Wednesday, April 6, 2011
Antibiotics - World Health Day 2011
Tomorrow is designated World Health Day by the World Health Organization. This year, appropriately, it targets antibiotic resistance. WHO Director General Dr. Margaret Chan says,
On this World Health Day, WHO is issuing a policy package to get everyone, especially governments and their drug regulatory systems, on the right track, with the right measures, quickly. Governments can make progress, working with health workers, pharmacists, civil society, patients, and industry. We all can plan and coordinate our response. We can expand surveillance efforts. We can improve drug regulatory and supply systems. We can foster improved use of medicines for human and animal health. We can actively prevent and control infections in health services and beyond. And, we must stimulate a robust pipeline for new antimicrobials, diagnostics and vaccines.
Of course, number one on my own hit parade to fix the antibiotic pipeline is the FDA. Clearly, companies will continue to abandon the area if the FDA follows its current course of releasing trial design guidelines that are infeasible. But number two on my hit parade is providing incentives designed to make it possible for biotech companies and academia to develop new antibiotics all the way to market if necessary. We need incentives that will take the need for the deep pocket large pharmaceutical companies out of the equation since there are now so few that are actually pursuing new antibiotics either from a discovery or an in-licensing standpoint.
The perfect storm swirling around antibiotic R&D and incentives that might work to ameliorate the situation are discussed in an article that just appeared in the journal Nature today - Fix the Antibiotics Pipeline – by Matt Cooper and me. We recommend the push-pull package of incentives proposed by the London School of Economics which is currently being considered by the European Commission. In the LSE’s proposal, the push includes funds to support development. We believe that this must include the expensive phase III trials required for registration. This push essentially de-risks late stage development and makes the earlier funding well within the reach of venture capitalists and even some government grants like those obtained through NIH and BARDA. The pull would come from some guaranteed market such as a purchase of government stockpiles upon approval. The size of this purchase would probably have to be several hundred million dollars spread over the first year or two post-launch. Such an investment provides an immediately positive NPV, especially when combined with the push. The pull will also help attract larger investors such as the large pharmaceutical companies and even possibly private equity investors into the mix. The availability of new, effective antibiotics to treat serious and deadly infections caused by highly resistant pathogens will save lives and will provide a significant economic benefit to governments therefore providing a rationale for the push-pull approach.
It seems likely that, here in the US, given the current political climate, such incentives will not be forthcoming in the near future. That leaves us dependent on the European Commission to bail us out. Further, the push-pull is not viable if the European regulatory agency, EMA, goes the way of the FDA. In that case, even if one could provide a push-pull incentive, no new antibiotics will be approved since the trial designs required for registration will still be infeasible. I have to say that I never thought I would see the day when the world was depending on Europe to save us from the scourge of resistant bacteria we now face. But here we are.