Category Archive: NEJM

The Graham–Cassidy Plan — The Most Harmful ACA-Repeal Bill Yet

Senate Republicans are making one last attempt to pass legislation repealing major provisions of the Affordable Care Act (ACA) before September 30, when their ability to use the “budget reconciliation” procedure to prevent a Democratic filibuster expir…

FDA Oversight of Postmarketing Studies

To the Editor: In their Perspective article in this issue of the Journal, Woloshin et al. raise concerns about the status of postmarketing studies after new statutory authority was provided to the Food and Drug Administration (FDA) in the FDA Amendment…

Tuberculosis Elimination in the United States — The Need for Renewed Action

Once called “the captain of all these men of death,” tuberculosis continues to kill 1.8 million people globally each year. In 2014, the World Health Assembly embraced an ambitious resolution to reduce deaths from tuberculosis by 95% by 2035. But despit…

The Fate of FDA Postapproval Studies

Both Congress and the Food and Drug Administration (FDA) have sought to accelerate the availability of new drugs by allowing sponsors to wait to resolve many questions about safety and benefit until after their drugs receive marketing approval. As a re…

Patent Foramen Ovale after Cryptogenic Stroke — Assessing the Evidence for Closure

The Amplatzer PFO Occluder was approved by the Food and Drug Administration (FDA) on October 28, 2016. The device is indicated for percutaneous transcatheter closure of a patent foramen ovale to reduce the risk of recurrent ischemic stroke in patients who’ve had a cryptogenic stroke that a…

Vaccination Rates among Younger Siblings of Children with Autism

To the Editor: Recent outbreaks of illnesses that may be prevented by vaccines have increased public debate about vaccination behaviors (i.e. whether or not and when parents choose to vaccinate a child), and California has been a key affected state. On…

Hospital-Readmission Risk — Isolating Hospital Effects from Patient Effects

The measurement and reporting of 30-day hospital-readmission rates by the Centers for Medicare and Medicaid Services (CMS) has had a major effect on the delivery of health care. These measures, which were first publicly reported in 2009, were subsequen…

Adjunctive Treatments for Type 1 Diabetes

The proliferation of new drug treatments for type 2 diabetes in the United States in the past 15 years, with more than 17 drugs approved in six new classes of antidiabetic drugs, has been promoted by several factors. First, the recognition of the impor…

Dreams Deferred — The Public Health Consequences of Rescinding DACA

After months of conflicting statements, President Donald Trump has announced that the Deferred Action for Childhood Arrivals (DACA) program, a landmark immigration program introduced during the Obama administration, will be rescinded as of March 2018. …

Tragedy, Perseverance, and Chance — The Story of CAR-T Therapy

In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukemia (ALL). Though her parents were told that if you had to have a kid with cancer, ALL was the best one to have, Emily’s course was hardly typical. After two rounds of chemotherapy, necrotizing fasciitis developed in…

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