Ibogaine Politics Science Nyc2006
Transcript of Ibogaine Politics Science Nyc2006
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1. Ibogaine(brief review)
2. Ibogaine Development
Introduction to Presentation by HS Lotsof
2006 NYC Ibogaine Conference
Columbia University
Saturday, February 25
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Ibogaine Found in a West
African plant Tabernanthe
iboga
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T. Iboga is Valued
for its roots
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Iboga alkaloids are concentrated
in the bark of the root
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Usable forms include scraped or
ground root bark
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Total Alkaloid extract
Courtesy Sara Glatt
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Purified ChemicalProposed as an approved regulated drug
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Physical Characteristics of ibogaine base
Source Merck IndexChemical formula C20H26N2O
Mol. Wt. 310.42
Melting Point 152-153
Practically insoluble in water.
Soluble in ethanol, ether, chloroform
Molecular structure
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Ibogaine Development
or Lack Thereof:
Howard S. Lotsof
Dora Weiner Foundation
http://www.doraweiner.org
Politics
Policy
PrejudiceProfit
Science
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Politics
The activities within a government or agency or other
human endeavor that may include debate and conflict.
Prohibition
Legalization or RegulationWar on Drugs
War on Some Drugs
War on Drug Users
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Drug Politics may be top down from
government agencies such as the
ONDCP
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DEA
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FDA
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Drug Politics are also bottom up from
grassroots organizations such as theSSDP
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Harm Reduction Coalition
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Cures Not Wars
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Precedents for Ibogaine
Activist Organizations
International Coalition for Addict Self-Help(ICASH)
Dutch Addict Self-Help (DASH)
Cures-Not Wars (ibogaine and other issues)
Ibogaine Underground
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ICASH logo
Used to attract attention of government officialsand media
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Nico Adriaans was one of the founders of both the RotterdamJunkies Union and Dutch Addict Self-Help (DASH). DASH wasan ibogaine self-help organization that petitioned the Dutchgovernment and organized drug users to demand ibogaineavailability. DASH provided ibogaine at no cost to heroinusers.
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ICASH Organizing in the US
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Cures-Not-Wars placed pressure on
NIDA to support Ibogaine researchthrough protests
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Mindvox Ibogaine List
(user advocacy continues)
We all got to help each other best we can. No one
else gives a shit bout us hippy freak junkies? anon.
To join send an email to
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FM- I'm not really privy to what's happening in thatregard here in the US. Suffice to say, nothing hasworked which is why we're here. We feel thatcontinuing the focus offshore, outside the US, has notserved a majority of people inside the US. Like manyother grassroots movement, which facilitated change,treatments, sessions, need to be done where theybelong, in all major US cities, as cost effectively aspossible.
http://www.drugwar.com/ibonyc.shtm
Ibogaine underground appears 2004
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Policy
A course or principle of action adopted or proposed bya government, party, business, or individual
Harm Reduction
Demand ReductionHow Ibogaine is Viewed
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Ibogaine represents both harm
reduction and demand reduction
DEA desk officer in the Netherlands asks how theDutch are allowing a demand reduction drug likeibogaine to be researched in the Netherlands?
Ibogaine proponents view the drug as significant harmreduction tool and basis for political action.
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Prejudice
A generally negative preconceived opinion that is notbased on reason or actual experience
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Prejudice incorporates
Stigma
A mark of disgrace associated with a particular
circumstance, quality, or person : the stigma ofchemical dependence.
Discrimination
The unjust or prejudicial treatment of differentcategories of people or things.
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Focuses attention on those who
produce rejection and exclusion
Discrimination
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Focuses attention on the
victim
Stigma
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Prejudice, stigma and discrimination, in
part, determine what drugs will beregulated, what drugs will not beregulated and what medications will be or
not be made available to treat chemicaldependence
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Ibogaine Effects on Stigma
Ibogaine is reported to have the ability
to remove the stigmatized condition,transforming the patient to a stateoften described as a preaddictive.
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Additional Ibogaine Effects on Stigma
The transformation of a stigmatized person
into one who is not stigmatized will havesignificant effects on the person and thesociety within which the individual lives as itallows for personal growth and thepossibility of a greater contribution to
society. This dynamic is expressed withinthe activities of the ibogaine advocacymovement in the services they offer tochemically dependent persons and thepolitical actions taken to promote ibogaineavailability.
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ProfitA financial gain, The difference between the amount
earned and the amount spent in buying, operating, orproducing something : | their eyes brightened at theprospect of profit.
Politics
Policy
Prejudice
Science
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Profit is a core issue in thepharmaceutical industry whoseprimary purpose is to return profit to
corporate shareholders.
This effects what drugs will be developed and
the areas of medicine for which drugs will beavailable.
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ScienceThe intellectual and practical activity encompassing the
systematic study of the structure and behavior of thephysical and natural world through observation andexperiment
PoliticsPolicy
Prejudice
Profit
Intellectual Conformity
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National Institute on Drug Abuse
(NIDA) funds 85% of drug addictionresearch worldwide
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NIDA Initially Rejects Ibogaine
Research.
NIDA was petitioned to perform ibogaine research 1984 -1990, first by the Dora Weiner Foundation and from 1986 onby NDA International, Inc., a company established to make
ibogaine available as an approved medication. In 1991, NIDAformed its Medications Development Division (MDD) andaccepted a Product Profile Review (PPR) from NDAInternational that resulted in NIDA starting their ibogaineresearch program.
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The following are examples demonstrating thescientific contention between NIDA and pro-ibogaine researchers that played out between1988 and 2000.
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First scientific publication of
ibogaine antiaddictive effects
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NIDA Response: It doesnt work
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Ibogaine Scientists Answer
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NIDA contracts neurotoxicologist Mark
Molliver to determine ibogaine
neurotoxicity
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Ibogaine researcher Helen
Molinari responded
Further research by OHearn
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Further research by O Hearn
and Molliver
Xu et al. eventually produce research
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Xu et al. eventually produce research
showing no neurotoxicity at clinical
doses(2000)
Xu et al. accomplished research in part at the
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p p
National Center for Toxicological Research an
FDA laboratory.The research demonstrated noneurotoxicity at 25 mg/kg.
Ibogaine science continues to grow providing
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100s of peer reviewed papers
A few key papers relating to ibogaine research
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A few key papers relating to ibogaine research
and second generation ibogaine-like drugs to
treat chemical dependence follow. These include
ibogaine effects on opioid narcotics.
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Ibogaine effects on cocaine
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Ibogaine effects on alcohol
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Tissue distribution and availability
Review papers
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Opioid withdrawal in human subjects
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Second generation ibogaine-like
d t b lit ib i i
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drug, metabolite noribogaine is
identified
Another second generation ibogaine-like
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drug, 18-methoxycoronaridine,diminishedmorphine withdrawal
18-methoxycoronaridineeffects on
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alcohol
18-methoxycoronaridineeffects on
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methamphetamine and nicotine
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18-methoxycoronaridine and noribogaine have notbeen administered to human subjects. Ibogaineremains the only iboga alkaloid that has been shown to
be effective in humans, supporting claims made in theoriginal ibogaine patents awarded between 1985 and
1992.
Ibogaine Patents
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1. Rapid method for interrupting the narcotic addiction syndrome, US
4,499,096 (1985)2. Rapid method for interrupting the cocaine and amphetamine abuse
syndrome US 4,587,243 (1986)
3. Rapid method for attenuating the alcohol dependency syndrome,
US 4,957,523 (1989)4. Rapid method for interrupting or attenuating the nicotine/tobacco
dependency syndrome, US 5,026,697 (1991)
5. Rapid method for interrupting or attenuating poly-drug dependency
syndromes, US 5, 124,994 (1992)
Why ibogaine is not available
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y g
1. Industry deems ibogaine not to be profitable. (not a maintenancedrug)
2. The molecule is found in nature and cannot be owned.
3. Stigmatized patient population with liability higher than generalpopulation.
4. Government, industry and academia chose to place their interestto treat narcotic dependence in the development of opiate drugswith which they are familiar.
5. Ibogaine represents a new scientific paradigm to the
understanding of addiction.
6. Lack of prioritization of pharmacotherapies.
7. Intellectual conformity.
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Failed to adequately respond
to make ibogaine available
The medical community
The pharmaceutical industry
Government
Brief comparison of discovery and
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Brief comparison of discovery and
development of ibogaine, methadone
and buprenorphine. All are effective in
treating opioid dependence.
Methadone
NYC
1964Doctors administer to
drugs users
Opioid agonist
activity
Ibogaine
NYC
1962Drug users
administer todrug usersMulti-receptor
activity
Buprenorphine
Lexington, KY
1975Government and
industry
Co-Development
Mixed opioidagonist antagonist
activity
Background: Ibogaine
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Botanical source Tabernanthe iboga. Used for 100s of years in
African medicine and religion
1901 ibogaine isolated by Dybowski and Landrin
1958 molecular structure determined Bartlett et al.
1962 Lotsof discovers Antiaddictive effects
1991 NIDA initiates evaluation of ibogaine
1995 NIDA Ibogaine Clinical Review Meeting. Decision: Noclinical studies of ibogaine
Background: Ibogaine
Background: Methadone
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1937 synthesized by Max Bockmhl and Gustav Ehrhart,
I.G. Farbenindustries. Patent issued 1941
1950 use in treatment of opioid abstinence syndromeestablished in US
1964 use in opioid maintenance therapy
1964 - 1973 Golden age of Dole and Nyswander
1973 Federal regulation of Methadone
2002 Revised Federal regulation of Methadone
Background: Methadone
Background: Buprenorphine
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1965 synthesized by KW Bentley at Reckitt & sons, UK.
1975 - 1978 DR Jazinski et al. Indicate utility in treating opiate addiction
1977 - 2003 John Lewis champions analgesic and antiaddictivedevelopment
1994 NIDA signs CRADA with Reckitt & Colman Pharmaceuticals, Inc.
2000 Drug Addiction Treatment Act authorizes use in opioidmaintenance therapy
2002 FDA approves use to Reckitt Benckiser to treat narcotic addiction
Is NIDA responsible for blocking ibogaine?1994 ll b ti h d
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1994 collaborative research anddevelopment agreement for buprenorphine
NIDA director signs agreement to
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NIDA director signs agreement todevelop buprenorphine 1994
NIDA says NO to clinical
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NIDA says NO to clinical
development of ibogaine 1995
Paths to ibogaine availability
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1. Pharmaceutical company or government agencyprepared to finance regulatory development.
2. Supplies of pharmaceutical grade ibogaine.
3. Grassroots constituency demanding availability ofibogaine.
4. Political advocacy movement to pressure government
and industry into action.
5. A scientific community supporting ibogaine research.
Why ibogaine should be available
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Based on drug user reports ibogaine is a
medication that significantly reduces withdrawal
signs and interrupts drug craving thus returning
patients to what they describe as a preaddictive
state. This is a state that most drug users thoughtthey would never experience again after years
of being dependent. It is a state in which free
choice is returned to the user and that is
important to understand.
Its in your hands now!
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