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Wednesday, August 15, 2012

Don Benjamin-The Efficacy of CANCER THERAPIES


1. The Efficacy of Radiotherapy
By Don Benjamin

There has never been a properly run randomised trial that showed that radiotherapy saved any lives or even produced a significant increase in survival for any type of cancer.  Radiotherapy can reduce the rate of recurrence, but has never been found to increase overall survival. In rare cases radiotherapy can extend life for a while by shrinking a tumour that is threatening a vital organ. 

In contrast to this there is quite a lot of good evidence suggesting that it does more harm than good. 

1.   For example a 1993 US study of the deaths of 470,000 cancer patients found that about 27% of those who didn't die from their cancer had died from their conventional cancer treatment that had mainly damaged the heart and respiratory system (mainly radiotherapy and chemotherapy)1.  The authors of this study attributed the deaths to treatment because most of the extra deaths occurred in the year just after diagnosis.

2.   A review of randomised trials of radiotherapy for breast cancer showed that it increased mortality, mainly from damage to the heart and respiratory system2,3

3.   A review of randomised trials of radiotherapy following surgery for early breast cancer showed that overall survival was not affected, with the reduction in deaths from breast cancer being accompanied by an equal increase in death from other causes due to the radiotherapy4.

4.                  A review of data on 2,128 patients from nine randomised trials of post-operative radiotherapy (PORT) for non-small cell lung cancer comparing post-operative radiotherapy plus surgery with surgery alone showed that after a median follow-up of 3.9 years there was a significant adverse effect of postoperative radiotherapy on survival (hazard ratio 1.21). This 21% relative increase in the risk of death is equivalent to an absolute detriment of 7% at 2 years, reducing overall survival from 55% to 48%5.

5.   A review of randomised trials evaluating the effect of mammograms showed that although overall survival was not affected by treatment, the treatment had resulted in women who would have died of breast cancer instead dying of other causes, mainly ischemic heart damage and respiratory failure, probably due to the post-operative radiotherapy6.

6.   An analysis was carried out over a 20-year period of the mortality of 960 Swedish operable breast cancer patients randomised to preoperative radiation therapy, postoperative radiotherapy or surgery alone between 1971 and 1976.  The study analysed the number of myocardial infarctions (heart attacks), deaths from cardiovascular disease and ischaemic heart disease and correlated these factors against dosage of radiotherapy received by the heart.

Compared to the surgery only group the number of myocardial infarctions in the group receiving high dose radiotherapy was 30% higher, the number of cardiovascular disease deaths was 100% higher and the number of ischaemic heart disease deaths was 150% higher7

Because the higher radiation dose caused increased cardiovascular and ischaemic heart disease deaths but not increased heart attacks overall, the authors concluded that the mechanism of damage was radiation-induced microvascular damage to the heart.

7.      An analysis of trials comparing survival after adjuvant radiotherapy plus surgery with surgery alone for colorectal cancer showed that there was no significant overall improvement of survival from radiotherapy compared with surgery alone.  As with the breast cancer case in item 3 above, the reduction in deaths from colorectal cancer was accompanied by a comparable increase in deaths from other causes8,9.

Misleading Information


To counter this negative evidence, a review of the trials used in Item 3 above was re-analysed and by selecting some of the trials and ignoring others the authors claimed that “surgical adjuvant radiotherapy significantly improves overall survival of breast cancer patients [by 12.4%] provided that current techniques are used and treatment is given with standard fractionation.  For the best sub-groups we observed an odds of death reduction of more than 20%.  The results of this study stress the importance of reducing cardiovascular and other late toxicity in adjuvant radiotherapy for breast cancer.”10

The National Strategic Plan for Radiation Oncology makes the simple statement that "radiation treatment is a proven, cost effective treatment for cancer"11.  To substantiate this claim it cites a Swedish Report that states that "radiotherapy is effective as a curative treatment of many cancers"12. The Swedish report in turn does not cite results from randomised trials.  Instead it admits that the claims of efficacy of radiotherapy are not based on results from randomised trials but on clinical experience.

For example in the section called “What is Radiotherapy and Does it Work" it states that “there is no question that radiotherapy works, in the sense that it kills cancer cells…It can cure many different types of cancer…” It does not define "curative" but it is clear from the context of the Study that the word cure refers to the ability of radiotherapy to eliminate all cancer cells in small tumours and radiosensitive tumour.  This assumes that the tumour is the disease. This does not refer to increased survival and there is no evidence presented in that Swedish Report than any such treatment is curative.  The meaning of “cure” in this context can be gauged from the statement that “of all patients cured of cancer, the majority is cured by surgery alone (around 60%).  For this statement it refers to a study by Tobias and Tattersal13,14.   Yet there is no evidence from any randomised trials that surgery has any effect on survival for any type of cancer.  So this definition of cure is based on the ability to remove the tumour and the patient surviving a minimum of 5 years.  This does not mean any reduction in mortality has been achieved.  The Swedish Report also states that Radiotherapy plays a curative role in the treatment of about 30-40% of patients, either as a sole agent, or as part of combined therapy15.

To justify why effectiveness has not been proven the Swedish Report states that “in all of medicine including radiotherapy, however, it is quite difficult and often impossible to organize randomized trials.  One problem is that many techniques used in radiotherapy are considered clinically effective based on clinical experience, so withholding them from a patient to evaluate their scientific merit may be considered unethical…. For these and other reasons, other types of controlled prospective studies are more common than randomized trials…. Although the results of these types of studies are considered less valid and reliable than the results of randomized clinical trials, they may still provide valuable information on effectiveness.”

It is therefore a gross misuse of public funds to channel scarce health funds into equipment that has not been shown to be effective and has been shown to be harmful.

It is important that the principles of evidence-based medicine be applied to all such claims for funds.  The Inquiry you refer to should start off which an investigation of why 35% of cancer patients are being given radiotherapy with no proven survival benefits rather than fewer than 5% who are likely to have their life extended temporarily by shrinking a tumour that is threatening a vital organ such as the bowel or brain.
1. Brown, Barry W et al.  Non-cancer deaths in White Adult Cancer Patients. JNCI 1993; 85 (12): 979-987.
2. Stjernswärd, J. Decreased survival in early operable breast cancer. Lancet 1974; ii: 1285-1286.
3.  Cuzick J, Stewart H, Rutqvist L et al.  Cause-Specific Mortality in Long-term Survivors of Breast Cancer Who Participated in Trials of Radiotherapy.  J. Clin Oncol 1994; 12 (3): 447-453.
4.Early Breast Cancer Trialists’ Collaborative Group.  Effects of Radiotherapy and Surgery in Early Breast Cancer – An Overview of the Randomised Trials. NEJM 1995; 333 (22): 1444-1455.
5. PORT Meta-analysis Trialists Group. Post-operative radiotherapy in non-small-cell lung cancer:  systematic review and meta-analysis of individual patient data from nine randomised controlled trials. Lancet 1998; 352: 257-263
6. Benjamin, DJ. The efficacy of surgical treatment of breast cancer. Medical Hypotheses 1996; 47 (5): 389-97.
7.  Gyenes G, Rutqvist LE, Liedberg A, Fornander T. Long-term cardiac morbidity and mortality in a randomized trial of pre- and postoperative radiation therapy versus surgery alone in primary breast cancer. Radiother Oncol 1998 (Aug); 48(2): 185-190.
8.  Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview  of 8507 patients from 22 randomised trials.  Lancet  2001; 358: 1291-304.
9. Moss, RW. Preoperative and postoperative radiotherapy and survival in colorectal cancer. Lancet (March  23) 2002; 359: 1068-69. 
10.   Van de Steene J, Soete G, Storme G. Adjuvant radiotherapy for breast cancer significantly improves overall survival: the missing link. Radiother Oncol 2000 Jun;55(3):263-72.
11. National Strategic Plan for Radiation Oncology, August 2001. Royal Australian and Mew Zealand College of Radiologists 51 Druitt St, Sydney.
12. Swedish Council on Technology Assessment in Health Care – Radiotherapy for Cancer.
13. Tobias J. Clinical practice of radiotherapy.  Lancet 1992; 339: 159-164.
14. Tobias J, Tattersall M. Doing the best for the cancer patient. Lancet 1985; 1: 35-38.
15. van der Schueren. 1991?
=================================

2. The Efficacy of Chemotherapy for Cancer

In my previous article (Natural Health, December 1995/January 1996) I focused mainly on the efficacy of surgery. In this article I try to answer several questions related to chemotherapy:

Chemotherapy acts differently from surgery and radiotherapy. It is designed to kill off fast-growing cells. But it also kills many fast-growing healthy cells. In addition it damages the immune system (see below) and is toxic. Also unlike surgery and radiotherapy, chemotherapy is a systemic therapy (as is hormone therapy). If cancer is a systemic disease, as claimed by most alternative practitioners, chemotherapy is the most likely of the orthodox therapies to be effective if only its toxicity could be reduced.

Proof of efficacy of a cancer treatment such as chemotherapy requires a randomised trial in which it has been shown that the group treated with chemotherapy experienced a significantly increased survival when compared with that of an untreated group. This has never been done. Unfortunately most claims for the efficacy of chemotherapy come from trials showing shrinkage of tumours; or from comparison of survival rates of unmatched groups over time.
Tumour response trials assume a particular paradigm, eg the tumour is the disease. If this paradigm is wrong and the tumour is only a symptom of a systemic disease, the symptom can be removed, destroyed or shrunk without affecting the course of the disease. Unless tumour shrinkage is accompanied by evidence of increased survival the treatment cannot be claimed to be effective. Tumour response trials rarely produce such evidence of increased survival1. Tumour shrinkage can however reduce pain.
Comparison of unmatched groups over time can be valid if a very large increase in survival is observed and this cannot be attributed to other factors. For example when used to treat acute lymphocytic leukemia (ALL) in children, chemotherapy using different types of drugs has been shown to increase 10 year survival from less than 10% in the 1950s to about 60% in the 1980s2. Part of this increase is only apparent because it is due to earlier diagnosis extending the survival starting time and the increasing incidence of less-fatal forms. However it is unlikely that more than a third of this improvement is due to these factors. The percentage survival has continued to increase steadily over this thirty-year period whereas improvements in diagnostic methods and an increase in less-fatal forms are unlikely to have developed in this way.
For other forms of leukemia the evidence is questionable. An analysis of 3-year survival rates between the 1950s and 1960s showed increased percentage 3-year survival over this period for all forms of leukemia, yet for all forms combined the survival remained unchanged3. Unlike the case of ALL above, all of this increase can be attributed to the effects of earlier diagnosis extending the survival starting time and the changing proportion of the more fatal forms in the total cases.
A less dramatic improvement in survival has been observed for some lymphomas1. However much of this increase can again be attributed to poor methodology.
According to a leading epidemiologist, "for most cancers in adults, and particularly for epithelial cancers, there has been so little progress that it is difficult to distinguish any real   improvement in survival rates from artifacts due to improvements in diagnosis and cancer registration4"..(survival is also slightly prolonged using tamoxifen for breast cancer; oestrogens for prostatic cancer; cytotoxic chemotherapy for small cell lung cancer and ovarian cancer; adjuvant therapy for resected breast cancer and possibly colorectal cancer.)
"The efficacy of most other treatments is not established, however, and a small proportion of patients are certainly killed by the short or long-term effects of cytotoxic treatment4."
"There have been considerable advances in avoiding disfigurement by radical surgery, limiting tissue damage by radiotherapy and controlling chemotherapeutic toxicity, but for the majority of adult epithelial cancers it is not clear whether the withdrawal of all cytotoxic therapy would measurably alter the annual number of cancer deaths."....
"....In the many situations where it is still not known whether treatment will prolong remission or survival, the oncologist is therefore in the invidious position of having to weigh the cost, inconvenience and toxicity of treatment against its unknown clinical benefit. Not surprisingly, many clinicians respond by developing a set of firmly held but unsupported beliefs in the merits of particular regimens. The primary treatment of advanced non-metastatic laryngeal cancer, for example, will usually be by surgery at certain treatment centres and by radiotherapy at others. Whether chemotherapy is given as well and, if so, what form it will take, are also determined more by the idiosyncrasies and outpatient arrangements of the particular treatment centre than by objective evidence of long-term efficacy. Similar examples could be taken from most areas of cancer therapy4."
Similarly claims that chemotherapy have produced increased percentage 5-year survival for other cancers, such as cancer of the large bowel1, could be attributed to poor methodology because none of these cancers exhibited a divergence between incidence and mortality rate curves over time5.
Ulrich Abel reviewed the evidence for the efficacy of chemotherapy for invasive epithelial cancer6, the types of cancer for which chemotherapy is most commonly used. He concluded that there was some evidence from randomised trials that chemotherapy increased survival only for small-cell lung cancer. Yet even here the gain in survival was measured in weeks or months.
Adjuvant chemotherapy for breast cancer
It is widely claimed that adjuvant chemotherapy extends survival with late-stage breast cancer. For example, in a letter in the Sydney Morning Herald of 22 November 1996 Professor Allan Langlands claimed that the results of a meta-analysis of more than 100 trials of adjuvant systemic therapy in many thousands of women with breast cancer have confirmed a reduced risk of death by more than 20% over the next 10 years. Presumably he was referring to the results of 133 randomised trials involving 75,000 women published in the Lancet in 1992.
There were 11,041 women in these trials who were randomised to long-term polychemotherapy vs. no chemotherapy. This was the chemotherapy with the best results. Looked at ten years after their participation in a randomised controlled trial, these women seemed to show a 6.3% survival advantage (51.3 % vs. 45.0%). For node-negative women the advantage was just 4% (67.2% vs. 63.2%). For node-positive women it was less than 7% (46.6% vs. 39.8%). This small difference led two researchers from Manitoba to write in the Lancet that "no overall survival advantage has been seen so far".
Before these figures can be relied on the original trials need to be analysed to see if they were methodologically sound. It is likely that they contain results from many trials that have since been found to be flawed. The history of randomised trials of adjuvant therapy for breast cancer is dotted with examples of fraud and poor methodology.
In Italy, where the first positive survival effect was seen using the combination chemotherapy of cyclophosphamide + metho-trexate + fluorouracil (CMF), later analyses revealed that many patients had been excluded because they could not complete the rather arduous treatment. So randomised comparisons were of the healthier treated women against all controls, rendering the trial results invalid.
In the United States randomised trials of chemotherapy were begun in earnest in 1957 under the auspices of the National Institutes of Health (NIH). This program eventually became the National Surgical Adjuvant Project for Breast and Bowel Cancer (NSABP), headed by Bernard Fisher. In 1994 Fisher was sacked from the program because he had failed to notify the National Cancer Institute (NCI) of enrolment of inappropriate patients, a fact that had been known for three years. Further irregularities were then discovered in data from 12 other treatment centres. Some of the earlier NSABP trials had also involved exclusions that would have affected results, as in the Italian trial.
The results referred to by Professor Langlands include the results of both the Italian and NSABP Trials.
Adjuvant treatment of breast cancer with cytotoxic drugs is one of the lynch pins of chemotherapy and the NSABP was the key element within that program for more than 40 years. According to Irwin D. Bross, writing in the New England Journal of Medicine in 1994 "..the statistical quality control was grossly inadequate in the NSABP studies. Hence, whether or not some fraudulent cases are eliminated post hoc, any findings lack scientific validity"7.
Ulrich Abel makes the following points about claims of efficacy in adjuvant breast cancer therapy6:
1.       Good and consistent evidence of beneficial effects of adjuvant systemic chemotherapy on survival exists only for breast cancer, and more specifically, for patients with at most three positive nodes;
2.       So far no positive results seem to have been published for definitely postmenopausal patients;
3.       The restriction of beneficial effects to this small group appears somewhat strange;
4.       It is probable therefore that the effect is not due to the direct cytotoxic effects on the tumour but rather to treatment-related suppression of the ovarian function.
Chemotherapy for invasive cervical cancer
Recent claims have been made that chemotherapy helps with invasive cervical cancer. In fact the US National Cancer Institute is claiming a breakthrough in the treatment of late stage invasive cervical cancer according to a news item in the Sydney Morning Herald of 24 February 1999. They claim this is the first breakthrough in the treatment of this type of cancer in more than 40 years. (Many years ago it was being claimed that surgery was effective. This claim has now been abandoned.) However this new evidence warrants closer consideration because, unlike the claims made for surgery, this new one is based on the results of randomised trials. The evidence found from 5 randomised trials is that adding chemotherapy in the form of cisplatin at the same time as radiotherapy, following hysterectomy, increased the percentage 3-year survival by about 10-12%.
Thus for women with Stage IIB, III and IVA cancer survival increased from 63% to 75%. For women with earlier invasive cancer, Stage IA2, IB and IIA, survival increased from 77% TO 87%. It suggests that chemotherapy and radiotherapy have a synergistic effect when used together and possibly that chemotherapy stops cancer cells from repairing the damage caused by radiation.
Unfortunately trials comparing these types of treatment with no treatment have never be carried out so it is also possible that percentage survival is increasing towards what it would be without treatment. Radiotherapy has been found to increase deaths in many types of cancer so it is possible that the same result could have been achieved simply by eliminating the radiotherapy.
After considering these developments there is no reason for changing my original estimate that fewer than 6% of cancer cases would benefit from chemotherapy.
Chemotherapy for neuroblastomas in children.
A recent case involving a court requiring chemotherapy against the parents wishes for a child with a neuroblastoma raises the question: is chemotherapy effective against this type of tumour? Neuroblastomas are tumours that can occur anywhere in the sympathetic nervous system, as well as the adrenal gland, the chest or pelvis. The response rate is said to be 59% with cyclophosphamide and combinations involving high-dose cisplatin, vincristine and other drugs1. For high-risk patients the survival rate is said to be 15% "despite several therapeutic apporaches"1. This contrast between response rate and survival rate is a good example of the invalidity of most claims for efficacy with chemotherapy. This low percentage survival figure is confounded by the fact that neuroblastomas sometimes regress spontaneously

There are three main areas of harm:
·         Weakening the body's natural defences
·         increasing mortality
·         decreasing the quality of life
Weakening the immune system
Chemotherapy has been found to reduce the activity of natural killer cells by 96%8. So if there are tumours growing elsewhere in the body and the immune system helps to control tumour growth, then chemotherapy could make things worse by allowing more rapid growth of other tumours present. However there is little hard evidence from orthodox immunotherapy that the immune system is a major controlling factor. In fact a recent editorial reporting on an immunotherapy conference in Canberra in September 1998 suggests it might be a major factor only in cancers of viral origin9.
On the other hand Immuno-Augmentative Therapy as practised at the IAT Clinic in the Bahamas appears to produce between 15 and 18% 5-year survival with late stage cancer patients10. Similarly the Issels Wholebody Therapy produced 16.6% 5-year survival among late-stage cancer patients11. (Expected 5-year survival for late-stage cancer patients using orthodox therapies is less than 2%.) As these two therapies are based on boosting the immune system using natural methods, it appears that that orthodox immunotherapy and alternative immune-boosting techniques must be completely different.
Increasing mortality
By analysing non-cancer deaths among cancer patients it is clear that orthodox therapies often do more harm than good, a phenomenon that helps explain certain claims of apparently effective treatments. (For example cancer treatment can damage the heart and cause deaths from heart failure. This means fewer deaths from cancer.) As there is little evidence that surgery actually causes harm other than temporarily suppressing the immune system8, it would appear that most of the harm is done by radiotherapy and chemotherapy.
Analysis of the results of records of 1.2 million cancer cases in the US SEER (Surveillance Evaluation & End Results) database showed that non-cancer deaths accounted for 21% of all deaths. These deaths were in excess of the rate expected for such patients. This excess was observed in all types of cancer with an overall figure of 37%. The excess ranged from 9% for breast cancer to 173% for lung cancer12. During the year following diagnosis this excess was about 5 times higher, so it ranged from about 50% for breast cancer to about 800% for lung cancer. The authors attributed this effect to the damage caused by cancer treatment (presumably mainly radiotherapy and chemotherapy).
Decreasing the quality of life
There is no shortage of evidence that chemotherapy usually causes a serious reduction in the quality of life. The only question is whether or not the worsening in the quality of life is justified in view of the very limited claimed increased survival.
What are the opinions of practising oncologists about the efficacy of chemotherapy?
The following are extracts from the Home Page of the Burzynski Research Institute on the World Wide Web13:
"…In an article entitled "Chemotherapy: Snake-Oil Remedy?" that appeared in the Los Angeles Times of 1/9/87, Dr. Martin F. Shapiro explained that while "some oncologists inform their patients of the lack of evidence that treatments work...others may well be misled by scientific papers that express unwarranted optimism about chemotherapy. Still others respond to an economic incentive. Physicians can earn much more money running active chemotherapy practices than they can providing solace and relief.. to dying patients and their families."
"Dr. Shapiro is hardly alone. Alan C. Nixon, PhD, Past President of the American Chemical Society wrote that 'As a chemist trained to interpret data, it is incomprehensible to me that physicians can ignore the clear evidence that chemotherapy does much, much more harm than good'."
In 1986, McGill Cancer Center scientists sent a questionnaire to 118 doctors who treated non-small-cell lung cancer. More than 3/4 of them recruited patients and carried out trials of toxic drugs for lung cancer. They were asked to imagine that they themselves had cancer, and were asked which of six current trials they themselves would choose. 64 of the 79 respondents would not consent to be in a trial containing cisplatin, a common chemotherapy drug. Fifty eight found all the trials unacceptable. Their reason? The ineffectiveness of chemotherapy and its unacceptable degree of toxicity14. "
The more familiar these doctors were with the treatment the less likely they were to accept it for themselves.
Similar findings came from two other studies published in 198715,16.
A study of how expert physicians would wish to be treated for genito-urinary cancer found a similar situation in 198817.
In relation to the treatment of 252 advanced breast cancer patients one author observed that the "risk" of being treated by cytotoxic therapy was three times as high in the terminal stage as in the remainder of the patients18. As Abel points out, this does not point to the use of a therapy that is particularly geared to patients’ wellbeing6.
In March 1989 German biostatistician Dr Ulrich Abel himself investigated physicians’ choices in cancer treatment. He received 150 replies to a questionnaire sent to oncologists and research units around the word, trying to gauge these doctors’ feelings about the use of chemotherapy in advanced carcinoma. He reported that "the personal views of many oncologists seem to be in striking contrast to communications intended for the public"1,6.

"…The failure of chemotherapy to control cancer has become apparent even to the oncology establishment. Scientific American featured a recent cover story entitled: "The War on Cancer -- It's Being Lost." In it, eminent epidemiologist John C. Bailar III, MD, PhD, Chairman of the Department of Epidemiology and Biostatistics at McGill University cited the relentless increase in cancer deaths in the face of growing use of toxic chemotherapy". He concluded that scientists must look in new directions if they are ever to make progress against this unremitting killer. "13
In a 1997 reassessment of the situation Bailar's view had not changed19.
John Cairns, professor of microbiology at Harvard University, published a devastating 1985 critique in Scientific American. "Aside from certain rare cancers, it is not possible to detect any sudden changes in the death rates for any of the major cancers that could be credited to chemotherapy. Whether any of the common cancers can be cured by chemotherapy has yet to be established.13
Why so much use of chemotherapy if it does so little good? Well for one thing, drug companies provide huge economic incentives. In 1990, $3.53 billion was spent on chemotherapy. By 1994 that figure had more than doubled to $7.51 billion. This relentless increase in chemo use was accompanied by a relentless increase in cancer deaths.13
Oncologist Albert Braverman MD wrote in 1991 that "no disseminated neoplasm (cancer) incurable in 1975 is curable today...Many medical oncologists recommend chemotherapy for virtually any tumor, with a hopefulness undiscouraged by almost invariable failure."13
The main problem with chemotherapy is that the general public is generally unaware that in most cases chemotherapy does more harm than good; most doctors knowledgeable in the area know this and will admit it in private. When an oncologist is asked what he or she can do for a patient's cancer it is hard to say - Chemotherapy is unlikely to help you!

REFERENCES
  1. Moss, RW. Questioning Chemotherapy. Equinox Press, New York 1995.
  2. Lilleyman, JS. Childhood leukemia, The facts. OUP, Oxford, 1994.
  3. Enstrom, JE & Austin, DF. Interpreting cancer survival rates. Science 1977; 195: 847-851.
  4. Peto, J & Easton, D. Cancer treatment trials – past failures, current progress and future prospects. Cancer Surv 1989; 8: 513-533.
  5. Benjamin, DJ. The efficacy of surgical treatment of cancer. Medical Hypotheses 1993; 40 (2): 129-138.
  6. Abel, U. Chemotherapy of advanced epithelial cancer: a critical review. Biomedicine & Pharmacotherapy 1992; 46: 439-452.
  7. Bross, ID. NEJM 1994; 331: 809.
  8. Beitsch, P et al. Natural immunity in breast cancer patients during neoadjuvant chemotherapy and after surgery. Surgical Oncology 1994; 3 (4): 211-219.
  9. Goodnow, CC. Editorial. MJA 1998; 169: 570.
  10. Walters, R. Options, The Alternative Cancer Therapy Book, Avery Publishing, New York, 1993.
  11. Issels, J. Immunotherapy in Progressive Metastatic Cancer - A Fifteen-Year Follow-up. Clinical Trials Journal, August 1970: 357-365 with editorial on pp 355-356.
  12. Brown, Barry W et al. Non-cancer deaths in White Adult Cancer Patients. JNCI 1993; 85 (12): 979-987.
  13. Chemotherapy Report, Do we need a new approach to cancer? Burzynski Research Institute Home Page, http://www.cancermed.com/chemo.htm.
  14. McKillop, WJ, et al. The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer. Br J Cancer 1986; 54: 661-667.
  15. Hansen, HH. Advanced non-small-cell lung cancer: To treat or not to treat? J Clin Oncol 1987; 5: 1711-12.
  16. Anonym. Ein gnadenloses Zuviel an Therapie. Teil I. Zweifel an den chemischen Waffen. Der Spiegel, 1987; 26, 128-47.
  17. Moore, MJ, Tannock, IF. How expert physicians would wish to be treated if they developed genito-urinary cancer. Abstract No. 455. Proc. Amer. Soc. Clin. Oncol. 1988; 7: 118.
  18. Holli, K, Hakama, M. Treatment of the terminal stages of breast cancer. BMJ. (Jan 7) 1989); 298(6665):13-14.
  19. Bailar JC & Gornik HL. Cancer Undefeated. NEJM 1997; 336 (22): 1569-1574.
=========================
3. The Efficacy of Cancer Surgery

[This articles shows conclusively that cancer is a systemic (whole-body) diseaseThis is a version of an article that appeared in the magazine Natural Health December 1995 / January 1996 updated in the light of recent developments as of April 2003.]
CISS - The Cancer Information and Support Society, 13/1A Berry Road St Leonards NSW 2065 AUSTRALIA. Phone: +61-2+9906 2189 Website: www.ciss.org.au Email: maxwell@webone.com.au

Introduction
Throughout the Western world the amount of money spent on research and treatment of cancer is about US$400 billion. Of this about half (US$200 billion) is spent in the United States, which works out at about $1000 per capita of population or about $200,000 per cancer patient.
In Australia the figure is about $2 billion or about $100 per capita or about $40,000 per cancer patient.
What I plan to show in this article is firstly that this cancer industry that costs Australians $2 billion dollars every year (and the world $400 billion every year) is based on a treatment – surgery - that doesn't work; that there is no scientifically acceptable evidence that conventional treatment of cancer saves any lives or even produces any significant extension of life except in two situations:
(1) where a tumour is threatening life by obstructing a vital organ like the colon, or pressing on the brain. Clearly in such cases removal or shrinking of such tumours using surgery or radiotherapy can save a life, but it doesn't follow that this affects the course of the disease. Removing a benign growth can also save a life in such circumstances.
(2) there is evidence that chemotherapy can have a significant effect on survival when used in some systemic cancers such as some acute childhood leukemias and some lymphomas and possibly a minor effect on some solid tumours. But these together constitute only about 6% of all cancer cases.
Secondly, that there is evidence that some alternative cancer therapies work.
I believe the reason that orthodox therapies don't work and some alternative therapies do work is because the orthodox theory of what cancer is, is wrong and those alternative therapies that do work are based on a more valid theory or paradigm.
I am defining cancer as those conditions involving tumours that invade surrounding tissue and tend to metastasise; and malignancies in the blood and lymphatic systems. This therefore excludes most so-called skin cancers apart from melanomas. Strictly speaking it also excludes the carcinoma-in-situ (CIS) since these are not invasive.

Theories of cancer
There are many theories about what cancer is, but most of these fall into two main schools of thought or paradigms. These are as follows:
The current paradigm in orthodox circles is that cancer is a localised disease when first detected. If detected too late it can spread to regional lymph nodes and also possibly to remote sites (metastases), at which stage the cancer has become incurable or inoperable. It can also recur in another nearby site but is then sometimes referred to as a new primary cancer.
The alternative paradigm sees cancer as a systemic disease caused by the breakdown of many bodily functions including metabolic, endocrine and immune processes. During its later stages tumours appear in one location and later in others. This theory does not rely on the process of spreading or metastasising. In the same way recurrences are not new cancers but fresh symptoms of the same cancer.
One way of testing the two hypotheses or paradigms is to measure the efficacy of the treatments based on the respective theories.

Efficacy of treatment
I am defining an effective treatment as one that alters the course of the disease, as demonstrated either by significantly improved survival or reduced mortality.
Measuring Efficacy
There are four different ways of demonstrating efficacy of a cancer treatment:
1. Anecdotal information - These are accounts of individual cases. Usually there are several different treatments being used at the same time. It is therefore not possible to separate the effects of these different treatments. Not very useful except as a guide for further research. Not acceptable scientifically.
2. Survival Rates - Usually the percentage of patients alive five years after diagnosis is quoted. These are only useful if it can be shown that the rate has improved in a group of patients when compared with a similar group matched with regard to age, gender and stage of tumour at the time of diagnosis who received the same treatment in the past. Very questionable because many factors other than treatment can affect survival figures. For example earlier diagnosis following screening starts the survival clock earlier. A patient can still die at the same time but appear to have lived longer. This is the usual basis for justifying orthodox therapies such as surgery.
3. Tumour response trials - Usually effective means a 50% reduction in tumour size. This assumes the tumour is the disease. If this assumption is wrong and the tumour is only a symptom of a systemic disease, the symptom can be destroyed or shrunk without affecting the disease or survival. Wrong conclusions are usually drawn from the results of such trials.
4. Randomised Trials - The basic principle of all randomised trials is that you start with two identical groups, a study group and a control group. You add one treatment in the study group and compare the results of the two groups. If the survival in the study group is better, or the mortality rate is lower, it is valid to conclude that the treatment that was used or added in the study group caused the improvement. This is the only reliable method of demonstrating that a treatment is effective.
I first investigated the evidence that surgery had affected survival or mortality as shown in randomised trials.
The Efficacy of Surgery
I found that no randomised trial has ever been held to demonstrate the efficacy of surgery1,2,3.
Since proper randomised clinical trials have never been carried out to prove the efficacy of surgical treatment of cancer, what other scientific methods can be used to throw some light on the impact of surgery on cancer?
I looked at the results of using six different methods:
1. Graphical method
2. Comparative Studies
3. Epidemiological Studies
4. Long-term follow-up of treated patients
5. Randomised mixed treatment trials
6. Comparison Of Incidence and Mortality
The Graphical Method
This is based on the fact that from birth to death populations die at an increasing mortality rate, the rate doubling about every 8.5 years, a so-called exponential curve. When plotted on special (log-linear) graph paper these curves become straight lines. People with cancer, and other degenerative diseases, have a higher mortality rate for their age, but their mortality still continues to double every 8.5 years. It is as if getting cancer has aged these people by about 15 years. If people are successfully treated for these diseases these sub-populations drop back onto lower (healthier) mortality rate curves. There is no evidence that surgical treatment for any type of cancer produces this mortality lowering effect.
Comparative Surgery Studies
By comparing the survival or mortality of different groups of cancer patients who have undergone different amounts of surgery it is possible to evaluate the efficacy of surgery itself. According to the orthodox rationale for cancer surgery it is important to remove all malignant cells; otherwise the remaining cells will continue to grow and maybe spread. Therefore the more extensive the surgery, the less the likelihood of any malignant cells remaining and the lower the mortality rate should be. If this rationale is wrong, and tumours are only local, late?stage symptoms of a systemic disease, there would be no difference in survival or mortality between groups receiving different amounts of surgery.
Several randomised clinical trials have been carried out to compare the survival of breast cancer patients after different amounts of surgery. No difference in survival was observed between women who had received radical mastectomy, total (simple) mastectomy, quadrantectomy, segmental mastectomy (lumpectomy) and excisional biopsy4.
The results of these comparative trials therefore suggest that surgery has no impact on the course of the cancer because it is a systemic disease.
Epidemiological Studies
There are claims that there is some evidence from epidemiological studies that surgery may be effective for invasive cervical tumours. For example, the decline in mortality from cervical cancer that has been observed in many countries throughout the world is attributed to the introduction of PAP smear programs, when it can be assumed that more women were diagnosed early with, and therefore treated for, invasive cervical cancer.
However there are counter claims that this decline began in the late 1930s, over 20 years prior to the introduction of the PAP smear. There is no observed acceleration of this decline after the introduction of the Pap test on a widespread basis5.
Long-term Follow-up of Treated Patients
Long-term follow-up of breast cancer patients (30-40 years) by medical researchers has failed to identify any group of patients with evidence of cure. They found that the mortality rate for the longest surviving breast cancer patients was at least twice that of healthy women the same age. They therefore concluded that breast cancer is incurable6,7.
Randomised Mixed Treatment Trials
Other evidence that breast cancer is incurable has come from randomised treatment trials over the years where radiotherapy or chemotherapy has been added to surgery. For example James Devitt when delivering the opening address at the Lancet Conference "The Challenge of Breast Cancer" in April 1994 summarised the situation as follows:
"..Amputating, irradiating or ignoring involved lymph-nodes does not affect survival. Preventing local recurrence after mastectomy by radiotherapy does not affect survival. The reappearance of cancer in the breast after conservative surgery does not worsen survival. Failing to find some breast cancers and finding others later does not prejudice outcome...Perhaps the breast lesion is not the cause of the disease but merely the local expression resulting from a combination of changes in both local organ-tissue and systemic growth-restraining training factors"8,9.
Comparison Of Incidence and Mortality
If, as the above evidence suggests, surgery is ineffective, what is the explanation for the apparent improvement in the percentage five year survival rates for all cancer sites between 1960 and 1975 as claimed by the American Cancer Society?10
Two possible explanations have been offered:
(1) These figures are unreliable for reasons of poor methodology.
(2) Earlier figures with lower survival applied when more aggressive treatments were being used and were reducing survival.
The main example of poor methodology is that related to the increased percentage five year survival rates. This increase can result from death happening later - This would be real progress. It can also result from making an earlier diagnosis, as has happened in more recent times for most types of cancer - There is no progress here. Death still occurs at the same time but the existence of the cancer has been known for a longer time, leading to an "apparent" increase in survival.
Other factors include comparison between unmatched groups. For reasons such as these epidemiologists have concluded that "survival rates should not be used as a sole or primary measure of progress in cancer control because factors unrelated to the efficacy of treatment play an important role in the determination of those rates and their trends"11.
Whatever the reason, survival figures are unreliable as a measure of the efficacy of surgery as a treatment for cancer.
Epidemiologists state that a better measure of progress in cancer treatment is to compare the incidence of each type of cancer with the mortality rate over the time interval in question. For, so long as incidence and mortality remain unchanged, or change proportionately, no genuine change in survival can occur. Progress in cancer control requires that the mortality rate decline more rapidly or rise more slowly than the incidence for the particular type of cancer11.
If incidence is compared with mortality over the period from 1950 to 1970 it is found that there have been large changes in incidence and mortality over this time with several types of cancer but none of the mortality rate changes satisfy this requirement. So there are no clear cases where survival could have improved as a result of surgery. The US General Accounting Office has confirmed that claims of increased survival have been overstated12. This is further evidence that surgery has not had a proven impact on the course of cancer.
The Efficacy of Mammograms and Earlier Surgical Intervention for Breast Cancer
Another example of poor methodology is the group of randomised breast cancer screening trials. It has been claimed that breast cancer screening saves lives, as shown by results of several randomised breast cancer screening trials carried out in the US, UK and Sweden. It is argued that earlier diagnosis following screening enables earlier surgical intervention before the cancer has spread.
I identified a common flaw in the design of these trials. There were at least five factors, other than earlier surgical intervention, that differed between the study and control groups that could have affected the results. I confined my analysis to radiotherapy.
I found that the trial with the most earlier surgery in the study group saved the least number of lives; and the trial with the least earlier surgery saved the most lives. So earlier surgery could not have saved any lives.
Radiotherapy has been shown to reduce survival and increase mortality with breast cancer. It does this by suppressing the immune system and damaging the heart13,14. So I investigated its possible effects in these trials.
I found that all of the apparent saving of lives could be explained either by less radiotherapy being used in the study group; or more radiotherapy being used damaging the heart and causing deaths due to heart or respiratory failure instead of deaths due to breast cancer, thus reducing the deaths from breast cancer. Thus the reduction in deaths from breast cancer was accompanied by an equal increase in deaths from other causes, with no overall benefit.
The observed reduction in the mortality of breast cancer patients following mammograms can therefore be explained by poor methodology, not earlier surgical intervention as claimed15.
A more recent review of these mammography trials has confirmed my conclusion that mammography has not been shown to save any lives16.
The Efficacy of the PSA Test and Early Intervention for Prostate Cancer
A recent paper reported on the result of a randomised trial comparing Radical Prostatectomy with Watchful Waiting for prostate cancer. It also contained serious flaws. For example it used an ambiguous definition of “death from prostate cancer” and claimed a 50% reduction in mortality using surgery as compared with watchful waiting. The reduction in overall mortality was not significant17. An analysis of the deaths from other causes showed that most of the apparent reduction in deaths from prostate cancer can be explained by wrong attribution of deaths from prostate cancer to deaths from other causes in the treated group or deaths from other causes attributed to prostate cancer deaths in the watchful waiting group.
Similarly a paper reporting on results of a randomised trials comparing mortality after PSA screening with an unscreened control group also contained serious flaws. Although its authors claimed a 69% reduction of deaths as a result of screening18 they arrived at this figure by comparing only 23% of those invited for screening in the Invited group with 93.5% of those in the Uninvited group, a meaningless comparison in randomised trials. In a second analysis they combined part of the Invited group with part of the Uninvited group and compared their mortality with that of a different group made up from combining another part of the Invited group with a part of the Uninvited group, another meaningless comparison. When the whole Invited group was compared with the whole Uninvited group the difference in mortality was not significant.
An even more serious flaw was that they completely ignored the deaths from other causes.
The Efficacy of Radiotherapy
The reason for the damage caused by the radiotherapy mentioned above was that, up until the end of the 1960s, the radiation doses were very high. Later as the damage being caused became apparent the doses were significantly reduced (by factors of more than a hundred). This became possible with more modern technology. However some damage still occurs with the more modern techniques14.
In recent years randomised trials evaluating conservative breast cancer management (lumpectomy plus radiotherapy) have shown a significant reduction of recurrence of breast cancer. (Recurrence refers to another tumour growing nearby.) This has led to claims that radiotherapy is effective because it reduces recurrence. However these claims are invalid because no effect was observed on overall survival19. As mentioned before, these false claims arise from a wrong assumption. When there is no link between reduced recurrence and increased survival this shows that the presence or absence of a tumour is not a reliable indication of the presence or absence of cancer. In other words cancer is a systemic disease unaffected by tumour removal.
From these trials I concluded that radiotherapy is not effective in reducing deaths from breast cancer. I have also found that other randomised trials carried out to evaluate radiotherapy for other forms of cancer, such as colon cancer have produced the same results. Post-operative radiotherapy (PORT) for lung cancer has been found to increase the mortality from cancer.
The Efficacy of Chemotherapy
When I started investigating chemotherapy I found this had already been done. Ulrich Abel, a biostatistician at the Institute of Epidemiology and Biometry of the University of Heidelberg, Germany carried out a comprehensive analysis of the efficacy of chemotherapy in prolonging survival in advanced epithelial cancer (i.e. solid tumours). He concluded that there was little proof of efficacy20.
In the one case where increased survival was demonstrated with randomised trials, small-cell lung cancer, the gain in survival was measured in weeks or months. The treatment was still questionable because this small extension of life was hard to justify in view of the serious side effects and reduction in quality of life.
Ralph Moss, who has also questioned the efficacy of chemotherapy21, found that the assumption that the tumour is the disease had led to wrong conclusions being drawn from the efficacy trials. Where a trial showed that there was more tumour shrinkage in the study group than in the control group the treatment was claimed to be effective, even though there was usually no improvement in survival. As with radiotherapy the term "disease-free survival" was also used to describe a part of the study group who had an improved survival when compared with those in the control group. Such comparisons are invalid. Whenever the entire study group was compared with the control group no improved survival was observed.
Although no randomised trials have been carried out to test the efficacy of chemotherapy with some acute childhood leukemias, the increased percentage ten-year survival figures (from less than 10% in the 1950s to about 60% in the 1980s22) is sufficiently large for these claims of efficacy to be accepted, although some of this apparent improvement is probably due to poor methodology described above. A similar but much smaller increase has been observed over time with some lymphomas.
Thus in most trials evaluating the efficacy of orthodox therapies a wrong assumption has been made about what cancer is; then a false conclusion has been drawn from the results obtained, usually with the help of poor methodology.
Epidemilogists Peto and Easton state that in the many situations where it is not known whether treatment is effective, "many clinicians respond by developing a set of firmly held but unsupported beliefs in the merits of particular regimens. The primary treatment of advanced non?metastatic laryngeal cancer, for example, will usually be by surgery at certain treatment centres and by radiotherapy at others. Whether chemotherapy is given as well and, if so, what form it will take, are also determined more by the idiosyncrasies and outpatient arrangements of the particular treatment centre than by objective evidence of long?term efficacy. Similar examples could be taken from most areas of cancer therapy"23.
Comparison of Survival After Treatments Based On Different Hypotheses
The best five year survival statistics have been produced using therapies based on the hypothesis that cancer is a systemic disease, and tumours are only local symptoms. Therefore the cancer patient should be treated using a therapy designed to restore the body's own natural healing mechanisms.
After undergoing such a therapy "terminal" cancer patients showed a 16.6% five year survival compared with less than 5% expected with conventional therapies and a 15% fifteen year survival compared with less than 1%. With pre-terminal patients there was an 85% five year survival compared with about 50%24.
Similarly a therapy designed to augment the body's own immune system is reported to have produced 50% five year survival with 11 cases of peritoneal mesothelioma, a malignancy with an expected prognosis of about 12 months25.
A third example is psychotherapy. A randomised study of 86 patients with metastatic breast cancer showed that a 90-minute weekly supportive group therapy session resulted in a doubling of survival from 19 months to 37 months26.
Two other randomized trials of structured psychotherapy have produced similar dramatic improvements in survival27,28.
These are further evidence that cancer is a systemic disease.

Conclusion
It is therefore clear that the claims that surgery, radiotherapy and chemotherapy are effective are invalid for most types of cancer. Yet dozens of trials, including some randomised ones, have been carried out that result in claims that these therapies are effective and save lives.
Can it be that all the scientific papers reporting on these results are scientifically unsound? Is medical science so badly organised that most of the results of their clinical trials are invalid?
To answer this question I quote from an editorial in the British Medical Journal in October 1991 - "Where is the Wisdom...? The poverty of medical evidence"
"…only about 15% of medical interventions are supported by solid scientific evidence… ...This is partly because only 1% of the articles in medical journals are scientifically sound29".
For cancer the figure is about 6%, not 15%.
How is it that the peer review system, that determines which scientific papers are of sufficient quality to warrant publication, lets all these unsound papers through? To answer this question I quote from Tom Jefferson, from the Cochrane Collaboration’s Methods Group interviewed by the Guardian (UK) in January this year. He said:
“If peer review were a medicine it would never get a licence…We had great difficulty in finding any real hard evidence of the system’s effectiveness, which is disappointing, as peer review is the cornerstone of editorial policies worldwide”30.
I therefore I believe I have proved my case.
-------

REFERENCES
18. Labrie F et al. Screening decreases prostate cancer death: first analysis of the 1988 Quebec Prospective Randomized Controlled Trial. Prostate 1999; 38: 83-91. Comment by Rob Boer and F Schröder. Quebec Randomized Controlled Trial on Prostate Cancer Screening Shows No Evidence for Mortality Reduction. The Prostate 1999; 40: 130-131; and Freda Alexander and Robin Prescott. Reply to Labrie et al. The Prostate 1999; 40: 135-136.
====================================
An Assessment of Orthodox Treatments of Cancer
By Don Benjamin
CISS - The Cancer Information and Support Society, 13/1A Berry Road St Leonards NSW 2065 AUSTRALIA. Phone: +61-2+9906 2189  Website: www.ciss.org.au   Email: maxwell@webone.com.au

This is a version of an article that appeared in the magazine Natural Health December 1995 / January 1996 updated in the light of recent developments as of April 2003.

  • Introduction
  • Theories of cancer
  • Efficacy of treatment
  • Measuring Efficacy
  • The Efficacy of Surgery
  • 1. Graphical method
  • 2. Comparative Studies
  • 3. Epidemiological Studies
  • 4. Long-term follow-up of treated patients
  • 5. Randomised mixed treatment trials
  • 6. Comparison Of Incidence and Mortality
  • The Efficacy of Mammograms and Earlier Surgical Intervention for Breast Cancer
  • The Efficacy of the PSA Test and Early Intervention for Prostate Cancer
  • The Efficacy of Radiotherapy
  • The Efficacy of Chemotherapy
  • Comparison of Survival After Treatments Based On Different Hypotheses
  • Conclusion




Throughout the Western world the amount of money spent on research and treatment of cancer is about US$400 billion.  Of this about half (US$200 billion) is spent in the United States, which works out at about $1000 per capita of population or about $200,000 per cancer patient.

In Australia the figure is about $2 billion or about $100 per capita or about $40,000 per cancer patient.

What I plan to show in this article is firstly that this cancer industry that costs Australians $2 billion dollars every year (and the world $400 billion every year) is based on a treatment – surgery - that doesn't work; that there is no scientifically acceptable evidence that conventional treatment of cancer saves any lives or even produces any significant extension of life except in two situations:

(1)  where a tumour is threatening life by obstructing a vital organ like the colon, or pressing on the brain.  Clearly in such cases removal or shrinking of such tumours using surgery or radiotherapy can save a life, but it doesn't follow that this affects the course of the disease.  Removing a benign growth can also save a life in such circumstances.
(2)  there is evidence that chemotherapy can have a significant effect on survival when used in some systemic cancers such as some acute childhood leukemias and some lymphomas and possibly a minor effect on some solid tumours.  But these together constitute only about 6% of all cancer cases.

Secondly, that there is evidence that some alternative cancer therapies work.

I believe the reason that orthodox therapies don't work and some alternative therapies do work is because the orthodox theory of what cancer is, is wrong and those alternative therapies that do work are based on a more valid theory or paradigm.

I am defining cancer as those conditions involving tumours that invade surrounding tissue and tend to metastasise; and malignancies in the blood and lymphatic systems.  This therefore excludes most so-called skin cancers apart from melanomas. Strictly speaking it also excludes the carcinoma-in-situ (CIS) since these are not invasive.

Theories of cancer


There are many theories about what cancer is, but most of these fall into two main schools of thought or paradigms.  These are as follows:

The current paradigm in orthodox circles is that cancer is a localised disease when first detected.  If detected too late it can spread to regional lymph nodes and also possibly to remote sites (metastases), at which stage the cancer has become incurable or inoperable.  It can also recur in another nearby site but is then sometimes referred to as a new primary cancer.

The alternative paradigm sees cancer as a systemic disease caused by the breakdown of many bodily functions including metabolic, endocrine and immune processes.  During its later stages tumours appear in one location and later in others.  This theory does not rely on the process of spreading or metastasising.  In the same way recurrences are not new cancers but fresh symptoms of the same cancer.

One way of testing the two hypotheses or paradigms is to measure the efficacy of the treatments based on the respective theories.

Efficacy of treatment


I am defining an effective treatment as one that alters the course of the disease, as demonstrated either by significantly improved survival or reduced mortality.

Measuring Efficacy


There are four different ways of demonstrating efficacy of a cancer treatment:

1.  Anecdotal information - These are  accounts of  individual cases.  Usually there are several different treatments being used at the same time.  It is therefore not possible to separate the effects of these different treatments. Not very useful except as a guide for further research.  Not acceptable scientifically.

2. Survival Rates - Usually the percentage of patients alive five years after diagnosis is quoted.  These are only useful if it can be shown that the rate has improved in a group of patients when compared with a similar group matched with regard to age, gender and stage of tumour at the time of diagnosis who received the same treatment in the past. Very questionable because many factors other than treatment can affect survival figures.  For example earlier diagnosis following screening starts the survival clock earlier.  A patient can still die at the same time but appear to have lived longer. This is the usual basis for justifying orthodox therapies such as surgery.

3.  Tumour response trials - Usually effective means a 50% reduction in tumour size.  This assumes the tumour is the disease.  If this assumption is wrong and the tumour is only a symptom  of a systemic disease, the symptom can be destroyed or shrunk without affecting the disease or survival.  Wrong conclusions are usually drawn from the results of such trials.

4.  Randomised Trials - The basic principle of all randomised trials is that           you start with two identical groups, a study group and a control group.  You add one treatment in the study group and compare the results of the two groups.  If the survival in the study group is better, or the mortality rate is lower, it is valid to conclude that the treatment that was used or added in the study group caused the improvement.  This is the only reliable method of demonstrating that a treatment is effective.

I first investigated the evidence that surgery had affected survival or mortality as shown in randomised trials.

The Efficacy of Surgery


I found that no randomised trial has ever been held to demonstrate the efficacy of surgery1,2,3.

Since proper randomised clinical trials have never been carried out to prove the efficacy of surgical treatment of cancer, what other scientific methods can be used to throw some light on the impact of surgery on cancer?

I looked at the results of using six different methods:

1. Graphical method
2. Comparative Studies
3. Epidemiological Studies
4. Long-term follow-up of treated patients
5. Randomised mixed treatment trials
6. Comparison Of Incidence and Mortality

The Graphical Method


This is based on the fact that from birth to death populations die at an increasing mortality rate, the rate doubling about every 8.5 years, a so-called exponential curve.  When plotted on special (log-linear) graph paper these curves become straight lines.  People with cancer, and other degenerative diseases, have a higher mortality rate for their age, but their mortality still continues to double every 8.5 years. It is as if getting cancer has aged these people by about 15 years. If people are successfully treated for these diseases these sub-populations drop back onto lower (healthier) mortality rate curves.  There is no evidence that surgical treatment for any type of cancer produces this mortality lowering effect.

Comparative Surgery Studies


By comparing the survival or mortality of different groups of cancer patients who have undergone different amounts of surgery it is possible to evaluate the efficacy of surgery itself. According to the orthodox rationale for cancer surgery it is important to remove all malignant cells; otherwise the remaining cells will continue to grow and maybe spread.  Therefore the more extensive the surgery, the less the likelihood of any malignant cells remaining and the lower the mortality rate should be.  If this rationale is wrong, and tumours are only local, late‑stage symptoms of a systemic disease, there would be no difference in survival or mortality between groups receiving different amounts of surgery.

Several randomised clinical trials have been carried out to compare the survival of breast cancer patients after different amounts of surgery.  No difference in survival was observed between women who had received radical mastectomy, total (simple) mastectomy, quadrantectomy, segmental mastectomy (lumpectomy) and excisional biopsy4.

The results of these comparative trials therefore suggest that surgery has no impact on the course of the cancer because it is a systemic disease.

Epidemiological Studies


There are claims that there is some evidence from epidemiological studies that surgery may be effective for invasive cervical tumours.  For example, the decline in mortality from cervical cancer that has been observed in many countries throughout the world is attributed to the introduction of PAP smear programs, when it can be assumed that more women were diagnosed early with, and therefore treated for, invasive cervical cancer.

However there are counter claims that this decline began in the late 1930s, over 20 years prior to the introduction of the PAP smear.  There is no observed acceleration of this decline after the introduction of the Pap test on a widespread basis5.

Long-term Follow-up of Treated Patients


Long-term follow-up of breast cancer patients (30-40 years) by medical researchers has failed to identify any group of patients with evidence of cure.  They found that the mortality rate for the longest surviving breast cancer patients was at least twice that of healthy women the same age.  They therefore concluded that breast cancer is incurable6,7.

Randomised Mixed Treatment Trials


Other evidence that breast cancer is incurable has come from randomised treatment trials over the years where radiotherapy or chemotherapy has been added to surgery.  For example James Devitt when delivering the opening address at the Lancet Conference "The Challenge of Breast Cancer" in April 1994 summarised the situation as follows:
"..Amputating, irradiating or ignoring involved lymph-nodes does not affect survival. Preventing local recurrence after mastectomy by radiotherapy does not affect survival.  The reappearance of cancer in the breast after conservative surgery does not worsen survival.  Failing to find some breast cancers and finding others later does not prejudice outcome...Perhaps the breast lesion is not the cause of the disease but merely the local expression resulting from a combination of changes in both local organ-tissue and systemic growth-restraining training factors"8,9.

Comparison Of Incidence and Mortality


If, as the above evidence suggests, surgery is ineffective, what is the explanation for the apparent improvement in the percentage five‑year survival rates for all cancer sites between 1960 and 1975 as claimed by the American Cancer Society?10

Two possible explanations have been offered:

(1)   These figures are unreliable for reasons of poor methodology.
(2)   Earlier figures with lower survival applied when more aggressive treatments were being used and were reducing survival.

The main example of poor methodology is that related to the increased percentage five‑year survival rates.  This increase can result from death happening later - This would be real progress.  It can also result from making an earlier diagnosis, as has happened in more recent times for most types of cancer - There is no progress here.  Death still occurs at the same time but the existence of the cancer has been known for a longer time, leading to an "apparent" increase in survival.

Other factors include comparison between unmatched groups.  For reasons such as these epidemiologists have concluded that "survival rates should not be used as a sole or primary measure of progress in cancer control because factors unrelated to the efficacy of treatment play an important role in the determination of those rates and their trends"11.

Whatever the reason, survival figures are unreliable as a measure of the efficacy of surgery as a treatment for cancer.

Epidemiologists state that a better measure of progress in cancer treatment is to compare the incidence of each type of cancer with the mortality rate over the time interval in question.  For, so long as incidence and mortality remain unchanged, or change proportionately, no genuine change in survival can occur.  Progress in cancer control requires that the mortality rate decline more rapidly or rise more slowly than the incidence for the particular type of cancer11.

If incidence is compared with mortality over the period from 1950 to 1970 it is found that there have been large changes in incidence and mortality over this time with several types of cancer but none of the mortality rate changes satisfy this requirement.  So there are no clear cases where survival could have improved as a result of surgery.  The US General Accounting Office has confirmed that claims of increased survival have been overstated12. This is further evidence that surgery has not had a proven impact on the course of cancer. 

The Efficacy of Mammograms and Earlier Surgical Intervention for Breast Cancer


Another example of poor methodology is the group of randomised breast cancer screening trials. It has been claimed that breast cancer screening saves lives, as shown by results of several randomised breast cancer screening trials carried out in the US, UK and Sweden.  It is argued that earlier diagnosis following screening enables earlier surgical intervention before the cancer has spread. 

I identified a common flaw in the design of these trials.  There were at least five factors, other than earlier surgical intervention, that differed between the study and control groups that could have affected the results.  I confined my analysis to radiotherapy.

I found that the trial with the most earlier surgery in the study group saved the least number of lives; and the trial with the least earlier surgery saved the most lives.  So earlier surgery could not have saved any lives.

Radiotherapy has been shown to reduce survival and increase mortality with breast cancer.  It does this by suppressing the immune system and damaging the heart13,14.  So I investigated its possible effects in these trials.

I found that all of the apparent saving of lives could be explained either by less radiotherapy being used in the study group; or more radiotherapy being used damaging the heart and causing deaths due to heart or respiratory failure instead of deaths due to breast cancer, thus reducing the deaths from breast cancer.  Thus the reduction in deaths from breast cancer was accompanied by an equal increase in deaths from other causes, with no overall benefit.

The observed reduction in the mortality of breast cancer patients following mammograms can therefore be explained by poor methodology, not earlier surgical intervention as claimed15.
A more recent review of these mammography trials has confirmed my conclusion that mammography has not been shown to save any lives16.


A recent paper reported on the result of a randomised trial comparing Radical Prostatectomy with Watchful Waiting  for prostate cancer. It also contained serious flaws.  For example it used an ambiguous definition of “death from prostate cancer” and claimed a 50% reduction in mortality using surgery as compared with watchful waiting. The reduction in overall mortality was not significant17.  An analysis of the deaths from other causes showed that most of the apparent reduction in deaths from prostate cancer can be explained by wrong attribution of deaths from prostate cancer to deaths from other causes in the treated group or deaths from other causes attributed to prostate cancer deaths in the watchful waiting group.

Similarly a paper reporting on results of a randomised trials comparing mortality after PSA screening with an unscreened control group also contained serious flaws.  Although its authors claimed a 69% reduction of deaths as a result of screening18 they arrived at this figure by comparing only 23% of those invited for screening in the Invited group with 93.5% of those in the Uninvited group, a meaningless comparison in randomised trials.  In a second analysis they combined part of the Invited group with part of the Uninvited group and compared their mortality with that of a different group made up from combining another part of the Invited group with a part of the Uninvited group, another meaningless comparison. When the whole Invited group was compared with the whole Uninvited group the difference in mortality was not significant.

An even more serious flaw was that they completely ignored the deaths from other causes.

The Efficacy of Radiotherapy


The reason for the damage caused by the radiotherapy mentioned above was that, up until the end of the 1960s, the radiation doses were very high.  Later as the damage being caused became apparent the doses were significantly reduced (by factors of more than a hundred).  This became possible with more modern technology.  However some damage still occurs with the more modern techniques14.

In recent years randomised trials evaluating conservative breast cancer management  (lumpectomy plus radiotherapy) have shown a significant reduction of recurrence of breast cancer.  (Recurrence refers to another tumour growing nearby.)  This has led to claims that radiotherapy is effective because it reduces recurrence.  However these claims are invalid because no effect was observed on overall survival19.  As mentioned before, these false claims arise from a wrong assumption.  When there is no link between reduced recurrence and increased survival this shows that the presence or absence of a tumour is not a reliable indication of the presence or absence of cancer.  In other words cancer is a systemic disease unaffected by tumour removal.

From these trials I concluded that radiotherapy is not effective in reducing deaths from breast cancer.  I have also found that other randomised trials carried out to evaluate radiotherapy for other forms of cancer, such as colon cancer have produced the same results.  Post-operative radiotherapy (PORT) for lung cancer has been found to increase the mortality from cancer.

The Efficacy of Chemotherapy


When I started investigating chemotherapy I found this had already been done.  Ulrich Abel, a biostatistician at the Institute of Epidemiology and Biometry of the University of Heidelberg, Germany carried out a comprehensive analysis of the efficacy of chemotherapy in prolonging survival in advanced epithelial cancer (i.e. solid tumours).  He concluded that there was little proof of efficacy20

In the one case where increased survival was demonstrated with randomised trials, small-cell lung cancer, the gain in survival was measured in weeks or months.  The treatment was still questionable because this small extension of life was hard to justify in view of the serious side effects and reduction in quality of life.

Ralph Moss, who has also questioned the efficacy of chemotherapy21, found that the assumption that the tumour is the disease had led to wrong conclusions being drawn from the efficacy trials.  Where a trial showed that there was more tumour shrinkage in the study group than in the control group the treatment was claimed to be effective, even though there was usually no improvement in survival.  As with radiotherapy the term "disease-free survival" was also used to describe a part of the study group who had an improved survival when compared with those in the control group.  Such comparisons are invalid.  Whenever the entire study group was compared with the control group no improved survival was observed.

Although no randomised trials have been carried out to test the efficacy of chemotherapy with some acute childhood leukemias, the increased percentage ten-year survival figures (from less than 10% in the 1950s to about 60% in the 1980s22) is sufficiently large for these claims of efficacy to be accepted, although some of this apparent improvement is probably due to poor methodology described above. A similar but much smaller increase has been observed over time with some lymphomas.

Thus in most trials evaluating the efficacy of orthodox therapies a wrong assumption has been made about what cancer is; then a false conclusion has been drawn from the results obtained, usually with the help of poor methodology.

Epidemilogists Peto and Easton state that in the many situations where it is not known whether treatment is effective, "many clinicians respond by developing a set of firmly held but unsupported beliefs in the merits of particular regimens.  The primary treatment of advanced non‑metastatic laryngeal cancer, for example, will usually be by surgery at certain treatment centres and by radiotherapy at others.  Whether chemotherapy is given as well and, if so, what form it will take, are also determined more by the idiosyncrasies and outpatient  arrangements of the particular treatment centre than by objective evidence of long‑term efficacy.  Similar examples could be taken from most areas of cancer therapy"23.

Comparison of Survival After Treatments Based On Different Hypotheses


The best five‑year survival statistics have been produced using therapies based on the hypothesis that cancer is a systemic disease, and tumours are only local symptoms.  Therefore the cancer patient should be treated using a therapy designed to restore the body's own natural healing mechanisms. 

After undergoing such a therapy "terminal" cancer patients showed a 16.6% five‑year survival compared with less than 5% expected with conventional therapies and a 15% fifteen‑year survival compared with less than 1%.  With pre‑terminal patients there was an 85% five‑year survival compared with about 50%24

Similarly a therapy designed to augment the body's own immune system is reported to have produced 50% five‑year survival with 11 cases of peritoneal mesothelioma, a malignancy with an expected prognosis of about 12 months25.

A third example is psychotherapy. A randomised study of 86 patients with metastatic breast cancer showed that a 90-minute weekly supportive group therapy session resulted in a doubling of survival from 19 months to 37 months26.

Two other randomized trials of structured psychotherapy have produced similar dramatic improvements in survival27,28.

These are further evidence that cancer is a systemic disease.

Conclusion


It is therefore clear that the claims that surgery, radiotherapy and chemotherapy are effective are invalid for most types of cancer.  Yet dozens of trials, including some randomised ones, have been carried out that result in claims that these therapies are effective and save lives. 

Can it be that all the scientific papers reporting on these results are scientifically unsound?  Is medical science so badly organised that most of the results of their clinical trials are invalid?

To answer this question I quote from an editorial in the British Medical Journal in October 1991 - "Where is the Wisdom...? The poverty of medical evidence"
"…only about 15% of medical interventions are supported by solid scientific evidence… ...This is partly because only 1% of the articles in medical journals are scientifically sound29".

For cancer the figure is about 6%, not 15%.

How is it that the peer review system, that determines which scientific papers are of sufficient quality to warrant publication, lets all these unsound papers through? To answer this question I quote from Tom Jefferson, from the Cochrane Collaboration’s Methods Group interviewed by the Guardian (UK) in January this year. He said:

“If peer review were a medicine it would never get a licence…We had great difficulty in finding any real hard evidence of the system’s effectiveness, which is disappointing, as peer review is the cornerstone of editorial policies worldwide”30.

I therefore I believe I have proved my case.

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