David's New Book

Friday, October 21, 2016

Low Expectations

I don’t know about you, but for me, this is the season of low expectations.  My brother-in-law constantly reminds me to keep my expectations low and my standards high. In this US campaign season, I find that it is increasingly hard to avoid feeling blue by continually lowering those expectations.

A good example is the result of the UN General Assembly.  The opportunity to actually do something concrete about the emerging crisis of antibiotic resistance in the absence of a robust pipeline of new antibiotics was an exciting one. But as often happens when multiple players with competing interests get together to try and accomplish something, we now play a waiting game. Although what to expect at the end of the wait is not really clear.  Recently, Allan Coukell of the Pew Charitable Trust wrote a summary of the UNGA statement. 193 countries signed a political statement that is extremely vague and does not include any commitment for financial resources to spur innovation. 13 pharmaceutical companies signed a separate statement where exploring new ways for the public and private sector to collaborate to spur innovation was a goal. The divide between industry and government seems clear.  The UNGA expects to revisit the issue in two years.
What we need now is some way to assure antibiotic developers that they will achieve a return on their investment. There are a number of ways this could be funded.  First, the savings on health care provided by having the means to treat infections will be enormous – it just requires a capital investment in our future.  Second, if more immediate funding is required, we could charge a very small tax on current pharmaceutical sales that would be dedicated to an antibiotic market fund. This tax would be applied to all pharmaceuticals without exception – but would need to be pennies or less on the dollar.

A nagging worry for me is whether, at this point in time, even if we identify a financial mechanism to assure a return on investment, pharmaceutical companies will be interested enough to return to antibiotic research. I have been asking the folks at DRIVE AB to investigate this – but have heard nothing as yet. I recently heard that Merck was skeptical of the market entry rewards that we have been discussing.  They may be more interested in pricing and reimbursement as the preferred market mechanism.  That will likely remain the way forward in the US in any case.

We need to train our antibiotic hunters of the future before we lose all our expertise to the ravages of time and the current lack of funding for antibiotic research.

And we need to continue working on new regulatory pathways for antibiotic development – especially for pathogen-specific products.

We need to raise the prices of key generic antibiotics like penicillin to avoid drug shortages.

Beyond all this, we need to improve our surveillance globally, control the use of antibiotics in agriculture, and improve our stewardship of antibiotic use in humans. But even with these steps, we will have a constant need for new, effective antibiotics and for that we need to correct our current problem of the market failure for antibiotic discovery.

I find that I am unable to lower my expectations sufficiently to avoid this current state of depression around the state of progress in global antibiotic policies that is afflicting me. A sure cure would be the commitment of at least a few national authorities to the market entry rewards that Astra-Zeneca was negotiating before their antibiotics business was sold to Pfizer. But, alas, I fear that all this is now on hold.