Documents from the DEA Scheduling Hearing of MDMA, 1984-1988

1. Introduction to the Legal Record of the DEA's 1984-1988 MDMA Scheduling Hearings

DEA Announcement of proposed scheduling of MDMA as a Schedule I Drug, Federal Register, July 27, 1984  

2. Before the Hearing: Letters Supporting MDMA Research and Petitioning the DEA for a Scheduling Hearing to Determine Legal Status of MDMA

Letter from Dr. Greer to DEA requesting scheduling hearing, August 22, 1984

Letter from Dr. Grinspoon and Prof. James Bakalar requesting a scheduling hearing, August 28, 1984

Letter from Prof. Tom Roberts, requesting scheduling hearing, August 13, 1984

Letter from Nathaniel Branden, Ph.D., stating that scheduling MDMA would be a scientific calamity, August 23, 1984

Letter from David B. Katzin MD, Ph.D., requesting a hearing, August 27, 1984

Letter from Joel Alter, DO, FACOS, opposing scheduling of MDMA, August 29, 1984

Letter from C. Quincy, DO, citing potential benefits of MDMA, August 29, 1984

Letter from Dr. Shulgin, arguing that MDMA should be placed in Schedule III, August 29, 1984

Letter from ARUPA (Association for Responsible Use of Psychoactives) describing a survey of the clinical use of MDMA and urging against Schedule I, August 29, 1984

Letter from Rodney A. Houghton, M.D. a psychiatrist and medical director of Sandoval County Human Services, requesting a scheduling hearing

Letter from June E. Riedlinger, R.Ph. urging against Schedule I

Letter from David E. Nichols, Ph.D., professor of medicinal chemistry, recommending the postponement of scheduling until further research can be done, August 17, 1984

Letter from Dr. Greer to Dr. Grinspoon & Prof. Roberts on the possibilities of animal or human research with MDMA, April 21, 1984

Copies from letters to editor of Journal of American Medical Association, August 1984, regarding FDA

3. The hearing is scheduled

Letter from attorney Richard Cotton to DEA Administrator Francis M. Mullen, Jr., stating that a scheduling hearing is now required by law, September 12, 1984

DEA notice of scheduling hearing for MDMA Federal Register, December 31, 1984

Memo and order by Administrative Law Judge Francis L. Young announcing hearing, February 8, 1985 

4. Documents from the opening of the hearing

Memo for from Richard Cotton to potential witnesses in MDMA proceedings, March 1, 1985

First Memorandum of Law Submitted on Behalf of Dr. Grinspoon, Greer, et al. (stating that it is possible to schedule MDMA in schedules other than schedule I)

Memo from Administrative Law Judge outlining the proceedings to follow, March 22, 1985

5. Opening memos from each party and lists of witnesses

Opening Memo on Behalf of Dr.s Greer, Grinspoon, Profs. Bakalar and Roberts (includes appendix with witness summaries)

List of witnesses giving testimony for Greer et al.

Government's opening statement. Includes appendix with witness summaries.

Final witness list for Hoffman-LaRoche, Inc., a pharmaceutical company interested in the interpretation of "accepted medical use", April 25, 1985

6. Testimony from witnesses for Greer et al.

Testimony from Morris Lipton, Ph.D., M.D., biochemist and psychiatrist supporting further research on MDMA and deconstructing the DEA's argument for Schedule I status, April 24, 1985

Testimony of Dr. Lester Grinspoon, comparing the decision to schedule MDMA to the scheduling of LSD, halting potentially beneficial research, and discussing MDMA's promise in therapy, April 18, 1985

Testimony of Norman Zinberg, M.D., discussing MDMA's low risk and potential benefits as a therapeutic agent, April 22, 1985

Testimony of David E. Nichols, Ph.D., a medicinal chemist stating that MDMA represents a new type of pharmacologic agent and cannot be considered to be either an hallucinogenic agent or an amphetamine-type stimulant

Testimony of George Greer, MD April 22, 1985, discussing his clinical experience with MDMA

Attached: "The Legal, Safe and Effective Use of MDMA", George Greer M.D.

Testimony of Robert DuBois Lynch, M.D. (a psychiatrist who sees therapeutic benefits)

Testimony of Richard Ingrasci, M.D., MPH, a psychiatrist who found therapeutic benefit of MDMA, April 22, 1985

Testimony of Richard Seymour, the Director of the Haight Ashbury Training and Education Projects of the Haight Ashbury Free Medical Clinics reporting on his observations of clients using MDMA in an non-therapeutic context, and his assessment of MDMA as having a relatively low abuse potential, April 22, 1985

Testimony of Philip E. Wolfson, M.D. psychiatrist who found therapeutic benefits and sees low abuse potential, April 24, 1985

Testimony of Rick J. Strassman, M.D., discussion of pharmacology of MDMA

Testimony of Joseph J. Downing, M.D. describes his experience testing MDMA as a therapeutic tool (includes an appendix written by a patient who used MDMA-assisted therapy to cope with a sexual assault) April 24, 1985

Testimony of Lance S. Wright, M.D. stating low abuse potential and belief in therapeutic potential

Testimony of Thomas B. Roberts, Ph.D. recommending further studies and that MDMA not be scheduled at this time, April 23, 1985

Testimony of June E. Riedlinger, R.Ph., a pharmacist commenting on MDMA's low abuse potential, structural differences from MDA, and usefulness in therapy

7. Testimony from DEA witnesses

Identification of DEA's witnesses and affadavit of direct testimony, April 26, 1985

Testimony of Special Agent Robert C. Chester, Jr. regarding ecstasy trafficking in Texas, April 25, 1985

Testimony of John P. Docherty, MD, a government psychiatrist noting methodological problems in Dr. Greer's study, April 24, 1985

Testimony of Richard A. Glennon, Ph.D., arguing that MDMA has amphetamine-like properties, similar to MDA, April 22, 1985

Testimony of Harold F. Hardman, Ph.D., M.D., a pharmacologist, stating that MDMA is a stimulant, less toxic than MDA and more toxic than mescaline, April 18, 1985

Testimony of Frank Sapienza, M.S., a DEA chemist, discussing MDMA street use, laboratories & some literature, April 25, 1985
Includes exhibits: Early article about ecstasy, series of flyers given with pills advising on usage

Testimony of Ronald K. Seigel, Ph.D., a psychopharmacologist arguing for Schedule I status

Testimony of Edward Charles Tocus, Ph.D., an FDA pharmacologist, arguing for Schedule I status

8. Government witnesses' rebuttal testimony

Government's rebuttal testimony witnesses, May 20, 1985

Memo from Richard Cotton to witnesses, enclosing DEA rebuttal testimony, June 3, 1985

Testimony of Joel Kleinman, M.D., Ph.D., critiquing Greer et al's MDMA studies, May 18, 1985

Testimony of Lewis S. Seiden, Ph.D., critiquing studies, discussing neurotoxicity potential, and advising caution in administering MDMA to humans, May 15, 1985 
Exhibits from this witness:

Rebuttal testimony of Harlan E. Shannon, Ph.D., responding to Dr. Nichols' statement, May 17, 1985

Rebuttal testimony of James M. Sheahan, DEA Chief of Registration Unit, describing the process by which one becomes registered as a Schedule I researcher, May 20, 1985

Rebuttal testimony of Larry Snyder, a DEA investigator, describing the recordkeeping and storage requirements of scheduled drugs, May 16, 1985

Rebuttal testimony of Edward Charles Tocus, Ph.D., critiquing testimony by Lynch, Downing, and Dziewanowska, May 16, 1985

Rebuttal testimony of D. Bruce Vaupel, Ph.D., a NIDA pharmacologist responding to Dr. Nichols' statement, May 17, 1985

9. Greer et al rebuttal testimony

Letter from George Greer to witnesses outlining what to focus on in rebuttal testimony (includes the earlier DEA testimony)

List of witnesses submitting rebuttal testimony for Greer et al. May 20, 1985

Rebuttal testimony of George Greer, MD (rebuttal to testimony of Dr. John Docherty, Professor Ronald Seigel, Dr. Edward Tocus)

Included: FDA document on obtaining approval, May 16, 1985

Letter from Dr. Shulgin to Dr. Greer, May 17, 1985

Rebuttal testimony of Rick J. Strassman M.D. (rebuttal to Dr. Docherty. Seigel, and Tocus) May 16, 1985

Testimony of Rodney A. Houghton, M.D. evaulating Dr. Greer's use of MDMA, April 29, 1985

Rebuttal testimony of Will L. MacHendrie M.D., member of Dr. Greer's Peer Review Commttee, April 30, 1985

10. Cross-examination

Government's list of witnesses called for cross-examination, May 31, 1985

11. Meanwhile: Emergency Scheduling of MDMA

Temporary placement of MDMA into Schedule I (the emergency scheduling), May 28, 1985

DEA Press Release on Emergency Scheduling, May 31, 1985

Letter from Richard Cotton to Secretary Margaret Heckler, Department of Health and Human Services arguing that there is a discrepancy between MDMA's emergency scheduling due to an "imminent public health hazard" and the FDA-approved marketing of amphetamines, which are more often abused June 5, 1985

Statement by Greer et al on the May 31, 1985 emergency scheduling of MDMA, June 10, 1985

Draft of an argument against the emergency scheduling

Letter from Greer et al to Rep. Henry Waxman, Chairman of Subcommittee on Health and the Environment, requesting Congressional review of the DEA's emergency scheduling, July 1, 1985

Same Letter as above, to Rep. William J. Hughes, Chairman of Subcommittee on Crime

Same Letter as above, to Senator Paul Laxalt, Chairman, Subcommittee on Criminal Law

Same Letter as above, to Senator Paula Hawkins, Chair, Subcommittee on Alcoholism

Response to Richard Cotton from James O. Mason, M.D., Dr.Ph., Acting Assistant Secretary for Health, regarding the DEA emergency scheduling July 8, 1985

12. The Hearing Continues...

Report on orally administered MDMA toxicity in rats Nichols, Summer 1985

Administrative Law Judge Francis L. Young's Opinion and Recommended Decision on Preliminary Issue, June 1985

Letter from Jo Brugmans, M.D., Vice President of Janssen Pharmaceutica to Frank Sapienza, stating that his company engages in research with Schedule I drugs with the cooperation of the DEA and FDA, October 18, 1985

Letter from Albert Kurland, M.D. (LSD researcher at the Maryland Psychiatric Research Center) to Lester Grinspoon, discussing the difficulties of research with Schedule I drugs, July 11, 1985

Motion for Leave to File Additional Documents on Behalf of Dr.s Greer and Grinspoon, Professors Bakalar and Roberts, July 19, 1985

Additional documents submitted on behalf of Dr.s Greer, Grinspoon, Prof.s Bakalar and Roberts, July 19, 1985 (Letters from DEA detection labs showing that MDMA not widely abused)

Letter from Charlotte Johnson to Richard Cotton, July 16, 1985, regarding DEA's requests for info on MDMA from detection labs
Below are all letters from labs regarding MDMA:

Letter from Paul S. Gipe to Frank Sapienza, June 12, 1979
Letter from Stark Ferriss to Frank Sapienza, June 12, 1979
Letter from Sandra J. Stoltenow and Michael L. Rehberg to Frank Sapienza, June 13, 1979
Letter from J. W. Brackett, Jr. to Frank Sapienza, June 26, 1979
Letter from F. E. Perry to Frank Sapienza, August 2, 1979
"Efficacy, Dependence Potential and Neurotoxicity of Anorectic Drugs", Schuster & Johnson

Cover Letter from Roland R Griffiths, Ph.D., to Frank Sapienza with enclosed report on MDMA self-injection study, September 30, 1985

Article on reinforcing effects of MDMA on baboons (Griffiths et al.)

Cover Letter from Charlotte Johnson (DEA attorney) to Richard Cotton for NIDA studies, October 3, 1985

Article on Relative Abuse Liability of Triazolam: Experimental Assesment in Animals and Humans (Griffiths et al.)

Article on PCP Self-Injection by the Baboon (Griffiths et al.)

Article on Predicting the Abuse Liability of Drugs with Animal Drug Self-Administration Procedures: Psychomotor Stimulants and Hallucinogens (Griffiths et al.)

Memo from Richard Cotton to Dr. Greer et al November 5, 1985 with enclosure:

Response to Agency Exhibits by Drs. Grinspoon et al., November 4, 1985, critiquing government animal studies

Addendum Report of 28-Day Oral Toxicity of MDMA in Dogs and Rats Sponsored by Earth Metabolic Design Laboratories, April 17, 1986

Memorandum for interested parties from Dr. Greer, overviewing the proceedings to date and what remains; includes some interesting and sympathetic quotations from the Administrative Law Judge, November 8, 1985

Letter from Prof. James Bakalar to Richard Cotton regarding "accepted medical use" as defined in medical literature, December 23, 1985

13. The Hearing's Conclusions

Government's proposed findings

Agency's Proposed Findings of Fact, Conclusions of Law and Argument by Stephen Stone and Charlotte Johnson, December 10, 1985. 
(The DEA's statement that MDMA currently has no accepted medical use, has a high potential for abuse, and has not been studied sufficiently to allow therapeutic use in humans)

Pharmaceutical company's proposed findings 
Hoffman-La Roche Inc.'s Proposed Finding of Fact, Conclusion of Law, and Argument
A pharmaceutical company's argument regarding the DEA's narrow interpretation of "accepted medical use" and the limits this places on research

Greer et al's proposed findings

Memo from Richard Cotton to interested parties.

Enclosures: Brief, Including Proposed Findings of Fact and Conclusions of Law on Behalf of Drs. Greer and Grinspoon, et al. January 15, 1986

Government's response to Greer et al.'s proposed findings

Government's response to the Findings of Fact, Conclusions of Law, and Arguments Submitted by Drs. Greer and Grinspoon, et al., February 10, 1986

Administrative Law Judge's decision

Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision of Administrative Law Judge, on Issues Two through Seven, recommending that MDMA be placed in Schedule III. May 22, 1986

Government's exceptions to the Administrative Law Judge's Decision

Governments Exceptions to the Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of the Administrative Law Judge, June 13, 1986
Submitted to the DEA Administrator from Stephen E. Stone and Charlotte A. Johnson, Counsel for DEA, arguing that Judge Young is biased and did not consider the evidence, and MDMA should be placed in Schedule I.

Greer et al's response to government's exceptions

Cover Letter from Richard Cotton to Judge Young, June 27, 1986

Enclosures: Response of Drs. Grinspoon, Greer, et al., to the Government's exceptions to the opinion of the Administrative Law Judge, June 27, 1986

Motion to Strike Portions of the Exceptions filed by the DEA
(Portions which state a bias of the Administrative Law Judge) June 27, 1986

Request for opportunity for oral presentation to the administrator from Greer, Grinspoon et al, June 27, 1986

Cover Letter for Response to DEA Exceptions, from Rick Cotton to Greer, Grinspoon, Shulgin, and Harlow, July 14, 1986

DEA Administrator's Response

Order from John C. Lawn, Administrator agreeing that the DEA's allegations of Judge Young's bias were improper, unfounded, and should be stricken from the record; also denying respondents' request for oral presentation, August 15, 1986

14. And meanwhile, across the globe...documents from the international scheduling of MDMA by the World Health Organization

FDA request for data and comments to submit to the WHO regarding scheduling of MDMA and other phenylethylamines, Federal Register, July 19, 1984

"Phenethylamines", by the Department of Health and Human Services, prepared in response to the WHO request for info on 30 phenethylamines (including MDMA), January 1984

Letter from Dr. Shulgin to Paul Grof, M.D., Stan Grof's brother, and chair of the WHO Expert Committee determining MDMA's scheduling status, April 6, 1985

"Summary review of certain phenylethylamine related substances recommended for control by WHO", May 1985, by the 22nd Expert Committee on Drug Dependence, WHO, Geneva, from April 22-27 1985 recommending that MDMA be placed in Schedule I, but also stating that it is an interesting substance and more research should be encouraged, and noting Dr. Paul Grof's dissent

WHO Expert Committee on Drug Dependence: Twenty-second report, Geneva, 1985
Assessment of 28 phenylthylamines, including MDMA

Letter from the Secretary General of the United Nations to the U.S. Secretary of State, stating that the WHO has found that MDMA should be placed in Schedule I, and that the Commission on Narcotic Drugs will schedule MDMA during its next session. July 18, 1985

15. Phase II: The Appeals Process

Memo from Richard Cotton to Greer et al, with an appeal court decision regarding the DEA (demonstrating the difficulty of overturning a DEA decision), June 10, 1986

Extension of temporary schedule I status of MDMA, Federal Register, June 17, 1986

DEA places MDMA in Schedule I, Federal Register, October 14, 1986

Petition for Review of DEA, U.S. Court of Appeals, First Circuit (the appeal, from Dr. Lester Grinspoon)

Administrative Law Judge Docket Card submitted to Court of Appeals, December 3, 1986

Notice from appeals court stating that record on appeal has been filed, December 8, 1986

First draft of appeals brief, with cover Letter from James Bakalar to Richard Cotton, December 22, 1986

Letter from Lyn B. Ehrnstein to Lester Grinspoon, supporting his appeals case, December 29, 1986

Letter from Court of Appeals to lawyers stating due date for filing briefs, December 30, 1986

Notice from Court of Appeals stating due date for filing briefs, January 12, 1987

Petition for Review of Final Order of DEA: Brief for Petitioner, January 12, 1987

Joint Appendix in appeals case (document containing much of the material from the scheduling hearing), January 12, 1987

Motion for leave to cite material not reproduced in the joint appendix, from Richard Cotton on behalf of petitioners, January 29, 1987

Notice of receipt of Letter and identification of petitioners' counsel by Richard Cotton, February 13,1987

DEA's brief, February 11, 1987

Petitioner's counsel appearance form

Letter from Richard Cotton to the appeals court stating that the petitioner served the petition to parties named in the letter

Motion for leave to cite material in the record not reproduced in the join appendix, from Richard Cotton, February 18, 1987

Motion for summary grant of petition, to strike brief, or for order that appellee not be heard (from petitioner, because the DEA's brief was filed late), February 18, 1987

Court Order denying petitioner's motion to strike DEA's brief, February 20, 1987

Reply brief for petitioner, February 23, 1987

Appeals Court docket stating date and time of hearing

Appeals court docket stating time allowed appellant and appellee in hearing

Appeals court order asking both parties to comment on 28 U.S.C. Sections 813 (the Analogue Act, which states that analogues of Schedule I drugs be scheduled the same way) in light of the undisputed finding that it is an analogue of MDA, a Schedule I drug, July 10, 1987

Petitioner's response to legal issues pertaining to 28 U.S.C. Section 813, stating that the Analogue Act only pertains to unscheduled drugs, and MDMA could be placed in Schedule III.

Appeals Court decision not to overturn the DEA, but to recommend that the DEA's scheduling be reconsidered due to improper interpretation of "accepted medical use"

DEA request for time extension to file rehearing petition

Letter from the court granting respondent an extension of time to file petition for rehearing, October 1, 1987

DEA's petition for rehearing of the part of the court's decision which stated that the DEA Administrator applied an improper legal standard in determining that MDMA has no currently accepted medical use

Court Order denying the DEA's petition for rehearing, December 14, 1987

16. Later court cases relevant to the emergency scheduling