When will personalised medicine deliver on its promise?
A recent survey has attempted to identify why the deployment of personalised medicine into mainstream medicine is occurring so slowly. With its promise of more effective treatments with fewer side effects, personalised medicine has the potential to be a significant medical development, but there are many barriers hindering development that will require EU action if they are to be resolved.
"That there should be a European dimension is a widely held view," Richard L. Hudson, CEO and Editor of Science|Business, told Pharmaceutical Technology Europe in an exclusive interview. "Our survey, conducted with the Swedish medical university Karolinska Institutet, found that 80% of respondents support EU coordination — a pretty radical view, given that the provision of healthcare is a national, not EC, responsibility."The survey — a lengthy questionnaire aimed at examining the promise and problems of personalised healthcare — was sent to more than 800 healthcare specialists in Belgium, France, the Netherlands and the UK.
So what are the problems facing the implementation of personalised medicine? A principal issue is cost. Although 46% of survey respondents expect personalised medicine to lower medical costs in the longterm, 38% and 58% believe that it will raise costs in the long- and short-term, respectively.
According to the Science|Business report, The Promise of Personalised Healthcare in Europe, which is based on the survey results, the general picture is that costs will rise before they fall, which is an obvious barrier. "Human nature being what it is, present pain usually gets more attention than future gain," says the report.
"Beyond science, such as the identification of biomarkers and understanding of biology, the biggest barrier is finance," said Hudson. "Seventy eight percent of respondents identified insufficient investment and funding as a significant barrier."
Another issue, which will come as no surprise, is the regulatory system. "More than 60% say the absence of clear regulatory guidelines is causing delay. Not surprisingly, industry executives feel this most strongly, but patient advocates fully agree with them."
Fortunately, initiatives are already taking place at the European Medicines Agency (EMA) that may go some way to aiding the situation. Hudson explained that the EMA has already published guidelines for the development of biomarkers, and is also developing its first guidelines regarding the use of biomarkers in pharmacokinetics.
Bet, but don't bet big just yet
Although personalised medicine is disrupting traditional healthcare models, Hudson adds: "It's both exciting and scary for the industry — much like the way personal computers and the internet turned the electronics, computing and media industries upside down, creating new winners and losers. Disruptive technologies upset the old order in every industry."
So what must companies do to stand any chance of success in the new order of healthcare? In truth, nobody really knows. "The technical issues will be resolved — that's a challenge well within the capability of the pharmaceutical industries, biomedical researchers and the wider business world to solve, but the real wild card is the public sector," said Hudson. "Even today, for breast cancer treatment, in many European countries Herceptin diagnostics are simply not used by doctors nor reimbursed by the insurers or health services — this is despite years of evidence that tandem diagnostic/drug treatment is vital to the treatment's success," said Hudson.
In the present situation, the advice from Hudson is: "Don't get left behind, but equally don't yet bet the whole company on it."
The full interview with Richard L. Hudson can be read at: http://www.pharmtech.com/hudson