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The removal of 5 pharmaceuticals from the market in a 12-month period because of unexpected adverse events raised concerns about the adequacy of the drug review process at the US Food and Drug Administration (FDA). Specifically, concerns were raised about improvements in drug review efficiency that significantly reduced FDA review times. We have reviewed the circumstances of the 5 removals to determine whether there was any relationship to the increased efficiencies in the drug review process. When the removed drugs were analyzed by date of approval, no increase in the number of drugs taken off the market was seen, demonstrating that reduced review processing time was not the reason for the cluster of removals. We conclude that the agency's drug review procedures and postmarketing surveillance system after a drug has been marketed are currently adequate but must continually adjust to future challenges. [ABSTRACT FROM AUTHOR]

Presents an abstract of the study 'Anomia in Patient With a Basal Forebrain Lesion,' by D. H. Jacobs, J. Shuren, D. Bowers and K. M. Heilman, which appeared in the 1995 issue of 'Neuropsychiatry, Neuropsychology and Behavioral Neurology' journal.

A letter to the editor is presented in response to an article by Katrina Armstrong and colleagues about the availability of sildenafil on the Internet in the October 28, 1999 issue.

Investment, collaboration, and coordination have been key.

Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology. Early feasibility studies are an important component of the 21st Century Cures Act, enacted by Congress in 2016. Although regulatory processes have improved since the introduction of the Early Feasibility Studies Program, impediments at the hospital and clinical site level remain. In this paper, the authors review these issues and outline the structure and function of a clinical site consortium designed to address the problems and improve the U.S. clinical trial ecosystem., (Copyright © 2018. Published by Elsevier Inc.)

Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients. For this to succeed, a holistic reform of the clinical studies ecosystem for performing early-stage clinical research in the United States is necessary. The authors review the current landscape of the U.S. EFS and make recommendations for developing an efficient EFS process to meet the goal of improving access to early-stage, potentially beneficial medical devices in the United States., (Copyright © 2016 American College of Cardiology Foundation. All rights reserved.)

Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare. This article examines the Transcatheter Valve Therapy Registry, which captures clinical information on all US patients undergoing new nonsurgical heart valve treatments. The registry has patient-level data from more than 27,000 patients treated with the novel devices. Patient- and procedure-related data are gathered from hospitals, patient-reported outcomes are assessed pre- and postprocedure, and longer-term data on mortality and repeat hospitalization are provided by linking the registry's data to Medicare patient data. The registry is a model of collaboration among professional societies, the FDA, the Centers for Medicare and Medicaid Services, hospitals, patients, and the medical device industry. It has been used to support Medicare coverage decisions, expand device indications, provide comprehensive device surveillance, and establish national quality benchmarks. Beyond having it serve as a collaborative model, future goals for the registry include shortening the FDA-approval timeline for devices, providing data for decision-making tools for patients, and public reporting of hospital performance., (Project HOPE—The People-to-People Health Foundation, Inc.)

Many patients with Alzheimer's disease (AD) are apraxic and the apraxia has been posited to be related to a loss of movement representations. Whereas patients with Alzheimer's disease have been reported to demonstrate normal motor learning on a rotor pursuit skill acquisition task, it is unknown whether AD subjects who are apraxic demonstrate normal skill-learning. We tested subjects with probable AD and normal controls on a rotor pursuit task. We also tested the AD subjects for ideomotor apraxia. Subjects with AD who were apraxic had normal motor learning. In addition, praxis score did not correlate with performance on the skill-acquisition task. The results suggest that ideomotor praxis and motor learning are at least partly dissociable.

This study reports the writing performance of a dysgraphic patient with Alzheimer's disease and moderate dementia who frequently perseverated on strokes and letters. Letter formation errors were also frequently produced. Oral spelling was superior to written spelling. The habitual style of writing (cursive writing) was significantly more prone to perseverations than writing in uppercase letters, a form of writing less frequently used by the patient. Central (linguistic) spelling processes were relatively preserved. The pattern of preserved and impaired functions is consistent with impairment of the peripheral mechanism that generates the graphic motor patterns code. We suggest that damage to the peripheral orthographic mechanism may cause deficits in some patients with Alzheimer's disease.

Unilateral spatial neglect can be reduced by cold water caloric stimulation of the contralesional ear. Three hypotheses may account for this response. Caloric stimulation may increase the arousal of the damaged hypoaroused hemisphere. Moving stimuli to ipsilesional space improves the performance of patients with neglect. Caloric stimulation may move viewer-centered spatial maps in an ipsilesional direction. Unilateral neglect may be related to a spatial attentional bias. Vestibular stimulation may temporarily influence this bias. To learn if vestibular stimulation may induce an attentional spatial bias, the authors studied eight normal subjects by having these subjects attempt to bisect lines before and during vestibular stimulation. If caloric stimulation alters neglect because it changes the attentional spatial bias, the authors should be able to induce neglect in normal subjects by pertubating the vestibular system. Vestibular stimulation was induced by spinning a chair and then abruptly stopping the spinning chair. The authors found that after normal subjects were rotated to the left, they misbisected lines to the left but did not misbisect lines after they were rotated to the right. Although these results support the postulate that vestibular stimulation can induce an attentional spatial bias, the authors' results also suggest that there are intrinsic attentional asymmetries.

Normal subjects attend toward the middle of grouped items (center of mass effect). In order to learn if mass effect could influence performance on line bisection tasks and if the spatial orientation of the line (vertical vs. horizontal) could influence center of mass effect, we administered bisection tasks to 16 normal subjects using either lines composed of two unequal segments (one thick and one thin) or unsegmented lines. When the longer segment was to the right, left, up, or down, subjects erred by deviating their bisection toward the longer segment (center of mass effect). Our results demonstrate that the center of mass effect can be seen with bisection tasks and is greater in the vertical than in the horizontal dimension.

Evidence for picture superiority in verbal learning following moderate to severe closed head injury (CHI) was found in a study involving 31 participants with CHI and 31 noninjured participants. A multitrial free-recall paradigm was implemented incorporating three modalities: Auditory, visual, and simultaneous auditory plus visual. Participants with moderate to severe CHI learned fewer words and at a slower rate than the noninjured participants. The visual presentation of objects (with or without the simultaneous auditory presentation of names) resulted in better learning than the auditory presentation alone.

To learn if there are brain asymmetries for image generation we asked 50 right-handed normal subjects to image one-half of an object and to report which half (right or left) they saw. We found that these subjects were more likely to image the right half of objects than the left. We also found that right hemi-imagers demonstrated a greater degree of right-handedness than did left hemi-imagers. Our results suggest that in strongly right-handed subjects the left hemisphere is more adept at object image generation than is the right hemisphere.

Current models of spelling posit that information from the orthographic output buffer can be translated into physical letter codes for written output or into name letter codes for spoken output. It is not known, at present, whether or not visualization of these codes is necessary to spell or recognize orally spelled words. We report a 73-year-old woman who could spell words better than she could image them and who demonstrated near flawless recognition of orally spelled words. We conclude that visual imagery is not necessary to either spell or recognize orally spelled words.

According to the traditional model of language organization, repetition deficits arise following damage to the arcuate fasciculus of the dominant hemisphere (conduction aphasia). Conduction aphasia may result from lesions that spare the arcuate fasciculus. However, these patients have atypical language organization. We describe a man with normal language architecture who underwent a resection of the anterior portion of his arcuate fasciculus and retained his ability to repeat words and sentences. We propose that the arcuate fasciculus is not necessary for speech repetition by the lexical route.

Some patients with aphasia lack awareness of the language errors they make. We describe a man with undifferentiated jargonaphasia and preserved auditory comprehension who was unaware of his speech production errors when he had to both speak and listen simultaneously. However, when listening to a recording of his speech, he could detect the speech errors he had made. We attribute this patient's unawareness of his speech production errors to a reduced attentional capacity for simultaneous linguistic tasks.

Normal subjects bisect vertical lines above the true midpoint. We posited that the portion of the page farthest from the line or the page's geometric center, though not the focus of attention, would still engage attention. Therefore, subjects should make bisection errors in the direction of the distant portion or geometric center. We expected the greatest superior bisection errors to be made when lines were placed at the bottom of the page and the smallest errors to be made when the lines were placed at the top of the page. Ten young, normal subjects bisected vertical lines placed in 1 of 3 positions on a page (top, center, bottom) with the page located in 1 of 3 spatial locations (superior, middle, inferior). The results of our study were consistent with our predictions. Thus, although the page on which a line is bisected is often ignored, it is not neglected.