NYTimes: Government Needs to Aid Industry Research
Brad Spellberg is a professor of medicine at the Los Angeles Biomedical Research Institute at Harbor-U.C.L.A. Medical Center. He is the co-author of “Rising Plague: The Deadly Threat from Deadly Bacteria and Our Dwindling Arsenal to Fight Them.”
New antibiotic approvals by the Food and Drug Administration have declined almost 90 percent over the last 30 years. This antibiotic market failure is largely due to unfavorable economics (low revenues for antibiotics) and hostile regulations (clinical trials are riskier and more expensive than previously).As a result, in 2011 the London School of Economics estimated that a typical, newly discovered intravenous antibiotic was worth minus $50 million to a company. No wonder we have a market failure.
We need new economic approaches to rekindle the antibiotic pipeline. Economic incentives that don’t kick in until after a drug is approved (e.g., prolonged market exclusivity, prizes, guaranteed markets) are inefficient because their value is greatly eroded by time discounting (a standard economic practice in which future money is devalued to account for risk and inflation).
In contrast, “push” incentives act earlier by reducing up-front development costs and risks, and are subject to less time discounting. Public-private partnerships are potent push incentives, joining public dollars with industry to encourage specific programs that meet a need. Such partnerships for antibiotics are principally funded in the United States by the Biodefense Advanced Research and Development Agency, the National Institutes of Allergy and Infectious Diseases and agencies with theDepartment of Defense, and in Europe by the Innovative Medicines Initiative. Working with industry, these agencies are providing “life support” for the moribund antibiotic pipeline.
These partnerships also help tailor antibiotic development to less common resistant infections that have limited alternative therapies, rather than zeroing in on common infections for which numerous treatments are already available. This is a new concept that we must encourage. The limited scope of approval and higher pricing for such antibiotics will protect them from overuse, so they will remain effective longer.
Another, new and transformative approach is to develop drugs to prevent microbes from causing disease without seeking to kill them, which should cause slower emergence of resistance.
In parallel with economic incentives, the Division of Anti-Infective Products at the Food and Drug Administration needs to continue to reform its approach to antibiotic clinical trials. In an encouraging 2012 meeting at the Brookings Institution, F.D.A. leaders announced a “reboot” of their approach. We need the F.D.A. to establish feasible, sensible and patient-centric rules governing antibiotic clinical trials. The European Medicines Agency has led the pack, and we need to learn from them. In this era of global economy, a regulatory approach harmonized across nations ultimately will be required.
Read more in NY Times on topic: http://www.nytimes.com/roomfordebate/2013/12/29/avoiding-a-time-when-bac...