Alternative Medicine and Cancer

 

 

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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:

1. McLeish JA, Thursfield VJ, Giles GG. Survival From Colorectal Cancer in Victoria: 10-year follow up of the 1987 management survey. ANZ J. Surg. 2002,72: 352-356)

2. Kronz JD, Westra WH, Epstein JI. Mandatory Second Opinion Surgical Pathology at a Large Referral Hospital. Cancer 1999; 86: 2426-35.
 

3 Epstein JI, Walsh PC, Sanfilippo F. Clinical and cost impact of second opinion pathology. Review of prostate biopsy
prior to radical prostatectomy. Am J Surg Pathol 1996;20;851-857.

4. Smith J, Cheifetz RE, Schneidereit N, Berean K, Thomson T. Can cytology accurately predict benign follicular nodules?Am J Surg. 2005 May;189(5):592-5; discussion 595.

5. Contact me privately for details.  The patient at most had an early stage 11 cancer.

6. Oral Shark Cartilage in the Treatment of Patients with Advanced Primary Brain Tumors. A Phase II Pilot Study (Meeting abstract).
Rosenbluth RJ, Jennis AA, Cantwell S, DeVries J
Proc Annu Meet Am Soc Clin Oncol; 18:A554 1999 UI: 99700550

7, Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancer.
Miller DR, Anderson GT, Stark JJ, Granick JL, Richardson D
J Clin Oncol; 16(11):3649-55 1998 UI: 99032199

8. TWO PHASE II STUDIES OF OraL DRY SHARK CARTILAGE POWDER (SCP) IN PATIENTS (pts) WITH EITHER METASTATIC BREAST OR PROSTATE CANCER REFraCTORY TO STANDARD TREATMENT (Meeting abstract).
Leitner SP, Rothkopf MM, Haverstick L, Rodman DD, Michaelson ra
Proc Annu Meet Am Soc Clin Oncol; 17:A240 1998 UI: 98700240

9. Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancers (Meeting abstract).
Miller DR, Granick JL, Stark JJ, Anderson GT
Proc Annu Meet Am Soc Clin Oncol; 16:A173 1997 UI: 97621046  Cancer. 2005 Jul 1;104(1):176-82. Related Articles, Links


10. Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Loprinzi CL, Levitt R, Barton DL, Sloan JA, Atherton PJ, Smith DJ, Dakhil SR, Moore DF Jr, Krook JE, Rowland KM Jr, Mazurczak MA, Berg AR, Kim GP; North Central Cancer Treatment Group.
 

11. Italian Study Group for the Di Bella Multitherapy Trials. Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. British Medical Journal 318:224-228, 1999.

12. Lesperance ML, Olivotto IA, Forde N, Zhao Y, Speers C, Foster H, Tsao M, MacPherson N,
Hoffer A.  Mega-dose vitamins and minerals in the treatment of non-metastatic breast cancer: an
historical cohort study. Breast Cancer Res Treat. 2002 Nov;76(2):137-43.  Medline

13  Michael P. Mac Manus, Jane P. Matthews, Morikatsu Wada, Andrew Wirth, Valentina Worotniuk, David L. Ball.  Unexpected long-term survival after low-dose palliative radiotherapy for non small cell lung cancer
http://www3.interscience.wiley.com/cgi-bin/fulltext/112303827/HTMLSTART

14 Quddus AM, Kerr GR, Price A, Gregor A. Long-term survival in patients with non-small cell lung cancer treated with palliative radiotherapy. Clin Oncol. 2001; 13: 95-98.

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