Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Despite superbug crisis, progress in antibiotic development 'alarmingly elusive'

18.04.2013
Policy update: Time dwindling to meet IDSA goal of 10 new antibiotics by 2020

Despite the desperate need for new antibiotics to combat increasingly deadly resistant bacteria, the U.S. Food and Drug Administration (FDA) has approved only one new systemic antibiotic since the Infectious Diseases Society of America (IDSA) launched its 10 x '20 Initiative in 2010 — and that drug was approved two and a half years ago.

In a new report, published online today in Clinical Infectious Diseases, IDSA identified only seven new drugs in development for the treatment of infections caused by multidrug-resistant gram-negative bacilli (GNB) bacteria. GNB, which include the "nightmare bacteria" to which the Centers for Disease Control and Prevention (CDC) alerted the public in its March 2013 Vital Signs report, represent the most pressing medical need. Importantly, there is no guarantee that any of the drugs currently in development to treat GNB will make it across the finish line to FDA approval and none of them will work against the most resistant bugs we're worried about today.

"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."

"We're losing ground because we are not developing new drugs in pace with superbugs' ability to develop resistance to them. We're on the precipice of returning to the dark days before antibiotics enabled safer surgery, chemotherapy and the care of premature infants. We're all at risk," said Helen W. Boucher, MD, lead author of the policy paper and a member of IDSA's Board of Directors and ARC.

Entitled "10 x '20 Progress: Development of New Drugs Active against Gram-negative Bacilli: An Update from the Infectious Diseases Society of America," the paper outlines actions that must be taken to address the synergistic crises of an anemic antibiotic pipeline coupled with an explosion in multi-drug resistant pathogens. A multi-pronged approach is needed, including new economic incentives to encourage antibiotic research and development (R&D); clarification of FDA's requirements for antibiotic approval; increased research funding; improved infection prevention; and new public health efforts including better data collection and surveillance of drug resistance and use of antibiotics. We also need to encourage "antibiotic stewardship," which includes measures that health care facilities, providers and even patients can take to preserve the life-saving power of antibiotics by limiting their inappropriate use.

IDSA leaders have been exploring with other stakeholders specific solutions to address the pipeline problem including the creation of a Limited Population Antibacterial Drug (LPAD) approval pathway to speed drugs to approval as well as new R&D tax credits and reimbursement models. Congressional Republican leaders in the U.S. House of Representatives announced last month their intent to make fixing the antibiotic R&D pipeline a priority for the 113th Congress.

Ironically, at this urgent time of greatest need, the number of pharmaceutical companies investing in antibiotic R&D has plummeted. Pharmaceutical companies typically put R&D resources into the development of chronic disease drugs – including those to treat high cholesterol, diabetes, and cancer – which provide significant financial rewards, partly because they are intended to be taken for long periods of time. Antibiotics, which are intended to be taken for short courses, just can't compete. The results are playing out in real time, with the smaller pharmaceutical company Polymedix – which has one of the seven drugs in development noted in the 10 x '20 paper – filing for bankruptcy protection in early April 2013. Moreover, the policy update reports that only four large multinational companies remain in antibiotic R&D. One of these, AstraZeneca, which has two of the seven drugs in development, plans to reduce its future investments in antibiotics, its CEO, Pascal Soriot, recently announced. The current pipeline of antibiotics is fragile indeed, and the dwindling roster of antibiotic developers has dire consequences for public health, patient care and national security.

New antibiotics are critically necessary to save the lives of people such as Josh Nahum, a healthy 27-year-old man who died from an overwhelming Enterobacter aerogenes infection as he was recovering in the hospital after a skydiving accident. Although his doctors tried desperately to save Josh, they ran out of antibiotics to treat this virulent bug. Read more about Josh's story and the experiences of others whose lives have been devastated by antibiotic resistance: http://www.idsociety.org/Joshs_Story.aspx.

IDSA first warned of the looming antibiotic apocalypse with its 2004 report, "Bad Bugs, No Drugs." Nearly 50 other medical societies and organizations, including the American Medical Association, have endorsed the 10 x '20 initiative so far.

"IDSA is committed to ensuring proper use of currently-available antibiotics to make certain we can continue to count on them. But that is not enough. Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it – now," said IDSA President David A. Relman, MD. "In the past year, the heads of CDC and the World Health Organization, along with the United Kingdom's chief medical officer, have all sounded the alarm about rising rates of antibiotic resistance. The lack of new antibiotics to treat these potentially life-threatening infections signals the end of modern medicine as we know it."

To see the policy update, which appears in the May 15 issue of Clinical Infectious Diseases (CID), contact Jerica Pitts (jpitts@pcipr.com) at 312-558-1770. See also a fact sheet on antimicrobial resistance here: http://www.idsociety.org/AntibioticResistanceFactSheet-April2013.pdf.

EDITOR'S NOTE: Although the paper published in CID recognizes two drugs approved by the FDA since 2009, the 10 x '20 Initiative was launched in April 2010 following the approval of one of these drugs.

The Infectious Diseases Society of America (IDSA) is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, patient care, prevention, and public health. The Society, which has more than 10,000 members, was founded in 1963 and is based in Arlington, Va. For more information, see http://www.idsociety.org.

Jerica Pitts | EurekAlert!
Further information:
http://www.idsociety.org

More articles from Health and Medicine:

nachricht Spanish scientists create a 3-D bioprinter to print human skin
24.01.2017 | Carlos III University of Madrid

nachricht Tracking movement of immune cells identifies key first steps in inflammatory arthritis
23.01.2017 | Massachusetts General Hospital

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Scientists spin artificial silk from whey protein

X-ray study throws light on key process for production

A Swedish-German team of researchers has cleared up a key process for the artificial production of silk. With the help of the intense X-rays from DESY's...

Im Focus: Quantum optical sensor for the first time tested in space – with a laser system from Berlin

For the first time ever, a cloud of ultra-cold atoms has been successfully created in space on board of a sounding rocket. The MAIUS mission demonstrates that quantum optical sensors can be operated even in harsh environments like space – a prerequi-site for finding answers to the most challenging questions of fundamental physics and an important innovation driver for everyday applications.

According to Albert Einstein's Equivalence Principle, all bodies are accelerated at the same rate by the Earth's gravity, regardless of their properties. This...

Im Focus: Traffic jam in empty space

New success for Konstanz physicists in studying the quantum vacuum

An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Sustainable Water use in Agriculture in Eastern Europe and Central Asia

19.01.2017 | Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

 
Latest News

Breaking the optical bandwidth record of stable pulsed lasers

24.01.2017 | Physics and Astronomy

Choreographing the microRNA-target dance

24.01.2017 | Life Sciences

Spanish scientists create a 3-D bioprinter to print human skin

24.01.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>