Post by Ask Jan on Mar 18, 2012 10:27:15 GMT -8
Medical Marijuana--Why we need standards in this new field
Patients need medicine that is free of pesticides and safe from microbiological contamination, and they need to know its potency (dosage). At the same time, opponents of medical marijuana have seized the opportunity to portray its quality in the worst possible light in order to suppress dispensaries that are legal in certain states. As a result, no federal and state regulatory protections are in place, and the cannabis products distributed by dispensaries are not subject to reliable oversight.
As health care providers, they need to improve procedures for buying and distributing medical marijuana, and provide more detailed information about the medicine. The industry has yet to see legal cases involving contaminated marijuana, but they are likely to arise as the use of medical marijuana grows.
Medical Marijuana advocates need to promote the testing of marijuana in order to dispel opinions that “crude” herbal marijuana, and especially its preparation, should not be considered medicinal.
The Need to Develop Standards for Medical Marijuana
— To self-regulate their processes in order to assure safe and clean medicines and advance the cause of marijuana therapeutics. Independent testing can reduce the risks of contamination, and thereby improve the overall quality of the marijuana distributed as medicine through the dispensaries.
Growers can ensure quality and improve their operations. Advocates, patients, dispensaries, and growers all benefit from testing that helps to legitimize medical marijuana. Rather than suffering a quality crisis that fuels the opposition, the medical marijuana industry can thrive in an atmosphere of self-regulation and control, and ensure that the medicines are safe and effective. However, the present completely decentralized system of production and distribution requires some form of third-party quality control if patients are to have confidence in their medicine, assuming that they are unwilling or unable to grow it themselves.
Patients battling severe pain or who must undergo chemotherapy deserve safe marijuana products — they should not have to grow their own medicine or turn to the black market. “Cannabis should be subject to rigorous quality control oversight, like any other medicine.”
Patients need high-quality medicine
The medicines you buy in a pharmacy have been run through a battery of tests to insure their quality. The potency of a drug is clearly stated on the label so one knows the correct dose. Unfortunately, this is not the case with medical marijuana. Patients need to have confidence that they are administering an appropriate dose. “Certain minimum levels of [the active ingredient] in the herb must be maintained (upwards of 10%) for practical reasons of economy and smoke-inhalation minimization.” “As CBD and possibly other cannabinoids may add or subtract from the primary THC effects, and have effects themselves, their presence should also be accounted.” Dr. Pate
Patients also need medicine that is free of pesticides, which are sometimes used in growing operations.
Exposure to these chemicals can be harmful to patients; they are toxic at high levels and can be harmful even at lower doses. Even outdoor plants can be exposed to pesticides. Levels of these compounds can range from zero to massive, depending on cultivation practices. Some of these compounds might potentially produce acute symptoms, but probably the greatest danger occurs with chronic exposure. Insidiously, the consumer is completely unaware of this exposure until symptoms manifest. Hence detection of potential chemical contamination is of paramount importance.
Microorganisms, such as molds, bacteria and yeast, are found in small amounts in food and drink and the air we breathe, as well as in marijuana and other herbal remedies. Carefully cultivated and harvested marijuana harbors a minimum of hazardous microorganisms, but for added protection, material must be screened for contamination before it is packaged for use as medical marijuana. In the Netherlands, marijuana is grown for medical use by two cultivators who are licensed by the government’s Office of Medicinal Cannabis, and the product is irradiated and distributed by licensed pharmacies.
Canada runs a government-sponsored and licensed cultivation program for small and industrial growers in which marijuana is irradiated before distribution. For those with severely compromised immune systems, the presence and amount of certain fungi or bacteria may pose a significant health threat.
In a U.S. marijuana dispensary, however, there is no such quality control. No federal and state regulatory protections are in place, and the marijuana distributed by dispensaries is not subject to reliable oversight. The federal Environmental Protection Agency must develop Pesticide Tolerance Limits for medical marijuana and industrial hemp, as they have done for every other agricultural crop produced in the United States . Even the Drug Enforcement Administration (DEA) recognizes that the U.S. government has both domestic and international responsibilities to protect the health and safety of patients and to promote the responsible development of modern medications.
U. S. patients who need medical marijuana deserve to know what they are getting so that they can choose the highest-quality medicine. Due to political opposition that has blocked Food and Drug Administration (FDA)-approved research for decades, marijuana has been distributed through completely unregulated channels and remains on the frontier of medical research. The illegal nature of the supply network does not encourage quality assurance.
Dispensary personnel need training in proper sterile techniques to protect against on-site bacterial or other contamination of the herbal material. The dispensaries also come under fire from groups such as Friends of the DEA, which recently made recommendations to the Obama Administration “to take a measured approach in addressing marijuana dispensaries.” The report criticized the administration’s hands-off approach, stating that it “would effectively ban the DEA from any significant marijuana interdiction, leading to a free-for-all of medical marijuana dispensaries across the state and potentially, across the nation... marijuana dispensaries would allow informal, quasi-medical networks to spring up across the nation, thereby putting at risk the critical protections so carefully crafted under the national food and drug legislation of the 20th and 21st centuries.” Their report cites dispensaries that freely offer medical information and advice to patients despite a lack of training and accreditation.
Knowing the cannabinoid profile and potency of medical marijuana is fundamental in allowing the patient to choose the correct medicine for their needs, as well as determining the appropriate dose.
This is especially important for edible forms of marijuana, where a greater percentage of active ingredients reaches the bloodstream. Taking the correct amount of medical marijuana can bring welcome relief to a patient’s symptoms; however taking too much can have negative side effects such as feelings of anxiety and paranoia.
• Cannabidiol (CBD): CBD is a non-psychoactive compound, important for pain relief and other health related effects, representing anywhere from 0.1-12 percent. CBD alone is not psychoactive and doesn’t contribute to the potential negative side effects of medical cannabis. CBD has been shown to relieve convulsions, inflammation and much more. Recent studies have shown that CBD is an effective antipsychotic in treating schizophrenia. Smokers of cannabis are less likely to experience schizophrenia-like symptoms if there is a higher CBD to THC ratio. CBD can also decrease the social isolation induced by THC. Although CBD has its own particular medicinal value, it is the interaction between the two that gives rise to the effect that sometimes alleviates the symptoms of various medical conditions. Testing and certification will enable growers and dispensaries to find strains that offer a higher CBD to THC ratio. CBD is known as "The Pain Annihilator"
Tetrahydrocannabinol (THC): the psychoactive compound. AlsoTHC has been well known to have positive anti-inflammatory health benefits. Slow the progression of dementia, inhibit this enzyme and slow the formation of these plaques in Alzheimer’s disease. good effects in diseases with multiple symptoms that encompassed within the spectrum of THC effects, for example, in painful conditions that have an inflammatory origin (e.g., arthritis), or are accompanied by increased muscle tone (e.g., menstrual cramps, spinal cord injury), or in diseases with nausea and anorexia accompanied by pain, anxiety and depression, respectively (e.g. AIDS, cancer, hepatitis C). Improvement of mood in reactive depression , improved bladder control, pain, paraesthesia, tremor and ataxia, beneficial effect on spasticity caused by multiple sclerosis or spinal cord injury has been observed, appetite enhancing effect of THC, Tourette's syndrome, dystonia and tardive dyskinesia. The anti-emetic, the appetite enhancing, relaxing effects, analgesia, and therapeutic use in Tourette's syndrome were all discovered in this manner.
Cannabigerol (CBG): is another of the six phytocannabinoids and is known as "The Tumor Beater." Little research has yet to be performed on CBG but is known to promote bone and cell growth and kill surface bacteria. This particular cannabinoid is only found in trace amounts in marijuana.
• Cannabinol (CBN): CBN is a degradation product of THC. There is very little of it in a fresh marijuana plant. CBN content increases as THC degrades in storage and with exposure to light and air. It is only mildly psychoactive and can cause drowsiness, disorientation, and sleepiness in the smoker . “The Sleeper” reduces pain, inflammation, spasms, and convulsions. Antioxidant properties.
Cannabichromene (CBC): which is known as "The Fungal Fighter." It reduces pain and inflammation, kills bacteria and fungi, promotes bone and cell growth, and constricts blood vessels.
Tetrahydrocannabivarin (THCV): also known as "The Lean Machine" is a very interesting cannabinoid. Its effect on type 2 diabetes and obesity. More recent studies have found that it has the ability to reduce appetite .
It is possible that medical marijuana could be the most useful remedy to treat the widest variety of human diseases and conditions, a component of preventative healthcare, and an adaptive support in our increasingly toxic, carcinogenic environment .
Medicinal marijuana needs testing to be legitimate as medicine
Since the early 1960s, the U.S. government has blocked research on marijuana and the testing of marijuana products, even after scientists found that marijuana was relatively harmless and perhaps beneficial as medicine for specific illnesses. Now, paradoxically, government agencies such as the Food and Drug Administration (FDA) are insisting that marijuana can not be considered a legitimate medicine because it has not been properly researched and tested. In 2001, in rejecting a petition for the rescheduling of marijuana, the FDA stressed that it could not conclude that marijuana has an acceptable level of safety — “without assurance of a consistent and predictable potency and without proof that the substance is free of contamination.”
Many of the risks cited by the FDA can be directly reduced by independent testing and certification. In cities and towns across California and other states, lawmakers are now proposing regulations that would require dispensaries to test medical marijuana for various sorts of contamination.
In other states, such as Tennessee, proposed acts will establish state-managed programs that produce medical cannabis under secure, safe specifications that include growing only strains of known chemical composition to make sure that the medicine is safe, reliable, and targeted to provide maximum relief to patients suffering a discrete set of serious medical conditions.
Additional testing of marijuana strains to identify and assay their chemical constituents will provide more predictable medicinal effects that will benefit both patients and providers. In addition, patients can use the information about levels of THC, CBD, and CBN to choose strains that are less psychoactive.
In certain instances, CBD has a beneficial medical effect but is non-psychoactive, and often people prefer that. (A forty-year-old businessman does not want to become incapacitated just because he needs the pain relief.)
Quality Assurance Testing for Safe Cannabis
Independent testing can reduce the risks of contamination, and thereby improve the overall quality of the marijuana distributed as medicine through the dispensaries. Using Gas and High-performance Liquid Chromatography and a Mass Spectrometer, as well as other high-tech lab equipment tests can be conducted for pesticides and mold, as well as measure potency in samples of marijuana. There is a movement to mandate that medical marijuana adhere to the same standards as other food and drugs .
Give patients the information they need to compare strains. Patients need potency data so they can individualize their dosing. Industry leaders argue that some kind of standardization or quality control is essential to the long-term success of marijuana as a medical treatment.
Who Is In Charge of Quality Assurance?
Medical marijuana, of which there are dozens of varieties and potencies, is not regulated by any central authority, such as the Food and Drug Administration or the USDA. Consumer safety issues are almost entirely dealt with within the industry, and efforts are driven in large part by pioneers of the medical marijuana movement along with consumers.
Quality-control testing is the best-conceived method to date for making medical marijuana available to seriously ill patients in a safe, secure, controlled, cost-effective and patient centered fashion. Patients are also insisting on higher quality packaging for medical marijuana to protect it from oxidation and degradation.
• Aspergillus is one of the more potentially deadly molds. Some species produce large amounts of aflatoxin, which is both a carcinogen and a toxin. Exposure can also cause allergic reactions and infections in immune deficient patients.
• Penicillium exposure can cause severe allergic reactions to patients that are sensitive to the antibiotic penicillin.
• Cladosporium is a group that contains the most common molds. It produces no mycotoxins, but over-exposure can cause asthma attacks and even pneumonia in some patients. Cladosporium is a plant pathogen and can degrade the quality and yield of cannabis.
• Alternaria is a plant pathogen and allergen in humans. Exposure to it can cause hay fever and may lead to asthma. It can also cause serious infections in immune compromised patients.
• Yeasts are another group of microorganisms that are often found in cannabis samples. Some are pathogenic or allegenic and should be avoided by patients that are immune compromised.
• Escherichia Coli is a gram negative bacteria that lives in the mammalian gastrointestinal tract. While most strains are harmless, several strains can cause severe food poisoning in humans.
Testing for pesticides
Pesticide residue in medical marijuana can include neurotoxins (the chemical warfare agent Saran is a member of this class of compounds), which are poisons at high dose and are linked to chronic brain disorders at low but repeated exposure. Exposure to pesticides has been linked to ADHD and Alzheimer’s, and can cause asthma and allergic reactions — and at high levels, neurotoxicity. Currently there are no USDA guidelines for residual pesticides in medical marijuana.
The testing program includes the most commonly used pesticides in medical marijuana cultivation:
Organophosphates, Carbamates, Pyrethroids, and Avermectins.
• Organophosphates and carbamates refer to a group of insecticides that are neurotoxins, which means they affect the brain and nervous system. Some are highly toxic and account for many cases of poisoning worldwide. Examples of organophosphates include: parathion, malathion, methyl parathion, chlorpyrifos, diazinon, dichlorvos, phosmet, tetrachlorvinphos, and azinphos methyl.
• Pyrethroids are a group of man-made pesticides similar to the natural pesticide pyrethrum, which is produced from chrysanthemum flowers. Exposure to pyrethroids can be allergenic and can cause asthma in some patients. Examples of pyrethroids are: permethrin, cypermethrin, resmethrin, cyfluthrin, and tetramethrin.
• Avermectins are microbial based pesticides that affect neural transmission. Exposure to high doses can depress the central nervous system resulting in tremors and loss of coordination. Direct contact with skin can cause irritation. The most common avermectin is abamectin (trade name Avid).
The challenge for medical marijuana advocates and patients is to promote self-regulation and the testing and certification of marijuana in order to assure that its quality and preparation meet the standards of modern medicine and therefore should be considered medicinal. Advocates, patients, dispensaries, and growers all benefit from testing that helps to legitimize medical marijuana.
Growers need to differentiate by quality and level of contaminants
Competitive forces are driving the marijuana-growing industry, and small growers of higher-quality marijuana for medicinal purposes need to differentiate their products by quality and purity. Today’s medical growers differentiate their products with brand names identifying strains (such as “White Widow,” “Northern Lights,” “Purple Haze,” etc.). However, brand names do not provide reliable information about the product’s contents, and do not take into consideration grower practices, the use of pesticides, or fungus contamination. The potency and overall quality of any cannabis strain is affected by the environmental conditions under which it is grown. Patients are completely in the dark about potency levels and actual quality.
The industry has yet to see legal cases involving contaminated marijuana, but they are likely to arise as the use of medical marijuana grows. Moldy marijuana (is suspect) in hastening the death of at least one person with a compromised immune system. All hell will break loose. All it might take is one story of an immune-compromised person dying from Aspergillus infection from smoking marijuana to give rise to patient lawsuits. Growers and dispensaries will find themselves at risk, just as pharmaceutical companies are now with their products. As health care providers, they need to improve procedures for buying and distributing medical marijuana, and provide more detailed information about the medicine.
A safe marijuana seal and packaging program increases quality control for the industry by changing the model to give producers the opportunity to certify and package their products before they come to market.
Nitrogen packaging services for legal medical collective and cooperative growing operations (e.g., those permitted under the Mendocino County 9.31 exemption) are available. The tamper-proof packaging keeps the marijuana as fresh as the day it was sealed, substantially reducing mold and bacterial growth, and significantly reducing degradation and discoloration. To ensure safety, each package includes oxygen and humidity indicators, which will also show if the package has been tampered with.
I predict that by fall (2012), all medical marijuana going into a dispensary, will require testing and certification!