[Ibogaine] Ibogain vs Iboga and safety, FDA trials

Charles Rossouw charles.rossouw at gmail.com
Mon Jan 19 18:20:38 EST 2009

My reasoning makes it the opposite:  More unknowns makes it more risky.

On Mon, Jan 19, 2009 at 9:29 PM, DC from AZ <dcollier9 at cox.net> wrote:

> having said all that, isnt bwiti iboga use much safer than ibogaine
> reference the cardiac data, and so therefore would be eligible for FDA
> trials ?
> the article mentions bwiti initiation usage, but does not differentiate
> that one is root bark, the other is a high potency powder.
> maybe iboga contains more alcoloids that provide a better effect and less
> risk
> ibogaine safety issues may box one into a corner, and should be very
> careful of course. BUT
> the usefullness of iboga in general has not been refuted. iboga being the
> root bark or extract from same
> we need more safety data from the bwiti per dosages etc
> ---------------------------------------------------------------------------------------
> Donzo
> "Love converts hearts, and gives peace."
> __________________________________________________
> ----- Original Message ----- From: "Vector Vector" <
> vector620022002 at yahoo.com>
> To: "The Ibogaine List" <ibogaine at mindvox.com>
> Sent: Monday, January 19, 2009 6:59 AM
> Subject: Re: [Ibogaine] Ibogaine in the Netherlands
>> Yeah that's Sara's house?
>> Much more in depth version of the same thing
>> http://content.nejm.org/cgi/content/full/360/3/308
>> New England Journal of Medicine
>> Volume 360:308-309        January 15, 2009        Number 3
>> Next
>> Long-QT Syndrome Induced by the Antiaddiction Drug Ibogaine
>>   PubMed Citation
>> To the Editor: Anecdotal evidence suggests that ibogaine alleviates drug
>> craving and relapse of drug use in humans, as has been confirmed for
>> animals.1 Ibogaine is currently used as an antiaddiction drug in alternative
>> medicine. In 1993, the Food and Drug Administration approved a clinical
>> trial in humans to study those effects. The National Institute on Drug Abuse
>> decided not to fund this study because of safety issues.2,3
>> Ibogaine is a naturally occurring alkaloid with hallucinogenic and
>> psychedelic effects, derived from the bark of the root of the West African
>> Tabernanthe iboga plant and is used in Gabonian initiation ceremonies. At
>> least 11 sudden deaths were described after ibogaine use, in which the cause
>> of death remained unclear even after autopsy.4 It was hypothesized that
>> ibogaine might dysregulate the autonomic nervous system, causing sudden
>> death.5
>> A 31-year-old American woman was admitted to our emergency department
>> because of a seizure-like attack after she had taken a single dose of 3.5 g
>> of ibogaine 15% (usual dose, 2 to 6 g). She had not taken any other drugs or
>> alcohol concurrently with the ibogaine. Her medical history was
>> unremarkable, and there was no family history of cardiac-rhythm
>> abnormalities. Besides nausea, she had no specific symptoms to report. She
>> had come to the Netherlands to receive ibogaine as an alternative medicine
>> for treatment-resistant alcohol addiction.
>> Electrocardiography showed a severe prolonged QT interval of 548 msec (QT
>> interval corrected for the heart rate, 616 msec) and ventricular
>> tachyarrhythmias during prolonged monitoring (Figure 1). Laboratory findings
>> revealed mild hypomagnesemia (magnesium level, 0.49 mmol per liter [1.2 mg
>> per deciliter]; reference range, 0.70 to 1.00 [1.7 to 2.4]), hypokalemia
>> (potassium level, 3.2 mmol per liter [12.5 mg per deciliter]; reference
>> range, 3.8 to 5.0 [14.9 to 19.5]), and a normal serum osmolal gap (3.1 mOsm
>> per kilogram; reference value, <10). Despite rapid correction of the
>> electrolyte levels, the QT interval remained prolonged. During admission to
>> the intensive care unit, with no further doses of ibogaine given, the QT
>> interval normalized at 42 hours after presentation. The patient was
>> subsequently discharged, in good condition.
>> In this case, ibogaine use was associated with severe lengthening of the
>> QT interval and ventricular tachyarrhythmias, which normalized after 42
>> hours. These findings are suggestive of a causal relation. The electrolyte
>> imbalance may also have played a role. The previously described sudden
>> deaths may thus have been caused by cardiac-rhythm abnormalities induced by
>> QT-interval lengthening, ventricular tachyarrhythmias, or both.
>> At the doses currently used, ibogaine can lead to serious cardiac-rhythm
>> abnormalities. The use and possible future trials of the drug should be
>> permitted only under strict medical observation and continuous
>> electrocardiographic monitoring.
>> Dianne W.M. Hoelen, M.D.
>> Wilko Spiering, M.D., Ph.D.
>> Gerlof D. Valk, M.D., Ph.D.
>> University Medical Center Utrecht
>> 3584 CX Utrecht, the Netherlands
>> g.d.valk at umcutrecht.nl
>> References
>> He D-Y, McGough NNH, Ravindranathan A, et al. Glial cell line-derived
>> neurotrophic factor mediates the desirable actions of the anti-addiction
>> drug ibogaine against alcohol consumption. J Neurosci 2005;25:619-628. [Free
>> Full Text]
>> Vastag B. Addiction treatment strives for legitimacy. JAMA 2002;288:3096,
>> 3099-101.
>> Vastag B. Addiction research -- ibogaine therapy: a `vast, uncontrolled
>> experiment.' Science 2005;308:345-346. [Erratum, Science 2005;308:1260.]
>> [Free Full Text]
>> Lotsof HS, Wachtel B. Manual for ibogaine therapy: screening, safety,
>> monitoring & aftercare. Second revision. The Ibogaine Dossier, 2003.
>> (Accessed December 22, 2008, at http://www.ibogaine.org/manual.html.)
>> Maas U, Strubelt S. Fatalities after taking ibogaine in addiction
>> treatment could be related to sudden cardiac death caused by autonomic
>> dysfunction. Med Hypotheses 2006;67:960-964. [Medline]
>> ----- Original Message ----
>> From: Mindvox <mindvox at lunartproductions.com>
>> To: The Ibogaine List <ibogaine at mindvox.com>
>> Sent: Monday, January 19, 2009 5:22:25 AM
>> Subject: [Ibogaine] Ibogaine in the Netherlands
>> Near-fatal treatment in the Netherlands...
>> Links:
>> http://www.artsennet.nl/content/resources//AMGATE_6059_1_TICH_R2438011050651223//
>>   'Afkickmedicijn' ibogaïne veroorzaakt hartritmestoornis
>> Bron(nen): UMC Utrecht
>> Smart drug en 'afkickmedicijn' ibogaïne kan dodelijke hartritme
>> stoornissen veroorzaken. Dit schrijven artsen van het UMC Utrecht in een
>> case report in het tijdschrift New England Journal of Medicine van 15
>> januari. Ze verklaren daarmee als eerste de schadelijkheid van het omstreden
>> middel.
>> In het case report beschrijven internisten een 31-jarige Amerikaanse vrouw
>> die op de spoedeisende hulp van het UMC Utrecht kwam nadat zij onwel was
>> geworden na het gebruik van ibogaïne. Dit had zij gebruikt om van haar
>> alcoholverslaving af te komen. Tijdens haar behandeling op de spoedeisende
>> hulp kreeg zij een ernstige hartritmestoornis. Het duurde bijna twee dagen
>> voordat de hartritmestoornis was verdwenen. Het verband tussen het gebruik
>> van ibogaïne en het optreden van de hartritmestoornis ligt volgens de artsen
>> van het UMC Utrecht voor de hand.
>> Ibogaï vrij verkrijgbaar
>> Ibogaïne is in een beperkt aantal landen, waaronder Nederland, vrij
>> verkrijgbaar. Het wordt gebruikt als smart drug. Daarnaast claimen
>> alternatieve genezers en sommige artsen dat een eenmalige dosis van het
>> middel mensen van hun drugs- of alcoholverslaving af kan helpen. Voor dit
>> effect bestaan weliswaar wetenschappelijke aanwijzingen bij proefdieren,
>> grootschalige onderzoeken bij mensen ontbreken echter. Onderzoek naar
>> ibogaïne is lastig omdat het middel levensgevaarlijk kan zijn. Het is bekend
>> dat gebruikers van ibogaïne soms overlijden. Waardoor dat komt was tot nu
>> toe onduidelijk.
>> Hulpmiddel afkicken
>> "Ibogaine wordt momenteel in Nederland gebruikt als hulpmiddel bij het
>> afkicken in situaties zonder medisch toezicht waardoor het juist
>> levensbedreigend kan zijn", concludeert internist-endocrinoloog dr. Gerlof
>> Valk van het UMC Utrecht, één van de internisten betrokken bij de opvang van
>> de patiënt. "De risico's voor de gezondheid gelden zowel voor de toepassing
>> als smart drug, maar ook voor het gebruik als afkickmiddel. Wij vinden dat
>> ibogaïne alleen onder medisch toezicht gebruikt mag worden voor
>> therapeutische doeleinden."
>> De artsen hebben de ibogaïne-vergiftiging gemeld bij de Inspectie voor de
>> Gezondheidszorg.
>> Translation:
>>   Detox-medicine ibogaïne cause heart rhythm impairment
>> Source (nen): UMC Utrecht
>> Smart drug and `detox-medicine' ibogaïne can cause deadly heart rhythm
>> impairments. This letter doctors of the UMC Utrecht in a case report in the
>> illustrated magazine New England Journal or Medicine of 15 January. They
>> explain with that as first the harmfulness of the controversial means.
>> In case report internists describe a 31 year old American woman who came
>> on the emergency service of the UMC Utrecht after she had become indisposed
>> after the use of ibogaïne. This had they uses to descend of its alcohol
>> addiction. During its treatment on the emergency service she got a serious
>> heart rhythm impairment. It lasted almost two days before the heart rhythm
>> impairment had disappeared. The link between the use of ibogaïne and acting
>> the heart rhythm impairment lies according to the doctors of the UMC Utrecht
>> for the hand.
>> Ibogaï rather available
>> Ibogaïne are a number of countries limited in, among which the
>> Netherlands, rather available. It is used as smart drug. Moreover
>> alternative healers claim and some doctors that a one-off amount of the
>> means people of their drugs or alcohol addiction finished can help. For this
>> impact indeed scientific indications exist at test animals, large-scale
>> researches at people are lacking however. Study into ibogaïne is cumbersome
>> because the means can be perilous. It has been confessed that users of
>> ibogaïne die sometimes. How that comes were so far unclear.
>> Appliances kick the habit
>> Ibogaine are at present used in the Netherlands as appliances at kick the
>> habit in situations without medical supervision as a result of which it can
>> be correctly life-threatening, internist endocrinoloog conclude dr. Gerlof
>> falcon of the UMC Utrecht, one of the internists involved at the relief of
>> the patient. The risk for health applies both for the application and smart
>> drug, but also for the use as afkickmiddel. We find that ibogaïne can be
>> only used under medical supervision for therapeutic aims.
>> The doctors have communicated ibogaïne poisoning at the inspection for the
>> health care.
>> AND:
>> http://www.trouw.nl/nieuws/Wetenschap/article1959054.ece/Afkickdrug_kan_dodelijk_uitpakken_.html
>> Afkickdrug kan dodelijk uitpakken
>> De iboga-wortel, een populair alternatief middel tegen verslaving, kan
>> dodelijke hartritmestoornissen geven. In Utrecht is een vrouw er bijna aan
>> overleden.
>> Een 31-jarige Amerikaanse vrouw heeft ternauwernood een vergiftiging met
>> een extract van de Afrikaanse iboga-wortel overleefd. Ze was speciaal naar
>> Nederland gekomen om zich met dit sterk hallucinogene middel, ibogaïne, te
>> laten behandelen tegen haar alcoholverslaving.
>> De drug, in de meeste landen verboden, is in Nederland toegestaan. Hij
>> wordt in het alternatieve circuit gebruikt, naar verluidt met groot succes.
>> Met één dosis ibogaïne raak je een paar dagen compleet van de wereld. Als je
>> wakker wordt, ben je clean, zo wil het verhaal.
>> Maar bij de Amerikaanse liep het anders. Ze belandde op de intensive care
>> van het Universitair Medisch Centrum Utrecht, met ernstige
>> hartritmestoornissen die haar fataal dreigden te worden. Pas na twee dagen
>> herstelde het hart zich, melden haar artsen vandaag in het vakblad The New
>> England Journal of Medicine. Ze hebben de Inspectie voor de Gezondheidszorg
>> gewaarschuwd.
>> „Op zich kunnen we niet met zekerheid vaststellen dat ibogaïne de oorzaak
>> van de klachten was", relativeert de behandelend internist Gerlof Valk.
>> „Maar de aanwijzingen zijn sterk. De klachten begonnen kort na de inname en
>> verdwenen een paar dagen later. De patiënte had verder geen middelen
>> gebruikt. Lichamelijk konden we ook geen andere verklaring vinden."
>> De artsen noemen de vondst belangrijk omdat deze nieuw licht werpt op de
>> raadselachtige dood van elf eerdere ibogaïne-gebruikers. Zelfs een autopsie
>> heeft in die gevallen geen duidelijkheid gebracht over de doodsoorzaak. Het
>> bleef daardoor onzeker of de drug de boosdoener was, of misschien de alcohol
>> of iets anders wat de slachtoffers tegelijkertijd hadden ingenomen.
>> De nieuwe waarneming, waarbij de drug als het ware 'op heterdaad' is
>> betrapt, maakt het volgens de Utrechtse artsen een stuk aannemelijker dat
>> het middel zelf riskant is. Ze pleiten er daarom voor om de stof voortaan
>> alleen nog onder medische begeleiding en onder permanente hartbewaking toe
>> te dienen. Dat zou het gebruik door alternatieve therapeuten sterk
>> bemoeilijken.
>> Overigens is het de vraag of ibogaïne echt zo fabelachtig tegen verslaving
>> werkt als alternatieve therapeuten beweren. „Op internet zijn allerlei
>> filmpjes te zien van mensen die dankzij ibogaïne van hun verslaving zijn
>> afgekomen", zegt Valk. „Maar hard wetenschappelijk bewijs ontbreekt." Goed
>> onderzoek met patiënten is nooit gedaan, onder meer vanwege twijfel over de
>> veiligheid. Wel is gekeken naar verslaafde ratjes; die toonden zich dankzij
>> ibogaïne inderdaad minder afhankelijk van morfine, cocaïne of alcohol.
>> Hoeveel mensen zich tot nu toe met de drug hebben laten behandelen, is
>> onduidelijk. Het tv-programma 'Nova' repte in 2006 van duizenden mensen
>> wereldwijd, en van ruim 220 patiënten die door de Nederlandse therapeute
>> Sara Glatt waren geholpen. In de uitzending stelde een deskundige dat de
>> reguliere verslavingszorg met ibogaïne een grote kans liet liggen.
>> Behalve als afkickmedicijn gebruiken sommigen de iboga-wortel als smart
>> drug, omdat hij zo'n intense en langdurige roes veroorzaakt. Die diepe
>> trance is ook de reden waarom Afrikaanse stammen de plant inzetten tijdens
>> riten.
>> Translation:
>> Detox-drug can unpack deadly
>> Iboga-root, the popular alternative means against addiction, can give
>> deadly heart rhythm impairments. In Utrecht a woman is there almost to
>> deceased.
>> A 31 year old American woman a poisoning with an extract of African
>> iboga-root has just survived. She especially to the Netherlands had come
>> with this strongly hallucinogenic means, ibogaïne, let treat itself against
>> its alcohol addiction.
>> The drug, prohibited in the most countries, in the Netherlands it has been
>> permitted. He is used in the alternative circuit, according to reports with
>> large success. With one amount of ibogaïne touch you a couple days
>> completely of the world. If you become awake, be you clean, this way it
>> wants tale.
>> But at American it ran differently. She ended up on the intensive care of
>> the university medical centre Utrecht, with serious heart rhythm impairments
>> which threatened become its fatally. Just after two days repaired the heart,
>> its doctors communicate themselves The New England Journal or Medicine today
>> in the profession booklet. They have warned the inspection for the health
>> care.
>> „In itself cannot determine we with certainty that ibogaïne were the cause
>> of the complaints, relativise the treating internist Gerlof falcon. „But the
>> indications are strong. Days started the complaints later shortly after
>> ingestion and disappeared a couple. The patient had further used no
>> resources. Physically we could find other declaration also no.
>> The doctors call the find important because these throw slightly new on
>> enigmatic dead of eleven earlier ibogaïne users. Even an autopsy has which
>> fallen no clarity brought concerning the cause of death. It remained
>> uncertainly as a result, or the drug the cause was, or perhaps the alcohol
>> or something else what the victims had taken at the same time.
>> New perception, where the drug as it were has been caught, makes it
>> according to the Utrechtse doctors a piece more plausible that the means
>> himself is risky. They plead for this reason to administer the substance as
>> of now only still under medical accompaniment and under permanent heart
>> guarding. That it strongly would hamper use by alternative therapists.
>> Moreover it is the question if ibogaïne work really this way fabulous
>> against addiction such as alternative therapists claim. „On Internet are all
>> kinds of see small films of people who have descended thanks to ibogaïne of
>> their addiction, say falcon. „But rapidly scientific proof are lacking. Well
>> research with patients has been never done, including because of doubt
>> concerning the security. However, it has been looked at to addictive little
>> rats; those showed themselves thanks to ibogaïne indeed less dependent on
>> morphine, cocaine or alcohol.
>> How many people itself so far with the drug have let treat, is unclear.
>> The tv-programma Nova' mentioned in 2006, of thousands of people worldwide,
>> and of wide 220 patients who had been helped by the Dutch therapist Sara
>> Glatt. In the retransmission put to an expert to that to the regular care
>> and treatment of drug addicts with ibogaïne to a large chance let lie.
>> Except as detox-drug uses some iboga-root as smart drug, because he causes
>> such a intense and long-term fuddle. That deep trance is also the reason why
>> descends African the plant uses during rites.
>> Translation is done through an online web translator, so as you just read,
>> it is not very accurate...
>> Best Wishes,
>> Ben De Loenen
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