Ethics and data protection

Use of PGx profiles has been criticised by those who argue that manufacturers and sellers overstate their usefulness and are profiting from their sales at a time when the clinical benefit is unclear. 

There is clearly some considerable potential but apart from specific targeted testing (such as the carbamazepine example highlighted earlier), much research still needs to be done to prove the scientific validity of wider profiling. 

It could even be argued that the value of these tests has not lived up to the initial promise. An example is hypertension where, although it is known that individuals may respond differently to various drug classes, doing genetic tests has as yet not shown much benefit in identifying responders versus non-responders and in improving clinical outcomes. 

Another issue relates to how individuals’ DNA samples are used and who ‘owns’ them. This raises concerns about data protection, confidentiality, who may get access to the DNA results, and how testing is regulated. Furthermore, these results may convey more information than that just related to drug metabolism. An extreme example is finding genetic abnormalities that have major health implications.