Alternative Medicine and Cancer

 

 

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what DO alternative methods really do? --- The inside story

In this section I look at material published in alternative medical journals by the promoters of several alternative methods or with their cooperation.  It offers  rare insight into the methods' true  performance with cancer under presumed optimum available conditions and as revealed by the practitioners' own records.  

There have been numerous other examinations of these and other popular alternative methods,  with similar negative conclusions.  The importance of the results described here is that they must be regarded as reflecting the true level of activity of the treatments.   The apparently poor results cannot be attributed to medical bias or conspiracy.    

The results are consistent with the methods having no effect at all on cancer, once established.   Yet the instigators of all these treatments claimed very high success rates even with advanced and otherwise incurable cancer.     Livingstone-Wheeler claimed an 82% success rate in her book "the Conquest of Cancer".  Gerson claimed 50% success in "far advanced cases".  We can assume what Hoxsey claimed in his book,  "You Don't Have to Die"!    Claims for the Gonzales/Kelley method are described below. 

The first two examples are from a project of the  Centre for Alternative Medicine Research at the University of Texas [1]. The objectives were were to "determine the feasibility of (1) obtaining and collecting data from medical records, (2) determining 5-year survival, and (3) comparing 5-year survival to that of conventional treatment."

1. The Livingstone Wheeler Foundation Medical Center, San Diego, California

The Livingstone -Wheeler (L-W) clinic offers vaccines and other measures purported to enhance  immunity to a pleomorphic bacterium believed to be the cause of cancer.  BCG vaccine is used along with a multifaceted treatment program:  vegetarian diet, vitamins, antioxidants, detoxification, nutritional counselling, support groups.  Patients are monitored with tests of immune function and vitamin levels. 

The five year survival rate (5YSR) was determined for 193 patients with various types and stages of cancer patients treated during the year 1992.    Only 10 were lost to follow up. Patient documentation was excellent.  This clinic shows what alternative practitioners could provide in the way of information if they cared to.

Only 28 patients out of 193 were found to be still alive five years later, giving a five-year survival rate (5YSR) of 14.5%.    Livingstone-Wheeler's claims are immediately refuted.

Does the treatment improve cancer survival at all?    Here is some additional information to help you  decide.  

The results look not too bad when you consider that about half (101) of the patients presented to the clinic with metastatic cancers  (stage IV). 

On the other hand, only eight of  those with metastases survived five years.   These were all in cancers that have significant five year survivals naturally or with the conventional treatments also used by most patients.   Three   (out of 25 = 12%) had metastatic breast cancer which normally has about a 15% or more 5YSR.  Three ( out of 9 =33%) had metastatic prostate cancer,  which is renowned for often being slowly progressive and hormonally sensitive, with a 5YSR of about 30%.   The remaining two patients had a cystadenocarcinoma of the ovary and non-Hodgkin's lymphoma. They also have low grade variants with substantial natural five year survival.

Equally disappointing is that  there were no 5 year survivors in 31 cases of  metastatic lung and colorectal cancer.  This is also normal experience.  These results suggest that the L-W treatment does not materially prolong survival with metastatic cancers.    

What about the 20 other patients who survived five years?    We are not advised directly what kind of cancer these patients had, but they are drawn from 93 patients of which 15 had only "localised disease" (presumably stage I).    30 had "regional disease" e.g. presumably mostly stage II (meaning lymph node involvement).  Stage  II cancers of the breast, colon and other organs have  substantial five year survivals naturally.  Eight had "no evidence of disease".   I am not sure what this means but it suggests a reasonable prognosis.   14 had unknown disease stage.   

 A 20-25% survival rate in such a mixture of patients is no better  than  that expected from the conventional treatments these patients also received, or received before arriving at the clinic.

Poor results within alternative cancer practice are often defended by the claim that the patients have more advanced cancers.   That cannot be a major influence here.   87% of patients attended the L-W clinic within one year of diagnosis or staging.

My Verdict:  The L-W treatment either has no beneficial effect on cancer survival, or an effect too small to be detected by such small uncontrolled (no comparison group) studies     Livingstone-Wheeler's claims are not supported.    

2. The Biomedical Centre, Tijuana, Mexico.

The main treatment at this clinic is the tonic promoted by ex coal-miner Harry Hoxsey, and widely used for cancer in America early last century.   It was the subject of a film "How Healing Becomes a Crime".      Some of the nine or ten herbal constituents of the tonic have been shown to have anti-cancer activity in vitro (on tissue culture).    Dietary advice is usual and the clinic offers other popular alternative modalities.  

The results at the Biomedical Centre were broadly similar to those of the L-W clinic.   Only 17 (11%) out of an initial 149  patients could be established to be alive five years later.   68 were known to be dead, but a colossal 64 were lost to follow-up and therefore had unknown outcomes. 

There was also a poorer level of patient documentation at this clinic.  Only 85 out of the initial 149  could be evaluated for stage and the researchers rightly did not bother with any full analysis of the results.   The types of cancers were similar to those at the L-W clinic except that there were more brain tumours and skin cancers.   Four skin lesions described as basal cell carcinoma or squamous cell carcinoma,  normally excellent prognosis conditions  were included, the numbers of locally (27.3% vs 9%) and regionally confined (26.6% vs 17.9%) cancers were higher, and the number of metastatic cancers lower (38.5% vs 68.3%) than with the L-W group, indicating that this was a much better prognosis group of patients.   A similar number had "no evidence of disease".    

Very likely reasons for loss of contact with patients are death, or obvious cancer progression despite the treatment.    It can be argued that the lost patients are likely to be heavily weighted with poor outcomes.   However, even if they  survived at the same rate as the others, they would contribute about 13 more survivors (multiply 64 by 17 and divide by 85) creating a  20% overall 5 YSR.   Again,  not very impressive in such a mixed patient population . 

75% of patients presented to the biomedical centre within one year of diagnosis/ staging.

My Verdict:  Similar to that for the L-W clinic.       

3. The Gerson Clinic Study on Melanoma

The Gerson treatment is one of the most highly regarded and often recommended alternative methods.  It includes low calorie and low protein diets, salt restriction, and the "juicing" and coffee enemata often incorporated into the programs of other alternative advisers.  

Gar Hildenbrand and others performed a retrospective study of all patients treated for  melanoma by the Gerson method [2]  Melanoma was chosen for study because it was thought that there were a number of "unusually positive outcomes" with that cancer - already a curiously muted statement concerning a treatment heavily promoted as an alternative to conventional measures by Howard Strauss, Dr Max Gerson's grandson.  

This  was another serious attempt to gather good data, to the clinic's credit.   Unfortunately there was again a  very high rate of loss of patients to follow-up (21%).  A further 19% had to be excluded from evaluation because they could not be accurately staged from the traceable documentation.  Nevertheless the remaining patients do give a fairly clear  impression of the clinic's results to be set alongside  Dr Max Gerson's claims of fifty per cent success rates even  in "far advanced cases",

Of 235 patients with cutaneous melanoma,   45 (19%) were known to be alive five years later.   Full information was available for only 153.

How good are these results?    Again, judge for yourself.    There were NO 5  year survivors in by far  the largest group of patients, the 85 who had internal metastases  (Stage IVB).   

14  of the 5 year survivors were scattered over various good prognosis categories (Stages I and II in the classification used)   in such small numbers for each as to be not worthy of evaluation.  For example,  the four survivors with Level 1A melanoma should have been excluded altogether.  This is carcinoma-in-situ, almost always curable by the simple excision needed to make the diagnosis.   Likewise three 5 year survivors out of four  with level IV melanoma is not exceptional.   These levels refer to the depth of invasion of the initial melanoma within the skin on biopsy - they have nothing to do with the extent of spread

It is only in patients with lymph node metastases but no other spread (Stage III) that the results look moderately impressive.   21 out of 27 (78%) lived five years,  comparing favourably with conventional results of about 45% for this stage (see graph below- but also later comments).  

                Survival of cutaneous melanoma by stage (Source: American Cancer Society)

The one survivor out of four with only "in transit" metastases (metastases confined to the local lymphatics) is about the usual with this condition. 

The 7 out of 18 survivors in stage IVA (those with "non-regional cutaneous, subcutaneous or lymph metastases") is also claimed to be impressive,  although most of these patients  would have had cutaneous (skin) metastases alone, which are well-known to be compatible with quite prolonged survival.    This group presumably accounts for most of the approximately 10% five-year survival found with  stage IV melanoma in conventional studies (see same graph).  

The authors of the study  ask for this IVA group to be regarded separately, but that leaves no basis for comparison of the results.  It would also be somewhat deceptive.  It so happens that if all the stage IV   patients (those with any kind of distant metastasis, whether  visceral or cutaneous/lymphatic) are lumped together, as per usual practice,  their 7 survivors out of 103 (85+18) patients has to be compared with the  10% survival of this stage in large  conventional studies (again see graph).     

Note that most of Gerson's patients had conventional treatments, especially surgery,  so we are again looking at the effects of the addition of the alternative treatment to standard care.   Also, melanoma has variants that can be very slow progressing or late recurring after periods of apparent dormancy.  It is thus important to realise that five year survival does not equate to cure with this cancer ( it does approximate cure with  some other cancers  such as colon - see discussion here).    Illustrating the point,  three Gerson patients died shortly after the five year cut-off point.   These all happened to be  in the stage 111 (lymph node metastases) group, the only group in which survival benefits looked  likely at first sight.    .

We cannot make much of the apparently good results with that stage, and not becaue of the three deaths occurring shortly  after  the five year cut-off point.   Retrospective comparisons of results from different centres are notoriously unreliable, and on even shakier ground than usual here because of the 82  Gerson  patients who could not be evaluated, either through loss of contact or deficiencies in the data.   It can be argued, as above, that any untraceable stage III patients are more likely to have died.   Deficiencies in the data are also be more likely in the deceased, due to the added difficulties in chasing up pathology results and a reduced incentive to pursue them.  Likely biases are all in the clinic's favour.     

Also missing from their tables is the Stage lllC of the current ACS classification of melanoma [9] .  These are cancers with ulceration of the primary, which has a very poor prognosis and a 5YSR of 15-25%.   If the Gerson happened to have treated none of these very poor prognosis patients that would help explain the results. 

My Verdict:  No convincing effect, and certainly none on more advanced cases.   A small beneficial effect not excluded but these are extremely disappointing results for the  cancer  thought to be most responsive to this very intense and life-consuming treatment method.  

(See  http://www.cam-cancer.org/CAM-summaries/Diet-nutrition/Gerson-diet/How-well-does-the-Gerson-diet-work

  for a more detailed overview of the Gerson method.)

4. The Kelley/Gonzalez regime

Dr Nicholas Gonzales MD describes the present version of Kelley's treatment thus: 

"The therapy itself is quite complex, but basically involves three components: diet, aggressive supplementation with nutrients and enzymes, and detoxification. The protocols are individualized and each patient receives a diet designed for his or her specific needs. The diets are quite variable, ranging from a pure vegetarian program to a diet requiring fatty red meat 2-3 times a day.

The supplement regimens are also individualized, and intense: each cancer patient consumes between 130 and 175 capsules daily."
 

The most widely publicised claim for the Kelley treatment is that five patients treated by Kelley for proven advanced pancreatic cancer  lived on in good health  for a spectacular mean period of nine years.  That equates to cure for this kind of cancer.  The claim derives from a study Dr Nicholas Gonzalez MD performed on Kelley's patients while a medical student     Rather curiously,  the story appears on Gonzalez' web site only  in the form of a third party account by an insurance executive with no medical or scientific qualifications  [3].   

I wrote to Gonzales in September 2004 asking him if he stood by this claim and whether the data on which it was based was available anywhere.   There were grounds for doubt.   Kelley was a dentist with very weird ideas.  You can confirm this for yourself by reading his book  "The One Answer to Cancer " online [1].    He diagnosed pancreatic cancer in himself and in his patients using bizarre groupings of symptoms and other criteria that knowledgeable medical persons would find odd.  That I can determine, no one within alternative medicine  has chosen to apply them since.   I had doubts as to whether  Gonzales as a junior medical student already having leanings towards alternative medicine would have applied sufficient rigour to the assessment of Kelley's cases, even though it is claimed that he went to some lengths to check the diagnoses.  

Gonzales kindly replied, but without indicating whether he stood by the claims others make on his behalf and that he is using to promote his alternative medical practice.   He simply said "the data described is from an unpublished monograph that is no longer available".    It is rather difficult to believe that material purported to demonstrate the cure of incurable cancer could somehow be mislaid.  

The episode adds to my wariness about a later study from Gonzalez.  In 1999 he published an account of patients with biopsy-proven inoperable pancreatic cancer, apparently showing remarkably good survival in what is normally a very poor prognosis cancer [5].    From the paper abstract --

 As of 12 January 1999, of 11 patients entered into the study, 9 (81%) survived one year, 5 (45%) survived two years, and at this time, 4 have survived three years, Two patients are alive and doing well: one at three years and the other at four years. These results are far above the 25% survival at one year and 10% survival at two years for all stages of pancreatic adenocarcinoma reported in the National Cancer Data Base from 1995. This pilot study suggests that an aggressive nutritional therapy with large doses of pancreatic enzymes led to significantly increased survival over what would normally be expected for patients with inoperable pancreatic adenocarcinoma.

These look at first sight to be very good results, although it can be shown that they are not as good as the abstract implies, and they  certainly fail to confirm  claims still being widely made about Kelley's pancreatic cancer patients.  

Much of the benefit  can be explained by the inevitable selection biases in such a study.   Gonzalez had almost complete liberty in the selection of cases, excluding  four patients "because they presented with  multiple significant medical problems requiring multiple medications.",   and two others because of end stage liver disease and prior radiation therapy.   Mind you,   he had to be rather selective -- the patients had to be capable of applying a somewhat gruelling  treatment program for a reasonable period.   

The difficulty is that the doctors whose patients figure in the National Cancer Database and that are being compared with Gonzalez' patients had no such luxury.   Conventional survival figures include "all comers" by default.     It wouldn't matter if the patients were very old and frail, very sick with other illnesses, or even if they were terminal at the time of diagnosis, which is not very unusual with this very serious kind of cancer.    It wouldn't matter if they died while under investigation, or from attempts to relieve jaundice or duodenal obstruction;  such patients would drag down the published survival figures but never reach Gonzales so as to undergo his further weeding out of unsuitable patients .         

There are other quibbles:  

Case H was almost certainly a bile duct cancer, which has a far better prognosis than cancer of the pancreas. .  How do I know?  Because the patient presented with jaundice and the initial diagnosis was made by brush biopsy at ERCP at a stage when there was no localised mass lesion on CT scanning.  That strongly suggests a growth arising in the ducts  rather than the pancreatic glandular tissue.  A much later core biopsy said, perhaps revealingly,  "adenocarcinoma IN pancreas" not  ."adenocarcinoma OF pancreas".  (I would have preferred more detailed biopsy reports than are included in G's paper.)

Case J had a Whipple's procedure for an early pancreatic cancer.   This case should not have been included, as the fact that the cancer was deemed operable indicates a more favourable prognosis for the case.   Experienced centres claim 20% five year survival in operable cases [6].

Case K is not certainly pancreatic cancer.  The diagnosis rests upon a surgeon's opinion from palpation of an unbiopsied pancreatic mass (known to be unreliable) and a  pathological opinion as to the likely source of pelvic cancer deposits (also not reliable). 

Case L could well be  a better prognosis duodenal or ampullary adenocarcinoma, having presented initially with jaundice and having a "large fungating mass extending to the ampullary region".    Nevertheless this patient has had extraordinarily prolonged survival if he had cancer when initially presenting with jaundice many years before a positive diagnosis of cancer was made.

Some may regard these concerns as trivial,  but  those four cases happen to have the more prolonged survivals (37-47 months).  The  10-29 month survival in the other seven patients is good but not overly convincing evidence of a treatment effect in a such a highly selected group.   

Patients K and L were still alive at the time the paper was written.  I have written to Dr Gonzales to find out how they fared subsequently, and will advise the results.  It is a pity, however,  that  that they are not more clear-cut examples of pancreatic adenocarcinoma.  (Gonzales has not replied but these patients apparently soon succumbed to their disease.  A 2002 news item sympathetic to him states: "In Gonzalez's pilot study, two patients lived for four years and one for almost five." )

As a result of this study the National Cancer Institute is performing a 1.3 million dollar trial comparing Gonzalez treatment to gemcitabine-containing chemotherapy regimens.    

Verdict:  Superficially impressive results, in very small numbers of highly selected cases.   Not conclusive, as Gonzalez himself allows.  No evidence that the Gonzalez/Kelley treatment is able to cure cancer as per  the original claims.   Also, apparently, no patient showed objective remission of their cancer.   It will be interesting to see the results of the controlled trial.  

(Update October 2009:  The final results of that study have been published   http://jco.ascopubs.org/cgi/content/abstract/JCO.2009.22.8429v1   They are disastrous for the Gonzales/Kelley ("enzyme") approach.  

  Survival graph

Due to small numbers of suitable patients accepting randomisation, the study had to be completed on the basis of patients choosing which treatment to receive.  This can introduce bias and there were small biases towards sicker patients in the Gonzales/Kelley  group such as more with distant metastases.   Gonzales also alleges that some of the patients allotted to him were too sick to follow or complete his treatment.  This is certainly possible.  Inoperable pancreatic cancer is a rapidly progressing and debilitating condition, and patients may have also exaggerated their ability to consume the required diets and handfuls of supplements in their eagerness to be accepted for the study.    

Yet even if we doubled the survival of the Gonzales/Kelley patients  at 10 months so as to completely exclude some obviously excessive early mortality in this group, there is still no indication of any beneficial influence from this complex regime over the average medical care that the SEER figures reflect.. 

The benefits of chemotherapy are admittedly rather modest with this condition.)   

5. The Contreras Clinic and Laetrile

 Dr Ernesto Contreras was a famous champion of Laetrile (amygdalin, "Vitamin B17").  Three naturopaths, in a search for alternative methods  worthy of further interest,  followed up 31 patients  treated by Contreras at his Mexican clinic in 1983-84  using postal questionnaires [7].   The patients were treated with Laetrile, a modified vegan diet, proteolytic enzymes, and antioxidant supplements.     

 9 of the patients were lost to follow-up, suggesting death or decline in at least most.   The 22 remaining patients were confirmed to have died within a mean period of seven months.    To be fair, these patients could have had more advanced cancers than are usually treated in alternative clinics nowadays.   Few details are available.  

This is a less in depth study than those quoted above.  It is included because it provides some independent confirmation of the results of many other studies showing no useful anti-cancer effect of Laetrile.   It helps counter the common allegation of those promoting amygdalin products  that such studies were faulty due to the (deliberate?) use of an inactive preparation  (despite some patients experiencing cyanide toxicity in the Mayo clinic studies [8]).    Contreras,  as a Laetrile advocate,  presumably knew what he was using. 

NB The same researchers also tried to follow up patients at the Gerson clinic Biomedical (Hoxsey) clinic  Of 38 patients at the Gerson clinic 20 were lost to follow-up.   17 of the 18  remaining were known to have died and the sole known survivor still  had active Non-Hodgkin's Lymphoma.   This is consistent with the findings noted above.  Of 39 patients treated via Hoxsey 23 were lost to follow-up     10 of the 16 remaining were known to have died but there were 6 survivors with an average follow-up of 58 months.  Not enough information is provided about the survivors to allow any conclusions.   

Comments

These studies cover most of the popular themes in current alternative cancer practice: diets, vitamins and other supplements, herbs, detoxification, enzymes, building up the immune system, Laetrile  and psychological support      There is no reason to expect any other alternative treatment program to perform better, but I am  prepared to look at material from other claimants if readers can find any providing sufficiently detailed  information .        

 Such studies cannot exclude the possibility of small effects on cancer survival (actually for either good or ill).  What they do demonstrate beyond reasonable doubt is that any beneficial effects of these popular methods are so small or infrequent as to be unlikely to have ever been reliably detected by  the clinically inexperienced inventors of the methods, or by later  well-meaning supporters,  from casual clinical observations.    

How could such dramatic claims arise?    I suggest from a combination of misplaced enthusiasms and factors that I have described elsewhere:  lack of understanding of the normal progress of cancer and its response to conventional measures, unreliable assumptions as to diagnosis and staging, and the  misinterpretation and misattribution of  clinical events.   

The thrall of the false hypothesis is well-known to science.   A recent example is  the French scientist Benveniste clinging to the belief that he was sometimes seeing  homeopathic effects in his tissue culture experiments,  and repeating them over and over again,  when he should have been ruthlessly ensuring that all  possible sources of contamination and experimental artefact had been eliminated.   

It seems to be the same with cancer treatment.  A very  few cases of seeming success can ensnare the unwary mind.  These studies show how  belief,  or at least the will to keep trying,  can be sustained despite any number of failures.   It is far easier for the committed to find excuses for failure than to ever re-evaluate  the original basis for belief.   The patient got here too late, it was the chemotherapy,  they didn't do everything properly,  some "toxin" or parasite mustn't have  been successfully eliminated, or death was due to something other than the patient's terminal cancer .  

The basic ineffectiveness of alternative methods prompts constant tinkering with treatment programs in the hope of getting them to work better.     This is how they can evolve into fearsomely involved healing rituals, and costly combinations of innumerable agents once  promoted as capable of curing cancer on their own.      

 When I first encountered such beliefs all over the Internet, I was not at first quite sure what to believe, as I am sure applies with many readers.  In our normal lives we don't often encounter apparently honest people making major public claims without being sure of their ground, especially in life an death matters.  

My scepticism began to reassert itself  with the finding that there were simply far too many claims hanging upon about the same level of very weak anecdotal evidence.  Some of the methods had originated within conventional circles and were once widely tried out .   Doctors are not in the habit of discarding useful cancer treatments,  whatever some may think.  Some claims were mutually exclusive, but no one seemed to mind.   Some were ridiculously implausible  but still had ardent supporters.    

I describe other reasons for doubt  in What's so Hard About Showing a Cancer Cure Works?.    Andrew Vickers PhD has recently summarised much of of the experimental work on alternative cancer treatments and suggested that most of them should be regarded as disproved rather than unproven [5}.   

I try to keep my mind open -- not so easy when also disgusted by the unethical and unscientific behaviour now accepted as the norm within the alternative cancer industry .   By opening themselves up to outside examination the above clinics have shown that they have been acting in  good faith; they have some belief in what they do.   It  is very unfair that they can now be singled out for critical appraisal , but cancer sufferers will perhaps like me deduce that those who have never opened their books in like manner are more likely to be frankly fraudulent, or to have even less to show for their claims.  Feel free to tell them I and others are saying so.  

References

1.  Assessment of outcomes at alternative medicine cancer clinics: a feasibility study. Richardson MA, Russell NC, Sanders T, Barrett R, Salveson C.  J Altern Complement Med. 2001 Feb;7(1):1-3.

2. 5-year survival rates of melanoma patients treated by diet therapy after the manner of Gerson: a retrospective review. Hildenbrand GLG, Hildenbrand C, Bradford K, Cavin SW. Altern Ther Health Med 1995-09;1(4):29-37 Online here

3.   http://www.dr-gonzalez.com/maver_article_txt.htm

4. Available Online at http://www.drkelley.com/CANLIVER55.html.

5. Evaluation of Pancreatic Proteolytic Enzyme Treatment of Adenocarcinoma of the Pancreas, With Nutrition and Detoxification Support.  Nutrition and Cancer, 3J(2),117-i24  Nicholas James Gonzalez and Linda Lee Isaacs

5. . Alternative Cancer Cures: "Unproven" or "Disproven"? Andrew Vickers, PhD.  CA Cancer J Clin 2004; 54:110-118                http://caonline.amcancersoc.org/cgi/content/full/54/2/110

6. See http://pathology2.jhu.edu/pancreas/surgicaltx.cfm

7. Long Term Follow-up of cancer patients using Contreras, Hoxsey and Gerson therapies.  Austin S et al. J. Naturopathic Med. 1994; 5(1):74-75

8. A clinical trial of amygdalin (Laetrile) in the treatment of human cancer.  Moertel CG, Fleming TR, Rubin J, Kvols LK, Sarna G, Koch R, Currie VE, Young CW, Jones SE, Davignon JP.  N Engl J Med. 1982 Jan 28;306(4):201-6.
 

9. http://www.cancer.org/docroot/cri/content/cri_2_4_3x_how_is_melanoma_staged_50.asp

 

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