Surprise! The big
news this week is that antibiotic resistance is getting worse here in the
US. The CDC has been following
carbapenem-resistance in Enterobacteriaeceae over the last decade. Do they do this in a systematic and
prospective way covering all of the US?
Is this a reportable infection?
No and no. The data
they show is still disturbing. Among
Klebsiella, carbapenem resistance has gone from 1.6 to 10.4% in the National
Nosocomial Infection Surveillance data and from 0 to 5.3% in the Eurofins TSN
microbiology surveillance network over the last decade. The data only go up to 2011 – so expect 2012
to be even worse. The CDC data does not address carbapenem resistance in other
important Gram negative pathogens like Pseudomonas and Acinetobacter.
It is time for the CDC to start easing off on MRSA
surveillance and to start working on Gram negative resistance – especially
resistance to our last line of antibiotics for Gram negatives, the
carbapenems. Many of these strains are
either completely untreatable or are only susceptible to antibiotics that have
not demonstrated efficacy in very serious infections like hospital acquired
pneumonia caused by these strains (tigecycline and colistin). Based on data from 2007, about 63,000
Americans suffered such highly resistant infections in hospitals every
year. That number has certainly
increased and may have even doubled since then.
One might cynically ask why the CDC is publicizing these
data at this moment in time. Is it
related to funding concerns with the sequester looming? If so – more power to them – but they need to
focus on the emerging resistance issues and public health threats of today. And – we need prospective active and ongoing
surveillance to get accurate population-based incidence rates for these
resistant infections.
At the same time, the FDA seems to be trying to reboot. This reboot is absolutely required for us to
have the robust pipeline of new antibiotics we need to combat these resistant
infections. As noted in the last blog,
the FDA has been involved in a number of fora recently including a public
hearing on the LPAD pathway for rapidly getting new antibiotics active against
these highly resistant pathogens to patients who desperately need them. But
they have also stopped following their own guidance on more traditional
antibiotic development pathways. In this
regard, I pointed out at the last Brookings meeting that the FDA MUST go
public. Either the guidance documents
must be revised to reflect the actual guidance they are currently providing to
sponsors (this will take a long time) or they need to publicly note which areas
of guidance they are no longer following.
They are allergic to “guidance by pulpit” – but they have to do
something to get their current thinking out to the public.
As you faithful readers would have seen from my blog Calling
All Large PhRMA back in December of last year, I invited a number of
companies who had abandoned antibiotic R&D to get back in. I believe that Roche-Genentech is dipping
their toes in the water with a new deal with RQx
to discover new antibiotics active against bacterial signal peptidase. Whether this can be called a victory for the
pro-antibiotics effort or not is hard to tell.
Lots of companies have already broken their teeth at least once on this
target – but maybe RQx-Genentech have something special going on.
In addition to the blog, I wrote several companies. I had a response from one – who said no
thanks. I know that that particular
company is well versed in what is going on in terms of the new regulatory
environment and potential for new pricing models for antibiotics – so their
decision seems to have been deliberate and strategic for them. But for the rest – no response. Is this
because they have given this possibility careful and informed consideration and
decided not to go forward or is it because they no longer have the internal
expertise to even think about getting back into antibiotic R&D? Is it because they couldn’t care less? I have no idea.
But the FDA going public might help encourage companies to
get back in. So – FDA – back to you!
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