the monofactorial conceptual construction of necessity has an equal portion of cognitive dissonance. It cannot process unwanted or new infomation developed from outside the paradigm. As Americans drop like flies to the pandemic of cancer, it should be clear that what we need is a new paradigm; a multifactorial view of cancer causation; a multifactorial, holistic, or bodywide concept of its management, and an abandonment of the status quo which has ill served the nation. Nothing could be more obscene than the spectacle of dying Americans denied freedom of choice in therapy having to go underground, go abroad, or do without. I say that as a representative of a foreign hospital. Nothing is more disturbing to the republican mind, lower case "r", than the spectacle of government power being used to arrest, harass, chasten, and destry physicians and researchers who, by adopting so-called alternative or unorthodox or unproven approaches, are only trying to help their patients. The vicious system which, on the one hand says "we cannot cure you", and on the other hand says, "but don't try some unproven remedy" and warns you always not to sneak off to Tijuana, must come to an end. It is blatantly immoral. And along with it is the controlled, randomized, placebo controlled, double-blind study. I can't think of any (unintelligible) or more immoral than using that as a rational scientific exercise. The solution to all this, of course, is not scientific. It is political. If people have to take to the streets to secure what should be their birthright, freedom of choice in medicine, against the tyrannical concentration of economic and vested interests, then they will. The Committee for Freedom of Choice in Medicine, Inc. hopes that the hour is not yet too late -- that we can, in fact, together, construct a new thought system, a new model, to save us from the plague of cancer in particular, and of chronic disease in general. There will be freedom of choice in medicine, with informed consent for physician and patient. Having said that... STEVENS: Thank you. Questions and comments from the panel. LERNER: I'm going to become a little repetitive here, but I want to ask whether your hospital has available a significant set of well documented best cases that you'd be willing to submit to OTA? CULBERT: Yes, we have oodles and we'd be delighted to have some kind of framework in which we could present these cases. STEVENS: I'd like to make a comment, too, which I think relates both to this and some other of the comments we've heard this morning from the panel and from some speakers, that discussing unconventional therapies relies on discussing the totality of cancer treatment, and that was the goal of the request of this particular report. I think it's very important that we both propose the goal of this report and the awkwardness of looking at one set of standards without looking at the whole (unintelligible). Thank you. Any other questions and comments from the panel. Gar. HILDENBRAND: Briefly, I think that Mr. Culbert's comments accurately reflect the view from one end of the spectrum, and I think that understanding that end of it, which is not easy, especially for people who live at the other end of the spectrum, is important from an antropological point of view. It's imperative to understand where this man's coming from. And I appreciate the comments. SHEALY: As we do have a moment, I think he's raised an interesting point that hasn't been addressed in the issues in the OTA report and that is the whole concept of restriction of trade, if you will. As a physician who's privileged by license to practice I am well aware that there are intellectually extensive arguments against the system that we have which does prohibit freedom of choice by physicians far more than almost any other country in the world. And that's something that OTA might want to spend at least a few paragraphs on. There are two excellent books on the subject. One is called "Of Foxes and Henhouses" by Stanley Gross, and the other is the one by People's Medical Society which essentially deals with regulations and licensure and the inadequacy thereof. ACHTERBERG: I'd also like to comment on your idea that medicine is an art; and I think it can also be a science. I think the problem is that our narrow definition of good science has to do with blind placebo and randomized control, and I think that's absolutely false. I think good science is beautiful, and there are all sorts of methodologies that can apply to it that will yield the kind of information we can use. I would like to see us come on, not unscientific, but scientific in a true sense. CULBERT: The reason I brought this up was, from a lay aspect, that we get lost in the semantics of our favorite thought systems. And, my God, by the end of the day I even have to -- I'm rarely in the position of correcting Peter Chowka but the extrapolation for 1990 of that fifteen hundred and eleven people will be dead within twenty-four hours while we're debating this -- and my God, Dr. Brenner has got it right. If we cannot cure these people conventionally, what is to be lost by letting them try Chinese herbs, even laetrile injections, iscador, etc. This is a moral imperative which supercedes the semantics of science, and we must recapture that, that's all I'm saying. (ATTACHMENT) Michael L. Culbert: The committee for Freedom of Choice in Medicine, Inc. 1180 Walnut Ave Chula vista, CA 92011 (619)429-8200 800-227-4473 STATEMENT OF THE COMMITTEE FOR FREEDOM OF CHOICE IN MEDICINE, INC., TO THE ADVISORY PANEL FOR UNORTHODOX CANCER TREATMENTS OF THE OFFICE OF TECHNOLOGY ASSESSMENT, U.S. CONGRESS March 9, 1990 Ladies and Gentlemen: I am Michael L. Culbert, Chairman of the board, Committee for Freedom of Choice in Medicine, Inc., a California corporation. I also represent the Bradford Research Institute of California and Mexico and the American Biologics-Mexico S.A. Medical center. Tijuana, Mexico. (This statement is being offered in the memory of one of the most active proponents of the OTA study on unconventional cancer therapies, the late Curry Hutchinson). Our review of the second draft of the OTA study on unconventional cancer treatments leads us to these observations: First. Probably a good-faith effort has been made to assess treatments and devices developed outside the standard medical models currently in vogue in the United States. Second. We are cheered that the draft notes that provision should be made for ways to evaluate "best-case" scenarios and subjective response. Our Committee and the affiliated AB-Mexico hospital would be interested in possible collaboration along those lines. Third. The draft of course raises far more questions than it answers simply because of the sweep and depth of the problem. Therefore, it turns out essentially to be an irrelevant document. Irrelevant because as we sit here a little more than 1 American PER MINUTE is dying of cancer (up to 550,000 deaths this year alone) and at least 2 Americans PER MINUTE are being diagnosed with cancer. The extent of cancer and mortality from it are greater in our history than ever before, mollifying comments by this nation's cancer establishment attempting to put a gloss on this notwithstanding. This document refers to "scientific medicine" and therin lies not only the fallacy of the document but indeed of the entire thought system of the American medical establishment. (When, pray, did medicine cease to be an art and become perverted into a science?) Orthodoxy cannot escape its blind allopathic paradigm, one based on essentaially discarded Newtonian mechanistic principles. It cannot any more grasp the concept of individualized, integrated total metabolic protocols in the management of cancer than it can abandon its obsession with animal tumor systems, cell lines, tumor types and its central, key concptual error: concerning cancer to be tumors. The dopcument refers to the difficulty of attmpting to evaluate outside-the-pale cancer approaches within the existing framework. Indeed there is difficulty: it is positioning square pegs into round holes. It just doesn't work. The same mind-set which underirds the monofactorial conceptual construction of necessity ahs an equal portion of cognitive dissonance: it cannot process unwanted or new information developed from outside the paradigm. As Americans drop like flies to the pandemic of cancer, it should be clear that what we need is a new paradigm - a multifactorial view of cancer causation, a multifactorial, holistic or body-wide concept of its management, and an abandonment of the status quo, which has ill served the nation. Nothing could be more obscene than the spectable of dying Americans denied freedom of choice in therapy having to go underground, go abroad or do without. Nothing is more disturbing to the republican mind than the spectable of government power being used to arrest, harass, chasten and destroy physicians and researchers who, by adopting so-called alternative or unothodox or unproven approaches, are only trying to help their patients. The vicious system which on the one hand says "We cannot cure you" and on the other "but don't try some unproven remedy" must come to an end. It is blatantly immoral. The solution here, of course, is not scientific. It is political. If the people have to take the streets to secure what should be ther birthright - freedom of choice in medicine - against a tyrannical concentration of political and economic vested interests, then they will. The Committee for Freedom of Choice in Medicine, Inc., hopes that the hour is not yet too late - that we can in fact, together, construct a new thought system, a new model, to save us from the plague of cancer in particular and of chronic disease in general. There will be freedom of choice in medicine, with informed consent, for physician and patient. (END ATTACHMENT)

STEVENS: Thank you very much, and we'll have some time to reflect on that (unintelligible). Michael Evers. MICHAEL S. EVERS (OTA Contract Report Author): Thank you, Dr. Stevens. Today, I'll abbreviate these comments because I want to get right in and ask some questions. In my opinion, this report is a travesty. Its authors have violated every known rule dealing with fairness and impartiality. A high-ranking science official, a policy official, once wrote that OTA was created to provide political leaders "clear, objective, accurate and unbiased information." The authors of this report have failed to abide by those guidelines. This report presents information that is unclear, subjective, inaccurate and biased. For example, their bias is revealed early on when they introduce the American Medical Association and its infamous Committee on Quackery. The authors suggest that the AMA's opposition to chiropractors "ended with a 1987 ruling against the AMA and several other professional societies after an eleven year lawsuit brought by Chester Wilk and three other chiropractors, who charged that the organizations had engaged in a conspiracy to boycottt chiropractors. Folks, Wilk did more than just charge that the AMA had conspired. He proved it. But to the authors of this report, it's merely a charge, not at all conclusive. Well, the authors undoubtedly will be saddened to learn that Dr. Wilk's charges of conspiracy were upheld last month by the Seventh Circuit Court of Appeals which areeed with Judge Getzendanner that the AMA violated the Sherman Act by conducting an illegal boycott of chiropractors. The authors inaccurately portray unconventional cancer treatments as more expensive than orthodox treatments by presenting costs associated with treatment for melanoma and stomach cancer. They rely on a 1988 Medicare report to suggest that initial treatment charges in the first three months after diagnosis are a mere $10,000. Average monthly expenses thereafter are a mere two hundred and thirty-five dollars. This slanted presentation attempts to minimize the true impact of cancer in this nation, which, as we all know, is estimated to cost more than seventy-five billion dollars annually. In fact, a recent survey conducted by the American Society of Clinical Oncoloogy found that treatment for acute leukemia or lymphomas treated with chemotherapy resulted in an average of only twelve days in the hospital, but that cost over eight thousand three hundred dollars. That's twelve days, not three months. These figures are deliberately misleading. In fact, the eventual cost of dying of cancer is now estimated to be well over eighty thousand dollars per person. The authors reveal their subjective judgements when they introduce the American Council of Science and Health, just an offhand remark in there about them, but they introduce them as "a group that seeks to protect consumers by providing them with valid scientific information." What a farce! The American Council on Science and Health seeks to protect the pharmaceutical and chemical industries by providing distorted information to consumers. Alar is good for you. Asbestos: what a great thing. So much for accuracy in reporting. What OTA should have done -- and I'm abbreviating from the comments in the prepared statement -- OTA should have done Fitzgerald's assessment. He made his charges about the AMA and the conspiracy and the attempts to suppress this type of alternative treatment, he made those charges in 1953. OTA suggests that there is very little to be learned there. I think the most glaring example of where OTA went wrong, however, is how it dealt with this advisory panel, at least what's left of it today. In 1987, the OTA said that the most important function of this advisory panel was "to serve as a quality control mechanism through thorough review of drafts. So, what did they do? Well, they sent you the draft a year and a half ago with a little letter that said, "Well we've not given you as much time as we'd wanted for review; there's just a week before the panel meeting; we're hoping all of you have some long plane rides so you can read it on the way here." And I know, in fact, that at least two of these members had never had an opportunity to review that report when they met here in July of 1988. OTA has abused this advisory panel process. Today, I wonder how many advisory panel members have read this five hundred and sixty page document. In the final analysis, Congress is going to have to decide if OTA has presented a fair and accurate picture of the conflict between the conventional cancer therapies and the unconventional ones. OTA's reputation is on the line here, with this report as it is with every other report. I believe much remains to be done. They may think that this is a first draft, but it's not a first draft, it's close to the final draft. I think it's very close to being a first draft. I agree with the panelists who encourage that OTA consider this as a first draft and have another advisory panel meeting. We wouldn't even be here today if we hadn't requested this meeting. They tried to cut this off in July of 1988; said that was the final meeting. In the end analysis -- and by the way, that high ranking science policy official who said OTA was created to provide biased, excuse me, clear, objective, accurate and unbiased information, was OTA's director, John Gibbons. Thank you. STEVENS: Would you identify yourself, please. EVERS: I'm Michael Evers. I'm Executive Director and President of Project Cure, an organization that lobbies for the impartial evaluation of alternative cancer treatments. STEVENS: Thank you. Questions, comments from the panel. LERNER: I just want to keep taking advantage of these minutes that we have to follow up, because I think it's relevant to Michael Evers testimony and Norm Shealy's comment, on restrictions of trade and provision of freedom of choice. And I wanted to say that I think the chapter on legal issues is another example of an area where the middle ground was not pulled out. And I know this is a concern of Kieth Block's, which he may speak to later. But, here again, what did not emerge is the great damage done to independent researchers and clinical practitioners by functioning in an atmosphere of fear or of uncertainty as to whether they are able to practice. I'm talking, just to speak of the middle ground, I'm talking of well qualified, well credentialed physicians engaged in cancer care who, knowing the limitations of conventional therapy, want to include other modalities, or when conventional modalities do not work want to integrate some of the unconventional modalities. And that middle ground does not emerge in the legal chapter as it does not emerge in the nutritional chapter or the spiritual chapter. And I know the OTA is capable of identifying that middle ground because it did so so well in the psychooncology section. The point, again, is that by bringing out the middle ground, the end of the spectrum, as Gar Hildenbrand put it, of the explicitly alternative therapies, makes more sense, and you see it in a less polarized environment. So that, although you may say there's no specific proof regarding A, B, or C therapies, it's in a context in which the middle ground makes the plausibility of those therapies more apparent. STEVENS: Thank you. And this, again, underlines statements we've heard from other speakers this morning. Dr. Collins. COLLINS: I appreciate Michael's comments and, actually, Michael Culbert's comments on this legal issue and I think that we'll come to this in the advisory later. I think one of the disturbing aspects of this report, which is brought out very eloquently in the section on the legal, not only are we not achieving a middle ground, it appears that the court in the United States is beginning to set judgement on medicine, and judges are beginning to set judgement on medicine and I think this is a very dangerous precedent. I think that it is immoral for judges to take the ultimate stand on medical decisions. It comes through in trying to place emphasis. For instance, one section said that a judge said that anyone can arrange a swearing match and this is not the way that any medical decision making can be made. The report seems to give the implication that law, in that case, is then senior to medicine in terms of making decisions. BROWN: I just want to reemphasize what Michael was saying and what we were discussing earlier after reviewing the draft in prior days -- I think that this is a critical point -- a chapter that is really addressing almost health fraud is missing this entire issue. It almost creates a vacuum, sucking in anybody with intellectually honest, independent clinical work going on. They get sucked into that. It is this omission of the counterpoint, the counterbalance, that exists in a certain regard to this spiritual chapter that is basically a mockery on it; with the counterbalance in chapter two of the psychooncology. But, both in the nutrition section, and clearly here in the health fraud area, you have no counterpoint to it of talking about relevant issues in the nutrition section. Malnutrition in cancer in well, extensively written in the literature, and it's relevant, and we'll talk about more of it later this afternoon. I think it's a critical issue in terms of health fraud, as well. EVERS: I have one further comment. STEVENS: Very, very quick. EVERS: I heartily encourage OTA to take this as a good first draft. Listen to the comments of today, and the written comments that come in, but don't rush to get this thing finished through April and try to publish it by June. You'll be doing Congress a disservice. It's uninterpretable. You can't understand this report. It's a long way from really having the issue fleshed out. Thank you. (ATTACHMENT) Michael Evers: STATEMENT OF MICHAEL S. EVERS, J.D. TO THE ADVISORY PANEL OF THE OFFICE OF TECHNOLOFY ASSESSMENT UNCONVENTIONAL CANCER TREATMENTS PROJECT MARCH 9, 1990 Thank you for this opportunity to come before you today and express my grave concerns about the fraft report prepared by the staff of the Office of Technology Assessment. EVERY SIXTY SECONDS another person dies of cancer in the United States. EVERY THIRTY SECONDS another person is told they have cancer. EVERY YEAR the numbers go higher and higher and we are told "Be patient; a cure is just aroudnt the corner." The authors of this report say "The U.S. cancer research establishment is pointed firmly in the direction of identifying, developing, and testing new cancer treatments with the aim of improving the lot of cancer patines." (1) We've all heard it all before. This rport is a travesty. Its authors have violated every known rule dealing with fairness and impartiality. A high-ranking science policy official once wrote that OTA was created to provide political leaders "clear, objective, accurate and unbiased information." (2) The authors of this report have failed to abide by those guidelines. This report presents information that is unclear, subjective, inaccurate, and biased. For example, their bias is revealed early on when they introduce the american Medical Association and its infamous Committee on Quackery. The authors suggest that the AMA's opposition to chiropractos "ended with a 1987 ruling against the AMA and several other professional societies after an 11-year lawsuit brought by chester Wilk and three other chiropractors, who charged that the orgfanizations had engaged in a conspiracy to boycott chiropractors." (3) Wilk did more than just "charge" that the AMA had conspired. He proved it. but to the authors of this report, its merely a "charge", not at all conclusive. Well, the authors undoubtedly will be saddened to learn that Dr. Wilk's "charges" of conspiracy were upheld last month by the Seventh Circuit court of Appeals which agreed with Judge Getzendanner that he AMA violated the Sherman Act by conducting an illegal boycott of chiropractors. (4) The authors inaccurately portray unvonventional cancer treatments as more expensive than orthodox treatments by presenting costs associated with treatment for melanoma and stomach cancer. (5) They rely on a 1988 Medicare report to suggest that initial treatment charges in the first three months after diagnosis average $10,000. Average monthly expenses thereafter are a mere $235. This slanted presentation attmepts to minimize the true impact of cancer in this nation, correctly estimated to cost more than $75 billion annually. (6) A recent survey conducted by the American Society of Clinical Oncology found that treatment for acute leukemia or lymphomas treated with chemotherapy resulted in an average of only 12 days in the hospital costing more than $8,300. (7) That's TWELVE DAYS, not three months. The eventual cost of dying from cancer is calculated to be as much as $80,000 in the United States. (8) The authors reveal their subjective judgments when they introduce the American Council on Science and Health as "a group that seeks to protect consumers by provideing them with valid scientific information". (9) what a farce! The American Council on Science and Health seeks to protect the pharmaceutical and chemical industries by providing distorted information to consumers. Alar is good for you. Asbestos is real neat too! So much for accuracy in reporting. The last time Congress had a real opportunity to deal with this issue of suppression of alternative cancer treatments was when Benedict FizGerald, a special investigative attorney from the Department of Justice, looked into the question and concluded: My investigation to date should convince this committee that a conpiracy does exist to stop the free flow and use of drugs in interstate commerce which allegedly have solid therapeutic value. Public and private funds have been thrown around like confetti at a country fair to close up and destroy clinics, hospitals, and scientific research laboratories which do not conform to the viewpoint of medical associations. (10) His report was ignored by congress and now by OTA as well. Here was a clear chance to investigate FitzGerald's charges, but what they say about the report? Hoxsey's point of view was echoed by a 1953 report to the Senate Interstate and Foreign Commerce committee by Benedict FitzGerald, an attorney who examined records of Hoxsey's litigation with the AMA and the Federal Government. After reading about the circumstances of these attempted case reviews FitzGerald wrote that NCI "took sides and sought in every was to hinder, suppress, and restrict [The Hoxsey Clinic] in their treatment of cancer." To date, no independent, comprehensive assessment has been made to resolve the many allegatiions and issues raised by Hoxsey's tumultuous career. (11) OTA should have done THAT assessment, an independent, comprehensive assessment of FitzGerald's allegations. Instead, it is attempting to hide its head in the sand and pretend that all is well in Cancer Land. Throughout the report, the authors seem to suggest that orthodox medical practitioners know what works best and how to select appropriate treatments. In fact, as OTA pointed out more than a decade ago, very few medical technologies are thoroughly evaluated before finding their way into common use. Dr. Robert Centor, chairman of the division of general medicine at the Medical College of Virginia, speaking on behalf of the American College of Physicians, testified before a congressional committee last year and said doctors lack the tools they need to make sound decisions because medical science cannot tell them what kind of treatment works for many common ailments.(12) This uncertainty led Congress to create a federal Agency for Health Care Policy and Research and earmark nearly a half a billion dollars over the next five years to carry out a "Medical Treatment Effectiveness Program" to determine what medical treatments work.(13) How come OTA thinks orhtodox physicians have all the answers when the physicians themselves admit that they don't? At the outset of this project, OTA emphatically stated that it would "not come to any conclusions regarding the efficacy and safety of any particular unorthodox treatments, including IAT," and "it was never OTA's intent to make any judgments on the efficacy and safety of any specific unorthodox cancer treatments."(14) Nevertheless, the authors did just that. Time and time again they present subjective observations about the therapies under consideration and go out of their way to malign them. For example, they say one of the byproducts of Burzynski's research is a "controlled substance" because it is a component of "angel dust?"(15) Two pages are devoted to highlighting the negative comments of Burzynski's research by Blackstein and Bergsagel and one line is presented to respond. "Burzynski wrote a rebuttal; to their report, contesting their reading of the clinical data."(16) Then the authors go on to say, "It is not possible, based on the information presented in Blackstein and Bergsagel's report and in Burzynski's rebuttal, to determine whether the original case reprots were assessed properly." (17) That ought to really help congress understand this question better. Perhaps the most glaring example of OTA's mishandling of this project is how they dealt with this advisory panel. In 1987, OTA sid the most important function of the advisory panel is to serve as "a quality control mechanism (through extensive review of drafts)."(18) Yet what did they do with the first preliminary draft a year and half ago? They mailed it to panel membewrs only a few days before the scheduled meeting and said "We have not given you as much time as we wanted to for review - - there is just a week before the panel meeting. We're hopingu have some long plane rides planned."(19) This time around OTA gave the panelists almost three weeks to digest a 570-page document and scheduled today's meeting without any apparebt onsultation with the panelists. A number of them have complained and some are not in attendance due to the short notice given by OTA. According to at least one panelist, nearly a year passed without any communication from OTA.(20) Does this osund like OTA wants "extensive review of drafts" by this advisory panel? In the final analysis, Congress will decide whether OTA has presented a fair and accurate picture of the conflict between conventional cancer therapies and unconventional ones. OTA's reputation is on the line with this report, as it is with every one of its undertakings. I believe much remains to be done with this project before it can be published and presented to Congress. It needs to be clearer, more objective, more accurate and less biased. By the way, that high-ranking science policy official who said OTA was created to provide political leaders "clear, objective, accurate and unbiased information" was John H. Gibbons, OTA's director.(21) I hope his subordinates are listening. 1. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, page 11-1. 2. Gibbons, JH, Science, Technology and Law in the Third Century of the Constitution , in Science and Technology Advice to the President, Congress, and Judiciary (Pergamon Press 1988), page 415. 3. Unconventional Cancer Treatmenst , Office of Technology Assessment, February 1990 draft report, pages 1-8 through 1-9. 4. Wilk v. american Medical Association , ___F.2d.___,1990 WL 9722 (7th Cir. Feb. 7, 1990) 5. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, page 9-18. 6. Rice, DP, et. al., The Economic Burden of Cancer, 1985: United States and California , in Cancer Care and Cost: DRG's and Beyond (Health Administion Press 1989), page 53. 7. Ratkin, GA, A Professional Perspective on the Issue , in Cancer Care and Cost: DRG's and Beyond (Health Administration Press 1989), pages 168-170. 8. Schaeffer, LD and Gould, BS, Cancer Care and Cost: The Blue Cross of California Approach , in Cancer Care and cost: DRG's and Beyond (Health Administration Press 1989), page 185. 9. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, page 7-12. 10. FitzGerald, BF, Jr., Report to the Senate Interstate Commerce committee on the Need for Investigation of Cancer Research Organizations , congressional Record - Appendix, August 3, 1953, page A5353. 11. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, pages 4-19 through 4-20. 12. Boyd, RS, Doctors' problem? They don't know , Detroit Free Press, Feb. 4, 1990. 13. Boyd, RS, Doctors' problem? They don't know , Detroit Free Press, Feb. 4, 1990. 14. Facts Concerning OTA's Study of Unorthodox Cancer Treatments , Office of Technology Assessment, Washington, DC, September 9, 1987. 15. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, page 5-18. 16. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, pages 5-28 through 5-30. 17. Unconventional Cancer Treatments , Office of Technology Assessment, February 1990 draft report, pages 5-29 through 5-30. 18. Facts Concerning OTA's Study of Unorthodox Cancer Treatments , Office of Technology Assessment, Washington, DC, September 9, 1987. 19. Letter from Hellen Gelband to Advisory Panel Member (July 18, 1988). 20. Letter from Gar Hildenbrand to Hellen Gelband (Feb. 6, 1990). 21. Gibbons, JH, Science, Technology and Law in the Third Century of the Constitution , in Science and Technology Advice to the President, congress, and Judiciary (Pergamon Press 1988), page 415. (END ATTACHMENT) STEVENS: Robert Houston. ROBERT G. HOUSTON: Let me introduce myself. I am a science writer and research analyst. My paper on repression and reform in the evaluation of alternative therapies was distributed by the OTA to the advisory panel. I've been very impressed by individuals in the OTA that I've come in contact with. I think Roger Herdman is a very fine official and Hellen Gelband is a very intelligent and competent worker at the OTA. I am very sorry to say that we are disappointed with the results of this draft. The study was requested by forty members of Congress, concerned that alternative cancer therapies such as IAT be fairly evaluated. The Congressmen requested a comprehensive evaluation, but what the five hundred and sixty page report provides is, instead, a comprehensive devaluation, presenting mainly derogatory statements and innuendoes concerning the therapies, interlarded with puffery for the agencies that repress them. A pattern of prosecution without defense which was established in the first draft is now extended to supporting studies as well, which are determinedly belittled. In most cases, all independent corraborative studies are ignored and descriptions of proponent studies are faint and fragmentary. The report is comprehensive, however, regarding negative information and, I might add, misinformation. I wish to review a few of the, what I regard as, deceptive practices that would justify investigation by Congress if the report is rushed into print without major revision. In regard to revision, let me just state that one way to approach at least getting accuracy into the report would be if some of us who are in of the facts here were to meet with our documentation with the OTA staff for some working session, like an afternoon, that we iron out some of the details and try to get at least an accurate report. One of the problems is false standards of appraisal. In the report, all favorable clinical studies are rejected as methodologically unsound because they are not randomized controlled trials. Moreover, OTA's ivory tower proposal for testing IAT is a one hundred patient randomized trial in the U.S. which would cost millions of dollars and take years for FDA to approve. It is extremely rare, however, for spontaneous remissions to occur in verified carcinomas or for prolonged survival to occur in terminal cancer. NCI, and even FDA, now recognize this reality and no longer require randomized clinical trials for anticancer drugs. To be consistent in its view of randomization as a necessity for others, OTA must recommend abolition of FDA's Phase I and II trials, as these are generally uncontrolled. OTA also, for the sake of consistency, must judge surgery and unproven cancer remedy, since there is no large-scale randomized clinical trial proving a survival benefit of surgery versus nontreatment, the type of trial that you seek to apply to Burton's therapy. Another problem is charges without rebuttal. Negative information is extensively presented with virtually no mention of proponent points in rebuttal. A false impression is thus created that the charges are unanswerable and hence conclusive. For example, two pages are devoted to an attack on several Burzynski cases by Blackstein and Bergsagel, whereas on line mentions that Dr. Burzynski issued a rebuttal. This is on page twenty-nine of chapter five. Though Ms. Gelband had his rebuttal, had fourteen pages of exhibits, and wrote me that she would include his points, none were mentioned. Readers will not know that independent radiologists and oncologists had confirmed the remissions that Blackstein and Bergsagel dismissed. Nor is there any mention of Dr. Pauling's rebuttal from Nutrition Review of 1986 to the Mayo Clinic's trial of vitamin C. Pauling noted that the vitamin C was stopped after a median of only two and a half months, and after that both groups reveived 5-FU. Of course, the results were the same. Then there is the problem of misrepresentation of positive studies. OTA alleges, for example, that Burzynski, for example, published only four clinical studies on Antineoplastons, none peer reviewed, and that he paid for publication. All of these are patent falsehoods. His current bibliography show fourteen clinical papers, ten in peer reviewed journals. I have with me a letter from the journal in question that shows that his payment was for reprints, as is customary. The masthead of the journal states all studies are peer reviewed. Secondly, OTA claims the same thing of Dr. Revici, that he never published peer reviewed papers. But even the American Cancer Society cites Revici's papers "in peer reviewed journals" in the journal Ca in 1989. Regarding Burton's 1962 abstract from his animal studies, OTA states "the treated group lived longer, no data were presented, and the study was never fully reported." That's on page fifty-five of chapter five. In fact, survival data were given showing that treated mice survived fifteen times longer. The study was fully reported with accompanying tables in his 1962 and 1963 papers: OTA's own consultant, Dr. Terence Phillips of George Washington University stated in his contract report regarding this animal study, "The data presented are rational and support the conclusions of the authors." OTA said just the opposite in the draft. Finally, there's the question of the suppression of corroborative data. In most cases, OTA omits all mention of independent corroborative studies. Pauling's vitamin C results, for example, were confirmed in a controlled clinical trial in Japan by Morishige in 1978. Remissions on the Kelley therapy were substantiated in a careful fifty case review by Dr. Nicholas Gonzales which Ms. Gelband has. No mention in the report. Anticancer effects of Antineoplastons in animals were found in Japan and at the Medical College of Georgia, all published in peer reviewed journals. No mention in the report. Prevention of metastases by Laetrile was reported by Sugiura and Schmid at Sloan-Kettering. This is published. Laetrile by- product benzaldehyde regressed tumors in most patients in two Japanese clinical trials; refer to Kocki, Cancer Treatment Report , 1985. I have all these studies with me. By claiming comprehensiveness, however, as on page thirty-two of chapter one, that this report is comprehensive, OTA has deepened such sins of oamission. Its report exemplifies, therefore, techniques of repression in medical evaluation. ACHTERBERG: I appreciate the amount of information that this has, and you've hit on a point. I ended up reading the report and craving the rebuttal. I really want to see if it's damning in many instances. If there is no rebuttal, then I will make a certain type of judgement on these treatments; if there is a printed rebuttal, I'll make another type. I don't know that it's possible to include a point by point rebuttal in the document, but I would certainly tell a working committee, as we mentioned (unintelligible). HOUSTON: The GAO report on cancer survivals had a rebuttal from the NCI. Its at least a feasibiliity to have a rebuttal from groups representative of alternative cancer therapies. LERNER: I just want to say that I think Bob has made some important points. First of all, the point on methodology. In terms of bringing up the middle ground again, Gar Hildenbrand has pointed out that the policy end of this report is still very weak. Given the reality, that is to say, if this report were framed so that one understood, that the vast majority of conventional therapies in scientific medicine have never met the criteria for randomized controlled trials -- they haven't met it -- and so if you are looking for the middle ground you have to say that very strongly. Even in the report, it says that, while new drugs come in through randomized clinical trials, that procedures don't: your point about surgery. And, God knows, there are many procedures being done with cancer patients, some of which are tremendously harmful, toxic and difficult which simply do not meet these criteria. Now, it is not balanced, it is not fair, in my judgement, again saying how far this report has come and how very far ahead it is of any existing report, but we haven't achieved balance when we haven't pulled out that middle ground. And I also want to say that, on the specific, well two more specific points, Jeanne Achterberg, a panel member, is an expert on human research and paradigms other than randomized controlled clinical trials and we don't get that in this. We don't get the issues of human research and the kind of thoughtful discussions of human research that we really ought to have. We shoudn't just be saying that the randomized controlle clinical trial in human research is the only way to go. The final point I want to make is that I strongly agree that the supportive information on Burzynski implies that the absence of -- when we claim comprehensiveness, which we should, we have a strong obligation to include these, and not only did Pauling rebutt the findings on vitamin C, but there was an excellent article in the New Scientist which should have been covered here, which covers the Pauling thing, and from the New Scientist point of view -- that's a very credible journal -- said that they though Pauling had a case, said his rebuttal had a case. So I do believe we have a long way to go on many of the specific therapies on citing the corroborative evidence. STEVENS: Can you please hold, unless it is directly connected? RIEGELSON: Maybe it's a generic comment. STEVENS: All right. Could you please hold that, please, but make sure you do hold it and you've got it. We've got to start going again with everybody. We're particularly going to be coming up again and again to some of these very important (unintelligible). So thank you very much. Robert G. Houston: (attachment) Deceptions by OTA in a Report on Cancer Alternatives After three years of controversy, OTA has finally released the revised draft of its report on Unconventional Cancer Treatments. The study was requested by 40 members of congress, concerned that alternative cancer therapies such as IAT be fairly evaluated. Congress requested a "comprehensive evaluation," but the 560 page report provides instead a comprehensive devaluation, presenting mainly derogatory statements and innuendoes concerning the therapies, interlarded with puffery for the powerful agencies that repress them. In the first draft, released in July, 1988, the project staff attempted to perpetrate a genteel hoax, claiming that in the world medical literature they could find only one abstract supportive of any alternative cancer treatment. Volumes of published studies previously sent to OTA were then shown to the Advisory Panel and to OTA officials, who properly extended the time and scope of the study. Calls for changes in project staff went unheeded, however. Citations of positive studies in the new report invalidate the prior draft. The new draft, dated February 12, 1990, carries the art of distoriton to a level rarely approached by responsible agencies. Counterposed to pages of scurrilous charges against a treatment stands only a line about a rebuttal. The pattern of prosecution without defense, established in the first draft, is now extended to supporting studies as well, which are determinedly belittled. In most cases, all independent corroborative studies are ignored and descriptions of proponent studies are faint and fragmentary. The report is comprehensive, however, regarding negative information, which is exhaustively detailed and includes every sleazy slur and baseless innuendo from the fevered imaginations of the most zealous "quackbusters". Feigning neutrality while teeming with calumny, the report may well qualify its main author, Ms. Hellen Gelband, for an award as "Quackbuster of the Year." The folowing are some of the patterns of deception that justify investigation by Congress if, as planned, the report is rushed into print without major revision. Determined Debunking . All favorable data are subjected to "critical review," i.e., belittlement, and rejected as evidence. Most negative information however, is accepted uncritically. The practice of "critical evaluation," championed by hostile groups such as Emprise, Inc., requires a negative stance and consequent bias against supporting information. This is inimical to fair evaluation, which requires an appreciative balance. (All glasses are partly empty, and all studies are deficient in some respect.) OTA falsely equates evidence with conclusive proof, ignoring any gradations in types of evidence (preliminary, suggestive, prima- facie, etc). This results in sweeping claims of "no evidence" despite dozens of studies showing positive results. False Standards of Appraisal . In the report, all favorable clinical studies are rejected as methodologically unsound because they are not randomized controlled trials. Moreover, OTA's ivory tower proposal for testing IAT is a 100-patient RCT in the U.S., which would cost millions and take years for FDA approval. It is extremely rare, however, for spontaneous remissions to occur in verified carcinomas or for prolonged survival to occur in a dvanced cancer. NCI, and even FDA, now recognize this reality and no longer require RCTs of anticancer drugs. To be consistent, OTA must recommend abolition of FDA's Phase I and II trials, as these are generally uncontrolled. OTA must also judge surgery an unproven cancer therapy, since there is no large-scale RCT proving a survival advantage of surgery versus nontreatment. Disregard for Evaluator Bias . Data is frequently rejected by OTA because of negative opinions of orthodox critics. All we are told about RCTs for Iscador, for example, is that a Swiss oncology group found "flaws" (p. 4-50); the favorable results are not even mentioned. OTA naively recommends "Best Case Reviews" by NCI as a means of evaluation (p. 1-45), ignoring the fact that many excuses are available to reject remissions and that NCI has rejected all alternative case reports, except in a blinded NCI review of Laetrile. Blinded review or use of neutral panelists are essential procedures to minimize evaluator bias, especially when an agency has negative positions on a therapy. Charges Without Rebuttal. Negative information is extensively presented with virtually no mention of proponent points in rebuttal. A false impression is thus created that the charges are uanswerable and hence conclusive. For example, two pages are devoted to an attack on several Burzynski cases by Drs. Blackstein and Bergsagel, whereas one line mentions that Dr. Burzynski issued a rebuttal (p. 5-29). Though Ms. Gelband had his rebuttal with 14 pages of exhibits and wrote that she would include his points, none were mentioned. Readers will not know that independent radiologists and oncologists had confirmed the remissions that Blackstein and Bergsagel dismissed. Nor is there mention of Dr. Pauling's rebuttal (Nutr. Rev. 44:28, 1986) to the Mayo Clinic's trial of vitamin C: Pauling noted that the vitamin was stopped after a median of only 2.5 months and that both groups then received 5-FU. Misrepresentation of Positive Studies . OTA alleges that Burzynski published only 4 clinical studies on Antineoplastons, one peer- reviewed, and that he paid for publications (p. 5-21). But his current bibliography shows 14 clinical papers, 10 in peer- reviewed journals; a letter from the journal in question shows that his only payment was for reprints, as customary; its masthead page states all studies are peer-reviewed. The papers include documentation and X-ray photos of complete remissions in measurable advanced cancer, all ignored by OTA. Similarly, OTA claims Dr. Revici never published peer-reviewed papers, but even ACS cites Revici's papers "in peer reviewed journals" (Ca 39:119, 1989). OTA prints 1/4th of Burton's 1965 abstract, and without ellisis marks omits key sentences in the middle about tumor necrosis (p. 5-58). Regarding his 1962 abstract, OTA states "the treated group survived longer ... No Data were presented and this study was never fully reported" (p. 5-55). In fact, survival data were given showing the treated mice survived 3 to 17 times longer; the study was fully reported with accompanying tables in his 1962 and 1963 papers. Regarding the 1962 paper OTA claims "no experimental data were included; their conclusions were purely speculative." Yet OTA's consultant Dr. Phillips stated in his contract report regarding this animal study, "The data presented ... are rational and supports the conclusions of the authors." Suppression of Corroborative Data . In most cases, OTA omits all mention of independent corroborative studies. Pauling's vitamin C results, for example, were confirmed in a controlled clinical trial in Japan (Morishige, J. Int.Ac.Prev.Med. 5:54, 1978). Remissions on the Kelley therapy were substantiated in a careful 50-case review by Nicholas Gonzales, M.D. Anticancer effects of Antineoplastons in animals were found in Japan and at the Medical College of Georgia. Prevention of metastases by Laetrile was reproted by Sugiura and Schmid at Sloan-Kettering, and its by- product benzaldehyde regressed tumors in most patients in japanese clinical trials (Kochi, Ca Treat. Rep. 69:533, 1985). Its report exemplifies techniques of repression in medical evaluation. (END ATTACHMENT) STEVENS: Richard Jaffe. RICHARD JAFFE: Good morning. My name is Richard Jaffe. I'm an attorney in New York City and my law firm represents a number of alternative practitioners throughout the country, including two which the OTA has reviewed, Dr. Burzynski and Dr. Revici. We've also had the good fortune and responsibility of handling a number of cases that are referred to both in the legal section and in the insurance section. I'm here today to raise some concerns on behalf of Dr. Burzynski regarding the OTA's treatment of him. First, let me just say that we certainly appreciate the size of the task and that it is truly remarkable that this report was done. It requires the work of experts in law and medicine and it's difficult to find that in one person. To the extent that anything was produced at all, I think the OTA deserves the credit. On the other hand, we believe that the OTA's report on Dr. Burzynski is simply unfair. What do I mean by that? I mean that it's based on bad science. I mean that it's not complete. And I mean that it's not balanced. These three points are evidenced by the three studies relied upon in the report. The first study is NCI's 1983 study on Burzynski's Antineoplastons using the P338 mouse leukemia tumor model. I submit that this is bad science at its worst and the OTA is simply propagating it. Dr. Burzynski told Dr. Mead that this treatment does not work on leukemia, let alone mouse leukemia. Therefore, it should come as no surprise that NCI's study showed that the treatment had no effect. Now, this is something which I'd suspect that no intelligent layman -- a mistake no intelligent layman would make. Cancer is a multi-facet disease, it's a hundred diseases. What works on one kind of cancer doesn't necessarily work on the other kinds of cancer. It's a very simple point. And yet, for all these years, NCI has been using this P338 mouse leukemia study as if that were the determinant of whether a treatment works. Not only is it bad science, it's admitted to be bad science. In 1986, Dr. Mead who in 1983 found that the studies, the treatment, did not work, admitted that, basically, his assay did not provide good results for solid tumors. Well, why should it? It's not a test for solid tumors. All right? And, indeed, as we speak, supposedly, the NCI is trying to develop a more, a broader approach to trying to determine whether cancer treatments work. So my question is, if the NCI itself rejects this study, or at least the methodology of the study, why is it in this report? What is the scientific basis of it? Secondly, the report is not complete. It's not complete because, contrary to the NCI study which everyone knows is invalid, there have been tumor studies, in vitro and animal studies, which show that the treatment does work. Bob Houston refers to some of those studies, not done by Dr. Burzynski, done by researchers at a major teaching university in Japan and the Medical College of Georgia, indicating at least that there's some possibility that this treatment works, at least in vitro or mouse. Why is there no mention of these studies? I should also tell you, and the OTA would have no way of knowing this, that on March twenty-third researchers from the Department of Defense will be presenting a study, an international conference on chemotherapy which tends to show that Burzynski's theories of reprogramming cancer cells may be accurate. I should also tell you that a major insurance company has now completed a twelve month review, wherein they sent people, along with the director of medical services and the director of research, they completed a review and they are now paying for the treatment and, indeed, they are recommending patients to the treatment. There is no way the OTA could know this, but certainly, if there were better communications, some of these things might come out. And finally, the report is not balanced for the reasons that Bob Houston said about the Blackstein report, and I will not go over that again. As the attorney that handled a lot of these cases, let me just make a few comments, brief, less than thirty seconds, on the legal and insurance section. To be frank, I think it needs a little more work. From the general now to the specific, I note that, at least as a lawyer, one of the things that, at a minimum, you have to be, is you have to be accurate. The worst thing you can do, as a lawyer, is to cite the wrong case or cite not the final decision. There are numerable instances of that. Zuckerberg was reversed on appeal in in 1984. Dallas versus Aetna, it was not cited for the right -- it also went up on appeal and the court case is exactly the opposite. In our case, Schneider versus Revici is grossly inaccurate. I note that in this document there were numerous references to personal correspondence with all of my adversaries. Right? And nobody ever calls up to see if any of these statements are accurate, and I would think that that's something that should be alleviated. Thank you. Oh, actually, one other point, sir, I'd like to address this specifically to Mr. Everly (sic). Today, JAMA came out with a new series of articles, "Guarding the Guardians: Research on Editorial Peer Review". The last article was entitled, "The Philosophical Basis of Peer Review and the Suppression of Innovation", and I would strongly suggest that each of you review this, and I would also suggest that, if we follow Mr. Everly's (sic) advice, there wouldn't be -- no one would be treated for advanced, metastatic solid tumors because there are no effective treatments, and as we all know, people are being given treatments all the time. And also, the reports -- the JAMA itself -- under the JAMA standards no articles would be published on anything in advanced cancer because none of them satisfy any of the criteria mentioned by Mr. Everly (sic). Thank you. STEVENS: You have -- as a known witness you won't wince at your own words -- I'm getting too overcome by this however -- as one of the speakers, you've given us your given us your comments, and also, all speakers who've had things to say on the draft and on the study, specific suggestions... JAFFE: Right, we will, we have included it in my written version of my speech, we will refine later. HERDMAN: Those will include questions that you mentioned in your talk. JAFFE: Sure. HERDMAN: Those are going to be specifically pointed out. JAFFE: Right. Not on behalf of Burzynski, but just as a lawyer reviewing it. We'll certainly do that, thank you. STEVENS: Thank you. Jonathon. COLLIN: Actually, on the question of witnessing, I have been very concerned about the statement that Burzynski, who probably, more than any other unconventional practitioner has published literature, and that this Swiss journal has actually taken two entire monographs to publish many of his articles, I wonder if you have any clue as to the total amount of money that Burzynski has actually paid this journal. JAFFE: I don't think that's the accurate question, sir. I think you have to question what has he paid for. He pays for the reprints. He doesn't pay to get them published. If he orders fifty thousand reprints, he pays whatever number of dollars it takes to reprint those publications. And I think it's a fundamental problem among the many problems. It's as if payment for research constitutes some kind of, what's the word, some kind of a book publishing for a fee. That's simply a fallacy. That's just not accurate. He pays five hundred thousand dollars, for example, to the Swiss publication, or maybe it's twenty thousand, but it's for the reprints as it's got to be. HILDENBRAND: If this is true, the report does create the impression that this was vanity publication. JAFFE: Exactly, that's correct, and that's simply inaccurate. I mean, he has the rejection notices to prove it. Some of the articles get rejected. Some of the articles get revised a half a dozen times. What else could be a review? HILDENBRAND: Are you saying that he didn't even pay a page fee for the printing which is common in some peer reviewed journals? JAFFE: Sometimes he does, sometimes he doesn't. But when he issues a check for five or ten or fifteen thousand dollars... HILDENBRAND: That's reprints. JAFFE: ...the accompanying letter says here's ten thousand dollars for the reprints. HILDENBRAND: That's significant. GELBAND: Well, I just had one thing. I wrote to the publisher about this and they told me that he paid for the entire publication of, for those issues. I'd be happy to send you a copy of that. JAFFE: That's correct, because all of the articles -- all of the articles were published -- I mean I have them here. They are a pamphlet published by this magazine. GELBAND: They're supplements. They're supplements to the journal. They're full supplements to the journal. JAFFE: Right. GELBAND: And I asked the publisher about the peer review and about the payment and they said that he gave the group page charges and plus the entire production of the supplement. HILDENBRAND: Was it peer reviewed? JAFFE: The entire supplement is contained in the -- all of his articles are the entire supplement, of course. But I don't think you asked the right question. STEVENS: May I interrupt here... (?): We're trying to clear this up. JAFFE: Well that can be done. STEVENS: This can be done between the two of you at some stage, and Dick, you want to make your point. RIEGELMAN: Right now? STEVENS: Very quickly. RIEGELMAN: It seems to me that one of the key issues here is going to be what are the systems of evaluating these therapies and what are the methods of evaluating the therapies. And I've heard from a number of speakers the kind of things they don't want to go on, and a little bit of hint that the best case scenario has a problem to deduce here. What I would think would be very helpful is to get from a number of speakers their suggestions for what is desirable, practical, in terms of how they would like to see these therapies done. JAFFE: I have a short, specific reponse to that. STEVENS: Can you please send that to Hellen in writing. JAFFE: It'll take fifteen seconds. HILDENBRAND: Let him make it.

JAFFE: What is strangely absent in this entire report are unbiased, objective oncologists and biochemists. Take five people that everyone can agree upon. Send them. Right? The OTA has done everything except the only thing that's important in this whole matter. The patient records. What happened to these patients? Take five people. Send them for a site visit. Let them stay two or three days there, look at the records, look at the path reports, and then the OTA will be in a position to make a fair evaluation. Thank you. (attachment) ABADY & JAFFE Attorneys at Law 500 Fifth Ave, Twenty-fourth floor New York, New York 10110 Comments on OTA Report on Dr. Burzynski We will be presnting a more detailed written response to the OTA's report on Dr. Burzynski by the March 30 deadline. For the purpose of the five minute presentation before the panel March 9, we summarize our concerns as follows. 1. Lack of Comprehensiveness and Objectivity The report contains almost every piece of negative data and evaluations about Dr. Burzynski and excludes the majority of the psitive information available and/or supplied to the OTA. The negative evaluations are related in excruciating detail. On the other hand, the OTA report merely mentions the fact that written rebuttals to the negative evaluations were made. No substantive infrmation about the rebuttals is provided. Therefore, despite the fact that the report states that the data do not allow any conclusions about the efficacy of the treatment, by only relating the substance of the negative reports, the clear import and intent of the report is to cast a negative light on the treatment. The positive data excluded from the OTA's report includes pre- clinical studies performed by a major medical university in Japan, and recent clinical experience from the same institution. Further there are several studies published by investigators at the Medical College of Georgia which are relevant to any discussion of Dr. Burzynski's work. These studies directly contradict the NCI studies referred to in the OTA report, have been available to the OTA since late 1988 and some of them were performed by a former NCI investigator. Most recently researchers from the Department of Defense have completed preclinical studies which tend to show that antineoplastons do in fact reprogram cancer cells. 2. Poor Science a. unsupported allegations of "angel dust" According to the OTA, Dr. Burzynski's product, 3-phenylacetylamino-2, 6- piperidinedone, "is listed as a 'controlled substance' requiring report of purchase to the U.S. Dept. of Justice, apparently because the chemical is also a component of PCP or 'angel dust', a common illicit street drug." (footnote 58 page 5-18). Dr. Burzynski requests that the OTA provide him with the statutory reference indicating that 3-phenylacetylamino-2, 6- piperidinedione is a controlled substance. Our review of the Controlled Substance Act and related statutory authority has not uncovered the basis of the OTA's claim. b. Seemin inability to interpret clinical data On pages 5-23 though 5-24, the OTA takes issue with Dr. burzynski's use of the term "advanced neoplastic disease" in describing patients in a particular study. The OTA: "in the first Burzynski study cited above, six 'complete remissions' were reported among 15 patients described as having 'advanced neoplastic disease'." The OTA then cites an example of one of these patients which the OTA states "would not be described as 'advanced' in conventional oncology terms." "Patient D.D., diagnosed with transitional cell carcinoma of the bladder, Grade II, had seven transurethral resections of the tumors and six recurrences in 16 months preceding the treatment with Antineoplaston A2." Dr. Burzynski's response: "Common medical logic dictates that the patient who had seven operations for cancer and six recurrences in 16 months has advanced disease." On page 5-15, the OTA attempts to dismiss Dr. Burzynski's Phase I clinical studies: "In sum, despite a substatial number of studies presented by Burzynski describing the clinical outcomes of Antineoplaston treatment in cancer patients, there is still insufficient information by which to judge whether this treatment is or is not effective." Dr. Burzynski's response: "OTA reviewer has difficulty in understanding that all of these are Phase I clinical trials and they should be treated as such (i.e. they are not trials to determine efficacy). The results of these trials are interesting and important enough to warrant furtherscientific investigation." c. Misrepresenting Results of Invalid Screening Technique It is astonishing that the OTA, and apparently the NCI, are still quoting results from the invalid mouse P388 tumor essay (5-26) even after the NCI has already publicly announced that the test is invalid. Three years after the NCI incorrectly tested Dr. Burzynski's treatment for solid tumors using a leukemia screen, an article in the NEW YORK TIMES reported that the NCI had changed its screening method from mice leukemia to tissue culture, which Dr. Burzynski had requested Dr. John Mead at the NCIO to use on antineoplastons in 1983. According to reporter Erik Eckhom in this 1986 article: "At present, (NCI) researchers select chemicals for study by watching their effects on mice with a single form of animal leukemia. This test has yielded some notable successes, mainly against leukemia and lymphomas, but has failed to produce drugs that work against the country's worst cancer threats. "'The live-mouse screen is just not producing action against the major tumors,' said Dr. John A.R. Mead, an official in the Cancer Institute's drug development division." "In the new system, all compounds will be tested against more than a hundred different strains of human cancer growing in test tubes. Officials believe the new mehtod will be far more sensititve than the old one, pinpointing drugs that act against specific types of cancer but that would have been dismissed as useless by the old screening technology." Over a year after this article appeared, an associate of Dr. Burzynski's called Dr. Mead to request that antineoplastons be retested using this "new" screening method. According to Dr. Mead, NCI researchers had yet not worked out a way to standardize the results of the new method and so had been unable to begin using it. Obviously, using the same screening method for all types of cancer are the same. Therefore, using a leukemia screen to test drugs for solid tumors is methodologically ridiculous and produces false negatives. By including this invalid NCI study in its report, the OTA is simply propagating bad science. Instead of using an admittedly invalid and outdated 1983 NCI study, why hasn't the OTA referred to a 1988 study underwritten by a grant from NIH published in the peer-review Journal of Steroid Biochemistry which concludes that "we have presented evidence that the non-toxic compound [antineoplaston] A10 is a potent antitumorigenic agent..."? d. Giving Credence to Anecdotal Evidence In its report, the OTA discusses in detail the results of an anecdotal account derived solely from a telephone survey allegedly performed by the Canadian Bureau of Prescription Drugs. However, the report states that its request to the Canadian Bureau of Prescription Drugs for further information about this survey has been denied, and states that "there may have been bias in reporting poor outcomes and it is not possible to draw conclusions about efficacy of antineoplastons treatment from this limited data." In light of the OTA's concerns, the lack of cooperation, and the absolutely horrendous scientific methodology of the telephone "study", why is any reference to the study made in the report? Of all of the "scientific evidence" put forth by the NCI and other organizations to discrdit Dr. Burzynski's 23 years of research, this is the most outrageous. The entire rport is a two- page memo to the Director of the Canadian Bureau of Human Prescription Drugs from a doctor in the Bureau's Division of Endocrinology and Metabolism. The review is actually a telephone survey of 25 physicians whose patients had allegedly been treated by Dr. Burzynski. This memo's author never saw any case records. Instead, according to him, "of the 25 physicians, case reports (by phone) were gleaned for 36