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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
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 organized 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 license…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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