From the beginning there has been a chasm between the way that psychopharmacologists refer to and think about psychiatric medication as opposed to the FDA, the lay press, and the marketing arms of the pharmaceutical companies. The FDA generally approves a medication for a disease indication according to the Anatomical Therapeutic Chemical (ATC) classification system. For example, we have anti-depressants, anti-anxiety medications, and anti-psychotics. However, all of these “classes” of medications may be utilized for one or more of the “indications” in the ATC system. The FDA regulations require that in order to obtain a new “indication” that the compound must show benefit in 2 of 3 clinical trials. The pharmaceutical company run 2-3 Phase 3 clinical trials to obtain each indication. This is the reason that the company will most often pursue a single indication for a given medication. Clinicians utilize the medication “off label” to treat other conditions in which clinical trials apart from the drug company demonstrate safety and efficacy. That is how we get to the point where when I prescribe an “anti-depressant” for an anxiety disorder, as is recommended for a first line treatment, I get the statement, “I’m not taking that, I’m not depressed”.
The Neuroscience-Based Nomenclature (NbN) was designed to describe a drug based on its pharmacology and mechanisms of action so that the treating physician has a clear alternative when selecting a treatment or altering a therapeutic regimen. The NbN was adopted first in Europe and has moved to the United States. The cause has been championed internationally by Dr. Stephen Stahl of La Jolla, California. This nomenclature has now been adopted by several of the leading journals of neuroscience and pharmacology. Most recently, this list was joined by the prestigious American journal, Biological Psychiatry. As an acolyte of Dr. Stahl, I have utilized the mechanism of action model to describe psychotropic medication for many years. At this point I am going to digress slightly and stress a fact that is all too often misunderstood and distorted, i.e., the mechanism of action describes only what the medication does at the level of the cell. This does not translate to the medication addressing the causation of the illness, even though the use of the medication alleviates the symptoms of the illness. In a crude analogy, just because we can fix a broken arm with a cast does not mean that a lack of fiberglass tape leads to a broken arm. This reasoning is how we get the phrase, “chemical imbalance”. There is not and never was a “chemical imbalance” leading to depression. This was a marketing phrase. The NbN includes four additional dimensions beyond the basic pharmacology: 1. Approved indications; 2. Efficacy and side effects; 3. Practical note (a summary of the most relevant clinical information); 4. Neurobiology (includes preclinical and clinical data and highlights preclinical findings of value to physicians). A full description of the NbN can be found at www.nbn2r.com .
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AuthorAndrew Bishop, MD FAPA Archives
February 2021
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