re Clinical Trials

Dr Weeks’ Comment:   Double blinded placebo controlled trials are the gold standard but often unethical and increasingly criticized as a profit driven model for corporate medicine.


The trial of the ages

“Evidenced based medicine”: validation of the scientific method vs. obstruction of progress and innovation.

The history of medicine dates back for 8,000 years. Significant civilizations of the past from India, China, Egypt, Greece, Rome, Incas and to modern civilizations, there has always been controversy as to the implementation of new ideas and innovation. In the 20thand 21stCenturies the controversy has reached fever pitch and epic opposition. The legal modern day controversies dates back to 1910 with the arrival of the Flexner Report. By 1918 the organized opposition was so formidable that Mark Twain said “that science moves ahead one funeral at the time”. What he meant by that is the fact that the industrialists had taken over medicine and all opposition will be crushed by any legal means. By 1940, all wisdom of the past and all innovations of the past were put on hold for 50 years, while we were awaiting for the czars of the industry to die. However, his prophetic statement continuous to be true to this day. One of the twists of the early 1900s was the innovation of very appealing but very clever term “the scientific method”.

“The scientific method” carries enormous weight in the minds of the scientists and the eyes of the public. It absolutely should! However, there is a twist or “spin” to the scientific method as it was conceived by the clever advertisers of industrialized medicine. Before I go any further, we must understand that there are several disciplines in medicine, such as acupuncture, homeopathy, naturopathy, nutritional science, etc. that cannot be validated by the “modern definition the scientific method”. To the true scientist, the scientific method includes observations that can be duplicated over and over by another trained scientist or physician.

Today’s “scientific method” has very little to do with medicine, except pharmaceutical medicine, and everything to do with the law of medicine. Specifically, in the USA “the scientific method” and the “standard of care” apply only to Western Medicine research and excludes all other disciplines. The “Western Medicine scientific method” is an excellent method to verify the efficacy and toxicity of a single chemical, usually a pharmaceutical. Western Medicine research is the only medical discipline that evaluates single agents. If one was to examine the way Western Medicine does research on a single chemical substance, one has to enforce the following: 1) study must be randomized, 2) study must have a placebo group, 3) the study must prove the level of the lethal dose – LD 50 ( what is the dose that will kill 50% of the experimental animals). All other disciplines observe not only the multiple properties of a compound or nutrient but also how this compound or nutrient affect the disease state and the person as a whole. There is no LD-50 in the study of any other medical discipline.

To make things even more “twisted” or complicated, the legal medical system has added another parameter the “evidenced based medicine”. Again, to most scientists and to the public this sounds like Holy Grail of science. What could be better? Houston we have a problem! The problem is that “evidenced based medicine” depends on observations that are made based on another Western Medicine perk, “the double blind placebo randomized controlled trials”. Again these trials fit perfectly in the pharmaceutical model but not to any other model or discipline. The best argument against the double blind placebo randomized trials is an article that appeared on the British Medical Journal 2003; 327:1459, titled “Parachute use to prevent death and major trauma related to gravitational change: systemic review of randomized control trial”. Reading this article is medically comical but legally dead serious. The article reports the following: 1) The design: systemic review of randomized control trials. 2) Study selection: studies showing the effects of using parachute during free fall. 3) Main outcome measure: death or major trauma, defined as an injury severity score >15. 4) Results: we were not able to identify any randomized controlled trials of parachute intervention. Conclusion: As in any intervention intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomized controlled trials.

In the “parachute” article if one were to take away its comical design, one can see that “the science of legal medicine” is totally out of bounds. One can also make the same argument about surgical procedures such as amputations, open heart surgery and brain surgery. These procedures are done in every major hospital and teaching university every day of the week. Has anyone done randomized control trials on these procedures? In conclusion, evidenced based medicine randomized trials should only be done with FDA approved pharmaceuticals. This pseudo-scientific method does not apply to any discipline in medicine, except in single chemical pharmaceutical research. The author of the “parachute” article has a great suggestion for the advocates of evidence based observational data: “everyone might benefit if the most radical protagonists of evidence based medicine organized and participated in a double blind, randomized placebo controlled, crossover trial of the parachute”.

It is time for the “legal medical system” to stop the innovation of pseudo-scientific terms that are designed to discredit the wisdom of medical science for 8,000 years. I think it’s time for the scientists and the physicians to take the practice of medicine away from “lawyers and the justice medical system” and endow the hard working dedicated physicians the ability to practice medicine and offer care and innovation to the ill patient.

Leave a Comment

Your email address will not be published. Required fields are marked *