Wednesday, March 18, 2015

Jim O'Neill for the UK and Antibiotics!

The Prime Minister of the United Kingdom, David Cameron established a commission chaired by Jim O’Neill, an accomplished economist, to lead a review of the antibiotic-resistance crisis and to make recommendations on what to do about it by mid-2016. The commission, with help and sponsorship from the Wellcome Trust and the British Government has already published three reports.  The first was a rather exaggerated view (my opinion) of the world if resistance had become so widespread that antibiotics no longer worked.  The economic consequences of such a catastrophe were estimated in the$100 trillion range globally. Of course, this provides a wide range for the economics of proposed solutions to come later . . .

The second report – the most interesting in my view – is a survey of folks carrying out research and development of antibiotics. The commission asked small, medium sized and large pharma companies and non-profits a number of questions. Barriers to investment in antibiotic R&D were those described in my book – Antibiotics the Perfect Storm.  The most important was one of return on investment where 30% of products from the 1990s failed to provide such. Next was the scientific difficulty of discovering new products. Third was the regulatory risk where the FDA was the most often cited problem but 55% cited Europe as well.  The respondents were encouraged by recent actions at these regulatory agencies but most felt they could go farther.

The most likely drivers of research according to the respondents are early grant funding (e.g. IMI and BARDA), higher prices and better hospital reimbursement.  I was surprised to see longer patent life at number 4 but I attribute this to the smaller companies and non-profits in the survey.  I was also surprised to see that patent vouchers was not a popular solution anymore.  This must be because pharma companies are rapidly running out of the double digit billion dollar blockbusters they had when patent vouchers swere first proposed back in the early 2000s. (A patent voucher would allow you to get extra years of exclusivity on a high earning product in return for introducing an antibiotic active against resistant pathogens to the market).
The first report to deal with proposed solutions is number three on O’Neill’s list of released reports. To me, one of the most important observations contained in this report is the paltry funding of antimicrobial resistance work by the NIH in the US.  Figures from the UK’s MCR are not presented (hmmmmm). One of the suggestions is a global innovation fund to supplement the obviously inadequate availability of funds from existing sources (NIH, MCR, IMI, BARDA, etc.).

The other issue O’Neill notes is related to attracting researchers into the field of antibioics and resistance research.  He suggests the establishment of centers (centres) of excellence to carry out this work.  In my view, this will only be practical if it includes training in antibiotic discovery and development with everything from preclinical to manufacturing to formulations to clinical development.  This is a tall order and it better happen soon because we are losing trained experts by the second.

All in all, the O’Neill effort will supplement  and in some ways surpass the US PCAST report in its detail and recommendations.  But, given Prime Minister Cameron's drive to austerity, we may end up with the same admonition at the end of it all.  Show me the money!!

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