US budget cuts slash into fight vs superbugs

LONDON – A mixture of sequestration cuts is hindering the shift of American medicine from treatment to prevention of disease, and could leave US residents vulnerable to the growing threat of infectious diseases, according to analysts from leading research and consulting firm GlobalData.

From hospital superbugs carbapenem-resistant Enterobacteriaceae (CRE) and methicillin-resistant Staphylococcus aureus (MRSA), to new mutated strains of gonorrhoea, more pathogens are becoming drug-resistant. However, research into new antibiotics and the provision of vaccines is under threat due to budget cuts.  For example, the Centers for Disease Control and Prevention (CDC) is expected to see its budget slashed by close to US$450m, or about 8% of its total funding for FY2013. According to CDC director Dr. Tom Frieden, the cuts will compromise the agency’s fundamental ability to protect people from infectious disease outbreaks and epidemics. 

Despite the escalating need for novel antibiotics, Big Pharma has been decreasing antibiotic R&D. The expensive, lengthy drug approval process, low prices, short duration of antibiotic therapy, and competition from generics has led pharmaceutical companies to shift their focus towards more profitable therapy markets, such as cancer and cholesterol therapeutics.

The Generating Antibiotic Incentives Now (GAIN) Act came into force in October 2012, providing incentives for pharmaceutical companies to develop novel antibiotics including fast track status and priority review with the promise of speeding up approval from the US Food and Drug Administration. Antibiotics approved under the GAIN Act also have an additional five years of market exclusivity giving them an extra financial boost.

MRSA (yellow) surrounded by cellular debris (orange) National Institute of Allergy and Infectious Diseases

However, Dr. Brad Tebbets, GlobalData analyst covering Infectious Diseases,  refers to the GAIN Act as a “stopgap solution”, stating: “These carrots will not be large enough to entice Big Pharma to revive its antibiotic R&D, though they could increase interest in smaller companies with novel antibiotic pipelines.” He cites a low return on investment as the main issue for antibiotic development, stating: “The GAIN Act acknowledges the needPrime Hype DF 2016 EP