Europa moet optree om tred te hou met inisiatief Obama

Deur Europese Alliansie vir Persoonlike Geneeskunde (EAPM) Uitvoerende Direkteur Denis Horgan

Earlier this year, US President Barack Obama launched his Precision Medicine Initiative (PMI) – essentially what we tend to call ‘personalised medicine’ in Europe. In his State of the Union Address on 20 January, Obama stated that the idea was to “bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalised information we need to keep ourselves and our families healthier.”  Personalised medicine is a fast-moving field that sees treatments and drugs tailored to a patient’s genes, as well as his or her environment and lifestyle. It relies on DNA sequencing and other new technologies and aims to give the right treatment to the right patient at the right time. It can also work in a preventative sense.

Up to now, doctors have tended to prescribe medicines and treatments by population. If a treatment works for the biggest percentage of patients, most will default to that. However, it is clear that we are all different and one-size-fits-all approaches no longer work in modern-day health care.

Logically, there is little to be gained by giving a cancer patient chemotherapy if there is a large chance that it will not work. This is a waste of time and money and, potentially, a human life. It is far better to know in advance what the best treatment will be, to discuss it in a fully transparent way with the patient and then to point him or her in the right direction.

To augment this, the holistic approach of personalised medicine aims to ensure that the patient’s lifestyle is taken into account when prescribing treatments and also seeks to ensure that the patient is involved at every stage of the development and treatment of his/her disease or diseases.

This co-decision requires not only knowledge on the part of the patient but also up-to-date training for the healthcare professionals and others involved in the process. A willingness to share this information in an equal relationship with the patient is a cornerstone of personalised medicine.Proponents of the personalised approach (of which there are many and the number is growing all the time) have watched Obama’s initiative unfold – especially here in Europe where lessons may well be learned. We cannot fall behind. Six months on in the US and the view across the Atlantic is that the widespread adoption of precision medicine may have a profound effect on US competitiveness and the economy.

The $4 billion investment in the Human Genome Project has already blossomed into an estimated $965 billion in economic growth. But matters have yet to go far enough. Many American stakeholders closely watching the situation ‘at home’ believe that continued innovation in biomedical technology and research is still required for American to sustain a leading role in the emerging field. PMI has a plan to follow health outcomes over many years, identifying biomarkers that are predictive of future development of a large number of diseases, allowing new opportunity for disease prevention and therapy, on top of providing new understandings of factors that predict variation in response to current therapies.  The huge amount of data that PMI is collecting (and will continue to collect) will provide exceptional opportunities for innovative analyses, but will also require mechanisms to provide ready access to data for research while maintaining the highest standards for data security and maintenance of privacy of participants.

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As in Europe, PMI will undoubtedly need to draw upon diverse talents via a multi-stakeholder approach taking expertise from academia, industry, health-care organizations, government, policymakers and, of course, patient groups. It will also need a long-term budget commitment in order to succeed.  The Americans are moving quickly and have come to some (one could argue) obvious conclusions including that health equals wealth and that investment in research and innovation, alongside laws and rules that are fit-for-purpose and reflect the swiftly changing world of medicine, are vital.

Europe needs to grasp these points at every level - not just the vision of an EU that creates a competitive environment that attracts investment, but also for the benefit of the millions of potential patients spread across 28 Member States.

Fortunately, organizations such as the Brussels-based European Alliance for Personalised Medicine (EAPM) have been working hard to pull down walls, encourage cooperation among different stakeholders and disciplines, involve patients at the heart of their own healthcare and impress upon policymakers that urgent changes need to be made.

The advancement of science has never, nor ever will, reflect borders or legislation. Legislation and cross-border collaboration must, therefore, keep up with scientific advances.

The Alliance believes that, in a 500 million citizen-strong EU staring into the abyss of a society with an aging population that will inevitably become ill at some stage, giving patients access to the best possible treatment available in Europe is a moral issue, and it’s a financial one, too. That’s because investment in research and innovation will lead to a better quality of life for patients and make them less likely to need expensive hospital treatment. This means more time spent in the workplace contributing to the wealth of the EU and its individual countries.  Patients are all for personalised medicine but regulators are wary and, in some cases, behind the times. And, of course, payers have their own views on what constitutes ‘value’.

However, there is no doubt that personalised medicine is here to stay. So much so that the current rotating presidency of the EU, Luxembourg, not only held a high-level conference on the subject in July but will also make recommendations in respect of personalised medicine in its December Council Conclusions.

This is a first in the EU and a huge leap forward. But the momentum must continue.

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