Deborah Mash Research FDA

Deborah Mash Research FDA

Deborah Mash Research FDA

Professor, Dr. Deborah Mash about Ibogaine

Professor, Dr. Deborah Mash about the study of Ibogaine as an alternative treatment for addiction diseases since 1990.
Dr. DeborahMash is a professor in the Department of Neurology and professor in the Department of Cellular Molecular Pharmacology at the School of Medicine, University of Miami. Dr. Mash is a recognized internationally recognized expert in the field of neuropharmacology and neurology. Her doctoral dissertation was devoted to the study of degenerative changes in the brain in Alzheimer’s disease and the possibility of restoring lost brain functions. Dr. Mash completed an internship at Harvard University and was admitted to the faculty of the University of Miami in 1986 and currently leads the national post-mortem database of the human brain for people with degenerative and neuropsychiatric disorders.
The study of addiction problems and the development of new methods for treating addiction have become a priority for Dr. Mash since 1988. Her numerous scientific works in the field of neuro-pharmacology are constantly published in the world and American medical journals.
Dr. Mash is also Secretary of the South Florida Health Committee.
Paradoxically, the healing power of Ibogaine was discovered due to its psychedelic properties. Ibogaine is an extract of the root of the shrub Tabernante Iboga (TabernantheIboga), naturally growing in equatorial Africa. For centuries, local tribes used Ibogaine extract in small doses to maintain an awake state during the hunt, and in large doses to perform religious rituals. In 1962, the amazing properties of Ibogaine were accidentally discovered, allowing people suffering from drug addiction to instantly get rid of physical and mental dependence on drugs without any symptoms of withdrawal.

Paul de Rienzo (journalist) (PR): Dr. Mash, how did you hear about Ibogaine?

Deborah Mash: Ibogaine came into my field of vision as a result of three events that somehow happened almost simultaneously in my life. I worked with a coca ethylene partner. I do not know if you know that if you drink alcohol at the same time as cocaine, the body produces a third substance, which is the leaded analog of cocaine. We demonstrated I think, it was in 1990 that coca-ethylene is formed in the liver, circulates in the blood, enters the brain, and is a more active and more addictive substance than cocaine itself. We suspected that coca-ethylene was a more common cause of death than cocaine itself and convincingly proved that coca-ethylene was a long-lasting substance and a stronger euphoric than cocaine. This explained the fact that the dependence of the simultaneous use of alcohol and cocaine was spread. We have also demonstrated that cocaethylene is a more lethal substance than cocaine. With this fact, we tried to explain the epidemic of lethal overdoses in Dade County (South Florida).

Working on these studies, we have attracted attention nationwide. I was in constant trips, discussing and clarifying the situation. At one of these forums, a gentleman, an African-American, came up to me and asked if I knew anything about an herbal substance from Africa, which miraculously relieves people of cocaine and heroin addiction. At that moment I was busy, looked back and said: “Uh … sorry, thank you very much, but I have to talk to those people about my research.”

A month later, I listened to a presentation by Dr. S. Glick from the Albany Medical School at the College of Drug Addiction Problems. Glick gave Ibogaine to rats that were accustomed to self-use of heroin and cocaine. From the report, it followed that Ibogaine significantly suppressed the drug-associated behavior of rats, their attraction to the drug. So the second time I ran into Ibogaine. The third time, I got a call from a man who was seriously engaged in the Ibogainov project and said that he has something that will interest me very much.

That was the last straw. I asked myself: “Good. Let’s see what Ibogaine is? ”How the scientist was intrigued by the fact that it was a substance. What is this molecule? What does its structure look like? Who uses Ibogaine? What is the point? ”

OL: Is Ibogaine a hallucinogen like LSD?

D.Mash: No. I do not consider Ibogaine to be like LSD or any other hallucinogen. But, unfortunately, Ibogaine in the USA is classified as a potent psychotropic drug from the first list, which makes it very difficult to study it in a laboratory or in an academic medical center. Drugs from this list have no medical use, and their use is strictly regulated.
Ibogaine has an extremely unique molecular formula. The uniqueness lies in the fact that the plant naturally created an amazing chemical compound, where the basis is a serotonin-like structure. Serotonin is a natural neurotransmitter, which is usually associated with depression and antidepressants in our country. Ibogaine also has another alkaloid, which is an addition to the basic structure and which, in chemical structure, resembles cocaine. It turned out that the ibogaine molecule has a chemical affinity for both opioids and cocaine. It caught my attention as a scientist. Something fundamental lies in the chemical structure of Ibogaine, which explains its effectiveness. And everything seemed to be anecdotal stories of a miraculous cure by Ibogaine turned out to be true.

PR: How did the Ibogaine research begin?

D. Mash: I love riddles. I could not believe that all the stories about Ibogaine were true. And yet, somewhere instinctively, I felt that there was something here that could really help people. Is Ibogaine truly a miracle cure? Is there a clue? In the pharmacology of the drug? In the molecular formula? Or maybe Ibogaine is just an intermediate substance in the mysterious process of getting rid of addiction? Then I put aside my judgments and was determined to find answers to the questions posed scientifically. I began to gather a group of researchers around me. From the very beginning, we had a team of 20 people of various specialties: pharmacologists, cardiologists, neuropsychologists, neurologists, psychiatrists, toxicologists, pharmacokinetics. I was not alone.

PR: What is pharmacokinetics?

D.Mash: Pharmacokinetics are specialists studying the process of interaction between drugs and the body, how the drug is metabolized by the body, what is the degree of bioavailability, what is the difference in the reaction to the drug between the female and male body, etc.
We needed a license to work with drugs from the 1st list, which in itself took a lot of time. Even on the right to have Ibogaine, we needed permission from a special commission on the circulation of potent drugs. We have received such permission. At our disposal was a reliable laboratory in terms of the reliability of the results in one of the best medical centers. We have a team of top-notch professionals.
We also needed the permission of the ethics commission to test Ibogaine in public. I had to convince specialists of various specialties of the necessity and safety of this step. Fortunately, I had a good reputation in academia, and we were allowed to start research.
In the end, we had to get the final permission from the FDA (Food and Drug Administration). You know how difficult it is to get FDA approval. In this case, my personal experience with clinicians and FDA scientists was positive. FDA approval has been obtained.

PR: I spoke with a specialist from NIDA (National Institute Institute DrugAddiction), whose name I will not name, who spoke about the existing resistance regarding the prospects of Ibogaine. There are people who are trying to ignore your research.

D.Mash: I think so. When you look at how science develops, you can see that such resistance is present in all branches of science. This applies not only to Ibogaine. A drug against AIDS or something else, when it comes out of the field of established scientific stereotypes, causes resistance. Unfortunately, Ibogaine is a substance from the list of No. 1 and people often perceive Ibogaine as another hallucinogen from the 60s. This is really sad because we are often stigmatized by what can be a breakthrough in science in many ways.

PR: I have never heard of cases of using Ibogaine as a drug.

D.Mash: Ibogaine has no drug potential. The problem is that many mistakes were made during the study of psychotropic drugs in the 60s. Drugs that threaten the health of the nation, the foundations of society should be banned. Ibogaine simply mechanically fell into the group of drugs like LSD. Let me give you an example. Any drug addict or LSD user who has also tried Ibogaine will tell you that there is nothing in common between LSD and Ibogaine. Ibogaine is not LSD!
The Ibogaine molecule is completely unique. The effect of Ibogain on the human mind, brain, desire to take drugs, and withdrawal symptoms is so different from what we know about other substances that Ibogaine should be considered as a separate substance that does not belong to any class of known psychotropic drugs.

ETC: What can you say about the discovery of ibogaine metabolites, such as, for example, noribogaine?

D.Mash: On the forums on the network dedicated to self-treatment of addiction, and just among drug addicts there is a myth about Ibogaine as a silver pool in the treatment of addiction. Ibogaine is not a silver bullet. However, the existing undeniable numerous cure facts and scientific evidence in animal experiments (StanGlicklaboratory) confirm the powerful therapeutic effect of Ibogaine. How can this be explained? Apparently, Ibogaine turns into an intermediate substance, which is fixed on certain parts of the brain for a very long time, determining the so-called delayed effects (“after-effects”). I use in this case the term Stan Glick, which he used in experiments on rats.
Working with the same team that worked on the discovery of coca-ethylene, we found that Ibogaine is being converted to 12-hydroxybogaaminamine, which we designated Noribogaine. The metabolite is present in the human body for a much longer time than in animals. We still do not know the pharmacokinetics of Noribogaine. Research continues. But we know for sure that the Noribogaine molecule has an electrical polarity, which allows it to be fixed in certain parts of the brain. It seems to us that this is a fundamental find and that we are moving in the right direction.

PR: I recently read in the New York Times that Ibogaine primarily affects the cerebellum. What parts of the brain are affected by ibogaine?

D.Mash: This is quite controversial information about the activation of cerebellar structures by Ibogaine from a group of researchers from Johns Hopkins University. The cerebellum is the back of the brain, resembling a cauliflower in appearance, responsible for the balance and accuracy of movements. When you learn to ride a bicycle or play the piano, you activate your cerebellum. When you think about taking drugs, looking for drugs, whether it’s opiates, cocaine or alcohol, you are in a trap of addictive dynamic stereotypes. Now we are conducting studies on the role of the cerebellum in the formation of behavioral reactions.
I am not a supporter of this direction, because dependence is, first of all, a disease of higher nervous activity, which is determined by the formation of a pathological process of information exchange between the frontal lobes of the brain (the “new brain”) and the hypothalamic and limbic structures of the so-called “ancient” brain. Of course, the brain functions as a whole, including the cerebellum, and how Ibogaine integrates into this complex mechanism of functioning is still a mystery.

PR: The article cites researcher Mark Molliver (JohnsHopkinsUniversity), which indicates that Ibogaine damaged Purkinje cells in experiments on rats. Have you found any damaging moments in Ibogaine in your research?

D.Mash: Neurotoxicity is a flag that greatly hinders the development of new drugs. When the FDA hears about neurotoxicity, no doubt your research will be frozen soon. A group from Johns Hopkins University used extremely high doses of ibogaine in experiments on rats, which, incidentally, metabolize ibogaine differently than mice or primates. They really proved that almost lethal doses of ibogaine administered every 12 hours for 7 days cause a decrease in the number of Purkinje cells in the cerebellum tissues. This information deserves attention. However, we also gave therapeutic doses of Ibogaine to primates in the drug safety study program, and we never recorded even the slightest toxic effect. Researcher Helen Molinari has conducted a fundamental study of the effect of increasing doses of ibogaine on rodents. The results of the study are presented to the FDA.

PR: What dose of ibogaine is called effective?

D.Mash: The dose of the drug at which the necessary therapeutic effect is achieved is called effective. In this case, the therapeutic effect is the lack of attraction to the drug. You give a certain dose of Ibogaine to a rodent accustomed to drug use. At this dose, the rodent continues to function normally, but at the same time, it stops taking the drug. Helen Molinari has convincingly demonstrated that with such therapeutic doses, ibogaine does not cause any toxic effects.
If you take too much dose of Dilantin, which is a very good anticonvulsant, you will get a neurotoxic effect. Many psychotropic drugs, when taken in very high doses, damage the brain, but no one is going to do it. Therefore, we conduct these studies and work closely with the FDA to draw the right conclusions.
We examined people before and after Ibogaine treatment using very sensitive neurological tests. Dr. Juan Sanchez-Ramos has developed a special program that captures even the smallest neurological abnormalities, and yet we did not observe any persistent negative effects in terms of the neurotoxicity of Ibogaine. We are convinced that the professional use of ibogaine is safe.

ETC: Why do you avoid using the word addict?

D.Mash: Because it carries a stereotype that contains a prejudice in terms of social inferiority. I look at this situation differently. Addiction is a disease, just like any other neurological disease such as Parkinson’s or Alzheimer’s disease or diabetes or heart disease. This is a violation that must be pharmacologically corrected. We must give humanity to this issue.

PD: What do you know about deaths associated with Ibogaine? Why did this happen?

D.Mash:I reliably know only two deaths associated with taking Ibogaine. The first case occurred in Switzerland during a psychotherapy session with physician Peter Baumann. The woman had a very sick heart and was not a patient for Ibogaine therapy under any circumstances. The second death occurred in the Netherlands. We do not know the exact mechanism of death, but we know for sure that it was respiratory failure.
The conclusion from these cases is that Ibogaine can be used only by professional doctors, only in medical institutions and only with full confidence in its chemical purity. It is impossible to obtain chemically pure Ibogaine outside special technological laboratories. Therefore, if you hear the sentence: “Do you need Ibogaine? I know where to get it, ”please just ignore it. Never agree to treatment in unlicensed clinics, and even more so in a hotel room.

PR: So there is a big difference between Ibogaine and the so-called hallucinogens. I have never heard of deaths associated with taking LSD or MDMA (ecstasy). Is it so?

D, Mash: LSD has a large supply of therapeutic safety. You cannot easily overdose LSD. Another thing is MDMA (Ecstasy). Deaths after taking MDMA are not uncommon. They are not associated with an overdose of the drug, but an overload of life support systems. People who, under the influence of Ecstasy, dance for several hours in a row and do not drink water, expose themselves to severe dehydration. Heat exchange is disturbed, the danger of vascular collapse and cerebral edema sharply increases. Against this background, fatalities are not uncommon.
Ibogaine has been used by millions of Africans in God knows what dosages for hundreds of years. In addition, we have hundreds of more examples of addiction treatment. Yes, the danger flag for the unprofessional use of Ibogaine is raised. But if treatment takes place inappropriate medical centers with the participation of specialists in the field of Ibogaine therapy, then the risk of complications is extremely low.

PR: What are clinical trials? What is its purpose?

D.Mash: Clinical trials for any new drug tests for its safety and effectiveness. Tests pass 3 phases, after which the drug is put on the pharmacological market.
The first phase of testing is testing for the safety of the drug. We ask and look for answers to such questions: how is the drug metabolized, what complications can there be, who can receive treatment with Ibogaine, who cannot? We have a test plan for increasing doses of the drug when we very slowly increase the dose of Ibogaine by 2 mg per kg of patient weight until we get the necessary therapeutic effect: elimination of withdrawal symptoms and lack of desire to take the drug.
Ibogaine is a rather strange drug. We have developed several methods to increase its bioavailability. The more we study the drug, the more we will learn how and in what doses it works most effectively. According to our calculations, the effective dose of Ibogaine is in the range of 10-14 mg/kg of body weight.
The second phase of the study answers the question: how effective is the drug.
The third phase, the so-called “gold standard”, is a double-blind study conducted in several medical centers at the same time.
Dependence is a multi-factorial disease. This is not only impaired neurochemical mechanisms but also a deep personality disorder. This is a deformed perception of oneself, the world, society, family. It is obvious to me that if you want to defeat addiction, the fight should be waged at all levels, and not just at the level of neurochemical correction.

PD: What do you think of methadone?

DM: Methadone is a highly controversial substance. Many people say, “Praise God that there is Methadone.” A whole industry serving the interests of methadone clinics has already managed to grow. I would like to see people free from any substances. However, for some people, methadone seems to work, allowing them to function, improving their quality of life. It is important. But it is also important to understand that methadone is a highly addictive substance. Getting rid of methadone is very difficult. Those who at least once tried to go through detox from Methadone know what it is.
There are currently several types of quality drug detox protocols. Ibogaine detox is one of them. We have observed hundreds of cases of detoxification from substances of all kinds (mainly from opioids) using Ibogaine. Almost all of them were effective and did not require any other methods of detoxification.
I remember a patient from Holland. I kept the detox protocol and saw how Ibogaine blocks the symptoms of opioid withdrawal symptoms, I saw the progress of the patient, I saw how this young man step by step walked away from addiction. This is an impressive observation. He was a drug addict from the age of 14. Everything in his life was against him. He had a deeply deformed personality. When he was under the influence of Ibogaine, I talked about the fact that Ibogaine is that magical bridge that will help him move from a state of voluntary slavery (“borrow a stone and bear it”), from a state of impossibility of development into a mature person in a state where he sees himself as a full member of society.
What does it mean to feel normal? What does the road to recovery mean? What is the role of ibogaine in this? How does ibogaine help change the world? How does it help to develop new adaptation mechanisms in such a way as to avoid relapse of the disease? I’m a scientist. I want to know the answers to these questions.
PR: Where should people go if they want more information about Ibogaine?
D.Mash: People who want more information about Ibogaine should contact scientists or clinicians. Please do not trust your health and life with clandestine providers. Only God knows what they can offer you under the name “Ibogaine.” And if complications happen for whatever reason, then they will all be associated with Ibogaine. This is a discrediting method. Treatment should be carried out only in accredited medical centers. Please do not support those people who use Ibogaine illegally, in non-specialized centers or even outside medical facilities.

PR: It seems that the study of Ibogaine allows you to better understand how the human brain functions, which in turn leads to the emergence of a new class of drugs and the solution of pressing problems.

D.Mash: Yes. I sincerely believe that Ibogaine’s research will help us to obtain new fundamental information about the functioning of the brain, to better understand what pathological processes in the brain explain the formation of addiction, and how we can treat the brain and soul in a new way.