Alice O'Leary: The First Lady of medical marijuana
Alice discusses the state of medical cannabis in the USA.
Illegally healed.com
Robert Randall and his partner Alice O'Leary
Talk about Robert's fight to use cannabis to treat his glaucoma and the early cannabis law reform movement in the US.
Medical Cannabis Cases
US v Randall 1976
US v Randall was the first legal case in the Untied States to extend the necessity defence to the crimes of possession or cultivation of cannabis, and brought about change to cannabis policy,
In 1972, an ophthalmologist told Randall he had glaucoma and would be blind in 5 years. He was 24 at the time and was advised to go on disability and start learning Braill.
In the months that followed, he tried every treatment option available to ease his symptoms and stop the deterioration of his sight. At first several methods were successful, and temporarily stabilised his elevated intraocular pressure (IOP), which is the primary cause of vision impairment and eye loss in patients with glaucoma but as his tolerance to each treatment increased, so did his IOP. To complicate matters, the drops prescribed by his ophthalmologist came with a disconcerting side effect of blurred vision. Surgery was ruled out, as it could have resulted in immediate blindness.
One night Robert Randall noticed a peculiar effect on his vision he looked out his apartment window at the streetlights and saw a telltale sign of the elevated eye pressures associated with glaucoma halos around the lights. Turning away he decided to forget his troubles and smoke some cannabis. Some time later he looked out his window again and immediately realised that the halos were gone. Robert Randall thought it too good to be true. Later he wrote in his memoirs, Marijuana RX. “Marijuana beneficial? A delicious thought perhaps, but nothing to hang your sight on.”
As time progressed he recognised more and more that cannabis was the only treatment that helped his glaucoma. In 1975, he began cultivating cannabis on the back porch of his Washington, DC, apartment. In August, he and his partner, Alice O’Leary returned home from vacation to find that their plants had been seized by local law enforcement. He was charged with cultivation and possession of "marijuana."
Wanting to prove in court the validity of his claim that cannabis was a medical necessity for him to treat his glaucoma , he sought counsel from leading researchers. The key witness was Robert Hepler, MD, a UCLA opthalmologist. In 1971, Hepler and his colleague, Ira R. Frank, MD, were the first doctors to report that cannabis lowered IOP by 25% to 30% in a small number of patients for a short period of 3 to 4 hours. Their findings were published in the Journal of the American Medical Association, and are still mentioned today in reports of clinical trials on cannabis and glaucoma.
Dr Hepler monitored Randall's use of all the pharmaceutical drugs available to treat glaucoma, including an oral form of delta-9-tetrahydrocannabinol, dronabinol which is the primary active ingredient in cannabis, before adding inhaled cannabis to the experiment. The results confirmed conventional treatments failed to keep Randall's IOP in check, whereas smoking 8 to 10 cannabis cigarettes reduced it by approximately 35%, and could stop the progression to blindness.
In court Randall submitted that cannabis was a medical necessity for him to treat his glaucoma. In response to Randall’s medical necessity defence, the Court recognised its responsibility to set forth clearly its understanding of the applicable law. In finding that the necessity defence was available to Randall, the Court set forth the requisite elements of the defence:
1. the defendant did not intentionally bring about the circumstances that precipitated the unlawful act;
2. the defendant could not accomplish the same objective using a less offensive alternative; and
3. that the evil sought to be avoided was more heinous than the unlawful act perpetrated to avoid it.
The Court balanced Randall’s interest in his health against the state’s interest in enforcing drug laws that protect the public, and accepted his necessity submission, that his right to preserve his sight outweighed the state’s interest in outlawing the drug.
Here are the facts as recounted by Judge Washington in his decision:
"The government has established, and the defendant has not attempted to refute, that on or about August 21, 1975, police officers in the course of their normal duties noticed what they believed to be cannabis plants on the rear porch and in the front windows of defendant's residence… A warrant was issued and a search of the premises conducted on August 23, 1975. Several plants and a dried substance later identified as marijuana were seized and defendant's arrest followed.
"At trial, the government's evidence demonstrated that the substance seized at defendant's residence was marijuana, possession of which is prohibited by D.C. Code Section 33-402, thus establishing all the elements of the crime charged. Moreover, defendant admitted that he had grown the marijuana in question and that it was intended for his personal consumption. He further testified that he knew that possession and use of this narcotic are restricted by law.
"Defendant nonetheless sought to exonerate himself through the presentation of evidence tending to show that his possession of the marijuana was the result of medical necessity. Over government objection of irrelevancy, defendant testified that he had begun experiencing visual difficulties as an undergraduate in the late 1960s. In 1972 a local opthalmologist, Dr. Benjamin Fine, diagnosed defendant's condition as glaucoma, a disease of the eye characterized by the excessive accumulation of fluid causing increased intraocular pressure (IOP), distorted vision and, ultimately, blindness.
"Dr. Fine treated defendant with an array of conventional drugs, which stabilized the intraocular pressure when first introduced but became increasingly ineffective as defendant's tolerance increased. By 1974, defendant's IOP could no longer be controlled by these medicines, and the disease had progressed to the point where defendant had suffered the complete loss of sight in his right eye and considerable impairment of vision in the left.
"Despite the ineffectiveness of traditional treatments, defendant during this period nonetheless achieved some relief through the inhalation of marijuana smoke. Fearing the legal consequences, defendant did not inform Dr. Fine of his discovery, but after his arrest defendant participated in an experimental program being conducted by opthalmologist Dr. Robert Hepler under the auspices of the United States Government.
"Dr. Hepler testified that his examination of the defendant revealed that treatment with conventional medications was ineffective, and also that surgery, while offering some hope of preserving the vision which remained to defendant, also carried significant risks of immediate blindness. The results of the experimental program indicated that the ingestion of marijuana smoke had a beneficial effect on defendant's condition, normalizing intraocular pressure and lessening visual distortions."
Case of First Impression
"This is a case of first impression in this jurisdiction," wrote Judge Washington in his decision, "one which raises significant issues. Consequently, the Court recognizes its responsibility to set forth clearly and in some depth its understanding of the applicable law."
Citing case law, Washington concluded that "the common law recognizes the defense of necessity in criminal cases... where the actor is compelled by external circumstances to perform the illegal act." He listed three exceptions. The necessity defense cannot be used when "1) The duress or circumstance has been brought about by the actor himself; 2) The same objective could have been accomplished by a less offensive alternative which was available to the actor; or 3) The evil sought to be averted was less heinous than that performed to avoid it."
"While the exact cause of defendant's glaucoma is unknown, neither the government nor any of the expert witnesses has suggested that the defendant is in any way responsible for his condition. Similarly, no alternative course of action would have secured the desired result through a less illegal channel. Because of defendant's tolerance, treatment with other drugs has become ineffective, and surgery offers only a slim possibility of favorable results coupled with a significant risk of immediate blindness. Neither the origin of the compelling circumstances nor the existence of a more acceptable alternative prevents the successful assertion of the necessity defense.
"The question of whether the evil avoided by defendant's action is less than the evil inherent in his act is more difficult. It requires a balancing of the interests of this defendant against those of the government. While defendant's wish to preserve his sight is too obvious to necessitate further comment, the government interests require a more detailed examination.
"One of the oldest recognized drugs, marijuana was not regulated in the United States until the Pure Food and Drug Act of 1906, which required that the presence of marijuana be indicated on the labels of products of which it was a component. The modern prohibition began in 1937, in response to primarily economic pressures without significant inquiry into its effects on users.
"Liquor manufacturers and distributors, still recovering from the effects of Prohibition, were interested in eradicating the potential competition from a drug often used for recreational purposes. In addition, criminalizing marijuana simplified the task of eliminating the competition for jobs during the Depression posed by the principal users of the drug, Mexican migrant laborers."]
"The 1970 Controlled Substances Act continued the prohibition of the use of marijuana, but a Presidential Commission was appointed to study its effects. Pending receipt of this report, marijuana was classified as a non-narcotic and although its use was still prohibited, the penalties were considerable reduced, with first offenders being discharged conditionally. The District of Columbia law, however, was not changed, and retains the narcotic classification based on the 1937 Uniform Narcotics Act. Medical evidence suggests that the prohibition is not well founded...."
"Reports from the President's Commission and the Department of Health, Education and Welfare have concluded that there is no conclusive scientific evidence of any harm attendant upon the use of marijuana. According to the most recent HEW study, research has failed to establish any substantial physical or mental impairment caused by marijuana. Reports of chromosome damage, reduced immunity to disease, and psychosis are unconfirmed; actual evidence is to the contrary.
"Furthermore, unlike the so-called hard drugs, marijuana does not appear to be physically addictive or to cause the user to develop a tolerance requiring more and more of the drug for the same effects. The current HEW report also notes the possibility of valid medical uses for this drug...
"The Court finds that this defendant does not fall within the third limitation to the necessity defense. The evil he sought to avert, blindness, is greater than that he performed to accomplish it, growing marijuana in his residence in violation of the District of Columbia Code. While blindness was shown by competent medical testimony to be the otherwise inevitable result of defendant's disease, no adverse effects from the smoking of marijuana have been demonstrated...
Judge Washington could have ended his decision at this point, but he went on to assert its applicability to other necessity defence cases. He refuted an argument that would deny the necessity defence based on the literal wording of the DC Code section, which makes no reference to extenuating circumstances. He also discussed whether a defendant should have to prove necessity "beyond a reasonable doubt" and concluded that "by a preponderance of the evidence" was sufficient.
Consequently the Court held that Randall was “not guilty” of the crime of the possession of "marijuana." His case helped establish the legal concept of medical necessity for the possession of cannabis. Not only was he acquitted, his lawyer also convinced the United States federal government to provide him with a consistent, legal supply of the drug.
After the case, a new ophthalmologist was appointed by the National Eye Institute (NEI) and the National Institute on Drug Abuse to continue researching Randall’s case. In 1976 Randall began receiving his first supplies of medical cannabis from the government. Randall spoke freely to the press on the subject without fear of prosecution.
However in 1978 federal agencies, agitated by Randalls’ outspoken opposition to the medical prohibition of cannabis, sought to silence him by disrupting his legal access to his government supply of cannabis. In response, Randall brought suit against the FDA, DEA, NIDA, the Department of Justice and the Department of Health, Education & Welfare. Twenty-four hours after the suit was filed, federal agencies requested an out-of-court settlement which resulted in the provision to Randall with prescription access to cannabis through a federal pharmacy located near his home making him the first legal medical cannabis patient in the United States since 1937.
The settlement also became the legal basis for the FDA's Compassionate IND program. Initially, this program was limited to patients afflicted by cannabis-responsive disorders and some orphan drugs. In the 1980’s the concept was expanded to include HIV-positive people seeking legal access to drugs, which had not yet received final FDA marketing approval.
A 1979 report from the Wisconsin State Journal wrote: “Now Randall, who won a lawsuit to obtain legal marijuana, carries the marijuana cigarettes, prescribed for him by an eye doctor, in a brown plastic pill bottle bearing his name and the instruction, ‘Smoke as directed.’”
The Compassionate IND program was closed in 1992 to any future patients. At that time there were 15 patients receiving cannabis from the NIDA-sponsored cannabis farm at the University of Mississippi. By 1995 seven of those patients had died leaving only 8 federal medical cannabis patients.
After gaining his right to medical cannabis he and his wife, Alice O’Leary formed the Alliance for Cannabis Therapeutics and started the patient movement across the United States to end the prohibition of medicinal cannabis. The medical necessity defence was used in several cases in State Courts across the United States, and paved the way for the introduction of significant reform measures. Keith Stroup, founder of the National Organization for the Reform of Marijuana Laws (NORML) dubbed him “the father of the medical marijuana movement.”
At the time of Randall’s death in 2001, 8 states had established some form of legislation that allowed for the use of medical cannabis rather than patients needing to rely on the defence of necessity in Court. Since Randall's death, over 30 states have implemented “compassionate use” laws for cannabis. All of the state laws in the United States list glaucoma as an approved condition which seems to point to cannabis’s established reputation as a viable alternative treatment for glaucoma.
Glaucome Research
"Pupil constriction after marijuana smoking," R.S. Hepler MD, Ira M. Frank, M.D. , J. Thomas Ungerleider, M.D. Department of Ophthalmology, Jules Stein Eye Institute, and the Department of Psychiatry, UCLA School of Medicine, Los Angeles, California, American Journal of Opthalmology, December 1972, Volume 74, Issue 6, Pages 1185–1190.
In 1971, Hepler and his colleague, Ira R. Frank, MD, were the first doctors to report that cannabis lowered IOP by 25% to 30% in a small number of patients for a short period of 3 to 4 hours. Their findings were published in the Journal of the American Medical Association, and are still mentioned today in reports of clinical trials on cannabis and glaucoma.
Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits
and Adverse Effects of Legal Clinical Cannabis, Ethan Russo, Mary Lynn Mathre, Al Byrne, Robert Velin, Paul J. Bach Juan, Sanchez-Ramos, Kristin A. Kirlin, Journal of Cannabis Therapeutics, Vol. 2(1) 2002
Marijuana Rx: The Patients' Fight for Medicinal PotPaperback – November, 1998
by Robert C. Randall (Author), Alice M. O'Leary (Author), Amazon
Part history, part biography, part expose, "Marijuana RX: The Patients' Fight for Medicinal Pot" Paperback on the legal battles, government "shell games, public triumphs, and individual tragedies that have marked the long and ongoing struggle for legalisation of this controversial drug for medicinal use.