Larsen: I think, to that point, there is not going to be a silver bullet when it comes to an incentive for every single company and for every stage of development. What we really need to be putting on the table is a constellation of incentives that almost ideally would be like an à la carte menu of incentives that companies could go and select based upon the products that they’re developing and their end markets. That’s really where a lot of discussion is around both higher reimbursement, transferable exclusivity vouchers, market entry awards, tax credits. All of that could play a potential role in changing the NPV calculation to something where, in my view, we get to a point where companies are driven to invest in the next compound that they’re developing, because of the profits they’ve derived from the first one.

Kennedy: That’s a very important point, and I think that the reason antimicrobial resistance is so predominant today – and such a scary topic – is because I remember Jeff Stein requoting the surgeon general who in 1965 said, "Infectious disease: Check, we’re done."

We’re never going to be done with infectious disease, so we have to have a set of sustainable, long-lasting incentives that encourage continual activity in this space, because bugs are really smart, and whatever we put forward to deal with these infections, they’ll come up with a way around it. So we need to be ahead of them, not trailing these clinical challenges.

And the only way to do that is to view antibacterial and antifungal products almost like medical infrastructure that you need in order to be able to practice medicine in the best way. And if you don’t invest in your infrastructure, bridges fall down. Things happen. And routine surgeries and cancer treatments become much more challenging than they used to be.

I think that if we change the mindset around antimicrobial products to be things that are not optional – they’re not a nice-to-have, they’re a must-have – we can continue to improve outcomes for patients. That’s a very different type of a mindset.

Schroeder: Yeah, and I agree that [what's needed are] a constellation of not only incentives, but a constellation of policies as well. Because we need to address the agricultural use of antibiotics and we’re actually doing a better job of that in the United States, but we’ve got a long way to go. We need to think about stewardship in an appropriate way; what are the appropriate uses of antibiotics or antimicrobials? And not just as a cost containment exercise, but as a legitimate view toward, how do we best treat this patient when they present?

Because the truth of the matter is, if you kill a microbe dead at the beginning, they don’t replicate and they don’t evolve. It’s the survivors that you worry about. It’s the survivors that come back that kill you. And I’m not a big fan of the WHO guidelines, because I think they’re a little naive, because they’re kind of moving towards saying, “Well, use these less effective antibiotics first and see how they do." (Also see "Latest WHO Essential Medicines List: New Drugs And A New Way Of Tackling Antibiotic Resistance" - Pink Sheet, 6 June, 2017.)

Kennedy: You’re just promoting resistance.

Schroeder: You’re just promoting resistance, so I’m not sure that those guidelines really address the problem. Maybe in some developing parts of the world where they’re not getting antimicrobial exposure at all, that’s appropriate. I’m not sure in the developed Western world that’s really going to solve our problem. I actually think that the US has done a better job – and Europe has done a better job – of it.

Larsen: What you’re saying is getting people off of empiric treatment, and to do that we need diagnostics, and we also need a business model that’s going to reimburse the use of diagnostics, and we’re not there. I’m not defending WHO, but I think their intent was that, for the vast majority of infections, they are still susceptible to generic antibiotics, and those should be used and preserve the newest antibiotics for when we absolutely need it.

But that, of course, does not engender high profits. Our current business model for antibiotics is completely counter to what we want to do from public health objectives, and it hurts industry making profit enough to make reinvestments in the R&D pipeline. We need to be thinking of different ways to address that.

AMR Roundtable: The Push And Pull Of Antimicrobial Development Incentives (Part 1)

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