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New England Journal of Medicine

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https://www.readbyqxmd.com/read/29320637/rejuvenating-regenerative-medicine-regulation
#1
R Alta Charo, Douglas Sipp
The Food and Drug Administration (FDA) recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products (HCT/P) of unknown safety and efficacy. By clarifying its position on the handling and therapeutic use of cells, the agency has..
January 10, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320308/when-the-chips-are-down-health-coverage-and-care-at-risk-for-u-s-children
#2
Lisa C Dubay, Genevieve M Kenney
Despite bipartisan agreement on a 5-year plan in both the Senate and the House of Representatives, Congress failed to reauthorize the Children’s Health Insurance Program (CHIP) last fall, causing uncertainty and worry for families and state CHIP directors alike. Families in several states,..
January 10, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320302/federal-right-to-try-legislation-threatening-the-fda-s-public-health-mission
#3
Steven Joffe, Holly Fernandez Lynch
The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked with ensuring the safety of medical products. In 1962, Congress expanded the FDA’s mandate again, requiring it to..
January 10, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29298128/the-public-and-the-opioid-abuse-epidemic
#4
Robert J Blendon, John M Benson
No abstract text is available yet for this article.
January 3, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29298116/somatic-activating-kras-mutations-in-arteriovenous-malformations-of-the-brain
#5
Sergey I Nikolaev, Sandra Vetiska, Ximena Bonilla, Emilie Boudreau, Suvi Jauhiainen, Behnam Rezai Jahromi, Nadiya Khyzha, Peter V DiStefano, Santeri Suutarinen, Tim-Rasmus Kiehl, Vitor Mendes Pereira, Alexander M Herman, Timo Krings, Hugo Andrade-Barazarte, Takyee Tung, Taufik Valiante, Gelareh Zadeh, Mike Tymianski, Tuomas Rauramaa, Seppo Ylä-Herttuala, Joshua D Wythe, Stylianos E Antonarakis, Juhana Frösen, Jason E Fish, Ivan Radovanovic
Background Sporadic arteriovenous malformations of the brain, which are morphologically abnormal connections between arteries and veins in the brain vasculature, are a leading cause of hemorrhagic stroke in young adults and children. The genetic cause of this rare focal disorder is unknown. Methods We analyzed tissue and blood samples from patients with arteriovenous malformations of the brain to detect somatic mutations. We performed exome DNA sequencing of tissue samples of arteriovenous malformations of the brain from 26 patients in the main study group and of paired blood samples from 17 of those patients...
January 3, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29281801/president-trump-s-mental-health-is-it-morally-permissible-for-psychiatrists-to-comment
#6
Claire Pouncey
No abstract text is available yet for this article.
December 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29281477/psychiatrists-diagnosing-the-president-moral-imperative-or-ethical-violation
#7
Jeffrey A Lieberman
No abstract text is available yet for this article.
December 27, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29262271/trial-of-contralateral-seventh-cervical-nerve-transfer-for-spastic-arm-paralysis
#8
Mou-Xiong Zheng, Xu-Yun Hua, Jun-Tao Feng, Tie Li, Ye-Chen Lu, Yun-Dong Shen, Xiao-Hua Cao, Nai-Qing Zhao, Jia-Ying Lyu, Jian-Guang Xu, Yu-Dong Gu, Wen-Dong Xu
Background Spastic limb paralysis due to injury to a cerebral hemisphere can cause long-term disability. We investigated the effect of grafting the contralateral C7 nerve from the nonparalyzed side to the paralyzed side in patients with spastic arm paralysis due to chronic cerebral injury. Methods We randomly assigned 36 patients who had had unilateral arm paralysis for more than 5 years to undergo C7 nerve transfer plus rehabilitation (18 patients) or to undergo rehabilitation alone (18 patients). The primary outcome was the change from baseline to month 12 in the total score on the Fugl-Meyer upper-extremity scale (scores range from 0 to 66, with higher scores indicating better function)...
December 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29261403/plague-in-madagascar-a-tragic-opportunity-for-improving-public-health
#9
Paul S Mead
When plague first arrived in Madagascar in November 1898, its appearance mirrored events in port cities around the world. Alexandria, Bombay, Buenos Aires, San Francisco, Saigon, and Sydney were all affected as part of the "third pandemic," a global event that began in China but spread widely with..
December 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29261363/the-regulatory-accountability-act-of-2017-implications-for-fda-regulation-and-public-health
#10
Jonathan J Darrow, Erin C Fuse Brown, Aaron S Kesselheim
In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme from the Trump administration and some prominent legislators has been opposition to regulation. Last spring, Congress took a substantial step toward making regulation by federal agencies..
December 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29261362/rewiring-to-regain-function-in-patients-with-spastic-hemiplegia
#11
Robert J Spinner, Alexander Y Shin, Allen T Bishop
No abstract text is available yet for this article.
December 20, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29236573/massachusetts-proposed-medicaid-reforms-cheaper-drugs-and-better-coverage
#12
Benjamin D Sommers, Aaron S Kesselheim
While health policy attention in recent months has focused on Washington, D.C. several proposals from individual states have garnered less publicity despite their potentially far-reaching implications. One such proposal comes from Massachusetts, which has applied for a waiver from federal rules in..
December 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29236567/sexual-harassment-in-medicine-metoo
#13
Reshma Jagsi
The news is filled with stories of celebrities who have engaged in egregious sexual misconduct. A recent poll suggested that more than half of U.S. women have experienced "unwanted and inappropriate sexual advances" at some point in their lives. Because I led a study of workplace sexual harassment..
December 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29231133/daratumumab-plus-bortezomib-melphalan-and-prednisone-for-untreated-myeloma
#14
María-Victoria Mateos, Meletios A Dimopoulos, Michele Cavo, Kenshi Suzuki, Andrzej Jakubowiak, Stefan Knop, Chantal Doyen, Paulo Lucio, Zsolt Nagy, Polina Kaplan, Ludek Pour, Mark Cook, Sebastian Grosicki, Andre Crepaldi, Anna M Liberati, Philip Campbell, Tatiana Shelekhova, Sung-Soo Yoon, Genadi Iosava, Tomoaki Fujisaki, Mamta Garg, Christopher Chiu, Jianping Wang, Robin Carson, Wendy Crist, William Deraedt, Huong Nguyen, Ming Qi, Jesus San-Miguel
Background The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. Methods In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression...
December 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29231094/edoxaban-for-the-treatment-of-cancer-associated-venous-thromboembolism
#15
Gary E Raskob, Nick van Es, Peter Verhamme, Marc Carrier, Marcello Di Nisio, David Garcia, Michael A Grosso, Ajay K Kakkar, Michael J Kovacs, Michele F Mercuri, Guy Meyer, Annelise Segers, Minggao Shi, Tzu-Fei Wang, Erik Yeo, George Zhang, Jeffrey I Zwicker, Jeffrey I Weitz, Harry R Büller
Background Low-molecular-weight heparin is the standard treatment for cancer-associated venous thromboembolism. The role of treatment with direct oral anticoagulant agents is unclear. Methods In this open-label, noninferiority trial, we randomly assigned patients with cancer who had acute symptomatic or incidental venous thromboembolism to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily (edoxaban group) or subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (dalteparin group)...
December 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29226797/axicabtagene-ciloleucel-car-t-cell-therapy-in-refractory-large-b-cell-lymphoma
#16
Sattva S Neelapu, Frederick L Locke, Nancy L Bartlett, Lazaros J Lekakis, David B Miklos, Caron A Jacobson, Ira Braunschweig, Olalekan O Oluwole, Tanya Siddiqi, Yi Lin, John M Timmerman, Patrick J Stiff, Jonathan W Friedberg, Ian W Flinn, Andre Goy, Brian T Hill, Mitchell R Smith, Abhinav Deol, Umar Farooq, Peter McSweeney, Javier Munoz, Irit Avivi, Januario E Castro, Jason R Westin, Julio C Chavez, Armin Ghobadi, Krishna V Komanduri, Ronald Levy, Eric D Jacobsen, Thomas E Witzig, Patrick Reagan, Adrian Bot, John Rossi, Lynn Navale, Yizhou Jiang, Jeff Aycock, Meg Elias, David Chang, Jeff Wiezorek, William Y Go
Background In a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy. Methods In this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. Patients received a target dose of 2×106 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine...
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29226781/a-milestone-for-car-t-cells
#17
Eric Tran, Dan L Longo, Walter J Urba
No abstract text is available yet for this article.
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29226764/chimeric-antigen-receptor-t-cells-in-refractory-b-cell-lymphomas
#18
Stephen J Schuster, Jakub Svoboda, Elise A Chong, Sunita D Nasta, Anthony R Mato, Özlem Anak, Jennifer L Brogdon, Iulian Pruteanu-Malinici, Vijay Bhoj, Daniel Landsburg, Mariusz Wasik, Bruce L Levine, Simon F Lacey, Jan J Melenhorst, David L Porter, Carl H June
Background Patients with diffuse large B-cell lymphoma or follicular lymphoma that is refractory to or that relapses after immunochemotherapy and transplantation have a poor prognosis. High response rates have been reported with the use of T cells modified by chimeric antigen receptor (CAR) that target CD19 in B-cell cancers, although data regarding B-cell lymphomas are limited. Methods We used autologous T cells that express a CD19-directed CAR (CTL019) to treat patients with diffuse large B-cell lymphoma or follicular lymphoma that had relapsed or was refractory to previous treatments...
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29224505/progress-in-the-treatment-of-hodgkin-s-lymphoma
#19
Dan L Longo, Vincent T DeVita
No abstract text is available yet for this article.
December 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29224502/brentuximab-vedotin-with-chemotherapy-for-stage-iii-or-iv-hodgkin-s-lymphoma
#20
Joseph M Connors, Wojciech Jurczak, David J Straus, Stephen M Ansell, Won S Kim, Andrea Gallamini, Anas Younes, Sergey Alekseev, Árpád Illés, Marco Picardi, Ewa Lech-Maranda, Yasuhiro Oki, Tatyana Feldman, Piotr Smolewski, Kerry J Savage, Nancy L Bartlett, Jan Walewski, Robert Chen, Radhakrishnan Ramchandren, Pier L Zinzani, David Cunningham, Andras Rosta, Neil C Josephson, Eric Song, Jessica Sachs, Rachael Liu, Hina A Jolin, Dirk Huebner, John Radford
Background Brentuximab vedotin is an anti-CD30 antibody-drug conjugate that has been approved for relapsed and refractory Hodgkin's lymphoma. Methods We conducted an open-label, multicenter, randomized phase 3 trial involving patients with previously untreated stage III or IV classic Hodgkin's lymphoma, in which 664 were assigned to receive brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) and 670 were assigned to receive doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The primary end point was modified progression-free survival (the time to progression, death, or noncomplete response and use of subsequent anticancer therapy) as adjudicated by an independent review committee...
December 10, 2017: New England Journal of Medicine
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