It is widely known that any drug can be therapeutic for some individuals but ineffective for others, triggering adverse effects in some patients while others remain unaffected. Fortunately enough, a revolutionary and truly personalised concept for healthcare is currently being debated in medical, scientific and political fora: a new approach to medicine that would come at the crossroads of major breakthrough technologies dealing with genetic information and patients’ response to drug treatment.
A unique treatment for a unique genetic profile
Personalised healthcare can be defined as the management of a patient’s disease – or disease predisposition – using molecular analysis and the individual’s genetic profile to tailor drug treatments that achieve optimal medical outcomes. The association of individuals with a particular gene variant will be used in the future to prescribe the most efficient drug treatment and avoid adverse reactions. But a more targeted therapy is not the only benefit of personalised healthcare. This medical revolution based on genetic information is expected to predict disease risk and address individuals while they are still healthy, shifting towards a prevention-focused healthcare system, and stimulating pro-active behaviour among the population.
Breast cancer as an example of personalised healthcare
‘Personalised’ breast cancer research demonstrates a paradigm shift from traditional methods of patient diagnosis and treatment, towards a more targeted and patient-centred approach. While conventional radio and chemotherapy are used to treat all cases of breast cancer with varying outcomes, advances in genetics and molecular biology led scientists to identify that – of all sub-types of breast cancer – 30% of women carry a mutation in the HER-2/neu gene leading to uncontrolled cell growth. Within this 30%, conventional chemotherapy is far less effective than a drug treatment targeting the abnormality caused by this particular gene mutation.
Pharmaceutical industry: to take or not to take the risk
Personalised healthcare could provide society great benefits such as the avoidance of adverse drug effects and a reduction in unnecessary medical interventions and diagnostic errors. Yet, multiple barriers are to be overcome in order to bring this revolutionary science from the lab to the clinic, and to make it available for patients. These obstacles stem from the far-reaching implications that personalised healthcare is predicted to have on pharmacology, diagnostics, therapies, current approaches to clinical trials, drug design and validation – to name just a few. By tailoring therapies to the patient’s unique genetic profile, personalised healthcare triggers a broader dilemma for the pharmaceutical industry: whether or not to take the risk and invest in development of specific drugs for smaller groups of patients based on genetic variations; abandoning – at the same time – the blockbuster drugs with lower efficacy, and the conventional model of drug treatment based on ‘one size fits all’. The personalised approach is particularly challenging for the pharmaceutical industry: it disrupts the traditional business models of drug development, clinical trials, health management and delivery by addressing large patient populations, irrespectively of the potential genetic variations.
Governments: to reimburse or not to reimburse
The price to pay might be well worth spending: it is estimated that, while in the first years of implementation personalised healthcare will result in an increase of medical costs for healthcare – especially in diagnostics – long-term benefits will decrease the spending, thanks to reduction of medical errors and unnecessary interventions. Uncertainty arises when discussing whether or not the newly developed drugs and companion diagnostic tests will be a part of future reimbursement schemes. This is a major issue preventing a smooth and fast development of personalised healthcare, since in the EU many different healthcare systems are in place, and they all foresee different healthcare reimbursement policies.
Knowledge-management and R&D: the fundamental points
COST has been working on a number of initiatives to drive EU research and science coordination on personalised healthcare, and has successfully become a gateway to researchers’ networks in this field. Offering its unique scientific insight and networking capacity, COST is knowledge-partner in a cutting-edge consortium of industrial, non-profit and professional partners guided by Science¦Business and Stockholm’s famed medical university Karolinska Institutet. This consortium is promoting personalised healthcare and supporting the dialogue between policymakers, institutions and the scientific community in order to accelerate its deployment into mainstream medicine. Karolinska Institutet and Science¦Business recently conducted a survey on the future of personalised healthcare. Through their answers, European scientists in academia and industry indicated that a lack of understating of basic biology is among the obstacles on the path towards fully implemented personalised healthcare. Most importantly, the study pointed out that the main structural barrier is – not surprisingly – insufficient funding in R&D. Coordination of research programmes and fostering of multi-disciplinarity are thus top priorities to make significant and fast advancements in this cutting-edge field.