Global spending on pharmaceuticals is predicted to reach one trillion dollars per year by 2017. But how many of those products will actually work for those they are treating? Would you believe that in 2011 it was barely a third in some cases!
According to Professor Bjourson: “The one size fits all approach to medicine doesn’t work for most people as we all respond differently to drugs because of our genetic make-up and our environmental exposures.”
The answer, largely made possible by the sequencing of the human genome, is personalised or stratified (aimed at a strata of the population) medicine. “This is a way of analysing our genetic make-up,” Professor Bjourson says, “so that, along with the use of clinical data, we can much more accurately diagnose and treat disease in individuals.”
It is hardly surprising that stratified medicine was identified as a priority by DETI, the Public Health Agency and Invest NI some five years ago, leading to the setting up off the centre. This revolution in medicine will bring improved targeted screening and treatments to hundreds of millions around the world who may have failed to respond to drugs which don’t work specifically for them.
And, with the Centre for Stratified Medicine at its heart, the North West will become a key region for this pioneering work, leading to numerous possibilities for investment.
It will also allow pharmaceutical companies to target their products at those for whom they know they are more likely to work. That will make the process both far more efficient for doctors and patients and more profitable for the pharmaceutical companies.
The Centre for Stratified Medicine which undertakes research in several areas, including heart disease, strokes, dementia and cancer, is a partnership between its host, C-TRIC, the Western Health and Social Care Trust and the University of Ulster Biomedical Sciences Research Institute. Professor Bjourson is director of this highly rated Institute, which incorporates the new Northern Ireland Centre for Stratified Medicine.
“Yet, currently, many treatments exists on a largely trial or error basis. For instance, it is estimated that for 90% of prescribed drugs, up to 30 to 50% of patients will not respond to treatment.”
Professor Bjourson gives the example of the treatment of type two diabetes. “A patient may be prescribed a particular drug for a period, then recalled to see how it is working. If they are not responding the patient may be prescribed a different drug and so on. It’s not that there is negligence on the part of the clinicians, it’s simply the best that can be achieved with current technology.” But it’s not just wasteful of resources. In some cases adverse drug reactions can be life threatening so the trial and error approach is simply not good enough.
Similarly with mental health issues, clinicians don’t have the tools to identify which drugs patients will respond to. The problem is also particularly worrying in some cancers where positive responses to treatments can be very low.
The answer? The Centre of Stratified Medicine has been working on a blood test which can determine who will respond positively to these drugs and who won’t. Firstly, they discovered genes associated with the response or non-response to the drugs and carried out tests on 330 volunteer Rheumatoid arthritis patients, partly at C-TRIC.
There is another major obstacle with the current approach that impacts on the development of treatments. “Many drugs fail clinical trials because they will only work on a small percentage of the population and they therefore fail clinical trials and are not commercially produced,” Professor Bjourson says. “But if you have a tool that will identify who belongs to that small group of patients that will respond to a particular drug, then you have a drug that can obtain regulatory approval and a marketable product. So, far from being a threat to pharmaceutical companies, this is a way to develop new niche drugs or rescue previously failed drugs and boost profits by developing more personalised therapeutic products.”
So using genetic and clinical data, researchers at the centre are working to create more personalised forms of treatment, identifying drugs that meet the specific needs of individual patients. They are also looking at better diagnoses of disease and at diagnostic devices too, such as the blood test they are developing in tandem with Randox Laboratories.
A class of drugs –called anti-TNFs – have been developed which very effectively treat inflammatory conditions such as Rheumatoid arthritis. This condition affects up to 580,000 adults in England alone. The problem is that 30% to 40% of rheumatoid arthritis patients don’t respond to these new drugs, and at a cost of £10,000 per patient per year, that’s a very significant waste of money.
They then collaborated with Randox Laboratories, leaders in the field with a global operating market, to produce a diagnostic test that identifies who is suitable for this treatment and who is not.
With this revolutionary new approach to medicine comes new demands. “One of the problems with stratified medicine,” Professor Bjourson says, “is the shortage of graduates who combine pathology, bio medical and IT skills, which are so important in this area of research. As well as the ability to see how a cancer develops, for instance, you also need maths and computation skills.”
And, as Professor Bjourson adds, ‘this is a great region for companies to locate to; a skilled workforce, reasonable costs and a nice environment for families, with good schools and lovely scenery.”
To help counter this shortage, the centre is offering the first undergraduate degree course in stratified medicine, teaching both bio medical and IT/computational skills. It’s the only place in the UK and Ireland offering this course. “It has been estimated that it will take up to 15 years to upskill doctors, nurses and technicians in this area, so we also offer an online postgraduate course,” Professor Bjourson says.
Since opening, the centre has appointed fifteen new research lecturers, five research associates to work with them, one technician and an administrator and they are taking on 15 new PhD students. But that is just the beginning, according to Professor Bjourson: “We will grow. As well as our very strong academic research base, as the students on our course graduate we will have a highly skilled workforce that is unique in the world.”