Friday, July 29, 2016

Money for New Antibiotics - What Could be Wrong with That?

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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