1. Ibogaine (brief review) 2. Ibogaine Development

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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 Chemical Proposed as an approved
regulated drug
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Physical Characteristics of ibogaine base Source
Merck Index
Chemical 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
Politics Policy Prejudice Profit Science
Howard S. Lotsof Dora Weiner Foundation http//www
.doraweiner.org
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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 Regulation War 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 the SSDP
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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 officials
and media
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Nico Adriaans was one of the founders of both the
Rotterdam Junkies Union and Dutch Addict
Self-Help (DASH). DASH was an ibogaine
self-help organization that petitioned the Dutch
government and organized drug users to demand
ibogaine availability. DASH provided ibogaine at
no cost to heroin users.
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ICASH Organizing in the US
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Cures-Not-Wars placed pressure on NIDA to support
Ibogaine research through 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
• ibogaine-subscribe_at_mindvox.com

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FM- I'm not really privy to what's happening in
that regard here in the US. Suffice to say,
nothing has worked which is why we're here. We
feel that continuing the focus offshore, outside
the US, has not served a majority of people
inside the US. Like many other grassroots
movement, which facilitated change, treatments,
sessions, need to be done where they belong, in
all major US cities, as cost effectively as
possible. http//www.drugwar.com/ibonyc.shtm
Ibogaine underground appears 2004
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Policy
A course or principle of action adopted or
proposed by a government, party, business, or
individual
Harm Reduction Demand Reduction How Ibogaine is
Viewed
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Ibogaine represents both harm reduction and
demand reduction
DEA desk officer in the Netherlands asks how the
Dutch are allowing a demand reduction drug like
ibogaine to be researched in the
Netherlands? Ibogaine proponents view the drug
as significant harm reduction tool and basis for
political action.
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Prejudice
A generally negative preconceived opinion that is
not based on reason or actual experience
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Prejudice incorporates
Discrimination
The unjust or prejudicial treatment of different
categories of people or things.
Stigma
A mark of disgrace associated with a particular
circumstance, quality, or person the stigma of
chemical dependence.
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Discrimination
Focuses attention on those who produce
rejection and exclusion
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Stigma
Focuses attention on the victim
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Prejudice, stigma and discrimination, in part,
determine what drugs will be regulated, what
drugs will not be regulated and what medications
will be or not be made available to treat
chemical dependence
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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 state often 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 have significant
effects on the person and the society within
which the individual lives as it allows for
personal growth and the possibility of a greater
contribution to society. This dynamic is
expressed within the activities of the ibogaine
advocacy movement in the services they offer to
chemically dependent persons and the political
actions taken to promote ibogaine availability.
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Profit
A financial gain, The difference between the
amount earned and the amount spent in buying,
operating, or producing something their eyes
brightened at the prospect of profit.
Politics Policy Prejudice Science
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Profit is a core issue in the pharmaceutical
industry whose primary purpose is to return
profit to corporate shareholders.
This effects what drugs will be developed and the
areas of medicine for which drugs will be
available.
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Science
The intellectual and practical activity
encompassing the systematic study of the
structure and behavior of the physical and
natural world through observation and experiment
Politics Policy Prejudice Profit Intellectual
Conformity
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National Institute on Drug Abuse (NIDA) funds 85
of drug addiction research 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 on by NDA International, Inc., a
company established to make ibogaine available as
an approved medication. In 1991, NIDA formed its
Medications Development Division (MDD) and
accepted a Product Profile Review (PPR) from NDA
International that resulted in NIDA starting
their ibogaine research program.
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The following are examples demonstrating the
scientific contention between NIDA and
pro-ibogaine researchers that played out between
1988 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
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Further research by OHearn and Molliver
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Xu et al. eventually produce research showing no
neurotoxicity at clinical doses (2000)
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Xu et al. accomplished research in part at the
National Center for Toxicological Research an FDA
laboratory. The research demonstrated no
neurotoxicity at 25 mg/kg.
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Ibogaine science continues to grow providing 100s
of peer reviewed papers
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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
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Review papers
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Opioid withdrawal in human subjects
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Second generation ibogaine-like drug, metabolite
noribogaine is identified
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Another second generation ibogaine-like drug,
18-methoxycoronaridine, diminished morphine
withdrawal
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18-methoxycoronaridine effects on alcohol
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18-methoxycoronaridine effects on methamphetamine
and nicotine
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18-methoxycoronaridine and noribogaine have not
been administered to human subjects. Ibogaine
remains the only iboga alkaloid that has been
shown to be effective in humans, supporting
claims made in the original ibogaine patents
awarded between 1985 and 1992.
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Ibogaine Patents

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)

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Why ibogaine is not available

• Industry deems ibogaine not to be profitable.
  (not a maintenance drug)
• 2. The molecule is found in nature and cannot be
  owned.
• 3. Stigmatized patient population with
  liability higher than general population.
• 4. Government, industry and academia chose to
  place their interest to treat narcotic dependence
  in the development of opiate drugs with which
  they are familiar.
• 5. Ibogaine represents a new scientific paradigm
  to the understanding of addiction.
• Lack of prioritization of pharmacotherapies.
• 7. Intellectual conformity.

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Failed to adequately respondto make ibogaine
available

• The medical community
• The pharmaceutical industry
• Government

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Brief comparison of discovery and development of
ibogaine, methadone and buprenorphine. All are
effective in treating opioid dependence.

• Methadone
• NYC
• 1964
• Doctors administer to drugs users
• Opioid agonist
• activity

Ibogaine NYC 1962 Drug users administer to drug
users Multi-receptor activity
Buprenorphine Lexington, KY 1975 Government and
industry Co-Development Mixed opioid agonist
antagonist activity
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Background Ibogaine
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 No clinical studies of
ibogaine
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Background Methadone
1937 synthesized by Max Bockmühl and Gustav
Ehrhart, I.G. Farbenindustries. Patent issued
1941 1950 use in treatment of opioid
abstinence syndrome established 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
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Background Buprenorphine
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
antiaddictive development 1994 NIDA signs
CRADA with Reckitt Colman Pharmaceuticals,
Inc. 2000 Drug Addiction Treatment Act
authorizes use in opioid maintenance therapy
2002 FDA approves use to Reckitt Benckiser to
treat narcotic addiction
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Is NIDA responsible for blocking ibogaine?1994
collaborative research and development agreement
for buprenorphine
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NIDA director signs agreement to develop
buprenorphine 1994
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NIDA says NO to clinical development of
ibogaine 1995
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Paths to ibogaine availability

1. Pharmaceutical company or government agency
   prepared to finance regulatory development.
2. Supplies of pharmaceutical grade ibogaine.
3. Grassroots constituency demanding availability of
   ibogaine.
4. Political advocacy movement to pressure
   government and industry into action.
5. A scientific community supporting ibogaine
   research.

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Why ibogaine should be available
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
thought they 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.
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Its in your hands now!