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https://www.readbyqxmd.com/read/29610885/assessing-pharmaceutical-research-and-development-costs-reply
#1
Vinay Prasad, Sham Mailankody
No abstract text is available yet for this article.
April 1, 2018: JAMA Internal Medicine
https://www.readbyqxmd.com/read/29590518/financial-conflicts-of-interest-at-fda-drug-advisory-committee-meetings
#2
Michael J Hayes, Vinay Prasad
The U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and harms of novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA...
March 2018: Hastings Center Report
https://www.readbyqxmd.com/read/29514787/frequency-and-level-of-evidence-used-in-recommendations-by-the-national-comprehensive-cancer-network-guidelines-beyond-approvals-of-the-us-food-and-drug-administration-retrospective-observational-study
#3
COMPARATIVE STUDY
Jeffrey Wagner, John Marquart, Julia Ruby, Austin Lammers, Sham Mailankody, Victoria Kaestner, Vinay Prasad
OBJECTIVE: To determine the differences between recommendations by the National Comprehensive Cancer Network (NCNN) guidelines and Food and Drug Administration approvals of anticancer drugs, and the evidence cited by the NCCN to justify recommendations where differences exist. DESIGN: Retrospective observational study. SETTING: National Comprehensive Cancer Network and FDA. PARTICIPANTS: 47 new molecular entities approved by the FDA between 2011 and 2015...
March 7, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29431373/is-precision-medicine-ready-to-use-in-primary-care-practice-no-it-is-barely-ready-for-testing
#4
Vinay Prasad, Adam Obley
No abstract text is available yet for this article.
December 15, 2017: American Family Physician
https://www.readbyqxmd.com/read/29423200/idiopathic-membranous-nephropathy-in-patients-with-diabetes-mellitus-a-diagnostic-and-therapeutic-quandary
#5
Dharmendra Bhadauria, Anand Chellappan, Anupma Kaul, Praveen Etta, Vinay Badri, Raj Kumar Sharma, Narayan Prasad, Amit Gupta, Manoj Jain
Background: Proteinuria and renal dysfunction is common in diabetic patients and may occur due to variety of causes. Nondiabetic renal diseases (NDRD) account for 30% of the renal biopsies, and idiopathic membranous nephropathy (iMN) is a common non diabetic glomerular disease that can exist alone or in combination with diabetic nephropathy (DN). Immunosuppressants used in iMN may be associated with complications of worsening glycemic control and recurrent infections. There is a paucity of literature on the clinical course, outcomes and treatment adverse effects of patients with iMN and diabetes...
February 2018: Clinical Kidney Journal
https://www.readbyqxmd.com/read/29382668/the-relation-between-publication-rate-and-financial-conflict-of-interest-among-physician-authors-of-high-impact-oncology-publications-an-observational-study
#6
Victoria Kaestner, Jonathan B Edmiston, Vinay Prasad
BACKGROUND: Despite the abundant research on financial conflict of interest regarding provider behaviour and the interpretation and results of research, little is known about the relation between these conflicts in academia and the trajectory of one's academic career. We performed a study to examine whether the presence of financial ties to drug makers among academics is associated with research productivity. METHODS: We hand-searched 3 high-impact general medical journals (New England Journal of Medicine, JAMA and The Lancet) and 3 high-impact oncology journals that publish original science (The Lancet Oncology, Journal of Clinical Oncology and Journal of the National Cancer Institute) to identify physicians based in the United States who were first or last authors on original papers on hematologic or oncologic topics that appeared in 2015...
January 30, 2018: CMAJ Open
https://www.readbyqxmd.com/read/29343497/most-medical-practices-are-not-parachutes-a-citation-analysis-of-practices-felt-by-biomedical-authors-to-be-analogous-to-parachutes
#7
Michael J Hayes, Victoria Kaestner, Sham Mailankody, Vinay Prasad
BACKGROUND: In a 2003 paper in BMJ, the authors made the tongue-in-cheek observation that there are no randomized controlled trials (RCTs) of parachutes. This paper has been widely read, cited and used to argue that RCTs are impractical or unnecessary for some medical practices. We performed a study to identify and evaluate claims that a medical practice is akin to a parachute. METHODS: Using Google Scholar, we identified all citations to the 2003 paper. We searched for claims that a specific practice was akin to a parachute...
January 15, 2018: CMAJ Open
https://www.readbyqxmd.com/read/29285544/cancer-drugs-approved-based-on-biomarkers-and-not-tumor-type-fda-approval-of-pembrolizumab-for-mismatch-repair-deficient-solid-cancers
#8
Vinay Prasad, Victoria Kaestner, Sham Mailankody
No abstract text is available yet for this article.
February 1, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29236937/why-the-us-centers-for-medicare-and-medicaid-services-cms-should-have-required-a-randomized-trial-of-foundation-medicine-f1cdx-prior-to-paying-for-it
#9
Vinay Prasad
No abstract text is available yet for this article.
December 11, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29228077/nusinersen-for-spinal-muscular-atrophy-are-we-paying-too-much-for-too-little
#10
Vinay Prasad
No abstract text is available yet for this article.
February 1, 2018: JAMA Pediatrics
https://www.readbyqxmd.com/read/29223353/editor-s-choice-late-open-surgical-conversion-after-endovascular-abdominal-aortic-aneurysm-repair
#11
Vinay Kansal, Sudhir Nagpal, Prasad Jetty
INTRODUCTION: Late open surgical conversion following endovascular aneurysm repair (EVAR) may occur more frequently after performing EVAR in anatomy outside the instructions for use (IFU). This study reviews predictors and outcomes of late open surgical conversion for failed EVAR. METHODS: This retrospective cohort study reviewed all EVARs performed at the Ottawa Hospital between January 1999 and May 2015. Open surgical conversions >1 month post EVAR were identified...
February 2018: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/29182165/me-too-drugs-with-limited-benefits-the-tale-of-regorafenib-for-hcc
#12
Bishal Gyawali, Vinay Prasad
This corrects the article DOI: 10.1038/nrclinonc.2017.100.
January 2018: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/29167883/overall-survival-vs-disease-specific-survival-reply
#13
Sham Mailankody, Vinay Prasad
No abstract text is available yet for this article.
November 22, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/29159370/unanticipated-outcomes-a-medical-memoir-a-book-review
#14
Vinay Prasad
No abstract text is available yet for this article.
November 20, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/29149669/effective-clinical-classification-of-chronic-epilepsy-into-focal-and-generalized-a-cross-sectional-study
#15
Shambhu Kumar, Mamta Bhushan Singh, Garima Shukla, Sreenivas Vishnubhatla, M V Padma Srivastava, Vinay Goyal, Kameshwar Prasad, Victor Patterson
PURPOSE: Investigations such as EEG and brain imaging are often difficult to obtain in primary care settings of resource-limited regions impacting millions of epilepsy patients. We wanted to test the hypothesis that classification of chronic epilepsy into focal and generalized based on clinical history and examination alone would be comparable to making such a classification with additional inputs from EEG and brain imaging. METHODS: Two investigators independently classified consecutive chronic epilepsy patients into focal, generalized and unclassified epilepsy...
December 2017: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/28981174/reversal-of-warfarin-era-thinking
#16
Joseph J Shatzel, Molly M Daughety, Vinay Prasad, Thomas G DeLoughery
Anticoagulation offers benefits in appropriately selected patients, however, all anticoagulants increase the risk of bleeding, which can be, at times, life threatening. For decades, vitamin K antagonists were the only oral anticoagulants available to physicians and their patients. In recent years, we have witnessed the approval of five direct oral anticoagulants (DOACs), which have shifted prior paradigms in anticoagulation such as omitting the need for routine therapeutic monitoring and lessening concerns about food and drug interactions...
October 5, 2017: Journal of Internal Medicine
https://www.readbyqxmd.com/read/28980180/non-inferiority-trials-in-medicine-practice-changing-or-a-self-fulfilling-prophecy
#17
EDITORIAL
Vinay Prasad
No abstract text is available yet for this article.
January 2018: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/28978548/do-cancer-drugs-improve-survival-or-quality-of-life
#18
EDITORIAL
Vinay Prasad
No abstract text is available yet for this article.
October 4, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28975930/immunotherapy-tisagenlecleucel-the-first-approved-car-t-cell-therapy-implications-for-payers-and-policy-makers
#19
Vinay Prasad
No abstract text is available yet for this article.
January 2018: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/28956596/anticancer-activity-of-iridium-iii-complexes-based-on-a-pyrazole-appended-quinoline-based-bodipy
#20
Rajendra Prasad Paitandi, Sujay Mukhopadhyay, Roop Shikha Singh, Vinay Sharma, Shaikh M Mobin, Daya Shankar Pandey
A pyrazole-appended quinoline-based 4,4-difluoro-4-bora-3a,4a-diaza-s-indacene (L1, BODIPY) has been synthesized and used as a ligand for the preparation of iridium(III) complexes [Ir(phpy)2 (L1)]PF6 (1; phpy = 2-phenylpyridine) and [(η5 -C5 Me5 )Ir(L1)Cl]PF6 (2). The ligand L1 and complexes 1 and 2 have been meticulously characterized by elemental analyses and spectral studies (IR, electrospray ionization mass spectrometry,1 H and13 C NMR, UV/vis, fluorescence) and their structures explicitly authenticated by single-crystal X-ray analyses...
October 16, 2017: Inorganic Chemistry
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