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October 4, 2012  Vol. 367 No. 14

Audio Summary of this Issue

Perspective
1277-1279
User Fees and Beyond — The FDA Safety and Innovation Act of 2012
D.B. Kramer and A.S. Kesselheim
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President Barack Obama recently signed into law the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA),1 ending a long discussion among regulators, industry representatives, legislators, and patient advocates. The driving force behind ...

1279-1281
France's New Framework for Regulating Off-Label Drug Use
J. Emmerich, N. Dumarcet, and A. Lorence
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A new French law aimed at strengthening drug safety and a related decree regarding “Temporary Recommendations for Use” provide a regulatory process for temporarily supervising the prescribing of drugs for indications for which they are not yet licensed.

1281-1284
Unpredictable and Difficult to Control — The Adolescence of West Nile Virus
L.R. Petersen and M. Fischer

    The current outbreak of West Nile virus ison track to be among the largest ever recorded. Future inquiry will no doubt focus on untangling the confluence of ecologically interrelated drivers responsible for the outbreak. And timely national surveillance is required.

    1284-1285
    Head and Shoulder
    S. Koven
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    Over the years, a primary care internist had often told medical students that every illness is psychosomatic — involving both the mind and body — but it wasn't until she injured her shoulder that she fully understood how true that is.

    Original Articles
    1287-1296
    Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock
    H. Thiele and Others
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    • CME
    • Comments

    The rate of death among patients with cardiogenic shock complicating acute myocardial infarction is high even when the patients undergo early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).1–4 ...

    1297-1309
    Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization
    M.T. Roe and Others
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    • CME

    Clinical-practice guidelines for patients with acute coronary syndromes consisting of unstable angina or myocardial infarction without ST-segment elevation recommend a strategy of early invasive management (angiography within 48 to 72 hours with ...

    1310-1320
    C-Reactive Protein, Fibrinogen, and Cardiovascular Disease Prediction
    The Emerging Risk Factors Collaboration
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    There is an evolving debate about the value of assessing levels of C-reactive protein (CRP) and other soluble biomarkers of inflammation for the prediction of first cardiovascular events. In 2003, the Centers for Disease Control and Prevention and the ...

    1321-1331
    Phenotypic Heterogeneity of Genomic Disorders and Rare Copy-Number Variants
    S. Girirajan and Others
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    Most chromosomal deletions and duplications (copy-number variants) that are associated with neurodevelopmental disorders are known to result in a wide variation of clinical phenotypes. This study describes a genetic mechanism for such variation.

    Review Article
    1332-1340
    200th Anniversary Article: The Past 200 Years in Diabetes
    K.S. Polonsky
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    • Interactive/Multimedia
    • Comments

    Although scientific advances have led to effective prevention strategies, the pathway to a cure for diabetes has remained elusive. This anniversary article describes progress in the understanding, diagnosis, and management of diabetes during the past 200 years.

    Images in Clinical Medicine
    1341
    Mydriasis in the Garden
    A. Vunda and G. Alcoba
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    A healthy 3-year old boy was brought to the emergency department because of an acutely dilated right pupil, which developed after he had played in the garden. Half an hour before presentation, his parents noticed he had been crying.

    e19
    Mites in the External Auditory Canal
    E.-C. Liao and K.-C. Chang
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    • Video

    A 70-year-old man presented with a 2-month history of pruritus and a sense of fullness in the right ear. There was no hearing impairment, tinnitus, or otorrhea.

    Clinical Problem-Solving
    1342-1347
    An Intricate Interplay
    R.H. Moseley, B. Manoogian, T. Shehab, and S. Saint
    • CME
    • Comments

    A 55-year-old man presented with sinus congestion, headaches, chills, mild nausea, fatigue, and a “foggy” sensation that had lasted approximately 1 week. He reported darker urine than usual and had noticed that his eyes were turning yellow.

    Editorials
    1349-1350
    Evidence for Overturning the Guidelines in Cardiogenic Shock
    C.M. O'Connor and J.G. Rogers

      Cardiogenic shock complicating acute myocardial infarction continues to be a devastating event associated with extremely high mortality. The results of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial,1 now reported in the ...

      1350-1352
      The Variability of Genetic Disease
      H.G. Brunner

        It is never boring to be a physician because patients are so different. Each patient has a story to tell, and few have disorders that match textbook descriptions. By the same token, we need to be careful when predicting the future for our patients, and ...

        Statistics in Medicine
        1353-1354
        Missing Data
        J.H. Ware, D. Harrington, D.J. Hunter, and R.B. D'Agostino, Sr.,

          Missing data threaten the validity of many clinical trials. In this issue of the Journal, the members of an expert panel convened by the National Research Council (NRC) provide recommendations regarding the design, conduct, and analysis of studies to ...

          Special Report
          1355-1360
          The Prevention and Treatment of Missing Data in Clinical Trials
          R.J. Little and Others
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          Background

          Missing data have seriously compromised inferences from clinical trials, yet the topic has received little attention in the clinical-trial community.1 Existing regulatory guidances2–4 on the design, conduct, and analysis of clinical trials have ...

          Clinical Implications of Basic Research
          1361-1363
          The Shear Stress of Busting Blood Clots
          D.M. Wootton and B.R. Alevriadou

            Systemic delivery of tissue-type plasminogen activator (t-PA) to dissolve a thrombus after a heart attack or stroke is accompanied by the risk of hemorrhage. A recent study shows the use of nanoaggregates to target t-PA to the thrombus in mouse models of mesenteric injury and pulmonary embolism.

            Correspondence
            1364-1365
            MEK Inhibition in BRAF-Mutated Melanoma
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            To the Editor: Although the efficacy of serine–threonine protein kinase (BRAF) inhibitors has been shown in patients with advanced melanoma who have the V600E BRAF mutation,1,2 data on the population with the V600K BRAF mutation are more limited and less ...

            1365-1367
            Early Surgery for Infective Endocarditis
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            To the Editor: Kang et al. (June 28 issue)1 report significantly better outcomes with early surgery than with conventional treatment in patients with infective endocarditis and vegetations with a diameter greater than 10 mm. More than 90% of the patients ...

            1367-1370
            Vitamin D Dose Requirements for Fracture Prevention
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            To the Editor: In a recent pooled analysis of vitamin D dose requirements for fracture prevention, Bischoff-Ferrari and colleagues (July 5 issue)1 reanalyzed data from clinical trials by taking into account vitamin D supplementation taken by participants ...

            1370-1373
            Management of Opioid Analgesic Overdose
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            To the Editor: Boyer (July 12 issue)1 reports that use of naloxone to treat opioid overdose is logical because it is a direct antagonist of mu opioid receptors. Other strategies for treating opioid-induced respiratory depression and oversedation are now ...

            1373-1374
            Four-Year Follow-up after Two-Year Dietary Interventions
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            To the Editor: Data from trials that compare the effectiveness of weight-loss diets are frequently limited to the intervention period. In our 2-year workplace-based study, called the Dietary Intervention Randomized Controlled Trial (DIRECT),1,2 we ...

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