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
|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.
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:
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.
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.
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.
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!
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.
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.
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.
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?
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.
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.
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: 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?
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.
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?
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.
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.
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.
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!
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.
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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…
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.
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.
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.