Ahead of last week's Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in Washington, the World Health Organization (WHO) had issued its first comprehensive report on antimicrobial resistance, including antibiotic resistance, drawing data from 114 countries. The results are cause for concern and reveal instances of resistance to antibiotics, especially "last resort" antibiotics, in all regions of the world.

The document, published at the end of April, doesn't pull any punches – the situation presents a real global threat, which is not some nightmarish future scenario but "it is happening right now in every region of the world and has the potential to affect anyone, of any age, in any country," the report warns.

This publication is the forerunner of a global effort led by WHO, which will address drug resistance and the suggested activities in this effort will encompass the development of tools and standards and improved collaboration around the world to track drug resistance, measure its health and economic impacts and design targeted solutions.

The WHO report, "Antimicrobial resistance: global report on surveillance," describes the fact that resistance is occurring across many different infectious agents, but it confines its attention to antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhea, pneumonia, urinary tract infections and gonorrhea.

In a statement on the release of the report, Keiji Fukuda, WHO's assistant director-general for Health Security, said "Unless we take significant actions to improve efforts to prevent infections and also change how we produce, prescribe and use antibiotics, the world will lose more and more of these global public health goods and the implications will be devastating."

Among the key finding of concern: resistance to one of the most widely used antibacterial therapies for the treatment of urinary tract infections caused by E. coli – fluoroquinolones – is very widespread. For example, 30 years ago, when these drugs were first introduced, resistance to them was virtually zero. Now, the report notes, there are countries in many parts of the world where this treatment is now ineffective in more than half of patients.

In addition, treatment failure to the last resort of treatment for gonorrhea – third generation cephalosporins – has been confirmed in Austria, Australia, Canada, France, Japan, Norway, Slovenia, South Africa, Sweden and the UK. With more than 1 million people becoming infected with gonorrhea around the world every day, the disease may soon become untreatable as no vaccines or new drugs are on the horizon, the report says.

MOBILIZING ACTION

The WHO is adding its weight to a growing list of high level initiatives and the release of papers and reports during the past couple of years on what has been a growing concern that because research and development to discover new antibiotics has languished or not been effective it is going to be extremely difficult to play "catch up." (See BioWorld Insight, June 24, 2013.)

In the U.K., for example, new science minister Greg Clark announced in July he was creating what he termed his "war cabinet" to tackle antimicrobial resistance on all fronts by drawing together all of the country's research councils to help in this quest.

Leading the way will be the Medical Research Council (MRC) on a cross-council initiative backed by eight government bodies and the Wellcome Trust. The MRC will coordinate with medical researchers, biologists, engineers and social scientists to address this complex global issue.

The MRC cites the telling statistic that in the UK alone more than $500 million has been spent on researching the problem since 2007. Yet, to date, no effective solutions have been found and it has been estimated that antibiotics being prescribed today will be all but useless within the next two decades.

In the U.S. the President's Budget Request for fiscal year 2015, which would more than double the funding for antibiotic R&D, includes a proposed allocation of the Centers for Disease Control and Prevention's overall budget of $30 million annually for a Detect and Protect Against Antibiotic Resistance Initiative. (See BioWorld Today, March 6, 2014.)

With an estimated 23,000 deaths caused by antibiotic resistance each year, the initiative if established, would support a "Detect" network of five regional laboratories that will characterize emerging resistance and rapidly identify outbreaks of dangerous antibiotic resistance threats, according to the CDC.

Other activities would include the scale up of health care prevention focused on improving antibiotic use and preventing deadly infections caused by Clostridium difficile, carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas, and methicillin resistant Staphylococcus aureus (MRSA); outpatient antibiotic prescribing and targeting community antibiotic resistance threats including resistant Salmonella, and drug-resistant gonorrhea would be improved; and the program would establish a specific laboratory library of resistant isolates to help support drug and diagnostic development.

BIOTECH IS THE KEY

On a positive note new antibiotics are coming to market. In June Cubist Pharmaceuticals Inc. gained FDA approval for Sivextro (tedizolid phosphate) its once-daily oxazolidinone antibiotic for treating certain gram-positive bacterial infections, including MRSA. (See BioWorld Today, June 24, 2014.)

A month earlier, Durata Therapeutics Inc. received the FDA green light for its antibiotic dalbavancin for use in acute bacterial skin and skin structure infections caused by gram-positive microorganisms, including MRSA. (See BioWorld Today, May 27, 2014.)

These new therapies move the Infectious Diseases Society of America's 10 x '20 Initiative (10 new antibiotics by 2020) a step closer to achieving its goal.

Obviously, biotechnology innovation will be one of the keys to coming to grips with the problem, but there are concerns that not enough companies are involved in this sector. In next week's issue, the second part of this article will examine just how deep the antibiotics product pipeline really is and we speak with companies who are fresh off presenting at ICAAC to find out their views on the need for sustainable antibiotic innovation.