Improving the Quality of 'Personalized Medicine' Research and Practice

Through an Ethical Lens

George P Browman; Jochen Vollmann; Alice Virani; Jan Schildmann

Disclosures

Personalized Medicine. 2014;11(4):413-423. 

In This Article

Marketing PM: A New Paradigm?

Except for a few dramatic successes, the early promises for PM in cancer we now know to have been exaggerated on a number of fronts. First, there continue to be growing pains in validating laboratory correlation studies for molecular targeted therapy.[19] Second, while there have been improvements in cancer outcomes through targeted therapies based on patient genomic selection in clinical trials, some of these have been only modest, and even when substantial, survival curves for treated and control subjects are similarly shaped.[20,21] These examples are significant in terms of patient selection for improved outcomes but do fall short of marketing promises for cure, and they challenge claims for a paradigm shift in medicine. Sparing patients the toxicities and inconvenience of treatments to which they are unlikely to respond based on biomarker studies will be an important clinical contribution. However, this only expands an already ingrained practice, for example, in how breast cancer patients are chosen for hormonal versus other types of therapy. Third, early hopes that targeted therapies would eliminate problems of drug resistance have not been borne out, although our ability to more precisely understand mechanisms of resistance has improved;[22] and finally, it is too early to tell whether the PM era will lead to more affordable healthcare delivery as often claimed, especially since there is limited control over pricing policies of new drugs and companion diagnostics required for patient selection.[23,24]

Faced with these emerging observations, we need to be more circumspect in how we make claims for the benefits of PM for individuals and for the system, especially in the shorter term. A more realistic portrayal might also help maintain public trust and confidence in science and the medical system over the longer term.

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