Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.More info
On August 22, researchers at the National Institutes of Health released a scientific paper detailing the use of advanced genetic technology to trace a deadly infection, untreatable by nearly every antibiotic, that spread through the NIH’s Clinical Center last year. The superbug eventually infected 17 patients. Eleven died, six from bloodstream superbug infections. Nicole Mahoney, Senior Officer of the Antibiotics and Innovation Project at the Pew Health Group, says this case illustrates the need for the development of new antibiotics to treat life-threatening illnesses.
- 'Superbug' Stalked NIH Hospital Last Year, Killing Six (Washington Post)
- NIH Superbug Outbreak Highlights Lack of New Antibiotics (Washington Post)
- Tracking a Superbug at NIH (Washington Post editorial)
- Use of Last-Resort Antibiotics Rises in VA Hospitals, National Study Finds
- Date added:
- Aug 23, 2012
The President’s Council of Advisors on Science and Technology held a public meeting on April 4 to discuss the issue of antimicrobial resistance. Drug safety and innovation director Elizabeth Jungman testified on the need to spur the development of new antibacterial drugs.More info
Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. According to a Centers for Disease Control and Prevention report, 2 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 23,000 of them die. Doctors routinely encounter patients with infections that do not respond to available treatment, and when new drugs come to market, bacteria quickly develop resistance. To ensure that the supply of new antibiotics keeps pace with these evolving pathogens, it is necessary to have a robust pipeline of new drugs and innovative pathways to get this medicine to the patients who need it the mostMore info
The process of creating new medicines is complex, time-consuming, and costly. Moving a potential therapy from concept to market can take between 10 and 15 years and cost developers as much as $1 billion. Indeed, industry also bears the cost of failure: For every drug that ultimately receives approval from the U.S. Food and Drug Administration, some 5,000 to 10,000 compounds don’t make it through the process.More info
Surveys of the animal production industry by the U.S. Department of Agriculture demonstrate that many farms and ranches administer antibiotics to healthy animals at low doses to offset overcrowding and poor sanitation and to accelerate livestock growth—practices that the medical and public health communities document as a significant factor in human antibiotic resistance. In 2013, FDA took steps to address these concerns.
In the State of the Union address, President Barack Obama recognized the need to “stay ahead of drug-resistant bacteria” and that developing therapies to fight these threats is an opportunity for American innovation and discovery. The threat of drug-resistant bacteria is real, and the need for antibiotic development clear.More info
A bipartisan group of representatives introduced in the U.S. House of Representatives a bill that would create an accelerated approval pathway for antibiotics and antifungals for use in limited populations and would update the criteria that HHS uses to determine breakpoints for drugs.More info