PharmaTimes World News online talks to Professor Trevor Jones CBE, one-time Group R&D Director at Wellcome (and at Sigma-Tau) and more recently a Commissioner at the World Health Organisation, about Ebola and research on low-return medicines.
PT: Ebola was first discovered in 1976 and yet there is no approved treatment for the disease - are you surprised by this?
TJ: No. There are tens of thousands of “rare” diseases in both the Developed and the Developing World and there is simply not sufficient capacity/finance to tackle all of these simultaneously. Importantly, for infectious diseases that primarily afflict patients in the developing world, public private partnerships by the pharmaceutical industry, for more that a decade, have been addressing the major causes of morbidity and mortality (specifically, HIV/AIDS, malaria and tuberculosis…but also Leishmaniasis and other parasitic disease).
PT: Is the current drug development system fit for the 21st century?
TJ: Drug Development is in a constant state of change as our understanding of the complexity of diseases and their genetic variability unfolds. The system is heavily influenced by regulatory requirements. Whilst regulatory processes have, necessarily, been introduced to evaluate quality, safety and efficacy, arguably the balance of “risk” and “benefit” has swung too far such that the time to deliver potentially important advances to the benefit of patients world wide is now excessive. We need a better dialogue on this issue; particularly where the need is urgent…such as with the current Ebola outbreak.
PT: What can be done ensure that new treatments are developed for diseases that won’t reap massive returns for pharmaceutical companies?
TJ: The pharmaceutical industry has a proud record over the last century for developing medicines for Developing World diseases e.g. for Leprosy, Cholera, River Blindness and, for more than a decade, has been leading public: private partnership initiatives to introduce new, better and cheaper medicines for major diseases such as HIV/AIDS, malaria and TB. These are heavily dependent on charitable organisations, such as the Gates Foundation, for funding. The Dutch, Swiss, Irish, US and especially the British governments have made significant commitments to these endeavours, but more nations need to step up to the mark in the war against these diseases.
PT: It has been suggested that ‘prizes’ for new drugs, paid by governments, could encourage the development of low-return medicines - what are your thoughts on this?
TJ: The creation of ‘prizes’ to encourage pharmaceutical companies to increase their R&D on developing world diseases is a flawed concept. Often in drug discovery and development, several programmes run in parallel in different organisations in the same therapeutic area/disease. So, how many prizes should there be for each disease, just the first, or any that follow? What would the projected total prize money be, and, given the time it takes for discovery and development, are governments likely to be willing to commit to those totals over at least a 10-15 year period? What percentage of the cost of drug discovery and development would the prize need to be to incentivise small and large companies to invest in those diseases over and above their other portfolio projects? What assurances would the prize givers make to purchase and, importantly, deliver these new products once they are approved? And, what assurance is there that the process of selection and judging is free from political bias?
It is a sad reflection on the current state of world healthcare that despite the availability of medicines in the developing world...often generic and costing a dollar or less per treatment/cure… every minute a child in the developing world dies from an infectious disease. Of course we need new medicines, but the urgent priority is to deliver the products that currently exist to those in need and create efficient and effective pathways to deliver those in development.
PT: How can the value of a wider public health benefit be better recognised to promote pharmaceutical innovation in areas with small target populations?
TJ: The major causes of morbidity and mortality in the developing world are infectious diseases. The provision of clean water, adequate housing, sanitation and hygiene has shown - over centuries - to be the most effective means of reducing the burden and preventing the spread of such diseases. There is no doubt that, in addition, effective medicines are an essential element in this battle; not least in combating the rise in resistant microorganisms whether these be bacteria, viruses or parasites. Healthcare providers should understand that prevention and early treatment of infectious diseases is not just life saving but also cost effective and work with the pharmaceutical industry to ensure that the infrastructure (and funding) is in place to deliver these benefits.
PT: Do you think the situation with Ebola, and the fact that the WHO has fast-tracked experimental therapies, might drive a shift in drug development and regulation?
TJ: The current Ebola crisis has certainly woken up many authorities to the need to revisit their requirements for early access to potentially life saving/modifying new treatments. This is equally the case for diseases of both the developed and the developing world. There needs to be careful dialogue on for which conditions early access is appropriate and the criteria that should be applied in any particular disease. Fortunately, in recent years, the European Medicines Agency and the US Food and Drug Administration have already initiated such discussions…especially for those conditions which are life threatening and for which no adequate treatment exists. The Ebola situation is, perhaps, somewhat unique, but should act as a spur to more detailed discussions on how to balance “risk” and “benefit”; a discussion that must include patients.