Alternative Medicine and Cancer
What's so hard About showing That a cancer cure works?
A manual for those who Think they've got one! (Part 1)
Let's assume that there are "alternative" cancer cures out there that work as claimed, and you've got one of them. How to get it recognized?
One matter needs clearing up from the start. It is quite true that those providing "alternative" cancer treatments don't usually have the resources to test them out in randomized controlled trials (RCTs - studies where patients are randomly allotted to differently managed groups and the results compared. The control group acts rather like the "blank" in a test tube experiment). It is also true that such trials are the only reliable way showing activity for many kinds of medical treatment, for example pain relievers or antidepressants.
Is this why so many cancer cures are being ignored by the medical profession? Their discoverers simply cannot produce "the kind of evidence the doctors want?"
Well, despite this fairly standard complaint from many promoters of dubious cancer treatments, RCTs are definitely NOT the only possible next step up from usually third-rate testimonial!!.
The truth is that RCTs are not even used in conventional oncology when initially assessing cancer treatments. This comes as a surprise even to some skeptics! New cancer treatments are always initially tested for their ability to produce regression of cancer in patients with measurable cancer in very simple uncontrolled studies ( Phase 1 and :Phase 11 studies), just as similar patients might walk into an "alternative" cancer practice An example of a simple Phase 1/11 study, one that strongly suggests a useful treatment effect for a dendritic cell vaccine in advanced melanoma, follows. There are other examples among the references below [7-11]. Are similar studies too much to ask of the promoters of "alternative" methods?
"Dr Joseph Fay, from the Baylor Institute for Immunology Research in Dallas, outlined the results of a dendritic cell vaccine in patients with melanoma. ----------- Five of the 18 patients in this study had a complete response (CR) to vaccine treatment alone. Two additional patients achieved a CR after additional vaccinations and surgery. Seven patients are alive at a median of 39 months from the start of the study. Interestingly, responses were seen in patients with liver and brain metastasis."(Fay J, Palucka K, and Banchereau J, Dendritic Cells and Induction of Immunity Against Cancer. Conference on the Development of Therapeutic Cancer Vaccines, Los Angeles CA April 27-29, 2008.)
RCTs are of vital importance to oncology but they come into play at a later stage, when treatments with known activity against cancer are compared to find out which works best.
Simple forms of evidence such as the above can carry considerable weight in cancer treatment for one simple reason: cancer is, in general, very predictable. In the absence of effective treatment it is nearly always a progressive condition. Thus, so long as the initial state of cancer is accurately known and the treatment effect is obvious, each patient can act as their own "control" (comparison case). This does NOT apply with subjective symptoms such as pain or depression or even with the symptoms that cancers can cause. They can fluctuate markedly in severity over a matter of hours. They can also appear to be responsive to sham treatment (placebo), for complex reasons related to non-specific patient reactions to medical care and biases in the reporting and observing of complaints.
A conclusion: The true weakness of the dubious cancer claims lies not with the anecdotal or uncontrolled nature of the evidence provided, whether in the form of testimonial, case reports, or other clinical observations. The problem is the generally very low quality of the evidence. For a typical example, see my examination of Gerson's "famous" fifty cases.
What follows is part of a work in progress - an educational exercise for myself that may hopefully be of use to others. It may (yes, I am not sure yet) eventually arrive at a description of the minimum kinds of evidence needed to stimulate general interest in an "alternative" method i.e. what might separate the potential Nobel prize winners from the sleazy Tijuana also-rans. So far as I know, no one else has ever attempted this task, leaving the "alternative" community free to allege impenetrable bias, conspiracy, or a constant re-raising of the bar, whenever they fail to convince a mythical medical "establishment" they are regularly curing cancer.
In truth, the most effective method of attracting attention has nothing to do with the evidence. Inciting public, media and political pressure works very well. The ball can be set rolling with one or two patients prepared to say to the hosts of current affairs programs that they have been cured. Recent examples are the Di Bella treatment in Italy and the Holt treatment in Australia. The problem is, what then? If business is booming (and with "alternative" medicine being such a glamour industry at the moment you should be looking for another job if it is not) why risk opening your books to skeptical examination? Here is what you need to know if you don't fancy Mexico or are simply sick of all the sniping from skeptics .........
The elements of good anecdotal material in cancer treatment
It is vital to demonstrate the remission of previously progressive cancer.
This may seem obvious to many readers, but defenders of CAM sometimes decry the emphasis that conventional medicine places on remission (i.e. cancer shrinking or disappearing completely ) as a measure of treatment success with cancer. They are quite right that lesser benefits such as symptom relief or slowing of cancer progression would be of real value to some patients. It must also be admitted that the remissions produced by some conventional treatments (usually in desperate cases) can be few, transient, and bought at the risk of serious side effects.
Nevertheless, there are compelling reasons for demanding examples of well-documented cancer remission from anyone claiming to have a major cancer treatment.
1.. The heaviest consumers of "alternative" methods are patients with advanced cancer who have unquestionably been led to believe there is some possibility of major remission. Are such expectations being fraudulently aroused?
2.. All methods having proven impact upon cancer, whether physical, chemotherapeutic, hormonal or immunological , have been able to induce major remissions with some cancers even if having lesser or no effect upon others.
3.. Complete remission is essential to any claim to have cured cancer. Cure = complete remission plus normal life expectancy (see here for fuller discussion).
4. Lesser claims, such as that patients live longer with their cancers, or experience symptom relief, or tolerate chemotherapy better, involve outcomes that are far too variable from patient to patient even with the same general kind of cancer for the anecdotal experience of the practitioner to carry much weight. Even experienced oncologists working under much more favourable conditions than the average alternative practitioner would not be trusted to make such judgments purely from day-to-day experience and fallible recall. Here, RCTs ARE definitely needed.. And, I note again, "alternative" claims are rarely so modest.
6. Nothing relieves the symptoms of cancer as efficiently as causing the cancer to regress (shrink). Many, if not most, symptoms of cancer would not be fully relieved by anything less. Difficulty in swallowing from cancer of the esophagus, vomiting from cancer of the stomach, inability to pass urine with cancer of the prostate are a few examples of symptoms that require regression for satisfactory relief.
7. Finally, and most importantly of all for present purposes -- in order to demonstrate cancer regressing there has to have been firm knowledge as to the state of cancer to begin with. There has to have been tangible, measurable cancer, as well a statement in a biopsy report.
This is the missing element in most of the anecdotal material that "alternative" medicine produces. It is easy to delude yourself into believing you are sometimes curing cancer if you are making unsafe assumptions as to the diagnosis, staging and prognosis of even a few of your patients. Such assumptions are always unsafe (i.e. not secure enough to support claims of that magnitude) when active cancer was not definitely present when treatment commenced.
(Keep in mind in the rest of this discussion that it is always the ability to produce cancer remission that is being sought from alternative claimants. The first duty of anyone offering a cancer treatment should be to find this out, if only so that patients can be properly advised.)
A common source of false assumption: medical error.
Low quality testimonials and case reports often hang upon "what the doctors said". Often an obviously garbled hearsay version is quoted, as in the flagship testimonial of one well-known "alternative" clinic, wherein the patient actually had a "Level 1V, superficial spreading melanoma ", not a "stage 1V, spreading " melanoma with its much worse prognosis .
Additionally, cancer diagnosis, staging and prognosis are not yet the exact sciences that "alternative" practitioners and supporters often assume. In one long-term study of patients having surgery for bowel cancer, an age-adjusted 7% of those regarded by the surgeons as having palliative operations (i.e. assumed incomplete removal of cancer) were still alive at ten years, and thus cured . These patients would have been given extremely poor or hopeless prognoses.
Even tissue diagnosis can sometimes be wrong. In 814 cases where expert second pathological opinions were sought, 8 lesions diagnosed as malignant were reclassified as benign and in 33 there was a change in the type of cancer diagnosed . Prostatic core biopsies were found to be falsely diagnosed as cancerous in 1.3% of cases in one study . False positive rates in cytological diagnosis can be much greater, for example in thyroid nodules .
The staging of cancer will be subject to at least as much error, especially if reliant upon minimal findings using imaging techniques or upon clinical judgment. For example the clinical diagnosis (by feeling the glands) of cancerous involvement of axillary lymph glands in breast cancer was wrong at least 10% of the time even in the hands of experienced surgeons.
Such factors help explain some of the out of the ordinary outcomes that occur within conventional oncology. Doctors get unexpected results in seemingly hopeless cases, too. For example, few cancers have a poorer prognosis than inoperable non-small-cell lung cancer. Yet when treated with low-dose palliative (not expected to cure) radiotherapy it has a 1% five year survival, with some patients surviving ten years with no evidence of disease progression [13,14].
Complete remission of proven, previously progressive cancer for no good reason is, on the other hand, quite rare in most kinds of cancer (see Part 2:: A Preliminary challenge).A glimpse into the skeptical mind - understanding the enemy.
It is admitted that the skeptic is exquisitely sensitive to, and ever on the alert for any weakness in CAM anecdotal material. Is this so odd? What claim could be more deserving of the most rigorous standards of evidence than that of being able to cure "incurable" cancer, especially when that should be so easy to demonstrate with present technology? The claims are also not being advanced tentatively, merely as hypotheses worthy of further evaluation. Desperately ill people are being induced to gamble substantial sums of money on them, and a few their very lives.
The skeptic is of course not impressed by the theory that there is a conspiracy against "alternatives". He/she is often, like myself, in a position to KNOW that this is bunkum from personal involvement in the field. The common, quaint rationale of "alternative" lore that goes something like: "Golly Gee!, the doctors wouldn't be wanting to suppress this cancer cure unless it really worked! " thus does not inspire much trust. What a good idea, to portray those whose opinion you wish to influence as heartless monsters!
No, there is no conspiracy, but certainly bias. If such self-serving conceits didn't provoke it there would still be the unlikely provenance and theory behind most of the "alternatives", the unethical marketing practices, and at best a lackadaisical approach to scientific validation.
The skeptic is biased, too, by a considerable history of like claims. Claims to be able to cure cancer are two a penny, and many of the more notorious and strongly promoted methods have already been proved to be almost certainly ineffective when put to formal clinical testing, most recently shark cartilage [6,7,8,9], the Di Bella method in Italy , and Hoffer/Pauling's orthomolecular treatment .
The skeptic will also have observed that popular methods don't even hold sway for long within the constant informal testing of cancer treatments that goes on within "alternative" circles. Instead of an expected narrowing of treatment choices down to a few methods that might work --at all, let alone as well as the claims often imply!--- the number of treatments being promoted has progressively expanded in the last twenty years or so. And none are ever completely discarded. Cancer sufferers are now obliged to use as many as they can afford with little real guidance as to what to choose. It seems that either none of them work well enough in practice to outdo even the least likely or more obviously fraudulent ones (so why bother?), or the conventions by which "alternative" circles evaluate methods (seemingly testimonial, rumour and hearsay) are not up to the task of detecting useful methods (so why bother?).Some "alternative" writers have likewise been unable find any intelligible pattern of success within the alternative treatment of cancer. They conclude that the occasional apparent cancer cures are not attributable to any particular methodology. Perhaps the patient's mental state is the most important element, or it is the spiritual observances, or some happy conjunction of many methods. Failure can conversely simply mean that the patient did not try hard enough to apply often dauntingly complex regimes or to think the right thoughts. The question for science herein is simply whether the number of authentic, confirmable cases of such cure within "alternative" medicine exceeds the spontaneous cure rate of cancer. There should be a handful of the latter yearly within the USA alone (see Part 2 "A Preliminary Challenge").
But such theories do not concern us further here. We are assuming we have a method that works in its own right.
The problem for the person who thinks they really can cure cancer is how to stand out from the crowd of pretenders in such a skeptical environment. I am trying to work out how.
Part 2. A Preliminary challenge
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5. Contact me privately for details. The patient at most had an early stage 11 cancer.
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A Phase II Pilot Study (Meeting abstract).
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