Friday, August 29, 2014

Labor-day and Antibiotics

Today is the beginning of the Labor Day weekend here in the US. I find my thoughts turning to all those who fought so long and worked so hard to bring new antibiotics to the patients and physicians who so desperately need them. At the same time, I find it depressing to see that the future of antibiotics is as threatened today as it was a decade ago. This seems true even though the FDA awoke from their Ketek-induced psychosis over two years ago; even though the world has never been so aware of the threat of antibiotic resistance; even though more new antibiotics have been approved over the last year or two than over the previous 10 years; even though there is greater understanding of the economic value of antibiotics today than ever before and with this, a greater willingness of private investors to fund antibiotic-focused biotech. Why are antibiotics still under the gun?

I hate trying to answer “why” questions. I think that the answer lies in a congruence of events. First, there is that big gorilla out there – Pfizer. Pfizer is once again looking for an acquisition – preferably one where the tax bite is less.  The two main candidates people are discussing are AstraZeneca and Actavis.  It just so happens that the entire avibactam B-lactamase inhibitor pipeline of three combinations – all with varying activity against highly resistant superbugs – are owned jointly by these two companies.  Yet Pfizer is the company that jettisoned their entire antibiotic research and development group several years ago.  AstraZeneca is the company that is still considering dumping its antibiotic research effort because they worry, in spite of all the evidence to the contrary, that they will not make a sufficient return on their antibiotic research investment. The loss of the antibiotics efforts of AstraZeneca would be a serious blow to antibiotic research.  The loss of Actavis as well – in spite of all their issues – would only make things even worse. The optimism that currently reigns over private investment in antibiotic research could evaporate overnight. 

Then there is the persistent worry  that nations and societies will be unwilling to make antibiotic research provide an appropriately valued return for the research investment.  So far, there has been much talk, many taskforces and no money.  Show me the money!

Finally, there remains a certain regulatory uncertainty since no one has yet successfully undertaken the kind of feasible trials outlined in both European and US FDA guidance focusing on resistant pathogens.  Until this occurs, or we somehow get more assurance from the regulators that they will, in fact, entertain such designs, this uncertainty will persist.

In spite of all this potential doom and gloom, I remain the optimistic pessimist.  I just can’t help believing that everything will somehow work out such that we do have a future with the antibiotics that we need.  In that light, at the start of this Labor-day weekend, I raise my glass (even though its still early today) to all those who have dedicated their lives to the search for these new antibiotics.  May you all have all the success that you and all the rest of us deserve!

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