UNCONVENTIONAL CANCER TREATMENTS
U.S. Congressional Office of Technology Assessment
March 9, 1990 Advisory Panel Meeting
600 Pennsylvania Ave. SE
Washington, D.C.
ROSEMARY STEVENS (Advisory Panel Chair): The purpose of today's meeting is to review the content of the review draft. As an advisory panel this is our last chance, and our task is to listen to and discuss with each other a broad view of this report. We both have been asked by OTA to listen to some strong criticisms of the report from outside reviewers and we are very happy to have their published statements available. In the morning, this morning, we will only hear from 16 outside reviewers. That is the 16 who responded to OTA's invitation to present their criticisms of the report.
I'd like to keep concentrated on the major issues. This is a very rich report and I want everybody to have a fair share of time so that we might define the more important stuff to take each comment from the advisors. So I'd like you to keep concentrated on the major issues, including the findings of options, rather than on the many details of the report which can be handled through written recommendations from individuals as written responses. Detailed written comments should be sent to the OTA staff directly along with any supporting material, and I know that many of you have already done this. Thank you.
We're happy to have all the other observers, as well, who are not scheduled to speak. We're happy to have you here, listening. Unfortunately, we cannot invite you to speak, and we will not take questions or comments from observers who've not called. The OTA staff would be very happy to hear from you, too, in writing or by telephone. We are all anxious to have appropriate comments.
Those introductory remarks having been said, can you now hear me? No? Is it on?
SOUND TECHNICIAN: Yes.
STEVENS: We'll do with it. This morning, in a sense, it's more important that the speakers have adequate mics. Can you keep working? We'll need to keep going as fast as we can. I would like to hand over now to Dr. Gibbons.
JOHN GIBBONS (OTA Director): Thank you madam Chairman. I personally want to thank you and the advisory panel for your long service, extensive guidance, and critique of this assessment, and also, although most of them aren't here, to the many additional reviewers that have, as usual, supplemented and complemented the kind of review that the panel was able to give us.
Our work -- and you know that, while its ultimately OTA's job to do the final writing and delivery of the information to the Congress -- in other words we excuse the panel from any blame or credit -- we depend extremely heavily on our advisory panel and our review process to make certain that our small band is able to capture effectively and accurately the national wisdom on the issue. We very much appreciate the extraordinary amount of time and effort you've put into this.
I also note that we have a little unusual number of visitors with us. The last time this number joined us, I think, was about a month ago when we were doing a final review of the financial markets of the U.S., and we had a lot of people from stock exchanges in other parts of the country and it was an interesting and busy day. So, we do welcome you with us, and because many of you are not as familiar with OTA and its work for Congress as the rest, I thought I'd take just a moment to remind you of what we are.
We're the smallest of the four support agencies to Congress. The General Accounting Office is the largest by a factor of about 35 times larger than we are. Their job is to audit the operations of Government and make sure the agencies are doing what the law says they should be doing. The Congressional Research Service, which is a part of the Library of Congress, is a common resource for all Members and Committees for whatever subjects they need to be given a quick review, in terms of what the literature has to say. They handle thousands of requests for information each year. The Congressional Budget Office and OTA are the smallest of the agencies. The Budget Office is the Congressional counterpart to the Office of Management and Budget, and they look at issues of finance and financial implications of proposed legislation.
OTA, on the other hand, is charged with looking at the impact or implications of changing technology on the issues before the Congress. We work only for the Committees of Jurisdiction of the Congress and, again unique in the four agencies, we are governed by the Technology Assessment Board which is a twelve member group, a working board of directors, that meets about every six weeks to enable the agency to use its limited resources in a way that's most effective for the whole of the Congress.
Typically, a study at OTA is requested by a group of Committees, all of which have some jurisdiction in the matter, and our job is to act as a shared resource to these Committees in doing the analysis of the uncertainties of the implications of changing technologies on society.
Our mission is not to tell the Congress what they should do. Our mission, rather, is to try to help narrow breadth of the debate about social/technical issues to a point that it's more manageable by these, our elected representatives. Our job, in other words, is to help focus debate by narrowing the argument as best we can, leaving those things that must be adjudicated to the Members. Having done as much narrowing as we can, we then try to provide, not recommendations about what Congress should do, but rather options and alternatives of what Congress has at its hands that can be derived from a careful analysis about what sort of a road map Congress has. We don't try to tell them which road to take, we simply try to provide them with information about what the roads look like.
Our Board of Directors approves the undertaking of each major study, and we always have about two dozen studies going on at any time. Once that approval for undertaking is given by the board, it's up to OTA and its advisory panel to pace the work and complete the study, usually in as brief a time as possible. Typically our work will take eighteen to 24 months, or so. This work has taken twice that time, and that indicates the fact that, sometimes, a study is so complicated, or other issues of priority pushed aside our resources for a while, that more time is required to complete the work.
It was about a year ago that we had a major meeting on this. We realized, as a consequence of that meeting, we still had some more work to do, and that's why we are yet another year down the road. But I think Congress, and we, and all concerned people are interested in seeing how this issue can close, and we hope, and believe that this will be the last meeting of the advisory panel.
Our process after today will be to carefully review the happenings of the day, the information that has come in from reviews, and from the dialogue. We will then prepare a draft that will go to our board who will have two weeks to consider it. This will probably happen in the late spring, and if the Board considers -- authorizes -- its release we will then undertake a final review and edit before we publish at sometime, I would presume, around near the midsummer; June or July.
Again, I want to thank the panel for its perseverance and help, and also for our reviewers, our supporters, our critics, because we are, we are a little bit of what I call the Archemedes principle of analysis. We manage to stay upright and on target only if we have appropriate pressure from all sides, and it's this gathering of national wisdom that's occurring here aging today that enables OTA to much more accurately reflect the collective national wisdom to try to focus the arguments for Congress and then provide them with some options for their careful consideration.
So, I want to thank you again. There are some materials about OTA in the outer hall, and I will stop because my job today, as usual, is to listen and learn, and we have a busy day before us. Thank you.
STEVENS: Thank you. We will now have an introduction by the project director Hellen Gelband just for those of you who haven't seen the agenda. We will then have brief sets of remarks by the panel members, and then we will go directly on to the statements which will all be given this morning. So it's a full morning, and, I think, a very important one. And without ado I will turn to project director Hellen Gelband.
HELLEN GELBAND (OTA "Unconventional Cancer Treatments" Project Director): Thank you. I'd like to add my welcome to Rosemary and Dr. Gibbons'. I also want to mention that there are a number, several advisory panel members who couldn't make it to the meeting today, but I've heard from most of them and I've talked with them and had correspondence with them, so I also have a sense of their reading of the report, and if it's appropriate I'll mention their comments.
Actually all I'm going to do is go through a few administrative details before we get right into the meeting. I think Dr. Gibbons covered the central things that are necessary. For the press, since there are a number of press here, there's a press room on your way in, it's conference room H. You're welcome to use that room for interviewing speakers or panel members or to make phone calls. We ask that no filming or videotaping be done while the meeting is in session, or flash pictures while the meeting is in session. Audio taping is fine.
There are bathrooms the back of the lounge area over here to my right and down the hall to the left. When we break for lunch the advisory panel will meet down the hall in the room on the left, and for all the visitors there are many places outside on Pennsylvania Avenue. There's no smoking anywhere in the building except in the lobby.
The meeting materials, I hope everyone found, for visitors and speakers are in the room, in the back of the room where there's visitor seating. There's coffee back there and coat racks and reading material which include the statements provided by specific speakers. We don't have them all yet and some of them are still being copied, so as we get them and they are copied we'll have them available there. Otherwise, thank you very much.
STEVENS: Yes.
MICHAEL LERNER (Special Consultant): Yes, may I? Just a point of information for Hellen. Hellen, you spoke of press interviewing panel members. I thought that our rule was panel members are not supposed to comment on the thing in public. I just wondered if that's incorrect.
GELBAND: Well, I would hope that we'll be treating the contents of the report still as a draft, but people are free to express opinions.
ROGER HERDMAN (OTA Deputy Director of Health): Hopefully the draft process relies on the material being considered changeable in the draft because our preference is that the press not be told options and conclusions in such a way that they think that this is OTA saying it. But a panel member or anybody else who decides they would like to talk to press is on their own. We have no control over that. Obviously that's the type of organization we are. We prefer a draft be considered a draft.
STEVENS: Let's move ahead then and go around the room giving the advisory members a chance to introduce yourselves and make a brief -- very, very brief, please -- general statement, if you have one, about the draft. We've got to move on to the outside reviewers, and I feel like a time cop here. Please help me out because the advisory panel clearly has the opportunity for a great deal of input later as well. So, perhaps we could go around this way and start with Jeanne Achterberg.
JEANNE ACHTERBERG (Advisor): I'm Jeanne Achterberg and I'm director of research now at the Institute of Transpersonal Psychology in Menlo Park. I'm pleased to say that I never thought I would see this document in my lifetime. With all the criticism we may subsequently make of it, it is a first, almost clear picture of what we're dealing with in federal problems we face in terms of managing cancer.
I would like to be able to see us, if not today at least in the near future, come up with a clear set of recommendations so that the document itself doesn't die on the vine. It isn't worthy of that. It needs to go forth. I would like to see us come up with a clear understanding that curing is not the only endpoint in the treatment of disease, and if we come to that then a lot of focus in the document starts to shift in terms of the way we look at the data.
I would like to see us pull out the middle ground of those things that are not intended to cure but are intended to care. That's a lot of work for today and I don't have any illusions that that's going to take place at a set point (unintelligible).
GIBBONS: You mean by middle ground to pull out...
ACHTERBERG: Pull out those that don't pretend to be curative treatments, and there are many, many things in there that don't project that.
GIBBONS: To emphasize the, not remove them?
ACHTERBERG: Yes.
KIETH BLOCK (Advisor): My name is Keith Block and I'm a physician in Illinois. I'm a private physician, although I teach at the university of Illinois, and I believe the right approach is a clinical program which combines the best of both worlds. I'm somewhat embarrassed as a physician that it took really a response to political pressure instead of scientific zeal to get to this point, and I really believe, while this has been a wonderfully mammoth project in its undertaking, and that there's some extraordinarily good points within this, that there's also some significant details which I'll deal with in writing, omissions as well as some structure here and there, very significant and very substantial.
Read me a little bit concerned about as it is in its present state. I think its been echoed by some of us in conversation that if this were a first draft we'd all be very, very comfortable with it. Seeing that this is our last real opportunity to give interactive communication over this face to face, it's a little bit concerning to me.
I have one last opinion. I'll give you a number of points this afternoon in terms of my feelings about the middle ground as Jeanne has said in what specific omissions I see and specific structural problems I see with the piece as it stands now, but I really don't believe that anyone yet has earned the public credibility, has really earned the right yet, for any kind of exclusive on cancer care. And I think that that's one of the things that this piece has to ask us is "Where do we go from here?" If this is a jumping off point, that's great, but if this is the final statement as to where the industry as it exists in both worlds right now is at, I think we have some problems.
JONATHON COLLINS (Advisor): I'm Jonathon Collins, practitioner in Washington State, and I employ conventional and unconventional therapies. I also edit the Townsend Letter which is a publication for all the alternative community. From a report that I had feared being a complete wash out, I think that this report has some balance that I'm pleased with, although a great deal of the writing had some significant negative implications on most of the proponents of unconventional cancer treatments. I feel that, unlike most of the writing that appears in the New England Journal , and other journals, this report presents the position of unconventional practitioners in a way that offers some fairness, at least from their position of what these treatments are.
I also think that one of the respective ways of approaching unconventional cancer therapies that is coming out of this report is the description of best case reports, and I don't think that that idea has ever been something that has been accepted in the study of conventional treatments. I think that this a means of recording data in the future which the conventional oncology community will need to take seriously and will have to confront, because there is a very serious interest in unconventional cancer treatments.
MICHAEL LERNER (Special Consultant): My name is Michael Lerner, and I'm the president of Commonweal, a health and environmental research institute in Marin County, and for the past ten years I've devoted essentially half my time to the analysis of alternative and adjunctive cancer therapies. I want to associate myself with all of the remarks that the preceding three panelists have made. I think that this report will be a source document in the national debate over unconventional cancer therapies. I want to associate myself with the specific comment that if this had been the first draft, we would all be very pleased, because this would be a starting point for refinement that I believe should take place if this report is to reach the level of quality that OTA is well known for.
So I think that, although light years of progress have been made from the first draft to this draft, there are still some very, very important corrections. Specifically, I'd like to associate myself with the comment that what I think is missing most of all is that the middle ground, that does come forward in the section on psychological approaches, is absent in the sections on nutritional and spiritual approaches, just to take the most obvious ones. And that if the nutritional middle ground were there, there would be a placing of many of the alternative nutritional therapies in a scientific context in which they would make much more sense.
As it is, the negatives that are applied to the specific nutritional therapies take place in an absence of the context of the premises that do scientifically substantially suggest that some of these approaches have grounds. I think that that is very important, and I, personally, have such respect for the OTA process, that I would like to see what I believe would be a historic document really fulfill its promise and to see OTA take the time and the effort that will be needed to take that next step.
Finally, I would like to say that I think that what Mr. Gibbons mentioned, basically the narrowing to key options, I'd really like to see the key options section strengthened, and I think that one of the most constructive things that could happen that would unify us all in this area is that I know that many of the people who brought this request into being wanted to see funding and a regular mechanism for the evaluation of unconventional therapies. And I think that would serve everyone. And so I think that a strengthened section on a regular and fair and objective system for the evaluation of unconventional therapies, including funding earmarked for that, and a decision process that represented all constituencies, that would go a long way toward overcoming the present absence of scientific information which leads and organization like OTA to the many specific negatives that we see in this report.
GAR HILDENBRAND (Advisor): I'm Gar Hildenbrand. I'm the executive director of the Gerson Institute. I am also, possibly, one of the more outspoken critics of OTA's process and of the report as it stands right now. Without going into detail, but just simply from an overview, I think that my greatest concern is that, while the science issues have been addressed, the purely policy issues, socioeconomic issues which could possibly be legislated by Congress -- because Congress can't legislate science -- are not, to me, seem not to be clearly articulated.
And I do not see, in the options in this draft, solutions to those socioeconomic issues which are meaningful, and I'll submit detailed comments in writing regarding that. It has to do with legal decisions as well. Overall, I am able to say that I think there's enough structure here to hammer nails into, and I think that I would like to echo Michael's sentiment that this is a good first draft. Would that we were eighteen months away from a full draft and an outside review, because the possibility does exist to get from this, as a starting point, to an adequate description of the socioeconomic problems in the trades. That's my comment at least at this point.
ROBERT C. EYERLY (Advisor): I'm Bob Eyerly and I represent the American Cancer Society, and we have decided to make a general statement right now and then sometime within the next two weeks we will have a more detailed written statement that we shall offer Miss Gelband and her staff.
At this time the Society commends, as many others have thus far, the Office of Technology Assessment, for the thorough research and painstaking review of unconventional therapies presented. We are well aware of the difficulties in gathering information and data on unconventional therapies. The staff has done a tremendous job. Our major concern is the evaluation data of the efficacy of unconventional therapies. We believe in order to prove a therapy is effective in treating cancer the promoter should be able to demonstrate the three following basic questions in the affirmative:
1. Has the method been objectively demonstrated in the peer reviewed scientific literature to be more effective than nothing?
2. Has the method been objectively demonstrated in the peer reviewed scientific literature to be as safe as doing nothing, or has it shown potential for benefit which clearly exceeds the potential for risk?
3. Have objective studies been conducted under appropriate peer review and approved by reasonable human studies committees to answer these questions?
It is clear from the evidence in this document that these unconventional therapies do not answer these questions in the affirmative.
The Society also cautions that even the best case review has historically failed to produce valid conclusions. It must be understood that it is impossible to demonstrate efficacy by best case review.
The report is punctuated by editorial comments throughout that appear to be logically invalid. For example, there is frequent citation throughout the report that the lack of evidence regarding the safety and efficacy of unconventional therapies constitutes evidence. This appears to rationalize their use. The constant use of the word "alternative" to describe unconventional methods is inappropriate.
And, as I said previously, these are our opening comments and we will be having a written document within the next two weeks to the project director. Thank you.
C. NORMAN SHEALY (Advisor): I'm Norm Shealy of the Shealy Institute for Comprehensive Health Care of Springfield, Missouri. I believe that the improvement that has been made in this draft is so great that I trust that the final refinements will further complete that, and I think that the document is really, as it stands, an excellent overview of the tough opposition that exists in unconventional therapies. The major difficulty is funding.
Pharmaceutical houses routinely spend up to a hundred million dollars getting a new drug to the market place, and I think you've done a really elegant job of emphasizing the lack of great scientific validity for some of the current conventional therapy of cancer.
What I would like to recommend is a policy that Congress fund a national research policy or fund for unconventional therapies to be managed outside NIH, NCI, or universities; that a committee of fifteen people be chosen, one third of them being neutral conventional scientists, one third being unconventional proponents, and one third being neutral laypersons to choose grants for such unconventional research.
JOHN FINK (Advisor): I'm John Fink, president of the Santa Barbara chapter of Cancer Victors and Friends. I'm well aware of all of the tremendous amount of work that's gone into this report; also aware of much of the work that may be ahead. In the order of brevity I'd like to say that I agree with most of the sentiments -- most of the sentiments -- that have been expressed previously, and I would like to withhold my comments for this afternoon when we go down and specifically address each chapter.
RICHARD RIEGELMAN (Advisor): I'm Dick Riegelman, an internist and epidemiologist, and I'm very impressed with this document as a very thorough expression of the current state of the art. My focus, however, is really on the process and the methodology used to evaluate future therapies as well as these therapies.
As the day proceeds I would like to make some comments on the options that are available for methodologies. I do think it's important that this report express the full spectrum of options here.
But as a report that frames the issues needed to be (unintelligible).
BARRIE R. CASSILETH (Advisor): I'm Barrie Cassileth of the University of Pennsylvania Cancer Center and like everyone else I appreciate the work that went into this draft and, more than that, I appreciate difficulty of writing the document that required somehow communicating with, at this point, two polar opposites. Hopefully in the future that won't be so, but I think that it is right now.
A number of the panelists have mentioned the importance of methodology and evaluation and that's my feeling as well. I think we can regard 95% of the document as a review of what is happening now. And I would like to focus it on where do we go from here and how do we do it. And I'd like to see a much earlier emphasis on that last little part. I'd like to expand it considerably.
I think that we need to talk about options; the value, the relative value of given options; what appropriate methodology is. I think the one thing that we can do as a panel, more important than anything else, is to agree on a (unintelligible) of evaluation -- that's not upon methodology -- but agree on a quality, a standard of what we would like to see in order to go forth with a particular regimen or treatment. Thank you.
STEVENS: We're having a little technological difficulty up here with the microphone. (Unintelligible) I think I've covered all panel members. Perhaps we could get those OTA members who haven't introduced themselves. Perhaps you would like to introduce yourselves so everybody knows who everybody is.
ROGER HERDMAN (Assistant Director OTA Health and Life Sciences Division): I'm Roger Herdman, assistant director of OTA for health and life sciences.
CLYDE BEHNEY (OTA Health Program Manager): Clyde Behney, Health Program Manager.
JULIA T. OSTROWSKY (OTA "Unconventional Cancer Treatments" Principal Analyst): I'm Julie Ostrowsky, OTA. I've been primarily involved in the assessment of unproven treatments and I'll be continuing with the revision.
GWEN SOLAN (OTA Analyst): My name is Gwen Solan and I'm a physician practicing in Massachusetts. I've had some experience, clinical experience, with families and patients going through cancer treatments. I'm here today because, for two out of three years of the project, I worked as an analyst on the staff on a lot of key sections, and I join the staff in looking forward to (unintelligible).
SARAH DRY (OTA Research Analyst): I'm Sarah Dry, OTA Staff.
STEVENS: Thank you very much, everybody. Have all of you been gotten around the table? Everybody's spoken? I'm Rosemary Stevens of the University of Pennsylvania. I'm a historian. I feel this report, again, I'm impressed by the way the report has evolved over time. The purpose of writing this draft has been a dialogue, a process. I think it's been rather clear from the comments of people around this table, we're dealing with, largely, a panel which was drawn from a variety of different perspectives. (unintelligible) At the moment, it may be impossible to produce a report which will reflect everybody's views adequately.
It's important to get different views out for discussion, across disciplines and areas which traditionally have not done very much about that sort of (unintelligible). I very much look forward to the views of the other panel members and those who have made some criticisms of the report at this stage, and also those who were thorough enough to make a deliberation going chapter by chapter which is going to take place later today.
I'm glad everybody's here to start to participate in what I think is an occasion which it would have been very beautiful to see even ten years ago. That's my historian's perspective, speaking so delicately. And we will come back to some of these, some mentioned criticisms of the report, particularly in terms of the way we see these recommendations and the substance of the evaluations as we go on later today.
You will be amazed to note that we are actually ahead of time. So I congratulate the advisory panel in doing this, so that we can now go on directly to invited scheduled speakers in the room. And I would reiterate, the major invitation, the invitations were given to individuals to whom the report was sent who have particularly critical views. The range, the speakers do not reflect the entire range of responses to the report. But Hellen as invited people who have particularly strong beliefs so that at least we would be sure that these would be available to members of the advisory panel and to observers as well.
We told the speakers in advance that each person would be given five minutes. Each of you will have five minutes for a statement and five minutes for questions of the advisory panel. And we will be keeping time by that little light panel. This advisory panel has not done that before. I am informed that this is the common practice in other public spheres. The green light will stay on for five minutes, and then the red light will come on. Don't be alarmed. I'm supposed to give a rap on the gavel when it turns red. Just finish your statement. Try to wrap it up then. As soon as it turns red the light will be reset to green for the second five minutes. If you run into the second five minutes, what you will be doing is you will be cutting into the discussion time. And I guess I do a particularly hearty rap when the light goes off, so we'll just have to play it as it goes.
If any of you, at the beginning of this, were not yet here you will obviously be given the chance to reorganize, to reorder as we go. Does anybody on the advisory panel have any comments or questions before we move ahead?
STEVENS: All right, the first statement is by Seymour M. Brenner. Is Seymour Brenner here?
SEYMOUR M. BRENNER: Yes.
STEVENS: Thank you.
BRENNER: Where do I go?
STEVENS: There by this ominous looking battery of mics, and if you need any visual aids, let us know.
BRENNER: My time starts now?
STEVENS: Yes.
BRENNER: Essentially, I am a physician who treats cancer in New York. I'm basically a radiation oncologist. I've been doing it for thirty-nine years. I have a rather successful practice, in that I see, pr |