Don't Get High….. Get Well

Posts Tagged ‘allan frankel’

Please see my recent blog regarding the US patent in 2003 by the Federal government for CBD. In addition, the patent boldly also states the many benefits of CBD and other cannabinoids.

The application was applied for April 21, 1999 and was finalizing in 2003. The findings were published in Drugs R D. 2003;4(5):306-309 which is almost 10 years ago and I have wondered why this happened at that time. Well, this article, explains very clearly that GW was looking for and obtained support and I presume a lot of cash from Bayer Pharmaceuticals. Bayer was involved with GW before 2003 and the patent by the Feds in 2003 is no coincidence. Please read here, the abstract of GW Pharmaceuticals actions.

Here is the text of the abstract from the study:

Cannabis-Based Medicines – GW Pharmaceuticals: High CBD,
High THC, Medicinal Cannabis – GW Pharmaceuticals, THC:CBD

Drugs R D. 2003;4(5):306-309

ABSTRACT

GW Pharmaceuticals is undertaking a major research programme in the UK to develop and market distinct cannabis-based prescription medicines [THC:CBD, High THC, High CBD] in a range of medical conditions. The cannabis for this programme is grown in a secret location in the UK.It is expected that the product will be marketed in the US in late 2003. GW’s cannabis-based products include selected phytocannabinoids from cannabis plants, including D9 tetrahydrocannabinol (THC) and cannabidiol (CBD). The company is investigating their use in three delivery systems, including sublingual spray, sublingual tablet and inhaled (but not smoked) dosage forms. The technology is protected by patent applications. Four different formulations are currently being investigated, including High THC, THC:CBD (narrow ratio), THC:CBD (broad ratio) and High CBD. GW is also developing a specialist security technology that will be incorporated in all its drug delivery systems. This technology allows for the recording and remote monitoring of patient usage to prevent any potential abuse of its cannabis-based medicines.GW plans to enter into agreements with other companies following phase III development, to secure the best commercialisation terms for its cannabis-based medicines. In June 2003, GW announced that exclusive commercialisation rights for the drug in the UK had been licensed to Bayer AG. The drug will be marketed under the Sativex((R)) brand name. This agreement also provides Bayer with an option to expand their license to include the European Union and certain world markets.GW was granted a clinical trial exemption certificate by the Medicines Control Agency to conduct clinical studies with cannabis-based medicines in the UK. The exemption includes investigations in the relief of pain of neurological origin and defects of neurological function in the following indications: multiple sclerosis (MS), spinal cord injury, peripheral nerve injury, central nervous system damage, neuroinvasive cancer, dystonias, cerebral vascular accident and spina bifida, as well as for the relief of pain and inflammation in rheumatoid arthritis and also pain relief in brachial plexus injury. The UK Government stated that it would be willing to amend the Misuse of Drugs Act 1971 to permit the introduction of a cannabis-based medicine.GW stated in its 2002 Annual Report that it was currently conducting five phase III trials of its cannabis derivatives, including a double-blind, placebo-controlled trial with a sublingual spray containing High THC in more than 100 patients with cancer pain in the UK. Also included is a phase III trial of THC:CBD (narrow ratio) being conducted in patients with severe pain due to brachial plexus injury, as are two more phase III trials of THC:CBD (narrow ratio) targeting spasticity and bladder dysfunction in multiple sclerosis patients. Another phase III trial of THC:CBD (narrow ratio) in patients with spinal cord injury is also being conducted. Results from the trials are expected during 2003.Three additional trials are also in the early stages of planning. These trials include a phase I trial of THC:CBD (broad ratio) in patients with inflammatory bowel disease, a phase I trial of High CBD in patients with psychotic disorders such as schizophrenia, and a preclinical trial of High CBD in various CNS disorders (including epilepsy, stroke and head injury).GW Pharmaceuticals submitted an application for approval of cannabis-based medicines to UK regulatory authorities in March 2003. Originally GW hoped to market cannabis-based prescription medicines by 2004, but is now planning for a launch in the UK towards the end of 2003.Several trials for GW’s cannabis derivatives have also been completed, including four randomised, double-blind, placebo-controlled phase III clinical trials conducted in the UK. The trials were initiated by GW in April 2002, to investigate the use of a sublingual spray containing THC:CBD (narrow ratio) in the following medical conditions: pain in spinal cord injury, pain and sleep in MS and spinal cord injury, neurop spinal cord injury, neuropathic pain in MS and general neuropathic pain (presented as allodynia). Results from these trials show that THC:CBD (narrow ratio) caused statistically significant reductions in neuropathic pain in patients with MS and other conditions. In addition, improvements in other MS symptoms were observed as well.Phase II studies of THC:CBD (narrow ratio) have also been completed in patients with MS, spinal cord injury, neuropathic pain and a small number of patients with peripheral neuropathy secondary to diabetes mellitus or AIDS. A phase II trial of THC:CBD (broad ratio) has also been completed in a small number of patients with rheumatoid arthritis, as has a trial of High CBD in patients with neurogenic symptoms. A phase II trial has also been evaluated with High THC in small numbers of patients for the treatment of perioperative pain. The phase II trials provided positive results and confirmed an excellent safety profile for cannabis-based medicines.GW Pharmaceuticals received an IND approval to commence phase II clinical trials in Canada in patients with chronic pain, multiple sclerosis and spinal cord injury in 2002.Following meetings with the US FDA, Drug Enforcement Agency (DEA), the Office for National Drug Control Policy, and National Institute for Drug Abuse, GW was granted an import license from the DEA and has imported its first cannabis extracts into the US. Preclinical research with these extracts in the US is ongoing.

I have had two patients recently with breast cancer who were on Tamoxifen, an estrogen inhibitor. A fairly common side effect of Tamoxifen is joint pains. For many of these women, it presents as an arthritic condition affecting both large and small joints.

When these two women started using as little as 1 mg BID of CBD, their pains were significantly improved. One of them restarted exercising within a day.

I will be following these women and am communicating with their oncologists and will post more on this topic as more experience is gathered.

Below is a photo of an LA based Super Critical CO2 extraction setup. Most folks are familiar with extraction of cannabis into butter/oils for edibles, or alcohol/glycerin for tinctures. Well, with regard to tinctures, in the State of California, the only truly legal way to make tinctures is utilizing Super Critical CO2 extraction. This is basically a process where the plant material is extracted using liquid CO2. The extra plant material is removed and a pretty think white/yellow “goo” is what is left. From a pound of trim, one is left with approximately 1 oz of this very concentrated goo with which to make tinctures.

We recently saw a “goo” where there was just over 26% CBD. These people should come up with a pretty good rich CBD tincture. Although much more complex, using CO2, there is a much better cannabinoid extration.

So, here it is:

I generally never edit older posts, but have found that is is important to add some comments with regard to significant changes in the Cannabis Medicine Tincture’s available, at least in the Los Angeles area. The cost of professionally made CBD Rich tinctures for anxiety, manifestations of anxiety, pain, particularly neuritic and many other conditions, CBD based or “Cannabidiol” based tinctures and capsules are the future and have in fact become the present. As using CO2 extraction is not for patients at home – yet – I suggest you check out some of these tinctures at some local collectives.

As the CO2 extraction process is nearly 100% efficient, the cost ends up being not much different than making it yourself. Also, unless you find some rich CBD or flowers, it will just be a THC extraction, which is good, but just not great. It is well worth checking into if you are dealing with anxiety or pain. For Multiple Sclerosis and many degenerative neurological disorders, CBD is truly a miracle.

For the cost of a movie, popcorn and a drink you can now give it a go. I really think it is well worth few bucks and trip.

At the same time, I do want to make available to as many patients possible methods to create their own very high quality tincture, as independence from any legal restrictions may at some times, interfere with availability. To that end, have fun and don’t burn the stuff. Also, consider dropping by a couple of cc’s for testing. I can help get your sample tested for THC/CBD and the efficiency of decarboxylation for $50. I wish it were free, but this is a very fair price and we will all learn much.

Ingredients:
1 oz shake – select either sativa or indica
8 oz vegetable glycerin

Steps

1. Grind shake in coffee grinder
2. Mix ground shake into the glycerin. If overly thick, add water as necessary. They will easily mix.
3. Place into oven at 200 degress for 45 min DON’T GO ANY HIGHER TEMP THAN THIS
4. Take out of oven and let sit and cool for one hour
5. Place into crock pot and set on “keep warm”. MAKE SURE YOUR CROCK HAS A KEEP WARM SETTING.
6. “Keep warm” for 12 hours
7. Remove and strain thru cheese cloth as many times as needed (usually around 3 strainings)
8. DON’T BURN YOUR MOUTH. MAKE SURE IT IS COOL BEFORE BOTTLING into spray or dropper bottles
9. Generally 1/2 dropper bottle or 3 spritzes are adequate.
10. If too strong, dilute with water.

Consider two facts:

1. The city of LA is broke

2. The city of LA is not always on the best terms with the Medical Cannabis Community regarding “standards”

So, how about if we setup a committee to consider the following:

Standards for the dispensing of Medical Cannabis are jointly (pun intended) determined in a non “partisan” manner. To help ensure this, a city cannabis tax might be introduced within the dispensary system. A portion of this money would be to create standards which might become national standards. The balance and the lion’s share would go directly to the city of LA.

Thoughts?

As a physician practicing both internal medicine and cannabis medicine, I was particularly pleased to hear recent statements from the White House as well as our State Legislators widening the Cannabis playing field.

However, before we all begin to applaud too loudly, I would like to see this in some formal written statement. That statement must include two key points:
1. The States can run their own Medical Cannabis programs without any Federal interference.

2. Physicians should be able to run their own clinical trials on cannabis and begin answering many of the pro and con issues with the medication.

I suspect and feel comfortable that allowing physicians and scientists to finally legally study this amazing group of medications will lead to various therapies we only currently dream about.

Peanut Butter   9 and counting

Marijuana           0

Please refer back to my recent post on “Open Source Cannabis” for background on this concept.

One of the most challenging issues facing cannabis research is where to begin to understand how or even which chemicals in cannabis cause an effect on symptoms. Unfortunately, at least at this point in time, medical cannabis for clinical trials is just not available. I can only hope this will change, but in the meantime, I believe we can get started with an intermediate survey type study – Open Source Cannabis.

The idea is to create a database of information that crosses patient testimonials on how strains treat their symptoms with the chemical breakdown of that strain from a Gas Chromatography machine.  Regrettably, it takes weeks to get the results from a Gas Chromatography machine.  During this time, the strain usually is distributed from the dispensary resulting in patients being unable to use the GC analysis information. Perhaps in the future, the market will require all growers to perform their own analysis on their strains or send them in for analysis, but as with research into this subject, that will not soon happen.

So, as to a solution for the time delay, what if when any strain is delivered to the dispensary, it is assigned a random ID by a database program. With this database, the dispensaries can logon to the system and get the ID for the strain and send it off for GC analysis.

When patients find a particular strain that really works very well for them, they logon to the database and enter basic symptom questions as well as the strain ID that would be stamped on the label.

Over time, as the GC results come back, they are tied back to the strain IDs.

This will enable two things:

1.As individuals have entered data on strains that work very well for them, they can see what combination of Cannabinoids and Terpenoids work best for them. Over time, they would select their medications based upon this information and not just a name such as “bubble gum kush” – which can mean anything.
2.The patient community data should yield interesting results as well. As patients give feedback on strains analyzed by a GC, I suspect we will begin to see some trends of cannabinoid and terpenoid benefits that we cannot even currently imagine.

I would really appreciate feedback on this one.

I don’t know how I missed this letter from Congress to the DEA. I generally don’t cross the “political” boundaries as a physician, but I really thought this would put a smile on your face. As you will find in the article below, Congress has sent a very tough letter to the DEA. Congress is waiting for a response from the DEA, but will be holding hearings regardless. It seems that our Congress is not very pleased with how the DEA has been handling itself in California.

I am very hopeful.

http://www.greenbridgemed.com/wp-content/uploads/2009/01/Conyers_DEA_Letter-1.pdf

Although not the first such study, researchers in Milano, Italy, recently presented a study on whole plant extracts of Cannabis formulations to treat neuropathic pain. If you’d like to read the study, please see the reference at the end of this blog.

After reading the results, researchers learned that extracting a single active ingredient from cannabis does not produce the ends desired. This is one more well designed, although “rat-based”, study encouraging us to realize that including all genetic variations of the whole plant in medications will probably produce better and safer drugs than extracting one cannabinoid at a time.

Researchers might not be achieving the effects they desire, but this might be the result of ignorance in the knowledge of manipulating cannabinoids, or it might be that the whole plant is in fact “the medicine”.  Certainly the ratio of the various cannabinoids in different strains will greatly vary, but at the very least we can say that overall, cannabis is an extremely safe medication.

http://www.ncbi.nlm.nih.gov/pubmed/18618522

I recently saw a 70 y/o male as a new patient. He appeared in all ways to be a street person and seemed a bit out of place. However there was something in his eyes that got my attention. His body seemed much older than his stated age, but his eyes reflected something still very much alive and I escorted him to my exam room.

He was arrested 33 years ago in the State of Georgia for possession of 1 gram of marijuana. He showed me his prison admission form as well as discharge papers. He spent 32 years in prison and was beatup on so many occasions that he had become crippled. We discussed his options with medical cannabis and he left.

He returned last week just to say thanks and show me how much better he was feeling. He didn’t say that this new freedom made up for his lost 32 years, but he did say it took a bit of the sting out of it.

I am pleased to hear that, at least in California, non-violent criminals are going to be released in larger number for financial incentives. Whatever the reason, I am grateful. Often very good things happen for the wrong reasons, but this is an acceptable compromise. :)

Most patients are reluctant to be open regarding how much and how often they use Cannabis. I always encourage my patients to be as honest as possible, as this is the best starting point in any doctor-patient visit.

Further more, if we are discussing treatment for anxiety, depression or ADD……..we are talking about Sativa strains during the daytime hours. In my opinion, the most significant issue with daytime medicating is related to the smoking. If patients are using sativa tinctures, which are ideal for daytime mood disorders, they are no different than any other patient using xanax, valium or vicodan out of a pill bottle during the day.

The smoking and smell during the daytime are generally just not acceptable. I encourage everyone to learn more about the daytime use of sativa tinctures/concentrates. They just seem so much more like “real medicines”.

A recent interest of mine has been to research ingestion methods of cannabis.  In reviewing a few articles regarding the various means we all use at times to medicate, the following list results: to smoke in one form or another, vaporize, eat edibles or tinctures.

Since edibles and tinctures are generally not inhaled and have no tar issues, I will place them aside for this blog’s discussion.

What I found most interesting, however, is that BONGS actually absorb substantial amounts of THC – up to 30%, (!), while allowing tar products through.  In other words, water is NOT a good filtration system for smoking Cannabis.

Joints, surprisingly, were better than any other smoking methods – other than vaporizing. Even placing a true “filter” on a joint, has similar effects to water. So, other than vaporizing, a loose joint without any filter, is next best.

Perhaps it is time to “sell short” on bongs??

More to come on Tinctures next week.

My Director of Education, Michele Nelson, answers this question:

Prior to 1937, cannabis and hemp in America was used as medicine and material for various industrial needs. One of the plant’s greatest industrial benefits to early American’s was that it did not rot in seawater, therefore enabling sails and rigging. This made hemp essential to the new American country – without it; America could not have a navy.  John Adams felt hemp was so vital to the creation of the new country that it was one of the first items on his to do list when riding to the Continental Congress.  He wrote, “Encourage the cultivation of hemp.” Every farmer was required to dedicate a portion of his or her farm to hemp production. As a medicine, cannabis was used from children’s pain remedies to relieving adult’s depression, anxiety, and pain. During the mid-1800’s, there were over 600 tinctures of cannabis available on the market from pharmaceutical companies well known today – Pfizer and Merck for example.

However, in the 1930’s two things happened that made hemp/cannabis illegal. One, a machine was invented that processed the hemp/cannabis without using the heavy manual labor needed in the past. Some called it a “hemp gin” like the cotton gin. Suddenly, hemp was not such an expensive fiber. At the time, Popular Mechanics magazine ran an article calling hemp “America’s billion dollar crop”. Industrialists began experimenting with hemp and discovered that it could be used to create plastics, was an excellent bio-fuel and was a strong fiber for paper.

At the same time hemp was being touted as a new raw material, the petrol chemical industry was emerging. The Dupont’s were at the center of this industry, discovering other uses for petroleum such as plastics and nylon. Also during this time, William Randolph Hearst the newspaper tycoon, needed to secure paper for his news empire, so he invested in forests for paper. Because hemp could replace both petrol chemicals and trees to make products cheaper, easier, (and it’s a renewable resource that many could profit from producing) these two families joined forces with former Alcohol Prohibitionist, Harry Anslinger to create and pass the Marijuana Tax Stamp Act in Congress.

Many consider the Marijuana Tax Stamp Act as “industrial espionage”.   At the time, marijuana was not a recognized name for hemp or cannabis and so the act was passed without the medical or farm community’s awareness. The tax stamp act gave the US government control over what farmers could plant and destroyed the cannabis pharmaceutical business. If farmers didn’t apply and receive a tax stamp, they were subject to fines and possible imprisonment for growing the plant. Cannabis/hemp production plummeted. Doctors begged Congress to allow cannabis to be used as a medicine, but they failed to overturn or even modify the Marijuana Tax Stamp Act.

Marijuana prohibition started because two families needed to have a monopoly on business. However, in today’s economic and environmental climate the prohibition that resulted from that decision might not be viable any longer.  Cannabis and hemp might be needed soon.

Michele Nelson, GreenBridge Director of Education

There has been some international uproar of late regarding the closure of some “coffee shops” in Amsterdam as well as the closure by local authorities of dispensaries allowing communal “medicating”.

Don’t get me wrong. I like the idea and freedom of being able to smoke in private clubs with a group of like-minded individuals. Perhaps in the future this will be the direction to head; however, it would have to be at a time when the political climate accepts the use of Cannabis for purely recreational reasons. Under today’s laws, using Cannabis for recreational reasons is clearly illegal, if only a misdemeanor in some states.

My problem with cafes, at least in the US, is that we are struggling to simply get Medical Cannabis accepted legally at regional levels as well as hopefully ultimately nationally. As a physician, I just can’t see the medical benefit of medicating as a group in a public setting. Until a lot more education and enlightenment occurs, It is just too hard to justify in the current setting and as far as I can see, for some time to come.

Alcohol is very different, and as far as I know, it is the only drug we use socially in public groups that are legal. At the same time, I just don’t know many – if any – physicians, including myself, who would be drawn into “prescribing” alcohol for a patient. Even in the waning years of alcohol prohibition nobody was pushing for Medical Alcohol!

So, I would prefer to keep Cannabis in the medical arena and out of the café world. Many of us need this medication for help with serious issues. Let’s all please be careful not to become insensitive to the big picture.