The following are verbatim quotes, taken from the official US government transcripts of the Medicare Coverage Advisory Committee meeting on Human Tumor Assays, held in Baltimore, MD, November 15 and 16, 1999. I have tried to find and present quotations which best summarize the feelings and opinions of each of the committee members, after hearing pro and con presentations by both proponents and critics, including the laboratories,representative oncologists (and a patient) familiar with the assays, the FDA, American Society for Clinical Oncology (ASCO), the NCI, HCFA itself, and two outside consultants.

Links to the full transcripts of this meeting can be found elsewhere on this website.

Each of the Committee members introduces herself or himself, followed by the verbatim quotations.

MS. SIMMERS: I am Lisa Simmers. I'm from Bridgewater, Virginia. I am currently a health care administrator, and am here in the interest of the laboratory community, I guess.

MS. SIMMERS: I think this fits into the category of the tools that a physician should use in order to dose, or what course of treatment to endeavor and to go in that dialogue between the patient and the physician and the family. I think the one presenter and one panel member pointed out something that I think about all the time, at least in one region, and I think it unfair to have Medicare beneficiaries pay their insurance premium and not get access to that test. So I'm very much the 35,000 foot view of the Medicare beneficiaries' needs and how well what we decide to recommend would serve those beneficiaries. And I think Dr. Bagley's point about they help pay for it is very valid. They do help pay for it, and as insurance carriers are paid, I think the same level of access should be available to Medicare beneficiaries that there are provided for those who have private insurance.

I have some concerns, however. Certainly the accessibility of the test, although I am convinced there are ways to address that, I think there would be a duty to promote this as, promote its accessibility not only in very small regional areas, but nationwide, should we decide to cover it. I think there are some valid research and scientific questions to be answered. I do believe that this is a diagnostic test and should be held to that criteria, and not to that of therapy. I think that was clear, and although I think the science could be better, it's not a perfect world, and what we see is at least compelling evidence to continue.

The policy specific issues, certainly I am not the expert in that area, but is does seem to be available to us to look at those cancers and what circumstances with what drugs are best pursued under this coverage recommendation, should we make it. It seems to me the processes are in place to do that, so I don't fear that it can't be done. And certainly, the devil will be in the details of that kind of process.

But after everyone has said their piece, I guess if ny of us in this room were to face the terrible news from our clinician tomorrow that we had cancer, who among us would say no, this assay is not for me. And I believe if it's for us, it is for Medicare beneficiaries as well. So that's my comment.

DR. SUNDWALL: I'm David Sundwall. I'm a physician and I'm president of the American Clinical Laboratory Association, in Washington, D.C.

DR. SUNDWALL: Thank you. I feel fortunate going at the end of this discussion, so I get the benefit of all these experts, and I don't mean to be flip about that. I really appreciate the expertise of the panel, more analytical than those of you who carefully reviewed the studies. My perspective is that of a family physician like Paul, who is taking care of patients, diagnosed cancer, followed them through chemotherapy, and seen sometimes the benefits, more often the heartache and morbidity that's associated with that. That doesn't mean I'm not a believer, it's just that I think we need to have a very healthy skepticism about current cancer treatments.

I am also coming at it from the perspective of someone who's spent most of my adult life in health policy here in Washington in different capacities, and I'm very familiar with the tension between those advocating something new and wonderful, and the payers who in their responsibility to monitor how we spend our funds, make sure they are done appropriately.

However, I must admit that through the course of the discussion yesterday, I was reminded of a quip I once heard about economists, which was intended to be funny, but the economists were described as people who, when something is proven to work in practice they want to find out if it works in theory. And it seemed to me the preponderance of evidence was that this is in fact a useful tool, it's information, I think in some respects it has been oversold in what it promises, but I look at it more simply as Grant described, it's information. And it clearly would be useful to me and my patients in making decisions about chemotherapy. I think to put it in context of reasonable and necessary is wise. It is reasonable. Whether it is necessary, I think must be left to the discretion of those experts who are going to be using it. The last comment I would just make is, I think from a health policy standpoint, we keep talking about quality access and costs, and access I think is important, and this is a useful technology and ought to be accessible to Medicare beneficiaries appropriately applied. I do think the cost issue is promising. I was disturbed by the testimony of the [American Society of Clinical Oncology] clinical oncologist yesterday. It seemed very self serving. We're neutral, but by the way, cover chemotherapy, and don't you dare tell us what we can't use. And I really thought that was not constructive, and I think it's troublesome.

DR. KLEE: I am George Klee. I am from Rochester, Minnesota, and I'm a clinical pathologist.

[Note: Dr. Klee's detailed statements showed that he was misled by the presentations by HCFA's Dr. Burken, who had showed multiple slides of studies of assay technologies which had been abandoned in the mid-80s and which were not among the technologies being considered for Medicare reimbursement.]

[The following is a direct quote from the Committee Chairman, Dr. Ferguson, concerning HCFA's presentations:

"So I am not certain that the protagonists were given all the critique information. We didn't have it...I think that that could be done a little bit better in the sense that if all the critiques of presented papers could be given to the presenters in advance, they might have time to prepare some rebuttal and response to the critiques.]

[So, based on his incorrect understanding of the literature, Dr. Klee made the following motion:]

I move that the advisory committee recommend that there is not sufficient scientific evidence to demonstrate the clinical utility of HTASs in selecting appropriate cancer chemotherapy.

[vote was 8 - 1 against the motion, with two abstentions; abstaining were Drs Mintz and Brooks, in favor was Dr. Klee, the rest voted against the motion.]

DR. FISCHER: Paul Fischer. I'm a family physician from Augusta, Georgia.

The question is whether Medicare should pay for it given what we know about it at this point in time and you know, I think the data is pretty persuasive. I am hopeful that that will change the practice of oncology, because I see a very different part of that practice than what the average oncologist does. And they're the patients and their family who have failed chemotherapy with very terrible results. And I just want to repeat this one more time. In the total practice, in my total practice, there has been as much harm as benefit from oncology.

DR. BROOKS: John Brooks. I am chairman of pathology and laboratory medicine at Roswell Park Cancer Institute.

DR. BROOKS: As a pathologist, I certainly came to this without much knowledge or interest, in a sense of one who would give chemotherapeutic drugs, and kind of evaluated it in the same way as I would evaluate any new upcoming test that we have actually to evaluate, almost every week I would say, in the clinical laboratories. As a pathologist, generally, my thought would be that we like to see more tests done and certainly, useful tests are very helpful to people. So you know, in evaluating the information that I got beforehand and that we heard here, I was certainly impressed with how much had been done. I was actually a little bit surprised at how much had not been done, however. I mean, in some settings, it ertainly seems to me like the data is there for utility. I am not doubting that the test, I mean it's been mentioned before by a number of people that, you know, I actually believe that the test does test resistance and so forth, and that we may have to decide which of the tests might be recommended, or maybe two tests, A and B, whatever, but histology specific type of data wasn't necessarily there, except in certain situations.

MR. BARNES: Rod Barnes. I am the industry rep on the panel. I work for AlCon Labs in Fort Worth, Texas.

I was sitting here thinking that there are a number of small companies or even very small labs who can't quite present the randomized clinical trial that many of us would like to see, the conclusive once and all for cause and effect, RCT. But they do seem to present a good mass of evidence suggesting patient benefit, as has been mentioned, and I certainly, if I personally or someone in my family was involved, I would like them to have access to this test.

DR. FERGUSON: I am John Ferguson. I am a practicing neurologist, and I have just retired from the NIH, where I directed the consensus development program for the last 11 years.

I was impressed with some of the leukemic studies and some others that there is some usefulness and that it needs to be mined, but mined carefully and under the right conditions.

Just another comment about randomized trials. Where I sat at theNIH as chair of the technology assessment committee for the American Academy of Neurology for a number of years, the number of randomized trials with outcome measurements for diagnostic tests, I don't believe I could have counted on one hand. I would have to look very hard to find those tests. I remember seeing reference to one or two, but -- and there may be more, but I think there is no question that for diagnostic tests, randomized trials with good clinical outcomes are extremely rare and I believe that, however, they should be done. We need better standards.

DR. MURRAY: I'm Robert Murray, a clinical biochemist in practice in Chicago, Illinois.

Spending my life generally in the laboratory, I tend to analogize all of the situations, the questions, to existing laboratory tests. There is no question that many laboratory tests which are routinely approved currently have nowhere near the evidence, nowhere near the accuracy and predictive value that the tests that we're considering today, that we heard about yesterday, have already demonstrated. Yes, we do have to look at outcomes. We have to look at outcomes measured in different ways. We have to look at evidence. But the evidence, even if the bar is raised higher, the evidence that we have heard certainly exceeds the evidence that we have for many, many tests currently in use.

DR. LOY: I'm Bryan Loy. I am with the Kentucky Medicare carrier. I represent the Medicare system at the state carrier level.

I have a couple of comments, first of all regarding the presentations. I noticed a number of cancers were being elaborated on. I am still not clear at what point in the clinical progression of the disease, or how often the testing should take place. However, having said that, this does sound like this is a tool that be could be very useful. But having listened to the presentations yesterday, again, we were focusing on specific cancers, and to try to take that tool and apply it to all cancers at this point in all clinical scenarios, doesn't seem to be quite reasonable at this point. We really didn't talk a lot about the sarcomas, or trying to talk about such broad fields as hematopoietic neoplasms. I think at least in my mind, I would need some more convincing evidence to try to apply this technology wide spread, and I think that this is certainly germane to a policy type discussion. The other piece that's still lacking in my mind is where this really fits clinically. Because some cancers are clearly curable with chemotherapy, or they're curable with radiation therapy in combination with chemotherapy, or they're curable with surgical resection, or any of those combinations. And trying to really fit this into that niche is going to be quite difficult to do from a policy perspective. Having said that, I think that there certainly is some promise. I think there is some utility that has been potentially demonstrated here, but I am not clear on where this fits yet.

MS. SNOW: I am Kate Snow. I am the consumer rep on this panel, and I am the director of senior services for Northern Michigan Regional Health Service, and I am an advanced practice nurse in gerontology.

I believe that if I were a cancer victim, I would want this study available for my use. I would feel it was reasonable and I would also very much feel it was necessary. Listening to the quality of life and the cost of life that could be gained, and to decrease the burdens for individuals was also very compelling. If it takes the guess out of the therapy that's used, I think it's a very good tool to have available to us.

I struggle with whether or not this test will be available in a way where those of us in northern rural Michigan will have access to this kind of tool or not, and what that might look like in the future.

DR. KASS: I am Mary Kass. I am chairman of pathology atWashington Hospital Center, and director of integrated laboratory services for MedStar Health.

First of all, I think my first question was about the testing methodology, but I think that there is overwhelming evidence to show that these tests meet all the normal QC, all of the normal standards that all other laboratory tests have to meet. I think that they're valid, I think that they are reproducible, so the third generation of tests for me is no longer a concern in that respect.

The question has been raised about necessary versus clinical utility. I don't know how to define a necessary laboratory test; I think that's really in the mind of the user. When I was in training, which wasn't all that long ago, the emergency room of a downtown urban hospital in Washington, D.C. didn't even have a laboratory open from midnight until eight a.m. because there were no laboratory tests that were necessary to make clinical diagnoses. But we've come a long way since then, and I think medicine has grown and realized that there are many things that can help physicians do a better job in taking care of their patients. So the clinical utility of this test, I think has been demonstrated, to certainly my satisfaction. The fact that the test is difficult to do because you have to acquire fresh tissue, it has to be shipped in a certain way quickly to a laboratory, that doesn't bother me either. That doesn't change its utility. I remember when we first started doing flow cytometry, the transport of specimens to do flow cytometry on was a big challenge to us. Now we do it routinely and we don't lose specimens in the transport process. It is very intriguing to me that this particular methodology may be very helpful in evaluating new drugs, the number of new chemotherapeutic agents that are rapidly being introduced to try to help us have a greater impact to the treatment of cancer. I think that anything that we could use to help define which modalities have a greater possibility of working and which don't, would be very helpful. I think it also allows the earlier consideration of other treatment modalities for patients, rather than going through a whole course of chemotherapy and waiting for the end point of no response. Earlier in the course of that, a clinician may have an opportunity to switch a chemotherapeutic drug, or remove one which has a very toxic side effect from the treatment regimen.

I guess in summation, I think that we haven't done a terrific job in treating most of the solid tumors. I think everyone is very disappointed in the fact that we haven't been able to have greater success than we have. I think that this is another tool, one of many, that could be available to clinicians that might help, certainly in terms of the quality of life, if we could remove drugs from the treatment regimen that were not effective, and perhaps in a better outcome. I think the patient that testified yesterday, that's one case, it's anecdotal. However, I've practiced pathology for 32 years; I have never seen a patient with widely disseminated pancreatic carcinoma that survived. You have to take notice of that. I think that's worth listening to.

DR. HAUSNER: I am Richard Hausner. I am a pathologist practicing in Houston, Texas.

DR. HAUSNER: For me, I would like to take the approach to try and put my comments in the context of my own clinical experience, my own day-to-day, I'm a working pathologist, although I am on the active clinical faculty of Baylor College of Medicine and the University of Texas Health Science Center in Houston. I practice in a community hospital, but I have very long reach in terms of my clinical experience. I have a big practice. And I can tell you that in Houston, Texas, where there is quite a bit of health care going on on a daily basis, not once ever in my life, with all of the cancer patients that I've seen, have I once been asked to harvest tissue for this procedure. Not ever. And I can tell you that if any of the patients in my practice had had this testing, that we would have been involved in the harvesting by definition, because the surgeons would have surely asked. So I know that it hasn't happened.

Nevertheless -- and I came in here reading the source material with that bias, because I had that bias from the very beginning. But nevertheless, somewhere around the middle of yesterday afternoon, my thoughts began to crystallize, and they crystallized during the time that, in the afternoon session when the data was put up to a tremendous amount of scrutiny and a very sophisticated critique, and I thought that it held up pretty darned well. And I have come to the conclusion that while over the past 20 years of the research that has developed for this technique, it clearly was a research tool and not ready for prime time, that the decision was correct not to allow this into Medicare's realm and therefore, give it the validity to go forward. Because what is someone's exciting front line technique comes very close to someone else's quackery, and at some point it would have been premature to allow this. But I believe now that the third generation technologies clearly take this beyond a research tool and that from this point forward, I would hope that the clinical studies will be conducted to refine where this could be best used.

Another analogy would be that a, that if this technique is not permitted in its current state, then the panel ought to reconvene and consider removing microbiologic sensitivity testing from the armamentarium of physicians, if this is not approved. The truth, I believe, lies somewhere in the middle, therefore, and just like so many other things we do in medicine, that this is a useful tool, imperfect as it is, and the ground rules may have to be carefully defined, but to turn the test away in its entirety, I believe would be inappropriate.

And in closing, I would point to the final paragraph of Dr. Weisenthal's paper in which he talked about whether we use the civil or criminal criteria of preponderance of evidence versus beyond a reasonable doubt. Beyond a reasonable doubt, we don't have. Preponderance of evidence, I believe we do. And therefore, my conclusion is, as a rough sketch, is that something ought to be done towards bringing this test into, as another tool for physicians to use.

MS. KRAFT: I am Cheryl Kraft, administrative director of laboratory services, Minneapolis.

I think, again, this laboratory test is a tool for a physician. The physician should take advantage of all the tools available to him to treat a patient. And since studies show that only 25 to 30 percent, again, of patients do respond to the test and/or the drugs and/or the correlation of the drugs and the chemotherapy that we have available to them, should we not consider, due consideration to looking at the advantage of these human tissue assay tests and the resistance that has been found to chemotherapy drugs?

So one concern of mine is that they, in defining what they're going to reimburse, that they contact some of the scientists and physicians in the audience that are doing this research, that they find out what is the cost of producing the test and get some real life cost data, so when they set what they are going to pay the physicians for doing these tests, that they have realistic up to date direct costs.

DR. HELZLSOUER: I'm Kathy Helzlsouer, oncologist and professor of epidemiology at Johns Hopkins School of Public Health.

...although there's a correlation with survivors, it's the problem we always have with reviewing issues, that responders always do better than non-responders, and it's probably a good marker for responders. But I think we have to see how we can clinically use that in either choosing chemotherapy, and I think the compelling argument is the issue of avoiding unnecessary chemotherapy, but I'm not sure I have the evidence to say that would actually be done in practice.

I think it should guide but not dictate care. I don't think we can use the test to dictate care, and there would be lots of reasons in addition to the fact that you might have a situation, since 20 percent would respond even if they were resistant on this assay, according to the literature we have, and that's based on sensitivity response. You could have a situation where somebody, you still have a 20 percent chance, and in combination you might choose a less toxic drug rather than a more toxic to which they are sensitive, because you're using it in combination. There are a variety of scenarios you can come up with that this test alone should not be your sole, to dictate therapy alone, and there has to be a combination of other factors along with this test result.

DR. MINTZ: I am Paul Mintz. I direct the clinical laboratories and blood bank at the University of Virginia Health System, where I'm a professor of pathology and medicine.

DR. MINTZ: My concerns have been already stated by others, but I want to use this opportunity to state that I think the sense of the committee was best expressed in motion number three, and that these tests show promise for clinical utility, and that motion deliberately did not state, distinguish between sensitivity and resistance testing, so I think the sense of the committee reflects that it is supportive of both sets of testing. And I would only add that I also hope the coverage is adequate to permit this technology to be used.