Major new essay by D. Hoye entitled "Cannabinoid M
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http://iequitycancerfoundation.org/index.php/...omed?id=88
INTRODUCTION:
Cannabinoid Medicine – A New Era in Biomed?” is an article skillfully written by our own chief scientist, Dave Hoye. This article encompasses all the background information pertaining to medical marijuana, specifics dealing with SK3, what Berkeley Bio is trying to accomplish, and what the movement is all about. Maryann gives a whole new outtake on the views of marijuana and how this natural plant is making a huge positive impact on the medical field and what that holds for the future in medical advancements.
Cannabinoid Medicine – A New Era in Biomed?
Could it possibly be that the claims we are hearing about medical marijuana have basis in fact, and molecules found in the Cannabis Sativa plant have a future in medicine? Recent developments in the study of marijuana as a medicine have yielded some fascinating results, some of which are now being developed by several different research-oriented firms specializing in the development of marijuana-based medicines.
The history of marijuana in medicine goes back thousands of years, when various forms of the hemp/cannabis plant were a major part of the herbal pharmacopeia of many different cultures around the world. Around the turn of the 20th century modern medicine, based usually upon single-element medicines that can be extracted or synthesized in a laboratory, began to edge hemp out of the picture, causing it to be looked at by most as an antique remedy from the era of patent medicines.
In the early part of the twentieth century, an ambitious director of the Federal Bureau of Narcotics named Harry J. Anslinger, found a way to bring great attention to himself, and create lifetime job security, by demonizing the marijuana plant as “the Assassin of Youth.” Marijuana for any purpose was soon seen by society in the same light as heroin.
For many decades, marijuana was not a part of the national picture, its use confined to minorities, jazz musicians, and a few brave explorers of the forbidden. But in the 1960s, with the advent of the civil rights movement and the Viet Nam war, pot suddenly reared its head on college campuses, seemingly directly linked to the anti-war and social justice movements.
Now the users were disaffected middle-class kids, sent off to college by their parents. Instead of following the pre-planned mold of chasing the “American dream,” as it was portrayed in the 50s and early 60s, these upstart young people were protesting against the inequalities of the government, and not happily marching off to war, as everyone did in the previous generation, probably because the perceived threat of the domino theory causing the communisation of SE Asia was not seen as nearly the threat of the Axis powers in WWII.
Marijuana was declared public enemy number one, and the government launched a five-decade war against any and all aspects of marijuana. So feared was the kind herb that Richard Nixon is said to have directly declared that if you smoke pot once, you will become a Communist.
The so-called War on Drugs included every different method the government could come up with to stop the use of cannabis. One of the things they did was commission a study at the University of Virginia Medical College, which they hoped would prove that marijuana causes cancer. This was in 1975 and the very complete study was carried out by a team led by A. E. Munson. They did a number of good experiments in laboratory equipment, as well as on live animals, and came up with some very fascinating results.
Munson’s results were incredible. Cannabinoids increased life span in cancer-infected rats by 36%, inhibited leukemia cell growth 71%, and showed a dose-dependent inhibition of lung cancer cell growth, ranging from 20% to 80%.
Many people would think that results such as this would cause the government to dedicate some serious resources into funding further research. Not so. Munson’s work was hushed up, the funding withdrawn, and no future studies of cannabis were commissioned by the government for several decades.
In 2000, a group at the University of Madrid led by Dr. Manuel Guzman decided to see if there was any basis in Munson’s findings and took his research several steps down the road over the next few years.
Dr. Guzman’s team established the following:
Cannabinoids, the active components of marijuana and hemp, inhibited tumor growth in laboratory animals by modulating key cell-signaling pathways, thus causing direct growth arrest and death of tumor cells. Additionally, the study also found that cannabinoids inhibited angiogenesis and that cannabinoids were usually well tolerated and did not produce the generalized toxic effects of conventional chemotherapies.
In about 1990, researchers discovered the presence of cannabinoid receptors in humans. For a short time, some people were quite fascinated that the human body had developed a receptor for a plant chemical. It was soon discovered that the human body produced it’s own natural cannabinoids, which the researchers who discovered it named Anandamide (“Ananda” being a Sanskrit term for “bliss.”)
Further research showed that the newly-discovered endo-cannabinoid system acted as a controlling mechanism for many other internal systems, such as the immune system, and a well-functioning endo-cannabinoid system contributed greatly to overall health.
The first product to come out as a result of the discovery of the endo-cannabinoid system was a diet drug named rimonabant. It was a cannabinoid receptor antagonist that, in effect, turned off the endo-cannabinoid system. The science here was based on the appetite-increasing phenomenon known as the “munchies” that resulted from marijuana smoking.
The science here was right on. Rimonabant was indeed an effective diet pill, nearly eliminating the appetite altogether. It was released in several countries in South America and Europe. It was soon withdrawn from the market, however, as negative side-effects became obvious, and as further research showed that a healthy and functioning endo-cannabinoid system was indeed an asset, and a non-working endo-cannabinoid system was a recipe for disaster.
Interestingly, the way that the concept of medical marijuana first surfaced was a blatant example of the value of stimulating a compromised endo-cannabinoid system with marijuana. In the early 1990s, the AIDS epidemic was devastating the gay population of San Francisco. The final stop for many patients was the advanced AIDS ward in San Francisco General Hospital. When a patient took a bed, the doctors knew that it would be available again in four months or so--just like clockwork.
Suddenly there was a logjam. People quit dying and many of the emaciated, nearly dead began putting on weight. The doctors were amazed because they hadn’t been doing anything different. Then they realized that a kindly old lady from Marin County named Brownie Mary Rathbun had been sneaking strong marijuana brownies to the patients on her weekly visits.
The doctors embraced the idea because they had made zero progress against the epidemic up until this time with traditional medicine, and anything offering a ray of hope was to be pursued. Word soon got out in the gay community and the doctors talked to the city fathers, and a city law was passed saying that pot was okay for patients in the city if they had a recommendation from a doctor to use the herb.
Enter Dennis Peron. Dennis told the Supervisors that he would sell cannabis to patients with doctor’s recommendations, if they would give him the okay to do so.
They did, and he did, and the first Cannabis Buyers Club was opened in San Francisco.
Along with Dennis and Brownie Mary, the third hero of the early medical cannabis movement soon emerged. This was San Francisco District Attorney Terence Hallinan, who embraced the help that cannabis was giving to those in need, and allowed Dennis, and several subsequent clubs, to flourish.
Dennis was raided twice by the State of California. Conservative Attorney General Dan Lungren did not see eye-to-eye with Dennis on the benefits of the herb in the treatment of AIDS.
Lungren was politically ambitious and was running for governor. Dennis implemented a campaign for governor also, running against Lungren on the Republican ticket. With the two of them running for the same office, it was hard for Lungren to bust Dennis, and he did not do so during the campaign.
This gave Dennis the opportunity to put Proposition 215 on the ballot, which legalized medical marijuana in California in 1996. Dennis won 3% of the vote, Lungren a bit more, but neither was elected governor.
The entire situation surrounding medicinal research into the cannabinoids is quite unique, having created a climate for research that is different from any other that has ever existed before. While the federal government says that they provide for research into cannabis as medicine, the funds and approval have ranged from non-existent to very spotty at best. Numerous teams of qualified researchers have applied for permission to do quality studies, some of them applying over and over for many years.
Almost all funding for cannabis research has been directed through the National Institute of Drug Abuse, and they are up front in explaining that the focus of their research is directed towards proving the harmfulness of marijuana. The very few studies that they have funded have shown tremendous potential for cannabinoid medicines, especially in the treatment of cancer. The most recent was a study done by Harvard in 2007 that showed that the doses chosen for the experiment cut cancerous tumor growth by 50% in just three weeks of treatment.
Many of the mechanisms that cannabinoids use in fighting cancer are dose-dependent. The LD-50 (lethal dose) of cannabis is thousands of times the effective dose. Almost all of the research on laboratory animals used dosages that approximated those associated with human recreational use of marijuana. In comparison to the dosages used in traditional cancer drugs, where the effective dose is often a sizeable percentage of the lethal dose, cannabis research has been done utilizing a tiny percentage of the dosage possible.
One of the first revelations that larger doses of cannabinoids likely have a place in this new medicine came from the pioneering efforts of a Nova Scotia farmer named Rick Simpson in about 2007. Mr. Simpson is responsible for a great deal of the awareness of cannabis as an effective treatment for cancer, thanks to his unselfish efforts as an activist, spreading the word through his internet video “Run from the Cure,” which has been viewed by thousands and is responsible for a huge number of anecdotal reports that his method has cured many forms of cancer (and other diseases and conditions) in a myriad of individuals.
Mr. Simpson developed his methods after coming down with cancer himself. He studied the literature available at the time, notably the works of Munson and Guzman, and realized that there was a possibility that marijuana was directly able to kill cancer. Simpson tried a treatment designed to get the most cannabinoids possible into his system, and keep his system saturated with cannabinoids for several months. He acquired a pound of high-quality marijuana flowers from a local underground pot grower, soaked the flowers in a solvent to dissolve the essential oils, filtered out the vegetable matter, then evaporated the solvent to yield a potent green oil containing about 50% cannabinoids.
Simpson self-administered the oil by rubbing a gram on his gums each day. This is the equivalent of smoking up to 100 marijuana cigarettes daily and is a very strong “psychedelic” experience. By the time Simpson had consumed the oil made from the entire pound of marijuana buds, his cancer was gone.
Simpson then treated numerous individuals in his town who had cancer, with similar results. He then posted his YouTube video on the internet, resulting in countless others following his therapy suggestions, with a plethora of cures claimed by those who successfully witnessed cannabinoid medicine eliminate their cancer.
As expected, cannabis activists around the world seized on the results that the Simpson therapy demonstrated, and treating cancer with so-called “Simpson Oil” became a much-discussed, and practiced, event in the world of cannabis.
The overwhelmingly positive anecdotal evidence came in at a rapid rate. High Times Magazine voted Simpson “Freedom Fighter of the Year.” When Simpson went to Amsterdam to collect his award, the government of Canada issued warrants for his arrest, forcing him into exile for a period of time.
The medical community finally began to take notice of this “underground” phenomenon. More and more researchers applied for government funding and the “official” government-grown marijuana that must be used for “legitimate” research, as well as the legal ability to even possess the research material while studying it. As has been the case for decades, the powers-that-be did everything they could to stifle the research that had been done and prevent anything more than a trickle of new research from happening.
One of the few studies allowed, performed at Harvard, showed that the doses used in the experiment cut tumor growth by 50%, and validated much of the previous research done by other universities. While many think that this should have been the event that triggered a huge research effort by the CDC and other medical research facilities around the country, it did not. In fact, it now seems even harder for researchers to obtain government permission to study cannabis as a treatment for cancer.
A case in point is the efforts of Dr. Donald Abrams of the University of California San Francisco to do clinical studies on cannabis oil in the treatment of cancer, to see if it can be proven that the Simpson treatment is as efficacious as all the anecdotal evidence suggests. Dr. Abrams has previously been granted permission to study cannabis medicine; his most recent work showed that a pain patient can obtain relief from half the normal dose of vicodin if the treatment is augmented with smoked marijuana.
Dr. Abrams recently closely followed an “unofficial” study on the treating of cancer with so-called Simpson oil, which brings into play a whole new twist on the development of cannabis medicine – a factor that is unique to this area of medicinal research. Nowhere else in the history of medical science has there been a drug or treatment that has developed under these circumstances. (Brings to mind the time when the AMA sanctioned doctors for declaring the benefits of washing the hands before performing surgery.)
One of the factors that made the development of cannabis medicine so different from the normal route is politics. Thanks to five decades of underground popularity, the cannabis movement has developed millions of loyal activists, who have worked very hard via the voter initiative process to see medicinal cannabis legal in 20 states. What has developed is a set of circumstances where the top university medical researchers in the nation are denied the right to do what they do best, and sincerely want to do, while any person with a doctor’s recommendation in a liberal medical state can possess reasonably large amounts of a myriad of different cannabis products and strains.
This unique situation has given rise to a number of “independent” research laboratories in states where medical marijuana has been legalized. These operations work under the auspices of the state marijuana laws and, in effect, ignore the federal Controlled Substances Act.
Interestingly, these independent laboratories have made tremendous strides forward in developing and understanding this medicine, when compared to those who have followed the federal guidelines for bringing a new medicine to market.
A case in point is Sativex, a mixture of THC and the non-psychoactive cannabinoid, CBD that is administered as an oral spray for treating pain from cancer. Sativex, made by GW Pharmaceuticals--a subsidiary of the multinational Japan-based corporation, is an approved pharmaceutical medicine in Canada and some European countries. It is currently undergoing clinical trials in the US. Approval as a prescription medicine is expected in the next few years.
Sativex entered the pharmaceutical review process necessary for approval many years ago. It still is not approved in the US. Use of cannabis as a palliative measure in treating cancer pain was gaining medical acceptance when Sativex first began the process; now a vast body of research shows that cannabinoid medicine may possess considerable direct anti-cancer and anti-tumor properties.
A small number of “independent” research laboratories and organizations have been exploring the use of cannabinoid medicine as a direct treatment for cancer for a number of years, operating under the auspices of state laws which permit medicinal cannabis. Along with doing pure research in the laboratory, the distribution framework created by the medical cannabis industry has allowed for a great deal of anecdotal evidence to be gathered.
As the anecdotal evidence built up in the medicinal cannabis community, top “legitimate” medical researchers in the field took notice. An example is a group of cannabis activists in Santa Cruz, California who have been supplying Simpson oil to cancer patients. In this convincing study on multiple types of cancer, 25 stage four patients were directed to the group by a San Francisco oncologist, who has chosen to remain anonymous. The treatments were observed and monitored by Dr. Abrams, who could not participate officially because the cannabis oil came from the world of medical marijuana instead of the official government marijuana farm in Mississippi.
Dr. Abrams was amazed to see that 24 of the 25 stage four cancer cases went into remission. Statistically, this is unheard of in the world of medicine. In actuality, it is common among those who have treated their cancer with cannabis according to Simpson’s instructions on the internet.
Dr. Abrams increased his efforts to obtain some official oil to do the placebo-controlled double-blind experiments. The scientist running the government marijuana farm says he has a vial of oil just sitting there waiting for the okay to send it to Dr. Abrams. Has it happened? No. Is it expected soon? Who knows?
In light of all the evidence, several small research laboratories have sprung up in cannabis-friendly states operating under the auspices of state laws. Unfettered by federal regulations since August 29, 2013 when the federal government announced they would respect state laws on these matters, these independent laboratories are working on all aspects of cannabis medicine, from pure research into the inner workings of the molecules to development of delivery systems which will allow medicinalization of the raw herb.
One such independent laboratory is Berkeley Bio-Organic Research Laboratories, LLC, located in the San Francisco Bay Area. Operated by two long-time advocates of cannabis science and cannabis medicine, Berkeley Bio’s main concentration is the medicinalization of cannabinoid therapy, especially for the treatment of cancer.
Founded by cannabis researcher and author D. Gold and later Charles Apel, Ph. D., an astro-biologist with NASA, SETI and Los Alamos with a distinguished history of discoveries in pure science, Berkeley Bio may well represent the crossroads of medical science and cannabis activism.
Berkeley Bio was first founded to create medicines for the Simpson treatment. It was funded by the Dharma Care and Hospice Program, a non-profit that has been supplying free cannabis medicine to terminal patients in California with a doctor’s recommendation for cannabis, but no funds to pay for the medicine at a dispensary.
Berkeley Bio was created with the intention of developing a non-psychoactive treatment for cancer that was equivalent to the gram of psychoactive oil daily recommended in Simpson therapy. Having treated a large number of patients over the last few years with the Simpson oil through the Dharma Care and Hospice Program, the crew at Berkeley Bio noted two very important events.
First, the Simpson oil seems to be a very effective therapy against many forms of cancer. Many “spontaneous” remissions of various stages of cancer were witnessed in those who tried the therapy, and this gave those seeing the results substantial hope.
But the therapy had a dark side of sorts. The extreme psycho-activity of 100 or so joints of marijuana every day became intolerable to some of those trying the treatment. Contemplating the possible end of one’s life in such an emotional state can be very difficult. Several patients ceased the Simpson treatment because of the side effects, and they died.
Earlier this year, Berkeley Bio was acquired by SK3 Group. This move provided the funding and resources that Berkeley Bio needed to successfully complete its current work, medicinalization of the phytocannabinoids into a powerful cannabinoid medicine, without the overwhelming psychoactive side effects of THC.
THC is the psychoactive cannabinoid found in marijuana. The higher the levels of THC, the stronger and more intense the high. But THC is only one of the 80 or so different related molecules that are called cannabinoids. CBD is a “chemical cousin” to THC, and exhibits many of the same anti-tumor and anti-cancer properties. CBD is non-psychoactive; a patient can take large doses with minimal side effects.
There has been a great deal of research done on CBD because researchers believed that funding and approval would be easier with CBD than the psychoactive THC. Numerous laboratory experiments have shown that CBD is likely as effective as THC in many but not all cases.
CBD is an important part of Dharmanol™ a new natural medicine recently developed by Berkeley Bio. Along with CBD, Dharmanol™ contains a wide array of natural cannabinoids that have been extracted from hemp/cannabis and preserved in their non-psychoactive form utilizing a proprietary technology developed by Gold and Apel.
The use of cannabinoids in their non-psychoactive “carboxylate” form was pioneered by Dr. William Courtney of Willits, California. Along with being an MD with a thriving practice, Dr. Courtney is the founder of the Cannabis International Foundation.
For a number of years, Dr. Courtney has been treating patients with huge doses of cannabis juice. He has seen outstanding results that he has described on several YouTube videos.
The drawback to Dr. Courtney’s therapy is that it requires the patient to maintain 40 to 80 live growing marijuana plants in order to have a daily dose of juice. While perhaps not as effective as the fresh, green, living, juice that is consumed with Dr. Courtney’s method, the carboxylates present in Dharmanol™ go a long way towards providing the same benefits without the extreme difficulty of maintaining live marijuana plants.
Along with the CBD and mixed cannabinoid carboxylates, the third component of Dharmanol™ is a steam-distilled extract of a variety of strains of cannabis. This preparation contains the terpenes and terpenoids found in marijuana, many of which have been shown to have substantial medicinal value in themselves, as well as potentiating the activity of some of the cannabinoids.
Berkeley Bio developed Dharmanol™ to contain as much of the wide spectrum of medicinally active elements of the plant as possible. This is known in the world of medicinal cannabis as “whole plant” therapy, and most perceive a wide array of the cannabis medicinals to be far more effective than single isolated elements of the cannabis plant, whether extracted or synthesized.
The Dharma Care and Hospice Program has been supplying patients with a whole-plant preparation in capsule form for many years. Formulated to contain as many elements of the raw plant as possible, many patients in California have found that whole-plant therapy is superior to any purified and isolated compounds. Dharmanol™ has been designed to provide the widest spectrum of beneficial compounds of the cannabis plant, in their non-psychoactive form, just as the aforementioned capsules provided the widest healing array possible, but included the psychoactive THC.
Dharmanol™ has been designed to treat any of the myriad of conditions for which physicians are now recommending that patients try cannabinoid medicine. Modern research tells us that this includes treatments for a great number of different conditions.
The main focus of Berkeley Bio has been the development of medicines for the prevention and treatment of cancer. Dharmanol™, in both low-dose and high-dose forms, may prove to be an effective medicine in both prevention and treatment.
Low-dose tablets contain 5mg. CBD, 5 mg. mixed cannabinoid carboxylates, and 5 mg. of steam-distilled terpenes and terpenoids. A daily supplement such as this will gently stimulate the endo-cannabinoid system, which regulates and enhances many of the body’s own health-promoting processes, such as the immune system. These are the systems that keep cancer and other opportunistic diseases in check in otherwise-healthy individuals.
High-dose Dharmanol™ therapy is designed to provide the same effects as Simpson oil therapy without the psychoactive side effects. While neither Dr. Courtney’s juicing therapy, or treatment with non-psychoactive CBD has had near the amount of “anecdotal” study as Simpson’s therapy with standard cannabis oil, the scientific studies on CBD, and the anecdotal evidence of the numerous patients treated with Dr. Courtney’s carboxylates, indicates that high-dose Dharmanol™ therapy should be every bit as effective as Simpson oil, but without the physical, mental, and emotional side effects.
Two additional benefits are present with Dharmanol™ that are not to be found with standard Simpson therapy. The removal of the psychoactivity allows patients who cannot tolerate Simpson oil to treat their conditions with adequate amounts of cannabinoids, and the removal of the psychoactivity allows patients to tolerate much larger doses.
The capacity to increase the dosage by removing the psychoactivity holds much promise. The “standard” Simpson dose is well under one one-thousandth of the dose of cannabinoids said to be capable of causing physical harm to the organism. The reason that one gram is the dose recommended by Simpson is that few people could possibly tolerate more than this.
With the amazing anecdotal results surrounding Simpson oil, combined with the fact that many of cannabis’ mechanisms are dose-dependent, it stands to reason that increasing the daily dose of cannabinoids ten, or perhaps one hundred times, could provide a medicine that no cancer could possibly stand up against. Hopefully, clinical trials of Dharmanol™ will show whether this is so.
David Hoye is the Research Director, Berkeley Bio-Organic Research Laboratories. He works in conjunction with Dr. Charles Apel, who is Chief Science Officer.