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FEMALE PATIENT SAFETY One 24-year-old female patient, treated for chemical depen- dence in ibogaine trials in the Netherlands, died from undiagnosed causes. Although the autopsy did not determine the cause of her death, ibogaine levels of 0.75mg/litre were recorded in the blood. This level has not been seen to be toxic in animal research or in prior human studies undertaken by NDA International. Subsequent to this death (and to a previously reported death of a Swiss woman who received ibogaine during a psychotherapy session in Europe which was totally unrelated to NDA's research program) the FDA excluded women from the clinical trials presently taking place at the University of Miami. However, the FDA decision is contrary to the gender guidelines of the National Institutes of Health. The NIH guidelines call for the inclusion of women at the earliest stages of clinical trials, in order to provide the greatest determination of safety for women. NDA International reports that 30 per cent of its patients have been women and they have shown no negative effects from taking ibogaine either during or after treatment. However, considering all of the circumstances, the Lotsof Procedure should be adminis- tered only in a hospital or clinic with the patient under continuous staff observation and electronic monitoring. An ongoing international research program is collating evi- dence to determine an hypothesis for the cause of death of the woman in the Netherlands. Additionally, NDA International is seeking Swiss Government cooperation concerning the death of the Swiss woman. The cost of an individually scheduled treatment is significantly higher. These charges do not include the preliminary medical evaluations, or transportation to and costs in New York for required pre-treatment and post-treatment medical screening. Start campaigning to make Ibogaine available in Australia now! Contact practitioner and help get loved ones off drugs of dependency! f= nanan ee Hee -- 0 =n Feet ee order to provide the greatest determination of safety for women. If you require further information on referral for ibogaine treat- NDA International reports that 30 per cent of its patients have —_ ment, write to: been women and they have shown no negative effects from taking Intake Department ibogaine either during or after treatment. However, considering NDA International, Inc. all of the circumstances, the Lotsof Procedure should be adminis- PO Box 100506 tered only in a hospital or clinic with the patient under continuous Staten Island, NY 10310-0506 staff observation and electronic monitoring. USA An ongoing international research program is collating evi- Your letter should provide statements including the following: dence to determine an hypothesis for the cause of death of the 1. You are seeking treatment with ibogaine. woman in the Netherlands. Additionally, NDA International is 2. You understand that ibogaine is an experimental therapy and seeking Swiss Government cooperation concerning the death of has not been approved by the US Food and Drug Administration the Swiss woman. (FDA). If you reside in a country other than the United States, state that you understand that ibogaine is an experimental therapy IBOGAINE TREATMENT LOGISTICS and not approved by the health department of the country where NDA International, Inc. has received many requests for infor- you reside. mation concerning ibogaine treatment for drug dependence. 3. Include a brief history of your current and previous drug use. Currently, the only treatments authorised by a health ministry 4. List any medical conditions you are aware of, and any med- are administered in hospitals in Central America as part of an ications you are taking or have taken during the last 12 months experimental program. (including, but not limited to, anti-psychotics, anti-depressants, Due to the significant expense of hospitalisation and the logis- cardiovascular drugs, anti-hypertensives and anti-convulsants). tics involved with this program, the base cost per person can be 5. Print and sign your complete name and provide your mailing US$15,500 for participation in treatment within a group of three. address, telephone number and e-mail address. oo References (continued) Glick, S.D., "Interactions between Ibogaine, a Lajtha, A., "Ibogaine Antagonizes Cocaine- 18. Karler, R, Calder, L.D., Chaudhry, LA., Potential Anti-Addictive Agent, and Morphine: Induced Locomotor Activity in Mice", Life Turkanis, S.A., "Blockade of ‘Reverse An In Vivo Microdialysis Study", European Sciences 50:1079-1086, 1992. Tolerance’ to Cocaine and Amphetamine by Journal of Pharmacology 199:35-42, 1991. 34. Sershen, H., Hashim, A. and Lajtha, A., MK-801", Life Sciences 45:599-606, 1989. 26. Mash, D.C., Douyon, R., Hearn, W.L., "Tbogaine Reduces Preferences for Cocaine 19. Khanna, J.M., Kalant, H., Shah, G. and Sambol, N.C. and Sanchez-Ramos, J., "A Consumption in CS57BL/6By Mice", Chau, A., "Effect of D-cycloserine on Rapid Preliminary Report on the Safety and Pharmacology, Biochemistry and Behaviour Tolerance to Ethanol", Pharmacology, Pharmacokinetics of Ibogaine", Biological 47(1):13-19, 1994. Biochemistry and Behaviour 45(4):983-986, Psychiatry, 1995 (in press). 35. Sheppard, S.G., "A Preliminary 1993. 27. Naranjo, C., "Psychotherapeutic Investigation of Ibogaine: Case Reports and 20. Lotsof, H.S., "Rapid Method for Possibilities of New Fantasy Enhancing Drugs", | Recommendations for Further Study", J. Interrupting the Narcotic Addiction Syndrome", Clinical Toxicology 2(2):209, 1969. Substance Abuse Treatment 11(4):379-385, US Patent No. 4,499,096, 1985. 28. Naranjo, C., The Healing Journey, Pantheon 1994. 21. Lotsof, H.S., "Rapid Method for Books/Random House, New York, USA, 1973, 36. Sisko, B., "Interrupting Drug Dependency Interrupting the Cocaine and Amphetamine pp. 174-228. with Ibogaine: A Summary of Four Case Abuse Syndrome", US Patent No. 4,587,243, 29. Personal communication with Howard Histories", MAPS IV(2):15-23, Summer 1993. 1986. Lotsof (author wishes to remain anonymous), 37. Trujillo, K.A. and Akil, H., "Inhibition of 22. Lotsof, H.S., "Rapid Method for 1994. Morphine Tolerance and Dependence by Attenuating the Alcohol Dependency 30. Popik, P., Layer, R.T. and Skolnick, P., NMDA Receptor Antagonist MK-801", Science Syndrome", US Patent No. 4,857,523, 1989. "The Putative Anti-addictive Drug Ibogaine isa — 2512:85-87, 1991. 23. Lotsof, H.S., "Rapid Method for Competitive Inhibitor of [SH]MK-801 Binding 38. Village Beat, New York, NY, May 1990. Interrupting or Attenuating the to the NMDA Receptor Complex", 39. Woods, H.W., Medzihardsky, F., Smith, Nicotine/Tobacco Dependency Syndrome", US — Psychopharmacology 114:672-674, 1994. C.B., Winger, G.D. and Prince, C.P., 1989 Patent No. 5,026,697, 1991. 31. Sabom, M.B., Recollections of Death, Annual Report: Evaluation of New Compounds 24. Lotsof, H.S., "Rapid Method for Harper & Row, USA, 1982. for Opioid Activity, NIDA Research Monograph Interrupting or Attenuating Poly-drug 32. Sanchez-Ramos, J. and Mash, D.C., 95(563):655-656, 1990. Dependency Syndromes", US Patent No. "Tbogaine Research Update: Phase I Human 40. Zeff, L., First International Ibogaine 5,124,994, 1992. Study", MAPS, IV(4):11, Spring 1994. Conference, Paris, France, January 1987 (video- 25. Maisonneuve, I.M., Keller, R.W., Jr, and 33. Sershen, H., Hashim, A., Harsing, L. and tape). 34 © NEXUS your local politician and health-care AUGUST - SEPTEMBER 1997