Autors: DR. Lester Grinspoon, and James B. Bakalar
Yale University Press, Copyright 1993
The marihuana, cannabis, or hemp plant is one of the oldest psychoactive plants known to humanity. It is botanically classified as a member of the family Cannabaceae and the genus Cannabis. Most botanists agree that there are three species: Cannabis sativa, the most widespread of the three, is tall, gangly, and loosely branched, growing as high as twenty feet; Cannabis indica is shorter, about three or four feet in height, pyramidal in shape and densely branched; Cannabis ruderalis is about two feet high with few or no branches. There are also differences among these species in the leaves, stems, and resin. According to an alternative classification, the genus has only one highly variable species, Cannabis sativa, with two subspecies, sativa and indica. The first is more northerly and produces more fiber and oil; the second is more southerly and produces more of the intoxicating resin.Cannabis has become one of the most widespread and diversified of plants. It grows as weed and cultivated plant all over the world in a variety of climates and soils. The fiber.has been used for cloth and paper for centuries and was the most important source of rope until the development of synthetic fibers. The seeds (or, strictly speaking, akenes - small hard fruits) have been used as bird feed and sometimes as human food. The oil contained in the seeds was once used for lighting and soap and is now sometimes employed in the manufacture of varnish, linoleum, and artists' paints.
The chemical compounds responsible for the intoxicating and medicinal effects are found mainly in a sticky golden resin exuded from the flowers on the female plants. The function of the resin is thought to be protection from heat and preservation of moisture during reproduction. The plants highest in resin therefore grow in hot regions like Mexico, the Middle East, and India. When the reproductive process is over and the fruits are fully ripe, no more resin is secreted.
The cannabis preparations used in India often serve as a folk standard of potency. The three varieties are known as bhang, ganja, and charas. The least potent and cheapest preparation, bhang, is produced from the dried and crushed leaves, seeds, and stems. Ganja, prepared from the flowering tops of cultivated female plants, is two or three times as strong as bhang; the difference is somewhat akin to the difference between beer and fine Scotch. Charas is the pure resin, also known as hashish in the Middle East. Any of these preparations can be smoked, eaten, or mixed in drinks. The marihuana used in the United States is equivalent to bhang or, increasingly in recent years, to ganja.
The marihuana plant contains more than 460 known compounds, of which more than 60 have the 21-carbon structure typical of cannabinoids. The only cannabinoid that is both highly psychoactive and present in large amounts, usually 1-5 percent by weight, is (-)3,4-trans-delta-l- tetrahydrocannabinol, also known as delta-1-THC, delta-9-THC, or simply THC. A few other tetrahydrocannabinols are about as potent as delta-9-THC but present in only a few varieties of cannabis and in much smaller quantities. A number of synthetic congeners (chemical relatives) of THC have been developed under such names as synhexyl, nabilone, and levonatradol. The other two major types of cannabinoid are the cannabidiols and the cannabinols. It appears that the plant first produces the mildly active cannabidiols, which are converted to tetrahydrocannabinols and then broken down to relatively inactive cannabinols as the plant matures.
The recent discovery of nerve receptors in the brain stimulated by THC (and the cloning of the gene that gives rise to these receptors) suggests that the body produces its own version of the substance. The receptors are found mainly in the cerebral cortex, which governs higher thinking and in the hippocampus, which is a locus of memory (1).
A native of central Asia, cannabis may have been cultivated as long as ten thousand years ago. It was certainly cultivated in China by 4000 B.C. and in Turkestan by 3000 B.C. It has long been used as a medicine in India, China, the Middle East, Southeast Asia, South Africa, and South America. The first evidence for medicinal use of cannabis is an herbal published during the reign of the Chinese emperor Chen Nung five thousand years ago. Cannabis was recommended for malaria, constipation, rheumatic pains, "absentmindedness," and female disorders. Another Chinese herbal recommended a mixture of hemp, resin, and wine as an analgesic during surgery. In India cannabis has been recommended to quicken the mind, lower fevers, induce sleep, cure dysentery, stimulate appetite, improve digestion, relieve headaches, and cure venereal disease. In Africa it was used for dysentery, malaria, and other fevers. Today certain tribes treat snake bites with hemp or smoke it before childbirth. Hemp was also noted as a remedy by Galen and other physicians of the classical and Hellenistic eras, and it was highly valued in medieval Europe. The English clergyman Robert Burton, in his famous work The Anatomy of Melancholy, published in 1621, suggested the use of cannabis in the treatment of depression. The New English Dispensatory of 1764 recommended applying hemp roots to the skin for inflammation, a remedy that was already popular in eastern Europe. The Edinburgh New Dispensary of 1794 included a long description of the effects of hemp and stated that the oil was useful in the treatment of coughs, venereal disease, and urinary incontinence. A few years later Nicholas Culpeper summarized all the conditions for which cannabis was supposed to be medically useful.
But cannabis did not come into its own in the West as a medicine until the middle of the nineteenth century. During its heyday, from 1840 to 1900, more than one hundred papers were published in the Western medical literature recommending it for various illnesses and discomforts (2). It could almost be said that physicians of a century ago knew more about cannabis than contemporary physicians do; certainly they were more interested in exploring its therapeutic potential.
The first Western physician to take an interest in cannabis as a medicine was W B. O'Shaughnessey, a young professor at the Medical College of Calcutta who had observed its use in India. He gave cannabis to animals, satisfied himself that it was safe, and began to use it with patients suffering from rabies, rheumatism, epilepsy, and tetanus. In a report published in 1839, he wrote that he had found tincture of hemp (a solution of cannabis in alcohol, taken orally) to be an effective analgesic. He was also impressed with its muscle relaxant properties and called it "an anticonvulsive remedy of the greatest value" (3).
O'Shaughnessey returned to England in 1842 and provided cannabis to pharmacists. Doctors in Europe and the United States soon began to prescribe it for a variety of physical conditions. Cannabis was even given to Queen Victoria by her court physician. It was listed in the United States Dispensatory in 1854 (with a warning that large doses were dangerous and that it was a powerful "narcotic"). Commercial cannabis preparations could be bought in drug stores. During the Centennial Exposition of 1876 in Philadelphia, some pharmacists carried ten pounds or more of hashish (4).
Meanwhile, reports on cannabis accumulated in the medical literature. In 1860 Dr. R. R. M'Meens reported the findings of the Committee on Cannabis Indica to the Ohio State Medical Society (5). After acknowledging a debt to O'Shaughnessey, M'Meens reviewed symptoms and conditions for which Indian hemp had been found useful, including tetanus, neuralgia, dysmenorrhea (painful menstruation), convulsions, rheumatic and childbirth pain, asthma, postpartum psychosis, gonorrhea, and chronic bronchitis. As a hypnotic (sleep-inducing drug) he compared it to opium: "Its effects are less intense, and the secretions are not so much suppressed by it. Digestion is not disturbed; the appetite rather increased; ... The whole effect of hemp being less violent, and producing a more natural sleep, without interfering with the actions of the internal organs, it is certainly often preferable to opium, although it is not equal to that drug in strength and reliability." Like O'Shaughnessey, M'Meens emphasized the remarkable capacity of cannabis to stimulate appetite.
Interest persisted into the next generation. In 1887, H. A. Hare recommended the capacity of hemp to subdue restlessness and anxiety and distract a patient's mind in terminal illness. In these circumstances, he wrote, "The patient, whose most painful symptom has been mental trepidation, may become more happy or even hilarious" (6). He believed cannabis to be as effective a pain reliever as opium: "During the time that this remarkable drug is relieving pain, a very curious psychical condition sometimes manifests itself; namely, that the diminution of the pain seems to be due to its fading away in the distance, so that the pain becomes less and less, just as the pain in a delicate ear would grow less and less as a beaten drum was carried farther and farther out of the range of hearing" (7). Hare also noted that hemp is an excellent topical anesthetic, especially for the mucous membranes of the mouth and tongue - a property well known to dentists in the nineteenth century.
In 1890, J. R. Reynolds, a British physician, summarized thirty years of experience with Cannabis indica, recommending it for patients with "senile insomnia" and suggesting that "in this class of cases I have found nothing comparable in utility to a moderate dose of Indian hemp." According to Reynolds, hemp remained effective for months and even years without an increase in the dose. He also found it valuable in the treatment of various forms of neuralgia, including tic douloureux (a painful facial neurological disorder), and added that it was useful in preventing migraine attacks: "Very many victims of this malady have for years kept their suffering in abeyance by taking hemp at the moment of threatening or onset of the attack." He also found it useful for certain kinds of epilepsy, for depression, and sometimes for asthma and dysmenorrhea (8).
Doctor J. B. Mattison, urging physicians to continue using hemp, in 1891 called it "a drug that has a special value in some morbid conditions and the intrinsic merit and safety of which entitles it to a place it once held in therapeutics" (9). He reviewed its uses as an analgesic and hypnotic, with special reference to dysmenorrhea, chronic rheumatism, asthma, and gastric ulcer, and added that "it has proved an efficient substitute for the poppy" in morphine addicts. One of his cases was "a naval surgeon, nine years a ten grains daily subcutaneous morphia taker ... [who] recovered with less than a dozen doses" (10). The use of cannabis in treating drug addiction had already been reported in 1889 by E. A. Birch. He treated a chloral hydrate addict and an opiate addict with pills containing Cannabis indica and found a prompt response in both cases, with improved appetite and sound sleep (11).
But for Mattison the most important use of cannabis was in treating "that opprobrium of the healing art - migraine." Reviewing his own and earlier physicians' experiences, he concluded that cannabis not only blocks the pain of migraine but prevents migraine attacks (12). Years later William Osler expressed his agreement, saying that cannabis was "probably the most satisfactory remedy" for migraine (13). Mattison's report concluded on a wistful note:
As he noted, the medical use of cannabis was already in decline by 1890. The potency of cannabis preparations was too variable, and individual responses to orally ingested cannabis seemed erratic and unpredictable. Another reason for the neglect of research on the analgesic properties of cannabis was the greatly increased use of opiates after the invention of the hypodermic syringe in the 1850s allowed soluble drugs to be injected for fast pain relief; hemp products are insoluble in water and so cannot easily be administered by injection. Toward the end of the nineteenth century, the development of such synthetic drugs as aspirin, chloral hydrate, and barbiturates, which are chemically more stable than Cannabis indica and therefore more reliable, hastened the decline of cannabis as a medicine. But the new drugs had striking disadvantages. Five hundred to a thousand people die from aspirin-induced bleeding each year in the United States, and barbiturates are, of course, far more dangerous yet. One might have expected physicians looking for better analgesics and hypnotics to have turned to cannabinoid substances, especially after 1940, when it became possible to study congeners (chemical relatives) of THC that might have more stable and specific effects.
Dr. Suckling wrote me: "The young men rarely prescribe it." To them I specially commend it. With a wish for speedy effect, it is so easy to use that modern mischief maker, hypodermic morphia, that they [young physicians] are prone to forget remote results of incautious opiate giving.
Would that the wisdom which has come to their professional fathers through, it may be, a hapless experience might serve them to steer clear of narcotic shoals on which many a patient has gone a wreck.
Indian hemp is not here lauded as a specific. It will, at times, fail. So do other drugs. But the many cases in which it acts well entitle it to a large and lasting confidence (14).
But the Marihuana Tax Act of 1937 undermined any such experimentation. This law was the culmination of a campaign organized by the Federal Bureau of Narcotics under Harry Anslinger in which the public was led to believe that marihuana was addictive and caused violent crimes, psychosis, and mental deterioration. The film Reefer Madness, made as part of Anslinger's campaign, may be a joke to the sophisticated today, but it was once regarded as a serious attempt to address a social problem, and the atmosphere and attitudes it exemplified and promoted continue to influence American culture today.
Under the Marihuana Tax Act, anyone using the hemp plant for certain defined industrial or medical purposes was required to register and pay a tax of a dollar an ounce. A person using marihuana for any other purpose had to pay a tax of $100 an ounce on unregistered transactions. Those failing to comply were subject to large fines or prison terms for tax evasion. The law was not aimed at medical use of marihuana - its purpose was to discourage recreational marihuana smoking. It was put in the form of a revenue measure to evade the effect of Supreme Court decisions that reserved to the states the right to regulate most commercial transactions. By forcing some marihuana transactions to be registered and others to be taxed heavily, the government could make it prohibitively expensive to obtain the drug legally for any other than medical purposes. Almost incidentally, the law made medical use of cannabis difficult because of the extensive paperwork required of doctors who wished to use it. The Federal Bureau of Narcotics followed up with "anti-diversion" regulations that contributed to physicians' disenchantment. Cannabis was removed from the United States Pharmacopoeia and National Formulary in 1941.
A reading of the hearings in which the bill was examined by the House Ways and Means Committee before its passage shows how little data supported the judgment that marihuana was harmful and how much mass hysteria surrounded the subject. The only dissident witness was W. C. Woodward, a physician-lawyer serving as legislative counsel for the American Medical Association. He supported the aims of Congress but argued for less restrictive legislation on the grounds that future investigators might discover substantial medical uses for cannabis. In reference to marihuana "addiction," Woodward commented:
Congressmen questioned Woodward closely and critically about his educational background, his relationship to the American Medical Association, and his views on medical legislation of the previous fifteen years. His objections to the quality and sources of the evidence against cannabis did not endear him to the legislators. Representative John Dingell's questions are typical:
The newspapers have called attention to it so prominently that there must be some grounds for their statements. It has surprised me, however, that the facts on which these statements have been based have not been brought before this committee by competent primary evidence. We are referred to newspaper publications concerning the prevalence of marihuana addiction. We are told that the use of marihuana causes crime. But as yet no one has been produced from the Bureau of Prisons to show the number of prisoners who have been found addicted to the marihuana habit. An informal inquiry shows that the Bureau of Prisons has no evidence on that point.
You have been told that school children are great users of marihuana cigarettes. No one has been summoned from the Children's Bureau to show the nature and extent of the habit among children.
Inquiry of the Children's Bureau shows that they have had no occasion to investigate it and know nothing particularly of it.
Inquiry of the Office of Education - and they certainly should know something of the prevalence of the habit among the school children of the county, if there is a prevalence of the habit - indicates that they have had no occasion to investigate and know nothing of it. (15)
Mr. Dingell: We know that it is a habit that is spreading, particularly among youngsters. We learn that from the pages of the newspapers. You say that Michigan has a law regulating it. We have a State Law, but we do not seem to be able to get anywhere with it, because, as I have said, the habit is growing. The number of victims is increasing each year.Woodward was finally cut off with the admonition: "You are not cooperative in this. If you want to advise us on legislation you ought to come here with some constructive proposals rather than criticisms, rather than trying to throw obstacles in the way of something that the Federal Government is trying to do" (17). His testimony was futile. The bill became law on October 1, 1937. Many state laws, just as punitive and hastily conceived, followed.
Dr. Woodward: There is no evidence of that.
Mr. Dingell: I have not been impressed by your testimony here as reflecting the sentiment of the high-class members of the medical profession in my State. I am confident that the medical profession in the State of Michigan, and in Wayne County particularly, or in my district, will subscribe wholeheartedly to any law that will suppress this thing, despite the fact that there is a $1 tax imposed.
Dr. Woodward: if there was any law that would absolutely suppress the thing, perhaps that is true, but when the law simply contains provisions that impose a useless expense, and does not accomplish the result-
Mr. Dingell: (interposing): That is simply your personal opinion. That is kindred to the opinion you entertained with reference to the Harrison Narcotics Act.
Dr. Woodward: If we had been asked to cooperate in drafting it-
Mr. Dingell (interposing): You are not cooperating in drafting this at all.
Dr. Woodward: As a matter of fact, it does not serve to suppress the use of opium and cocaine.
Mr. Dingell: The medical profession should be doing its utmost to aid in the suppression of this curse that is eating the very vitals of the Nation.
Dr. Woodward: They are.
Mr. Dingell: Are you not simply piqued because you were not consulted in the drafting of the bill (16)?
One of the few public officials who responded rationally to the issue of marihuana in the 1930s was New York's Mayor Fiorello LaGuardia. In 1938 he appointed a committee of scientists to study the medical, sociological, and psychological aspects of marihuana use in New York City. Two internists, three psychiatrists, two pharmacologists, a public health expert, the commissioners of Correction, Health, and Hospitals, and the director of the Division of Psychiatry of the Department of Hospitals made up the committee. They began their investigations in 1940 and presented detailed findings in 1944 under the title "The Marihuana Problem in the City of New York." This largely disregarded study dispelled many of the myths that had spurred passage of the tax act. The committee found no proof that major crime was associated with marihuana or that it caused aggressive or antisocial behavior; marihuana was not sexually overstimulating and did not change personality; there was no evidence of acquired tolerance.
In September 1942 the American Journal of Psychiatry published "The Psychiatric Aspects of Marihuana Intoxication," by two of the study's investigators, Samuel Allentuck and Karl M. Bowman. Among other things, Allentuck and Bowman wrote that habituation to cannabis is not as strong as habituation to tobacco or alcohol. Three months later, in December, an editorial in the Journal of the American Medical Association described Allentuck and Bowman's article as "a careful study" and mentioned potential therapeutic uses of cannabis in the treatment of depression, appetite loss, and opiate addiction. But in the next few years that journal's editors were induced to change their minds under government pressure. They received and published letters denouncing the LaGuardia report from Bureau of Narcotics Director Harry Anslinger in January 1943 and from R. J. Bouquet, an expert working for the Narcotics Commission of the League of Nations, in April 1944. Finally, the American Medical Association expressed its agreement with the Federal Bureau of Narcotics in the following editorial, published in April 1945:
For many years medical scientists have considered cannabis a dangerous drug. Nevertheless, a book called Marihuana Problems by the New York City Mayor's Committee on Marihuana submits an analysis by seventeen doctors of tests on 77 prisoners and, on this narrow and thoroughly unscientific foundation, draws sweeping and inadequate conclusions which minimize the harmfulness of marihuana. Already the book has done harm ... The book states unqualifiedly to the public that the use of this narcotic does not lead to physical, mental or moral degeneration and that permanent deleterious effects from its continued use were not observed on 77 prisoners. This statement has already done great damage to the cause of law enforcement. Public officials will do well to disregard this unscientific, uncritical study, and continue to regard marihuana as a menace wherever it is purveyed.In the words of A. S. deRopp, the journal had "abandoned its customary restraint and voiced its editorial wrath in scolding tones. So fierce was the editorial that one might suppose that the learned members of the mayor's committee ... had formed some unhallowed league with the 'tea- pad' proprietors [owners] of places where marihuana users gathered to smoke] to undermine the city's health by deliberately misrepresenting the facts about marihuana" (18). For more than forty years after that editorial, the American Medical Association steadfastly maintained a position on marihuana closely allied to that of the Federal Bureau of Narcotics and its successor agencies.
Although virtually no medical investigation of cannabis was conducted for many years, the government did not entirely lose interest. Shortly after one of us (L.G.) published a book on marihuana in 1971, a chemist who had read it told us that his employer, the Arthur D. Little Company, had been given millions of dollars in government contracts to identify military uses for cannabis. He said they had found none but had come across important therapeutic leads. He visited us to discuss the economic feasibility of developing cannabinoid congeners commercially, but he could not give us the evidence because it was classified.
In the 1960s, as large numbers of people began to use marihuana recreationally, anecdotes about its medical utility began to appear, generally not in the medical literature but in the form of letters to popular magazines like Playboy. Meanwhile, legislative concern about recreational use increased, and in 1970 Congress passed the Controlled Substances Act. This law assigned psychoactive drugs to five schedules and placed cannabis in Schedule I, the most restrictive. According to the legal definition, Schedule I drugs have no medical use and a high potential for abuse, and they cannot be used safely even under a doctor's supervision. By that time the renaissance of interest in cannabis as a medicine was already well under way. Two years later, in 1972, the National Organization for the Reform of Marihuana Laws (NORML) petitioned the Bureau of Narcotics and Dangerous Drugs (formerly the Federal Bureau of Narcotics) to transfer marihuana to Schedule II so that it could be legally prescribed by physicians. As the legal proceedings have continued, other parties have joined, including the Drug Policy Foundation and the Physicians Association for AIDS Care.
The hearings before the Bureau of Narcotics and Dangerous Drugs (BNDD) were instructive. As one of us (L.G.) waited to testify on the medical uses of cannabis, he witnessed the effort to place pentazocine (Talwin ®), a synthetic opioid analgesic made by Winthrop Pharmaceuticals, on the schedule of dangerous drugs. The testimony indicated several hundred cases of addiction, a number of deaths from overdose, and considerable evidence of abuse. Six lawyers from the drug company, briefcases in hand, came forward to prevent the classification of pentazocine or at least to ensure that it was placed in one of the less restrictive schedules. They succeeded in part; it became a Schedule IV drug. In the testimony on cannabis, the next drug to be considered, there was no evidence of overdose deaths or addiction - simply many witnesses, both patients and physicians, who testified to its medical utility. The government refused to transfer it to Schedule II. Might the outcome have been different if a large drug company with enormous financial resources had a commercial interest in cannabis?
In rejecting the NORML petition, the Bureau of Narcotics and Dangerous Drugs failed to call for public hearings as required by law. The reason it gave was that reclassification would violate U.S. treaty obligations under the United Nations Single Convention on Narcotic Substances. NORML responded in January 1974 by filing a suit against the BNDD. The U.S. Second Circuit Court of Appeals reversed the bureau's dismissal of the petition, remanding the case for reconsideration and criticizing both the bureau and the Department of Justice. In September 1975, the Drug Enforcement Administration (DEA), successor to the BNDD, acknowledged that treaty obligations did not prevent the rescheduling of marihuana but continued to refuse public hearings. NORML again filed suit. In October 1980, after much further legal maneuvering, the Court of Appeals remanded the NORML petition to the DEA for reconsideration for the third time. The government reclassified synthetic THC as a Schedule II drug in 1985 but kept marihuana itself - and THC derived from marihuana - in Schedule I. Finally, in May 1986, the DEA administrator announced the public hearings ordered by the court seven years earlier.
Those hearings began in the summer of 1986 and lasted two years. The parties who sought rescheduling were NORML, a membership-funded educational organization, founded in 1970, which opposes all criminal prohibitions against marihuana and marihuana smoking; the Alliance for Cannabis Therapeutics, a nonprofit organization founded in 1980 to make marihuana available by prescription; the Cannabis Corporation of America, a pharmaceutical firm established with the intention of extracting natural cannabinoids for therapeutic use when cannabis is placed in Schedule II; and the Ethiopian Zion Coptic Church, which considers marihuana a sacred plant essential to its religious rituals. These groups were opposed by the DEA, the International Chiefs of Police, and the National Federation of Parents for Drug-Free Youth, another membership-funded educational organization.
The lengthy hearings involved many witnesses, including both patients and doctors, and thousands of pages of documentation. The record of these hearings constitutes the most extensive contemporary exploration of the evidence on cannabis as a medicine. Administrative law judge Francis J. Young reviewed the evidence and rendered his decision on September 6, 1988. Young said that approval by a "significant minority" of physicians was enough to meet the standard of "currently accepted medical use in treatment in the United States" established by the Controlled Substances Act for a Schedule II drug. He added that "marijuana, in its natural form, is one of the safest therapeutically active substances known to man .... One must reasonably conclude that there is accepted safety for use of marijuana under medical supervision. To conclude otherwise, on the record, would be unreasonable, arbitrary, and capricious." Young went on to recommend "that the Administrator [of the DEA] conclude that the marijuana plant considered as a whole has a currently accepted medical use in treatment in the United States, that there is no lack of accepted safety for use of it under medical supervision and that it may lawfully be transferred from Schedule I to Schedule II (19).
In determining what "currently accepted medical use" meant for legal purposes, Judge Young was adopting the view of the petitioners and rejecting that of the DEA, whose criteria were the result of a previous legal challenge involving the drug 3,4-methylenedioxymethamphetamine (MDMA). In 1984 the DEA placed this previously unscheduled drug in Schedule I. The placement was challenged by a group of physicians and others who believed that MDMA had therapeutic potential. After extensive hearings, the administrative law judge rejected the DEA's position that MDMA had no accepted medical use in treatment in the United States, and agreed with the challengers that it should be placed in Schedule III rather than Schedule I. The DEA administrator rejected this recommendation. The challengers appealed to the U.S. First Circuit Court of Appeals, which ruled in their favor, finding that formal approval for marketing by the Food and Drug Administration, the DEA's criterion for "accepted medical use in treatment in the United States," was unacceptable under the terms of the Controlled Substances Act (20).
The DEA administrator responded with the following new criteria for accepted medical use of a drug: (1) scientifically determined and accepted knowledge of its chemistry; (2) scientific knowledge of its toxicology and pharmacology in animals; (3) effectiveness in human beings established through scientifically designed clinical trials; (4) general availability of the substance and information about its use; (5) recognition of its clinical use in generally accepted pharmacopoeia, medical references, journals, or textbooks; (6) specific indications for the treatment of recognized disorders; (7) recognition of its use by organizations or associations of physicians; and (8) recognition and use by a substantial segment of medical practitioners in the United States. These were the criteria rejected by Judge Young in his marihuana decision.
The DEA disregarded the opinion of its own administrative law judge and refused to reschedule marihuana. The agency's lawyer remarked, "The judge seems to hang his hat on what he calls a respectable minority of physicians. What percent are you talking about? One half of one percent? One quarter of one percent?" DEA Administrator John Lawn went further, calling claims for the medical utility of marihuana a "dangerous and cruel hoax" (21). In March 1991 the plaintiffs appealed yet again, and in April the District of Columbia Court of Appeals unanimously ordered the DEA to reexamine its standards, suggesting that they were illogical and that marihuana could never satisfy them. An illegal drug could not be used by a substantial number of doctors or cited as a remedy in medical texts. As the court pointed out, "We are hard pressed to understand how one could show that any Schedule I drug was in general use or generally available" (22). The court returned the case to the DEA for further explanation, but it offered no direct challenge to the central dogma that marihuana lacks therapeutic value. The DEA issued a final rejection of all pleas for reclassification in March 1992.
In spite of the obstructionism of the federal government, a few patients have been able to obtain marihuana legally for therapeutic purposes. State governments began to respond in a limited way to pressure from patients and physicians in the 1970s. In 1978, New Mexico enacted the first law designed to make marihuana available for medical use. Thirty-three states followed in the late 1970s and early 1980s (23). In 1992, Massachusetts became the thirty-fifth to enact such legislation.
But the laws proved difficult to implement. Since marihuana is not recognized as a medicine under federal law, states could dispense it only by establishing formal research programs and getting FDA approval for an IND (Investigational New Drug) application. Many states gave up as soon as the officials in charge of the programs confronted the regulatory nightmare of the relevant federal laws. Nevertheless, between 1978 and 1984, seventeen states received permission to establish programs for the use of marihuana in treating glaucoma and the nausea induced by cancer chemotherapy. Each of these programs has fallen into abeyance because of the many problems involved.
Take the case of Louisiana, where a law was passed in 1978 establishing a program that allowed a Marihuana Prescription Board to review and approve applications by physicians to treat patients with cannabis. The board would have preferred a simple procedure in which medical decisions would be entrusted to the practicing physician, but federal agencies would not supply cannabis without an IND. That would have required an enormous amount of paperwork and would have made the program intolerably cumbersome. The board therefore decided to use an approved research program operated by the National Cancer Institute, which was limited to cancer patients and employed only synthetic THC. Marihuana itself was not made legally available to any patient in Louisiana. With these limitations, the program proved ineffective Patients felt compelled to use illicit cannabis, and at least one was arrested (24).
Only ten states eventually established programs in which cannabis was used as a medicine. Among these New Mexico was the first and the most successful, largely because of the efforts of a young cancer patient, Lynn Pierson. In 1978 the state legislature enacted a law allowing physicians to prescribe marihuana to patients suffering from the nausea and vomiting of cancer chemotherapy. The law was later modified to comply with federal IND regulations requiring a research program. Considerable friction immediately developed between the FDA and the people in charge of the New Mexico program. The FDA demanded studies with placebos (inactive substances) as controls; the physicians in the New Mexico program wanted to provide sick patients with care. The FDA wanted to proceed slowly; the attitudes of the physicians reflected the urgency of their patients' needs. Eventually a compromise was reached. Patients would be assigned at random to treatment with marihuana cigarettes or synthetic THC capsules. But prolonged delays suggested to the New Mexico officials that the FDA was not dealing in good faith, and tensions began to grow. At one point state officials even considered using confiscated marihuana, and the Chief of the State Highway Patrol was asked whether it could be supplied.
In August 1978, Lynn Pierson, who had made such a heroic effort to establish a compassionate program, died of cancer without ever having received legal marihuana. Now the FDA approved the New Mexico IND, only to rescind the approval a few weeks later, after the public furor surrounding Pierson's death had died down. At that point New Mexico officials considered holding a public press conference to condemn federal officials for "unethical and immoral behavior." Finally, in November 1978, the program was approved; supplies of marihuana were promised within a month, but not delivered for two months.
The random design of the program was soon violated. Patients discussed among themselves the relative merits of the two types of treatment and switched when they wanted; this also gave them a sense of control over their own care. But many believed, despite the denials of the National Institute of Drug Abuse (NIDA), that the cigarettes they received were not of adequate potency. The state never conducted an independent assay. Some patients left the program in order to buy cannabis on the streets, saying it was better than either government marihuana or synthetic THC.
From 1978 to 1986 about 250 cancer patients in New Mexico received either marihuana or THC; after conventional medications failed to control their nausea and vomiting. For these patients both marihuana and THC were effective, but marihuana was superior. More than 90 percent reported significant or total relief from nausea and vomiting. Only three adverse effects were reported in the entire program - anxiety reactions that were easily treated by simple reassurance (25).
The successful programs in other states resembled the one in New Mexico. It was understood that "research" was merely a disguise; the aim was to relieve suffering. Although the results did not meet the methodological standards for controlled clinical research, they did confirm the effectiveness of cannabis and the advantage of smoked marihuana over oral THC. Incidentally, none of the programs reported problems with abuse or diversion of either THC or marihuana cigarettes.
A New York State Department of Health report on the therapeutic use of cannabis asked why more patients and physicians had not enrolled in the New York Program. it concluded that there were several reasons. First, physicians were skeptical because of their limited training and experience. Second, bureaucratic obstacles were enormous. As the report states, "Hospital pharmacists and administrators complain about paperwork and procedures. Physicians complain about burdensome reporting and application requirements. At least 16 physicians have inquired into the availability of marijuana, but have chosen not to enroll in the program because they perceive a large amount of bureaucratic procedure." A third possibility was that many patients and physicians decided it was easier to get marihuana of good quality on the street.
At about the same time the state programs were being instituted, growing demand forced the FDA to institute an Individual Treatment IND (commonly referred to as Compassionate Use IND or compassionate IND) for the use of individual physicians whose patients needed marihuana. The application process was not easy, because INDs were designed for an entirely different purpose - making pharmaceutical companies assure the safety of new drugs. First the patient in need of cannabis had to persuade a physician to apply to the FDA for an IND. The physician then had to file a special form with the DEA covering Schedule I drugs. If the application was approved by both agencies, the physician then had to fill out special order forms for marihuana, which were sent to the National Institute of Drug Abuse (NIDA). NIDA grew cannabis on a farm at the University of Mississippi - the only legal marihuana farm in the United States and sent it to North Carolina, where it was rolled into cigarettes that were supposed to have the same potency as street marihuana (2 percent THC). NIDA then shipped the marihuana to a designated pharmacy that had to comply with stringent DEA regulations for drug security. The application process took four to eight months. Both the FDA and the DEA required constant prodding and rarely responded within the time specified by law. According to the Alliance for Cannabis Therapeutics, which helped a number of patients and physicians through the process, government agencies routinely seemed to lose some of the application forms, and the doctor had to resubmit them, sometimes more than once. Understandably, most physicians did not want to become entangled in the paperwork, especially since many also believe there is some stigma attached to prescribing cannabis.
In 1976 Robert Randall became the first patient to receive a Compassionate IND for the use of marihuana. In the next 13 years the government reluctantly awarded about a half dozen more. Then, in 1989, the FDA was deluged with applications from people with AIDS. A case that called attention to the absurd and appalling consequences of the medical ban on marihuana was the government assault on Kenneth and Barbra Jenks, a Florida couple in their twenties who contracted AIDS through a blood transfusion given to the husband, a hemophiliac. Both were suffering from nausea, vomiting, and appetite loss caused by AIDS or AZT; their doctor feared that Barbra Jenks would die of starvation before the disease killed her. In early 1989 the Jenks learned about marihuana through a support group for people with AIDS. They began to smoke it and for a year they led a fairly normal life. They felt better, regained lost weight and were able to stay out of the hospital; Kenneth Jenks even kept his full-time job.
Then someone informed on them. On March 29, 1990, ten armed narcotics officers battered down the door of their trailer home, held a gun to Barbra Jenks' head, and seized the evidence of crime, two small marihuana plants they had been growing because they could no longer afford the street price of the drug. Cultivation of marihuana is a felony in Florida; the Jenkses faced up to five years in prison. At their trial in July the Jenkes used the defense of medical necessity, which is rarely successful. The judge rejected this defense and convicted the Jenkses, although he imposed no real punishment. The conviction was later overturned by a higher court and the defense of medical necessity sustained.
The case received national publicity and the Jenkses were able to obtain a Compassionate IND. Now the FDA was inundated with new requests from AIDS sufferers. The number of extant Compassionate INDs rose from five to thirty-four in a year. In early June 1991, Deputy National Drug Control Policy Director Herbert D. Kleber assured a national television audience that anyone with a legitimate medical need for marihuana would be able to get a Compassionate IND. But a few weeks later, on June 21, James O. Mason, chief of the Public Health Service, announced that the program would be suspended because it undercut the administration's opposition to the use of illegal drugs. "If it is perceived that the public Health Service is going around giving marihuana to folks, there would be a perception that this stuff can't be so bad," Mason said. "It gives a bad signal. I don't mind doing that if there is no other way of helping these people... But there is not a shred of evidence that smoking marihuana assists a person with AIDS." Since then, no new Compassionate INDs have been granted, despite hundreds of applications.
After keeping the program in limbo "under review" for nine months, the Public Health Service discontinued it in March 1992. Twenty-eight patients whose applications have already been approved (including some whose stories follow) will not be supplied with the promised marihuana. Twelve patients now receiving marihuana will continue to receive it. After more than twenty years in which hundreds of people have worked through state legislatures, federal courts, and administrative agencies to make marihuana available for suffering people, these twelve are the only ones for whom it is not still a forbidden medicine.