The Politics of Medicine: the Scheduling of MDMA

By Richard Glen Boire         (c) 2000 CCLE

“The first casualty in war is truth,” wrote the Greek playwright and poet Aeschylus around 500 BC. In the war on drugs, Aeschylus’ proposition is surely realized. Drugs that patients and medical professionals have found beneficial are decreed to have “no accepted medical use” by the nation’s top drug cop—the Administrator of the DEA—and are declared off-limits for use in treatment of any kind. This ugly politicized process is clearly illustrated by the procedural history surrounding the scheduling of the drug MDMA.

First synthesized by the Merck pharmaceutical firm in 1912, but never marketed by the company, MDMA resurfaced in the early 1970s. With its short duration and unique characteristic for reliably heightening the capacity for introspection and self-acceptance, coupled with the easing of communication anxieties, MDMA soon caught the ear of psychotherapists who quietly began using the then-legal (but unapproved) drug as an adjunct to therapy.

One such psychiatrist was Dr. George Greer. Colleques of Dr. Greer discovered that MDMA facilitated the therapeutic process. After spending a few months researching the laws and regulations, Dr. Greer concluded that if he manufactured the MDMA himself, and had peer review and informed consent, that he could legally administer MDMA to his patients. He proceeded to synthesize a batch of MDMA with the assistance of Dr. Alexander Shulgin, Ph.D., and administered it to about 80 people over a five year period.

Although none of the patients to whom Dr. Greer administered MDMA suffered from disabling psychiatric conditions (Dr. Greer excluded such patients for safety reasons), well over 90% reported benefits that they considered significant. These included improvement of communication and intimacy during the sessions with spouses, and a general decrease in psychological problems afterward. Interpersonal relationships, self-esteem and mood also generally improved. Many patients reported that these improvements in their lives lasted from weeks to years, even after only one or two sessions utilizing MDMA.[1]

At the same time that Dr. Greer and a growing number of other psychotherapists were finding MDMA useful as an adjunct to therapy, recreational use of the drug was growing. In 1981 an underground manufacturer of MDMA gave it the marketing moniker “ecstasy” and recreational use ballooned. Word of MDMA soon reached the DEA which, in 1982, opened a file on the drug.

In the July 27, 1984 issue of the Federal Register, the DEA announced that it was moving to add MDMA to the list of Schedule I substances. The notice stated that MDMA had no legitimate medical use or manufacturer in the USA, was responsible for an undisclosed number of trips to emergency rooms, and had a high potential for abuse.[2]

Dr. Greer and other psychiatrists who were using MDMA in therapy were alarmed when they learned of the DEA’s intention to place MDMA in Schedule I. Dr. Greer and fifteen other medical professionals wrote the DEA explaining that in their professional experiences MDMA had proven to be a tremendous aid to therapy, and could be used safely under medical supervision. Placing MDMA in Schedule I would make it all but impossible for anyone—medical professionals included—to use the substance in therapy. Not one person wrote to support the DEA’s intention to place MDMA in Schedule I.

As a result of the doctors’ letters, the DEA was forced to hold hearings on the matter of MDMA’s proposed scheduling. Nine days of hearings were held in three cities during 1985. At the hearings, thirty-three witnesses testified and ninety-five exhibits were received into evidence. Psychiatrists testified that the drug was an invaluable therapeutic adjunct that was safe when used under professional supervision. Witnesses for the DEA countered that the psychiatrists were basing their testimony on nothing but anecdotes—that no controlled scientific studies existed to support their claims.

Shortly before the first hearing date, President Reagan appointed a new Administrator of the DEA. The appointee, John Lawn, had a long history as an upper-level special agent in the FBI but, like all other DEA administrator’s, absolutely no medical training or experience. In a remarkably unabashed slap to the hearing process that was already underway, the new Administrator, acting under emergency scheduling powers, unilaterally decreed that effective July 1, 1985, MDMA would be a Schedule I drug.[3] Administrator Lawn stated that notwithstanding the ongoing hearing on the issue of MDMA’s appropriate status, emergency scheduling was “necessary to avoid an imminent hazard to the public safety.”[4]

Over the next ten months however, the facts about MDMA were heard by Judge Francis Young, who presided over the hearings. After receiving and considering all the evidence admitted during the hearings, Judge Young issued his findings and recommendation on May 22, 1986. In a comprehensive opinion, Judge Young found that MDMA did not meet a single one of the three criteria necessary for placement in Schedule I. Judge Young reported that MDMA had a safe and accepted medical use in the US under medical supervision. Furthermore, he found that the evidence failed to establish that MDMA had a high potential for abuse. Based on his thorough examination of the evidence, Judge Young recommended that MDMA be placed in Schedule III, which would allow doctors to use it in therapy and prescribe it, while still keeping it unavailable to the public at large.

Administrator Lawn refused to accept Judge Young’s recommendation. In Administrator Lawn’s opinion, because MDMA was not an FDA approved drug it ipso facto lacked both any currently accepted medical use in treatment and an accepted safety for use under medical supervision. Administrator Lawn also averred that Judge Young gave too much weight to the testimony and evidence of doctors and patients, and not enough consideration to studies on rats, or the lack of FDA approval. In a flat rejection of Judge Young’s recommendation, Administrator Lawn decreed that effective November 13, 1986, MDMA would be permanently placed in Schedule I, not Schedule III.[5]

The medical community fired back. Lester Grinspoon, an associate professor of Psychiatry at Harvard Medical School sued the DEA, seeking to invalidate MDMA’s Schedule I status.[6] The federal circuit court that heard the case succinctly summarized the competing arguments: “The [DEA] Administrator reads “accepted [medical use]” to mean that the FDA must have approved the drug for interstate marketing. Dr. Grinspoon, on the other hand, prefers to interpret “accepted” as meaning that the medical community generally agrees that the drug has a medical use and can be used safely under medical supervision.”[7]

Calling Administrator Lawn’s argument “strained” and “unpersuasive,” the federal court rejected Lawn’s argument and sided with Dr. Grinspoon.[8] The court vacated MDMA’s Schedule I status, and remanded the case to the DEA for reconsideration—prohibiting Administrator Lawn from making the lack of FDA approval the basis for his decision.[9] Remarkably, in a perfunctory final rule decreed less than a month later, Administrator Lawn claimed that he had reconsidered the evidence and once again (but this time without absolute reliance on the lack of FDA approval), concluded that MDMA belonged in Schedule I.[10] Thirty days later (on March 23, 1998), despite clear evidence that MDMA showed promise in treating mentally suffering people, MDMA became a Schedule I “hallucinogen.” Possession of the drug, for any reason, remains a federal offense.


Notes

[1] For documented support of MDMA’s potential benefits in psychotherapy, see Chapter ___ , “A Conversation with George Greer and Myron Stolaroff,” pg___.

[2] 49 Fed. Reg. 30210-30212, July 27, 1984.

[3] The emergency scheduling provision allows the Attorney General to act without holding a hearing by asserting that there is an “imminent hazard to the public safety.” (21 U.S.C. Sec. 811 (h).)

[4] Administrator Lawn gave the following reasons for his decision to invoke the emergency scheduling provision:

Unapproved, so-called therapeutic use of MDMA continues in many sections of the country. Clandestine production, distribution and abuse of MDMA is occurring nationwide and appears to be escalating. The open promotion of MDMA as a legal euphoriant through fliers, circulars and promotional parties has recently surfaced in some areas. DEA agents estimate that 30,000 dosage units of MDMA are distributed each month in one Texas city. Drug abuse treatment programs have reported that they are seeing individuals seeking treatment who have taken multiple doses of MDMA…Of immediate concern to DEA is terms of hazard to public safety is a very recent research finding which suggests that MDMA has neurotoxic properties. A paper entitled “Hallucinogenic Amphetamine Selectively Destroys Brain Serotonin Nerve Terminals: Neurochemical and Anatomical Evidence” by G. Ricaurte, G. Bryan, L. Straus, L. Seiden and C. Schuster, describes studies which show that single or multiple doses of MDA selectively destroy serotonergic nerve terminals in the rat brain…Experts have concluded that because of the neurotoxic effects of closely related structural analogs of MDMA (MDA, amphetamine and methamphetamine) and because both MDA and MDMA cause the release of endogenous serotonin, it is likely that MDMA will produce similar nuerotoxic (sic) effects to those of MDA. (50 Fed. Reg. 23118-23119, May 31, 1985.)

 

In a subsequent case, the federal convictions of several defendants for distributing and conspiring to distribute MDMA were reversed by the Ninth Circuit Court of Appeals which found that Administrator Lawn overstepped his powers. The court held that the Attorney General never properly delegated to the DEA Administrator the emergency power to temporarily schedule controlled substances. (U.S. v. Emerson (9th Cir. 1988) 846 F.2d 541; accord, U.S. v. Spain (10th Cir. 1987) 825 F.2d 1426, 1429.)

[5] Ibid.

[6] Grinspoon v. DEA (1st Cir. 1987) 828 F.2d 881.

[7] Id. at p. 886.

[8] Ibid.

[9] Id. at p. 891. Forced to do so by the federal circuit court’s ruling, the DEA on January 27, 1988, deleted MDMA from Schedule I, pending the Administrator Lawn’s reconsideration of the evidence and Judge Young’s recommendation.

[10] 53 Fed. Reg 5156-5159 (Febr. 22, 1988). In his published ruling, Administrator Lawn paradoxically gave greater weight to the absence of certain evidence than to the actual evidence admitted during the hearing. Evidence that psychiatrists had administered MDMA to approximately 200 patients with positive effects was summarily dismissed by Administrator Lawn, as “merely anecdotal,” simply because it was not published. (Ibid.) According to Administrator Lawn:

[t]he published literature contains no references to the clinical use of MDMA nor animal studies to indicate such a clinical use. Recognized texts, reference books and pharmacopoeia contain no references to the therapeutic use of MDMA. The two unpublished studies supporting the therapeutic use of MDMA which were presented during the hearings, do not contain any data which can be assessed by scientific review to draw a conclusion that MDMA has a therapeutic use. (Ibid.)