Like any other controlled substances, the use of cannabinoids that are meant for medical use face the public-health regulatory controls which are administered by the Food and Drug Administration (FDA) of the Department of Health and Human Services (DHHS) and the Drug Enforcement Administration (DEA) of the Department of Justice. While FDA regulates human testing and the introduction of new drugs into the marketplace, the DEA determines the schedule of and establishes production quotas for drugs with potential for abuse to prevent their diversion to illicit channels. DEA also authorizes registered physicians to prescribe controlled substances (Grinspoon, & Bakalar, 2001).
Some drugs, such as marijuana (derived from a plant called cannabis sativa), are labeled Schedule I drugs in the Controlled Substance Act (CSA), and this adds considerable complexity and expense to their clinical evaluation (Grinspoon, & Bakalar, 2001). It is important to point out that Schedule I status does not necessarily apply to all cannabinoids. Marinol (dronabinol), a synthetic form of delta-9-tetrahydrocannabinol (THC), is a commonly used cannabinoid with approval for marketing in many nations today. It is an oral capsule, which got approval in 1985 from the FDA for treatment of nausea and vomiting that occur in cancer chemotherapy. This medication was efficient for this use and in 1992; it was approved by the same agency for treatment of anorexia in AIDS patients.
Cannabis is known to have several medical uses and it is also studied to present some extraordinary medicinal effect on symptoms such as nausea, vomiting, and pain in a number of illnesses. It is also known to cause some behavioral and/or physiological effects, which are categorized as positive or negative. The behavioral effects include:
- Changes in perceptual and cognitive function
- Impaired memory and time perception
- Improved mood characterized by giggling
The physiological effects include:
- Increased heart rate
- Decreased blood pressure
- Increased appetite (commonly referred to as “the munchies")
The history of natural cannabis
Natural cannabis is commonly known as marijuana and its medical use dates in the 19th century when the western medicine discovered the medical properties of marijuana that are beneficial for medical purposes. In some cases however natural cannabis was used for recreational purposes, some nations had no controlled use of it thus it was considered for medical purposes and for recreational purposes. It was however outlawed in the United States on the national level primarily because of fear of the effects of it on those who were using it. The United States went ahead and enacted an act (Marijuana Tax Act of 1937), which aimed to raise taxes on it such that it became unaffordable to many and even doctors at some levels were unable to dispense it. Following the enactment of the law, the testimonies given in hearing were those of people who were sex fiends or murders and used marijuana. Such cases formed a foundation for the description of marijuana as a dangerous substance and an illegal drug.
After intense studies on cannabis, in the recent years, many research groups for instance, the American Medical Association, started to rethink about the medical uses of marijuana following research on the ingredient of marijuana. tetrahydrocannabinol, THC was identified as the main ingredient and it was studied to reduce pain, reduces aggression, and increases appetite, and this made it to be recommended in helping patients suffering from the adverse effects of chemotherapy treatment.
It was further identified that unlike what was earlier said, medical cannabis does not have high levels of addiction and that it does not result to the illegal use of other drugs also, it cannot negatively affect the brain (Meyer, & Quenzer, 2005). Some states decided to register some medical institutions to use marijuana in their procedures, for instance, in Colorado medical marijuana doctors and clinics are registered by the state, help many of their patients lead better lives due to pain reduction, increasing appetite, and reduce nausea. Several other states are following Colorado in enacting laws to legalize marijuana for medical use.
In the United States, those who suffer from diseases and conditions like cancer, depression, anxiety, stress, attention deficit disorder, epilepsy, migraines, meningitis and chronic pain, marijuana may appeal to them as a medicinal drug. Many Americans believe that if this drug can relieve the pain and suffering of so many, then it needs to be considered for a medical purpose (Woolridge, 2005).
The Drug Policy Alliance, DPA, approved that cannabis is effective in reducing the nausea that follows cancer chemotherapy, elevating appetite in aids patients, and lowering intraocular pressure in glaucoma sufferers (Ware, et al 2002). Substantial evidence of cannabis reducing muscle spasticity in patients with neurological disorders has been given (Meyer, & Quenzer, 2005). A synthetic capsule is available by prescription only, but it is not as effective as smoked marijuana for many patients. Pure THC may also produce more unpleasant psychoactive side effects than smoked marijuana (Meyer, & Quenzer, 2005).
Joycelyn Elders, M.D. (2000) wrote in an editorial published in the Providence Journal in Rhode Island: “the evidence is overwhelming that marijuaa can relieve certain types of pain, nausea, vomiting and other symptoms caused by such illnesses as multiple sclerosis, cancer and aids—or by the harsh drugs sometimes used to treat them. In addition, it can do so with remarkable safety. Indeed, marijuana is less toxic than many of the drugs that physicians prescribe every day.”
Researchers from GW Pharmaceuticals wrote in an article published in the Journal of Cannabis therapeutics that in practice it has been found that, compared to the equivalent amount of cannabinoid given as a single chemical entity such as Marinol, extracts of cannabis offer greater relief of pain (Reuters News Wire, 2002). Cannabinoids taken by mouth begin working more gradually and are absorbed more unpredictably than inhaled marijuana, so many patients prefer the latter, University of Montreal pharmacologist Mohamed Ben Amar wrote in a paper posted in March by the Journal of Ethnopharmacology.
Marijuana is the most popular illegal drug in the United States today, states the Drug Policy Alliance. It has been said that people who have used drugs such as heroin, cocaine, and also, are likely to also use marijuana (Clark et al. 2004). Yet most marijuana users never use any other illegal drug. None of the medical tests, as per the Drug Policy Alliance, presently utilized to detect brain damage in humans have found harm from marijuana, even from long-term high-dose use (Plasse, Groter, & Krasnow, 2000).
An early study detailed brain damage in rhesus monkeys after six months exposure to high concentrations of marijuana smoke. In a recent, more carefully conducted study, researchers failed to find evidence of brain abnormality in monkeys that were forced to inhale the equivalent of four to five marijuana cigarettes every day for a year. The claim that marijuana kills brain cells originated from a provisional report dating back a quarter of a century that has not been sufficiently corroborated (Meyer, & Quenzer, 2005).
Cannabis for medical use
In patients at any stage of HIV infection, nausea and vomiting occurs but at times nausea may occur without vomiting. Nausea is also a common occurrence in the use of other medications especially in the first weeks of taking a new medication. When it occurs with vomiting, it results to severe discomforts and this commonly leads to ineffectiveness of a medication since its adherence is interfered with. It is also reported that nausea and vomiting are symptoms of severe complications in ARV therapy or neoplasm for patients who are in their late stage of AIDS and have opportunistic infections. Nausea is also common to patients with cancers who are undergoing chemotherapy.
According to Grinspoon & Bakalar, 2001, some recreational cannabis smokers who were undergoing chemotherapy reported that cannabis relieved them nausea and other side effects of the drugs that these patients take. In another study by Sallan et , 2000, with 22 cancer patients who showed resistant to other cancer treatments, a half of the patients were given placebo and the other half were given cannabis. It was later reported that cannabis was far more superior in the treatment of nausea and vomiting compared to the placebo, a synthetic drug. However, euphoria was reported in the patients with a dose of 10mg and sedation was in almost all the patients.
Marinol (dronabinol), is a legal synthetic cannabinoid which is the only cannabinoid approved by the US FDA. It is administered orally and is presented in measures of 2.5mg, 5mg, and 10mg dosages (Abramahov, 2005). Marinol is usually prescribed in the treatment of weight loss (cachexia) in patients of AIDS and also for the treatment of nausea and vomiting associated with cancer chemotherapy especially in patients who have failed to respond adequately to conventional antiemetic treatments (Abramahov, 2005).
NATURAL CANNABIS HAS THERAPEUTIC COMPOUNDS THAT MARINOL LACKS
Cannabinoids are the chemical compounds found in cannabis, 66 naturally occurring such chemical compounds have been identified in the cannabis. These chemical compounds are the ones responsible for cannabis numerous medical use. In marinol, THC is the synthetic compound, which has similar effects like one of the cannabinoids (Ware, et al 2002). Natural cannabis contains compounds such as terpenoids and flavonoids, which have therapeutic impacts (Clark et al. 2004). When taken in as a complex of compounds, these compounds work synergistically to relief major side effects related to some medications.
Cannabidol CBD is also a cannabinoid that is non-psychoactive; it is known to have anti-convulsing properties, and anti-tumoral properties. The many chemical compounds in natural cannabis to have a combination of many therapeutic properties that may be lacking in the synthetic marinol. The commonly known properties are such as anti-inflammatory, antidepressant, anti-tumoral, antioxidant and analgesic properties (Ware, et al 2002). This combination of properties slows progression of many diseases and conditions, clinical analysis further indicates that synergism of the compounds is efficacious than the use of THC which functions alone (Plasse, Groter, & Krasnow, 2000).
Patients on marinol complain of the many and adverse side effects related to its usage compared to patients using natural cannabis according to Campbell et al, 2001. These side effects range from drowsiness to coordination impairment and depression and the psychoactive effects last for 4-6 hours.<
The oral route of administering marinol is said to be the one main cause of the intense psycho activity related to it unlike natural cannabis, which is inhaled. The natural cannabis has cannabidiol as one of the chemical compound, which has an anxiolytic action associated with modifying and diminishing any psycho activity that may occur on usage.
VAPORIZATION OF CANNABIS OFFERS ADVANTAGES OVER ORALLY ADMINISTERED THC
Cannabis is often administered by smoking or through oral administration. Vaporization offers an alternative method of administrating it and this method is related with several advantages over the other two means. Oral administration of marinol prevents the risks associated with smoking but it is said to be slow in its expected effects as only five to twenty percent of it reaches the bloodstream, further, its reaction time is not until four hours after administration (Tashkin, et al 2002).
Vaporization is considered a safer method as it reduces the exposure to noxious smoke, which happens during smoking that leads to respiratory disorders (Tashkin, et al 2002). While oral synthetic cannabis avoids the risks related to smoking, oral consumption has its own drawbacks such as slow absorption into the bloodstream (Vinciguerra, 2003). This is connected to the prolonged psychoactive effects of consuming doses using oral method. Vaporization does not have such drawbacks, it is known to have rapid delivery of cannabinoids into the bloodstream, and thus its effects are rapidly experienced.
Due to the rapid onset of vaporization, natural cannabis is desired by patients than marinol especially those who require fast acting therapeutics to combat nausea or vomiting. This method of administration further favors patients with nausea and are vomiting as it provides an alternative route apart from swallowing which may heighten the situation. Cancer and AIDS patients due to use of marinol capsules which they swallow report that the capsules cannot be held down by the stomach during nausea and thus vaporization may be the best alternative for them, this results to many of such patients turning on to natural cannabis in controlling the symptoms (Tashkin, et al 2002).
Marinol slow action in the bloodstream has evoked the need for the scientists to develop new formulations which are rapid than swallowing. A pulmonary formulation, which is taken in through an inhaler, is the next best option for the marinol. However, the FDA is yet to approve pulmonary marinol and its inhaler (Wu, et al 1999). Sativex is an oral cannabis spray, which consists of natural cannabinoid extracts, its bioavailability bis much higher than that of oral synthetic THC. However, its bioavailability is not as greater as that of vaporized cannabis (Wu, et al 1999).
Marinol is expensive than natural cannabis
Marinol is synthetic, it is costly, and its manufacturing process is complex. Natural cannabis on the other hand is cheap as its preparation requires few and simple procedures. Patient customer of the marinol drugs bears the cost of the complex production and for patients with chronic conditions; this may limit their access to the drugs. Natural cannabis unlike the synthetic cannabis is affordable to the patients even when its black market value is inflated and it is also far much less that of oral synthetic cannabis.
Despite FDA approval, Marinol typically provides only limited relief to select patients, particularly when compared to natural cannabis and its cannabinoids. Marinol should remain a legal option for patients and physicians; however, federal and state laws should be amended to allow for those patients who are unresponsive to synthetic THC the ability to use natural cannabis and its cannabinoids as a medical therapy without fear of arrest and/or criminal prosecution. By prohibiting the possession and use of natural cannabis and its cannabinoids, patients are unnecessarily restricted to use a synthetic substitute that lacks much of the therapeutic efficacy of natural cannabis.
Marinol is an oral synthetic THC, which is legally available only with a prescription. It is studied to have relief effects only to a selected group of patients as compared to the natural cannabis. Marinol cause minimal relief and the patients may have unwanted side effects from this therapeutic. Additionally, doctors are hesitant in prescribing the drug due to the limitations that are placed by the laws. In spite of the legality on marinol, Patients continue to use natural cannabis risking arrest or criminal persecution as they report its therapeutic relieving efficiency.
From the intense researches and studies conducted, the active ingredient in marinol, THC, is said to be an analogue of a compound in the natural cannabis. Prohibiting the use and possession of natural cannabis unnecessarily burdens the patients with the need to buy the expensive and a synthetic substitute, which lacks the therapeutic efficiency of the natural cannabis.
Due to the difficulties faced by the patients of cancer and AIDS chemotherapy, the law should consider them and make marinol to be an option to the patients and it should also give an environment conducive for the development of more pharmaceutical industries for producing the cannabis therapeutics. It would also be of great significance if the laws were amended in favor of the patients who are unresponsive to the synthetic THC to use the natural cannabis as an alternative with no fear of criminal prosecution.