anecdotal evidence?

deartheo at ziplip.com deartheo at ziplip.com
Thu Feb 26 17:19:03 EST 2004


   If someone was willing to authorize and send to the FDA medical records (methadone clinic records), that suddenly stop after talking iboga/ine, would that still be considered only anecdotal evidence by them?
----- Original Message ----- 
From: deartheo at ziplip.com
To: ibogaine at mindvox.com
Sent: 25 Feb 04, 10:10 AM
Subject: [ibogaine] from DHHS and NPR e-mail address
(not much new here I'm afraid)
 
February 24, 2004
Mr. Jason Bursey
5827 Timbercrest Drive
Arlington, Texas 76017
Dear Mr. Bursey:
Your emails to Dr. Elias A. Zerhouni, Director of the National Institutes of Health, and
Mr. Claude A. Allen, Deputy Secretary of Health and Human Services, regarding ibogaine have
been sent to me for response.
In your emails, you ask a number of questions concerning the role of the Federal Government in
ibogaine research and scheduling. While anecdotal evidence of treatment successes (such as in
your case) and treatment failures with ibogaine have existed for years, the Food and Drug
Administration (FDA) requires that a substantial amount of data be submitted concerning the
safety and efficacy of a product prior to approving it for use as a therapeutic agent. Anecdotal
evidence (positive, negative, or both) does not meet the regulatory requirements of the FDA
under which new treatment agents can be approved.
In 1991, based largely on the information provided by Mr. Howard Lotsof, Dr. Deborah Mash
and others, the Medications Development Division (now the Division of Treatment Research and
Development) of the National Institute on Drug Abuse (NIDA), created a medications
development project directed towards exploring the potential development of ibogaine. This
occurred at a time when Mr. Lotsof, who owned patents concerning the use of ibogaine as a drug
addiction treatment agent, and the law firm he hired could not find any commercial entity in the
United States (U.S.) willing to license and/or develop ibogaine. As part of this initiative, the
project team carried out research studies addressing various issues including the pharmacology
and toxicology of ibogaine as required by the FDA. Preclinical studies showed that ibogaine
possessed dose related neurotoxic effects in the rat, dog, and monkey including the ability to
cause seizures, neuron losses, and cardiovascular-QT prolongation which has been associated
with an increased risk of ventricular arrhythmia, which may result in fatal arrhythmias. It is
important to note that dose related toxicity alone does not necessarily rule out further
development of a medication. However, a safe dose level must be determined for human use.
This information is critical, as literature exists potentially linking ibogaine to deaths (including
during ceremonial use in Africa).
In 1995, prior to commencing a Phase I clinical trial of ibogaine in opiate dependent human
subjects, a review was held with a panel of outside expert consultants who were charged with
reviewing the available data to help determine whether NIDA should pursue a clinical study with
ibogaine. A number of persons and organizations interested in ibogaine participated in this
Page 2 - Mr. Jason Bursey
review meeting. Mr. Lotsof presented data on the number of subjects he had treated with
ibogaine and their outcomes. In addition to the toxicological findings, the data presented by
Mr. Lotsof (number of treatment successes versus treatment failures, time to relapse) did not
appear to offer increased efficacy over existing methods of opiate detoxification. The majority
opinion of the consultants was that NIDA should not pursue a clinical trial of ibogaine.
Subsequent to NIDA’s decision not to directly perform clinical trials with ibogaine, Dr. Mash
and Mr. Lotsof entered a business agreement concerning the development of ibogaine and
received FDA approval to perform a Phase I study in the U.S. This study was never completed.
Dr. Mash has been administering treatment with ibogaine at the Healing Visions Institute for
Addiction Recovery on the island of St. Kitts.
Thus, although ibogaine is no longer part of NIDA's directed medications development efforts,
we will continue to fund research projects on ibogaine through grants that receive meritorious
scores in peer review. NIDA continues to make all of the preclinical data it developed (currently
residing as a Drug Master File with the FDA) available to researchers interested in conducting
clinical studies with ibogaine.
Some of the lack of interest in ibogaine may stem from the fact that the drug lacks a composition
of matter patent. Compounds lacking such protection are usually given short shrift by the
pharmaceutical industry as their commercial value is very limited.
Regarding current U.S. scheduling of ibogaine, under U.S. law, psychoactive substances that
meet defined criteria and have no FDA approved medical uses must be placed in Schedule I.
Ibogaine is considered hallucinogenic and thus far has no FDA approved medical use. This does
not mean that medical research cannot be performed with ibogaine or other Schedule I
substances, but researchers are required to meet certain storage and record keeping requirement
standards that pertain to Schedule I substances. For more information on scheduling, please
contact the U.S. Drug Enforcement Administration.
I hope that you find this information helpful.
Sincerely,
Nora D. Volkow, M.D.
Director  
--------------------------------------------------------------------------------------------------------------------------- 
 
(Morning Edition, the program which is running this special regularly reads
letters on-air. Email to morning at npr.org) http://www.npr.org/features/feature.php?wfId=1688762for more info.

 
 
 
Dear Mr. Bursey,
 Attached is the letter from Dr. Nora D. Volkow, Director of the National
Institute on Drug Abuse, responding to your emails to Dr. Elias Zerhouni and
Mr. Claude Allen regarding ibogaine.  I also sent this letter to you via
mail.
 
Best regards,
 
Monglan (Lana) Le 
Correspondence System Coordinator 
NIDA Executive Secretariat 
6001 Executive Blvd., Room 5101, MSC 9585 
(301) 443-6618 phone 
(301) 443-8756 fax 
mle1 at nida.nih.gov 
 
 
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