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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