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 ralternative" 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 ralternative" 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 ralternative" 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 ralternative" 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 ralternative" 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 ralternative" 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 ralternative" 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 ralternative" 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, ralternative" 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 ralternative"
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 ralternative" clinic, wherein the patient actually had a
"Level 1V, superficial spreading melanoma ", not a "stage 1V, spreading "
melanoma with its much worse prognosis [5]. Additionally, cancer diagnosis, staging and prognosis
are not yet the exact sciences that ralternative" 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 [1]. 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 [2]. Prostatic core biopsies were found to be
falsely diagnosed as cancerous in 1.3% of cases in one study [3]. False positive rates in
cytological diagnosis can be much greater, for example in thyroid nodules [4].
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 ralternatives". 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 ralternative" 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 ralternatives", 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 [11], and Hoffer/Pauling's orthomolecular treatment [12].
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 ralternative" 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 ralternative" circles evaluate methods (seemingly testimonial, rumour and hearsay) are not up to the task of detecting useful methods (so why bother?).
Some ralternative" 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 ralternative" medicine exceeds the spontaneous cure rate of cancer. There should be a handful of the latter yearly within the USA alone (see Part 2 ra 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
References:
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5. Contact me privately for details. The patient at most had an early stage 11 cancer.
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