by Richard Glen Boire, Esq. (1998)
Anyone who has ever had the dark cloud of serious physical illness descend into his or her life, knows well the associated mental dis-ease. To be struck with a grave physical illness is to be simultaneously enwrapped in dread, fear, and depression. The effect on the body cannot be separated from the effect on the mind, and the two feedback upon one another in complex patterns which will probably never be fully understood. Here in the West, medical doctors are just beginning to recognize the profound relationship between the mind and the body—a union long acknowledged by healers in other cultures. Eastern healers, for example, have long prescribed meditation with medication, and shamans, curanderas, and medicine people have, for millennia, utilized psychoactive plants and potions as primary healing tools.
As documented in the previous chapters, psychedelic medicines, those both ancient and modern, are unique in their ability to reliably access the mind-body interface. They hold out hope for healing where none might otherwise exist and, in those horrible cases when all hope has been lost, they may provide the only means of quickly coming to terms with impending death. Until the mid-1960s, psychedelic substances were untouched by federal criminal laws, and their potential as revolutionary medicines was enthusiastically being studied.[i] In 1963, a cancer patient using LSD as an adjunct to chemotherapy did not fear that his hospital bed would be transformed into a jail cot, nor did a doctor feel handcuffed in his or her choice of treatment options.
While possession of LSD was outlawed in 1968, it took two more years before federal drug control policy was consolidated with the enactment of the Comprehensive Drug Abuse Prevention and Control Act of 1970.[ii] In Title II, popularly known as the Controlled Substances Act, Congress established a five-schedule scheme for regulating various substances. Schedule I includes the most tightly controlled drugs. Under federal law, to be placed in Schedule I a drug must be unsafe for use even under medical supervision, have a high potential for abuse, and no currently accepted medical use. On the other end of the schedule spectrum is Schedule V, which contains those substances thought to have a low potential for abuse, relatively slight potential for physical or psychological dependence, and a currently accepted medical use.[iii]
When enacted in 1970, Schedule I included seventeen psychedelic substances, denoted as “hallucinogens.” The list currently includes thirty-one substances.[iv] With the sole exception of ketamine, the psychedelic substances discussed in this book have been placed in Schedule I of the federal Controlled Substance Act, thereby legislating that they have “no accepted medical use” and are “unsafe even under medical supervision.” Thus, it is all but impossible for medical doctors and psychiatrists to utilize these potentially beneficial substances in treating their patients. Indeed, merely possessing a drug placed in Schedule I is a federal crime punishable by imprisonment and fines. Additionally, despite ongoing attempts to reform the civil forfeiture laws, any property found to facilitate the possession of a Schedule I drug, or property which was allegedly obtained from the sale of such a drug, may be confiscated by the government.
Doctors v. Cops: Who Should Control Medicine?
As part-and-parcel of the nation’s drug war policy, government politicians and federal law enforcement agents have stationed themselves in the middle of traditionally private doctor-patient relationships. But should a government lawyer, politician, or bureaucrat have the right to dictate to a medical professional what treatment is permitted, and what is denied?
Dr. Thomas Szasz, professor emeritus of psychiatry at the State University of New York, Syracuse, has forcefully argued that since 1938, when federal prescription laws were enacted,[v] physicians have been “parentified” and now act as “agents of the therapeutic state.”[vi] As described by Dr. Szasz, under the 1938 law:
…[g]overnment bureaucrats became the final arbiters of what counted as a therapeutic drug and as legitimate medical treatment in general. As a result, the patient lost his right to drugs traditionally available in the free market; the doctor lost his freedom to medicate his patient as he saw fit, subject only to his patient’s consent; and the medical profession lost its integrity as an organization independent of the political vagaries of politics.[vii]
Regardless of whether one agrees with Dr. Szasz that prescription requirements are an affront to the autonomy of patients and doctors, it is impossible to dispute that sixty years after the 1938 Act, law enforcement agents, rather than medical professionals (or patients), determine the treatment options for some seriously ill and suffering patients.
Under federal law, ultimate authority over the scheduling of drugs (and hence over the determination of which drugs doctors can prescribe and which they cannot) is vested not in a medical organization, but rather in the Attorney General of the United States.[viii] In 1973, shortly after the Drug Enforcement Administration (DEA) was created by President Nixon, the Attorney General delegated his scheduling powers to the Administrator of the DEA.[ix]
The DEA is a law enforcement agency, not a medical body. The DEA is currently led by Administrator John Constantine, a thirty-year veteran of police work with absolutely no training or experience in medicine.[x] Yet, like DEA Administrators before him, Mr. Constantine is in charge of determining which drugs can, and cannot, be prescribed by physicians.[xi] Under federal law, the DEA Administrator’s scheduling power is theoretically checked by the Secretary of Health and Human Services, who must approve the Administrator’s intention to schedule a particular drug. In practice, however, the Secretary’s “check” is likely to be a rubber stamp of whatever the Administrator is recommending.[xii]
Once the Administrator has placed a substance in Schedule I, the drug is not available as medicine. Because of the extremist nature of the war on drugs, there is no federal exception for seriously sick or dying people. The urgent therapeutic needs of such patients are forced to take back seat to the government’s concerns about recreational drug use by healthy persons. Hence, a terminal cancer patient using LSD or MDMA to aid his or her mental preparation for death is treated no differently under federal law than a wild-eyed recreational user of crack cocaine.[xiii]
The Politics of Medicine: the scheduling of MDMA
“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.
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.[xiv]
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.[xv] 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.”[xvi]
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.[xvii]
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.[xviii] 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.”[xix]
Calling Administrator Lawn’s argument “strained” and “unpersuasive,” the federal court rejected Lawn’s argument and sided with Dr. Grinspoon.[xx] 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.[xxi] 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.[xxii] 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.
Criminalizing the Sick
Without a federal statutory protection for seriously sick or dying patients who use Schedule I psychedelics for medical treatment, patients who use the drugs face the constantly looming threat that their medical problems will be compounded by legal problems. For many patients, the fear and social stigma engendered by the fact that psychedelic-oriented treatment makes them federal criminals is too much to bear and they will reluctantly forgo potentially beneficial treatment. For otherwise law-abiding people who decide to go forward with psychedelic treatment despite its outlawed status, the treatment’s medical benefits can be compromised by the incumbent stress inherent in the patient’s suddenly precarious legal status.
For other patients, the dire need for relief from suffering, or the fact that death may loom near, can make the federal law nothing but a nuisance—outrageous nonetheless—but not something that will deter them. The testimony of an AIDS patient during the battle for an exemption that would allow terminally ill patients to use unapproved (but unscheduled) drugs, speaks to the situation currently confronting seriously suffering or terminally ill patients who seek to use Schedule I medications:
[It’s like being] in a disabled airplane, speeding downward out of control…[seeing] a parachute hanging on the cabin wall, one small moment of hope…[trying] to strap it on when a government employee reaches out and tears it off [your] back, admonishing, “You cant’ use that! It doesn’t have a Federal Aviation Administration sticker on it. We don’t know if it will work.”[xxiii]
Who would not snatch the parachute under such circumstances—even if it were a crime?
The Physician’s Role and Criminal Liability
A medical doctor or psychiatrist convinced that treatment or therapy with a particular Schedule I psychedelic drug may benefit a patient confronts an uneasy dilemma. The ethical question, of whether a physician has a moral duty to inform his or her patient of potentially beneficial treatment possibilities—even if ostensibly illegal—is one for each practitioner to consider individually. Legally, however, what should a doctor do if a seriously sick or terminally ill patient asks him or her for advice or assistance in: (1) obtaining a Schedule I medication, or (2) treating his or her medical condition with a particular Schedule I substance.
The answer to the first question is easy. Under federal law, a physician who provides a Schedule I drug to a patient—even as part of a thoughtful treatment plan consented to by the patient—is treated no differently than a street corner crack dealer.[xxiv] Both the doctor and the crack dealer are distributing an outlawed drug in violation of federal law. The crime of distribution does not require multiple sales, or any sales at all. Simply giving away the drug to another person can be sufficient for conviction.
A doctor who assists a patient in obtaining a Schedule I substance also commits a federal crime: namely, aiding and abetting the unlawful possession of a controlled substance. In most jurisdictions, this crime is punished just as harshly as if the doctor, him or herself, was the person who acquired and possessed the outlawed drug. Aiding and abetting is not only accomplished by physically procuring a Schedule I drug for a patient; the crime can also be committed by nothing more than speech. It is unlawful aiding and abetting, for example, if a physician tells a patient the name of a person who sells a Schedule I psychedelic, or arranges a meeting between the patient and a supplier of the drug.
With these legal concerns in mind, a physician who is asked by a patient for assistance in obtaining a Schedule I psychedelic is well-advised to explain to the patient that even if the doctor is sympathetic to the patient’s plight and believes that psychedelic therapy could be of benefit, the physician will not provide any assistance in obtaining such a drug. On this point, the physician cannot waver.
With the exception of speech that instructs a patient where or how to obtain an outlawed psychedelic, a doctor is within the law to speak openly about the pros and cons of alternative treatment methods, including a patient’s medical use of a particular outlawed psychedelic. Again, so long as the doctor does not provide information on how or where to obtain an outlawed drug, the First Amendment bars the government from dictating the content of a doctor’s conversion with a patient. A doctor, in other words, commits no crime by recommending particular books for the patient to read, or by conducting a search of Medline® or similar electronic databases for information on a psychedelic, and then providing the fruits of his or her research to the patient.
A very difficult situation can arise if a seriously ill patient asks a doctor to supervise the patient’s self-administration of a Schedule I psychedelic medicine. What, for example, are the potential criminal liabilities of a psychiatrist who is present when a terminally ill patient ingests a Schedule I medication?
As should be clear from the discussion so far, a doctor commits a federal crime if he or she procures an outlawed psychedelic for a patient, stores an outlawed psychedelic, or possesses an outlawed psychedelic, even only for the few moments it might take to administer it to the patient. But, short of such a clear violation of the law, criminal liability for a doctor falls into a spectral gray area. A psychiatrist, for example, commits no crime if a patient, independent of medical guidance, ingests MDMA, or some other psychedelic, and then calls the psychiatrist for advice or counseling. A psychiatrist in such a situation commits no criminal conduct by speaking with the patient over the phone, or by making a house-call.
The medical necessity defense
Plainly, an arrest for criminal drug possession, with its likely attendant jail time prior to bail, and the ongoing anxiety associated with defending oneself against criminal charges, will add an immense amount of stress to any patient’s life. Fortunately, a seriously ill patient who has been charged with possessing a small amount of an outlawed psychedelic medication, will likely be treated fairly leniently by a court. There are few criminal defendants more sympathetic than an otherwise law-abiding citizen who has been struck with a serious or terminal illness.
The goal at any trial involving a medical user of a Schedule I psychedelic is two-fold: (1) to obtain an acquittal based on a “medical necessity defense;” or, failing that (2) to educate the judge with respect to the medical use of the outlawed psychedelic and to the defendant’s serious medical condition. The hope is that even in the event of conviction, a fully informed judge will be lenient in imposing a sentence.
The general defense of “necessity” to charges of criminal conduct is centuries old. As a British court succinctly explained in a case decided in 1551, “where the words of [a law] are broken to avoid greater inconvenience, or through necessity, or by compulsion,” the law has not been broken.[xxv] In essence, the necessity defense protects a person who has been forced to chose between the lesser of two evils, and in doing so was compelled to break the law. For social policy reasons, if the harm which will result from compliance with a law is greater than that which will result from violating it, a person is, by virtue of the defense of necessity, excused from breaking the law. Paradigmatic examples are a prisoner escaping from a burning jail, or a person who steals food from a cabin after being lost in the woods for a week.
The medical necessity defense is a particularized type of necessity defense, one in which the defendant asserts that the harm done by using an illegal drug was less than would have resulted by obeying the law and foregoing the ostensibly illegal treatment. More specifically, a patient who possesses a Schedule I psychedelic exclusively to treat his or her own serious illness must establish the following elements in order to present the medical necessity defense to a jury:
(1) that the patent’s illness is not a fabrication and his or her suffering is severe;
(2) that lawful medical treatment was tried and found ineffective;
(3) that treatment with the particular Schedule I psychedelic reduces the patient’s severe suffering and does not harm the State’s interest in otherwise controlling drugs.
A physician can play a central role in assisting a patient to establish a medical necessity defense. Indeed, aside from the patent’s own testimony at trial concerning his or her illness and how the use of the Schedule I psychedelic helped to alleviate suffering, testimony by the patient’s primary care provider is likely to be the most important and compelling testimony presented.
Preparation for the defense must begin long before arrest. The doctor’s files should describe the severity of the patient’s suffering and the course of conventional treatment that was tried and found inadequate. Any legal medication that might possibly be a “substitute” for a Schedule I medicine must be tried, and the unsatisfactory results recorded in detail.
In the event that a patient is arrested and the doctor called upon to testify, the doctor should explain to the jury the patient’s extreme medical situation and difficult course of treatment. Next, the doctor should testify to the unique benefit derived by the patient’s use of the psychedelic. This explanation should be based on at least three considerations: (1) the patient’s self-report to the physician of treatment benefits, (2) the physician’s examination of the patient corroborating the benefit of the drug, and (3) the scientific literature confirming that the particular benefit claimed by the patient has been reported by others, or is otherwise supported by published studies. The physician should also testify that the particular psychedelic used by the patient has no substitute in conventional medicine, describing the particular conventional drugs tried and the reasons they were deemed inadequate (e.g., it must be given in extremely high doses, can reduce immunity, or runs a reasonable risk of compromising the patient’s health because of its side-effects). Finally, the doctor should testify that were it possible to legally prescribe the psychedelic medication for the patient, the doctor would do so.
Prisons or Hospitals? The Future of Psychedelic Medicine
In November 1996, voters in Arizona overwhelmingly approved a ballot initiative (Proposition 200) permitting any medical doctor licensed to practice in Arizona to prescribe a Schedule I substance “to treat a disease, or to relieve the pain and suffering of a seriously ill patient or terminally ill patient…” The landmark law, known as “The Drug Medicalization, Prevention and Control Act of 1996” set in place two prerequisites for prescribing a Schedule I medicine. First, the prescribing physician was required to show that scientific research supported the use of the controlled substance. Second, the physician was required to obtain a written opinion from a second doctor, affirming that the particular Schedule I substance was indeed an appropriate treatment. Assuming these requirements were met, a seriously sick or terminally ill patient who received, possessed or used a controlled substance prescribed by his or her doctor was exempt from criminal penalties.[xxvi]
The federal government reacted angrily to the Arizona law (as well as to a more limited law enacted by California voters). Maintaining that the new state laws did not shield doctors or patients from federal anti-drug laws, Attorney General Janet Reno warned doctors that if they approved treatment under the new provisions, the federal government might retaliate by prosecuting them as federal drug criminals or by revoking their prescription writing privileges.[xxvii]
In April 1997, politicians in Arizona completely usurped the citizens’ vote by amending the voter-enacted Drug Medicalization Prevention and Control Act to only allow the prescription of FDA-approved drugs.[xxviii] Because none of the substances in Schedule I have received FDA approval, this arrogant political deed effectively nullified the new law.
Outraged by the politicians’ action, 200,000 Arizona voters signed petitions to bar the politicians’ amendment until 1998, when the requirement of FDA-approval could itself be placed on the ballot.
Proposition 300 appeared on Arizonans’ November 1998 ballot. A “yes” vote would implement the politicians’ FDA-approval requirement. A “no” vote would preserve the Drug Medicalization Prevention and Control Act as enacted by the voters in 1996. On election day, 57.7 percent of the Arizona voters once again told the politicians that medical treatment decisions belong in the hands of patients and doctors—not in the hands of police, bureaucrats, or politicians. Thus, as of November 1998, Arizona doctors decide what is best for their patients and may legally prescribe Schedule I psychedelic medicines without fear of state prosecution.
As of this writing (November 1998) the federal government has had little reaction to the reaffirmed Arizona law, or to medical marijuana initiatives passed in four other states in the November election.[xxix] There is little reason, if any, to think that the federal government will embrace the Arizona law. One would hope, however, that federal officials would respect the state law twice endorsed by the voting public, and refrain from bullying Arizona doctors or patients with threats of federal prosecution. Federal policy makers with a genuine interest in rational but compassionate drug policy ought to consider Arizona’s Drug Medicalization Prevention and Control Act as a real-world test of the feasibility of accommodating the desperate needs of seriously sick and terminally ill patients while still strictly controlling drugs.
Accommodation is clearly called for, and not impossible. Under federal law, for example, peyote is a Schedule I substance. Nevertheless, a regulatory exemption permits members of the Native American Church to use peyote in their religious ceremonies.[xxx] This has not led to abuse, nor has it resulted in members of the general public obtaining peyote for recreational use. There is no reason why a similar exemption, but restricted to medical use under the supervision of a medical doctor, could not be enacted. Currently, limited amounts of almost all the Schedule I psychedelic medicines are being manufactured by pharmaceutical companies under federal authorization, [xxxi] and a strenuous procedure already exists for tracking and regulating the manufacture and distribution of pharmaceutically manufactured controlled substances, including those in Schedule I.[xxxii] Permitting doctors to prescribe Schedule I substances when they believe it is in the best interest of seriously sick or terminally ill patients, would require only a slight modification of the law. The problem, of course, is not one of practicality, but rather one of politics.
With the recent adoption by five states of laws permitting the medical use of marijuana, perhaps the political tide is turning. A truce in the drug war may not yet be possible, but more and more people agree that the wounded should be removed from the battlefield. Hopefully, the politicians will start listening.
[i] According to professors Grinspoon and Bakalar of Harvard Medical School, between 1950 and 1965 over 1000 clinical papers were published documenting psychedelic treatment with 40,000 patients. (L. Grinspoon & J. Bakalar, Psychedelic Drugs Reconsidered, The Lindesmith Center, New York, NY (1997) p. 192.)
[ii] 21 U.S.C. Sec. 801 et. seq.
[iii] 21 U.S.C. Sec. 812.
[iv] 21 CFR sec. 1308.11, susbd. (d) (April 1998).
[v] Federal Food, Drug & Cosmetic Act of 1938 52 Stat. 1040 (1938).
[vi] T. Szasz, Our Right To Drugs: The Case for a Free Market, Syracuse Univ. Press., Syracuse, NY, (1992) p. 134. For an excellent discussion of the early federal laws controlling drugs, see P. Temin, “The Origin of Compulsory Drug Prescriptions,” in 22(1) Jnl. of Law and Econ. 91-105 (April 1979).
[vii] Id. at p. 52.
[viii] In 1970 Congress initially allocated various substances to particular schedules, but then authorized the Attorney General to schedule, transfer between schedules, or remove a substance from a schedule. (21 U.S.C. Sec. 811(a).)
[ix] 28 CFR 0.100(b) (1986).
[x] Prior to being appointed Administrator of the DEA, Mr. Constantine was employed as the Superintendent of the New York State Police. He began his law enforcement career in 1960 as a deputy with the Erie County Sheriff’s Department. In 1962 he entered the New York State Police as a uniform trooper and served as: a Narcotics and Major Crime Investigator, Sergeant, Lieutenant in Charge of Recruiting, Captain of the Statewide Organized Crime Task Force, Major, Troop Commander, Staff Inspector, and Assistant Deputy Superintendent.
[xi] In making the required findings for scheduling any given drug, federal law requires that the Administrator consider the following eight factors: (1) The drug’s actual or relative potential for abuse. (2) Scientific evidence of the drug’s pharmacological effect, if known. (3) The state of current scientific knowledge regarding the drug or other substance. (4) The drug’s history and current pattern of abuse. (5) The scope, duration, and significance of abuse. (6) What, if any, risk there is to the public health. (7) The drug’s psychic or psychological dependence liability. (8) Whether the drug is an immediate precursor of another controlled substance. (21 U.S.C. Sec. 811 (c).)
[xii] In the Grinspoon case (discussed, infra), the U.S. Court of Appeals for the First Circuit criticized the HHS Secretary for just such a rubber stamp approval with respect to MDMA, commenting:
The record…reveals that the HHS performed in a less than admirable fashion in making its recommendation to the Administrator. The record indicates that HHS failed to look beyond its files upon receiving the Administrator’s…request for a scientific and medical evaluation; neglected to consult any organization of medical professionals or even the FDA’s own panel of experts, the Drug Abuse Advisory Committee; and simply rubber stamped the Administrator’s conclusion by adopting the…analysis already performed by the DEA. (Grinspoon, infra, 828 F.2d 881, 897.)
[xiii] Actually, based on its schedule status, crack cocaine (AKA cocaine base) is considered less dangerous than most of the psychedelic substances. Crack cocaine has been placed in Schedule II, rather than the more tightly controlled Schedule I, wherein most of the psychedelic substances reside. (See 21 U.S.C. sec. 812(c)(II)(a)(4).)
[xiv] 49 Fed. Reg. 30210-30212, July 27, 1984.
[xv] 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).)
[xvi] 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.)
[xviii] Grinspoon v. DEA (1st Cir. 1987) 828 F.2d 881.
[xix] Id. at p. 886.
[xxi] 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.
[xxii] 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.)
[xxiii] Address by Martin Delaney at the 26th Annual Meeting of the Infectious Disease Society of America (Oct 27 & 28, 1988), reprinted in Delaney, The Case for Patient Access to Experimental Therapy, 159 J. Infectious Diseases 416 (1989).
[xxiv] Actually, under federal law, “crack” (AKA cocaine base) is not a Schedule I substance, but rather a Schedule II substance, meaning it is actually more available as medication than any of the Schedule I psychedelics.
[xxv] Reninger v. Fagossa (1551) 1 Plowd. 1, 19, 75 Eng.Rep. 1, 29-30.
[xxvi] The Drug Medicalization, Prevention and Control Act of 1996 (Proposition 200), in pertinent part amended Title 13, Chapter 13, Arizona Revised Statutes, by adding section 13-3412.01, which reads as follows:
13-3412.01. Prescribing controlled substances included in schedule i of 36-2512 for seriously ill and terminally ill patients
- Notwithstanding any law to the contrary, any medical doctor licensed to practice in Arizona may prescribe a controlled substance included in Schedule I of 36-2512 to treat a disease, or to relieve the pain and suffering of a seriously ill patient or terminally ill patient, subject to the provisions of 13-3412.01. In prescribing such a controlled substance, the medical doctor shall comply with professional medical standards.
- Notwithstanding any law to the contrary, a medical doctor must document that scientific research exists which supports the use of a controlled substance listed in Schedule I of 36-2512 to treat a disease, or to relieve the pain and suffering of a seriously ill patient or terminally ill patient before prescribing the controlled substance. A medical doctor prescribing a controlled substance included in Schedule I of 36-2512 to treat a disease, or to relieve the pain and suffering of a seriously ill patient or terminally ill patient, must obtain the written opinion of a second medical doctor that the prescribing of the controlled substance is appropriate to treat a disease or to relieve the pain and suffering of a seriously ill patient or terminally ill patient. The written opinion of the second medical doctor shall be kept In the patient’s official medical file. Before prescribing the controlled substance included in Schedule I of 36-2512 the medical doctor shall receive in writing the consent of the patient.
- Any failure to comply with the provisions of this section may be the subject of investigation and appropriate disciplining action by the Board of Medical Examiners.
[xxvii] Federal News Service, White House briefing news conference, December 30, 1996.
On January 15, 1997, “drug czar” Barry R. McCaffrey, reiterated the Department of Justice’s position that a physician’s action of “recommending or prescribing Schedule I controlled substances” will lead to administrative action by the DEA to revoke the practitioner’s registration and exclude him or her from participation in the federal Medicare and Medicaid programs. (62 Fed. Reg. 6164 (Feb. 11, 1997).)
[xxviii] Arizona House Bill 2518 (1997). Interestingly, over a decade ago the FDA acknowledged that people suffering from “serious or immediately life-threatening condition(s)…for whom no comparable or satisfactory alternative drug for therapy is available” ought to be permitted to obtain and use drugs that have not yet received FDA approval. (See, 21 CFR sec. 312.24(a) (1990).)
For more information on the FDA’s efforts to accommodate the urgent medical needs of terminally ill patients, see L. Terrizzi, “The Need for Improved Access to Experimental Drug Therapy: AIDS activists and their call for a Parallel Track Policy,” 4(3) Admin. Law Jnl. 589-634 (Winter 1991).
[xxix] Also, in November 1998, voters in the District of Columbia appear to have approved a medical marijuana initiative (Initiative 59). The official results of the election remain unknown however, because an unprecedented action by Congress has prevented DC election officials from releasing the election results for Initiative 59. The Congressional action was spearheaded by Rep. Dennis Hastert (R-IL) and Rep. Bob Barr (R-GA) who, just before the DC election, attached an amendment to the D.C. Appropriations Act for 1999, providing “[n]one of the funds contained in this Act may be used to conduct any ballot initiative which seeks to legalize or otherwise reduce penalties associated with possession, use, or distribution of any schedule I substance under the Controlled Substances Act (21 U.S.C. 802) or any tetrahydrocannabinols [THC] derivative.”
Arthur Spitzer, Legal Director of the ACLU of the National Capital Area, aptly noted that under the First Amendment, Congress has no right to impose a viewpoint-based restriction on the voting rights of D.C. citizens. “The Barr Amendment prohibits any initiative that would reduce the penalties for marijuana, but allows any initiative that would increase those penalties. That is like saying voters can vote for Republicans but not for Democrats, or can vote to build nuclear power plants but not to ban them.”
Despite the Congressional action, DC ballots had already been printed so the medical marijuana issue was presented to the voters. Exit poling indicates that Initiative 59 passed by a wide margin, but the votes remain uncounted.
[xxx] 21 C.F.R. sec. 1307.31; 21 C.F.R. sec. 16(c) (1967).
[xxxi] Under the 1998 controlled substance production quotas, specified pharmaceutical companies are authorized to manufacture: 20 grams of MDMA, 25 grams of MDA, 7 grams of mescaline, 2 grams each of DOB, 2-CB, psilocybin and psilocin, and a whopping 57 grams of LSD. (See “Controlled Substances: Revised Aggregate Production Quotas for 1998,” 63 Fed. Reg. 49369-49370 (Sept. 15, 1998); 21 U.S.C. sec. 826.)
[xxxii] See 21 U.S.C. secs. 821-829.