I was honoured to be invited to present at the European Ibogaine Conference in Vienna, September 2017. Here are some slides from the event.
If there was another way of kick-starting your recovery journey from your addiction and substance misuse problem, would you dare try it? We bridge the gap by combining our tailored version of the 12steps, CBT, Ibogaine (optional) and Holistic Therapies. We are proud to be pioneering the new generation of Rehab Centres. Why wait? Make the call!
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The document discusses regulations around access to and classification of medicines in the UK and Europe. It describes three categories of medicines in the UK - prescription only medicines (POM), pharmacy medicines (P), and general sales list medicines (GSL). POM medicines require a prescription, P medicines can only be sold under pharmacy supervision, and GSL medicines can be sold in any retail outlet. There has been a trend of increasing medicines moving from POM to P to GSL status, making them more accessible over the counter without a prescription. This deregulation aims to empower consumers, improve access, and reduce costs, but must balance this with safety and professional oversight.
Gesamt publikation understanding the pharmaceutical care concept and applying...nuretampan
This document provides an overview of pharmaceutical care initiatives in Europe based on a scoping exercise conducted by Gesundheit Österreich GmbH. It summarizes the results of a literature review and case studies of pharmaceutical care practices in Austria and Portugal. The literature shows long-standing traditions of pharmaceutical services in some Western European countries but less advanced implementation in Central and Eastern Europe. Disease-specific programs for conditions like heart disease and asthma are common. International projects like the Pharmaceutical Care Network Europe coordinate joint initiatives. The case studies describe specific programs in Austria like medication safety reviews and public health days, and comprehensive care programs in Portugal. Several disease areas and potential indicators for evaluating pharmaceutical care are also discussed.
This document discusses pricing and reimbursement systems for pharmaceuticals in Germany and the Netherlands. It provides timelines for reimbursement processes, data requirements for dossiers submitted for assessment and reimbursement, how incremental clinical benefit is assessed, the role of health economics analyses, exceptions to rules, and implications. The key lessons are that incremental clinical benefit evidence from RCTs is crucial for successful reimbursement outcomes, health economics is gaining importance in Germany with new legislation, dossiers must be prepared well in advance, and following scientific advice can help optimize applications. Exceptions apply for orphan drugs in both countries.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
DPA Conference - Innternational Reform Drug Policy Conference, LA, USA 2011Paula Vale de Andrade
This document summarizes Portugal's approach to drug policy and harm reduction. It describes how Portugal shifted from criminalizing drug use to a public health approach in 2000. This led to decreased drug-related harms and drug-related criminal justice involvement while increasing access to treatment. The document also outlines Portugal's harm reduction strategies, which aim to reduce health and social risks for people who use drugs through services like needle exchange and opioid substitution treatment.
Dependencia química / Ibogaina
Tratamento de drogas
O atual momento da ibogaína merece uma tomada de consciência e um grande senso de responsabilidade das pessoas... Estão aparecendo a cada dia novas pseudo-clínicas, todas alardeando uma experiência e um conhecimento que não possuem, buscando atrair os incautos pacientes e familiares que, desesperados, tentam qualquer coisa sem pensar direito no que estão fazendo.
Como sempre dizemos, o tratamento com ibogaína é um procedimento que não é isento de riscos, deve ser feito em ambiente médico-hospitalar, com o paciente internado, para ser protegido e monitorado. O paciente deve estar limpo de drogas e de remédios por um tempo variável, de acordo com cada situação individual, e deve ser submetido a uma bateria de exames antes do procedimento. E a medicação utilizada, deve ser GMP, ou seja, fabricada segundo as boas práticas farmacêuticas.
Não confie em locais que usam, como diferencial para fazer propaganda, o argumento de que não é necessária internação, nem exames e nem abstinência prévia. Pelo menos 60 dias de internação são necessárias sim, para inclusive proteger o paciente de qualquer evento adverso .
Não confie em locais e sites que dão a entender que a ibogaína é a "cura" da dependência química, isso é simplificar demais um problema sério.
Desde que se descobriram os efeitos anti-dependência da ibogaína, em 1962, ocorreram cerca de 20.000 tratamentos em todo o mundo. Nestes 20.000 tratamentos, ocorreram 19 mortes, todas relacionadas a problemas de saúde prévios ( que teriam sido detectados se o paciente tivesse feito um check-up antes do procedimento) e também a uso de drogas muito perto do uso da ibogaína ( o que teria sido evitado se o paciente estivesse sob vigilância especializada).
Então, não confie em pessoas que menosprezam o poder da substância, que não entendem do assunto e visam apenas lucro.
Não confie tambem em locais que indicam a ibogaína como uma panacéia, que cura tudo, desde a dependência até queda de cabelo. Claramente, isso é uma tentativa de angariar mais pacientes e aumentar os lucros.
Mesmo sendo derivada de uma planta, certos cuidados devem ser tomados. Não é toda medicação derivada de plantas que é "tranquila" ou "fraquinha", quem fala isso demonstra que não entende do assunto.
A ibogaína é muito eficiente, principalmente se comparada aos outros tratamentos disponíveis, mas para atingir bons resultados, é necessária uma expertise que alguns locais que fazem propaganda disseminada não possuem.
Apenas a título de informação, aqui está o link para um trabalho científico comentando essas mortes às quais me referi. Observe como no texto é dito que esses casos todos foram de pacientes com problemas de saúde prévios, usando medicação de origem desconhecida.
Experience of an Ibogaine treatment provider finalaleyarok
The document provides information on conducting safe and effective ibogaine treatment, including:
1. Guidelines for screening patients, determining inclusion/exclusion criteria, monitoring safety, and developing an aftercare plan.
2. Details on the typical phases and visions experienced during ibogaine treatment, and the importance of qualified medical staff and proper facilities.
3. A list of needs for an ibogaine treatment location and protocols for patient monitoring, medical record keeping, and ensuring patient safety and comfort during the session.
Enfermedad minoritaria, terapias nuevas. Una patología que afecta a menos de cinco personas por cada 10.000 habitantes es considerada una enfermedad rara o minoritaria. 35 millones de europeos se ven afectados por alguna de ellas. El 80% son de origen genético y conseguir un diagnóstico rápido es vital para asegurar la calidad de vida futura. La clave, una vez más, es apostar y potenciar la investigación biomédica. Se revisarán los resultados obtenidos los últimos 14 años, en el marco científico y regulador impulsado por la UE desde el año 2000. Sin embargo, se analizarán las dificultades y oportunidades para impulsar la investigación traslacional en estas enfermedades.
Sigue la presentación en Youtube: https://www.youtube.com/watch?v=d4U4a8xFCzA&
The document discusses regulations around access to and classification of medicines in the UK and Europe. It describes three categories of medicines in the UK - prescription only medicines (POM), pharmacy medicines (P), and general sales list medicines (GSL). POM medicines require a prescription, P medicines can only be sold under pharmacy supervision, and GSL medicines can be sold in any retail outlet. There has been a trend of increasing medicines moving from POM to P to GSL status, making them more accessible over the counter without a prescription. This deregulation aims to empower consumers, improve access, and reduce costs, but must balance this with safety and professional oversight.
Gesamt publikation understanding the pharmaceutical care concept and applying...nuretampan
This document provides an overview of pharmaceutical care initiatives in Europe based on a scoping exercise conducted by Gesundheit Österreich GmbH. It summarizes the results of a literature review and case studies of pharmaceutical care practices in Austria and Portugal. The literature shows long-standing traditions of pharmaceutical services in some Western European countries but less advanced implementation in Central and Eastern Europe. Disease-specific programs for conditions like heart disease and asthma are common. International projects like the Pharmaceutical Care Network Europe coordinate joint initiatives. The case studies describe specific programs in Austria like medication safety reviews and public health days, and comprehensive care programs in Portugal. Several disease areas and potential indicators for evaluating pharmaceutical care are also discussed.
This document discusses pricing and reimbursement systems for pharmaceuticals in Germany and the Netherlands. It provides timelines for reimbursement processes, data requirements for dossiers submitted for assessment and reimbursement, how incremental clinical benefit is assessed, the role of health economics analyses, exceptions to rules, and implications. The key lessons are that incremental clinical benefit evidence from RCTs is crucial for successful reimbursement outcomes, health economics is gaining importance in Germany with new legislation, dossiers must be prepared well in advance, and following scientific advice can help optimize applications. Exceptions apply for orphan drugs in both countries.
APIFARMA, the Portuguese pharmaceutical industry assocation, holds a series of conference throughout they year. OHE's Jorge Mestre-Ferrandiz, an expert on pricing and reimbursement (P&R) in Europe, was the lead speaker at the October 2014 conference on access to innovation. His presentation covers existing and potential approaches to evaluating new medicines as a condition for P&R in France, Germany and the UK.
DPA Conference - Innternational Reform Drug Policy Conference, LA, USA 2011Paula Vale de Andrade
This document summarizes Portugal's approach to drug policy and harm reduction. It describes how Portugal shifted from criminalizing drug use to a public health approach in 2000. This led to decreased drug-related harms and drug-related criminal justice involvement while increasing access to treatment. The document also outlines Portugal's harm reduction strategies, which aim to reduce health and social risks for people who use drugs through services like needle exchange and opioid substitution treatment.
Dependencia química / Ibogaina
Tratamento de drogas
O atual momento da ibogaína merece uma tomada de consciência e um grande senso de responsabilidade das pessoas... Estão aparecendo a cada dia novas pseudo-clínicas, todas alardeando uma experiência e um conhecimento que não possuem, buscando atrair os incautos pacientes e familiares que, desesperados, tentam qualquer coisa sem pensar direito no que estão fazendo.
Como sempre dizemos, o tratamento com ibogaína é um procedimento que não é isento de riscos, deve ser feito em ambiente médico-hospitalar, com o paciente internado, para ser protegido e monitorado. O paciente deve estar limpo de drogas e de remédios por um tempo variável, de acordo com cada situação individual, e deve ser submetido a uma bateria de exames antes do procedimento. E a medicação utilizada, deve ser GMP, ou seja, fabricada segundo as boas práticas farmacêuticas.
Não confie em locais que usam, como diferencial para fazer propaganda, o argumento de que não é necessária internação, nem exames e nem abstinência prévia. Pelo menos 60 dias de internação são necessárias sim, para inclusive proteger o paciente de qualquer evento adverso .
Não confie em locais e sites que dão a entender que a ibogaína é a "cura" da dependência química, isso é simplificar demais um problema sério.
Desde que se descobriram os efeitos anti-dependência da ibogaína, em 1962, ocorreram cerca de 20.000 tratamentos em todo o mundo. Nestes 20.000 tratamentos, ocorreram 19 mortes, todas relacionadas a problemas de saúde prévios ( que teriam sido detectados se o paciente tivesse feito um check-up antes do procedimento) e também a uso de drogas muito perto do uso da ibogaína ( o que teria sido evitado se o paciente estivesse sob vigilância especializada).
Então, não confie em pessoas que menosprezam o poder da substância, que não entendem do assunto e visam apenas lucro.
Não confie tambem em locais que indicam a ibogaína como uma panacéia, que cura tudo, desde a dependência até queda de cabelo. Claramente, isso é uma tentativa de angariar mais pacientes e aumentar os lucros.
Mesmo sendo derivada de uma planta, certos cuidados devem ser tomados. Não é toda medicação derivada de plantas que é "tranquila" ou "fraquinha", quem fala isso demonstra que não entende do assunto.
A ibogaína é muito eficiente, principalmente se comparada aos outros tratamentos disponíveis, mas para atingir bons resultados, é necessária uma expertise que alguns locais que fazem propaganda disseminada não possuem.
Apenas a título de informação, aqui está o link para um trabalho científico comentando essas mortes às quais me referi. Observe como no texto é dito que esses casos todos foram de pacientes com problemas de saúde prévios, usando medicação de origem desconhecida.
Experience of an Ibogaine treatment provider finalaleyarok
The document provides information on conducting safe and effective ibogaine treatment, including:
1. Guidelines for screening patients, determining inclusion/exclusion criteria, monitoring safety, and developing an aftercare plan.
2. Details on the typical phases and visions experienced during ibogaine treatment, and the importance of qualified medical staff and proper facilities.
3. A list of needs for an ibogaine treatment location and protocols for patient monitoring, medical record keeping, and ensuring patient safety and comfort during the session.
Enfermedad minoritaria, terapias nuevas. Una patología que afecta a menos de cinco personas por cada 10.000 habitantes es considerada una enfermedad rara o minoritaria. 35 millones de europeos se ven afectados por alguna de ellas. El 80% son de origen genético y conseguir un diagnóstico rápido es vital para asegurar la calidad de vida futura. La clave, una vez más, es apostar y potenciar la investigación biomédica. Se revisarán los resultados obtenidos los últimos 14 años, en el marco científico y regulador impulsado por la UE desde el año 2000. Sin embargo, se analizarán las dificultades y oportunidades para impulsar la investigación traslacional en estas enfermedades.
Sigue la presentación en Youtube: https://www.youtube.com/watch?v=d4U4a8xFCzA&
Opioid dependence syndrome management legal and policy aspectsTashi Dr
This document discusses the laws and policies around opioid use and treatment in India. It provides an overview of:
1. International drug conventions and India's key drug laws like the NDPS Act which regulate opioids.
2. Government agencies involved in drug control, and national policies focused on both supply reduction and demand reduction.
3. Specific medications allowed for opioid dependence treatment under the conventions and Indian law, and regulations around medications like buprenorphine.
4. How branding substance use as illegal and users as criminals affects opioid disorder management, and how legal issues impact assessment and treatment in different settings. Questions are raised about whether current laws and policies encourage evidence-based treatment.
Methadone is commonly used to treat opioid addiction through maintenance therapy or detoxification. Methadone maintenance involves long-term administration of methadone to reduce withdrawal symptoms and drug cravings without producing euphoria. Studies show methadone maintenance is more effective at treating heroin addiction than short-term detoxification programs due to lower relapse rates and reduced criminal behavior.
The document discusses experiences providing ibogaine treatment and outlines guidelines for safely conducting treatment. It describes screening patients, determining appropriate dosages, monitoring patients during treatment, common signs and symptoms, and discussing aftercare. Safety is emphasized, including evaluating patients' medical histories and cardiac health before treatment.
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...EUPATI
This document discusses increasing patient involvement in medical research and development. It notes that the medical landscape is transforming rapidly through innovations like personalized medicine and biomarkers. While this benefits patients, it also means smaller trial populations and a need for more post-marketing data. The document advocates for increasing patient involvement in areas like clinical trial design, setting research priorities, measuring quality of life, and pharmaceutical policy. It highlights the European Patients' Academy (EUPATI) project, which aims to empower patients through education on medical research and development processes in order to facilitate greater patient engagement.
1. Graham Love discusses the development of personalized medicine in Ireland from the perspective of the Health Research Board.
2. While some personalized cancer care exists, moving towards personalized medicine research requires large-scale sequencing efforts and clinical trials to validate biomarkers and treatments.
3. For personalized medicine to become a true revolution, there needs to be greater efforts to educate decision-makers and the general public about what personalized medicine is and its potential benefits.
Tabula Rasa Retreat presentation at The European Ibogaine Forum 2018Alvaro de Ferranti
Tabula Rasa Retreat is europe's favourite ibogaine treatment centre. We focus on medically assisted iboga / ibogaine therapy to help eradicate addiction and psycho-spiritual malaise.
You are safe with us.
https://tabularasaretreat.com
#Ibogainetreatment #ibogainetherapy #ibogatherapy #ibogaineportugal #ibogaineeurope #tabularasaretreat #tabularasa #trr #recovery #addiction #rapiddetox #getmeoffdrugs #ibogaine #iboga #cocaine #heroin #meth #ptsd #depression #trribogainevidsrock
This new Economist Intelligence Unit (EIU) report, commissioned by Gilead Sciences, explores important questions about the Portuguese healthcare system.
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
UNDP at The International Healthcare Waste ConferenceUN SPHS
1) The document discusses healthcare waste management in the context of global health initiatives. It notes that healthcare waste systems often do not exist in developing countries and hazardous waste is mixed with non-hazardous waste.
2) UNDP is developing a toolkit for healthcare waste management and has assessed the environmental impact of Global Fund grants by examining waste from HIV/AIDS programs, which generates infectious, sharps, and pharmaceutical waste.
3) Infrastructure for treating and disposing of healthcare waste is often weak, with simple incinerators causing environmental problems. A project is reducing releases of dioxins, mercury, and pathogens from healthcare waste.
Drug use, Treatment, Rehabilitation and HIVHerrupribadi77
The document discusses UNODC's mandate related to drug use, treatment, rehabilitation, and HIV issues. It notes that UNODC works with the Commission on Narcotic Drugs and the Commission on Crime Prevention and Criminal Justice on these topics. It then discusses why drug dependence treatment and rehabilitation are important, noting the high rates of HIV and tuberculosis in prison populations. The document advocates for integrating drug treatment, HIV prevention, and healthcare and supports expanded treatment and rehabilitation options.
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
Six Steps to Pesticide Reduction - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~ leefmilieu.nl
This document contains an interview with Fabio Bernabei, the director of OsservatorioDroga in Italy and author of the book "Cannabis Medica. 100 Risposti sull’uso terapêutico della Marijuana". Bernabei rejects the use of medical marijuana and argues that its legalization and distribution through health systems would increase recreational use and black market production and sales. He believes prevention is the best way to fight organized crime and the drug trade. Bernabei is also skeptical of claims that Portugal's decriminalization of drug possession has been a success.
This document contains an interview with Fabio Bernabei, the director of OsservatorioDroga in Italy and author of the book "Cannabis Medica. 100 Risposti sull’uso terapêutico della Marijuana". Bernabei rejects the use of medical marijuana and argues that its legalization and distribution through health systems would increase recreational use and black market production and sales. He believes prevention is the best way to fight organized crime and the drug trade. Bernabei is also skeptical of claims that Portugal's decriminalization of drug possession has been a success.
De las intervenciones breves a los farmacos. malaga 2015 Antoni Gual
Conferencia sobre los problemas derivados del alcoholismo y su tratamiento, impartida el 6 de marzo del 2015 en la reunión de la Red de Trastornos Adictivos, realizada el Hospital Universitario de Málaga
The document discusses supervision and law enforcement of pharmaceutical marketing in the Netherlands. It describes the country's regulatory framework, the roles of different regulators like the Health Care Inspectorate and codes of conduct organizations. It also outlines enforcement options for minor, intermediate, and serious violations ranging from self-regulatory measures to fines. Complications around areas like disease mongering and conflicts of interest in clinical guidelines are also mentioned.
What is the current Synthetic opioid situation in Europe? How can countries be better prepared and equipped for a continued rise in synthetic opioid prevalence, use, and incidents?
Labelling, a legal obligation with positive impact 7th sept 2011BTitran
explaining how labelling of alcohol beverages may be an adequat support for medical and consumer security working.
alos how it's a legal obligation for producers.
The FOOD Programme aims to promote healthy eating habits among employees in workplaces. It began as an EU-funded pilot project in 8 countries. The programme's methodology involves assessing needs, making recommendations, piloting communications, evaluating results, and disseminating best practices. Over 500,000 employees and 370,000 restaurants across 12 countries have participated. Evaluation found the programme successfully increased awareness of healthy eating. It now seeks to expand to new countries and topics like allergies and sustainability.
This document provides a summary of a joint research report from the International Alliance of Patients’ Organisations (IAPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on biologic medicines. It discusses how biologics have benefited over 350 million patients worldwide by treating illnesses like cancer, heart disease, and arthritis. The report aims to inform patients, health organizations, and policymakers on ensuring optimal, safe, and appropriate access to biologics globally. It explains what biologics are, how they should be regulated and monitored, and how patients can make informed decisions about their use. The document was authored by the Institute for Optimizing Health Outcomes, commissioned by IAPO and
Opioid dependence syndrome management legal and policy aspectsTashi Dr
This document discusses the laws and policies around opioid use and treatment in India. It provides an overview of:
1. International drug conventions and India's key drug laws like the NDPS Act which regulate opioids.
2. Government agencies involved in drug control, and national policies focused on both supply reduction and demand reduction.
3. Specific medications allowed for opioid dependence treatment under the conventions and Indian law, and regulations around medications like buprenorphine.
4. How branding substance use as illegal and users as criminals affects opioid disorder management, and how legal issues impact assessment and treatment in different settings. Questions are raised about whether current laws and policies encourage evidence-based treatment.
Methadone is commonly used to treat opioid addiction through maintenance therapy or detoxification. Methadone maintenance involves long-term administration of methadone to reduce withdrawal symptoms and drug cravings without producing euphoria. Studies show methadone maintenance is more effective at treating heroin addiction than short-term detoxification programs due to lower relapse rates and reduced criminal behavior.
The document discusses experiences providing ibogaine treatment and outlines guidelines for safely conducting treatment. It describes screening patients, determining appropriate dosages, monitoring patients during treatment, common signs and symptoms, and discussing aftercare. Safety is emphasized, including evaluating patients' medical histories and cardiac health before treatment.
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...EUPATI
This document discusses increasing patient involvement in medical research and development. It notes that the medical landscape is transforming rapidly through innovations like personalized medicine and biomarkers. While this benefits patients, it also means smaller trial populations and a need for more post-marketing data. The document advocates for increasing patient involvement in areas like clinical trial design, setting research priorities, measuring quality of life, and pharmaceutical policy. It highlights the European Patients' Academy (EUPATI) project, which aims to empower patients through education on medical research and development processes in order to facilitate greater patient engagement.
1. Graham Love discusses the development of personalized medicine in Ireland from the perspective of the Health Research Board.
2. While some personalized cancer care exists, moving towards personalized medicine research requires large-scale sequencing efforts and clinical trials to validate biomarkers and treatments.
3. For personalized medicine to become a true revolution, there needs to be greater efforts to educate decision-makers and the general public about what personalized medicine is and its potential benefits.
Tabula Rasa Retreat presentation at The European Ibogaine Forum 2018Alvaro de Ferranti
Tabula Rasa Retreat is europe's favourite ibogaine treatment centre. We focus on medically assisted iboga / ibogaine therapy to help eradicate addiction and psycho-spiritual malaise.
You are safe with us.
https://tabularasaretreat.com
#Ibogainetreatment #ibogainetherapy #ibogatherapy #ibogaineportugal #ibogaineeurope #tabularasaretreat #tabularasa #trr #recovery #addiction #rapiddetox #getmeoffdrugs #ibogaine #iboga #cocaine #heroin #meth #ptsd #depression #trribogainevidsrock
This new Economist Intelligence Unit (EIU) report, commissioned by Gilead Sciences, explores important questions about the Portuguese healthcare system.
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
UNDP at The International Healthcare Waste ConferenceUN SPHS
1) The document discusses healthcare waste management in the context of global health initiatives. It notes that healthcare waste systems often do not exist in developing countries and hazardous waste is mixed with non-hazardous waste.
2) UNDP is developing a toolkit for healthcare waste management and has assessed the environmental impact of Global Fund grants by examining waste from HIV/AIDS programs, which generates infectious, sharps, and pharmaceutical waste.
3) Infrastructure for treating and disposing of healthcare waste is often weak, with simple incinerators causing environmental problems. A project is reducing releases of dioxins, mercury, and pathogens from healthcare waste.
Drug use, Treatment, Rehabilitation and HIVHerrupribadi77
The document discusses UNODC's mandate related to drug use, treatment, rehabilitation, and HIV issues. It notes that UNODC works with the Commission on Narcotic Drugs and the Commission on Crime Prevention and Criminal Justice on these topics. It then discusses why drug dependence treatment and rehabilitation are important, noting the high rates of HIV and tuberculosis in prison populations. The document advocates for integrating drug treatment, HIV prevention, and healthcare and supports expanded treatment and rehabilitation options.
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
Six Steps to Pesticide Reduction - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~ leefmilieu.nl
This document contains an interview with Fabio Bernabei, the director of OsservatorioDroga in Italy and author of the book "Cannabis Medica. 100 Risposti sull’uso terapêutico della Marijuana". Bernabei rejects the use of medical marijuana and argues that its legalization and distribution through health systems would increase recreational use and black market production and sales. He believes prevention is the best way to fight organized crime and the drug trade. Bernabei is also skeptical of claims that Portugal's decriminalization of drug possession has been a success.
This document contains an interview with Fabio Bernabei, the director of OsservatorioDroga in Italy and author of the book "Cannabis Medica. 100 Risposti sull’uso terapêutico della Marijuana". Bernabei rejects the use of medical marijuana and argues that its legalization and distribution through health systems would increase recreational use and black market production and sales. He believes prevention is the best way to fight organized crime and the drug trade. Bernabei is also skeptical of claims that Portugal's decriminalization of drug possession has been a success.
De las intervenciones breves a los farmacos. malaga 2015 Antoni Gual
Conferencia sobre los problemas derivados del alcoholismo y su tratamiento, impartida el 6 de marzo del 2015 en la reunión de la Red de Trastornos Adictivos, realizada el Hospital Universitario de Málaga
The document discusses supervision and law enforcement of pharmaceutical marketing in the Netherlands. It describes the country's regulatory framework, the roles of different regulators like the Health Care Inspectorate and codes of conduct organizations. It also outlines enforcement options for minor, intermediate, and serious violations ranging from self-regulatory measures to fines. Complications around areas like disease mongering and conflicts of interest in clinical guidelines are also mentioned.
What is the current Synthetic opioid situation in Europe? How can countries be better prepared and equipped for a continued rise in synthetic opioid prevalence, use, and incidents?
Labelling, a legal obligation with positive impact 7th sept 2011BTitran
explaining how labelling of alcohol beverages may be an adequat support for medical and consumer security working.
alos how it's a legal obligation for producers.
The FOOD Programme aims to promote healthy eating habits among employees in workplaces. It began as an EU-funded pilot project in 8 countries. The programme's methodology involves assessing needs, making recommendations, piloting communications, evaluating results, and disseminating best practices. Over 500,000 employees and 370,000 restaurants across 12 countries have participated. Evaluation found the programme successfully increased awareness of healthy eating. It now seeks to expand to new countries and topics like allergies and sustainability.
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Alvaro de Ferranti - presentation for the European Ibogaine Conference Vienna, September 2017 slideshow
1.
2.
3. Ibogaine Forum Vienna
8-10th September 2017
By Alvaro de Ferranti
Tabula Rasa Retreat
Portugal
Ibogaine has been shown to be a widely successful tool in
therapy and a valuable aid in recovery from drug dependence
Iboga / Ibogaine in Portugal
4. Introduction
Portuguese drug decriminalization
What we did with regards to Iboga / Ibogaine in Portugal
The people we brought together
The support we received
Challenges and lessons learned
Some recovery stories
Importance of Aftercare
Our vision going forward
6. The Portuguese Story
In 2001 Portugal Decriminalized drugs
16 Years on the findings are mostly positive
Decriminalization v’s Legalization
What is different ?
- 10 day supply limit
- Assessment by Social workers, psychologists and
Lawyers
- Few experience further consequences
- High risk invited to treatment
- Drug rehabs are voluntary with a small percentage
forced into the system
7. The Portuguese Story contd…
We can only rely on statistics provided however the data
is encouraging…
- Helped with disease prevention and reduction
- HIV and Hepatitis C greatly reduced
- Portugal had on of the highest rates of HIV within the
IV using community
- Mortality rates four times lower than European average
- Drug use up / down ? Hard to tell
- Drug related crime decreased
8. The Portuguese Story contd…
- Prison incarcerations have risen but fewer attributed to
drug crime
- Homicides have risen, hard to ascertain if drug related
Pro-Campaign - attribute these rises to resources being
channeled to deal with more substantial crime
Anti-Campaign – attribute lax laws to more crime, often
drug related, but not registered as such
9. The Portuguese Story contd…
Success not attributed to decriminalization alone
- Strong foundation of Public healthcare
- Recognizing addiction as a healthcare issue rather than
criminal issue
- Socio-Economic Factors (eg. recent downturn led to more alcohol
abuse)
Portugal have combined decriminalization with a heavy
focus on harm reduction, treatment and rehabilitation
90% of public money spent fighting drugs in Portugal is
channeled toward these health goals. Just 10% on police
enforcement
10. The Portuguese Story contd…
Portugal has done wonders for the rights of addicts, reduced
related diseases and associated crime. However, Many addicts
remain slaves to the big Pharma dealers via prescriptions to
Methadone, Buprenorphine and other OST (Opioid Substitution
Treatments).
Excerpt - EMCDDA "...Opioid substitution treatment (OST) is
widely available in Portugal through public services such as
specialised treatment centres, health centres, hospitals,
pharmacies, NGOs and non-profit organisations. Methadone
has been available since 1977, buprenorphine since 1999, and
the buprenorphine/naloxone combination has recently been
approved for use..."
No mention of Iboga or Ibogaine. No surprises there !
11. What we did…
Early 2015 Iboga introduced to Dr. João Goulão and top
psychologist
Goulão has received much of the credit for helping turn
the devastating drug situation in Portugal around
Goulão, is the national drug coordinator for Portugal and
the head of SICAD (The General Directorate for
Intervention on Addictive Behaviours and Dependencies),
he is also the Chairman of the EMCDDA Management
Board, the European Monitoring Centre for Drugs and
Drugs addiction.
Clinical trials the only way forward
12. What we did next…
- Contact with GMP Ibogaine manufacturer
- Solid protocol to conduct a Phase I and II clinical trial
- Co-sponsors
The clinical protocol was titled “An open, single dose,
escalating fixed dose study of the safety and efficacy of
Ibogaine in Opioid dependent subjects”.
Our objective was to investigate the short-term effects of
Ibogaine on opioid withdrawal during a one-week
detoxification period (our in-patient phase).
13. What we did next… contd
Furthermore, to investigate the safety of ibogaine during
acute in-hospital opioid withdrawal and during an 8-week
post treatment evaluation.
To investigate the long-term effects on craving and
substance use of opiates during a two month (8 week)
follow up period (our Out-patient phase)
Secondary questioning with regards to possible somatic
(the physical effects) and psychological effects of
ibogaine, and possible predictive factors for response to
Ibogaine and the evaluation of Pharmacokinetics (the
characteristic interactions of a drug and the body in terms
of its absorption, distribution, metabolism, and excretion).
14. What we did next… contd
Sample size was of 12 active opioid dependant subjects
seeking treatment at the time.
In addition to detoxifying with ibogaine, patients would
also be subject to multiple Medical screenings,
Neurological, Psychiatric, and cognitive examinations
Further examined with Drug-Dependency and Drug
withdrawal check lists and indices. Each patient would
also have to voluntarily sign an Informed Consent
document before participating in the study.
15. The ‘I’ Team
Co-sponsors
PI - Principal Investigator (research group leader)
Clinic - near Lisbon with own Lab facilities
PM - Project Managers
CRO - Contract Research organisation
Log the trial with EUDRA (European Clinical Trials
Database)
Submit papers to Ethics committee
Serious headway was being made…
16.
17. Disappointment
Patient Sample size was too small
Only a Pilot Study
Insufficient to achieve market approval
€7 to €15M
We had to abandon…
18. Orphan Drug Status ?
Orphan Drug status ?
The Orphan Drug Act (ODA) provides for granting special
status to a drug or biological product (“drug”) to treat a rare
disease or condition upon request of a sponsor. This status
is referred to as orphan designation (or sometimes “orphan
status”).
19. What did we do next?
Started treating patients
- Basic provision
- Experienced providers
- Reputable Iboga TA and PTA
- Fine tuned processes and systems
- Stringent eligibility criteria
- Zero adverse events
Finding Doctors challenging
Medicalisation vital
Adverse events are only a matter of time
20. Aftercare
Focus needs to be on Aftercare and Re-Integration
Other modalities worth considering
EFT (Emotional Freedom Techniques aka Tapping),
EMDR (Eye movement desensitization and reprocessing -
positive for Trauma work),
Kundalini Yoga, Meditation, Reiki, Massage,
Exercise and Nutrition, Social and Cultural activities, Walks in
Nature, Laughter Therapy, Family Mediation, Service.
and the more alternative, Ayahuasca, Rapé, Kambo therapies to
name a few.
It is all about the detoxification and ongoing nurture of the Mind,
Body and Soul.
My name is Al and I am a former crack cocaine mis-user whose lights turned on after an Iboga treatment in Holland in 2013. I run three businesses in the UK and I find myself at a crossroads, to carry on doing what I do, or explore Iboga further. I have structured my presentation into several sections. I’ll start off with scratching the surface of the Portuguese decriminalisation of drugs story, followed by what we did with regards to Ibogaine in Portugal, the people we brought together, the support we received, the challenges and hurdles, lessons learned, some recovery stories, the importance of aftercare (so often overlooked) and going forward with regards to materialising my vision.
May the journey begin…
Portugal did something very brave in 2001, they decriminalized drugs. The socialist party at the time (who had a majority) managed to push the bill through parliament. 16 years on, the findings show a mostly positive impact.
We mustn’t however confuse decriminalisation with legalisation. I am often told that Portugal is the perfect place to treat people with Iboga because drugs are legal… this is not the case. Drugs are still illegal, however users carrying less than a 10 day supply will be tackled in a more lenient fashion, rather than court appearances with resulting fines and prison, they are usually assessed by social workers, psychologists and lawyers. Very few experience further consequences. Higher risk cases may receive invitations to undergo treatment. It must be noted that drug rehabs in Portugal are voluntary, in all but the most exceptional of cases.
We can only rely on statistics provided however the data is encouraging…- Helped with disease prevention and reduction- HIV and Hepatitis C greatly reduced- Portugal had on of the highest rates of HIV within the IV using community- Mortality rates four times lower than European average- Drug use up / down ? Hard to tell- Drug related crime decreased
- Prison incarcerations have risen but fewer attributed to drug crime- Homicides have risen, hard to ascertain if drug relatedPro-Campaign - attribute these rises to resources being channeled to deal with more substantial crimeAnti-Campaign – attribute lax laws to more crime, often drug related, but not registered as such
The success in Portugal may not be attributed to decriminalisation alone. Factors such as a strong foundation of socialised public healthcare and recognising drug misuse as a social healthcare issue rather than a criminal issue. So many other factors such as economic and social cycles all play their part. Portugal have combined decriminalisation with a heavy focus on harm reduction, treatment, and rehabilitation.
Goulao says 90 per cent of public money spent fighting drugs in Portugal is channelled toward those health-care goals — just 10 per cent is spent on police enforcement.
Portugal has done wonders for the rights of addicts, reduce related diseases and associated crime. However, many are slaves to the big pharma dealers via prescriptions to buprenorphine and other OST's...
Excerpt - EMCDDA "...Opioid substitution treatment (OST) is widely available in Portugal through public services such as specialised treatment centres, health centres, hospitals, pharmacies, NGOs and non-profit organisations. Methadone has been available since 1977, buprenorphine since 1999, and the buprenorphine/naloxone combination has recently been approved for use..."
No mention of Iboga or Ibogaine. No surprises there !
So we set off to do something about it !
In early 2015, I introduced Iboga and Ibogaine to Dr. Joao Goulão and his top psychologist. He has received much of the credit for helping turn the devastating drug situation in Portugal around. Goulão, is the national drug coordinator for Portugal and the head of SICAD (The General Directorate for Intervention on Addictive Behaviours and Dependencies), he is also the Chairman of the EMCDDA Management Board, the European Monitoring Centre for Drugs and Drugs addiction. My presentation was very well received and Iboga became planted into their minds and remains a seedling, it now needs more water and more fertiliser. He informed me that the undertaking of clinical trials with ibogaine would be the only way that INFARMED (the Portuguese equivalent of the FDA) would consider Ibogaine as a medicinal treatment for addiction therapy…
I was very fortunate to have been contacted by a reputable Ibogaine HCL manufacturer who had put together a solid protocol to conduct a Phase I and II clinical trial to get the ball rolling. We became co-sponsors. I the financier and co-sponsor and they the sponsors and manufacturer of the GMP Ibogaine HCL and architects of the clinical trial.The clinical protocol was titled “An open, single dose, escalating fixed dose study of the safety and efficacy of Ibogaine in Opioid dependent subjects”.
Our objective was to investigate the short-term effects of Ibogaine on opioid withdrawal during a one-week detoxification period (our in-patient phase).
To investigate the safety of ibogaine during acute in-hospital opioid withdrawal and during an 8-week post treatment evaluation.
To investigate the long-term effects on craving and substance use of opiates during a two month (8 week) follow up period (our Out-patient phase)
Secondary questioning with regards to possible somatic (the physical effects) and psychological effects of ibogaine, and possible predictive factors for response to Ibogaine and the evaluation of Pharmacokinetics (the characteristic interactions of a drug and the body in terms of its absorption, distribution, metabolism, and excretion).
I won’t go into the design of the whole study; however, I can tell you that the sample size was of 12 active opioid dependant subjects seeking treatment at the time. In addition to detoxifying with ibogaine, patients would also be subject to multiple Medical screenings, Neurological, Psychiatric, and cognitive examinations and further examined with Drug-Dependency and Drug withdrawal check lists and indices. Each patient would also have to voluntarily sign an Informed Consent document before participating in the study.
With protocol in hand, which we tweaked here and there to match the profile of the typical opioid user in Portugal, we set off to build the ‘I’ Team.
I was fortunate enough to have connected with a gentleman who became our Principal Investigator who was to ultimately present the study to the Ethics Committee and run the trial for me. He worked at an innovative neuroscience laboratory in Lisbon, Portugal. He headed the Clinical Research Unit for the study of the effect of a patient’s mind on the matter of Disease. He was perfect and has a keen interest in Entheogens. Together we started to assemble the team. We found a clinic, close to Lisbon, that had their own in-patient and out-patient drug rehabilitation clinic and aftercare program. In addition, they owned their own medical testing laboratories, a further bonus. Having appointed a very able Clinical Trial project management company, we then interviewed several CRO’s (Contract Research Organisations)… we found the perfect CRO partner. In the background, countless documents were being written and re-written, submittals to log the study with EUDRA CT (this is a process whereby an application to conduct a clinical trial must have a unique number logged by the European Clinical Trials database, and then be submitted for authorisation to the competent authority of the Member state in which the sponsor plans to conduct the study, in our case, Portugal).Meetings after meetings, sometimes in a language so complex for a layman, frustration after frustration we felt we were finally making some headway…
only to be advised
… that the Patient sample size was too small to conduct a clinical trial and that it was more of a Pilot Study. Whilst the findings may be very beneficial and would undoubtedly get published, the study would be insufficient to get market approval. And to get such approval, investments could range from €7 to 15 Million… so we had to abandon. Despite our naivety, and inexperience in this area, we haven’t given up.
We are conducting an investigation on how to achieve ‘Orphan’ Status for Iboga / Ibogaine in Portugal and hopefully Europe. To explain, The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). Orphan drugs are developed to treat patients suffering from very serious diseases for which no treatment, or at least a satisfactory one, has so far been available. These diseases affect only a small proportion of the population (less than one person per 2,000 in Europe).
So, we did what many others have done… we treated people who needed help. It was a basic provision. We used very experienced providers, reputable product, we fine-tuned our processes, all in anticipation of the bigger plan, that is, to open a first class holistic and iboga detox rehab in the future (all under one roof). Our major challenge, other than the clinical trials, has been to find a doctor in Portugal willing to assist ibogaine treatments. Although we had zero adverse events due to our stringent eligibility for treatment criteria, it is clear medicalisation of treatment is the way forward. It is only a matter of time before an adverse event takes place. In relation to the doctors, if it isn’t prescribed, and doesn’t have a pharmaceutical brand name across the packaging, they are fearful of being involved. The search continues. Hopefully someone in this audience may have some ideas?
Aside from the very important Iboga / Ibogaine therapy, the focus needs to be aftercare and re-integration. Other modalities, used alongside some of the more traditional therapies worth considering are EFT (Emotional Freedom Techniques aka Tapping), EMDR (Eye movement desensitization and reprocessing - positive for Trauma work), Kundalini Yoga, Meditation, Reiki, Massage, Exercise and Nutrition, Social and cultural activities, Walks in Nature, Laughter Therapy, Family Mediation, Service - Giving back…and the more alternative, Ayahuasca, Rapé, Kambo therapies to name a few. It is all about the detoxification and nurture of the Mind, Body and Soul.
Iboga is the catalyst for change, the hard work starts afterwards and aftercare and consistent follow up is vital. I cannot underestimate this fact. I have seen it with myself and countless patients.
Whether it be conducting clinical trials, setting up a clinic, a rehab, these are all big challenges. Portugal, despite its forward-thinking Policy, still has a long way to go before they are open to other modalities other than Opioid replacement therapies and standardised rehabilitation programmes. I am confident we will be heard, once again, and that headway will be made.My vision… that Iboga / Ibogaine be also made available on the national health, to all those that need it. That Iboga be considered as a parallel and potentially recognised alternative or addition to other treatments modalities, and, rather than maintain patients in their addictions, be it with illegal or legally prescribed pharmaceutical alternatives, that iboga be at least given the same importance, resulting in choices and further options for patients to make informed decisions.
To remind you, my name is Álvaro de Ferranti, and I am the co-owner of the visionary, and ambitious Tabula Rasa Retreat project in Portugal. Thank you for listening.
To remind you, my name is Álvaro de Ferranti, and I am the co-owner of the visionary, and ambitious Tabula Rasa Retreat project in Portugal. The team are currently exploring a suitable site to house their patients and associates. Thank you for listening.