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[h=1]Combating Emerging Threats ? Accelerating the Availability of Medical Therapies[/h] Luciana Borio, M.D., Edward Cox, M.D., M.P.H., and Nicole Lurie, M.D., M.S.P.H.
August 5, 2015DOI: 10.1056/NEJMp1508708
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Article Life-threatening emerging or reemerging infectious diseases increasingly inspire demands for access to novel, often untested therapies. Recent concern about transmission of the Middle East respiratory syndrome coronavirus (MERS-CoV) in Asia underscores the need to rapidly evaluate investigational therapies during outbreaks, identify those that actually benefit patients, and protect against those that cause harm. Although a traditional sequence of studies in animals followed by phased clinical trials works well for many therapeutics, that process may be too slow during public health emergencies. We propose establishing a new paradigm for accelerating evaluation of investigational therapies during public health emergencies so that therapies shown to be safe and effective can reach patients as soon as possible.
The primary approach to containing outbreaks of emerging infectious diseases involves standard public health measures, such as identifying and isolating infected persons, tracing their contacts to detect secondary infections, and protecting contacts and health care workers from exposure. General supportive medical care for anyone who becomes infected is essential, in addition to use of any proven specific treatments. When such treatments are lacking, clinicians commonly try therapies on the basis of experience with other diseases (usually on the basis of a postulated mechanism of action) in the hope of improving outcomes. For example, during the 2003 epidemic of the severe acute respiratory syndrome (SARS), several small observational studies examined the use of interferon, ribavirin, steroids, and convalescent plasma.1 Unfortunately, the inability to implement properly designed trials precluded any clear demonstration of benefit, and some evaluations suggested possible harm.
full text
http://www.nejm.org/doi/full/10.1056/NEJMp1508708?af=R&rss=currentIssue&
August 5, 2015DOI: 10.1056/NEJMp1508708
Share:
Article Life-threatening emerging or reemerging infectious diseases increasingly inspire demands for access to novel, often untested therapies. Recent concern about transmission of the Middle East respiratory syndrome coronavirus (MERS-CoV) in Asia underscores the need to rapidly evaluate investigational therapies during outbreaks, identify those that actually benefit patients, and protect against those that cause harm. Although a traditional sequence of studies in animals followed by phased clinical trials works well for many therapeutics, that process may be too slow during public health emergencies. We propose establishing a new paradigm for accelerating evaluation of investigational therapies during public health emergencies so that therapies shown to be safe and effective can reach patients as soon as possible.
The primary approach to containing outbreaks of emerging infectious diseases involves standard public health measures, such as identifying and isolating infected persons, tracing their contacts to detect secondary infections, and protecting contacts and health care workers from exposure. General supportive medical care for anyone who becomes infected is essential, in addition to use of any proven specific treatments. When such treatments are lacking, clinicians commonly try therapies on the basis of experience with other diseases (usually on the basis of a postulated mechanism of action) in the hope of improving outcomes. For example, during the 2003 epidemic of the severe acute respiratory syndrome (SARS), several small observational studies examined the use of interferon, ribavirin, steroids, and convalescent plasma.1 Unfortunately, the inability to implement properly designed trials precluded any clear demonstration of benefit, and some evaluations suggested possible harm.
full text
http://www.nejm.org/doi/full/10.1056/NEJMp1508708?af=R&rss=currentIssue&