Concerns and prospects for pharmacogenomic testing

29 July 2009

The American College of Clinical Pharmacy (ACCP) has published a position statement on direct-to-consumer genetic testing, calling for federal government oversight of companies offering such tests. The ACCP expressed concern about the potentially adverse impact from advertising of DTC genetic tests to consumers, saying that it could have "both immediate and long-term effects on public health and the future adoption of pharmacogenetic/genomic testing" [Ameer B, Krivoy N (2009) J Clin Pharmacol. 49(8):886-8]. 

The US Food and Drug Administration (FDA) regulates the advertising of prescription drugs, and the ACCP called for this oversight to be extended to genetic testing. Their primary concerns are that poor consumer experiences of DTC genetic testing (for example, in the absence of a clinician or geneticist to explain the reliability or meaning of results) might lead to widespread distrust of genetic testing in general, and potentially lead to the development of inequitable regulatory policy that could stifle “innovation in the creation of validated genetic tests" and hinder the translation of pharmacogenetic testing into clinical practice.

They propose that clinical pharmacologists should help members of the public who have or are considering purchasing DTC genetic tests (see press release) by suggesting that they:

• Obtain advice from a ‘genetic clinician’ about advertisements of genetic testing
  
• Appreciate that many DTC genetic test providers do not offer interpretation of results
  
• Recognise the scientific limitations of each test, particularly with respect to the lack of (genuine) clinical implications

It is noted that direct assistance with specifically pharmacogenetic testing may be provided by pharmacologists .

Recently, a report from the US Federal Coordinating Council for Comparative Effectiveness Research made recommendations for the application of personalised medicine in comparative effectiveness studies. The Annual Report on Comparative Effectiveness Research noted the increasing potential to use genomic patient information to “use more effectively the therapies we have now and to identify significant areas where research and development of new products may be needed", adding that pharmacogenomics “is expected to be a hallmark of this approach”. In the report, the council also noted the need to include racial and ethnic subgroups in some study designs, to avoid potential health disparities.

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