Calls for strict regulation of direct-to-consumer genetic testing

6 March 2011

The American Medical Association (AMA) has called for all forms of genetic testing to be subject to supervision by a qualified health care professional.

In a letter to the Molecular and Clinical Genetics panel of the Food and Drug Administration (FDA), which is due to hold hearings on direct-to-consumer (DTC) genetic testing this week, the AMA said DTC testing in many cases ‘represents the unauthorized practice of medicine’. The letter says that such tests, whilst offering some benefits, may ‘cause harm to consumers and over time increase health care costs’.
The AMA calls for strong regulatory oversight of DTC genetic testing, to include requirements for providers to make the potential and limitations (including clinical validity and utility) of tests explicit, and to refer users to independent health care professionals for further information. For tests for inherited and serious forms of disease, considered to have the highest risk of harm to patients if misinterpreted, they propose that it should be compulsory for results to be reported directly to the purchaser’s doctor or genetic counsellor.
Comment: The AMA’s calls for clear and explicit information on the clinical utility of DTC genetic tests are wise, as are suggestions that health professionals need improved education on the interpretation of personalised genetic test results. The recognition that some forms of testing have potentially much more serious impacts than others is also valid.
However, the insistence on linking all forms of testing to health professionals is questionable. It certainly detracts from patient autonomy, and implies that any health professional will be better placed to interpret even clearly explained test results than any consumer – which is not necessarily true.
Is the real concern solely that of harm to the public, or is there also fear that the growth of DTC testing will as stated ‘undermine the physician-patient relationship’? Good health professional education about genetic data and clear information about genetic testing for consumers could address this fear more effectively than heavy-handed regulation.

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