Friday, May 15, 2015

O'Neill's Latest - Antibiotics in Neverland

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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