Ibogaine Politics Science Nyc2006

8/3/2019 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

[email protected]


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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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Ibogaine Politics Science Nyc2006

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