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
By Nicole Mahoney, The Pew Charitable Trusts
More and more, we hear about drug-resistant bacteria—superbugs that few, if any, available therapies can kill. Recently, the Centers for Disease Control and Prevention, or CDC, released a report warning that infections from these pathogens result in at least 2 million illnesses and 23,000 deaths every year in the United States.
This week, CDC is spreading the word about what patients can do to curb the threat of drug resistance. In observance of Get Smart About Antibiotics Week, the agency is emphasizing steps the public can take to prevent antibiotic-resistant infections and to slow the evolution of new strains of resistant bacteria. But Congress also needs to act in the fight against superbugs.
Emergence of these bacteria is outpacing development of new drugs. Even if all patients used antibiotics appropriately—taking the full course when prescribed and avoiding them for viral illnesses such as the common cold—drug resistance would remain an issue.
As a recent Frontline documentary on “nightmare bacteria” admonishes, even healthy people are at risk. Their stories demonstrate the pressing need for action on all fronts to address resistance. And we have been making progress.
Last year, President Barack Obama signed the Generating Antibiotic Incentives Now, or GAIN, Act into law as part of the Food and Drug Administration Safety and Innovation Act. This bipartisan legislation increases the commercial value of antibiotics intended for serious or life-threatening infections through a five-year extension of the period during which the drugs can be sold without generic competition.
GAIN is an important first step to promote the development of novel antibiotics, but we’re still losing the race. Too many people are contracting drug-resistant infections that physicians cannot treat.
We need legislation to streamline clinical testing and regulatory approval—two of the main challenges to development of antibiotics that patients need the most.
To meet this challenge, The Pew Charitable Trusts and other organizations are advocating for limited population antibacterial drug legislation, which would speed approval of drugs for patients who have serious or life-threatening infections and limited treatment options. Bipartisan interest in this legislation has been expressed in the House and Senate.
Helping patients "get smart" about antibiotics is an important part of the overall effort to curb the threat of superbugs. Congressional leaders must complement the CDC’s public education efforts with action to help make new drugs available to physicians as quickly and safely as possible.
Nicole Mahoney is the senior officer for Pew's antibiotics and innovation project, which addresses the growing public health challenge of multidrug-resistant infections by supporting policies that stimulate and encourage the development of antibiotics to treat life-threatening illnesses.
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
Last spring, Arjun Srinivasan, an associate director of the CDC, delivered a presentation to state health officials with some alarming information. Before the year 2000, he said, it was rare to find cases of bacteria resistant to carbapenems, a class of powerful, last-resort antibiotics. But by February 2013 they had been seen in almost every state. On March 5, Thomas Frieden, director of the CDC, issued a public warning about “nightmare” bacteria, a family of germs known as CREs. They can kill up to half the patients who get bloodstream infections from them, resist most or all antibiotics and spread resistance to other strains.More info