Annals of the New York Academy of Sciences
-
Discovery of the neuromuscular effects of botulinum toxin began in the early 19th century and has continued to evolve. Currently, onabotulinumtoxinA is approved by the U. S. ⋯ OnabotulinumtoxinA significantly reduced the number of headache days per 28-day cycle relative to placebo at week 24 (change from baseline: -8.4 days for onabotulinumtoxinA versus -6.6 days for placebo; P < 0.001, pooled data). OnabotulinumtoxinA improved health-related quality of life and had an acceptable safety profile. OnabotulinumtoxinA is the only approved treatment specifically for CM prevention and represents a safe and effective therapeutic for chronic migraineurs.
-
Ann. N. Y. Acad. Sci. · Nov 2014
ReviewDevelopment of the Trevo ProVue Retriever for intracranial clot removal in acute ischemic stroke.
It is estimated that 15 million people worldwide have a stroke each year. Of the estimated 795,000 strokes that occur in the United States annually, the majority are ischemic strokes resulting from an obstruction within a vessel supplying blood to the brain. The treatment goal for these patients is to restore blood flow as quickly as possible. ⋯ Food and Drug Administration clearance in 2012, the Trevo® Retriever is a stent-like structure to be deployed at the site of an occlusion to allow the occluding thrombus to integrate into the device for subsequent removal and restoration of blood flow. The subsequent generation of the device, the ProVue Retriever, is fully radiopaque and designed to provide physicians with maximal information about the interaction of the device with the clot, providing enhanced feedback during the procedure. In this brief historical review, the development pathway, clinical experience, and future directions of the Trevo devices are summarized.
-
Ann. N. Y. Acad. Sci. · Sep 2014
ReviewThe risk/benefit of predicting a post-antibiotic era: is the alarm working?
There have been concerns about antimicrobial resistance since the first widespread use of antibiotics in humans. More recently, this concern has grown and become the focus of clinical, scientific, and political activity. In part, the political interest is a consequence of publicizing a bleak picture of a post-antibiotic world. ⋯ Many governments now use a risk assessment approach to identify security concerns, based on reasonable worst-case scenarios. There is no doubt that for effective policy-based action to occur, antimicrobial resistance needs to be seen as a national and international security priority, particularly as the major cost of inaction will mostly be felt in the future. We conclude that presenting the evidence in a manner that is used to encourage prioritization of security policy is not only justified, it is essential to drive action in this area.
-
Ann. N. Y. Acad. Sci. · Sep 2014
ReviewThe evolution of the regulatory framework for antibacterial agents.
The rising tide of antibacterial resistance and the lack of a diverse, vibrant pipeline of novel antibacterial agents is a global crisis that impairs our ability to treat life-threatening infections. The recent introduction of a tiered approach to the regulatory framework in this area offers one path to resolving some of the challenges. ⋯ There are limitations to these pathways, and they are not easy to implement, but making reliable noninferiority-based approaches available is critical to reinvigorating the global antibiotic pipeline. With the recognition of these ideas by key regulatory authorities in recent guidance, the next challenges in this area will focus on interpretive breakpoints, the extent of data in the prescribing information, ensuring that multiple agents can be progressed, and the challenge of the antibiotic business model.
-
Ann. N. Y. Acad. Sci. · Aug 2014
ReviewFine- and coarse-filter conservation strategies in a time of climate change.
As species adapt to a changing climate, so too must humans adapt to a new conservation landscape. Classical frameworks have distinguished between fine- and coarse-filter conservation strategies, focusing on conserving either the species or the landscapes, respectively, that together define extant biodiversity. ⋯ Novel approaches combine coarse- and fine-scale approaches--for example, prioritizing species within pretargeted landscapes--and accommodate the difficult reality of multiple interacting stressors. By taking a diversified approach to conservation actions and decisions, conservationists can hedge against uncertainty, take advantage of new methods and information, and tailor actions to the unique needs and limitations of places, thereby ensuring that the biodiversity show will go on.