With the explosion of genetic testing and the emerging field of pharmacogenetics, patients can now take a DNA test and receive psychiatric drug recommendations customized to fit their genetic makeup. In an editorial for the latest issue of the Journal of Nervous and Mental Disease, Columbia University Psychiatrist Robert Klitzman warns that clinicians need to be aware of the limitations of these genetic tests being sold to them.
“Several tests are now being marketed to psychiatrists, based on reports of genetic markers found to be associated in various samples of patients with a range of psychiatric conditions,” Klitzman writes. “But the replicability and clinical utility of these have been limited.”
For-profit companies can legally develop these tests and market them directly to psychiatrists without demonstrating their effectiveness or receiving FDA approval. “The policy that permits marketing of such tests has raised controversy, in part because federal agencies do not ordinarily undertake post-marketing surveillance of these tests.”
Klitzman adds that this direct-to-physician marketing can be particularly problematic in this case as many physicians “have a limited understanding of genetics, and may thus accept, rather than question these companies’ claims.”
For instance, several tests are currently being marketed that claim that genetic markers have been identified that are associated with certain psychiatric diagnoses. However, Klitzman points out, that mental health conditions are influenced my much more than genetics, and can arise from “life circumstances and interpersonal and environmental interactions.”
Unfortunately, the marketing appears to be working. Klitzman reports that 41.6% of psychiatrists report having a patient ask about genetic testing in the last six months, and 14% have ordered these tests.
As these new genetic tests increase in use and visibility, the New England Center for Investigative Reporting (NECIR) reports that “the research behind them is scant, incomplete, or biased, and the potential for conflicts of interest is enormous.”
The subject of their investigation, a man from Vermont, was convinced by his doctor to take the tests and ended up suicidal and then institutionalized after following its recommendations.
The Need for Vigilance in the Marketing of Genomic Tests in Psychiatry. Klitzman R J Nerv Ment Dis.2015 Oct ; 203(10):809-810. PMID: 26421971 (Abstract)