So, the Republican and Democrat candidate tickets have been formally ratified in the United States for the election coming up in November, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.
Donald Trump (with running mate Mike Pence) will take on Hillary Clinton and Tim Kaine to see who will replace President Barack Obama in early 2017. The Democrats rallied round Clinton, with several key figures taking time out to heavily criticize Trump in their conventions speeches.
Obama called the Republican candidate a “home-grown demagogue”, and he was joined in his condemnation of ‘The Donald’ by big hitters Vice President Joe Biden, Kaine and even independent former New York mayor Michael Bloomberg. As Obama prepares to step down, one of his finest achievements during two presidencies has been his setting up, announced in early 2015, of the Precision Medicine Initiative (PMI).
In his State of the Union address, Obama said 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”.
The PMI programme began with committed initial funding of $215 million. The intention of the project is to build a research cohort of at least a million Americans, (over a three-to-four yearperiod, but it will look to increase that number down the line) incorporating information from genomic analysis as well as clinical information to inform on cancer and other diseases and integrate this into routine healthcare.
Regardless of who becomes America’s 45th president, it seems more than likely that PMI will continue to be rolled out - and that’s good news for patients across the United States.
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 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. Understanding of genomics has increased substantially since the year 2000, by which point the majority of the genome had been sequenced as part of the Human Genome Project. Research since that monumental time has greatly furthered understanding of the genome’s implications for health. These advances have been matched by a revolution in technology that has slashed the costs of sequencing and increased its availability.
In Europe, organisations 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.
A number of genome sequencing initiatives have occurred in the last few years to try and capitalise on the potential of cutting-edge genetics. Within the EU the UK has led the way with the 100,000 Genomes Project. This looks at the genome sequences of patients with a rare disease or cancer. It is highly ambitious and looking to develop the requirements for performing whole genome sequencing in a clinical setting (including appropriately educated workforce, clinical pathways and infrastructure) to derive patient benefit.
Along with this it looks to capitalise on the potential for multi-disciplinary collaborative research and stimulate the life science industry of a nation. Now, EAPM has put forward the idea of what it calls ‘MEGA’ - the Million European Genomes Alliance - on the basis that if the US can pull off a project of such magnitude with its 300 million citizens then, surely, the EU can achieve the same with 500 million across 28 member states.
Better use of our increasing understanding of the genome is recognized as being one of the main determinants of future improvement in health care as part of personalised medicine and is already being increasingly deployed in routine clinical practice. Sequencing of the all the genetic material of an individual, whole genome sequencing, is becoming an affordable and achievable test for clinical use and creates a powerful resource for research.
The availability of data from a large number of individuals increases the ability to investigate questions across a large number of diseases in different populations and also provides more information for understanding the results for clinical care in an individual.
Researchers would potentially be able to access millions of genetic markers and accelerate science towards better understanding of diseases and specific patients. Crucially, this would guide choice of therapy, prevention and screening programs, increasing overall health-care efficiency and patient outcomes.
These projects demonstrate the commitment at a national level and raise the question: ‘What benefits would be realised by undertaking a million genome project in a co-ordinated effort across European countries?’
EAPM and its stakeholders believe that a project of this magnitude would capitalise on previous and current European programmes to derive a number of benefits:
• Improve care across all stated health priorities and reduce current inequalities in access to innovative technologies such as genetic testing, with the most immediate health and care impact being on rare diseases;
• develop deeper and broader collaboration across European researchers and provide a database of enormous lasting value to this community;
• provide a positive vehicle for patient engagement on use of health data, involvement in research and become more active participants in their own health and health-care decisions;
• encourage clinical education programmes to develop a workforce capable of embracing the technology revolution in healthcare that is in progress;
• stimulate the European life science and health industry and embrace new companies active in this space focused on the European market, and;
• take advantage of the scale of Europe allied with the less fragmented and predominantly social health systems to lead in personalised medicine and achieve the health and economic benefits from increasing preventative and participatory health care.
The gene genie is already out of the bottle and, regardless of who is running things politically on either side of the Atlantic, the stopper cannot be put back in. Now is the time for Europe to react to Obama’s PMI with its own ambitious initiative.
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