What is needed to incorporate clinical pharmacogenetic tests into the practice of psychopharmacotherapy?

Abstract

This editorial considers two questions in psychopharmacotherapy: 1) What is needed to market pharmacogenetic tests in the US, since the US appears to lead other countries? and 2) What is needed for US-marketed pharmacogenetic tests to be incorporated by prescribers into long-term practice? US marketing of pharmacogenetic tests requires 1) understanding the pharmacological complexity of drug response, 2) modifying the oversight of non-FDA regulatory agencies, 3) clarifying the FDA’s role and 4) promoting innovative marketing. The incorporation of pharmacogenetic tests into long-term practice requires 1) not jeopardizing pharmacogenetic testing by short-sighted marketing of non-validated tests, 2) educating prescribers about benefits, 3) educating patients about limitations and 4) considering the differences between isolated testing and generalized testing incorporating big data.

KEYWORDS:

• Biological markers
• cytochrome P-450 enzyme system/genetics
• genotype
• histocompatibility testing
• pharmacogenetics
• psychotropic drugs/administration and dosages
• United States Food and Drug Administration

Financial & competing interests disclosure

No commercial organizations had any role in the completion or publication of this study. This article was completed without any external funding. J de Leon personally develops his presentations for lecturing, has never lectured using any pharmaceutical or pharmacogenetic company presentation, and has never been a consultant for pharmacogenetic or pharmaceutical companies. In the past, J de Leon has received researcher-initiated grants from Eli Lilly (one ended in 2003 and the other, as co-investigator, ended in 2007), from Roche Molecular Systems, Inc. (ended in 2007), and, in a collaboration with Genomas, Inc., from the NIH Small Business Innovation Research program (ended in 2010). He was on the advisory boards of Bristol-Myers Squibb (2003/04) and AstraZeneca (2003). Roche Molecular Systems supported one of his educational presentations, which was published in a peer-reviewed journal (2005). His lectures have been supported once by Sandoz (1997), twice by Lundbeck (1999 and 1999), twice by Pfizer (2001 and 2001), three times by Eli Lilly (2003, 2006, and 2006), twice by Janssen (2000 and 2006), once by Bristol-Myers Squibb (2006), and seven times by Roche Molecular Systems, Inc. (once in 2005 and six times in 2006). E Spina has participated in speakers/advisory boards and lectures supported by AstraZeneca, Bristol-Myers, Eli Lilly & Co., Janssen Pharmaceuticals, Lundbeck and Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editing assistance was provided by Lorraine Maw at the Mental Health Research Center at Eastern State Hospital, Lexington, KY, USA.