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Similar to Alvaro de Ferranti - presentation for the European Ibogaine Conference Vienna, September 2017 slideshow
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Alvaro de Ferranti - presentation for the European Ibogaine Conference Vienna, September 2017 slideshow
- 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
- 5. It’s a long road…
- 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…
- 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.
- 21. Concluding thoughts Big challenges ahead. Portugal has a long way to go before they are open to other modalities My vision…
- 22. THANK YOU
- 23. Image: French documentary 'L'Iboga’ Music: Moungongo - Bwiti - Gabon
Editor's Notes
- 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 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
- 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.