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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