Mending invisible wounds: The efficacy and legality of MDMA-assisted psychotherapy in United States' veterans suffering with post-traumatic stress disorder.

• Jurisdiction: United States
• Author: Perry, Jonathan
• Date: 22 June 2016

1. INTRODUCTION 273 II. BACKGROUND 276 A. Brief History of MDMA: Origins, Therapeutic Uses, and Cultural Impact 276 B. Public Opposition, the Controlled Substances Act, and the Grinspoon Case 279 III. ACCEPTED MEDICAL USE OF MDMA TO TREAT POST-TRAUMATIC STRESS DISORDER IN VETERANS 284 A. Accepted Medical Use Defined 284 B. DEA Findings and Rationale in Scheduling MDMA 285 C. MDMA 's Accepted Medical Use in the Context of Medically Assisted Psychotherapy 287 IV. APPLYING THE CHEVRON STANDARD TO DRUG ENFORCEMENT AGENCY SCHEDULING 292 A. The First Circuit Correctly Concludes that Director Lawn's Findings Were Not Arbitrary and Capricious 293 B. The First Circuit Incorrectly Concludes that the Director's Conclusions were Sufficient under the "Substantial Evidence" Standard 295 V. MDMA IN SCHEDULE III 297 A. Meeting the Schedule III Criteria 297 B. Impact of Schedule III Classification of MDMA Treatment in Veterans Suffering with PTSD 300 VI. CONCLUSION 300 I. INTRODUCTION

   In 2001, the United States invaded Afghanistan. (1) Two years later, American armed forces were fully deployed in both Afghanistan and Iraq, and their presence persists to this day. (2) Amidst the loss of life exists a subtler tragedy: psychiatrists report that around 20% of service members suffer from post-traumatic stress disorder upon returning home from combat. (3) More distressingly, an average of 22 veterans commit suicide each day. (4)

   Though anecdotal, the story of Andrew Brennan provides an extreme but powerful narrative of PTSD's suffocating grasp on returning veterans. (5) The State of Alabama recently refused to stay the execution of the 66-year-old Vietnam veteran who was imprisoned for shooting an Atlanta police officer in 1998. (6) At trial, Mr. Brennan's lawyers pointed out that he had been diagnosed with severe posttraumatic stress disorder as a result of his service in Vietnam. (7) On the night of the shooting, Mr. Brennan was "in the throes of an emotional flashback" when he pulled a rifle from his truck and began shooting at the officer. (8) At the time of the tragedy, Mr. Brennan had been prescribed anti-psychotic medication for a diagnosed bipolar disorder. (9) This approach--a reliance solely on prescription medication as a remedy for PTSD--proved unsuccessful here, as it has so many times before. (10)

   Although many of organizations exist to support troops suffering with posttraumatic stress disorder, (11) a veteran's ability to receive effective emerging treatments from their healthcare provider is frustrated by outdated legislation. (12) Emerging treatments and research seeking to combat PTSD are hindered by the Drug Enforcement Agency's ("DEA") interpretation, and subsequent reinterpretations, of the Controlled Substances Act. (13) Scheduling substances as "Schedule I" prohibits healthcare professionals from utilizing emerging remedies in PTSD treatment by erecting various administrative and bureaucratic barriers to research. (14) As a result, some substances with positive medical purposes are kept from those who must be afforded all possible remedies. (15)

   Schedule I classification requires medical researchers to obtain FDA approval before experimentation, a burdensome hurdle in the way of furthering understanding of the substance. (16) Researchers are further required to record and secure all testing procedures in conformance with DEA guidelines, a process that further confines the scope of research. (17) Lastly, classifying drugs as Schedule I has historically created a stigma that makes research vastly more difficult, as volunteers become scarce and the incentive to investigate becomes associated with criminal behavior and a poor professional reputation. (18) The timing of the classification strikes a massive blow to the mental stability of returning troops; neurological and psychopharmacological research began providing its most insightful and promising research just as the federal government began crippling access to the substance. As a result, a massive pool of veterans, ranging from Vietnam to the current engagement, were stripped of a chance to alleviate the vicious symptoms of post-traumatic stress disorder.

   The most compelling emerging treatment is commonly referred to as "MDMA-assisted psychotherapy," in which psychiatrists incorporate 3,4-methylenedioxy-methamphetamine into one-on-one or group therapy sessions with veterans suffering with PTSD. (19) Although psychiatrists studied the therapeutic benefits of MDMA-assisted psychotherapy throughout the 1970's and 1980's, research was suppressed by the DEA's classification of MDMA as a Schedule I substance in 1986. (20) In the last decade, however, there has been a resurgence of interest, funding, and medical research on the efficacy, safety, and necessity of MDMA-assisted therapy. (21) This comes as a result of the current state of veteran treatment effectiveness, which cannot suppress the growing prevalence of the disorder. (22)

   Though Veteran Affairs has provided crucial life sustaining--and often lifesaving--treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. (23) One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA's facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. (24) Addiction is one of the key symptoms of posttraumatic stress disorder, and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of suicide. (25) If there is any hope of treating this debilitating psychotic phenomenon--or at least containing its rapid growth and addressing its profound depth--alternative remedies as a means must not be ignored for a normative end. (26)

   Accordingly, this article will argue that physicians must be able to treat PTSD victims through MDMA-assisted psychotherapy, an alternative remedy to PTSD treatment that has shown overwhelming promise in domestic and international medical research. In doing so, it will first discuss 21 U.S.C.A. [section] 812, which labels MDMA as a Schedule I substance and prohibits healthcare professionals from using MDMA-assisted psychotherapy to treat PTSD victims. (27) Next, the article will assert that the Drug Enforcement Agency ("DEA") erroneously categorized MDMA as a substance lacking an accepted medical use and lack of safety under medical supervision. (28) The article will set out studies, domestic and international, where clinical testing of MDMA-assisted therapy to treat PTSD have been met with overwhelmingly positive results. Finally, the article will argue that MDMA's accepted medical use, low physical and psychological dependence, and known safety under medical supervision support its classification as a Schedule III under the CSA, and that the 1986 classification of MDMA as a Schedule I narcotic was, and continues to be, an arbitrary and capricious agency interpretation of an otherwise viable piece of congressional legislation.

2. BACKGROUND

   1. Brief History of MDMA: Origins, Therapeutic Uses, and Cultural Impact.

      In 1914, the German pharmaceutical company Merck & Co. patented the substance 3, 4-methylenedioxymethamphetamine, commonly known as MDMA. (29) The origins of its synthesis are unclear: some assert that the purpose behind Merck's patent was to create an anorectic or diet suppressant, while others suggest that Merck utilized MDMA as a precursor to hydrastinine, a haemostatic drug. (30) Some evidence suggests that both American and German researchers resynthesized MDMA in the 1950s while seeking to create stimulants for Air Force pilots, however this fact is also contested. (31)

      The first officially documented experiments involving MDMA in the United States occurred in a U.S. military-sponsored animal study in 1953. (32) The results of the study remained classified until 1972. (33) In this study, researchers investigated the lethal dosage levels ("LDs" or "LD/50s") of mescaline and seven analogs in five separate species of mammals: mice, rats, dogs, guinea pigs, and monkeys. (34) The core purpose of the study was to identify a lethal dosage of the substances in mammals. (35) For obvious ethical reasons, however, the lethal dosage levels in humans could only be inferred. (36)

      In 1965, Alexander Shulgin, a chemist working at Dow Pharmaceutical Company, resynthesized MDMA. (37) Shulgin then published the first study testing MDMA's psychotropic effects in human subjects. (38) This study compared the effects of MDMA, 3,4-Methylenedioxyamphetamine ("MDA"), and 2-(5-Mefhoxy-lH-indol-3-yl)ethanamine ("mexamine") on human subjects. (39) Shulgin's study concluded that MDMA had a higher threshold than MDA, (40) and further that the substance "appear[ed] to evoke an easily controlled altered state of consciousness with emotional and sensual overtones. It canbe compared... to psilocybin, devoid of the hallucinatory component, or to low levels of MDA." (41) Additionally, Shulgin acknowledged a need for further acute studies of psychotropics in human subjects, specifically in regards to MDMA's potential effect on mental illness. (42)

      Two years later, researchers investigated MDMA's pharmacological properties in humans. (43) In 1978, Dr. George Greer published a clinical study whereby experimenters administered MDMA in humans. (44) Greer administered low level of MDMA to 29 patients in a medical setting. (45) The test sought to curtail "drug abuse problems, facilitate communication and intimacy between people involved in emotion relationships, and... as an adjunct to insight-oriented psychotherapy." (46) The test produced some undesirable side effects, none of which were serious and none that lasted longer than a week. (47) These included increased blood pressure and heart rate over the span of two hours...