In his seminal work, 'The Controlled Clinical Trial: An Analysis', Dr. Harris L. Coulter concluded, after a thorough examination, that the double-blind -
- "Controlled Clinical Trials" (CCT) or
- "Randomized Clinical Trials" (RCT)
…used to trump up new allopathic medicines, appliances, surgeries, etc. :
- Are not scientific
- Cannot guarantee safety & efficacy of the new drug / procedure / equipment
- Their results are often ambiguous and uninterpretable
- Because of several other compounding problems like treacherous patient-to-patient & physician-to-physician subjectivity, they are not dependable enough to test out new modes of treatments .
Methodology: The CCT / RCT is performed on patients by dividing them into a "test" group and a "control" group.
The test group receives the new medication, surgery or other mode of treatment, while the control group receives the existing way of treatment or nothing at all, maybe a placebo.
Their purported scientific validity rests entirely upon two basic assumptions :
- The groups are "homogeneous" : i.e., there are substantial biological similarities amongst the trial participants who are suffering from the medical condition being investigated.
This allows us to presume that their bodies will respond to the new drug / treatment in a comparable fashion.
- The groups are "generalizable" : i.e., their body's represent the biology of the entire population which is likely to suffer from the medical condition being investigated.
But till date not a single randomized controlled clinical trial matching this textbook definition has ever been performed because these theoretical requirements are practically unrealistic, to say the least.
But is that what they call science?
1. Non-existent Homogeniety: First of all there is no such thing as a "homogeneous" group. We are all unique; & when it comes to disease – the differences matter more than the similarities.
Therefore it is impossible to obtain 2 exactly identical groups due to each patient’s unique bio-psychological makeup. For e.g. their
- Sensitivity to the drug dosage & frequency
- Responsiveness to different methods of treatment,
- Severity & range of symptoms,
- Past history of illnesses,
- Prior treatments,
- Food habits,
- Mood, attitude, motivation,
- Toxicity level,
- Family & social support,
- Commitment to strictly adhering to the do's & don'ts; And honestly reporting back any non-compliance, etc.
There will always be many other unknown & inadequately understood factors involved.
Other trial corrupting variables include :
- Wrong selection of candidates
- Communication gaps
- Complexity of the technique
- Practicality of the test protocol (do's & don'ts)
- Observer bias : The varying ability & sincerity of the physicians in
- Conducting the trial
- Making observations
- Monitoring patients
- Their faculty of judgment
- Whom did he/she checked just before working on the next person (referential bias), etc.
These uncontrollable variables irreversibly jeopardize the outcome of all so-called controlled clinical trials. And hence CCTs can not be relied upon.
So how much of a science was that?
2. Absence of Repeatability:
One study showed that there was no correlation between the estimates of one physician and that of another. How can a matter of opinion be passed around as sound science?
Given the person-to-person biodynamics mentioned above, the positive results, if any, are difficult to reproduce in another group at some other time & place.
Now, was that science?
3. Little / unreliable Measurability:
- All physical ailments have a psychological footprint & vice versa. The feelings cannot be measured… yet.
- As for the bio-physical components, a lot remains undiscovered; so forget about measuring them.
- Even in the known bio-chemistry, not everything can be measured properly.
How valid is an experiment if the raw data collected is not even adequately measureable?
Shall we still call it science?
4. Unacceptable Precision:
A proper scientific study starts by precisely defining the objects or phenomena to be studied. But continuing from the above line of arguments -
- There are biological parameters that are measurable to a varying degree, but many of them do not exhibit a consistent level of preciseness.
- Instruments from different manufacturers have been found to yield different readings for measurements made on the same patient at the same time.
- Even the machines made by the same manufacturer tend to show variance due to -
- sensitivity deterioration due to aging,
- model-to-mode design changes,
- upkeep & maintenance problems.
- scale mis-adjustments,
- wrong way of usage, incompetency, etc.
This means that a decent amount of accuracy is not achievable in an allopathic clinical trial of living beings – more so humans; then how can we call it a science?
5. Lack of Generalizability / representativity:
When experimenting with animals or chemicals, one can choose what species or compounds he/she wants, but then it comes to humans, they are ones who decide whether to participate in a trial or not.
So how can the test results be extrapolated for all of us, because the samples themselves are NOT randomly chosen by the allopaths?
Those recruited for allopathic trials generally come from the -
- urban poor,
- military recruits,
- impoverished students looking for a quick buck or
- those who are already hospitalized;
… hardly anyone from -
- the affluent classes,
- those with minor symptoms or
- those who prefer alternative therapies.
- Young women & old folks are generally under-represented.
Thus any results obtained with those 2 sample groups are not transferable to the rest of the people suffering from that particular disease in question because -
- The trial participants do not constitute a statistically valid selection. They do not represent us. They are merely examples of a large population that cannot be narrowly specified.
- Results of "random sampling" can not be uniformly applied to each & every one, biomedically speaking.
- Efficacy in expert hands during clinical is no guarantee of effectiveness in a typical high-paced real life encounter with a busy GP or under over-loaded / less trained paramedics in a crowded hospital .
- If a trial finds that in a study group of 1000 patients 70% respond well to treatment and 30% don’t, one may surmise that the therapy works for 70% of people 100% of the time.
But the same data also imply that 70% people benefit some of the time; & at others times a totally different percentage of people may benefit.
Are we still calling it science?
5½. Allopathy’s therapeutic paradox:
- If the group participating in a clinical trial has low internal homogeneity it doesn't form a good sample for testing; as reasoned above.
- But let's say, theoretically you do get a group with high internal homogeneity,…
… ironically, it wouldn't represent the general populace truly which has such deep heterogeneity in their biochemical & psycho-physical ways of suffering the disease symptoms under study.
Thus, these two core conditions of designing a scientifically sensible clinical trial are themselves in irreconcilable mutual conflict.
What kind of science is that?
"The CCT can never tell a doctor how a given patient will react to a given drug at any given time. The findings from the so-called controlled clinical trial are useless in one-on-one doctor patient interactions."
– Dr. Harris L. Coulter; The Controlled Clinical Trial: An Analysis
Independent reviewers found that about 85% of new drugs offer few if any new benefits – Dr. Donald W. Light .
The benefits of drugs & other interventions may be meager or last for a short while, but the harms are immense in the longrun :
Drugs cause more than 2.2 million hospitalizations and 110,000 hospital-based deaths a year .
That's because these counter-health practices, make your body a fertile ground for all kinds of destructive microvita, which carry out the rest of your premature life-decimation or atleast compromise your wellness in other unobvious ways.
This only adds to the bottom-line of allopathic businessmen.
Even the lethal ones amongst the negative microvita entities are mostly intelligent enough to have figured out that they shouldn't kill their host immediately, lest they lose their source of physical subsistence & evolution.
That's why such human bodies stagger towards their occupants self-sentenced death penalty, executed slowly, over time.
Instead of the misnamed 'randomized controlled clinical trial', what about a 'customized integrated self-rejuvenation drive' for a change?
Think of the last time you prevailed over a health foul-up. Irrespective of the medication used, it was purely because you succeeded in raising up your bank balance of positive microvita above red.
On the contrary have you ever been on the receiving side of a hardy illness?
That happened because negative microvita from external sources like poor diet, lifestyle, allopathy, sick people, etc., had struck root & started flourishing more than the positive microvita occupying your bio-space.
Get your house in better order; may be you do deserve a cozier microvita ambience :
Or may be you need a slightly better diagnosis, without which you won’t land a better treatment.
1. The controlled clinical trial – an analysis; Harris L. Coulter, Ph.D.
2. The Risks of Prescription Drugs; Columbia University Press
3. The $800 Million Pill: The Truth Behind the Cost of New Drugs; Merrill Goozner; University of California Press
4. Dirty pharmaceutical tactics against dissenting researchers