Friday, September 15, 2017

Antibiotics and Climate Change

What do antibiotics and climate change have in common? We have our heads in sand for both.  If we can’t see it, it won’t hurt us. I was inspired by an article in the New York Times today on climate change contending that even some Republican congressmen and senators are reconsidering their hardline positions on climate change in the wake of hurricanes Harvey and Irma. I asked myself , “Is this what it takes? Do we have to suffer through death and destruction to recognize the accuracy of climate science?”  If the answers to these questions are “yes,” then I guess we also have to wait for the antibiotic apocalypse before we get a substantial change in policy.

On the antibiotic-resistance front, we seem to be able to insist on antibiotic stewardship.  Initiatives from the Centers for Disease Control with enforcement through the Center for Medicare and Medicaid Services assure that hospitals and now outpatient and even long term care facilities will establish antibiotic stewardship programs in the US. But these regulatory moves (mandated by the 21st Century Cures Act) don’t cost much in terms of real government funding and, ultimately, will probably save healthcare dollars. The same thing is true for regulatory moves that will establish feasible and rapid clinical development pathways for antibiotics that target very specific, small populations of patients such as those that are only active against a single species of bacterial pathogens (Limited Population Antimicrobial Development [LPAD] in the 21st Century Cures Act) (LPAD Guidance is expected soon from FDA).  All of this and more in the 21st Century Cures Act is good and we should all be thankful that Congress was able to get its act together and pass this important legislation.
But all of this, including the critically important regulatory innovations will be for naught if we don’t fix the broken antibiotics market. Without a clear path for a return on their research and development dollars, private industry will simply not invest.  Companies that are currently investing in the area may finally give up the ghost and, like many before them, abandon the area altogether.

In thinking about the climate change article in the Times, I am reminded of the global pandemic of methicillin-resistant staphylococcal (MRSA) infections that began in the early 1980s. By the 1990s, MRSA became part of common language.  I gave a lecture at a retirement community yesterday and everybody recognized the term, MRSA. These resistant isolates grew to 30-50% of all staphylococcal infections, and in emergency rooms, up to 70% by the turn of the century.  Until 1999 there was only a single reliable antibiotic to treat serious MRSA infections – vancomycin.  By 1989 vancomycin resistant enterococcal (VRE) infections had emerged and were causing havoc in US intensive care units.  In 1999 linezolid (Pfizer) was approved and in 2003 daptomycin (Cubist) was approved.  Both these drugs became over $1B per year sellers because they offered an alternative to the only other drug available for MRSA, and they offered possible therapy for enterococcal infections as well.  But look what we had to endure before these drugs came out.

Today, we are dealing with KPC, NDM-1, Acinetobacter and other highly resistant infections.  Yes, we have drugs available today that we didn’t have just a few years ago and we have more to come in our thin but existing pipeline. The question is, will we have to wait until emerging resistance in Gram-negatives becomes like the MRSA and VRE of this century. To be assured of a robust antibiotic pipeline, we must take this last step and provide an assured return on investment for those companies that deliver such needed new therapies. If we wait for the apocalypse, it will take us a decade or more to rebuild lost abilities to discover and develop antibiotics.

There have been a number of well-considered proposals on how to fix this broken market (stay tuned for more details). All involve spending real money.  I’m talking about a total of $2 billion per year for 10 years globally.  The US share would depend on which other countries would partner with us (I assume Europe would do so. China?). And here we run into the problem.  Just like climate change, we would have to spend real money.  Of course, compared to jet fighters, nuclear arsenal maintenance, and other priorities, $20 billion over ten years is peanuts. But to our administration and to congress, this seems to be an insurmountable obstacle.

Please – lets not wait for the apocalypse. Lets do something now before we lose more companies and more expertise to denial of the inevitable.

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