TITLE

Electroconvulsive Therapy in the Spotlight

AUTHOR(S)
Goodman, Wayne K.
PUB. DATE
May 2011
SOURCE
New England Journal of Medicine;5/12/2011, Vol. 364 Issue 19, p1785
SOURCE TYPE
Academic Journal
DOC. TYPE
Editorial
ABSTRACT
The author offers insights on the effectiveness and safety of electroconvulsive therapy (ECT) devices. The author refers to the possible persistence of retrograde amnesia as a primary concern regarding the use of ECT. He views that ECT devices will exit the market before safety and effectiveness issues are resolved and before viable alternatives are identified. He stresses that a PMA requirement for new trials is not the only option and that the U.S. Food and Drug Administration (FDA) FDA could clear ECT for certain indications such as depression.
ACCESSION #
60596246

 

Related Articles

  • Playing �Kick the FDA� � Risk-free to Players but Hazardous to Public Health. Wood, Alastair J.J. // New England Journal of Medicine;4/24/2008, Vol. 358 Issue 17, p1774 

    The author reflects on a decrease in the U.S. public's confidence in the U.S. Food and Drug Administration (FDA). He suggests that it is of grave concern when an agency with pervasive effects on the lives of U.S. citizens loses the public's confidence. He argues that ensuring the safety and...

  • Steering for success.  // Nature Reviews Drug Discovery;Nov2009, Vol. 8 Issue 11, p829 

    An FDA initiative to enable companies to discuss options for future trial design following completion of early-stage trials could have an important role in addressing the high costs and failure rates of pivotal clinical trials.

  • Tracking Inclusion of Women in Clinical Studies. Wood, Susan F. // Journal of Women's Health (15409996);Mar2009, Vol. 18 Issue 3, p301 

    The author reflects on the issue regarding the inclusion of women in clinical studies. He argues that there is an increase in the participation of women in clinical studies submitted to the U.S Food and Drugs Administration (FDA). He mentions that women were excluded from clinical trials...

  • FDA Rejects Promising Prostate Cancer Drug. Faloon, William // Life Extension;Sep2007, Vol. 13 Issue 9, p7 

    The authors reflect on the decision of the U.S. Food and Drug Administration (FDA) to prohibit the use of the immune-boosting vaccine Provenge despite its efficacy shown in a controlled clinical trial. The government believed that advanced prostate cancer patients must not risk using any drug...

  • US FDA Guidance: Apropos of PROs. Kind, Paul // PharmacoEconomics;2006, Vol. 24 Issue 9, p833 

    As modellers push to make their models more accurate, the ability of others to understand the models can decrease, causing the models to lose transparency. When this type of conflict between accuracy and transparency occurs, the question arises, “Where do we want to operate on...

  • Credit for clinical trial data.  // Nature Genetics;Nov2012, Vol. 44 Issue 11, p1171 

    The author reflects on the sharing of clinical trial data in which data producers are separated from their data set. He states that existing authoring conventions should allow trial investigators to coauthor and take shared responsibility for data reanalyzes. An overview of the concerns of the...

  • Successful Investigational New Drug Preparation without Reinventing the Wheel. Gorell, Emily S.; Tichy, Andrea L.; Lane, Alfred T. // Journal of Investigative Dermatology;May2011, Vol. 131 Issue 5, p996 

    The author reflects on the process of developing drug products in the U.S. It states that the Dermatology Department at Stanford University School of Medicine creates drugs for the treatment of epidermolysis bullosa since 1988. Furthermore, the drug development process includes the approval from...

  • FDA and Duke Collaborate to Modernize Clinical Trials.  // Clinician Reviews;Jan2008, Vol. 18 Issue 1, p13 

    The article reports that the U.S. Food and Drug Administration and Duke University Medical Center in Durham, North Carolina, have begun a collaboration aimed at modernizing the way clinical trials are conducted. It states that the participants will develop new standards and identify new methods...

  • Transparency and Ethics. Kirst, Julie // 24x7;Oct2009, Vol. 14 Issue 10, p8 

    The article reports on the efforts announced by the U.S. Food and Drug Administration (FDA) to better ensure the safety and effectiveness of medical products. It states that the FDA has the authority to disqualify researchers who conduct clinical trials of new devices if they have not followed...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sign out of this library

Other Topics