WHO: Post-Antimicrobial Era Is a ‘Very Real Possibility’

A lack of surveillance and standards for methodology, data-sharing and coordination are leading to ever-increasing rates of antimicrobial resistance, says an April 30 report from the World Health Organization.

Such resistance leads to use of more expensive therapies, as well as longer illnesses and hospital stays, potentially increasing the economic burden on families and countries, WHO says. It also could compromise such life-saving staples as organ transplantation, basic surgery and chemotherapy. In addition, the report warns that antimicrobial resistance could raise by up to three times a country’s normal healthcare expenditures.

Data gleaned from 129 member states and published in Antimicrobial Resistance: Global Report on Surveillance showed:

• All continents except Antarctica had 25 percent penicillin-resistant Streptococcus pneumoniae;
• Three continents had 25 percent fluoroquinolone-resistant nontyphoidal salmonella;
• Two continents had 25 percent fluoroquinolone-resistant Shigella species;
• Three continents had third-generation cephalosporins- resistant Neisseria gonorrhoea;
• Five continents had Escherichia coli with at least 50 percent resistance to third-generation cephalosporins and fluoroquinolone;
• Six continents had Klebsiella pneumoniae with at least 50 percent resistance to third-generation cephalosporins and carbapenems; and
• Five continents had Staphylococcus aureus with at least 50 percent resistance to methicillin (MRSA).

 ‘The Way Forward’

The way forward, according to the report, is to facilitate development of tools and standards for harmonized surveillance on resistance in humans and in food-producing animals. WHO also recommends creating or strengthening regional and global surveillance centers and to elaborate on strategies for population-based surveillance and its impact of public health and economies.

Donna Eberwine Villagran, spokeswoman for the Pan American Health Organization, told Drug Daily Bulletin that the Latin American/Caribbean arm of the WHO has been working with its member countries to build lab capacity, strengthen surveillance and infection control and prevention, as well as promote better antibiotic use and build regulatory capacity.

Industry leaders and policymakers should be fostering the research and development of vaccines, as well as diagnostics and treatments, WHO says.

The U.S. lawmakers addressed this issue in the 2012 FDA Safety and Innovation Act, which includes incentives for drugmakers to develop new vaccines. A provision in the law, known as Generating Antibiotics Incentives Now, identifies 12 qualified pathogens, including Neisseria gonorrhoeae, Staphylococcus aureus and Mycobacterium tuberculosis, andprovides manufacturers with fast-track status and five years of marketing exclusivity under the Hatch-Waxman Act if their products are approved.

Meanwhile, the European Medicines Agency (EMA) in November 2013 released its own guidelines to spur development of drugs that treat infections. Drugmakers looking to market new anti-infectives in the EU can begin discussions on clinical development with regulators as soon as they have sufficient pharmacokinetic and pharmacodynamic data. Safety and efficacy can be monitored in postmarket studies once drugs receive approval. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.