Unconventional Cancer Treatments - Advisory Panel meeting transcript.

Author: Office of Technology Assessment


This is a transcript of an extraordinary meeting held near the end of the process of preparing the OTA Unconventional Cancer Treatments report.

The Foreward to the report by John H. Gibbons, Director, mentions this meeting thus:

… The debate concerning unconventional treatments is passionate, often bitter and vituperative, and highly polarized. To ensure that all relevant voices were heard and that OTA was accessible, particularly to advocates of unconventional treatments, OTA took several unusual measures during the course of this assessment in addition to its normal process of analysis and review. The project advisory panel, representing a diversity of views, played an important role. Under its Chairperson, Professor Rosemary Stevens of the University of Pennsylvania, the panel persevered through diffilcult discussions and provided valuable counsel. Much of the final meeting of the advisory panel was organized to hear from critics of the draft report, who were invited by OTA to present their concerns to the advisory panel and OTA staff. OTA’s standing Technology Assessment Advisory Council devoted a meeting to this assessment, discussing the science and policy issues related to unconventional cancer treatments and providing counsel to OTA. Many other individuals and groups in the public and private sectors also contributed their ideas and criticism, for which they are gratefully acknowledged. …

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 patients.”

The telephone surveyor finisnished his review with the statement that “The Health Protection Branch has not received any case reports from Dr. Burzynski.” With good reason – no one ever contacted Dr. Burzynski. Surely, the way this “review” was conducted, and used, violates basic scientific principles and ethics and has no place in a report sponsored by the United States Congress.

e. Unequal Representation On pages 5-28 through 5-30, the OTA reports extensively on a 2 and 1/2 hour visit by two Canadian doctors, Blackstein and Bergsagel, to Dr. Burzynski’s clinic. After devoting two full pages to their negative findings, the OTA gives no space for Dr. Burzynski written rebuttal to their report. In fact, the only time the OTA even suggests that there is another side to the story is in its final line when it finally mentions that Dr. Burzynski has a rebuttal: “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 reports were assessed appropropriately.”

Had the OTA included Dr. Burzynski’s rebuttal, the reader would have learned that the two hours and fifteen minutes that Drs. Blackstein and Bergsagel spent at the clinic in 1982 could scarecely be described as a basis for sound scientific evidence against Dr. Burzynski’s then sixteen years of research. They did not review pathology slides and most of the x-ray films confirming the responses to the treatment. They did not examine any patient whose charts were presented. Yet they claimed that the pathology reports, radiology reports, and reports from Board Certified specialists in various cases, including Radiologists, Pathologists, Urologists, Oncologists, Otolaryngologists, and Surgeons, were false. Responses of the patients whose records were presented to Drs. Bergsagel and Blackstein were established by numerous Board Certified specialists in various specialty areas not associated with the Burzynski Research Institute.

There is very little doubt that the main purpose of this “site visit” was to give an excuse to the Provincial Government of Ontario to deny medical claims for antineoplaston treatment. According to the OTA, “The government was interested in the treatment because Ontario residents treated by Burzynski wanted the Provincial Universal Health Insurance to cover the treatment.”

As medical writer Robert G. Houston wrote two years ago to the OTA:

“Having read their (Blackstein and Bergsagel’s sloppy transcript, I am amused that you would give it such fawning attention while ignoring all of the over 90 published supporting studies by Burzynski et al. , most of them in peer-reviewed medical journals. You failed to mention that Blackstein and Bergsagel’s report concerned a 1982 site visit lasting only 2 hours, and that they were sent as paid consultants of the Ontario Ministry of Health, whose Health Insurance Pland had been refusing insurance claims for Burzynski’s therapy. Thus selected and obligated to discrdit that treatment, they were hardly impartial, independent observers. “Evidently, you made no effort to obtain Burzynski’s rebuttal to the Blackstein report …The full rebuttal includes 14 pages of exhibits by independent radiologists and pathologists documenting tumor regression in the patients falsely dismissed by Blackstein and Bergsagel. Also enclosed is a letter strongly supporting Burzynski from a truly independent Canadian oncologist, Dr. David Walde, who also visited the clinic in 1982, not just for 2 hours, but for 3 days.”

After receiving Mr. Houston’s letter, Hellen Gelband on October 8, 1988 wrote Dr. Burzynski and sked him for David Walde’s report. He sent that to her 9 days later, on October 17, and yet there is no mention of his report in the current OTA draft. Instead, they chose to report only on the negative results of the paid insurance consultants who spent only 2 hours, rather than on the objective results from an independent oncologist with no bias who spent 3 days.

Furthermore, recently a large insurance company has completed a twelve month review and evaluation of Dr. Burzynski’s treatment. The review included two extensive site visits with the participation of among other people its Directors of Medical Services and Research. Their conclusion was that this treatment is one of the most promising new approaches to cancer. And despite its experimental status this company has decided to pay for the treatment.

3. Misrepresentations of Dr. Burzynski’s Published Works

a. Implications that he paid to have his works published On page 5-21, the OTA states “These supplements were devoted entirely to Antineoplastons and all publication and printing charges for these supplements were borne by Burzynski.” Dr. Burzynski state that this is untrue, and as with any medical journal, he paid only for the reprinting in the journal not for acceptance of this initial publication.

b. Allegation that Publications are not Peer-reviewed On page 5-21, the OTA states “Seven of the 11 phase I clinical studies are listed only as presentations made at conferences outside the United States. These reports are not available in the open literature, they have had not peer-review…”

Dr. Burzynski has written ten papers on his phase I clinical studies, nine of which are published in peer-reviewed journals. He has correspondence from the reviewers on all of his published papers that corroborate that these publications are peer-reviewed. At least seven of the papers are readily available at the Houston Medical Center Library, so one must assume readily available in other cities, in “the open literature.”

c. Double Standard In pages 5-22 through 5-25, the OTA criticizes Dr. Burzynski’s papers for providing “very little information” regarding his Phase I studies. They continue to list all of the information that Dr. Burzynski should have included with these papers. We submit that using OTA’s standard most Phase I studies including those done at Momorial Sloan-Kettering are subject to the same criticism. Dr. Burzynski asserts that the details the OTA lists are not part of the format of a paper on a Phase I study – the format does not allow it.

(END ATTACHMENT)

STEVENS: Thank you very much. The next speaker is Wolfram Kuhnau. I’m sorry we’re having to rush through much as we are. I hate to cut people off. But we’ve got to work to hear everybody that’s on the schedule.

WOLFRAM KUHNAU: Thank you for the honor to speak here. I am a scientist. I am endochrinologist. I am one of the oldest members of the Society of Endochrinology in Germany in the wonderful International Society of Comparative Endochrinology.

So we have the truth now, the scientific truth that these “live cells” are working, how they are working. (Unintelligible) I have here some statements and articles to give you. The details are proved. The live cells, the main organelles of them, lysosomes, microsomes, are brought to the target organ of the body and we know also since Dr. Levi-Montalcini in Rome, the wonderful Nobel Prize winner in the excercizes on the fertilized egg and she did inject cancer cells into the egg and found the neuron growth factor and altered production of the nerve cells.

And so we have the doctor in Germany, in Frankfurt, which found out the hepatopoetic factor which is leading cells or whatever the material is to the liver in case the liver is damaged. If the liver is not damaged, we have a lot of other factors. That is the basic idea. Of course a lot of things have to be done. But now we have the scientific proof that the live cell is working, that they are going to the organs.

Now, to the question about the application. This is right, and in Germany happened something what should never happen. For business, some commercialized factories suggest there have to be more and more cells. Our absolute unique in Tijuana, our hospital American-Biologics, has six cells, not more. You cannot call it hundreds, it’s ridiculous.

This has to be in the hands of serious scientists. I am absolutely agreeing with you that if this works in cancer treatment it has to be proved before toxic treatment.

Which things are (unintelligible) — not the double blind test. That is impossible. The moral question cannot forget hundred patients without any treatment, give them distilled water.

I need to mention Dr. Martini which has written a basic book in Germany in the 1930s which states one case scientifically proved and cited carefully is more worth than hundred or thousand statistic cases. Is quite right, and we have now wonderful ELISA test, you know, immunological enzyme tests, we can determine performance from (unintelligible) and mammograms and the little tiny amounts (unintelligible) and there is no excuse, by example, thyroid deficiency, then I have a look. Is it truly the thyroid, or is it maybe the pituitary gland, or is it really the hypothalamus. All is the limbic system, what my speciality is.

Now, I am the researcher (unintelligible) and interrupted by six years of the war time but all the time had opportunity to work with Nobel prize winner Dr. (unintelligible) then after the war I did work on the same field together with Dr., Nobel prize winner, my goodness, the name — I don’t know. However, we made research on the elimination of twenty-four hours urine, the hormones, metabolites, (unintelligible), the pituitary hormones, the hypothalamus hormones and so on.

We found that there was high (unintelligible) estrogens before the treatment, they went down to normal levels, and when there was lower levels by some other things that went higher to the normal level. It was first time that with this therapy was able to harmonize the system. Never seen before. If they have (unintelligible) operation I’m giving them five hormones to substitute. We are the first time that science is able to determine that it can do something (unintelligible).

About the cancer treatment, the main concern has to be the immune system and especially the bone marrow, the interleukin II. The interleukin II as you know recently discovered in the nude mice, and the nude mice have no thymus at all, they have no immune system, you can transplant even chicken skin, they are growing (unintelligible). So those nude mice, they have almost no cancer. The question is no immune system, almost no cancer, and the key problem is interleukin II.

If you give the purified interleukin II, that is very toxic, you can kill the patient. When we give the same amount interleukin II with our live cells, then has nothing, no side effects, almost none (unintelligible). So, I suppose that there is a protective factor, (unintelligible) which we have not with the purified substance. And I call it Protectin. We are (unintelligible) now in our hospital, and I (unintelligible) and we can do soon, hopefully, that we have better treatment than with purified substance.

So, the last question is in the quest, (unintelligible) possibility of use human cells (unintelligible) in Parkinson’s disease inject embryonic cells which are (unintelligible) tolerated into the brain of Parkinson’s patients and so I would warn (unintelligible) human cells, nothing can happen to them to be sure that they are free of AIDS, to be sure that they are free of hepatitus B, (unintelligible).

I was in New Guinea myself and did study the famous (unintelligible) Nobel prize winner in medicine in 1977 with so called Kuru. The Kuru is a terrible disease and we treated it in Germany with 20 to 100 cells. We had the same symptoms, maybe, in autoimmune disease which is terrible. So if you give (unintelliigible) amounts they get nothing and the animal cells are doing the same job as the human ones. We can prove it. We can make the urine analyze (unintelligible) they are doing the same job as human cells. We are even better because there is no danger from the cells. Our brain has receptors for human material but not for bovine.

And so I think the future is with the application of animal cells. And the Nobel prize winner, excuse me I now have that, the name is Dr. Dormach, with whom I did work before the war.

(Unintelligible) I give the patient one tablet of aspirin and nothing happens I give him thirty, that’s ridiculous, that would kill him. And so, the same thing with the cells. You have to be very careful, you have not to be a business, you have to be an empiric doctor, responsible doctor, and of course I am agreeing with you, we have to make more research in ethical (unintelligible) and after the treatment how these different parameters are reacting. Thank you very much.

STEVENS: Thank you. We’ve got time for something. A comment?

LERNER: Yes, this is a comment. Since Dr. Kuhnau is addressing one of the — cell treatment, which is in the pharmacologic and biologic treatment — I want to point out what I regard as another example of the search for balance and middle ground in this section. In the beginning of that section, it’s announced that Livingston-Wheeler, Burzynski, Revici, Burton and Nieper will be discussed in detail, and then other things, laetrile, megavitamins, cell treatment and so forth will be discussed, and only when you get down to it in the back is there a discussion of hydrazine sulfate.

Now, hydrazine sulfate happens to be probably the most single successful unconventional pharmacological to cross the line into mainstream medicine. And the question is, in terms of balance, why isn’t hydrazine sulfate right in the beginning of the chapter as an example of the contribution that takes place to mainstream medicine, because hydrazine sulfate is not only effective in cancer cachexia, but a number of clinical trials, including a very recent one, a controlled clinical trial indicating life extension with lung cancer using hydrazine sulfate.

Now, from my point of view, in terms of balance, that should be a headline in this report, and it should be an example of why we need methodologies and so forth to help more of these things be adequately assessed.

STEVENS: Other questions and comments from the panel?

KUHNAU: We are treating the cause of the disease, and not the symptoms you know. And the cause by some cancer can be in the hypothalamus area, and cancers can start there in the limbic system. And so we are treating and I think we are in the right treatment.

STEVENS: Virginia Livingston.VIRGINIA LIVINGSTON: I would say that your work is quite extensive, but not always accurate. Seldom accurate, I should say.

STEVENS: Excuse me a second. We’re having some sound problems. Let’s try it again.

LIVINGSTON: All right. I think that your compendium was extensive, but not well informed. What it did cover was, perhaps, somewhat accurate. But my work was not covered in any sense of the word. After more than a half a century of research and publication in peer reviewed journals and verification by various research institutions of my findings, I wish to enter these into the record.

I believe that cancer is caused by a microbe which I’ve isolated and which I call progenitor-cryptocides. It is an obligant symbiant. It is present in us from birth. It is present in the sperm of every man. It is essential to life. It is pleomorphic, non-species-specific, acid-fast, belonging to the actinomyces family, and is an infectious agent. Anyone can isolate it. I have now clarified the methods. It can be seen any time, anywhere, from cancer patients or even from the sperm of a normal male. This culture is now in the National Test Culture Collection and has been used by many people.

Progenitor cryptocides is called that because it’s associated with embryonation in healthy states and with cancer in its pathological state. It produces a bacterial hormone, HCG, which is similar to human HCG. This has been corroborated by many people. The abnormal, pathological HCG produces a stimulation of tumor, and the normal HCG, which comes about by enzymatic action in the body, is healing.

I have prepared vaccines from this progenitor cryptocides which both prevents and helps put cancer into remission. I now have the United States Government license for California for this vaccine for the treatment of chickens with cancer, with Merrick’s disease and with other cancers. It was obtained from a woman, cultured, bacterial cultured, and was made for chickens. We have thousands of chickens now who are totally immunized against cancer by this use of this vaccine.

In 1986, I presented my vaccines to the NCI, but nothing was done. And then I made these tremendous books on every form of the organism, its pathology, treatment, appearance, and everything else, and I brought it here several years ago and it was not put to use. And I’ve come back again to offer it. And I’m willing to teach or show anyone who wants to know how this work is done.

In 1986, Medicare rescinded my privileges to use Medicare. We had extensive legal action, and we won. Not only did we win, but we were awarded a large sum of money which we have been unable to collect.

Just last week, Sacramento prohibited me from using my autogenous vaccines. We have literally thousands of people that receive the vaccines. We have a very high remission rate, and our patients who are well now are very angry and very upset that this has been taken away.

We have a patent on the production of HCG. I hope that there will be enough interest in studying this. As you know, in Europe, the microbe is well known. We have here a compendium of all the corroborative articles. Here is a book containing case histories which we challenge people to review. And we have a new book coming out called “The Hidden Plague”, and somebody said that that referred to conventional doctors.

HILDENBRAND: I have a question for the doctor. What — can you describe a little bit more the impact of receiving an order to cease and desist use of autogenous vaccines on a practice involving, I assume, hundreds and perhaps thousands of people with cancer and families and some thirty medical staff?

LIVINGSTON: It’s a very serious impact, but I’m keeping my equilibrium, because there’s no way to avoid producing good effects with immunotherapy. There are many other agents besides autogenous vaccines, almost too numerous to count. There are at least twelve that can be used, and so this does not affect my practice. I will find new ways to help the sick and dying, to which I am absolutely dedicated.

LERNER: In the ten years that I traveled the world and the United States looking at unconventional therapies, I want to say, that Dr. Virginia Livingston-Wheeler was, to me, quite a paradigm of the ethical, committed, qualified physician who, whether or not you agree with her findings, should, in the United States of

America, be allowed to practice medicine, and I really feel that the banning of her vaccine is an example of why this report needs the middle ground so badly.

And, I mean, I would tell you, without pointing to individuals, that there are highly qualified, neutral professional evaluators of unconventional cancer therapies who are on the other side of the fence, sometimes vociferously in opposition to alternative therapies in general, who, in looking at Dr. Livingston-Wheeler’s work, are convinced that she does — you know, one of the points I’ve heard — “about as well as the oncologists do” in treating cancer.

Now, whether or not she would agree with that assessment, this is why I think that it is so important that this report, if we really are to maintain the standards of OTA, not go to press before that middle ground establishes that, in the legal area as in the nutritional area and the spiritual area, we need the middle ground that we’ve already got in the psychological area of the report.

LIVINGSTON: Dr. Cassileth.

CASSILETH: I’d like to jump in and make a comment. Dr. Virginia, I think it would be very helpful for those of us here who may not be too familiar with your background if you can describe briefly who you are professionally.

LIVINGSTON: I’ve worked with Dr. Cassileth now two years and we’ve tried to match patients, and I thought we did rather well. We don’t have the final report as yet.

CASSILETH: Could you tell us about your training, your professional training so we could put that in the record.

HILDENBRAND: Your curriculum vitae.

LIVINGSTON: Well, I graduated from Vassar College quite a long time ago. I’m going to a class reunion in June. I graduated from New York University and I interned in various places. I was the first woman resident in New York City, of all places, in a hospital for prostitutes. And then I worked at Rutgers University as a professor for a long time and also at the University of San Diego. And now I’m practicing full time in San Diego.

I see many, many very, very sick people and I can say, happily, that I am reversing them. I believe this, and I have seen many of them get well, and so I must go on whatever the odds may be. Thank you.

STEVENS: We’d best keep going straight through. This is extremely helpful. The next speaker is Patrick McGrady.

PATRICK M. MCGRADY: My name is Patrick McGrady. I am director of CanHelp which is a cancer patient information referral service. I talk to 2,500 approximately cancer patients every year. My background is that of a journalist, and information specialist. I am not a physician. I’m not a PhD. I’m the past president of the National Society of Journalists and Authors.

Newsweek bureau chief in Moscow and a medical writer for the last 20 some years. And if I were an editor, judging this report on the grounds of journalism, the language is Ph.D. but the reporting strictly cub.

It is totally inadequate. The bias is unilateral. If she had bilateral bias it would be one thing, but this is unilateral bias. The bias is universally against alternative therapies, and the desire of patients to have freedom of medical choice which is really the important question here, not the survival of any of the doctors.

Dr. Virginia mentioned that the impact on her depriving her patients of autogenous vaccines is not that great because she’ll just go on to other achievements. And I’m sure she will. But what was ignored was the impact on patients whose lives depend on serum from Dr. Burton, Antineoplastons from Dr. Burzynski, Dr. Revici’s medication and Dr. Virginia’s autogenous vaccine.

There are more vigilante groups around now, as one from your panel which presumes to grab the stamp of approval or disapproval for herself and her group of vigilantes and decide what therapy shall pass and shall not pass. What is interesting is that this woman is also in the pay of the insurance industry and indeed offers her services to the health insurance industry as a way of saving money in reimbursing patient claims.

The real problem today is that there are groups that claim to have the stamp of approval. I don’t think any group ought to have the stamp of approval over a therapy. All information that we have now is, at the very least, obsolescent. All medical information. Look back at any part of medical history. And the information that was so good for George Washington, that bleeding him of many pints of blood would save him from his infections. We laugh at it now, but we have equally ridiculous treatments in the field of cancer therapy. (unintellibible) talks about proven medications. Where is the safety and proof for platinum, for vincristine, for cyclophosphamide, or any of the chemotherapeutic agents. These kill hundreds and thousands of patients every year and this is well documented. And you point to hypothetical adverse effects of the alternative therapies? HOW DARE YOU!

(applause)

You asked for data. You got data. What the hell did you do with it?

You got this book. It is not mentioned therein. This is a meticulous piece of reporting on Dr. Kelley’s results. You ignore it totally; they are the best results I have ever seen, certainly in cancer of the pancreas, which is one of the absolutely untreatable diseases in this field. And yet there is not one mention of that very valuable study of 23 patients. And those six patients among whom were fully compliant with the therapy, the only six that were, and who survived, I think the range was something like 5 to 14 years. Anybody in the American Cancer Society ever reproduce that result? The American Cancer Society has never funded a single winner. There’s not one breakthrough that was funded by the American Cancer Society before the breakthrough occured. After, of course, they were happy to give money to Dr. Papanicolaou.

My father was science editor for the American Cancer Society for 25 years. And toward the end of his time there, the last dozen years or so, he realized the bankruptsy of this approach of routinely condemning therapies out of hand because they didn’t fit a certain academic mould. It is so false to have done this because the Cancer Society itself is forced to withdraw its condemnation of at least four of the therapies. Hyperthermia: quackery it said for years, and doctors were dissuaded from exploring hyperthermia. Now hyperthermia, no pun intended, this was said by one of the presidents of the Cancer Society, is one of the hottest things we have.

Coley’s toxins, one of the great developments in immunotherapy, condemned as quackery. And finally, people, the really good people in the field said we’re using things very similar to it. Stimulation of the immune system is very valuable for cancer patients.

I hope you will take into account the papers which are going to be given to you by some of the other people here. I side with every single remark that has been made by the critics. I don’t think this report is ready for publication. I don’t know if it ever will be. I think the whole approach is wrong. I hope that revisions will be made, and I hope that those responsible for missions like this, and the direction of this report, will own up to it, and tell us why.

(applause)

Miss Gelband, I have one here for you.

STEVENS: We may have some comments and questions from the panel?

BLOCK: I think you raise an interesting issue that all but the leaders and their whole thinking of cancer care on both sides of the —

MCGRADY: Would somebody get me a glass of water. My mouth is dry.

BLOCK: I really think we keep talking about best cases, best cases, and what we missed out on, in terms of both the conventional world and the unconventional world, is a look and a review with some serious commentary on worst cases. On what exactly happens to some of these patients that go through either side of the …and what some of the travesty and devastation is with it. I know, and there is literature, I provided and some of it and will gladly provide some also to the OTA, where a number of interventions in terms of life-style interventions, psycho- oncology, nutri-oncology, demonstrated reductions and side effects, and in fact, some piecemeal but human studies demonstrating critical information in terms of enhancing response to conventional therapies by using outside ones and when we echo, which a group of has been very concerned about it, that this piece misses middle ground, those are critical and important areas of middle ground.

MCGRADY: To insist that Dr. Burton use his therapy in a trial of patients who are practically ready for the undertaker, that have been heavily pretreated with chemotherapy — biological therapies, in fact, no therapy really, biological therapies do not work well on pre-treated patients with radiation and or chemotherapy. The liver and pancreas toxicity from the chemotherapy, the radiation induced fibrosis, makes it very difficult for anything to penetrate tumor tissues again. It’s an unfair trial. He should be given much more benefit. He is accused of not cooperating with the panel. The panel did not cooperate with science or with Dr. Burton (applause) and this should be reconsidered. Any study that shows three months of time and half million dollars — over half a million dollars expenditures — and can’t come up with a better recommendation than that we follow FDA guidelines, which created the problem in the first place, which is fine for Burroughs Welcome or Pfizer to spend a hundred million dollars and ten years, but it isn’t fine with the cancer patient who doesn’t have all that time, and a doctor who doesn’t have all that money.

The reason that some of these fees are very high — Dr. Bryzynski’s fees are very high. Why? Most of it goes to legal defenses to defend himself against the vigilantes. Totally unwarranted attacks. I’ve known the man for a long time, he’s an honest man. His data are solid. And unless we eliminate that problem we’re going to continue to have the same problems we have.

This report fails completely to answer the charge of Congress and answer the complaints of the American people. And it’s got to be scrapped and I think you’ve got to start all over.

(applause)

STEVENS: We’re getting so efficient, we’ve got a little more time. Anybody else want to make a comment or ask a question? Thank you very much.

MCGRADY: You’re very welcome.

(applause)

STEVENS: Our next speaker is Clinton Ray Miller.

MILLER: Madam Chairperson and distinguished members of the OTA’s Advisory Panel for the study on unconventional Cancer Treatments and members of the audience, thank you for the opportunity to review, and comment on, the February, 1990 draft of OTA’s study of Unconventional Cancer Treatments.

I respectfully urge this committee to unanimously, firmly, and immediately repudiate the major conclusion of this draft report. You will find this conclusion in chapter 11, page 29.

After spending hundreds of thousands of precious tax dollars, unnecessarily delaying the draft report more than three years, taking a couple of staff trips to the Bahamas, and without interviewing one single cancer patient in that entire three and one half years, OTA’s project staff has come to the amazing conclusion that, from page 29, chapter 11 of the report: “It will never be possible, nor is it necessarily desirable, to evaluate FORMALLY all, or even all the most popular unconventional treatments used by cancer patients.

The key word here, which we’ve missed for four years, is FORMALLY.

What OTA says in its major conclusion of the 575 page draft report is that, in 1986, Rep. Dingell and forty-two members of Congress asked it to do something that was IMPOSSIBLE.

Did any member of the advisory panel have any idea, when you were asked to serve on this distinguished advisory panel, that you were supposed to advise OTA on the best way to do something that “will never be possible?”

Or is it possible that Chairman John Dingell and the other forty-two members of Congress unknowingly asked the wrong questions when they asked OTA to do this study?

In his superb book, Gravity’s Rainbow , Thomas Pynchon observed: “If they can get you asking the wrong question, they don’t have to worry about the answers.”

I’d like to ask the members a question of the panel: would you be willing to advise Congress how to ask the right question so that OTA will start to evaluate unconventional cancer treatments in a way that is both desirable and possible. If the secret is, and I think it is, I think we finally decoded the secret word, is to ask OTA for an INFORMAL, rather than a FORMAL, and this is the mould you were talking about, Mr. McGrady, then please advise Congress that is what they have to do.

Now on the right side of the folder which we gave to you, I’d like to list the history of our concerns up to this point. Nearly four years ago, OTA was asked by Congress to step into the middle of the cancer therapy wars. Please my see exhibits #1 and #2.

OTA immediately placed the study under the direction of Dr. Roger Herdman, a former Vice President of Sloan Kettering. The National Health Federation (NHF) felt this was a flagrant violation of OTA’s own code of conduct. We expressed our deep concerns to Dr. John Gibbons, the director of OTA, in person as well as in many letters. Please see exhibit #3.

As we predicted, the OTA staff heavily stacked the advisory panel, this advisory panel, against unconventional cancer treatments. It refused adamantly to allow Linus Pauling, who was most anxious to serve, to appear on this, and I talked to both Roger Herdman and Gibbons about it, and I was given the incredible answer: He doesn’t need to serve on the panel because “we know where Linus Pauling stands”. We asked Senator Charles E. Grassley to demand OTA balance the bias on the panel. See exhibit #4.

Jack Anderson reported NHF’s warning of a clear conflict of interest by Dr. Herdman’s ownership of and an incredible 100-fold profit in a couple of years from drug stocks. See exhibit 5.

We differ with those who feel the OTA project was put back on track again following its first 400 page draft report of July 18, 1988. We warned Congress again of the serious conflict of interest in violation of OTA’s ethics policy. See exhibit #6.

We learned that Congress has not created any oversight agency on ethics for OTA as it has for every other government agency. And that OTA handles its own ethics questions! This helps explain why OTA’s internal “checks and balances system” has failed. Please see exhibits #6 and #7.

All of the above criticisms directed by us at OTA may have been simply because we did not know how to ask Congress to ask the right questions of OTA when it requested this study.

We now understand we should have asked congress four years ago to request that OTA conduct an “INFORMAL” study of Unconventional Cancer Treatments. In an INFORMAL study they can interview cancer patients. In an INFORMAL study they can report the number of people who have been cured by unconventional therapies. All the questions that we have been asking them to do come under the informal study which Congress carries on every day of their lives. And they assume that this agency, which is one of their agencies, would naturally recognize that this was only fit for informal study.

Please see the form letter to Chairman Dingell which follows.

Now, we also have additional suggestions, corrections, documentation, and deletions and cites for the draft which will follow in a few days. (applause)

STEVENS: I’d like to, if I can, to ask you a couple of questions. One comment about the advisory panel being stacked against unconventional treatment, I think that is a matter of opinion. And it’s something that, as a panel, this panel has openly been very much sensitized to everybody’s point of view.

MILLER: May I just ask a question?

STEVENS: Sure.

MILLER: Do you think Linus Pauling should have been invited to be a member of the panel? A two time, the only two time Nobel prize winner that we’ve have. He was on the list. Why was Linus Pauling refused to be on the panel. Was that your choice?

STEVENS: It was not my choice. Panel members were selected by OTA as normal procedure. There were definitely other people who might have been selected who were not selected. The panel does reflect the variety of opinions.

MILLER: Madam chairman, I’m talking about heavyweights. When you put a panel together, you can have 57 lightweights and have one heavyweight. And one heavyweight can outweigh 57 lightweights. When you have the head of the American Cancer Society here, I want somebody like Linus Pauling on the other side. (applause)

STEVENS: Let me ask my other question. You raise very important question. You say that this study is not asking the right question. What is your opinion of the right question?

MILLER: I think the first right question to ask is to get a rough estimate of how many cured people there are in America today, living who used unconventional cancer therapies. The most simple question in the world, which could have been answered with very little cost, a fraction of what is cost this committee, and we could have that answer in 10 days, a rough estimate, which is exactly the way you started out this report. How many are there? It doesn’t even seem to occur to the staff to ask that question. I’d like to know how many there are in this room.

VOICES FROM THE HALL: One here. Here.

MILLER: Now I know that there are already 1, 2, 3, 4. And I would suggest that the staff talk to these people and begin to count them.

STEVENS: Other questions from the panel? I think we will come back to some of these general issues that you raised, which relate to the nature of evidence, and the passions that there have been and still are in this field, the long tradition of mutual distrust within the field, and I hope that again (unintelligible) Thank you.

MILLER: Thank you. (applause)

STEVENS: Our next speaker is Ralph MossMOSS: My name is Ralph Moss. I am the edictor of the Cancer Chronicles, author of 6 books on the cancer field, including the

Cancer Syndrome , and Cancer Industry . First let me say that I’m really astounded at this whole procedure. I’ve never been to a Washington hearing before and sometimes I feel like I’m wading through cotton candy. You people don’t seem to have the right spirit to conduct this whole report.

People are dying of cancer in this country. You remind me of that Ron Cobb cartoon where there is a little child dying of malnutrition in a crib and there are 8 or 10 doctors standing around pointing and questioning and rubbing their chins, like what’s going, we have to get the medical reports on this. People are dying.

We cremated Ron Wolin this week. And, you know, it’s a very interesting story. Ron was the co-founder of Patients’ Rights Legal Action Fund and he was a patient of Dr. Burzynski’s, and was lying on a couch in Dr. Burzynski’s office in Houston when the FDA came in and seized something like 11,000 documents out of his office. They took the filing cabinets, loaded them onto a U-Haul and drove away.

And the very same day, Dr. Burton’s clinic was shut down in the Bahamas. July 17, 1985.

You know, everyone’s thanking you for doing this wonderful report. Well I thank you Miss Gelband for one thing, and that is that you brought all these people here. And you brought us out into the halls of Congress, and got me off my ass to go in and talk to my Congressmen, and talk to three or four other people in Congress and finally to tell them things I should have told them twelve years ago. So thank you.

This report on “Unconventional Cancer Treatments” was supposed to investigate a coverup. Instead it has become part of that coverup. In its present form, it will set back the study of non- toxic cancer treaments for years to come.

From 1974-1977, I was Assistant Director of Public Affairs at Memorial Sloan-Kettering Cancer Center. In June 1974, I had one of the great experiences of my life. I went to the Walter laboratory in Rhine, New York, and interviewed Dr. Kanematsu Sugiura, one of the center’s most experienced and distinguished scientists. I didn’t go there with any intention of finding out anything about unconventional methods. I was totally orthodox in my thinking on medicine questions. I was naive. I just thought that Dr. Sugiura would make a wonderful story for Center News which was our employee newspaper. At the end of the interview, I said to him, “What are you doing now?” He was, you know, a cute little old man. I sort of thought it would be sort of a nice little addition to tell people how he was still working even though he was in his early 80’s at that time. And he said, “oh I working on amygdarin”. And it took me a second to realize he was talking about “amygdalin”. And that Amygdalin was laetrile. It’s rated laetrile that I was handing out press releases on, and saying that it was entirely negative in our studies. Studies were underway at that point. And I said to him, what is there to work on if it doesn’t work. And he took down from his shelf one of a series of volumes that he kept going back to the 1930’s with little mice, with little rubber stamps, and stamped very neatly and on it he showed me his experiments in which the tumors stopped growing for a period of time and then started growing again. And I said, well thats amazing, because, it was amazing to me not because these were the greatest results ever achieved in cancer, obviously they weren’t, but because I was saying just the opposite. That it was worthless. That the American Cancer Society had proven it worthless.

And that’s not the most important thing, he said, the most important thing is the stoppage of metastases. The spread of the cancer. And he showed me the data where in the control animals, and these were were F1 mice, 80% of the controls had lung metastases, by standard methods of evaluation, pathology department of Memorial Sloan Kettering, Memorial Hospital, and only 20% in the controls — excuse me, in the treated animals, had metastases. And that revealed to me that there was something funny going on. And from that time at Memorial we progressed into a coverup of the results on Laetrile. Until finally Dr. Stock said, in 1975, said it to Medical World News “We have found laetrile, amygdalin, negative in all the animal systems we have tested.

To make a long story short, I blew the whistle on this coverup and I was fired the next business day for failing to carry out my “most basic job responsibilities”: to lie on behalf of Memorial Sloan Kettering.

Now: WHERE ARE THE SUGIURA STUDIES IN YOUR REPORT? WHERE ARE THEY?

Twice you say that OTA report includes “the information presented about specific treatments is, in most cases all that could be found, rather than a selective culling through a larger body of literature”, pages one – 32/33; and introduction pages two, six, seven.

Really? There’s ten pages on laetrile. You’ve got space for pointing out the John Birch Society connection. But you have no no space to talk about the BIGGEST, MOST EXTENSIVE, and probably the BEST study ever done in a laboratory on ANY unconventional method.

It’s gone! It’s as covered up today as it was in 1975. Now I know what’s going on here. I’m not fooled and I’ll tell you something: that repression breeds resistance. Ron Wolin watched those records go out the door, then he founded an organization which forced the government to a standstill in the courts. And the same day, by coincidence, Frank Wiewel was in the clinic, in Burton’s clinic. You know, just a guy, with his father-in-law. And he watched Burton’s clinic be closed and look, here he is. He’s the head of two cancer organizations. And I was just a guy who happened to be in the right place at the right time, or from their point of view, the wrong place at the wrong time. So, I’m not afraid of you, and I’m not afraid of what you’re doing. You continue with this? Fine. We’ll continue to fight you. If you’re smart, you’ll save the reputation of OTA and you’ll radically revise this report.

(applause)

HILDENBRAND: A comment that may be germane at this time. And first let me say that Ralph I applaud your passion. I’m flabbergasted and I think it is one of the most admirable things we’ve seen. I think that the perception of bias in this report — and I am not announcing anything that isn’t fact. People think the report is biased, and I bet as authors you are scratching your heads and saying, “well why do they think it’s biased? I don’t think it’s biased” — the perception of bias in the report, I think revolves around a single sort of mechanism, a logical mechanism.

And I don’t pretend to be the Rand corporation, to be able to analyze written language as propaganda or as something that promotes even when it’s unintentionally promoting. But what I see is a parallel to what Judge Getzendanner outlined in her decision on Wilk vs. the AMA which was, very simply, that a boycott had been started a long time ago, decades ago, which boycott revolved on Principle 3 of the AMA, which doesn’t exist anymore. It was stricken because of legal problems. Principal 3 tells that it is unethical for physicians, members, to associate with unscientific practitioners. From that simple mechanism, the labeling of practitioners as “unscientific” resulted in excommunication and exclusion. And the finding was, in Getzendanner, that even though the Committee on Quackery which had stemmed from Morris Fishbein’s labors, had disbanded, that the boycott was still happening: something called “lingering effects”. Lingering effects.

Now, most people in this room know that; who are critical of the report and who say that it’s biased. And I must say that I can see why. Although I’m struggling to not see why, I think I see why it is biased, and I think that I agree that it is biased on the grounds that this report, too, through a mechanism of judgement as to what is scientific evidence, “something stemming from an RCT”, excludes as “unscientific” managements which have not been subjected to RCTs, which are, after all, a relatively recent development in design methodology and biometry. RCTs are relatively new. Hellen had to write — you had to write a book in 1982 for OTA promoting RCTs because they’re not used everywhere.

However, now, if we take the position that the RCT is the only way to go, and in this report that we are studying we use that as the standard by which to judge, and we point to only RCTs, and in discussions of therapies where there are no RCTs to point to we state “there is no scientific evidence”, we have labeled them as “unscientific”. And even if Judge Getzendanner did publish an injunction instructing physicians that they were conducting a boycott that they didn’t even know about — she had to tell them what it was — against chiropractors, there has been no similar injunctive relief for proponents of alternative cancer managements. And the report does seem to continue to play to our desire to not be associated with “unscientific practitioners”, to avoid discrediting ourselves professionally. I think that is the mechanism that can be referred to as bias in here. I don’t know if anyone else saw it, but I saw it.

(applause)

STEVENS: Thank you, Gar, that’s a very important view and we will want to hear everybody’s view about perception, general perception of this point where, as it’s been made very clear, the evidence all the way through cancer treatment is still, to me, quite crude in many ways.

HILDENBRAND: Is really quite what?

STEVENS: Crude.

HILDENBRAND: Yes.

STEVENS: And what I think, as I listen to the speakers, is here we are as an advisory panel and speakers and audience and professional staff, who are part of a very difficult process which I think we all want to share in, of trying to bring some better light on a field which is extremely frustrating for the kind of knowledge that science is something we can use as baseline way of looking at the problem.

MOSS: Can I talk to that?

STEVENS: Sure.

MOSS: I would have loved to have shared in the process of writing this report. I was proposed as a panelist. I was proposed as a contractor. Well, people have their own reasons for making decisions and that’s fine. I wrote to Dr. Herdman and I asked for the chance to meet with him to have input. And I’m not complaining, Dr. Herdman, because he was very nice to me. And that he did tell me I could be an outside reviewer. But I had no input into this report. My writing had no input into this report. At one point, my earliest book, of 1980, is referenced, because I use the word unorthodox, and it says “even proponents of alternative methods use the word unorthodox.”

I’m not a proponent of unconventional methods. I would probably see eye to eye with some of the more conservative members of this panel on some questions. For instance, as Ms. Gelband could have found out if she ever picked up the phone and talked to me, I wrote a book about breast cancer which happens to advocate surgery. Radical isn’t it? Surgery in the treatment of breast cancer. It’s called A Real Choice , I wrote it with a surgeon affiliated with the American Cancer Society, Leslie Strong. You can check that in the library. I think that the pattern, and I’m not the only person who feels that way, I think that, you know, the so-called radical, the strong voices, the people who could oppose the more extreme elements on the other side were excluded from this report. Their voices are not heard here. You’ve not really presented a true dicotomy. You presented a muffled dicotomy.

STEVENS: Thank you very much.

COLLIN: I think it’s quite important, since there is some tenuousness about how much modification is going to be made in this report that one thing that should be done, I notice in the pharmacologic section there’s a box on coffee enemas, and I think that it would also be appropriate to have a box on this particular study on laetrile and have Ralph Moss supply data about what exactly happened in it. (applause) Also some of the patients, which he could provide some information on as to what journals did in recieving this doctors data and not publishing it.

STEVENS: Thank you very much.

MOSS: I would happy to cooperate in any future committees or panels that you would like to set up to work on this. Thank you.

(applause)

(attachment)

THE CANCER CHRONICLES: Ralph W. Moss, Ph.D., Edictor
161 West 61st St. New York, NY 10023
(212)245-4639

March 9, 1990

STATEMENT TO THE OTA’S “UNCONVENTIONAL CANCER TREATMENTS” ADVISORY PANEL MEETING

“Unconventional Cancer Treatments” was supposed to investigate a coverup. Instead it has become part of that coverup. In its present form, it will set back the study of non-toxic cancer treatments for years to come.

From 1974-1977 I was Assistant Director of Public Affairs at Memorial Slozn-Kettering Cancer Center. In June 1974 I had the pleasure of interviewing Dr. Kanematus Sugiura, one of the Center’s most experienced and distinguished scientists. Sugiura showed me his experiments with laetrile, a treatment based on an extract of apricot kernels.

In Sugiura’s hands, Laetrile dramatically stopped the spread of cancer in mice. It improved their health and well-being, and was completely non-toxic. Sugiura repeatedly said, “I am sorry, Laetrile is NOT a cure for cancer. It is a good palliative drug.” He died in 1979 sticking to that belief.

Sugiura repeated thses results many times in three separate animal; systems. Quackery? In 1974 and 1975 Sloan-Kettering officials themselves pleaded the case for laetrile at two closed- door meetings in Washington. But when they were unable to convince their conservative peers they ran for cover. (1)

In public affairs, we were given increasingly negative statements to make about laetrile. To no avail, I objected to top officials of the center. Finally a vice president announced, “We have found Amygdalin [laetrile] negative in all the animal systems we have tested.” (2)

For me, that was the final straw. In November 1977 I publicly exposed the coverup. I was fired the next business day for failing to “properly discharde [my] most basic job responsibilities.”

Since then I have discovered that this pattern of deception is hardly limited to laetrile but pervades the entire treatment of alternatives by orthodoxy. To document this charge, I have written

THE CANCER SYNDROME, THE CANCER WAR (a PBS film), FREE RADICAL , and most recently THE CANCER INDUSTRY . I also edit a quarterly newsletter, The Cancer Chronicles subtitled “Serious Consideration of Alternative Ideas.”

My charges have been reported in The Sciences, Science Magazine, the Lost Angeles Times, and New York Times. I wrote a chapter for Dr. Louis Lasagna’s CONTROVERSIES IN THERAPEUTICS . Sloan- Kettering’s incomplete version of its laetrile experiments can also be found in the medical literature.(3)

The OTA report twice claims that “the information presented about specific treatments is, in most cases, all that could be found. Rather than a selective culling through a larger body of literature.” (pp. 1-32/33; also intro to 2-6/7).

Really? This report devotes 10 pages to laetrile yet says not a word about sugiura’s work. One of the most extensive laboratory tests ever performed on any unconventional cancer method. Nor does it deal with the revelations in my books of an extensive cover-up of many alternative therapies.

In fact, My services have been repeatedly rejected by OTA and I was never consulted in the course of this study. On page 1-7 I am dismissed as a “proponent” of unorthodox therapies. Nonsense. I am not a “proponent” of such therapies nor have I advocated their use. As a science writer. However, I am a proponent of fair and honest testing and truthful reporting.

Apparently, though, a carefully-reasoned analysis of the cancer industry is too much for the extremist “Quackbusters” whose thinking now dominates the OTA report. And behind the “quackbusters” stand huge and powerful economic interests that benefit from the suppression of cancer alternatives.

1. For fuller account, see The Cancer Industry (NY: Paragon House. 1989) Chapter 9.

2. C. Chester Stock, Medical World News , interview with David Leff. August 11, 1975.

3. Stock, et. al., Journal of Surgical Oncology , 10:81-88, 1978.

(END ATTACHMENT)

STEVENS: Vivien Newbold

NEWBOLD: Hi everybody. I’m Dr. Vivien Newbold. I’m a fellow of the American College of Emergency Physicians. Thank you very much for the opportunity to be here.

I am deeply concerned, like everybody else is, about this report. OTA says in its review in evaluating macrobiotics as a cancer treatment, OTA feels the available information has not turned up any studies of macrobiotic diets which provide valid evidence to support their use by cancer patients for cancer treatment. Information that is currently available consists of retrospective case reviews and anecdotal reports. The majority of which come from popular literature.

Dr. Eyerly you have stated clearly that you have taken the stand, that it is incumbent upon us to provide the evidence. I would like to ask you and your organization what kind of scientists are you? In the past throughout history, physicians and scientists have observed something just like Samuel Fleming, looked at the plate on the penicillin, and said, “gee there’s something going on here”.

I contacted the American Cancer Society and I said, I have a patient here with metastatic colon cancer, that has completely recovered. Are you interested? He used the macrobiotic diet. And what does your organization say to me? We have no interest. WHAT KIND OF SCIENTISTS ARE YOU?

(applause)

I am not a research scientist. It is not my job to do those studies. It is YOUR job. Or it is the job of NCI. They said the same thing. We have not interest. They won’t move. They laughed at me. I said, “Don’t you understand? 65,000 this year are going to die of metastatic colon cancer and you’re not interested?” And you’re organization said, “That’s right. We’re not interested.” THAT’S APPALLING! You have a responsibility to the American people.

(applause)

OK. So I got together five other cases of severe advanced cancer that was medically incurable. Your report breezed over that documentation. I submitted those papers. Those papers were biopsy proven. They were meticulously documented. I submitted them to the New England Journal , the Lancet , and the JAMA , and what did they say? IT IS OF NO INTEREST TO OUR READERSHIP! WHAT KIND OF STATEMENT IS THAT?

They are not interested? I submit to you that if we had had wonder drug X and we had one of those patients recovered it would have been all over the journal.

OK. So thank God. Dr. Carter, from Tulane University picked up my work. Because I’m a mother and I work, I can’t do this kind of research. If we looked at 23 cases of pancreatic cancer and how much longer did they live if they had just 3 months of macrobiotics? They lived 17.3 months compared to 6 months of standard conventional treatment that you provide.

We looked at eleven cases of prostate cancer. There are 11 cases with the average life of 81 months but that is going. Most of them are still alive compared to 36 months. And four of those patients, they had complete healing of bone lesions. Do you have ANYBODY? With complete healing of bone lesions? In metastatic prostate cancer, do you have one case? You don’t. So why do you ignore what I have? Why do you ignore what macrobiotics or any of these other people can produce. WHAT KIND OF SCIENTISTS ARE YOU?

I submit that you are NOT SCIENTISTS. YOU ARE NOT TRUE SCIENTISTS AT ALL. There are numerous numerous reports in the lay literature. Even I bump in to somebody, here who says you know I work here, my brother had severe leukemia and he is doing fantastically. What do they do now? They question the original diagnosis. They say that he didn’t have leukemia.

Everywhere you go you bump into someone who says “oh yes, the macrobiotic diet did very well”. I would like to give you guys a break and show you some pictures. Can you hit the lights for me please?

This is a patient who went into cardiac arrest on the table because they tried to do surgery on him for a highly undifferentiated malignant follicular cell carcinoma of the thyroid. Did you ever have anybody recover with that? It is a highly malignant disease. They uniformly die. OK. The next please. No one back. I would ask you to look at his face very carefully. Can any of our major medical institutes help this person to become a centered, happy person who loves himself. Next. This is two months later. Again. Next is one year later. Another 3 months later. He is on the macrobiotic diet. Again. Again. OK next. Please see the transformation in the entire human being. Can you do this? With medicine? Can modern medicine do this? Next. OK. All right? This is just one case. And the American Cancer Society doesn’t want to know why or how? Or is this person just a freak. Or how many other cases do we have like this? OK.

I would just like to close with one thing. As an emergency physician I, like Dr. Seymour Brenner, see many people who have medically totally incurable diseases. Those things for whom medicine can offer absolutely nothing. Is this a free country? I cannot say to this person, look, please try alternative medicine. I cannot say it. I submit to you that is communism in another form.

(applause)

ACHTERBERG: Let me support something that you said earlier. I do not believe that it is possible to use the criteria that something must appear in a peer-reviewed journal as true.

NEWBOLD: Yes, if they reject it, how can they — how can we say?

ACHTERBERG: I keep up two lines of research, one line is accepted by my peers, the other line is not accepted by peer- reviewed journals and it all stems on whether or not I am contesting the belief system of the mainstream. They come from the same tests, the same rigors, the same laboratories. So, if we’re going to use that as criteria, we’ve got a big problem.

NEWBOLD: Yes, that is correct.

LERNER: I”d like to support one other thing that you said. When you pointed to not only the physical but the psycho-spiritual transformation, and, to me, this again shows the extraordinary lack of middle ground in the spiritual section of the report, where we see stuff on crystals and stuff like that which really has no relevance, when all of use who are working in the field, in the life-style approaches now, that whether or not the person recovers from cancer, and I think we have to say, at least I would say, that I see very few recoveries from really life threatening cancers with any of the alternative therapies as well as the conventional, it’s rare. But what you do see, whether or not the person recovers, are these extraordinary psyco-spiritual movements and there is a language in mainstream medicine called bio-psycho- social medicine. And is the difference between bio-medicine and bio-psycho-social medicine, and this is well accepted. And it is a major theme. And again, to bring out the middle ground, now we should say that the spiritual aspect, the psycho-spiritual aspect in cancer therapy, macrobiotics and many other places, is a known extention of the major affirmation that is taking place. The President of the American Medical Association, his inaugural address is on humanistic medicine. So this is a major theme in medicine. And I believe those photographs point to it. And it is virtually entirely missing from mainstream cancer therapy.

NEWBOLD: There is one other thing that is very important, that’s also being missed. The statment like this one in your first paragraph here, and the statement thrown out by American Cancer Society and other people about macrobiotics and alternative medicine are very cruel. When you have — I have had recently a distant friend with a child with a terminal brain tumor. And they did not try alternative therapies because of this kind of report. And the reports coming out. YOU HAVE NOTHING TO OFFER THESE PEOPLE. THEN WHY ARE YOU SO CRUEL TO THEM? You know, this child died a few weeks ago.

(applause)

And why without the possibility of any of the other therapies. Not just mine. OK.

We are talking about a bigger issue. Freedom in the United States as opposed to situations where we work with our hands tied. I am afraid to tell people about this. I cannot say to people, “please try macrobiotics” because your organization and the law are going to come after me. OK? THIS IS NOT RIGHT!

(applause)

STEVENS: I hope you also have suggestions, specific suggestions on ways to …

NEWBOLD: Yes. Thank you very much.

BLOCK?: I’d just like to add that, and second some of what Michael said and what Vivien was acknowledging, there is one area of major omission throughout this piece. Virtually through each chapter, each section, I think the bottom line that is inferred throughout the piece is that the look and the search and the hope is for cytotoxcicity, instead of what I would call inspired living.

And I think the one thing that alternative care clearly does, and Greer points it out at King’s College, just a hoard of literature coming out, not only in the alternative world, but in conventional world, that this idea of inspired living is one of the few opportunities in people’s lives where all the — pardon the french — but all the bullshit gets stripped away, and we deal as authentic human beings. We start to look at the reality of our mortality. In the process of missing this in this piece, in not really addressing how all the different, not only alternatives but the entire approach, the model, that we’re using, the paradigm is wrong, that the paradigm has to push altogether to an alternative model, not to alternative care per se, but to an alternative model altogether.

STEVENS: Thank you very much. We have to keep going because we have four more speakers before we break.

(attachment)

Vivien Newbold, M.D.
4139 Apalogen Road
Philadelphia, Pennsylvania 19144
215-848-8888

March 9, 1990

Dear Advisory Panel Members, Ms. Gelband and OTA Staff:

I am deeply concerned that this report fails to focus on the potential benefit that macrobiotics may hold, and the urgent need for research into the efficacy of macrobiotics.

Instead, the report appears to scrutinize the possible flaws in macrobiotics and in the simple research into macrobiotics that has been done to date. The macrobiotic community, cousellors, and macrobiotic physicians do not have, have nver pretended to have, an cannot be expected to have the scientific knowlede, facilities an funding to conduct the massive research it is going to take to determine the efficacy of the macrocbiotic diet.

This report has failed to highlight:

1. The report of six patients with advanced medically incurable cancer who went on the macrobiotic diet and experienced total regression of ther cancers. Five of these patients have now no sign of cancer anywhere, and are in excellent health more than six years from the date when they were told they only had a few months to live. One of these patients had complete regression of her cancer lasting 2 years, only to suffer regrowth of the astrocytoma and die when she went off the diet.

It must be emphasized that cases of total sustained regression from advanced cancer are exceedingly rare. There are less than 500 cases of documented spontaneous regression of cancer, of these less than 40% lived more than one year. Here we have six cases of total regression of cancer, five of the cases are alive and well now, six years later. All these six patients had one thing in common, namely they all used the macrobiotic approach. It makes only sound common sense that this common factor, the macrobiotic diet, needs to be fully investigated to see if other patients with cancer can also benefit from macrobiotics.

In the hope of stimulating the interest among clinical investigators necessary to determine the efficacy of the macrobiotic diet, the author documented these cases, and submitted them to three major medical journals for publication: the New England Journal of Medicine , The Lancet , and The Journal of the American Medical Association . All three of these journals refused to publish the manuscript, stating in each case that it was of insufficient interest to their readership. If the research community refuses to publish articles documenting cases in which alternative therapies appear to have been helpful, then it is unreasonable for them to claim that a review of their literature shows no evidence to support macrobiotics or any other form of alternative therapy.

2. The study being done by Tulane University on patients with pancreatic cancer and patients with prostate cancer. This study notes that 23 pancreatic cancer patients who modified their diet to a macrobiotic diet for at least three months had a mean survival of 17.3 months, compared with 6 months in the control group. In 11 patients with stage D2 prostate cancer on the macrobiotic diet mean survival was 81 months, compared to 36 months in controls. Of great importance are 3 macrobiotic patients with stage D prostate cancer that had healing of bone metastases lasting more than 5 years, a result not observed in any of the controls, and never described in the literature that we are aware of.

3. The increasingly large numbers of anecdotal cases of advanced disease that have recovered using macrobiotics described in the lay literature.

It is truly perplexing that the major cancer research institutions have consistently disparaged or ignored macrobiotics, rahter than learn what macrobiotics has to offer. In the last 50 years modern medicine has not found any effective way of treating orpreventing most advanced cancers. Is it not self-evident, therefore, that a totally different way of thinking and approaching the healing of these cancers must be sought? Is it not self-evident that the major research institutuions should be extremely keen to determine why these 6 cases of dramatic regression of medically incurable cancer, the patients with pancreatic cancer, prostate cancer and the many testimonials in the lay literature did so astoundingly well?

Surely Congress and the American people urgently need to know what role macrobiotics can play in healing and health.

In conclusion, this report is irresponsible, as will be the final report, if it fails to emphasize the urgent need for large multi- center studies by the scientific community to determine the efficacy of macrobiotics:

a. in the treatment of medically incurable cancer;

b. as an adjunct in the treatment of cancers that are amenable to conventional treatment; and

c. as a standard diet for the prevention of cancer.

Thank you for the opportunity to address the Advisory Panel and OTA staff today.

Sincerely,

Vivien Newbold, M.D.

(END ATTACHMENT)

(attachment 2)

Cancers with Suspected Nutritional Links: Dietary Management? Part I: Primary Cancer of the Pancreas

James P. Carter, M.D., Dr. P.H, Gordon Saxe, M.P.H., Ph.D. (Cand.), Vivian Newbold, M.D., Charles E. Peres, M.D., Lynn Green, M.D., Richard Campeau, M.D.

Department of Nutrition
Tulane School of Public Health and Tropical Medicine
1430 Tulane Avenue, New Orleans, LA 70112

March, 1990

Abstract

Two prospective studies were performed to examine the effect of adoption of a very low-fat, high-fiber diet on survival of patients with cancers whose etiologies have suspected nutritional components. The first study, reported on here, examined the effect of dietary modification on survivial in primary pancreatic cancer. The second study, on survival and disease status in metastatic (stage D) prostate cancer, will be reported on in the second part of this publication.

In the study reported on here, one-year survival was significantly higher (z=6.74, p,.0001) in 23 pancreatic cancer patients who modified their diets than in SEER national tumor registry controls diagnosed during the same time period. Because survival differences may have resulted from selection biases or from attitudinal or non-dietary lifestyle changes that accompanied dietary modification, it is uncertain how much of the effect was due to dietary change and how much to non-dietary factors.

In the second study (to be reported on in part II), mean survival was found, in a preliminary analysis, to be 87 months in 11 stage D prostate cancer patients (all Gleason scores > 4) who had altered their diets compared with 36 months in patients from Tulane Medical Center matched for stage, grade, treatment, time to progression, and age (t= 7.05, p<.0001). Four of the 11 diet- modification patients had long-term (>5-year) healing of bone lesions, a result not observed in the controls and only rarely described in the literature.

These studies found strong statistical associations of dietary modification with enhanced survival in two types of cancer suspected of having dietary links. Because of the small sample sizes and the liklihood of biases in the selection of cases, these findings must be interpreted cautiously. Nonetheless, they raise an important question: could dietary modification serve a useful adjunctive role in the management of cancer?

(END ATTACHMENT)

MARYANN ROPER: I am Maryann Roper, I’m a pediatric oncologist and currently Deputy Director of the National Cancer Institute. I am accompanied today by Dr. Mace Rothenberg, who is in the audience, a Medical Oncologist and Special Assistant to the Director of the Division of Cancer Treatment at the NCI.

I’d like to comment this morning on two areas in my presentation.

First, NCI’s activities in evaluating new therapies obviously (unintelligible) and second some considerations for additions to the options that are presented in OTA’s draft report. I have, in addition, submitted written comments to Ms. Gelband with some other things that NCI has to say about the body of the report and we submitted these for the record.

NCI is interested in creating a “level playing field” so that all proponents of all therapies — conventional and unconventional — can adhere to the same rules and standards and have access to the same systems, if desired, for the sake of the patients to be treated.

The national Cancer Institute is a scholarly institution engaged in cancer research. NCI encourages new ideas, and has a process in place for incorporating new ideas into the system of laboratory evaluation which eventually leads to clinical trials, based on a system of peer review.

NCI is receptive to new ideas: Each year, the Institute funds approximately $750 million dollars worth of investigator initiated research. NCI assesses new approaches to cancer therapy: Whether it is through the use of new agents to treat cancer, or whether it is through evaluation of new methods of administering conventional therapies — for example, the use of a chronobiologic approach to administering conventional chemotherapy, that is, administering chemotherapy at the times of day when the body appears more likely to respond to it than elsewise.

In addition, we have tested leads obtained from traditional medicine, such as the mayapple plant which eventually led to testing periwinkle which obviously led to the Vinca alkaloids.

We also have done large scale clinical trials on unconventional agents for the purpose of assessing their activity in cancer, including laetrile and vitamin C.

Two of the most important factors (obscure) in evaluating any new agent or modality are to assess the safety and the efficacy of that agent.

We are committed to protecting the safety of patients participating in clinical trial systems. Any work involving human subjects must adhere to a number of statutes and regulations set in place for us by Congress. Specific standards also come into play when human clinical trials are conducted in another country under our auspices.

This includes attention to the safety of the product or agent being administered to a patient, ensuring that good manufacturing processes have been used, etc.

It also includes the responsibility of “informed consent” – — that is, telling patients about the nature and previous experiences of the treatment they are receiving as well as other possibilities that they might opt for in the case of their particuar cancer.

We don’t view these as bureaucratic impediments to doing human research, but rahter as solid principles to insure protection of the patients involved.

The second factor, or efficacy, of a new treatment agent or modality is evaluated through the peer review of stats presented about the results of a given therapy or a givne approach.

NCI is eager to keep an open mind and to receive new ideas from many sources and the staff have committed themselves to helping cancer patients.

The Office of Technology Assessment has suggested several options in its report for future action. The report suggests that additional research be conducted on the characteristics and motivations of cancer patients. Such a study is currently in progress under the auspices of the American Cancer Society. But in addition, such work could be undertaken through the NCI (unintelligible) through the mechanism of investigator initiated grants.

The report also suggests that NCI’s Cancer Information Service (CIS) be evaluated for the adequacy and quality of the information that it transmits on unconventional therapies. Please suggest how you would like us to do this rather than the way we are currently doing it.

The report suggests that NCI be mandated to pursue information about and facilitate the examination of unconventional therapies. NCI has checked the natural products and CAN test any “unconventional” agent in the existing screens. The limiting factors are: information about the chemical nature of the product to be tested, and that sufficient quantities the product to be tested be provided. We are well equipped to protect the confidentialities and proprietary interests of a provider.

The report suggests that we facilitate a “Best Case” series to first evaluate therapies. This approach has been offered to practitioners of unconventional treatments, and several have indeed submitted case material for review.

Evaluation of whether a new substance shrinks tumors is not complex: it involves evaluating tests in what the status of the tumor was before the treatment and again after the treatment has had appropriate time to work. It is not difficult. This is not out of reach for an average physician. The methods for evaluating tumor shrinkage are the same for unconventional therapies as they are for conventional therapies and this approach should not be made to appear more complex than it is.

In summary, NCI believes that many of the mechanisms that OTA suggests be put into place are already available. We would suggest adding to the report perhaps the way to access these mechanisms should this be desired. At least initially this can be done by starting through our office of Cancer Commuications, indicating that there is a new treatment idea to be considered, and then we can funnel this in the right direction to the Division of Cancer Treatment.

We are interested in helping cancer patients and we appreciate your comments or input on how we can do this better. I appreciate the opportunity to address (unintelligible). Thank you.

(applause)

REIGELMAN: Could we explore a little more detail about what you mean by new options. I’ve heard that there are new access points that NCI is looking for to have people bring them ideas and bring them biological samples. What I don’t hear is any change in the testing of efficacy once there are human tests on biological products. I don’t hear any suggestions for changing the current way in which testing is adopted for the standards of proof. Is that an accurate reflection of the position you bring?

ROPER: Yes and no. I think that it is true that I’m not standing here today saying there is going to be sweeping change. However I will also point out that the existing system is perhaps not as cut and dried and generally supportive, even within what type of approach works in the conventional community as perhaps has been protrayed. Several times we’ve referred to the in vitro screen. This is a product of perhaps the last five years that, at least at its onset, was meant to be a major experiment to attempt to replace the animal model system which was alluded to earlier and perhaps be more effective in identifying drugs that the animal model system was unable to detect.

Earlier speakers alluded to the fact that the animal screen perhaps was very able to detect drugs for the lymph (unintelligible) but not so adept at detecting new agents — please forgive me for using the word “drug”, let me say agent — in solid tumors. There is considerable disaggreement even amongst the National Cancer Institute’s advisors, whether they be the Scientific Council or the National Cancer Advisory Board, whether the cell line system is the best approach or whether the animal model system should continue. And I think we are left in a situation of saying we have to try it before we can know for sure.

REIGELMAN: That’s really — the question I’m trying to address is, if 2 years ago someone brought you and convinced you of a best case scenario, that there was theoretically potential efficacy, you would submit that to the standard NCI approach. Do you propose any changes in that standard NCI approach as it exists in the past to how it would exist in the future.

ROPER: I think one of the things we have offered is the “best case” scenario.

REIGELMAN: Let’s go beyond that. That’s the question.

ROPER: Once one has identified the best cases, I think perhaps what would have been done in the past is taking the agent or modality in question and putting it through the screen. I think we have offered, in this case, here a specific offer, I cannot stand here today and say it would sweepingly apply to everything, but I think we have opened the door, and when the door is opened you can be our judge of whether it stays open or not, we have made a specific offer in one case to say we would like to see cases reviewed in a best case way. Should that prove to be positive then we would be willing to take that forward to our National Cancer Advisory Board to answer the question, to present these cases and to answer the question of whether or not this would be the appropriate time to mount a clinical trial of that particular modality.

REIGELMAN: I guess the issue though is are there other alternatives soon being considered by NCI (unintelligible).

ROPER: NCI standard controlled clinical trial modalities, depending on what stage of drug evaluations you’re looking at, the controlled clinical trial is not the only way to go. But if you’re looking at stage III, typically, the new addition to an existing modality or a new modality, is tested against an existing modality to determine what the role of the new therapy is in going forward. If you’re looking at stage II, it’s not necessarily our position that it’s necessary to do a controlled trial in stage II. We’re simply looking to determine whether or not the given agent or modality has efficacy. A straightforward stage II can accomplish that same end. I don’t, I think we’re simply saying these are the various ways to do business, but I believe we are saying that, we feel that no matter who comes forward with a good idea from whatever source it is, the only way that we can maintain a level playing field is to allow everybody the same access, and perhaps the point that you would make is “access to the same bureaucracy”. But if you can suggest an alternative, we’d be pleased to hear that.

STEVENS: Perhaps we could stop here.

HILDENBRAND: I have a quick question that was handed me. I’m going to read this without comment. This came from behind me, I don’t know who gave it to me and I read it without associating myself with it or commenting on it. I appologize for the way in which this question is introduced, but maybe you can answer because there are people that percieve this. Why did NCI give Monaco $500,000 to create a “quack” database?

(applause)

GELBAND: Could I just say that this is not the OTA process and I don’t

MICHAEL EVERS: (from the audience) No, Hellen, let her answer. She’s here. Let her answer. I asked the question.

(applause)

STEVENS: Since time is very short we’ll have a very brief answer and then we’ll move on, and if there’s more debate, again, you might (unintelligible).

ROPER: I believe that is an SBIR, small business innovative grant, and that does come through a peer review system. I recognize that everyone does not agree with the method of peer review that was used, but I believe that was the basis of the award.

CASSILETH: How would an RO1 be (unintelligible)?

ROPER: I think when an R01 grant is submitted it’s really submitted to NIH. NIH farms it up to the appropriate institute and the appropriate institute would deal with it either by an existing peer review group by creating a special peer group if one exists for the subject matter covered by a different branch whether the subject matter, for example, was not represented in the existing peer review groups or whether the subject matter was broader than one of the existing peer review groups then a special one would need to be constituted.

I would like to cover two areas in my presentation this morning I would like to suggest that we reserve specific comments on the way that peer review is done for the afternoon and thank you very much for coming here today. And I’m very happy that the other speakers often could widen the dialogue on the matter of some very, very difficult questions.

(applause)

(attachment)

STATEMENT OF THE NATIONAL CANCER INSTITUTE IN RESPONSE TO THE OFFICE OF TECHNOLOGY ASSESSMENT’S DRAFT REPORT ON UNCONVENTIONAL CANCER TREATMENTS DATED FEBRUARY 1990

To be presented at a meeting of the OTA Advisory Panel

March 9, 1990

Good Morning.

I am Maryann Roper, Deputy Director of the National Cancer Institute. I am accompanied by Dr. Mace Rothenberg, a Medical Oncologist and Special Assistant to the Director of the Division of Cancer Treatment at the NCI.

The national Cancer Institute appreciates this opportunity to comment on the Office of Technology Assessment’s Draft Report on

UNCONVENTIONAL CANCER TREATMENTS.

I would like to cover two areas in my presentation this morning:

NCI’s activities in evaluating new therapies, and

Comments on the options presented in OTA’s draft report.

NCI had additional comments and corrections pertinent to the body of the report, but we will submit these for the record.

The national Cancer Institute is a scholarly institution engaged in cancer research. NCI encourages new ideas, and has a process in place for incorporating new ideas into the system of laboratory evaluation leading to clinical trials, based on a system of peer review.

NCI is receptive to new ideas:

*Each year, the institute funds approximately $750 million dollars worth of investigator initiated research, through RO-1 and PO-1 grants.

*NCI constantly assess new approaches to cancer therapy: Whether it is through the use of new agents to treat cancer, or through evaluation of new methods of administering conventional therapies — for example, the use of chronobiologic approach to administering conventional chemotherapy, or administering chemotherapy at the times of day when the body is more likely to respond maximally to those agents.

*NCI has also tested unconventional agents for the purpose of assessing their activity in cancer: for example, laetrile, vitamin C, where large scale clinical trials were funded.

NCI is interested in creating a “level playing field” so that all proponents of all therapies — conventional and unconventional– – adhere to the same rules and standards and have access to the same systems, for the sake of the patients to be treated.

The two most important factors in the evaluation of any new agent or modality are safety and efficacy.

NCI is committed to protecting patients participating in clinical trials. Any work involving human subjects must adhere to a number of statuets and regulations set in place by congress. Specific standards also come into play whenever human trials are conducted in another country.

This includes attention to the safety of the product or agent being administered to a patient, ensuring that good manufacturing processes have been used in the preparation of such products, etc.

This also includes the responsibilites of “informed consent” — that is, fully informing patients about the nature and previous experiences of a treatment that they are receiving, and about other possible approaches to treat their particular cancer.

These are not bureaucratic impediments to doing human experimentation. These are solid principles to insure protection for patients and for society.

The second factor, efficacy, of a new treatment agent or modality is evaluated through the peer review system. Peer review incorporates the best advice and opinions of scientific experts from universities and industries around the nation.

By this system of review, scientists and physicians are made aware of facts and existing data about a new treatment approach.

NCI is eager to keep an open mind and to receive new ideas from many sources. The staff at the NCI have committed themselves to government service, and have committed themselves to making progress in cancer.

The Office of Technology Assessment has suggested “options” for future action in its report, and I will address these specifically.

1. The report suggests that additional research be conducted on the characteristics and motivations of cancer patients…

* Such a study is currently in progress under the auspices of the American Cancer Society.

* In addition, such work could be undertaken through investigator initiated grants.

2. The report suggests that NCI’s Cancer Information Service (CIS) be evaluated for the adequacy and quality of the information that it transmits on unconventional therapies.

* NCI provide facts in the information that we convey regarding all methods of cancer treatmenr. Please duggest how you would rather have us do this, consistent with our legal obligations to provide facts.

3. The report suggests that NCI be mandated to pursue information about and facilitate the examination of unconventional therapies.

* NCI constantly screens new compounds and natural substances from plants, marine life, land animals, etc.

The in vitro screen has tested natural products, and can test any “unconventional” agent.

The limiting factors are: information about the chemical nature of the product to be screened must be shared with the institute, and sufficient quantitiesof the product must be provided. We are well equipped to protect the confidentiality and proprietary interests of a provider.

4. The report suggests that NCI facilitate a “Best Case” series approach to first evaluating unconventional therapies.

* This approach has been offered to practitioners of unconventional treatments, and several have submitted case information for review.

Evaluation of whether a new substance or treatment can shrink common cancers is not complex: It involves evaluating the tumor status of a petient before the treatment was administered, and again at an appropriate time after the treatment has had a chance to work.

This is not difficult, nor is it out of reach for an average physician. X-rays, photographs of tumors, microscopic examinations, etc., all provide strightforward ways of measuring whether a cancer has shrunk.

We can provide lists of necessary data at the request of a physician interested in submitting cases for review.

It should be clear that the methods for evaluating tumor shrinkage are the same for unconventional therapies as they are for conventional therapies. It should not be made to appear unnecessarily comples: this is a standard evaluative approach.

In summary, NCI believes that many of the mechanisms that OTA suggests be put into place are already available.

Perhaps the problem is rather in how to access the existing system. This can readily be done by starting at our office of Cancer communications, Building 31, Room 10A24, Bethesda, 20892.

Thank you for the opportunity to address this committee.

(END ATTACHMENT)

STEVENS: Our next speaker is Janet Smith.

SMITH: Thank you for the opportunity to comment on this revised draft. I speak as someone who has worked in the health care field for the last 19 years as a policy analyst, lobbiest, and journalist for public and private organizations on issues affecting the public health. For the last seven years I have focused particularly on unconventional cancer, unconventional treatments in general, and how a transition in the health care system may be effective to integrate the knowledge that unconventional treatments have to offer. I have just completed a chapter of a book for the Institute of Noetic Sciences on the health policy issues of the paradigm shift. And I also proposed (unintelligible) in cancer treatment.

HILDENBRAND: Give her another one.

SMITH:

(reading attachment)

Thank you for the opportunity to comment on this revised report. It appears that a number of the strong objections that were raised in relation to the earlier draft have been addressed. As I recall, at the last meeting, Clyde Behney stated that this report would not be issued until “we get it right”. I hope that the input received in response to this draft will convince staff that there is more work to be done.

My concerns can best be introduced with the following quote which I believe holds some answers to the dilemma we all feel in addressing this report. Perhaps you will recognize these words: “…the salvation of this human world lies nowhere else than in the human heart. In the human power to reflect, in human meekness, and in human responsibility.”

This is President Vaclav Havel’s speaking before Congress a couple of weeks ago. He continued as follows: “We are still a long way from that “family of man”. In fact, we seem to be receding from the ideal rather than growing closer to it. Interests of all kinds — personal, selfish, state, national, group, and, if you like, company interests — still considerably outweigh genuinely common and global interests…In other words, we still don’t know how to put morality ahead of politics, science and economics. We are still incapable of understanding that the only genuine backbone of all our actions. If they are to be moral, is responsibility.”

We cannot afford to overlook the very real implications of this statement for ourselves. In a book entitled Loosening the Grip , author Jean Kinney notes that denial is a defense mechanism for protection against the massive pain that would go with facing cold hard facts. Its function is to fool the self: not others. ( Loosening the Grip by Jean Kinney, M.S.W..Darthmouth medical School: 1983).

In this context, here are the key changes that I would like to see in the report on unconventional cancer treatment:

(1) A complete statment of the severity of the cancer problem and the estimated number of Americans using unconventional methods. Rather than the “thousands” noted in the report, estimates ranging from one-six to one-half of all cancer patients fall into this latter category. That represents anywhere from 150,000 to 500,000 people!

(2) Full recognition given to the fact that many credible people are available to testify on their successful use of unconventional cancer treatments.

(3) Clear reference to the mounting and widespread concern with the state of conventional medicine. Particularly in the wake of studies on extensive malpractice, runaway costs, high rates of certain categories of unnecessary surgery, and consumers’ search for human caring in health care.

(4) Elimination of the double standard that still remains in this report in addressing conventional and unconventional treatment. One obvious example are the references, in close proximity to each other in the report, to the U.S. government’s responsibility for protecting the public’s health and safety: the “proven” nature of conventional cancer treatment: and the highly toxic aspects of conventional cancer treatment! The inconsistencies here are painfully obvious and need to be addressed strightforward.

(5) Discard reliance upon the notion that the sociological background of unconventional cancer treatments is a compelling reason to further investigate such methods, rather than the overall dismal statistics of cancer survival.

(6) Discard options that would be a disservice to the cancer patient and instead serve only the interests of those who lobby against unconventional treatments. These include: a reporting system for adverse effects of unconventional cancer treatments: more readily accessible information on practitioners prosecuted for practicing medicine without a license: detecting fraudulent claims though insurance consultants. Also discard options that propose to restudy what was the subject of this study!

(7) Reference the shift that is occurring in the policy arena with respect to unconventional treatments in the context of the AIDS issue and suggest an option that would require the consideration of establishing a national tsk force to study common issues with respect to unconventional treatment. (and severe illness. The AIDS community has expressed to me for over a year the desire to work with the cancer community on this issue.)

In summary, there are most compelling reasons for consumers to consider unconventional cancer treatments, and OTA should clearly and forthrightly articulate these facts. I feel that the tone of the report undermines several of the good options presented, and does little to convey any sense of urgency with regard to the cancer problem.

I began with a reference to President Havel, and I would like to conclude on that note. The American tribute to Mr. Havel and St. John the divine in New York City was concluded with a candlelight ceremony, representing the hope and love of the human spirit. Perhaps we can hope to see such a ceremony here on Capitol Hill, when this important report is finally complete.

Thank you.

(END ATTACHMENT)

(applause)

STEVENS: Are there any questions from the panel? () thank you very much for coming. Our next speaker is Patricia Spain Ward () on behalf of the study. Welcome.

WARD: Thank you very much for giving me the opportunity to speak to you today.

(reading her attachment)My name is Patricia Spain Ward. I am an historian of medicine and science. I have been based for the last decade at the University of Illinois at Chicago. In 1987 I reluctantly agreed to work as a contractor on this project. Julia Ostrowsky’s assurances led me to hope — against all the historical odds — that OTA, with its sterling reputation for courage and fairness, would again capture the gratitude of the nation by producing a truly disinterested, unbiased treatment in the troubled realm of unconventional cancer treatment.

My doubts about this project grew out of my reading of American medical history. The price we have paid for the professionalization of American medicine is the decline of pluralism in health care. By the time of the Great Depression of the thirties, medical treatments (for cancer or for any other condition) had to secure approval from the American Medical Association or be labeled — and perhaps prosecuted — as quackery.

Over the past half-century the resulting adversarial atmosphere has generated a dreadful chasm between representatives of orthodox medicine and proponents of therapies not yet deemed worthy of acceptance into the conventional fold. I say “not yet accepted,” because history offers many examples in which the heresy of yesterday has become the orthodoxy of today: in the words of the great medical historian, Henry Sigerist, “Experience has preceded science in medicine more than once.”

By 1987 hostility and distrust so thoroughly pervaded both sides of this chasm, above all in the treatment of cancer, that only an agency of OTA’s standing could hope to bridge it. I believe that some of the staff on this project have made genuine efforts to overcome built-in skepticism about alternative methods that has long been part of the unacknowledged mental baggage of most of us, myself included. With the public good as well as OTA’s reputation at stake, it saddens me to see that they have failed, apparently because they have not been aware of their own preconceptions.

The authors tell us that “one major reason for wanting to find out whether unconventional cancer treatments work” is the large number of Americans now using them. It was that large number, of course, that initially prompted Congressional demand for this study. The authors do not state — and apparently do not feel — what should, to me, be an equally compelling reason for doing this study: that is, that we need to know whether any of these alternative methods can enhance our none-too-successful track record in the treatment of cancer.

Nowhere does this document reflect intellectual openness toward alternative therapies, let alone a genuine and urgent need to learn where they have merit and should therefore be pressed into wider use. In one of her recent publications, the Chair of this panel has reminded us (and I quote) “absolutes in medicine are few”; unhappily, I do not find this report reflecting such a healthy suspension of judgment.

In addition to serving Congress directly, this report must strive to bridge the chasm that separates growing numbers of alternative supporters from the ranks of orthodoxy. To do that will require a drastic change in tone that can arise only from an altered mind-set — and hence perhaps a new set of authors.

(applause)

Others are more qualified than I to address the details of the evaluation techniques suggested in this report. I can say only that history predicts trouble at several points in the proposed guidelines for testing.

First, developers and key practitioners should not only be involved in defining parameters of the clinical trial, as the report suggests; they should also have a role in the trial itself, working beside the principal investigator and as many additional staff as may seem necessary to ensure accurate observation and recording of results. Nowhere in the world of torthodox medicine and science, as I know it, is the developer or key practitioner barred from demonstrating a new technique or treatment.

(applause)

Why, then, is this proposed in trials of alternative cancer treatments?

The second likely trouble spot is the guidelines suggestion that drugs or devices involved in clinical trials, some of them now in use for a full century, be subject to FDA regulations governing new and unapproved drugs and devices. Here again OTA seems to be asking more sever constraints for alternative methods than apply to those already in conventional use.

In observing that a departure from these guidelines may occasionally be necessary but that it will jeopardize credibility, it seems to me that the OTA is thinking only of credibility among the orthodox. The authors rarely show a sminilar concern for the very great problem of credibility among the proponents of alternative methods, especially when trial results are negative — as will sometimes be the case.

Also, developers and proponents will require far more assurance than this report affords that the NCI and FDA can be trusted to help them in preparing best case reviews…

(applause)

— to help them in preparing best-case reviews or new drug applications (NDAs): the record that these agencies have compiled in their dealings with alternative proponents does not inspire trust. In the same vein, before participating in registries, either of successes or of adverse effects, proponents will require guarantees against the prosecution that has historically been their lot.

This report brings together so much information never before available in a single document that it seems to me it would be a tragic waste to publish it without revising its tone. To bring it out in its present form, however, would only exacerbate an already inflammed situation, bringing bitter diappointment to all who have hoped for a fair hearing from the OTA. Thank you.

(END ATTACHMENT)

(applause)

COLLIN: I think Patricia Ward’s comments about being involved in investigations is going to require a trust should certainly be emphasized in this report. If anything, in the last three years since this report has begun, we had advanced in this country to a minor state of terror among practitioners involved in unorthodox treatments. More and more practitioners are beginning to be diciplined by vigilante district attorneys engaged in, if not outright terror techniques, semi-terror techniques, and it would seem appropriate to mention that while we are going to engage unorthodox practitioners in this type of more open process there needs to be some legislative type of thing coming from Washington to try to hold the steam off of all these diciplinary and quackbusting types of operations existing around the country.

WARD: Yes, I intended to insert a remark — I forgot to do that – – a reference really to Michael Lerner’s proposal here and, Kieth, you also made such a proposal. Something of a sort of a national agency with its own funding could well be the monitor overseeing and regulating the regulators. Such an agency is, I think, imperative, if you are to really begin doing evaluations.

STEVENS: A very quick question.

SHEALY: I want to say that I think that this is a very measured response, and I appreciate your comments. We have some remarkable changes in this document from the first one to the present. My personal hope is that with all the feedback is available to the OTA today and in the subsequent weeks, that the final document will include at least adequate documentation of the concerns of all the people who have requested to be here today.

(): I hope it will do that.

BLOCK: I applaud you. What a wonderful erudite presentation, Pat. How would you suggest going ahead in setting up an authentic, independent, impartial revue type committee for tracking and other needs.

WARD: I’m not really a scientist you know. I’m a historian.

BLOCK: I know and that is precicely why I ask you.

WARD: As I told the authors right from the beginning my expertise really ends at 1950 so. I’m not the right person. I like the idea that I believe you made – or a suggestion that you made of 15 people: five of them from – representing alternative sympathies, five of them of very conventional nature, and five lay persons. I thought that was a wonderful idea. I would like to see the lay public involved because thats where the distress and the skepticism also exist. Public opinion of orthodox medicine, and their trust of them, in the treatment of cancer, it seems to me is at an all time low.

BLOCK: Yes, it is. (applause)

STEVENS: Our next speaker is Frank Wiewel, our last speaker of the morning.

WIEWEL: Good afternoon. I’m Frank Wiewel. I am the president of the IAT patient’s Association and I am the founder of People Against Cancer. I was the person who suggested that we come to the OTA for this study. Sadly, today I’m sorry. I’m sorry I suggested the OTA. Not for the process, not for the great reputation of OTA, but for this document. I am sorry.

This year 1,000,000 American citizens will be diagnosed with cancer and 500,000 will die. We have spent over 20 billion dollars. Cancer incidence is up, the mortality is up, over-all survival rate remains the same. We must have a fundamental change.

Advances in science often come from discoveries outside of the established system. It is therefore important that there be a valid means of recognizing such new advances. The National Cancer Institute has no valid mechanism for evaluating these therapies. In the absence of a valid scientific method, there has been blanket rejection and official condemnation of these therapies.

In response to the desperate cries of cancer patients from around the nation, Congressman John Dingell and 42 members of the United States Congress called for this study of alternative cancer therapies and a study of Immuno-Augmentative Therapy in particular. They asked Congress to examine the existing evidence of efficacy and develop a protocol for a clinical trial.

After nearly 4 years, the OTA has refused to examine the existing evidence of efficacy of IAT. They have failed to design a clinical trial. This draft report is a “wolf in sheep’s clothing”, which cleverly blends mild criticism of orthodox failure with a hatchet job on non-toxic alternative therapies. It presents positive data as “anecdotal”. It presents negative information as “proof”. The authors of this report weave a premeditated pattern of outright lies and gross misrepresentation.

(applause)

What emerges is a disturbing picture of self-delusion and fraud at the OTA. It is a cover-up of the truth. The OTA report, is, in itself, a “case study” of the unfair practices that WE intended to investigate.

(applause)

Throughout the course of this study, Hellen Gelband, the project director has been uncooperative and combative. She dismisses anyone from the alternative side who disagrees with her as “proponents”. Hellen, I am not a proponent of IAT. I am however an advocate of freedom of choic and freedom of information for people with cancer.

(applause)

This report directs its full fury at IAT. It’s so called STUDY of IAT is based on 14 undocumented “personal communications” and 16 “unpublished studies”, unavailable to the rest of the world. The fair evaluation of IAT, requested by congress, has been reduced to a character assasination of Dr. Burton and his life’s work.

(applause)

Gelband has included detailed accounts of every negative charge made against Dr. Burton and IAT. All detailed remedies which were suggested by the IATPA have been ignored. Nothing positive is included. Incredibly, the authors commissioned a paper on the “Adverse consequences of Alternative Therapies”. WHERE IS THE PAPER ON THE POSITIVE CONSEQUENCES of Alternative Therapies? WHERE IS IT? THIS IS A JOKE!

The report states: “OTA has attempted to design a clinical trial in collaboration with Dr. Burton but the effort ended in failure.” In fact, OTA’s relationship to burton has been a “case study” in double dealing and obstruction.

In 1987, Dr. Burton and Dr. Herdman of OTA signed a memorandum of understanding for a clinical trial of IAT. Dr. Burton then proposed mesothelioma but OTA rejected it. Burton then proposed non-hodgkins lymphoma and OTA rejected it. Dr. Burton then proposed colon cancer stages Dukes C and D surgically treated with no radiation or chemotherapy. Burton accepted a proposal by NCI for a small non-randomized clinical trial to precede the full scale randomized trial in the U.S. Dr. Burton proposed that NCI conduct before and after evaluations of patients who would self-select IAT.

But then the OTA suddenly rejected the more promising Dukes C without consulting with Dr. Burton. Dukes D patients are generally terminal and have had their immune systems ravaged by conventional therapies.

OTA also rejected the pre-trial stating the “neither OTA, FDA, nor NCI will play a role in planning or facilitating the pre-test”. Incredibly, OTA then turned its back on the scientific method, by stating “No single clinical trial can produce an answer to the question, ‘Is IAT a safe and effective treatment for any type of cancer?'”.

MY GOD! WHAT IS IT WE ARE DOING HERE, PEOPLE? Hellen Gelband. Despite all these difficulties and deceptions, I do NOT blame Dr. Roger Herdman, the assistant director of OTA; he has been fair. He has been even-handed throughout the process and personally willing to move forward. He recently stated that “interest in the unconventional therapies is a strong strain running through American culture…it doesn’t help to take an uncompromising attitude.” Sadly, however, Dr. Herdman is not the writer of this report.

Hellen Gelband is hopelessly biased and must be removed as the author of this report.

(applause)

THE REPORT MUST BE REJECTED, THE STUDY HALTED, until a major revision is undertaken!

This study came about as a direct result of significant political pressure in Congress and from the people for relief from ever escalating tragedy of human suffering and death. Despite claims of improving cure rate, increasingly people see their friends and family members die of devestating illnesses often unaffected by treatments feared more than the disease itself.

There’s a growing recognition within the medical community and the general public that we are losing the war on cancer. And in a matter so vital to the national interest, as a people we can not afford to overlook any possible alternative for any reason.

(applause)

STEVENS: I have a question of you that came up with another couple of speakers. Supposing the decision was taken to stop the report, would that be better?

WIEWEL: Than the current situation? Would it be better to stop the report?

STEVENS: In your view, would it be better to have…

WIEWEL: Yes.

STEVENS: …a report which is not going to please everybody, or no draft at all.

WIEWEL: It would be better to have no report than this report.

(applause)

WIEWEL: The reason for that is that I truly don’t believe that we we’re a part of this process. I have continually and repeatedly submitted detailed responses to the charges which have been brought against these alternative therapies. And they have been ignored. The process has broken down. The system doesn’t work. OTA will be damaged by report.

(applause)

OTA will meet great damage with this report, disgrace.

WOMAN’S VOICE FROM HALL: There will be children in the streets.

STEVENS: Thank you very much Mr. Wiewel. We’ll take just a couple comments from the panel.

HILDENBRAND: How can you follow that?

STEVENS: I thank all of the speakers of the morning. Thank you for keeping within the time. Thank you for participating. We are on time and we will reconvene at 1:30.

cc:
Jeanne Achterberg
Ken Ausubel
Keith Block
Peter Chowka
Jonathan Collin
Michael Evers
John Fink
Michael Lerner
Ralph Moss
Brendan O’Regan
Norm Shealy
Andrew Weil
Frank Wiewel