Everything You Need to Know About CBD

Facts and Talking Points

Components of marijuana have medical value, but that does not mean we should smoke or vaporize non standardized products to get that value.

Recently, due to CNN and other media outlets, there has been a flood of interest in CBD a component contained in marijuana.  CBD does not get you high, and as such, it has been generally bred out of modern, smoked marijuana. But it can be grown under special conditions.

There is some limited anecdotal and other evidence showing CBD effectiveness for epilepsy, especially in children.

We should find a way to get CBD to patients who need it, but we owe those who suffer a product with safety assurances. Many products on the current “medical” marijuana market have no such assurances, are never tested in FDA-registered labs, and have no guarantees of quality and content or information on dosing or side effects.

For those who might benefit from CBD, a company in Britain has developed a standardized CBD product which will soon be in clinical trials in the U.S. and which may also be available from physicians through special FDA-approved channels.

What is CBD?

 CBD and THC are the two primary cannabinoids produced by the cannabis (marijuana) plant. CBD does not have THC like psychoactivity. CBD was essentially bred out of high potency modern recreational cannabis, but there has been recent interest in its therapeutic potential. As a result, a number of breeders claim to have “high CBD” strains and numerous purveyors are selling products that they claim are high in CBD. However, many of these products also contain significant levels of THC.

How does CBD work?

CBD works through a number of complex mechanisms. Preclinical studies indicate that

CBD has analgesic (pain relieving), anti-convulsant, anti-psychotic and neuroprotective effects. Unlike THC, it does not bind to the CB1 or CB2 cannabinoids receptors, which is why it does not produce THC-like psychoactivity.

Many groups are trying to sell or give away CBD in different states without going through any FDA or NIH process. However these products have no such safety assurances.

SAM is working on a long-term solution to expand and accelerate the current research so that every patient who might benefit from CBD can obtain it.

Are these CBD products safe? 

“High CBD” plant material usually also contains varying levels of THC, sometimes significant amounts. Most simple extraction processes cannot reliably extract CBD solely or primarily. Indeed, extremely complex and expensive equipment is required to remove the THC from a “high CBD” extract.  The situation is made more hazardous by the fact that existing research demonstrates that, in many cases, large doses of CBD are needed to achieve a specific therapeutic effect. Accordingly, a child taking a therapeutic dose of CBD (100-1000 milligrams per day) would potentially also be exposed to a large amount of THC. For example, using a 10:1 preparation, a child who ingested 300 mg of CBD per day would also be ingesting 30mg of THC. That is the equivalent of three of the highest dose (10mg) Marinol capsules, which would make most adult patients intoxicated.  A 2:1 or 1:1 plant ratio product would contain even higher levels of THC.

What is the legal status of CBD?

Because CBD is a component of the cannabis/marijuana plant, it is a Schedule

I substance under the federal Controlled Substances Act (CSA). The FDA has recently confirmed that CBD is, indeed, a Schedule I substance. Lisa Kubaska, PharmD, who works for the FDA’s Center for Drug Evaluation and Research stated in an email to an inquiry from a journalist:“CBD meets the definition of Schedule 1 under the Controlled Substance Act.”  For example, some companies advertise the following as “high CBD” strains:

Harlequin at 11.6%/6.9% CBD: THC;

Canna Tonic at 8.11%/6.9% CBD: THC;

Sour Tsunami at 7.24%/4.32% CBD: THC (see http://www.synergymmj.com/products.html).

It is also unclear whether their advertised ratios are accurate, i.e., whether the testing results are valid. Recent internet comments by parents complain that batches of “artisanal” CBD products do not have a consistent or anticipated effect and/or they are horrified that their children become “high”. This is a problem because medicines should be standardized and consistent among batches.  Finally, in many cases, the “high CBD” products may be contaminated by pesticides, synthetic fertilizers, and dangerous microbes.  Pesticides are neurotoxic, which could be quite dangerous to children with epilepsy. A number of physicians are reporting instances of bacterial infections, allegedly resulting from the use of these products.

Don’t you need some THC to synergize with CBD?

There is absolutely no reliable scientific evidence that THC is necessary to synergize the effects of CBD. Instead, there is evidence from preclinical research that THC may be pro-convulsant in sensitive brains; other research indicates that chronic use of THC can impair IQ in adolescents. Physicians are beginning to report instances of THC toxicity in children taking “high CBD” preparations, e.g., high anxiety, increased seizures, insomnia, etc. Until more is known, the most conservative course of action would be to remove THC entirely from a CBD product.

Why is there so much interest in CBD now?

 A number  of years ago, Project CBD in California, inspired by research being conducted by GW Pharmaceuticals in the U.K. (see below), began to educate interested patients and others about the therapeutic potential of CBD, which was virtually absent in high-THC marijuana in the U.S. Indeed, before GW embarked on its cannabinoid research and development program, many individuals in the U.S. believed that CBD was an inert compound. There were also anecdotal reports of some adults with epilepsy who discovered that inhaled marijuana seemed to prevent or reduce their seizures. As more and more scientific research demonstrated that CBD had a variety of therapeutic effects, interest in the use of CBD in epilepsy grew.

The CNN program hosted by Dr. Sanjay Gupta in August 2013 portrayed the case of a little girl with horrible, life-threatening intractable epilepsy. According to Dr. Gupta, her condition was greatly improved by a CBD-rich preparation produced by a company in Colorado. Understandably, this program resulted in enormous interest in CBD from families of children with epilepsy. As desperate parents sought “high CBD” products wherever they could purchase them, a number of dispensaries and other opportunistic vendors began to sell these products. However, the labelled potency and composition are often inaccurate and uneven, depending on the marijuana strain from which they come, the methods of manufacture used to prepare them, and the quality of the testing facility/procedures. At many places in the cultivation and manufacturing process, lack of standardization can result in higher levels of THC and lower levels of CBD –as well as the varying levels of dangerous microbes or pesticides -in the final preparation, e.g. growing from seed rather than clones; differences in the cultivation, harvesting, and drying conditions; uneven decarboxylation; and use of toxic extraction chemicals, such as butane or non-pharmaceutical ethanol.

Should the law be changed to allow high CBD, low THC products? 

 A state considering such a change in law should look to the example of other states where “high-CBD” products are legal for medical use, such as California.

In California, various preparations are available, and children can readily be given these products with 1) parental consent and 2) a physician’s recommendation.

Nevertheless, for the reasons stated above, the “legality” of these products has not made properly tested and standardized CBD products available to parents.

Products vary in consistency; testing laboratories do not provide reproducible and reliable results; testing each batch is expensive; most testing CBD laboratories do not test for pesticides or microbes; parents do not know how to prepare extracts from plant materials; the products themselves can be expensive; no dosing information is available; and more. Legislation is a blunt instrument, and any change in state law will, necessarily, be quite broad (e.g. “high CBD, low THC”) to permit various opportunistic growers and vendors to enter the state and prey upon vulnerable parents. Unless an elaborate testing system is established and enforced by the state, this will not ensure the safe, tested, and standardized products that parents seek for their children. Even certain more popular products are of uncertain composition, quality and efficacy. Companies selling these products have not made public the composition/ratio of an adequate number of batches, nor have they provided full battery anonymized case studies showing how many patients benefit and to what extent, how many patients get little or no benefit, what side effects they experience, and what they charge for the product. At most, 11 “selected” case studies have been presented, all of which show

However, these are anecdotal cases reported by parents, and it is unlikely that current CBD preparations work for all seizure conditions.

Source:  www.learnaboutsam.org  2013

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