I was beaming with pride in those who worked to bring the
public-private effort to fund a major new effort in the discovery and
development of antibiotics as was announced
yesterday. CARB-X will establish a sort of incubator for academic groups and
small or even mid-size companies, potential spin-offs and others working on
early to mid-stage antibiotic development. The entity is a partnership between Boston
University Law School (I’ll try and explain below), the Department of Health
and Human Services (BARDA) in the US, the Wellcome Trust in the UK and the new
AMR Centre also in the UK. The National
Institutes of Health will provide “in kind” support like access to their
preclinical services.
The really good thing about this is the clear recognition by
people with money that we need to develop new antibiotics to address the
emerging problems of antibiotic resistance today and those that will surely be
here tomorrow. Another potentially important aspect of this is the coalition
that brought this forward. But why Boston University Law School? Maybe because
that is where Kevin Outterson is. BU
will be the center of the advisory board for the effort and will include a mix
of scientists and clinical developers with experience in antibiotics. There
will obviously be legal issues around the formation of new companies, patents,
intellectual property and other topics that will require legal advice. Having a
legal team available to help will be important going forward.
I consider this a very important step forward. But at the same time, I have a few thoughts
for us to consider (and I’m not the only one). According to Kim Lewis, who spoke
with Asher Mullard for Nature (quoted here in Scientific
American), “If more money is going into the general area of
antibiotics, that’s a good thing. But I’m really surprised that we are getting
another influx of funds into development rather than into discovery.” The main
problem, says Lewis, is the lack of compounds that can punch through the outer
membranes of ‘gram-negative’ super-microbes such as Escherichia coli and Klebsiella pneumoniae. Researchers
need to work out how to systematically make or find compounds that can slip
through bacterial protective barriers, he says. And Kim is right. As Kim
points out, we need new compounds to develop. We absolutely need more money for fundamental
antibiotic discovery research. The NIH
has been woefully behind in their efforts in this important area (although they
have just had a new influx of funds).
Their “in kind” support mechanisms are helpful, but extremely slow and
bureaucratically cumbersome to use. Sure
– if you have no choice these services are a lifesaver for academics or even
small companies. But this could be done much more efficiently.
The
other problem I have been harping on (to no avail) for the last 12 years is the
lack of training for our antibiotic researchers and developers. Perhaps the CARB-X will provide this training as well, but it
seems to me that those who are untrained are simply not likely to be funded or “placed”
in the incubator.
Erik
Gordon, professor at the
University of Michigan's Ross School of Business, speaking
to CIDRAP News, was even more skeptical. "Antibiotic development needs the
backing of non-profit organizations to make the economics work," he said.
He added, however, "I'm not sure funneling that much money into an
accelerator system based at a law school, where few antibiotics have ever been
developed, with so many cooks, is the best use of the money or the best way to
develop the new antibiotics we need."
Another looming
problem
to be addressed has nothing to do with money.
At least some, if not most, of the antibacterial compounds that will
come out of CARB-X will be adjunctive therapies or perhaps pathogen-specific
therapies. We need a clear and feasible regulatory pathway for the
development of these compounds.
And this brings
me, finally, to post-market or “pull” incentives. That’s where the rubber hits the road, folks.
Very simply, if we don’t make the economics
work for antibiotics, we won’t have any.
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