Alternative Medicine and Cancer
What's so hard About showing That a cancer cure works?
Part 2. A Preliminary Challenge.
In Part 1 I established that anyone claiming to have an effective cancer treatment and promoting it as such to cancer sufferers should be able to show established cancer melting away, at least some of the time.
A Challenge ---
Case reports of a detail and documentation not usual in ralternative" promotional material are needed to show this. The patients concerned should be accessible, and all records, imaging and biopsy results should be available for independent review.
Relatively few cases with these specifications would be needed to inspire medical interest. Leaping in at the deep end, I suggest that many doctors, including myself, might be very intrigued should any alternative clinic, or practitioner, or seller of alternative cancer products produce even two or three cases of this quality with certain kinds of cancer. I personally think none could meet even this rather modest requirement, even though we know many thousands of suitable patients are passing through their hands every year, and that these folk have often been led to expect quite spectacular results. I could easily be proved wrong ----.
Let this be a standing preliminary challenge to any who are sincere in the belief that they have an important cancer treatment.
Meeting this challenge could lead to an immediate recommendation for further testing in an oncological clinic. The NCCAM has been looking for promising CAM cancer treatments to investigate for some years, and has funds for that purpose right now. Some CAM methods have undergone formal testing on the basis of less tangible evidence.
Conversely, those unable to meet such a challenge should reconsider their involvement in cancer patient care, if they are at all sincere about it. They should at least, in accordance with modern standards of informed consent, look carefully at what expectations their promotional materials are designed to arouse. And, above all, they should stop accepting patients who have a good chance of cure with standard medical care. If they must treat such patients let them do so in a strictly complementary role and after fully informed consent..
Not Your Average Best Case Request
"Best case" requests similar to the above have been the usual way of assessing the claims of those unable or unwilling to perform simple planned investigations. They are not intended to yield final proof or disproof. They simply allow the outsider to find out why the claimant thinks they can cure cancer, through an examination of the same cases
The Office of Cancer Complementary and Alternative Medicine (OCCAM), a division of the National Cancer Institute, has a standing invitation for CAM practitioners to present best cases, and detailed instructions can be found on its web site. It is calling for best cases in 714X users right now.
In the main, best case reviews have not specified precisely what properties useful case histories should have, or how many are needed. Most of those submitted are likely to be unconvincing or uninterpretable (See Gerson's "Famous" Fifty Cases).
Also, in any sizeable number of cancer cases (and some ralternative" clinics treat hundreds of cases yearly) there are liable to be a few unexpected outcomes in very poor prognosis patients, regardless of any treatment used. It can be difficult for those sitting in judgement to be sure of the significance of these. They may be unable to either endorse or completely dismiss the claims. A wishy washy " there is no clear evidence that --- " or "we need more cases" judgement can ensue.
Everyone is unhappy. The claimant, dazzled as much by the blind (but often transient) devotion of his patients as by anything in the data, is angry. If it is good enough for my patients why not the doctors? (Well, the most appalling of cancer charlatans gather intensely loyal followers. Patients are like that if they think someone genuinely is trying hard to help.).
Many ralternative" supporters have usually already made their minds up (somehow), and are equally dismayed. While few of us harbour false illusions that we are aeronautical engineers, many find it hard to accept that there could be limitations to their ability to assess the true efficacy of treatments, even at some distance. There can be only one possible explanation for the failure to embrace the amazing new treatment -- the doctors are corrupt!.
The public in general bemoans the lack of clear answers, especially when the inevitable counter-claims start to appear.
This scenario has been played out repeatedly in recent decades. It is thus very desirable and fair that claimants should be told in advance precisely what kind of case is needed, and why (see Part 1, also the OCCAM site). Let us go further and advise them as accurately as possible how they will be evaluated.
How cases will be evaluated.
Remember we are not yet looking for final evidence of effectiveness. In medical science that always awaits the independent replication of results.. We are simply looking for patterns of events that make it likely that a true treatment effect has occurred, Especially in these preliminary stages, science is about the probabilities and, whether the claimants and their supporters understand this or not, the probabilities can only be gauged by reference to considerable background knowledge. (NB: we are also not yet talking about the cure of cancer. Cure requires that complete remission is sustained for a period which varies from cancer to cancer.)
So, as already outlined, there needs to be measurable cancer, not otherwise recently treated, and clear evidence of regression. Ideally the target cancer should be biopsied, even if metastatic, but typical appearances on imaging or strong evidence from marker studies would usually be acceptable as evidence of metastases if the cases are otherwise consistent.
Assuming these requirements are fulfilled, cancer type has to be considered in relation to the possibility of spontaneous remission (SR) While virtually all cancers have been known to undergo spontaneous remission  it is rare in most cancer types, and specifically in lung cancer, high-grade non-Hodgkin's lymphoma, chronic myelogenous leukemia, and acute leukemia. Its incidence in these and many other cancer types is possibly of the order of 1 in 100,000 cases .
Now, one such case in the usual practice treating up to a few hundred cancer patients yearly would not mean much. Even at this low rate of SR there will be enough each year for one, two or more to occur while under ralternative" treatment simply by chance (over half a million new patients develop progressive cancer yearly in the USA alone despite standard care and at least forty per cent of those are said to use ralternative" methods).
Two recent cases in the same practice, however, is a rather less likely coincidence. Add a third and the odds against chance happenings are escalating dramatically. A fourth and -- , well, I doubt if such a recent success rate within the same practice with these kinds of cancer could even be kept hidden, considering the intense public and media interest that follows the merest hint of a new cancer cure.
This is the basis for the "two or three cases" of my challenge.
Candidates need to be aware, however, that spontaneous remissions are surprisingly common with some other kinds of cancer. According to a recent review by Kappauf et Al [ 2], nearly two thirds of all SRs occur in these five cancers: malignant melanoma, kidney cancer, low-grade non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and neuroblastoma in children. SR rates of up to 6% have been reported with renal cancer metastases after treatment of the primary . SR is also very common in low-grade lymphoma and an extraordinary rate of 30% has been reported in "follicular small cleaved cell" . Metastatic malignant melanoma regresses spontaneously in about 1 in 400 cases, but much more often in patients with unknown or regressed primary tumours .
Since the probability that a remission represents a true treatment effect depends upon such statistics, we may have to almost completely discount single cases of remission of cancers with very high rates of SR, and want more than these few cases of those with moderate rates of SR. Where known, the number of patients with established cancer who had to be treated to obtain the remissions would also be taken into consideration..
Diagnostic or staging errors may still crop up, although, as explained in Part 1, most of them will be eliminated if the strict specifications are met. An example familiar to doctors in sunny Australia is the keratoacanthoma, a skin lesion that can look like a squamous cell carcinoma (SCC), that resembles it under the microscope, and that is even regarded by some as a variety of SCC (in which case it is really an example of virtually 100% spontaneous remission) They grow very quickly, look nasty (see here , link to another site), but will disappear leaving scarcely a trace if left alone for a few months. Some testimonials are suggestive of this condition.
rare self-regressing inflammatory pseudotumors occur in many sites, and might occasionally be misdiagnosed as malignant on inexpert pathological examination. There may well be other sources of error of these types that I am not personally familiar with.
Misattributions: as hinted at earlier, many of those offering ralternative" cancer treatments are not very knowledgeable about cancer. It is inevitable that some of the remissions attributed to their treatment will have other explanations when the cases are carefully examined. This is particularly likely to occur with hormonally dependent cancers such as many of the breast and prostate. Here hormonal preparations and hormone antagonists, ovarian surgery, the menopause, testicular failure for any reason, or even drug-contaminated or hormonally active herbal products might be the true cause of temporary remission. Sometimes the only way to be sure of all medications that patients are taking is to ransack their house, so that the amount of weight given to remissions with this kind of cancer may depend upon how certain we are as to the completeness of information.
Some candidates will be delighted to know that plausibility is not likely to arise as a major issue. If authentic remissions are being produced in the required numbers the sceptic has little "wriggle room" on any basis. This is a great virtue of my challenge for the claimant. The NCCAM has also shown itself prepared to investigate methods with quite implausible elements with its 1.3 million dollar study of the Gonzales/Kelley treatment method, involving oral enzymes and coffee enemata. Extreme implausibility could, however, carry the day if the data presented was of marginal quality.
If anyone wishes to send me case histories, I would be happy to have a preliminary look at them, and also, if necessary, help you understand which are worthwhile and which are not. I am also always willing to have my personal opinions challenged. You should either send the particulars free of identifying characteristics, or obtain the patient's consent.
Alternatively, take them to the OCCAM or NCCAM. If you prefer, take them to one of the CAM-promoting congressmen, or a prominent ralternative" doctor, or an alternative medical journal, or Prince Charles of the British Royal family, or even to the media - they love this stuff. There is no end of quite sympathetic options for those who are sincere in the belief that they can cure cancer.
The time was never riper for anyone to advance honest claims. Doing nothing, on the other hand, is strong evidence of something else. Remember Sherlock Holmes and the dog that didn't bark in the night?
Part 3 A Better Way.References
1. Spontaneous Remission-An Annotated Bibliography. C Hirshberg and B O'Reagan. http://www.noetic.org/research/sr/biblio.html (Large PDF files)
2. Complete spontaneous remission in a patient with metastatic non-small-cell lung cancer. Case report, review of the literature, and discussion of possible biological pathways involved. Kappauf H, Gallmeier WM, Wunsch PH, Mittelmeier HO, Birkmann J, Buschel G, Kaiser G, Kraus J. Ann Oncol 1997 Oct;8(10):1031-9
3. Placebo-associated remissions in a multicentre, randomized, double-blind trial of interferon gamma-1b for the treatment of metastatic renal cell carcinoma. The Canadian Urologic Oncology Group. Elhilali MM, Gleave M, Fradet Y, Davis I, Venner P, Saad F, Klotz L, Moore R, Ernst S, Paton V. BJU Int. 2000 Oct; 86(6): 613-8.