"Evidence-Based Medicine or Evidence-Biased?"
Dr. Esselstyn's landmark study showing even advanced triple vessel coronary artery disease could be reversed
with a plant-based diet has been criticized for being such a small study,
but the reason we're used to seeing such large studies is that they typical show such small effects.
Drug manufacturers may need to study 7,000 people
in order to show a barely statistically significant 15% drop in ischemic events in a subsample of patients,
whereas Esselstyn got a 100% drop in those who stuck to his diet,
all the more compelling given that those 18 participants experienced 49 coronary events, such as heart attacks,
in the eight years before they went on the diet.
And these were the worst of the worst, most of whom having already failed surgical intervention.
And so when the effects are that dramatic
how many people do you need?
Before 1885, symptomatic rabies was a death sentence until July 6th,
when little Joseph Meister became the first to receive Pasteur's experimental rabies vaccine.
The results of this and one other case were so dramatic
compared with previous experience
that the new treatment was accepted with a sample size of two.
So dramatic compared with previous experience,
no randomized controlled trial was necessary.
Would you — having been infected by a rabid dog — be willing
to participate in a randomized controlled trial (RCT)
when being in the control group had a certainty of a ''most awful death''?
Sadly, such a question is not entirely rhetorical.
In the 1970's, a revolutionary treatment for babies with immature lungs
called ECMO - extracorporeal membranous oxygenation -
transformed mortality in these babies from 80% down to 20% nearly overnight,
from 80% dead to 80% alive.
Despite this dramatic success, they felt forced to perform a randomized controlled trial.
They didn't want to.
They knew they'd be condemning babies to death.
They felt compelled to perform such a trial because their claim that ECMO worked would, they judged,
carry little weight amongst their medical colleagues unless supported by a randomized controlled trial.
And so at Harvard's Children's Hospital 39 infants were randomized to either get ECMO or not --
just be consigned to conventional medical therapy.
They decided to stop the trial after the fourth death so as not to kill too many babies.
And that's what they did.
The study was halted after the fourth conventional medical therapy death,
at which point nine out of the nine ECMO babies had survived.
Imagine being the parent of one of those four dead children.
Just as one can imagine being the child of a parent
who died from conventional medical or surgical therapy for heart disease.
Medical students in the United States are taught very little about nutrition.
Worse yet, their training actually biases them against the studies
that show the power of dietary approaches to managing disease,
by encouraging them to ignore any information that does not come
from double-blind, randomized controlled trials.
Yet human beings cannot easily be blinded to a dietary intervention.
They tend to notice what they're eating.
As a result, physicians may be biased in favor of drug treatments
and against dietary interventions for the management of chronic disease.
Evidence based medicine is a good thing.
However, the medical profession may be focusing too much on one type of evidence to the exclusion of all others,
degenerating into a ignoring-most-of-the -truly-important-evidence based medicine.
And heart disease is the perfect example.
On a healthy enough plant based diet,
our #1 cause of death may simply cease to exist.
The Cornell-Oxford-China Study showed that even small amounts of animal-based food was associated
with a small, but measurable increases in risk of some of these chronic diseases.
In other words, the causal relationship between dietary patterns and coronary artery disease was already well established
before Ornish and Esselstyn undertook their clinical studies.
The value of their studies was not so much in providing evidence that such dietary changes would be effective,
but in showing that physicians can persuade their patients to make such changes,
and also providing interesting data on the speed and magnitude of the change in severe atherosclerotic lesions as a result of dietary therapy.
So any complaints that these studies were small or unblinded are simply irrelevant,
because the evidence of the role of diet in causing atherosclerosis is already so overwhelming,
you know, assigning a patient to a control group
eating the standard American diet could be considered a violation of research ethics.
Evidence of the value of plant-based diets for managing chronic disease
has been available in the medical literature for decades:
Kempner at Duke, John McDougall, The Physician's Committee for Responsible Medicine.
Denis Burkitt had warned us that the standard Western diet
is a standard cause of death and disability in the Western world for decades.
Yet physicians in the US are still busily staffing the ambulances at the bottom of the cliff instead of building fences at the top.