Emma Hitt, PhD
March 18, 2010 ( UPDATED March 19, 2010 ) — A goal of developing 10 new antibiotics by 2020 has been put forward by the Infectious Diseases Society of America (IDSA). A statement was published online this week and in the April 15 issue of Clinical Infectious Diseases.
The new goal, known as the 10 × '20 initiative, is designed to bring together various resources to "create a sustainable global antibacterial drug [research and development] enterprise with the power in the short-term to develop 10 new, safe, and effective antibiotics by 2020," according to the statement.
Specially, antimicrobials are needed to treat infections caused to the so-called "ESKAPE" pathogens that currently cause the majority of US hospital infections (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species).
According to the IDSA, the decreasing investment in antibacterial drug development, coupled with the increase in antimicrobial resistance, represents an "impending disaster."
"Despite the good faith efforts of many individuals, professional societies, and governmental agencies, the looming crisis has only worsened over the past decade," state the authors from the IDSA Antimicrobial Availability Task Force, led by David Gilbert, MD.
What It Will Take
Dr. Gilbert and colleagues describe the objective as an "audacious" goal. However, Dr. Gilbert explains that "if all of the stakeholders get behind the idea, we certainly have the resources to have 10 new antibacterial drugs in 10 years." He went on to tell Medscape Infectious Diseases that it will take "financial and intellectual investment to get it done."
According to Dr. Gilbert, the goal will require the effort of the scientific community, the legislative branch of the government, and the pharmaceutical industry. He added that the US Food and Drug Administration (FDA) will also need to "adjust their policies such that the traffic pattern through the FDA is smoothly and easily accomplished."
He noted that infectious disease professionals can help by providing support and advocacy in their communities. "Infectious disease consultants are well aware of the need for new antimicrobials," Dr. Gilbert said, "so they should continue to share their anxieties and concerns about the issue."
A Challenging but Not Impossible Goal
"I think that it is possible to meet this goal," said Neil Fishman, MD, president, Society for Healthcare Epidemiology of America, and director, Healthcare Epidemiology, Infection Prevention and Control, University of Pennsylvania Health System. "We are an imaginative and resourceful society, and we certainly answered a similar challenge in the development of antiretroviral drugs for HIV, so I believe we can respond to this challenge."
However, Marin H. Kollef, MD, professor of medicine in the Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri, pointed out that "the recent experiences with ceftobiprole, telavancin, and tigecycline indicate that the development of new antimicrobials with approvals from the FDA will be a slow process." "This is partly because agreement on the design of studies for indications such as pneumonia has not been reached between the agency and industry," he told Medscape Infectious Diseases.
According to Dr. Kollef, increasing resistance is certainly a problem, but in addition, the industry has shifted away from antibiotic development because these drugs are "not as profitable as drugs for chronic conditions such as hypertension and diabetes," he said. "Also, the recent lack of approvals for new agents will certainly cause drug makers to rethink any investments in this area."
Clinical Effect of 10 New Drugs
Dr. Kollef noted that the effect of 10 new antimicrobials will depend on their ability to overcome current patterns of resistance. "If they are active against the currently problematic pathogens that are often resistant to currently available drugs, then meeting this goal would have a significant impact," he said, but "this would not be true if they were simply 'me too' drugs."
"New drugs are important for addressing the problem of antimicrobial resistance, but they are not going to be the only answer," said Jean Patel, PhD, deputy director of the Centers for Disease Control and Prevention's Office of Antimicrobial Resistance. "It is an important part of addressing the problem," she told Medscape Infectious Diseases, "but we're going to need to continue with prevention and control measures, and it will take both to really address this problem."
Society for Healthcare Epidemiology of America President Dr. Fishman concurred that solving the antimicrobial resistance problem will take more than just the development of new antibiotics. "Resistance is a complex problem, and therefore requires multifaceted solutions," he said. "We need antimicrobial stewardship to make certain that new agents are used appropriately or we will see rapid development of resistance," he said. "We also need infection control to prevent transmission of resistant bacteria when they do occur."
Dr. Gilbert, Dr. Fishman, and Dr. Patel have disclosed no relevant financial relationships. Dr. Kollef is a consultant for the speakers bureau of Merck, Pfizer, Astellas, AstraZeneca, Bard, Kimberly Clark, Accelr8, and Ortho-McNeil. IDSA's initiative has been endorsed by several health agencies including the American Academy of Pediatrics, the American Gastroenterological Association, the Society for Healthcare Epidemiology of America, and the European Society of Clinical Microbiology and Infectious Diseases
March 18, 2010 ( UPDATED March 19, 2010 ) — A goal of developing 10 new antibiotics by 2020 has been put forward by the Infectious Diseases Society of America (IDSA). A statement was published online this week and in the April 15 issue of Clinical Infectious Diseases.
The new goal, known as the 10 × '20 initiative, is designed to bring together various resources to "create a sustainable global antibacterial drug [research and development] enterprise with the power in the short-term to develop 10 new, safe, and effective antibiotics by 2020," according to the statement.
Specially, antimicrobials are needed to treat infections caused to the so-called "ESKAPE" pathogens that currently cause the majority of US hospital infections (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species).
According to the IDSA, the decreasing investment in antibacterial drug development, coupled with the increase in antimicrobial resistance, represents an "impending disaster."
"Despite the good faith efforts of many individuals, professional societies, and governmental agencies, the looming crisis has only worsened over the past decade," state the authors from the IDSA Antimicrobial Availability Task Force, led by David Gilbert, MD.
What It Will Take
Dr. Gilbert and colleagues describe the objective as an "audacious" goal. However, Dr. Gilbert explains that "if all of the stakeholders get behind the idea, we certainly have the resources to have 10 new antibacterial drugs in 10 years." He went on to tell Medscape Infectious Diseases that it will take "financial and intellectual investment to get it done."
According to Dr. Gilbert, the goal will require the effort of the scientific community, the legislative branch of the government, and the pharmaceutical industry. He added that the US Food and Drug Administration (FDA) will also need to "adjust their policies such that the traffic pattern through the FDA is smoothly and easily accomplished."
He noted that infectious disease professionals can help by providing support and advocacy in their communities. "Infectious disease consultants are well aware of the need for new antimicrobials," Dr. Gilbert said, "so they should continue to share their anxieties and concerns about the issue."
A Challenging but Not Impossible Goal
"I think that it is possible to meet this goal," said Neil Fishman, MD, president, Society for Healthcare Epidemiology of America, and director, Healthcare Epidemiology, Infection Prevention and Control, University of Pennsylvania Health System. "We are an imaginative and resourceful society, and we certainly answered a similar challenge in the development of antiretroviral drugs for HIV, so I believe we can respond to this challenge."
However, Marin H. Kollef, MD, professor of medicine in the Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri, pointed out that "the recent experiences with ceftobiprole, telavancin, and tigecycline indicate that the development of new antimicrobials with approvals from the FDA will be a slow process." "This is partly because agreement on the design of studies for indications such as pneumonia has not been reached between the agency and industry," he told Medscape Infectious Diseases.
According to Dr. Kollef, increasing resistance is certainly a problem, but in addition, the industry has shifted away from antibiotic development because these drugs are "not as profitable as drugs for chronic conditions such as hypertension and diabetes," he said. "Also, the recent lack of approvals for new agents will certainly cause drug makers to rethink any investments in this area."
Clinical Effect of 10 New Drugs
Dr. Kollef noted that the effect of 10 new antimicrobials will depend on their ability to overcome current patterns of resistance. "If they are active against the currently problematic pathogens that are often resistant to currently available drugs, then meeting this goal would have a significant impact," he said, but "this would not be true if they were simply 'me too' drugs."
"New drugs are important for addressing the problem of antimicrobial resistance, but they are not going to be the only answer," said Jean Patel, PhD, deputy director of the Centers for Disease Control and Prevention's Office of Antimicrobial Resistance. "It is an important part of addressing the problem," she told Medscape Infectious Diseases, "but we're going to need to continue with prevention and control measures, and it will take both to really address this problem."
Society for Healthcare Epidemiology of America President Dr. Fishman concurred that solving the antimicrobial resistance problem will take more than just the development of new antibiotics. "Resistance is a complex problem, and therefore requires multifaceted solutions," he said. "We need antimicrobial stewardship to make certain that new agents are used appropriately or we will see rapid development of resistance," he said. "We also need infection control to prevent transmission of resistant bacteria when they do occur."
Dr. Gilbert, Dr. Fishman, and Dr. Patel have disclosed no relevant financial relationships. Dr. Kollef is a consultant for the speakers bureau of Merck, Pfizer, Astellas, AstraZeneca, Bard, Kimberly Clark, Accelr8, and Ortho-McNeil. IDSA's initiative has been endorsed by several health agencies including the American Academy of Pediatrics, the American Gastroenterological Association, the Society for Healthcare Epidemiology of America, and the European Society of Clinical Microbiology and Infectious Diseases
