5 October 2007
The US Department of Health and Human Services (HSS) has published what it terms a ‘reconnoitring’ report entitled Personalized Health Care: Opportunities, Pathways, Resources. Produced as part of a HSS priority initiative on personalized health care, it presents a long-range plan for achieving individualized treatment for patients based on the ability to predict individual susceptibility to disease and to target medicines more precisely and safely. The ultimate goal is to allow patients and their doctors to make better, safer health choices based on knowledge of an individual’s genetic profile in addition to other clinical and personal factors. The report articulates how ongoing work from programmes coordinated by HSS (such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the National Cancer Institute), and elsewhere, are likely to come together in the future to offer the prospect of ‘the right treatment, at the right time’ for each individual patient. The report also looks ahead to a point where developments could allow early detection and monitoring of diseases basked on molecular biomarkers, and even individualized tools for preventing disease.
The report emphasises that in order to develop clinically useful products it is essential that advances in biomedical sciences (including systems biology, bioengineering, genomics, proteomics, epigenetics, nanotechnology, cellular and tissue engineering, bioimaging, computational methods and advances in information technologies, especially health information technology) be integrated fully with insights from population sciences, humanities and social sciences. Only such comprehensive integration will result in appropriate regulatory structures that support development of safe, effective interventions that are accepted and trusted by the medical community, patients and the public in general. The importance of electronic health information in gathering patient data to support clinical care and develop new or more appropriately targeted new interventions is underlined, with the observation that advances in medicine require both scientific knowledge and evidence, and appropriate technology ‘to make complex information useful’.
Early examples of personalized health care are cited, such as anti-cancer drugs like Herceptin tailored to specific genetic features of the tumour, or BRCA mutation testing for inherited susceptibility to breast and ovarian cancer. The report implies that, inevitably, such examples will become increasingly common until the whole practice of medicine is shifted from something of an art, to a precise science where treatment is dictated by detection and analysis of multiple and complex biomarkers, this data simultaneously providing a platform for further biomedical research and assessment and refinement of interventions. This new ‘smart’ approach is heralded as the dawn of a new era in which not only will treatments be more effective and more economic, but also patients will become increasingly in control of their own health care based around genetic testing and therapy, managing their own ‘health portfolios’ in consultation with medical advisers
Barriers to progress are also considered, including the rate of scientific advances which is said to outstrip the ‘ability of clinicians and providers to remain up-to-date on the latest medical information’; hampering the adoption of new approaches ‘such as the incorporation of genetic testing practices in routine clinical decision-making’. It is not clear what form of genetic testing they consider to be clinically useful but currently underused due to ignorance on the part of health practitioners, though the report does concede a need ‘to ensure that medical genetic test information is both clinically and analytically valid’.
The sheer scale and complexity of the information on molecular pathways and interactions involved in health and disease, and the effects of genetic and environmental factors on these networks, is alluded to but never made explicit. The report does call for further research in various areas – outlining current research initiatives - but does not go into detail about the necessity for revolutionary breakthroughs in computing that would be necessary to record, handle and analyse the vast mass of data from such research.
HHS Secretary Mike Leavitt commented: “Personalized health care means knowing what works, knowing why it works, knowing who it works for, and applying that knowledge for patients. These goals may sound elementary, but a generation of effort lies ahead of us in achieving them” (see press release). Whilst the earliest examples of personalised medicine are already with us, realising the full potential of the field as envisioned by the report may be rather more than a generation ahead.