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NEJM—Health Policy and Reform

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https://www.readbyqxmd.com/read/28538133/accelerated-approval-and-expensive-drugs-a-challenging-combination
#1
Walid F Gellad, Aaron S Kesselheim
For serious or life-threatening disease, the Food and Drug Administration (FDA) can approve drugs on the basis of surrogate end points that are "reasonably likely to predict clinical benefit," through its accelerated approval review track. This pathway, which dates back to the early 1990s, was..
May 25, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28538132/emerging-from-ehr-purgatory-moving-from-process-to-outcomes
#2
Allan H Goroll
The widespread adoption of electronic health records (EHRs) during the past decade has been hailed as a major advance in medical practice. Recently, however, a growing number of clinicians have spoken out about the counterproductive effects of these systems on patient care. The national push toward..
May 25, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28538128/medical-assistance-in-dying-implementing-a-hospital-based-program-in-canada
#3
Madeline Li, Sarah Watt, Marnie Escaf, Michael Gardam, Ann Heesters, Gerald O'Leary, Gary Rodin
An aging population and shifts in Western societies toward secularism, populism, and an emphasis on individual autonomy and personal control have fueled the movement to legalize assisted dying. It has now been legalized in some form in five European countries (the Netherlands, Belgium, Switzerland,..
May 25, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28538119/racial-disparities-in-risks-of-stroke
#4
LETTER
Wilson Nadruz, Brian Claggett, Mir Henglin, Amil M Shah, Hicham Skali, Wayne D Rosamond, Aaron R Folsom, Scott D Solomon, Susan Cheng
To the Editor: The incidence of stroke in the United States has been decreasing as efforts have been made to control vascular risk factors. However, the extent to which modifications in changes in the risk of stroke have occurred in blacks as compared with whites has not been widely studied. We..
May 25, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28537844/preserving-the-fogarty-international-center-benefits-for-americans-and-the-world
#5
Paul K Drain, Ramnath Subbaraman, Douglas C Heimburger
In his proposed budget for fiscal year 2018, President Donald Trump recommended eliminating the Fogarty International Center (FIC) at the National Institutes of Health (NIH). Although the NIH actually received increased funding in the fiscal year 2017 budget that was signed on May 5, the FIC — a..
May 24, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28537794/undermining-genetic-privacy-employee-wellness-programs-and-the-law
#6
Kathy L Hudson, Karen Pollitz
Genetic information is becoming ubiquitous in research and medicine. The cost of genetic analysis continues to fall, and its medical and personal value continues to grow. Anticipating this age of genetic medicine, policymakers passed laws and regulations years ago to protect Americans’ privacy and..
May 24, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28514623/a-21st-century-health-it-system-creating-a-real-world-information-economy
#7
Kenneth D Mandl, Isaac S Kohane
Data generated as a by-product of the day-to-day work of delivery systems are a fundamental currency of the 21st Century Cures Act. How efficiently and effectively we use this "real-world" evidence will shape the way medicine is practiced and the way drugs are approved. In 2009, the Health..
May 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28514608/the-committed-perspective-policy-principles-for-regional-health-plans
#8
Ceci Connolly, Thomas H Lee
At a recent Washington gathering, a bipartisan contingent of health policy wonks compared the Affordable Care Act (ACA) to the Beatles. Take away the individual mandate and purchasing subsidies, and you’re left with George and Ringo. Wipe out the Medicaid expansion and you’re down to just Ringo — a..
May 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28528558/state-sepsis-mandates-a-new-era-for-regulation-of-hospital-quality
#9
Tina B Hershey, Jeremy M Kahn
Sepsis is a major cause of illness and death in the United States, affecting more than 1.5 million Americans each year at an annual cost of over $20 billion. To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and..
May 21, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28514226/the-march-of-science-the-true-story
#10
Lisa Rosenbaum
"The human understanding when it has once adopted an opinion...draws all things else to support and agree with it." Francis Bacon, the "Father of Empiricism," came to this conclusion in the 17th century, and some 350 years later, three Stanford psychologists confirmed its validity. They recruited..
May 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28489481/efficient-trial-design-fda-approval-of-valbenazine-for-tardive-dyskinesia
#11
Michael C Davis, Brian J Miller, Jasmeet K Kalsi, Thomas Birkner, Mitchell V Mathis
A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics available as quickly as possible to patients with unmet medical needs. In the case of valbenazine, which was recently approved by the U.S. Food and Drug..
May 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28467878/the-failure-of-solanezumab-how-the-fda-saved-taxpayers-billions
#12
Chana A Sacks, Jerry Avorn, Aaron S Kesselheim
The November 2016 announcement that Eli Lilly’s investigational drug solanezumab failed in a phase 3 clinical trial dashed hopes that it would be a long-anticipated disease-modifying treatment for Alzheimer’s disease. For people living with Alzheimer’s — along with their relatives and caregivers,..
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28467870/health-insurance-and-emergency-department-use-a-complex-relationship
#13
Benjamin D Sommers, Kosali Simon
Throughout the nearly decadelong debate over the Affordable Care Act (ACA), policymakers have questioned how having health insurance affects health care utilization and, in particular, what expanded insurance coverage means for use of the emergency department (ED). ED use is of particular interest..
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28467868/academic-foundation-and-industry-collaboration-in-finding-new-therapies
#14
REVIEW
Bonnie W Ramsey, Gerald T Nepom, Sagar Lonial
Breakthroughs in the ability to probe and better understand biologic systems during the past 30 years have enabled the medical community to develop new therapeutic agents and change the course of many life-shortening diseases. Despite this success, bridging the gap between promising laboratory..
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402246/resident-duty-hours-and-medical-education-policy-raising-the-evidence-bar
#15
David A Asch, Karl Y Bilimoria, Sanjay V Desai
On March 10, 2017, the Accreditation Council for Graduate Medical Education (ACGME) issued revised common program requirements for residents that go into effect this July. The revisions emphasize the importance of teamwork, flexibility, and physician welfare during training, but all the attention..
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28467732/separating-families-at-the-border-consequences-for-children-s-health-and-well-being
#16
Michael J MacKenzie, Emily Bosk, Charles H Zeanah
Decades of research on child development confirms that children develop best in the context of safe, supportive, nurturing relationships. Positive relationships with primary caregivers are essential for children’s healthy physical and emotional development. For children who experience serious..
May 3, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28445664/beyond-genes-and-molecules-a-precision-delivery-initiative-for-precision-medicine
#17
Ravi B Parikh, J Sanford Schwartz, Amol S Navathe
In 2015, President Barack Obama launched the Precision Medicine Initiative (PMI), aimed at enabling "a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care." He requested $215..
April 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28423291/addressing-the-opioid-epidemic-opportunities-in-the-postmarketing-setting
#18
Bruce M Psaty, Joseph O Merrill
The Food and Drug Administration (FDA) recently developed a multipart action plan in response to the opioid epidemic. As part of that initiative, it invited recommendations from the National Academy of Medicine about a regulatory framework that might allow public health considerations to be..
April 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28423282/good-riddance-to-big-insurance-mergers
#19
Leemore S Dafny
Eighteen months after four of the five largest U.S. health insurers announced multibillion-dollar merger deals, federal judges, siding with the Department of Justice (DOJ), have issued preliminary injunctions halting the two transactions. These decisions will cost the insurers: they spent over $2..
May 11, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402776/lessons-from-standing-rock-of-water-racism-and-solidarity
#20
David Goldberg
"I heard you were in Standing Rock." So began a visit with Mr. Y. and we leaned in toward one another. In the past, I’d felt off balance with Mr. Y. who often seemed to push me away. "Why can’t you just fix this?" he asked, referring to his diabetes. Mr. Y. is a traditional Navajo, or Diné. In the..
April 13, 2017: New England Journal of Medicine
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