Marijuana
The History Of Cannabis (Part II)
From the book Marihuana, the Forbidden Medicine
By Lester Grinspoon and James B. Bakalar.
Copyright © 1993 Yale University.
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.
Notes
- L.A. Matsuda, S. J. Lolait, M. J. Brownstein, A. C. Young, and T. I. Bonner, Structure of a Cannabinoid Receptor and Functional Expression of the Cloned cDNA, Nature 346 (Aug. 9, 1990): 561-564.
- T. H. Mikuriya, ed., Marijuana: Medical Papers, 1839-1972 (Oakland: MediComp, 1973).
- W. B. O'Shaughnessey, On the Preparations of the Indian Hemp, or Gunjah (Cannabis indica): The Effects on the Animal System in Health, and Their Utility in the Treatment of Tetanus and Other Convulsive Diseases, Transactions of the Medical and Physical Society of Bengal (1838-1840): 42l-461.
- E. L. Abel, Marihuana: The First Twelve Thousand Years (New York: Plenum, 1980).
- R. R. M'Meens, Report of the Committee on Cannabis Indica, Transactions, Fifteenth Annual Meeting of the Ohio State Medical Society, Columbus, 1860.
- H. A. Hare, Clinical and Physiological Notes on the Action of Cannabis indica, Therapeutic Gazette 11 (1887): 225-226.
- Ibid., 226.
- J. R. Reynolds, Therapeutic Uses and Toxic Effects of Cannabis indica, Lancet 1 (1890): 637.
- J. B. Mattison, Cannabis indica as an Anodyne and Hypnotic, St. Louis Medical Surgical Journal 61 (1891): 266.
- Ibid., 268.
- E. A. Birch, The Use of Indian Hemp in the Treatment of Chronic Chloral and Chronic Opium Poisoning, Lancet 1 (1889): 625.
- Mattison, Cannabis indica as Anodyne, 266-267.
- W Osler, The Principles and Practice of Medicine, 8th ed. (New York: Appleton, 1913), 1089.
- Mattison, Cannabis indica as anodyne, 271.
- U.S. Congress, House Ways and Means Committee, Hearings on H.R. 6385: Taxation of Marihuana, 75th Cong., lst sess., Apr. 27, 1937, 91, 94.
- Ibid., 116.
- Ibid., 117.
- S. Allentuck and K. M. Bowman, The Psychiatric Aspects of Marihuana Intoxication, American Journal of Psychiatry 99 (1942): 248-251; Editorial: Recent Investigation of Marihuana, Journal of the American Medical Association (hereafter JAMA) 120 (1942): 1128-1129; Letter: Anslinger, The Psychiatric Aspects of Marihuana Intoxication, JAMA 121 (1943): 212-213; Letter: Bouquet, Marihuana Intoxication, JAMA 124 (1944): 1010-1011; Editorial: Marihuana Problems, JAMA 127 (1945): 1129; R. S. deRopp, Drugs and the Mind (New York: St. Martin's, 1957), 108-109.
- Drug Enforcement Agency (hereafter DEA), In the Matter of Marijuana Rescheduling Petition, Docket 86-22, Opinion, Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision of Administrative Law Judge, Sept. 6, 1988
- Grinspoon v. DEA, 828 F.2d 881 (1st Cir. 1987).
- Marijuana Scheduling Petition, Denial of Petition, Federal Register 54, no. 249 (Dec. 29, 1988), 53784.
- U.S. Court of Appeals, District of Columbia Circuit, Docket 90-1019, Petition for Review of Orders of the DEA, Apr. 26,1991, 9.
- Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Michigan, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin
- DEA, Marijuana Rescheduling Petition, Docket 86-22, Affidavit of Philip Jobe, Ph.D.
- Ibid., Affidavit of Daniel Danzak, M.D.
- Annual Report to the Governor and Legislature on the Antonio G. Olivieri Controlled Substances Therapeutic Research Program, New York State Department of Health, Sept. 1, 1982.
back to part 1
Books Marihuana, the Forbidden Medicine
Two eminent Harvard researchers describe the medical benefits of marihuana, explain why its use has been forbidden, and argue for its full legalization to make it available to patients who need it.
Examples of the ways that marihuana alleviates symptoms of cancer chemotherapy, multiple sclerosis, osteoarthritis, glaucoma, AIDS, and depression, as well as symptoms of such less common disorders as Crohn`s disease, diabetic gastroparesis, and post-traumatic stress disorder.
Marihuana, the Forbidden Medicine Marijuana Myths Marijuana Facts:
A Review Of The Scientific Evidence
You might want to read this if you are interested in marijuana, or want to discuss marijuana with your kids, but do not have enough facts to begin.
This is not propaganda put out by anti-drug crusaders, it is a scientific study of the facts. If you need to talk to your children about marijuana, and have them respect your opinion, get the facts, not the hype.
Marijuana Myths Marijuana Facts Reefer Madness:
The History of Marijuana in America
Reefer Madness is the authors reply to the movie of the same name. But this is an honest version of the social history of marijuana use in America.
Beginning with the hemp farming of George Washington, author traces the fascinating story of our nation's love-hate relationship with the resilient weed we know as marijuana.
Reefer Madness The Emperor Wears No Clothes:
The Authoritative Historical Record of Cannabis
and the Conspiracy Against Marijuana
Probably the best book around about the history, uses, and war on this plant. Over 300 pages of text, photos, illustrations and charts.
This book has been an eye opener to me and everyone else I know that has read it. You would be hard pressed to find a more complete source for information relating to the suppression of the hemp industry in the United States.
The Emperor Wears No Clothes
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