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Health Law, Ethics, and Human Rights
Regulation of Medical Devices in the United States and European Union
Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate…
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Editorial
The Debate over Thyroid-Function Screening in Pregnancy
Maternal hypothyroidism in pregnancy has been associated with a range of adverse outcomes, most importantly miscarriage, preterm delivery, and reduced cognitive function in offspring. In surveys, almost half the obstetricians in private practices in Maine and the majority of obstetricians in a…
Editorial
Reviewers for the Journal, July–December 2011
Each year thousands of reviewers contribute their expertise to peer review, a process that contributes critically to the quality of the Journal. The editors and the authors of the papers submitted to the Journal are grateful for the help of all our reviewers. Here we acknowledge, with special…
Clinical Implications of Basic Research
Gene Therapy Meets Stem Cells
Stem cell–based therapies have the potential to repair and even correct the defects related to human diseases. Although tantalizing niche applications have moved forward in the clinical setting, progress seems to be slow, and ethical challenges have yet to be definitively addressed. The goal of…
Editorial
Brain Stimulation, Learning, and Memory
Advances in electrophysiology and high-resolution brain imaging have improved our understanding of the neural circuitry of episodic memory, including differential contributions of the hippocampus and the rhinal cortices. These advances are timely: the aging of the human population makes the…
Editorial
Chemotherapy Alone for Early-Stage Hodgkin's Lymphoma
Extensive radiation therapy was the first therapeutic advance in the treatment of early-stage Hodgkin's lymphoma. More recently, less extensive radiation therapy in combination with chemotherapy has resulted in the lowest reported rates of early relapse. The HD10 trial (ClinicalTrials.gov number,…
Editorial
Uterine Fibroids and Evidence-Based Medicine — Not an Oxymoron
The 2011 report from the Agency for Healthcare Research and Quality on comparative management of uterine fibroids noted, "Despite the prevalence and possible complications of uterine fibroids, few published studies examining the effectiveness of treatment strategies exist." Few therapies are…
Editorial
Fighting Fire with Fire: Rekindling the Bevacizumab Debate
The results of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-40 trial and the GeparQuinto (GBG44) trial, both of which are reported in this issue of the Journal, are particularly timely given the definitive announcement by the Food and Drug Administration (FDA) on November 18,…
Clinical Implications of Basic Research
Closing the Iron Gate
Genetic hemochromatosis is a prevalent iron-overload disease resulting from inadequate production of the iron-regulatory hormone hepcidin. Recently, Preza and colleagues developed an oral, biologically active hepcidin mimic that offers a new experimental approach to treating hemochromatosis and…
Editorial
A Watershed Moment in the Treatment of Hepatitis C
More than 170 million persons harbor chronic infection with hepatitis C virus (HCV), the leading indication for liver transplantation worldwide. For more than 20 years, treatment of chronic hepatitis C infection has relied on the use of the nonspecific antiviral cytokine interferon alfa, which…
Editorial
RAF around the Edges — The Paradox of BRAF Inhibitors
The recent success of BRAF inhibitors represents a great stride forward for melanoma research. When used to treat patients with melanoma who harbor the BRAF V600E mutation, these inhibitors lead to the remission of even advanced lesions. However, resistance to BRAF inhibitors emerges within months.…
Editorial
HER2 Therapy — An Abundance of Riches
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a distinct subset of breast cancer characterized by overexpression of the HER2 protein. Clinically, HER2-positive tumors are associated with a more aggressive phenotype and poor outcomes. With the introduction of trastuzumab,…
Editorial
How Much Atrial Fibrillation Is Too Much Atrial Fibrillation?
Modern cardiac pacemakers and defibrillators function as permanently implanted cardiac monitors, detecting atrial and ventricular arrhythmias. Although the principal purpose of collecting this information is to manage the patient's cardiac rhythm, these data can also be used to detect and study…
Clinical Implications of Basic Research
Diet and Intestinal Immunity
"You are what you eat." A couple of recent studies underscore the relevance of this adage to the immune system. New studies by Kiss et al. and Li et al. show how certain dietary components derived from vegetables interact with intestinal immune receptors and thereby regulate the organogenesis of…
Editorial
NEJM@200 — Two Centuries at the Journal
Two hundred winters ago, in January 1812, the New England Journal of Medicine and Surgery was born. In the centuries since then, the Journal has chronicled the evolution of medicine and bioscience. Immunization strategies have eradicated smallpox and have protected millions from other formerly…
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Editorial
Employees of the Massachusetts Medical Society in the 200th Year of the New England Journal of Medicine
On the 200th anniversary of the New England Journal of Medicine, I wish to gratefully acknowledge the employees of the Massachusetts Medical Society for their contribution to our mission of inspiring discovery and advancing care. Jeffrey M. Drazen, Editor-in-Chief Brendan Abel Cara Adler Jonathan…
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Editorial
A New Era in Secondary Prevention after Acute Coronary Syndrome
During the past two decades, the use of antiplatelet therapies has been the focus of new studies of secondary prevention after acute coronary syndromes, with more than 75% of patients in contemporary practice treated with dual antiplatelet therapy (aspirin plus a thienopyridine) on hospital…
Clinical Implications of Basic Research
Diabetic Stem-Cell “Mobilopathy”
Hematopoietic stem-cell (HSC) transplantation remains the primary curative treatment for patients with a variety of hematologic cancers. Transplantation of either autologous or allogeneic stem cells requires the acquisition of sufficient numbers of HSCs to ensure rapid and consistent trilineage…
Editorial
Mutations in RNA Splicing Machinery in Human Cancers
Massively parallel sequencing of cancer genomes is revealing a panoramic view of the genetic drivers of human neoplasms. In this issue of the Journal, Wang et al. describe an analysis of the coding sequences of samples from 91 patients with chronic lymphocytic leukemia. The disease is characterized…
Editorial
Transfusion Thresholds in FOCUS
Even though red-cell transfusion is an accepted and widely used intervention, questions regarding which patients should receive transfusions and under what circumstances continue to spark debate. There has been limited evidence from clinical trials to inform policy. Meanwhile, concern about…
