The Challenge of Psycho-Pharmacology

As a practicing psychiatrist, I am constantly struggling with balancing purported efficacy with known risks of somatic interventions. While currently approved interventions have demonstrated efficacy relative to placebo, the rate of improvement with placebo remains consistently above 30%. With the increasing prevalence of polypharmacy, there is an increasing risk of adverse side effects for the hope of improved outcomes. In addition to evaluating the risk/benefits of various treatments, we know from multiple studies most patients are not adherent to the prescribed medication regimens and discontinue medications altogether within a relatively short period of time.

My goal is to treat the presenting illness but my primary duty to my patients is to “do no harm”. Avoiding harm typically results in an approach that follows a spectrum of interventions beginning with treatments that pose the least risk of adverse side effects.
The harm reduction approach increases the likelihood patients will benefit without being exposed to unnecessary risks of harm. CES should be included in the spectrum of available treatments as it poses very low risk of harm to patients.

The Agency has expressed concern as to utilization of CES without first employing more “conventional” treatments. Unfortunately, as a practicing psychiatrist I have found the more conventional treatments at times are not only ineffective but also in many circumstances contribute to a worsening of the condition or result in deleterious side effects. CES would not result in other main stream treatments being offered. These treatments would be offered if CES were deemed ineffective.

While the panel will weigh the methodologies of the submitted studies to determine efficacy, there is excellent data and clinical experience to support the safety and lack of adverse side effects from CES. The safety profile of CES should be given considerable importance in considering its classification. Frequently, patients will tell me about the advertisements they see on television by various attorneys soliciting patients who have been harmed by approved medications, ECT or other treatments. They are worried about being harmed by prescribed treatments. They become suspicious of their health care professionals. The necessary therapeutic alliance adversely impacted. From discussions with my colleagues, their concerns are centered more on litigation about adverse side effects than on efficacy.