Shortcomings in Genetic Testing as Revealed By the New England Center for Investigative Reporting

Several new companies have introduced genetic tests aimed at making treatment of psychiatric illnesses more predictable and effective. Test makers assert that psychiatric genetic testing minimizes patients’ risk of adverse side effects by enabling physicians to select appropriate medications with less trial and error. However, a recent investigative report conducted by the New England Center for Investigative Reporting (the “Report”) raises significant questions about the effectiveness of these genetic tests.

Among the concerns raised in the Report, the lack of independent oversight and financial conflicts of interest are the most serious. The Report suggests that test makers may be overstating findings and have failed to seek outside review of their unproven products. The Report also alleges that financial incentives may be causing improper referrals because test makers have been paying medical professionals to speak favorably about their tests, which have yet to be proven effective. Furthermore, as a result of a highly controversial FDA exemption, the majority of these genetic tests have been introduced into the marketplace without FDA review. Although the FDA recently announced plans to regulate these tests, no timeline has been established.

Despite the ethical concerns raised in the report, psychiatric genetics may still hold the key to unlocking a definitive approach for identifying the drugs most likely to be effective for individuals suffering from a multitude of psychiatric conditions. Only time will tell if the analysis of an individual’s genetic make-up can be used to effectively determine drug response.


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