Dr. Lester Grinspoon, chairman of the Board of the National Organization for the Reform of Marijuana Laws (NORML) has written the book 'Marijuana the Forbidden Medicine' regarded as the book on marijuana. However, the scientific community has expressed other opinions.
His book was described as consisting of "reassembled anecdotes" in both 'The New England Journal of Medicine (332:274, 1995) and in 'The Annals of Internal Medicine (120:348, 1994) and on February 18, 1994 the U.S. Court of Appeals ruled against NORML in their bid to reschedule marijuana as medicine saying that the pro marijuan I parties relied on non-scientific anecdotes rather than solid scientific evidence.
As a commentary to the referendum about accepting marijuana as a medicine in California lately, we publish the following article about why marijuana should not be considered as a medicine. The article is extracted from the newsletter of European Cities Against Drugs , August 21, 1996.
Why isn't marijuana a medicine?
By Janet D. Lapey M.D.
By federal law, a substance may not be marketed in the U.S. until it has scientifically been shown to be safe and effective. Marijuana has never been shown scientifically to be safe or effective for the treatment of any condition.
Why must a substance be shown to be safe and effective?
Before 1906, the prevailing philosophy was "caveat emptor" (let the buyer beware), as many unscrupulous doctors peddled unlabelecl medicines which did more harm than good. These "snake oil" salesmen's potions often contained addictive substances, such as marijuana, cocaine, or morphine, and many people unwittingly became addicts. In order to protect the public from such scams and quackery, laws were enacted which ensure that no substance is marketed as medicinal until proven to be both safe and effective. The 1906 Pure Food and Drug Act required that ingredients be listed on the label; then the Food, Drug and Cosmetic Act of 1938 gave the Food and Drug Aclministzˇ ation (FDA) the authority to requzˇre that manufacturers prove their products' safety. In 1962 this requirement was expanded to include both safety and efficacy.
If the ingredients of marijuana were listed on the label. What would this list include? Marijuana is not a pure substance but is an unstable, varying, complex
mixture of over 400 chemicals, many of which are harmful substances which have not been well-studied either alone or in combination with each other. New harmful chemical components of marijuana are still being discovered (1). When smoked, marijuana produces over 2,000 chemicals, including hydrogen cyanide, ammonia, carbon monoxide, acetaldehyde, acetone, phenol, cresol, naphtalene, and well-known carcinogens such as benz(a)pyrene, benz(a)anthracene, benzene and nitrosamine ;. Many of these cancer-causing substances are present in higher concentrations in marijuana smoke than in tobacco smoke (2).
What are the harmful effects, of manjuana?
Marijuana is addictive (3); it adversely affects the immune system (4), leads to the use of other drugs, such as cocaine (5); it causes cancer, including cancer of the lungs, mouth, lip, and tongue (6).
Marijuana also casues respiratory diseases (7) and mental disorders, such as schizophrenia and other psychoses, depression, panic attacks, hallucinations, paranoia, hostility, depersonalization, flashbacks, decreased cognitive performance, disconnected thought, delusions, and impaired memory (8). Since marijuana impairs coordination and judgment, it is a major cause of accidents (9). Babies born to women who smoke marijuana during pregnancy have an increased incidence of leukemia (10), low birth weight (11) and other abnormalities.
How is a drug approved as a medicine?
The process by which drugs are approved begins with studies of their chemistry, pharmacology, and toxi-cology. Interchemical reactions must be known and reproducible, and dosages must be measurable with exactitude. After a potential medicine is tested in animals, there are several required phases of testing for safety and efficacy in healthy human volunteers and later in patients. These clinical trials must be carefully controlled and conducted by qualified scientists.
Have there been any studies on marijuana as medicine?
Although marijuana continues to be available for research, over 12,000 scientific studies on marijuana have been published, and the drug has never been shown to be safe or effective for the treatment of any condition. In June 1991, the U.S. Public Health Service ordered a study of this issue by scientists at the National Institutes of Health (NlH). The report, issued in March 1992, concluded that scientific studies have never shown marijuana to be safe or effective as medicine and that there are better, safer drugs available for all conditions considered.
The National Eye Inffitute reported that the intraocular pressure lowering action of marijuana is not effective enough to prevent optic nerve damage from glaucoma and that "there is no scientifically verifiable evidence that marijuana or its derivatives are safe and effective in the treatment of glaucoma."
The National Cancer Institute reported that newer antiemetic agents such as ondansetron have been shown to be more useful than THC as a first line therapy.
The National Institute of Neurological Disorders reported that no studies have shown marijuana to have beneficial effects on patients with multiple sclerosis.
The National Institute of Dental Research reported that there have been no controlled studies which substantiate claims of marijuana s antipain effects.
The National Institute of Allergy and Infectious Disease reported that the many carcinogens in marijuana smoke would be a health hazard for patients with compromised immune systems (12).
Why is marijuana a Schedule I Drug?
A Schedule I Drug, such as LSD, is a drug which is higly abusable with no medicinal value. A Schedule II Drug, such as cocaine, is also highly abusable, but has limited medicinal use. In 1972, the National Organization for the Reform of Marijuana Laws (NORML), a pro-marijuana legalization group, and related organizations commenced litigation against the Drug Enforcement Administration (DEA) in an attempt to reschedule marijuana from Schedule I to Schedule II. On February 18, 1994, the U.S. Court of Appeals (D.C. Circuit) ruled in favor of the DEA. The Court noted that the promarijuana parties, which included physicians connected to NORML, relied on non-scientific anecdotal testimonies. On the other hand, numerous highly qualified experts testified that marijuana's medicinal value has never been proven in sound scientific studies. In addition to the NIH, the FDA, the Amencan Medical Association, the Arnerican Cancer Society, the American Academy of Ophthalmology, the National Multiple Sclerosis Society, and the American Glaucoma Society have all stated that marijuana has never been shown to be safe or effective as medicine. Thus marijuana remains a Schedule I drug: highly abusable, with no medicinal use (13).
What is the THC pill and why is it in Schedule II? A synthetic form of delta9tetrahydrocannainol, THC, the main psychoactive ingredient of marijuana, was approved by the FDA in 1985 as an anti-nausea agent for cancer chemotherapy patients who had failed to respond to other drugs. In 1992 it was approved as an apptetite stimulant for patients with AIDS Wasting Syndrome. Synthetic THC (Marinol) is available by prescription in pill form and is a Schedule II drug: highly abusable, with limited medical use. Unlike marijuana, Marinol fits the definition of a modern pharmaceutical in that it is a stable, well-defined, pure substance in quantified dosage form. The medical use of THC (Marinol) is very restricted because of harmfizˇl side effects, such as addiction and mental disorders, which are doserelated, as noted in the Physicians' Desk Reference (14). Forh~nately, newer, better anti-emetic medications have been developed recently. Only a very low dose of Marinol is recommended for appetite stimuladon, since larger doses increase adverse effects without increasing efficacy. Smoking marijuana produces higher plasma THC levels than are obtained when THC is taken in pill form and therefore these harrnful side effects are greater.
Why do some people claim that marijuana has medical benefits?
Due to a placebo effect, a patient may erroneously believe a drug is helpfiul when it is not. This is especially true of addictive, mind-altering drugs like marijuana. Therefore, when a patient anecdotally reports a drug have medi cinal value, this must be followed by objective scientific studies. For in stance, in 1990 Dr. J.P. Frankel con
ducted a scientific study of the effect of smoked marijuana on his patients with Parkinson's Disease because one of the patients had claimed the drug to be beneficial. Dr. Frankel's research showed that the drug did not improve the symptoms of Parkinson's Disease in any patient, including the patient who had originally believed it useful (15).
Similarly, anecdotal reports had clazˇmed that marijuana caused improvement in multiple sclerosis. However, a scientifically-controlled 1994 study by Dr. H.S. Greenberg showed that smoking marijuana makes the symptoms of multiple sclerosis worse (16). The situation is similar to an athlete believeing that he is performing better under the influence of a drug when in actuality his performance is worse!
What groups are trying to claim that marijuana is a medicine?
Just as there is a powerful tobacco lobby, there is a wellfunded marijuana lobby which consists of groups, such as the National Association for the Reform of Marijuana Laws (NORML), which aim to legalzˇze marijuana. In 1979, Keith Stroup, NORML s founder, told an Emory University audience that they would be using the issue of medicinal marijuana as a red herring to give marijuana a good name (17). The tobacco industry also promoted cigarettes as medicine until the Federal Trade Commission halted the practice in 1955. 'Camels' were said to prevent fatigue and aid digestion, and 'Kools' were said to prevent the common cold (18). Currently, NORML backs state and federal 'medicinal marijuana' bills which aim to bypass consumer protection laws. The tobacco industry similarly tried to undermine the FDA.
Did the Journal of the American Medical Associa tion advocate marijuana as medicine?
No. There was an opinion piece in that journal written by Dr. Lester Grinspoon, the psychiatrist who is chairman of the board of NORML. Grinspoon is a long-time advocate of drug legalization. His book, 'Marijuana, the Forbidden medicine', promotes marijuana for almost any condition, including pain, itching, menstrual cramps, asthma, insomnia, depression, and other psychiatric conditions which marijuana is actually known to cause. The book downplays marijuana's harmfi~lness, referring to its addictive and gateway properties as a "hoary myth" (p. 158). It was similar misinformation from Grinspoon downplaying the harmfill effects of cocaine (19) which was pinpointed by many experts (20) as causing the nation's cocaine epidemic. On the NBC nightly news, June 20, 1995, Grinspoon said "marijuana is much safer than aspirin." This is not tme.
What was the Federal Compassionate Use Program?
In the late seventies, promarijuana activists pressured the federal government into providing marijuana ågarettes as 'medicine' for conditions they claimed it benefited. Following the NIH report, the Bush Administration stopped accepting new customers for the governmental marijuana handout program in 1992. The Clinton Administration reviewed the policy and came to the same conclusion in July 1994. It was determined that it is not compassionate to pass out drugs which do more harm than good
For instance, studies show that HIV positive smokers progress to fullblown AIDS twice as fast as nonsmokers (21) and HIV positive rnarijuana smokers have an increased incidence of bacterial pneumonia compared to nonmarijuana smokers (22). Most of the persons who received government-supplied marijuana died, and their deaths could have been accelerated by smoking marijuana. No scientific studies were ever carried out.
In the nation's rush towards deregulation, we must not forget that government has a very crucial role to play in protecting the public from modern day snake oil salesmen. Those who aim to legalize marijuana are preying upon our most vulnerable citizens: the sick and the dying. We should learn by the history of tobacco that addictive dangerous drugs wreak great harm upon society when they manage to escape FDA regulation. It is not compassionate to promote drugs as 'medicine' which have never been scientifically shown to be safe or effective.
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(This article is published courtesy, of Dr Janet D. Lapey, Conceroed Citizens for Drug Prevention Inc., Hanover, MA, U.S.A. Copyright: Janet D. Lapey)