A History of the Science, Politics and Advocacy of ibogaine: A Brief Overview

1. A History of the Science, Politics and Advocacy of ibogaine:A Brief Overview

2. Ibogaine Found in a West African plant Tabernanthe iboga Tabernanthe iboga being cultivated in Gabon.Tabernanthe iboga being cultivated in Gabon.

3. Iboga alkaloids are concentrated in the bark of the root Ibogaine is found in the roots of the West African Plant Tabernanthe ibogaIbogaine is found in the roots of the West African Plant Tabernanthe iboga

4. Usable forms include scraped or ground root bark Root scrapings are used in Bwiti initiation rites. At times a liquid extraction is used.Root scrapings are used in Bwiti initiation rites. At times a liquid extraction is used.

5. Total Alkaloid extract

6. Purified Chemical 

7. Proposed as an approved regulated drug Bottles of purified Ibogaine hydrochloride that is used to treat chemical dependence.Bottles of purified Ibogaine hydrochloride that is used to treat chemical dependence.

8. Physical Characteristics of ibogaine Source Merck Index Chemical data courtesy of Merck Index.Chemical data courtesy of Merck Index.

9. Background: Ibogaine Ibogaine�s antiaddictive effects were discovered by drug users in the 1960s and promoted and developed by drug users and former drug users from the 1980s through this date. Ibogaine�s antiaddictive effects were discovered by drug users in the 1960s and promoted and developed by drug users and former drug users from the 1980s through this date.

10. Ibogaine Patents

11. Regulatory and Scientific Development

12. Lotsof periodhistorical development

13. NIDA Initially Rejects Ibogaine Research.

14. First scientific publication of ibogaine antiaddictive effects- Dzoljic et al. -

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

16. NIDA Response to Dzoljic: It doesn�t work

17. Additional research supports Dr. Dzoljic�s findings. Dr. Stanley D. Glick at Albany Medical College begins the publication of what will become dozens of research papers

18. Ibogaine effects on cocaine

19. Ibogaine effects on cocaine (Cappendijk & Dzoljic)

20. Ibogaine effects on alcohol

21. Ibogaine effects on alcohol(Rezvani et al. 1995)

22. Opioid withdrawal in human subjects

24. Return to preaddictive state?

25. Tissue distribution and availability

26. NIDA contracts neurotoxicologist Mark Molliver to determine ibogaine neurotoxicity

27. Ibogaine researcher Helen Molinari responded

28. Further research by O�Hearn and Molliver

29. Xu et al. eventually produce research showing no neurotoxicity at clinical doses (2000)

30. Xu et al. accomplished research in part at the National Center for Toxicological Research an FDA laboratory. The research demonstrated no neurotoxicity in rats at 25 mg/kg.

31. Review papers

32. Review of the use of ibogaine outside of the African Bwiti religious context

33. Ibogaine science continues to grow providing 100s of peer reviewed papers

34. Ibogaine: Multiplemechanisms of action & receptor system effects where drugs of abuse also show activity

35. The objective the of pharmaceutical industry is to return profit to corporate shareholders

36. NIDA has focused on already existing drugs which are then developed for addiction as a new indication, and not the development of fundamentally new pharmacological strategies such as ibogaine. NIDA�s signing of a Collaborative Research and Development Agreement (CRADA) with Reckitt Benckiser for buprenorphine as determining factor in NIDA�s decision not to proceed to clinical studies with ibogaine?NIDA�s signing of a Collaborative Research and Development Agreement (CRADA) with Reckitt Benckiser for buprenorphine as determining factor in NIDA�s decision not to proceed to clinical studies with ibogaine?

37. NIDA director signs agreement to develop buprenorphine 1994 NIDA director Alan Leshner signs Collaborative Research and Development Agreement (CRADA) for buprenorphine development 1994.NIDA director Alan Leshner signs Collaborative Research and Development Agreement (CRADA) for buprenorphine development 1994.

38. NIDA says �NO� to funding clinical development of ibogaine 1995 The result of NIDA�s 1995, Ibogaine Review meeting was a decision not to proceed to clinical studies of ibogaine. Approximately a year earlier, NIDA signed a CRADA for the development of the mixed agonist buprenorphine withThe result of NIDA�s 1995, Ibogaine Review meeting was a decision not to proceed to clinical studies of ibogaine. Approximately a year earlier, NIDA signed a CRADA for the development of the mixed agonist buprenorphine with

39. In 2004 NIDA makes available under the Freedom of Information Act (FOIA) a Drug Master File (DMF) provided to FDA comprising 16 volumes of data of approximately 4,000 pages. In light of the possibility of ibogaine clinical development taking place outside of the United States, NIDA released their FDA drug master file for ibogaine.In light of the possibility of ibogaine clinical development taking place outside of the United States, NIDA released their FDA drug master file for ibogaine.

40. Partial list of broad-ranging studies in FDA Drug Master File (DMF) included in 16 volumes of data submitted by US National Institute on Drug Abuse (NIDA) for ibogaine.

41. Among the 16 volumes of data are mutagenicity studies showing ibogaine not to be a thalidomide-like drug. Despite the thousands of cases of severe birth defects caused by thalidomide in Europe, there were very few cases in the US, less than 20, because it was never approved in the US. The New Drug application (NDA) for thalidomide was submitted to the FDA in 1960. Despite intense pressure from the manufacturer, the FDA refused to approve it until the NDA was withdrawn in 1961. Francis Kelsey, the FDA medical officer most responsible the decision to deny approval for thalidomide, was regarded as a national hero and presented with an award by President Kennedy himself. Schools and streets were named after her. This is the same FDA that approved clinical research in which human subjects received ibogaine in 1993. If thalidomide had been subject to the same preclinical toxicological evaluation it would never have been approved. It would have failed the Ames test for mutagenicity and likely neurotoxicity studies as well By the way, thalidomide was eventually found to be useful in treating multiple myeloma, and now it�s now a first line treatment. Australia was the first country to approve thalidomide for the treatment of multiple myeloma in 2003. The drug is used with very tight controls to make sure that it is not given to pregnant women. Despite the thousands of cases of severe birth defects caused by thalidomide in Europe, there were very few cases in the US, less than 20, because it was never approved in the US. The New Drug application (NDA) for thalidomide was submitted to the FDA in 1960. Despite intense pressure from the manufacturer, the FDA refused to approve it until the NDA was withdrawn in 1961. Francis Kelsey, the FDA medical officer most responsible the decision to deny approval for thalidomide, was regarded as a national hero and presented with an award by President Kennedy himself. Schools and streets were named after her. This is the same FDA that approved clinical research in which human subjects received ibogaine in 1993. If thalidomide had been subject to the same preclinical toxicological evaluation it would never have been approved. It would have failed the Ames test for mutagenicity and likely neurotoxicity studies as well By the way, thalidomide was eventually found to be useful in treating multiple myeloma, and now it�s now a first line treatment. Australia was the first country to approve thalidomide for the treatment of multiple myeloma in 2003. The drug is used with very tight controls to make sure that it is not given to pregnant women.

42. Comparative safety perspectivesDrug-related fatalities (d-rf)

43. Drug-related fatalities/treatment episodes

44. Ibogaine Activist Advocacy Organizations PlayRole in Ibogaine Development International Coalition for Addict Self-Help (ICASH) 1989 Dutch Addict Self-Help (DASH) 1990 Cures-Not Wars (ibogaine and other issues) 1994 Freedomroot Ibogaine Underground 2004 Political action groups formed coalitions to provide Ibogaine therapy and petition governments to make it an approved drug.Political action groups formed coalitions to provide Ibogaine therapy and petition governments to make it an approved drug.

45. ICASH logo As a shock tactic and to gain attention the International Coalition for Addict Self-Help chose this graphic prepared by the Amsterdam squatters movement as their logo that was printed on mailing envelopes to attract attention.As a shock tactic and to gain attention the International Coalition for Addict Self-Help chose this graphic prepared by the Amsterdam squatters movement as their logo that was printed on mailing envelopes to attract attention.

46. Nico Adriaans was one of the founders of both the Rotterdam Junkies Union and Dutch Addict Self-Help (DASH), and the first needle exchange in 1981. 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. Adriaans was a social activist and researcher for the European Addiction Research Institute at Erasmus University Rotterdam.Adriaans was a social activist and researcher for the European Addiction Research Institute at Erasmus University Rotterdam.

47. ICASH Organizing in the US Organizing in the US assumed YIPPIE tactics of street media and protest. Ibogaine banner seen during the 1991, NYC Gay Pride Parade.Organizing in the US assumed YIPPIE tactics of street media and protest. Ibogaine banner seen during the 1991, NYC Gay Pride Parade.

48. Cures-Not-Wars placed pressure on NIDA to support Ibogaine research through protests Cures-Not-Wars, the YIPPIE derived anti-drug-war and AIDS activist group organized protests at the National Institute on Drug Abuse to pressure NIDA for Ibogaine research.Cures-Not-Wars, the YIPPIE derived anti-drug-war and AIDS activist group organized protests at the National Institute on Drug Abuse to pressure NIDA for Ibogaine research.

49. Mindvox internet 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 Ibogaine activism continues today on the internet where ibogaine is the subject of an international list with over 7,000 members of the ibogaine/Iboga community.Ibogaine activism continues today on the internet where ibogaine is the subject of an international list with over 7,000 members of the ibogaine/Iboga community.

50. �FM- � We feel that continuing the focus offshore, outside the US, has not served a majority of people inside the US. Like many other grassroots movements, 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 While this presentation was being developed (July - Nov 2004) the issues that it addressed of the rights of drug users to have access to ibogaine moved from concept and discussion to reality with the emergence of an Ibogaine underground railroad that brought Ibogaine to inner city drug users. Interview posted to drugwar.com August 26, 2004. While this presentation was being developed (July - Nov 2004) the issues that it addressed of the rights of drug users to have access to ibogaine moved from concept and discussion to reality with the emergence of an Ibogaine underground railroad that brought Ibogaine to inner city drug users. Interview posted to drugwar.com August 26, 2004.

51. Ibogaine represents both harm reduction and demand reduction

52. Stigma

53. Ibogaine Effects on Stigma

54. Why ibogaine is not available

55. Paths to ibogaine availability

56. Why ibogaine should be available

57. Its in your hands now!Activism, advocacy and science Patient rights - User rights