As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.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)
- Date added:
- Oct 17, 2012
"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."More info
"And a new survey out today from the Pew Charitable Trusts and the U.S. Centers for Disease Control and Prevention (CDC) shows 79% of adults know they can harm their own health by taking unneeded antibiotics."More info
''Americans are not as smart about antibiotics and antibiotic resistance as they should be, a new poll shows. For instance, although almost 90 percent of Americans know that antibiotics are effective for treating bacterial infections, more than a third also erroneously believed the drugs can fight viral infections such as the common cold or the flu."More info
Nearly nine in 10 Americans recognize that antibiotics are effective treatments for fighting bacterial infections like strep throat, but more than a third mistakenly believe the drugs are also appropriate treatments for viral infections such as the common cold.More info
"One of the most urgent global public health problems is the increasing capability of bacteria to resist antibiotic drugs. The crisis of antimicrobial resistance is particularly acute in hospitals, where superbugs able to resist multiple drugs have spawned. More than 70 percent of the bacteria that cause hospital-related infections are already resistant to at least one type of antibacterial drug."More info
"As doctors battled a deadly, drug-resistant superbug last year, they turned to an antibiotic of last resort. But colistin, as it’s called, was discovered in 1949. Between 1945 and 1968, drug companies invented 13 new categories of antibiotics, said Allan Coukell, director of medical programs at the Pew Health Group. Between 1968 and today, just two new categories of antibiotics have arrived."More info
''The menace posed by germs resistant to powerful antibiotics was all too apparent when a deadly, drug-resistant form of pneumonia bacteria struck the Clinical Center of the National Institutes of Health last year. It infected 17 patients and killed 6 of them. This disheartening episode shows again the importance of slowing the development of resistant strains by reducing rampant overuse of antibiotics — and of developing new, more effective antibiotics."More info
On August 22, researchers at the National Institute 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.More info
Since Operations Iraqi Freedom and Enduring Freedom began, many American servicemen and women have been infected with antibiotic-resistant bacteria. While our men and women in uniform increasingly survive severe wounds sustained in combat, their injuries leave them susceptible to life-threatening, hard-to-treat infections. Marine Lance Corporal Jonathan Gadsden’s story reflects the growing need for new antibiotics that can treat these dangerous diseases, against which most drugs are useless.More info
Bacteria have become increasingly resistant to the drugs we've come to rely on. Only a concerted effort can avert a public health crisis.More info
Passed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.More info
In an editorial stressing the need for new antibiotics, the Washington Post cites that some bacteria have become resistant to multiple antibiotics while the pipeline of new drugs is drying up. But a promising step by Congress could give pharmaceutical companies the incentive they need.More info