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
In “Tracking a Hospital Outbreak of Carbapenem Resistant Klebsiella pneumoniae with Whole Genome Sequencing” (Science Translational Medicine, August 2012), Dr. Evan Snitkin and co-authors analyzed a 2011 outbreak of antibiotic resistant bacteria in the National Institutes of Health Clinical Center that affected 18 patients, 11 of whom died. Nicole Mahoney, Senior Officer of Pew's Antibiotics and Innovation Project, discusses the report.
Q: What did this new NIH report tell us?
Mahoney: This report gives more urgent proof that we need a comprehensive strategy for fighting antibiotic resistant bacteria, also known as superbugs. The NIH reported on an antibiotic-resistant infection outbreak that they had in their clinical center in 2011. They outlined the spread of the bacteria, which they tracked through modern genetic techniques, and they talked about how the infection spread from patient to patient despite their best infection-control efforts.
Q: What can superbugs do to someone who gets infected?
Mahoney: These patients were infected with an antibiotic-resistant bacterium called Klebsiella, a type of bacteria that’s deadly in a lot of cases because the drugs we have today are often not effective for treating it.
Q: What does this tell us about what strategies we need to fight antibiotic-resistant infections?
Mahoney: This paper shows us that despite our best efforts at infection control, bacterial outbreaks happen. It also reminds us just how big a threat antibiotic resistance is. What we need is a comprehensive, three-part strategy for tackling antibiotic resistance. First of all, we need good infection-control measures. That means we need to contain infection outbreaks and we need to prevent the spread of infections in our health care facilities. The second thing we need is to use antibiotics wisely. Every time you use an antibiotic, you increase the chances of causing antibiotic resistance, so we want to use them minimally and sparingly to make sure that they’re effective in the future. And the third thing we need is a stream of new antibiotics to combat emerging threats and infections, and superbugs.
Q: Can you quantify the lack of antibiotics?
Mahoney: We’re always going to need new antibiotics, and unfortunately fewer have been coming to market in the last few decades. In the 1980s, 29 new systemic antibiotics came to the market. In the 1990s, that number dropped to 23, and from 2000 to 2010, only nine antibiotics were approved for use in this country.
Q: What are the challenges we’re facing?
Mahoney: There are three major sets of challenges that face antibiotic drug developers: scientific, economic and regulatory. On the scientific front, it’s very difficult and expensive to discover new antibiotics. There are plenty of fundamental scientific questions about bacterial infections that we’re still struggling to answer. The second challenge is economic. Drug developers have a lot of economic disincentives for getting into this field. That’s because antibiotics command lower prices than some other drugs, and they’re also not taken as long as drugs for chronic diseases. The third challenge is regulatory. Antibiotics are different than some other drugs because of antibiotic resistance and other factors, and we really need to make the pathways for how companies need to test these drugs for safety and effectiveness very, very clear. Companies do not invest in the face of regulatory uncertainty. The FDA and companies need to work together, to figure out clear pathways to get new antibiotics to market.
Q: Are there any drugs that worked for these patients? What’s the take-away here?
Mahoney: The patients that were discussed in this study were treated with a drug of last resort called colistin. Some developed infections that became resistant to that drug, leaving no other options. At least one patient who contracted a colistin-resistant infection died of the infection, though another survived. Doctors typically reserve colistin for when they don’t have any other treatment options -- when bacteria are resistant to all other drugs -- and the reason is because it causes kidney damage. What this tells us is we desperately need new antibiotics because when drugs of last resort fail, there’s really nothing left.
Learn more about the superbug outbreak and the need for new antibiotics with the related resources below.
- Video: Recent Outbreak Stresses Need for New Antibiotics (Nicole Mahoney video interview)
- '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)
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
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
Letter from Pew Thanking Representatives Gingrey and Green for Leadership on New Antibiotics LegislationRepresentatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced legislation intended to bring antibiotics to patients with few other treatment options. In a letter, Pew called the bill, named the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, “a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them the most.” More info
On July 9, 2012, the Generating Antibiotic Incentives Now, or GAIN, provisions were signed into law by President Barack Obama as part of the Food and Drug Administration Safety and Innovation Act. This bipartisan legislation extends by five years the exclusivity period during which certain antibiotics—those that treat serious or life-threatening infections—can be sold without generic competition. This additional period of exclusivity increases the potential for profits from new antibiotics by giving innovative companies more time to recoup their investment costs.More info