Ethical use of off-label disease-modifying therapies for multiple sclerosis

Background: Off-label disease-modifying therapies (DMTs) for multiple sclerosis (MS) are used in at least 89 countries. There is a need for structured and transparent evidence-based guidelines to support clinical decision-making, pharmaceutical policies and reimbursement decisions for off-label DMTs. Objectives/Results: The authors put forward general principles for the ethical use of off-label DMTs for treating MS and a process to assess existing evidence and develop recommendations for their use. Conclusion: The principles and process are endorsed by the World Federation of Neurology (WFN), American Academy of Neurology (AAN), European Academy of Neurology (EAN), Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Middle-East North Africa Committee for Treatment and Research in Multiple Sclerosis (MENACTRIMS) and Pan-Asian Committee for Treatment and Research in Multiple Sclerosis (PACTRIMS), and we have regularly consulted with the Brain Health Unit, Mental Health and Substance Use Department at the World Health Organization (WHO)

Global barriers to the diagnosis of Multiple Sclerosis

Background and Objectives: Recent data suggest increasing global prevalence of multiple sclerosis (MS). Early diagnosis of MS reduces the burden of disability-adjusted life years and associated health care costs. Yet diagnostic delays persist in MS care and even within national health care systems with robust resources, comprehensive registries, and MS subspecialist referral networks. The global prevalence and characteristics of barriers to expedited MS diagnosis, particularly in resource-restricted regions, have not been extensively studied. Recent revisions to MS diagnostic criteria demonstrate potential to facilitate earlier diagnosis, but global implementation remains largely unknown. Methods: The Multiple Sclerosis International Federation third edition of the Atlas of MS was a survey that assessed the current global state of diagnosis including adoption of MS diagnostic criteria; barriers to diagnosis with respect to the patient, health care provider, and health system; and existence of national guidelines or national standards for speed of MS diagnosis. Results: Coordinators from 107 countries (representing approximately 82% of the world population), participated. Eighty-three percent reported at least 1 “major barrier” to early MS diagnosis. The most frequently reported barriers included the following: “lack of awareness of MS symptoms among general public” (68%), “lack of awareness of MS symptoms among health care professionals” (59%), and “lack of availability of health care professionals with knowledge to diagnose MS” (44%). One-third reported lack of “specialist medical equipment or diagnostic tests.” Thirty-four percent reported the use of only 2017 McDonald criteria (McD-C) for diagnosis, and 79% reported 2017 McD-C as the “most commonly used criteria.” Sixty-six percent reported at least 1 barrier to the adoption of 2017 McD-C, including “neurologists lack awareness or training” by 45%. There was no significant association between national guidelines pertaining to MS diagnosis or practice standards addressing the speed of diagnosis and presence of barriers to early MS diagnosis and implementation of 2017 McD-C. Discussion: This study finds pervasive consistent global barriers to early diagnosis of MS. While these barriers reflected a lack of resources in many countries, data also suggest that interventions designed to develop and implement accessible education and training can provide cost-effective opportunities to improve access to early MS diagnosis

National plans and awareness campaigns as priorities for achieving global brain health

Neurological conditions are the leading cause of death and disability combined. This public health crisis has become a global priority with the introduction of WHO's Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022–2031 (IGAP). 18 months after this plan was adopted, global neurology stakeholders, including representatives of the OneNeurology Partnership (a consortium uniting global neurology organisations), take stock and advocate for urgent acceleration of IGAP implementation. Drawing on lessons from relevant global health contexts, this Health Policy identifies two priority IGAP targets to expedite national delivery of the entire 10-year plan: namely, to update national policies and plans, and to create awareness campaigns and advocacy programmes for neurological conditions and brain health. To ensure rapid attainment of the identified priority targets, six strategic drivers are proposed: universal community awareness, integrated neurology approaches, intersectoral governance, regionally coordinated IGAP domestication, lived experience-informed policy making, and neurological mainstreaming (advocating to embed brain health into broader policy agendas). Contextualised with globally emerging IGAP-directed efforts and key considerations for intersectoral policy design, this novel framework provides actionable recommendations for policy makers and IGAP implementation partners. Timely, synergistic pursuit of the six drivers might aid WHO member states in cultivating public awareness and policy structures required for successful intersectoral roll-out of IGAP by 2031, paving the way towards brain health for all.</p

National plans and awareness campaigns as priorities for achieving global brain health

Neurological conditions are the leading cause of death and disability combined. This public health crisis has become a global priority with the introduction of WHO's Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022–2031 (IGAP). 18 months after this plan was adopted, global neurology stakeholders, including representatives of the OneNeurology Partnership (a consortium uniting global neurology organisations), take stock and advocate for urgent acceleration of IGAP implementation. Drawing on lessons from relevant global health contexts, this Health Policy identifies two priority IGAP targets to expedite national delivery of the entire 10-year plan: namely, to update national policies and plans, and to create awareness campaigns and advocacy programmes for neurological conditions and brain health. To ensure rapid attainment of the identified priority targets, six strategic drivers are proposed: universal community awareness, integrated neurology approaches, intersectoral governance, regionally coordinated IGAP domestication, lived experience-informed policy making, and neurological mainstreaming (advocating to embed brain health into broader policy agendas). Contextualised with globally emerging IGAP-directed efforts and key considerations for intersectoral policy design, this novel framework provides actionable recommendations for policy makers and IGAP implementation partners. Timely, synergistic pursuit of the six drivers might aid WHO member states in cultivating public awareness and policy structures required for successful intersectoral roll-out of IGAP by 2031, paving the way towards brain health for all.</p

The global patient-reported outcomes for multiple sclerosis initiative: bridging the gap between clinical research and care – updates at the 2023 plenary event

Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. The initiative prioritizes the global integration of patient (For the purposes of the Global PROMS Initiative, the term “patient” refers to the people with the disease (aka People with Multiple Sclerosis – pwMS): any individual with lived experience of the disease. People affected by the disease/Multiple Sclerosis: any individual or group that is affected by the disease: E.g., family members, caregivers will be also engaged as the other stakeholders in the initiative). insights into the management of MS care. It merges subjective PROs with objective clinical metrics, thereby addressing the complex variability of disease presentation and progression. Following the completion of its second phase, the initiative aims to help increasing the uptake of eHealth tools and passive PROs within research and clinical settings, affirming its unwavering dedication to the progressive refinement of MS care. Looking forward, the initiative is poised to continue enhancing global surveys, rethinking to the relevant statistical approaches in clinical trials, and cultivating a unified stance among ‘industry’, regulatory bodies and health policy making regarding the application of PROs in MS healthcare strategies

Borgerfellesskap, kirkeinnflytelse og partistatens krise i Italia : en analyse av Den katolske kirkens rolle i italiensk politikk og samfunnsliv 1870-1992

Temaet for denne hovedoppgaven er forholdet mellom Den katolske kirken og den italienske staten i perioden 1870-1992. Pavestatenes geografiske plassering har gjort at pavedømmets politikk først og fremst har vært knyttet til Italia og områdene rundt Middelhavet, og Den katolske kirken har historisk sett vært en viktig innflytelsesfaktor i italienske samfunnsforhold. Samlingen av Italia mellom 1861 og 1870, resulterte i en konflikt mellom de nye makthaverne og Den katolske kirken. Lederne av samlingsprosessen ønsket å grunnlegge den italienske staten på liberale, sekulære prinsipper om " en fri kirke i en fri stat". Kirken anså imidlertid innlemmingen av pavestatene i Italia som illegitim, og svarte med å nekte å anerkjenne den nye staten. Det spørsmål jeg tar opp i denne hovedoppgaven er på hvilken måte Den katolske kirken har påvirket den italienske statens politiske liv, og hvilke konsekvenser dette har fått. Mitt utgangspunkt for undersøkelsen av denne problemstillingen, er Robert D. Putnams forestillinger om betingelsene for et aktivt, effektivt demokrati. Ifølge Putnam fungerer demokratiet best dersom omgivelse kan beskrives som et borgerfellesskap, og et viktig kjennetegn ved medlemskap i et borgerfellesskap er aktiv deltakelse i offentlige anliggender. Formålet med denne oppgaven er å avdekke hvorvidt- og i så fall på hvilken måte - Den katolske kirken gjennom italiensk historie de siste 130 årene har bidratt til en svekkelse av borgerfellesskapet, og dermed til å etablere en politisk kultur preget av klientisme. Jeg vil dessuten drøfte hvorvidt man kan si at denne historiske arven - dersom jeg finner den dokumentert - har bidratt til den partipolitiske krisen som oppsto i Italia på begynnelsen av 1990-tallet. Hovedfokus for oppgaven vil være årene etter den annen verdenskrig. Jeg mener imidlertid at det ikke er mulig å redusere analysen av problemstillingen bare til denne perioden, men at man må trekke linjer enda lenger tilbake i historien. I analysen av problemstillingen vil jeg derfor benytte meg av såkalt retrospektiv analyse - en metode som karakteriseres av at man søker å forklare nåværende strukturer ved å gripe tilbake til den historiske opprinnelsen. Den betydning jeg tillegger den historiske dimensjonen er også bakgrunnen for at jeg ønsker å bruke Stein Rokkans modell for statsdannelse og nasjonsbygging i Europa som bidrag til å belyse problemstillingen. Den katolske kirken oppfattet den nyopprettede italienske staten som en trussel. Det katolske hierarkiet fryktet at de sekulære myndighetene skulle stille seg mellom Kirken og de troende, og forsøkte å hindre dens virke. Det viktigste for Kirken i denne situasjonen ble å forsøke å sikre sine egne privilegier og bevare sin posisjon i det italienske samfunnet. Kirkens svar på den italienske statens annektering av pavestatene, var at den forbød katolikkene å delta i det politiske liv gjennom det såkalte Non expedit-dekretet. Bestrebelsene etter å kontrollere katolikkenes deltakelse førte til en depolitisering av samfunnet - en svekkelse av befolkningens deltakelsesferdigheter. Resultatet var utvikling av en korrupsjonskultur som etter hvert gjennomsyret hele det italienske samfunnet. Gjennom Non expedit-politikken hindret Kirken katolikkene i å delta aktivt i det politiske liv, unntagen når deltakelsen fant sted i former organisert og kontrollert av Kirken selv. Resultatet var st man ikke lyktes i å få demokratiet til å slå særlig dype røtter i den italienske befolkningen. Kirkens streben etter å sikre sine egne privilegier og bevare sin posisjon i samfunnet, var avgjørende for dens måte å forholde seg til deltakelsesspørsmålet på. Under pave Pius XI (1922-39) var Kikrens strategi ikke-innblanding i politikken i et forsøk på å tekkes facistene og stanse sosialismens fremmarsj. Da det etter den annen verdenskrig ble klart at en slik linje ville bidra til å styrke heller enn til å svekke venstresiden, gikk Pius XII (1939-58) bort fra sin forgjengers strategi og oppfordret til "timelig engasjement" fordi dette nå var nødvendig. Katolikkene ble oppmuntret til å delta i politikken når det katolske hierarkiet mente dette var nødvendig for å sikre Kirkens egne interesser og fremme pavedømmets konservative synspunkter. Etter den annen verdenskrig gav paven, kurien og de italienske biskopene, gjennom åpen og aktiv støtte til det kristelig-demokratiske partiet, ideologisk legitimitet til et parti og et system som gav dem mange fordeler. I stedet for å oppnå legitimitet gjennom representasjon og effektivitet, fikk staten sin legitimitet fra pavedømmet som på denne måten underminerte statens autoritet, og her ligger kilden til det italienske etterkrigssystemets klientisme. Følgene av Kirkens påvirkning på politikken var at den bidro til å legitimere et korrupt system. Dens inngripen i politikken bidro til å konsolidere kristelig-demokratenes makt, og dermed til å konsolidere etterkrigstidens politiske regime. Kirkens fokusering på forfølgelsen av egne mål gjorde at den kom i skade for å bygge opp under krefter i samfunnet om svekket det borgerfellesskapet Putnam mener er nøkkelen til godt styre

What do bonobos (Pan paniscus) understand about physical contact?

The present study aimed to test what bonobos (Pan paniscus) understand about contact. The task consisted of a clear horizontal tube containing a piece of food and a stick with a disk attached. The bonobos chose which side to push or pull the stick for the disk to contact the food and make it accessible. There were 9 variations in tube design, which differed in the positions of the stick, disk, and food. All 5 bonobos passed at least I configuration. A recent study (A. E. Helme, N. S. Clayton, &amp; N. J. Emery, 2006) found that rooks could learn only tube configurations that provided an asymmetrical stick cue, whereas bonobos did not demonstrate an understanding of contact but showed more individual variation, attending to the positions of the food, disk, and stick.</p

What do bonobos (Pan paniscus) understand about physical contact?

The present study aimed to test what bonobos (Pan paniscus) understand about contact. The task consisted of a clear horizontal tube containing a piece of food and a stick with a disk attached. The bonobos chose which side to push or pull the stick for the disk to contact the food and make it accessible. There were 9 variations in tube design, which differed in the positions of the stick, disk, and food. All 5 bonobos passed at least I configuration. A recent study (A. E. Helme, N. S. Clayton, &amp; N. J. Emery, 2006) found that rooks could learn only tube configurations that provided an asymmetrical stick cue, whereas bonobos did not demonstrate an understanding of contact but showed more individual variation, attending to the positions of the food, disk, and stick.</p

Barriers to Access Multiple Sclerosis Disease-Modifying Therapies in Middle East and North Africa: A Regional Survey-Based Study

International audienceMultiple sclerosis (MS) management varies markedly between different countries of the Middle East and North Africa (MENA) region based on disease-modifying therapies (DMTs) availability, accessibility, and reimbursement. In general, introduction of novel DMTs in most MENA countries is usually delayed, as drug approval can take several months to years once approved for use by the Food and Drug Administration (FDA) or European Medicines Agency (EMA), depending on the country. To our knowledge, there are no published studies assessing the accessibility to DMTs across different countries of the region