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 Federal Register / VoL 53, No. 34 / Monday, Februsry 22, 1988 / Ru|es and Reg_lations 5_57
 ,n ,i, ,i _ i rl n.
 Do Three reports published by a_leged MDMA to the study and loss. Dr. Oreer's and Dro Downing's
 Alexander Shulgin and others beginning determined the dose to be taken. The studies suffer from severe
 in '197S mention the effects of MDMA in subiecte concluded that they had methodological and other problems
 humane. These studies describe "benefitted" from the use of MDMA, Dr, which lead experts to conclude that th_y
 MDMA's psychopharmacologica| profile Downing concluded that "there is contain no scientific evidence to _s_s
 in relation to other psychoactive drugs insufficient evidence to judge accurately the safety of MDMA. Dr. Downing
 such as mariiuana_ psilocybir_ and MDA. either harm or benefit." Scientific concluded that there is i_sufficient
 Minimal descriptions of test procedures experts who reviewed Dr. Downing's evidence to accurately judge MDMA's
 were included, and the studies included work concluded that his study suffers safety°
 no data to indicate a potential from the same problems as Dr. Greer's L. The substance administered by Dr
 therapeutic utility of MDMA as an and that it has little or no scientific Greet in his study° as well as that
 sdiunct to psychotherapy in humans, merit. An FDA pharmacologist_ administered by the other psychi_trisls,
 The therapeutic use of MDMA ia experienced in evaluating the eafety and was made by them under the
 not mentioned _n any medical, efficacy of d_g_. concluded that the supervision o_ a medicinal chemist and
 pwchiatric or psychotherapy textbooks° study presents so data or evidence to was nee manufactured or tested under'
 pharraacopeia or clinical pharmacoJogy support a claim that MDMA is effective controlled conditioner
 textbooks, as a therapeutic agento Mo The substances ingested by the.
 F. An unpublished study entitled H. Four psychiatrists presented subiects in Dr_ Downing's study were
 ..... '°MDMA: A New Psychotropic and its evidence that _hey had used MDMA i_ provided by the subiects thems_Hves,
 Effects in Humans" was prepared by Dr. their practices. Several other and were of unknown origin°
 George Greet° Dr. Greet is a psychiatrist psychiatrists testified that use of MDM_ composition and purity.
 in New Mexico with a private practice by these individuals was consistent with
 end little or no background as a accepted medical practice in their Discs_ioz_
 researcher° His report describes the community. E_ch physician also In order for a drug or othdr suhs_ _
 administering of MDMA _o 29 described MDMA only in terms of _o be p_aced into Sch_du]e L _ fimlin_ is
 individuals for a variety of reasons therapeutic potential A|_ agreed that so required that the substance has "n_
 ranging from curiosity and fun to a scientific studies were done on which to currently accepted medical use in
 desire to change consciousness and conclude that MDMA has therapeutic treatment in the United States." The
 behavior patterns. Only nine of the utiHtyo Most of these physicians had other four Schedules require a findir_g
 individuals had diagnosable psychiatric used MDMA themselves. The number of that the drug or other substance has a
 disorders. Dr. Greet reported that all the physicians who have used MDMA in "currently accepted medical use in
 individuals experienced "positive" their practices is very small in re|atior_ treatment in the United States." The
 effects and relatively few side ef_ectso to the physician population. United States Court of Appe_s for the
 The conclusions were based upon the L The World Health Organization First Circuit has indicsted thus
 subiective observations of Dr, Greet and (WHO) Expert Committee on Drug "currently accepted medical use in
 a nurse° as wel_ as conclusions of the Dependence reviewed MDMA for ' treatment in the United Steres°" does
 subiectso Dr. Greer described the study possible scheduling under the 197'I
 as anecdotal and not a study designed Convention on Psychotropic Substances _ot mean that a drug or other substance
 _o determine the efficacy of MDMA. i_ April '19_. The Expert Committee is lawfully marketed in the United
 Experts in psychiatry, psychotherapy included internationally recognized States pursuant to the Federal Food.
 and pharmacology concluded that Dro experts in the field of psychiatry, Drug and Cosmetic Act of 1938. While
 Greer's study did'not provide a clinical pharmacology _nd other medical the Court clearly stated that whether a
 reasonable basis for regarding MDMA professions. The Committee found that substance is lawfully marketed in the
 United States may be a factor to be
 as efficacious for enhancing therapeutic MDMA had no defined therapeutic use°
 benefits of psychotherapy, and lacked The Committee further noted that the considered in making a determination of
 scientific merit. They agreed that the a_ecdota_l date regarding MDMA's accepted medical use, it may not be the
 _tudy was not scientifically sound and clinical utility _ere _ntriguin_ but _hat sole factor upon which the
 produced only anecdotal results. The the studies _acked appropriate Administrator relies in making that
 study contained no controls: it was not a methodological design to ascertain the determination°
 blind or double blind study _nd thus re_iabi|ity of the obse_stions and The characteristics of a drug or other
 si_i_cant bias was introduced; there results. The Expert Committee substance with an accepted medical use
 were no criteria to measure recommended _hat MDMA be placed in treatment include scientificul_y
 improvement or change; there wa_ no into Schedule _ of the Convention determined and accepted know,edge o_
 defined therapeutic procedure_ end the because there was ir_sufficient evidence its chemistry: the toxicology and
 :
 investigator lacked standing as _ to indicate that the substance has phar_naco_ogy of the substance in
 sciestist and researcher, therapeutic usefulness° The United animals; establishment of its
 Go An unpublished study entitled. States is a party to the 197'_ Convention effectiveness in humans through
 "MDMA Pilot Study_PhysiologicaL on Psychotropic Substances° scientifically designed clinical trials:
 Psychological and Sociological Study," |. Published scientific literature does general availability o_ the substance and
 by Dr. _oseph _. Downing examined the not support the surety of MDMA for use information regarding the substance and
 _ffecte of MDMA in 21 healthy _n humans. _t strongly suggests that its use: recognition of its clinical use in
 individuals with no diagnosable MD_A may not be safe for human use. generally accepted pharmacopeia.
 psychiatric disorders. Dr° Downing is K. Unpublished studies by Drso Greet medical references, iourna_s or
 nots researcher and has tittle or no and Downing indicate that all textbooks: specific indications for the
 experience in designing and conducting individuals who took MDMA under their treatment of recognized disorders;
 toxicological or clinical studies. All the supervision experienced unpleasant side recognition of the _se of the s_:bst_n_ _,
 subiects had previously used MDMA effects ranging from nausea and by organisations or associations of
 and a variety of other psychoactive vomiting to ataxta, anxiety attacks, physicians; and recognition and us_. <_
 _rugs, The individuals brought their own hailucinatlons and ehort_term me_or_ the substance by a substantival s_grn_