Monday, April 7, 2008

Patients Out of Time'sRebuttal to DEA's "Exposing the Myth of Medical Marijuana"

Patients Out of Time assumes that the current budget of the DEA enables it, if it desired, to have the most relevant and current information available on its official web page (address below). From its very first statement on their document, Exposing the Myth of Medical Marijuana, to its last statement, it has not done so. Please consider the source of all information provided and the semantics used to describe the federal government's position on therapeutic cannabis.

The 1999 Institute of Medicine's Report, "Marijuana as Medicine: Assessing the Science Base" was commissioned in 1997 at the request of the drug czar. We encourage everyone to read the study or at least the executive summary. Its conclusions, after assessing all known US research, were essentially similar to other major studies conducted in various countries in the past.
A list of the major studies is available at Patients Out of Time's website MedicalCannabis. com

Below are questions about marijuana posed by the DEA on their web page with their "factual" responses. Patients Out of Time finds this DEA document to be misleading and biased, containing half-truths and duplicity. Patients Out of Time offers rebuttals to the statements and encourages the readers to review some of the suggested readings at the end of this paper for a better understanding of the current science on marijuana/cannabis.

Q: Does marijuana pose health risks to users?

• Marijuana is an addictive drug with significant health consequences to its users and others.

Many harmful short-term and long-term problems have been documented with its use:

The Institute of Medicine's Report discussed concerns of dependence and withdrawal: "A second concern associated with chronic marijuana use is dependence on the psychoactive effects of THC. Although few marijuana users develop dependence, some do. Risk factors for marijuana dependence are similar to those for other forms of substance abuse" (p. 6). Its conclusion: "A distinctive marijuana withdrawal syndrome has been identified, but it is mild and short-lived. The syndrome includes restlessness, irritability, mild agitation, insomnia, sleep EEG disturbance, nausea, and cramping" (p.6). In other words, it's not highly addictive.

• The short term effects of marijuana use include: memory loss, distorted perception, trouble with thinking and problem solving, loss of motor skills, decrease in muscle strength, increased heart rate, and anxiety.

The IOM report stated, "...except for the harms associated with smoking, the adverse effects of marijuana use are within the range of effects tolerated for other medications." Since the side effects of Marinol ®, a single synthetic compound called THC, are very similar to whole cannabis, it is duplicitous of the DEA to refer to Marinol as a safe effective medicine (schedule 3) and cannabis as useless therapeutically.

• In recent years there has been a dramatic increase in the number of emergency room mentions of marijuana use. From 1993-2000, the number of emergency room marijuana mentions more than tripled.

This statement is misleading - the reason for seeking emergency care may not have anything to do with the marijuana "mention." A mention of past marijuana use becomes a marijuana report in the ER. The numbers quoted come from the Drug Abuse Warning Network (DAWN), which has also been coined as "Data About Worthless Numbers," because the information gathered only reflects the drugs consumed by ER patients, the drug mention is NOT necessarily related to the ER visit. Changes in reporting procedures have marred these statistics beyond validity; plus in 1998 54% of ER admissions were criminal justice system referrals.

• There are also many long-term health consequences of marijuana use. According to the National Institutes of Health, studies show that someone who smokes five joints per week may be taking in as many cancer-causing chemicals as someone who smokes a full pack of cigarettes every day.

Chronic cannabis usage was first studied in 1894 and published as the Indian Hemp Drugs Report by the British government. This was a three-year study that interviewed hundreds of Indian and Western doctors about therapeutic cannabis use. The conclusion was that cannabis had negligible adverse effects on health, even in chronic application. Similar conclusions were reached by The LaGuardia Report of 1944 (NYC), which was the first study to employ clinical and scientific methods of research. Three important systematic epidemiological studies undertaken in the 1970's exhaustively examined medical issues in chronic cannabis use. Ganja in Jamaica: A Medical Anthropological Study of Chronic Marijuana Use (Rubin and Comitas 1975) with 60 patients; a Greek study, Hashish: Studies of Long-term Use (Stefanis, Dornbush and Fink 1977) with 60 patients; and Cannabis in Costa Rica: A Study of Chronic Marijuana Use (Carter 1980) with 41 patients - all reached the same health conclusions as stated in the IOM report of 1999.

New studies of the 21st century also report minimal negative long-term effects of cannabis use. In May of 2001, four of the seven surviving U.S. legal medical marijuana patients (supplied with medical cannabis by the federal government through the FDA's Investigational New Drug program) were examined intensively for three days, at St. Patrick's Hospital in Missoula, MT (known as the Missoula Chronic Use Study).
The complete study is available at www. medicalcannabis. com.
These patients had used cannabis for 25 years, 27 years, 26 years and 11 years. Monthly consumption was 8 or 9 cured ounces with one patient receiving 11 cured ounces every three weeks. The study concluded that with very minor pulmonary negative changes (within that expected for age) each patient was in very good health and took no additional medications. Although the U.S. government provided these patients their medicine, they never cared enough to study what it did to them. We did and now we know it has been vital to their health and the quality of their lives. We also know that the DEA has not identified these studies to the US public or has not read them. Consider the source.

The Canadian Senate Committee on Illegal Drugs just released its 2-year study of cannabis in September 2002. The Committee recommended that cannabis be legalized and regulated for sale to adults as alcohol is presently handled. It further recommended that all criminal record of possession be expunged.

• Marijuana contains more than 400 chemicals, including most of the harmful substances found in tobacco smoke. Smoking one marijuana cigarette deposits about four times more tar into the lungs than a filtered tobacco cigarette.

There are 360 compounds in a tomato - does that mean we shouldn't eat them? There are more than 400 compounds in Cannabis, about 60 of them are classified as cannabinoids and so far science shows that many of them work synergistically to be therapeutically valuable. Cigarette smoking kills more than 400,000 people in this country annually. Cannabis smoking has not killed anyone. The folks at NIDA, NIH and the DEA know, or they should know, that cannabis use therapeutically or recreationally can be administered in a variety of ways. One of their own scientists, the nice man in charge of growing the medical cannabis at the University of Mississippi for the federal government and Missoula Study patients, has a patent pending on a cannabis suppository. Benedictine monks over several centuries made a ton of money making and selling cannabis in topical form, just like the Body Shop does these days. Elvy Musikka, one of the Missoula patients eats her cannabis at night in cookie form. If you look beyond the borders of the United States as our government does continually, it would seem with blinders installed, the DEA could certainly find GW Pharmaceuticals of the UK. They have developed and patented a sublingual (under the tongue) spray of tincture of the whole cannabis plant. Canisol, a cannabis based eye drop for glaucoma was developed and is available to patients in Jamaica. Vaporizers (a method of inhalation in which the plant material is heated to the point of releasing vapor but is not hot enough to cause combustion) are currently being developed on several continents for patients who find great benefit from an inhaled administration. These vaporizers will allow patients to inhale the therapeutic properties of cannabis without the tar or other dangerous substance released when cannabis is burned and the smoke inhaled.

• Harvard University researchers report that the risk of a heart attack is five times higher than usual in the hour after smoking marijuana.


This study was presented at the American Heart Association conference held in March 2000, but was never published. An American Journal of Nursing article (April 2001) by Mathre, notes that the study, (Mittleman MA, et al "Triggering of myocardial infarction by marijuana." Circulation 2000:101(6):713; concludes that further study into this possibility is needed.

• Smoking marijuana also weakens the immune system4 and raises the risk of lung infections.5 A Columbia University study found that a control group smoking a single marijuana cigarette every other day for a year had a white-blood-cell count that was 39 percent lower than normal, thus damaging the immune system and making the user far more susceptible to infection and sickness.

What the references given are saying is that smoking anything can raise the risk of lung infection and this is especially true for patients if their medicine comes by way of a barge, a semi or a crop duster rather than from a known source with quality control. The IOM was far more reasonable about making a judgment on the matter. Rather than select three studies that may support the federal policy they looked at every study done in the US. The IOM concluded, "Cell culture and animal studies have established cannabinoids as immunomodulators - that is, they increase some immune responses and decrease others. The variable responses depend upon such experimental factors as drug dose, timing of delivery, and type of immune cell examined." It goes on, "Many of the effects noted above appear to occur at (high concentrations) and.... is enough to produce strong psychoactive effects". These dosages and effects are far beyond that needed or sought by the ill.

• Users can become dependent on marijuana to the point they must seek treatment to stop abusing it. In 1999, more than 200,000 Americans entered substance abuse treatment primarily for marijuana abuse and dependence.

Anyone found possessing cannabis is considered in the semantics of the drug war, as an abuser or an addict. Abusers/addicts get a choice: go to jail or go to treatment. In addition, abuse of medicine is synonymous with "addiction". Addiction is defined as a pattern of drug abuse characterized by an overwhelming preoccupation with the compulsive use of a drug, securing its supply, and a high tendency to relapse if the drug is taken away.

A question one must ask is: Are cannabis users seeking treatment for help with a cannabis addiction problem or are they seeking treatment as an alternative to jail or job loss because they were caught using cannabis or had a drug screen positive for cannabis?

• More teens are in treatment for marijuana use than for any other drug or for alcohol. Adolescent admissions to substance abuse facilities for marijuana grew from 43 percent of all adolescent admissions in 1994 to 60 percent in 1999.

If this were true, it would indicate that the drug war has been a failure. Over the years our government has poured billions of dollars into the war on drugs, with a high priority aimed at preventing teens from using the drug. Obviously the war has not been very successful. On the other hand, is there an epidemic of marijuana dependence/addiction among our teens? Are more teens in treatment for cannabis dependence or for cannabis use? If teens get caught smoking cannabis or with a positive drug test for cannabis they may be forced into treatment or suffer other consequences per school administrators, law officials, or their parents. Clearly teens should avoid use of psychoactive drugs, but experimental use of drugs is normal adolescent behavior. Some of the teens in treatment for cannabis dependence may have a serious problem with cannabis, but it seems highly unlikely that cannabis is the leading drug "problem" for teens.

• Marijuana is much stronger now than it was decades ago. According to data from the Potency Monitoring Project at the University of Mississippi, the tetrahydrocannabinol (THC) content of commercial-grade marijuana rose from an average of 3.71 percent in 1985 to an average of 5.57 percent in 1998. The average THC content of U.S. produced sinsemilla increased from 3.2 percent in 1977 to 12.8 percent in 1997.

Eight decades ago any patient, without a prescription, could have walked into any pharmacy in North America and bought tincture of cannabis. These products were produced and bottled by pharmaceutical giants like Eli Lily and Parke-Davis. The potency of these preparations was up to 100 fold the potency of today's sinsemilla (a female without seeds/without pollination). A circa 1920 tincture of cannabis bottle's label advises the user to "take until the desired effect is recognized." The range of potency cited by the DEA is simply the result of experts growing the plant in a manner that provides the patients with the flowers of the cannabis plant, where the heaviest concentration of THC is located. Cannabis that was available in the 1970s and 1980s, included stems, seeds and leaf material, which was therapeutically marginal and mathematically reduced the total volume of active therapeutic ingredients. The notion left by the DEA statement is that a stronger medicine is bad. To the contrary a stronger controlled dose means less inhalations if the patient chooses smoking.


Does marijuana have any medical value?

• Any determination of a drug's valid medical use must be based on the best available science undertaken by medical professionals. The Institute of Medicine conducted a comprehensive study in 1999 to assess the potential health benefits of marijuana and its constituent cannabinoids. The study concluded that smoking marijuana is not recommended for the treatment of any disease condition. In addition, there are more effective medications currently available. For those reasons, the Institute of Medicine concluded that there is little future in smoked marijuana as a medically approved medication.

There they go again. Under "Physiological Risks" the IOM authors concluded, "When interpreting studies purporting to show the harmful effects of marijuana, it is important to keep in mind that the majority of those studies are based on smoked marijuana, and cannabinoid effects can not be separated from the effects of inhaling smoke of burning plant material and contaminants". They recommended, "Studies to define the individual health risks of smoking marijuana should be conducted, particularly among populations in which marijuana use is prevalent." The IOM report noted, "Clinical trials of marijuana use for medical purposes should be conducted under the following limited circumstances: trials should involve only short term marijuana use (less than 6 months); be conducted in patients for which there is a reasonable expectation of efficacy; be approved by institutional review boards; and collect data about efficacy." The report continues: " The goal of the clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug, but rather as a first step towards the possible development of non-smoked rapid onset cannabinoid delivery systems." They felt this might take a while so, "In the meantime, there are patients with debilitating symptoms for whom smoked marijuana might provide relief." Please note the earlier mentions of other delivery systems such as that patented by GW Pharmaceuticals in 2001, just two years after the IOM report. Please note as well that the DEA seems to have an agenda that does not rely on truth or science.

• Advocates have promoted the use of marijuana to treat medical conditions such as glaucoma. However, this is a good example of more effective medicines already available. According to the Institute of Medicine, there are six classes of drugs and multiple surgical techniques that are available to treat glaucoma that effectively slow the progression of this disease by reducing high intraocular pressure.

Again the DEA leaves out part of the picture, the part that says for some patients, all of the above treatments, are absolutely useless. The failure of every drug and surgical procedure, throughout a battery of federally demanded experiments with his sight, convinced the federal government that Robert Randall, a glaucoma patient, should be given therapeutic cannabis. That was in May of 1978. When Robert died in June of 2001, he still had sight. All patients must be afforded the right to seek the option of using cannabis therapeutically to augment the standard medical procedures of today.

• In other studies, smoked marijuana has been shown to cause a variety of health problems, including cancer, respiratory problems, increased heart rate, loss of motor skills, and increased heart rate. Furthermore, marijuana can affect the immune system by impairing the ability of T-cells to fight off infections, demonstrating that marijuana can do more harm than good in people with already compromised immune systems.

From the IOM, "For most people, the primary adverse effect of acute use is diminished psychomotor performance". " In addition, a minority of marijuana users experience dysphoria, or unpleasant feelings. Finally, the short term immunosuppressive effects are not well established but, if they exist, are not likely great enough to preclude a legitimate medical use". Recent studies underway in Spain indicate the opposite of the DEA statement of fact concerning cancer. In preliminary results cannabis has reduced or eliminated glioblastoma multiforme tumors of the brain. Mild temporary increase in heart rate, tachycardia, is often dose related and may last from immediate use up to 45 minutes. This may be a risk to persons with angina or other cardiac problems, and consequently should be used with caution by them and under medical supervision.

• In addition, in a recent study by the Mayo Clinic, THC was shown to be less effective than standard treatments in helping cancer patients regain lost appetites.

The "munchies" is a term well known on the streets of the US. It is common slang for the results of using cannabis. For the edification of DEA agents everywhere it means when you use cannabis you get hungry. This is not a new idea. In Cannabis in Medical Practice: A Legal, Historical and Pharmacological Overview of the Therapeutic Use of Marijuana, Mathre 1997, it is reported that the Indian Hemp Drug Commission listed appetite stimulation as a therapeutic use. Galen, the second century physician renowned for making compound drug preparations (still called galenicals), said the cannabis seed is hard to digest but, "cooked and consumed with dessert after dinner, stimulates the appetite for drinking". Muslim texts of the 14th century mention hashish as an aid to digestion, while DaOrta in 1563 wrote in "Colloquies on the Simple and Drugs of India" that, "the Indians eat either the seeds or the pounded leaves to assist or quiet the women. They also take it for another purpose, to give an appetite".

More recently studies with Marinol have demonstrated the effectiveness of THC as an antiemetic - that is why it has been approved as medicine. Cannabis users will argue that the whole plant product works better than the THC alone. The fact that THC is not the "best" per their cited study, does not negate the fact that it works very well for some patients.

• The American Medical Association recommends that marijuana remain a Schedule I controlled substance.

The American Medical Association (AMA) recommended that cannabis use carry no criminal penalty in 1977 and has never changed their position. They hold the present position that cannabis therapeutic use needs additional study. The oldest and largest professional health care organization in the US, the American Public Health Association (APHA), a group of over one million one hundred thousand health care professionals in 1995 recommended the immediate transfer of cannabis to health care control from law enforcement essentially echoing the AMA call of 1977. Dozens of other professional health care groups all over the world have joined with the APHA.
A list is available at MedicalCannabis. com.

• The DEA supports research into the safety and efficacy of THC (the major psychoactive component of marijuana), and such studies are ongoing, supported by grants from the National Institute on Drug Abuse.

The efficacy and safety of cannabis is well known to the federal government and especially the DEA. In 1986 the DEA ordered their Chief Administrative Law Judge, to study therapeutic cannabis potential and report on the action the DEA should undertake. After over 5,000 pages of testimony and almost two years of investigation Judge Francis L. Young, ruled that, "The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefit of this substance in this record." Judge Young further stated that cannabis was "the safest therapeutic agent known to mankind". Consider the source. THC has been approved as medicine already (Marinol) and has been placed in schedule three, which means it can be prescribed by a physician for any valid medical condition, so it is meaningless to state that they support more research on THC. The DEA continues to block efforts to study whole cannabis.

• As a result of such research, a synthetic THC drug, Marinol, has been available to the public since 1985. The Food and Drug Administration has determined that Marinol is safe, effective, and has therapeutic benefits for use as a treatment for nausea and vomiting associated with cancer chemotherapy, and as a treatment of weight loss in patients with AIDS. However, it does not produce the harmful health effects associated with smoking marijuana.

In the late 1970's six states undertook individual studies involving large numbers of patients on the efficacy of whole cannabis as compared to Marinol. Cannabis in Medical Practice examines one such study, the Lynn Pierson Therapeutic Research Program. Data on 169 patients was analyzed and the conclusion by the study director was "The results achieved strongly indicate that both the inhaled natural cannabis and the pill form of its active ingredient, delta-9-THC, are effective for control of nausea and vomiting as well as for appetite stimulation." The combined data from all six studies indicate similar results and all indicate that patients preferred, in the seventy plus percentage range, whole cannabis to Marinol for a variety of reasons.

• Furthermore, the DEA recently approved the University of California San Diego to undertake rigorous scientific studies to assess the safety and efficacy of cannabis compounds for treating certain debilitating medical conditions.

This is a commendable, reasonable, scientifically valid and long overdue display of professionalism and compassion by federal bureaucrats.


Does marijuana harm anyone besides the individual who smokes it?

• Consider the public safety of others when confronted with intoxicated drug users:

• Marijuana affects many skills required for safe driving: alertness, the ability to concentrate, coordination, and reaction time. These effects can last up to 24 hours after smoking marijuana. Marijuana use can make it difficult to judge distances and react to signals and signs on the road.

As noted previously by the IOM report, psychomotor skills may be diminished when using cannabis but for a limited period that may extend four hours. Studies in the US, Australia and the United Kingdom do not share the DEA conclusion. The most recent study, completed in March 2002, by the Transportation Research Laboratory in Crowthorne, England indicated that drivers using cannabis alone were aware of their state and drove cautiously to compensate. They in effect were driving safer than those who were sober.

• In a 1990 report, the National Transportation Safety Board studied 182 fatal truck accidents. It found that just as many of the accidents were caused by drivers using marijuana as were caused by alcohol -- 12.5 percent in each case.

This is a causal relationship that has no validity. The issue should be intoxication at the time of the accident but that is not what this data indicates. This data only supports the conclusion that in the month or so prior to the accident, if the test given was accurate and a large percentage are not, a driver had used cannabis. No data is presented indicating that cannabis intoxication was present or was a causal factor in the accidents.

• Consider also that drug use, including marijuana, contributes to crime. A large percentage of those arrested for crimes test positive for marijuana. Nationwide, 40 percent of adult males tested positive for marijuana at the time of their arrest.

This again is a distorted fact. Cannabis is fat-soluble and its metabolites can stay in the body for up to a month, whereas most other drugs are out of the body within a day or two. Urine testing at the time of arrest indicates past use of cannabis only. The test results do not indicate intoxication at the time of the arrest or the time of the crime.


Is marijuana a gateway drug?

• Yes. Among marijuana's most harmful consequences is its role in leading to the use of other illegal drugs like heroin and cocaine. Long-term studies of students who use drugs show that very few young people use other illegal drugs without first trying marijuana. While not all people who use marijuana go on to use other drugs, using marijuana sometimes lowers inhibitions about drug use and exposes users to a culture that encourages use of other drugs.

This is the fabled "stepping stone theory" described above. It ignores that children are first introduced to the drug called caffeine by their parents, to nicotine and alcohol by the marketing professionals of our society, and to Ritalin by their pediatricians.

The most recent work in this area is a study about to be published by the Centre for Economic Policy Research, London. It concludes that cannabis does not lead to the use of hard drugs. This confirms the IOM's characterization of the long discredited gateway drug theory, which was, "There is no conclusive evidence that the drug effects of marijuana are casually linked to the subsequent abuse of other illicit drugs. An important caution is that data on drug use progression cannot be assumed to apply to the use of drugs for medical purposes. It does not follow from those data that if marijuana were available by prescription for medical use, the pattern of drug use would remain the same as seen in illicit use.


• The risk of using cocaine has been estimated to be more than 104 times greater for those who have tried marijuana than for those who have never tried it.

A 2001 study in the American Journal of Public Health in discussing "serious drug users" wrote, "They were more likely to have used marijuana before using alcohol, and more likely to have used other illicit drugs before using marijuana." They further stated, "These findings suggest that for a large number of serious drug users, marijuana does not play the role of a 'gateway drug'. We conclude that prevention efforts which focus on alcohol and marijuana may be of limited effectiveness for youth who are at risk for serious drug abuse.

In Summary:

• Marijuana is a dangerous, addictive drug that poses significant health threats to users.

• Marijuana has no medical value that can't be met more effectively by legal drugs.

• Marijuana users are far more likely to use other drugs like cocaine and heroin than non-marijuana users.

• Drug legalizers use "medical marijuana" as red herring in effort to advocate broader legalization of drug use.

In summary we conclude that the DEA conclusions are politically motivated and scientifically unsupportable. We conclude that placing a law enforcement agency in charge of public health decisions is a direct threat to the public health of the nation and in particular those that require the option of using cannabis therapeutically under medical supervision. We conclude that the DEA agenda and lack of forthright communication in their web page makes them an unreliable source of information concerning therapeutic cannabis.

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