The US Expert Panel on the Appropriate Use Recommendations of Aducanumab in Clinical Practice

2021 ◽  
pp. 1-1
Author(s):  
S. Gauthier ◽  
P. Rosa-Neto
Keyword(s):  
Clinical Practice ◽  
Expert Panel ◽  
Amyloid Plaques ◽  
Public Domain ◽  
Phase Iii ◽  
Appropriate Use ◽  
The Public ◽  
New Class ◽  
The Us ◽  
The Brain

The authors of these recommendations must be congratulated on rapidly putting together a workable set of guidelines on the best use in clinical practice of the first drug approved (1) in a new class of medications acting on the excessive deposition of amyloid plaques in the brain of persons with early symptoms of Alzheimer’s disease (AD). These guidelines have been written despite the current lack of peer-reviewed publications about the Phase III pivotal studies so changes may be required once all the data is available in the public domain (2, 3, 4).

scholarly journals Aducanumab: Appropriate Use Recommendations

2021 ◽  
pp. 1-2
Author(s):  
P. Scheltens ◽  
E.G.B. Vijverberg
Keyword(s):  
Eligible Patient ◽  
Surrogate Marker ◽  
Amyloid Plaques ◽  
Phase Iii ◽  
Amyloid Pet ◽  
Small Step ◽  
Appropriate Use ◽  
The Us ◽  
General Feeling ◽  
Giant Leap

June 7, 2021 will not likely be forgotten soon by many Alzheimer Disease (AD) researchers. To paraphrase a famous quote: ”a small step for man, but a giant leap forwards for the field”. That day, AduhelmTM (aducanumab) was approved by the US Food and Drug administration (FDA), because of its profound effect on amyloid plaques as shown by amyloid PET as a surrogate marker. Although this decision was not met with great enthusiasm uniformly, the general feeling during a 4 hour webinar hosted by the Alzheimer Association (1) was that the benefits seem to outweigh the risks, but proper guidance was needed on who would be eligible for treatment, because all attendees felt the label was far too broad and unspecific. The latter was amended on july 8, jointly by FDA and Biogen to more accurately reflect the eligible patient population that was studied in the Phase III program.

scholarly journals Viola Bernard and the case study of race in post-war America

2017 ◽  
Author(s):  
Joy Damousi
Keyword(s):  
Race Relations ◽  
Public Domain ◽  
Us History ◽  
The Public ◽  
The Us ◽  
Post War ◽  
The Relationship

It is in the US that the case study genre is reinvented within a politicised psychiatric-psychoanalytical framework in the work of Viola Bernard. Bernard’s writings pose enduring questions about the relationship between activism and US psychiatry, politics and race relations. This chapter traces Bernard’s efforts to develop a new, authoritative and politically effective narrative through her case notes and advocacy about black subjects. This involved mobilising the case study genre in the public domain at large, for political as well as medical purposes, in the context of a turbulent period in US history.

scholarly journals Discovery of Oxazolidinone-Based Heterocycles as Subtype Selective Sigma-2 Ligands

2021 ◽  
Author(s):  
Benjamin E Blass ◽  
Richie Rashmin Bhandare ◽  
Daniel J. Canney
Keyword(s):  
Therapeutic Target ◽  
Amyloid Plaques ◽  
Therapeutic Options ◽  
Potential Therapeutic Target ◽  
Root Cause ◽  
Amyloid Hypothesis ◽  
Medical Need ◽  
The Us ◽  
Subtype Selective ◽  
The Brain

Abstract Alzheimer’s disease is a major, unmet medical need that impacts 6 million people in the US alone. Therapeutic options are limited, and the root cause of this condition remains unclear. The Amyloid Hypothesis has been proposed as a means of explaining the formation of amyloid plaques in the brain of patient. The sigma-2 receptor was recently identified as a potential therapeutic target capable of arresting the formation of amyloid plaques. Herein, we report the identification of a series of novel, functionalized oxazolidin-2-ones sigma-2 ligands.

scholarly journals Aducanumab: Appropriate Use Recommendations

2021 ◽  
pp. 1-13
Author(s):  
J. Cummings ◽  
P. Aisen ◽  
L.G. Apostolova ◽  
A. Atri ◽  
S. Salloway ◽  
...  
Keyword(s):  
Expert Panel ◽  
Informed Decision Making ◽  
Practice Setting ◽  
Efficacy And Safety ◽  
Appropriate Use ◽  
Patient Centered ◽  
The Us ◽  
Expected Outcome ◽  
Potential Risks ◽  
Prescribing Information

Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer’s disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied. Aducanumab is titrated to a dose of 10 mg/kg over a 6-month period. The Expert Panel recommends that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. Dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. Recommendations are made for measures less cumbersome than those used in trials for the assessment of effectiveness in the practice setting. The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.

scholarly journals Potentially Curable Pancreatic Adenocarcinoma: ASCO Clinical Practice Guideline Update

2019 ◽  
Vol 37 (23) ◽  
pp. 2082-2088 ◽  
Author(s):  
Alok A. Khorana ◽  
Shannon E. McKernin ◽  
Jordan Berlin ◽  
Theodore S. Hong ◽  
Anirban Maitra ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Pancreatic Adenocarcinoma ◽  
Expert Panel ◽  
Phase Iii ◽  
Combination Regimen ◽  
Irinotecan Hydrochloride ◽  
Additional Information ◽  
Cancer Guidelines ◽  
Leucovorin Calcium

PURPOSE The purpose of this guideline update is to incorporate recently reported practice-changing evidence into ASCO’s recommendations on potentially curable pancreatic adenocarcinoma. METHODS ASCO convened an Expert Panel to evaluate data from PRODIGE 24/CCTG PA.6, a phase III, multicenter, randomized clinical trial of postoperative leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) versus gemcitabine alone, presented at the 2018 ASCO Annual Meeting. In addition, PubMed was searched for additional papers that may influence the existing recommendations. RECOMMENDATIONS The Expert Panel only updated Recommendation 4.1 as a result of the practice-changing data. Recommendation 4.1 states that all patients with resected pancreatic adenocarcinoma who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The modified combination regimen of 5-fluorouracil, oxaliplatin, and irinotecan (mFOLFIRINOX; oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 D1, and 5-fluorouracil 2.4 g/m2 over 46 hours every 14 days for 12 cycles) is now preferred in the absence of concerns for toxicity or tolerance; alternatively, doublet therapy with gemcitabine and capecitabine or monotherapy with gemcitabine alone or fluorouracil plus folinic acid alone can be offered. Additional information can be found at www.asco.org/gastrointestinal-cancer-guidelines .

scholarly journals What Happens When Books Enter the Public Domain? Testing Copyright’s Underuse Hypothesis Across Australia, New Zealand, the United States and Canada

2019 ◽  
Author(s):  
Jacob Flynn ◽  
Rebecca Giblin ◽  
Francois Petitjean
Keyword(s):  
United States ◽  
New Zealand ◽  
Public Libraries ◽  
The United States ◽  
Public Domain ◽  
The Public ◽  
The Us ◽  
Widespread Access ◽  
Analyse Comparative ◽  
Access To Knowledge

The United States (‘US’) extended most copyright terms by 20 years in 1998, and has since exported that extension via ‘free trade’ agreements to countries including Australia and Canada. A key justification for the longer term was the claim that exclusive rights are necessary to encourage publishers to invest in making older works available — and that, unless such rights were granted, they would go underused. This study empirically tests this ‘underuse hypothesis’ by investigating the relative availability of ebooks to public libraries across Australia, New Zealand, the US and Canada. We find that books are actually less available where they are under copyright than where they are in the public domain, and that commercial publishers seem undeterred from investing in works even where others are competing to supply the same titles. We also find that exclusive rights do not appear to trigger investment in works that have low commercial demand, with books from 59% of the ‘culturally valuable’ authors we sampled unavailable in any jurisdiction, regardless of copyright status. This provides new evidence of how even the shortest copyright terms can outlast works’ commercial value, even where cultural value remains. Further, we find that works are priced much higher where they are under copyright than where they in the public domain, and these differences typically far exceed what would be paid to authors or their heirs. Thus, one effect of extending copyrights from life + 50 to life + 70 is that libraries are obliged to pay higher prices in exchange for worse access.This is the first published study to test the underuse hypothesis outside the US, and the first to analyse comparative availability of identical works across jurisdictions where their copyright status differs. It adds to the evidence that the underuse hypothesis is not borne out by real world practice. Nonetheless, countries are still being obliged to enact extended terms as a cost of trade access. We argue that such nations should explore alternative ways of dividing up those rights to better achieve copyright’s fundamental aims of rewarding authors and promoting widespread access to knowledge and culture.

scholarly journals “Flagging the Lines”: Basque immigrant sheepherders and the early US Forest Administration in Nevada, 1890-1920

2018 ◽  
pp. 137-168
Author(s):  
Iker Saitua ◽  
Keyword(s):  
Public Domain ◽  
Forest Service ◽  
National Forests ◽  
National Forest ◽  
Economic Interests ◽  
The Public ◽  
Grassland Ecosystems ◽  
The Us ◽  
Us Forest Service ◽  
Forest Lands

In the early twentieth century, the US Forest Service began to exclude itinerant sheep operations from the public-domain lands it administered: the National Forests. But beyond the National Forests, the extensive public-domain lands devoted to grazing were not regulated. To some local ranchers and stockmen, the increasing presence of itinerant sheepherders, including Basque immigrants, represented the first of a growing number of competitors on Nevada’s public-domain lands. These stockmen blamed itinerant sheepherders for all the problems affecting the water and grassland ecosystems, such as the deterioration of the ranges and the fouling of springs and streams. Their representatives requested an expansion of National Forest boundaries as a means of asserting exclusive use of the range for stockmen. Although at first the Forest Service keenly appreciated the problems of local stock raisers, it opposed the idea of expanding the National Forests in Nevada solely for the purpose of range control. This article explores how some ranchers advocated expanding the National Forest lands within the State of Nevada as a strategy to protect their economic interests and force itinerant sheepherders out of business.

scholarly journals O domínio público e a função social do direito autoral | Public domain and the social function of copyright law

2011 ◽  
Vol 7 (2) ◽  
Author(s):  
Carlos Affonso Pereira de Souza
Keyword(s):  
Social Function ◽  
Public Domain ◽  
Copyright Law ◽  
Public Interests ◽  
The Public ◽  
The Social ◽  
The Us ◽  
Private And Public ◽  
Access To Knowledge

Resumo O artigo debate as funções desempenhadas pelo direito autoral, identificando o estímulo à criação como função promocional e o acesso ao conhecimento e à informação como sua função social. O texto desenvolve o papel do domínio público como instituto fundamental para garantir o equilíbrio entre interesses privados e públicos na proteção autoral a partir do ordenamento constitucional e reflete sobre a experiência norte-americana envolvendo a prorrogação do prazo de proteção das obras autorais. Palavras-chave Direitos Autorais; Domínio Público; Função SocialAbstract The article debates the functions of copyright protection, identifying the incentive to intellectual creation and the access to knowledge and information as its two major functions. The text explores the role of the public domain as a fundamental institute for the better understanding of the balance between private and public interests in copyright in the light of Brazilian Constitutional Law and the US experience on the extension of the protection term. Keywords Copyright; Public Domain; Social Function

scholarly journals Initial Management of Noncastrate Advanced, Recurrent, or Metastatic Prostate Cancer: ASCO Guideline Update

2021 ◽  
pp. JCO.20.03256
Author(s):  
Katherine S. Virgo ◽  
R. Bryan Rumble ◽  
Ronald de Wit ◽  
David S. Mendelson ◽  
Thomas J. Smith ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Metastatic Prostate Cancer ◽  
Expert Panel ◽  
Locally Advanced ◽  
Local Treatment ◽  
Phase Iii ◽  
Standards Of Care

PURPOSE Update all preceding ASCO guidelines on initial hormonal management of noncastrate advanced, recurrent, or metastatic prostate cancer. METHODS The Expert Panel based recommendations on a systematic literature review. Recommendations were approved by the Expert Panel and the ASCO Clinical Practice Guidelines Committee. RESULTS Four clinical practice guidelines, one clinical practice guidelines endorsement, 19 systematic reviews with or without meta-analyses, 47 phase III randomized controlled trials, nine cohort studies, and two review papers informed the guideline update. RECOMMENDATIONS Docetaxel, abiraterone, enzalutamide, or apalutamide, each when administered with androgen deprivation therapy (ADT), represent four separate standards of care for noncastrate metastatic prostate cancer. Currently, the use of any of these agents in any particular combination or series cannot be recommended. ADT plus docetaxel, abiraterone, enzalutamide, or apalutamide should be offered to men with metastatic noncastrate prostate cancer, including those who received prior therapies, but have not yet progressed. The combination of ADT plus abiraterone and prednisolone should be considered for men with noncastrate locally advanced nonmetastatic prostate cancer who have undergone radiotherapy, rather than castration monotherapy. Immediate ADT may be offered to men who initially present with noncastrate locally advanced nonmetastatic disease who have not undergone previous local treatment and are unwilling or unable to undergo radiotherapy. Intermittent ADT may be offered to men with high-risk biochemically recurrent nonmetastatic prostate cancer. Active surveillance may be offered to men with low-risk biochemically recurrent nonmetastatic prostate cancer. The panel does not support use of either micronized abiraterone acetate or the 250 mg dose of abiraterone with a low-fat breakfast in the noncastrate setting at this time. Additional information is available at www.asco.org/genitourinary-cancer-guidelines .

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