No. 04-1084
In the Supreme Court of the United States
ALBERTO R. GONZALES, ATTORNEY GENERAL, ET AL., PETITIONERS
v.
O CENTRO ESPIRITA BENEFICIENTE UNIAO DO VEGETAL, ET AL.
ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE TENTH CIRCUIT
JOINT APPENDIX
(VOLUME 2)
PAUL D. CLEMENT
Solicitor General
Department of Justice
Washington, D.C. 20530-0001
(202) 514-2217
Counsel of Record
for Petitioners
NANCY HOLLANDER
Freedman Boyd Daniels
Hollander & Goldberg P.A.
20 First Plaza, Suite 700
Albuquerque, NM 87102
(505) 842-9960
Counsel of Record
for Respondents
PETITION FOR A WRIT OF CERTIORARI FILED: FEB. 10, 2005
CERTIORARI GRANTED: APR. 18, 2005
Department Directors and Secretariat
Rua Caiubi 1004, CEP 05010-000 São Paulo-SP Phone/
fax 11-3673-8298
e-mail: demec@udv.org.br
DEMEC-Medical-Scientific Department of the UDV
Summary of Case No. 21
I. Identification (at notification time):
Administrative Unit: São João Batista Núcleo
Initials: J.C.B.
Marital Status: single
Age: 38 (October 1999)
Sex: male
Profession: electronics technician
Experience Using Tea: from 1998 to August 1999
UDV Level: members cadre
Date notified: October 1999
II-Observed Situation Report: according to the first visit with psychologist Eunice Brito, after showing up at the Núcleo in August, 1999, after two months away from the UDV sessions, subject was perceived to have symptoms of mental confusion and slowness, with difficulty putting together thoughts, and inarticulate speech. A very small amount Hoasca tea was administered and subject was instructed to seek help from mental health professional by both the psychologist and núcleo administrators.
III-Personal and Family Background: in interviews with the subject we found: he was absent from sessions during the months of July and August, 1999, and unaware of that. Subject relates that for approximately three months subject has been suffering from fears, irritability, difficulty concentrating and cramping with Hoasca use, claiming to feel confusion following the sessions. Subject relates that during the same period, subject had difficulty swallowing the tea, vomiting repeatedly after its ingestion, but nonetheless had apparently strong burracheiras which ended five hours after the closing of the sessions.
Subject relates that since he began attending the UDV, he felt emotional during the sessions, alternating between laughing and crying. Subject says that prior to beginning of the sessions he felt anxious and had trouble standing. In August/99 subject understood more clearly the depth of his confusion, losing track of time, for subject made two out-of-state trips and only realized it afterward.
Subject relates that since adolescence he frequently forgot things, had wandering thoughts and could not handle sequential reasoning-also with restless sleep and nightmares. Subject relates that such manifestations worsened in recent months, interfering with his concentration at work.
Subject's main worry is from having acted impulsively in the presence of a 3-year old niece, at which time, while extremely irritable, subject smashed a PVC plastic plate on the ground, which reminded him of past explosive and extremely violent outbursts, with loss of consciousness.
Subject tells of having drunk Hoasca tea in a Santo Daime church in 1994 some seven times, and went no further because he felt a lack of orientation [or guidance] during that experience. Subject has always been connected with spiritual searches, including martial arts and religions. Subject trained in Kung Fu, aikido, and especially judo, including tournaments. Subject tells that before these he often felt very nervous, not taking nourishment and having successive fainting spells. Subject claims to have suffered memory lapses on various occasions in life.
Subject states that at age 14 he violently struck a judo classmate who hit him in the testicles. He actually caused arm and collarbone fractures from not feeling the pain and the force he exerted. At age 23-24 he had violent reactions and enjoyed them: five (5) boys gave him dirty looks and he knocked them out for that. In 1990, on a bus, he had his most violent reaction in an altercation with a boy who was disrespecting some girls. Likewise in the situation he was unaware of himself and felt no pain. Some years ago, at home alone, he had a sort of crisis with loss of consciousness, fracturing a jaw and breaking 4 teeth. Subject explains that he has not been training martial arts these past 10 years, feels tired, loss of strength, and has gained 22 pounds this past year. In recent months he has been working a lot and sleeping little.
Subject further explains that for some seven years he has been having delusions, feeling cornered, trapped, and also told of having delirious feelings of some vague persecution.
With regard to recreational drug use, subject tells of having smoked marijuana once at age eighteen with non consequences.
Subject lives with his 78-year old mother, the father having died in 1992 from acute myocardial heart attack.
IV-Diagnosis: CID: F.20.9-unspecified schizophrenia.
V-Developments: by order of the Representative Mestre subject was immediately barred from communion with Hoasca tea until further notice, and referred for psychiatric and psychotherapeutic treatment, and did not return to Hoasca use.
Subject was administered neurcleptics and tranquilizers by the psychiatrist, in conjunction with psychotherapy with a psychologist. Inasmuch as subject was showing significant improvement in mid-2000, the medication was suspended and subject kept in psychotherapy.
In June of 2001 subject again showed worsening confusion, necessitating again the administration of neuroleptic medication and low doses for satisfactory control.
VI-Relation of Tea use to clinical situation:
Our understanding is that Hoasca tea use was a factor in renewal of acuteness (category 2) in the event observed in August 1999, for examination reveals significant psychiatric history and clinical psychosis symptoms antedating Hoasca tea use.
VII-Current Situation, regarding:
1. Using Hoasca tea: none taken since August, 1999
2. Fraternization with the brotherhood: maintains occasional friendly contact with a few closer friends.
3. Home life: still single and living with his mother
4. Job situation: a regular worker, relatively satisfactory.
VIII-Last Revision: October of 2001.
IX-Professional in Charge: Dr. Francisco Assis de Sousa Lima-psychiatrist
(signed) Dr. Francisco Assis de Sousa Lima CRM 25257
Department Directors and Secretariat
Rua Caiubi 1004, CEP 05010-000 São Paulo
Phone/fax 11-3673-8298
DEMEC-Medical-Scientific Department of the UDV
Summary of Case No. 22
I - Identification (at notification time):
Administrative Unit: Samaúma Núcleo
Initials: C.M.O.
Marital Status: single
Age: 23 (February 1999)
Profession: farmer
Experience Using Tea: since 1998
UDV Level: members cadre
Date notified: February of 1999
II - Observed Situation Report: During the last week of January/99, some ten days after partaking of Hoasca tea, subject showed behavioral changes. Had four sleepless nights, did not eat, had aggressive reactions and state of mental confusion. Frequented Umbanda ceremonial grounds, began eating plants such as lawn grass. Also drank swamp water and swallowed a piece of chlorine. His mother says that he made flower and candle offerings to lemanjá (spirit entity) at home, and that he felt threatened and persecuted.
[She] said that as a boy "they had stitched his mouth to a frog [sic]" and alluded to black magic, and was getting negative signals of this sort. His offerings were intended to offset such negative feelings, which even emanated from his mother. Asked if he had used any substances before the events, he replied that he'd only drunk nightshade tea. Denied having visual or auditory hallucinations, but apparently intended suicide and threatened to run away from home to parts unknown for suicide purposes.
III - Personal and Family Background: Tells of recreational drug use of use since age 18, beginning with marijuana, followed by alcohol abuse [cane whiskey], inhalants (thinner and ether) and cocaine. Also referred to using nightshade tea and crack cocaine, which use subject explained was not continuous, except in the case of marijuana, used for longer. And on a daily basis "to work faster" (sic). Subject used crack for approximately four months in 1997, which use was interrupted after they delirium episode in which subject felt panic; a strong sensation that armed men were coming to beat him.
Between ages 16 and 21 subject went to many churches, starting with the Catholic Church, followed by Protestant: "Bible Pentecostal," "Assembly of God," and "God is Love."
[Subject] relates that since the age of six, when parents separated, subject has lived in the town of Salto de Itu with the father, losing touch entirely with the mother and some siblings who remained with the mother.
Subject claims to have always been nervous, irritable, truculent and mean, with impulses to kill if at all crossed. At approximate age of 15-16 subject twice came to the verge of suicide: almost jumped off a bridge and nearly grabbed hold of a high-voltage power line tower.
Subject presents his life as one of suffering, unbearable suffering which filled him with revulsion. Asked about what may have brought on the recent crisis, subject claims that everything began with the boss lady insisting that he perform cleanup work at the farmhouse of residence, beyond its boundaries, and threatened to evict him and his family (which indeed happened immediately after the crisis). This greatly increased worries over unemployment.
Regarding re-establishing family relations with the mother, subject relates that at age 21, after using crack, he felt he should look her up to learn about his past and reduce his suffering. So it went, and after moving in with the mother, subject evinced an interest in attending the UDV. At the request of the mother, who was seeking for her son some religious guidance and social restructuring, the Representative Mestre considered his entry into the UDV and requested a psychiatric evaluation. In view of prior drug abuse and borderline condition, subject was medicated with Carbamazepin 200mg, it being suggested to the Representative Mestre that Hoasca tea doses be small. This suggestion was followed. After two months the medication was discontinued but monitoring-even by relatives-was difficult. Since the subject appeared to be relatively under control, tea use was kept at the recommended dose.
IV - Diagnosis: unspecified schizophrenia (CID-10; F20.9) plus drug abuse (antecedents CID-10:F-19)
V - Developments: subject was admitted to a psychiatric hospital in the city of São Paulo for approximately ten days, medicated with neuroleptics and apparently improved.
Upon release from the hospital subject was monitored as an outpatient at a Basic Health Unit, medicated with risperidone and monitored clinically. In August of 1999 subject interrupted treatment of own accord, and underwent another psychotic episode in 2001. Several weeks following admission, subject fled the psychiatric ward and returned home. According to his mother he has been keeping relatively stable, although still refusing formal psychiatric treatment. Monitored since then by this professional through frequent contact with relatives.
With regard to Hoasca tea use, the Representative Mestre promptly suspended Tea use until further notice, and so it stands.
Following subject's first discharge from the hospital, some steps were taken to create a comforting environment for the subject so as to motivate and ease his re-entry into the religious community, even though barred from partaking the tea. Among these, subject was authorized to participate in a few sessions, albeit with no tea.
Despite all efforts, subject's refusal to accept psychiatric treatment and successive recidivism eventually defeated that strategy, and of course precluded further use of Hoasca tea.
After repeated episodes of socially inappropriate behavior, subject was excluded from fraternizing with the UDV brotherhood, and is monitored by the UDV directors through relatives.
VI - Relation of tea use to clinical situation: we believe that Hoasca tea contributed as a predisposing factor in the psychotic episode of January/99, but played no role in later episodes (when he no longer partook of it)
In addition to history indicating prior psychosis -until then unknown to relatives-the clinical situation observed did not immediately follow use of the tea, and other factors may also have contributed toward bringing that on, such as losing his job, threatened eviction, and swallowing poison.
VIII - Current Situation, regarding:
1. Hoasca tea use: barred from Hoasca communion since situation's onset.
2. Fraternity with the brotherhood: sent away
3. Home life: according to his mother, subject's behavior is unstable, sometimes markedly aggressive.
4. Job situation: has been receiving health-related dole from the National Social Security Institute and doing occasional odd jobs.
VIII - Last Revision: September/2001.
IX - Professional in Charge: Dr. Francisco Assis de Sousa Lima - psychiatrist
(Signed) Dr. Francisco Assis de Sousa LimaCRM 25257
Department Directors and Secretariat
Rua Caiubi 1004, CEP 05010-000 São Paulo-SP Phone/
fax 11-3673-8298
e-mail: demec@udv.org.br
DEMEC-Medical-Scientific Department of the UDV
Summary of Case No. 23
I. Identification (at notification time):
Administrative Unit: Samaúma N.
Initials: J.P.T.
Marital Status: single
Age: 30 (Nov. 1999)
Profession: public relations and administrative assistant
Experience Using Tea: since 1985
UDV Level: Instructive Body
Date notified: November of 1999
II-Observed Situation Report: subject relates that in October of 1998 he was under intense emotional pressure, having suffered significant losses: during his last year of college he underwent the breakup of a meaningful relationship and was fired from the job he had worked at for 14 years. Subject claims that on the occasion he had sharp depressive symptoms, and began using fluoxethine without a medical prescription. Subject sought out the DEMEC mental health professional to admit to having been using the medication.
III-Personal and Family Background: subject spoke of having had traumatic experiences since early childhood, the most significant being an automobile accident and approximately age 20, in which he suffered serious burns-while caught in the wreckage-over his entire body, amounting to one huge burn and calling for specialized plastic surgery up until now. Subject has already had more than 30 surgical procedures so far with important appearance consequences.
Subject relates that some months following the accident he began to feel "strange," due to significant changes and his life.
In November of 1993 subject for the first time sought psychiatric guidance, complaining of a "fog in the head," "stunned feeling," causeless remorse, hot forehead, nape and neck, and sluggishness at work. Diagnosis at the time was moderate depression and subject was medicated with imiprazine, which treatment was discontinued after some weeks following clinical improvement.
Subject developed relative stability, with periods of deeper sadness, albeit without significant loss of functionality.
Subject relates that his father, mother, two sisters and one brother have depressive histories (two of them attended the UDV: see summaries of cases 09 and 10)
IV-Diagnosis: Recurring Depressive Disorder (CID-10: F33.9)
V-Developments: subject was advised to continue formal psychiatric treatment, and was kept on the same medication by the assistant psychiatrist. At the UDV, at DEMEC's suggestion, the Representative Mestre ordered a decrease in Hoasca tea taken. Subject's clinical picture improved and stabilized, relatively speaking.
In early 1999 subject traveled abroad, remaining there nearly a year without partaking of Hoasca tea. Subject states that during the first months of his stay he was well but later began showing symptoms of depression which sharpened shortly before his return to Brazil.
Two months after said return, subject had worsening, depression symptoms, and used fluoxethine for two months, replaced by venlafaxine in mid-2001, which medication he used for one year.
Currently on no medication with condition relatively compensated.
VI-Relation to Tea use to clinical situation: no causal connection (category 4)
VII-Current Situation, regarding:
1. Hoasca tea use: regularly attending sessions drinking reduced amounts of tea
2. Relations with the Brotherhood: stable, with good social adaptation
3. Home life: still single, living with mother and siblings.
4. Job situation: doing temporary work in computer-related service area.
VIII-Last Revision: September of 2001
IX-Professional in Charge: Dr. Francisco Assis de Sousa Lima-psychiatrist
(signed) Dr. Francisco Assis de Sousa Lima CRM 25257
Department Directors and Secretariat
Rua Caiubi 1004, CEP 05010-000 São Paulo-SP Phone/
fax 11-3673-8298
e-mail: demec@udv.org.br
DEMEC-Medical-Scientific Department of the UDV
Summary of Case No. 24
I. Identification (at notification time):
Administrative Unit: São João Batista N.
Initials: R.M.
Marital Status: separated
Age: 31 (in 1999)
Sex: male
Profession: general helper, no steady job (under-the-counter)
Experience Using Tea: since 1991, on and off
UDV Level: members cadre
Date notified: June of 1995
II-Observed Situation Report: subject was referred for psychiatric evaluation by a psychologist from the DEMEC Mental Health Commission by request of the Representative Mestre. The reason for the referral was renewed cocaine use and quarrels with his wife.
III-Personal and Family Background: subject used drugs from age 15, and was a frequent marijuana user till age 23, cocaine ages 18 through 22; and amphetamines and whiskey for a year. Subject was admitted five times between 1990 and 1991 for aggressive and self-destructive behavior. Subject became agitated, confused, imagined shadows, talked to himself, and seemed to hear voices. Subject claims to have always been bitter, and never understood why he was in an orphanage as a child and felt rejected. Subject mentions a broken home, separated parents, marijuana use, excessive smoking and drinking. Stepfather also drank and struck the mother. Father died of stroke at age 44, when the patient was 13 years old. Maternal grandfather was also alcoholic. Patient claims his older brother was "nervous." [Irritable-tr]
IV-Diagnosis: drug abuse (CID-10: F19) + personality disorder (F60.9)
V-Developments: patient was initially medicated with carbamazepine and prescribed psychotherapy in 1995. Patient abandoned the proposed medication treatment some months later.
Following psychiatric evaluation, at which he seemed relatively stable, subject began regularly participating in UDV sessions. In October of 1997, subject submitted to the Hoffman Quadrinity Process.
In mid-1998 subject again began using cocaine, crack and marijuana, and claims that such behavior-while still partaking of Hoasca tea-was to due to the impending break-up of their marriage, unemployment and emotional imbalance. Subject was barred from communion with Hoasca tea until further notice due to again having used the abovementioned substances. Resumption of psychiatric treatment subject had abandoned was made a prerequisite for again partaking of Hoasca tea.
Only in January of 1999 did subject again seek psychiatric help, and was admitted for ten months in a rehabilitation institution for drug abusers.
After being discharged, subject obtained separation from his wife and moved to another state in Brazil, but kept in contact intermittently with DEMEC mental health professional through his ex-wife.
VI-Relation to Tea use to clinical situation: no casual relation (category 4)
VII-Current Situation, regarding:
1. Hoasca tea use: still barred from the UDV
2. Relations with the Brotherhood: intermittent contact through ex-wife
3. Home life: separated, living in another state with mother
4. Job situation: no steady job
VIII-Last Revision: October/2001
IX-Professional in Charge: Dr. Francisco Assis de Sousa Lima-psychiatrist
(signed) Dr. Francisco Assis de Sousa Lima 25257
[Plaintiffs' Exh. 5B]
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW MEXICO
No. CV-00-1647 JP/RLP
O CENTRO ESPIRITA BENEFICIENTE,
UNIAO DO VEGETAL, ET AL., PLAINTIFFS
vs.
JOHN ASHCROFT, ET AL., DEFENDANTS
Volume II
TELEPHONIC CONFERENCE CALL DEPOSITION
OF GLACUS DE SOUZA BRITO
* * * * *
[120]
The deposition of GLACUS DE SOUZA BRITO was convened on Wednesday, September 26, 2001, commencing at 11:00 a.m. EST, with the court reporter appearing at the offices of the U.S. Department of Justice, 901 E Street, N.W. Washington, D.C., before Karen K. Brynteson, Registered Merit Reporter and Notary Public.
* * * * *
[223]
loss.
A. Yes, these were found.
Q. Now, were these results published anywhere?
A. They are included in Grob's study.
Q. In his published article?
A. There is also a report at the University of Sao Paolo which undertook the research.
Q. I'm sorry, is there a publication, in addition to Dr. Grob's publication?
A. There was a publication undertaken by the Psychiatry Department, and he was responsible for base line psychiatric evaluation. And those results are cited in Grob's work.
Q. Okay. Would you agree that the 1993 study was an effort to collect a basic body of data and was not an attempt to relate this data to either possible detrimental effects or therapeutic effects? Would you agree with that statement?
A. What we can say about that 1993 study was that in 15 long-term tea drinkers, no decisive detrimental effects were found. There is no way to [224] extrapolate from these finding any conclusions that would be valid or applied to the entire population. For one thing, there were not even any women participating in the study.
Q. You said it showed that 15 people did not suffer detrimental effects, but isn't it true that you don't know yet whether the heart problems are something that could be considered a detrimental effect.
A. Yes, yeah, the changes, the cardiac changes, as I said before, are the sort of changes that one does find in a normal population. And other ones, other heart problems that were identified, those are known to be endemic to that particular population.
Q. But if it is true-
A. So no conclusions can really be drawn one way or the other until a larger study, such as the one we are trying to-what this is is this is largely anecdotal findings, as you would say in America.
Q. If hoasca were found to be causing or [225] contributing to branch blocks in the heart, would you consider that a detrimental effect?
A. Yes. It is based on a random, a larger study with a larger population chosen at random and with due controls to account for those kind of variations.
Q. So basically you can't from this study decide whether anything good is happening or whether anything bad is happening as a result of hoasca; is that what you are saying?
A. All I can really conclude from that is that among these 15 people, the one that turned up these cardiovascular changes did not reveal any other symptoms, any clinical symptoms, nor did they have any kind of mental problems.
Q. Okay. I just want to go back to my original question and ask you if the hoasca were causing branch blocks in the hearts of people who take it, would you consider that to be a detrimental effect?
MS. HOLLANDER: I am going to object that that has been asked and answered.
* * * * *
[Plaintiffs' Exh. 11]
DECLARATION OF CHARLES S. GROB, M.D.
1. My name is Charles Stephen Grob. I make this declaration on behalf of the Centro Espirita Beneficente Uniao do Vegetal ("UDV"). I have been asked by the UDV to give opinions on the matters set forth in the following paragraphs. The opinions set forth in this declaration are my own, and any facts set forth in this declaration are within my personal knowledge and each such fact is true and correct.
2. I have a Bachelors of Science Degree from Columbia University and a Medical Degree from the State University of New York in Brooklyn. I am currently Professor of Psychiatry at the UCLA School of Medicine and Director of the Division of Child and Adolescent Psychiatry at Harbor-UCLA Medical Center. My qualifications and experience are set forth in detail in my curriculum vitae, attached as Exhibit 1.
3. In 1993, I was the principal investigator of an international, multi-disciplinary research project on hoasca (the Portuguese transliteration of "ayahuasca") within the Uniao do Vegetal (UDV), a Brazilian syncretic church. In Brazil, use of hoasca within the context of religious practice has been permitted by law since 1987. As a result of our data collection during June and July, 1993, in Manaus, Brazil, our collaborative group has published six papers in the medical-scientific literature detailing our findings.
4. In addition to my research on hoasca, I have also conducted FDA-approved Phase l research examining the effects of synthetic phenethylamine 3,4- methylenedioxymethamphetamine (MDMA) on volunteer human subjects with previous experience with the drug.
5. Besides my work with hoasca and MDMA, I have also published in the peer reviewed literature other articles on related topics, ranging from the history of psychiatric research with hallucinogens to cross-cultural perspectives on adolescent drug use and abuse. Currently, I am involved with research investigations on the safety and efficacy of a selective serotonin re-uptake inhibitor medication on in the treatment of major depression in children and adolescents and the long-term neuropsychiatric effects of methamphetamine on children exposed to the drug while in utero.
6. The effects of hoasca, which the members of the UDV take within the context of their religious structure, lasts for approximately four hours.
For the first thirty minutes, individuals who have taken hoasca as part of a UDV ceremony sit quietly in chairs, without any interaction with their neighbors, listening to a recitation of the fundamental tenets of the religion. Between thirty minutes to one hour from ingestion of the hoasca tea, the beginning of the altered state of consciousness is encountered, marked initially by the perception, with eyes closed, of patterns of light and color. As the session progresses, individuals report the occurrence of well formed images within the context of thematic visions, often with particular relevance to the mythology of the UDV. During this time, individuals who take hoasca at UDV ceremonial sessions are almost always oriented and aware of their surroundings. They are able to speak coherently and listen attentively to what others are saying. In fact, during much of the customary UDV religious meeting, mestres speak to the congregation about their religion's mythology and address relevant moral issues. Except for the newest participants, all members report excellent awareness and recall of the content of the mestre's talk. The effects begin to wane at about the three hour point; and, after four hours, when the sessions are ritually closed, participants have returned to their normal state of consciousness.
7. Ingestion of hoasca causes a range of subjective effects and psychological changes. The acute psychological changes induced by hoasca include: (1) alterations in thinking, including short-term changes in concentration, attention, memory and judgment; (2) altered time sense, including subjective sensations of timelessness, or the experience of time either accelerating or decelerating;
(3) fear of loss of control, caused by internal resistance to the experience, and which may cause an amplification of underlying anxiety; if there is positive cultural conditioning and understanding of the experience, mystical and positive transcendent states may ensue; (4) changes in emotional experience, which can range from states of despair to states of ecstasy; (5) changes in body image, often associated with dissolution of boundaries between self and others and states of depersonalization and derealization where the usual sense of one's own reality is temporarily lost or changed; such experiences may be regarded as strange and frightening, or as mystical, oceanic states of cosmic unity, particularly when sustained within he context of a belief system conditioned for spiritual emergent encounters; (6) perceptual alterations, including increased visual imagery, hyperacuteness of perception and overt hallucinations; the content of these perceptual alterations is influenced by cultural expectations, group influences and individual wish-fufillment fantasies; (7) changes in the meaning or significance of their experiences, ideas or perceptions may be encountered during the altered state of consciousness; an experience of great insight or profound sense of meaning may occur, with significance ranging from genuine wisdom to self-imposed delusion; (8) sense of the ineffable; because of the uniqueness of the subjective experience associated with these states and their divergence from ordinary states of consciousness, individuals often have great difficulty communicating the essence of their experience to those who have never had such an encounter; (9) feelings of rejuvenation; many individuals emerging from a profoundly altered state of consciousness report a new sense of hope, rejuvenation and rebirth; such transformed states may be short-term or may lead to sustained positive adjustments in mood and outlook; (10) hyper- suggestibility; while in the throes of altered state experience, individuals experience an enhanced susceptibility to accept or respond uncritically to specific statements; nonspecific cues, reflecting cultural belief systems or group expectations, may similarly assume directives of weighty importance. The role of session facilitator, or in the case of the UDV, the mestre, is one of great vested responsibility, as individual participants are highly susceptible to verbal and nonverbal input directed to them. The content and outcome of such altered states experiences are often directly attributable to the integrity and skill of the leader.
8. As is the case with all hallucinogens, the hoasca experience is profoundly affected by the extrapharmacological factors of set and setting. Intention, preparation, and structure of the session are all integral to the content and outcome of any encounter with hallucinogens, a clear distinction from all other psychotropic drugs. It was the consistent observation by members of our research team that the UDV had constructed a ceremonial structure for their ritual use of hoasca that optimized safety and minimized the likelihood of adverse consequences. All potential new participants were carefully screened to exclude anyone with underlying medical or psychiatric vulnerabilities, taking prescription medications that might adversely interact with the hoasca or with inappropriate motives for taking part in the UDV religious ceremony. During actual sessions, new participants in particular are watched carefully for signs of difficulty by presiding mestres, who intervene if necessary to assist individuals encountering problems. In the days and weeks after participation in a UDV ceremony, appropriate follow-up for assessment and support are conducted when indicated. As a result, the record of the UDV for ensuring safety and well-being of participants has been very impressive.
9. Physiologically, hoasca appears to be well tolerated in healthy individuals. Effects on cardiovascular function appear to be modest. The one area where pronounced short-term effects are encountered is the reaction of the gastrointestinal system. Hoasca often induces a significant degree of nausea and acute gastrointestinal distress. It is not uncommon for participants during a UDV ceremony to get up from their seats and walk to the restrooms, where they vomit and/or have diarrhea. Generally, individuals vomit only once during a session, and thereafter they report having no further gastrointestinal distress. Given the degree of nausea and vomiting that commonly is encountered following ingestion of hoasca, however, as well as our culturally conditioned aversions to those experiences, it is likely that the gastrointestinal component of the experience functions as a protective factor against the possibility that hoasca could be consumed in a maladaptive abuse context.
10. One area of potential physiological risk is adverse drug interactions. Along with one of my colleagues from the hoasca research project, J.C. Callaway, a biochemist from the University of Kuopio in Finland, I have written (Journal of Psychoactive Drugs 30:367-369,1999) of possibly dangerous interactions between drugs of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants and hoasca. Because of hoasca's monoamine oxidase inhibiting (MAOI) effect, in vulnerable individuals the excess neurotransmitter serotonin made available would not be metabolized sufficiently, thus inducing a condition called a serotonin syndrome, that is caused by excess serotonin and which manifests in elevated temperature, tremor and confusion. Although its association with hoasca is uncommon and its expression relatively mild compared to seretonin syndromes reported by interactions of pharmaceutical medications, it is nonetheless a serious concern that calls for preventive measures. Following discussions of our concerns with physicians of the UDV, all prospective participants in ceremonial hoasca sessions have been carefully interviewed to rule out the presence of ancillary medication that might induce adverse interactions with hoasea. In this and other matters, it has been my consistent observation that the leadership of the UDV has responded with very high degrees of responsibility to ensure optimal safety for all who take part in the religious activities of their religion.
11. Hoasca, when used within the context of the UDV, consists of two plants, Banisteriopsis caapi and Psychotria viridis. The active alkaloids are believed to be the harmala alkaloids (harmine, harmaline and tetrahydroharmine) of the Banisteriopsis and dimethyltryptamine (DMT) from the Psychotria. When taken alone through oral ingestion, the Psychotria has no effect. However, when prepared with the Banisteriopisis, a profound altered state of consciousness is induced. Apparently, the monoamine oxidase inhibiting action of the harmala alkaloids prevents inactivation of the DMT in the gut by monoamine oxidase enzymes, and allows for absorption and central nervous system activation. This represents a very complex series of plant psychopharmacological reactions.
12. The utilization of hoasca within the ceremonial context of the UDV significantly minimizes the degree of risk incurred by participants. For members of the UDV, hoasca is never consumed outside of the religious structure. Furthermore, a principal tenet of the UDV is that no non-medicinal drug should ever be consumed, in any circumstances. This proscription against non-medicinal drugs, includes not only illicit substances such as heroin, cocaine, amphetamine and marijuana, but also alcohol and tobacco. Consequently, the health of UDV members is benefitted by their abstention from taking such drugs as well as the minimization of risk of adverse drug interactions when ritually consuming hoasca. Also, the careful monitoring of all participants during UDV sessions by mestres ensures prompt intervention if psychological or physiological difficulties are encountered, particularly by those less experienced with the process.
13. Neither I nor my professional colleagues who helped conduct our investigation of the effects of hoasca were able to identify any signs of addiction to the hoasea tea. We observed no evidence of tolerance or withdrawal phenomena encountered by members of the UDV. During times between UDV sessions, participants demonstrated no signs of drug-seeking behavior. In fact, their high level of functioning when compared to the general populace was clearly evident.
14. The experience of orally ingested DMT, in the form of hoasca, is profoundly different from that of injected or inhaled DMT. Whereas the orally ingested hoasca induces a relatively mild to moderate altered state of consciousness, injected or smoked DMT precipitates a highly intense hallucinogenic experience with an extremely rapid onset (on the order of several seconds from administration) and relatively short duration (approximately ten minutes). Strassman and colleagues at the University of New Mexico School of Medicine have described (Archives of General Psychiatry 51:98-108, 1994)) how, immediately following injected or inhaled administration, DMT induces an overwhelming "rush," which leads to a transient dissociated state where euphoria alternates or coexists with anxiety. In the clinical laboratory setting, with eyes closed, subjects I reported seeing rapidly moving, brightly colored visual displays of images. Thematic visions, however, as commonly described by individuals drinking hoasca within the context of the UDV, do not occur with inhaled or injected DMT. Furthermore, risks of acute adverse reaction are considerably higher for individuals who smoke or inject DMT as opposed to those who drink the prepared hoasca drink. Some individuals who smoke DMT, particularly those with underlying psychiatric vulnerabilities, report prolonged dissociative states, which can catalyze latent anxiety disorders to manifest for prolonged periods of time. The likelihood of such pathologies occurring following oral ingestion of hoasca is, in comparison, extremely low. Smoked and injected DMT appear to present greater risk of physiological reactions than orally consumed hoasca. Whereas hoasca has only mild cardiovascular effects, smoked and injected DMT can induce significant elevations of blood pressure and increased heart rate, which, for individuals with underlying cardiovascular vulnerability, may be injurious. Finally, the protective nature of hoasca utilization within the context of the UDV religious structure does not occur with individuals informally smoking or injecting DMT.
15. The Hoasca Project, conducted in 1993, was an international, multi-disciplinary research study, with collaborators from the United States, Europe and Brazil, investigating the range of psychological, physiological and pharmacological effects of hoasca on individuals taking the substance within the context of the UDV. Fifteen subjects were recruited, from the second oldest UDV nucleo (religious center) in Brazil, Nucleo Caupari, in Manaus, the capital city of the state of Amazonas. These fifteen subjects were randomly selected from a larger group of sixty volunteers, all of whom had consumed hoasca within the context of the UDV for at least the ten previous years. To limit variables, all of the subjects in this pilot investigation were men. Control subjects were matched along all demographic parameters, with they exception that they did not belong to the UDV and had never consumed hoasca. The findings of our preliminary scientific and medical research on the effects of hoasea are detailed in a series of articles published in the scientific literature (Psychopharmacology 116:385-387, 1994; Journal of Nervous and Mental Disease 184:86-94, 1996; Journal of Analytical Toxicology 20:492-497, 1996; Journal of Psychoactive Drugs 30:367-369, 1998); Journal of Ethnopharmacology 65:243-256, 1999).
16. A variety of parameters were utilized to assess past and current levels of psychological function. Both hoasca-experienced subjects and normal controls were administered structured psychiatric diagnostic interviews (Composite International Diagnostic Interview [CID]), life story interviews, personality testing (Tridimensional Personality Questionnaire [TPQ]), and neuropsychological evaluation (WHO-UCLA Auditory Verbal Learning Test). Hoasca-experienced subjects were asked to fill out an additional questionnaire (Hallucinogen Rating Scale [HRS]) following a hoasca session. Each of the hoasca subjects was also interviewed in accordance with a semistructured format designed to ascertain his life story. In addition to this psychiatric investigation, a research methodology designed to evaluate serotonin biochemistry, through the examination of platelet serotonin receptor activity in both experimental and control subjects, was pursued. Additional biological investigations included tryptamine and harmala pharmacokinetics and acute physiological and neuroendocrine effects of hoasca in long-term users.
17. Pertinent results included the identification, by diagnostic and life-story interviews, of appreciable past psychiatric and substance-abuse histories in the subjects before their entry into the UDV, including 73% with a history of significant alcohol use, 33% with alcohol binging associated with violent behavior, 27% with stimulant abuse, and 53% with tobacco dependence. For all of these subjects, however, past psychopathology had resolved following initiation and regular attendance at UDV ceremonies. Personality testing identified significant differences between the hoasca-using and nonusing groups. These included measures of novelty seeking, with UDV members being more reflective, rigid, loyal, stoic, slow-tempered, frugal, orderly and persistent, and also scoring higher on measures of social desirability and emotional maturity than controls. Hoasca-using subjects were also distinguished from controls in the harmavoidance domain as being more confident, relaxed, optimistic, carefree, uninhibited, out-going and energetic. Overall, the hoasca-using group scored higher on traits of hyperthymia, cheerfulness, stubborness and overconfidence than their nonusing counterparts. Baseline neuropsychological testing also revealed differences between the two groups, with the long-term ayahuasca users demonstrating significantly higher scores on measures of concentration and short-term memory. The final psychological instrument, employed on hoasca subjects only, was the Hallucinogen Rating Scale, designed to correlate the intensity and phenomenology of the subjective state with known measures of intravenous dimethyltryptamine (as per Strassman et al. 1994). In this study of hoasca, scores in the relatively mild 0.1 to 0.2 mg/kg range of intravenous DMT were recorded.
18. Life-story interviews were employed to gather additional personal histories of UDV subjects before hoasca initiation, the nature of their first hoasca experience, and an account of how their lives had changed following entry into the UDV. For most of the interview sample, their lives before entry into the UDV were described as impulsive, disrespectful, angry, aggressive, oppositional, rebellious, irresponsible, alienated and unsuccessful. Many of them had had profound initial encounters with hoasca. A common theme for their visionary experience was the perception of being on a self-destructive path that would ultimately lead to an ignominious end unless they radically reformed their personal conduct and orientation.
19. All of the long-term hoasca-using subjects reported during the life-story interviews that they had undergone a personal transformation following entry into the UDV and regular participation in ritual hoasca use. In addition to entirely discontinuing cigarette, alcohol and recreational drug use, they reported a radical restructuring of their personal conduct and value systems. One subject described how: "I used to not care about anybody, but now I know about responsibility. Every day I work on being a good father, a good husband, a good friend, a good worker. I try to do what I can to help others . . . I have learned to be calmer, more self confident, more accepting of others . . . I have gone through a transformation." Subjects emphasized the importance of "practicing good deeds," watching one's words, and having respect for nature. Subjects also reported sustained improvement in memory and concentration, persistent positive mood states, fulfillment in day-to-day interactions, and a sense of purpose, meaning and coherence to their lives.
20. All of the subjects interviewed unequivocally attributed the positive changes in their lives to their experiences within the UDV and their participation in the ritual ingestion of hoasca. They described hoasca as a catalyst for their moraland psychological evolution. They also insisted, though, that it was not necessarily the hoasca alone that was responsible, but rather partaking of the hoasca within the ritual context of the UDV ceremonial structure. Without the structure of the UDV, these subjects asserted, hoasca experiences may be unpredictable and lead to an inflated sense of self. Within the "house of the UDV," however, the hoasca-induced state is controlled and directed "down the path of simplicity and humility."
21. During our research, each of the fifteen UDV subjects participated in one hoasca session, presided over by a designated mestre. Every twenty minutes for four hours, measurements were recorded of oral temperature, pupil diameter, respiratory rate, heart rate and blood pressure. An intravenous catheter was placed in each of the subject volunteers, from which blood samples were taken at baseline and every twenty minutes for four hours, and then twice more at three hour intervals and one final draw at the twenty-four hour point. Results included very mild sustained elevations of temperature and respiratory rate. Mild pupil enlargement was also recorded. Heart rate and blood pressure measurements were observed to undergo an initial mild elevation, which was followed by a gradual return to baseline. Plasma assays included pharmacokinetics of dimethyltryptamine and the three harmala alkaloids-harmine, harmaline and tetrahydroharmine. Subsequent assays of plasma samples also included serial measures of three neuroendocrine hormones-cortisol, prolactin and growth hormone. All measures of neuroendocrine response showed robust responses, indicating intact serotonergic neurotransmitter function, over basal levels for each volunteer, followed by gradual return to baseline over the next several hours. All subjects tolerated the session well; and, except for the accustomed nausea and vomiting experienced by several, no distress was reported by any of the subjects. An additional neurochemical study conducted at baseline on both UDV subjects and non-ayahuasca-using controls consisted of assays of platelet serotonin receptor density. The very intriguing and unique finding of serotonin upregulation and increased receptor density may be an underlying mechanism or reflection of hoasca's putative antidepressant properties. In our opinion, serotonergic upregulation and increased receptor density would infer greater responsivity to available serotonin, leading to more efficient serotonin function. With many other serotonin active drugs (including antidepressants) given daily, downregulation occurs, which may imply less efficient serotonergic neural transmission.
22. Leaders and members of the UDV have welcomed outside, objective scientists and physicians interested in investigating the UDV's psychoactive ritual sacrament. They were confident that our results would corroborate their subjective experience that their collective use of hoasca had significantly enhanced their physical, psychological and spiritual health.
I declare under penalty of perjury under the laws of the United Sates that the foregoing is true and correct and that this Declaration was executed this 30th day of March, 2000 at Irvine, California.
/s/ CHARLES S. GROB, M.D.
CHARLES S. GROB, M.D.
In order not to burden the record, plaintiffs have removed the Curriculum Vitae identified as Exhibit 1 to this declaration. Plaintiffs have provided a copy of the exhibit to opposing counsel and will provide a copy to the Court, if requested.
[Plaintiffs' Exh. 12]
SECOND DECLARATION OF CHARLES S. GROB, M.D.
1. My name is Charles S. Grob, M.D. I have provided information regarding professional identification in my previous declaration. I have been asked to respond on this occasion to the declaration of Dr. Sander G. Genser, dated January 24, 2001, which is attached as Ex. D to the Government's Opposition.
2. Dr. Genser states that "there is a dearth of reliable medical or scientific literature addressing the effects of ayahuasca." This is correct, up to a point. It is true that the phenomenon of ayahuasca has only recently been "discovered" by medical science, yet interest in developing research investigations with state of the art methodologies is increasing. From our own collaborative study, conducted in the field in the Brazilian Amazon city of Manaus in 1993, we have, to date, published eight articles in the medical and scientific literature and three book chapters. Currently, we are finalizing research protocols for several new investigations which our medical collaborators in Brazil will implement. Furthermore, other investigators from the United States, Europe and Israel have now begun to initiate research studies which will further broaden our understanding of the effects of ayahuasca.
3. The syncretic church whose members we studied, the Uniao do Vegetal, has established a proactive record of facilitating scientific investigations into the effects of ayahuasca. A special Medical Studies Section within the Uniao do Vegetal has systematically been collecting detailed information on the health of their members. Individuals requesting to participate in UDV sessions and possibly join the church are carefully screened for medical or psychiatric problems. Scrupulous attention is given to screening for medications which may be contraindicated. To date, the Uniao do Vegetal has demonstrated a remarkable record in monitoring and maintaining high health standards among those who participate in their religious ceremonies. The UDV has also sponsored three international scientific and medical conferences in Brazil examining ayahuasca. Given the importance of their religion and ceremonial sacrament in the lives of their members, the UDV is strongly committed to expanding the knowledge and understanding of ayahuasca.
4. Given that our study was the first investigation utilizing modern research technologies, it was by necessity a preliminary study. Dr. Genser is correct when he asserts that we have acknowledged in our publications that our study design possessed inherent "limitations." Indeed, it is entirely appropriate when publishing reports in the scientific literature, particularly in new and relatively unexplored areas, to qualify enthusiasm and express caution when discussing the implications of exciting new research findings. Nevertheless, our investigation did identify that in a group of randomly collected male subjects who had consumed ayahuasca for many years, entirely within the context of a very tightly organized syncretic church, there had been no injurious effects caused by their use of ayahuasca. On the contrary, our research team was consistently impressed with the very high functional status of the ayahuasca subjects. Since many of these men upon whom we had conducted rigorous assessments had, prior to their entry into the ayahuasca church, many years previously harbored serious psychopathology and behavioral dysfunction, we were even more struck by the overall salutary changes they had experienced.
5. I was a co-author of the original article in the medical literature describing the potential for adverse reactions between ayahuasca and serotonin reuptake inhibitors. Since my colleague, Dr. J.C. Callaway, and I alerted the leadership of the UDV that we suspected that individuals taking SSRIs were running the risk of experiencing a potentially dangerous serotonin syndrome, they have gone to great efforts to insure that no one in the church would be exposed to this interaction. Subsequently, the UDV, a church with an approximate membership of over 8,000 in Brazil, who participate at least twice monthly in religious ceremonies employing ayahuasca as a psychoactive sacrament, has reported no episodes of serotonin syndromes caused by this mechanism. Therefore, in the course of one year, a safe context has been provided for UDV members who drink their sacramental tea approximately 200,000 times. This should demonstrate that it is possible to effectively protect people who take ayahausca from potentially dangerous SSRI interactions.
6. The plant hallucinogen ayahuasca is known to have reversible monoamine oxidase inhibition. Dr. Genser, in his declaration, discusses at length the dangers of interactions between SSRIs and irreversible pharmaceutical MAOIs (e.g. phenelzine). But since ayahuasca's MAOI action is reversible, these descriptions are of only marginal relevance. Furthermore, the serious interactions induced by tryamine containing foods (e.g., aged cheeses, avocados) and irreversible MAOIs are of far less significance with ayahuasca. In the UDV in Brazil, participants in ayahuasca ceremonies have not found it necessary to impose any dietary restrictions. Given the extent to which ayahuasca is used throughout Brazil, the lack of reports of adverse events caused by ayahuasca and food interations is reassuring. Another protective feature of ayahuasca is that its effects are relatively brief, usually in the range of 4 - 6 hours. In comparison, pharmaceutical irreversible MAOIs are usually given at least twice daily, with stable blood levels sustained for prolonged periods of time. I agree entirely with Dr. Genser's statement that "the greater the degree and persistence of MAO inhibition for an individual, the more vulnerable that individual would be to more severe reactions to contraindicated medications and foods." Unlike pharmaceutical MAOIs, however, the MAOI effect in ayahuasca is relatively mild, with comparatively lesser degrees of risk for dangerous interactions. Even in the case of serotonin syndrome we reported in our article on ayahuasca-SSRI interactions, as well as others I've heard of since, the duration of the event was relatively brief when compared to more severe cases of serotonin syndrome caused by combinations of SSRIs and pharmaceutical irreversible MAOIs.
7. In his discussion of the risks of exogenous DMT (dimethyltryptamine) to individuals with pre-existing psychiatric disorders, Dr. Genser raises the important question of risk. The route of administration, however, is an important variable which also merits attention. In that context, it is necessary to clarify that the Strassman et al. study referred to by Dr. Genser is actually an investigation of the effects of intravenous DMT in volunteer research subjects. By contrast, ayahuasca is a decoction ingested orally with a relatively gradual onset of action. Subjective effects of ayahuasca do not peak until the 1 -1 1/2 hour point, with progressive lessening of effect and return to normal consciousness after 3 - 4 hours. The onset of intravenous DMT, however, begins within seconds of injection, rapidly peaks and returns to baseline in 5 - 10 minutes. The qualitative experience of the intravenous DMT experience, compared to oral ayahausca, is of a far greater magnitude of intensity.
8. Dr. Genser, in his declaration, raises the sensible issue of driving under the influence of ayahuasca. What should be emphasized in this context, however, is that the UDV maintains strict oversight of their religious ceremonies where ayahuasca is taken as a sacrament. Religious maestres carefully monitor all sessions, providing particular attention to those with less experience and to anyone appearing to be in distress. Leaving the ceremonial setting before the end of the religious service is not permitted, and I have never heard of an incident in Brazil of anyone prematurely departing from a UDV ayahuasca meeting and driving a car. Such behavior is easily controlled by the strict structure and consistent setting employed by the UDV.
9. My medical colleagues in the UDV inform me that they have never received a report of persisting perceptual disorder ("flashbacks") induced by ayahuasca. I have also heard of no such report from any other source.
10. Dr. Genser understandably provides a description of the range of adverse effects of the general class of hallucinogens. It should be kept in mind, however, that ayahuasca has many unique attributes when compared to other hallucinogenic drugs. Overall, ayahuasca is of significantly shorter duration and a milder experience than many of the classic hallucinogens, including LSD and mescaline. It should also be emphasized that with ayahuasca, as with all hallucinogens, the outcome is determined by the critical variables of set and setting. In the UDV, a strict mental and physical assessment is conducted, in order to screen out individuals with pre-existing vulnerabilities (e.g., serious psychiatric illness) who might be at greater risk for experiencing adverse reactions.
11. An issue of highest priority for the UDV in Brazil is the health and well-being of their children. During pregnancy, women in the UDV regularly participate in religious ceremonies where ayahuasca is ingested. They also take ayahuasca during labor and delivery. The UDV has existed for forty years. If ayahuasca was a teratotoxin, I suspect evidence would have come to light by now. The members of the UDV with whom I have had considerable discussion, are firmly convinced that the participation of pregnant woman in religious ayahuasca ceremonies is salutary for both mother and child alike. Currently, I am collaborating with Brazilian and American colleagues on developing and implementing research protocols designed to assess developmental and neuropsychological health in children and adolescents whose mothers consumed ayahuasca while pregnant. My preliminary observations, from having spent considerable time conducting field work on our previous studies in Brazil, and attending subsequent scientific meetings there, are that the children and adolescents of UDV families often appear to be in excellent psychological and physical health.
12. In conclusion, while it is critical to raise questions addressing health effects of ayahuasca, I have concluded after extensive study of the field that the use of ayahuasca by the UDV in Brazil has been conducted in an optimally safe and responsible manner. While it is true that the study of ayahuasca is of relative recent origin, its safe and salutary incorporation within this particular religious organization should allow for a more favorable analysis of relative risk verus potential benefit.
I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct and that this Declaration was executed this 8th day of February, 2001, at Cazadero, CA.
/s/ CHARLES S. GROB, M.D.
CHARLES S. GROB, M.D.
[Plaintiffs' Exh. 16]
DECLARATION OF MARK ALBERT ROBERT KLEIMAN, Ph.D.
1. My name is Mark Albert Robert Kleiman. I make this declaration on behalf of the Centro Espirita Beneficiante Unaio do Vegetal (UDV). I have been asked by the UDV to give opinions on the matters set forth in the following paragraphs. The opinions set forth in this declaration are my own, and any facts set forth in this declaration are within my personal knowledge and each such fact is true and correct. This declaration sets forth my knowledge of the meaning of the schedules created by the Controlled Substances Act (CSA) and of the potential contribution is to the substance abuse problem, and especially the problem of the abuse of orally active preparations of dimethyltriptamine (DMT), should permission be granted for the UDV to import limited quantities of sacramental hoasca.
2. I received my Bachelor of Arts degree (magna cum laude) from Haverford College, with majors in political science, philosophy, and economics in 1972, my Master of Public Policy degree from Harvard University in 1977, and my Ph.D. degree in Public Policy, also from Harvard University, in 1985. Since 1979, my work has focused on substance abuse control policy. From 1979 through 1982, I was Associate Director for Drug Control Policy of the Office of Policy and Management Analysis in the Criminal Division of the U.S. Department of Justice. In 1982 and 1983, I was Director of that office. From 1983 through 1996, I was affiliated with Harvard University, as a research fellow first at the Harvard Law School and then at the John F. Kennedy School of Government, and from 1988 through 1996 as Lecturer in, and then Associate Professor of, Public Policy at the Kennedy School. From 1996 to 1998, I was a research fellow of the Division on Addictions at Harvard Medical School. I am also associated with Harvard's university-wide Program on Drugs and Addictions, and remain a Research Fellow in the Program in Criminal Justice Policy and Management of the Kennedy School. Since 1996, I have been Professor of Policy Studies at the University of California, Los Angeles, where I direct the Drug Policy Analysis Program. I am co-chair of the Drug Policy Project of the Federation of American Scientists, and editor of the Drug Policy Analysis Bulletin. I have published two books and many articles on drug policy. As an individual and through the BOTEC Analysis Corporation, of which I am chairman, I have consulted on drug policy to a wide variety of public agencies, including the Office of National Drug Control Policy.
3. The CSA establishes five "schedules" of controlled substance, setting out criteria for placement of a substance in each schedule, at 21 U.S.C. § 812. Schedules II-V include drugs having recognized medical use and recognized safety for use under medical supervision. Schedule II includes those drugs with the greatest potential for abuse, while Schedules III-V represent diminishing levels of risk.
4. Schedule I drugs are defined by the statute according to three criteria: high abuse potential, lack of accepted medical use, and lack of accepted safety for use under supervision.
5. However, if these three criteria were read to require that a substance meet all of them to qualify for Schedule I placement, the CSA would make no provision for the scheduling of a substance with moderate or low abuse potential but no recognized medical use, regardless of its safety for use under supervision. This difficulty has been resolved in practice by placing any substance that appears to have abuse potential and no recognized medical use in Schedule I. If a drug has no accepted medical use, then its safety in such use is a question without practical implication. Whatever its degree of risk, such a drug does not meet the criteria for any of the other schedules, which embrace only medically useful drugs.
6. Thus the placement of a drug in Schedule I does not imply that it has been adjudged to have high abuse potential or that it is unsafe even for supervised use. In particular, the placement of DMT in Schedule I does not reflect any judgment about the degree (as opposed to the existence) of its abuse potential, or about its safety for supervised use. Those judgments would only need to be made were it proposed for rescheduling, which would require evidence of its medical utility.
7. The example of delta-9 tetrahydrocannabinol (delta-9 THC) illustrates this point. Delta-9 THC is recognized as the primary psychoactive agent in cannabis (marijuana). Both research agencies such as the National Institute on Drug Abuse and enforcement agencies such as the Drug Enforcement Administration rate the potency of marijuana according to its delta-9 THC content: the greater the concentration, the greater the potency and therefore the greater the risk.
8. Marijuana, of whatever potency, was placed in Schedule I at the passage of the CSA, and remains there. Oral administration of cannabis, though relatively rare, is considered riskier in terms of substance abuse than smoking, because the user has less control over dosage and therefore a higher probability of, for example, panic attacks or dysphoria. While smoking carries its own health risks, no one would say that pure oral THC is a less threatening drug than the plant material.
9. Delta-9 THC was originally also placed in Schedule I.
10. A preparation of pure delta-9 THC in sesame oil was approved as a prescription appetite enhancer in 1986, and was consequently rescheduled to Schedule II of the CSA under the generic name dronabinol (trade name Marinol). This rescheduling did not reflect any change in scientific opinion about the abuse liability of THC, but was the consequence of the approval of Marinol for medical use by the Food and Drug Administration.
11. More recently, that same preparation was rescheduled to Schedule III. This rescheduling was based on evidence that Marinol was not, in practice, being diverted from medical to nonmedical uses, not on any new evidence about its abuse potential or safety in supervised use.
12. It is my understanding that from the point of view of the UDV, hoasca is a sacrament, involving parts of two specific plant species, prepared and used under ritual conditions. To a member of the UDV, a pharmacologically similar, or even identical preparation, involving different plants or made and used outside the church, would not be hoasca.
13. However, from the point of view of substance abuse, hoasca is simply one specific variety of a range of mixtures, referred to generically as ayahuasca or yage, containing DMT and beta-carbolines, including the harmala alkaloids harmine and harmoline. The beta-carbolines enable DMT, which if taken by itself orally would be rendered inactive by the digestive system, to survive in active form until it crosses the blood/ brain barrier. Moreover, the harmala alkaloids have their own psychoactivity. This DMT/harmala combination is the defining characteristic of ayahuasca.
14. The extent to which the independent psychoactivity of the harmala alkaloids and other betacarbolines, as opposed to their effect in making DMT orally active, contributes to the subjective effects of ayahuasca, is an open question. But there is no reason to think that the specific plant origin of the chemicals has any important influence on their hallucinogenic effects.
15. Therefore, to someone merely wishing to experience the mind-altering effects of such preparations, the precise details of origin and preparation are largely irrelevant.
16. For someone merely wishing to abuse DMT orally, any preparation that included DMT and a sufficient quantity of any monoamine oxidase inhibitor would suffice.
17. The harmala alkaloid, and the plants containing them, are not controlled substances.
18. Both DMT and harmala alkaloids occur in many plant species that grow in the United States. Some of these, including DMT-bearing plants such as phalaris grass, are commonly available from nurseries and garden-supply stores.
19. Information about the creation of orally active DMT preparations (under such names as ayahuasca borealis or "pharmahuasca") is available from several books and on various websites, as well a being orally disseminated both informally and at conferences and workshops. Some of these accounts involve the use of chemical reagents and apparatus, but others rely on nothing more complicated than a wheatgrass juicer.
20. To my knowledge, there have been no published reports of any criminal prosecutions for the preparation or use of such materials, or for growing the plants in question or selling the plants or their seeds. This may reflect a relatively low incidence of the use of such preparations and/or the low enforcement priority assigned to them. But it also reflects the sheer difficulty of making such cases. While the specific intent to use a substance for its psychoactive effect is not an element of the offense of possession under the CSA, it would be extremely difficult to convict someone for growing, for example, a lawn full of phalaris grass with seed bought from a garden supply store along with some plants of Syrian rue, which contains no controlled substance at all.
21. Many of those preparations lack the nauseant and emetic activity of the typical Brazilian ayahuasca preparations, including the hoasca used by the UDV. While many drug abusers tolerate a variety of inconveniences and discomforts associated with the drugs they take and the ways in which they take them, it is not reported that drug abusers as a class, or users of hallucinogens in particular, enjoy nausea or vomiting. Thus, other things being equal, one would expect those whose interest is in drug abuse to prefer preparations without those side-effects, and such preparations would be expected to have a greater abuse liability than hoasca itself.
22. According to the research literature, hallucinogenic substances, including DMT, score much lower on scales measuring reinforcement, and have much less tendency to create dependency, than opiates, such as heroin. That is, those exposed to hallucinogens once display far less motivation to experience second and subsequent doses than those exposed to opiates, and a far smaller proportion of them develop drug dependency as defined by accepted clinical criteria ("addiction"). This would suggest that a much smaller proportion of hallucinogen users than of opiate users would be so strongly driven to seek out the drug experience as to neglect the presence of side-effects.
23. Any abusable substance approved for licit use, whether for research, medicine, industrial application, or worship, faces some risk of diversion for drug abuse. The extent of that risk depends on the abuse liability of the material itself, the volume of licit material, the tightness of the controls surrounding it, and the availability of substitutes.
24. Thus in the case of dronabinol, the widespread availability of marijuana greatly reduces the motivation for diversion, and in fact very little such diversion occurs.
25. In the case of hoasca, the widespread availability of pharmacologically equivalent substitutes, some of them with fewer unwanted side-effects and less apparent legal risk, would greatly reduce the motivation to divert the sacramental material for purposes of drug abuse. Similarly, there would be little motivation for those merely interested in abusing DMT to simulate an interest in the UDV as a religion in order to gain access to hoasca.
26. According to the research literature, hoasca is considered a sacrament within the UDV, and its use outside the ceremonial religious context of the church is considered by members of the UDV to be sacreligious and a serious offense under the doctrine of the church. The UDV also imposes strict internal controls over its hoasca to prevent any possibility of diversion. To my knowledge, there are no reports of diversion of hoasca from the UDV to non-religious use.
27. Even if permission to import hoasca is denied, orally active DMT/harmala combinations will remain easily available to those interested in experiencing their psychoactive effects.
28. Consequently, it is my opinion that the supply-side effects on the abuse of DMT resulting from permission for the UDV to import hoasca for ritual use will be zero (within measurement error).
29. It is possible that there will be non-zero effects on the demand side. Interest in ayahuasca analogs has clearly been stimulated by reports about the practices of the UDV and Santo Daime churches. That interest could increase as a result of reports, both by word of mouth and in the mass media, of UDV activity in the United States, though the extent of this effect would be limited by UDV's practice of non-proselytization. It is also possible that members might leave the church but retain an interest in the psychotropic experience provided by hoasca, though such cases have not been documented. As a consequence, permission for the ritual use of hoasca could have indirect, demand-side effects in the direction of increasing the extent of non-religious use of DMT preparations. There is no currently available evidence or analysis to suggest that such effects, were they to occur, would be large.
30. The experience with legal permission for the use of peyote in ceremonies of the Native American Church (NAC) is reassuring on this point. Both peyote and its primary psychoactive agent, mescaline, are abusable substances and are in fact used illicitly. But the extent of that use, as measured by surveys, and its ill consequences, as measured by emergency-department it "mentions," remains very small by comparison with lysergic acid diethylamide (LSD), whose hallucinogenic effects are similar to those of mescaline but which is not permitted for any religious use. Nor have there been any reports of increased illicit use of either peyote or mescaline since the passage in 1994 of the American Indian Religious Freedom Act Amendments, even in states where such use was illegal before that enactment but legal thereafter.
31. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct and that this Declaration was executed this 9th day of February, 2001, at Los Angeles, California.
/s/ MARK ALBERT ROBERT KLEIMAN, PH.D
MARK ALBERT ROBERT KLEIMAN, PH.D
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW MEXICO
No. CV 00-1647 JP/RLP
O CENTRO ESPIRITA BENEFICIENTE
UNIAO DO VEGETAL, ET AL., PLAINTIFFS
v.
JOHN ASHCROFT, ET AL., DEFENDANTS
[Filed: Aug. 30, 2001]
CERTIFICATE OF SERVICE
Counsel for plaintiffs certify that a copy of this certificate and a copy of the following reports:
1. Second Expert Report of Mark Albert Robert Kleiman, Ph.D.
2. Expert Report of David E. Nichols, Ph.D. were served on opposing counsel this 30th of August, 2001 as follows:
by first class mail to: and by Federal Express to:
Phyllis Dow, Esq. Elizabeth Goitein, Esq.
U.S. Attorney's Office United States Dept. of
201 Third Street, N.W., #900 Justice
Albuquerque, NM 87102 Civil Division
Washington, D.C. 2004 901 E Street, N.W.,
Room 1032
Washington, D.C. 20004
FREEDMAN BOYD DANIELS
HOLLANDER
GOLDBERG & CLINE P.A.
By:________________________
Nancy Hollander
John W. Boyd
20 First Plaza, Suite 700 (87102)
P.O. Box 25326
Albuquerque, NM 87125
(305) 842-9960
Attorneys for Plaintiffs
[Plaintiffs' Exh. 17]
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW MEXICO
NO. CV 00-1647 JP/RLP
O CENTRO ESPIRITA BENEFICIENTE
UNIAO DO VEGETAL, ET AL., PLAINTIFFS
v.
JOHN ASHCROFT, ET AL., DEFENDANTS
SECOND EXPERT REPORT
OF MARK ALBERT ROBERT KLEIMAN, Ph.D
1. My name is Mark Albert Robert Kleiman. I am making this report on behalf of the Centro Espirita Beneficiante Unaio do Vegetal (UDV). I have been asked by the UDV to give opinions on the matters set forth in the following paragraphs. These opinions are supplemental to those set forth in my declaration of February 9th of this year, and I offer them in rebuttal to the expected testimony of Terrance Woodworth. The opinions set forth in this report are my own, and any facts set forth in this report are within my personal knowledge and each such fact is true and correct.
2. I maintain my previously stated opinion that, should the UDV receive permission to import and use hoasca, the probability of any substantial diversion to illicit use would be very low, even in the absence of special controls. The bases of that opinion include: (A) The nausea-inducing properties of the material itself, limiting demand for it outside its ritual context; (B) The availability of other DMT-bearing materials with comparable psychoactivity, some of them reportedly less nauseous; (C) The availability of other (non-DMT) hallucinogens; (D) The small quantity involved, which would tend to retard the development of an illicit market; (E) The bulkiness of the material, which would greatly complicate the problems faced by traffickers in transporting and storing it and in consummating transactions discreetly and efficiently; (F) The interest of the UDV in tracking down diverted materials, which would increase the risk from any potential trafficker's viewpoint and make, e.g., Internet marketing virtually impossible.
3. The apparent absence of any diversion problem involving peyote harvested and acquired for use in the ritual of Native American Churches also supports the view that the probability of any substantial hoasca diversion would be minimal.
4. Even assuming that there were some substantial probability of diversion, reducing that probability would not require forbidding entirely the importation and distribution of hoasca, thus in effect banning the hoasca, religious practice of the UDV in the United States. Less restrictive alternatives exist, as described below.
5. Any diversion of hoasca to illicit use, were permission to be granted for the UDV to import and distribute hoasca for ritual use, would have to occur at one of the following points in the process. (A) It could be diverted at the point of production by UDV officials in Brazil; (B) It could be stolen in transit in Brazil; (C) It could be stolen in transit between Brazil and the United States; (D) It could be stolen in transit within the United States; (E) It could be stolen from UDV property; (F) It could be diverted by UDV officials.
6a. Diversion by church officials in Brazil seems quite implausible on its face. Moreover, it is not a risk created by the permission in question. Hoasca production by the UDV is already lawful activity in Brazil, and the contribution of the American church to the total amount of hoasca required is tiny (less than one part in fifty based on a comparison between the UDV membership in Brazil and in the United States).
6b. Theft in transit in Brazil is less implausible (still assuming that the material has sufficient illicit-market value to be worth stealing). But it is not clear why hoasca for export to the United States would be at any greater risk of diversion than hoasca produced for Brazilian use, or why the hypothetical illicit hoasca traffickers would choose to steal sacramental supplies rather than brewing their own from the same two plants used by the church or from pharmacologically equivalent plants. To my knowledge, there have been no reports of non-religious shipments of ayahuasca preparations from Brazil to the United States, or of such preparations being offered for sale on the illicit market.
6c. Theft in international transit presents a risk for anything of value so shipped. The magnitude of that risk: can be reduced in a variety of ways, some of them as simple as heavily insuring each shipment, thus increasing the incentive of the shipping agency to use special care in handling. At greater cost, each shipment can travel with a passenger as checked baggage. The sheer bulk of each dose of hoasca decreases its attractiveness to a potential thief. Again it is far from clear why a hypothetical illicit hoasca trafficker would choose to steal hoasca from international transit rather than brewing a pharmacologically equivalent ayahuasca preparation in Brazil. Reportedly, the UDV shipped hoasca from Brazil to the United States several times before the seizure that generated the current dispute, and did so without incident.
6d. As for theft in the United States, whether in transit or from church property, the Drug Enforcement Administration has regulations in place concerning the shipment and storage of controlled substances for pharmaceutical, research, and industrial uses. Those regulations prescribe both practices and record-keeping. Many substances covered by those regulations have established illicit markets and far higher ratios of illicit value to bulk than an is the case for hoasca. These regulations could be imposed if there were evidence of a theft problem.
6e. Members of the UDV are expected to participate in its services on a regular basis. Church membership changes ranges very slowly. Thus the amount of hoasca required in the course of any given month by any given UDV congregation is highly predictable. That fact would make any diversion attempt within the church stand out prominently.
7. In theory, another practice tantamount to diversion might emerge, in which fees were charged for participation in individual services, giving the church itself (or rogue officials within it) financial incentives to recruit participants who might have no interest in religious practice as opposed to drug-taking. (This would be the quasi-religious analogue of "script doctoring.") It is my understanding that the practice of the UDV involves no per-service payment. Furthermore, the doctrine of the UDV considers any commercial use of hoasca to be sac-religious, the church leaders are highly trained and carefully selected, and the UDV imposes severe sanctions for any abuse of church leaders' authority. It is also my understanding that an agreement between the UDV (and other ayahuasca-using religious bodies) and the Brazilian government explicitly forbids any commercial activity. Permission for the UDV to import and distribute hoasca could reasonably be made subject to a restriction that no per-service or per-dose fee or contribution be collected.
8. In addition, the UDV could reasonably be required to notify the government in advance of each shipment of hoasca from Brazil (date and means of shipping, quantity of material, expected date of arrival, person authorized to receive the material from the shipper), and to report promptly any theft in transit or from church property.
9. The combination of those three requirements - non-commercialization, pre-notification of shipments, and reporting of theft-would constitute a minimally intrusive set of controls. The government would be able to check on shipments as they arrived to monitor the total volume of material. A rapid increase in volume might reasonably trigger an inquiry as to its use, as would any evidence of hoasca being offered or consumed on the illicit market.
10. A somewhat more intrusive approach would rely on the predictability of the hoasca requirements associated with UDV practice. That more intrusive approach could either be put in place from the start or held in reserve in the (in my opinion) unlikely eventuality that diversion of hoasca proved to be a problem. It might work as follows:
(A) Each year, the church would be required to calculate the average annual requirement of hoasca on a per-member basis and submit that figure to the Drug Enforcement Administration, modifying it if and as its practices change.
(B) Also each year, the church would be required to submit a statement of the number of its active members, and its estimate of how it expects that figure to change over the coming year. Again, that estimate might have to be revised during the course of the year.
(C) The product of the annual per-member requirement of hoasca and the estimated number of members for any year would be the estimated total hoasca requirement for that year.
(D) Each year, the church would be required to submit a "materials balance" statement showing the amount of hoasca on hand at the beginning of the year, the amount brought in during the course of the year, and the amount on hand at the end of the year, thus allowing a computation of net hoasca consumed that could be compared with the estimate calculated in (C) above, along with an explanation of any variance.
These requirements would be in addition to the requirements of noncommercialization, pre-notification of shipments, and prompt reporting of thefts suggested above.
11. While more intrusive than the minimal control set described in sections 7-9 above, the approach described in section 10 would still allow the government to assume an almost entirely passive role: receiving reports, checking calculations, and perhaps verifying the quantities of some shipments or monitoring the Internet for reports or offers of diverted hoasca. As long as the quantity imported remained consistent with the quantity legitimately required, and unless there were other evidence that hoasca had leaked into illicit use, nothing more would be required. If there were evidence of diversion or theft, that system might be tightened in various ways. For example, if theft were a problem, the UDV might be required to comply with DEA regulations for storing and shipping controlled substances.
12. In summary, it is my opinion that even in the absence of the controls discussed above, the probability of any substantial diversion of hoasca would be very small, and that a variety of low-intensity controls would be more than adequate to meet any residual risk. It would be reasonable to proceed in phases, starting with the least intrusive controls and tightening if and as necessary.
13. I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct and that this report was executed this 21st "day of August, 2001, at Los Angeles, California.
MARK ALBERT ROBERT KLEIMAN, PH.D
[Plaintiffs' Exh. 18]
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW MEXICO
No. CV 00-1647 JP/RLP
O CENTRO ESPIRITA BENEFICIENTE, UNIAO DO VEGETAL, ET AL, PLAINTIFFS
V.
JOHN ASHCROFT, ET AL., DEFENDANTS
DEPOSITION OF MARK ALBERT ROBERT KLEIMAN, Ph.D., taken on behalf of the defendants at 10:11 a.m., Tuesday, August 14, 2001, at 300 North Los Angeles Street, Los Angeles, California, before Jennifer W. Pertusati, CSR.
* * * * *
[53]
Q. I'm only talking about looking at it, looking at the substance.
A. Yeah, and not smelling it.
Q. Not smelling it, just looking.
A. I actually don't know. I-I haven't-having not seen it the answer is I don't know.
Q. Going back to the issue of alcohol during Prohibition, apparently the bulk of alcohol during Prohibition wasn't an enormous factor in reducing illegal trafficking; isn't that true?
A. Oh, I must disagree with you.
Q. Okay.
A. Despite very inadequate levels of enforcement, and despite a regime in which the users were completely invulnerable to enforcement because the use of alcohol was never prohibited, alcohol-yes, alcohol Prohibition-you look surprised. Alcohol Prohibition, as it's always called in the debate and the history and as it was [54] referred to at the time, was a regime which we would call decriminalization if applied to any controlled substance today. It was illegal to manufacture or to sell or to transport. It was not illegal to possess or consume.
Q. That's interesting, I didn't know that.
A. In fact, all the way through Prohibition there were private clubs that-or allegedly private clubs that you could join for $5 at the door. They would keep bottles that were allegedly members' private stocks under the bar and they would sell you water and fizzy water and ice and glasses.
So a very inadequate enforcement regime nonetheless was able to more than triple the price of alcohol during Prohibition. Had the material been less bulky, enforcement would have been considerably harder. Reportedly, during-now again, we're off my expertise; I'm not [55] the share of distilled spirits rose because an historian on Prohibition. But reportedly, during Prohibition, the share of beer in total alcohol consumption fell and it was more efficient to distribute the more concentrated form of alcohol.
Q. But there was significant illegal trafficking in alcohol, isn't that right, during Prohibition?
A. There was.
MS. GOITEIN: Off the record.
(Recess)
BY MS. GOITEIN:
Q. Okay, you just told us that there was significant illegal trafficking of alcohol during Prohibition despite its bulk. Why would that not be the case with hoasca? Why is it in the case of hoasca that bulk would be a significant factor, which I assume is what you're saying, in reducing illegal trafficking in hoasca when it didn't seem to have-I mean, obviously it [56] affected, but didn't by any means minimize the trafficking of alcohol?
A. Again, competition from other hallucinogens available in less bulky form would be a significant factor. That is, if this mug is a dose of hoasca and the U on this thing that says Exhibit U was a dose of LSD, I mean, the thickness of this sheet of paper and the area of that U is a dose of LSD, both the trafficker and the consumer are going to find it safer to go with the less bulky form.
Q. So the bulkiness only really matters if there is another substance that can substitute; is that right?
A. No, it matters in any case. The total cost and particularly the enforcement risk of the hypothetical illicit hoasca traffic is much greater than it would otherwise be because it's bulky. Now you said, well, yes, but alcohol was trafficked even though it was bulky, which my answer was, well, the [57] enforcement wasn't very great and there was no substitute; neither of those is the case here.
Again, alcohol was something that people wanted to use outside ceremonial context which were legal. So during Prohibition, for example, I'm not aware of any reports of diversion of communion wine to illicit traffic.
Q. Have you researched that?
A. I haven't, but I mean, I've read-certainly read lots about Prohibition. I know all the-I think, all the prominent ways that people either broke the law or got around it. For example, getting medical prescriptions for alcohol was a very common way to get around Prohibition, and there were also herbal remedies that were made that had 10 percent alcohol in their solution and they were sold. Jamaica ginger extract, right? But stealing communion wine was not an important [58] source of alcohol during Prohibition because it wasn't the most convenient way to get alcohol.
So in order to understand the likely diversion pattern: you have to look at the demand for the substance, the illicit demand-do people what to take this for nonritual purposes? the substitutes-and that's a wide range of possibilities, and the technical difficulty both of acquiring the stuff for diversion, that is figuring out a way to steal it, and then turning around and figuring out a way to sell it.
Q. But if there is-for example, if you say the other two factors, if there is a high demand for a substance, if there are no good substitutes for that substance, the fact that it's bulky is not necessarily going to eliminate illegal trafficking, is it?
A. The fact that it's bulky will not necessarily eliminate illegal trafficking, * * *.
* * * * *
[144]
Q. BY MR. SZUBIN: How are coca leaves-
A. I don't know.
MS. HOLLANDER: Do you agree, Adam, that he is not looking at the Controlled Substances Act?
MR. SZUBIN: I agree he is not looking at the Controlled Substances Act.
Q. Do you know when and how DMT was scheduled?
A. My understanding is that it was grandfathered into the CSA along with everything else that was prohibited at that time when it got on that list. I don't know.
Q. Do you know whether there was any assessment of its abuse at that time?
A. I am not familiar with it. When I read the legislative history of the CSA, there is no reference.
Q. So you don't know if there was any assessment made of its abuse potential?
A. No.
Q. Do you know whether there was any assessment made for its safety of supervised use?
A. No. I do not know. Though, if supervised use includes research use, then it's quite common to use Schedule I drugs in research. They are used all the time, including DMT. So that if inclusion in Schedule I meant it was never ever safe to give anyone this * * *.
* * * * *
[Plaintiffs' Exh. 24]
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW MEXICO
NO. CV 00-1647 JP/RLP
O CENTRO ESPIRITA BENEFICIENTE
UNIAO DO VEGETAL, ET AL., PLAINTIFFS
v.
JOHN ASHCROFT, ET AL., DEFENDANTS
EXPERT REPORT OF DAVID E. NICHOLS. Ph.D.
A. Opinions
1. My name is David Earl Nichols. I make this expert report on behalf of the Centro Espirita Beneficente Uniao do Vegetal ("UDV") in rebuttal to the anticipated testimony of Drs. Genser and Jasinski, and Terrance Woodworth, and the materials upon which they relied and considered. I have been asked by the UDV to give opinions on the matters set forth in the following paragraphs. The opinions set forth in this expert report are my own, and any facts set forth in this expert report are within my personal knowledge and each such fact is true and correct. This expert report sets forth the outlines of my knowledge regarding the history, use, psychopharmacology, and toxicity of DMT and ayahuasca (also herein referred to as hoasca), as obtained by my reading of the medical literature, participation in technical reviews, attendance at professional conferences, committee service, discussions with colleagues, and my own research over a period of more than thirty years.
2. I have a Bachelors of Science Degree in Chemistry in 1969 from the University of Cincinnati, and a Ph.D. degree in Medicinal Chemistry in 1973 from the University of Iowa College of Pharmacy in Iowa City, Iowa. I was a Postdoctoral Fellow in Pharmacology at the College of Medicine, University of Iowa, until November 1974. I am presently Professor of Medicinal Chemistry and Molecular Pharmacology in the School of Pharmacy and Pharmacal Sciences at Purdue University, West Lafayette, Indiana. My qualifications and experience are set forth in detail in my curriculum vitae, attached as Exhibit 1.
3. I began my graduate studies in 1969; and in the years since then one of the major foci of my own research has been the structure-activity relationships of hallucinogens, including N-N dimethyltryptamine (DMT) and related molecules. As will be seen in Exhibit 1, I have given many presentations, written numerous scientific publications, participated in several symposia, and written several monographs and book chapters concerned specifically with the chemistry and pharmacology of hallucinogens. Although I have published mainly scientific papers dealing with the pharmacology of hallucinogens in animal species, particularly rats, I have read widely on the history and anthropological aspects of hallucinogens as background for my scientific work. My public presentations often contain educational background information on the uses of hallucinogens in other cultures.
4. Hallucinogens are considered by the scientific community to be physiologically safe molecules. That is, these drugs are powerful in producing changes in consciousness, but they do so at doses that are not toxic to mammalian organ systems. There is no evidence that any of the hallucinogens, including DMT, or even the very powerful semisynthetic hallucinogen LSD causes damage to any human body organ. In 1967 Cohen (1967) stated, "Death directly caused by the toxicity of LSD is unknown." This statement was reiterated in 1985 by Jaffe (1985), "In man, deaths attributable to direct effects of LSD are unknown." This observation still remains true today. Hallucinogens, including DMT, do not cause life-threatening changes in blood pressure, cardiovascular, renal, or hepatic function because they have little or no affinity for the biological receptors and targets that mediate vital vegetative functions. They do not engender drug dependence or addiction (O'Brien 2001) and are not generally considered to be reinforcing substances. For example, in a recent article concerning drugs of abuse that activate brain reward pathways, drugs considered were opiates, nicotine, cannabis, phencyclidine, cocaine, amphetamine, alcohol, benzodiazepines, barbiturates, and even caffeine. There was no mention of hallucinogens such as DMT or related substances (Wise 1998). Whereas Parker (1995) has shown that high doses of LSD can produce conditioned place preference, a measure of reinforcing quality of a drug, there is no similar report for DMT. This finding can probably be explained by the fact that at high doses LSD can interact with dopamine receptors (Watts et al. 1995) whereas DMT has no significant affinity for dopamine receptors. In June 2000, I carried out a computer search of the medical literature in the National Library of Medicine back to 1965 using PubMed, with the topic DMT linked to the following key words: adverse, death, lethal, and fatal and found no reported instance of any overdose death caused by DMT. Strassman (1984) and Halpern and Pope (1999) have published studies on the adverse reactions or long term sequelae following hallucinogen use based on their analysis of published literature reports. Halpern and Pope reached a conclusion that was similar to Strassman's with regard to repeated use of psychedelic drugs, that the results were controversial, but that if any long term adverse effect did occur it was, "subtle or nonsignificant."
5. Their principal effects are on consciousness. As Jaffe (1985) has stated, "the feature that distinguishes the psychedelic agents from other classes of drugs is their capacity reliably to induce states of altered perception, thought, and feeling that are not experienced otherwise except in dreams or at time of religious exaltation." The nature of the effects is heavily dependent on the expectations of the user and the environment or setting in which the use takes place. Thus, expectations of religious content typically lead to the anticipated outcome, while use in a non-structured or recreational way can have unpredictable psychological consequences. The dangers of psychedelics lie principally, in their psychological effects. Thus, while LSD has not directly caused overdose death, fatal accidents and suicides during LSD intoxication have occurred (Jaffe 1985). Because all of the hallucinogens can cause similar psychological reactions, it is important that they be used only in supervised settings, with experienced supervision. Strassman (1984) and Malpern and Pope (1999) have specifically developed their conclusions of low incidence of adverse reactions based on reviews of supervised clinical use of hallucinogens.
6. N,N-Dimethyltryptamine (DMT) is a naturally-occurring hallucinogen that is found distributed throughout the plant kingdom (Schultes 1976). DMT is not active following oral administration in humans. It is widely believed that it is destroyed after oral ingestion by the first pass through the liver, where monoamine oxidase and aldehyde dehydrogenase metabolically break it down into indole acetic acid, a biologically inactive metabolite. Numerous scientific studies show that the human body actually produces DMT under normal conditions. As one example of these many investigations, Saavedra and Axelrod (1972) demonstrated the formation of N,N-dimethyltryptamine by an enzyme in the human brain. Similarly, Christian et al. (1977) conclusively demonstrated the presence of DMT in the rat brain and have proposed that it may have a regulatory function similar to other neurotransmitters. Nevertheless, under normal physiological conditions, endogenous DMT would be quickly degraded by the monoamine oxidase and aldehyde dehydrogenase present in the human body. Thus, under ordinary circumstances DMT produced by the body would never achieve concentrations necessary to provide an hallucinogenic effect. The observation that DMT can be produced within the human body serves to show, however, that DMT is not a substance foreign to mammalian systems, and that various natural enzymes exist to terminate its physiological effects.
7. When isolated and purified, or when obtained by synthesis, DMT has been used as a recreational drug. In those instances where it is used as the pure substance, it is typically smoked as the free base. Pure synthetic DMT has been given to humans in at least five published studies, by Szara (1956), Gillin et al. (1976), Rosenberg et al. (1963), Turner and Merlis (1959), and Strassman and Qualls (1994) and Strassman et al. (1994). In each study except that of Strassman et al. the DMT was administered by intramuscular injection, and in the study by Strassman et al. it was administered intravenously. Typical of the clinical findings are those of Gillin et al. (1976), who replicated earlier results by observing that the effects of DMT (0.7 mg/kg), given by intramuscular injection, produced evident psychological effects within five minutes of injection, which peaked at about 10-15 minutes, and ended within 45 to 120 minutes. Blood levels of DMT closely paralleled the observed psychological and autonomic changes, reaching peak plasma concentrations of approximately 100 ng/mL about 10-15 minutes after DMT injection.
8. Strassman et al. (1994) and Strassman and Qualls (1994) have described human clinical experiments with intravenously injected DMT fumarate; the injected DMT produced psychopharmacological effects comparable to those from smoked doses. In those experiments, 0.4 mg/kg was sufficient to provoke an intense experience, which began in only a few seconds, and lasted less than 30 minutes. Peak plasma levels of 32 to 204 ng/mL of DMT following intravenous administration of 0.4 mg/kg occurred within 2 minutes after injection and then dropped to baseline levels by 30 minutes.
9. The plant decoction known as hoasca has a long and documented history of use in the Amazon valley of South America as a psychoactive preparation that has served as the focus of various rituals. Hochstein and Paradies (1957) first identified the harmala alkaloids as major components of hoasca. Principal alkaloids were determined to be harmine, harmaline, and tetrahydroharmine. These alkaloids are known as beta-carbolines, and generally would be expected to have similar pharmacology. Rivier and Lindgren (1972) carried out a similar characterization of banisterioposis and psychotria, the two plants used to prepare hoasca. Both harmine and DMT were the principal alkaloids identified. These latter workers concluded that a typical dose of hoasca (200 mL) would contain 25 mg of DMT and 40 mg of beta-carbolines.
10. It is presently believed that the admixture of DMT with harmala alkaloids (harmine, harmaline, tetrahydroharmine) that is contained in hoasca leads to oral activity of the DMT therein because the harmala alkaloids inhibit the function of monoamine oxidase in the liver and elsewhere that would ordinarily destroy orally administered DMT (McKenna 1996; Strassman et al. 1996). Oral administration of DMT following inhibition of monoamine oxidase would be expected to produce a slower onset of action of the DMT than following smoking or parenteral administration. That is exactly what is observed in subjects who have consumed hoasca.
11. It is not proven, however, that all of the psychological effects of hoasca are simply the result of oral administration of DMT. On the basis of interaction studies between beta-carbolines and DMT in the rat, Freedland and Mansbach (1999) suggest that the unique effects of hoasca may be due to factors in addition to an increase in bioavailability of orally ingested DMT. They speculate that differences in the interactive effects of DMT with harmine and the extract, though subtle, could reflect the actions of other alkaloids present in-banisteriopsis. Thus, the psychological state produced by hoasca may not necessarily be completely attributed to the simple combination of DTM with beta-carbolines, but may be more complex as a consequence of the ingestion of other alkaloids contained in the hoasca tea, even if those alkaloids are only present in minor amounts.
12. Callaway et al. (1999) measured plasma levels of DMT in 15 male subjects who had orally ingested an average of 28.8 mg of DMT contained in a sample of hoasca. Peak plasma concentrations occurred approximately 100 minutes after ingestion, and reached an average concentration of 15.8 ng/mL. In all published studies, psychological effects have been shown to parallel plasma concentration levels of DMT. Thus, the 100 minutes to peak concentration in this study can be contrasted with the 10-15 minutes reported by Gillin et al. (1976) for peak plasma concentrations following intramuscular injection, and to the 90-120 seconds observed by Strassman and Qualls (1994) following intravenous administration. The peak plasma concentrations of DMT measured in these studies also vary: about 16 ng/mL in the study by Callaway et al. (1999), 100 ng/mL in the Gillin et al. study (1976), and between 32 and 205 ng/mL in the Strassman and Qualls study (1994).
13. One can readily conclude several things from these data. First, when hoasca is ingested orally, peak plasma DMT levels are the lowest, and are achieved only after approximately 100 minutes, second, administration of pure DMT by the intramuscular route gives much higher peak plasma DMT levels (100 ng/mL) in the much shorter time of 10-15 minutes. Finally, intravenous administration of DMT gives very high peak plasma concentrations of up to 204 ng/mL in less than two minutes after injection.
14. The descriptions of the intensity of effects of these three experimental conditions are completely accounted for by these observed clinical phenomena. Orally ingested hoasca produces a less intense, more manageable, and inherently safer altered state of consciousness. By contrast, when pure DMT is given by injection, either intramuscularly or intravenously, the reported experiences are very intense, in some cases frightening, and inherently less psychologically safe because of the possibility of inducing panic, anxiety, or a paranoid reaction. These conclusions are perhaps amplified by the realization that in the analyses carried out by Callaway et al. (1999), the dose of DMT consumed in the hoasca was 0.48 mg/kg, as the free base. Although this dose is nearly two-fold higher than the 0.4 mg/kg fumarate dose (but equivalent to only 0.25 mg of the free base) used by Strassman and Qualls (1994), in the latter study the dose was administered intravenously and it produced rapid, very intense effects. Because of the facts noted above, a similar dose of DMT, given orally, would be expected to have a slower onset. Because plasma concentrations would not peak suddenly, as they would following intravenous administration, but would rise slowly, the psychopharmacological effects of DMT would be expected not to be as intense or as unpredictable. One would anticipate that an oral dose would precipitate less anxiety and lower the potential for any adverse psychological effects.
15. No published evidence suggests that DMT possesses significant physiological toxicity, and there is very little published evidence concerning the toxicity of harmine or harmaline. One may be reasonably sure that, if the beta-carboline type alkaloids possessed unique or unusual toxicity or other pharmacological properties, due to the fact that they have been ingested for many years in the form of hoasca, studies reporting the toxic effects of these substances would have appeared in the literature.
16. The principal recognized pharmacology of the beta-carbolines is as reversible inhibitors of monoamine oxidase (MAO inhibitors). MAO inhibitors were the first successful class of antidepressant agents. Toxicity associated with these drugs generally occurred when patients using MAO inhibitors subsequently ingested foods that contained pressor amines such as tyramine, which could elevate blood pressure. A similar toxicity might occur in patients who had ingested beta-carbolines and then ingested tyramine-containing foodstuffs. A major difference however, is that the early MAO inhibitors used for treating depression were irreversible and long acting, whereas the beta-carbolines are reversible and relatively short-acting substances.
17. Toxicity of beta-carbolines would be related to the dose consumed, so it is appropriate to consider what dosages of harmine or beta-carbolines might be ingested in a typical dose of hoasca. The best quantitative study so far published concerning the amounts of beta-carbolines present in hoasca was by Callaway et al. (1999). In the study by Callaway et al. hoasca was prepared from the pounded bark of B. caapi Spruce ex Grisebach (Malpighiaceae) and the leaves of Psychotria viridis Ruíz et Pavón (Rubiaceae). Analysis of a batch of hoasca prepared under the auspices of the Uniao do Vegetal (UDV) in Brazil in 1993 revealed a beta-carboline content of:
Harmine: 1.70 mg/mL
Harmaline 0.20 mg/mL
Tetrahydroharmine 1.07 mg/mL
This preparation, freshly prepared, was administered to 15 human male members of the UDV, ranging in age from 26 to 48. These subjects had used hoasca as part of their regular religious practice for at least 10 years. The members of the UDV typically ingest hoasca on a biweekly basis. The amount of hoasca administered was approximately 2 mL/kg of body weight. For a 70 kg man, therefore, the typical dose of the three alkaloids consumed in this study would be as follows:
Harmine: 238 mg
Harmaline 28 mg
Tetrahydroharmine 150 mg
DMT 35.5 mg
Maximum plasma concentrations (Cmax) of the three beta- carbolines were as follows:
Harmine: 114.8 ± 61.7 ng/mL (n = 14)
Harmaline 6.3 ± 3.1 ng/mL (n= 5)
Tetrahydroharmine 91.0 ± 22 ng/mL (n = 14)
18. It was noted that harmaline levels were already low in the hoasca, and the plasma harmaline levels of 9 of the & volunteers were below the limits of detection of the assay.
19. Grob et al. (1996) undertook neurological and psychiatric assessment of the same 15 subjects, members of the UDV, and compared them to matched controls. Although specific testing was not carried out for neurological deficits of the sort that occurred following administration of a very large dose of harmaline to rats (O'Hearn and Molliver, 1993, discussed below), such deficits would have been obvious to the investigators had they been present.
20. There has been some speculation, e.g. Cobuzzi et al. (1994), that N-methyl-beta-carbolinium analogues might produce effects resembling those of MPP+, a dopamine neurotoxin that can lead to a severe form of drug-induced parkinsonism. The symptoms of parkinsonism are readily evident in humans and would include signs such as tremor and musclar rigidity, none of which has been observed in long term users of hoasca. One is led to conclude that this concern is unwarranted with respect to hoasca consumption.
21. One report has been published showing that harmaline given at a dose of 40 mg/kg caused loss of Purkinje cells in narrow radial bands of cerebellum (O'Hearn and Molliver 1993). These same investigators later postulated (O'Hearn and Molliver 1997) that the degeneration of these Purkinje cells following harmaline could be attributed to a sustained increase in neuronal firing in an area of the brain known as the inferior olive. Repetitive firing of these neurons causes the release of the amino acid neurotransmitter glutamic acid in the cerebellum. Glutamic acid is an excitatory neurotransmitter, and excessive release onto Purkinje cells in the cerebellum leads to their overstimulation and death through a mechanism known as excitotoxicity. Although this might appear to be an area of concern regarding harmaline toxicity, a closer inspection reveals certain facts that minimize this concern. O'Hearn and Molliver administered to rats intraperitoneal doses of harmaline either of 40 mg/kg one time, or 24 mg/kg three times, every 24 hours. A simple extrapolation of the 40 mg/kg dose to humans would lead to an equivalent dose of 2400 mg in a 60 kg man. A dose of hoasca would not contain this amount of harmaline. Amounts of harmaline present in hoasca have been determined in all studies to be very small. One can also use a scaling procedure that corrects for body weight. For example, Mordenti (1986) has provided an equation that makes possible an estimation of doses in one animal species, given the dose in other species. Using the weight of the rats in the study by O'Hearn and Molliver (1993) as 200g and the dose as 40 mg/kg, the comparable estimated dose for a 70 kg human is calculated as: Human dose = 8 mg (70/0.20)^0.7 = 483 mg. The actual approximate human dose ingested in the study reported by Grob et al. (1996) was only 28 mg, 17-fold smaller than the dose employed in the study by O'Hearn and Molliver. A second reason for reduced concern about potential cerebellular damage from beta-carbolines is the observation that neurotoxic doses of harmine and harmaline also cause tremor in mice or rats (Zetler et al. 1972; 1974). For example, in the work by O'Hearn and Molliver (1997) the neurotoxic regimen of harmaline led within minutes to a high frequency generalized tremor of the trunk, head, and limbs, and ataxic gait, followed by a period where the animals lay limp and motionless. The high frequency tremor in rats lasted about 12 hours. There is no report of users of hoasca experiencing tremor or atonia that would be related to repetitive firing of olivary neurons or excessive stimulation of the cerebellum.
22. Speculation that harmaline might produce neurotoxicity in humans similar to that observed in rats however, is not supported by the actual results of the neurological examinations of the 15 UDV subjects who had taken hoasca regularly over a period of ten years. It is commonly recognized that lesions of the cerebellum would produce observable toxic effects such as ataxia, loss of motor coordination, postural tremor, and other overt symptoms. The assessments in the 15 sub-jects did not reveal any such problems, nor is there any evidence for an increased incidence of any, adverse or abnormal mental or physical effect among members of the UDV in Brazil. Significant lesions of the cerebellum should be easily detected if they occur. Ataxia, or loss of motor control, is a common symptom of certain types of cerebellar damage (Bastion 1997). Symptons of bilateral cerebellar damage, which would be anticipated if harmaline or harmine produced loss of Purkinje cells in humans, would include impaired ability to plan and program daily activities, deficits in visuospatial organization for a concrete task and deficient visual-spatial working memory, lower general intellectual abilities than controls, difficulties with memory retrieval, and slower speed of information processing (Botez-Marquard and Botez 1997). Data from clinical and functional studies indicate that the cerebellum has a central coordinating function not only of movement but also regulating thought (Arriada-Mendicoa et al 1999). In view of the results of the neurological examination of UDV members carried out by Grob et al. (1996) there is absolutely no evidence to suggest that the use of hoasca on a regular basis within the context of the UDV ritual produces neurological deficits of the kind that would be expected by damage to the cerebellum. Such deficits should be readily detected but in fact the UDV members were as a group higher functioning than the matched controls.
23. The is known that beta-carbolines such as harmine and harmaline can interact with DNA. Studies have shown, however, that although harmine and harmaline may modify or enhance genotoxic consequences of other compounds, or may inhibit DNA excision repair mechanisms, they are not mutagenic in and of themselves (de Meester 1995; Shimoi et al 1992). That is, concern about this potential chemical property of the beta-carbolines would only be relevant if hoasca users were concurrently ingesting substances known to produce direct damage to DNA.
24. Finally, concerns over potential toxicity of harmine are also somewhat reduced by the fact that it was used under the name "banisterine" to treat Parkinson's disease in the late 1920s. It was administered subcutaneously by several groups (see review by Sanchez-Ramos 1991) in doses of 3-50 mg. It produced some beneficial effect but was ineffective in relieving tremor. Doses of 40 mg tended to cause nausea and bradycardia in one study but in another the side effects were reported to be slight. A self-experiment reported by Halpern (1930) indicated that an oral dose of 40 mg or 30 mg subcutaneously produced predominantly restlessness, with no effect on consciousness.
25. Taken as a whole, although there is actually very little known about the toxicity of beta-carbolines, it is my opinion that there is nothing in the scientific literature to suggest that these substances represent a significant toxicological hazard when used episodically in the context of the UDV ritual. Speculation about any relationship between toxicity in rats and humans is presently resolved by the fact that members of the UDV who have used hoasca for at least 10 years manifest no apparent neurological abnormalities (Grob et al 1996).
26. The government relies on an affidavit of Natalia P. Urtiew which claims that, "the extraction of dimethyltryptamine from the tea-like solution is relatively simple compared to preparing the compound synthetically." The government further claims that, "DMT in its smokeable or injectable form is easily extracted from ayahuasca; indeed it is easier to extract DMT from ayahuasca than to synthesize it." Opp. at 30. Both assertions are incorrect.
27. It is my opinion that the extraction of hoasca tea will not lead to a useful drug of abuse, either if administered by smoking or inhalation, or by injection. I do not believe that diversion of hoasca tea represents a significant drug abuse threat with respect to extraction of one of the alkaloids, DMT, and use of pure DMT obtained therefrom. Any person who was committed to illegal trafficing of DMT would not attempt to obtain same by extraction of hoasca tea, but rather would find it far more economical and practical to prepare synthetic DMT. The reasons for my opinion are as follows.
28. Because the hoasca represents the total plant extract, a simple basification of the hoasca, followed by organic solvent extraction, as Urtiew suggests, will lead to an extract containing the entire alkaloidal content of the hoasca tea. Using as an example the analyzed content reported by Callaway et al. (1999), extraction of 1.0 liter of hoasca tea would lead to an extract containing approximately the following:
Harmine: 1700 mg
Harmaline 202 mg
Tetrahydroharmine 1071 mg
DMT 239 mg
The total extract would weigh in excess of 3.21 g, containing in addition to that amount an unknown quantity of other uncharacterized alkaloids. When smoked, the dose of DMT for a 70 kg human is approximately 50-60 mg, similar to the 0.7 mg/kg administered via the intramuscular route by (Gillin et al. (1976). Thus, an organic extract of 1.0 liter of the analyzed hoasca tea would represent approximately 4 x 60 mg smoked doses, with each dose contained in a matrix of mixed plant alkaloids weighing 803 mg 3.21 g alkaloids/4 doses). The problem with the government's claim is the simple fact that it is unlikely that an individual would be able efficiently to smoke, and thus pyrolyze, 803 mg of a complex plant extract that would probably be physically characterized as a brown, sticky, gum-like material. Furthermore, there is no report on whether humans can physically tolerate large amounts of vaporized beta-carbolines within the lungs and respiratory system. In addition, it is unknown whether pyrolysis of 803 mg of crude alkaloids, only approximately 7% of which is DMT, will efficiently deliver a psychoactive amount of DMT to the lungs from this complex mixture. The only solution to this problem would be a complex separation method of the crude hoasca extract, probably involving a preparative column or high performance liquid chromatography. This separation step would be expensive and time-consuming and would completely eliminate any economic advantage that might be seen in the ready availability of an organic solvent for the extraction.
Separation of the alkaloids to obtain pure, or nearly pure, DMT is not likely to be applied on a useful scale because it is simply uneconomical. Large glass columns and a large amount of expensive column packing material would be required, or very expensive HPLC and preparative HPLC equipment would be necessary. In addition, some DMT would be lost in the purification scheme, because there are inevitable losses in any purification scheme.
29. Urtiew states that the chemicals to prepare synthetic DMT are not readily accessible (Urtiew affidavit). This is incorrect. Only a few reagents are required, all of which are available in large quantity as Industrial chemicals. The synthesis involves only three very simple reactions, carried out in only two discrete steps. The skill required to carry out these reactions is easily acquired, and is not extensive. She also claims that these chemicals possess inherent dangers (Urtiew affidavit ). Although this is true, the same could be said for most chemicals in a laboratory. Oxalyl chloride, one of the necessary reagents, is toxic; diethyl ether and tetrahydrofuran are flammable; and lithium aluminum hydride is flammable and ignites if water is added to it. Nevertheless, in my opinion, procedures using these chemicals are really no more complicated or dangerous to a chemist than those required to prepare other synthetic drugs of abuse such as amphetamine or methamphetamine.
30. One who is disposed to traffic in DMT itself and who has committed the laboratory resources to this activity, will be able to obtain the commercial chemicals necessary to prepare the pure material. Several years ago in my laboratory we prepared pure DMT for an FDA-approved clinical study by Dr. Rick Strassman at the University of New Mexico School of Medicine, as part of a collaborative medical research project (Strassman and Quails 1994; Strassman et al., 1994). Although we purchased the reagents to synthesize DMT in small amounts and in high purities, constraints under which a clandestine laboratory would not operate, I have calculated that the approximate costs for the chemicals to prepare 34.5 g of DMT were approximately $283 (obtained from the Aldrich Chemical Company, Milwaukee, WI: 60 g indole; 64.8 g oxalyl chloride; 53.5 g dimethylamine; 21 g of LiA/H4; 4 liters of anhydrous diethylether, and 300 mL of anhydrous tetrahydrofuran). No special approvals were required to purchase these chemicals. This 34.5 g of DMT, corresponding to 690 x 50 mg doses, was obtained after extensive purification to obtain the material in a high state of purity to meet FDA standards, and it is highly probable that a clandestine laboratory might obtain a larger yield (i.e. more doses) of less pure product. If one considers that 1.0 liter of the hoasca tea theoretically provides approximately four or five doses of DMT, to obtain 690 x 50 mg doses by extraction of hoasca tea, one could calculate that a volume of 172.5 liters (approximat