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The Darwin Principle for Integrated Trials
Majid Ali,
M.D.
In Darwin, Dysox, and Disease
(2006), I introduced the term Darwin Principle in
medicine for a principle by which simple conclusions
are drawn from extended and integrated study of a
large body of clinical and laboratory observations.
This principle accepts the validity of each clinical
and scientific observation concerning any part
of the whole but holds that none of them singly
be accepted as the definitive evidence of any
conclusion about the condition of the whole. The
core tenet of the Darwin Principle is: No part can
be understood except through an understanding of its
relationships with the whole. I consider the Darwin
Principle of crucial importance for both
understanding the molecular biology of diseases, as
well as for designing rational and scientifically
sound treatment plans for them.
In 1831, Charles Robert Darwin
(1809-1882), started his journey aboard the British
Navy ship H.M.S. Beagle around South America.
Over a period of five years, he accumulated an
enormous number of biologic and geologic samples,
studied them intensively, reflected on the
interconnectedness of all of them, and formed his
simple — yet comprehensive— biological theory of
natural selection. In 1850, he published On the
Origin of Species which, in my view, is the most
significant work in biologic sciences. For
individuals interested in the control of cancer,
Darwin's core message is this: No aspect of cancer
can be understood except through an understanding of
its relationships with the whole. Translation: No
treatment plans for cancer which do not address
nutritional, environmental, and anger-related issues
can be considered scientific.
The clinical application of the
Darwin Principle calls for clinical trials which are
radically different from the model of blinded and
controlled trials that test single drugs at a time.
The clinical trials based on the Darwin Principle
must be designed to address the macro furies (toxic
thoughts, toxic environment, and toxic foods), as
well as the three micro furies (oxidosis, acidosis,
and dysoxgenosis) of disease. Such investigations
can be conducted only as open, integrated trials in
which teams of experienced clinicians enter a
sizeable number of individuals with well-defined
clinicopathologic entities into trials and then are
free to address all macro and micro issues on basis
of the needs of individual patients. The
trial outcome is determined by evaluation of the
results by patients as well as clinicians
employing objective and subjective criteria. The
integrity of an outcome is assured by ensuring that:
(1) a sufficiently large number of clinicians
participate in the trial who categorically
have no financial interest in the outcome; (2) all
trials test—then validate or refute—integrative
management plans for all patients treated at
the center at which those trials are conducted; and
(3) all integrative trials are carried out for
sufficiently extended periods of study so that the
conclusions drawn from the data truly represent
long-term results of the trial. In Darwin,
Dysox, and Disease (2006), I present a
compendium of my philosophic discussion of the
Darwin Principle and the results of several
long-term clinical outcome studies designed and
conducted following the Darwin Principle.
The matter of patients
deciding the efficacy of treatment is likely to
raise some eyebrows. We have raised generations of
doctors who think no clinical trials must be
considered valid in which the patients have had
anything to say in determining the outcome of the
trial. However, who can gauge the quality of sleep
or energy — may I ask—better than the patient
himself? Or the freedom from toxic thoughts? Or the
qualities of mood, memory, and mentation? Or
digestive and menstrual health? Or sexual drive? Or
absence or presence of dry skin and muscle
suppleness? For decades, I have been baffled by
hearing otherwise intelligent doctors mindlessly
insist that the patient's voice must be vigorously
excluded from clinical trials.
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