The latest installment of Jim O’Neill’s report for the UK government on
securing a future for antibiotics has just appeared. Like the other chapters of the report, there
is much to like here. But when it comes
down to the key next step – money – his shot is wild.
Entitled, “Securing New Drugs for
Future Generations,” it suggests three interventions to get us across the
goal. (1) Create a more predictable
market for new antibiotics. (2) Provide focused funding for early research into
new antibiotics. (3) Create centralized platforms for the efficient clinical
development of antibiotics targeting resistant pathogens. There is nothing new in any of these
proposals – but its good to get confirmation from a task force with the stature
of this one. In fact, we are already doing (2) and (3) – jut not enough and not
very well. Partly, this is a problem of
training, something O’Neill does not discuss. What we are not doing at all is
(1).
O’Neill suggests a global buyer provide somewhere in the
range of $1-3 billion as an upfront payment for an appropriate new
antibiotic. The global buyer, by such a
purchase, would immediately provide a significant return on investment to the
company that developed the antibiotic.
The buyer would then distribute the drug according to demand and need and
would monitor usage. Such a payment would immediately de-link marketing from
sales or use of the antibiotic since the buyer would be the distributor. The
obvious problem with this is to try and designate such a global buyer who could
actually coordinate distribution and use on a global scale. The only entities I
know who come close to this are pharmaceutical companies and they are not so
good on the stewardship side of things. Governments are notoriously useless
here to say nothing of WHO or the UN or the EU.
A hybrid approach includes an upfront payment that reimburses
costs of development including prior failures – still in the $1-3 billion range
– but that allows the company to sell and make its profit in that way. But here, the price would remain low since
the company no longer has to make up its research investment. The de-linkage and stewardship components
would not be the same, but would be much easier to manage since sales pressures
would be lower.
O’Neill, for the most part, dismisses high prices as a way
forward. My own belief is that his other
proposals are simply not implementable on this planet today. Therefore, a model including high prices in
some markets (US, I’m talking about you!) is inevitable. Further, a global buyer is off the table. Funds from governments where individual markets then work out their own distribution systems - probably involving the pharmaceutical company - is a much more realistic way forward.
The report also includes a proposal on funding early
research and here O’Neill takes a page from the Innovative Medicines Initiative
in Europe and suggests that the pharmaceutical industry fund these efforts.
Well . . . .I think maybe too much beverage from the northern reaches of the UK
was available when the committee was thinking about this one. There is a dearth of funding for research
largely because the pharmaceutical industry has abandoned the area. Why we think those companies who have
abandoned antibiotics will now fund research in the area is beyond me. Of course, if large, upfront payments become
a reality, this might happen – but not before.
The final portion of the report is dedicated to centralizing
the clinical development of antibiotics using centers designed to provide
patients to participate in such trials.
There is also the requirement that regulatory requirements for trials be
harmonized. This, currently, is mostly the
case for the US and EU – even though trial endpoints differ in the two
jurisdictions. But this issue is
relatively easily handled through the use of two different statistical analysis
plans, one for the EU and one for the US.
Its outside of these jurisdictions where things are getting stickier
these days and O’Neill’s report does not go into those issues.
So, while I think that the report is a good one in terms of
the monetary figures proposed, in terms of practical implementation, we seem to
still be in Neverland. Sorry, Jim, but the UK is actually going to have to put
up real money, as will its European (for now) colleagues. I think the US will remain the land of high
prices.
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