by Gerald Epling

The headline of January 15th read, “6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France“.  Just past the headline we can see Marisol Touraine, the health minister of France, discussing the unprecedented “accident of exceptional severity”.

The accident was the result of a Phase I clinical trial.  Phase I trials help us to understand how safe or not safe a drug may be.  Phase I uses basic research to explore the safety of a potential medication.  Basic research may be the only way to answer questions like, “Will this particular ingredient alter liver or kidney function?”  People selected for such a trial are often relatively healthy.  In this case 128 healthy people volunteered for the trial.  90 of them received various doses of the drug.  So, what went wrong with this clinical trial, which began on January 7th?  The short answer is, we do not know.  Undoubtedly, the people in charge of the study are focused on how to care for the six men between the ages of 28 and 49, who were severely injured, including one who is now brain dead.

From the reports, we know that the drug was intended to relieve pain.  Additionally, we can assume that the drug was a molecular medicine and not a natural medicine.  From a video report of the exceptionally bad outcome, we can hear the health minister of France, Marisol Touraine state that, “This drug does not contain cannabis.  Nor is it a product or a drug derived from cannabis.”  Continuing on, the minister states that the drug, “… acts on a natural system that fights pain.”  She then goes on to explain that the system that is targeted by the drug is the endocannabinoid system.  This statement is quickly followed with, “But I must stress, there is no cannabis in this drug.”

A lot of information was packed into a few words with this public statement about the failed drug trial.  Let’s take some time to unpack it.  A good place to begin is with the “system” that the drug is intended to affect.  The system here refers to groups of cells that are activated or quieted by some sort of stimulation.  By example serotonin is a naturally occurring neurotransmitter, found in all healthy / normal brains.  The neurons that respond to, or are soothed by serotonin are considered to be part of the serotonergic system.  You may have heard about Selective Serotonin Reuptake Inhibitors (SSRI).  These drugs cause the serotonin to languish as a transmitter for a longer time than the natural body might normally experience.  Opinions vary on the usefulness versus the disruption of normal brain activity that comes with SSRI’s.

Drugs that are used to affect serotonergic activity in the brain tend to contain molecules with fluorine in them.  This sort of medicine is considered molecular medicine.  Molecules that are used to disrupt the activity of a brain system may have little or no connection to the naturally occurring chemicals in a healthy / normal brain.  Therein lies the distinction that is so clearly made in the press release from France two days ago.  The drug acts on the naturally occurring cannabinoid system of the brain and apparently pain perception.  The use of the term “endo” in connection with endocannabinoid system identifies the system as a naturally occurring system in the brain.  Just as the normal / healthy brain modulates serotonin, so the normal / healthy brain modulates cannabinoids, such as those derived from the cannabis plant.

Many of the drugs that are in use today contain poisons, which are delivered in small, metered doses for a limited time or for a special purpose.  This is not easy to do and requires medical supervision and testing of the effect of the medication on the various systems of the body, which may be weakened by the medicine, such as the kidneys, liver, and so forth.

Now, the picture of a molecular medicine that is not related to the natural cannabis begins to take shape.  Such a manipulation is by nature very risky.  Introducing engineered molecules into the body in order to manipulate natural systems must have been weighed against the possibility of relieving pain.  Perhaps, the pain that is targeted is a pain for which we currently have no treatment?

The use of cannabis derived drugs such as cannabidiol oil (CBD) has proven effective in controlling epileptic seizures, which were previously not treatable.  There is relief from some extreme forms of epilepsy in the cannabis plant.

Trying to manipulate the receptors associated with the naturally occurring, endogenous cannabinoid or endocannabinoid system with molecular medicine appears to be very difficult.  For the foreseeable future, it may be best to stick with the naturally derived drugs from the cannabis plant and to move away from an exogenous, molecular medicine approach where the endocannabinoid system is concerned.

 

 

Relevant Reading

6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France  bNew York Times.

 

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