1. Ibogaine (brief review) 2. Ibogaine Development Introduction to Presentation by HS Lotsof 2006...

1. Ibogaine (brief review)2. Ibogaine Development

Introduction to Presentation by HS Lotsof

2006 NYC Ibogaine Conference Columbia University

Saturday, February 25

Ibogaine Found in a West African plant Tabernanthe iboga

T. Iboga is Valued for its roots

Iboga alkaloids are concentrated in the bark of the root

Usable forms include scraped or ground root bark

Total Alkaloid extract

Courtesy Sara Glatt

Purified Chemical Proposed as an approved regulated drug

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

Ibogaine Development or Lack Thereof:

Howard S. Lotsof

Dora Weiner Foundation

http://www.doraweiner.org

Politics

Policy

Prejudice

Profit

Science

Politics

The activities within a government or agency or other human endeavor that may include debate and conflict.

ProhibitionLegalization or Regulation

War on DrugsWar on Some Drugs War on Drug Users

Drug Politics may be top down from government agencies such as the ONDCP

DEA

FDA

Drug Politics are also bottom up from grassroots organizations such as the SSDP

Harm Reduction Coalition

Cures Not Wars

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

ICASH logo

Used to attract attention of government officials and media

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.

ICASH Organizing in the US

Cures-Not-Wars placed pressure on NIDA to support Ibogaine research through protests

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@mindvox.com

“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

PolicyA course or principle of action adopted or proposed by a government, party, business, or individual

Harm ReductionDemand Reduction

How Ibogaine is Viewed

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.

Prejudice

A generally negative preconceived opinion that is not based on reason or actual experience

Prejudice incorporates

Stigma

A mark of disgrace associated with a particular circumstance, quality, or person : the stigma of chemical dependence.

Discrimination

The unjust or prejudicial treatment of different categories of people or things.

Focuses attention on those who produce rejection and exclusion

Discrimination

Focuses attention on the victim

Stigma

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

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.

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.

ProfitA 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

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.

ScienceThe 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

National Institute on Drug Abuse (NIDA) funds 85% of drug addiction research worldwide

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.

The following are examples demonstrating the scientific contention between NIDA and pro-ibogaine researchers that played out between 1988 and 2000.

First scientific publication of ibogaine antiaddictive effects

NIDA Response: It doesn’t work

Ibogaine Scientists Answer

NIDA contracts neurotoxicologist Mark Molliver to determine ibogaine neurotoxicity

Ibogaine researcher Helen Molinari responded

Further research by O’Hearn and Molliver

Xu et al. eventually produce research

showing no neurotoxicity at clinical doses (2000)

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.

Ibogaine science continues to grow providing 100s

of peer reviewed papers

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.

Ibogaine effects on cocaine

Ibogaine effects on alcohol

Tissue distribution and availability

Review papers

Opioid withdrawal in human subjects

Second generation ibogaine-like drug,

metabolite noribogaine is identified

Another second generation ibogaine-like drug,

18-methoxycoronaridine, diminished morphine withdrawal

18-methoxycoronaridine effects on alcohol

18-methoxycoronaridine effects on methamphetamine and nicotine

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.

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)

Why ibogaine is not available

1. 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.

6. Lack of prioritization of pharmacotherapies.

7. Intellectual conformity.

Failed to adequately respondto make ibogaine available

The medical community The pharmaceutical industry Government

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

MethadoneNYC1964

Doctors administer to drugs users

Opioid agonistactivity

IbogaineNYC1962

Drug users administer to drug users

Multi-receptor activity

BuprenorphineLexington, KY

1975 Government and

industryCo-Development

Mixed opioid agonist antagonist activity

• 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

Background: Ibogaine

• 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

Background: Methadone

• 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

Background: Buprenorphine

Is NIDA responsible for blocking ibogaine?1994 collaborative research and development agreement for buprenorphine

NIDA director signs agreement to develop buprenorphine 1994

NIDA says “NO” to clinical development of ibogaine 1995

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.

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.

Its in your hands now!