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Tuesday, December 2, 2014

If you think Ebola was bad...



"It's all hands on deck, 24/7, for Ebola," one prominent federal health official told me during the hysteria, but "we're ignoring antibiotic resistance."

Yet, each year, more than 5 million people in the U.S. and Europe become infected with serious, resistant bacterial infections across the globe, with at least 48,000 of those people dying as a direct result of these infections, according to the U.S. Centers for Disease Control and Prevention and the European Centre for Disease Prevention and Control. Globally, the bacteria responsible are growing increasingly resistant to these treatments. And more than 2 million children, mostly in the undeveloped world, die each year of bacterial pneumonia alone.
As drug-resistant bacteria proliferate, without increased action a nightmare scenario will emerge. Physicians will become increasingly unable to safely administer treatments as basic as chemotherapy and dialysis, much less perform standard surgical procedures. Pneumonia could spread unchecked. Medical care will revert to the pre-antibiotic 1920s. The death rate worldwide from otherwise manageable infections will skyrocket, to Ebola-like dimensions, with bloodstream infection rates expected to run higher than 50 percent.
International policy makers can no longer ignore this public health crisis. We've known about this fast-growing hazard for some time now. I testified no fewer than three times before the U.S. Congress to deliver ever-escalating warnings about the dangers of antibiotic resistance, first back in 2008, then again in 2010, and most recently in 2012. In my first appearance before the U.S. Committee on Energy and Commerce Subcommittee on Health, the title of my statement—"Emergence of the Superbug: Antimicrobial Resistance in the U.S."—left no doubt we faced a serious problem.
We must implement effective measures to combat antimicrobial resistance. The years since have amply confirmed that the risks to public health at home and abroad are severe, and, equally troubling, that the shortcomings of our medical preparedness and our therapeutic options are growing worse.
Make no mistake: the worldwide chorus advocating reforms in our approach to drug-resistant bacteria has gotten louder. The World Health Organization, the National Institutes of Health, the Food and Drug Administration and British Prime Minister David Cameron, among others, have forged a consensus calling for timely, targeted action. Only this past September, the Obama Administration issued an executive order for a national strategy to combat antibiotic resistance and the President's Council of Advisors on Science and Technology recommended innovation and investment against antibiotic resistance.
Better still, the GAIN Act (Generating Antibiotic Incentives Now), enacted through Congress in 2012 to accelerate the discovery of new antimicrobials, took a step in the right direction, at least in the United States. Already, as a result, the FDA has approved three new antibiotics, with 35 other similarly designated drugs now in clinical trials.
Yet more needs to be done to stop drug-resistant bacteria from taking over the world, and soon. Though I credit Congress for its efforts, systematically convening hearings, listening to expert testimony, participating in dialogues with patient groups, public health specialists and industry leaders—we must act even more aggressively. The pipeline for new antibiotics remains dangerously thin. Between 1983 and 2011, the number of antibiotics receiving FDA approval dwindled from 16 during the first four-year period to merely two in the last one. The challenges to coming up with such antibiotics—scientific, regulatory and economic alike—have forced almost all manufacturers to opt out.
Here's my four-point blueprint for next steps. First, we should enforce better surveillance and stricter all-around infection control in our hospitals, tracking all data globally. Second, we should demonstrate vigilant stewardship, using antibiotics only when necessary. Third, we should reform reimbursement policies to accelerate investment and innovation. Fourth, we should develop new, targeted antibiotics through clear-cut regulatory pathways and rapid diagnostics.
Let the Ebola scare, then, serve as our long-overdue wake-up call about drug-resistant bacteria. Stakeholders from both the private and public sectors globally should finally come together to create policies that promise concrete solutions.
Above all, we should remove any barriers that still prevent millions of people annually from getting the right medicine at the right time. Only then can we expect to head off a panic far worse than any we have yet seen or imagined.
Commentary by Barry I. Eisenstein, M.D., a former chair of microbiology and immunology at The University of Michigan and a former Professor of Medicine at Harvard Medical School. He is an infectious-disease specialist and senior vice president of Scientific Affairs at Cubist Pharmaceuticals, which specializes in developing new therapies to treat infections. He is the author of more than 100 original papers, book chapters, and editorials, and editor of several books, on infectious diseases and microbiology.

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