There has been much press lately about President Obama’s
plan to address the growing crisis of antibiotic-resistant bacterial pathogens.
And I agree with many that there is much to like in the plan. But I also find a number of key deficiencies
that will lead us nowhere.
The goals of the plan are all laudable –
1.
Slow the emergence of resistant bacteria and prevent the spread of resistant
infections;
2.
Strengthen national One-Health surveillance efforts to combat resistance;
3.
Advance development and use of rapid and innovative diagnostic tests for
identification and characterization of resistant bacteria;
4.
Accelerate basic and applied research and development for new antibiotics,
other therapeutics,
and vaccines; and
5.
Improve international collaboration and capacities for antibiotic-resistance
prevention, surveillance, control, and antibiotic research and development.
Who
can argue with that?
To
achieve the first goal, the plan contains a number of key elements. Among them are strengthening of antibiotic
stewardship in both inpatient and outpatient settings including long term care.
Surveillance is to be strengthened by providing regional reference centers to
detect resistant strains in clinical and veterinary settings. Importantly,
there is a plan to streamline the regulatory process for approving
susceptibility-testing devices such that they are available when a new
antibiotic is marketed instead of the one to two year delay that now
occurs. I like that one especially.
Another piece of this plan is to establish a national database on antibiotic
use. That’s another one I like, but man, will that be hard to implement.
An
obvious goal is to eliminate the use of medically important antibiotics as
growth promoters in animal feed.
Wow. What a surprise. But the plan does not include an outright ban.
Rather, it supports the FDA’s efforts, which could ultimately succeed, I
suppose, to get the industry to back off. But why is there such consternation
around an outright ban? I don’t know.
One
piece of the plan calls for establishing a susceptibility-testing network for
animal pathogens. It seems like this is
aimed at providing better and more focused therapy for infected animals. Good idea. What
this will require is an entirely new approach to animal pathogens including
setting breakpoints for what is considered resistant or susceptible in
different animal species. Right now, the
assumption is that animals are humans – which I can tell you - physiologically,
they’re not. Who is going to do all the sophisticated PK/PD experiments in the
different species to establish these breakpoints? Is there going to be funding
for this piece? Or is there no one but
me who sees this as a possible pitfall?
The
there is the section on establishing rapid diagnostic testing. See my blog on this. I say again.
It has to be bedside and idiot-proof.
This could take a while, folks.
Finally,
there is the part on accelerating both basic and applied research aimed at
finding new antibiotics, vaccines and other therapeutic approaches. But the way
this is worded sounds like a way to let the NIH off the hook. For the last 50 years, the NIH has been
shortchanging antibiotic research and funneling money into the study of
vaccines and pathogenesis of infections.
I don’t argue that these are not worthy of study. I just will state that antibiotic research
has always gotten the short end of this stick.
And, if I read the plan correctly, this is unlikely to change in the
future.
What
is glaringly absent from the plan is what was recommended by PCAST in terms of
providing for a return on investment for companies who pursue the research and
development of new antibiotics for resistant infections. Of course, that was
the most expensive part of the PCAST report.
That report would augment funding for BARDA in its effort to support
applied research in academia and industry. It would also provide for various
pull incentives such as an upfront purchase or so-called patent voucher system.
Without this, as far as the development of new antibiotics is concerned, the
plan is another piece of paper in a long line of such. Show me the money!!!
So
here we are. There is much good here.
But it is clear that the much-touted “doubling of funding” that the
press is so excited about is less than it seems. Not only that, but what makes
anyone think that the President’s budget, where this plan is enshrined, will
pass? If it does, will it have to do so on the back of Medicare, Medicaid or
food stamps? I’m sorry – but my eyes are on Jim O’Neill and the UK for now.
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