Superbugs 2013: Why We Are Losing the Arms Race
Startling fact: Just one organism, MRSA, the super staph bacteria that is resistant to antibiotics, kills more Americans every year than emphysema, HIV/AIDS, Parkinson's disease, and homicide combined.
In March, the U.S. Centers for Disease Control and Prevention (CDC) alerted the public about a growing threat from CRE (carbapenem-resistant Enterobacteriaceae). They reported that this type of infection had increased by 400 percent in recent years and, worse, has killed half of the people it infects. There are tragic stories like that of Josh Nahum, a healthy 27 year old who died from an antibiotic resistant bacterial infection while he was recovering from a skydiving accident in a hospital after all antibiotics available were unable to treat him.
There is also growing evidence that antibiotic resistant bacteria are prevalent in the food chain. In 2011, the Food and Drug Administration (FDA) collected and tested random samples of grocery story meat, and found that 81 percent of all ground turkey, 69 percent of pork chops, 55 percent of ground beef, and 39 percent of chicken meats contained superbugs that had evidence of antibiotic resistance.
In addition, more than two million Americans develop hospital-acquired infections and 100,000 die from those infections every year.
In sum: efforts must be stepped up to prevent an invisible epidemic from spreading.
This is one reason that the Infectious Disease Society of America (IDSA) launched the 10x20 initiative back in 2010. The organization has called for political leaders, researchers, regulators, and manufacturers to develop 10 new antibiotics by 2020 to combat the looming threat of antibiotic-resistant bacteria.
The U.S. FDA has only approved one drug since the program was initiated and that was in 2010 at the beginning of the initiative. Today, the Infectious Disease Society of America released a report stating that only seven drugs are currently in development for the treatment of multi-antibiotic resistant bacterial infections. There is no guarantee that any of these drugs will make it through clinical trials and gain FDA approval by 2020.
"In the past, the 10 x '20 goal would have been considered modest, but today the barriers to approval of nine additional antibiotics by 2020 seem insurmountable," said Henry Chambers, MD, chair of IDSA's Antimicrobial Resistance Committee (ARC). "Some progress has been made in the development of new antibiotics, but it's not nearly enough, and we absolutely must accelerate our efforts."
The ISDA suggests a few ways to quickly address the problem:
- Create a Limited Population Antibacterial Drug (LPAD) approval pathway to speed drugs towards approval
- Provide new R&D tax credits
- Craete reimbursement models
On a good note, 113th Congress has made it a priority to fix the Research and Development pipeline to develop new and innovative antibiotic therapies.
An update on the 10x20 program published in the journal Clinical Infectious Diseases can be found here.