In re MDMA Scheduling (ALJ Young opinion)

I. Introduction

This is a rulemaking proceeding pursuant to the Controlled Substances Act as amended (the Act or the CSA) to determine in which schedule, if any, of the five schedules established by the Act, the substance 3, 4-methylenedioxymethamphetamine, also known as MDMA, should be placed. The proceeding is being conducted pursuant to Subchapter II of Chapter 5 of Title 5, United States Code, the Administrative Procedure Act, after opportunity for a hearing. The Act itself placed a great many substances in one schedule or another. It vested the Attorney General with the authority, after considering several prescribed factors, to place other substances in appropriate schedules, to move substances from one schedule to another, and to de-schedule them. That authority has been delegated to the Administrator of the Drug Enforcement

Administration (DEA) .3

1 p.L. 91-513, 84 Stat. 1242, 21 U.S.C. §§ 801, et seq. 2 21 U.S.C. § 811(a).

3 28 C.F.R. § 0.100.

At the commencement of this proceeding in July 1984 MDMA was not listed in any schedule. At that time DEA published in the Federal Register4 a notice of proposed rulemaking to place the substance in Schedule I. A number of persons filed comments and objections and requested a hearing. This administrative law judge was requested by the then-Deputy Administrator to preside and to provide the Administrator with a certified record and recommended findings of fact, conclusions of law and decision.

At a preliminary prehearing conference of participants on February 1, 1985 it was suggested that one of the issues identified presented a purely legal question which might be decided without the need of any evidence and in advance of the other issues in the case. (The Deputy Administrator had specified this issue as one on which a recommended conclusion was to be prepared for the Administrator.) After considering memoranda submitted by the participants the administrative law judge agreed and accepted the suggestion. The judge called for briefs from the parties on that issue. It was designated issue number 1. and was stated thus:

1. Assuming that a substance has a 'potential for abuse and has no currently accepted medical use in treatment in the United States, can the substance be placed in any schedule other than Schedule I?

After studying the briefs the judge issued a recommended decision on that issue, dated June 1, 1985. He recommended, first, that the language of the Act was such that a substance with a potential for abuse less than a "high" potential, and having no currently accepted medical use in treatment, cannot be placed in any of the five schedules. (Clearly, a substance with a "high" abuse potential and no accepted medical use in treatment, must be placed in Schedule

I.) Alternatively the judge recommended, based upon court decisions inter-

preting the Act, actions of the Congress, legislative history and DEA's own past

4 49 F.R. 30210 (1984).

actions, that such a substance should be placed in either Schedule III, IV or V depending upon its degree of potential for abuse. In a letter to the administrative law judge dated October 7, 1985 the Administrator advised that he had decided not to issue a final agency ruling on that initial issue until he had received the entire record at the conclusion of the case.

Meanwhile, the proceeding continued with respect to the remaining issues.

[Sections II ("Recommended Ruling"), III ("Issues"), and the opening of IV, in which the judge works through the legal standard for "currently accepted medical use" — including case law on the "respectable minority" rule in medical malpractice — are omitted.]

V. Findings of Fact — "Currently Accepted Medical Use" of MDMA

There is testimony in this record from reputable physicians, i.e., responsible medical authorities who constitute a respectable minority, that the use of MDMA is acceptable in the treatment of certain kinds of patients.

Dr. George Greer is a psychiatrist in private practice in New Mexico. He is Board Certified. He is also a part-time consultant psychiatrist at the penitentiary in New Mexico where he treats inmates. Prior to July 1, 1985 Dr. Greer had been doing clinical work with MDMA for four and one-half years. He had administered it to 76 patients. He found MDMA to be helpful as an adjunct to psychotherapy in certain cases. He considers himself a clinician, not a researcher. He has studied extensively in the field of using altered states of consciousness to facilitate psychotherapy and personal development.

In January 1983 Dr. Greer learned that MDMA was being used recreationally. He became concerned that its legitimate medical use might be challenged, so he wrote a paper describing his work with the substance. In this paper Dr. Greer _ intended simply to present the results of his experience using MDMA with patients. It was not his intention there to report on a formal, controlled testing program for MDMA to present a convincing argument definitely establishing the efficacy of MDMA. He believes that MDMA should be scheduled and

subjected to some controls by DEA. He desires to see it placed in Schedule III.

He desires to see formal research undertaken with the drug and funding made available for such research. He has informally sought such funding from at least two pharmaceutical companies, but they were not interested. The drug cannot be patented. He made informal contact with officials at FDA, suggesting that FDA provide funding for studies and promote research in the use of the

drug. So far no one has made such funding available.

Dr. Rick J. Strassman is Assistant Professor of Psychiatry, University of New Mexico School of Medicine, in Albuquerque. He is medical director and principal investigator of a program in which marihuana or THC is being used to combat cancer chemotherapy-induced nausea and vomiting. This project is funded by the State of New Mexico with approval of FDA and the National Institute of Drug Abuse (NIDA). Previously he was Assistant Professor of Psychiatry at the University of California, Davis Medical Center. He has served as a psychiatrist at mental health centers in California and Alaska. He is board certified by the American Board of Psychiatry and Neurology.

Dr. Strassman is a member of the peer review committee which had been overseeing Dr. Greer's work with MDMA. Dr. Strassman testified:

As a member of [Dr. Greer's] peer review board in New Mexico, I have reviewed his inclusionary and exclusionary criteria for entrance into the protocol, informed consent forms, protocol for administration of MDMA... ., the setting in which sessions occur, his results of follow-up, etc. In my opinion, he has included appropriate safeguards and has not experienced significant adverse reactions to this form of treatment, and that all individuals have experienced significant benefit. Therefore, within the standards of practice set forth by the physicians' community, MDMA has a currently accepted medical use in the hands of a qualified clinician (e.g., Dr. Greer).

Strassman Rebuttal Testimony, at 1-2.

Dr. Rodney A. Houghton was another member of Dr. Greer's peer review committee. He is a former Chief Resident in the Department of Psychiatry at the University of New Mexico and has conducted psychiatric clinics in four rural New Mexico counties. In this connection among other things he provided in-service

training on various aspects of clinical psychiatry for law enforcement agencies

including policemen, jailors and local sheriffs. He has served as an expert on

psychiatric care to the New Mexico State Department of Health and Environment

concerning the State Mental Health Programs. As a psychiatrist he has been medical consultant to the Social Security Administration, HHS, reviewing psychiatric disability cases for the Disability Determination Unit of New Mexico. He has served as a member of the committee reporting to the State agency responsible for funding and maintaining standards for community mental health programs. He is a Clinical Assistant Professor of the University of New Mexico Department of Psychiatry. He is a member of the medical staffs of two psychiatric hospitals in Albuquerque. Dr. Houghton is in contact with and has worked with psychiatrists and other mental health care professionals throughout New Mexico. Dr. Houghton testified in this proceeding as follows:

In summary, during the nine years of practicing psychiatry in New Mexico, I have become well acquainted with the academic community, rural and private practice standards of psychiatric evaluation and treatment. I have been involved at all levels of developing and maintaining quality medical treatment of psychiatric patients in this state — in the political and government agency area, in the grassroots community level, and in the private profit and not-for-profit hospitals.

In my expert opinion, as one who is familiar with the accepted standards of psychiatric practice in New Mexico, indeed, having established many of those standards for five rural communities and community programs throughout the state, I believe Dr. Greer's use of MDMA is an accepted and safe medical practice. I base this opinion not only on my own experience and what I believe to be

acceptable, but also on my conversations with teachers and colleagues about his work.

Houghton Rebuttal Testimony, at 3-5.

[Similar testimony from three more members of Dr. Greer's peer-review committee (Drs. MacHendrie, Wolfson, and Downing) and from psychiatrist Robert Lynch, all to the same effect, is omitted.]

Four additional psychiatrists testified in these proceedings that, before its being placed in Schedule I on July 1, 1985, MDMA had a currently accepted medical use in psychotherapy for certain purposes and under certain conditions. They were Dr. Morris Lipton, professor of psychiatry at the University of North Carolina, Chapel Hill, and Deputy Editor of the American Journal of Psychiatry of the American Psychiatric Association; Dr. Norman Zinberg, clinical professor of psychiatry, Harvard Medical School; Dr. Lance Wright, practicing psychiatrist and Assistant Clinical Professor of Psychiatry, University of Pennsylvania and Associate Professor of Child Psychiatry, Hahnemann Medical College; and Dr. Richard Ingrasci, a psychiatrist in private practice in Watertown, Massachusetts.

No testimony to the contrary by any witness is brought to the attention of the administrative law judge by the Agency or any other participant.

Conclusion

The administrative law judge finds and concludes that, prior to its being proscribed effective July 1, 1985, MDMA did have "a currently accepted medical use in treatment in the United States." It is not presently being used in

treatment because it has been proscribed.

[The judge's lengthy legal argument in Section VI on the meaning of "accepted safety for use," including his rejection of the government's position that only FDA approval can satisfy the standard, is omitted.]

VI. Findings of Fact — "Accepted Safety for Use" of MDMA

With respect to the safety of MDMA, the following facts are established in this record by the preponderance of the evidence.

MDMA has been utilized by some psychiatrists as an adjunct to psychotherapy. It is usually administered to the patient only once, or at most twice, at the beginning of a course of psychotherapy. It is administered by, or in the presence of, the treating psychotherapist. The psychiatrist remains with the patient, or is immediately available, during the period after ingesting of the substance when it might adversely affect normal functioning. All of this is in

marked contrast to the manner of administering many other controlled drugs,

which patients self-administer at home or elsewhere with scant regard for possible immediate contact with the physician.

There are many other oral medications, controlled substances, that are not so restricted by the treating physician, i.e., to only one or two administrations and in such relatively low doses.

MDMA has been administered to animals in a number of different studies.

The injection LD 5014 has been established and the oral LD 50 has been reliably estimated. The doses of MDMA administered therapeutically by psychiatrists to patients have been less than one percent of the LD 50. This indicates a very high margin of safety with MDMA when it is used in treatment.

Clinical trials with humans were reported in 1978 in a monograph, published by the National Institute on Drug Abuse. Dr. Greer has written a report on his clinical experiences administering MDMA to patients. Others interested in using MDMA in therapy had read copies of this report although it had not been published as of the time of the hearings in this proceeding. Dr. Ingrasci, a psychiatrist in private practice, has reported on his clinical observations in administering the drug to nearly 100 individuals over 5 years, from 1980 to 1985.

No evident harm resulted to any of these persons from his use of the drug. Dr. Downing has reported on an informal study of the physiological effects of MDMA on some 20 human volunteers. None of them suffered apparent harm. Although there was no verification by scientific analysis, it is reasonable to accept, in the circumstances, that all these volunteers had ingested MDMA in the quantity assumed for purposes of the study.

In addition, other psychiatrists have been using MDMA in their practices

over the past 10 years. Because MDMA cannot be patented, no pharmaceutical

14 see finding 27, page 45, below.

company has had the financial incentive to carry out the extensive animal and clinical tests required by the FDA for approval to market the drug on an interstate basis. Nevertheless, the overwhelming weight of medical opinion evidence received in this proceeding concurred that sufficient information on MDMA existed to support a judgment by reputable physicians that MDMA was safe to use under medical supervision. No evidence was produced of any instances where MDMA

was used in therapy with less than wholly acceptable safety.

Conclusion

The administrative law judge finds and concludes that there is no "lack of accepted safety for use" of MDMA "under medical supervision." On the contrary,

there is accepted safety for use.

[The remainder of Section VI, Section VII ("Effect of Secretary's Findings"), and Section VIII ("Proper Schedule For MDMA") — in which the judge weighs abuse-potential evidence, addresses HHS's contrary recommendation that MDMA remain in Schedule I, and works through the statutory criteria for Schedule III placement — are omitted. His conclusion follows.]

IX. Recommended Decision

Drs. Grinspoon, et al., assert that there are two courses of action open to the Administrator at this point: Either the Administrator can review all the evidence of record and reach a decision, based thereon, on all the issues, or the Administrator can send the record, together with the administrative law judge's findings and conclusions, to HHS for review and comment on the scientific and medical issues.

The administrative law judge finds neither authority nor merit for the second alternative.

The statute clearly provides that, in a situation such as ours, where DEA initiates a scheduling, DEA shall, "before initiating proceedings" and after gathering necessary data, request an evaluation and recommendations from HHS.

21 U.S.C. § 811(b). That was done. After HHS responded to the request, DEA initiated this proceeding. The statutory scheme clearly contemplates that at that point opportunity will be provided, in open hearings pursuant to the Administrative Procedure Act, for the presentation of further "data" or evidence on all issues. The Administrator is then to make the final Agency decision, which must be based on that record. The statute contemplates that the record may contain scientific and medical information not considered by HHS at the outset.

Referral of the matter at this point to HHS for a second time may well result in a record that could not pass muster under the Administrative Procedure

Act.

The Administrator of DEA has no authority to direct the Secretary of HHS to take any action. The Administrator provided the Secretary with the opportunity the statute requires.

If the Administrator of DEA carefully considers the entire record now provided in this proceeding, there is no reason why he cannot come to the informed decision the law requires of him as the Agency head.

Needless to say, nothing in this opinion is to be taken as being in any way critical of the Agency's emergency scheduling of MDMA which became effective on July 1, 1985. That action was taken pursuant to certain statutory authority with which this proceeding is not concerned. That action was wholly unilateral,

reflecting a view based on evidence then available to the Agency but without opportunity for the presentation of countervailing evidence or argument. This proceeding, a wholly separate process, has provided that opportunity. A complete record, with input from different perspectives, has now been assembled for the benefit of the Administrator, the head of the Agency.

The record now assembled contains much more material about MDMA than the Agency was aware of when it initiated this proceeding by publishing a notice almost two years ago.

Based upon this record it is the recommended decision of the administrative law judge that the substance 3, 4-methylenedioxymethamphetamine, also known as MDMA, should be placed in Schedule III.

Dated: MAY 22 1986

[signed] Francis L. Young Administrative Law Judge